Protecting Our Troops So They Can Protect Us...

  Mission:
Protecting Our Guardians is a non profit 501(c)(4) organization dedicated to protecting military members from the hazardous Anthrax vaccine and Anthrax Vaccine Immunization Program (AVIP) and supporting safe alternatives.

About Us:
POG is a military family advocacy group composed of doctors, nurses, veterans, military families and concerned citizens across the country.

Contact:
Protecting.Our.Guardians@gmail.com
POG delegates to Congressional leaders standing in front of Union Station.
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Anthrax Bacteria

Excerpts from the Mayo Clinic staff:

Overview

"Anthrax is a disease caused by the bacterium Bacillus anthracis, which is housed in a hardy spore, a cell that is dormant but may come to life in the right conditions. The disease usually affects livestock, but - as the world has become fully aware - it also infects humans. A naturally occurring disease known since biblical times, anthrax has been developed into a modern biological weapon."

"All three forms of anthrax can be prevented or treated with antibiotics."

Signs and symptoms

"Inhaled anthrax spores (upper-right inset) can settle in the tiny air sacs (alveoli) of the lung (upper-left inset). Once inside the lungs, the spores transform into bacteria (lower-right inset), which spread to the lymph nodes, bloodstream and elsewhere in the body. The bacteria multiply and eventually produce toxins that cause severe damage to the lungs and other tissues."

Anthrax Causes

"From 1955 to 1999, 236 cases of anthrax in humans were reported in the United States. Most involved cutaneous anthrax, and most occurred in people who work with animal carcasses or products."

"To date, the worst documented outbreak of inhalation anthrax in humans occurred in Russia in 1979. Anthrax spores were accidentally released from a military biological weapons facility near the town of Sverdlovsk, killing at least 66 people."

"Experts say that biological agents such as anthrax are more of a threat to individuals, who can be infected by anthrax sent through the mail, rather than a threat against large groups."

 

  Links to other pertinent websites:

An objective overview of anthrax bacteria and the anthrax vaccine, http://www.aviationmedicine.com/anthrax.htm


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Soldiers' Synopses of Adverse Reactions

1. Here is Sgt. Eric Colon's story, a medic in Iraq, from the Operation Truth website:

http://www.iava.org/index.php?option=content&task=view&id=102&Itemid=119

A Medic Talks about the Anthrax Vaccine (Eric Colon) - 11/4/04 | Print |  Email
Sgt. Eric Colon served as a combat medic Iraq and Kuwait from December '02 to July '03. 

 
I recently began to personally have quite a few symptoms that I have sought assistance for at a local VA Clinic. I am an 'Iraqi Freedom' vet., who until recently had had no significant medical problems. While in Kuwait I received four shots of anthrax from a few batches - not sure which ones, but I think fav078.
 
As a medic I was in charge of administering these vaccines to trops arriving in theater. I was in Kuwait from Jan '03 till June '03. I administered many injections - probably in the thousands. I have begun this blog in order to try and create a resource for soldiers and sailors equally, to find answers to an illness that no VA doctor claims to be.

 
My symptoms are as follows; severe onset acute reaction 3 times since I returned (07/03), red bumps on my trunk and arms after exertion r heat, pain and numbness on the right said eof my face constantly, severe joint pain in my knees and pain in my neck, chronic fatigue.
 
To see Eric's blog and for more info on the Anthrax virus, click here !

 
Also, check out these other great links and inform yourself about the controversial vaccine:

 
(1) Click here for an archive of Congressional reports, testimony, FDA inspection reports &c., on the Anthrax vaccine.

 
(2) An article on the possible connection between antibodies and 'Gulf Illnesses'.

 
(3) The United States General Accounting Office's report to Jack Metcalf, House of Representatives, on Gulf War Illnesses.

 
(4) Dr. Robert Garry's testimony to the 'House Subcommittee on National Security, Veterans Affairs and International Relations' suggesting that there is a strong correlation between the Anthrax vaccine and Gulf War Illnesses.
 
Colon, 32 years old, is from Apopka, FL, and has been stationed at Camp Arifijan, Camp Doha, and Camp Specter in Tikrit. 


2.  The Homeland Security Policy Institute Group: Anthrax Vaccine has some interesting accounts on "blog" by soldiers of the harm the anthrax vaccine has done to them and/or their loved ones.  There are chats by veterans with Gary Matsumoto, author of Vaccine A, on here.  Go to http://www.hspig.org/MT/weblogs-hspig/archives/2004/11/anthrax_vaccine_1.html


3. Tulsa KOTV news broadcast

Ret. Captain Kelli Donley

Attorney's life comes to a halt after she received the Anthrax vaccine.

KOTV Interview


To save this video, right click this link and click Save File As.

Spc Kent Stewart finds himself sick from the vaccine.

To save this video, right click this link and click Save File As.



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4. Son dies, father is deported

Eric Boehlert, Salon.com, December 11, 2003

www.refusingtokill.net/USGulfWar2/USGulfWar2-SonDiesFatherDeported.htm

U.S. Army soldier Zeferino Colunga Jr. died four months ago from a mysterious illness he contracted while serving in Iraq and was buried with full honors in a Texas cemetery. Last week, with the family still in mourning, the soldier's father was deported to Mexico as an illegal immigrant. Now family members wonder if the deportation of Zeferino Colunga Sr. was connected to their public demand for an independent investigation into the young soldier's death.

The son's passing, and now the father's deportation, have shocked and saddened many in the small Texas community of Bellville, 60 miles west of Houston, where the Colungas have lived for nearly 20 years. But the U.S. Department of Homeland Security insists the death and the deportation were completely unrelated. And a review of the facts suggests the family may simply be suffering from a cruel twist of fate. But even the Austin County, Texas, sheriff who handled the case doesn't think it's fair that the still-grieving father was deported so soon after his son was buried.

"Sometimes I see things that I don't totally agree with even though I'm a lawman doing my job, and this is one of those times," says Sheriff DeWayne Burger. "Maybe my patriotism gets the best of me, but the man gave up his only son to serve the United States, and now we're deporting him?"

Colunga's strange death made headlines this summer, coming amid a rash of mysterious pneumonia-type illnesses that struck more than 100 soldiers serving in Iraq as well as Southwest Asia. Some have suggested the cases are tied to the military's controversial anthrax vaccine program.

Colunga, a 20-year-old who held the rank of specialist, died on Aug. 6 in Germany after being airlifted out of Iraq. For a month he had been complaining of chest pains. Army doctors diagnosed him with having acute leukemia. He contracted pneumonia soon after his airlift and died as his temperature reached 105, says his sister, Teresa. He was buried stateside in late August.

Three months later, the elder Colunga, a mechanic and truck driver, was picked up on an outstanding warrant for having entered the country illegally in 1999. He was deported Dec. 5. He had been deported once before, in 1993, after pleading guilty to an aggravated felony charge of marijuana possession in 1987. "He was removed in '93 as an aggravated felon. After he was deported he came back, but he can't reenter the United States if he's an aggravated felon," says Louisa Aquino, spokeswoman for the Houston office of the Department of Homeland Security, which now oversees deportations.

"Tragic as his son's death may be, it's irrelevant to this case," Aquino says. "Based on the laws on the books, we don't have any recourse but to remove illegal reentries. This case does not qualify for any hardship."

The bureaucratic efficiency leaves 19-year-old Teresa Colunga stunned. "I lost my brother in the war, and now I'm losing my father," she says. "The government doesn't even care that his son just died serving his country. I asked the Army to help us and they told me there was nothing they could do."

Texas politicians all sent sympathy cards when her brother died, she says. But, she adds, when she contacted their offices for help on the deportation case, "they shut their doors on me."

A spokeswoman for Rep. John Carter, a Texas Republican whose district includes Bellville, says the congressman's office is looking into the case. But she stressed that their options for helping a client are limited when the courts are involved. "The administration or the INS would have to take it up," the spokeswoman said.

The Pentagon is currently investigating the pneumonia outbreak, which, it says, has claimed two lives. It does not count Colunga's among them, however, since Army doctors say he actually died of leukemia. The family is still waiting for a copy of the final autopsy.

All of the sick soldiers took the mandatory anthrax vaccination shots. Earlier this year, Rachael Lacy, an Army reservist, died of pneumonia-like symptoms five weeks after receiving her shots. For months the Pentagon denied the vaccination had anything to do with her death, but then, in November, conceded that it might have.

On Aug. 12, the Colunga family, along with another whose soldier son died of the same pneumonia, wrote to Secretary of Defense Donald Rumsfeld seeking an independent investigation into the deaths. "We as a family are concerned that we are not being told the truth," the families wrote. "It is our right to receive truthful, honest and unfiltered answers just as the military required truth, honesty and commitment from our son."

"The family definitely thinks the deportation is payback, to try to keep us quiet," says Teresa. "If they want to report illegals, they should report half the town of Bellville. Why single my dad out, why now?"

According to Sheriff Burger, Colunga was riding as a passenger in a car that got pulled over for a traffic ticket in late November. When the deputy ran a check on the two people in the car, Colunga's outstanding warrant came up. He was arrested, the INS was notified, and a week later Colunga was deported. "It was a routine traffic stop," Burger says.

In the small town of Bellville, where Spc. Colunga's funeral drew a 200-car procession, it's likely the arresting patrolman knew about the father's loss. "I'm sure the officer did not take any pleasure putting the man in jail," the sheriff said. "But he was just doing his job."

Six months ago, Teresa Colunga, her brother and their parents made a family of four. Now both men are gone. "He gave this country his son, and they won't let him be buried next to him," Teresa said. "After my brother's death, we bought plots on either side of his tombstone for mom and my dad. Now we can't have that."

http://www.notinourname.net/detentions/deported-11dec03.htm

 

5. Chicago attorney wants anthrax vaccines stopped

BY MOLLY BROWN
Medill News Service

In 2000, an Air Force captain stationed in Oklahoma received three anthrax vaccinations.

She soon began experiencing numbness and tingling in her arm, hand and fingers.  When she called the medical center, she was told the problems would go away. 

Months later, however, she had trouble using stairs and riding a bicycle.

She said she was “generally clumsy” and her speech was slurred and slowed.

After undergoing medical tests, her doctor said her cerebellum, which controls motor functions, had shrunk and the damage was permanent.

In her early 30s, the woman- who asked not to be identified – said she never had any health problems before the vaccinations.  Though she admits there is no proof her condition resulted form the anthrax vaccine, she said there is no other explanation.  Her neurologists have found no other logical cause either.

Still enlisted, she fears she’ll be discharged within the year because of her condition.   

http://www.kansascity.com/mld/kansascity/12214696.htm ?

 

6. Anthrax vaccine under fire

Refusal rate concerns military; troops speak out
By DAVID GOLDSTEIN
The Star’s Washington Correspondent

WASHINGTON –– Shonya McBride remembers very clearly the night she rolled over in her sleep and her hand fell across her husband’s chest. She awoke with a start.

“His heart was just pounding out of his chest,” she said. That was in 1999, after Travis McBride, a 22-year-old Marine Corps sergeant, had received the second of six mandatory inoculations of the anthrax vaccine.

By the fourth shot, he had developed serious heart problems, chronic fatigue and severe joint pain. McBride never made it to the fifth. Within a year, he was medically discharged.

Sargent Dan Cole took the anthrax vaccine in February 1996 and died in December 1996. 

08/28/05

By Helen Barrett

Alva Review Courier

online edition

(excerpts from the article)

Despite reservations, E-4 Kent Stewart of the Oklahoma National Guard, HHB45th, Field Artillery Brigade rolled up his sleeve and obeyed. 

Almost immediately after taking the first round of vaccines, Stewart began experiencing severe headaches.  He received his third series following April 4th.

Dizziness, tingling on the left side of his face, in his hands and legs, and attitude changes manifested themselves.
Stewart received his fourth round of the vaccine on December 7, 2003.
Vomiting, weight loss, insomnia, and other symptoms started.

During the summer of 2004, Stewart suffered a pancreatic attack.
His condition worsened until he was hospitalized Nov. 22, and placed on intravenous antibiotics for a week.  Two days after his release the condition returned. 

He was referred to Dr. Tarek Neguib, M.D. who specializes in immunology. 
In his official report dated March 28 of this year, Dr. naguib listed his medical impression as:

1.        Immunoglobulin A deficiency

2.        Immunodeficiency due to #1

3.        Multiple neurological manifestations with no structural disease on imaging and no infections etiology on work up.  Suggestive of probable immunologic reaction to vaccination.

Dr. Naguib further stated, “The patient has a history of anthrax vaccination series 5 out of 6 doses among other vaccinations that preceded the evolution of symptoms in this previously healthy 37-year-old male.  Makes vaccines a suspect etiology for this unusual presentation.”

Unable to work because of his compromised immune system and continual illness, the Stewart family faces foreclosure on their home in addition to mounting medical costs. 

FDA Warning Letters were sent to the manufacturer in 1995 and 1997 threatening to revoke their license.  The Gulf War Vets website says an FDA report documented 84 quality control and procedure violations by the manufacturer. 

7. Greg Sapp's Story (served 1997-1999)

Hello,

On March 17, 2008, I was diagnosed with Transverse Myelitis, an
uncommon neurological disorder that only affects 1 to 4 people per
million. At the time of illness I was in relatively great health and
was an avid runner in major 10K races and marathons. Within a few days
I was paralyzed from the bellybutton downward. This disorder causes
extremely uncomfortable nerve pain and spasticity in the muscles
within the spinal cord affected area.

In 1997, the 3rd Infantry Division of Ft. Stewart, Georgia, was called
to be deployed to Iraq and the Middle East. The unit immediately
initiated a mandatory anthrax vaccination for all soldiers in our
brigade as a deterrent to possible nerve agents used by Saddam. This
forced vaccination was of course in violation of the Nuremberg Code of
Ethical treatment. I did not consent to having the vaccinations and
was told that failure to participate would warrant an immediate
dishonorable discharge, which would haunt my record. Given the
threats, I was given 6 shots during the year prior to deployment.

After doing extensive research I have found that the anthrax vaccine,
especially the lot numbers from this time period, always caused
paralysis in laboratory animals. It is my firm belief that the vaccine
was squalene-based, which caused the Transverse Myelitis diagnosis.
The vaccine remains dormant in the body and compromises the immune
system over time. How can I get the word out about this tragedy so
that others can come forward and share their story? If I am correct,
there will be more people from my brigade who are having the same
trouble or similar problems neurologically. Thanks for your help.

Greg Sapp

 

Defense Alternatives for Anthrax Threat in the News 

1. Terry Collins Develops “Green” Catalysts for Potential Use in Industry and Biological Warfare

www.cmu.edu/corporate/news/2004/0604_TAML.html

(excerpts)

Fe-TAML activators could be used to decontaminate anthrax 

Terry Collins, the Thomas Lord Professor of Chemistry at Carnegie Mellon University, has developed environmentally safe oxidation catalysts that can be used to decontaminate biological weapons, such as anthrax, and eliminate toxic residues produced by several industries.  Members of Collins’ laboratory presented the latest findings on this work at the recent American Chemical Society (ACS) meeting in New York City.   

At the ACS meeting, Collins and his research group discussed FETAMLs’ effectiveness in killing an anthrax simulant (a benign form of the deadly biological warfare agent), reducing fuel pollutants, detoxifying pesticides, treating pulp and paper processing byproducts, cleaning wastewater from textile dye manufacturing and catalyzing chemical reactions with oxygen instead of hydrogen peroxide. 

 2. Press Releases October/2001

http://www.mnstate.edu/publications/anewsreleases.htm/oct.2001news.htm#anthrax

(excerpts)

MSUM ALUM ON THE CUTTING EDGE OF RESEARCH TO DETOXIFY ANTHRAX

Moorhead, MN….Disabling the lethal toxins in anthrax and other bio-weapons would go a long way in protecting America from terrorism.

 That’s why Moorhead native and Minnesota State University Moorhead distinguished alumnus Rodney Tweten, now a professor of microbiology at the university of Oklahoma’s Health Sciences Center, received a three-year, $2.48 million grant to fund research for a new drug that has the potential to do just that.

 He and his colleagues have developed a method to rapidly generate and screen mutants of anthrax toxin that could neutralize the deadly effects of the bacteria.  These agents could potentially be used to reduce or eliminate deaths among late stage inhalation anthrax disease victims.

 “Unfortunately, today’s anthrax vaccine is not appropriate for protecting the general public,” said Tweten, who’s heading the research team.  “There is a critical need to develop new therapies that could be quickly administered following a bio-terrorist attack.  The drug we’re working on could be much more effective, since it would target toxin activity after the initial anthrax infections.”

 “Anthrax toxin is comprised of three proteins, and these proteins have to work together to create the actual toxin,” he said.  “One of my former students who did his post-doctoral studies at Harvard University discovered that if you mutated one of these proteins in the right place, when it combines with the other anthrax proteins, it inactivates the toxins.  We’re simply replacing a functional sub-unit with a dysfunctional one.”

 With the grant, Tweten and his team will try to discover additional mutants that can be used as a therapeutic to block the action of the toxin.  In the late stages of anthrax, he said, it is the toxin, not the growth of bacteria, which kills people. 

 3. American Society for Microbiology

5-30-2005

http://www.sciencedaily.com/releases/2005/05/050528145418.htm

(excerpts)

Treated Fabric Kills Anthrax Spores

 BALTIMORE, MD (March 22, 2005) – Military textile fabric treated with an antimicrobial compound can kill dormant anthrax spores and could provide the basis for enhancing military protection in the event of a biological attack.  Scientists from the U.S. Air Force Research Laboratory (Aberdeen Proving Ground, MD) report their findings today at the 2005 American Society for Microbiology Biodefense Research Meeting.

 “The dormant phase of the anthrax spore is the hardiest phase of the spore and the most difficult to kill.  If this can kill dormant spores, then it could more easily kill germinating spores,” says Jon Calomiris.  Calomiris conducted the study as part of a research program, headed by Heidi Gibson of the U.S. Army Natick Soldier Center (Natick, MA), to investigate the feasibility of antimicrobial textiles. 

 “This difference is not really surprising because for disinfectants, as you increase the temperature the effectiveness of a disinfectant increases,” says Calomiris.  “What’s important is that we have proven the concept to be viable.”

 Additional research must be done to determine what effects, if any, the disinfectant may have on human health and will also focus on potential applications for this technology in the field.

 “This treatment could be useful for a variety of fabrics where you might have concerns about exposure to a microorganism.  Applications of antimicrobial fabric could include clothing, tents and tarps,”says Calomiris.

 4. UAB tailors antibiotic for anthrax:  Terrorism safeguard in testing offers hope for tough infections

The Birmingham News  Tuesday, September 5, 2000
by Dave Parks
News Staff Writer

(excerpts)

 A powerful new antibiotic capable of protecting troops and civilians from anthrax could be ready for use in an emergency within three years, and it also may be effective against tough, common infections, a top UAB researcher says. 

 The drug was designed at the University of Alabama at Birmingham’s Center for Macromolecular Crystallography. 

 “The Army has spent $6.5 million to develop the antibiotic over four years, and an estimated $16 million more is needed, [Larry] DeLucas said.  The Army has indicated it will likely approve another portion of funds, he said. 

 The drug was tested successfully on anthrax at the Army’s Medical Research Institute of Infectious Diseases at Fort Detrick, MD.  It also was tested successfully on animals to ensure it wasn’t toxic. 

 DeLucas said the antibiotic was designed using crystallography.  That process allows a drug to be precisely tailored to block the internal workings of a virus or bacteria. 

 Anthrax bacteria are protected by a spore until they enter the body.  then, they germinate into deadly bacteria.   DeLucas then said the new antibiotic allows the anthrax to germinate, but blocks an enzyme that stops it from developing further. 

“As it tries to become a bug, it dies,” he said.

 DeLucas said that UAB’s new antibiotic could be more effective against anthrax than Cipro. 

5.  Antibiotics are effective post-exposure (Cipro and Dioxycyclene).  In fact Cipro has been standard issue as part of every soldier's gear during Operation Enduring Freedom and Iraqi Freedom.

6.  Detection capabilities are improving (Congressional Hearing, Rep. Christopher Shays, May 19, 2003)
The USA is currently using Biological Integrated Detection System (BIDS), as well as JointPoint, Joint Biological Point Detection System, and the P3I in the field.  The goal is to have BIDS in every major city.  According to a member of a Chem Unit that we spoke with, it would be more effective to put billions of dollars into more BIDS rather than innoculating people against numerous possible toxins.

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How to Report Illness 

If you or your loved one have had a bad reaction to the anthrax vaccine (or any vaccine), please fill out a VAERS form (the Vaccine Adverse Event Reporting System).  To get a VAERS form, go to www.vaers.hhs.gov, or call 1-800-822-7967.  Be sure and keep a copy for yourself in case your form is accidentally lost.


 Anthrax Health Registry:

Look at the anthrax vaccine adverse reaction health registry at www.milvacs.org  You can see the common side-effects and reactions to the anthrax vaccine or file a report about your reaction to the anthrax vaccine.


 Survey for Adverse Reactions to AVA

A team of veterans has formed Team Archangel under the leadership of James Hines Jr., Esq. to help service members and veterans who have had adverse reactions to the Anthrax Vaccine. Click the link below to learn more about what the team is doing, and take their evaluation survey if you believe you are suffering. All information will remain confidential.
https://sites.google.com/site/teamarchangel1/contact-information
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About the Department of Defense (DoD) and its Anthrax Vaccine Immunization Program (AVIP) 

The DoD began the mandatory AVIP in 1998.  Anthrax vaccines were given before then during the two Persian Gulf Wars of the 1990s. However, not much is known from that time period because medical records were often not kept in good order.  The AVIP was halted by Federal Judge Emmet G. Sullivan on Oct. 27, 2004.  Donald Rumsfeld, Secretary of Defense, said “This is just a pause.”  More than 500 military members were forced to take the anthrax vaccine in violation of the court’s injunction as late as March of 2005.  The AVIP resumed under the Emergency Use Authorization (EUA) of the new Bioshield Act, but it was a voluntary program.  The Judge’s decision has been appealed by the DoD.  After the first EUA expired (6 months), another EUA was granted.  Currently, the AVIP has become mandatory for all military members again....(click on title above for full document)

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About FDA 

The Food and Drug Administration has been both helpful and harmful concerning the safety of the current anthrax vaccine.  On the one hand, the FDA detected the squalene (also called MF59) contamination in the 5 lots of anthrax vaccine in parts per billion (ppb) at Dover Air Force Base, in October of 2000, and had those bad lots quarantined.  Unfortunately, soldiers were already becoming severely ill as documented in Dr. Walter Schumm’s article in Medical Veritas, vol. 1, of 2004, titled “Anthrax vaccine and Gulf War illness symptoms in Captain Jean Tanner’s Dover Air Force Base survey” (163-5).  In 2005, the FDA also stated that five more people’s deaths can be attributed to the anthrax vaccine, bringing the total number up to 21 people who have died since 2000 from the anthrax vaccine; and, 5,120 people have reported adverse reactions (via Vaccine Adverse Event Reporting System) from the anthrax vaccine since the early 1990s.  These numbers only include those who have taken the initiative to report their reactions.  We do not know how many adverse reactions go unreported.  The FDA inspected Bioport’s anthrax vaccine plant on 4 separate occasions.  Bioport failed these inspections, and after dozens of violations (such as unknown particulates, temperature violations, tampering with expiration dates on labels, potency levels, and more) went uncorrected, the plant was shutdown in 1999.  The American public, especially our military members, are grateful for the FDA’s role in these safety measures that were taken concerning the anthrax vaccine.... (click on title above for full document)

 


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Contacting Congress
 

How to contact your Congressman or Congresswoman
http://www.house.gov/writerep
or call 202-225-3121

Congressional Example Letter March 2007 

How to contact your Senators
http://www.senate.gov
or call: 202-224-3121

Senatorial Example Letter March 2007

 To Contact the President
President Barack Obama
The White House
Washington, DC 20500
202-456-1111, for comments to the President
202-456-2461, fax
president@whitehouse.gov

 

POG Petition 2008


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Legislation and Congressional Hearings

http://www.nti.org/d_newswire/issues/2005_5_3.html#FEF1E57A

“Bioshield II calls for tax incentives to promote capital investment in research, patent incentives and other intellectual property protections, and liability protections for manufacturers whose vaccines cannot be fully tested, as they would be designed to counteract potentially fatal infections.

The legislation pledges federal money for products that meet government specifications, but sets no specific funding levels, the press release states.

 

Testimonies at Congressional hearings and accounts of illnesses

http://www.house.gov/reforms/ns/press/witness_list929.htm
http://www.dallasnw.quik.com/cyberella/Anthrax/Richter.html
http://www.dallasnw.quik.com/cyberella/Anthrax/Piel.html
http://www.dallasnw.quik.com/cyberella/Anthrax/Rovet.html
http://www.dallasnw.quik.com/cyberella/Anthrax/hearing.html
http://www.dallasnw.quik.com/cyberella/Anthrax/Dover4-1.html
 

 Senator Rockefeller Letter to FDA, 10-2-96

“I am deeply concerned by today’s announcement that anthrax vaccine will be given to our military personnel for potential exposure to inhaled anthrax…detailed information about testing, side effects, and record keeping should be provided to troops, the Congress, and the public before soldiers are ordered to take another vaccine.”

¨       Letter requests all data on this DoD decision to inoculate the entire force against anthrax

¨       FDA October 15 response mentions MBPI IND

¨       FDA claims to have no informed consent waiver requests or other info related to DoD’s decision
 

John D. Rockefeller IV

Ranking Minority Member

A Ranking Member of the Committee on Veteran’s Affairs
 

Internal FDA Memo or Rockefeller Letter, 10/11/96

Brief Summary of Events Regarding DoD use of Anthrax Vaccine
10/01/96—DoD Meeting of Senior Medical Leaders Chandler/Novak Talk
Note:  FDA’s Chandler & Novak brief senior DoD medical leaders (on what?) the day before the AVIP announcment and Wash Post Story
 

DoD 10-10-96 memo on Sen Rockefeller Letter

Memorandum for the Secretary of the Army
Subject: Request for Information on Anthrax Vaccine—
                Information Memorandum

                Attached is a coordinated memorandum from the Assistant Secretary of Defense (Health Affairs), subject as above.  His office was requesting coordination on a draft letter to Senator Rockefeller in response to his request for information on anthrax vaccine.

“The response indicates that DoD has not finalized a decision on anthrax immunization.”

Notes:

¨       DoD response planned to offer the Senator safety and efficacy studies and the MBPI IND filing as justification for force-wide shots

¨       DoD and FDA provided Congress and the public with little to evaluate the rationality of the 1996 decision to inoculate all service members against inhaled anthrax

¨       The Pentagon backed off their vaccine decision reported in the Washington Post

Rockefeller Releases Committee Staff Report on Health Risks of Secret Military Research and Other Intentional Exposures

106th Congress' hearings from the House Oversight Committee in 1999-2000

________________________________________________________________________________________________________________________

Information from the November 9th Hearing, (the second panel is right on target)
http://www.house.gov/reform/ns/hearings/testimony/CS119.htm
Information from the October 12th Hearing,
http://www.house.gov/reform/ns/hearings/healthcare/99.10.12.htm
________________________________________________________________________________________________________________________

Congressman Spencer Bachus

U.S. Representative, Alabama’s 6th District
442 Cannon House Office Building
Washington, DC 20515
Phone: 202-225-4921
Fax:  202-225-2028

Many Alabamians applaud Congressman Bachus for co-sponsoring two bills concerning the anthrax vaccine problem.  His words in a letter to Congressman Floyd Spence, Chairman of the House Armed Services Committee, still ring true after almost 6 years.  During this time, the FDA had documented 16 deaths from the anthrax vaccine.

From:  Spencer Bachus
To:  Floyd Spence
 

Dear Mr. Chairman:

In a time when all branches of our military are having trouble recruiting and retaining quality personnel, the last thing our government should be doing is driving people away from military service.  Unfortunately, the Defense Department’s mandatory anthrax vaccination program is having just such an effect.

But these vaccinations, under a cloud of safety concerns, are forcing these patriots to choose between the safety and security of their families and their services to our nation.  Given the lack of information we have about the vaccine and the reports of harmful side effects, it is not surprising that a growing number of our nation’s military personnel are choosing to leave the service rather than take a potentially unsafe vaccine.

Exacerbating these concerns are that many Gulf War veterans suffer from unexplained illnesses that may have been caused by anthrax vaccinations they received during the war.

Even Secretary of the Army Louis Caldera has admitted the potential dangers of the anthrax vaccine.  A memorandum he wrote in September 1998 and quoted by the San Diego Union-Tribune says the vaccine “involves unusually hazardous risks associated with the potential for adverse reactions in some recipients and the possibility that the desired immunological effect will not be obtained by all recipients.

Mr. Chairman, if the Secretary of the Army raises these concerns, how can we expect the most junior soldier, sailor, airman or Marine to accept the vaccine without question?

I know the Armed Services Subcommittee on Military Personnel conducted a hearing on the anthrax vaccine program in September.  Since then, two bills have been introduced that will address the concerns so many of our military personnel have about the vaccine.  One, H.R. 2548, suspends the vaccine program until an independent study by the National Institutes of Health is conducted on both the safety and effectiveness of the vaccine.  This bill also suspends the vaccine program until a separate study by the General Accounting Office is completed on the effect the program is having on moral, recruitment and retention.  The second bill, H.R. 2543, makes the anthrax vaccination program voluntary, which is the policy of our own State Department for its personnel stationed overseas.

As a co-sponsor of both bills, I am respectfully requesting that you schedule time for the Armed Services Committee to hold hearings on both of these bipartisan bills with the intention of bringing one or both of them to the floor for a vote as soon as possible. I pledge to work with you on toward this end in any way I can.

Sincerely,

Spencer Bachus
Member of Congress

 

Bachus seeks anthrax vaccination curb

MICHAEL BRUMAS
News Washington correspondent
11/14/99

WASHINGTON - Congress should hold hearings and pass legislation that would curb the military's mandatory anthrax vaccine program, U.S. Rep. Spencer Bachus says.

"In a time when all branches of our military are having trouble recruiting and retaining quality personnel, the last thing our government should be doing is driving people away from military service," the Vestavia Hills Republican said in an interview last week.

"Unfortunately, the Defense Department's mandatory anthrax vaccination program is having just such an effect."
 

Politics

Several pilots in the Birmingham-based 117th Air National Guard said recently they will leave the military rather than be subjected to a mandatory anthrax vaccination.

The wife of one 117th pilot has become so concerned that she formed a spouses' support group, called Protecting Our Guardians. The group is circulating a petition urging Congress to approve legislation that would suspend the vaccine program or make it voluntary.

The vaccine is being administered to protect American troops against the biological warfare agent anthrax, but some servicemen have reported side effects, including fever, muscle pain, soreness and dizziness.
 

Hearings sought

Bachus wrote to the chairman of the House Armed Services Committee, Rep. Floyd Spence, R-S.C., recently asking that the panel convene hearings on two bills dealing with the issue.

One bill would suspend the vaccine program until an independent study by the National Institutes of Health is conducted on the safety and effectiveness of the vaccine.

The legislation also would suspend the vaccine program until a separate study by the General Accounting Office is completed on the effect the program is having on morale, recruitment and retention.

The second bill would make the anthrax vaccination program voluntary, which is the policy of the U.S. State Department for its personnel stationed overseas.

Defense Secretary William Cohen last year ordered all 2.4 million active duty and reserve troops to get the anthrax vaccine, and so far about 340,000 service members have been immunized.

The Defense Department insists the vaccine is safe and that the six-shot regimen - including an annual booster - is the only known way to prevent rapid deaths in troops who inhale anthrax.
 

Quit military

But the adverse side effects, questions about proper dosage and lack of data on potential long-term effects of the vaccine, have prompted more than 200 resignations from the military, while another 220 who refused the vaccine have been disciplined or are awaiting disciplinary action, Bachus said.

Several part-time pilots with the 117th air refueling wing told The Birmingham News recently that they would leave the service before taking the vaccine.

The pilots, who also fly professionally for Federal Express and other carriers, expressed particular concern that the vaccine's side effects could force them to surrender their civilian pilot licenses. The Federal Aviation Administration, however, has said the vaccines wouldn't be a cause for disqualification unless the side effects were significant.

The issue is particularly sensitive for 117th pilots such as Capt. Reid Alan Armistead, of Birmingham, who is a full-time guardsman with no civilian job to fall back on.

It's Armistead's wife, Marguerite Majilton, who recently formed the Protecting Our Guardians support group, and who is circulating the petition to Congress.

"I don't want to take it, but I don't want to be unemployed either," Armistead, 31, said in a telephone interview. "I love my job, and the people at the base have been real good to me. I don't want to leave but I feel like I'm being forced to leave. This is my body, the only one I'm going to get. If they screw this vaccine up, it's going to be me who suffers. I don't want to gamble with my health like that."

Ms. Majilton, 29, who has an 8-month-old daughter, raised concerns about the possibility of birth defects resulting from the inoculations.

"We don't want our daughter to be an only child," she said. "We want more children. But I've seen a lot of anecdotal evidence ... that there's an increase in birth defects after people have taken this vaccine."

No evidence seen

The Pentagon, however, said that in nearly 30 years of licensed use of the anthrax vaccine, there is no evidence of reproductive problems, including fertility, birth defects or miscarriage.

Nevertheless, Ms. Majilton said she and her husband are "waiting for God's burning bush to show us what to do."

"In the meantime we can try to encourage Congress to pass legislation and hope we won't have to choose between his career and gambling with his health," she said.

The Pentagon considers anthrax, a virulent disease that causes death within a few days, among the greatest biological weapon threats to U.S. forces. It is a naturally occurring bacteria found in domesticated animals.

A dried form of anthrax spores can be loaded into artillery shells, bombs and missiles or can be sprayed from planes. Although anthrax has never been used in combat, the Pentagon fears Iraq, North Korea and other countries - as well as terrorist groups - might try.

"If we are attacked with this agent and we have a force that's vaccinated, our soldiers, sailors and marines will survive," Lt. Gen. Ronald Blanck, the Army's surgeon general, recently testified before Congress. But without it, he added, soldiers "will inevitably die."
 

Letter from Congressman Bachus to Floyd Spence

Letter to Congressman Bachus

Two Bills Concerning DOD's Mandatory Anthrax Vaccine Policy

 

A List of Three Legislative Initiatives supported by Protecting Our Guardians
1. Make all taxpayer sponsored health databases open to independent analysis (with personal identifiers removed)

2. Federal sponsorship of a center to perform serious vaccine safety research, independent of CDC and FDA (and not the bogus center at JHU)

3. Define (and enshrine) research fraud, scientific misconduct, and similar terms. Specify penalties for research fraud. Protect whistleblowers.
 

A Summary of Congressman Jack Metcalf's Report

Congressman Jack Metcalf announced to a House Committee investigating Gulf War illnesses today that he has issued a report stating that squalene, a substance in unapproved vaccine adjuvant formulations, was found in the anthrax vaccine in amounts that could boost immune response---raising the possibility that squalene was used in innoculations given to gulf War era vets. GAO science investigators have documented concerns regarding the use of novel adjuvant formulations in vaccines, including squalene.

Metcalf compiled the report over a three year period, putting together a team led by his special Assistant,Norma Smith. It contains a series of documented conclusions, and an extensive compilation of supporting documents.

Congressman Metclaf's statement to the House Subcommittee on National Security,Veterans Affairs, and International Relations.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Executive Summary

Congressman Jack Metcalf has issued a report culminating a three year investigation into the conduct of the DOD (Department of Defense) with regard to the possibility that squalene, a substance in vaccine adjuvant formulations not approved by the FDA, was used in inoculations given to Gulf War era service personnel. According to the GAO (General Accounting Office), scientists have expressed safety concerns regarding the use of novel adjuvant formulations in vaccines, including squalene.

The report reveals that the FDA has found trace amounts of scalene in the anthrax vaccine. The amounts recorded are enough to "boost immune response," according to immunology professor Dr. Dorothy Lewis of Baylor University. Therefore, the report concludes that immediate action should be taken to halt the current AVIP (Anthrax Vaccination Immunization Program). It further states that an aggressive investigation must be undertaken to determine the source of the squalene, and the potential health consequences to those who have been vaccinated, both during and after the Gulf War.

The report also documents at length DOD "stonewalling" attempts to resolve this issue, which GAO investigators characterized as "a pattern of deception." The GAO stated the DOD denied conducting extensive squalene testing before the Gulf War, then admitted it after being confronted with the public record. The GAO revealed that DOD officials deliberating deployment of the anthrax vaccine expressed a "willingness to jump out and, use everything:" in discussing experimental vaccines containing adjuvants not approved by the FDA.

GAO also found Peter Collis, DOD official who headed vaccine efforts, refused to cooperate with them. The report states that the DOD has refused to act in good faith upon the GAO recommendation to replicate the findings of a test developed by renowned virologist Dr. Robert Gary of Tulane University, although DOD admitted they could easily do so. The work of theTulane researchers has been peer-reviewed in a scientific publication of high standing.

Finally, the report states that "Congress should take immediate action to review the findings of the GAO and the Armed Services Epidemiological Board, and provide independent oversight for the immediate implementation of their recommendations. "The board called on the DOD to engage in close cooperation with the Tulane researchers.

Congressman Metcalf believes it is clearly within the oversight responsibility of the Congress to get to the bottom of the labyrinth that has become known as "GulfWar Illnesses." We have an obligation to pursue the truth, wherever it may lead us. To do less would be to act dishonorably reward the dedicated men and women who stand between us and a dangerous world, willing to die if necessary to defend our nation.


________________________________________________________________________________________________________________________

Money Down the Drain

Congressman Tim Hutchinson was asked to comment upon Bioport, and he noted that it was a bad idea for the Department of Defense to contract with a single producer with a single facility to produce all of the anthrax vaccine used to protect our armed forces in case of anthrax attack.  Hutchinson noted that the Defense Department has spent [$42] millions on Bioport, including its facilities.

http://www.bushwatch.com/bioterrorism.htm
________________________________________________________________________________________________________________________
 

Opening Statement by Chairman Dan Burton, Government and Reform Committee Hearing, on Oct. 11, 2000
(for full text go to http://www.avip2001.net/DOCS/Chairman001011.pdf)

When under scrutiny, the Department's first action was to attack the veracity and integrity of the accusers and their data. When the men and women in our armed services - individuals who have volunteered to give their lives to protect this country if necessary- questioned Secretary Cohen's program, these men and women were portrayed by the Defense Department as malingerers. The Defense Department has insulted the honor and integrity of anyone who has dared question the anthrax vaccine program. We have had numerous Air Force Academy graduates testify before this Committee. I wonder how many malingerers manage to graduate from the Air Force Academy?

________________________________________________________________________________________________________________________

Private Medical Data Not Really Private Anymore

According to Barbara Loe Fisher, of NVIC, the Health Insurance Portability and Accountability Act allows one’s personal medical data to be shared with third parties like insurance companies, employers, and medical researchers.  This Act goes further in that obtaining the voluntary or informed consent of individuals and families participating in medical research can be suspended whenever an IND board decides to waive consent such as for public health judged to be in the public interest.

Barbara Loe Fisher has also pointed out that the CDC often recommends that a vaccine/s be mandatory for all children; that pharmaceutical companies are usually free of liability for any harm resulting from these mandatory shots; that there is computerized data tracking of what vaccines children have been given without their parents’ knowledge and informed consent; and that each state receives money for each child that has been given the mandatory vaccines—usually about $50/child.

Doesn’t this corrupt the objectivity of those who are supposed to protect our public’s health?
________________________________________________________________________________________________________________________
 

DEPARTMENT OF THE ARMY
OFFICE, CHIEF OF LEGISLATIVE LIAISON

CONGRESSIONAL HEARING SUMMARY

SUBJECT: Anthrax Vaccine Program
DATE/TIME/LOCATION: 13 April 00, 1000-1330, Senate Russell 222
COMMITTEE: Senate Armed Service Committee
 

“This document is funny because people keep referring to the “anthrax virus” instead of the anthrax bacteria.”

www.hqda.army.mil/ocll/hearing_summaries/04-13-2000_sasc_anthrax_vaccine_program.htm

Protecting Our Guardians

Position Paper

concerning the Anthrax Vaccine Immunization Program (AVIP)

June 27, 2005
 

WHEREAS, Federal District Court Judge Emmet G. Sullivan ordered AVIP immediately halted twice, the last injunction being on Oct. 27th, 2004.* 

WHEREAS, More than 500 military members were given the anthrax vaccine which was a breach of the court's injunction as late as March 7th, 2005.**

WHEREAS, the court's injunction was circumvented by DoD through the Emergency Use Authority (EUA) of the Bioshield Act of 2004.  Although Judge Sullivan requested substantiation of an emergency twice, none was given, ostensibly for security reasons.

WHEREAS, A Congressional report recommended suspension of AVIP:  The Department Of Defense Anthrax Vaccine Immunization Program:  Unproven Force Protection** *

WHEREAS, The 1962 Brachman study, upon which the DOD bases the anthrax vaccine's safety and efficacy, was debunked by Dr. Walter Schumm in 2004, in several articles published in Medical Veritas, as well as his 2005 articles in Medical Veritas.

WHEREAS, The anthrax vaccine was proven ineffective for troop protection by Dr. George Robertson because the vaccinated soldiers would still be extremely ill for 2-3 weeks and be unable to defend themselves from an attack or capture, according to "Anthrax Shots' Effect Challenged" by Thomas Ricks of the Washington Post.

WHEREAS, The anthrax vaccine is reported to have caused, at minimum, 16 deaths; and 4,136 VAERS reports (Vaccine Adverse Event Reporting System) of adverse reactions to the anthrax vaccine have been filed. ****

WHEREAS, The reported data yields a death rate of one in every 60,000 anthrax vaccine recipients, and a serious adverse reaction/s for one in every 4,000 anthrax vaccine recipients.

WHEREAS, The 2002 anthrax vaccine product insert reveals a systemic adverse reaction rate of 5-35%, which includes side-effects such as (as quoted in the package insert): "Anaphylaxis and/or other generalized hypersensitivity reactions… … cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system… … Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma  (1).

WHEREAS, The FDA announced in Oct. 2000 that it had found squalene, an illegal adjuvant, in all five lots of anthrax vaccine sent to Dover AFB.  The squalene was in incrementally increasing dosages and indicates "a dose range experiment" according to immunologists Dr. Asa and Dr. Garry at Tulane University.  These were lots that Lt. General Charles Roadman, then Surgeon General of the Air Force, said were safe.  Squalene causes arthritis and auto-immune diseases.  And, anthrax vaccine recipients are being diagnosed with arthritis and auto-immune diseases. To date, the FDA does not test the current lots to ensure that the vaccine is free of squalene and the DoD has not requested routine testing for squalene contamination.

WHEREAS, The manufacturer of the anthrax vaccine, Bioport, failed four separate FDA inspections and had at least 18 violations according to Barbara Walters on 20/20.  For example, expiration dates had been tampered with, the vaccine's potency was not uniform, the temperature had not been kept in the proper range, and mold and mildew covered the ceilings and walls of the laboratory. Many vaccine lots were quarantined and (after much effort from concerned citizens) later destroyed.  Bioport was shut down and completely renovated to meet FDA standards with hundreds of millions of tax dollars.

WHEREAS, Despite the plant renovations, the anthrax vaccine continues to be the most reactogenic shot on the market.  According to Dr. Raymond Browne who wrote the FDA about this vaccine, and Dr. Waltz, a neurologist, any product with a reaction rate higher than 1% would necessitate pulling it off the market (anthrax vaccine reaction rate is 5-35%).

WHEREAS, There are now 4 Walter Reed Vaccine Injury Healthcare Centers for those affected by the anthrax vaccine and other vaccines.

WHEREAS, Bioport received another contract with DoD and HHS for $122.7 million and 5 million more doses of the anthrax vaccine in May 2005, rather than being shut down permanently for its numerous problems concerning sterility, potency, contaminants such as squalene, financial troubles, and failure to meet deadlines. Each shot has gone from the price of $2 to $24.50 per shot, in the 6 shot series.

WHEREAS, Congressional hearings with testimonies from Sen. McCain, the former Sen. Regal, and William Cohen reveal that only two countries have the ability to weaponize anthrax: the former Soviet Union and the USA.  No WMDs have been found in Iraq. The potential benefits of AVIP cannot be measured, but the harm done to anthrax vaccine recipients can most certainly be measured.

WHEREAS, The survival rate in guinea pigs was only 23 - 71%, depending on which strain of anthrax was used, and the best survival rate in mice was even less. (http://www.gulfwarvets.com/aftimes.htm). 

WHEREAS, An anthrax attack may involve genetically engineered strains of anthrax that the vaccine cannot protect against.

WHEREAS, The General Accounting Office reported a 25% loss in Guard and Reserve aircrews and an additional 18% intending to leave the military due to the AVIP (GAO-01-92T).  With each pilot being a $6 million investment with 9 years of training according to Cong. Dan Burton, the AVIP is thereby costing taxpayers a great deal of money in loss of personnel, healthcare, and retraining.

WHEREAS, the vaccine’s efficacy has often been questioned by credible investigators: "…but to what extent, against what amount of anthrax, against which strains, and how long protection lasts, are not known" according to Dr. Kwai Chan of the General Accounting Office concerning the efficacy of the anthrax vaccine in his statement to the House of Representatives on April 29, 1999.

WHEREAS, no studies have been conducted on the long-term effects of the anthrax vaccine.

WHEREAS, The information flyer, that Judge Sullivan ordered the DoD to produce in order to disclose the fact that the anthrax vaccine is now voluntary with no penalties for refusal under the EUA, and to disclose the known side-effects of the anthrax vaccine, does not provide military members with accurate information.  It is misleading.  For instance, the flyer fails to list the serious systemic adverse reactions that may occur.  It also fails to cite the fact that 5 - 35% (that's 120,000 - 840,000 people) of recipients will have systemic adverse reactions.  Information from the product insert that may save lives should be on the information flyer given to military members.

WHEREAS, “The current vaccine against anthrax is unsatisfactory for several reasons.  The vaccine is composed of an undefined crude culture supernatant adsorbed to aluminum hydroxide.” …”No direct determination of the content or structure of the protective antigen in the vaccine has been made, and it is unknown whether the protective antigen is biologically active.” …”The undefined nature of the vaccine and the presence of constituents that may be undesirable may account for the level of reactogenicity observed.” (Vaccines co-authored by Dr. Arthur Friedlander, MC Colonel and head of Bacteriology at Ft. Detrick’s USAMRIID

RESOLVED, By Protecting Our Guardians on May 23, 2005 that Congress shall cease all appropriations to the AVIP immediately.

* Federal District Court Judge Emmet G. Sullivan order for AVIP immediate halt:   (http://www.dcd.uscourts.gov/Opinions/2004/Sullivan/03-707c.pdf

** "Early letter may affect anthrax ruling, " March 30, 2005: http://www.washtimes.com/upi-breaking/20050330-105542-2530r.htm

*** Congressional report  recommending suspension of AVIP --  The Department Of Defense Anthrax Vaccine Immunization Program:  Unproven Force Protection** , 106th Congress, 2d Session, House Report 106-556, Union Calendar No. 304, in 2000.

**** FDA Memorandum titled Adverse Events Following Anthrax Vaccine Reported to the Vaccine Adverse Event Reporting System, from Dec. 12, 2004: (http://www.anthrax.osd.mil/media/pdf/adverseEventMemo.pdf)

***** "Ex-DAFB commander says troops used as guinea pigs," Oct. 10, 2004, Lee Williams and Hiran Ratnayake
 

Dr. Robert Garry's Testimony to the House Subcommittee on National Security, Veterans Affairs and International Relations

He suggests there is a strong correlation between the Anthrax vaccine and Gulf War Illnesses. Dr Garry is a professor in the Department of Microbiology and Immunology and Tulane Medical School. He testified in this Congressional hearing on Jan 24, 2002.  from http://www.whale.to/v/garry.html

 

Statement by Barbara Dunn

STATEMENT BY

BARBARA DUNN

TO GOVERNMENT REFORM COMMITTEE

HEARING ON ANTHRAX

OCTOBER 3, 2000

Mr. Chairman and members of the House Government Reform Committee:

I am appearing before you to at least try to ensure that no other person or family goes through what my family has been through as a result of the Department of Defense/BioPort Anthrax Program.

As you know, my husband, Richard Dunn, had worked for BioPort and Michigan Biologic Products Institute, since 1992. Dick’s job was to care for and monitor test animals at BioPort, and he was required to take the same anthrax vaccine given to our nation’s military personnel.

Dick received 11 doses of the vaccine. The last two were given April 2, 2000 and April 13, 2000, both in the left arm. An autopsy performed in August suggests the vaccine as a factor, according to the Ionia County Chief Medical Examiner Dr. Robert Joyce. Dr. Joyce said Dick had an "inflammatory response" to the vaccine throughout his body.

Immediately after the results of the autopsy were performed, BioPort went on television and said they had no idea Dick had ever shown symptoms. BioPort also said the worst reactions they had ever heard of were minor headaches and localized pains.

First of all, let me tell you that my husband, Dick, had more than a headache after his vaccine was given to him in two parts in April. Soon afterward, he started suffering swelling in his left arm, wrist and hand. Dick also had some nausea, joint pain, and his arm was hot to the touch. These symptoms never went away, and they were no different than the other reactions he had every year, except this time they were much worse. I understand that these are the same chronic symptoms our military people have suffered.

On May 11, 2000, the swelling in the left side was much worse; the joint pain was worse, as was his fatigue. My husband seemed much worse than the month before. He went to work on May 13 and called me to say he needed to see a doctor. Dick was put off from work that day. When he would see the BioPort worker’s compensation doctor in Lansing, he always stopped to see his friends at BioPort. His company knew of his ongoing symptoms, because they always helped us with paper work and because of the many calls they made to see how Dick was doing. I am very grateful for that. He did think of them as his family. However, when Dick returned to work, he was still swollen and very tired and still suffered joint pain. Nevertheless, he was given a release to return to work with limitations.

Dick died on July 7, 2000, and that has changed my life and the lives of my children forever. This is fact, not fiction. Dick believed in this program, but also wanted it to be a safe program. I know that BioPort has had a lot of legal troubles and that you, the government, have been investigating the company for safety reasons. Only recently did I learn that in late August, BioPort had to recall three products, including the anthrax vaccine, because the wrong expiration date was put on labels. I don’t know what lot or batch of vaccine the company gave Dick, but I do know that a lot of other Americans have been made sick by the vaccine, and that is why I am here today. Nothing can be done to bring my husband back, but I ask this committee to please rethink this program and make it a safe one. I hope someday that, if any of you need to take this vaccine, you will have an option of whether or not to take it, and that if your option is to say "no," there will not be any repercussions.

Barbara Dunn

611 North Dexter

Ionia, MI 48846


Press Release on 2-17-00: DOD never followed Congress' recommendation
NP ABUSE is gratified that the House National Security Subcommittee has released its findings and recommendations today regarding the Department of Defense (DOD) mandatory anthrax vaccine program. NO ABUSE believes the committee's recommendation to "enroll all anthrax vaccine recipients in a comprehensive clinical evaluation and treatment program for long term study" is especially appropriate. Given the unanswered questions surrounding the vaccine's safety and reports of hospitalizations and crippling effects, this clinical study recommendation is also the strongest indictment against the value of the vaccine.

It is significant that NO ABUSE is officially activated on the same day the Congressional report is released. This organization represents the commitment of the relatives and friends of military members, as well as many concerned  citizens, to seek the whole truth about anthrax vaccine issues. NO ABUSE wants to ensure the Congressional recommendation to suspend the program is fully implemented.

In that regard, a permit has been obtained to conduct a demonstration on the grassy area west of the Ellipse, across 17th St NW from Constitution Hall (Daughters of the American Revolution), in Washington, D.C. on February 21, 2000, from 5-7pm. This rally is meant to send a message to the Secretary of Defense who is sponsoring an entertainment event in Constitution Hall that same evening at 7pm-"A Tribute to the Hero of the Century: the American Gl and the Selfless Service of the Military Family." The message of military family members and friends who gather to protest is: Stop risking the health of our family members and breadwinners with the anthrax vaccine.

The President of NO ABUSE, Redmond H. Handy, is a former Air Force Colonel who retired in protest of the policy and testified before two Congressional committees about the vaccine's effects. He established NO ABUSE in conjunction with hundreds of others concerned that the anthrax vaccine represents another episode in DOD's legacy of questionable and even harmful medical practices. "Nearly 80% of military members and their families oppose the mandatory shot (Army Times Poll), and for good reason," Redmond said, adding, "We hope the DOD and the administration now will finally take the initiative to respond to these concerns in a compassionate and definitive manner by discontinuing the shots."

NO ABUSE also believes it is imperative that Congress get to the bottom of the anthrax threat issue, especially considering several recent reports and experts have cast double on whether the administration has dealt with his threat in a productive and rational manner.

 

DOD Appropriations Bill Provision Orders Studies to Research Unanswered Anthrax Vaccine Questions
 

Suspension of anthrax program urged, Feb. 17, 2000

WASHINGTON (AP)- The military's program to inoculate all 2.4 million troops against anthrax as protection against biological warfare is based on "dangerously narrow scientific" evidence and should be suspended, a House panel says. The anthrax vaccine should be considered experimental because its effectiveness against biological warfare is uncertain and the safety of troops taking the anthrax shots is not being monitored adequately, according to the sharply critical report being released Thursday by the Government Reform Committee's national security subcommittee. A draft of the report obtained by The Associated Press says the immunization program "is an unmanageably broad military undertaking built on a dangerously narrow scientific and medical foundation." Defense spokesman Jim Turner said Wednesday that the department is reviewing the congressional study. Defense officials have said repeatedly the vaccine is safe and effective. The 80-page report was written by the subcommittee's Republican majority after six hearings on the vaccination program. The vaccine has come under increasing scrutiny from congressional lawmakers as soldiers, including pilots in the National Guard and reserves, have expressed concerns about taking the sex-shot regimen. Complaints included fevers, muscle pain and dizziness. Some reserve pilots testified that would resign to protect their health and flying careers while other soldiers in the active military have faced courts maritial. In 1998, Defense Secretary William Cohen ordered all active duty and reserve troops to get shots of the anthrax vaccine, starting with soldiers most likely to encounter biological warfare overseas. Some 340,000 service members have been immunized so far.



Department of Defense Anthrax Vaccine Immunization Program: Unproven Force Protection
 

Testimony before A VIP hearing
 

PREPARED STATEMENT OF MARK S. ZAID, ESQ. EXECUTIVE DIRECTOR, THE JAMES MADISON PROJECT

BEFORE THE SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS AND INTERNATIONAL RELATIONS COMMITTEE ON GOVERNMENT REFORM U.S. HOUSE OF REPRESENTATIVES

WEDNESDAY, MARCH 24, 1999

"THE PERFORMANCE OF THE ANTHRAX INOCULATION PROGRAM"  

Mr. Chairman, distinguished members of the Subcommittee, thank you for the opportunity to appear before you and offer my comments on the Pentagon’s Anthrax Vaccination Program. I shall briefly summarize my testimony and would ask that my written statement, and to the extent they can the exhibits, be included in the record in their entirety. My comments today are my own opinion, and do not necessarily reflect the views of my organization The James Madison Project.

I have been involved with the anthrax issue since April 1998, when I was requested to represent about one dozen sailors who were refusing the vaccine aboard the U.S.S. Independence. In June 1998, I filed a lawsuit under the Freedom of Information Act for information on the anthrax vaccine. Most recently, I served as the lead civilian defense counsel for Airman Jeffrey Bettendorf, who was the first serviceman to face court- martial for refusing to take the vaccine.

My oral testimony will focus on the circumstances arising when a member of the military refuses the vaccine and the exposure of several significant problems with the Pentagon’s policy.

After being retained by the Independence sailors, I investigated the prospect of a class action lawsuit in order to halt the program. The planned strategy was to challenge the safety, effectiveness and necessity of the vaccine. Legal research, however, quickly revealed that the likelihood of success was virtually non-existent.

The focus then turned to obtaining information. The FOIA lawsuit against the Departments of Army, Navy and Air Force and the FDA was quite comprehensive. It sought all data that related to the anthrax vaccine - studies, production information, composition, discipline policies, etc. The overwhelming majority of the released documents have never been publicly discussed before today.

Let me first address the legal issues, which are very straightforward. There is no set policy as to how a refuser will be dealt with, except as any other military discipline problem. Because of the sensitivities surrounding the program, many officers first emphasize counseling and education before imposing punishment. Some, however, resort to threats of force, although official departmental policy is that no force will be used.

Until recently the military had been fairly consistent in imposing penalties. Typically the following would happen. A soldier refuses the vaccine. He is taken to an Article 15 non-judicial proceeding. He is found guilty, reduced in grade, fined, restricted to ship or base and assigned extra duty. Eventually he would be administratively discharged. If he had a clean disciplinary record, a General Discharge under Honorable Conditions would likely be approved. In at least two cases that I know of, even where an individual went AWOL, a general discharge was still granted.

It was only a matter of time, however, before someone would proceed to a court- martial. Airman Jeffrey Bettendorf, who was stationed at Travis Air Force Base in California, followed the typical pattern at first. Clean record. Wife and child. Church- going. A basic boy scout. Unlike prior cases, somewhere in his chain-of-command someone wanted to set an example and Airman Bettendorf found himself facing a court-martial.

The key issue in an anthrax refusal case becomes whether the order to take the vaccine was lawful. The biggest hurdle is that the vaccine is FDA-approved. Therefore the order is presumed valid. From my work on Gulf War Syndrome issues, I was aware of theories that the vaccine had been modified in order to hasten or increase its potency.

Therefore, our primary defense strategy was that the order was unlawful because the vaccine being used may not have been FDA- approved and was therefore experimental. As a matter of law, consent was required. It was also our position that legal precedent gave us the right to challenge whether the vaccine was safe, effective or even necessary.

Through discovery we pushed for samples of the vaccine for independent testing, but before we went to trial the Air Force agreed to accept Airman Bettendorf’s earlier request for a discharge and he was processed out of the service under Other Than Honorable conditions.

Airman Bettendorf’s case has unfortunately now changed the gameplan. Rather than a discharge, refusers will now face much greater prospects for a court- martial. Once a conviction is obtained in one case, a precedent will be set that will be nearly impossible to overcome, absent extraordinary circumstances.

Let me now address some very important concerns about the program, and I will do so through the Pentagon’s model of Fact vs. Myth.

MYTH: "This vaccine has been routinely used in the US since 1970."

FACT: No industry routinely uses this vaccine. Some use can be found among veterinarians and livestock workers, but no evidence exists of widespread usage. If you ask someone from within these two fields about use of the vaccine, the typical response is one of - what vaccine? In fact, only about 30,000 individuals have received the vaccine since 1970, and relatively few people outside of the military receive the shot each year. The private sector uses between 400-500 doses per year. This amounts to perhaps 100-300 people per year using the vaccine. The inoculation of 150,000 servicemen during the Gulf War was the first major use of the vaccine in any significant quantity; nearly six times the number of people were inoculated than had been in the prior 30 years combined.

MYTH: "There have been no long term side effects from this vaccine," or "no long term consequences have been demonstrated.

FACT: These statements are totally unsupportable. The Defense Department has never researched whether use of the vaccine may result in long-term health consequences. In fact, no studies within either the public or private sector have examined potential long-term consequences. Moreover the manufacturer’s label itself reveals that no cancer or fertility studies have ever been performed.

When confronted with these statements of fact, the Pentagon’s PR machinery invariably responds that the vaccine has been widely used for 30 years and that it would be unethical to conduct tests on humans.

No one is calling for the initiation of human testing. Accepting the Pentagon’s assertions, however, that the vaccine has been widely used for nearly three decades, how difficult would it be then to locate several hundred or more individuals who once took the vaccine and, after taking into account all appropriate variables, examine their health? Do they suffer from cancer, or leukemia or Alzheimer or any medical malady? Can it be traced to the vaccine? When 2.4 million lives are at stake, there is a moral, if not legal, responsibility of the Pentagon to undertake such an effort rather than offer excuses.

MYTH: "A safe and effective vaccine is available that will protect our forces."

FACT: Setting aside the fact that new anthrax spores have been apparently developed that would not be effected by the present vaccine, the current program is actually not the most effective according to internal documentation.

Withheld from the public’s knowledge until the FOIA lawsuit, the Pentagon discovered years ago that the current vaccination series of six shots is outdated and unnecessary. In September 1996, the vaccine manufacturer, with the approval of the Army, filed an initial Investigational New Drug application with the FDA to reduce the vaccination schedule. The new proposal would be two initial doses with annual boosters, as compared to the licensed six-dose series over 18 months. Despite ample proof of the redundancy of the six series shot, the Pentagon still implemented the current program. By not waiting for the FDA’s approval, the Pentagon cost taxpayers at least an additional $32 million dollars in vaccination costs.

My final comments pertain to the adverse reaction rate. The manufacturing label for anthrax states that systemic reactions occur in fewer than 0.2 per cent of recipients, and are characterized by malaise and lassitude. Chills and fever were reported in only a few cases. The real truth, however, has been that systemic reactions among those in the military have been nearly seven times greater. Internal documentation revealed that up to 1.33% of recipients suffered a systemic reaction. It is vitally important to understand the significance of a systemic reaction. It is potentially extremely harmful and possibly fatal. While a percentage rate of 1.33% may not seem high, when applied to the fact that 2.4 million servicemen will be receiving the vaccine, this means that as many as 32,000 servicemen may suffer serious or fatal reactions.

Reports of systemic reactions, such as fever and prolonged muscular weakness, have been occurring since the program began. Even more shocking, stories have filtered back that medical officers have been reluctant or have even refused to file adverse reaction reports. And that they routinely assert that after-effects had little or nothing to do with the anthrax vaccine.

The Pentagon’s response has been to distribute disinformation by manipulating the statistics and the words. Documents being publicly disseminated now assert that systemic reactions of 0.2% or more are "very rare", which is contrary to its own reports. More importantly, fever and chill symptoms have been re-categorized as "severe local reactions" rather than the systemic that they are. This gives the false impression that such reactions are more common, when the fact is such a reaction could be deadly.

Mr. Chairman, it is a sad fact that we regulate industries, such as machinery and automobiles, far better than we do those that affect what may be placed within our own bodies. The anthrax vaccine currently in use for the military probably would not withstand FDA scrutiny were it submitted for approval today. Yet no one seems concerned that we do not know whether this vaccine is actually a safe product over the long term. And no one seems alarmed that the adverse reaction rates far exceed the figures supplied by the vaccine manufacturer itself, or that the Defense Department has sought to masquerade these ill effects through questionable wording changes.

To be sure anthrax is an intensely dangerous biological weapon. It is imperative that we seek out ways to adequately detect the spores before contact and protect ourselves afterwards. But the Pentagon’s anthrax program represents nothing more than an easy out from the hard task of devoting time and money to developing adequate detection equipment and, if possible, efficient vaccines that are truly safe and effective.

The Pentagon has knowingly misled the American people concerning this vaccine. Whether in twenty years from now advanced medical technology will demonstrate that the vaccine was either dangerous or safe is anyone’s guess. But until we know the full facts surrounding the safety, effectiveness and necessity of the anthrax vaccine, 2.4 million people are potentially being placed in harm’s way for possibly no legitimate reason. Until the proper studies have been undertaken the United States should follow the lead of the United Kingdom and implement its anthrax vaccination program as voluntary.

Thank you.

 

NEWS RELEASE
Congressman Walter B. Jones

http://www.house.gov/jones

FOR IMMEDIATE RELEASE
July 16, 1999

CONTACT: Kimberly Nielsen
202-225-3415

Bill Scraps Mandatory Program Until FDA Approves New Vaccination or Reduced Shot Course

WASHINGTON, D.C. - Congressman Walter B. Jones (R-NC), Member of the House Committee on Armed Services, today introduced legislation to make the current Department of Defense anthrax vaccination immunization program voluntary for all members of the Uniformed Services.

Jones' bill, the American Military Health Protection Act, will make the current mandatory program voluntary to United States military personnel until the Food and Drug Administration (FDA) approves a new anthrax vaccination for humans or approves a reduced course of shots, down from the existing six-shot program.

"The lack of a single, conclusive independent study on the long-term health effects of the anthrax vaccine on humans has created legitimate growing concerns among our men and women in uniform," Jones said. "Despite continued assurances by the Department of Defense that adverse reactions to the vaccination are minimal, the Department's standards used to measure the reactions haven't been able to support their claims."

"Without conclusive data on the long-term health effects of this vaccination, we have literally forced our United States soldiers, sailors, airmen, and Marines to choose between the safety and security of their families and their commitment to serving this great country," Jones said. "Until we can successfully provide the necessary information to lay to rest the concerns of our U.S. troops, making the program voluntary is the most fair and reasonable solution to the problem."

"Currently, Rep. Christopher Shays (R-CT) is moving forward with a series of congressional hearings looking into the anthrax vaccine program, which include the safety and effectiveness of the program and adverse reactions to it. The need for these hearings is substantial justification that we have a serious problem on our hands. Until we can determine its safety, we cannot expect our military to continue receiving what may be an unsafe immunization," Jones said.

"I have heard from too many military officers and enlisted personnel from the State of North Carolina alone, whose fierce loyalty and dedication to this country has forced them to leave the service rather than disobey a direct order to take the inoculation," Jones said. "I feel that I would be failing in my responsibility if I did not take action to protect the troops who willingly sacrifice their own lives in defense of this nation and its citizens."

Jones represents North Carolina's Third Congressional District - which includes Marine Corps Base Camp Lejeune, Marine Corps Air Station Cherry Point, Seymour Johnson Air Force Base, and the Elizabeth City Coast Guard Station - in the U.S. House of Representatives.

 

Statement on the Bioshield II Act

Protecting Our Guardians

 

   428 Park Avenue Birmingham, AL  35226 Tel: 205/823-2698 Email:protecting.our.guardians@charter.net

October 22, 2005

Dear Congressman Bachus:

The Biodefense and Pandemic Vaccine and Drug Development Act, S. 1873, which recently passed through the Senate HELP Committee, contains four specific areas with potential for harmful effects on American citizens, both military members and their families, the very constituents that you are so diligently trying to protect. We thought you would appreciate this information outlining our concerns regarding liability, judgment, economics and implementation, as listed below. Our association, Protecting Our Guardians, is a 501c4, non-profit, military family advocacy group focused on protecting military members from the hazardous anthrax vaccine so that they are healthy and able to protect our country. Thank you for your diligence in providing sound legislation to protect the safety and health of Americans. Please do not hesitate to contact anyone of us with questions. We appreciate your service.                                                                                               

1.      Liability.  This Act would free pharmaceutical and biologics companies of liability.  These companies would be given the gift of indemnity for their products.  When someone is harmed or killed by a new biodefense vaccine, they will not be able to hold the company accountable.  This approach has been repeatedly tried before and has failed.  For example, Bioport was granted indemnity for its anthrax vaccine and given large sums of money.  The FDA has documented 4,136 adverse reactions reported, and 16 deaths just since 2000, from this anthrax vaccine in a report dated Dec. 22, 2004.  The FDA also closed Bioport after it failed 4 separate inspections.  The FDA also discovered a contaminant, squalene, in all of Bioport's  lots of vaccine that were tested.  Its product has led to injury, death, and distrust within our military community.  After more than seven years of  tragedies, Bioport has still not been held accountable for its poor product. 

Another example, was when the approval of new drugs was sped up under the first Bush administration, and we saw an increase in citizens injured and killed by those new products.  Dr. David Graham testified to this before Congress at length, citing Celebrex and Vioxx and other new drugs that had been proven dangerous but were ignored in the interest of speed and convenience.  It was revealed that frequently doctors with financial stakes in such products are allowed to vote on what is supposed to be an objective FDA committee/s.  The companies also did not follow through with safety reports of how the drug performed once it was put out into the market as they were legally bound to do.  When the responsibility for safety and evaluation of new drugs is left in the hands of the companies and those who have a direct interest in the product's success, the consumers inevitably suffer the severe health consequences.  We are already giving these companies financial incentives to develop these vaccines.  Let us continue to  maintain our traditional  judicial and compensatory consequences if the product proves more harmful than good.  Please do not permit a repeat of past errors and free these pharmaceutical companies of liability.

 

2.      Judgement.  This Act would take the authority out of the hands of our courts, and place the judgement of any guilt or wrongdoing in the hands of a single person in HHS.  When someone has been disabled or killed by a drug, they have always gone to the courts for justice.  In a Capitalistic country like ours, profits are critical.  The best recourse a victim can take is to receive financial compensation when they are wantonly or negligently harmed by a product.  This system of government has worked well for our country.  To take judicial powers out of the courtroom and put them in the hands of a single person is extremely dangerous.  It throws off our system of checks and balances between the judicial, legislative, and executive branches of government.  It turns democracy into autocracy and despotism.  It denies citizens their rights to a fair trial by a jury of their peers.  Please close this loophole before great harm is done to our country's democratic process and American lives.

3.      Economics.  This Act would pour a massive amount of taxpayers' money into development of new biovaccines.   While citizens desire protection from these biological threats, it is not scientifically possible to give it to them no matter how much money is spent to that end.  Due to advancements in genetic engineering, a bioweapon can be altered with a new strain of bacillus or virus to render our newly developed vaccines useless.  This is basic science.  Our vaccine stockpiles would be powerless to protect us.  Our country's relatively new pharmaceutical and biologics companies are limited in what they can realistically offer to us at such great expense to our mounting deficit.  The best protection for our citizens is to have excellent intelligence on our enemies and eliminate them before they strike.

4.      Implementation.  It is unclear how these newly developed, minimally tested, products will be marketed.  It is imperative that measures be taken to preserve people’s right to voluntary and informed consent, including military members.  The marketing of these biodefense products should be grounded in our traditional system of Capitalistic supply and demand.  Drug companies must claim responsibility for the marketing of these products so that we do not blindly walk down a slippery path towards mandatory vaccinations for our military members, first-responders, or citizens.  Their profits must depend on the quality of their product, and stringent standards must be followed to ensure that quality.  Otherwise safety will be compromised, and innocent people will suffer as shown above.  It is another fact of science that a blanket approach to medicine is futile.  A single drug or medicine will not work for everyone because of numerous differences in people's individual immune systems.  If a drug is ever made mandatory or compulsory, there are those who will suffer side-effects and worse from it.  Please place protections in this Act for citizens and military members to receive biovaccines and the like on a strictly voluntary basis.

Protecting Our Guardians greatly appreciates your attention to these serious matters of concern as S. 1873 and the Bioshield II Act move through the Senate and on to the House.  

Most sincerely,

//signed//
 

Marguerite M. Armistead

Protecting Our Guardians, President

Lt. Col. Redmond Handy, Ret., Vice President

 

Elaine Wood, Secretary

Elaine Clinton, Treasurer

 

Support H.R. 6093

Barbara Damon Day's Bill

Protecting Our Protectors —

A Commission to Protect the Lives and Health of Members of the Maine National Guard

By Ramona du Houx

When Maine Army National Guard Capt. Patrick Damon died of undetermined causes in June 2006 in Afghanistan, a shock wave consumed the Statehouse. Damon was a dedicated public servant and had worked in the Capitol for ten years, during which he became chief of staff to a speaker of the house before taking a job in the administration at the Public Utilities Commission. Damon was known as "a tireless public servant who built a legacy of looking out for the people who couldn’t look out for themselves," said Governor Baldacci. Damon, 41, had two young children.

His family and friends were prepared, as much as they could be, to hear that he had given his life in combat. But the media reports which said that he died of a heart attack and the military saying he died from "undetermined causes" left his death surrounded in mystery. His mother, Barbara Damon-Day, started asking questions and searching for solutions.

"I became a woman with a mission," said Damon-Day. "Anyone who knew my son understood that he was a healthy, young, family man."

After researching what happened, Damon-Day thinks extensive immunizations were the major factor in her son’s death.

"Shortly after Pat received his deployment orders, he was given vaccinations, and that is when the trouble began," said Damon-Day. "He began to have strange swelling that was visible even in photos he sent home, and other severe symptoms that should have been recognized as an adverse reaction and a serious health issue. I have come to accept that we will never know exactly why Pat died, but I believe that his death was a reaction to those vaccines. If anything can be gained from this tragic loss, I hope it is that we pass this law to put in place safety measures and reviews that will protect the health of those still serving and offer our families an independent source of information and a place to turn."

(Photo: Damon-Day with Gov. Baldacci at the announcment of the legislature)

"When the Maine National Guard is deployed, these citizen soldiers of Maine require a high level of certainty that the medications they receive will not put them in jeopardy and that they will receive the best preventative medical care available," said Speaker of the House Glen Cummings. "Their jobs are dangerous enough without being subjected to further peril by the very medications meant to protect them."

In most branches of the military, soldiers are herded through lines and immunized before going into combat. It’s rare that medical charts are checked and many military personnel end up receiving shots for immunizations that they already had. When anthrax immunizations were introduced, some military personnel started to complain about dizziness, and there were deaths attributed to unexplained blood clots.

"It’s not the first time this has happened to our military," said Gary Lawyerson of the Maine Veterans Coordinating Committee. Many Veterans from the First Gulf War are still suffering from the effects the vaccinations had upon them, though the official military position doesn’t acknowledge their illnesses are due to the shots.

"It knocked me off my feet," said Lawyerson, a Marine, referring to when he was given a vaccine for anthrax before the First Gulf War. "The shots they gave us were supposed to help protect us, but for many of us they had the opposite effect. I think this proposed legislation is a home run. We’ve suffered too long. We were only serving our country."

The legislation was the governor’s bill, sponsored by more than 155 members of the Maine House and Senate. It passed with unanimous support.

The bill was introduced because Damon-Day kept on fighting for her son, serving her state and country.

"I am looking for something positive to come out of my son’s death," said Damon-Day. "Soldiers are far more likely to die in a non-combat incident. Death from preventable illnesses needs to be looked at, and I think a partnership between the Maine CDC and the Guard is the best way to proceed."

"When this country sends its men and women into harm’s way, we have a moral obligation to make sure we take care of them, not only when they are in combat, but also when they come home. We can tolerate nothing less," said Governor Baldacci. "It was a tragedy almost a year ago that started us down the path toward today. But it is not tragedy or sadness that keeps us going and keeps us working. Instead, it is hope that we can — all of us — come together and find the answers to make things better."

The new law creates a nine-member commission to review all preventive health treatment practices and protocols, vaccinations, and other medications administered to members of the Maine National Guard. Working with the state Department of Defense and Veterans Services and the Maine Center for Disease Control, the commission would propose recommendations for safer healthcare practices and medications to the U.S. military. The panel also would assist families with members who have died or been wounded while in the National Guard. The commission would include at least one physician, a veteran who has served in a war zone, a pharmacist, a person with a military-related disability, and a psychologist.

"Here in Maine, we take care of our people. And that’s what this bill is all about," said Baldacci.

"I really believe this law will get something changed in Washington. Again Maine will lead the way," said Damon-Day. Shortly thereafter, she met with Congressman Tom Allen and inspired him to sponsor an amendment calling for better medical screening of military personnel, which was attached to a federal defense-spending bill.

"Vaccinations are intended to protect our armed forces from disease, but there are real concerns about serious potential harm that may result from multiple vaccinations given to troops at one time," said Representative Allen.

Allen’s amendment is based on the governor’s legislation and directs the U.S. Defense Department to assess policies governing vaccinations given to military personnel and to study whether multiple vaccinations in a 24-hour period are safe and effective.

"Today was a good day," said Damon-Day, after the press conference in Augusta. "Sometimes when I’m gardening, I think I can hear him tell me I’ve done well. He keeps me going."

 

Dr. Nass' Final Senate Vets Affairs Oct. 1 2007

Dr. Nass' Answers to the House VA Health Subcommittee  Oct. 1 2007
 

1.  In your professional estimation, what is the biggest challenge facing VA today with regard to Gulf War Illnesses?

For at least ten years, the personnel in place to implement Gulf War Illness programs have prevented good research, good diagnostics and good treatments for Gulf War veterans.  A group of individuals at VA have had control over research, outreach and treatment, and these officials have ensured that the focus of both research and treatment has been primarily psychological. The medical evaluation strategies adopted by the VA have specified that investigations of veterans’ symptoms be limited, and the recommended treatment strategies have primarily used psychiatric drugs.  However, I must assume that these individuals have carried out VA policy, since there is no evidence they were instructed to do otherwise.  Unless and until VA policy aligns with the goal of doing our best for GW veterans, things cannot change.

A true story:  in 1999, a Committee on Government Reform staffer told me that the reason Gulf War veterans were being diagnosed and treated for psychiatric illnesses was because disability pensions could be limited to two years more easily than if they were acknowledged to have physical illness.  I cannot confirm if this is true, but it may be relevant to the question of why VA made the choices it did regarding GW research and patient care.  Recent revelations about the use of “personality disorder” diagnoses[1] by the Army to discharge veterans without a medical board or pension suggest that these choices have been deliberate.
 

What would your recommendations be to VA to ensure that what has happened to the Gulf War veterans does not happen to the newest generation of veterans returning from OEF/OIF?

At the Senate Veterans Affairs Committee hearing where I testified on Sept. 25, 2007, DOD’s representative, Michael Kilpatrick, M.D., stated in answer to a question that “15-20% of those who've fought in Iraq recently are returning with "’ill-defined’ medical symptoms, Kilpatrick said.”  (McClatchey-Tribune, Sept 26)  Later Kilpatrick told a reporter he did not mean to imply they all had GWS.

It should be a concern to all of us that DOD has already identified a developing medical problem in a significant number of returning soldiers.

In order to provide optimal care to OIF and OEF veterans, VA needs to know the types and severity of medical conditions these veterans face, and their frequency. An accurate needs assessment cannot be made without reliable information from DOD to VA.  Media reports suggest VA relies on information from military medical boards, but note that many veterans whose status should prompt a medical board are not going through the board process.  How has this affected VA planning? 

Therefore, since information supplied by DOD on the health of troops has not always been accurate and complete, VA should be performing its own surveillance of new veterans, in order to best predict the medical needs of returning soldiers. 

New entrants to the VA system should complete a detailed questionnaire and evaluation by practitioners who are knowledgeable about the physical and psychological needs of veterans returning from combat.  Creating a database from these assessments could help to prepare further investigations and treatments for returning troops, and identify those who have developed chronic medical conditions for specialized care.

Congressional oversight should address VA’s programs for dealing with the 15-20% of troops with ill-defined conditions identified by Dr. Kilpatrick, as these veterans are most at risk of slipping through the cracks in the way that happened to veterans with Gulf War Illnesses.
 

Do you believe that this exchange of information between VA and DoD has improved with current deployments to Afghanistan and Iraq?

Regarding whether things have improved, I can only refer to the GAO report of September 26, 2007:[2] [3] DOD and VA: Preliminary Observations on Efforts to Improve Health Care and Disability Evaluations for Returning Servicemembers.  See pages 19-22.

http://www.gao.gov/new.items/d071256t.pdf

Clearly, information exchange is not where it should be.

My experience has been that DOD jealously guards information on the health of troops.  Spokespersons have not always reported accurately to media on this issue, and military medical studies are frequently at odds with independent research on the health of troops.  The Congressionally-mandated Defense Medical Surveillance System database is being maintained, but the data are not shared with independent researchers, despite federal advisory committee recommendations. The data are only 80-90% accurate, according to GAO, CDC and the Navy Environmental Health Center in San Diego.  Presumably, more effort could be made to improve the accuracy of the database.  Congress could require that data be shared.

Unpublished studies of the database are not shared either.  Accompanying this response, I have included two lists, obtained via Freedom of Information Act requests, of titles of informal studies performed by the Army Medical Surveillance Activity, which used this database for the studies. I have so far been unable to obtain any of the actual studies from the Army (using FOIA).  Many of these studies, especially those on GWS and on anthrax vaccine, should be of interest to the Congress and the VA.
 

In your professional opinion, would you say the lack of information exchange or delayed exchange was a primary factor in hindering research efforts regarding Gulf War Illnesses?

Yes.  Procedures for investigating and dealing with toxic exposures could have been initiated, appropriate infections sought, etc., had VA been aware of the types of exposures that had been experienced by individual veterans when they first arrived in the VA system.   The lack of good information from DOD made it very difficult to study most of the Gulf War exposures, since without accurate information it was uncertain who was exposed to what, and the magnitude of the exposures.  The problem is only partly one of information exchange; it is uncertain whether DOD monitored and recorded noxious exposures to which its soldiers were exposed.  This includes exposures to sarin, to unvented tent heaters, to vaccines, pyridostigmine bromide (PB) and depleted uranium.  Thus the later research had to rely on so-called “self-reports” of exposures—but the research was also criticized for using these unvalidated reports.

However, the main factor that hindered good Gulf War illness research after the immediate post-war period was the lack of will to do so, shared by VA and DOD.
 

What are your thoughts on creating another task force or entity to look into ALS?

A task force is a good way to review the problem and recommend directions to pursue.  However, the value of a task force is totally dependent on its chairman, members and staff.  It also needs to be given unfettered access to data, and the power to have its recommendations carried out in a meaningful way.

For example, exposure to electromagnetic fields has been linked to ALS in a number of studies.[4]   In order to pursue this link most productively, information on the electromagnetic fields generated by DOD weapons, communications systems and other equipment would need to be known, and the exposures in different groups of soldiers identified.  It is unlikely that DOD would cooperate in providing these data.

In order to avoid reinventing the wheel, it should be noted that in 2001, a UK (government) expert panel made some research recommendations about ALS and electromagnetic fields:[5]

“Case-control studies are, however, appropriate for investigating the aetiology of amyoptrophic lateral sclerosis and, in view of the rarity of the disease, are generally preferred to cohort studies. A large-scale case-control study might, therefore, be profitably undertaken in which special enquiries were made about:

   1. employment in electrical occupations, with special reference to the occurrence of severe electric shocks.

   2. medical treatment with electroconvulsive therapy that could be confirmed from hospital records.

   3. exposure to transcranial magnetic stimulation (Walsh and Cowey, 1998), a technique for magnetic induction of neuronal activity in small brain volumes, which is used both experimentally and clinically.

More work is needed to explore the effects of electromagnetic fields on neurons and glial cells. In particular, the effects of both brief explicit shock and prolonged exposure to electromagnetic fields on intracellular Ca2+, superoxide dismutase (SOD) activity and enzyme function in neurons deserve particular attention.”
 

Do you believe that the direction VA is taking with ALS is the right way?

I cannot comment.  ALS has been one disease that has been associated with 1991 Gulf War service.  We do not know how many more diseases may also be associated, as the  (relatively simple) epidemiological research to study this has not been done by VA and DOD.

 

What would your recommendations be on how to effectively move forward with Gulf War Illnesses research, outreach, education and treatment?

As I was preparing my responses to these questions, the Senate Veterans Affairs Committee asked me to provide testimony on Gulf War Illnesses.  My response is included in that document, which I am attaching.

Accountability for program success is crucial to the effort, and Congress should demand regular reports on the Gulf War Illness program.

 

Based on my practices and studies, do I believe there is a connection (between anthrax vaccine and Gulf War Illnesses)?

There is no doubt about their connection, which has been identified in at least 6 different studies.  What I was trying (clumsily) to say in my testimony was that the magnitude of the anthrax vaccine contribution to Gulf War Illnesses was not known.  In other words, we do not know what percentage of cases might be due to anthrax vaccine alone, though we do know the vaccine alone has caused an illness identical to GWS in non-deployed soldiers.  (Even the FDA-approved label for anthrax vaccine lists GWS, as defined by CDC, as a reported adverse reaction.) In my opinion, anthrax vaccine added to the burden of toxic exposures faced by soldiers in the Gulf and increased the number of soldiers who developed chronic illnesses.  Many soldiers who never received anthrax vaccine became ill, but receiving the vaccine almost certainly increased one’s risk of developing GWS.

Meryl Nass, M.D.

September 30, 2007

[1] http://www.thenation.com/doc/20071015/kors

Joshua Kors. Specialist Town Takes His Case to Washington. The Nation. September 27, 2007.

[2] http://www.gao.gov/new.items/d071256t.pdf

DOD and VA: Preliminary Observations on Efforts to Improve Health Care and Disability Evaluations for Returning Servicemembers. GAO-07-1256T, September 26, 2007. Pages 19-22 cover the data sharing issue.

[3] Hope Yen. GAO Again Slams VA and DoD for Failing to Care for Wounded Iraq War Veterans. AP/Army Times September 27, 2007.The report said the Pentagon and VA still remain far away from having a comprehensive system for sharing medical records as injured veterans move from facility to facility.”

[4] Christoffer Johansen and Jørgen H. Olsen. Mortality from Amyotrophic Lateral Sclerosis, Other Chronic Disorders, and Electric Shocks among Utility Workers. American Journal of Epidemiology Vol. 148, No. 4: 362-368. “The excess mortality from amyotrophic lateral sclerosis seems to be associated with above-average levels of exposure to electromagnetic fields and may be due to repeated episodes with electric shocks.” http://aje.oxfordjournals.org/cgi/content/abstract/148/4/362

[5] ELF Electromagnetic fields and neurodegenerative disease. Report of an advisory group on non-ionising radiation. National Radiological Protection Board, 2001. 12(4). http://www.hpa.org.uk/radiation/publications/documents_of_nrpb/pdfs/doc_12_4.pdf

 

Dr. Nass' Written Testimony for the House VA SubCommittee on Health Jul. 26 2007

Letter to Congressman Hinchey to support H.R. 6093

Text Box: Protecting Our Guardians
A 501(c)(4) non-profit Military Family Association
“Protecting Our Troops so they can Protect Us”
Committed to protecting military members from the dangers of the anthrax vaccine
 

 

 


 

www.ProtectingOurGuardians.org

428 Park Avenue

Birmingham, AL 35226

Tel: 205.823.2698

Protecting.Our.Guardians@gmail.com

 

Steve Fisher , President

Lt. Col. (Ret) Redmond Handy, Vice President

Dr. Meryl Nass, Medical Advisor
 

Congressman Maurice Hinchey

Attention: Mr. Liam Fitzsimmons
June 7, 2008

 

Dear Congressman Hinchey,

Thank you for authoring the much needed Carmelo Rodriguez Military Medical Accountability Act, H.R. 6093.  We are writing to you in support of this important legislation.  As one member of our Board of Directors stated “…one Carmelo Rodriguez ‘incident’ is too many!” 

Our organization has seen hundreds of similar tragedies; and research reveals that there have been thousands of strong, healthy, military members who have become crippled, disabled, or even died, after taking the anthrax vaccine under orders from the Department of Defense and its Anthrax Vaccine Immunization Program (AVIP).  Our delegations of veterans, concerned spouses, and our Medical Advisor, Dr. Nass, have visited Capitol Hill countless times over the past several years in order to speak with Senators, Representatives, and legislative assistants about the dangers of the anthrax vaccine, its detrimental impact on our soldiers, our national security, and on military families. 

“Military Medical Accountability” is needed to stop the reckless disregard for military members’ health when their lives are at stake.  In fact, as you know, the Feres Doctrine prevents military members from seeking recourse for medical negligence or malpractice.  In addition, those disabled or killed by their anthrax vaccine shots also have no other recourse to pursue, because the manufacturer (Bioport, now called Emergent BioSolutions) was given indemnity under Public Law 85-804 by the U.S. Secretary of the Army, Luis Caldera, in September of 1998, who cited, "unusually hazardous risks.”  We would like to see that change.  When H.R. 6093 passes, soldiers will be able to hold those who are responsible for their sudden illnesses to be held accountable.  Ultimately, when H.R. 6093 passes, we will see our soldiers getting better healthcare and serving our country for longer periods of time.  Your legislation upholds truth, justice, and compassion. 

In the meantime, we still have veterans like Fred Conklin, who suffer.  He had two anthrax vaccines and almost died from Stephen Johnson Syndrome.  Doctors down in Mobile County, AL were able to save his life.  His injuries were not considered Line-of-Duty, so he and his wife have had to fight an uphill battle for years to get his disability with the VA and go through PEB/MEB proceedings.  They lived on just $800 dollars a month--with two teenage sons in a home that was declared a total disaster because Hurricane Katrina had ruined it.  Fred is in constant pain, needs a wheelchair, and needs oxygen.  H.R. 6093 will help Fred and his family.

We will be notifying our members and associates across the nation about the Carmelo Rodriguez Military Medical Accountability Act and asking them to support it by contacting their various Representatives.  Thank you again for your efforts, and insights, on behalf of military members and their families.

 

Sincerely,

//signed//

Steve Fisher

Protecting Our Guardians

President

 

Letter to Congressmen and Committees in Support of H.R. 6093
 

July 3, 2008

Dear Honorable Congressmen of the House Veterans’ Committee:

Thank you for your many efforts to help military members.  I am writing to you to specifically thank you for your support of the bill HR 6093, the Carmelo Rodriguez Military Medical Accountability Act.  I would like to ask you to redouble your efforts to get this vital bill passed, because we know that HR 6093 will help thousands, up to hundreds of thousands, of military members and their families. 

Our organization is called Protecting Our Guardians (POG), and we work to protect our troops from the devastating adverse reactions to the anthrax vaccine.  We would like to offer our help in supporting HR 6093 as constituents and, more importantly, as those who can testify, first-hand, about the unconscionable lack of accountability when military members fall victim to bad medicine.

Allow me to explain what we see on a regular basis here at Protecting Our Guardians. Here is a brief background.  Forty four deaths have been reported to the FDA using VAERS forms because of the anthrax vaccine and nothing has been done.  5,329 adverse reactions to the anthrax vaccine have been reported on VAERS forms too.  The manufacturer, Emergent BioSolutions (formerly called BioPort, formerly called Michigan Biologics Institute) was given indemnity by Luis Caldera, who was Secretary of the Army, in Sept. 1998.  Soldiers have not been able to sue the company for their crippling disabilities nor have they been able to hold the government accountable because of the Feres doctrine.

 Members of POG's Board of Directors routinely see soldiers in their twenties on up, over and over again, going before the PEB or the MEB and being given 20% for their disabilities.  They are told that their adverse reactions to the anthrax vaccine, or to a combination of vaccines, were not Line of Duty (LOD) and so cannot be covered by the government.  One Medic from the Army was even threatened by members of the MEB/PEB.  He was told "How long do you think a man in your condition would last in Iraq?"  His meaning was clear: "Take what we are offering you or we will send you to Iraq to die of a third heart attack."  This friend, and fellow veteran, has now lost the home that he raised his children in and everything he owned. He and his wife simply don't have enough money to make ends meet.  How can anyone survive on 10-20% of their income--especially when they are too sick to work and have hefty medical bills? 

These same soldiers then go to the VA and, after years of paperwork, are told that they are 280% disabled or 240% disabled.  The VA then gives them 100% disability which helps them.  These soldiers usually have to be taken care of by a wife or a parent for the rest of their lives.  HR 6093 will give these soldiers a way to hold the government, and in turn, the anthrax vaccine manufacturer accountable for their medical care and ultimate survival. Military members deserve the same rights to medical accountability as average citizens enjoy, or even a greater degree of accountability.

We hope we have not upset you by giving you a glimpse of what we are facing and how much your fellow soldiers need your help.  Please redouble your efforts to pass HR 6093.  For some veterans, you are their last hope.

 

With gratitude,

//signed//

Marguerite M. Armistead
Protecting Our Guardians
Immediate Past President

POG Position Paper Apr. 15 2007

Text Box: PROTECTING OUR GUARDIANS
A 501(c)(4) non-profit Association
www.ProtectingOurGuardians.org
428 Park Avenue
Birmingham, AL 35226
Tel: 205.823.2698
Email:  Protecting.Our.Guardians@gmail.com
 
 

 

 

 

 

 

POSITION PAPER

 

Protecting Our Guardians is a 501(c) (4) non-profit association committed to:

 

AVIP FACTS:

1.       Biothrax is the nation’s most reactogenic vaccine.   5,120 adverse reactions and at least 21 deaths have been reported on this substance through FDA’s voluntary Vaccine Adverse Event Reporting System (VAERS), and   a former FDA Commissioner admitted VAERS probably captures only 1% of total reactions.  The 2002 manufacturer's product insert lists 40 different reported serious side effects (see note at bottom of next page), and an acknowledged systemic reaction rate of 5 to 35%.  Many reactions, including immune and neurological disorders, persist for years without relief or resolution.  By comparison, the swine flu vaccine program in the 1970s was discontinued after only three related deaths. 

2.       Recent FDA approval of the anthrax vaccine is no guarantee of safety or efficacy.  Since 1999, seven expert groups have pointed out the need for long-term safety studies.  The December 2005 FDA Final Rule on anthrax vaccine failed to address critical issues, such as the acceptance of data from an older vaccine formula to justify the current vaccine, and the absence of any human efficacy data for the licensed vaccine.  Senate Finance Committee hearings demonstrated multiple well-publicized FDA failures to regulate drug safety in 2005.  Biothrax is another drug for which the FDA has failed to provide appropriate regulatory oversight.

3.        Vaccines are easily defeated.  It is not currently possible to develop a vaccine that will protect against every strain of anthrax; nor can the military anticipate new weaponized anthrax strains that might evade vaccine protection, according to US and former USSR experts.  The threat of overwhelming retaliation worked to deter communist aggression in the Cold War, but it is unknown if bioterrorists are deterred by vaccinated targets. 

4.        The vaccine’s dosing schedule requires 24 shots in a full 20 year military career to maintain unproven immunity.  This requirement has been proven to be logistically unfeasible, fails to meet modern inoculation standards, and amplifies the risk of adverse reactions.  A Congressional investigation (House Report 106-556) identified these features of the AVIP program.  The DoD demonstrated an inability to comply with the regimen of six shots in eighteen months, followed by yearly boosters, thus administering a program of de facto experimentation for thousands of service members.  This issue especially impacts Guard and Reserve members, whose duty schedules make compliance with the shot’s regimen difficult, if not impossible.  Also, the anthrax vaccine regimen requires 14 shots in the first decade to maintain uncertain immunity, whereas protection against tetanus requires only one shot every 10 years and has a demonstrated efficacy record.

5.        The presence of contaminants, toxic components, or ingredients not found in other licensed US vaccines has never been ruled out.  The FDA discovered illegal squalene in 5 older vaccine lots and notified Congressman Jack Metcalf who reported his findings in a House National Security, Veterans Affairs, and International Relations Subcommittee hearing on September 27, 2000.  DoD had tested only to parts per million and said no squalene was present.  The FDA has not reported testing newer lots.  Vaccine components have not undergone standard toxicology testing.  Assurance that the vaccine is free of these substances can only be obtained by stringent independent testing and analysis of every vaccine lot, using equipment that can measure squalene and other potentially injurious substances in parts per billion.

6.        Morale, refusal, legal, and family problems associated with the previous mandatory AVIP program have already resurfaced (http://www.cbsnews.com/sections/i_video/main500251.shtml?id=2684326n), CBS broadcast on 4/14/07.  The vaccine’s high risk is an additional threat to service member’s life and health on top of IEDs, mortars, and bullets in deployed Global War on Terrorism locations.  Continuing to use the Biothrax vaccine will result in further injuries to the health of military members, problems with retention and recruitment, additional legal actions on behalf of military members, and a weakened National Security.

7.        The vaccine’s use is unjustified given alternative biodefense measures and the controversial bioweapons claims in Iraq and elsewhere.  The strategy of pre-exposure vaccination should be reassessed in light of many other means of anthrax protection.  These means include physical protection measures such as impenetrable, spore-proof fabric and more detection equipment in the field, as well as various post-exposure treatment options such as antibiotics, antiserum, many new drugs in development and monoclonal antibodies that can be targeted to those who are at risk or who have been exposed.  Such a strategy review should determine the most cost-effective and least hazardous solution(s) proportional to the anthrax threat.  Also, with the degree of controversy over which nations have weaponized anthrax and the alleged misuse of intelligence on WMD matters, the credibility of a vaccine defense is commensurately in question and should be reviewed by independent experts.

8.        Service women are highly vulnerable to the vaccine’s side effects.  The data show that women have twice the systemic adverse reaction rate as men (GAO-02-445).  FDA notes there is evidence the vaccine can cause birth defects, placing it in Category D, yet it is given to women in their peak childbearing years.

9.        The DoD is facing enough health care challenges already.  Recent public disclosures of substandard care for the war-injured at Walter Reed are indicative of funding choice problems faced by the Department.  Funding for DoD's four Vaccine Healthcare Centers has also been in question during the past two funding cycles, requiring action by Congress for the healthcare centers to remain open.  Cessation of appropriations for the DoD's four Vaccine Health Care Centers would result in inadequate evaluation and treatment of vaccine injuries.  The VA also lacks such centers, but needs them.  Thus far, the science of caring for vaccine injuries is still in an early stage of development and requires directed research.  Many service members injured by anthrax vaccine have been discharged without benefits, which places a burden on the VA system but spares DoD the cost of caring for these victims.  In fact, a recent investigation by Senator Levin revealed that 13,000 discharged service members who received no disability rating from the DoD received an average of 56% disability from the VA.

10.     The VA system is equally incapable of absorbing the burden of anthrax vaccine related disabilities.  In the midst of the conflict in Iraq, Veterans’ Administration Hospitals and caseworkers are already overloaded with sick and injured veterans.  A recent study from Harvard University predicts that the cost of lifetime medical care and compensation benefits for returning veterans could eventually reach $660 billion.  The VA system is currently not prepared to handle a large number of soldiers with persisting vaccine reactions; nor can it easily provide pensions to veterans disabled as a result of vaccine injuries.

 

CONCLUSION

The original $130M AVIP program cost has ballooned astronomically to include inseparable expenditures for examining and treating vaccine reactions, injuries, and/or deaths; rebuilding the manufacturing plant; imprisoning or discharging refusers; conducting extra medical evaluation boards; additional VA disability case reviews; lost productivity from injuries; lost warfighting capability from Guard/Reserve aircrew departures (GAO-01-92T), and a 2004 failed contract with VaxGen for $877.5 million to produce a more effective the anthrax vaccine, among other measurable impacts.  These costs do not include intangibles such as public relations, DoD leadership, and Congressional hearing time, as well as the loss of trust and morale among citizens, those in uniform and their family members, or those considering military service.  The only reasonable solution for this magnitude of negative return on taxpayer investment is for Congress to defund the AVIP program.

Note:  The anthrax vaccine product insert reveals a systemic adverse reaction rate of 5-35%, which includes, but is not limited to, side-effects such as "Anaphylaxis and/or other generalized hypersensitivity reactions… … cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system… … Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma  (1).

 

 

___________________________________________________________________________________________________________________________
Anthrax Vaccine and Biothreat

Two Books You Must Read

1.       Anthrax:  a deadly shot in the dark by Retired Lieutenant Colonel Tom Heemstra.  Forward by Congressman Shay S. Heemstra who was an F-16 squadron commander.  www.deadlyshot.com

2.       Vaccine A by Gary Matsumoto

 

Three Documentaries You Must See

1.       Direct Order, www.directorder.org

2.       Raven Warrior, www.directorder.org

3.       A Call to Arms, www.acalltoarmsmovie.com

 

Dr. Robertson shows vaccine ineffective

Anthrax Shots' Effect Challenged

By Thomas E. Ricks

The controversial anthrax vaccine that the Pentagon is trying to inject into 2.4 million troops does not provide complete immunity to an anthrax attack, according to an outside expert who has examined Defense Department records of laboratory tests.

Soldiers who are exposed to anthrax may become quite sick and be incapacitated for up to two weeks, even if they have received the full set of six inoculations, said Dr. George A. Robertson, a molecular biologist specializing in pharmaceuticals… …[and] an expert in biological warfare [and a Retired Army Reserve Colonel].

…the monkeys sickened even though they had been given significantly larger doses of vaccine than humans receive, relative to their weight.

…If it turns out that even fully inoculated soldiers would be unable to fight after exposure to anthrax, the implications for U.S. military operations are enormous, said Chris Seiple, a former Marine officer who serves on a panel studying chemical and biological warfare issues at the Center for Strategic and International Studies.

To view the entire article, go to http://www.washingtonpost.com/wp-dyn/articles/A61149-2000Jul17.html?referrer=emailarticle

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c/o E-mail Customer Care
1515 N. Courthouse Road
Arlington, VA 22201
© 2004 The Washington Post Company

 

How "adequate and well-controlled" was the "clinical trial" of a human anthrax vaccine, 1955-1959?

Anthrax vaccine and Gulf War illness symptoms in Captain Jean Tanner's Dover Air Force Base survey

A statistical reanalysis of Brachman et al.'s 1962 study of a human anthrax vaccine

 

Antibiotic Against Anthrax from UAB

Dr. Larry DeLucas, a former astronaut and currently director of UAB Biophysical Science & Engineering, has tailored an antibiotic for anthrax, according to Dave Parks' article in The Birmingham News on Sept. 5, 2000. "DeLucas said the antibiotic was designed using crystallography. That process allows a drug to be precisely tailored to block the internal workings of a virus or bacteria. 'It's like a hand going into a glove… a very powerful approach.'" DeLucas asserted that "UAB's new antibiotic could be more effective against anthrax than Cipro." As of 2000, the "Army has spent $6.5 million to develop the antibiotic over four years, and an estimated $16 million more is needed, said DeLucas."
 

New antibiotics for anthrax?

2 April 2003

New antibiotics for anthrax?
 
A US patent was granted early this year for a new class of compounds that could eventually represent a family of drugs with antibiotic properties against the anthrax bacterium, Bacillus anthracis.

The new class of drugs would have the important benefit of being active against other pathogenic bacteria while leaving the endogenous microflora of the human intestinal system intact.

Although the drugs are still in the earliest stages of development, officials at both VDDI Pharmaceuticals and the University of Alabama at Birmingham's Center for Biophysical Sciences and Engineering (UAB-CBSE, who jointly filed the patent, are optimistic about the future use of the compounds, the first of which appears to discriminate between Gram-positive and Gram-negative bacteria.

As director of the UAB-CBSE, Larry DeLucas chose to first develop compounds that were designed to block NAD synthetase, an enzyme critical to the bacteria's transition from its sporulated state to its potentially lethal vegetative form. The enzyme is one of several that could provide future drug targets for the anthrax bacterium, and was a natural first choice because the crystal structure had already been published.

The research is partially funded by the US Department of Defence, in hopes that the compounds could be used to protect potential victims of a biological attack with anthrax. Normally, when a spore is inhaled, DeLucas explains, it is engulfed by a macrophage. Once the spore encounters the right environment - "water, a few crucial amino acids, like alanine," - it begins to germinate. "The spore is harmless... it has to lose its outside core," said DeLucas. "Then it becomes a vegetative cell. It looks black; it begins to divide and multiply, you get so many in the lungs, and then they begin to release toxin." He sums up the consequences simply: "Then you have big problems."

The new compounds were designed to shut down the bacteria's emergence from its protective coating. DeLucas explains that the spore tries to become the bug and it eventually loses its shell; however, when NAD synthetase is blocked, the walls break apart and it looks like "a bomb went off, and you get no bug."

DeLucas stresses that the compounds have only just begun down the long road of drug design but, if successful, could be a powerful prophylactic against a biological attack. Even with a large number of spores in the air, they would just fall apart and infection would be prevented. The currently used antibiotic Cipro, in contrast, is only effective when anthrax exists in its vegetative state, which means that the victim is already becoming infected. Compounds that inactivate NAD synthetase would also be useful against the vegetative cell after the spore has germinated, adds DeLucas, because the enzyme is still vitally important to the organism.

Indeed, the enzyme is vital to any bacterium, so DeLucas was surprised when the new inhibitors showed "an absolute predilection for Gram-positive bacteria," while leaving Gram-negative bacteria, such as E. coli, intact. The researchers are hoping that this means that it is not going to kill all internal microflora, "but it is difficult to predict whether a compound will act with such specificity," said DeLucas; "it is likely to depend on subtle structural differences in the proteins."

Although researchers at the UAB-CBSE have not yet co-crystallized NAD synthetase with the bound inhibitor, they have compared the crystal structures of the enzyme from Bacillus subtilis and from E. coli, and they hypothesize that a small amino acid loop near the active site in the Gram-negative bacterial enzyme might prevent the compound from disabling NAD synthetase.

DeLucas and his group aimed to design compounds that would specifically disable their target by binding to the enzyme's active site. Structure-based drug design has many advantages, says DeLucas, primarily that such a drug is effective: "the enzyme just can't work," he said.

In addition, a compound that binds at a protein's active site is less likely to lead an organism to develop resistance. Amino acids on the surface of a protein could be easily mutated without affecting function but the active site is different, explains DeLucas. "If you look at any protein...there will be certain amino acids that are critical for it to function," he said. By making a drug that binds to those specific residues, you use an area of the protein that is less likely to naturally mutate and thereby confer resistance.

J. Todd Weber, of the National Center for Infectious Disease at the US Center for Disease Control (CDC), says that it is "clear that we do need new classes of antimicrobial drugs," because, notes, rates of resistance are increasing all the time. Although Weber is not familiar with the unpublished details of the current work, he noted, "any advance to create new drugs that get around the mechanisms of developing antibiotic resistance would certainly be valuable".

Currently, researchers must also consider a non-natural source of mutations that might lead to drug resistance: those engineered by potential bioterrorists. DeLucas suggests that by making the active site the drug target, you could protect the drug's efficacy. Vaccines, too, are subject to lose their effectiveness through natural protein mutations. "Does this mean we should not use vaccines" to protect people against a biological attack, DeLucas asked. "No. They present another hurdle for terrorists," and fighting biological warfare, he says, "should use a dual-pronged approach." DeLucas predicts that one day the newly developed compounds will be used in that fight.

This article was originally published in Drug Discovery Today.

BioMedNet
26 March 2003


 


Bracing for Bioterrorism: The Push to Prepare


  By Russ Willcutt
Photography By Marc Bondarenko and Steve Wood
From UAB Magazine, Winter 2002 (Volume 22, Number 1)


 

UAB Mag Winter02: bioterrorism18a
 


 
“When we first learned of the attack, we were in our hotel in Brooklyn, near the foot of the bridge. Thousands of people were streaming over the bridge from Manhattan, most of them covered with a gray, powdery dust,” says Thomas E. Terndrup, M.D. “We did what we could to help people there, but at some point we decided—without actually saying anything—that we needed to get closer. So we started making our way across the bridge, against the flood of people who were trying to get away from the site of the attack.”

Terndrup, who is chair of the UAB Department of Emergency Medicine and director of UAB’s Center for Disaster Preparedness (CDP), speaks calmly as he recalls his experience in New York on September 11, just after the World Trade Center towers were attacked. He was in the city attending a conference, along with Sarah McNutt, M.D., a UAB emergency medicine physician, and paramedic Shannon Stephens. When the three emergency health professionals saw the stream of injured people, their natural instincts drew them into the streets.

Throughout the rest of the day, Terndrup, McNutt, and Stephens worked at triage stations, rinsing debris-filled eyes and essentially providing “extra hands” for New York City firefighters, police officers, and emergency response personnel.

The experience, Terndrup says, brought into sharp focus the willingness of community professionals, such as those in New York, to do whatever is necessary and make sacrifices to help others in need. It also brought home some of the realities of a full-scale, terrorist-triggered human disaster—something he and his colleagues at the CDP have been studying and preparing for throughout the past couple of years.

Understanding the Unthinkable

As an emergency medicine specialist, Terndrup is acutely attuned to the consequences of disasters of all kinds—from catastrophic illness to traumatic injury. But he became particularly focused on the impact of large-scale disasters in 1999, about a month after he arrived at UAB. His interest was stirred by a call he received from an FBI agent, who asked him if anyone at UAB was working on developing mechanisms for rapidly identifying anthrax spores.

 

“I had no idea,” Terndrup says. “But after a few phone calls, I discovered that quite a few scientists at UAB were hard at work in that very area. I was struck by the fact that anthrax was an issue of intense international concern—even two years ago—and that it was the focus of research being conducted by many people at UAB.”

Terndrup decided to begin pulling together a network of experts on bioterrorism, from UAB and beyond, to study the emerging threat of anthrax and other biological agents. Within six months, he was deep into discussions with representatives of five UAB schools, as well as scientists from the UAB-affiliated Southern Research Institute (SRI) and Samford University’s McWhorter School of Pharmacy. By June 2000, the university system’s board of trustees had officially approved establishing the CDP.
 

UAB Mag Winter02: bioterrorism20a
 

“I wanted to surround myself with smart people from a variety of disciplines who could bring to the table clinical perspectives, medical response perspectives, public health perspectives—anyone and everyone who could address the issue of responding to the threat of bioterrorism,” Terndrup says.

In the two years since the CDP was founded, Terndrup has assembled an impressive group of professionals from a wide variety of disciplines, including emergency medicine, biodefense, public health, microbiology, and pharmacology. The CDP’s overall commitment is to “preparedness” for all kinds of disasters—whether inflicted by terrorists or by nature—but its major focus so far has been bioterrorism.

“We chose that focus because a lot of work had already been done to prepare for disasters such as fires, tornadoes, and chemical spills, but there was a sense that we were not prepared for something like the release of biological agents by hostile forces,” Terndrup says.

Stolen Security

Today, with shock and grief over the World Trade Center disaster compounded by anxiety about the anthrax attacks that have occurred across the country—and with fears mounting about other biological and chemical agents—the question of the release of harmful substances by hostile forces is no longer hypothetical. Given the harsh new reality of terrorism inside the United States, how are experts in UAB’s Center for Disaster Preparedness addressing the new threat, and what reassurances can they give the average American, whose sense of security has been stripped away by recent atrocities?

According to David R. Franz, D.V.M., Ph.D., vice president of SRI’s Chemical and Biological Defense Division and deputy director of the CDP, the most important message for health professionals and the media to communicate to the public is simple: Don’t panic.

“Right after the terrorist attacks in New York, people began running out and buying gas masks,” he says. “But that’s just not a rational thing to do. How would you even know when to put one on? I myself don’t own a gas mask.

“We saw a similar kind of panic last fall about anthrax, with people rushing out and pleading with their physicians to give them antibiotics. That’s not reasonable, because only a small number of people have actually been exposed, and the mass use of antibiotics could create additional problems—shortages for those who really need them, for example, and, even more frightening, the emergence of drug-resistant strains.”

Allaying Alarm

A former colonel in the United States Army, Franz has studied chemical and biological terrorism for many years. He has served as commander of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and was chief inspector on three United Nations biological warfare inspection missions to Iraq at the conclusion of the Persian Gulf War, among other related assignments.

Today, Franz works with trainees at the Department of Justice’s Center for Domestic Preparedness in Anniston; he also teaches first-responders, such as police officers, paramedics, and firefighters throughout the country the best ways of dealing with biological and chemical agents. Throughout all of his educational efforts, he urges his audiences—especially the media—to understand the technical issues and to avoid panic.

“I remember some years back an anti-Semitic group left a petri dish containing a red, jellylike material at a B’nai B’rith center in Washington, D.C.,” he says. “The group claimed it was something dangerous, and since the first-responders had no experience with such things, they panicked, closing down entire city blocks and showering people off in the streets. I was following all this on television, and when I saw a banner across the bottom of the screen reading ‘Chemical Attack on D.C.!’ I knew it was time to do something to educate the media.

“Anyone who goes through the course at Anniston knows that chemical agents are neither volatile nor are they dermally active, and the vast majority of biological agents could’ve been handled by placing a wet towel over the dish and pouring bleach into it.”

Franz has since conducted numerous seminars specifically geared toward broadcast and print journalists. “Everyone I’ve met has had a sincere desire to learn how to handle these situations better,” he says. “The journalist who understands these issues can make a real contribution, not only to deterrence but also to the response process. And the one who doesn’t can have a very negative impact on our ability to protect the public.”

Enlisting Experts

One CDP member who has been quoted frequently by the media is Ken Alibek, M.D., a former Soviet scientist who is known worldwide as a top expert on biological agents. Alibek is also president of Advanced Biosystems, Inc., a subsidiary of Hadron, Inc., which is devoted to research and development of medical defenses against biological weapons.

As the former first deputy chief of Biopreparat, the civilian arm of the Soviet Union’s biological weapons program, Alibek oversaw the efforts of some 40,000 scientists charged with developing biological weapons of mass destruction. Since defecting to the United States in 1992, he has helped the government in its efforts to eliminate the danger of biological weapons—even addressing Congress on terrorist and intelligence operations in 1998.

Great strides in dealing with the threat have been made in recent years, according to Alibek. “In the past six or eight years, our preparedness for biological attacks has changed considerably for the better,” he says. “Heightened awareness of the biological threat has led to a number of positive developments—such as the creation of extensive databases on biological weapons, the development of detection equipment, analysis of possible attack scenarios and their consequences, and training for those who would serve as first-responders in case of an attack.”

Despite these advances, Alibek is convinced that the solution to the preparedness dilemma will be found in medical interventions. “Years of research on the medical aspects of biodefense have resulted in three major responses—treatment prior to exposure using vaccination, prophylactic treatment after exposure but before symptoms arise, and chemotherapy after the onset of the illness,” he says. “In my opinion, post-exposure prophylactic treatments hold the most hope. In the case of anthrax, for instance, we should devote our resources to finding ways to prevent the disease from occurring after exposure, since the main cause of death is the release of toxins into the body.

“Since the primary goal of developing bio-defense is to save human lives, we must greatly increase our efforts to develop new treatment and urgent prophylaxis techniques,” Alibek says. “Such efforts, as well as the funds spent on research and development, will pay for themselves many times over.”

Preparing for the Possibilities

According to Franz, experts such as Alibek are key to the CDP’s agenda of addressing biological threats—and that’s why he has sought to assemble a network of specialists who can collaborate on strategies. “My role in the center is really to bring people together,” he says. “Biodefense is a fairly small community, and after spending 27 years in the military, I know almost everybody in the neighborhood.”

One longtime resident of that neighborhood, says Franz, is UAB epidemiologist Michael Maetz, V.M.D., M.P.H., who serves as associate director of the CDP’s Public Health Surveillance Unit. As chair of the Department of Epidemiology and International Health in the UAB School of Public Health, Maetz is an important link between the CDP and the Alabama Department of Public Health.

A specialist in the spread of disease, Maetz was one of the first people Franz thought of when, some time ago, he was approached by an Armed Forces Medical Intelligence Agency colleague who was seeking experts to examine the human factors associated with an outbreak of plague. “With Mike and other experts from Dartmouth and MIT, we were able to assemble a team to examine the epidemiology of plague,” says Franz. “As a result, we’ve submitted a proposal to the Army to create a computer model of a plague outbreak. Most interestingly, this same model would apply to other biological agents, such as anthrax and smallpox.”

A couple of years ago, Maetz was integral to Alabama’s efforts to secure a grant from the Centers for Disease Control and Prevention (CDC) to establish a bioterrorism preparedness and response plan. “The CDC grant funds several projects—including epidemiologic monitoring, setting up a biological laboratory, and creation of the Health Alert Network, which is a communications and training system for public health personnel and health care providers throughout the state,” says Maetz. “The part I’m responsible for focuses on developing a state public health bioterrorism preparedness plan.”

Working with Maetz on this project is an advisory council with representatives from more than 35 entities, such as the state medical association, public-health agencies, the FBI, and the media, including television stations and newspapers. “We’ve met roughly twice a year to develop and draft the plan,” he says. “We’ve tried to come up with a concise, working document that can be reviewed regularly and revised as needed.

“Once the plan has been finalized and approved,” says Maetz, “it’s something we’d like to see in the hands of first-responders such as fire, police, and rescue units, and also local health departments and hospital personnel, particularly emergency room and infection control people.”

Managing the Microbes

While Franz, Maetz, and others in the CDP work to devise strategies to prepare for broad-scale bioterroristic attacks, scientists in the center’s Disease Agent Research Unit are focusing their efforts on the tiny, invisible instruments of bioterrorism—the microbes themselves.

Suzanne Michalek, Ph.D., associate director of the unit, says that the unit’s strength—like that of the center as a whole—lies in its ability to bring together scientists from many disciplines who can share ideas and findings about destructive microbes.

One such scientist is Larry DeLucas, O.D., Ph.D., director of the UAB Center for Biophysical Sciences and Engineering (CBSE), who is working on methods for detecting and disarming anthrax. One of the most promising avenues he’s pursuing—and an approach that fits perfectly with Ken Alibeck’s strategic vision—is a drug that’s being developed with funding from the U.S. Army. “This is a drug that stops anthrax at a much earlier stage than any of the antibiotics you’re hearing about now,” says DeLucas. “It works on a protein that’s critical for the germination of anthrax spores—which leads to the release of toxins into the body. If you can stop the spores from proceeding to this vegetative state, then you’ll never have to worry about anthrax harming you—whether it’s the inhaled or the cutaneous form.”

Although CBSE scientists haven’t yet arrived at the drug’s final form, DeLucas believes it may one day be used prophylactically—“as long as there aren’t too many side effects,” he notes. “But even if it does produce side effects and can only be taken post-exposure, it will still be a very fast-acting and effective drug.”

DeLucas says that in addition to developing anti-anthrax drugs, CBSE members are designing devices that will detect anthrax in the environment. For example, structural biologist Christie Brouillette, Ph.D., and engineer Ken Banaziewicz, along with UAB physicist Sergey Mirov, Ph.D., are working on a “suitcase-sized” anthrax detector. “Basically, it sucks in liters of air, processes the air, and then detects anthrax based on a chemical interaction between proteins on the surface of anthrax spores and compounds that we’ve developed for the device,” DeLucas explains.

Military Molecules

Conducting related studies are UAB microbiologists Charles Turnbough, Ph.D., and John Kearney, Ph.D., who are developing molecules that will be used by the military to detect anthrax. “Other scientists are designing the actual instrumentation,” Kearney notes. “Our job is to equip the instruments with easily detectable molecules that will bind specifically to anthrax spores.”

The molecules Kearney works with are monoclonal antibodies that are formed as part of an immune response to anthrax. To obtain he antibodies, he exposes mice to “safe” forms of anthrax and then, when the mice begin generating antibodies, he attaches fluorescent “tags” to the antibodies to isolate them. These molecules are then incorporated into an air-sampling device. “If anthrax spores are present in samples, the antibodies attach to them,” Kearney explains, “and you can see that happen because of the fluorescent tags. Used correctly in very simple devices, these antibodies could detect anthrax quickly at the front lines of an outbreak.”
 

Turnbough’s approach is similar, although he focuses on peptides, which are much smaller and hardier than antibodies. “Our hope is that peptides will be more robust and will be able to survive in harsher environments,” he says. “In addition, it’s possible that smaller peptides can be incorporated into different detection platforms more easily than antibodies, which are chemically fragile under certain circumstances.” Turnbough notes that the molecules that he and Kearney are developing can be incorporated into several different kinds of spore-detecting devices—including optical, electrical, and even acoustical detectors.

In addition to his work on spore detection, Turnbough and his colleagues are battling anthrax on other biological fronts.
 
UAB Mag Winter02: bioterrorism23a
 

“We are working with Dr. De-Chu Tang at Vaxin, Inc., to develop a noninvasive DNA-based vaccine,” he says, “and my lab is identifying sites on the anthrax spore surface that we could block, thereby sabotaging its viability and virulence.”

Victory with Vaccines?

Several scientists in the CDP’s Disease Agent Research Unit are working on vaccines that could actually keep people from becoming infected by biological agents. Michalek’s own research on a vaccine for equine encephalitis—funded by a grant from the U.S. Army—is applicable to defending against any airborne contaminant.

“My work deals mainly with the mucosal membranes, so I’m interested in what happens with anything we inhale or ingest,” she says. “If you think about it, those surfaces are our first line of defense, and that’s especially important when it comes to agents of biological warfare.”

Another CDP scientist, infectious disease specialist Mark Mulligan, M.D., who directs the Alabama Vaccine Research Center at UAB, has just received a $4.3-million grant from the CDC to test an FDA-approved anthrax vaccine. “What’s currently in use by the military is a vaccine that’s administered in six injections over an 18-month period, with annual booster shots after that,” he says. “As you can imagine, keeping track of such a schedule is very difficult for a highly mobile military force. So we’re doing a clinical trial that will attempt to take the existing vaccine and alter the injection schedule to make it more ‘user-friendly,’ if you will. We’re hoping to go as low as three injections in the first 18 months, followed by boosters every two or three years. Preliminary data prepared by the Department of Defense (DOD) suggest that lower doses produce the same level of antibodies, so we feel that our chances of altering the schedule are pretty good.”

Mulligan’s work also focuses on the manner in which the vaccine is injected. “It’s currently injected under-the-skin, unlike most vaccines, which are injected straight into the muscle of the arm. The body tolerates intramuscular injections much better than subcutaneous, or under-the-skin, injections,” he says. “Again, initial DOD studies have shown that the intramuscular injection method produces just as many antibodies as the subcutaneous method.”

While the vaccine is currently available only to the military, Mulligan says that recent events may lead to increased supplies and civilian rationing. “When the supply becomes available, decisions will have to be made about whether the vaccine should be given to postal workers and fire, police, and emergency medical personnel,” he says. “In this new world we’re living in, with a war being fought right here on the homefront, there’s certainly the chance that anthrax vaccines will be used more broadly at some point.”

Even if vaccines are developed for these agents, however, Michalek says that mass producing, storing, and distributing vaccines will present formidable challenges. “People tend to think that, if a vaccine exists, then large quantities should be available, but that’s not necessarily the case,” she says. “If we do develop a vaccine for a particular agent, we’d need to determine exactly how much of a threat that agent is in order to decide how much vaccine to produce. Then, where would it be stored? What about shelf life? And who would manufacture it?

“The CDC and the military really aren’t in the business of manufacturing, storing, or distributing medications, so you’d have to find a company willing to make the vaccines, and that would be a pretty major commitment for any profit-based business. A drug company would have to be willing to go out on a limb to agree to produce most vaccines in large quantities.”

Drug Distribution Dilemmas

Distribution of drugs to treat bioterrorism-caused diseases is the focus of yet another CDP unit—the Pharmaceuticals Preparation Unit, headed by Susan Alverson, D.P.A., assistant dean of Samford University’s McWhorter School of Pharmacy.

According to Alverson, fluctuations in the demand for certain medications could actually serve as harbingers of disease outbreaks associated with biological warfare.

“The biological agent at the top of most everyone’s list is anthrax, which resembles the flu in its earliest stages,” says Alverson. “So pharmacists would really be in an excellent position to notice a rise in people getting medications for flu-like symptoms or people who are experiencing such symptoms at an unlikely time of year, like early summer.”

Pharmacists can also detect outbreaks by keeping a close watch on inventory levels of certain drugs, Alverson says. “Pharmacies restock their shelves daily and place orders with their distributors nearly every day. That, along with the invoices they constantly receive from distributors, would make it quite easy to detect escalated sales of flu medications.”

As for the drugs that can treat anthrax and other diseases associated with biological warfare, Alverson says she has already put in motion a statewide survey to determine what medications exist, in what quantities, and where they’re located. Such an effort has never before been mounted in the United States, to Alverson’s knowledge, and she has already received a great deal of interest from pharmacists in other states. “It’s a monumental task, to be sure, especially since there are more than 2,000 pharmacies—and 5,000 pharmacists—in Alabama,” she says. “But we’ve got to determine what we have on hand before we can attempt to predict what we’d need in case of an outbreak.”

Alverson has experience in dealing with disease outbreaks. As former director of pharmacy for the State of Virginia, she was on the front lines in an effort to prevent a major outbreak of swine flu in that state during the mid-1970s. “We’d never encountered anything like that before, and we had to vaccinate the whole state, which was a real learning experience for everyone involved.”

Preparing the Push Packs

In addition to determining Alabama’s current state of pharmacologic preparedness, Alverson is helping to establish an efficient means of locating and distributing medications in case an outbreak should occur. “If we find that we don’t have the necessary medications on hand,” she says, “the state health department would contact the federal government to send in what’s known as a ‘push pack,’ which is basically a fully equipped field hospital. These packs fill two military cargo planes, and they are stored and kept ready to fly at eight undisclosed locations around the country—the idea being that you can get them to any city within 12 to 24 hours.”

As comforting as it is to know that these push packs exist, the challenge of breaking them down and getting the medications into people’s hands is yet to be dealt with. “How should we go about doing that?” Alverson asks. “Would pharmacists be allowed to dispense medication without prescriptions? Would we want people venturing out into the community, running the risk of exposure? If we decided to deliver the meds straight to people’s doors, who would make the deliveries? These are just a few of the questions that we’ve got to address.

“And every question just seems to lead to another one,” she says.

Dealing with Dread

By definition, terrorism is designed to create fear. In the case of bioterrorism, the agents of fear—the weapons that terrify—are not even visible to the human eye. UAB environmental health scientist Steven Becker, Ph.D., has conducted numerous studies on how victims of biological, chemical, and radiological incidents have reacted to “invisible threats.”

“In a sense, terrorism involving weapons of mass destruction—including biological agents such as plague and anthrax—represents a combination of two broad characteristics, each of which is sufficient to create enormous stress,” Becker says. “First, such incidents involve agents that people are totally unfamiliar with; they are insidious and invisible, and that tends to trigger more concern than other kinds of danger.

“Second, such incidents are not mistakes or accidents, but calculated, intentional acts aimed by human beings at inflicting pain, injury, suffering, and death on other human beings,” he says. “This combination—of invisible, toxic agents coupled with the intent to harm—makes such acts of terrorism especially stressful.”

One reaction Becker has witnessed, both recently in the United States and in other countries after suspected or confirmed disease incidents, is panic-buying of medications. “This reaction is not altogether unexpected, since we’ve seen it after infectious disease outbreaks in the recent past,” he observes. “For example, following a 1994 plague outbreak in Surat, India, many people went to great lengths to purchase antibiotics. In that situation, health-care professionals were concerned that the indiscriminate use of antibiotics would reduce the effectiveness of treatment. So the run on the antibiotic Cipro that we’ve observed here is not a new phenomenon.”

Becker says the situation will likely improve once health officials make clear the risks of indiscriminate antibiotic use, “and once people come to understand that federal agencies have a large antibiotic stockpile and the means to rapidly get preventive medicine to those who may need it.”

The Armor of Awareness

Perhaps the strongest shield that can be wielded against bioterrorism is simple awareness—of the signals of trouble and the steps to take if those signals appear. The CDP has launched several projects to disseminate such information across the state and country, according to Program Manager Margaret Tresler, M.P.H. “We’ve already done presentations at local schools to give students a general understanding of what ‘bioterrorism’ means, and we hope to expand that function in the coming years,” she says. “We might send a microbiologist to a biology class, for instance—someone who could provide students with certain insights. We feel that, by fostering an understanding of the issues, we can dispel unnecessary fears.”

The center is also increasing awareness among health care professionals through a screensaver that can be loaded onto the computers of doctors, nurses, and various emergency-room personnel to help them spot symptoms of bioterrorism-associated diseases. Developed by the CDP with funding from the Agency for Healthcare Research and Quality, the screensaver provides detailed information through images and text about anthrax and smallpox—the effects of which most clinicians have never actually seen. “Our hope is that, by providing this information, we’ll help health-care professionals who encounter unfamiliar symptoms determine if what they’re seeing might be associated with anthrax or smallpox,” says Tresler.

Another education and outreach effort sponsored by the center is an annual, two-day conference that draws bioterrorism specialists from across the country to the UAB campus. Last year’s event, “The Statewide EMS and Disaster Preparedness Conference,” drew more than 400 people and was broadcast via satellite to some 2,000 more by the Alabama State Department of Public Health. The center has also launched an interactive Web site that can be accessed at [www.bioterrorism.uab.edu].

“I think one of the most important roles the center can play is bringing different groups of people together to exchange ideas—making them aware of what other groups are doing,” says Tresler. “We believe that UAB is in a prime position to be a leader in developing response plans to biological events, because we’ve already managed to bring together so many people with such a high degree of expertise.”

Terndrup, the center’s director, agrees. “The overriding issue, of course, is that of ‘preparedness’—being prepared for the possibility of any kind of attack,” he says. “Terrorists have demonstrated their intent to harm Americans, and we know now that they will go so far as to use biological agents. We also know that they have succeeded in their agenda of creating terror. People are understandably frightened of the microbes these terrorists are capable of releasing.

“But, with the army of experts we have in our center, there is much we can do—and are doing—to prepare.”

____________________________________________________________________________________________________
Executive Order and Human Testing

Schumm WR, Bronneman, Rl, Arieli, B et al. A Statistical reanalysis of Brachman et al.'s 1962 study of a human anthrax vaccine.Medical Veritas 2004; Vol 1, 171-178.

Abstract

In late 2003, the Brachman et al. (1960,1962) field study of an earlier anthrax vaccine became the basis for an FDA regulatory determination that the currently licensed vaccine was effective against B. anthracis strains, regardless of the route of exposure. Here, the Brachman et al. (1962) field study is reexamined statistically, analyzing the vaccine's effectiveness as a function of risk levels, levels of vaccination status, types of anthrax infection, mill locations, and two study components (total versus experimental groups). Fisher's Exact Tests were used to compare the vaccine and non-vaccine groups because Fisher's Exact Tests are more accurate than the traditional chi-square tests, especially when cell sizes or probabilities are small. Numerous limitations of the trial were discovered or reaffirmed. Even taking both cutaneous and inhalational anthrax into account, we found that the vaccine's protective effects were not statistically significant (p<0.05) in 75% of the mills studied. We found no evidence for the effectiveness of incomplete vaccinations, although design or reporting flaws in the original study mitigated against finding such evidence. The reanalysis of Brachman et. al. (1962) does indicate that the anthrax vaccine may help provide some marginal protection against inhalation anthrax. In conclusion, our reanalysis indicates that Brachman et al.'s (1962) data actually fell far short, as had actually been long acknowledged by leading anthrax experts until some time after 1999, of demonstrating the efficacy of the anthrax vaccine in humans.

A summary from the concluding paragraph reads: We can only conclude that the FDA's action in approving the current anthrax vaccine was not supported by the evidence from Brachman et al. [7, 17, 18] as demonstrated here, and therefore was not rational from a strictly scientific perspective. Therefore, the U.S. military's current approach of universal mandatory vaccination with an anthrax vaccine of clearly (as shown here) questionable efficacy and, as discussed elsewhere [2,3,4,14,15] uncertain safety, must be deemed inappropriate, if not illegal.

 

Military couple feels betrayed
"I'm 36 years old. i'm not supposed to be falling apart."

by Lee Williams
The News Journal
10/10/2004

Summary: John Salzano and his wife Tammy Hull have devoted their lives to the U.S. Air Force. Both have suffered from receiving mandatory anthrax vaccinations.

Quotes from the article:

"Minutes after receiving the first anthrax injection in 1998, Hull began having reactions: intense headaches coupled with muscle spasms throughout her upper body. She reported the "adverse reaction," an immediate onset of arthritis-like symptoms, and was sent to Walter Reed Medical Center in Washington, D.C."

Salzano also took the shots and was a diabetic for 23 years, and is convinced the vaccine aggravated his disease-causing his kidneys to shut down. He now undergoes dialysis three times a week. He was medically retired last month when doctors amputated half of his right foot.

At Walter Reed, a doctor unofficially disclosed the root cause of Hull's problems as being by the shot.

"Added Hull: In a roundabout way, she told us she couldn't admit it, but that the problems were all caused by the shots. She said she was not permitted to tell us officially that all the problems were caused by the shot."

"Hull's medical problems intensified after each anthrax shot. She continued filling out adverse reaction reports, though nothing was done with the documents. There was no follow-up care."

"Hull was recently diagnosed with arthritis in her knees and shoulders, but she knows her husband's problems are far worse."

from www.delawareonline.com/newsjournal/local/2004/10/10militarycouplef.html-this link is no longer valid but the article can be purchased from archives of www.delawareonline.com

 

Schumm WR. Was it statistically legitimate to combine data from the four textile mills in Brachman et al.'s (1962) study of the effectiveness of a human anthrax vaccine? Medical Veritas 2005; Vol 2, 342-343

Abstract
In late 2003, the Brachman et al. (1960, 1962) field study of an earlier anthrax vaccine became one important basis for an FDA regulatory determination that the currently licensed vaccine is effective against B. antracis strains, regardless of the route of exposure. One issue overlooked earlier (Schumm, Brenneman, Arieli, Mayo-Theus, $ Muhammad, 2004) was whether or not it was legitimate, from a statistical perspective, to combine the results from the four textile mills to assess the effectiveness of the anthrax vaccine. Therefore, the Brachman et al. (1962) field study was again reexamined in terms of its statistical validity. The Box's M test, which evaluates the statistical legitimacy of combining data from different groups (in this case, the four mills), was very significant (p<.001) in all three statistical tests performed, indicating that the data from the four mills should not be combined. Arguments for combining or pooling the data from the four mills cannot be justified from statistical or scientific evidence.
Copyright 2004, Pearblossom Private School, Inc- Publishing Division. All Rights Reserved.

Implications from this study:
While it may be politically desirable to combine the data from the four textile mills, it is not scientifically appropriate. Given that, it remains clear that the anthrax vaccine demonstrated only cutaneous efficacy at just one mill (Mill S)- and not the mill (Arms Mill, Mill A) where the inhalation cases of anthrax infection occurred. Given that, the results for Mill A. never were and are not now significant (p<.05) even when including the cutaneous cases of anthrax infection, our results here further demonstrate that there never has been any scientifically valid basis for arguing that the vaccine was effective against inhalation anthrax in Brachman et al's study [4]. In inferring from Mill S alone that the vaccine was effective against cutaneous anthrax requires an assumption that the data from the four mills can be combined legitimately. Of course, it might seem logical to infer that partial success of the vaccine leaves us with our best hope to prevent both cutaneous and inhalation anthrax infections. However, science rests on proving facts, not merely wishing them to be so.

Schumm WR. Were the rights of human subjects violated at the Arms Mill in Manchester, New Hampshire in 1957 during the human anthrax vaccine trials? Medical Veritas 2005; Vol 2, 344-347

Ethical limitations of the clinical trial of anthrax vaccine as exemplified at the Arms Mill in Manchester, New Hampshire in 1957 are described and discussed. Researchers and physicians have codes to "do no harm." Once the epidemic began and one worker had died, far better coordination should have occurred between the Arms Mill, local hospitals, local physicians, and the government specialists in anthrax infections. It would be interesting to have today's institutional review boards evaluate the design of the 1955-1959 trials. It is doubted that the design would be considered ethically acceptable today, as well as lacking sufficient protocols for protecting workers should they become infected. Thus, not only were the design and statistical issues in the trials problematic, but the procedures and protocols of the study can be challenged from an ethical standpoint. As it reviews the efficacy and safety of the anthrax vaccine, the Food and Drug Administration should consider the root of the tree, the uncertain ethical validity of this key study of the anthrax vaccine.
Copyright 2004, Pearblossom Private School, Inc-publishing division. All rights reserved.

Scumm WR, Jurich AP, Bollman SR, Webb, FJ, Castelo, CS. The long term safety of anthrax vaccine, pyridostigmine bromide (PB) tablets, and other risk favtors among Reserve component Veterans of the First Persian Gulf War. Medical Veritas 2005, Vol. 2. 348-362.

Abstract
Data from several hundred Reserve Component Persian Gulf War veterans were analyzed to assess associations between Gulf War veterans were analyzed to assess associations between Gulf War illness as defined by both the CDC and Kansas classifications and a variety of potential risk factors. The most significant risk factors, in order of importance for their possible contributions to Gulf War illness were perceived exposure to nerve agent, ciprofloxacin pills, gum problems, insect repellant, anthrax vaccination, use of personal insecticide, reported reactions to vaccines, and botulim toxoid vaccine. Of those, PB tablets, gum problems, insect repellants, insecticide use, and anthrax vaccination were more significant statistically when veterans reported that they had experienced reactions to vaccines. Insect repellant and insecticide remained significantly related to Gulf War illness among veterans who remained in the United States during the war; among those non-deployed veterans, anthrax vaccine was associated with Gulf War illness (10% versus 4% for those with or without anthrax  vaccine), but the relationship was not statistically significant if those who were "not sure" about their vaccination were removed from the analysis. For anthrax vaccine, Gulf War veterans needed only to report a "mild reaction" to maintain a significant relationship with Gulf War illness under the reaction condition. Anthrax vaccine seemed to be more reactive than other vaccines, especially for female veterans. A does-response relationship was observed for PB tablets. Recall bias was reduced in several ways but may not have been eliminated. It is recommended that PB tablets, ciprofloxacin pills, as well as insect repellants and insecticides be used with caution, especially not exceeding recommended daily amounts. Anthrax vaccine should be administered on a voluntary basis only, given the long-term safety risks observed here, especially for those who experience even mild reactions.

Notes from the paper
All vaccines involve a balance between the good they can do versus their inherent risks

Previously, even though several studies in at least three nations that had revealed a correlation between either anthrax vaccination or vaccinations in general with subsequent self-reports of ill health [4,5,6,7], the Institute of Medicine [2] had given the vaccine a nearly clean bill of health, basically discounting nearly all self-report research as later noted in a critique of their analysis of the survey conducted by U.S. Air Forced Captain Jean Tanner [8].

The Randy study concluded that even self-reported subjective health status was relatively unbiased [19:113].

"The burden of proof for the safety of vaccines is therefore even higher than the burden of proof for the safety of other medical interventions."

"No one should think that will fix the problem because well over 50% of some groups had mild reactions, which as our testing showed, was a sufficient condition for health problems after the war. At the same time, it appears that veterans who do not react to the vaccine (or perhaps even PB tablets) when given may have little chance prospects of coming down with Gulf War illness.
 

Animal Research on the Anthrax Vaccine

There is minimal research using guinea pigs, monkeys, and mice. In 27 out of 33 anthrax strains tested, 50% or more of the guinea pigs died. The mice did even worse. The tests using monkeys did not use enough monkeys to be conclusive. Further, Dr. George Robertson has already proven that the monkeys were so sick, after exposure to the anthrax, for 2-3 weeks that if they had been soldiers they would have been captured or killed by the enemy anyway ("Anthrax Shots' Effect Challenged" by Thomas Ricks of the Washington  Post).

I think we can all agree that human anatomy is different from guinea pigs. Therefore, we need clinical, peer-reviewed, data on the effects of the anthrax vaccine on humans. There have been individuals who have offered their bodies to science. This is informed consent.


Anthrax Vaccine Tests on Humans

It has been argued that it would be unethical to test the anthrax vaccine on human beings in order to find out if it provides immunity against inhalation anthrax. No studies have been done on this in the past.

There is a current study being done in the UK on a different anthrax vaccine using humans with informed consent according to an article by Nice Fleming entitled, "400 Wanted for Trials of Anthrax Vaccine."

A clinical trial was planned in the USA using the current anthrax vaccine, aka A.V.A., from Bioport and a new anthrax vaccine to test for safety and effectiveness. The problem was that in this clinical trial the volunteers would be 100 first and second graders, as well as 350 18-20 year olds. The Protocol Number with the NICHD was 04-CH-2083. Naturally, there was an uproar. Dr. Nass, DSBR and Protecting Our Guardians brought the issue up in meetings with numerous Senators and Congressmen. Sen. Bingaman issued a letter to the NIH, after which the clinical trial was altered to only using the 18-20 year olds as test subjects for now. After scientists see how the adults fare, then they still plan to use the children. Using healthy children to test this hazardous vaccine is unethical and a violation of the Federal Regulations according to Barbara L. Fisher of the NVIC and Dr. Nass. Three articles about it: www.kcstar.com, on June 29, 2004, "Plans to test anthrax shot on children questioned" by David Goldstein and 2. http://www.nti.org/d_newswire/issues/2005_7_8.html#56E710CG, National Institute of Health Decision Delayed on Anthrax Vaccine Testing on Children by David Ruppa on July 8, 2005. 3. "Critics Blast Anthrax Vaccine Test," http://www.courant.com/news/health/hc-anthraxkids0623.artjun23,0,491226.story?coll=hc-headlines-health. (link not valid)

Finding volunteers for vaccine trials is not as difficult as some might have us believe. For example, 8000 people signed up for HIV vaccine studies according to Gerald J. Stine, PhD, at the University of North Florida in his report, AIDS Update 2001: Annual Overview of Acquired Immune Deficiency Syndrome. On page 209, we read that 18 of those people did "become HIV infected from the vaccines."

The study conducted on the medical staff at Tripler Army Medical Center showed a 48% systemic adverse reaction rate to the anthrax vaccine. These were medical professionals reporting the side-effects they experienced.

The small studies described on Bioport's 2002 product insert are insufficient to claim safety or efficacy for several reasons. Bioport has combined all the number for cutaneous and inhalation exposure in the various groups of mill workers. The current anthrax vaccine is very different from the one that was tested on the mill workers (the Brachman study from 1962) but it still operates under the FDA license for the older version. Also, Bioport's request for indemnity states that the studies were too small to guarantee safety or effectiveness of the anthrax vaccine, and too small to know what long-term side effects may occur.

Moreover, the Brachman study was debunked by Col. Dr. Walter Schumm et al. in several articles published in Medical Veritas in 2004 and 2005.

A presentation by Lea Steele, PhD, at a meeting of the Research Advisory Committee on Gulf War Veteran's illnesses on April 7, 2004, entitled "Gulf War illnesses and Vaccines: Overview of Epic Findings, Remaining Issues," revealed consistently high OR's to anthrax vaccine in 5 separate Gulf War Veteran's studies. The OR's ranged from 1.28 to 3.72, with p<0.05 indicating statistical significance.

 

UAB gets $12M contract for anthrax vaccine study
Birmingham Business Journal
November 11, 2004

The University of Alabama and Birmingham has received a five-year, $12 million contract from the National Institute of Allergy and Infectious Diseases, to study genetic factors that influence how well individuals respond to the anthrax vaccine.

The research will provide valuable information about individual differences in immune response and in adverse reactions to the anthrax vaccine," said Dr. Richard Kaslow, professor of epidemiology in UAB's School of Public Health.

The national anthrax vaccine trial, funded by the Centers for Disease Control and Prevention, is aimed at determining whether the vaccine is equally safe and effective when injected into the muscle rather than under the skin. It also examines an altered dosage schedule.

UAB is one of six medical institutions across the country contributing to the trial.


Bioterrorism and compulsory vaccination
Tom Jefferson
BMJ (2004) 329: 524-525

bmj.com
http://bmj.bmjjournals.com/cgi/content/extract/329/7472/977-c
BMJ (2004), 239:977-978 (23 october), doi: 10.1136/bmj.329.7472.977-c

Arguments for current vaccines are based on inadequate support for older vaccines

Jefferson discussed some of the major flaws of the study by Brachman et al with respect to policies making certain vaccines compulsory in the US military.1 2 Additional shortcomings of the study by Brachman et al have been described in fuller detail elsewhere.3-5 For example, the often reported rate of 92.5% effectiveness for the anthrax vaccine sounds impressive but should be considered against the actual results in which 99.7% (378/379) of vaccinated workers avoided anthrax infection compared with 96.4% (399/414) of placebo workers. Thus the vaccine protected only an additional 3.3% of workers compared with no treatment.

Moreover, officials from the Department of Defense continue to ignore criticism of the 2002 Institute of Medicine report on the anthrax vaccine.w1 w2 At least three major studies in England, Canada, and the United States had found problems with the anthrax or other vaccines among military.... (see article for full text)

Presidential Exec. Order 13139
Improving Health Protection of Military Personnel Participating in Particular Military Operations

Quotes:

Military personnel....could....be exposed to....chemical, biological, and radiological weapons as well as disease endemic to an area of operations."

"...the President may waive the informed consent requirement for the administration of an investigational drug to a member of the Armed Forces....upon a written determination by the President that obtaining consent:

Is not feasible
Is contrary to the best interests of the member; or
Is not in the interests of the national security"

Reactions from the Press about  13139
"A day after Republican Rep. Chris Shays of Connecticut ended congressional hearings on the controversial decision mandating the inoculation of 2.4 million U.S. troops against anthrax, President Clinton quietly signed an executive order, or EO, that denies soldiers the right to refuse experimental vaccines."

Some Congressmen saw this as an attack by the president on the House Government Reform subcommittee on National Security, Veterans Affairs and International Relations, where testimony indicated the Pentagon had violated the FDA's procedures on how to administer the anthrax vaccine. Those hearings- as well as others held by the full House Committee on Government Reform- had put the FDA on the spot for letting the Pentagon disregard sensible FDA regulations. The Pentagon wanted to administer the shots now and, as a result, long-range studies were not conducted and an inadequate reporting system was set up to hide the large number of adverse effects, critics charged."

Source: "Clinton Orders Human Experiments," By Timothy W. Maier, Insight Magazine, Vol. 15, No. 42 - November 15, 1999 http://www.fmscommunity.org/experiments.htm

"During the 1970s, when presidential scrutiny was taken seriously, historian Arthur Schlesinger penned the influential work entitled The Imperial Presidency. Time has hastened to fulfill the worst of expectations. Never before has concern over unbridled presidential power been more aptly needed than in reference to the current Washington palace."

"The executive branch has been feverishly ambitious over the course of the past few years in the seizure of authority. Presidential action in the form of executive orders and other tangible presidential memoranda has created an illicit reapportionment of power."

"Through this executive order (13139), the government essentially has the authority to perform medical experimentation on a selected segment of our society. Servicemen and women are being forced to accede to the intake of unapproved drugs, despite the fact that any vaccine not approved by the FDA is illegal and, if somehow administered, would certainly mandate consent of the recipient. The timing of this executive order is also questionable, since criticism of the anthrax program appeared to have been gaining momentum. "

Source: "Profiles in Constitutional Contempt," Dr. James L. Hirson, J.D., PhD, January 11, 2000.
NEWSMAX.COM
http://www.truepatriot.com/profiles_in_constitutional_contempt.html


Spencer Bachus, Congressman
Congressman Spencer Bachus, along with other legislators, is working to protect our military and pass these bills. He wrote a persuasive letter to Chairman Floyd Spence asking for a hearing http://members.home.net/flyinghi/Mr_Chairman.tif. (link not valid)
He has also expressed deep concern over Clinton's executive order which allows experimental and investigational drugs to be given to any and all military personnel without informed consent under certain circumstances, including chemical and biological threats. http://www.pub.whitehouse.gov (link not valid) (go to search documents and enter number 13139). This allows short-cuts through established and necessary safety protocols. This executive order also opens the door for the 322 million dollar, 10 year, Pentagon program to develop (and test?) up to a dozen other biological warfare vaccines that Patrick Eddington, a former CIA military analyst, mentioned in the ABC news report found at http://www.abcnews.go.com/onair/2020/2020_990312_anthrax_feature.html (link not valid)


Anthrax as beginning of other controversial vaccines
As you can see, the anthrax vaccine is the beginning of many possible controversial vaccines. As Charles R. McCarthy said in an Associated press article, Troops to be given, written by Tom Raum, "Military personnel do not surrender all of their rights. [They must] not be ordered to participate in bioledical or behavioral research." Right now, in light of the fact that criminals are protected from drugs that haven't been thoroughly researched, this nation's criminals are allotted more respect for their basic human rights than are our patriotic military members.


Anthrax given to veterinarians? No proof from Bruce P/ Majilton, former president of South Florida Veterinary Medical Association
The DOD reassures those who must take the anthrax vaccine that approximately 68,000 doses were given to civilians, mostly veterinarians, between 1970 and 1989. This means that about 10,000 people were inoculated. Quite a large group when one considers that in 1970 there were only 25,000 veterinarians in the entire U.S.

Yet Dr. Bruce P. Majilton, DVM, former President of South Florida's Veterinary Medical Association has never heard of this vaccine being offered to veterinarians. In addition, at Auburn University (renowned for its School of Veterinary Medicine) the veterinary professors have not heard of the anthrax vaccine ever being offered or administered to veterinarians either. We have only heard of one veterinarian who received the anthrax vaccine.

More research needed
More research and testing of the anthrax vaccine is needed since there is no data on its long-term effects or its effects on a person's fertility. Moreover, no large group testing has ever been conducted with this produce.

"Kathryn Zoon, head of the FDA's Center for Biologics Evaluation and Research, pointed out in a May 1998 letter that data on long-term side effects for this vaccine have never been submitted to the FDA" (http://www.dallasnw.quik.com/cyberella/Anthrax/Nass4_29oral.hrm). (link not valid)

According to Victor W. Sidel, MD, Meryl Nass, MD, and Todd Ensign, JD, LLM, in their study The Anthrax Dilemma, in the journal Medicine & Global survival, "The potential risks to inoculated military personnel are still largely unknown. Sufficient small-scale testing of a similar vaccine convinced the FDA to license the current vaccine for use i nprotecting small numbers of at-risk workers. But there are no published studies of the results of surveillance of vaccine recipients, and no data regarding long term side effects have been submitted to the FDA. There is no reported experience with its use on a scale comparable to the inoculation of 2.4 million people/ Experience with other vaccines that have been used widely after relatively small field trials indicates that unanticipated problems can develop in the course of massive use of approved drugs or vaccines."

..."Closely related is the question whether the Pentagon conducted adequate record keeping and follow-up on the approximately 150,000 US troops who are reported to have received anthrax immunization during the Persian Gulf War. ...If the military indeed conducted research on this population, such data have not been released publicly so that impartial analysts can review them. If the US military had placed the highest priority on the safety and efficacy of this vaccine, it would have started with placebo-controlled, carefully-monitored trials limited to troops who are willing to give free and informed consent to be guinea pigs in such an experiment. (http://mars.healthnet.org/MGS/V5N2Anthrax.html) (link not valid)

When the DOD listed what studies had been done  on the anthrax vaccine, Dr. Meryl Nass pointed out that those studies involved an earlier version of the vaccine, not the present human vaccine, and furthermore that the two studies from the 1990s completely ignored long term effects. In critiquing the DOD's claim that the anthrax vaccine is as safe as any other vaccine, Dr. Meryl Nass noted that the aluminum component of the vaccine and the large number of shots needed could have a cumulative effect, making it more dangerous than others. Dr. Nass went on to say that although there is no data on anthrax and fertility, "....the anecdotal reports of increased birth defects in PGW veterans underscores the need to study this question. ....Similarly, anecdotal repots of Persian Gulf Illness (PGI) being transferred whether undiscovered live viruses or other contaminating microorganisms might be a contributor to illness and/or fetal harm." (http://www.dallas.quik.com/cyberella/Anthrax/DoD_answ.html) (link not valid)

 

President Bush and Homeland Security Act
The Homeland Security Act signed into law by Pres. G.W. Bush calls for voluntary vaccination in the event of an emergency where mass vaccination would be implemented.

 

Clinton Orders Human Experiments
By Timothy W. Maler

Insight Magazine
Vol. 18, No 42- November 15, 1999
www.insightmag.com

Excerpts from the article:

Executive Order 13139 is requiring military personnel to receive experimental vaccines not approved by the Food and Drug Administration. Courts-martial are pending.

"A day after Republican Rep. Chris Shays of Connecticut ended congressional hearings on the controversial decision mandating the inoculation of 2.4 million U.S. troops against anthrax, President Clinton quietly signed an executive order, or EO, that denies soldiers the right to refuse experimental vaccines."

"E013139, titled "Improving Health Protection of Military Personnel Participating in Particular Military Operations," caught Congress off guard as it directed the Pentagon to disregard the authority of the Food and Drug Administration, or FDA. The order authorized use of experimental vaccines -- those not approved by the FDA and therefore illegal -- to be administered to members of the armed forces without informed consent."

"The Pentagon wanted to administer the shots now and, as a result, long-range studies were not conducted and an inadequate reporting system was set up to hide the large number of adverse effects, critics charged."

"The FDA's failure to take a stand against the Pentagon has prompted a group of concerned congressmen, led by Republican Rep. Walter Jones Jr. of North Carolina, formally to complain to the agency. ["The FDA didn't do its job," says Jones, a member of the House Armed Services Committee. "Our men and women are too valuable and they're not going to be guinea pigs."]"

"Jones, who has asked the Pentagon's inspector general to launch a probe into the growing anthrax controversy, warns that Clinton's executive order "might encourage more men and women to get out of the military. I think Clinton did it to give cover to what the DOD [or Department of Defense] is doing." And with the FDA having rolled over, Jones says, he is even more determined to learn why the White House and the Pentagon doubled the contract of Michigan-based BioPort Corp., which manufactures the vaccine, from $25.7 million to $49.8 million and at the same time reduced the volume to be delivered by 2.3 million shots (see "Why BioPort Got a Shot in the Arm," Sept. 20)."

"The Pentagon has claimed the inoculation protects against all anthrax strains, and BioPort made the same claim to Insight -- despite the fact that an experiment at the Fort Detrick chemical and biological warfare center in Maryland using guinea pigs showed nine of the 27 anthrax strains tested killed 50 percent of the vaccinated subjects."

"Kwai-Cheung Chan, the director of the special studies and evaluations, national-security and international-affairs division of the General Accounting Office, testified before the House Government Reform Committee that there have been no studies to "determine the optimum number of doses of the anthrax vaccine. Although annual boosters are given, the needs for a six-shot regimen and annual booster shots have not been evaluated."

"Mark Zaid, an attorney representing dozens of troops who refused to take the mandatory anthrax inoculation, says, ["There are big problems. Why, all of a sudden out of nowhere, especially when the opposition to the program is getting so much steam and criticism of the Department of Defense was running rampant, does Clinton sign an executive order that assures DOD can implement any experimental program it wants? This whole thing is DOD doing an end run around the FDA. The FDA should step up to plate and do its job."]"

The FDA may be starting to take note, according to a September letter from the agency obtained by Insight. The letter was written the day Shays' hearing ended. Katheryn Zoon, director of the Center for Biologics Evaluation and Research, wrote to Assistant Secretary of Defense Sue Bailey:

"Recently it has come to the agency's attention through congressional sources that some troops may not be receiving the vaccine in accordance with the schedule found in the approved labeling. As you know, the approved anthrax labeling states that full immunization involves six doses of the vaccine to be administered following the first dose at two and four weeks, six months, 12 months and 18 months, with yearly boosters thereafter. This schedule is the only regimen shown to be effective in protecting humans against anthrax and is the only schedule approved by the FDA. Data received by FDA from congressional sources indicate that a number of reserve and active military personnel are receiving their anthrax vaccine dose significantly later than the FDA approved schedule."

"Yet Clinton signed EO13139 to use experimental vaccines on U.S. troops despite the scandals created by exposure of the secret use of experimental vaccines ranging from administering LSD in the 1950s to the drug pyriostigmine bromide, or PB, given to troops bound for the Persian Gulf War. PB, which protects against nerve gas, may be linked to some of the gulf-war illnesses, according to the Rand Corp., a California-based think tank that recently published a 385-page review of the drug."

 

Proposed Anthrax Vaccine Testing on 100 Children

After strong action was taken by Sen. Binjamin, Dr. Maryl Nass, and others concerned, the testing on children has been postponed until the scientists see how the 350 adult volunteers fare first.

Protocol Number: 04-CH-0283
Title:
Anthrax Vaccine Clinical Trials
Number: o4-CH 0283

Summary: This study will examine the recombinant, that is, produced by genetic engineering, protective antigen (RAP) that brings about antibodies to neutralize the anthrax toxin and that could therefore be predicted to offer protection against anthrax. Today, anthrax is rarely encountered in the United States, since the introduction of vaccines for cattle in the 1930s. A human vaccine was licensed in 1970. Vaccination against anthrax has been confined to people at risk, such as wool sorters and some veterinarians. However, the rising prospects of B. anthracis being used as a weapon have led to routine administration of the anthrax vaccine to member of the armed forces.

Adults who are in good health and children who are in good health may be eligible for this study. The involvement of 350 adult volunteers and 100 children in first and second grade is planned.

Participants will have a general physical exam and test for vital signs. There will also be collection of blood for chemistry and hematology; urinalysis; tests for HIV, hepatitis B and C, and liver function; and a pregnancy test, if applicable.

On a random basis, patients will receive either the rPA will be evaluated, 10 u (Micro)g and 20 u (Micro)g. This evaluation aims to establish the safety and most desirable level of dosage. Patients will receive one injection of the vaccine, administered in the left shoulder or left thigh. About 30 minutes later, their temperature will be taken, and the injection site will be inspected. Rare but severe reactions could occur if there is extreme sensitivity to a vaccine. however, such an occurrence is extremely rare following a vaccine, and if there are any dangerous symptoms, they can be effectively treated by medications available to patients while they are at the clinic. if there are no significant abnormal results, patients may return home. About 6 hours later and daily for 7 days, they will take their temperature and examine the injection site. The vaccine may cause a temporary discomfort at the side of injection, and participants may experience a mild fever for 1 or 2 days after vaccination.

Patients will receive diary cards, a digital thermometer, and instructions on taking their temperature and measuring redness and swelling at the injection site, as well as for recording aches, muscle pain, or sensitivity to light for 7 days. They will be examined at the clinic at 72 hours following vaccination and request an exam. Meanwhile, a clinic staff member will call patients and discuss the findings. Then patients will receive a second and third injection of the same vaccine at 2-month intervals. There will also be interviews about patients' health at each visit to the clinic, plus monitoring of the vaccination after 6 hours and for 7 days. One year later, patients will receive a fourth injection of the same vaccine.

Direct benefit to participants in this study is not guaranteed, although an antibody response is predicted. The results in this study will help in the development of improved vaccines for anthrax.

Sponsoring Institute:
National Institute of Child Health and Human Development (NICHD)

Recruitment Detail
Type:
Active Accrual of New Subjects
Gender:
Male & Female

Referral Letter Required:
Yes

Population Exclusions:
None

Eligibility Criteria:

INCLUSION CRITERIA: Phase I
Healthy 18 to 20 year-olds of either sex.

EXCLUSION CRITERIA:
Patients receiving chronic medication, are pregnant or intend to become pregnant during the study.

Individuals are HIV positive, have abnormal liver function, had anthrax, or received anthrax vaccine, have received or intend to receive an experimental vaccine or medication within 30 days of injection of the experimental anthrax vaccine.

Special Instructions: Currently Not Provided

Keywords:
PA
Phase I
Phase 2
Safety
Immunogenicity

Recruitment Keyword(s):
None

Conditions(s):

Investigational Drug(s):
None

Investigational Device(s):
None

Intervention(s):
Procedure: Blood chemistry
Procedure: Hematology
Procedure: Urinalysis

Supporting Site:
N/A

Contact(s):

Patient Recruitment and public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local), 1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail: prpl@mail.cc.nih.gov

Citation(s): Not Provided

If you have:
Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.
 

Anthrax Shots Before Attack Not Worthwhile: ABC News Report

Reuters

Apr. 19, 2005
- NEW YORK (Reuters Health) -Vaccinating an entire population against anthrax before there is an immediate threat of a biological warfare attack is not cost-effective, results of statistical analysis suggest. If an attack does occur, mass vaccinations plus administration of antibiotics would be the best strategy, Dr. Robert A. Fowler at the University of Toronto in Canada and colleagues explain in their report in the Annals of Internal Medicine.
The authors compared the costs, harms and benefits of offering vaccination or antibiotics to a hypothetical cohort of people in a large metropolitan city. They assumed that they yearly probability of an attack is 1 percent, that 10 percent of the population would have sufficient exposure to anthrax spores to cause clinical disease, and that 95 percent of these would develop severe inhalational anthrax unless given antibiotics or a vaccine. A combination strategy of three vaccinations administered 2 weeks apart and antibiotics after an attack would prevent more cases of anthrax and more deaths than either approach alone, the teach calculated. It would also save $355 per person compared with vaccination alone. No preventative measures at all would be the most expensive strategy, the investigators note, because of the high cost of treating inhalational anthrax. "These findings highlight the critical need for distribution systems that can rapidly provide prophylaxis and vaccination for hundreds of thousands, perhaps millions, of exposed people," Fowler and colleagues conclude.
Dr. Glenn F. Webb, at Vanderbilt University in Nashville Tennessee, says in an accompanying editorial that the researchers did an excellent job analyzing the policy issues of an attack, but "they may underestimate the incalculable societal impact of such an attack," which might result in social panic and chaos.
Webb says measures such as implementation of technology to detect the release of anthrax spores, stockpiling of emergency supplies, and scientific research into the development of vaccines, antibiotics, and antidotes "are imperative."
SOURCE: Annals of Internal Medicine, April 19, 2005.

Copyright 2005 Reuters News Service. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Copyright 2005 ABC News Internet Ventures

 

http://www.annals.org/cgi/content/abstract/142/8/601

Cost-Effectiveness of Defending against Bioterrorism: A Comparison of Vaccination and Antibiotic Prophylaxis against Anthrax

javascript:ol('
http://www.annals.org/cgi/content/abstract/142/8/601%23FN');Robert A. Fowler, MD, MS; Gillian D. Sanders, PhD; Dena M. Bravata, MD, MS; Bahman Nouri, MD; Jason M. Gastwirth, MBA; Dane Peterson, MBA; Allison G. Broker, MBA; Alan M. Garber, MD, PhD; and Douglas K. Owens, MD, MS

19 April 2005 | Volume 142 Issue 8 | Page 601-610
Intervention: We evaluated 4 postattack strategies: no prophylaxis, vaccination alone, antibiotic prophylaxis alone, or vaccination and antibiotic prophylaxis, as well as preattack vaccination versus no vaccination.

Outcome Measures: Costs, quality-adjusted life-years, life-years, and incremental cost-effectiveness.

Results of Base-Case Analysis: If an aerosolized B. anthracis bioweapon attack occurs, postexposure prophylactic vaccination and antibiotic therapy for those potentially exposed is the most effective (0.33 life-year gained per person) and least costly ($355 saved per person) strategy, as compared with vaccination alone. At low baseline probabilities of attack and exposure, mass previous vaccination of a metropolitan population is more costly ($815 million for a city of 5 million people) and not more effective than no vaccination.

Results of Sensitivity Analysis: If prophylactic antibiotics cannot be promptly distributed after exposure, previous vaccination may become cost-effective.

Limitations: The probability of exposure and disease critically depends on the probability and mechanism of bioweapon release.

Conclusions: In the event of an aerosolized B. anthracis bioweapon attack over an unvaccinated metropolitan U.S. population, postattack prophylactic vaccination and antibiotic therapy is the most effective and least expensive strategy.

 

Critics Blast Anthrax Vaccine Test
Hartford Courant
June 23 2005

National Institutes of Health Officials Plan Trial On 100 Children
By THOMAS D. WILLIAMS
Courant Staff Writer

The National Institutes of Health is under fire from critics over a plan to test two anthrax vaccines on children.

The trial will test and compare the reactions in humans to the vaccine manufactured by BioPort Corp. of Lansing, Mich., and another being developed by NIH. Bob Bock, an NIH spokesman, said the trial planned for 100 children in first and second grade will not occur until the vaccines are fully tested on 350 adults and shown to be safe for them.

"The results in this study," says an NIH announcement, "will help in the development of improved vaccines for anthrax." The NIH and U.S. Health and Human Services Department are calling for development of the vaccine to protect civilians from terrorist or other attacks.

Critics, however, are appalled.

"This vaccine is totally inappropriate for children, because the [exposure] threat is so remote," said Barbara Loe Fisher, president of the National Vaccine Information Center. "They will likely never be exposed to anthrax either through contamination by animal products or inhalation of weaponized anthrax."

"Children are involved in trials of vaccines that benefit children," she said, "but this vaccine will not do so." Fisher said based on the NIH announcement of "rare severe reactions" to BioPort's vaccine, she fears the parents of children used in the experiments will not be given proper warnings of the vaccine's potential for adverse reactions.

However, Bock said adults and parents or guardians of the children will be given complete information on the two vaccines and their benefits and risks.

"I don't understand how they can do efficacy tests with children at the same time that we are discovering more and more U.S. soldiers who have been harmed by the vaccine," said Steve Robinson, executive director of the National Gulf War Resource Center for service members and veterans. "[NIH officials] want parents to want their children to be vaccinated against the anthrax terrorist attacks that have not happened."

But Bock said that if terrorist attacks occur, both children and adults would be at risk.

BioPort's vaccine, used almost exclusively on soldiers, has already demonstrated an adverse reaction rate 100 times the figure initially stated on the label. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to its use.

BioPort officials did not respond to repeated messages seeking comment Wednesday.

Retired Air Force Col. John Richardson, who has independently researched the vaccine extensively, said that in 2003, there were 16,869 federal adverse reaction reports for all vaccines and of those, 1,068 were for the anthrax vaccine. The anthrax vaccine drew more than 6 percent of all vaccine complaints, said Richardson, even though anthrax vaccinations represented less than 1 percent of an estimated 100 million immunizations of all types administered that year.

For last year, he said, there were 15,488 federal adverse reaction reports for all vaccines, and 806 for anthrax, or 5.2 percent of the total.

Complaints to the reporting system - which even federal officials acknowledge typically represent as few as 10 percent of all adverse reactions to vaccines - can be filed by vaccine users, doctors and medical personnel.

The vaccine, aimed at protecting soldiers against anthrax spores fired into the air in combat, has been under attack by service members and their advocates ever since the Pentagon mandated its use in 1998. Aside from the anthrax spore attacks aimed at government officials 3½ years ago, no such attacks are known to have been used during modern warfare or by terrorists.

News@nvic.org is a free service of the National Vaccine Information Center and is supported through membership domations. learn more about vaccines, diseases and how to profect your informed consent rights http://www.nvic.org

Become a member and support NVIC's work
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National Institutes of Health Decision Delayed on Anthrax Vaccine Testing on Children
http://www.nti.org/d_newswire/issues/2005_7_8.html#56E710CB
By David Ruppe
Global Security newswire

 

WASHINGTON — A plan to conduct safety tests of two experimental anthrax vaccines on children could proceed, despite the recent removal of any reference to such testing from a notice on the National Institutes of Health Web site (see GSN, June 27).

Researchers from the National Institute for Child and Human Development (NICHD) last year proposed including 100 first- and second-graders along with 350 adults in a clinical study assessing the relative safety, safe dosage levels, and side effects of a currently used vaccine and a new one for protection against inhalation anthrax.

A NICHD review board approved the study in July 2004, but directed that a decision on whether to include children be deferred until after the adults, ages 18-30, were tested and the results assessed.

The study formally began Sept. 8, 2004 and its completion is dependent, in part, upon recruiting volunteers. As of last week, 52 adult patients had been vaccinated using either the focal point of the testing, a genetically engineered anthrax vaccine now under development by NIH, or the controversial Anthrax Vaccine Adsorbed, which is now administered to U.S. military personnel deployed to certain regions of concern (see GSN, July 7).

The National Institutes of Health has published advertisements seeking participants for the trials in the Washington, D.C. area, offering compensation totaling $400 for eight clinical visits over the course of a year.

Compensation is not unusual and typically covers expenses and time, said Dr. Stephen Kaler, clinical director of the NICHD intramural research program. The institute would obtain parental consent for children to participate, if that component of the study is approved, he said.
 

Web Site Notice Changed

Complaints have surfaced in recent weeks that the trial, at least initially, should not include children and that no children should be vaccinated with the older vaccine because of doubts about its safety.

“I have grave concern about any intent to proceed with clinical trials with children at this point,” Senator Jeff Bingaman (D-N.M.) wrote in a July 1 letter to Health and Human Services Secretary Mike Leavitt.

“Surely considerable information regarding the safety of the new vaccine, as well as about its potential effectiveness, should be obtained in adults long before any consideration is given to providing it to children. And, based on what already is known about the adverse event profile of the older vaccine, it should not be ‘tested’ in children at all,” he added.

Critics have also expressed their doubts in U.S. newspapers.

“There is almost no risk to these children of being exposed to a form of … anthrax that has been weaponized,” Barbara Loe Fisher of the National Vaccine Information Center told the Kansas City Star. “The benefits are zero and the risk is quite high.”

A notice published in 2004 by the NIH Patient Recruitment and Public Liaison Office, which said the trial planned to include 100 children, prompted the criticisms. The institute recently removed that statement from the notice.

Kaler said there was a misunderstanding that children were already part of the trial. He said an additional decision by the Institutional Review Board, following the outcome of testing on adults, would be needed before children might be included. 

Whether children would ultimately be included is an “open question, because it hasn’t been approved,” he said

Kaler said some view a perceived benefit from testing the new vaccine on children.

“Whether we do this in children is tempered by the feeling of some that children would be at risk in a bioterrorism attack and it would be unfortunate if children weren’t included in the study,” he said.
 

Safety Questions

There are uncertainties about the safety of both vaccines. 

This trial phase is the first human testing for the NIH vaccine, which is still under development, according to Kaler. 

If the vaccine passes, it could then be subjected to two additional phases of trials involving larger numbers of patients, according to Food and Drug Administration regulations. One phase would evaluate its effectiveness and further evaluate its safety, and the second would seek to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that would allow the drug or treatment to be used safely, according to the regulations.

After that, the Food and Drug Administration could determine whether to license the vaccine as safe and effective against inhalation anthrax, the method of contraction of foremost concern from biowarfare or terrorism. The entire process apparently could take years.

The NIH vaccine is distinct from another genetically engineered anthrax vaccine, under development by the company VaxGen. The Health and Human Services Department in November purchased 75 million doses of that vaccine for $878 million, enough to vaccinate 25 million people against inhalation anthrax, according to the company (see GSN, May 6).   The department also awarded the company up to $69 million for, among other things, testing on children and the elderly after the Food and Drug Administration has approved the vaccine, according to Vice President of Public Affairs Paul Laland. The VaxGen vaccine is in its second phase of testing.

The older Anthrax Vaccine Adsorbed was licensed in 1970 as safe and effective against anthrax contracted through the skin, the disease form likely to infect textile and farm workers, and veterinarians. The Food and Drug Administration has not yet licensed it effective against inhalation anthrax. 

Questions recur about its safety, with rare reports of debilitating reactions after vaccination and experts questioning whether there is a link to multisymptom illnesses effecting soldiers after the first Gulf War (see GSN, Nov. 16. 2004).

The Defense Department insists the vaccine is as safe as other commonly used vaccines, or safer. “Study after study shows: people vaccinated against anthrax are as healthy as unvaccinated people,” according to a statement on the DOD Web site.

It is uncertain how many military and civilian personnel have experienced severe reactions from the existing vaccine. However, of approximately 1.3 million personnel vaccinated against anthrax during 2003 and 2004, hundreds were said to have been treated for “complex” cases following those and other vaccinations at four special vaccine treatment clinics, ranging from muscle and joint weakness and pain to multiple sclerosis (see GSN, May 6).

The military since May has been administering the vaccine to select military personnel on a voluntary basis, after a judge found that the treatment could not be required because the Food and Drug Administration had not yet properly licensed it against inhalation anthrax. About half the civilian and military personnel offered the vaccine have refused the shot. A Food and Drug Administration review for that license is under way, which could allow mandatory vaccinations to resume.

The new vaccine however should be safer, according to an NIH advertisement for trial volunteers, provided by Kaler.

“The vaccine is expected to be as effective as the licensed anthrax vaccine (AVA) but it is purer and should be safer,” it says.

Randi Airola
517-819-5926

 

Children Won't Be Used in Vaccine Test Trials

Hartford Courant: Children Won't be Used in Vaccine Test Trials - 12 Jul 2005
http://www.thenhf.com/vaccinations_63.htm

By THOMAS D. Williams
Courant Staff Writer

July 19, 2005

The National Institutes of Health says it made a mistake in announcing it would be using children to conduct anthrax vaccine test trials.

But the agency has not ruled out using children in future tests.

"Approval was not granted to enroll children in [the anthrax testing trial]. The Web announcement ... was in error. It has since been corrected," said Robert Bock, a NIH spokesman. "Any planning to test anthrax vaccine on children in [that trial] can be viewed only as a contingency."

The NIH was sharply criticized in June when it posted an Internet announcement that 350 healthy adults and 100 healthy children in the first and second grades were being sought as volunteer test subjects.

A new vaccine NIH is developing and the one currently in use by the military, manufactured by BioPort Corp. of Lansing, Mich., are being compared in the NIH test trials.

Days after news stories surfaced on the NIH's announcement, Sen. Jeff Bingaman, D-N.M., wrote Mike Leavitt, secretary of the U.S. Department of Health and Human Services, to express "grave concern" about clinical anthrax vaccine trials for children.

"Surely considerable information regarding the safety of the new vaccine, as well as about its potential effectiveness, should be obtained in adults long before any consideration is given to providing it to children," Bingaman wrote. "And, based on what already is known about the adverse event profile of the older vaccine, it should not be `tested' in children at all."

The NIH does do trials on children for other vaccines, Bock said. "[It] is currently conducting a study of a vaccine for typhoid fever in infants, in Vietnam. The institute is also conducting a study of a vaccine for shigella among 1- to 4-year-olds in Israel."

In its initial announcement, posted on its website, the NIH stated:

"Adults who are in good health and children who are in good health may be eligible for this study. ... On a random basis, patients will receive either the rPA dose or the licensed vaccine, for comparison of the properties of both vaccines.

"Rare but severe reactions could occur if there is extreme sensitivity to a vaccine. However, such an occurrence is extremely rare following a vaccine, and if there are any dangerous symptoms, they can be effectively treated by medications available to patients while they are at the clinic."

BioPort's vaccine, used almost exclusively on soldiers, has shown an adverse reaction rate 100 times the figure initially stated on the label. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to its use.

The six-shot vaccine plus annual booster is being used to eventually protect all 2.4 million in the armed services against anthrax spores that can be inhaled after being spread or fired by terrorists or enemies of the United States.

The NIH and U.S. Health and Human Services Department are calling for development of the vaccine to protect civilians from terrorist or other attacks. Hundreds of millions of dollars have been spent on developing a new vaccine, in addition to the new one NIH is testing.

Copyright 2005, Hartford Courant

 

Facts from the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

The Alliance for Human Research Protection (AHRP) sought expert advice about the latest CDC experiment. Professor Garth Nicolson of The Institute for Molecular Medicine in Huntington Beach, CA, a knowledgeable expert on the anthrax vaccine's trials and tribulations, responded with a specific concern:

"The only problem with this approach (passive immunity against anthrax using immune globulin) is that the vaccines used for producing immunity in Armed Forces personnel (Anthrax Vaccine Adsorbed) have been questioned as to whether they contain bacterial contaminants that could result in chronic infections [1]. This may be the reason that 40% of vaccinated Gulf War illness patient test positive for mycoplasmal infections, over 80% of these have one specific infection, Mycoplasma fermentans [2-4]. In some cases the infection has spread to immediate family members who present with signs and symptoms similar to Gulf War illness [5]. This primitive bacteria has been the subject of many studies by the Armed Forces Institute of Pathology [6], and an Army pathologist holds the patent on this bug [7]. The chance that an immune globulin fraction against anthrax might contain microorganisms like M. fermentans is real and should not be dismissed without careful consideration.

References:
1. Nicolson GL, Nass M, Nicolson NL. The anthrax vaccine controversy. Questions about its efficacy, safety and strategy. Med. Sentinel 2000; 5:97-101
2. Nicolson, GL and Nivolson, NL. Diagnosis and treatment of mycoplasmal infections in Gulf War Illness - CFIDS patients. Intern. J. Occup. Med. Immunol. Tox. 1996; 5: 69-78.
3. Nicolson, GL, Nicolson, NL and Nasralla, M. Mycoplasmal infections and Chronic Fatigue Illness (Gulf War Illness) associated with deployment to Operation Desert Storm. Intern. J. Med. 1997; 1:80-92
4. Vojdani A, Franco AR. Multiplex PcR for the detection of Mycoplasma fermentans, M. hominis and M. penetrans in patients with Chronic Fatigue Synfrome, Fibromyalgia, Rheumatoid Arthritis and Gulf War Illness. J. Chronic Fatigue Syndr. 1999; 5: 189-197.
5. Nicolson GL, Nasralla, Nicolson NL, Haier J. High prevalence of mycoplasmal infections in symptomatic (Chronic Fatigue Syndrome) family members of mycoplasma-positive Gulf War illness patients. J. Chronic Fatigue Synfr. 2002; 10:in press.
6. 7. Nicolson GL, Berns P, Nasralla M, Haier J, Nicolson NL, Nass M. Gulf War Illnesses: chemical, radiological and biological exposures resulting in chronic fatiguing illnesses can be identified and treated. J. Chronic Fatigue Syndr. 2002; 10:in press
7. Lo CS-C. Pathogenic mycoplasma. U.S. Patent 5,242,820. Issued September 7, 1993.


Public Health Vaccination Policies for Containing an Anthrax Outbreak

Brookmeyer R, Johnson E, Bollinger R.

Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street. Baltimore, Maryland 21205, USA

excerpts from the article:

Concern about biological weapons has raised questions about the most effective public health policies to contain an anthrax outbreak. We developed a probability model to predict the impact of different anthrax antibiotic and vaccination policies. An anthrax outbreak can be significantly contained by minimizing the delay until initiation of antibiotic prophylaxis. However, even if mass distribution of antibiotics is completed within six days of the initial exposure, then at most about 70% of cases can be prevented. Post-exposure vaccination will not significantly increase that prevention rate if adherence to antibiotic regimens is similar or higher than that attained in the 2001 US outbreak. However, post-exposure vaccination can be useful either in shortening the duration of a prolonged antibiotic regimen, in the event of an antibiotic-resistant strain, or if antibiotic adherence rates are very low. Here we show that a mass pre-exposure vaccination programme for the general population would require very high population coverage rates to significantly increase prevention rates from that achieved with targeted and rapid post-exposure prophylaxis programmes.

 

Cost-effectiveness of Defending Against Bioterrorism: A Comparison of Vaccination and Antibiotic Prophylaxis Against Anthrax.

Fowler RA, Sanders GD, Bravata DM, Nouri B, Gastwirth JM, Peterson D, Broker AG, Garbor AM, Owns DK.

Sunnybrook and Women's College Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. rob.fowler@sw.ca <rob.fowler@sw.ca>

BACKGROUND: Weaponized Bacillus anthracis is one of the few biological agents that can cause death and disease in sufficient numbers to devastate an urban setting. OBJECTIVE: To evaluate the cost-effectiveness of strategies for prophylaxis and treatment of an aerosolized B. anthracis bioterror attack. DESIGN: Decision analytic model. DATA SOURCES: We derived probabilities of anthrax exposure, vaccine and treatment characteristics, and their costs and associated clinical outcomes from the medical literature and bioterrorism-preparedness experts. TARGET POPULATION: Persons living and working in a large metropolitan U.S. city. TIME HORIZON: Patient lifetime. PERSPECTIVE: Societal. INTERVENTION: We evaluated 4 postattack strategies: no prophylaxis, vaccination alone, antibiotic prophylaxis alone, or vaccination and antibiotic prophylaxis, as well as preattack vaccination versus no vaccination. OUTCOME MEASURES: Costs, quality-adjusted life-years, life-years, and incremental cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: If an aerosolized B. anthracis bioweapon attack occurs, postexposure prophylactic vaccination and antibiotic therapy for those potentially exposed is the most effective (0.33 life-year gained per person) and least costly (355 dollars saved per person) strategy, as compared with vaccination alone. At low baseline probabilities of attack and exposure, mass previous vaccination of a metropolitan population is more costly (815 million dollars for a city of 5 million people) and not more effective than no vaccination. RESULTS OF SENSITIVITY ANALYSIS: If prophylactic antibiotics cannot be promptly distributed after exposure, previous vaccination may become cost-effective. LIMITATIONS: The probability of exposure and disease critically depends on the probability and mechanism of bioweapon release. CONCLUSIONS: In the event of an aerosolized B. anthracis bioweapon attack over an unvaccinated metropolitan U.S. population, postattack prophylactic vaccination and antibiotic therapy is the most effective and least expensive strategy.

 

 

Have veterinarians been getting Anthrax vaccinations or NOT....?

				Dod debunked, Anthrax refusers support group
			
				searches in vain for the vaccinated veterinarians!!
			
			Connecticut Air National Guard refusers searched in vain for veterinarians who had received 
anthrax vaccinations.  And they uncovered many readily available documents that either 
directly refute the DOD claims of safety and efficacy or cast serious doubt on these claims.  
(URL at page bottom)

"Depending on the source, the number of people vaccinated from 1970 until the  start of the 
Gulf War ranges from 3000 to ten of thousands. (It is interesting to note that, contrary to
DOD claims, a medical technician at the Connecticut Air National  Guard  spent several days 
in  early  October  1998  trying  to locate  any  civilian  who had  ever  administered  or 
received the vaccine.  No medical school,  veterinary  school,  the   Peace   Corps,  Sheep  
Ranchers  Association, etc., no  one  could be  found  that  had   any  knowledge  of  this 
vaccination.  Finally after making unsuccessful calls to at least two  African  nations  he 
gave up.)"

Below, Anthrax support group for refusers exchange  e-mails  regarding  veterinarians  NOT 
getting this vaccine

One of the pilots writes:
An example of why this theme needs to be developed, and the Vet. assertion needs to be 
debunked is that in the CTANG we were told that the Cornell Vet School had used this shot 
for years by our Medical Technician in a briefing to all our personnel to show them the 
shot was safe and effective. One of our pilots stood up and said, 'Oh yeah - I went to 
Cornell - and I know the Dean of the Vet. school - and I called him - they do not use this 
vaccine."   Silence.
- - - - - - - - - - - - - - - - - 
I sent an e-mail to the University of California - Davis Veterinary College (BIG Vet-college!) 
and got the following replies from them today. Dr Bradford P. Smith is the Veterinary Medical 
Teaching Hospital Director and Associate Dean for Clinical Programs.  After getting these 
e-mails from him today I'm pretty confident that the line " ...vets have been taking this 
vaccine for years" is a bunch of crap.  But that doesn't solve our problem. I've posted my 
e-mails below, the first one (at the bottom) was to Dan Mitchell, who forwarded it to Dr. 
Smith

The answer:
>>>As far as I know , veterinarians are not routinely vaccinated against anthrax. I graduated
>>>in 1970 and have never met anyone who was vaccinated.  Sorry that I don't have any info 
>>>about the human vaccine. We do sometimes vaccinate livestock. Dr. Bradford P. Smith, VMTH 
>>>Director and Associate Dean for Clinical Programs.

Jerry


From: Gbozarth@xxxxxxxxxx

"Tufts does not make the recommendation for vaccination against anthrax for its students. 
I am not vaccinated against anthrax.  Most school recommend/require vaccination against 
rabies only."

Mary Rose Paradis, DVM, MS
Associate Professor, Department of Clinical Sciences
Tufts University School of Veterinary Medicine
200 Westboro Rd
N. Grafton, MA 01536
Office: (508)839-5395, ext. 4840 


Yet another Anthrax-no list member tries to find any animal docs taking it.

Called veterinarians in Northern Illinois.  No one in this area has taken it.  One asked 
me how many vaccinations were given and replied "Oh My, no wonder they are getting sick!" 
Thinking on this line in the response from Dr. Nass about Texas area How many shots did 
those lab workers take and how close together? I was thinking when my children were 
little they never received vaccinations 2 weeks apart!!

Mary G.


Mary, I have contacted all the vets in Menomonie, WI and none have ever had the vaccine 
or known any one that has. One vet from  SE MN, for 40 years, hasn't  received  the  
vaccine.  This vet also taught in the West Indies.  We assumed the results were  due to 
our  location.  Maybe, it is more common in the western states? I'll be anxious to here 
from other areas. Thank you, 

Patty E.


Rob & Traci, 
My letter will be in the mail tomorrow. Also, to  the  list, I called two Veterinarians
in my area (Spokane, WA)  today and asked them if they ever had the shots  or if they  
knew anyone  who had.  One got very uptight with me asking questions. I assured her that 
I was just interested and why. She told me that no one up here needs it, maybe down south 
although no one she knows has submitted to these. The second vet said much the same thing 
but was more curious and I fully explained that we have conflicting information regarding 
numbers of Vets who supposedly received this vaccine since 1970-from 3000-10,000. He said 
that he felt that any numbers like those has to be erroneous. 
- - - - - - - - - - - - - - - - - - 
Speaking of "down south" What did we find? read on:

I spoke to Dr. Robert Field at Texas A&M University today.  Before I got through to him, 
I spoke with Dr. Joanne Lupton.  She had never heard of the anthrax vaccine for people. 

Mary C.
- - - - - - - - - - - - - - - - - -
To All,

According to Dr Lingappa at the CDC, it is not routine for vets to take the anthrax vaccine
because there is not such a threat of being exposed.  He said if there is indeed an outbreak,
it is quickly extinguished with antibiotics.  In other words, the threat is very low unlike 
rabies which all vets get.    
                                                                                                                         
Also, who said that vets had been taking the shots?  The DoD?

Traci.
- - - - - - - - - - - - - - - - - -

In all the searching, I believe we found one veterinarian who worked for a gov lab who took
Anthrax vaccine.

Yet here are the military claims according to Phil Diehl, staff writer North County Times 
Oceanside, CA "An anthrax  vaccine for  humans was  developed in the  United States in the
1960s and  has been routinely administered to veterinarians, laboratory workers and livestock
handlers since 1970, states information on a Defense Department Web site."  NOTE: that in 
this list of those getting the shots veterinarians are mentioned FIRST that is designed so 
you will believe they are the ones getting MOST of the Anthrax vaccines so far.

and another such claim made by: Dr. Bailey (Dr. Sue Bailey, the Assistant Secretary of 
Defense for Health Affairs) with Secretary Bacon, Rear Admiral Mike Cowan at the DoD News 
Briefing Friday, Aug. 14, 1998 - 2:00 p.m. (EDT) Anthrax vaccine has been shown to be 
extremely safe. Again, a 28-year history, mostly with those working with animals, because 
this is what's considered a zoonotic disease. That would be people working around wool, 
sheep, other animals. And it has therefore been given to veterinarians and we have also 
been giving it to special forces so that we now have a long history of safe use. We have 
given over 133,000 doses and, as I mentioned, we've only had seven adverse effects."  

Notice in the deceptive quote above that most of it refers to animals and people working
with them, and as a kind of after thought, special forces is also mentioned as getting the 
shots!   

Note:

The full research paper compiled by the Air National Guard pilots can be found at:
http://www.dallasnw.quik.com/cyberella/Anthrax/refute.html
Our support group is located at:  (http://www.onelist.com/subscribe.cgi/Anthrax-no

It is an excellent paper and begins: 

Controversy continues to surround this program.  Our original  charter as  members  of  a 
Military Tiger Team was to get the facts, without prejudice to either viewpoint. While we
have tried to be as accurate and factual as possible, we are not medical  researchers  or
medical experts.  Our six month search  has,  however, uncovered many  readily  available 
documents that either directly refute the DOD  claims of  safety and  efficacy,  or  cast 
serious doubt on these claims.  We continue to look for  documents  to  support  the  DOD 
position, yet have  found none  to necessitate a mandatory inoculation policy.   From the 
outset, we believed that the burden of proof in this  vaccination  policy  rests  on  the 
shoulders of the commanders at the  highest  levels  of  the  DOD.   Unfortunately, Field 
commanders and service members are forced to fill in the myriad of unanswered  questions. 
At this point our research finds another side to  the  anthrax  vaccination  policy  that 
warrants review.  We recommend all service members do their own research, and make  their 
own informed decision. 
		
			http://www.dallasnw.quik.com/cyberell/Anthrax/V_survey.html
		
 

NUREMBERG CODE

From "Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10", Vol. 2, Nuremberg, October 1946-April 1949. (Washington, DC: US Government Printing Office, 1949). pp 181-182

The great weight of the evidence before us is to the effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical, and legal concepts.

  1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
    The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
     
  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
     
  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
     
  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
     
  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
     
  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
     
  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
     
  8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
     
  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
     
  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.




LAWMAKER: HOLD ANTHRAX SHOTS

Marine Corps Times
May 10, 1999

Reports of Squalene Antibodies in Gulf War Veterans Cited
By Deborah Funk
Times Staff Writer

A North Carolina congressman has asked the Pentagon to stop immunizing service members against anthrax until defense officials conduct a "more thorough examination" of possible side effects.

Rep. Walter B. Jones, R-N-C., pointed to reports that independent researchers have found evidence of squalene antibodies in sick Gulf War veterans, including those who did not deploy.

Scientists have been experimenting with squalene - a substance found naturally in shark and human livers - to see if it can boost the effectiveness of vaccines by improving the body's immune response. It hasn't been licensed for general use by the Food and Drug Administration.

The body produces antibodies to neutralize toxins, proteins and other substances, which is how the body develops immunity.

The presence of squalene anti-bodies in Persian Gulf War veterans indicates they came in contact with squalene somehow, but the Defense Department says it wasn't part of the anthrax vaccine given to Gulf War vets.

Congress asked the General Accounting Office to look into the matter, but investigators couldn't determine whether Gulf War veterans were given vaccines containing squalene. GAO recommended the Defense Department test veterans for squalene anti-bodies to determine the extent of their presence and whether they are a factor in Gulf War illnesses.

But Pentagon officials declined, saying they would wait until the researchers' work is published in a scientific journal before considering whether to test veterans.

In a letter to Defense Secretary William S. Cohen, Jones urged the department to test the veterans now and suspend the anthrax vaccination program until possible health risks are ruled out.

Jones said he understands the importance of protecting troops against biological warfare. But, he said, "I am concerned the department may be moving ahead with implementation of an anthrax vaccine program prior to conducting the full range of scientific and medical tests necessary to appropriately reduce the risks of unintended health consequences for those required to receive the inoculation...

"I urge you to impose a moratorium on involuntary anthrax vaccinations until a more thorough examination of the connection between previous vaccinations and adverse health effects has been completed," Jones wrote.

Pentagon spokesman Kenneth Bacon said the anthrax vaccine has been licensed for nearly 30 years with a solid safety record.

"The question one has to ask is what would happen if there were an anthrax attack and we hadn't taken precautionary measures to protect our troops," Bacon said.

The only times the Defense Department has used squalene in vaccines given to people were in five tightly controlled, voluntary clinical trials, three for malaria and two for HIV vaccines, a Pentagon spokesman said. Military researchers used squalene as a vaccine-enhancer in several studies involving animals, the spokesman said. The anthrax vaccine was one of those tested.

www.gultwarvets.com/marine2.htm

 

GAO Calls for Squalene Tests

By Paul M. Rodriguez

Although the Defense Department denied having a role in the presence of the adjuvant squalene in the bloodstreams of gulf-war veterans, a GAO report raises questions about that.

        In a surprisingly abrasive report released March 29, the General Accounting Office concluded -- and so recommended to Congress -- that the Defense Department immediately should begin studying the discovery of antibodies in the blood of sick Persian Gulf War veterans to a compound called squalene. The object of such studies would be to determine if squalene, however it got into the bloodstream, is a contributing factor in gulf-war illness.
. . . . The GAO report follows by a week a report in Insight detailing final laboratory results from a two-year study conducted by the prestigious Tulane School of Medicine in New Orleans (see "Breakthrough on Gulf War Illness," April 19). That study confirmed the presence of the squalene antibodies in sick veterans of the Persian Gulf War era -- antibodies found in the blood of those who served overseas as well as of those vets who never left U.S. soil during that conflict.
. . . . Squalene is an experimental adjuvant used to speed the immune system. It has not been approved by the Food and Drug Administration. Tulane's research was conducted by the widely respected immunologist Robert Garry, and his findings were peer-reviewed. According to Dr. Garry and to Dr. Russell B. Wilson of Autoimmune Technologies LLC, a firm hired by Tulane to market its patented protocol for the test, the presence of the squalene antibodies points to some outside source. They suggest, for example, experimental injections.
. . . . "Yes, it's pretty significant," Wilson tells Insight. "We're not saying we know how [the antibodies] got [in the sick soldiers], but we are saying we have proof positive of an objective marker that they do exist." Garry agrees, adding that it's up to the Congress and the Department of Defense, or DOD, to investigate further, because "we now can confirm [the squalene antibodies] do exist [in the blood of the sick vets] and that further testing certainly is in order to find out why, because it would be extremely remote that such antibodies would appear as a result of natural causes."
. . . . When Insight first reported the preliminary lab results showing these antibodies, the DOD dismissed the findings. Because the department never used squalene in any medication or vaccine given to gulf-war soldiers, let alone experimented with the substance, officials contended, the DOD would be foolish to conduct an independent analysis.
. . . . Now the General Accounting Office, or GAO, after its own six-month probe into Insight's reports concerning Tulane's previously secret laboratory work, sternly has criticized the DOD for obfuscating on the issue. Indeed, the GAO discovered that the DOD long has known about squalene as a possible adjuvant drug and that the military has been experimenting with squalene-based medicines for more than 10 years, even conducting trials in Thailand involving squalene as an adjuvant for an anti-AIDS drug.
. . . . "Time is critical for many gulf-war-era veterans who continue to suffer from illnesses and have been waiting for the past seven years for an explanation about the nature of their illnesses," the GAO report said. "Independent researchers [at Tulane] ... have concluded that squalene antibodies are present in sick gulf-war-era veterans who have participated in their research and are a potential contributing factor to these veterans' illnesses."
. . . . Although officials at the DOD told the GAO, according to the report, that the Defense Department could develop its own tests, it would not do so because the DOD claimed "it did not use adjuvant formulations with squalene" and wanted to wait for the research work to be published. The GAO was not impressed: "Given that gulf-war-era veterans already have waited a significant amount of time for information on their illnesses, we believe that DOD should act now to expand on the research already conducted" at Tulane.
. . . . The GAO report was stunning. It said that despite being told by the DOD that gulf-war-era troops were not vaccinated with a squalene-based drug, it could not "say definitively whether or not [veterans] were given vaccines with adjuvant formulations containing squalene for a number of reasons." Although DOD officials claimed to the GAO that they did not administer such vaccines, "they stated they did not have documentation on the process and results of decision-making related to the administration of vaccines at the time of the gulf war. Also, some officials involved in the decisions were no longer employed with DOD ... and we were either unable to locate them or they declined to be interviewed," the GAO said in its 24-page report (GAO/NSIAD-99-5).
. . . . Rep. Jack Metcalf, the Washington state Republican who requested the GAO probe, tells Insight that he has been "deeply concerned about this issue since it first was brought to my attention by veterans that are suffering from gulf-war illnesses. They had read [the Insight stories] about blood samples of some gulf-war-era veterans containing antibodies to squalene. They want to know the truth about why they are sick, and my sole motivation has been and remains still to help these men and women find the truth."
. . . . The three-term congressman, who has been a lone voice barking at the DOD on the issue, further told this magazine that "with over 100,000 of our veterans suffering, the DOD's history of foot-dragging and obfuscation on this issue is inexcusable.... We have a moral obligation to stand with the honorable men and women who sacrificed for this nation in their search for effective treatment of Persian Gulf War illnesses and demand DOD act on the GAO recommendations."
. . . . In ever-increasing numbers since 1991, American vets have been reporting unexplained illnesses, including symptoms of lupus and rare cancers, to name but a few. For years the DOD has stonewalled. Enter Tennessee immunologist Pamela Asa with her initial theory that so much illness might have resulted from a covert inoculation administered to the troops. Though the DOD attacked Asa and then denied -- as it since has to Insight and to the GAO -- that it ever used any secret vaccines involving experimental compounds, the military also initially denied it was experimenting with squalene.
. . . . And the GAO not only confirmed the extensive military testing using squalene-based adjuvants, it also revealed for the first time that DOD officials considered but allegedly then decided against using just such a vaccine -- supposedly to protect U.S. troops from potential Iraqi biological or chemical attacks. Congressional investigators tell Insight that they found these GAO conclusions profoundly shocking.
. . . . Although the GAO and the DOD have not revealed what immunizations were under consideration for use with squalene as an adjuvant, military and congressional sources say they believe these must have been antianthrax drugs. "It would be inconceivable that the Pentagon would have experimented on soldiers involving anything else," says a senior military official who has tracked Insight's reports on this issue but asks to remain anonymous. However, according to the GAO, the military claimed it never experimented with a squalene-based anthrax drug.
. . . . The GAO said that while determining what the DOD may have done to cause 100,000 cases of gulf-war illness has been difficult, the GAO did uncover squalene-linked human testing protocols going back to 1988 when 500 subjects were administered an antimalaria vaccine. In 1990, another 12 human subjects were given a similar concoction and then another 121 in 1994. Between February 1995 and September 1997, at least 341 people received experimental anti-AIDS vaccines in Thailand involving squalene as an adjuvant at the same time that 93 people were administered placebos.
. . . . But, the stonewalling continues. The DOD still claims that, despite changing story lines about its experiments with squalene-based drugs, it never used squalene on gulf-war soldiers, so there is no need to test. In fact, the DOD told the GAO that "to test veterans seems scientifically and fiscally irresponsible." The DOD even said the GAO's recommendation "to test for squalene antibodies showed a lack of understanding of scientific methods."
. . . . Adamant refusals by the DOD to test a relatively inexpensive protocol doesn't make sense to Garry and his people at Tulane or to the GAO, given the millions of dollars spent to date on far more complicated probes and medical investigations into the causes of gulf-war illnesses. But it is beginning to look like something will be done.
. . . . House Veterans' Affairs Committee Chairman Bob Stump of Arizona and House Armed Services Committee Chairman Floyd Spence of South Carolina say through aides they find the position taken by the DOD alarming. The two chairmen plan to refer the Tulane and the GAO studies to their committees for evaluation and possible hearings into the mystery of how antibodies to squalene got into all those sick soldiers. Meanwhile, GAO stands ready to dig deeper.

Copyright © 1999 News World Communications, Inc.
http://www.insightmag.com

 

§ 1520. Use of human subjects for testing of chemical or biological agents by Department of Defense; accounting to Congressional committees with respect to experiments and studies; notification of local civilian officials

 

 

LEXIS LAW PUBLISHING'S CODE OF FEDERAL REGULATIONS

Copyright © 1999, LEXIS Law Publishing

*** THIS SECTION IS CURRENT THROUGH THE 1/18/99 ISSUE OF ***

*** THE FEDERAL REGISTER ***

21 CFR 50.23

[PUBLISHER'S NOTE: Paragraph (d)(1) of this section was amended at 64 FR 396, 399, Jan. 5, 1999, effective May 20, 1999. For the convenience of the user, paragraph (d)(1) has been set out twice below. The first version is effective until May 20, 1999. The second version is effective May 20, 1999.]

(a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:

(1) The human subject is confronted by a life-threatening situation necessitating the use of the test article.

(2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.

(3) Time is not sufficient to obtain consent from the subject's legal representative.

(4) There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

(b) If immediate use of the test article is, in the investigator's opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (a) of this section in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.

(c) The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.

(d)(1) [Effective until May 20, 1999.] The Commissioner may also determine that obtaining informed consent is not feasible when the Assistant Secretary of Defense (Health Affairs) requests such a determination in connection with the use of an investigational drug (including an antibiotic or biological product) in a specific protocol under an investigational new drug application (IND) sponsored by the Department of Defense (DOD). DOD's request for a determination that obtaining informed consent from military personnel is not feasible must be limited to a specific military operation involving combat or the immediate threat of combat. The request must also include a written justification supporting the conclusions of the physician(s) responsible for the medical care of the military personnel involved and the investigator(s) identified in the IND that a military combat exigency exists because of special military combat (actual or threatened) circumstances in which, in order to facilitate the accomplishment of the military mission, preservation of the health of the individual and the safety of other personnel require that a particular treatment be provided to a specified group of military personnel, without regard to what might be any individual's personal preference for no treatment or for some alternative treatment. The written request must also include a statement that a duly constituted institutional review board has reviewed and approved the use of the investigational drug without informed consent. The Commissioner may find that informed consent is not feasible only when withholding treatment would be contrary to the best interests of military personnel and there is no available satisfactory alternative therapy.

(d)(1) [Effective May 20, 1999.] The Commissioner may also determine that obtaining informed consent is not feasible when the Assistant Secretary of Defense (Health Affairs) requests such a determination in connection with the use of an investigational drug (including a biological product) in a specific protocol under an investigational new drug application (IND) sponsored by the Department of Defense (DOD). DOD's request for a determination that obtaining informed consent from military personnel is

not feasible must be limited to a specific military operation involving combat or the immediate threat of combat. The request must also include a written justification supporting the conclusions of the physician(s) responsible for the medical care of the military personnel involved and the investigator(s) identified in the IND that a military combat exigency exists because of special military combat (actual or threatened) circumstances in which, in order to facilitate the accomplishment of the military mission, preservation of the health of the individual and the safety of other personnel require that a particular treatment be provided to a specified group of military personnel, without regard to what might be any individual's personal preference for no treatment or for some alternative treatment. The written request must also include a statement that a duly constituted institutional review board has reviewed and approved the use of the investigational drug without informed consent. The Commissioner may find that informed consent is not feasible only when withholding treatment would be contrary to the best interests of military personnel and there is no available satisfactory alternative therapy.

(2) In reaching a determination under paragraph (d)(1) of this section that obtaining informed consent is not feasible and withholding treatment would be contrary to the best interests of military personnel, the Commissioner will review the request submitted under paragraph (d)(1) of this section and take into account all pertinent factors, including, but not limited to:

(i) The extent and strength of the evidence of the safety and effectiveness of the investigational drug for the intended use;

(ii) The context in which the drug will be administered, e.g., whether it is intended for use in a battlefield or hospital setting or whether it will be self-administered or will be administered by a health professional;

(iii) The nature of the disease or condition for which the preventive or therapeutic treatment is intended; and

(iv) The nature of the information to be provided to the recipients of the drug concerning the potential benefits and risks of taking or not taking the drug.

(3) The Commissioner may request a recommendation from appropriate experts before reaching a determination on a request submitted under paragraph (d)(1) of this section.

(4) A determination by the Commissioner that obtaining informed consent is not feasible and withholding treatment would be contrary to the best interests of military personnel will expire at the end of 1 year, unless renewed at DOD's request, or when DOD informs the Commissioner that the specific military operation creating the need for the use of the investigational drug has ended, whichever is earlier. The Commissioner may also revoke this determination based on changed circumstances.

HISTORY:

[46 FR 8951, Jan. 27, 1981, as amended at 55 FR 52817, Dec. 21, 1990; 64 FR 396, 399, Jan. 5, 1999]

  

LEXIS LAW PUBLISHING'S CODE OF FEDERAL REGULATIONS

Copyright © 1998, LEXIS Law Publishing

*** THIS SECTION IS CURRENT THROUGH THE 1/22/99 ISSUE OF ***

*** THE FEDERAL REGISTER ***

TITLE 21 -- FOOD AND DRUGS

CHAPTER I -- FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER F -- BIOLOGICS

PART 601 -- LICENSING

SUBPART F -- CONFIDENTIALITY OF INFORMATION

21 CFR 601.50

§ 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product.

 

(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.

(b) The availability for public disclosure of all data and information in an IND file for a biological product shall be handled in accordance with the provisions established in § 601.51.

(c) Notwithstanding the provisions of § 601.51, the Food and Drug Administration shall disclose upon request to an individual on whom an investigational biological product has been used a copy of any adverse reaction report relating to such use.

HISTORY:

[39 FR 44656, Dec. 24, 1974]

 

LEXIS LAW PUBLISHING'S CODE OF FEDERAL REGULATIONS

Copyright © 1998, LEXIS Law Publishing

*** THIS SECTION IS CURRENT THROUGH THE 1/22/99 ISSUE OF ***

*** THE FEDERAL REGISTER ***

TITLE 21 -- FOOD AND DRUGS

CHAPTER I -- FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER F -- BIOLOGICS

PART 601 -- LICENSING

SUBPART F -- CONFIDENTIALITY OF INFORMATION

21 CFR 601.51

§ 601.51 Confidentiality of data and information in applications for establishment and product licenses.

 

(a) For purposes of this section the biological product file includes all data and information submitted with or incorporated by reference in any application for an establishment or product license, IND's incorporated into any such application, master files, and other related submissions. The availability for public disclosure of any record in the biological product file shall be handled in accordance with the provisions of this section.

(b) The existence of a biological product file will not be disclosed by the Food and Drug Administration before a product license has been sent to the applicant, unless it has previously been publicly disclosed or acknowledged. The Director of the Center for Biologics Evaluation and Research will maintain a list available for public disclosure of biological products for which a license has

been issued.

(c) If the existence of a biological product file has not been publicly disclosed or acknowledged, no data or information in the biological product file is available for public disclosure.

(d)(1) If the existence of a biological product file has been publicly disclosed or acknowledged before a license has been issued, no data or information contained in the file is available for public disclosure before such license is issued, but the Commissioner may, in his discretion, disclose a summary of such selected portions of the safety and effectiveness data as are appropriate for public consideration of a specific pending issue, e.g., at an open session of a Food and Drug Administration advisory committee or

pursuant to an exchange of important regulatory information with a foreign government.

(2) Notwithstanding paragraph (d)(1) of this section, FDA will make available to the public upon request the information in the IND that was required to be filed in Docket Number 95S-0158 in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations involving an exception from informed consent under § 50.24 of this chapter. Persons wishing to request this information shall submit a request under the Freedom of Information Act.

(e) After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown:

(1) All safety and effectiveness data and information.

(2) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial or financial information in § 20.61 of this chapter.

(3) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of:

(i) Names and any information that would identify the person using the product.

(ii) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.

(4) A list of all active ingredients and any inactive ingredients previously disclosed to the public, as defined in § 20.81 of this chapter.

(5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and it is shown to fall within the exemption established in § 20.61 of this chapter.

(6) All correspondence and written summaries of oral discussions relating to the biological product file, in accordance with the provisions of part 20 of this chapter.

(7) All records showing the manufacturer's testing of a particular lot, after deletion of data or information that would show the volume of the drug produced, manufacturing procedures and controls, yield from raw materials, costs, or other material falling within § 20.61 of this chapter.

(8) All records showing the testing of and action on a particular lot by the Food and Drug Administration.

(f) The following data and information in a biological product file are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter:

(1) Manufacturing methods or processes, including quality control procedures.

(2) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.

(3) Quantitative or semiquantitative formulas.

(g) For purposes of this regulation, safety and effectiveness data include all studies and tests of a biological product on animals and humans and all studies and tests on the drug for identity, stability, purity, potency, and bioavailability.

HISTORY:

[39 FR 44656, Dec. 24, 1974, as amended at 42 FR 15676, Mar. 22, 1977; 49 FR 23833, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 61 FR 51498, 51530, Oct. 2, 1996]

 

 

 

Clinton Orders Human Experiments
By Timothy W. Maier

A day after Republican Rep. Chris Shays of Connecticut ended congressional hearings on the controversial decision mandating the inoculation of 2.4 million U.S. troops against anthrax, President Clinton quietly signed an executive order, or EO, that denies soldiers the right to refuse experimental vaccines.

E013139, titled "Improving Health Protection of Military Personnel Participating in Particular Military Operations," caught Congress off guard as it directed the Pentagon to disregard the authority of the Food and Drug Administration, or FDA. The order authorized use of experimental vaccines -- those not approved by the FDA and therefore illegal -- to be administered to members of the armed forces without informed consent.

Some congressmen saw this as an attack by the president on the House Government Reform subcommittee on National Security, Veterans Affairs and International Relations, where testimony indicated the Pentagon had violated the FDA's procedures on how to administer the anthrax vaccine. Those hearings -- as well as others held by the full House Committee on Government Reform -- had put the FDA on the spot for letting the Pentagon disregard sensible FDA regulations. The Pentagon wanted to administer the shots now and, as a result, long-range studies were not conducted and an inadequate reporting system was set up to hide the large number of adverse effects, critics charged.

As a result of the unprecedented implementation of the vaccination program, more than 1,000 troops are awaiting trial on a felony charge of refusing to obey, hundreds more have left the armed forces and dozens have been prosecuted.

The FDA's failure to take a stand against the Pentagon has prompted a group of concerned congressmen, led by Republican Rep. Walter Jones Jr. of North Carolina, formally to complain to the agency. "The FDA didn't do its job," says Jones, a member of the House Armed Services Committee. "Our men and women are too valuable and they're not going to be guinea pigs."

Jones, who has asked the Pentagon's inspector general to launch a probe into the growing anthrax controversy, warns that Clinton's executive order "might encourage more men and women to get out of the military. I think Clinton did it to give cover to what the DOD [or Department of Defense] is doing." And with the FDA having rolled over, Jones says, he is even more determined to learn why the White House and the Pentagon doubled the contract of Michigan-based BioPort Corp., which manufactures the vaccine, from $25.7 million to $49.8 million and at the same time reduced the volume to be delivered by 2.3 million shots (see "Why BioPort Got a Shot in the Arm," Sept. 20).

The Pentagon has claimed the inoculation protects against all anthrax strains, and BioPort made the same claim to Insight -- despite the fact that an experiment at the Fort Detrick chemical and biological warfare center in Maryland using guinea pigs showed nine of the 27 anthrax strains tested killed 50 percent of the vaccinated subjects.

Kwai-Cheung Chan, the director of the special studies and evaluations, national-security and international-affairs division of the General Accounting Office, testified before the House Government Reform Committee that there have been no studies to "determine the optimum number of doses of the anthrax vaccine. Although annual boosters are given, the needs for a six-shot regimen and annual booster shots have not been evaluated."

Chan's biggest criticism, however, involves the process in which the vaccine was made. He notes the deficiencies that FDA identified in its February 1998 inspection. "These fell into two categories: those that might affect only one or a limited number of batches, and those that could compromise the safety and efficacy of any or all batches." The facility was as a result shut down in early 1998. BioPort is addressing the processing problems, but the FDA has yet to approve its laboratory to produce the controversial vaccine.

Meanwhile, since Insight last reported on the anthrax vaccination, still more troops and civilians have fallen ill after receiving the shots, according to the FDA. From 1990 to Oct. 1, 1999, 425 reports of adverse events associated with the anthrax vaccine have been reported. Critics argue the incidents are being underreported because, unless the side effects involve chills or fatigue, some doctors say they can't report the symptoms (see "A Dose of Reality," Sept. 20).

Mark Zaid, an attorney representing dozens of troops who refused to take the mandatory anthrax inoculation, says, "There are big problems. Why, all of a sudden out of nowhere, especially when the opposition to the program is getting so much steam and criticism of the Department of Defense was running rampant, does Clinton sign an executive order that assures DOD can implement any experimental program it wants? This whole thing is DOD doing an end run around the FDA. The FDA should step up to plate and do its job."

The FDA may be starting to take note, according to a September letter from the agency obtained by Insight. The letter was written the day Shays' hearing ended. Katheryn Zoon, director of the Center for Biologics Evaluation and Research, wrote to Assistant Secretary of Defense Sue Bailey:

"Recently it has come to the agency's attention through congressional sources that some troops may not be receiving the vaccine in accordance with the schedule found in the approved labeling. As you know, the approved anthrax labeling states that full immunization involves six doses of the vaccine to be administered following the first dose at two and four weeks, six months, 12 months and 18 months, with yearly boosters thereafter. This schedule is the only regimen shown to be effective in protecting humans against anthrax and is the only schedule approved by the FDA. Data received by FDA from congressional sources indicate that a number of reserve and active military personnel are receiving their anthrax vaccine dose significantly later than the FDA approved schedule."

In his order Clinton calls attention to the biological threat to which troops might be subjected, saying soldiers could "potentially be exposed to a range of chemical, biological and radiological weapons, as well as disease endemic to an area of operations." Defense Secretary William Cohen warned recently on ABC's Nightline that it is not a question of whether we could face a biological attack, it's a question of when.

But neither the president's top intelligence expert in this field nor the State Department are impressed by these claims. Richard Clarke, the bioterrorism expert with the National Security Council, also said on Nightline that he doesn't expect terrorists will turn to biological weapons. "I don't believe it's a certainty at all," he said. "I know that there are people who say it will eventually happen. But I think you have to remember, there has to be motivation. Someone has to do it. And that someone has to believe they can get away with it. They're not going to. If you look at our history in the last five years, after every major terrorist incident we have discovered the people who were involved. And even if they were on the other side of the earth, and even flit was four years later or 10 years later, we reached out and got them."

In addition, the State Department has posted this statement on its Website: "The Department of State has no information to indicate that there is likelihood of use of chemical or biological agent release in the immediate future. The Department believes the risk of the use of chemical/biological warfare is remote, although it cannot be excluded."

Meanwhile, even though U.S. embassies are prime targets of terrorists, the State Department isn't requiring its employees to have the anthrax shot before deployment. Jones called on the State Department to explain why it was not mandating the shot, and promptly was told it will take "four years to get that information." He then turned to House International Relations Committee Chairman Ben Gilman of New York, who quickly fired off a letter to State demanding action.

Yet Clinton signed EO13139 to use experimental vaccines on U.S. troops despite the scandals created by exposure of the secret use of experimental vaccines ranging from administering LSD in the 1950s to the drug pyriostigmine bromide, or PB, given to troops bound for the Persian Gulf War. PB, which protects against nerve gas, may be linked to some of the gulf-war illnesses, according to the Rand Corp., a California-based think tank that recently published a 385-page review of the drug.

Maj. Thomas "Buzz" Rempfer of the Air Force Reserve says there may be times when use of vaccines that have not been fully tested and FDA-approved may be necessary and appropriate during great crisis. "But this capability for our president is currently being jeopardized by the reckless mandatory vaccination of all service members against anthrax," he says. "The threat is not imminent and the integrity of the military institution is being compromised to implement a strategic or blanket program that is doctrinally unprecedented and unsound. The lack of trust we are breeding in the force today could sacrifice our military's capability to protect our troops on a tactical basis when threatened in the future."

COPYRIGHT 1999 News World Communications, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

EXECUTIVE ORDER

IMPROVING HEALTH PROTECTION OF MILITARY PERSONNEL PARTICIPATING IN PARTICULAR MILITARY OPERATIONS

   By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 1107 of title 10, United States Code, and in order to provide the best health protection to military personnel participating in particular military operations, it is hereby ordered as follows:

   Section 1.  Policy.  Military personnel deployed in particular military operations could potentially be exposed to a range of chemical, biological, and radiological weapons as well as diseases endemic to an area of operations.  It is the policy of the United States Government to provide our military personnel with safe and effective vaccines, antidotes, and treatments that will negate or minimize the effects of these health threats.

   Sec. 2.  Administration of Investigational New Drugs to Members of the Armed Forces.

   (a) The Secretary of Defense (Secretary) shall collect intelligence on potential health threats that might be encountered in an area of operations.  The Secretary shall work together with the Secretary of Health and Human Services to ensure appropriate countermeasures are developed.  When the Secretary considers an investigational new drug or a drug unapproved for its intended use (investigational drug) to represent the most appropriate countermeasure, it shall be studied through scientifically based research and development protocols to determine whether it is safe and effective for its intended use.

   (b) It is the expectation that the United States Government will administer products approved for their intended use by the Food and Drug Administration (FDA).   However, in the event that the Secretary considers a product to represent the most appropriate countermeasure for diseases endemic to the area of operations or to protect against possible chemical, biological, or radiological weapons, but the product has not yet been approved by the FDA for its intended use, the product may, under certain circumstances and strict controls, be administered to provide potential protection for the health and well-being of deployed military personnel in order to ensure the success of the military operation.  The provisions of 21 CFR Part 312 contain the FDA requirements for investigational new drugs.

   Sec. 3.  Informed Consent Requirements and Waiver Provisions.

   (a) Before administering an investigational drug to members of the Armed Forces, the Department of Defense (DoD) must obtain informed consent from each individual unless the Secretary can justify to the President a need for a waiver of informed consent in accordance with 10 U.S.C. 1107(f).  Waivers of informed consent will be granted only when absolutely necessary.

   (b) In accordance with 10 U.S.C. 1107(f), the President may waive the informed consent requirement for the administration of an investigational drug to a member of the Armed Forces in connection with the member's participation in a particular military operation, upon a written determination by the President that obtaining consent:

          (1)  is not feasible;

          (2)  is contrary to the best interests of the member; or

          (3)  is not in the interests of national security.

   (c) In making a determination to waive the informed consent requirement on a ground described in subsection (b)(1) or (b)(2) of this section, the President is required by law to apply the standards and criteria set forth in the relevant FDA regulations, 21 CFR 50.23(d).  In determining a waiver based on subsection (b)(3) of this section, the President will also consider the standards and criteria of the relevant FDA regulations.

   (d) The Secretary may request that the President waive the informed consent requirement with respect to the administration of an investigational drug.  The Secretary may not delegate the authority to make this waiver request.  At a minimum, the waiver request shall contain:

          (1) A full description of the threat, including the potential
          for exposure.  If the threat is a chemical, biological, or
          radiological weapon, the waiver request shall contain an
          analysis of the probability the weapon will be used, the
          method or methods of delivery, and the likely magnitude of its
          affect on an exposed individual.

          (2) Documentation that the Secretary has complied with 21 CFR
          50.23(d).  This documentation shall include:

               (A) A statement that certifies and a written
               justification that documents that each of the criteria
               and standards set forth in 21 CFR 50.23(d) has been met;
               or

               (B) If the Secretary finds it highly impracticable to
               certify that the criteria and standards set forth in 21
               CFR 50.23(d) have been fully met because doing so would
               significantly impair the Secretary's ability to carry out
               the particular military mission, a written justification
               that documents which criteria and standards have or have
               not been met, explains the reasons for failing to meet
               any of the criteria and standards, and provides
               additional justification why a waiver should be granted
               solely in the interests of national security.

          (3) Any additional information pertinent to the Secretary's
          determination, including the minutes of the Institutional
          Review Board's (IRB) deliberations and the IRB members'
          voting record.

   (e) The Secretary shall develop the waiver request in consultation with the FDA.

   (f) The Secretary shall submit the waiver request to the President and provide a copy to the Commissioner of the FDA (Commissioner).

   (g) The Commissioner shall expeditiously review the waiver request and certify to the Assistant to the President for National Security Affairs (APNSA) and the Assistant to the President for Science and Technology (APST) whether the standards and criteria of the relevant FDA regulations have been adequately addressed and whether the investigational new drug protocol may proceed subject to a decision by the President on the informed consent waiver request.  FDA shall base its decision on, and the certification shall include an analysis describing, the extent and strength of the evidence on the safety and effectiveness of the investigational new drug in relation to the medical risk that could be encountered during the military operation.

   (h) The APNSA and APST will prepare a joint advisory opinion as to whether the waiver of informed consent should be granted and will forward it, along with the waiver request and the FDA certification to the President.

   (i) The President will approve or deny the waiver request and will provide written notification of the decision to the Secretary and the Commissioner.

   Sec. 4.  Required Action After Waiver is Issued.

(a) Following a Presidential waiver under 10 U.S.C. 1107(f), the DoD offices responsible for implementing the waiver, DoD's Office of the Inspector General, and the FDA, consistent with its regulatory role, will conduct an ongoing review and monitoring to assess adherence to the standards and criteria under 21 CFR 50.23(d) and this order.   The responsible DoD offices shall also adhere to any periodic reporting requirements specified by the President at the time of the waiver approval.

The Secretary shall submit the findings to the President and provide a copy to the Commissioner.

   (b) The Secretary shall, as soon as practicable, make the congressional notifications required by 10 U.S.C. 1107(f)(2)(B).

   (c) The Secretary shall, as soon as practicable and consistent with classification requirements, issue a public notice in the Federal Register describing each waiver of informed consent determination and a summary of the most updated scientific information on the products used, as well as other information the President determines is appropriate.

   (d) The waiver will expire at the end of 1 year (or an alternative time period not to exceed 1 year, specified by the President at the time of approval), or when the Secretary informs the President that the particular military operation creating the need for the use of the investigational drug has ended, whichever is earlier.  The President may revoke the waiver based on changed circumstances or for any other reason.   If the Secretary seeks to renew a waiver prior to its expiration, the Secretary must submit to the President an updated request, specifically identifying any new information available relevant to the standards and criteria under 21 CFR 50.23(d).   To request to renew a waiver, the Secretary must satisfy the criteria for a waiver as described in section 3 of this order.

   (e) The Secretary shall notify the President and the Commissioner if the threat countered by the investigational drug changes significantly or if significant new information on the investigational drug is received.

   Sec. 5.  Training for Military Personnel.  (a) The DoD shall provide ongoing training and health risk communication on the requirements of using an investigational drug in support of a military operation to all military personnel, including those in leadership positions, during chemical and biological warfare defense training and other training, as appropriate.  This ongoing training and health risk communication shall include general information about 10 U.S.C. 1107 and 21 CFR 50.23(d).

   (b) If the President grants a waiver under 10 U.S.C. 1107(f), the DoD shall provide training to all military personnel conducting the waiver protocol and health risk communication to all military personnel receiving the specific investigational drug to be administered prior to its use.

   (c) The Secretary shall submit the training and health risk communication plans as part of the investigational new drug protocol submission to the FDA and the reviewing IRB.  Training and health risk communication shall include at a minimum:

          (1) The basis for any determination by the President that
          informed consent is not or may not be feasible;

          (2) The means for tracking use and adverse effects of the
          investigational drug;

          (3) The benefits and risks of using the investigational drug;
          and

          (4) A statement that the investigational drug is not approved
          (or not approved for the intended use).

   (d) The DoD shall keep operational commanders informed of the overall requirements of successful protocol execution and their role, with the support of medical personnel, in ensuring successful execution of the protocol.

   Sec. 6.  Scope.  (a) This order applies to the consideration and Presidential approval of a waiver of informed consent under 10 U.S.C. 1107 and does not apply to other FDA regulations.

   (b) This order is intended only to improve the internal management of the Federal Government.  Nothing contained in this order shall create any right or benefit, substantive or procedural, enforceable by any party against the United States, its agencies or instrumentalities, its officers or employees, or any other person.

WILLIAM J. CLINTON

THE WHITE HOUSE,
September 30, 1999.

 

The Institute of Medicine Weighs in on Anthrax Vaccine;
DOD Scores A Knockout


(But read the report, and the Institute doesn't have a leg to stand on)


By Meryl Nass, MD


Nearly two years ago, Congress asked the National Academy of Sciences (NAS) to review the existing data on safety and efficacy of the anthrax vaccine (AVA). A committee was created by the NAS Institute of Medicine (IOM) to do this, and the group met over the last seventeen months to review this complex and controversial issue.

I attended several of the open meetings, made an invited presentation, and supplied nearly 300 pages of supporting information to the committee.

The National Academy of Science's report 'The Anthrax Vaccine: Is it safe? Does it work?' was released March 6. It claimed to be a thorough compilation of all the existing data, weighted by reliability, and included a number of recommendations and ideas for further research.

What did the report conclude? Here is where it gets interesting.
 

The report's conclusions rely on ignoring many pieces of crucial information, and its recommendations give the Department of Defense everything it could have wanted. The report appears to be “spun” to support a number of DOD initiatives, and it provides the needed justification for restarting mandatory anthrax vaccinations over the objections of many in Congress.

Strong words. Can I back them up? Let's review the Executive Summary and see what the report concludes about efficacy, safety and vaccine manufacturing concerns (which closed the plant for four years, until it finally received FDA approval in January 2002). Several unexpected recommendations are also explored. I've excerpted from the text in bold, and used quotations.

EFFICACY

1.
"Because the vaccine exerts its protection via an antigen crucial to the action of the bacteria's toxins, AVA should be effective against anthrax toxicity from all known strains of B. anthracis, as well as from any potential bioengineered strains."

This particular fairly tale has been oft-repeated by a variety of DOD spokespersons over the last four years, in support of the anthrax vaccine immunization program. Although it makes logical sense, the statement is contradicted by the data, in which thousands of vaccinated animals have succumbed to challenge with many strains of anthrax, despite generating high levels of antibody to the vaccine antigen in question, 'protective antigen' or PA.

It furthermore ignores the work of Pomerantsev et al in Russia (published in the December 1997 issue of the journal Vaccine), in which a genetically engineered strain of anthrax had the PA antigen gene removed. Another gene for cereolysin was inserted, making the
engineered anthrax resistant to a PA-based vaccine like the current anthrax vaccine.

How did the IOM report deal with this information? It claimed Pomerantsev's study was “flawed” because anti-PA antibody titres of vaccinated animals were not given. This is a specious argument, because antibody titres in mice and guinea pigs have shown no correlation with survival. Then the report complains that hamsters were used, and “little is known about hamsters as an animal model.” The study was done in Russia, and the Russians who use hamsters as their model probably know plenty about hamsters and anthrax.
 

Pomerantsev works at NIH now, not far from IOM. If answers to these questions were really wanted, Pomerantsev could have been invited to come answer them.
 

The report also mentioned, but immediately ignored, the fact that DOD was so frightened
about this type of engineered anthrax, that it contracted with Battelle Memorial Institute to genetically engineer a similar strain. (See Miller J and Broad W. NYT September 4, 2001, page A1.) And who knows what Pomerantsev is concocting now at NIH?

Claims by IOM that a vaccine "should be effective" against all known strains and all potential bioengineered strains should be summarily dismissed as reckless optimism.


2.
"The macaque and the rabbit are adequate animal models for evaluation of the efficacy of AVA for the prevention of inhalation anthrax."

Many animal models have been used in anthrax experiments. DOD has found that only the rabbit and rhesus macaque show strong immunity after anthrax vaccine. The macaque, not surprisingly, has an illness that is closest pathologically to the human version of inhalation anthrax. The chimpanzee, however, which is normally considered closer to the human
than the macaque, develops an anthrax illness that more closely resembles that in guinea pigs and mice.

DOD has long claimed, without citing any data to support the claim, that because macaque anthrax looks like human anthrax, that the macaque is the best animal model for studying vaccine immunity. But just because the disease may be similar pathologically does not mean the macaque immune response to vaccine is similar to the human response. The IOM report entirely fails to explain this conceptual leap.

Another leap follows. The rabbit happens to develop stronger immunity after anthrax vaccination than the rat, mouse or guinea pig. Macaques are expensive, but rabbits are cheap. So DOD wants to conduct its vaccine efficacy studies in rabbits, not macaques or chimps. Rabbit anthrax does not resemble human anthrax closely.

IOM supplied DOD with the desired gold nugget to support rabbit experiments, based on the misleading argument that macaque anthrax looks like human anthrax, and the rabbit immune response to AVA looks like the macaque immune response, therefore rabbits are like humans!
 

We know rabbits get good immunity from anthrax vaccine, but the real question is do humans get good immunity? Where is the evidence that rabbits provide a good model for human immunity?

The report's assertion that these animals are good models for humans falls apart several paragraphs later. The IOM report says, "The data from animal studies already developed suggest that serological correlates of human immunity
can be developed in appropriate animal models. The committee commends this work and encourages its further development."

What that means is that at present, there is no way to compare the immunity developed by animals after vaccination, to the immune response of humans after vaccination. Bottom line: the IOM gave DOD its imprimatur to use rabbits, with no supporting evidence or logic, because they are inexpensive and likely to provide the forgone conclusion desired.

3.
"The committee finds that the available evidence from studies with humans and animals coupled with reasonable assumptions of analogy , shows that AVA as licensed is an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by any known or plausible engineered strains of B. anthracis."

Here the report makes several claims favorable to DOD, but unsupported by evidence, in a single sentence:

a) AVA is effective in humans, even for inhalation

b) The addition of the phrase "as licensed" appears to be an attempt to weigh in on the current case in Federal Court, which notes that the AVA license does not include an indication (an approved use) for inhalation, or biological warfare use. If a jury agrees, DOD will be prevented from forcing anthrax vaccine on troops.

c) The vaccine will be effective for genetically engineered strains.


Despite all the report's hand-wringing about PA, the main vaccine ingredient, there is clearly no way to know if the vaccine will be effective against engineered anthrax strains: it depends how they are engineered.

 

Ken Alibek's book Biohazard says that vaccine resistant anthrax strains are possible and were under development in the former USSR. Alibek was one of this report's reviewers. Were his concerns omitted too, or did he forget what he wrote 3 years ago?

A legal problem for the vaccine manufacturer, but ignored by FDA in its rush to license a vaccine to protect us from DOD-developed weaponized anthrax, released by God Only Knows Whom, and God Only Knows Why (the federal government hasn't a clue who grabbed its anthrax), is that there exist no human data to support efficacy of this vaccine for any form of anthrax in humans: not for cutaneous anthrax, not for inhalation. And under the regulations in place in 1970 when the vaccine was licensed, and still in place today, you had to have that data to obtain a license.

Is there reasonable evidence of efficacy? Not really. The vaccine works in some animals, but not in others. An older, never-licensed anthrax vaccine had partial efficacy. Maybe this one does too, but the data to show this in humans do not exist.


SAFETY

4.
"Local events, especially redness, swelling, or nodules at the injection site...are similar to the events observed following receipt of other vaccines..."

True, but they happen at a much higher rate than with other vaccines. Why wasn't this mentioned in the Summary?

5
. "Systemic events, such as fever, malaise and myalgia, are similar to the events observed following receipt of other vaccines currently in use by adults, but are much less common than local events."

Several studies gave 70-80% rates of local reactions, and 48% rates of systemic reactions for anthrax vaccines. Is 48% much less common than 70%? Both these rates are higher than for other vaccines.


6.
"There are sex differences in local reactions following vaccination with AVA..."

Here the report parrots a misstatement of the facts first made by DOD. The available data show that females have higher rates of both local and systemic reactions than males, by a factor of 2-3.

Local reactions are considered minor, and invariably resolve. But systemic reactions that occur after vaccination may be harbingers of chronic illnesses to come. Therefore, DOD is unwilling to acknowledge what its own data show about systemic reactions, and in particular to admit the existence of a rate disparity between the sexes. Acknowledging the gender difference in systemic reactions could result in women being exempted from.vaccination, something DOD very much wants to avoid. (Another anthrax vaccine case based on gender differences is also winding its way through the courts.)


7.
"The available data are limited but show no convincing evidence at this time that personnel who have received AVA have elevated risks of later-onset health events."

Every reference cited to support this statement was to a DOD briefer, with the exception of three citations to a series of papers looking at Fort Detrick personnel who each received many different vaccinations. The problem with these three papers (dated 1958, 1965 and 1974) is that
the research was done on all of them prior to 1971. The anthrax vaccine was licensed in 1970;
therefore, the anthrax vaccine received almost exclusively by these Detrick personnel was a different anthrax vaccine.

The problem with using only DOD briefers should be obvious.

What did the report scrupulously avoid in order to draw the above conclusion?

a) Preliminary data from the Navy were provided to the IOM shortly before the report was completed. A Navy study had found higher rates of birth defects in the offspring of vaccinated, as opposed to non-vaccinated sailors. The IOM report emphasized the preliminary nature of these data and other limitations in the Navy database, and did not mention the study in its recommendations.

b) Five studies of Gulf War syndrome found a statistically significant association between anthrax vaccine, or multiple vaccines given for the Gulf deployment, and the development of Gulf War Syndrome.
No studies exist that refute this association. These studies were done by five separate groups of researchers.

This is a major omission, especially since three of the five groups studied veterans who had received AVA, the identical vaccine being studied; the other two studies were of British veterans who received a different anthrax vaccine. The results were similar, however. How did the IOM report justify this oversight?

First, it claims that the Gulf War studies “were not designed to study the effects of vaccine exposure.” That is nonsense. Then the report criticizes the fact that multiple vaccinations were given. But some of the studies did look at the multiple vaccination issue, and got positive results. This tells you that at least one of the vaccines is likely causing problems, or that multiple vaccinations interacted to cause illness. Finally, the report criticizes the need to rely on self-reports of vaccine exposure. But since DOD did not put the vaccinations into US soldiers' shot records, all that researchers can do is use self-reports. That is, unless DOD decides to find the Gulf War vaccination records it conveniently lost ten years ago.

These pretexts do not justify junking this research, which has been published in top medical journals: The Lancet, American Journal of Epidemiology, and Occupational and Environmental Medicine.
 

Instead, the report says that unpublished DOD studies, in most cases done by young military scientists with little experience in epidemiology, and which were neither peer-reviewed nor published, were the “best available” sources of data on AVA and health outcomes.

The available data would not have been limited had IOM chosen to consider the Gulf War studies, done by seasoned and respected professionals.
 

I gave each committee member a published anthrax vaccine study done at a military base in England in 2000. Of 100 soldiers who volunteered to take anthrax vaccine, 71% dropped out of the vaccine series before their fourth dose. The author was not sure why so many who accepted the initial dose refused later doses, but the initial adverse reaction rate was extremely high, and prevented 28% of recipients from lifting or driving for at least 48 hours following vaccination. This paper also got no mention in the report.

c) IOM refused to draw any conclusions from the VAERS data (VAERS is a voluntary adverse event reporting system overseen by FDA and CDC) or from the Anthrax Vaccine Expert Committee (AVEC), which was formed by DHHS at DOD's request, to review every VAERS report on anthrax vaccine. IOM pointed out that the VAERS data should be used to generate hypotheses about vaccine effects, which should then be tested using methods that have
statistical validity, which VAERS lacks.

However, VAERS has to be studied in order to generate hypotheses: that is its purpose. FDA did this and put the information in the current anthrax vaccine's package insert. IOM prefers to imply that no chronic symptoms reported to VAERS are due to the vaccine, whereas FDA properly noted that some symptoms are reported with sufficient frequency after vaccination to be included in the vaccine's label.

 

Refusing to consider the VAERS data is another example of how the IOM report overlooked evidence that might lead in the wrong direction.
 

New Manufacturing Process

8
. "AVA will now be produced by a newly validated manufacturing process under strict controls, according to current FDA requirements. As a result, the post-renovation product has greater assurance of consistency than that produced at the time of original licensure."

If lack of consistency had been shown to be the reason AVA has not demonstrated safety or effectiveness, this would be good news. Since that is not the case, we remain in the dark about the 'newly licensed' vaccine's safety and efficacy, and how it compares to the previously licensed vaccine.

Previously manufactured lots of AVA vary in the concentration of their components by a
factor of 40 from lot to lot: some lots have 40 times as much active ingredient (PA) as others.

Last year, GAO informed Congress of filter changes at the vaccine manufacturer which led to a 100 fold increase (10,000 per cent increase) in the level of PA in anthrax vaccine. The series of filter changes began in 1990, but were not submitted to FDA for required approval. FDA only learned of these changes from GAO in 2000, and retroactively approved them several months later.

Somehow, the IOM report fails to mention the marked recent increase in vaccine potency, which might be an explanation for the higher reaction rates reported after 1990. Some newer lots may have 4,000 (40 x 100) times the potency of earlier lots.

This is a curious omission, since the current supply of vaccine is extremely limited. Anthrax vaccine might be effective at 1/100 th the dose, or perhaps be effective at even larger dilutions. The US is planning to dilute its existing inventory of 15 million doses of smallpox vaccine to 1/5 th its current strength: why not anthrax?

It would also be useful to learn whether the increases in PA and other vaccine components, which could now be 4,000 times greater than in lots of anthrax vaccine manufactured during the
1980s, affect vaccine safety and efficacy.

The IOM report fails to suggest any investigation of whether the anthrax vaccine potency changes have affected safety, efficacy or the optimal dose, although there is a glaring need for research in these areas.

Surprising Gifts to DOD Found in the Report

9
. "DOD should continue to support the efforts of CDC to study the reactogenicity and immunogenicity of an alternative route of AVA administration and of a reduced number of vaccine doses."

This is another nugget IOM threw to DOD, which wants a vaccine license amendment to permit deeper, intramuscular injections that will hide some of the local reactions.

10
. "The committee finds no scientific reason for the continued operation of AVEC in its present form. The IOM committee's observations about AVEC reflect no fault with the members of AVEC or its performance as that committee is constituted; rather, the IOM committee observes that AVEC was designed to pay extra attention to safety concerns
regarding the safety of AVA and that the data do not warrant the continuation of such exceptional attention...

"DOD should disband AVEC in its current form and instead assist FDA and CDC in establishing an independent advisory committee charged with overseeing the entire process of evaluating vaccine safety."


a) This recommendation was a big surprise. Commenting on the continued existence of AVEC is way beyond what the IOM committee was charged to do. Why did IOM overstep its guidelines to come up with this slap at AVEC? Is it possible that AVEC began identifying problems with the vaccine?

AVEC gave a CDC group investigating anthrax vaccine a list of adverse reactions to look for in subjects receiving anthrax vaccine. Could its acknowledgement of adverse vaccine reactions have earned AVEC the coup de grace?


b) Why did IOM ask DOD to assist FDA and CDC in the evaluation of vaccine safety? This recommendation has its origins in the twilight zone. Nothing in the committee charter could possibly be construed as inviting a recommendation like this one. Does the public want the Defense Department entering the civilian vaccine arena?

DOD's 'interest' in vaccine safety has been demonstrated by the following:

giving experimental vaccines to military servicemembers without informed consent or with inadequate information

storing vaccines for decades before use, and redating expired vaccines multiple times without proper testing

generating bad science to cover up the role of its vaccines and therapeutics in illnesses such
as Gulf War Syndrome.

Offering DOD a place at the vaccine safety table can only result in confounding the assessment of safety for civilian, as well as military, vaccines.

11
. "DOD personnel have used DMSS (Defense Medical Surveillance System) to conduct valuable analyses in response to concerns about health effects that might be associated with
vaccination with AVA...

"DOD should actively support and advance the development of DMSS data resources and staffing of units that will allow the continuing rapid and careful analysis of these data, including but not limited to the proposed collaboration between CDC and the Army Medical Surveillance Activity."

The DMSS database could have been a wonderful resource for studying an enormous variety of medical issues in active duty men and women. It collects diagnostic data from every outpatient visit and hospitalization of each servicemember within military treatment facilities. It does not capture data from the VA or non-military medical centers.

However, serious problems exist with DMSS, at least insofar as anthrax vaccine is concerned.

When three million person-years of non-anthrax-vaccinated servicemembers were compared with 500,000 person-years of vaccinated servicemembers, the results were unreal. It turned out that if you had received any vaccine doses, you were only about 60% as likely to report a
huge variety of medical problems than if you were never vaccinated. These results were highly statistically significant.

Since not even DOD can come up with a plausible explanation for these results, which imply that anthrax vaccine is the greatest health enhancer known to man, the results are due to either:

a) flawed statistical methodology

b) medical providers' fears of documenting illnesses in recipients of this 'safe' vaccine, the centerpiece of military medicine's biological warfare defense, or

c) vaccine recipients' apprehension that symptoms ascribable to the vaccine may lead to forced medical retirement, so they avoid seeking help for illnesses, or seek help elsewhere.

This is the database the IOM report applauds.

On the other hand, the DMSS database does suggest that anthrax vaccine is associated with an increased risk of diabetes, breast cancer, asthma, Crohn's Disease, thyroid cancer and multiple sclerosis. The IOM report acknowledged that these associations could be signals of a possible causal relationship, especially for diabetes, Crohn's Disease and multiple sclerosis. These are all autoimmune disorders, which are the kinds of long-term reactions to a vaccine that might be predicted, since vaccines act as immune stimulants.

The report recommends “additional follow-up.”

12
. "DOD should develop systems to enhance the capacity to monitor the occurrence of later-onset health conditions that might be associated with the receipt of any vaccine; the data reviewed by the committee do not suggest the need for special efforts of this sort for AVA."

So despite the fact that data on long-term effects are very limited, despite the concerns about the birth defect data and DMSS data on diabetes, multiple sclerosis and Crohn's Disease, despite the refusals of further vaccine doses by many in the UK and US, and despite the five Gulf War Syndrome studies, the report specifically recommends against any special efforts in vaccine safety monitoring for AVA, and wants to shut down the one committee designated to perform this. So much for the concept of “additional follow-up.”

Should we be surprised? After all, at least three past expert panels that were formed to debate the illnesses appearing in Gulf War veterans, including one from the Institute of Medicine, gratuitously recommended
against performing any research into the possible role of anthrax vaccine in Gulf War illnesses.

There is still only limited reliable information about the effects of dioxin (the most potent toxin in Agent Orange) in humans, thirty years after the US stopped using Agent Orange due to health concerns.

When have you previously seen scientists recommend against further research? Only in two cases: when an issue has been unquestionably resolved, or when someone is trying to hide something. Unfortunately, this report is a replay of a tawdry old tune. Esteemed expert panel meets to resolve complex scientific question. But read the report, and science is the one thing that's missing. Instead, it's politics (and coverup) as usual.

The book Science, Money and Politics: Political Triumph and Ethical Erosion by Daniel Greenberg recounts the history of lies and egregious behaviors by scientists that have eroded the values underpinning science in our society. Maybe one has to look no farther than to Greenberg to learn how reports like this one come to be.

IOM approval was what DOD had been waiting for, in order to restart the mandatory vaccination program, according to the vaccine manufacturer (March 7 NY Times, Sheryl Stolberg). With billions of dollars on the line for military biodefense vaccines, and the need to appear to be doing something meaningful about the bioterrorism threat, could this report possibly have produced any other conclusion?
 

If the government may be culpable for making its own soldiers sick, don't hold your breath waiting for the government-sponsored science that will prove it.

http://www.anthraxvaccine.org/IOM_Anthrax_critique.html

The safety and efficacy of anthrax vaccine have not been established, and the preponderance of the world's literature shows the vaccine is unsafe, and a contributor to Gulf War Syndrome is acknowledged in the vaccine's package insert

When the DoD's Anthrax Vaccine Immunization Program was announced in late 1996, published evidence for both safety and efficacy of the anthrax vaccine was lacking. Dr. Peter Turnbull, formerly head of anthrax research at Portion Down, and others had made this information available in the open literature. Rodent challenge studies showed poor efficacy of the UK and US killed human anthrax vaccines against highly virulent strains, and there existed no published safety data, apart from a study of an earlier, unlicensed "Brachman" (a.k.a. "Merck") anthrax vaccine. It contained little information on systemic adverse effects. A later unpublished DC 'open label' study of the licensed US anthrax vaccinations were administered had expressed concern about the adverse reactions , and these concerns were discussed at the CDC, she was overruled by the mill's doctor, and the documentary evidence suggests the matter was then dropped.

Reports of several panels that had been charged with investigating Gulf War Syndrome (GWS), and claimed the vaccine had nothing to do with it, were reviewed. The evidence they relied on to draw conclusions about the role of anthrax vaccine was shaky at best. The reports either cited no references to support their vaccine conclusions, or cited only briefings by military officers, not scientific studies.

Despite the finding by a Senate committee in 1994 that anthrax vaccine was being considered as a possible cause of GWS, and the statement by the Persian Gulf Veterans Coordinating Board that "all potential causes [of GWS] that have been identified are being investigated," when I reviewed the full portfolio of federal research on GWS in 1999, I found that of the 166 studies listed, none looked specifically at anthrax vaccine.

Only because the Wessely/Unwin study was designed to investigate all potentially noxious exposures that GW soldiers had faced, had data on anthrax vaccine been captured.

The low rate of GWS in French troops, who were unvaccinated, had used prophylactic doxycycline and consumed cleaner, bottled water, needed explanation. The issue of whether small numbers of French troops who did develop GWS were in liaison positions and were vaccinated alongside US and UK units, has been raised by the French Ministry of Defense, but has not been resolved.

Numerous vaccinated by nondeployed Gulf War 'era' soldiers in the US have developed similar multisystem illnesses as the deployed soldiers. Dr. Lea Steele was able to analyze this intriguing finding in a study of Kansas Gulf War veterans. She found that nearly 4% of the veterans who had not been deployed, nor vaccinated in preparation for deployment, met her GWS case definition. (She later concluded that this number is approximately the prevalence rate of a similar condition in civilians.) But those who were vaccinated in preparation for deployment, but never actually deployed, had a rate 3 times higher, nearly 12%.

The US Institute of Medicine (IOM) committee on GWS under Dr. Harold Sox was asked to review only published, peer-reviewed literature, and did a credible job looking at the published literature on anthrax vaccine. In September 1999 the committee concluded that no evidence existed to either support or refute anthrax vaccine as a cause of chronic adverse health effects, including GWS. (Since then, a 2003 Cochrane review of anthrax vaccines drew the same conclusion: "Further research should be carried out on the short and long term safety effects of available vaccines and if possible their effectiveness.")

However, the IOM committee overlooked several studies that linked anthrax vaccine to GWS. The first study was performed by a contractor to the Canadian Department of National Defense (DND), Gross-Gilroy, and was published on the DND website in 1998. The study used self-reports (as nearly all the GWS studies have done) and found that immunization with biological warfare vaccines, which for Canadian troops included only anthrax and plague vaccines, was associated with chronic fatigue.

Chronic fatigue was a cardinal feature of GWS, as defined by the CDC in a seminal paper by Fukuda et al in 1998.

In January 1999 a groundbreaking paper by Unwin and Wesseley et al in The Lancet showed that anthrax vaccine was associated with development of a GWS syndrome, defined by the authors, in both veterans of the Vulf War, and also in a small number of anthrax-vaccinated veterans of the Bosnia conflict. Because of the large number of veterans studied, and good statistical techniques, this research is very convincing. It furthermore showed that multiple vaccinations were independently associated with development of GWS.

In 1999, Colonel John Grabenstein, an army pharmacist who had just completed a PhD in Pharmacoepidemiology, was chosen to serve as the clinical head and deputy director of the anthrax vaccine program  agency. He was charged with supervising a portfolio of Army research to show the anthrax vaccine was a safe and effective as DOD had reported to Congress. Col. Grabenstein was also a consultant and trainer for Merck and Glaxo Smith Kline, and chaired a committee of the American Pharmacists' Association whose purpose was to train pharmacists to prescribe and administer vaccines without a doctor's prescription, and to pass legislation needed for them to do so in every state. He is on the Board of the Immunization Action Coalition, and industry-sponsored advocacy organization. Col. Grabenstein has written to pharmacists, "At present, about 50 serious vaccine-associated injuries occur each year in the United States, in the course of protecting a population of 275 million into which 3.9 million children are born annually.

Yet the FDA says that 15% of 12,000 reported yearly reactions are serious. His remarkable ability to spin even the worst news has led to his promotion to clinical chief and spokesperson for all military vaccinations. As quoted in the Washington Post, "Grabenstein said vaccinations of 524,000 military personnel had found only low risks such as sore arms, aches and fevers, with the rare serious reaction for 1 in 100,000." Grabenstein was quoted in the NY Times on December 21, 2001 as saying, "If people are getting sick, it is not due to the [anthrax] vaccine." He  has misrepresented the conclusions of a number of other studies of anthrax vaccine, claiming that eighteen studies prove the anthrax vaccine to be safe. He also worked closely with the Institute of Medicine committee that produced the March 2002 report "The Anthrax Vaccine: Is It safe? Does It Work?" He is thanked in the report's acknowledgments.

This report, cited repeatedly by FDA in its earlier, growwly flawed version of a final rule, is a cunical whitewash of the safety and efficacy concerns about anthrax vaccine, and makes a number of unsubstantiated and incorrect claims regarding both. Furthermore, the report acknowledges the DOD's Defense Medical Surveillance System database's findings of a statistical association between immunization with anthrax vaccine and later hospitalizations for diabetes, breast cancer, asthma, Crohn's Disease, thyroid cancer and multiple sclerosis. It notes that these associations could be signals of a possible causal relationship, especially for diabetes, Crohn's Disease and multiple sclerosis, and recommends "additional follow-up" in the text. However, when the report makes its final recommendations, it recommends against such follow-up, saying, "DOD should develop systems to enhance the capacity to monitor the occurrence of later-onset health conditions that might be associated with the receipt of any vaccine; the data reviewed by the committee do not suggest the need for special efforts of this sort for AVA."

The National Academy of Sciences division in which this report was produced is the Medical Follow-Up Agency, and it is 100% funded by the Department of Defense and the Department of Veterans Affairs. Would this division have retained its funding had the report provided an honest assessment of the vaccine?

Under Col. Grabenstein's oversight, the army has published at least four studies purporting to show anthrax vaccine is safe and effective. However, the data reported in these studies leave much to be desired. The most important study, the only one designed to evaluate long-term reactions, was conducted on 603 vaccinated medical staff at Tripler Army Medical Center. According to the principal investigator, "The objectives were to provide active surveillance of self-reported side effects and the duration of symptoms." Soldiers were asked to complete a questionnaire about symptoms that developed after their last anthrax vaccination, whenever they presented for a subsequent inoculation, or within two weeks of vaccination.

One case of multiple sclerosis and two other neurological reactions developed in vaccines. One neonatologist developed a tremor and upper extremity weakness associated with a CPK level over 1000. A pediatric cardiologist developed numbness and fasciculations, suggesting a brachial plexopathy, which resolved. Although the study was designed and initially advertised to seek persisting adverse reactions, the forms completed by soldiers only specified whether reactions lasted brief periods less than 72 hours or more than 72 hours, and the published paper provides no tables on side effect duration. The paper notes that only local reactions could be linked to vaccination, and appears to dismiss vaccine causality for other reactions without providing a rational for doing so. The exit questionnaire used was a general health questionnaire (Health Enrollment Assessment Review Survey), rather than a questionnaire designed to capture specific information related to vaccine adverse effects and their duration. In fact, the questionnaire used made no reference to anthrax vaccine.

Other problems with this study include the fact that although 603 persons were enrolled and originally reported on, the published paper lists only 601 subjects. The abstract notes that localized reactions occurred more often in women, but neglects to mention that systemic reactions did also, at approximately twice the rate of men. Although the published paper notes that one reason for enrollees to drop out was pregnancy, it omits mention that eleven women became pregnant during their vaccine series, and the outcome of these pregnancies remains unknown.

This is important because navy physician Cdr. Megan Ryan has found that women vaccinated for anthrax during the first trimester have a higher rate of birth defects in offspring than unvaccinated women. Apparently, this research was compelling enough, despite an army study to the contrary, for the FDA in 2002 to change the pregnancy warning on the vaccine label from a C (no data on risk) to a D (data suggests increased risk during pregnancy). However, the data have not yet been published.

Dr. Maria Araneta, also associated with the Naval Health Research Center and University of Californai, has shown that GW veterans are also lielier than controls to have children with certain birth defects.

According to the Tripler study authors, "Women in the immunized cohort were more likely to report (in their exit questionnaire) that their general health was "poor or fair" compared with the unimmunized cohort (RR 4.4; 95% Ci: 1.3-15.1)...otherwise there were no notable trends or associations."  Regarding the Tripler authors' claim that there were no notable trends in their data, one would think that the high female reaction rates and poorer female health at the study's conclusion would be notable, and that a serious neurologic reaction rate of 0.5% in a vaccine study should have raised some eyebrows.

Because all the army studies claim to show the vaccine is safe, sometimes in spite of evidence to the contrary, and all were supervised by the same individual, Colonel Grabenstein, while all the research done elsewhere has found that chronic illnesses are associated with anthrax vaccinations, an unbiased review is forced to disregard the army research.

Several years ago, in conjunction with the Harford Courant newspaper, I reviewed the first 1660 anthrax vaccine adverse events reports to FDA (found in the Vaccine Adverse Effect Reporting System (VAERS)), and found that about 160 met the CDC's case definition for GWS. Most of those reporting had not been to the Gulf. They had reported at least two of the following three problems: musculoskeletal pain, fatigue, and a cognitive or emotional disorder. I wrote to the FDA about this, and enclosed the Fukuda/CDC's case definition from the JAMA. I was later gratified to learn that the revised January 2002 anthrax vaccine package insert includes the CDC's GWS case definition in the list of reported adverse reaction, although the fact that this is the GWS definition is not started.

As early as May 1999, 14 months after the start of the Anthrax Vaccine Immunization Program, a group of military clinicians got together to identify illnesses developing after anthrax vaccination, develop criteria for waiving further vaccinations in certain ill individuals, and develop evaluation, prevention and treatment strategies. Col. Grabenstein later joined this group, which placed him in the interesting position of denying that chronic illnesses are caused by anthrax vaccine, while also coauthoring credible reports of vaccine adverse reactions, and coauthoring clinical guidelines for vaccine-related disorders. The guidelines have undergone several revisions since 1999. and can be found on the DOD website.

It is interesting that the unexpected reactions seen by these military clinicians in 1999, when they wrote the first draft of the guidelines, remain important and continue to be addressed by the guidelines four years later: these include neurological reactions, chronic fatigue, chronic pain syndromes, and 8th nerve dysfunction, among others.

One of the clinicians in the forefront of responding to illnesses that develop following military vaccinations is Col. Renata Engler, MD, the Army's chief allergist- immunologist. She evaluated severely affected soldiers at Walter Reed from the beginning, and founded the National Vaccine Healthcare Center in 2001. Subsequently the military's Vaccine Healthcare Network has expanded to four sites, and its mission has expanded to include illnesses developing after any vaccination. The centers have also treated smallpox vaccine reactions, and developed screening criteria for waiving both anthrax and smallpox vaccinations. They are involved in research on vaccine reactions. Over 1,000 in depth case reviews and patient evaluations have been performed. Despite the centers' successes, funding was about to be cut off in October 2004, but has been reinstated for one year as a result of Congressional interest.

According to Walter Reed National Vaccine healthcare Center authors, "between May `998 and july 2001, 82 patients were evaluated for complaints of prolonged systematic clinical problems whose onset was associated or attributed to anthrax vaccine exposure by the patient, referring provider or family member...the spectrum of systematic symptoms in this group is heterogeneous with the reasons for referral including (but not limited to) one or more of the following features: non-injection site skin rashes (15%); persistent headaches (12%); tinnitus (16%); other neurologic disease or symptoms (21%); prolonged fatigue with 50% functional loss for > 60 days (21%). Specific diagnoses are diverse with some patients manifesting prolonged disability...there continues to be a need to improve our understanding of these clinical scenarios."

In February of this year, Army Surgeon General James B. Peake issued new guidelines for treatment of soldiers' illnesses that do not respond  to standard treatments. He suggested that vaccine reactions be considered, that vaccine histories be taken, and that clinicians seek second opinions from the vaccine healthcare centers. His memo followed publicity about the death of Rachel Lacy, a 22 year old nursing student and army reservist who was called up for duty in Iraq, given five vaccines in one day, including anthrax and smallpox, rapidly became ill, and died 4 weeks later at the Mayo Clinic. Her autopsy revealed adult respiratory distress syndrome and eosinophilic lymphocytic myocarditis. Another military case of eosinophilic lymphocytic myocarditis was seen at Mayo Clinic around the same time, also associated with five vaccines including anthrax and smallpox, but the soldier lived to have an endomyocardial biopsy, receive high dose prednisone treatment, and recover.

The Surgeon General may also have been responding to media reports of over twenty "mystery pneumonias" in soldiers that were non-infectious, associated with eosinophilis in blood or bronchoalveolar lavage fluid, and resulted in a number of ventilator cases and several deaths.

After years of military physicians failing to report vaccine adverse reactions to FDA, and failing to acknowledge in the patients' medical records that such reactions have occurred, the Vaccine Healthcare Centers have begun to reverse this unfortunate trend. one soldier who I recently evaluated had been extensively worked up by the Vaccine Healthcare Center His record there stated,

"Staff Sergeant ****** was a high functioning, decorated service member prior to beginning the anthrax vaccine in 1998. He has had no disciplinary action. He has functioned well in his duty assignments and is highly regarded even now. Staff Sergeant ******'s life has been significantly altered due to his current disability, and hope for recovery is uncertain. The lack of clinical findings is discouraging and leave his providers baffled and powerless as to an effective treatment plan. His condition is not unique for us at the Vaccine Health Care Center. We have treated many proficient service members with debilitating conditions that cannot be diagnosed or medically substantiated, conditions that have developed in close temporal association to having received the anthrax as well as other vaccines. Hopefully future medical research and discovery will provide some definitive answers to these perplexting medical dilemmas and allow us to effectively treat individuals such as Staff Sergeant ******."

This statement was signed by Limone C. Collins, MD, director of the Walter Reed Regional Vaccine health Care Center and by Jeannette F. Williams, FNP, case manager, on January 14, 2004. It is gratifying to finally have these clinicians, who see the greatest number of patienst with post-vaccine illnesses, acknowledge that the too are baffled by patterns of symptoms in many patients who are debilitated and treatment resistant, and who have developed undiagnosable illnesses following vaccinations, usually anthrax alone or in combination with other vaccines.

Regarding the short-term adverse effects of recent anthrax vaccinations in the UK, in soldiers vaccinated before the recent Gulf deployment, two small studied have been done. The UK vaccine is given as four dose series over one year, with yearly boosters; the US vaccine is given in 6 doses over 18 months, with yearly boosters.

In the first paper by Hayes and World, 129 soldiers working in a military field hospital were offered vaccine, and 76% (98 soldiers) accepted and began the series. Initially, 63% had adverse reactions. "Forty-five percent of these caused incapacity." Approximately 22% of reactors had arm pain that prevented lifting or driving for 48 hours. Twenty-one percent of reactions were designated severe. only 27 of the 98 soldiers who began the vaccinations completed the four dose series. The authors noted, "Although the old vaccine is considered safe, the number of adverse reactions and incapacity reported by a military medical unit was unexpected."

Neither set of authors was able to explain the dropoff in vaccine uptake. Both studies were supported by the MOD.

In conclusion, for the FDA to assume the anthrax vaccine is safe, it would need to find a body of reliable, reproducible medical studies to refute the plethora of evidence I have just summarized. They do not exist. The so-called safety study overseen by the CDC from approximately 1967-1972 made no attempt to identify, quantify or follow systemic adverse vaccine reactions. It is therefore of no value in establishing vaccine safety. Anthrax vaccine must be considered a dangerous vaccine, whose benefit remains to be established. Given the fact that no reliable evidence has been provided by the US government of a risk to troops or civilians from anthrax, and given that the efficacy of this vaccine to an inhalation challenge with virulent strains of anthrax remains to be demonstrated, the risk/benefit equation for this vaccine can only be calculated os No Justification for Use.

Meryl Nass, MD
December 29, 2004

 

 

Dear Senator Bingaman,

I hope this finds you well. Thank you very much for sending this information to us. Senator Bingaman has been heroic in his efforts to protect children. Please review the remaining concerns below, which we hope Senator Bingaman will consider in light of the current trend in biodefense vaccine legislation.

1. Children continue to be at risk of receiving Vaxgen's experimental anthrax vaccine and the current anthrax vaccine (which Dr. Zerhouni admits in the letter is unsatisfactory because it causes too many side-effects_ after Phase 1 is finished.

2. "Protective antigen," or the rPA described in Dr. Zerhouni's letter, is toxic. It has shut down brain activity when tested on moneys. Dr. M. Nass can expound upon the studies behind this fact.

3. Bioport's anthrax vaccine will still be tested alongside VaxGen's anthrax vaccine, with a control group as well, as outlined in the proposed clinical trial. The Bioport vaccine has triggered a systemic reaction in at least 5-35% of recipients according to the 2002 product insert, with 6 deaths. Recent articles report that the FDA has linked 21 deaths with the Bioport vaccine. That is more than the number of people who died from the anthrax attacks. Therefore, a significant percentage of the participants in this clinical trial will have systemic reactions and will be risking a fatal reaction. if these serious side-effects occur in healthy adults, the effect on children will undoubtedly be more severe.

4. There is no mention of testing the lots to ensure that Bioport's anthrax vaccine (and Vaxgen's new vaccine are free of hazardous contaminants, such as the squalene found in ppb by the FDA at Dover AFB in 2000. There is also no mention of heat sterilization being put into use to kill viruses and the like. Such foreign materials can pass through the fine sieve Bioport uses to "sterilize" its product.

5. Is it legal for the Dept/ pf Jp,e;amd Security and the DoD to purchase/contract for this product from Vaxgen when the FDA has not licensed or approved this anthrax vaccine for use yet?

6.Children often have the opposite reaction to a chemical or medication that an adult would have. Therefore, it is impossible to determine or predict how a child will react to the anthrax vaccine/s based on how the adults fare in their reactions during Phase 1. The approach offered in the letter is not sound science.

7. Is it true that only President Bush and the Executive branch can decide whether or not to proceed with the AVIP: "Recommendations for acquisition are presented to the White House for determination and Congress is notified"? Does Congress not have the authority to intervene when constituents and military members are becoming seriously ill, disabled, and in some cases dying, from a poor pruduct in a detrimental program such as the current anthrax vaccine and the AVIP?

I would greatly appreciate hearing your thoughts and ideas on these remaining concerns when you have an opportunity to reply.

With warm regards,
Marguerite M. Armistead
Protecting our Guardians, President

 

The Honorable Jeff Bingaman
United States Senate
Washington, D.C. 20510

Dear Senator Bingaman,

Thank you for writing to Secretary Leavitt about your concerns regarding the development of new vaccines against anthrax and the potential for testing them in children. He has asked me to respond to your letter. I do so knowing that the protection and preservation of children's health is one of your top priorities.

In your letter, you raise a number of issues about the current NIH clinical trial for a new vaccine against anthrax. Let me assure you that, at this time, we are not testing this cavvine on children. The original protocol for this project proposed including children, but only after Phase I testing in adults was completed, and a determination made that it was safe to proceeed with testing in children. However, more than a year ago, in July 2004, the Institutional Review Board (IRB) for the National Institute of Child Health and Human Development (NICHD), the Institute whose intramural researches are working on this vaccine, met to review the proposed protocol and plans for testing. The individuals on this IRB have expertise in child heath and development. Following discussion, the principal investigator agreed to defer all plans for testing in children until the entire first phase of the study in adults, which will include findings on both safety and immunogenicity of the test vaccine, is finished. Further review, and approval, by both the IRB and the Food and Drug Administration (FDA) will be necessary before any decision to proceed with testing in children can be made. The clinicaltrials.gov web site was corrected to reflect the proper status. Since children are not currently enrolled in this trial, no informed consent/assent form is available, however, I have enclosed a copy of the consent form for adult volunteers.

I am also enclosing information that addresses your concerns. I hope this helps to answer your questions. Please let me know if you need any other information.

Sincerely,
Elias A. Zarhouni, M.D.
Director

 

NIH Information for Senator Bingamen
February 2005

In addition to finding new treatments and cures for disease, a major part of protecting the Nation's health is developing preventive measures such as new or improved vaccines. The objective of the NICHD clinical trial you inquires about is the development of an improved vaccine with minor or no side effects. Should this country experience widespread exposure to anthrax, infants and children would certainly be among those exposed. Antrhrax and methods for cultivating it are readily available, and the spores can remain active for decades. Still, no vaccine has been approved to prevent anthrax specifically in children, and the reported side effects of the currently available vaccine for anthrax warrant efforts to develop an improved version. The NICHD vaccine targets "protective antigen," a key protein needed to cause disease. The concept behind the vaccine is to prime the immune system to make antibodies against the protective antigen, thereby depriving the bacteria of its disease-causing ability. The vaccine consists of a recombinant protective antigen (rPA); it is the only protein from the anthrax bacteria contained in the vaccine

The focal point for other vaccine development and procurement activities of the Federal Government is the Weapons of Mass Destruction Medical Countermeasures Subcommittee and includes representatives from HHS, the DoD, and the Department of Homeland Security. Under the auspices of Project Bioshield, the Sub committee considers a number of factors in making decisions about the acquisition of vaccines and other countermeasures. Chief among those factors are the credibility and immediacy of specific threats, and whether these threats are sufficient to affect the national security or require measures to protect the public health. Recommendations for acquisition are presented to the White House for determination and Congress is notified.

Regarding the status of anthrax vaccination administered to member of the military, the U.S. District Court for the District of Columbia granted, on April 6, 2005, the government's motion to modify the court's 2004 injunction against mandatory anthrax vaccination through the Department of Defense (DoD) Anthrax Vaccine Immunization Program (AVIP). This authorization (EUA) issued by the FDA on January 27, 2005, so long as members of the armed services receive both education about the vaccine and an option to refuse the vaccine without penalty. This EUA is based on the determination by the Deputy Secretary of Defense of a significant potential for a military emergency and the declaration of the Secretary of HHS early last year. on July 22, 2005, the Commissioner of the FDA granted the request from the Assistant Secretary of Defense for Health Affairs, DoD, for an extension of the emergency use of anthrax vaccine adsorbed (AVA) for prevention of inhalation anthrax. Information on these actions can be found at

http://www.fda.gov/oc/bioterrorism/winkenwerder.html on the HHS/FDA Web site and at
http://www.defenselink.mil/releases/2005/nr20050503-2901.html on the DoD Web site.

The NICHD anthrax vaccine research is one of several ongoing efforts to improve existing vaccines. In the fall of 2001, DHHS experts assessed improved technologies, and a consensus evolved about the need to develop and acquire a next-generation anthrax vaccine using these technologies, which include rPA. The early and advanced development rPA programs were supported by the National Institute of Allergy and Infectious Diseases (NIAID) with contract awards in September 2002 and 2003, respectively. These were milestone-driven contracts with defined deliverables, including the manufacture of clinical-grade vaccine, the conduct of Phase I and Phase II clinical trials, and consistency lot manufacturing of vaccine. In late 2003, officials from the relevant federal agencies approved the decision to pursue the acquisition of this rPA vaccine. Using the Special Reserved Fund created by the fiscal year 2004 Department of homeland Security Appropriations Act, a contract was negotiated with the manufacturer, VaxGen, for the purchase of 75 million doses of the vaccine in order to have them readily available if needed.
 

Steven Fisher's Statement at Vaccine to Protect Children from Anthrax Public Engagement Workshop
July 7, 2011

My name is Steven Fisher and I represent Protecting Our Guardians. Thank you for this opportunity to speak. I am a disabled prior service member from the anthrax vaccine. Also, I am president of Protecting Our Guardians, a 501 C 4 organization whose mission is to bring exposure to the problems associated with the anthrax vaccine. I was injected with the anthrax vaccine Lot numbers 36 and 43. These injections occurred prior to the vaccine being licensed by the FDA. My injuries are too numerous to recite here. However, I will provide a short brief of what happened at my National Guard Unit. We were requested to deploy and our shot regimen was up to date. The only shot we needed was the anthrax vaccine. The briefings prior to receiving the vaccine indicated there were no complications with the vaccine. Approximately 150 of the maintenance group volunteered for the mission and were required to get the shot regimen. Seven of us were injured and when the pilots saw we were getting sick some refused and some resigned. The discussion here centers on the use of the anthrax vaccine on children. When you review the current anthrax vaccine package insert it does not reference the injuries and deaths associated with the vaccine as the previous vaccine package insert disclosed. Many may contend the vaccine has been approved by the FDA for use and is a new generation of vaccine. This is not a debate I am entering into. POG is still receiving contacts from injured service men and women from the cocktail shots, many with the same signature as the anthrax vaccine immunizations. POG and I are against any medical tests conducted on children using the anthrax vaccine. The antibiotics are tested and proven. I would also like to state for the record I find it suspect prior to this workshop a group of letters have been mailed to DC area schools. “Respectfully” I would remind the committee that at the height of the Anthrax public debate in early 2000’s, letters were mailed by the infamous Dr. Ivins clearly with motive. Thank you

Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/11 Ltr to NBSB from ASPR
>Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/11 Ltr to NBSB from ASPR PDF


Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/11 AV-WG Public mtg FRN
>Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/11 AV-WG Public mtg FRN PDF


Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/2011 Agenda
>Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/2011 Agenda PDF


Reader asks: Should we test the anthrax vaccine on children?
http://baltimorepostexaminer.com/should-we-test-the-anthrax-vaccine-on-children/2012/08/23

AnthraxVaccinationNavy


To the Editor,

Whether you are a parent, grandparent, military member, veteran, or a concerned citizen, you have been invited to participate in a vociferous debate regarding whether it is ethical to proceed with a clinical trial wherein children will be injected with the highly controversial anthrax vaccine.

The announcement posted in the Federal Register states that your letters must be received by Aug. 27, 2012. The notice in the Federal Register goes on to say that all letters must be sent by email to info@ bioethics.gov or by mail to Public Commentary, Presidential Commission For The Study Of Bioethical Issues, 1425 New York Avenue NW., Suite C-100, Washington, DC 20005.

The crux of the matter is that the Presidential Commission has the unenviable task of studying the ethics of experimenting on children with biological weapons vaccines, beginning with the anthrax vaccine, and other medical countermeasures.

The Federal Register makes it clear that there is a strong push for this experiment from the National Biodefense Science Board (NBSB): “… the National Biodefense Science Board recommended that the Department of Health and Human Services move forward with testing AVA [Anthrax Vaccine Adsorbed] before a public health emergency but only after the ethical considerations are adequately addressed and reviewed” which involves an in-depth, public discussion with the Presidential Commission For The Study Of Bioethical Issues concerning “… the ethical considerations of conducting a pre- and post- event pediatric study of Anthrax Vaccine Adsorbed (AVA) as a component of post-exposure prophylaxis” (“Department of Health and Human services: Request for Comments on Ethical Issues Associated with the Development of Medical countermeasures for Children” 38631-2). Your letters will become part of a public, historical document that may save the lives of our children.

Perhaps you’d like to know a few salient facts about this important debate and the anthrax vaccine’s side effects before responding to the request in the Federal Register. The debate began in Washington, D.C., during the “Protect Children from Anthrax Public Engagement Workshop” onJuly 7, 2011.

The NBSB under the Department of Health and Human Services (HHS) discussed in detail, for two days, how to conduct an experiment with the anthrax vaccine in children. Representatives from the National Institutes of Health (NIH), the Centers for Disease Control (CDC), and the Food and Drug Administration (FDA) were all there.

The CEO of Emergent BioSolutions, which manufactures the anthrax vaccine (Biothrax), was there as well. Col. John Grabenstein and Col. Arthur Friedlander, long-time supporters of the Department of Defense’s Anthrax Vaccine Immunization Program (AVIP) attended the workshop also. Representing the opposing point of view for non-profit groups such as Protecting Our Guardians and the National Vaccine Information Center were former military members who had been disabled by the anthrax vaccine.

With only two minutes of speaking time allotted to these veterans, the engagement with the public was somewhat limited. By the term “public engagement” did the NBSB intend to have a substantial dialogue with the public about the ethics of their proposal or was their intent to soften up the public to the notion of having their children participate in an experiment with the anthrax vaccine?

I don’t know, but it does seem strange that at the workshop the NBSB circulated a question-and-answer script for pediatricians to use when talking with parents or guardians about using the anthrax vaccine in their child. The last three questions on the script raised some eyebrows, especially the final question on the script:

15. Q- Since we do not know the exact dose of vaccine to give your child and its protective ability, except for the adult dose and data, would you want the U.S. government to collect data on pediatric dosing and protective ability during an event, that is, after an exposure? A study done only after an exposure would need to start with the adult dose that we believe will be effective, as a lower dose may not be effective.

Should we be testing the vaccine on children?

We will not know if this is necessary, since a lower dose may be as protective, but with fewer side effects. Enrolling your child in a study will help us figure this out for future children (or future doses for your child). (“Vaccine to Protect Children from Anthrax Public Engagement Workshop Hosted by the Anthrax Vaccine Working Group National Biodefense Science Board Questions and Answers”)

Question 15 begs the question: “Will an event, or exposure to anthrax because of a terrorist or latent spores, really occur?” According to the CDC, in the entire history of the United States, only 22 adults became ill from inhalational anthrax in 2001, five of whom died. Extrapolating from these numbers, there is a potential risk of .000027 percent to America’s 81.5 million school children of getting sick with inhalational anthrax.

Another question arises here as well: was the HAZMAT clean up in the Hart Building on Capitol Hill, in the Brentwood postal center,  and  in Florida performed correctly? Our senators and congressmen/women have not reported any anthrax infections over the past 10 years since that event occurred.

Is anthrax really a legitimate concern for American families or is it just hypothetical?

The last questions in the script seem to lead a parent to the conclusion that it is one’s duty to enroll one’s child in the clinical trial. However, I would submit to all American citizens that it may be a parent or guardian’s duty to protect the child with a polite “No, thank you.” If one must weigh the ethical appeal of protecting one’s child against a risky vaccine and the ethical appeal of helping one’s country for nationalistic reasons, isn’t the logical choice to defend one’s child — our country’s future hope?

The side effects mentioned in question 15 include more than 40 possible adverse reactions such as seizures, arthritis, leukemia, lymphoma, heart attacks, kidney failure, skin lesions, stomach paralysis, migraines, ringing in the ears, auto-immune diseases such as MS and GBS, anaphylaxis, inflammation of the brain and/or heart, muscle aches, fevers, and even six deaths, according to the manufacturer’s product insert from Jan. 31, 2002.

Moreover, this product insert reveals a 5 percent to 35 percent adverse reaction rate, with about 6 percent “listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening” (Bioport “Anthrax Vaccine Adsorbed [Biothrax]). According to retired Maj. Sonnie Bates, another study, conducted on adult medical personnel at Tripler Army Air Force Base, showed a 48 percent systemic adverse reaction rate; and the adverse reaction rate was 43 percent in the “Pitman Study”(http://www.mvrd.org/avn/sonnie/law/bates_21feb00.htm).

According to the Journal of the American Medical Association, during another study, the CDC’s phase 4 human clinical trial with the anthrax vaccine, there were seven deaths (which may or may not have been caused by the vaccine) and 229 severe adverse reactions (http://jama.ama-assn.org/cgi/content/short/300/13/1532).

The Government Accountability Office (GAO) conducted a survey and discovered that 85 percent of the National Guard and Reserve pilots, plus the aircrews, had experienced adverse reactions with one-fifth of those being systemic reactions (GAO-02-445 4). Another GAO report revealed an estimate that 1 percent to 2 percent of military members may become disabled or die from their vaccinations (GAO-07-787R 4).

Doctors and nurses have informed me that in general, excluding cancer drugs, any product or drug with an adverse reaction rate that is higher than 1 percent gets taken off the market. Is it ethical to allow this clinical trial to proceed forward when the facts show that at least 5 to 35 out of every 100 children who participate will possibly suffer from one or more of these side effects or potentially die?

Even if it weren’t for ethical considerations such as the Hippocratic Oath or the Nuremburg Code, there are still American policies in place that make this proposed clinical trial, using the anthrax vaccine in children, illegal. The 5 percent to 35 percent risk of an adverse reaction to Biothrax poses a higher threat than the possible exposure to inhalational anthrax. Any potential benefit is overshadowed by the risks of side effects.

The “Best Pharmaceuticals for Children Act of 2002” (P.L. 107-109) and the “Pediatric Research Equity Act of 2003” (P.L. 108-155) led to a report from the Institute of Medicine called, Ethical Conduct of Clinical Research Involving Children. It reads: “For research that involves a control group of healthy children without a disorder or condition and without prospect of direct benefit from the research, the research procedures for that group would have to involve no more than minimal risk.”

The definition of “minimal risk” in Subpart A of the HHS regulation (45CFR 46.102[i]; 21CFR 50.53[k]) is “that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Clearly, using anthrax vaccinations involves more than a minimal risk. The magnitude of harm posed by this clinical trial is much greater than that in ordinary life.

Furthermore, 45CFR46.407 states that one of the criteria for pediatric research is that there must be a “serious problem affecting the health and welfare of children,” which is not the case with anthrax exposure. Not one child in the United States is affected by inhalational anthrax, and that is good. Anthrax is not an infectious disease that can be transmitted from one person to another like a cold or flu. The anthrax bacterium has to be inhaled or get into an opening on the skin.

However, I submit for general consideration the fact that many children in military families are affected by the anthrax vaccine’s impact on their parent. For example, the Las Vegas Sun printed an article on June 16, 2005, titled “More Than 1,200 Who Had Anthrax Vaccine Now Sick.”

Moreover, the FDA has received more than 5,300 reports about adverse reactions to the anthrax vaccine in their Vaccine Adverse Event Reporting System (VAERS). The policy requirement that there already be a “serious problem” offers further protection for children from unnecessary testing under the law.

The Belmont Report, from 1979, is another statement of the department’s policy regarding biomedical research on human subjects. It states the importance of judging whether or not the assumptions behind the research are correct (i.e., will children be attacked with anthrax?), being clear about risks (i.e., 5 percent 35 percent adverse reactions), and looking at all other available studies (i.e., side effects on military members) (http://ohsr.od.nih.gov/guidelines/belmont.html). Isn’t it ethical for theHHSto abide by these government policies and not proceed further with this clinical trial?

Real public engagement again seemed to be lacking, at the Public Engagement Workshop on Sept. 22, 2011, when protesters held up posters and distributed copies of retired Col. Thomas S. Heemstra’s book, “Anthrax: a Deadly Shot in the Dark,” to those attending the meeting. After all that, the NBSB committee decided that the Presidential Commission for the Study of Bioethical Issues would have to study the ethics of using the anthrax vaccine on children in a clinical trial, before the clinical trial could move forward.

(Coutresy photo)

Doesn’t common sense dictate that if the ethics of any action must be put into question, then that action is ethically questionable and, thus, unethical? Will the Presidential Commission be able to perform its task: to find a way to ethically give the anthrax vaccine to children in a clinical trial? Is that even possible given the facts? The benefit to risk ratio does not add up.

Perhaps Americans would like to know that in January of this year, someone claiming to be the director of emergency response from the University of Chicago contacted one family that I know of (perhaps there were more parents contacted) to request that their child participate in this clinical trial.

Why was a child volunteer being solicited before the Presidential Commission had had its first meeting — let alone made a final decision about the ethics of this clinical trial? Is that an ethical action? Has a decision already been reached while the public goes through the empty motions of saying “Yea” or “Nay” to testing the anthrax vaccine in children? Perhaps.

During the meeting of the Presidential Commission on May 17, 2012, Secretary of Health and Human Services Kathleen Sebelius told everyone in attendance that the work the commissioners are doing is “incredibly important and that it “is critical to the President [Barack Obama].” Sebelius did state that “safety is the highest priority,” which is something everyone can agree upon (http://www.tvworldwide.com/events/bioethics/120517/).

Would President Obama really be pushing this clinical trial forward in an election year when Mitt Romney, Ron Paul and other opponents might use it to strengthen their campaign platforms? Why is this ethical advice from the Presidential Commission so “critical” to President Obama?

Jim Wagner, vice chairman of the Presidential Commission, later asked an important question that brings to mind the IOM’s Ethical Conduct report. He wanted to know if the risk of an “event” was assumed to exist by the NBSB, and Maj. Gen. John Parker replied that the board (the NBSB) had never deliberated the actual risk of an event but had left that up to others in higher positions.

If one was to follow this train of thought and agree that indeed there are biologically weaponized threats to our children that government officials are aware of, then one would expect detection equipment checking the air and water every hour in every city and a notice to parents that shares the information about possible dangers from a terrorist in their area. It would be akin to a nationwide Amber Alert. It would be announced on every radio, TV channel, and in newspapers. One would not expect an attempt at a clinical trial using the anthrax vaccine on children back in 2005 (which was averted due to the efforts of many people), or Dr. Nicole Lurie’s concern about the possibility of latent spores in D.C.’s soil, or a lengthy preemptive plan to be prepared just in case our children need biological countermeasures such as the anthrax vaccine and the others that are to follow. Doesn’t the voice of reason demand that facts and evidence of a possible event be established before carrying out a clinical trial with the anthrax vaccine (and later, other biological countermeasures) on children?

It would appear that the NBSB and the Presidential Commission are operating from the assumption that we really need biological countermeasures for children, of which the anthrax vaccine is one, when there are no facts to support this assumption. Unfortunately, looking at the facts regarding the anthrax vaccine is not pretty.

If one investigates the opposing point of view, one discovers that the anthrax vaccine is a Category D drug as written on the 2002 product insert. It is teratogenic and might harm a developing fetus. In fact, Assistant Secretary of Defense for Health Affairs William Winkenwerder sent directives out to be careful not to vaccinate pregnant military members with the anthrax vaccine. Therefore, one might ask “What will the anthrax vaccine do to the development and maturation of a child in this proposed clinical trial?” It is a logical question that the Presidential Commission should take into consideration before allowing the anthrax vaccine to ever be given to children in a test.

It is a fact that there are four Vaccine Healthcare Centers (VHCs) in this country to treat thousands of military members and veterans who are ill from their anthrax and/or smallpox vaccinations. At Walter Reed’s VHC, a study is being done with blood samples to try to determine why some people have adverse reactions to the anthrax vaccine, yet many people with serious cases are not allowed to participate in the study.

Shouldn’t we find out if there is a genetic predisposition in those with serious reactions to the anthrax vaccine, and what that genetic marker is, before conducting a clinical trial on children?

It is a fact that the FDA shut down production of the anthrax vaccine, in March 1998, while the manufacturing plant was renovated after four failed inspections (February 1998, March 1997, August 1995, March 1992) (GAO/T-NSIAD-00-140 2). It is a fact that Sammie Young, a former FDA inspector, said on camera that the anthrax vaccine is “adulterated.”

It is a fact that some anonymous military members filed a civil lawsuit in March 2003 against the manufacturer Bioport, now known as Emergent BioSolutions, because of the illnesses they developed after their anthrax vaccinations. It is a fact that Evanston Insurance sued its own client, Bioport, for allegedly not revealing knowledge it had about “incidents” to the insurance company.

It is a fact that Federal Judge Emmet G. Sullivan enjoined the AVIP on October 27, 2004 “unless or until” the anthrax vaccine could be proven safe and effective. It is a fact that then Health and Human Services Secretary Tommy Thompson was able to maneuver around this court ruling with an Emergency Use Authorization (EAU) on Jan. 27, 2005 to restart the AVIP.

It is a fact that the CDC’s Morbidity and Mortality Weekly Report on Jan. 24, 2003, revealed that the anthrax vaccine is one of the most reactogenic vaccines on the market with 1,818 VAERS reports sent to the FDA between 1998 and 2001 (and four more sent in 1993) (14-5). It is a fact that Emergent BioSolutions has indemnity due to “unusually hazardous risks,” and it cannot be sued if someone becomes ill or dies from Biothrax, as shown in Loius Caldera’s memorandum from Sept. 3, 1998.

Maybe President Obama and the HHS are right. We must protect our children from biological threats. We must be ready. If a psychopath used anthrax to attack our children or if spores “hatched” after 10 years of dormancy, we have other options. For instance, Cipro, Dioxycyclene and intravenous penicillin will kill the anthrax bacterium if administered within 72 hours. Does HHS have enough of those particular antibiotics stockpiled for every American citizen too? In addition, we already have enough BIDS equipment to monitor the air for biological weapons as well, if we would just use it here in the United States.

After reviewing these facts, I strongly encourage every American citizen to send his or her opinion to the Presidential Commission regarding the ethics of conducting a clinical trial using the anthrax vaccine on children. You may agree with me or disagree with me, but we can all certainly agree on the importance of free speech. So just do it. After Aug. 27, 2012, this opportunity to share your thoughts and insights will close. As the adage goes, “If we are not part of the solution, we are part of the problem.”

Marguerite M. Armistead, M.A.

Founding member of Protecting Our Guardians (POG), a 501(c)(4) military family advocacy group



Will Children Replace Chimpanzees in Government Research?
http://www.ahrp.org/cms/content/view/906/9/


Alliance for Human Research and Protection Responds to the Proposed Trial of Anthrax Vaccine in Children
http://www.protectingourguardians.org/Children_AnthraxVaccine_Moral_Cliff.pdf

________________________________________________________________________________________________________________________
Litigation

Manufacturers indemnified, military members forced to sue

Manufacturers have indemnification so military members have no recourse (but to sue govt.)  It looks like under BioShield II bill, in next legislative session, it’ll be more of the same

http://www.bizjournals.com/boston/stories/2004/11/15/story5.html

 

Unlawful Human Experimentation

Judge Sullivan’s two decisions in opposition to AVIP

TRI Sues Donald Rumsfeld & U.S. Military on Behalf of Air Force Sgt. Punished for Speaking Out About Tainted Anthrax Vaccine

(excerpts) 

Attorneys for The Rutherford Institute have filed suit in federal district court on behalf of the First Amendment rights of Air Force Sergeant Jason Adkins, who was sanctioned after reporting to sick call and voicing concerns that he could be suffering the ill effects of a tainted anthrax vaccine administered to select military personnel.  Sgt. Adkins is a 14-year decorated airman who served on the first C-5 aircraft flown into Baghdad in the recent Iraq War and other numerous classified special operations missions.  The suit, which names Adkins’ supervisors in the Air Force, as well as James Roche, the Secretary of the Air Force, Secretary of Defense Donald Rumsfeld and others, was filed in federal district court in Wilmington, Del., by Institute affiliate attorney Thomas S. Neuberger of the Neuberger Firm.

“Since his first day in the Air Force, Sgt. Adkins has been trained in one basic sacred safety principle – that flight officers with unsafe medical conditions are not to fly.  Even during a flight, if crew members become ill or overly tired, they are encouraged to declare ‘safety of flight,’ at which point they are relieved of their duties, no questions asked, and always without any fear of discipline or repercussions,”: said John w. Whitehead, president of The Rutherford Institute.  “Sgt. Adkins felt it was his moral duty as a Christian to speak out against this injustice, and he should be commended for his bravery.  If left unaddressed, the military’s actions could very well give rise to a dangerous chilling free speech effect on our servicepeople.”

[However], testing by the Food and Drug Administration discovered squalene in six of the inoculations administered to Sgt. Adkins.  research indicates that even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.  In keeping with flight safety protocol, on Oct. 21, 2004, Sgt. Adkins reported to the Dover Air Force Base flight surgeon with a “crippling” headache and was subsequently grounded from a scheduled flight mission.  Shortly afterwards, Sgt. Adkins was given a career ending written reprimand and was accused of dereliction of duty and faking his medical condition, allegedly in retaliation for having voiced his concerns that he might be suffering effects of the experimental anthrax vaccine.  Other military personnel have since echoed Sgt. Adkins’ concerns about the effects of the tainted vaccine.  In addition to the litigation, attorneys for The Rutherford Institute are proposing that Congress adopt legislation to modify the Feres Doctrine, a Supreme Court opinion that arose out of Feres v. United States that shields the government from personal injury claims by service members. 

The Rutherford Institute is an international, nonprofit civil liberties organization committed to defending constitutional and human rights.

 

Ongoing litigation

There is ongoing litigation concerning the anthrax vaccine that should be concluded before anymore anthrax vaccines are forced on our service members.  Besides Judge Emmet G. Sullivan’s two rulings, Air Force Sgt. Jason Adkins of Dover AFB filed a suit in Fall of 2004.  Six of his eight anthrax shots had squalene in them.  Here are some links concerning other anthrax vaccine lawsuits.

www.researchprotection.org/infomail/0503/21a.html (link not valid)

www.newsmax.com/archives/articles2002/7/24/185929.shtml (link not valid)

www.avip2001.net/OfficialDocuments_files/Lawsuit.htm

www.washingtonpost.com/wp-dyn/articles/A55581-2004May25.html

 
 

Ruling renders anthrax vaccine program illegal

John Doe v. Donald H. Rumsfeld
Civil Action No. 03-707
Memorandum Opinion issued October 27, 2004 by Judge Emmet G. Sullivan
http://www.dcd.uscourts.gov/03-707c.pdf

 

Oct. 29, 2004

A federal judge’s ruling on Wednesday ordering the Pentagon to stop forcing its troops to take the anthrax vaccine represents the latest setback for the Pentagon and its controversy-plagued inoculation program. 

The judge ruled the vaccine had never “been tested by the greatest scrutiny of all – public scrutiny.”

Despite a Pentagon spokeswoman’s comment Thursday that the ruling “hit us very suddenly and very unexpectedly,” the judge’s decision should not have come as a complete surprise, because on Dec. 22, 2003 the same judge ordered the Pentagon to halt the vaccination program.  Sullivan concluded the drug was experimental – and therefore illegal – because the FDA had never given its approval for the vaccine’s use against inhalation anthrax.  Then, just eight days later, after 18 years of inaction, the FDA announced the vaccine was safe and effective in battling inhalation anthrax.  The FDA insisted its decision was completely unrelated to the lawsuit, but Sullivan found the FDA’s Dec. 30 maneuver to be “highly suspicious.”  He lifted the temporary injunction on the use of the vaccine, and the lawsuit continued. 

 By contrast, Wednesday’s ruling was a permanent injunction that will remain in effect “unless and until the FDA” obeys the law, Sullivan wrote. 

In the fall of 2000, then candidate George W. Bush announced, “I don’t feel the current administration’s anthrax immunization program has taken into account the effect of this program on the soldiers in our military and their families.  Under my administration, soldiers and their families will be taken into consideration.”  There are indications that, urged by strategist Karl Rove, who was concerned about the political ramifications, the Bush administration early on tried to address the problems surrounding the vaccinations and do away with the mandatory program.  But then came the terrorist attacks of Sept. 11 and the subsequent anthrax deaths, followed by the run-up to war with Iraq, which was framed as a battle over WMD.  Suddenly, instead of trying to eliminate the vaccination program, the Bush administration accelerated its implementation. 

But the controversy has continued to grow.  In 2001, Connecticut’s attorney general, concerned the state might bear responsibility if its National Guardsmen got sick form the vaccine, wrote the Department of Defense and the FDA urging them to abandon the program.  That same year, John Buck, an Air Force captain, became the first military physician court-martialed for refusing to take the anthrax shot.  Soon after he refused, he met with an Air Force superior and talked about how he couldn’t, in good conscience, take the vaccine if he didn’t believe in the quality of the science behind it.

Also in 2001, during the anthrax scare on Capitol Hill, Senate Majority Leader Bill Frist, R-Tenn., a physician, urged Senate staffers not to take the vaccine because “there are too many side effects.”  (Some doctors think it’s safer to take the antibiotics after being exposed to anthrax than to be vaccinated in advance.”

On Oct. 10, the paper quoted a former Dover commander who halted the vaccine program after the rash of baffling illnesses as saying, “In my opinion, there was illegal medical experimentation going on.”

The anthrax vaccine controversy has not been confined to the United States.  In Britain, where the shot is voluntary for troops, roughly half of those deployed in Iraq have refused the vaccine.  On the eve of the war with Iraq, the president of the Australian Medical Association announced that in her opinion no definitive scientific evidence showed that the anthrax vaccine was safe.  And in a 2000 court-martial case, Canada’ top military judge ruled a soldier could refuse the vaccination on the grounds that it amounted to unsafe medical treatment. 

 

FOXnews.com – Politics -  Judge Suspends Military Anthrax Vaccinations

http://www.foxnews.com/story/0,2933,136953,00.html

 

Blocking the shot

A federal judge orders an end to the Pentagon’s program of mandatory anthrax vaccinations
By Eric Boehlert
http://www.salon.com/news/feature/2004/10/29/anthrax

  

Anthrax Vaccine Manufacturer Battles Suit

Dave Eberhart, NewsMax.com

Thursday, July 25, 2002
www.newsmax.com/archives/articles/2002/7/24/185929.shtml

excerpts

As the military ramps up its long-stalled next round of inoculations for service members considered in harm’s way of bio-attack, former Connecticut Air National Guard pilots Russ Dingle and Tom Rempfer are pursuing a claim on behalf of the United States against BioPort Corp. of Lansing, Mich., the sole American manufacturer of the anthrax vaccine, alleging the drug manufacturer was responsible for the presentation of the false claims to the government.

 “The inspections that FDA ultimately was able to conduct over time found a number of deficiencies, many of which were not corrected in a timely manner.  For example, the deficiencies that FDA identified in its February 1998 inspection fell broadly into two categories:  (1) those that, although serious, might affect only one or a limited number of batches that were produced when the deficiency was extant and (2) those of a generic nature that could compromise the safety and efficacy of any batch or all batches.”

 

Neuberger quote

http://www.delawareonline.com/apps/pbcs.dll/article?AID=/20050920/NEWS01/509200330/1006

 “No man is above the law, not even the secretary of defense, the secretary of the Air Force or a four-star general.  We now look forward to proving before a civil jury the abuse of power which ended this heroic airman’s career and which has endangered the lives of many of our heroes in uniform,”  Neuberger said. 

 

Judge Rules on Anthrax Vaccine

Military Personnel Can Refuse Shots
April 7 2005
excerpts

The Defense Department must notify all military personnel facing inoculation with the controversial anthrax vaccine that they will not be punished if they refuse to take it, a federal judge has ruled.

“The court’s injunction means you have the right to refuse to take the vaccine without fear of retaliation,” U.S. District Judge Emmet Sullivan said in the ruling issued Tuesday in Washington, D.C. 

U.S. Rep. Christopher Shays, R-4th-District, says he will hold hearings on the U.S. Department of Health and Human Services emergency authorization because he believes there is no emergency need for the vaccine.  He is chairman of the House Subcommittee on National Security, Emerging Threats and International Relations. 

 

Fisher Vs. U.S. – Docket 04A988

excerpts from e-mail

I had been a Medical Officer on active duty from 05-Jul-1989 until I separated on 31-Dec- 1996.  On 24-Sep-93, I got the anthrax shot – with neither my knowledge nor consent – during a  readiness training exercise. 

I began to have problems that culminated in my waking up with severe, painful left-hand extensor tenosynovitis on 29-Oct-1994.

I progressed to symmetric and systemic manifestations of what was eventually diagnosed as “seronegative rheumatoid arthritis” (SNRA)  [This was later refined to Adult –Onset Still’s Disease (AOSD)]

So now, ALL Veterans have DIRECT access to the Federal Courts should they desire to appeal the decision of any military board denying the Veteran a claim for money damages.  This is specific to such claims.  Other types of claims, such as for reconsideration of denied promotions, reinstatement to active duty, and others, are subjects of ongoing litigation. 

We WILL win everything connected with all the anthrax immunization has done to each of us.  It took Byron and me 51/2 years to win FISHER v. U.S., so don’t give up!



Ongoing litigation

Landmark Federal Court Ruling
by: Mark Sircus Ac., OMD
Medical News

This past Monday, Judge Emmet G. Sullivan of United States District Court for the District of Columbia issued a preliminary injunction halting the Pentagon from "inoculating service members without their consent." He ruled that the anthrax vaccine used in the Pentagon's mandatory program was "an investigational drug," being used for an unapproved purpose. That means that the Pentagon has been in violation of the Nuremberg Code and has been using its own troops as guinea pigs against their will. The injunction is the result of a class action lawsuit brought by military personnel and civilians working for the Pentagon. In his ruling, Sullivan pointed to the apparent risk in receiving the anthrax vaccination, noting that the rate of adverse reaction was recently revised upward from 0.2 percent to between 5 percent and 35 percent.

Dr. William Winkenwerder, assistant secretary of defense for health affairs discarded such accusations saying, "We do not use service members as guinea pigs." Dr. Winkenwerder, rejected suggestions that the Pentagon was experimenting on the troops but Judge Sullivan, in issuing the injunction, wanted to make sure saying "The United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs." "We stand behind this program," and "the anthrax vaccine is safe and effective," said Dr. Winkenwerder but it has been long suspected that Gulf veterans are suffering short and long-term effects of unproven anti-bacteriological warfare inoculations forcibly administered to troops by U.S. Army doctors in Saudi Arabia. But according to the General Accounting Office the vaccine is not as safe as advertised reporting that adverse reactions to the vaccine to be at double the rate claimed by the manufacturer, BioPort Corp. "This vaccine has been controversial, and it has caused serious reactions in some individuals," said Rep. Dan Burton, from Indiana.

Dr. Meryl Nass reported on other government’s investigations into what is known as the Gulf War Syndrome and found that the Canadian Department of National Defense, not quite believing or trusting the Pentagon either, hired Goss Gilroy Inc. to study the health of Canadian Gulf Veterans and look at various exposures. They found a significant relationship between receiving non-routine biological warfare immunizations and developing chronic fatigue, a very common symptom of Gulf War Syndrome. In 1999 the British also examined the issue and found that receiving the anthrax vaccine was related to developing an illness consistent with Gulf War Syndrome. They wrote, "Vaccination against biological warfare and multiple routine vaccinations were associated with the CDC multi-symptom syndrome in the Gulf War cohort." The French Ministry of Defense stood behind the English and Canadians stating, "multiple vaccinations given during the war, particularly those for anthrax, botulinum and plague, seem associated with an excess of Golf War Syndrome signs and symptoms. In an unconfirmed report it was said that French military personnel in the Gulf region, numbering the same as the British contingent, had been prevented from taking the vaccines on the direct orders of the French Commander-in-Chief. The story claimed that since the end of the Gulf War, not a single member of the French military has suffered from Gulf War Syndrome.

After the federal court injunction the New York Times reported one senior Pentagon official as saying that the anthrax vaccine would continue to be administered, but only to those who did not object. "It won't be mandatory," the official said. "If they object, they won't get it. We don't strap people down to the gurney and make them take the vaccine." But Pentagon officials said that several hundred military personnel declined the vaccine and many of them have been severely punished with court marshals or dishonourable discharges. Many more who would have liked to decline the highly dangerous small pox and anthrax vaccines but were threatened with such punishment and this is what the court has put a stop to.

Ironically the Nuremberg Code was promulgated by four American judges acting under the authority of the U.S. military. The key principle is the requirement for informed, voluntary consent by the individual subject of experimentation. “The Code makes no exceptions for members of the military or the exigencies of war. During the first Gulf War, the FDA granted a waiver permitting the use of pyridostigmine bromide and anti-botulinum vaccine, without consent. This was the first instance in which an official government agency officially sanctioned the direct violation of the Nuremberg Code,” stated Jane M. Orient, M.D., Executive Director, Association of American Physicians and Surgeons in written testimony submitted to a Subcommittee on National Security, in 1999. According to Doctor Orient mandatory vaccine programs are “A violation of the Nuremberg Code in that they force individuals to have medical treatment against their will, or to participate in the functional equivalent of a vast experiment without fully informed consent.”

For all practical purposes the military has been, in their own way, strapping their personal down to the gurney tables and jabbing them with a vaccine that contains formaldehyde, a substance totally intolerable to biological systems. And the FDA, on the testing of five different lots of the anthrax vaccine, found trace amounts of the additive squalene in it. This finding contradicts repeated assertions by the Pentagon that squalene is not present in the vaccine. U.S. Rep. Jack Metcalf, R-Washington, who has investigated this vaccine additive for three years, told a congressional committee that this raises serious questions about the vaccine's safety and the truthfulness of Pentagon officials. And to seal the coffin data published in the February 2000 and August 2002 issues of Experimental and Molecular Pathology strongly suggests that the anthrax vaccine contaminated with squalene causes Gulf War Syndrome.

Fortunately for military personal there are people like Representative Christopher Shays of Connecticut, who has called on the Pentagon to reopen the cases of all military personnel punished for declining the vaccine. Shays issued a statement demanding that the Defense Department "immediately begin a review of all disciplinary actions taken against those who refused the vaccine." The Pentagon won't admit to the real number of officers and enlisted members who have refused the shot and been punished, but by their own calculations, it is nearly a thousand.

For those who find it hard to believe that Americans would aggressively force their own to take dangerous vaccines know that on June 30, 2003 the Pentagon made public reports on cold war programs that tested the vulnerability of American forces to unconventional attack. They admitted and identified 5,842 people who may have been exposed to chemical or biological agents in deliberate experiments. It is known that deadly substances like VX and sarin had been sprayed on sailors, ships and even on American soil. And then we have the infamous Donald Rumsfeld, the Secretary of defense, who is single-handily responsible, as former CEO of the G.D. Searle Company for the worldwide distribution of approximately 800 million pounds of aspartame, a chemical used in diet drinks and thousands of other products that breaks down into formaldehyde. The Pentagon is not exactly staffed with people the public can trust.

According to Judge Sullivan six deaths are officially attributable to the anthrax vaccine. SGT Sandra Larson of Fort Riley, Kansas died just 30 days after completing her series of Anthrax shots. Her sister, Nancy Rugo, says the young NCO "went from a healthy woman just four weeks prior to her death - June 14, 2000 - to having no bone marrow, platelets and an extremely low count of red and white blood cells. It was as if there was something in her that was killing her immune system, shutting her down." And two panels convened at the Pentagon's request declared that multiple vaccinations administered to reservist Rachel A. Lacy of suburban Chicago probably caused her death. Lacy received several vaccinations in one day — for anthrax, smallpox, typhoid, hepatitis B and measles-mumps-rubella. The reservist got the shots March 2 at Ft. McCoy and died a month later. This habit of giving multiple vaccination shots in one day is now a horror happening in children’s clinics everywhere and this is being done without one scientific study to indicate either the safety or sanity of such practices. The Pentagon is not the only organization experimenting on the public, not the only ones breaking the Nuremberg Code.

Hundreds in the army reserve and National Guard have resigned rather than take the required series of six inoculations. Retired Air Force LTC Redmond Handy, who resigned his officer's commission rather than participate in what he calls a "terrible crime against our men and women in uniform," warned "there are others currently at risk because of this flawed vaccine. I'm afraid SGT Larson's death won't be the last," he said as he wondered, "When will the Pentagon end this madness?"

Dr Daniel H Duffy Sr. said, “Mandatory vaccination is the most repugnant idea ever put forth by organized medicine. It gives the government power to invade our most private space, our bodies.” For many, mandatory vaccinations put one in mind of the eugenics of Nazi Germany. The demand to yield to mandatory injection of a foreign substance into a human body is repulsive to most intelligent people and scientists. Surely Judge Emmet G. Sullivan deserves the Nobel Peace prize for single-handily stopping the Pentagon and a particular class of people in the scientific community (NIH, CDC, FDA, AMA, WHO, and the APA etc.) who feel that it is their divine right to coerce or scare the public into taking dangerous vaccines. It is these people who sing songs of vaccine safety no matter how many children and adults die from vaccines or fall to chronic syndromes with no cure.

http://www.congregator.net/medicalnews/sircus/landmark1.html



Significant Anthrax Immunization Complications Court Decision in favor of a Vet (Docket for 04A988)

We FINALLY won!

I had been a Medical Officer on active duty from 05-Jul-1989 until I separated on 31-Dec-1996. On 24-Sep-93, I got the anthrax shot - with neither my knowledge nor consent - during a readiness training exercise. (I was in a mobility slot at the time, deputy commander of a Flight Surgeon Medevac Team at Brooks AFB, TX.) Less than a year after receiving the shot, I began to have problems that culminated in my waking up with severe, painful left-hand extensor tenosynovitis on 29-Oct-1994. I reported to Rheumatology sick call the following Monday, 31-Oct-1994. (I figured out later what I had received after seeing the _60_Minutes_ segment on the Dover folks, Googling "anthrax vaccine", finding Dr. Nass's website and "Anthrax-No".) Over the course of the next two years, I progressed to symmetric and systemic manifestations of what was eventually diagnosed as "seronegative rheumatoid arthritis" (SNRA). [This was later refined to Adult-Onset Still's Disease (AOSD), based on subsequent findings.] Finding out that IU was sick, my boss's boss referred me for a fitness-for-duty MEB-PEB, , even though I then had the presumptive diagnosis of SNRA. The Orthopedic Hand Service (that had performed a total left-hand extensor tenosynovectomy a couple months earlier and that knew of my Rheumatologist's SNRA suspicions) referred me with the diagnosis of "wrist pain". The MEB rated me at 10%, and the informal PEB wanted me out of the Air Force. I requested a formal PEB, and it offered to discharge me with a 10% Disability rating, and $40,000 severance pay. I politely indicated where they could put that offer, and I opted to return to duty to finish out my contract that would expire on 31-Dec-1996. I figured that this would give me the opportunity to accumulate a significant subsequent medical record demonstrating disease progression and complications, and significantly strengthen my position should I need to meet another MEB-PEB, or possibly even litigate. I presented to my final MEB-PEB with the diagnosis of SNRA, and they returned me to duty, in spite of SNRA being incompatible with "continued military service". I thought I knew the system until I learned then that there was a DoD Regulation stating unambiguously that Medical Officers and General Officers were "presumed fit", and therefore not eligible to be "retired for physical disability". In the interim, I had trapped the Air Force into contradicting itself as well as committing a variety of procedural errors. I also had a seven centimeter thick medical record. All of these were to be to my benefit. I became a Life Member of the Disabled American Veterans (DAV) before I separated.

Out of the Air Force, I wasted no time plugging myself into the VA health care system. The DAV took care of the paperwork, and about 10 weeks after separating, I received a rating of 50% Service-Connected Disability from the VA. A few weeks later, after a "C&P" exam, this increased to 20%. I had a lot of things to do then, not the least of which was to get the Disability Retirement I knew should by rights be mine, DoD Regulations be damned!

We skip ahead two years, omitting the irrelevant stuff. In the interim, I'd moved from San Antonio, TX to Seattle, WA. I got the necessary forms together to launch my appeal, quickly realizing that this effort deserved to be displayed prominently under the heading of "DON'T TRY THIS AT HOME!" I contacted the Univeristy of Washington School of Law's Legal Clinic, and requested they refer me to an attorney who was skilled at such things. They referred me to the best attorney in the business.

In late 1999, my attorney, J. Byron Holcomb, and I petitioned the Air Force Board for Correction of Military Records (AFBCMR) to get me the Disability Retirement that was rightfully mine. The AFBCMR of course rejected my petition, citing the DoD "presumption-of-fitness" regulation. We appealed to the United States Court of Federal Claims (USCoFC). Case law regarding Veterans' disability was a reeking miasma of contradictions, ambiguities, and plain stupidity. (There were opinions that used "separation", "retirement", and "discharge" interchangably!) The Air Force/Government seized upon these to state that the CoFC didn't have the jurisdiction to grant me the declaratory relief I required to get my disability retirement, and in any event, no federal court had the authority to hear my complaint because of its essential military nature (my complaint wasn't judiciable) of civilian federal courts to hear appeals of courts martial. This has been the case since the 1830s, and is very much settled law. The Air Force wanted to stretch it to cover disability retirements and other Veterans' money-mandating claims against the government. The CoFC saw these issues as beyond its purview, and granted the government's motion to dismiss my complaint on those grounds. (The CoFC specifically declined to address the merits of my claim in dismissing it earlier. We have a very solid case on the merits.)

Byron and I appealed to the the Court of Appeals for the Federal Circuit (CAFC). On 22-Apr-2004, after a year and a half of deliberation (and much original scholarship), the initial CAFC three-Judge panel handed down its decision in FISHER v. U.S., deciding in our favor on every issue we raised. One Judge dissented, and on this basis the Department of Injustice requested _en_banc_ reconsideration (by all 23 CAFC Judges) of FISHER v. U.S. a few weeks later. After less than a year of additional consideration, the CAFC handed down its UNANIMOUS _en_banc_ decision in FISHER v. U.S. on 09-Mar-2005, again in our favor on every issue, even chastizing the government for some of the arguments it raised in its appeal. The Department of Injustice (DoI) then decided to petition to the Supreme Court of the United States for a Writ of Certiorari; appealing FISHER v. U.S. to the Supreme Court (thus "Docket for 04A988", the docket number for the government's petition). On 31-May-2005, the DoI requested a 30-day extension of the automatic 90 days an appellant gets to petition following a decision (from 07-Jun-2005 to 07-Jul-2005). We assented, and the Court granted the extension. On 27-Jun-2005, the DoI requested another 30-day extension. This time, we objected, stating that the DoI had already delayed too long our returning to the United States Court of Federal Claims to have my complaint heard on its merits. On 30-Jun-2005, the Chief Justice denied the request for extension, so FISHER v. U.S. became case law on 07-Jul-2005tragic as al Qa'ida's attack on London.

So now, ALL Veterans have DIRECT access to the Federal Courts should they desire to appeal the decision of any military board denying the Veteran a claim for money damages. This is specific to such claims. Other types of claims, such as for reconsideration of denied promotions, reinstatement to active duty, and others, are subjects of ongoing litigation. (With this, I've exhausted pretty much ALL my limited legal knowledge. For those of you with questions, I invite you to consult with Byron Holcomb, bylaw@aol.com ;

1-206-842-8429.)

We WILL win everything connected with all the anthrax immunization has done to each of us. It took Byron and me 5½ years to win FISHER v. U.S., so don't give up!

Frank

Frank Fisher, MD

LTC USAFR MC FS

Service-Connected 100% Disabled Veteran (Anthrax Immunization Complications)

www.gulfwarvets.com/anthrax_courtdecision.htm (link no longer valid)

 

Accountability of DoD, FDA and BioPort Officials For the Anthrax Vaccine Immunization Program (AVIP)

ConclusionofLitigation1-AnthraxEAJAOpinion

Doe v VON ESCHENBACH_Gates

Evanston's Lawsuit of Bioport

 

 

Haaretz Article, Experiments in Full Responsibility

Experiments in full responsibility

By Haaretz Editorial

Tags: Soldiers , Omer 2 , anthrax


The state's response to a High Court of Justice petition by soldiers who were subjected to medical experiments with anti-anthrax drugs (the experiments known as Omer 2) is a small but important step on the road to regulating one of the most neglected human rights issues in Israel. Admittedly, the state - in contrast to the soldiers - claims that the experiments were performed in accordance with accepted medical and ethical norms, and that there was nothing wrong with them. Nevertheless, it also stated, "The defense establishment bears full responsibility for the care of the soldiers who were harmed."

This announcement includes two important points: an admission of the causal link between the experiments and the damage to the soldiers' health, and an assumption of full responsibility for the soldiers' care and treatment.

The state thereby demonstrated a different approach than the one that has hitherto characterized the Defense Ministry, the chief of staff, the army's chief medical officer and the health minister. All had previously tried to deny any connection between the experiments and their results, as well as to evade any responsibility for the soldiers suffering to this day.

 

 

 

As part of the Omer 2 experiments, some 800 soldiers doing their compulsory service were injected with a vaccination against anthrax, a disease that had been defined as one of the great dangers facing Israel's citizens. The soldiers who were chosen, all from elite units, accepted at face value the establishment's promises that they would suffer no side effects other than mild discomfort, and that the injection had been successfully tested in the United States. At the insistence of those conducting the experiment, the soldiers maintained strict secrecy and did not even inform their commanders.

This secrecy was maintained even years later, when some of them developed serious symptoms: pneumonia, breathing problems, digestive tract inflammations, severe coughs, severe migraines, recurrent sores and other problems. Despite the army's promises of close and continuous medical monitoring, each of them was forced to deal with these problems on his own.

Only in 2007, when some of the injured soldiers discovered that they were not alone in the war and began comparing their medical problems, was the story of the secret experiment finally revealed in the press, and a group was formed to go to the bodies responsible - this time in an organized fashion. The soldiers had a simple and reasonable demand: that the system recognize them as a distinct group and take responsibility for the harm done to them, and that it give them their medical files so that they could obtain appropriate treatment.

When their repeated applications met only with repeated evasions, the group, numbering 34 soldiers, petitioned the High Court. As noted, the state's response to this petition bodes well. And no less important is its response to another petition, by Physicians for Human Rights, which asked the court to ban medical experiments on Israel Defense Forces personnel unless the issue is regulated through legislation. The state responded by undertaking to abide by certain interim restrictions until the necessary legislation is passed.

This response, which does not evade a fundamental discussion of the question of experiments on human beings in general, and on IDF soldiers as a "captive audience" in particular, arouses hope that the defense establishment will finally grasp the importance of human rights, and that the suffering caused to the petitioners will serve as a warning to defense and medical personnel.

 

 

 

Haaretz--A Researcher's Complaints Ignored

Last update - 06:18 01/06/2008

Researchers' complaints ignored over anthrax vaccine problems

By Yossi Melman

Tags: Biology , Israel , Antrhrax  


Despite the enormous investments in developing an anthrax vaccine, senior employees at the Israel Institute for Biological Research have warned that there are problems with the product. However, institute director Dr. Avigdor Shafferman ignored their claims, and demoted one of the complainants, a senior manager.

The Biological Research Institute, one of the most secret institutions in Israel, employs 350 persons and operates with nearly no external supervision. In terms of administration, the institute answers to the Prime Minister's Office, while physical and field security are handled by Malmab - the body responsible for security in the defense establishment at large.

According to foreign publications, the institute conducts research and development on biological and chemical weapons, and also develops antidotes - including medicines, vaccines and antibodies - against poison gas, microbes and viruses like anthrax, the plague, chicken pox and cholera.

 

 

 

Targeting the respiratory system

Anthrax is a virus that generally affects animals, but can also harm humans. During the Gulf War in 1991, the United States feared Saddam Hussein might use biological weapons against its troops, and some 40,000 members of its armed forces were vaccinated against the disease, which targets the respiratory system.

Biological science researchers at the Nes Tziona institute, then headed by Dr. Shafferman, conducted intensive research on the virus, and as a result of their work, the institute decided to try to develop a vaccine.

In 2001, scientific and defense sources said the institute had developed a vaccine for anthrax, and that large-scale production would commence within a few months, enough for the entire population of Israel.

Intelligence assessments hold that countries in the Middle East, including Syria, Egypt and Iran, have developed anthrax as a biological weapon.

However, a senior manager at the institute, Dr. Yaakov Hadar, recently complained that the institute's management of the anthrax vaccine was problematic. Dr. Hadar presented the issues in writing to Dr. Shafferman, who reprimanded Dr. Hadar, and convinced him to withdraw his letter of complaint.

Hadar was later demoted. Dr. Hadar refused to comment on the case, and directed Haaretz to Dr. Shafferman.

In its response to Haaretz's inquiry, the Defense Ministry did not acknowledge the claims that there are problems with the vaccination.

"During the development of the anthrax vaccination that was carried out on behalf of the defense establishment, there were no problems in the conduct of any party," the ministry spokesman told Haaretz.

Dr. Shafferman was appointed to head the institute in 1995, and employees have complained of his "dictatorial rule" several times.

The State Comptroller began an investigation last year into allegations that Shafferman allegedly had advised a pharmaceutical firm in developing anti-anthrax and nerve agent medicines, which would have been a conflict of interest.

Related articles:

·  Biological institute head suspected of advising foreign companies

·  Shafferman's vaccine

·  Secret IDF anthrax experiment participants develop illnesses</A< span>

 

 

 

Israeli Anthrax Vaccine Ijuries and Investigation

w w w . h a a r e t z . c o m
Last update - 01:42 27/07/2007
Abusing volunteers
By Haaretz Editorial
 
A secret medical experiment that injected soldiers with the anti-anthrax vaccine, run over eight years beginning in 1998, raises alarming questions about the army authorities' conduct.
 
The army conducted the experiment, code-named Omer 2, under a cloak of secrecy, furtiveness and panic. Now, as details emerge despite the military authorities, it is clear that the soldiers involved have been brushed aside with half-truths and evasion.
 
The experiment was carried out on obedient, motivated soldiers from elite units. Indeed, they volunteered for the mission, but in such circumstances, what they did cannot be called volunteering in any way. Had not a few of them started suffering from serious after-effects, they themselves would probably be covering up the system's blunders to this day.
 
The details are now beginning to see the light of day, after a petition was submitted to the High Court of Justice by a group of young adults suffering from breathing and skin problems and having various degrees of difficulty with everyday functions. The petitioners are demanding that the army accept responsibility for them and treat their condition. They are also demanding that it reveal the experiment's decision-making process and supervision mechanism. The defense establishment's refusal to provide a clear answer increases the sense of alarm over its conduct.
 
The authorities claim to this day that the American vaccine (which was given to a quarter of the group taking part in the experiment) was "completely safe" already at the time, because it had been tried successfully in the United States. However, it was known that until 2005 about half of the U.S.'s soldiers refused to be vaccinated with this substance due to the fear of after-effects.
 
Three-quarters of the Israeli soldiers in the experiment were injected with an Israeli vaccine, which had not been tried until then. Both those given the American vaccine and those given the Israeli vaccine are suffering from after-effects today.
 
The study was a closely-kept secret, although the director of the Israel Institute for Biological Research in Nes Tziona, Professor Avigdor Shafferman, who headed the experiment, now claims that the vaccine's composition was not classified. Details of the Israeli vaccine had been published already in 2001 in foreign periodicals and in the domestic press.
 
Public health laws stipulate that a doctor may not conduct an experiment on a person subject to his authority unless it is done under the supervision of the Helsinki Committee and the Health Ministry's pharmaceutical division. Needless to say, neither condition was kept when Omer 2 was conducted on soldiers. Those who conducted the experiment obtained the necessary permits, but it is not known which civilian authorities supervised it, to what extent they oversaw it at all and why there was no follow-up supervision of the inoculated soldiers.
 
A Knesset bill governing human experiments, which passed its preliminary reading earlier this week, tries to establish the boundaries for what was described as lawlessness in the 55th State Comptroller's Report. Nothing is easier than conducting an experiment on a "captive" group such as soldiers or infirm elderly people (like the experiments at Hartzfeld Geriatric Hospital in Gedera).
 
Until this business is regulated by law, a committee of inquiry must be set up to shed light on the concealed details, define the responsibility toward the young civilians who were harmed and prevent such occurrences in the future.
/hasen/objects/pages/PrintArticleEn.jhtml?itemNo=886754
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Meryl Nass, MD

 

Judge Affirms Win for Plaintiffs in Anthrax I Case

By Elaine M. Grossman
Global Security Newswire

WASHINGTON — For the first time, a federal judge last month declared six U.S. defense personnel the definitive winners in a four-year court battle over the anthrax vaccine (see GSN, Aug. 21).
The Aug. 21 decision, which revolves around payment of attorneys’ fees, is the latest chapter in a protracted struggle over whether the Defense Department can require service members to take the anthrax vaccine. U.S. District Court Judge Emmet Sullivan decided the government defendants must pay the plaintiffs’ expenses because the plaintiffs won the case.
The litigants — defense personnel who were required to take anthrax vaccine shots in a Defense Department effort that began in 1998 — won the first round of litigation in October 2004, when Sullivan issued a permanent injunction banning mandatory inoculations. Based on a finding that the vaccine was never certified to protect against “weaponized” airborne anthrax spores, the judge declared the Pentagon’s mandatory vaccinations “illegal” (see GSN, Oct. 28, 2004).
However, the Food and Drug Administration 14 months later certified the drug for preventing inhaled anthrax. Citing the FDA move, an appellate court in February 2006 officially “dissolved” the injunction (see GSN, Dec. 16, 2005).
The Pentagon restarted its mandatory shots program early this year.
In the latest matter under dispute, Justice Department attorneys argued the so-called “Anthrax I” plaintiffs were ineligible for government reimbursement of attorneys’ fees and expenses because they had not prevailed on appeal. The government defendants insisted they had won at the appellate court, where a three-judge panel allowed the Pentagon to restart its vaccine program.
Sullivan concluded otherwise, declaring: “There is no question that plaintiffs have prevailed overall as they achieved the permanent injunctive relief that they sought.”
The judge noted that the appellate court sent the case back to the lower court only after the Food and Drug Administration issued a final ruling that certified the anthrax vaccine for use in preventing inhaled anthrax. That was “the exact result” the plaintiffs sought, according to Sullivan.
In the end, then, the government appeal was unnecessary, Sullivan said. He thus termed it “reasonable” for the government to reimburse the plaintiffs for their expenses, “as they ultimately prevailed.”
The decision might well strengthen the hand of the two plaintiff attorneys, Mark Zaid and John Michels, who filed a second legal challenge to the Pentagon’s anthrax vaccination program last December.
Known as “Anthrax II,” the latest lawsuit alleges that the December 2005 FDA certification was invalid and that the Pentagon has resumed administering treatments inconsistent with the approved drug license. Zaid and Michels are asking the federal judge hearing that case, Rosemary Collyer, to impose another ban on the defense effort until the vaccine is properly tested and licensed for Pentagon use.
In last month’s decision, Sullivan bolstered from the bench the arguments the new set of eight plaintiffs make in their lawsuit. The judge clearly rejected the government’s long-standing contention that the original drug license allowed the vaccine to be used for the prevention of anthrax regardless of the route of exposure, including disease contracted through the lungs. The license cited a more narrow use for the vaccine: to prevent disease in mill workers, veterinarians or laboratory personnel, who might contract anthrax through the skin by handling animals or pelts.
When the Food and Drug Administration issued its court-mandated certification in 2005, the license was updated to reflect the agency’s contention that the vaccine could be used more broadly to prevent disease from airborne spores.
Sullivan’s new decision reaffirms the plaintiffs’ view that the vaccine was proven safe and effective only in “limited circumstances” and that a “lack of data permitted no meaningful analysis of the [vaccine’s] effectiveness against inhalation anthrax.”

 

Judge OKs Mandatory Anthrax Vaccine

By MATT APUZZO – Feb =9, 2008

WASHINGTON (AP) — The Pentagon can require its troops be =accinated against anthrax, a federal judge said Friday.

Judge Rosemary M. Collyer said the Food and Drug Administration acted =appropriately when it found the vaccine to be safe and approved its use. =he dismissed a lawsuit by military officials who argued the drug is =nproven and the scientific data unsound.

"The court will not substitute its own judgment when the FDA made no =lear error of judgment," Collyer wrote.

The dispute has languished in the court system for years. A federal =udge suspended the vaccination program in 2004 after faulting the FDA's =rocess for approving the drug. After the FDA redid the process and again found it =o be safe, the military announced plans to reinstate mandatory =accinations.

That prompted this latest lawsuit by eight military members who =rgued the vaccine should be optional.

The Pentagon continues to require the vaccine, saying the program is necessary to protect soldiers from anthrax attacks.

"We owe it to our service members to give them every possible =rotection," Pentagon spokesman Bryan Whitman said. "Force protection is the number =ne priority in the Defense Department and the anthrax inoculation program =s an important force-protection measure."

Mark Zaid, an attorney for the plaintiffs, said the FDA relied on =utdated studies that didn't prove the vaccine is safe or effective against =nhaled anthrax.

"It would appear the court has condoned an agency's manipulation of decades-old data to support a present-day policy objective," Zaid said. =We are absolutely going to appeal."

 

Lawsuit Against FDA and DOD, Aug 2007

 

Letter to Maryland Officials About Forced Vaccinations

Reid and Marguerite Armistead

428 Park Avenue

Birmingham, AL 35226 

Nov. 20, 2007 

Dear Governor Martin O’Malley, Attorney General Glenn Ivey, Honorable Judge William D. Missouri, Honorable Judge C. Philip Nichols Jr., Chairman R. Owen Johnson Jr., and Dr. Donald Shell, 

We are writing to you as concerned parents and as fellow American citizens.  We understand that you want what is best for the school children of Maryland.  Please consider the following points regarding the issue of forcibly vaccinating the students with Chicken Pox and Hepatitus B vaccines in Maryland. 

  1. The product insert for the Chicken Pox vaccine reveals that some babies who have received the chicken pox vaccine have died.  Some recipients of the Hepatitus B vaccine have also had severe reactions.  Therefore, the parents of these children have good reason to be concerned.
  1. Mercury is a component of the Hepatitus B vaccine.  Mercury is extremely toxic, is not approved by the FDA for human consumption, and has been linked to neurological diseases following receipt of such vaccines.
  1. The level of immunity derived from these vaccines is questionable.  That is why the boosters were requested in the first place.
  1. Everyone has a unique immune system which reacts in different ways to different environmental factors and stimuli.  For example, some people are allergic to peanuts while others are not.  Therefore, different people react to different vaccines in different ways—sometimes it is fatal.  Therefore, making any vaccine mandatory for all students inevitably leads to serious consequences for some of the vaccine recipients.  An article in the World Net Daily on Oct. 6, 2007 stated that “groups including the Texas Medical Association, the American Academy of Pediatrics, the Association of American Physicians and Surgeons, and the American Academy of Environmental Medicine have come out publicly against mandatory vaccination” ( http://wnd.com/news/article.asp?ARTICLE_ID=58004 ).  Again, the parents have reason to be concerned.
  1. The Constitution of the United States of America guarantees freedoms to the public that cannot be taken away by anyone, including the School Board, the state Court, or the Attorney General.  An attempt to force these vaccinations may make you vulnerable to a lawsuit, especially if any of these children have an adverse reaction to these forced vaccinations.  The preamble of the Constitution clearly states “We the people of the United States, in order to form a more perfect Union, establish justice, insure domestic tranquility, provide for the common defense, promote the general welfare, and secure the blessings of liberty to ourselves and our posterity, do ordain and establish this Constitution for the United States of America. 
  1. The children are the property of the parents, not the state of Maryland.  The parents are not the property of the state of Maryland either.  They are not cattle.  They are human beings with fundamental rights.  To deny them these rights would be to limit your own freedoms as Americans as well.  In the words of Dr. Martin Luther King, Jr. in his Letter from a Birmingham Jail, “Injustice anywhere is a threat to justice everywhere.”  Forced vaccinations are a national issue.

Thank you for considering these important points from a family that has already seen first-hand what a vaccine can do to a person’s health.  We pray that you will reconsider your position on this vital matter of essential freedom.  We look forward to hearing your thoughts. 
 

Sincerely, 

//signed// 

Reid and Marguerite Armistead 
 

 

Memorandum from Louis Caldera Regarding Indemnity

  
S E C R E T A R Y   O F   T H E   A R M Y
                        
WASHINGTON
 
September 3, 1998
 
MEMORANDUM OF DECISION
 
SUBJECT:  Authority Under Public Law 85-804 to Include an Indemnification 
          Clause in Contract DAMD17-91-C1086 with Michigan Biologic 
          Products Institute
          
 
    Michigan Biologic Products Institute (MBPI), a temporary agency of the
State of Michigan, has requested that the Department of the Army include
an indemnification clause under Public Law 85-804 (50 U.S.C. 1431-1435) for
Anthrax Vaccine Adsorbed (AVA) produced under Contract DAMD17-91-C-1139 
with the U.S. Army Medical, Research Aquisition Activity (USAMRAA).
 
    The contract is a firm-fixed effort for AVA production with insurance
and facility renovations being provided on a cost reimbursement basis.  At
present, MBPI is storing over six million doses of AVA at their Lansing, 
Michigan facility.  This vaccine has been accepted by the Government with 
storage costs identified as a part of the firm-fixed price.  MBPI is also 
responsible under separate contract for the security, testing, labelling 
and shipping of the Government Material, as required.
 
     The obligation assumed by MBPI under this contract involves unusually
hazardous risks associated with the potential for adverse reactions in some
recipients and the possibility that the desired immunological effect will 
not be obtained by all recipients.  Although AVA has been extensively tested 
under the auspices of the Food and Drug Administration, the size of the 
proposed vaccination program may reveal unforewarned idiosyncratic adverse 
reactions.  Moreover, there is no way to be certain that the pathogen used 
in tests measuring vaccine efficacy will be sufficiently similar to the 
pathogen that U.S. forces might encounter to confer immunity. These concerns, 
coupled with the uncertain and evolving state of product liability law with 
regard to vaccines, lead me to the conclusion that the performance of this 
contract will subject MBPI to certain unusually hazardous risks.
  
    The definition of the unusually hazardous risks to which the contract 
indemnification clause will apply is as follows:
 
        "The risk of adverse reactions, or the failure to confer immunity 
        against anthrax, from the administration to any person of the vaccine
----- 
Page 2
 
        manufactured or delivered under this contract.  For the purposed of 
        this clause, the phrase "adverse reactions" includes anaphylaxis and 
        any other foreseeable reactions, as well as any unforeseen reactions."
 
    I have considered the availability, cost, and terms of private insurance 
to cover these risks, as well as the viability of self-insurance, and have 
concluded that adequate insurance to cover these unusually hazardous risks is 
not available to the contractor at a reasonable cost.  While limited 
"claims-made" insurance is available to the contractor, the terms and 
conditions of the insurance are not deemed to be practicable.  On the basis of 
this review, I find  that use of an indemnification clause in the contract 
will facilitate the national defense.
 
    In view of the foregoing and pursuant to the authority vested in me by
Public Law 85-804 (50 U.S.C. 1431-1435) and Executive Order 10789, as
amended, I hereby authorize USAMRAA to include the indemnification clause 
set forth at FAR Subpart 52.250-1, together with Alternate I, in Contract No. 
DAM17-91-C-1139, provided the contract defines unusually hazardous risks
precisely as set forth above.
 
   Should it prove necessary in implementing this Memorandum of Decision to
incorporate language into the contract to clarify terms found in the
indemnification clause, the contracting officer shall not include any such 
clarifying language without the prior review and approval of the Office of the 
Assistant Secretary of the Army (Research, Development and Acquisition).
 
    It is not possible to determine the actual or estimated cost to the
Government as the result of the use of this indemnification clause, inasmuch 
as the liability of the Government, if any, will depend upon the occurrence 
of an incident in the definition of unusually hazardous risks. 
 
    The contractual documents executed pursuant to this authorization shall
comply with the requirements of FAR Subparts 28.3 and 50.4 as implemented by 
the Department of Defense and the Department of the Army.  This Memorandum
 
----- 
Page 3
 
of Decision shall be incorporated in its entirety into Contract No. 
DAMD17-91-C-1139, and shall specifically cross reference FAR 52.250-1.  The 
contracting officer shall not require, and the Army shall not reimburse the 
contractor for the cost of insurance coverage applicable to the unusually 
hazardous risks and in excess of the minimum required by FAR Subpart 28.3
 
                                           /signed/
                                          Louis Caldera

 

(Bio)shielding Industry

This Tuesday, October 18, a Senate committee moved a bill forward that would create a new agency within the Department of Health and Human Services (HHS).  This new agency would help spur private industry to develop and manufacture medical countermeasures for bioterrorism agents and natural outbreaks such as a possible avian flu pandemic.  But the bill also makes oversight and accountability of much of America's biodefense efforts nearly impossible.

S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, exempts industry from liability and a new agency within HHS, the Biomedical Advanced Research and Development Agency (BARDA) from the Freedom of Information Act (FOIA), the Federal Advisory Committee Act (FACA) and parts of the Federal Acquisition Regulations (FAR). Here's the October 17, 2005 text of the legislation (pdf).

Global Security Newswire lists other questionable aspects of the bill, such as forbidding government purchases of generic drugs thus tying the government's hands.

Several groups such as the National Vaccine Information Center and the Center for Justice and Democracy are opposed to the indemnification of industry.  And we at POGO don’t see how exempting BARDA from FOIA, FACA and FAR cost/accounting standards can even be justified.

BARDA would be responsible for handling the $5.6 billion Project Bioshield initiative to create a new biodefense industry with government incentives and contracts. Exempting BARDA would mean congressional and public oversight of the agency and its important activities would be severely curtailed. A less effective agency and an American public more vulnerable than it should be are the likely results of this erosion of transparency.

October 20, 2005 in Contract Oversight, Homeland Security, Open Government | Permalink

 

Veteran's Bill of Rights

THROUGHOUT AMERICAN HISTORY our military has provided for the national defense and preserved our way of life. The American military is not a faceless body but a collection of individuals — patriots united by a legacy of selfless service and sacrifice. America's veterans know the cost of freedom and have never looked to others to pay that price.

THAT SPIRIT POWERS this rallying cry to veterans. Now is the time to find your brothers and sisters, those who also once bore the nation's burden. Look not solely to government agencies but to each other, as well. As ten percent of the American population, you have the ability to inform, to employ, to mentor, to heal — to change the lives of other veterans.

Now is the time.

Rights associated with a veteran's standing are manifest in the following articles:

 

Article I

The Right to Understand Benefits

Veterans have the right to comprehensive and accurate information about pay, benefits, and health care that is easily understood. This right is assured regardless of what organization is providing the benefits — federal, state, or local.
 

Article II

The Right to Use Benefits

Veterans have the right of ready access to all of the benefits for which they are entitled. Veterans with physical or mental disabilities or those who simply don't understand "the red tape" surrounding benefits must be provided assistance that will allow them ready access.
 

Article III

The Right to a Good Job

Veterans have the right to jobs commensurate with the skills and experiences gained in the military. Veterans must have access to tools that will allow them to create resumes that properly translate their military skills into civilian skills and language. They also have the right to understand all of their options surrounding federal employment and veteran preference. At the same time, employers, especially veteran employers, have the responsibility of understanding the advantages that veteran employees bring to the marketplace.
 

Article IV

The Right to Keep That Job

Veterans have the right to serve in the nation's National Guard and Reserve forces with the confidence that if they must leave their civilian jobs for extended periods they will be protected. Both veterans and their employers should understand USERRA and what the law requires in terms of veteran employment and re-employment rights.
 

Article V

The Right to Treatment For Service-Related Illness

Veterans have the right to health care for any service-related illnesses, be they physical or mental. Further, veterans have the right to the best medical care the government can provide.
 

Article VI

The Right to Respect and Nondiscrimination

As a result of demonstrated patriotism and the selfless desire to protect our way of life, veterans have the right to respect and nondiscriminatory treatment from all Americans and organizations both public and private.
 

Article VII

The Right to Identity Protection

Veterans have the right to trust that government organizations that possess personal data will safeguard that data.
 

Article VIII

The Right to Education

Veterans have earned the right to pursue dreams through education. Organizations charged with facilitating a veteran's use of GI Bill benefits must be responsive. Places of higher education must also give veterans appropriate consideration and treatment.
 

Article IX

The Right to Community

Veterans have earned their place among veterans and can depend on the veteran community to keep them informed, empowered, and enabled with respect to the issues articulated in Articles I through VIII. For its part, Military.com pledges to continue as the forum for these activities.

 

Judge Emmett G. Sullivan's Ruling on Oct. 27, 2004

 

________________________________________________________________________________________________________________________
Membership and Donations

Welcome to our nation-wide organization! 

To become a member of Protecting Our Guardians or to make a donation, please send a check to our treasurer at: 

Protecting Our Guardians
2148 Whiting Road
Birmingham, AL 35216
 

Please note that this is not tax-deductible, because we are a 501 (c) (4) non-profit organization. That means we can work with Congressional leaders on desired legislation. Thank you for protecting our troops so that they can protect America.

 

 

Welcome Letter

December 20, 2008

Dear Patriot,

Thank you for contacting Protecting Our Guardians (POG)!  We are a non-profit, military family advocacy group that focuses solely on the anthrax vaccine and the Anthrax Vaccine Immunization Program (AVIP).    If you are a military member, a friend or a relative of a military member, a first-responder, a concerned doctor or medical professional, or a concerned citizen, we are working hard for you.

We are committed to:

  1. protecting military personnel from the dangers of the anthrax vaccine
  2. bringing an end to the mandatory anthrax vaccine administered to military members and the Department of Defense’s (DoD) contractors through the AVIP
  3. educating citizens about the harm the anthrax vaccine and the AVIP is doing to military member health and America’s National Security
  4. lobby and otherwise support legislation in furtherance of these objectives

Accomplishments:

  1. conducted a letter campaign to the FDA between December of 2004 and March of 2005 after Federal District Judge Emmett G. Sullivan halted the AVIP and ordered the FDA to adhere to its own rules and regulations by holding a 90-Day comment period that was open to the American public
  2. contacted all Veterans’ Service Organizations (VSOs) registered with Congress inviting them to speak out during the FDA’s 90-Day Comment period for the thousands of military members injured by the anthrax vaccine
  3. visited Congressional leaders, five times in 2007 alone, to share data concerning military members dying and becoming disabled from the anthrax vaccine -- and about the danger this vaccine series will pose to first-responders and medical personnel.  These legislative efforts began back in 2005
  4. June 2005, visited Congress to share information again, including a NICDH (National Institute of Child Health & Human Development) clinical trial that was proposed to test the anthrax vaccine on 100 first grade children (which would violate federal regulations) and 200 adult volunteers
  5. drafted model legislation with medical and military anthrax vaccine experts, called “The Anthrax Vaccine Moratorium Act of 2007,” that ceases all appropriations for the AVIP and have continually shared this desired legislation with Congressional leaders since June of 2005
  6. spoke with many reporters to bring this matter of life and death to the forefront

In January of 2007, Under Secretary of Defense, Dr. David Chu, made the anthrax vaccine mandatory again. For years, young and healthy military members have been experiencing autoimmune diseases, lesions on the brain and skin, migraines, neurological problems, heart problems, GI problems, tremors, and serious joint pains after following orders and taking the anthrax vaccine.  Forty-four deaths from the anthrax vaccine have been reported to the FDA ( http://anthraxvaccine.blogspot.com/2007/07/670-serious-adverse-events-reported-to.html) since the year 2000. There have also been 5,120 adverse reactions to the anthrax vaccine reported to the FDA.  This is unacceptable.  Our troops deserve better.

Therefore, we are actively working with Congressional leaders and others, to sponsor and support the aforementioned draft legislation before anymore military members die or become disabled from the anthrax vaccine.  We are gathering letters from military members impacted by the anthrax vaccine to provide to Congress.  Medical and military experts have made commitments to regularly travel to DC with vaccine injured veterans to meet with important members of the House and Senate, legislative assistants, and other organizations, because there is great Congressional interest in military member health at this time.  Simultaneously, we are working hard with many reporters to generate widespread publicity about the damage done by the AVIP.

The anthrax vaccine issue affects America’s citizens as well because HHS (United States Department of Health and Human Services) has purchased 10 million doses of the same anthrax vaccine from Emergent BioSolutions that has already crippled and killed military members, to stockpile, for citizen use. HHS may purchase 22.75 million more doses.  We need your help as voters to speak out for our troops and for American citizens in general.  With your help, we can succeed in ending the AVIP in 2007.

Things you can do:

  1. visit your Senators (each state has 2) and Congressman (only 1) at their local office or on Capitol Hill in DC; write letters to them; call and fax them.  Please cc us regarding who you spoke with and their willingness to help so we can follow up.  Please ask all your friends and relatives to contact their Senators (www.senate.gov) and Congressman (www.house.gov) as well.
  2. write a one or two page letter briefly and politely describing to your Senators and Congressman how the AVIP has impacted you or your loved one. You may want to mention problems that others you know have faced due to the anthrax vaccine.  Then ask for support of the draft legislation, “The Anthrax Vaccine Moratorium Act of 2007” which stops all funding of the AVIP.
  3. fill out a VAERS form if you’ve had a concerning reaction to the anthrax vaccine (request a VAERS form at 1-800-822-7967 or go to http://www.vaers.hhs.gov)
  4. let us know if you are willing to work with reporters to share your story
  5. let us know if you are willing to travel to DC to participate in our lobbying efforts
  6. offer financial support for all these efforts

Protecting Our Guardians is a 501 (c)(4) which means that we can lobby, support legislation, back candidates, and share information with anyone concerned about the anthrax vaccine issue.  In fact, Protecting Our Guardians is the only association in existence that has the power to legally lobby Congress and is solely focused on the anthrax vaccine.  Due to this power, the donations we receive are not tax deductible.  Donations are sorely needed to make our lobbying efforts broader.  POG is essential to getting laws that protect our troops from the current AVIP passed on Capitol Hill.  Please feel free to send your donations to our Treasurer at Protecting Our Guardians (POG), 2148 Whiting Road, Hoover, AL 35216 or just make a donation to POG ’s account at your local Compass Bank.

Protecting Our Guardians is working closely with the “Military and Biodefense Vaccine Project” (MBVP), (www.military-biodefensevaccines.org) which is part of the National Vaccine Information Center (NVIC), to help military members, contractors and emergency essential personnel regarding biodefense countermeasures and related issues.  MBVP is a 501 (c)(3) which means they can educate the public but cannot lobby Congress.  MBVP provides crucial information, concrete data, and counseling on military/biodefense vaccines.

Congress is listening to military members’ concerns.  Now is the time to end the AVIP.   Let’s work together to obtain justice for the thousands of men and women in uniform who have been harmed by the anthrax vaccine.  Let’s work together to support those who wish to serve their country without being subjected to the most “hazardous vaccine” on the market (as stated in a memo requesting indemnity for the manufacturer by the former Secretary of the Army, Louis Caldera).  Let’s work together to protect our citizens, especially first-responders, from another dangerous product.  Let’s work together before anyone else dies needlessly.  Thank you for taking action.  Thank you in advance for your contribution as well.

Sincerely yours,

//signed//                                                                      

Steve Fisher, President                                                 

 

POG Fund Drive Letter

December 20, 2008

Dear Patriot,

Thank you for your interest in helping America’s troops and in supporting Protecting Our Guardians (POG)!  Many of you have helped in the past by writing letters to the Food and Drug Administration, by writing letters to Congress, by representing Protecting Our Guardians at Congressional functions, by attending meetings with our Congressional leaders on Capitol Hill and in your home towns, by volunteering your time and talents, and by making financial contributions.  Thank you for taking action regarding this matter of life and death for our troops.

We are currently holding a fund drive so that these critical efforts can continue.  We hope that you will prayerfully consider making a donation to Protecting Our Guardians.  For every donation of $40.00 or more, we will send you a free copy of Anthrax: a Deadly Shot in the Dark by Lt. Col. (Ret.) Tom Heemstra (who proudly served as an F-16 squadron commander).  It is endorsed by Cong. Christopher Shays.

It may also interest you to know that Protecting Our Guardians is now endorsed by EANGUS, the ACT, and the Vietnam Veterans of America to name a few. Protecting Our Guardians is also working closely with the “Military and Biodefense Vaccine Project” (MBVP), (www.military-biodefensevaccines.org) which is part of the National Vaccine Information Center (NVIC ), to help military members, contractors and emergency essential personnel regarding biodefense countermeasures and related issues. 

We are a non-profit, military family advocacy group that focuses solely on the anthrax vaccine and the Anthrax Vaccine Immunization Program (AVIP).    If you are a military member, a friend or a relative of a military member, a first-responder, a concerned doctor or medical professional, or a concerned citizen, we are working hard for you.

Protecting Our Guardians is committed to:

  1. protecting military personnel from the dangers of the anthrax vaccine
  2. bringing an end to the mandatory anthrax vaccine administered to military members and the Department of Defense’s (DoD) contractors through the AVIP
  3. educating citizens about the harm the anthrax vaccine and the AVIP is doing to military member health and America’s National Security
  4. lobby and otherwise support legislation in furtherance of these objectives

Accomplishments:

  1. conducted a letter campaign to the FDA between December of 2004 and March of 2005 after Federal District Judge Emmett G. Sullivan halted the AVIP and ordered the FDA to adhere to its own rules and regulations
  2. contacted all Veterans’ Service Organizations (VSOs) registered with Congress, inviting them to speak out during the FDA’s 90-Day Comment period
  3. visited Congressional leaders, five times in 2007 alone, to share data concerning military members dying and becoming disabled from the anthrax vaccine -- and about the danger this vaccine series will pose to first-responders and medical personnel.  These legislative efforts began back in 2005
  4. June 2005, visited Congress to share information again, including a NICDH (National Institute of Child Health & Human Development) clinical trial that was proposed to test the anthrax vaccine on 100 first grade children (which would violate federal regulations) and 200 adult volunteers
  5. drafted model legislation with medical and military anthrax vaccine experts, called “The Anthrax Vaccine Moratorium Act of 2007,” that ceases all appropriations for the AVIP and have continually shared this desired legislation with Congressional leaders since June of 2005
  6. spoke with many reporters to bring this matter of life and death to the forefront

In January of 2007, Under Secretary of Defense, Dr. David Chu, made the anthrax vaccine mandatory again. For years, young and healthy military members have been experiencing autoimmune diseases, lesions on the brain and skin, migraines, neurological problems, heart problems, GI problems, tremors, and serious joint pains after following orders and taking the anthrax vaccine.  Forty-four deaths from the anthrax vaccine have been reported to the FDA ( http://anthraxvaccine.blogspot.com/2007/07/670-serious-adverse-events-reported-to.html).  There have also been 5,120 adverse reactions to the anthrax vaccine reported to the FDA. This is unacceptable.  Our troops deserve better.

Therefore, medical and military experts have made commitments to regularly travel to DC with anthrax vaccine-injured veterans to meet with important members of the House and Senate, legislative assistants, and other organizations, because there is great Congressional interest in military member health at this time.  Simultaneously, we are working hard with many reporters to generate widespread publicity about the damage done by the AVIP.

The anthrax vaccine issue affects America’s citizens as well because HHS (United States Department of Health and Human Services) has purchased 10 million doses -- of the same anthrax vaccine from Emergent BioSolutions that has already crippled and killed military members -- to stockpile for citizen use.  HHS may purchase 22.75 million more doses.  We need your help as voters to speak out for our troops and fellow citizens in order to end the AVIP in 2007.

Things you can do:

  1. visit your Senators (each state has 2) and Congressman at their local office or on Capitol Hill in DC; write letters to them; call and fax them.  Please cc us regarding who you spoke with and their willingness to help so we can follow up.  Please ask all your friends and relatives to contact their Senators (www.senate.gov) and Congressman (www.house.gov) as well.
  2. write a letter briefly and politely describing to your Senators and Congressman how the AVIP has impacted you, your loved one, or your friends. Then ask for support of the desired legislation, “The Anthrax Vaccine Moratorium Act of 2007” which stops all funding of the AVIP.
  3. fill out a VAERS form if you’ve had a concerning reaction to the anthrax vaccine (request a VAERS form at 1-800-822-7967 or go to http://www.vaers.hhs.gov )
  4. let us know if you are willing to work with reporters to share your story
  5. let us know if you are willing to travel to DC to participate in our lobbying efforts
  6. offer financial support for all these efforts

Protecting Our Guardians is a 501 (c)(4) which means that we can lobby, support legislation, back candidates, and share information with anyone concerned about the anthrax vaccine issue.  In fact, POG is the only association in existence that is focused on the anthrax vaccine and has the power to legally lobby Congress.  Due to this power, the donations we receive are not tax deductible, but donations are sorely needed to make our lobbying efforts broader.  POG is essential to getting laws that protect our troops from the current AVIP passed on Capitol Hill.  Please feel free to send your donations to POG’s Treasurer using the enclosed form or just make a deposit into the Protecting Our Guardians account at your local Compass Bank. 

Congress is listening to military families.  Let’s work together to: support those who wish to serve their country without being forced to take the most hazardous vaccine on the market; protect our citizens, especially first-responders, from another dangerous product; and to prevent needless deaths.  Thank you for taking action, and thank you in advance for your contribution.

Sincerely yours,

//signed//                                                                      

Steve Fisher, President                                                 

 

Donations to Protecting Our Guardians

Thank you for helping to protect America’s troops from the dangers of the anthrax vaccine! 

Check the appropriate line below.  Then make your check out to Protecting Our Guardians, or just go to your local Compass Bank and make a donation directly to the Protecting Our Guardians non-profit association.  Please note that this is not tax deductible.

____     I will make the best donation that I can.

____     I will donate $1,100 for a billboard near a military base in my hometown, or in the DC area, detailing the dangers of the anthrax vaccine.

____     I will donate $600, to send an anthrax vaccine-injured veteran, to give his/her testimony at an upcoming Congressional hearing.

____     I will donate $120 to support Protecting Our Guardians internet service for one year.

____     I will donate $70 towards business cards, informative brochures, and other business materials.

____     I will send a copy, for $40, of Lt. Col. (Ret.) Tom Heemstra’s book, Anthrax: A Deadly Shot in the Dark, to one of my Congressional Representatives in honor of our troops (or a certain soldier that I know).

Amount enclosed: _____________

Send your check to:

Protecting Our Guardians, Treasurer
2148 Whiting Road
Birmingham, AL
35216

*Those who send a donation of $40 or more will receive their own free copy of Anthrax: a Deadly Shot in the Dark by former F-16 squadron commander Tom Heemstra.  This book is endorsed by Congressman Christopher Shays.  It documents the disturbing facts behind the anthrax vaccine nightmare that thousands of military members, and their families, have suffered from.

May God bless you!  Thank you.

________________________________________________________________________________________________________________________
About Anthrax Vaccine Manufacturer

 

Researchers Try to Boost Supply of Flu Vaccine

Pentagon Unable to Back Claim of Three-Shot Anthrax Shield

Of Drugs and Dollars

http://pogoblog.typepad.com/pogo/2005/11/of_drugs_and_do.html

As its AIDS work was blowing up, VaxGen was working to get access to Fort Detrick’s anthrax vaccine technology.  It had friends.  VaxGen Chief Gordon is a long-time acquaintance of Philip Russell, the former chief of Army medical research.  Both sit on the board of the Albert B. Sabin Vaccine Institute in New Canaan, Conn.  Fort Detrick gave VaxGen the license to its anthrax technology in October 2003.  Russell, then an adviser to HHS, stepped in to settle a fight between government bureaucrats over whether VaxGen would pay royalties to the government.  “He said, “Dammit, I don’t care what you do, but settle it – don’t leave this company in the lurch,” recalls Gordon.

A year later HHS awarded VaxGen the BioShield award.  Gordon and Russell adamantly deny their relationship had any influence on VaxGen’s selection.  “I scrupulously stayed away from talking to him, to the point where I felt terrible about it,” said Gordon.  The company now notes Russell in its media kit:  “We have a lot of faith in this vaccine, and we believe it’s the right way to move forward to protect the country against anthrax.”

In a CNN/Money piece, Jeffrey Marshall, an analyst for Fairview Capital Group, said VaxGen has the “closest ties with the government” versus competitors for other Bioshield contracts.  Which given the Russell and Slater connections may be true.  But examination of VaxGen and its CEO and President Lance Gordon’s history lends even more weight to Marshall’s opinion.

Reminiscent of the Darleen Druyun-Boeing tanker lease scandal last year the Forbes article notes:

In 1999 [VaxGen] won an $8 million government contract to test its AIDS vaccine, but the official negotiating the contract for the Centers for Disease Control got in trouble for simultaneously talking to VaxGen about a job. 

And in 1998 the New York Times reported that OraVax’s vice president (OraVax was then headed by Gordon) may have influenced a high-level government meeting to shape the US government’s biodefense strategy to benefit Oravax financially, while not adequately disclosing his ties.

Is VaxGen capitalizing on its ties to the government in order to score hundreds of millions of dollars in government contracts?

 

Bioshield Act and Vaccine Manufacturers
http://www.bizjournals.com/boston/stories/2004/11/15/tory5.html

According to Sheri Qualters’ article “Bioshield:  Flaw in federal program deters applicants for bioterrorism fund,” the Project Bioshield Act of 2004 gave first contract to VaxGen Inc. of Brisbane, California.  VaxGen received $877.5 million dollar deal, almost a billion dollars, for 75 million doses of new anthrax vaccine.  The article did not let readers know several facts:  that VaxGen’s new anthrax vaccine is unproven, has only had phase 2 clinical trials, and has not been considered a successful company from its performance in 2003.

The article states that Avant Immunotherapeutics received a $5.8 million dollar contract for 2004 and 2005.  It is developing a single-dose oral vaccine for anthrax and plague.

The article revealed that Avant Immunotherapeutics and Coley Pharmaceutical Groups are pressuring Congress to give them 4 things:  indemnity/liability protection; a guaranteed market for their new vaccines; fewer safety regulations to follow; government funding for their research and development.  These requests are shocking, and defy our American tradition of protecting consumers and the general public form some of the dangers of injury in our free market.

The article does not ask a key question:  Will the Bioshield II Act cave into pharmaceutical and biologics companies’ unreasonable demands, or will it protect the public’s safety from risky business as Congressional leaders and Representatives are supposed to do?

 

Barbara Walters’ report on ABC’s 20/20 on Oct 10, 2001
(http://www.bushwatch.com/bioterrorism.htm )
Bioport closed since 1999 for failing FDA inspections of plant and product – at least 18 serious violations.
 

Congressman Tim Hutchinson on gov’t dollars spent at Bioport
Congressman Tim Hutchinson said the DOD has spent 42 million dollars on Bioport and its facilities (as of Oct 10, 2001)
 

Retired Admiral William Crowe, Jr.’s interest in Bioport
In contrast (to above), Ret. Adm. William Crowe, Jr. (former Chairman of the Joint Chiefs of Staff and former Chairman of the President’s Foreign Intelligence Advisory Board) has a 13% interest in Bioport.  Crowe also owns 22.5% of shares in Intervac L.L.C., the company that owns Bioport, even though he hasn’t invested a penny in the deal. 
 

Dr. Meryl Nass quote on safety of anthrax vaccine
http://www.bizjournals.com/boston/stories/2004/11/15/story5.html
However, Dr. Meryl Nass states that VaxGen’s anthrax vaccine has NOT been proven safe either (www.anthraxvaccine.org)

Coulter and Fisher quote from A Shot in the Dark
Harris Coulter and Barbara Fisher’s book A Shot in the Dark explains how “in 1975 MBPI produced a DPT vaccine *(Lot 1182) that the FDA found to be 3 times more virulent than allowed by law.  Now this vaccine has passed all of MBPI’s safety and toxicity tests.  The FDA refused to allow them to distribute the vaccine (400,000 doses) elsewhere.  This should have been the end of it and the lot destroyed.  Instead ‘ Michigan Health officials decided to see just how reactive it was by testing it on several hundred children in Ingham County.’  At least 3 children were left with seizures, paralysis and brain damage.” (httP://www.dallasnw.quik.com/cyberella/Anthrax/lamelab.html )

 

AVIP as a case of the “Emperor’s New Clothes”
AVIP is a case of the emperor’s new clothes.  The military-pharmaceutical industry has duped many people into thinking they will be/are protected from every bio-terrorist threat.  The mighty USA can strut around proud thinking it is invincible while it is really naked and vulnerable to the next day’s bioweapon flavor (biological weapons, especially anthrax, can easily be manipulated with new strains and combinations of biological agents””.  In the meantime, experienced soldiers are left by the wayside, crippled or dead, for an illusion of national security.  The best approach is to take out the terrorists, not try to turn our bodies into bioshields.

 

Anthrax vaccine impure and manufacturing unacceptable
The anthrax vaccine is an impure product due to substandard manufacturing processes.

Furthermore, inspections by FDA of the MBPI [Michigan Biologic Products Institute, then  re-named BioPort and now named Emergent Biosolutions] have revealed unacceptable manufacturing practices.  The FDA had sent the MBPI a warning letter in 1995 and threatened to revoke its license in 1997.  An FDA report of an inspection in February 1998 made dozens of serious charges regarding compliance problems, including contamination of the vaccine, reuse of outdated vaccines, and relabelling of lots [batches] that originally failed in order to place them in use.  The MBPI is now closed for renovation, but the vaccine being used by the Pentagon was produced while the unacceptable conditions were in place.

(http://mars.healthnet.org/MGS/V5N2Anthrax.html ) link not valid

 

the FDA inspection report on Michigan Biologic Products Institute
 http://www.dallasnw.quik.com/cyberella/Anthrax/anthrax1.htm

-As of April 28, 1999, the FDA declared that although 8 lots passed testing at MBPI, 11 lots failed supplemental testing and are to be quarantined. (http://www.dallasnw.quik.com/cyberella/Anthrax/DoD_answ.html ) -The article Anthrax vaccines expired in the Belleview News – democrat from May 25, 1998, brings this horrific reality to the public’s attention with, “[t]he U.S. Navy injected sailors in the Persian Gulf [aboard the USS Independence and the USS Stennis] with a five-year-old batch of anthrax vaccine [Lot FAV020], two months after federal regulators said the vaccine had been given a new expiration date improperly.

“Vaccine batches submitted to FDA for new expiration dates are supposed to be relabeled with an alternate Lot Number that indicates it has been redated….Lot FAV020, which was originally dated as being tested for potency on April 13, 1993, and redated on Feb. 6, 1998.
“….An estimated 14 sailors on the two ships refused to take the shots and have received administrative punishments ranging from reductions in rank to discharge from the Navy.  Navy spokesmen did not return repeated calls last week.  Pentagon spokesmen referred questions to the Navy” (http://www.dallasnw.quik.comcyberella/Antrhax/RodH_1.html)

 

IND SUBMISSION ACCEPTED FOR ANTHRAX IMMUNITY-STIMULATING MOLECULE
FOR IMMEDIATE RELEASE
August 18, 2004

Lansing, MI – BioPort Corporation today disclosed the recent acceptance of an Investigational New Drug (IND) submission by the U.S. Food and Drug Administration (FDA) related to anthrax vaccine.  The acceptance by the FDA of the IND submission will allow proof-of-concept studies in humans for an immune-stimulating molecule to be added to BioPort’s FDA-licensed anthrax vaccine, BioThrax.™ 

The addition of the molecule, if demonstrated to be safe and effective, would potentially reduce the number of doses of BioThrax™  vaccine required to reach and maintain a protective level of immunity against B. anthracis infection.

Research to evaluate the immune-system impact of the molecule will be funded by the Defense Advanced Research Projects Agency (DARPA).

 

HHS plans to buy disputed anthrax vaccine for civilian use
GOVEXEC.COM
By Chris Strohm

The Health and Human Services Department plans to buy 5 million doses of anthrax vaccine for civilian inoculations, even though a federal judge ruled last week that the product has not been properly validated as safe and effective.

HHS announced Thursday that it intends to negotiate a sole-source contract with BioPort Corporation of Michigan to buy up to 5 million doses of the company’s BioThrax vaccine within two years for the nation’s Strategic National Stockpile.  The contract is part of Project Bioshield, a $6 billion program to create and expand the nation’s stockpile of vaccines and treatments to combat potential bioterrorism agents.

“Unless and until FDA properly classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting [the military’s] use of AVA on the basis that the vaccine is either a drug unapproved for its intended use or an investigational new drug.”  Sullivan wrote.  “Accordingly, the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a presidential waiver.”

More than 1.2 million troops have been inoculated under this program since 1998.

On Thursday, HHS also awarded a contract worth almost $880 million to VaxGen Inc. of California to produce 75 million doses of a new type of anthrax vaccine, HHS Secretary Tommy Thompson announced. 

The vaccine is set to be produced using purified recombinant protective antigen, a protein that elicits antibodies to neutralize the toxins produced by the anthrax bacterium, according to an HHS press release.  About 25 million people would be inoculated through the plan, which stipulates a three-dose regimen for the new vaccine.

The contract is the first to be awarded under Project Bioshield.

 

Information on Congress’ Ethics Committee investigation of manufacturer

FDA inspection report on manufacturer

Mayors Support Anthrax Vaccine for Police, Firefighters (excerpts)

Washington, D.C. (July 14, 2004) – As the United States military announced plans to expand its soldiers’ anthrax and smallpox immunization program this month; the growing debate about how best to protect America’s front line patriots – police and firefighters – has also gained momentum after receiving a strong endorsement from the nation’s mayors.

Since 1998, some 1.1 million military personnel have been vaccinated against anthrax, one of the top biological warfare threats to U.S. troops.  The expanded vaccine program will add hundreds of thousands more soldiers serving in South Korea, Pakistan and North Africa.

This Department of Defense policy announcement last week coincides with a new resolution endorsed by the U.S. Conference of Mayors supporting the adequate supply of anthrax vaccine in the national stockpile.  Increasing the supply is seen as a necessary stop toward protecting America’s cities, particularly police, firefighters, and other first responders, in case of another anthrax attack on U.S. soil.

The federal government has decided to put 75 million doses in the stockpile, but is making the procurement with an experimental vaccine that is not yet licensed and has not been proven to work.

 

Contaminated Lots of Anthrax Vaccine
According to the FDA, 25 out of 40 lots (1 lot = 200,000 doses)  had contamination, poor manufacturing, potency problems, were quarantined, and later destroyed at Bioport.

New lots haven’t been tested for squalene.  Sammy Young, a former FDA inspector, said he’s shocked it hasn’t been shut down from squalene findings.  Reaction rates in military members haven’t changed with cleaner production plant. 
 

Make FDA test each lot for squalene in p.p.b. (parts per billion)

1.       P.R.I was responsible for bottling vaccine.  Did they do it?  DoD denies it.  BioPort denies it.  No perpetrator yet.  Investigation dead?

2.       Soldiers now demanding to know if squalene is in their anthrax shot

3.       Suing DoD from Rumthesford Institute:  Rumsfeld + Cohen

4.       Anthrax vaccine production still not being checked by FDA

5.       Troops need to trust in order to perform well in national security
 

Squalene is also called MF59

Bioport should be treated like ISRATEX
Bioport should be treated like ISRATEX.  Bioport failed 4 FDA inspections, but was put on taxpayer life-support.  Peopler were injured.  It costs taxpayers $3 million per month so Pentagon can continue the anthrax vaccine program.
(http://www.fas.org/spp/starwars/congress/2000_h/000621_mongeen_june21.htm)

 

BioPort bought out Michigan Biologic

BioPort bought out the state-owned Michigan Biologic Products Institute in 1998, and the department of Defense became its only customer.  The takeover itself is considered suspicious by some.  “The company acquired the Michigan Biologic Products Institute for the express purpose of taking over and acquiring a lucrative military contract,”  said a bio-warfare expert who asked not to be named and accused company officials of “war profiteering.”  BioPort’s most visible board member is Admiral William J. Crowe, former chairman of the Joint Chiefs of Staff.  the FDA repeatedly flunked BioPort in inspections in 1999 and 2000 because of contamination and suspicious changes made to expiration dates.  The agency has barred the company from releasing any of the vaccine as a result.  A third FDA inspection has not yet been scheduled.  If it passes, the company has told reporters it hopes to begin producing more anthrax vaccine this year.

“The problems don’t end with FDA inspections.  BioPort has also been questioned about where it has spent advance payments made by the military.  The military gave BioPort an $18 million advance in 1999.  Still, the company told the Pentagon in early 2000 it faced a possible cash shortfall of up to $18 million.  The department of Defense paid the company an additional $24 million in June 2000 to stay afloat.  An audit by the Pentagon’s inspector general in April 2000 reported that BioPort had spent more than $2 million inappropriately, according to Defense Week.  About $1 million went to renovate a plasma production operation, a commercial venture unrelated to the anthrax program.  Another $1.1 million was spent on office remodeling, furniture, parking lot and road paving.  Furniture for the company’s CEO, Fuad El-Hibri, cost 423,000, the audit said.  The report also said the company was incurring “excessive travel costs,

excessive severance pay and unsubstantiated consulting costs.”  The investigation found that $1.28 million had been set aside for senior management bonuses in 2000, or “109 percent greater than the managers’ base salary,” which inspectors deemed “unreasonable in light of its current financial condition.”

“The anthrax vaccine was the subject of controversy even before it was in such high demand.  Approximately 400 soldiers faced reprimands rather than take the vaccine because of side effects that some said were severe.  The FDA has found the vaccine to be effective, but approved it only for anthrax absorbed through the skin.  In the event of a bio-warfare attack, anthrax would most likely be released into the air and inhaled, which causes a different version of the disease for which the vaccine has not been tested.  The FDA could be in violation of federal law for allowing military personnel to take it. 

www.bushwatch.com/bioterrorism.htm

 

The Hartford Courant – Bioport Article
by Thomas D. Williams

October 31, 2000

excerpts from the article

BioPort Corp., the manufacturer of the controversial anthrax vaccine, has once again been sharply criticized by federal inspectors over its manufacturing process.  Last week, the U.S. Food and Drug Administration cited BioPort for 18 violations of manufacturing procedures after about 21/2 weeks of inspections of its Lansing, Mich., plant.  An FDA report on the inspections was not available to the public Monday, but BioPort acknowledged criticism from the FDA inspectors.  The FDA cited BioPort for lack of consistency in its manufacturing processes, and for problems with assurances of sterility in vaccines, drug products other than anthrax and its overall procedure for packaging and filling vaccines, said Kelly  Rossman-McKinney, a BioPort spokeswoman. 

The current vaccine to confer immunity to anthrax requires six shots over many months.  In addition to the length of time of the treatment, the vaccine also causes side effects, and may not provide ideal levels of immunity.  Moreover, government regulators three years ago shut down the plant where BioPort Corp. of Lansing, Mich., made the vaccine for a variety of deficiencies, according to the Wall Street Journal.  Subsequent inspections by the US Food and Drug Administration found continued problems.  The lack of an approved vaccine supplier, and what some scientists see as shortcomings of the current treatment, provides a huge opportunity for DynPort Vaccine and Avant.

 

Excerpt from Wired Magazine article on Bioport

Philipkoski, Kristen in Wired Magazine on Oct. 10, 2001

“The problems don’t end with the FDA inspections.  BioPort has also been questioned about where it has spent advance payments made by the military.  The military gave BioPort an $18 million advance in 1999.  Still, the company told the Pentagon in early 2000 it faced a possible cash shortfall of up to $18 million.  The Department of Defense paid the company an additional $24 million in June 2000 to stay afloat.  An audit by the Pentagon’s inspector general in April 2000 reported that BioPort had spent more than $2 million inappropriately, according to Defense Week.  About $1 million went to renovate a plasma production operation, a commercial venture unrelated to the anthrax program.  Another $1.1 million was spent on office remodeling, furniture, parking lot and road paving.  Furniture for the company’s CEO, Fuad El-Hibri, cost $23,000, the audit said.  The report also said the company was incurring “excessive travel costs, excessive severance pay and unsubstantiated consulting costs.”  The investigation found that $1.28 million had been set aside for senior management bonuses in 2000, or “109 percent greater than the managers’ base salary,” which inspectors deemed “unreasonable in light of its current financial condition.”

Pentagon announces second phase of vaccinations postponed because of Bioport’s failure to pass inspections

from article by Thomas D. Williams, The Hartford Courant

October 31, 2000

Last December, the Pentagon announced that the second phase of its vaccination program had been postponed for six months to a year because of BioPort’s failure to pass inspections to produce its own vaccine supply.  The company has been exclusively using old supplies of the vaccine since it purchased the operation from the state of Michigan’s health department two years ago.  The vaccine’s former manufacturer had been threatened with a shutdown of its operations during FDA inspections in 1996 and 1997.  More than 1,500 service people have complained about side effects, of varying severity, that they blame on the vaccine.  Hundreds of service people have refused to be inoculated and have been disciplined or discharged.”

Now that BioPort is producing its own vaccine supply, service members are still getting sick and becoming disabled.
 

Laura Rozen quote

In the words of Laura Rozen in her article, “Why did the Pentagon…” on Oct 13, 2001 in Salon, “How could [the Pentagon] let BioPort remain the sole maker of the vaccine after it failed repeatedly to gain FDA approval for its renovated facility?”

 

from Chairman Dan Burton
www.know-vaccines.org/bioterror2.html

“We need functional protective suits and masks that are not defective and that will offer real protection for both biological and chemical threats.  We need effective detection equipment.  And our strongest protection against anthrax or any other biological and chemical threat is a strong defense ready to respond to any threat or emergency."

“The General Accounting Office is providing results of their survey of Guard and Reserve pilots and aircrew members.  They learned that the adverse events for those who have taken the vaccine were much higher than has been reported to this Committee. They learned that there is little support for a vaccine approach to biological warfare protection.”

 

BioPort indemnified
Sept 1998
BioPort indemnified – no lawsuits – thanks to Secretary of the U.S. Army, Louis Caldera – government is liable

-BioPort – 6.3 million doses at $10 or $20 per shot
18 more vaccines against Biowarfare – wasted expenditure because terrorists can alter the threat
Not enough data to claim inhalation protection (FDA, 1985 interim ruling) (Judge Sullivan’s ruling on Oct 27, 2004 at http://www.dcd.uscourts.gov/03-707c.pdf

 

U.S. Moves Toward Making Anthrax Vaccine Available
www.bushwatch.com/bioterrorism.htm
by Nicholas Wade
October 24, 2001

 

Cipro?  We Got Your Stinkin’ Cipro

The Bush administration’s stiff upper lip can’t conceal the perilous state of the public health system.

 “Anthrax cultures are kept in countless labs in the U.S. and elsewhere.” 

 “In the event that the U.S. might maybe someday need to , you know, violate drug patents, then Thompson’s HHS would be empowered to pick up the tab for any legal and financial risks that fell to the manufacturers of generic substitutes.  National emergency or no, in other words, the United States will subsidize pharmaceutical companies who see their almighty patents trod upon.” 

 

The Anthrax Vaccine Scandal

Anthrax vaccine shipments from BioPort have been suspended by the FDA since 1998 because of questions about the facility’s quality control, forcing the Pentagon to dramatically reduce its program to vaccinate all 2.4 million U.S. soldiers and reservists against anthrax.  Now the lack of vaccine threatens to become a scandal, as the U.S. is sending thousands of soldiers overseas, calling up reserves, and as the public is clamoring for access to protection from the deadly bacterium.”

 

Anthrax Vaccine:  Barbara Walters Looks for Answers, but Gets a Run-Around

“First, the single facility in Michigan that produces the vaccine has been closed down since 1999 for failing to pass various FDA checks of its product and its facility, 18 violations in all.”

“First, the single facility in Michigan that produces the vaccine has been closed down since 1999 for failing to pass various FDA checks of its product and its facility, 18 violations in all.”

How do we know that the vaccine is not contaminated or does not have a trigger in it that could be set off later?  (as in case of Simean HIV test that was in kidney tissue used to make the small pox vaccine)

 

VAERS report states anthrax most reactogenic
According to VAERS reports sent in to the FDA, the anthrax vaccine is the most reactogenic vaccine on the market

 

Louis Caldera, Secretary of Army discuss risks of vaccine
Secretary of the Army, Louis Caldera, wrote in a memorandum in Sept. 1998, the vaccine “involves unusually hazardous risks associated with the potential for adverse reactions in some recipients and the possibility that the desired immunological effect will not be obtained by all recipients.”

 

AMA Journal, Valenskis doubts Iraq could develop inhalation anthrax
Journal of AMA (August, 2005) Raymond Valenskis, of The Monterey Institute of International Studies, 4 months before Cohen’s announcement of program “Iraq unable to develop dry anthrax that could be inhaled.”  GAO concurs.

Omersheriko group used anthrax 9 times, 100 scientists + 80 million dollars and were unsuccessful

 

Sammie Young states anthrax vaccine “adulterated”

Sammie Young, career as FDA inspector, stated on the video Direct Order that anthrax vaccine is “adulterated” according to the legal definition of that word and condemned it.  (www.directorder.org )

Appearing on the “Endangered Liberties” program on the new Renaissance Television cable and satellite network, former FDA  inspector Sammie Young said the anthrax program had bypassed the FDA’s drug approval process.”  according to Reed Irvine and Cliff Kincaid in an article called “Another Scandal at the FDA” on May 21, 2001.

 

Kathryn Zoon states long term side effects of anthrax unknown

Kathryn Zoon, head of the FDA’s Center for evaluation and Research, pointed out in a May 1998 letter that data on long-term side effects for this vaccine have never been submitted to the FDA”  (http://www.dallasnw.quik.com/cyberella/Anthrax/nass4_29oral.htm )

Kwai-Chenung Chan quote that studies show vaccine doesn’t protect against all strains of anthrax

Kwai-Chenung Chan, Director, Special Studies and Evaluations, before the National Security, Veterans Affairs, and International Relations Subcommittee, House Committee on Government Reform, revealed that “These studies [by the DoD in the 1980s} found that the licensed vaccine protected against some but not all strains of anthrax.”  (http://www.gao.gov/AindexF499/abstracts/ns99148t.htm)  There are over 60 strains of anthrax.  It can be manipulated and weaponized in such a way as to render the vaccine useless.

 

Steve Perry states anthrax spores available across the U.S.

According to Steve Perry’s article “Cipro?  We got Your Stinkin’ Cipro” on Oct 24, 2001, Anthrax cultures are kept in countless labs in the U.S. and elsewhere.” Thus it is impossible to cover all the bases.”

www.bushwatch.com/bioterrorism.htm

 

Vaccines book states current anthrax vaccine unsatisfactory

Vaccines, co-authored by Dr. Arthur Friedlander, MC Colonel and head of Bacteriology at Ft. Detrick’s USAMRIID, states “The current vaccine against anthrax is unsatisfactory for several reasons.  The vaccine is composed of an undefined crude culture supernatant adsorbed to aluminum hydroxide.”  …. “No direct determination of the content or structure of the protective antigen in the vaccine has been made, and it is unknown whether the protective antigen is biologically active.”  …”The undefined nature of the vaccine and the presence of constituents that may be undesirable may account for the level of reactogenicity observed.” (3)

http://www.dallasnw.quik.com/cyberella/Anthrax/refute.html )

 

US Government Material Data Safety Sheet on Anthrax

According to the US Government Material Data Safety Sheet, a principle chemical component of the anthrax vaccine, formaldehyde, is not approved for human consumption.

Another component is benzethonium chloride, which has never been evaluated for human consumption.

Aluminum hydroxide is another component.  Dr. Meryl Nass has noted that the aluminum and the large number of shots required (6 in series plus annual booster) could have a cumulative effect, making the anthrax vaccine more dangerous than others. 

http://www.dallasnw.quik.com/cyberella/Anthrax/DoD_answ.html 

According to Autoimmunity on a vaccine website, “Killed vaccines….have also been reported to induce and exacerbate autoimmune diseases to blood cells including platelets”  Kelton (1981) “and red blood cells”  Zupanska, et al. (1976).  …Studies show that human vaccines can induce autoimmunity when administered with autoantigens, exacerbate autoimmunity when given alone, and can even induce autoimmunity when administered without autoantigens.”  The anthrax vaccine is an inactivated vaccine.  It has caused bizarre autoimmune diseases (for ex., Guillan-Barre Syndrome in people as young as 17 years old, a rapidly progressing form of Multiple Sclerosis in men [usually this disease hits women and develops slowly], and so on)!

 

Two Memorandums Providing Indemnity for Manufacturer

1991

1998
 

A Report from Military Tiger Team

1999
 

Memorandum

1999
 

Dr. Burrow's Expertise?

1999
 

More Questions for Anthrax Vaccine Manufacturer from H.H.S

August 31, 1995
 

March 11, 1997
 

April 28, 1998

 

Summary of the 2/20/98 FDA Inspection Report on the Michigan Biological Products Institute
http://www.gulfwarvets.com/anthrax2.html

[All Anthrax Vaccine produced for U. S. use is manufactured by this lab. The FDA recently issued a notice of intent to revoke the license of the lab’s governing body, a research arm of the University of Michigan.]

Summary of the 2/20/98 FDA Inspection Report on the MBPI [Michigan Biologic Products Institute, Lansing, Michigan], Meryl Nass, M.D. May 19, 1998

Essentially all the issues in the report have to do with grossly inadequate quality control.  However, it appears that the production process was carried out in a particularly cavalier manner, as if the product would never be used on human beings, and was being manufactured solely to meet production quotas.  The issue of how MBPI was allowed to carry on despite repeat violations of standards over many years is another story; here I am trying only to list in a brief but comprehensible manner the issues enumerated in the FDA's report.

1. MBPI did not test the suitability of their own procedures, nor validate them:
a. storage times for bulk anthrax preparations in tanks lasted from a week to 4 months, before filling of containers;
b. mixing times not standardized; the product settles quickly in the tank and homogeneity of the suspension has not been demonstrated;
c. testing for contamination was sporadic;
d. the sporicide used was not validated;
e. sublots are held for 3 years or longer before being used in a lot (Stability data to support this hold time do not exist);
f. the filters used to harvest the vaccine were neither validated nor integrity tested prior to August, 1997;
g. validation of microbial retention by the filters was performed using inappropriate media, used for production of tetanus, not anthrax;
h. there is no validation of cleaning for the equipment which is in contact with the vaccine materials;
i. "there is no documentation of testing for container/closure integrity or container/closure compatibility for periods up to seven years."

2. Inadequate analytical methods:
a. the reference standard used for potency testing was from a lot produced in 1991;
b. "the analytical methods for determination of *** and *** in anthrax vaccine are not validated with respect to accuracy, precision, linearity, specificity and limit of detection;"
c. "potency testing of anthrax vaccine requires either testing one finished product vial, an aliquot from the formulated bulk tank, or a pilot bulk sample. There are no data demonstrating that these samples are representative of the lot."

3. Lack of written operating procedures:
a. for examination, rejection and disposition of anthrax sublots;
b. for redating expired vaccine to extend the expiration period; Example:  Lot FAV023 was tested twice for redating (presumably potency) and twice for stability in 1997 and failed all tests.  It was scheduled to be retested for redating on 4/21/98.
c. for time limits for which product can be exposed to room temperature;
d. "The firm's SOP (standard operating procedure) for handling manufacturing    deviations/departures does not address when a lot should be monitored on stability."

4. Inadequate testing procedures:
a.sublots are tested when produced, but not retested prior to formulation, which may occur several years later;
b. Test results are reported as "unsatisfactory" or "no test", indicating an invalid test, apparently in addition to frank "failed" results.   What do these results mean, and are lots with these designations used or retested?

5. Quarantined materials (what precisely is meant by quarantined? Failed testing?
a. These are held for extended periods; examples are given of a sublot quarantined in 1992 which was held, and only destroyed in 1997 due to mold contamination;
b. Other sublots failed potency tests but are still held in quarantine.

6. Expiration dates:
a. "expiration dates are assigned based on the latest valid potency test. There is no correlation between this date and formulation of bulk or filling of the finished product;"
b. expired vaccine lots are "redated", based only on another potency test. There is no analytic testing identifying and demonstrating the absence of degradants;
c. "there are no expiration dates for the working spore concentrations (virulent or avirulent strains)."

7. Labelling issues:
a. anthrax lots approved by CBER for redating are given alternate lot numbers to indicate they have been redated.  However, MBPI has used the original lot numbers for labelling, thus concealing the fact that the lot was "redated;"
b. "for anthrax vaccine lots #FAV008 through #FAV016, the firm unpacked the vials from the cartons and removed the labels...the firm does not have documentation of performing reconciliation of the vials before and after this operation."  [Does this mean the labels were removed and replaced with new labels and reused?  Why?]

8. Stability testing:
a. testing for stability only began in 1997;
b. "stability testing consists only of performing release tests at various intervals;" (What is a release test?)
c. stability testing does not address product degradation;
d. "there is no justification for putting lots manufactured as early as 1991 into the stability program;"
e. "the firm does not have a system in place to investigate and report stability failures."

9. Use of vaccine lots that failed testing.  Several examples:
a. lot FAV011 was filled on 10/17/91, redated in 1994, and again retested in 1997.   Its potency rating was 11 ppm, below the lower accepted limit, but the lot was not rejected nor placed in quarantine;
b. lot FAV023 was filled on 12/13/94.  It failed 3 potency tests in 1997, yet was retested for a 4th time in 10/97, where it was listed as passing by 0.01.  There was no investigation into the earlier results or justification for the additional testing;
c. "lot FAV016 had 6570 vials rejected due to particulates during post filling inspection.  These particulates were not identified, nor was an investigation conducted.  The batch was released;"
d. sublots AV383 and AV390 failed original sterility tests, but passed on repeat testing. It appears that such sublots were included in bulk lots.  Part of the report is missing here.

10. Sterility:
a. after harvest from the holding tank, including transfer of sublots to different buildings, samples were not placed on media "to validate aseptic manufacturing after harvest;"
b. "lot FAV035 had 409 vials rejected for faulty closure during post filling inspection; There was no investigation conducted."
c. When environmental monitoring indicates that environmental action limits are exceeded, the firm's procedures do not require that additional cleaning and increased sampling be performed.

11. Missing sections of the report:
a. my copy lacks part of section 9 until section 16; Sections 20 through 25 are completely whited out.  Elsewhere, many words and names are whited out as well.

 

Things you can do to force the government to accept
responsibility for the possible negative effects of the vaccine.

If you have less than 18 months remaining on active duty

--Insist on being exempted from the vaccine

--Failing that, insist the government sign a written agreement to incur all travel expenses required to give you the FULL 18 month vaccination series. The ONLY way the drug is FDA approved is if it is given according to the 18 month schedule.

- Insist the government provide a written statement of purpose for administering the vaccine.

- Insist your case be reviewed by a medical review board prior to being punished for "failure to obey a lawful written order."

- Consider objecting to the vaccine on religious grounds

- Insist the government sign a written statement acknowledging the drug has not been tested for its carcinogenic effects or potential impairment of fertility.

- Insist the government sign a written statement acknowledging the drug has not been tested for its ability to protect you from aerosolized (inhaled) anthrax exposure. (This is the primary reason DoD says you need the vaccine. In that respect, the vaccine is experimental since it’s ability to protect you has not been proven.)

- Insist the government sign a written statement agreeing to pay for all medical expenses relating to any future instance of cancer you may develop.

- Insist the government sign a written statement agreeing to pay for all medical expenses relating to any future instance of infertility you may experience.

- Write your Congressman or Senator.

--find your Congressman or Senator quickly at http://www.hoboes.com/html/Politics/electednet/

- Forward this to everyone you know in the military!

 

FDA Inspection Report on Michigan Biologic Products Institute

1999

 

________________________________________________________________________________________________________________________
Side-effects, Illness, and Fatalities

 

Quotes from the Anthrax Vaccine Product Insert (2002) on reactions and fatalities:

Approximately 6% of the reported events were listed as serious.  Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening.  The serious adverse events most frequently reported were in the following body system categories:  general disorders and administration site conditions, nervous system disorders, skin and subcutaneous tissue disorders, and musculoskeletal, connective tissue and bone disorders.  Anaphylaxis and/or other generalized hypersensitivity reactions, as well as serious local reactions, were reported to occur occasionally following administration of BioThrax.  None of these hypersensitivity reactions have been fatal. 

 Other infrequently reported serious adverse events that have occurred in persons who have received BioThrax have included:  cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barre Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulononephritis, renal failure, spontaneous abortion and liver abscess.   Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories:  fatigue, mood-cognition, musculoskeletal system.

 Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma (1).  [emphasis is mine] 

 The link to Bioport’s anthrax vaccine product insert from the year 2002 is http://www.protectingourguardians.org/docs/Package_Insert_2002.pdf

 [Please note that doctors and nurses have written to us here at Protecting Our Guardians that any reaction rate over 1% would necessitate taking the vaccine off the market, yet the anthrax vaccine with a documented reaction rate of 5-35% continues to be used.]

The FDA required Bioport to rewrite its product insert in 2002. There are forty side-effects (some deadly) and it is a category D drug.  Look at the new version of the product insert that Emergent BioSolutions (formerly called Bioport) has now created and compare the two for yourself. (http://www.protectingourguardians.org/docs/emergent_biosolutions_new_product_insert.pdf)

 Anthrax vaccine’s Contraindications Defy Common Sense

Anthrax vaccine product insert advises stopping the 6 shot regimen if contraindications (specifically any anaphylactic-like symptoms or Gullain-Barre Syndrome) occur.  Yet, other systemic adverse reactions are not allowed to stand as contraindications.  If the shots are making someone sick/systemic adverse reactions they should be allowed to stop the regimen before a permanent disability or another fatality occurs even when that particular symptomology is not one of the two contraindications listed on the product insert.  Where is the common sense?

 The Reaction Rate from the Tripler Army Medical Center Study

In 1998, 603 medical personnel at Tripler Army Medical Center filled out questionnaires about their reactions to the anthrax vaccine. Their systemic reaction rate to the anthrax vaccine was 48%, much higher than Bioport’s 5-35%.  According to Dr. Nass’ report to the FDA, entitled The safety and efficacy of anthrax vaccine have not been established, and the preponderance of the world’s literature shows the vaccine is unsafe, and a contributor to Gulf War Syndrome as acknowledged in the vaccine’s package insert , some serious reactions were reported.  One person developed Multiple Sclerosis.  Two people had neurological problems.  A neonatologist developed a tremor and upper extremity weakness associated with a CPK level that was over 1000.  A pediatric cardiologist developed numbness and fasciculations, indicative of brachial plexopathy, that later resolved.  Strangely, only 601 people were listed in the final published paper, not 603, as noted in the report by GAO (GAO/T-NSIAD-99-226).  It is also noteworthy that although eleven women became pregnant during the study, the outcome of these pregnancies was never mentioned. 

 This study is cited as: Wasserman, G, Grabenstein JD, et al. Analysis of adverse effects after AVA in US army medical personnel.  J Occ Envir Med 2003;45:222-233.

 UPI reports 10 deaths from vaccine

“United Press International reported that at least 10 people have died after receiving the vaccination,”  according to “Blocking the Shot:  A Federal Judge orders…”  by Eric Boehlert on Oct 29, 2004 http://www.salon.com/news/feature/2004/10/29/anthrax) (link not valid)

 FDA now links anthrax vaccine with 21 deaths

http://www.nti.org/d_newswire/issues/2005_11_21.html#B95427B4#B95427B4

Anthrax Vaccine Possibly Linked to 21 Deaths

Monday, November21, 2005 

“The existing anthrax vaccine could be linked to 21 deaths and more than 4,100 illnesses, Newsday reported yesterday.

Experts also questioned whether the vaccine now being stockpiled or those being developed could protect people who inhale the pathogen during a terrorist attack.

…”’The number of doses they are amassing is wildly out of proportion to any possible threat from anthrax,’ said David Ozonoff, a professor at the Boston University School of Public Health.  ‘What the benefits are is very unclear and there are always (health) risks… when you vaccinate a whole lot of people.’”

…A study led by the U.S. Army Medical Research Institute of Infectious Diseases in Maryland found the best results for treating monkeys exposed to anthrax came from using both the BioPort vaccine and antibiotics.  All monkeys that received both treatments following exposure survived.  Roughly 90 percent of monkeys survived if they received only the antibiotics, while only 20 percent of the monkeys that received only the vaccine lived.”

 Dr. Meryl Nass has treated servicemembers with anthrax related illnesses

Dr. Meryl Nass, physician in Maine who treats many service-members that have become ill from the anthrax vaccine, “estimates 10% of the recipients experience serious side-effects such as arthritis, neurological impairment, memory loss and migraine attacks states “Blocking the Shot:  A Federal Judge….” by Eric Boehlert on Oct. 29, 2004. Visit Dr. Nass’ website at www.anthraxvaccine.org

 Richard Dunn’s death attributed to anthrax vaccine

Richard “Dick” Dunn died on July 7, 2000 from “inflammation” due to the 11 anthrax vaccine shots he received, according to the medical examiner.  Richard worked with the lab animals at BioPort (the manufacturer of the anthrax vaccine) since 1992.  His wife, Barbara Dunn, testified before Congress Government Reform Committee on Oct. 3, 2000 (http://www.whale.to/v.dunn.html) (link not valid)

 Anne Spaith disabled from anthrax vaccine

Anne Spaith, a Microbiologist and former Department of Defense civilian employee who specialized in biological pathogens, became disabled after receiving what she characterized as the “extremely dangerous, forced” anthrax vaccine. 

 Barbara Loe Fisher, of the National Vaccine Information Center (NVIC), quotes:

“If we value individual human life, then as a society we’ll not place ourselves in the position of demanding risk-taking and sacrifice of a minority of individuals for the theoretical benefit of the majority, even if we have the power to force that sacrifice.”   

 “We must fund the research arm of FDA to fully study biological predispositions and mechanisms that lead to adverse reaction, vaccine injury and/or death.”

-- Barbara Loe Fisher at conference in Washington DC. 

Visit them at www.nvic.org

 

Connecticut atty general concerned about vaccine’s effect on guardsmen

“In 2001, Connecticut’s attorney general concerned the state might bear responsibility if its National Guardsmen got sick from the vaccine”, wrote the Department of Defense and the FDA urging them to abandon the program.  Asserts Eric Boehlert in “Blocking the Shot:  A  Federal Judge” on Oct. 29, 2004.

http://www.salon.com/news/feature/2004/10/29/anthrax

1970’s Vaccine Numbers versus 1990’s

In the 1970’s, people used to get 17 vaccines on average, but in the 1990’s that number is up to 76 vaccines.  There is great scientific debate going on about whether people’s immune systems can handle it or not.

Anthrax health registry

Look at the anthrax vaccine adverse reaction health registry at www.milvacs.org

Anthrax insert

Here is an excerpt from the anthrax vaccine package insert :  Across these studies, systemic reactions were reported in 5 – 35% of the vaccine and included reports of malaise, chills, rashes, headaches, and low-grade fever.  [most vaccines have an adverse reaction rate around 2%] 

News articles on reactions and fatalities:

Special operations sergeant reprimanded for going to surgeon at DAFB

By LEE WILLIAMS / The News Journal

10/31/2004

article reprinted from:  http://poisonevercure.150m.com/anthrax1.htm

DOVER -- Jason Adkins is a hero.

On May 13, 2003, the technical sergeant was on the first C-5 flown into Baghdad. The aircraft and the runway were blacked-out. Adkins, the pilots and the crew wore night-vision goggles, casting a green tint on the gunfire that filled the skyline.

His next mission was even worse.

On Jan. 8, 2004, after another C-5 had an engine shredded by a surface-to-air missile, Adkins was picked to help fly the crippled aircraft out of Baghdad on its three remaining engines - a bold feat even airworthiness experts didn't know was possible with a 374,000-pound aircraft.

"We knew if [the plane] took another missile, we'd be riding it into the dirt," he said. 

C-5s don't have ejection systems or parachutes for pilots or crew.

Adkins and the entire crew were recommended, and are still in line, for the Distinguished Flying Cross, one of the nation's highest awards for bravery.

Now, despite medals, special operations missions and an unblemished service record spanning 14 years, Adkins says commanders at Dover are making an example of him because he complained about his medical issues linked to the anthrax vaccine. Adkins believes he's being punished to send a warning to other personnel that they shouldn't call attention to the most controversial issue to hit the base since the Vietnam War. 

Adkins' former commander, retired Col. Felix Grieder, is enraged that an airman of Adkins' abilities is being singled out for speaking the truth.

"Sgt. Adkins flew two of Dover's highest-profile special operations missions into a war zone and performed exceedingly well," said Grieder, who commanded the 4,000 troops at Dover Air Force Base from 1997 to 1999. "Only Dover's very best fliers are selected for the special operations missions. Since their missions are classified, their accomplishments are not widely known. Sgt. Adkins has served our country and the Air Force well. Now, the Air Force needs to properly address his health issues and treat him with the respect that he deserves."

Base officials declined to comment about Adkins' situation or the uproar the vaccinations have caused at Dover.

 

Safety of flight

PRIVATE "TYPE=PICT;ALT=wpe7F.jpg (8602 bytes)"

Adkins arrived at Dover in 1998. It was the fifth duty assignment for the Alabama native.

He has started a part-time landscaping business out of his home in Smyrna, and he and his family are very involved in their church. Adkins plans to retire in Delaware some day.

"It feels like home to us," he said. "We love our church family and what we've made here."

Adkins got to Dover just as the anthrax vaccination program was taking off.

Six of his eight anthrax vaccinations were tainted with squalene, a fat-like substance linked to autoimmune disorders.

Adkins suffers memory loss, muscle and joint pain, an occasional racing heartbeat, weight loss and severe migraines, all of which he blames on the anthrax vaccine.

Once an avid powerlifter, Adkins weighed 252 pounds and could bench press 425 pounds before he received his first anthrax vaccination.

"I used to own the gym," he recalled.

Now, he weighs 200 pounds and struggles to bench press his own weight.

"I can't work out anymore because of the joint pain," he said.

On Oct. 22, after he was hit by a "crippling" migraine, Adkins told his squadron he was reporting to the flight surgeon rather than flying a mission.

He didn't want his illness to endanger his crew.

Air Force policy clearly dictates that sick personnel should not fly.

Even during a flight, if crew members become ill or overly tired, they are encouraged to declare "safety of flight," at which point they are relieved of their duties - no questions asked - without any fear of discipline or repercussions.

Adkins didn't mention the link between his migraines and the anthrax vaccine to the medical staff, but he didn't need to.

"Severe headaches," euphemisms for migraines, are cause for grounding of pilots and crew. And like "joint pain," headaches have become buzzwords at Dover for personnel suffering adverse reactions to the anthrax vaccine.

The flight surgeon prescribed Immotrex, an antimigraine medication, for Adkins' headaches and a narcotic pain reliever that grounded him for 20 days.

Because The News Journal has in the past month brought heightened awareness to the anthrax controversy, Adkins believes the response from his chain of command was immediate and unprecedented at Dover.

The chief flight engineer issued Adkins a letter of reprimand (LOR), a potential career-killer for an Air Force sergeant. Adkins' military lawyer says the LOR could bar Adkins from further promotion, access to specialty schools, choice assignments or possibly even re-enlistment.

"Your actions decreased the readiness of a high priority alert mission, caused last minute schedule disruptions and could have resulted in loss of training or inability of DoD assets to execute the mission," the letter states.

In addition to the written reprimand, issued contrary to the Air Force's policy of progressive discipline, which generally dictates a verbal warning followed by punishment that increases in severity, Adkins received 76 hours of additional duty. That forces him to do nothing while sitting next to another flight engineer in the base's control room - "on display" to every airman who walks by.

"They're making an example of me because I complained about the migraines," he said. "They associate that with the anthrax. They're scared of losing control."

Adkins can't appeal the reprimand, he can only write a response.

He went to Capt. Josh Slomich, an Air Force lawyer, for help.

Slomich has seen hundreds of letters of reprimand during his time at the air base, but few like Adkins'.

"This is a pretty bad one," he said.

The letter, Slomich said, is undeserved and unfair based on the facts.

"It's very unusual and strange he was given an LOR for going on sick call," he said.

Slomich and one of Adkins' former supervisors confirmed Adkins has never before been disciplined by the Air Force.

Adkins flew with Master Sgt. Dexter Joseph, the chief special operations flight engineer, on the mission out of Baghdad. The two later became close friends.

"We flew together all the time. We were on the same crew," Joseph said. "I trusted him with my life then. I trust him with my life now."

One former pilot said the reprimand will have far-reaching effects.

Retired Lt. Col. Jay Lacklen is a former Dover C-5 pilot who blames his advanced arthritis on the six squalene-tainted anthrax vaccinations he received at the base.

"By reprimanding Sgt. Adkins, Dover commanders are encroaching on a sacred safety principle established by generations of military fliers. When a crew member declares a safety of flight, he should never be challenged on that call, if valid," Lacklen said. "To do otherwise would intimidate crews into flying with unsafe medical conditions to avoid punishment. This would endanger the crew, the aircraft and the mission. This is a gravely unwise sanction for a flight engineer who did exactly as he should have."

Lacklen has spearheaded a public information campaign about the anthrax vaccination program and has interviewed scores of fliers with adverse reactions. But even Lacklen had never heard of a flier disciplined for going to sick call rather than the flight line.

"Apparently, the Air Force is reprimanding him for yielding to a condition they inflicted on him, a most unjust procedure that blames the victim for the crime," Lacklen said.

 

Bunker mentality

Personnel at Dover Air Force Base don't discuss their anthrax vaccinations openly.

"It's hush-hush," Adkins said. "We have to go behind closed doors. It's hardly even brought up."

Dover Air Force Base has become ground zero for the anthrax controversy. Problems began at Dover in May 1999 after some troops in their 20s and 30s began developing illnesses normally associated with old age.

Adkins was one of them.

"Sgt. Adkins has experienced a significant decline in his health since he started with the anthrax vaccination program at Dover Air Force Base in late 1998," Grieder said.

Grieder, who was then commander, halted the vaccination program, a move he said brought an end to his military career.

His decision thrust Dover into the national spotlight.

Testing by the Food and Drug Administration detected squalene in varying amounts in the vaccine administered at Dover. The substance was detected in all the vaccine sent to Dover, but not in vaccine sent to other military installations.

The Air Force and the Department of Defense have continually stressed the safety of the vaccine, despite the claims of scores of military personnel who say it made them ill.

On Wednesday, a federal judge in Washington, D.C., ordered the Pentagon to halt the mandatory anthrax vaccination program.

U.S. District Court Judge Emmet G. Sullivan issued the order, calling the program "illegal." Sullivan did not rule on whether the vaccine was dangerous, but he chided federal officials for not accepting enough public input before they declared the vaccine safe.

Adkins, Lacklen and others say the combination of national events and scrutiny from The News Journal has created immense pressure for senior officers at the air base.

"Dover commanders are unjustly shooting this anthrax messenger, Sgt. Adkins, to ensure there will be no more messengers," Lacklen said. "This reveals an integrity collapse at Dover Air Force Base."

Neither Col. John Pray Jr., Dover's commander, nor Command Chief Master Sgt. Stephen Maynard, the base's senior sergeant, returned calls or e-mails seeking comment for this story.

Dover Air Force Base is subordinate to the Air Mobility Command, located at Scott Air Force Base in Illinois.

Air Force Gen. John Handy, commander of Air Mobility Command, was unavailable for comment.

His spokesman, Mark Voorhis, said the safety and health of Air Force personnel are top priorities for Air Force leaders at all levels.

Voorhis hinted that Dover commanders may have gone too far in Adkins' case, though he declined to address it specifically, citing privacy concerns.

"It is not policy at any level to punish people for reporting to sick call," he said.

Despite the possible violation of Air Force policy, Voorhis said, "Wing and squadron commanders have the confidence of their senior leaders in their ability to effectively discharge command responsibilities at their levels."

On Thursday afternoon, after The News Journal started investigating Adkins' story - and after Voorhis made inquiries for his boss, a four-star general - the commanders at Dover intervened.

Adkins' entire squadron was recalled to the base for an unannounced meeting.

"Since I'm still grounded for the headaches, they told me I didn't need to attend," Adkins said. "They wouldn't tell me what it was about."

The pilots and crews were ordered to go through the base's public affairs chief, Maj. Cheryl Law, before talking to the media. They also were ordered to avoid talking about the anthrax vaccination program, and they were told they would be held accountable for what they say.

Law refused to disclose why the squadron was recalled, or on whose order the recall took place, or specifically what the personnel were told.

Lacklen pointed out that requiring the troops to go through public affairs does not deny them access to the media, but it does force them to publicly identify themselves before talking to reporters.

Structurally, they are filtering the soldiers' right to free speech, he said.

"It's something they may properly do to protect secrets," he said. "But they are doing it here to cover embarrassing information.

"Ominously, they apparently must warn their members not to tell the truth. The troops know nothing classified about the anthrax program, so speaking about it to the media shouldn't be a problem, but apparently it is," Lacklen said.  

 

Ready to move on

Adkins does not want to remain in the Air Force, and he will never again take another anthrax shot.

"I feel like I've been deceived and misled," he said. "The whole program has caused a lot of harm to a lot of people who are putting their lives on the line for this country. I am really thankful to Col. Grieder for having the courage to step forward when no one else would.

"If someone is suffering symptoms like mine, they need to come forward, because if you're suffering now, it's only going to get worse." 

Contact investigative reporter Lee Williams at 324-2362 or lwilliams@delawareonline.com.

 

Military Vaccine Flattens GI, 17

MONTEREY, Tenn., March 1, 2004


(CBS) Amid all the war stories that have come out of the conflict with Iraq, Tyran Duncan's hasn't been widely told. The willing soldier became an unwitting victim to the vaccinations he was required to take to deploy. And as CBS News Correspondent Sharyl Attkisson reports, he's not the only one.

Tyran Duncan was just 17 - Number "45" at Monterey High in Tennessee - when he signed up for the Army.

"I was excited," says Duncan. "I mean it's always been my lifelong dream to go into the military and, you know, be a soldier."

At boot camp, he eagerly lined up for vaccinations, including flu and anthrax.

"They gave us, I'd say, seven shots … at one time," he says.

First he got a rash, then flu symptoms.

"It got to where I couldn't walk at all," he says. "I couldn't even hold my glass up with both hands to take a drink out of it.

"Basically they accused me of faking it."

But Duncan wasn't faking. Within days, he was paralyzed, on a respirator and certain he'd die, until his grandmother who raised him came to help.

"There was nothing wrong with him when they got him," says Duncan's grandmother Faye Harville. "It had to be the vaccines. I'll never see it another way."

Rehabilitation video chronicles his difficult fight back. At one point last January, he weighed 96 pounds.

Months after his paralysis hit, he was finally back at home, but he still couldn't feed himself or put on his shoes.

Today, he remains unsteady, and muscle and joint pain are constant companions.

Duncan's paralysis was diagnosed as Guillain-Barre Syndrome, which is clearly listed under "adverse reactions" on the anthrax vaccine label.

But soldiers don't get to see that vaccine label when they get their shots. And the Pentagon publicly claims there are no long-term adverse events from the anthrax vaccine. So soldiers may end up misdiagnosed, then discharged with serious illnesses.


 

2. http://www.cbsnews.com/stories/2003/08/21/eveningnews/main569522.shtml

(excerpt)

Military Mute On Vaccine Danger?

WASHINGTON, Aug. 21, 2003


(CBS) A half million U.S. soldiers were inoculated for the war with Iraq. Some of them got sick after their vaccinations. Whether the vaccines were to blame remains an open question because, as CBS News Correspondent Sharyl Attkisson reports, the military may not be reporting all the cases properly.

When Army Reservist Rachael Lacy got her military shots last spring, she became deathly ill in a matter of weeks.

The coroner listed "recent smallpox and anthrax vaccination(s)" as contributors to her death.

Yet the military doesn't mention Lacy under "Noteworthy Adverse Events" in an article in the Journal of the American Medical Association touting its smallpox vaccine success. It claims no deaths.

It also makes no mention of a cluster of unexplained pneumonia cases that were beginning to surface. The military says it's investigating the pneumonia reports along with federal health officials.

But experts tell CBS News the military should have reported them as possible post-vaccine illnesses.

In the medical world, illnesses and deaths after inoculations - even if they're not obviously related to the vaccines - are supposed to be reported so experts can look for new side effects nobody knew about. But there are questions as to whether the military is coming clean about all the adverse events.

"You have to report everything," says Dr. Meryl Nass.

Nass, a civilian doctor, treats soldiers who think vaccines made them ill and who claim the military won't admit or report it.

Besides Lacy, the military also discounted the death of a National Guardsman who had a heart attack and NBC correspondent David Bloom who died of a blood clot after getting military shots for his war duties. It doesn't mean vaccines caused the deaths, but they're supposed to be reported and independently checked for patterns.

Yet, the Defense Department told CBS News it only reports deaths if its own clinicians conclude they're vaccine-related.

"Nobody who collects adverse event reports does that kind of filtering," says Nass.

 

3. http://www.prisonplanet.com/101303vaccines.html

Military Vaccine Woes Mount
(excerpt)
CBS News

(CBS) Dennis Drew was prepared to fight the enemy in Iraq, but never got the chance. After his military vaccinations, his immune system completely unraveled.

"Severe pneumonia and myocarditis, I think almost killed me," said Drew, a U.S. Army chemical weapons specialist.

Now living in constant pain, daily life is almost unbearable. His illnesses are nearly identical to those suffered by Rachel Lacy before she died last spring. The coroner said her military shots were likely to blame.

It's estimated thousands of soldiers claim serious illnesses from military vaccines. But to them, the most maddening thing is they don't exist -- at least in the eyes of top military brass -- who insist there is, quote, "no evidence, none whatsoever" that inoculations cause any long-term problems, reports CBS News Correspondent Sharyl Attkisson.

That includes blood clots.

The military denied any possible link to vaccines when NBC War Correspondent David Bloom died at age 39 of an apparent blood clot after his military shots.

Yet a CBS News investigation has uncovered more than a dozen cases of the vaccines being linked to blood clot problems.

 

4. http://www.cbsnews.com/stories/2003/06/19/eveningnews/printable559426.shtml

(excerpt)

Questions Mount Over Anthrax Shot

WASHINGTON, June 20, 2003


(CBS) Kamila Iwanowska is the latest soldier to get kicked out of the U.S. military for refusing the anthrax vaccine, CBS News Correspondent Sharyl Attkisson reports.

"It's not about defiance and it's not about being a bad soldier, because it's not," says Iwanowska, a former Army reservist, who received a bad conduct discharge.

She says it's about her belief that the anthrax vaccine could be dangerous. Since it became mandatory five years ago, hundreds of troops have been disciplined or booted out for rejecting it, and dozens of others have been court-martialed.

"If I knew then what I know now, I would have refused to take the vaccine," said Jason Nietupski, a former U.S. Army captain who got seriously ill after his shot in 2000.

"I developed blood clots in my legs," Nietupski says. "They found pulmonary nodules in my lungs."

But even when the Army finally documented that the vaccine was to blame, Nietupski says no one reported his case to the FDA, which tracks adverse events.

"There's a lot of people like me out there because doctors in the military are fearful of reporting adverse events to the Food and Drug Administration because of potentially being reprimanded for doing so," he says.

In fact, a General Accounting Office investigation last fall found that the rate of side effects from anthrax vaccine was hundreds, sometimes thousands of times higher than what the military claimed.

The Defense Department says it now encourages more accurate reporting of adverse events. But the latest numbers the military provided CBS News still fall short:

Among 600,000 people who got anthrax shots in the past year, possible side effects are reported by the military in only a fraction of one percent: .142 percent or 852 reports per 600,000 people. The GAO investigation released last fall found a much higher rate in a survey of vaccines: 85 percent, with side effects ranging from lumps and rashes to hospitalizations.

Dr. Bill Winkenwerder, the assistant secretary of defense for health affairs, oversees military vaccines and says he urges all problems to be reported.

He says it's "just not true" that the military hasn't provided the whole story as to how many people are getting sick from anthrax vaccines.

"We've been very forthcoming," Winkenwerder says. "There'd be no reason to be anything else other than that. Our personnel are our most important assets."

 

Article claims troops used as guinea pigs

Oct. 10, 2004 in The News Journal

http://www.delawareonline.com/newsjournal/local/2004/10/10exdafbcommander.html. 

Ex-DAFB Commander says troops used as guinea pigs (excerpts from article)

by Lee Williams and Hiran Ratnayake

After some of his troops in their 20s and 30s began developing arthritis, neurological problems, memory loss and incapacitation migraine headaches, Col. Felix Grieder took a drastic stop.  In 1999, he halted the vaccination program in Dover, a move he said ended his military career.  The decorated Air Force colonel has spent the past five years trying to discover the truth about the vaccine program in Dover, where he commanded 4000 troops.

“In my opinion, there was illegal medical experimentation going on,”  says Grieder, who lives in Texas.

In a March 1999 report, the General Accounting Office accused the defense Department of a “pattern of deception” and said the military confirmed human tests involving squalene only after investigators found out about them.

Of the first 50 batches of vaccine distributed worldwide for the mandatory inoculations, only five contained squalene – and those were all shipped to Dover.  After denying for more than a year that there was squalene in the vaccinations given at Dover, the Air Force admitted in 2000 that it had been wrong. 

The five batches of vaccine sent to Dover contained increasing concentrations of squalene, Food and Drug Administration tests show.  Some scientists say the pattern of squalene concentration could indicate that the military was measuring the troops’ response to different dosages.  Professor Dave smith, a microbiologist at the University of Delaware, is one:  “I’m certainly not saying they did or didn’t do it.  But you have to ask yourself, if you have five data points like that, what are the odds of that happening?”

An estimated 1.9 million service members have received anthrax vaccine.  Experts disagree widely over how may of them have experienced ill effects from the vaccine.   Estimates range from 0.007 percent, or 13,000 people, by the Air Force to 84 percent, or 1.6 million people, by the GAO.

In Feb. 2003, doctors at Walter Reed Army Medical Center wrote in a medical assessment of Senior Airman Daniel Tam of Dover:  “We have recently encountered numerous service members who have precipitation and exacerbation of headache syndromes with concomitatnt receipt of the anthrax vaccine.  The immunopathogenic mechanism has yet to be established.

Military personnel said they were afraid they could face a court-martial for speaking publicly because it would violate an order to keep silent.  Former military personnel, many of whom have taken jobs with commercial airlines, said they could lose their jobs if the extent of their illnesses became known. 

Some civilian experts say squalene suppresses the immune system so that people predisposed to specific illnesses can get sick years earlier than normal.  Some young troops have reported illnesses usually seen by people in their 60’s and 70’s. 

Ten months after the briefing, the Army applied for a patent for a new way to make anthrax vaccine with squalene as an ingredient.  The patent was granted two years later.  Smith, the UD microbiologist, reviewed the patent application for The News Journal and noted that squalene was a component.  The purpose of the squalene was not explained in the patent. 

In October 2000, the FDA announced it had found squalene in all five batches of vaccine sent to Dover – the lots Roadman said were safe. 

Despite the official denials, some military physicians have concluded that the Dover vaccine harmed some servicemen and servicewomen

The medical records of a Dover pilot, who feared for his career if his name was used in this story, show that several military physicians linked his advanced arthritis to the vaccine.

“The symptoms began after anthrax immunization, and are in the line of duty,” the records say. The pilot’s records also reveal the presence of an antigen associated with autoimmune disorders.

The symptoms included memory impairment, dizziness, ringing in the ears, joint pain, muscle pain, numbness in various parts of the body, miscarriage, cardiac problems, swollen testicles, hypothyroidism, chills, fever, rashes, photosensitivity and constant fatigue.

Sens. Joe Biden and Tom Carper and Rep. Mike Castle, all of Delaware, would not comment about Col. Grieder’s allegations.  Through their respective spokespersons, they said they didn’t know enough about Grieder’s claims. 

Metcalf’s report cites Defense Department “stonewalling” and characterizations from GAO investigators that accused the Defense Department of instituting “a pattern of deception.”

The GAO investigators reported a reluctance by the Defense Department to admit it had conducted five clinical trials with squalene, and had plans for one more.

“In fact, in most cases they only admitted to conducting research after we had discovered it in public records,”  Metcalf’s report states.  “On three occasions people attending the conference did not report their own research with squalene adjuvants.” 

Metalf and the GAO found that the Defense Department experimented with adjuvants “to use fewer inoculations, get a better response and to check unconquered antigens.”

Many of the military personnel interviewed for this story said they were forced to choose between their health and their career.  Cave said the likelihood of military punishment is significant for those who refuse vaccination.  “I have to advise them it’s in their best interests to take it.”

 

from www.delawareonline.com/newsjournal/opinion/view/10102004a.html  

Biden, Carper and Castle can’t ignore anthrax problems

(excerpts)

There are conflicting opinions about whether anthrax vaccinations are safe.  But there can be no debate that anthrax containing squalene, even in trace amounts, is potentially harmful.  And, as the story by Lee Williams and Hairan Ratnayake on the front page of today’s Sunday News Journal clearly delineates, the anthrax vaccination program at Dover Air Force Base went terribly wrong for awhile.  As a result, many people have been left with serious lingering medical problems such as arthritis, migraine headaches, neurological problems and memory loss. Some of those vaccinated are severely incapacitated.

Many people are becoming seriously ill after taking the mandatory anthrax vaccine, but the DOD does nothing to investigate or prevent this occurrence.  It has the appearance of caring more about its 112-130 million dollar contract and investments than about its people, which should be remedied before morale suffers further.  Meanwhile Congress seems divided on the issue and no proactive results are forthcoming.

 

Soldiers’ stories:  Pain and Punishment

by Lee Williams and James Merriwether

10/10/2004

www.delawareonline.com/newsjournal/local/2004/10/10soldiersstories.html  

Summary:  “The News Journal interviewed dozens of active-duty and retired pilots and crews, most of whom were afraid to speak out publicly.  Those still in the service feared military punishment, since they believe they have been ordered not to discuss their experiences with news media.  Many of those no longer on active duty fear their current employment, often with commercial aviation companies, could be threatened if the extent of their illnesses became known.  A few agreed to tell their stories to the news Journal, provided their names were not used.  The newspaper reviewed relevant military and medical records of people not identified.”

Excerpts:

“A Dover pilot with no family history of arthritis contracted the disease in his mid-30’s, after taking only two anthrax vaccines.”

“More worrisome is a brief notation in the pilot’s records that indicate the presence of an antigen associated with autoimmune disorder, which can suppress the immune system and cause AIDS – like symptoms.  

“Like most of the personnel at Dover, he was never told of the risks associated with the vaccine, and he was used to taking orders. 

“Another Dover pilot may refuse to submit to more anthrax vaccinations – a step that could lead to a court-martial, dishonorable discharge or military prison.”

“One senior pilot at Dover was sent to Spain after he refused to take the shot.  At that time, Air Force personnel in Spain were not required to take the anthrax vaccine.” 

“Other personnel who could prove an illness received a medical waiver.”

“The Air Force could court-martial someone for refusing a lawful order, and the Air Force already has determined that the vaccination order is lawful.”

“Senior Airman Danny Tam describes his home as a depressing bat cave.”  He is considered 100% disabled by the VA, and normal room lighting triggers the severe headaches. 

“Tam deployed to Saudi Arabia in October 2002, before the start of the war in Iraq.  However, his medical records stayed behind in Dover.  When Tam arrived in Saudi Arabia, he was ordered to take the shot.  Tam refused and was threatened with a dishonorable discharge.  He persuaded his commander to allow him to try taking one-third of a normal dose.  As Tam feared, the migraines were triggered again.  Despite this, he was ordered to take the rest of the vaccine, but instead of the two-thirds he had coming, he got a full dose.  The migraines returned on a daily basis.  Tam spent a year on convalescent leave, until he was medically retired last January.”

“Tech. Sgt. Jeffrey L. Moore, a reservist with the 512th Airlift Wing at Dover Air Force Base, received a first anthrax shot on July 27, 1999.  Four days later, his hands started aching severely, and by the first of September, his feet were aching, too.  Then it progressed to dizzy spells and memory loss and such as that, said Moore, who compiled 5,000 flying hours as a C-05 Galaxy loadmaster before being grounded because of the symptoms.” 

Moore has a permanent waiver from taking any more shots, and feels that he was lucky because he knew what to do and how to stop the shots. 

“Cheryl Angerer, a C-5 Galaxy pilot, took just one anthrax shot, but she says that was enough to trigger neurological problems that landed her in the Walter Reed Army Medical Center, in suburban Washington, D.C. “ 

She also received a waiver that lasted a year, but it expired.  She left the military but would like to still be flying, the shot requirement is what has kept her from going back.

 

Careers cut short after inoculations

By Lee Williams
The News Journal
10/10/2004

www.delawareonline.com/newsfournal/local/2004/10/10careerscutshort.html  

“Even before squalene was discovered in the anthrax vaccine administered at Dover Air Force Base, the vaccine was suspected as a cause of health problems.  Dozens of Web sites and support groups are dedicated to linking autoimmune disorders to the shot.  The vaccine has been the subject of several scientific studies that conclude it could be a factor in making soldiers sick.  Department of Defense officials say the vaccine is safe, with or without squalene.  Thousands of troops have taken the vaccine with no ill effects.  The military says it is normal for a small number of people to have a bad reaction to any vaccine.  Despite such assertions, military personnel continue to report problems after taking the vaccine, even when squalene is not known to be present.  Troops have reported a range of symptoms from minor irritation at the injection site to chills and fever to severe arthritis.” 

Layne Hill is a former pilot who is now 100% disabled.  He was diagnosed with lesions on his brain after receiving his first anthrax vaccinations while stationed at Yokota Air Force Base in Japan.  

“Victims of vaccine” reports anthrax vaccine unsafe:

Exposes 3 deaths of young, healthy service members from anthrax vaccine:  helicopter pilot Erik Nilson, army cook Sandra Larson, and Army reservist Rachel Lacy. 
 

N.C. troops say military program is unsafe

http://www.charlotte.com/mld/charlotte/9763416.htm?1c

ELIZABETH LELAND
Charlotte Observer 

Sun, Sep. 26, 2004

Two days after a military nurse injected Lavester Brown with the anthrax vaccine at Pope Air Force Base near Fayetteville, his heart failed.

Brown was 34, an avid athlete, career military. Doctors had warned him to avoid vaccinations, he said, because of a reaction to a malaria drug in the early '90s. But when Brown told superiors, he said, they warned he could be kicked out of the military if he didn't get vaccinated for anthrax.

Brown was afraid: of the vaccine, of losing his job. He had a wife and four young children to support "I kept telling them, `I can't take the shot.' "

The vaccination is mandatory, part of the military's war on terrorism. Brown had been in the Air Force 14 years and was trained to follow orders. So when a commander, a major, a captain and a first sergeant all ordered him to be vaccinated, Brown, a technical sergeant, rolled up his sleeve and took the jab.

He is now awaiting a heart transplant.

Thousands of soldiers have suffered unexplained illnesses after getting the anthrax vaccine, ranging from muscle aches to death. The federal Food and Drug Administration says the vaccine has no more side effects than other vaccines, but cases like Lavester Brown's raise troubling questions:

Is the vaccination safe?

Should the military require troops to take it?

There was concern about the anthrax vaccine long before the threat of global terrorism.

In the 1990s, the FDA found problems with quality control procedures at the only U.S. company that makes the vaccine, then owned by the state of Michigan. The FDA warned that if the problems were not corrected, the company could lose its license. The state halted production in 1998 and began renovations, then sold the plant to BioPort.

After terrorists hijacked planes on Sept. 11, 2001, and anthrax-laced letters killed five people and infected at least 13 others, demand for a vaccine erupted. In January 2002, the FDA gave BioPort approval to distribute its vaccine to the military.

The FDA and the Department of Defense and BioPort all say the vaccine is safe. A vocal group of current and former military personnel, doctors and members of Congress claims it is not. Three lawsuits challenging the vaccine are now in federal court.

To the emergency room

Brown knew nothing of the controversy on Friday, Feb. 27, when he got the fourth in a series of six anthrax shots.  He rarely got sick, not even a cold. He didn't drink. He didn't smoke. He stood 5 feet 11 1/2 inches and weighed 207 pounds, but so much was muscle, he looked lean.

The day after the fourth anthrax shot, Saturday morning, he played basketball at the gym as usual but quickly tired. He went to the emergency room that night, he said, and a military doctor diagnosed a gastrointestinal infection.

By Sunday, he felt as if his body was filling up with fluid. The muscles in his neck throbbed and bulged. He had trouble breathing. Back at the emergency room that night, he said, a doctor again diagnosed gastrointestinal infection.

Something else is happening, Brown remembers saying. I can't breathe.  He said his wife, Ebony, insisted on X-rays. "When they looked at the X-rays," Brown recalled, "the doctor got this look on his face. I knew something was terribly wrong."

Brown said his heart was so enlarged, it had almost stopped pumping. He now takes medication to keep it beating until a transplant becomes available. He has dropped to 151 pounds, and walking only a few feet exhausts him. Friday, he was medically retired from the Air Force.

Before he got sick, Brown sometimes worked two jobs to provide for Ebony and their four children, ages 5 to 12. Now Ebony works and the children help care for him, and that's been a tough transition.

"I wish we had done our homework before Lavester got in line (for the vaccine)," Ebony said. "We trusted the military."

Mandatory shots

Until recently, anthrax had been considered primarily a livestock disease. People can be infected in three ways -- through skin contact, by eating infected meat or by breathing airborne spores -- but it's rare.

The military became convinced that Iraq had developed biological weapons, including anthrax, and might pack its Scud missiles with the deadly bacteria. Nearly everyone who inhales anthrax dies if not treated.

In 1998, the Defense Department made vaccinations mandatory.

Since then, about 1.2 million military personnel have received the vaccine, six doses over 18 months, followed by yearly boosters. (Several hundred thousand, a Pentagon spokesman said, got the vaccine during the 1991 Persian Gulf War.)

Out of 4.7 million doses given since 1998, the government says it has received 3,817 reports of adverse reactions, from headache, fatigue and fever to cancer, cardiac arrest and autoimmune diseases. The reaction rate, the government says, is about the same as for other adult vaccinations.

Studies have reached conflicting conclusions.

The Pentagon cites a 2002 report by the Institute of Medicine, a private, nonprofit scientific group, that said a better vaccine is needed, but that the current vaccine is "acceptably safe and effective."

Other studies link the anthrax vaccine to Gulf War illness, a medically unexplained fatigue suffered by veterans of the first Gulf War. One study found more adverse reactions to the anthrax vaccine than to other vaccines, and urged doctors to report all reactions so the scope of the problem could be determined.

Many cases, critics say, still go unreported.

Dead at 29

Christine Nilson, who lives in Wilmington, hadn't heard about the controversy over the anthrax vaccine until after her husband, Erik, died.  Now she's convinced it killed him.

Erik Nilson flew CH-46 helicopters for the Marine Corps and was vaccinated twice, before two separate six-month deployments to the Mediterranean.

Soon after he came home for the second time, in October 2001, Christine noticed the whites of his eyes had yellowed. Doctors at Walter Reed Army Medical Center in Washington discovered bile duct cancer, a slow-moving, usually fatal cancer that most often attacks people over 60.

Nilson was 29 and had a 2-year-old son, Luke.

He was, Christine said, "a man's man," who loved hunting, fishing and the Marines. He had had a rough childhood, she said, and often told her he wanted nothing more than to be a good father.

Six months after the cancer was discovered, Erik Nilson died.

Christine Nilson said no one from the military ever mentioned a possible connection with the anthrax vaccine. The national Vaccine Adverse Events Reporting System has no record of Nilson's death.

But the more Christine Nilson read, the more she believed there was a connection.  "There is," she said, "no other explanation for it."

Rapid-acting diseases

Other service members have died of rapid-acting diseases after getting the vaccine, including Army cook Sandra Larson of Kansas. Four weeks after her sixth anthrax shot, she was diagnosed with aplastic anemia, a rare disorder resulting from failure of bone marrow to produce blood cells.

She died two months later. She was 32.

The package insert on the vaccine, approved by the FDA in 2002, cites her death and the deaths of five other vaccinated military members. But a panel of civilian doctors concluded that none of the deaths was related to the vaccine.

The Pentagon has linked only one death to the vaccine: Rachel Lacy, a 22-year-old Army reservist, who died in April 2003 of a pneumonia-like illness after receiving five vaccines, including anthrax. The Pentagon said the vaccines may have triggered the illness that led to her death, but that "the evidence was not conclusive."

Critics say the government is stonewalling the way it did with the herbicide Agent Orange in the Vietnam War and with Gulf War illness.

"The first thing they do is fight, deny, obfuscate ...," said Steve Robinson, executive director of the National Gulf War Resource Center, an advocacy group for veterans. "Meanwhile people are getting sick."

About 10,000 Vietnam veterans receive disability benefits because of exposure to Agent Orange, and tens of thousands of others suffer illnesses. An estimated 100,000 Gulf War veterans suffer a range of symptoms, including memory and thinking problems, fatigue, joint pain, depression, anxiety, insomnia, headaches and rashes.

No proof, no medical help

Robinson said he has spoken with hundreds of veterans who said they had adverse reactions to the anthrax vaccine, but they can't prove it and are not getting the medical help they need. They complain of chronic fatigue, bone and muscle pain, migraine headaches, short-term memory loss and cognitive impairment."While anthrax is a threat," Robinson said, "the American public, much less the military, should not be given an inferior vaccine."

Forced vaccinations

In federal court, two lawsuits are pending against BioPort, a third against the Food and Drug Administration, the Defense Department and the Department of Health and Human Services.

The lawsuits challenge whether the vaccine is safe, effective, even necessary.  On Dec. 22, 2003, U.S. District Judge Emmet Sullivan in Washington, D.C., blocked the Pentagon from forcing soldiers to get vaccinated. He ruled that the FDA had never approved the vaccine for use against inhaled anthrax. The military, he said, could not make troops "serve as guinea pigs for experimental drugs."  Eight days later, the FDA approved the vaccine against inhaled anthrax.

Although Sullivan called the timing of the order "highly suspicious," he lifted his injunction.  The military once again ordered vaccination.

Refusal, court-martial

As many as 500 active-duty personnel have been dismissed from the military for refusing vaccination, according to congressional testimony. At least 100 have been court-martialed.Tom Kaufmann, an airman first class at Seymour Johnson Air Force Base in Goldsboro, refused to be vaccinated in December 2002.

He had read about problems at the manufacturing plant, he said, as well as about illnesses among people who got the vaccine.  Kaufmann, now 22, was demoted, then discharged under "conditions other than honorable."

"My first sergeant repeatedly called me a coward, saying I was afraid of war, afraid of serving my country," Kaufmann recalled. "I told them that I wanted to deploy. I wasn't against the war."  He was, he said, only against the vaccine.

Anthrax comes from the Greek word for "coal" because infected skin forms ugly black lesions.

The rod-like bacteria were discovered in the 19th century. Louis Pasteur created the first vaccine in 1881.

Anthrax spores can live in soil for decades. People contract the disease in three ways: through skin contact, eating infected meat or breathing airborne spores.

Less Frequent Adverse Reactions

cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.

Fatalities

cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system lymphoma (1)

SOURCE: FDA-approved package insert for anthrax vaccine

Elizabeth Leland: (704) 358-5074; eleland@charlotteobserver.com.

 

Anthrax vaccine and Gulf War illness symptoms in Captain Jean Tanner’s Dover Air Force Base Survey

Walter R. Schumm, PhD

Abstract:  Air Force Captain Jean Tanner surveyed 252 members of her unit at Dover Air Force Base in 2000 to attempt to study the unusual symptoms being reported by a large number of her unit members, symptoms she believed to be related to their anthrax vaccinations.  Her data are evaluated in terms of classifications for Gulf War illness used by the Centers for Disease Control (CDC) and by Steele (2000).  Even assuming that her non-respondents had no symptoms whatsoever, nearly nineteen percent of the unit would have been classified as having Gulf War illness by the CDC definition.  Levels of illness were associated with outcomes, including seeking treatment, disability, submission of vaccine reaction reports, and ex3emption from further anthrax vaccinations.  Had Tanner used even relatively small control groups of unvaccinated subjects, it is likely she would have detected significant differences between vaccinated and unvaccinated subjects, unless a third factor, such as large scale spraying of the base with insecticide, were responsible for symptoms observed in both groups.  The results cast doubt on the safety of at least the lots of anthrax vaccine that were used at Dover Air Force Base at that time.

©Copyright 2004, Pearblossom Private School, Inc – Publishing Division.  All rights reserved.
 
 

A series of articles by investigative reporter, Bob Evans:

Special Report: Anthrax Puzzle

 Who's telling the truth about the military's anthrax vaccine? The Pentagon and government-financed experts, who say the drug is safe and effective? Or veterans who say their health took a nose-dive after they got the shot? Now that troops have a choice, they have to decide whom to trust. Decide for yourself, as the Daily Press brings you four days of coverage.

An Incomplete Picture
Despite promises that hospitalizations after anthrax vaccinations would be reported, the Pentagon withheld data on more than 20,000 cases.
The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who'd taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.

How anthrax attacks
The anthrax vaccine now licensed was developed to protect workers against skin disease from anthrax spores in animal fur. The spores are more deadly when inhaled. Scientists disagree over how effective the vaccine is against inhaled anthrax, and whether antibiotics can work just as well.

More information about the anthrax vaccine
The web has tons of information on the anthrax vaccine, but nearly all come loaded with bias about the safety and effectiveness of the shot. Check out these, but pay attention to who sponsors the site.

What should you know
Daily Press Librarian Tracy Sorensen and Reporter Bob Evans amassed hundreds of documents and records about the anthrax vaccine to help answer your questions about the safety and effectiveness of the drug.

'I'd known that kid ... That wasn't him'
Bill Noel's mental health declined rapidly after his second anthrax shot, leaving him spaced out, angry and paranoid. He died after setting himself on fire.
Bill Noel was a Navy man and a family man, happy to serve his country as a senior chief petty officer supervising the USS Abraham Lincoln's defense systems and eager to help his kids with their math homework - often by telephone a continent or more away.

'Young' men got Lou Gehrig's disease
Navy officers Denis Army and Brody Prieto were hit by amyotrophic lateral sclerosis soon after their shots.
For Navy Capt. Denis Army, the first clue came Sept. 21, 1998, when he stumbled while running the bases in a shipboard softball game. It was the day before the former college baseball player turned 45 and three days after his first anthrax shot.

'We wish it didn't happen at all'
An Air Force veteran's life was wrecked by anthrax shots, in one of few cases that the Pentagon will acknowledge as related to the vaccine.
Senior Airman Tom Colosimo loved the Air Force, especially the travel.

'I'll just stay on it as long as I can ...'
Five years after taking his first anthrax shot, 19-year Navy veteran Patrick Kelly was forced into retirement by a rare form of cancer.
Patrick Kelly was a rising star in the Navy, a junior-grade lieutenant who rose from entry-level seaman the hard way - working his way up without benefit of college or special programs.

Anthrax Options
Troops facing vaccination for anthrax now face education and a choice - not a forced march to the clinic and orders to take the shot or be court
Navy Lt. j.g. Patrick Kelly remembers well his first injection with the anthrax vaccine aboard the aircraft carrier Theodore Roosevelt in 1999.

'Still a little unclear what she died from'
Death by vaccine - but which one? Multiple shots cloud the issue of cause.
Army Spc. Rachel Lacy was killed in the line of duty.

'They gave me an order ... and I refused'
Jessica Bond skipped the anthrax shot. The result was loss of pay and rank, and dismissal from the service.
Senior Airman Jessica Bond of Yorktown knew what she'd say when the time came, and she knew what would probably happen as a result.

How a company cashed in on anthrax
The vaccine maker's frequent cries for help brought it millions of additional tax dollars - even when it could not deliver a product that troops could use.
In a two-year span, the nation's only licensed anthrax vaccine maker went from pleading poverty to announcing $100 million in acquisitions, including other pharmaceutical companies and a new manufacturing plant near Washington, D.C.

'The man had never been sick'
A Michigan lab worker's cause of death is still a mystery as experts' opinions conflict.
Richard Dunn worked with the test animals at the only anthrax vaccine manufacturing site licensed in the United States, so he had to get the shots regularly.

Anthrax Q&A
We asked readers if they had any questions about the anthrax vaccine or the vaccination program. Here are some of the questions and the answers:

Military may not change anthrax shot rules
The FDA's OK of the vaccine opens the door for mandatory shots, but it's unlikely to happen soon.
The U.S. Food and Drug Administration has once again decided that the anthrax vaccine used by the military meets safety and effectiveness standards, paving the way for the return of the controversial mandatory shot program.

Letter from veterans group protests drug legislation
The proposal effectively would prevent manufacturers from being sued for the vaccines' effects.
Three groups representing veterans and their families are protesting a plan that protects vaccine manufacturers from lawsuits brought by civilians and members of the armed forces.


More Information concerning Illnesses and Deaths:

100 DOD doctors take anthrax vaccine reactions more seriously 

A DOD informational meeting from May 25-7, 1999 for 100 military physicians, important information came to light.  

a) “In a study of 337 vaccinated service members from Korea, the rate of reaction (from minor to severe) was 40% in men, but 70% in women.”  Women seem to have twice the reaction as men.  b) “The ongoing study of 600 service members at Tripler Army Medical Center, Hawaii, has resulted in 20% (120 people) developing a systemic reaction after at least one of the first three injections.” 

c) At Dover Air Force Base, 20-25 persons have been identified with a similar, Gulf War-like illness resulting in a more than 50% reduction in function, compared to their pre-vaccine state, according to Col. (Dr.) Renata Engler, Chief of the Allergy/Immunology Department, Walter Reed, and Consultant to OTSG, Allergy-Immunology….

”Military physicians at this meeting have called for changes in policy to increase VAERS [Vaccine Adverse Events Reporting System] reporting, possibly make the vaccinations voluntary [as in all other countries were it is offered], and to more seriously evaluate and treat service members’ reactions due to the vaccine.”     

http://www/dallasnw.quik.com/cybrella’Anthrax/Ft.Det_meet.html

Is it 14 or 49 people impacted by vaccine?

Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs claimed that the anthrax vaccine is “effective and entirely safe,” that only 14 reactions at one military installation were serious enough to keep people off duty, and that they have all “fully recovered.”  Yet, the article Anthrax Vaccine Casualties discloses the details of 49 service members’ reactions at that installation – including fevers, chills, fatigue, ringing in ears, vertigo, black outs, photosensitivity, numbness, tingling, rashes, a miscarriage, lesions, cardiomyopathy followed by a stroke, seizures, pain and so on, and how those 14 with severe cases are still trying to get well.

www.dallasnw.quik.com/cyberella/Anthrax/dover4-1.htm  

Another fatality

On Feb. 1996, Sgt. Dan Cole received anthrax vaccine.  He died Dec. 1996.

 The shots of war
http://www.sptimes.com/2004/09/17/Floridian/The_shots_of_war.shtml
"Cristina Kutz thinks the anthrax vaccinations that she and other troops must undergo devastated her health. Her complaints are not unique, but doctors don't back her up."
By SUSAN ASCHOFF, Times Staff Writer, Published September 17, 2004

Army expands anthrax, smallpox vaccinations
http://www4.army.mil/news/article.php?story=6380
The Army vaccinates Soldiers to keep them healthy,? said Col. John Grabenstein
WASHINGTON (Army News Service, Sept. 22, 2004)

 

Why is anthrax vaccine highly reactogenic?

Vaccines, co-authored by Dr. Arthur Friedlander, MC Colonel and head of Bacteriology at Ft. Detrick's USAMRIID, states "The current vaccine against anthrax is unsatisfactory for several reasons.  The vaccine is composed of an undefined crude culture supernatant adsorbed to aluminum hydroxide."  ..."No direct determination of the content or structure of the protective antigen in the vaccine has been made, and it is unknown whether the protective antigen is biologically active."  ..."The undefined nature of the vaccine and the presence of constituents that may be undesirable may account for the level of reactogenicity observed." 

http://www.dallasnw.quik.com/cyberella/Anthrax/refute.html

 

Is it the formula that causes illnesses?

There are three ingredients in the anthrax vaccine that may have a harmful cumulative effect:

According to the US Government Material Data Safety Sheet, a principle chemical component of the anthrax vaccine, formaldehyde, is not approved for human consumption.

Another component, benzethonium chloride, which has never been evaluated for human consumption.

Aluminum hydroxide is another component.  Dr. Meryl Nass has noted that the aluminum and the large number of shots required (6 in series plus annual booster) could have a cumulative harmful effect, making the anthrax vaccine more dangerous than others. 

(http://www.dallasnw.quik.com/cyberella/Anthrax/DOD_answ.htm  

Is it contamination that causes illnesses?

Bioport pours each batch/lot of the milky-white anthrax vaccine through a fine sieve one time “to sterilize it.”  Dr. Nass points out that this is not sufficient, because viruses, bacteria of certain shapes, and mycoplasms can get through the sieve.  Heat sterilization is necessary to kill such organisms.  Even more disturbing is that Bioport has a troubling history of failing FDA tests and inspections as seen below. 

1.  Squalene, an oil-based adjuvant not allowed for use in humans, was found by FDA in ppb in 8 vaccine lots at Dover AFB, Mich.  Five of those lots were anthrax vaccine and all five contained incrementally increasing amounts of squalene, which indicates experimentation according to immunologists Dr. Asa and Dr. Garry at Tulane University.  These immunologists created the anti-squalene antibody assay and tested many sick military members with it.  They found the antibodies to the squalene in the military members’ blood.  Squalene causes immune diseases; and it cripples 100% of the rats in lab tests.

http://www.denverpost.com/Stories/0,1413,36~53~2535720,00.html  

http://www.delawareonline.com/newsjournal/local/2004/10/10exdafbcommander.html

Dr. Pamela Asa, immunologist, Tulane University, "This is an experiment. This is a dose-range experiment." (Bartholomew Sullivan's article "Anthrax vaccine blamed for illness: Book claims Gulf War GIs were guinea pigs" on Nov 17, 2004

http://www.commercialappeal.com/mca/local_news/article/0,1426,MCA_437_3334125,00.html 

When DoD officials said the squalene came from dirty fingerprints in the lab, Dr. Asa noted that the other 13 natural amino acids normally found on fingerprints were not found in the anthrax vaccine lots at Dover AFB, just squalene. So how did the squalene get inside the military members’ blood?  In 1999, Col. Felix Grieder, Commander, halted the AVIP at Dover AFB, saying, "In my opinion, there was illegal experimentation going on."

http://www.delawareonline.com/newsjournal/local/2004/10/10exdafbcommander.html  

2. BioPort was shut down in 1999 after failing 4 separate FDA inspections.  Lots (batches) of anthrax vaccine were quarantined and later destroyed due to dozens of serious violations.  Expiration dates were tampered with, potency wasn't uniform, temperature wasn't kept in range, contaminants discovered, and so on.  The government gave Bioport millions of taxpayers’ dollars to clean up its facility and yet people continue to get sick or die.  Dr. Nass has stated that “the harvester” was not changed out when the plant was cleaned up, which may account for the continued health problems this product triggers.  The DoD has given BioPort at least 330 million dollars between 1998 and 2005.

3. Professor Garth Nicolson of The Institute for Molecular Medicine in Huntington Beach, CA is concerned that Bioport’s (previously known as Michigan Biologics) anthrax vaccine may be a cause of Gulf War Illness.  He notes that approximately 40% of Gulf war Illness patients, who have been vaccinated, test positive for mycoplasmal infections, with 80% of these being Mycoplasma Fermentans, which sometimes spreads to family members who then get sick.  He points out that the Armed Forces Institute of Pathology has conducted many studies using Mycoplasma Fermentans, and that an Army pathologist holds the patent on this primitive bacteria.  He concludes with, “The chance that an immune globulin fraction against anthrax might contain microorganisms like M. fermentans is real and should not be dismissed without careful consideration.”

He cites the following references:

  1. Nicolson GL, Nass M, Nicolson NL.  The anthrax vaccine controversy.  Questions about its efficacy, safety, and strategy.  Med. Sentinel 2000; 5:97-101.
  2. Nicolson GL and Nicolson NL.  Diagnosis and treatment of mycoplasmal infections in Gulf War Illness-CFIDS patients.  Intern. J. Occup. Med. Immunol. Tox. 1996; 5:69-78.
  3. Nicolson GL, Nicolson NL and Nasralla, M.  Mycoplasmal infections and Chronic Fatigue Illness (Gulf War Illness) associated with deployment to Operation Desert Storm. Intern J. Med. 1997; 1: 80-92.
  4. Vojdani A, Franco AR. Multiplex PCR for the detection of Mycoplasma fermentans, M. hominis and M. penetrans in patients with Chronic Fatigue Syndrome, Fibromyalgia, Rheumatoid Arthritis and Gulf War Illness.  J. Chronic Fatigue Syndr. 1999; 5:187-97.
  5. Nicolson GL, Nasralla M, Nicolson NL, Haier J.  High prevalence of mycoplasmal infections in symptomatic (Chronic Fatigue Syndrome) family members of mycoplasma-positive Gulf War Illness patients.  J. Chronic Fatigue Syndr. 2002; 10:in press.
  6. Nicolson GL, Berns P, Nasralla M, Haier J, Nicolson NL, Nass M.  Gulf War Illnesses: chemical, radiological and biological exposures resulting in chronic fatiguing illnesses can be identified and treated.  J. Chronic Fatigue Syndr. 2002; 10:in press.
  7. Lo S-C. Pathogenic mycoplasma. U.S. Patent 5,242,820. Issued September 7, 1993.

 

Anthrax Vaccine and Birth Defects

Bioport’s anthrax vaccine product insert from 2002 shows that this is a Class D drug and not to be given to pregnant women.  Class D drugs are teratogens.

There was an unusually high number of babies born with Goldenhaar Syndrome to vaccinated Gulf War Vets, according to Gary Matsumoto, author of Vaccine A.

Dr. Nass reveals significant findings in her report to the FDA, The safety and efficacy of anthrax vaccine have not been established, and the preponderance of the world’s literature shows the vaccine is unsafe, and a contributor to Gulf War Syndrome as acknowledged in the vaccine’s package insert. Firstly, Cdr. Megan Ryan, a navy physician, discovered that women who had received the anthrax vaccine during their first trimester had a higher rate of birth defects than women who had not been vaccinated.  Secondly, Dr. Maria Araneta, of the Naval Health Research Center and University of California, clearly demonstrated that children of Gulf War Veterans were more likely to have certain birth defects than were the children of the control groups.

The references cited are:

  1. MMWR 127 vol 51 No. 6. Notice to Readers: Status of US Department of Defense preliminary evaluation of the association of anthrax vaccination and congenital anomalies.
  2. Johannes L. Anthrax Vaccine May Increase Incidence Of Birth Defects For Pregnant Women.  Wall Street Journal.  January 16, 2002.
  3. Araneta MRG, Schlangen KM, Edmonds LD et al. Prevalence of birth defects among infants of Gulf War veterans in Arizona, Arkansas, California, Georgia, Hawaii, and Iowa, 1989-93.  Birth Defects Res Part A. Clin Mol Teratol 2003; 67: 246-60.

 

Treatment of Vaccine-Injured Soldiers

The National Vaccine Healthcare Center was established in 2001 at Walter Reed Medical Center.  There are now four of these centers across the country.  This fact attests to the significance of vaccine injuries in our military members.
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Related Web Sites

www.directorder.org
www.military-biodefensevaccines.org
www.milvacs.org
www.anthraxvaccine.org
www.nvic.org
www.verpa.us
www.gulflink.org

www.actnat.com

www.eangus.org

www.brentwoodexposed.com

http://vva.org/

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Bulletin Board


Survey for Adverse Reactions to AVA

A team of veterans has formed Team Archangel under the leadership of James Hines Jr., Esq. to help service members and veterans who have had adverse reactions to the Anthrax Vaccine. Click the link below to learn more about what the team is doing, and take their evaluation survey if you believe you are suffering. All information will remain confidential.

https://sites.google.com/site/teamarchangel1/contact-information

Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/2011

Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/11 Ltr to NBSB from ASPR


Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/11 AV-WG Public mtg FRN


Vaccine to Protect Children from Anthrax - Public Engagement Workshop 7/7/2011 Agenda

Tough Guy Sells Tupperware:

I am an anthrax vaccine disabled veteran who sells Tupperware to help make ends meet for my family. Please visit my website at http://my2.tupperware.com/chuckrobey

Thank you very much,
Charles Robey

 


 
Current News:

Tom Heemstra - Accountability Check list
October 18th 2007 - Call To Arms; Letter from NVIC

September 7th 2007 - CBS, Montel Williams - "Dying to Serve"
A show devoted to the Anthrax Vaccine problems. Check it out!


A Letter Writing Campaign


 

Just spoke with one of Sen McCaskill's staffers. They do not expect the NDAA amendment with the vaccine injury provisions to pass but she said the Senator will be introducing a separate bill to provide TSGLI coverage for vaccine injuries. I encourage everyone to contact their senators and urge them to co-sponsor the bill - S.1467 and to add a provision that would force DoD to recognize vaccine injuries as "combat related".

S. 1467
To amend title 38, United States Code, to provide coverage under Traumatic
Servicemembers’ Group Life Insurance for adverse reactions to
vaccinations administered by the Department of Defense, and for other
purposes.IN THE SENATE OF THE UNITED STATES

July 16, 2009  Mrs. MCCASKILL introduced the following bill; which was read twice and referred to the Committee on Veterans’ Affairs
A BILL To amend title 38, United States Code, to provide coverage under Traumatic
Servicemembers’ Group Life Insurance for adverse reactions to
vaccinations administered by the Department of Defense, and for other
purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.This Act may be cited as the ‘Lance Corporal Josef Lopez Fairness for Servicemembers Harmed by Vaccines Act of 2009’.
SEC. 2. TRAUMATIC SERVICEMEMBERS’ GROUP LIFE INSURANCE COVERAGE FOR ADVERSE REACTIONS TO VACCINATIONS ADMINISTERED BY DEPARTMENT OF DEFENSE.

Here is a link to an interview about S. 1467:
http://www.homefrontonline.com/article.asp?articleid=1559