Protecting Our Troops So They Can Protect Us...

"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."

"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."

"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."

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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:

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

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4. Son dies, father is deported

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."

5. Chicago attorney wants anthrax vaccines stopped

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.

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.

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.

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 4^th.

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:

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.

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

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

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.

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.

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.

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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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.

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

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

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Legislation and Congressional Hearings

�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.

�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 claims to have no informed consent waiver requests or other info related to DoD�s decision

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

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.�

� 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

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U.S. Representative, Alabama�s 6^th 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.

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,

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."

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.

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.

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."

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."

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.

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.

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.

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?
________________________________________________________________________________________________________________________

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

WHEREAS, Federal District Court Judge Emmet G. Sullivan ordered AVIP immediately halted twice, the last injunction being on Oct. 27^th, 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-Barr� 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.

*** Congressional report recommending suspension of AVIP -- The Department Of Defense Anthrax Vaccine Immunization Program: Unproven Force Protection** , 106^th 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

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.

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.

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.

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

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."

"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."

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.

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.�

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.

[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 J�rgen 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

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.

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.

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

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.

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-Barr� 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).

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Anthrax Vaccine and Biothreat

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

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.

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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)

�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.

�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.

�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.

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."

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.

"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."

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.

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.

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

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

Jefferson discussed some of the major flaws ofthe study by Brachman et al with respect to policies makingcertain vaccines compulsory in the US military.^{1 2} Additional shortcomings of the study by Brachman et al have been describedin fuller detail elsewhere.^3-5 For example, the often reportedrate of 92.5% effectiveness for the anthrax vaccine sounds impressivebut 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 continueto ignore criticism of the 2002 Institute of Medicine reporton the anthrax vaccine.^{w1 w2} At least three major studies in England, Canada, and the United States had found problems withthe 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

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."

"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. "

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.

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."

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

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

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.

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.

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 vaccinationand antibiotic prophylaxis, as well as preattack vaccinationversus no vaccination.

^{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.

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

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.

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....?

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.

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.

� 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

[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:

(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.

� 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.

� 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

(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.

(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:

(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:

(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.

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."

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."

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.

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)

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.

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.

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.

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.

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

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.

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