• Pentagon clear to give anthrax shots again
• Defense Department Embarks On Dissinformation Campaign Concerning Anthrax Vaccination Program
• Reserves group calls for amalgam availability to support military forces
• Rebuttal: ..the Reserve Officer Association could not be more incorrect..
• Abstract: Expression of protective antigen in transgenic plants: a step towards edible vaccine against anthrax
• The needle and the damage done
• AVP goes public

Pentagon clear to give anthrax shots again

above: book cover

WASHINGTON, DC, Apr. 1 (UPI) -- The Department of Defense effectively was cleared Friday to resume vaccinating military service members with the controversial anthrax vaccine, but it also was placed under court order to submit weekly reports to assure the vaccinations would remain voluntary.

The inoculation program was suspended last Oct. 27 after U.S. District Court Judge Emmet Sullivan ruled the compound -- called Anthrax Vaccine Absorbed or AVA -- had not been properly approved for use against inhalation anthrax. It was illegal, the judge said, to administer it to service personnel until the Food and Drug Administration properly approved the drug. As a result he issued an injunction against the program.

When the injunction took effect, the only way AVA could be used prior to FDA approval was either with a presidential waiver or with the informed consent of those who agreed to the vaccination. The original program was mandatory and those who refused vaccination often were disciplined -- even court-martialed.

At the Friday hearing, however, Sullivan agreed to a Pentagon request to modify his injunction to allow vaccinations under a special emergency waiver called an Emergency Use Authorization.

The EUA was issued in January 2005 by the Department of Health and Human Services and the FDA under new authority granted by the Bioshield Act. Bioshield, the same bill that allocated over $5.5 billion for the purchase of new vaccines, was signed into law last year.

The modification will allow the military to proceed with its inoculations as long as it gives each serviceman or woman a brochure about the vaccine and makes sure they are aware they can forego vaccination without fear of penalty. That last point was very important to Sullivan, who said the change he was making to the injunction would not take effect until Monday, so it would give the Pentagon time to lay out a plan for making clear to military personnel they could refuse vaccination for anthrax.

"This is a weighty decision people have to make," Sullivan said. "I want them to know they have choices."

Effectively ignored in the debate, however, was the amount of information that would be provided to those facing inoculation. Under the original informed-consent approach, each person would have received a full statement of the vaccine's risks.

The brochure submitted to the court falls far short of that, critics said. While limiting the information slashes the amount of paper work -- a practical consideration in the face of vaccinating potentially thousands of enlisted, reserve and contract personnel -- it also means the Pentagon will not have to describe problems with the vaccine in detail.

The greatest concern has been the voluntary nature of the shots, not the question of informed consent, said Mark Zaid, an attorney representing opponents to the vaccine.

"Congress allowed the (Defense Department) to exempt informed consent in this statute," Zaid told United Press International. "I am not sure there is anything we can do about that."

Congress will review the issue again, said Lawrence Halloran, staff director and counsel for the House Government Reform Subcommittee on National Security.

"I suspect," Halloran told UPI, "we are talking about a hearing before anything else where we get HHS and FDA and DOD in here and say 'What were you thinking?'"

Sullivan made it clear whatever use was made of the EUA, the injunction remained in place. He ordered the Pentagon to submit weekly reports on any vaccinations given outside the permission granted by the EUA. The reports will show zero violations, assured attorney Andrew Tannebaum, who spoke on behalf of the Pentagon.

"If the answer is anything other than zero, the court will consider high monetary fines," Sullivan said. "I'm talking high five figures or six figures."

Defense Department Embarks On Dissinformation Campaign Concerning Anthrax Vaccination Program

Involuntary Vaccinations Must Stop For A Minimum Of Three To Four Months In Order For The Government To Comply With Court Order

WASHINGTON, D.C. --On October 27, 2004, the Honorable Emmet Sullivan of the U.S. District Court for the District of Columbia vacated an Order issued by the Food & Drug Administration and imposed a permanent injunction prohibiting the Department of Defense from administering the anthrax vaccine without informed consent or a presidential waiver. This second injunction followed Judge Sullivan's earlier decision of December 22, 2003, that the anthrax vaccine was investigational and unlicensed for its intended purpose to protect against inhalational exposure.

Since the imposition of a permanent injunction the Department of Defense has led a disinformation campaign to downplay the significance of the Court's decision, particularly regarding the length of time the injunction will remain in place. These efforts, which are made amidst convenient FDA silence, do a great disservice to the loyal men and women who are attempting to protect the United States of American in military and civilian positions.

"DoD is trying to equate Judge Sullivan's granting a permanent injunction with his earlier decision granting a preliminary injunction, but that's simply wishful thinking," said Mark S. Zaid, Esq. of the Washington, D.C. Law Firm of Krieger & Zaid, PLLC, one of two lawyers who brought the lawsuit on behalf of the plaintiffs. "In fact, given the state of the medical and scientific evidence, it will be extremely difficult for FDA to make a proper case that the vaccine has any effectiveness against inhalation anthrax. That means the vaccine stays an investigational drug and it cannot be used by the military without informed consent or a presidential waiver," Zaid added.

The Court found that the FDA failed to allow for public comment when it decided to ignore the recommendations of its own expert panel and determined the vaccine was properly licensed for inhalation anthrax. In addition to the Court's new findings, Judge Sullivan also explicitly incorporated his earlier findings that the vaccine was never licensed for inhalation anthrax, and that the FDA and DoD authorized the use of an experimental drug on service members.

"The upshot of the court's ruling on October 27, 2004, is that the anthrax vaccination program violated federal law from 1998 forward, at a minimum. Any order to submit to anthrax vaccination during the entire existence of the program was illegal, said the plaintiffs' co-counsel John Michels, a partner in the Chicago office of McGuireWoods, LLP. "The soldiers that DoD discharged for refusing to take the shots are entitled to back pay and allowances from the date they were removed from paid status to the point where DoD properly decides what to do with them. In fairness to the hundreds of service members who were wrongfully separated from active duty, DoD should begin processing each one for compensation and reinstatement, particularly if it wants to avoid congressional involvement," added Michels.

Both lawyers noted that the stockpiling of anthrax vaccine currently in progress is being done with a product that is untested and unapproved as a preventative measure against inhalation anthrax, the most likely type of anthrax to be used in a terrorist attack. They also commented that the DoD's statements that Judge Sullivan's order does not challenge the "safety or efficacy" of the vaccine are deliberately misleading.

"Vaccines are licensed only when they are proved to be both safe and effective. The court's ruling that the vaccine is not licensed goes to the heart of the matters of safety and efficacy for this vaccine. In fact, the license for the vaccine and the original FDA expert panel both recommended 0against widespread inoculation with the product", said Michels.

In addition to those service members who were wrongfully discharged, the plaintiffs' attorneys said that they are aware of hundreds of other service members who left active duty or the active reserves to avoid the vaccine, and many others who developed serious and debilitating illnesses immediately after receiving the shots. Whether these individuals will be allowed back into their units or receive proper compensation for illnesses caused by an experimental drug is probably up to the Veterans Administration and the National Guard or Reserve leadership. Additional legal action on behalf of those who were disciplined and who have fallen ill from the vaccine is currently being prepared.

The lawsuit was filed under pseudonyms on March 18, 2003, by six plaintiffs (and other similarly situated individuals) who are either members of the active duty and selected National Guardsmen components of the Armed Forces or civilian contract employees of the Defense Department. Each of the plaintiffs had been ordered to take the anthrax vaccine. The government has indicated it will shortly seek to vacate the injunction based on the FDA's Final Rule.

The plaintiffs were represented by John J. Michels, Jr., a partner in the Chicago office of McGuireWoods LLP, who previously represented Major Sonnie Bates and Captain John Buck, the highest military officers to refuse the anthrax vaccine, and Mark S. Zaid, Managing Partner of the Washington, D.C. law firm of Krieger & Zaid, PLLC, who has defended more than one dozen servicemembers courts-martialed for refusing the anthrax vaccine and has testified before Congress regarding the vaccine in 1999.

Reserves group calls for amalgam availability to support military forces

Washington -The national organization representing military reserve officers has adopted policy urging continued availability and use of dental amalgam "for optimal dental care for military forces."

"Dental readiness of our military forces is an important component of mission preparedness," the policy statement says. "Dental amalgam (silver fillings) is the most widely used material for dental repairs in the Department of Defense, and the bulk of scientific evidence has repeatedly demonstrated the efficacy and safety of dental amalgam."

A ban on use of dental amalgam, as legislation in the 107th Congress and several state legislatures have proposed, "would have far reaching and deleterious effects on dental readiness as well as introduce significant increased costs to the DoD," says ROA health care resolution 03-02.

"Therefore, be it resolved that the Reserve Officers Association of the United States urge the DoD and Congress to maintain the current dental amalgam in dental repairs for the preservation of dental readiness at the most cost effective levels."

Dr. Gordon Austin, U.S. Naval Reserves
The ROA's newest health policy statement reflects the interests of 100,000 active and retired reserve officers of seven uniformed services. The organization's legislative agenda urges Congress to improve dental coverage for reservists and their families and calls for tax relief for reservists and their employers.

Dr. Gordon Austin, a captain in the U.S. Naval Reserves who was recently called to active duty (http://www.ada.org/prof/pubs/daily/0303/0326ama.html0326ga.html see related report) in support of the war effort, said he promoted the new policy as ROA national dental surgeon to assure continued access to dental amalgam for military troops. "Issues like the preservation of access to dental amalgam and the dental readiness of the reserves have been my primary focus," he said in an interview.

The ROA national council adopted the amalgam policy statement Jan. 22 and posted it on the Web site. The Web site also offers information on current reserve force strength and service, asserting that reservists shoulder an "increasing portion of the burden of our national defense."

The ROA was founded in 1922 and chartered by Congress in 1950 to "support and promote the development and execution of a military policy for the United States that will provide adequate National Security." The national dental surgeon is elected annually and serves on the executive committee as the advisor on dental issues affecting the reserve force or national security. Services represented by the ROA include the Army, Navy, Marines, Air Force, Coast Guard, National Oceanic and Atmospheric Administration Corps and Public Health Service.

Document address:

Boyd E. Haley 859-257-7082
Professor and Chair
Dept. of Chemistry
University of Kentucky

Rebuttal: ..the Reserve Officer Association could not be more incorrect..

Dr. Gordon Austin of the Reserve Officer Association could not be more incorrect and his stand on mercury exposure from amalgams will likely cause a great deal of damage and injury to our military servicemen. I will explain below.

I and others (see Holmes, Blaxill & Haley, International J. of Toxicology, v22#4, in press) have been working on autism (now firmly proven to be caused by mercury in vaccines) where we have shown that the birth hair of autistic is exceedingly low compared to normal children. With normal children their birth hair increases with increased amalgams in the birth mother. With autistic children, there is no significant increase, even with birth mothers with 18 amalgams. Yet, on clinical analysis the autistic children carry a much higher toxic heavy metal burden.

The rationale for the above observation is that the autistic children cannot effectively excrete mercury from their cells into the blood stream, where it can also end up in the hair and nails. That is, autistic children retain mercury in their cells and neurons. Children not affected by vaccine mercury can excrete it.

Couple the above with the latest data from a collaboration I have with Dr. Mark Lovell that shows that testosterone (the male hormone) is a potent enhancer of thimerosal neurotoxicity and you have a credible explanation of the high boy/girl ratio in autism and the fact that boys represent the majority of the severe cases of autism. This explanation further supported by the observation (Dr. Baron Cohen, London, England) that the amniotic fluid of mothers who give birth to autistic children is unique in that this fluid contains high levels of testosterone compared to mothers who give birth to non-autistic children.

Proof of causal relationships in disease requires both the biological plausibility, as explained above, and supporting epidemiological studies. The latest epidemiological studies by Drs. M. Geier and D. Geier (J. American Physicians & Surgeions v8#1,p6,2003) clearly shows that exposure to vaccine based mercury is a major risk factor for AD, seizures and heart disease. Therefore, there is in the literature both explanations of the biological mechanism of the thimerosal (mercury) toxicity and the supporting epidemiological studies.

The autistic observations indicate that there is a sub-population of humans that cannot effectively excrete low levels of mercury. This sub-population does not disappear with aging and most likely reflects those individual adults who also develop neurological problems like Alzheimer's disease and Gulf War Syndrome. How does this reflect on other neurological diseases?

Consider Alzheimer's disease (AD). There is a plethora of scientific studies that show that mercury, and only mercury, can cause the aberrant biochemistry, and produce the widely accepted, diagnostic hallmarks of AD using the appropriate neurological study system. This is data ignored by the American Dental Association as it does not fit into their doctrine that a little mercury is not dangerous or toxic (I cannot identify what they mean by a "little mercury").

However, a review of older scientific literature (done by other labs) shows that the mercury levels in the hair and nails of Alzheimer's Diseased patients is lower than found in age-matched normal controls, even though the brain mercury levels in AD patient's bain was found elevated compared to normal brain by the same researchers. Further, as the severity of the dementia increases the level of mercury in the nails decreases. That is, as the individual becomes more and more demented, they further lose the ability to excrete mercury. Couple this observation with the fact that mercury, and only mercury, can cause AD like biochemistry and produce the diagnostic hallmarks of AD then one with a modicum of intelligence would surmise that mercury is most likely the central cause of AD, it would at least be a major exacerbating factor.

This above observations on AD subjects is very similar to the autistic child situation and implies that the AD subjects are also a sub-population incapable of excreting mercury. The only difference is that the autistic child gets exposed to injected organic mercury before the development of their nervous, renal and bilary transport systems and the AD subject is slowly made mercury toxic from chronic exposures to mercury from amalgams, vaccinations and possible environmental sources.

The publication used by the American Dental Association to claim amalgam safety is self-incriminating to anyone who reads it carefully (see Saxe et al.,JADA v130, p91,1999). I have lots of scientific objections to this publication which I will not go into here. But note, in the histogram in this paper they state that 6 of 101 total subjects (approximately 6%) had mercury levels above 1 micromolar (= 200ng/g tissue). These are levels that would definitely be lethal to neurons. Check this out with any neurotoxicologist or neurochemist--not your dentist. Researchers have observed neurotoxicity at one-hundreth the 1 micromolar level using neurons in culture. Therefore, one can consider the JADA article's entire data on mercury brain levels and reasonably assume that anything 10 times above the level that causes significant neuron death in cultures (10 nanomolar causes measurable neuron death in 24 hours) is obviously dangerous and should not be allowed. This computes to be any levels above 100 nanomolar which is equal to 0.1 micromolar. The level found in the 6 subjects mentioned above is 10 to 35 times greater than 0.1 micromolar. Look at the levels they report in this JADA article and it is obvious that a reasonably large percentage of the subjects in this JADA article died with what would be conservatively identified as having toxic levels (0.1 micromolar) of brain mercury. The major question is what effect does this have on the general health of our citizens? I am of the opinion that I know what the source of the mercury is since a NIH study has demonstrated that the bulk of mercury body burden in 1,127 American military men came from their dental amalgam fillings.

In spite of the overwhelming biological implications of mercury causing AD, there has not been any significant epidemiological evaluation of the contribution of amalgams (the major contributor to mercury body burden) to neurological diseases. It is my opinion that the lack of any major epidemiological study is primarily because of the political slickness of the American Dental Association (ADA) in getting non-scientifically trained associations such as the Reserve Officer Association of America to go along with the ADA propaganda. I am certain that Dr. Gordon Austin means well and is concerned for his fellow veterans. As a veteran (lowly PFC), I am also concerned. I think that mercury from amalgams and vaccines greatly affect our military personnel.

I am mostly concerned about the cavalier attitude that the American Dental Association pushes with regards to mercury exposure. Justifying the use of amalgams based on the fact that they are cheap is not the kind of consideration and treatment I would want to our veterans and our newly recruited military to receive. I think it is short-sighted, inconsiderate, and dangerous.

Consider, it is well known that the military personnel that had increased risk for Gulf War Syndrome (GWS) were those that received numerous vaccinations (mercury containing) required for service in that part of the world----these military personnel found to be at elevated risk did not have to go to the Gulf region, they only had to be vaccinated. (Note that the French did not take these vaccinations and they did not have significant GWS. The Americans, Brits and Aussies did and had significant GWS. Don't tell me that the French complain less than the latter group, I don't buy that.)

Mercury is a retention toxicity and it builds up as one is exposed to mercury from numerous sources---and the major source for American military are dental amalgams and vaccines!

I only wonder if we will have another GWS-II epidemic due to the fact that our federal agencies that are responsible for human health have sent a new group of military to war with a new batch of thimerosal (mercury) containing vaccines and a mouth filled with amalgams. If the Reserve Officers Association wants to really serve the military veterans well they should demand that the Food and Drug Administration set up a scientific panel (not like the previous one that was loaded with dentists) made up of neurochemists, toxicologists and medical doctors to evaluate all of the scientific literature, not just that approved by the American Dental Association bureaucrats. (Question? Is Dr. Austin an MD or a DDS?)

Please feel free to forward this to anyone concerned with the health and safety of our military personnel. I think it is imperative that the American Dental Association not be allowed to use patriotism to further their political goals and in the process damage and injure our American military personnel---or the soldiers of our allies.

Sincerely, Boyd Haley, Professor and Chair of Chemistry, University of Kentucky

Abstract: Expression of protective antigen in transgenic plants:

a step towards edible vaccine against anthrax

Protective antigen (PA) is the most potent molecule for vaccination against anthrax. In the present study, we have successfully integrated protective antigen gene in nuclear genome of tobacco plants by Agrobacterium mediated leaf-disc transformation method.

Expression of protective antigen gene was detected by immunoblot analysis using antisera raised against purified PA. A distinct band of approximately 83kDa lighted up in the protein extracted from transformed plants while there was no such band in untransformed plants. The plant expressed PA showed biological activity just like native PA, which was demonstrated by cytolytic assay on macrophage like cell lines with lethal factor.

This study establishes for the first time expression of PA gene in a plant system and thus marks the first milestone towards developing edible vaccine against anthrax.

The needle and the damage done

On the morning of December 17, 1998, Ronda Wilson, a supremely fit, strikingly beautiful American helicopter gunship pilot, was heading for military stardom. Just 21 and the only woman in her squadron, she had recently defeated her 63 male fellow pilots to earn the coveted Top Gun award in her first gunnery flight test. She was without peer in her cavalry unit, so skilled at handling the OH-58 Delta Warrior, armed with Hellfire missiles and .50-calibre machine guns, that she was described by her commanding officer as "one of the most outstanding pilots of her generation".

Above: early military inoculations

On that morning, at Fort Stewart, Georgia, she received a routine order that was ultimately to destroy her faith in the military family and American government which she loved beyond question, and which she says "I was willing to die for". She was told to "go get your jabs".

She was never told what the injection was for, and felt no need to ask. It was, she later discovered, the first in a six-dose course of anthrax vaccination. It was the moment she became part of the US government's compulsory, highly ambitious anthrax vaccination programme for all 2.4 million of its military personnel; the project was authorised by President Clinton himself, it had begun eight months before, and it was halted 18 months later amid damning congressional verdicts, lawsuits and accusations of a top-level cover-up.

There were many things Wilson was not told about the 0.5ml phial of milky liquid that was being injected into her arm. It was manufactured by a company that today, after a new lease of life for the vaccination programme, has begun to distribute millions of doses to immunise "high-risk" US troops heading to the Persian Gulf for an attack on Iraq. (British soldiers will not be immunised with this vaccine, but with a home-grown version, produced at Porton Down).

Critics of the vaccine, who include congressmen, senior military officers and more than 450 American servicemen who have been court-martialled or forced to leave the military for refusing to take it, say its ability to combat inhalation anthrax has never been proven and it has never been tested on humans; it has never been licensed to combat inhalation anthrax; and its long term effects have never been known. Those claims are supported by a congressional committee which issued a scathing and alarming report into the efficacy and supervision of the vaccine, and the immunisation programme, in April 2000.

Its critics also claim it is being forced on the country's soldiers as part of a politically-inspired attempt to persuade the American public that an effective vaccine against an anthrax terror attack exists, and that its soldiers are safe from Saddam Hussein's chemical and biological arsenal.

The Pentagon, and BioPort, the manufacturer, together with the Food and Drug Administration, which licenses US drugs, fiercely deny these claims. The Times has looked at thousands of pages of government, FDA, Army, congressional and medical reports stretching back 30 years. The extraordinary story of this anthrax vaccine, suddenly thrust on to centre stage in a new age of global terror, is one of high-level politics, furious scientific dispute, big business and great controversy.

One thing is certain - this vaccine has a history. Questions persist on two levels: the ability of the company that manufactures it to produce it safely, and the safety and effectiveness of the vaccine itself. There is testimony and documentation that raise the question of why the American military establishment and successive White House administrations have persisted with a company and a vaccine that by their own admission have suffered problems. It is a history that the hundreds of thousands of US troops about to receive the compulsory immunisation, and who have no right to refuse it, are not being told about.

Of all the things Wilson was not told about her first jab, perhaps the most crucial was this: that 10 months earlier, in February 1998, after an inspection of the Michigan laboratory that manufactures the vaccine, the plant had its authority to make the vaccine suspended by the FDA.

The inspection followed five years of warning letters citing concerns over the plant's record-keeping and violations in safety, potency consistency and sterility. The February 1998 FDA report, which effectively prevented the plant from manufacturing fresh supplies of the vaccine for three years, and a copy of which has been obtained by The Times, is damning.

The 95-page report found lots of the vaccine contaminated, a filtration process not authorised by the FDA, problems with cleanliness and the sterility of equipment and a failure to ensure a uniform potency of the drug.

"The firm routinely redates Anthrax Vaccine lots that have reached their labelled expiration date," the report says. And it states: "Lot FAV036 was at room temperature for 20 hours, the filling operation was aborted, it was placed back in the refrigerator." According to military records it was a dose from Lot FAV036 that was given to Wilson that December morning, eight months after the FDA report had been sent to BioPort.

"The patient reported no significant reactions with the first shot," her final military medical report states - written in April 2001 when a depressed, emaciated and mentally confused Wilson was discharged from her unit - "except for an immediate large painful local reaction at the injection site (described as being slightly smaller than a golf ball). The pain extended from her shoulder to her elbow. The military medical community reassured her this was normal. She also reported the onset of about three headaches a week."

After her second jab, from a different lot, in January 1999, she developed "irritability, loss of memory, fatigue. By late February to early March nausea and diarrhoea started. One week after her third anthrax vaccine dose her gastro-intestinal symptoms worsened further, evolving into her current disabling state of illness."

That current state is pitiful. Wilson, who four years ago was in superb health and in charge of one of the most potent weapons in the US armoury, can barely drive a car. She has lost a third of her body weight and suffers such agonising cramps every day that she is forced to curl up in a foetal position for hours at a time. She has stiff joints, chronic fatigue, anaemia, difficulty with simple sums, memory loss, blackouts, permanent abdominal pain and, according to her medical report, "loss of cognitive function".

She is sure the anthrax jabs caused her physical and mental degeneration, but understands the difficulty in proving it. The final medical report concluded: "There were no other risk factors present . . . that could account for her symptoms. The anthrax vaccination may have adversely affected her immunological balance. There is a clear temporal association with the onset of her illness and her anthrax vaccination. While it is not possible to scientifically prove causality between anthrax vaccination and the onset of her illness, it is impossible to disprove causality."

Wilson understands those problems of proof. What has destroyed her trust in everything she once held dear - the US military, the US government and her husband, a fellow pilot who has now left her - is that for 18 months she was led to believe she was a freak, the only soldier to have become ill after the injections, a strange one-off. Military doctors would diagnose stress, Aids, leukaemia, anything except a possible link to the vaccination. And, she says, as soon as she became ill, "they couldn't wait to get rid of me".

But in the summer of 2000, at the Walter Reed Army Medical Centre in Washington DC, she met another soldier reduced to a sad husk by, he claimed, an anthrax jab. He began to tell her what he had learnt about the vaccine, and about the hundreds of soldiers who claim it has made them chronically ill with fatigue, auto-immune diseases, severe joint pain and infertility.

It was a story that left Wilson feeling "betrayed by everything I once believed in". Sitting in her rented flat in Savannah, Georgia, and often close to tears, she asks: "How could they not tell me the history of this drug, to make me believe I was an aberration?"

Jon Irelan, a retired Army major and US Ranger, was on a tour of duty in Saudi Arabia in 1999 when he was given four anthrax jabs. Soon he was losing his hair and suffering fevers and muscular weakness, mood swings and bed-sweats. Ultimately he discovered that his testicles had shrivelled up and died. He will be on testosterone injections for the rest of his life. "Right from the beginning they refused to send me to an American medical facility," he says. ."They kept sending me to Saudi doctors. They told me it was a freak reaction. There were guys being airlifted to the Army Hospital in Germany for ingrowing toenails. I thought I was an anomaly."

In June 2000 Irelan, back in the US, contacted his congressman, Washington State's Jack Metcalfe, who sat on the House Government Reform Committee which was investigating the vaccine. "His office told me I was not alone. Then I started receiving calls from others, telling me I was not crazy. The calls have not stopped.

"I would have been happy to accept this if I had been told the problems with the vaccine. Shit happens. But they treated me like a dog." In October 2000, Irelan gave evidence before the House committee. "Members of Congress," he said, "I appear before you today to tell you that I would willingly lay down my life for the United States of America. But what I wish someone would explain is why it has been permitted to perpetrate this unproven drug on my fellow soldiers." It was a question worth asking, because a long paper trail shows how concerned the US Government has been about the vaccine for more than 15 years.

Above: Plowing in the Nivernais 1849, Rosa Bonheur, oil on canvas.

The first anthrax vaccine was designed in the 1950s to protect wool-mill workers from cutaneous anthrax, which enters the body through breaks in the skin. In 1970 the federal government issued the only licence to manufacture a similar vaccine to the Michigan Department of Public Health. That later became the state-owned Michigan Biologic Products Institute (MBPI). That licence was based on a scientific study of an earlier vaccine which had suggested an effectiveness against inhalation anthrax. "There was a presumption of effectiveness, but it has never been tested, which is a legal requirement," says a congressional aide on the House Government Reform Committee, which had called for the immunisation programme to be suspended in April 2000.

By the late 1980s MBPI, with antiquated facilities, was making small batches of the vaccine, about 15,000 to 17,000 doses every four years, selling them mostly to people in the animal hides business. It was the only US company making an anthrax vaccine. With the reduction in the relevance of nuclear weapons, the Cold War now over, the US Army had begun to take an interest in chemical and biological warfare. It investigated the possibility of contracting MBPI to supply the US military with the vaccine. This was before vaccinations became politically sensitive, and the Army and Pentagon statements are now a matter of public record. They are striking in their bluntness.

In 1985 a US Army report stated: "There is no vaccine in current use which will safely and effectively protect against all strains of the anthrax bacillus. A licensed vaccine against anthrax . . . is currently available for human use. The vaccine is, however, highly reactogenic, requires multiple boosters to maintain immunity and may not be protective against all strains of anthrax bacillus."

In 1989, a year after the Army had gone ahead with ordering 300,000 doses from MBPI, a letter from the Pentagon to Senator John Glenn stated: "Current vaccines, particularly the anthrax vaccine, do not readily lend themselves to use in mass troop immunisation for a variety of reasons, a higher than desirable rate of reactogenicity, and, in some cases, lack of strong enough efficacy against infection by the aerosol route of exposure."

Then came the Gulf War. Amid claims that the vaccine may have caused the illness of thousands of troops after 150,000 were vaccinated - allegations never proved - hearings were held by the Senate Veterans Affairs Committee.

In December 1994 it stated: "The efficacy of the vaccine against biological warfare is unknown." In the 1994 medical textbook Vaccines, Colonel Arthur Friedlander, the US Army's chief anthrax vaccine researcher, wrote: "The current vaccine against anthrax is unsatisfactory for several reasons. The vaccine is composed of an undefined crude culture . . . the degree of purity is unknown . . . the presence of constituents that may be undesirable may account for the level of reactogenicity observed."

This is the same vaccine - the same ingredients, if not the same batch - being administered to troops today. In October 2000, Col Friedlander gave evidence to the House committee. He said: "This vaccine is safe and effective, and it's the best vaccine we have to protect against this disease." Col Friedlander says he has taken the vaccine himself. There is no reason to believe his assertion before the committee was not genuinely held. One thing, however, had changed: the determination of the US government to immunise the entire military.

Throughout the 1990s, MBPI had been manufacturing millions of doses in the conditions so damned by the February 1998 FDA inspection, as political demands for the vaccine grew. In 1996 the Khobar Towers bombing in Saudi Arabia killed 19 US troops. Pan-Arab terrorism had begun in earnest. The spectre of biological terrorism was becoming a genuine political concern.

So the Army again looked at the anthrax vaccine. This time the plan was bold: a mass immunisation programme for all 2.4 million servicemen and women. In 1995 the Army contracted the SAIC Corporation, consultants to the Pentagon, to submit a plan that would enable them to obtain an FDA licence for inhalation anthrax. In its report, the SAIC's plan clearly identified the vaccine's legal status: "This vaccine is not licensed for aerosol exposure expected in a biological warfare environment." Under US law, the lack of such a licence meant that soldiers could not be given the vaccine without their "informed consent", a hurdle that would have made a mass immunisation programme impossible.

On September 20, 1996, MBPI submitted an Investigational New Drug (IND) application to the FDA. Again, one of its purposes was clear: "To obtain a specific indication for inhalation anthrax." That IND application has never been acted upon by the FDA.

Six months later the FDA's stance on the vaccine appeared to change. In 1997 a new Defence Secretary, William Cohen, made combating bio-terrorism a priority. On March 4, 1997, four days after the retirement of the long-serving FDA Commissioner David Kessler, the Assistant US Defence Secretary (Health Affairs), Dr Stephen Joseph, wrote to the acting FDA Commissioner, Dr Michael Friedman. Dr Joseph said the Defence Department had "long interpreted" the vaccine as being effective for inhalation anthrax. This was six months after the IND application.

Dr Friedman replied on March 13. It was a response that seemed to clear the regulatory hurdle for a mass immunisation programme: "While there is a paucity of data regarding the effectiveness of Anthrax Vaccine for prevention of inhalation anthrax, the current package insert does not preclude the use." The insert said the vaccine was licensed for "at risk" industrial and veterinary workers. It did not specify the type of infection.

Meanwhile, MBPI was in financial trouble. In June 1998 a private consortium named BioPort, headed by a Lebanese businessman, Fuad El-Hibri, bought the company for $24 million. A major shareholder and director of BioPort was Admiral William Crowe, Chairman of the Joint Chiefs of Staff under the Reagan and Bush Senior administrations, and a friend of El-Hibri; the two met while Crowe was Ambassador to the UK.

Less than a month after the sale of MBPI, BioPort landed an exclusive $29 million contract with the Pentagon to "manufacture, test, bottle and store the anthrax vaccine." Admiral Crowe has vehemently denied that he knew of the deal before BioPort purchased MBPI. He also insists that the vaccine is safe. Within months, BioPort too was in trouble. Unable to rectify in time the problems highlighted in the FDA's February 1998 inspection report, the new owner, like MBPI before it, was unable to ship any new vaccine. It appealed to the Pentagon for more money. By June 2000 the Anthrax Vaccine Immunisation Programme (AVIP) had all but ended, due in large part to dwindling supplies.

Not until January this year was BioPort authorised to start shipping new vaccines. But between March 1998 and January 2000, according to the Pentagon's own figures, 2.1 million doses of stockpiled, pre-February 1998 vaccines were administered to 535,000 troops. Only in August did the FDA prohibit BioPort from using any pre-1998 vaccine. During that period the Pentagon spent over $100 million of taxpayers' money renovating the plant. It is also paying about $20 a dose, more than three times the original price negotiated three years ago. And critics point out that no matter how much money has been spent renovating the plant and cleaning up the manufacturing process, the vaccine itself, given to troops heading to the Gulf today, has not changed.

Photo: Tom Colosimo with his bride.

Photo: Tom after anthrax innoculation.

Six months after the FDA inspection of the plant, Captain Tom Rempfer and Major Russ Dingle, officers in the Connecticut Air National Guard, were asked by their commanding officer to look into the vaccine. Misgivings about the jabs had begun to spread, and it was felt that their investigation would put the minds of fellow pilots at rest.

It didn't. The two officers wanted to go public when they discovered the FDA inspection report. Senior officers in their unit, they say, ordered them to keep their discovery secret. They then refused to take the jab, and were ordered to resign their commissions. Both pilots have filed federal lawsuits against BioPort challenging the effectiveness of the vaccine. The sister of Sandra Larson, a soldier who died three months after her sixth jab, has also been joined by Ronda Wilson in suing BioPort. Their lawyer, Alan Milstein, says he hopes to bring a class action involving hundreds of former servicemen. Their cases, they say, have been greatly helped by the House of Representatives.

In April 2000, after days of testimony, the House Government Reform Committee released its verdict on the vaccine. It stated: "The AVIP programme . . . leaves the Department of Defence captive to old technology and a single, untested company . . . based on a dangerously narrow scientific and medical foundation. The safety of the vaccine is not being monitored adequately." As a health care effort, "the AVIP compromises the practice of medicine to achieve military objectives." It derided the "preposterously low" adverse reaction rates reported by the Pentagon, which is "more concerned with public relations than effective force protection". It adds: "Adverse events following vaccination are reported by women at twice the rate among men." And it concludes: "AVIP raises an ominous question: who protects the force from ill-conceived force protection?"

The House committee, chaired by Dan Burton and Christopher Shays, both Republican congressman, recommended that the AVIP programme be suspended. Lawrence Halloran, a senior aide to Shays, says: "The FDA was leant on by the Department of Defence in 1997, and took a shortcut. They interpreted the old licence on the fly, giving the vaccine approval. It is not a standard you would find anywhere else. No other drug m manufacturer would be given approval for a product like this. "The committee concluded that it is not licensed for inhalation anthrax. There is no question it is harmful to some people's health. To persist with using this vaccine at the expense of developing a new one is a scandal." So how can the Pentagon be allowed to vaccinate troops with such a discredited product? "Because they can," Halloran says. "They felt a desperate need to have something at hand, and this was already on the shelf. After the Gulf War they panicked, and felt they had to do something. They have the weight to intimidate the FDA into ignoring the problems."

In August the FDA acknowledged problems with the vaccine. The product insert was altered dramatically. It said the vaccine could harm people with immunity disorders, could cause a host of serious long-term adverse reactions and could already be responsible for six deaths and a number of birth defects. According to the Pentagon, of the 535,000 troops inoculated, 1,578 have reported adverse reactions with 208 classified as "serious". The insert warnings were based in part on a report by the US General Accounting Office earlier this year, which stated that adverse reactions occur in five to 35 per cent of people who take the injection, vastly higher than a previous Pentagon claim of only 0.2 per cent. The GAO also criticised the pressure exerted on troops not to report adverse effects, so as not to jeopardise their military careers.

James Turner, a Pentagon spokesman, says: "The vaccine is safe and effective. Period." He points to the FDA's own evaluation of the vaccine. Kim Brennan Root, of BioPort, refers to the product insert, which states: "BioThrax is also indicated for individuals at high risk of exposure to bacillus anthracis spores." She says: "It doesn't say it is licensed for one type of anthrax over another. There are three types: inhalation, cutaneous and intestinal. The critics keep pointing to the 1996 IND application. They say the licence does not specify inhalation anthrax. Well, the licence merely specifies that it protects against the disease, regardless of what form you contract. If you follow the critics' line of argument, we would have to expose people to high levels of inhalation challenge. We have monkey studies which support the effectiveness of the product for all three types."

In August the FDA gave a 25-page, point-by-point response to a Citizen's Petition filed by Major Dingle. It stated that in 1972, when the FDA assumed responsibility for regulating the drugs industry, independent panels reviewed the vaccine, concluding that it is "safe and effective". Referring to its own February 1998 inspection of BioPort, the FDA states: "Inspectional observations do not necessarily render the anthrax vaccine unsafe or ineffective." Their assurances are of little comfort to Ronda Wilson. She says: "Everybody said I should get over my anger. But anger is the only thing that gets me out of bed in the morning. I have lost my marriage, my career, my dreams, my future, my pleasures. I would have died for my country. But I didn't think I would die like this."

Above photo: People Magazine, October 25, 1999 - Cohen allegedly receiving the 3rd of 6 shots.

AVP goes public

A few weeks prior to the December 15, 1997 announcement of the Anthrax Vaccine Program, US Secretary of Defense William S. Cohen held up a 5-lb. bag of sugar on national television and warned that if the bag contained anthrax, it could kill half of Washington, DC.

March 1998 Cohen gets publicly vaccinated and mass mandatory vaccinations began. This begs the question: did he get saline or the squaline??