The debate over the anthrax vaccine has taken on an even greater importance as tens of thousands of America’s military men and women go into harm’s way. It is a testament to the strength of our democracy that they are willing to put their lives at risk to protect freedom for the rest of us.

We owe them a debt of gratitude that can never be repaid. But we owe them something else as well – the assurance that the risks they face will be justified. Their lives are too precious to be squandered through arrogance, intransigence, corruption or bureaucratic inertia. The trouble is, the forced administration of the anthrax vaccine may be a product of all of these factors. If so, it will constitute a monumental breach of faith with those who serve so bravely in uniform.

IS THE VACCINE SAFE?

At the heart of the issue is the debate over whether the anthrax vaccine, or AVA, is safe and effective. Despite the growing criticism, the Department of Defense continues to insist that the anthrax vaccine is safe. DOD officials responsible for the Anthrax Vaccination Implementation Program point to recent reports by the National Institutes of Medicine’s Institute of Medicine (IOM) to back up their claim. Yet, these documents are far from the ringing endorsement the DOD officials would have the public believe. Indeed, the first IOM report, issued on March 30, 2000 concluded that:

“… in the peer-reviewed literature, there is inadequate/insufficient evidence to determine whether an association does or does not exist between anthrax vaccination and long-term adverse human outcomes.”

In another section the same report said:

“There is a paucity of published peer-reviewed literature on the safety of the anthrax vaccine.”

The IOM further noted that much of the research on the anthrax vaccine was conducted on animals. The report stated flatly that:

“Few meaningful conclusions regarding adverse effects in humans can be drawn from animal studies of the vaccine…”

The concerns about the lack of data voiced by the IOM echoed those expressed six months earlier at an October 1999 congressional hearing.

One important witness was Dr. Kwai Chan, Director of the Government Accounting Office Special Studies and Evaluation Group. At that October 1999 hearing – over three years ago mind you – he told members of the House Government Reform Committee that:

“The long-term safety of the vaccine has not yet been studied.”

In that same testimony Dr. Chan also discussed the high rate of reactions to the vaccine, noting that:

“About 35 percent (of the vaccine recipients) had local reactions, a figure that varied during the inoculation series.”

The group of anthrax vaccine recipients Dr. Chan studied was not the only one to suffer a high rate of reactions. As noted earlier, a 1993 study of soldiers receiving the anthrax vaccine at Ft. Bragg, N.C. reported that 44 percent had one or more systemic reactions to the inoculation. Similar results were found among male soldiers in Korea, while female soldiers suffered adverse effects at a rate of between 72 percent and 74 percent.

Despite this existing evidence, however, DOD officials testifying at the hearing insisted that there was no problem.

At the same hearing that Dr. Chan addressed, Dr. Sue Bailey, then DOD’s top medical official strongly disagreed stating:

“The Department is confident as is the Food and Drug Administration that the FDA-licensed anthrax vaccine is safe and efficacious for its intended use.”

This benign assertion, though, grossly overstates the FDA’s actual position. After performing a risk/benefit analysis of the anthrax vaccine, what the FDA actually said was:

“This vaccine is recommended for a limited, high-risk of exposure population.”

More important, it’s only approved use was for cutaneous (skin contact) anthrax, not the more deadly inhalation anthrax.

EVER-BROADER WAIVERS

The fact is that even the manufacturer of the vaccine has had continuing doubts about its safety. Why else would MBPI and its successor, the BioPort Corporation of Lansing, Michigan, have insisted on being granted three increasingly broad special waivers of liability before agreeing to produce the product?

As early as 1986, DOD, through Army Secretary John Marsh granted Michigan Biologics Products Institute or MBPI the original manufacturer indemnification of liability from “… the possibility that persons vaccinated may develop anaphylaxis or some unforeseen reaction of serious consequences, including death.”

In 1992, Army Secretary Togo West Jr. expanded the indemnification to include all liability arising from: “ … the unusually hazardous risks associated with potential reactions and the potential lack of efficacy of the AVA.”

In 1998, Army Secretary Louis Caldera again expanded the indemnification because “…the size of the proposed vaccination program may reveal unforwarned idiosyncratic adverse reactions.”

Yet despite these existing questions and the paucity of safety data concerning the anthrax vaccine, a remarkable event occurred in May of 2002. The Department of Defense announced that the Institute of Medicine had completed another study and proclaimed the anthrax vaccine safe and effective!

A DRAMATIC REVERSAL

In its earlier report, thet Institute of Medicine went to great lengths to emphasize the lack of credible information concerning the anthrax vaccine. To many observers it seemed remarkable that enough progress could be made in just eighteen months to satisfy the Institute's concerns. A close reading of the May 2002 report, however, helps to explain what really happened.

Oddly, it seems to be organized to specifically address each charge leveled by the vaccine’s critics.

For example, one criticism is that there has been little testing to ensure that the vaccine would be effective against inhalation anthrax – the greatest danger to our troops.

The IOM report first discusses a study of textile mill workers conducted in 1962 and a 1985 CDC study holding them up as proof that the vaccine is effective. It then goes on to state, however, that:

“The small number of inhalation cases in those studies provides insufficient information to establish the vaccine’s efficacy against inhalational infection, but the data suggest the vaccine has a protective effect.”

The report notes that exposing humans to inhalation anthrax would be unethical, and that animal experiments should be conducted instead.

The researchers are, of course, correct in labeling human experimentation unethical. They are also correct in their assertion that further animal testing should be conducted. The question, however, is how could they possibly state as fact that the anthrax vaccine is effective against inhalation anthrax and at the same time say more research is needed?

Perhaps the most troubling aspect of the report are the gyrations the researchers seemed to go through to justify their conclusion that “ … AVA as licensed is an effective vaccine for the protection of humans against anthrax, including inhalation anthrax…”

For example part of their justification is that “A vaccine similar to AVA was shown to be effective against cutaneous anthrax in humans …”

Shouldn’t they at least have relied on data about the vaccine they were declaring effective?

They also base their finding on what they term “… reasonable assumptions of analogy…” between human and animal testing. It is well established in medicine, however, that there is no guarantee that results achieved in animals will be duplicated in humans. To imply that animal data could readily be applied to humans is at best highly questionable.

Yet another troubling pronouncement is the assertion that the vaccine would be effective against “… any known or plausible engineered strains of B. anthracis.” Again, no data is presented to support this astounding assertion. Rather it is just stated with the assumption that the reader will accept it unquestioningly!

It’s just one more case of “We’re the experts – trust us!”

As in the case of efficacy, the IOM researchers were careful to cover their backsides!

In the report’s introductory chapter on safety, the researchers provide a long list of reasons why it is difficult to assess the safety of vaccines. They note that study populations are generally small. They discuss the difficulties in avoiding exposure to outside contaminants that could produce false results. They talk about the fact that adverse reactions can take many forms and that as a result there is a lack of unique symptoms researchers can point to.

What they are saying in essence is that there is no way to truly establish the safety of a vaccine!

After making this extraordinary assertion, the researchers then go on to dismiss concerns that critics have raised claiming that for the most part they are “self-limited and result in no serious, permanent health impairments.” They do, however acknowledge the differences in reaction rates for males and females, but only recommend further monitoring.

n discussing adverse reactions, though, the researchers primarily focused on those that occurred immediately. In regard to longer-term effects they state:

“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.”

This sounds reassuring, but it hides an important truth. According to the researcher themselves, “Although the AVA has been administered to military personnel for more than 3 years, unreliable documentation of vaccination before 1998 limits analysis of data for observation of potential vaccine-related health effects over longer periods.”

This is a critical omission because many of the immune system diseases associated with the vaccine may not show up for five or ten years. Despite the lack of information, the researchers still assert that:

“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.”

If there is no data, how can they be so sure?

Moreover, the data they do have may be tainted.

The researchers acknowledge that “Some service members have expressed concern that they have been discouraged from submitting VAERS (Vaccine Adverse Event Reporting System) reports regarding the anthrax vaccine.”

They go on to say:

“According to service member testimony to the U.S. Congress as well as statements to this Institute of Medicine committee, reporting to VAERS has at times ‘met reluctance’ or taken place only after delays.”

What the researchers are trying to sugar coat is a systematic suppression of adverse event reports concerning adverse reactions to the anthrax vaccine that permeates the military medical service. Service members have complained that when they attempted to report vaccine reactions they were ignored, accused of malingering, or simply threatened to prevent them from submitting the information.

In fact, the situation generated so many complaints to Congress that in October of 2000, the surgeons general of all three military services issued instructions to their medical care-givers to take complaints concerning vaccine reactions seriously and to report them promptly. What the IOM researchers fail to acknowledge was that if service members were still complaining to them more than a year after the instructions were issued, the instructions were clearly ignored. Therefore, the data submitted by the military was probably severely understating the extent of vaccine-related adverse events. Indeed, data that is contained in the IOM report indicate that anywhere from 60 percent to 70 percent of the vaccine-related adverse reactions were never reported.

Taken together, what all of this means is that there is no clear picture of what the real rate of reactions to the anthrax vaccine is, how severe those reactions might be, or what possible health threats may lie down the road for those who were inoculated.

The Institute of Medicine Committee may have had the same concerns, because they carefully hedged their bets in the first paragraph of the press release accompanying the anthrax report stating:

“The current vaccine can continue to be used, but the U.S. Department of Defense should vigorously support research efforts not only to improve the way it is administered, but also to develop an alternative.”

Further down in the release, the researchers again qualify their support:

“The most prudent course of action is to develop a new vaccine – given the nation’s war against terrorism and the domestic attacks where anthrax was used as a deadly weapon. In the meantime, the current vaccine is sufficiently safe and effective to be useful.”

This is hardly a ringing endorsement!

Yet, despite their ambivalence, the IOM committee members still gave DOD the green light to being the vaccination program, and it has proceeded apace. But, is this decision in the best interests of our men and women in uniform? Also, what is the Congress doing about the anthrax controversy? Finally, why is it that the anthrax vaccine seems to cause such severe reactions?

The answers to these questions and more will be found in the final installment of this series next month.