Two hundred years ago the Founding Fathers signed the Declaration of Independence pledging their lives, fortunes and sacred honor to the creation of the cause of freedom. This pledge was no mere flight of rhetoric: many paid a heavy price for their courage as did countless average citizen-soldiers who rallied to freedom’s cause. Their willingness to put nation above self set an example that that became ingrained in our national character.

Time and time again over the past two centuries, when our nation was in jeopardy, new generations of America’s citizen-soldiers answered the call.

This tradition of patriotism and self-sacrifice remains as strong today as it was during the terrible winter at Valley Forge. From the rugged mountains of Afghanistan to the searing deserts of the Arabian Peninsula, our brave young men and women are once again placing themselves in harm’s way.

But as they prepare to risk their lives for freedom abroad, serious questions are being raised as to whether they are being forced to face an unnecessary risk from home: the risk associated with the Anthrax Vaccine Immunization Program or AVIP.

As previously discussed in this series, the anthrax vaccine has been fraught with controversy from the beginning. Bioport Inc., the product’s sole manufacturer has had a troubled history, characterized by failures to meet FDA safe manufacturing process rules, questionable financial dealings and strong suspicions of conflicts of interest. Issues concerning the safety of the vaccine have been swept under the rug by Department of Defense officials unwilling or unable to recognize that a problem might exist. Data that challenged the safety and effectiveness of the anthrax vaccine has been misrepresented or misinterpreted. Highly qualified experts on vaccines who attempted to raise safety issues were dismissed out of hand or accused of fostering “Internet propaganda.”

In short, there is a real question as to whether the Anthrax Vaccine Immunization Program is in the best interests of the service men and women it is supposed to protect. One thing is clear, however, many of the sailors, soldiers and airmen who are being forced to take the anthrax vaccine certainly don’t think so.

THE GAO REPORT

In September of 2002, the Government Accounting Office (GAO), the official investigative arm of Congress, issued a scathing report regarding the impact of DOD’s Anthrax Vaccine Immunization Program on pilots and aircrew personnel in the reserves and National Guard. The report was based on surveys and interviews conducted between 1998 and 2000.

The reason these personnel were of particular concern arose from the fact that unlike some other reserve components, they often played key roles in ongoing military operations. Without them the ability of the Armed Forces to function would be severely hampered. What the GAO discovered was deeply disturbing.

Between September of 1998 and September of 2002, 16 percent of the pilots and aircrew members of the guard and reserve had either transferred to another unit to avoid receiving the anthrax vaccine, moved to inactive status or left the military. Moreover, these personnel were among the most experience with an average of over 3,000 flight hours. What was even more disturbing, however, was the indication that another 20 percent of experienced guard and reserve flight personnel planned to leave military service early. The report also noted that 24 percent of the pilots and aircrew who left the military did so before qualifying for military benefits! They would hardly take such a drastic step if there were not some severe underlying concern.

But, what was it?

The survey made the cause all too clear.

According to GAO’s investigation, fully 77 percent of the guard and reserve pilots and aircrew members would not have taken the anthrax vaccine voluntarily. Nine out of ten said they were concerned about its safety. Two thirds said they did not support the DOD mandatory anthrax vaccination program.

These results, however, did not reflect a general bias against vaccines. GAO investigators found that the guard and reserve personnel generally supported the notion of being vaccinated against potential health hazards. It was the anthrax vaccine specifically that they questioned – and apparently they had good reason.

ADVERSE EVENT RATES

Even though the adverse reaction rate reported by the anthrax vaccine’s manufacturer is high, it still apparently grossly understates what is really happening. The GAO found that among the 37 percent of guard and reserve pilots and aircrew members who had received at least one anthrax vaccine shot, 84 percent reported some type of reaction. This is almost THREE TIMES the 30 percent adverse event rate claimed by the manufacturer!

More important than the overall rate of adverse events, though, was the fact that almost one-fifth of them were systemic reactions, the most serious kind. Systemic reactions can often leave lasting effects or result in serious health problems years after they occur.

But even that wasn’t the worst.

Of even greater concern was the fact that about a fifth of the systemic reactions persisted for more than seven days. The reactions were often so severe that they had what GAO termed “negative implications” for safety and work performance. What the report’s clinical language is really saying is that the reactions could ruin someone’s career and permanently disable them!

Perhaps the most disturbing aspect of all, though, is that the rate of systemic reactions discovered by GAO was 100 TIMES as high as that claimed by the manufacturer! But given BioPort’s history it is not unsurprising. Both a 1997 survey of troops in Korea who had been given the anthrax vaccine and a study conducted among troops in Hawaii both found adverse event rates far in excess of those claimed by BioPort.

But why is there such a discrepancy between the adverse event rate claimed by the manufacturer and that uncovered by GAO?

One reason is that many of the reactions go unreported.

GAO found that concerns over the loss of flight status or of the effect on their military or civilian careers kept some vaccine recipients from reporting adverse reactions. Others simply didn’t know how – despite DOD’s assurances to Congress that it would be certain all personnel who were vaccinated were informed about how to report such reactions. Some personnel were afraid they’d be subjected to ridicule – again a violation of DOD’s assurances to Congress.

What all these factors taken together reveal is that the Department of Defense has continued to allow a climate of intimidation to exist aimed at minimizing the number of reported reactions to the anthrax vaccine. This notion is further reinforced by DOD’s reaction to the findings and conclusions of the GAO report.

As it has with any suggestion that there might be a problem with the anthrax vaccine, DOD simply dismissed GAO’s findings out of hand. GAO found the response less than satisfactory to say the least.

In its rebuttal of DOD’s assertion that no further monitoring of adverse events was needed the Government Accounting Office said:

“DOD’s selective use of a conclusion from the Institute of Medicine Report … ignores the comprehensive recommendations that the institute’s report actually made to DOD. … More importantly, DOD did not address two major findings from our survey (1) some of the adverse reactions that our respondents reported persisted for more than 7 days and (2) given that a large proportion of respondents were not reporting the symptoms to VAERS or their DOD health care practitioners, we do not know whether these reactions were resolved over time.”

In the concluding sentence of the GAO rebuttal the investigators exasperation with DOD intransigence became evident:

“… it is clear that the losses among the most experienced pilots (in bases where AVIP was implemented) resulting from the change in status were significant at some bases, resulting in the loss of an extremely seasoned workforce.”

How much of DOD’s resistance is simply a matter of bureaucratic inertia and how much is due to fears of the potential cost of treating individuals disabled by the anthrax vaccine is uncertain. What is certain, though is that the Department of Defense is simply refusing to acknowledge even the possibility that a problem might exist – a behavior that is reminiscent of DOD’s reaction to the problem of Agent Orange.

But is there a real threat to the long-term health of vaccine recipients or is the problem – as DOD contends – overblown?

A SMOKING GUN?

One sentence, tucked away in the GAO rebuttal, was a bombshell:

“Further, several studies in the United States and the United Kingdom now show a relationship between the anthrax vaccine and Gulf War Syndrome.”

What makes this sentence so significant is the fact that for years the Department of Defense not only claimed that the anthrax vaccine had no link to Gulf War Syndrome, it insisted that Gulf War Syndrome itself did not exist! Even now, DOD insists that service in the Persian Gulf War created no greater risk to the health of service members than any other conflict. The figures, however, suggest otherwise.

According to the Department of Veterans Affairs, As of April 2002, 198,716 veterans of the Gulf War have filed claims for disability status for one or more conditions. That amounts to 28 percent of all that served! Of the claims filed, up to that point, 151,031 had been granted. This compares with a disability rate of 8.6 percent for World War II, 5 percent for the Korean Conflict and 9.6 percent for the Vietnam War.

Granted, advances in far forward combat casualty care and Medivac capability have greatly increased a soldier’s chance of surviving a wound, but not to the degree reflected in the Gulf War figures. But surviving on the battlefield may not have been enough for many Gulf War Vets.

Some 7,758 Desert Storm Veterans have died. This death rate, over 1.1 percent is again remarkable considering the age of most of the conflict’s participants.

But why are Gulf War veterans getting sick?

Studies of British veterans of the conflict clearly suggest a connection with the vaccines they received.

The study, which was published in the respected British Medical Journal, compared the health outcomes of veterans of the Gulf War with those who performed peacekeeping duties in Bosnia. Not only did the study find a significant difference between the veterans who served in the Gulf and those who served in Bosnia, but they also found a particularly high incidence of so-called “multi-symptom illness,” what we now know as Gulf War Syndrome. Most important, the study directly linked this higher occurrence to the vaccines the soldiers received!

The British study broke down its statistics by individual vaccine as well as by the number of vaccines administered. It also compared results from service members who were vaccinated before being deployed to the Gulf with those who received their shots after they arrived.

The bottom line: soldiers who received vaccines were twice as likely to develop Gulf War Syndrome as those who did not.

But these statistics still don’t identify what was in the vaccine that could have caused the illness.

A number of researchers believe that they have found the answer: a substance called squalene.

WAS THE CURE WORSE THAN THE DISEASE?

Squalene is a substance that the body produces as it converts cholesterol to fat. Scientists have discovered that small amounts of the squalene can boost the body’s immune function. As a result, experiments have been conducted to see if squalene could be used in vaccines as what are called adjuvants.

Adjuvants are substances included in some vaccines to improve their immune response. They are not added to all vaccines, only those that require enhancement to protect the recipients. Many of the adjuvants currently used in vaccines are aluminum compounds, and were contained in the anthrax botulinum toxoid hepatitis B; tetanus-diphtheria and anthrax vaccines administered to troops during the Persian Gulf War.

DOD consistently claimed that it has never used squalene as an adjuvant in any vaccine, including the one for anthrax. The facts, however, do not confirm this assertion.

According to a report to Congress by the Government Accounting Office, between 1988 and 1998, the Department of Defense sponsored 101 human clinical trials of new vaccines. Roughly 20 percent of the vaccines tested included some form of adjuvant. A quarter of those containing an adjuvant included squalene.

In addition to the human trials, DOD also conducted a number of animal experiments on vaccines that contained a squalene adjuvant covering a wide range of diseases including toxic shock, malaria and, most importantly, anthrax!

The National Institute of Allergy and Infectious Disease (NIAID) has also sponsored human trials for vaccines using squalene as an adjuvant. In fact, such research began as early as 1987. Through 1999, the NIAID had conducted at least 23 trials of vaccines with a squalene adjuvant involving almost 1,200 human subjects!

Still, DOD officials have consistently insisted that they did not administer vaccines containing squalene to troops deployed to the Persian Gulf. Yet, GAO investigators found that this assertion, too, did not exactly square with the facts. Their 1999 report to Congress states:

“We cannot say definitively whether or not Gulf War-era veterans were given vaccines with adjuvant formulations containing squalene for a number of reasons. Although DOD officials told us 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 the vaccines at the time of the Gulf War. Also, some officials involved in the decisions were no longer employed with DOD at the time of our review, and we were either unable to locate them or they declined to be interviewed.”

In other words, at best, DOD simply doesn’t know, at worst they are covering up the truth!

But why all the fuss?

The reason is that while small amounts of squalene can boost the immune system, its effect is multiplied as much as 20,000 times with each successive dose. So, while a little bit might be helpful, too much can overcharge the immune system and actually trigger immune diseases – like Gulf War Syndrome!

Still, if there were no squalene in the vaccine, as DOD claimed, it wouldn’t matter.

The only trouble is, there was.

THE TRUTH COMES OUT

After years of denials by DOD, on September 28, 2000, the Food and Drug Administration announced that that it had discovered squalene in five lots of the anthrax vaccine. DOD officials were quick to assert that the amount of squalene discovered was so small that it could not be detected until a new and more sensitive test had been developed – this despite the fact that the test employed by the FDA had been in common use for two decades. They also claimed that the squalene that had been detected was probably from contamination that occurred during the testing. They then went on to claim that there was no assurance that the vaccine actually administered contained squalene in the first place, and that even if it did, the small amounts detected could not possibly have any health consequences.

What the officials were ignoring in their denials was the cumulative effect of squalene.

While a single dose at such low levels might not be a problem, the anthrax vaccine is administered in a series of six shots over eighteen months. Therefore, each successive dose would have a greatly magnified impact on the immune system.

Further, the FDA analysis was not the only evidence of squalene.

A study conducted at Tulane University on the presence of antibodies to squalene revealed a deeply disturbing pattern. The study examined blood samples from 144 Gulf War era veterans or military employees, 48 blood donors, 40 patients with systemic lupus erythematosus (SLE), 34 patients with silicone breast implants and 30 patients with chronic fatigue syndrome.

The study employed a “blinded” test – the gold standard in research – to determine if squalene antibodies were present.

What the researchers found was that 95percent of the Gulf War veterans suffering from chronic fatigue syndrome had antibodies to squalene, but that none of the Gulf War veterans who were healthy did. Moreover, only 5 percent of the blood donors had the antibodies, and only 10 percent of the patients with SLE or breast implants. Some 15 percent of the patients with chronic fatigue syndrome who were not Gulf War vets also had the antibody.

And what is DOD’s response to the mounting body of evidence?

It says it needs to develop a test for antibodies to squalene, but its development could take "several years.” Meanwhile, it is proceeding with anthrax vaccinations because they are necessary to protect the troops.

But is vaccination the only answer?

OTHER ALTERNATIVES

The anthrax laden letter attacks that followed the destruction of the World Trade Center created a new sense of urgency regarding biological warfare. But the attacks also made clear the fact that vaccination was not the only answer.

First of all, at least some of the five deaths tied to the attacks could have been avoided if medical personnel were more familiar with the symptoms of inhalation anthrax. It’s not surprising that they did not immediately recognize the disease, prior to the first death in Florida, there had not been a case of inhalation anthrax in the United States for three decades. Several of the other deaths were also ascribed to a failure to recognize the symptoms on the part of emergency room personnel who had never seen the disease.

What has been learned, though, is that early, aggressive treatment with antibiotics can prevent the disease from being fatal. Moreover, even common, relatively inexpensive antibiotics such as ampicillin can be effective for many people. In other instances powerful members of the fluoroquinilone family of antibiotics are needed, but the important fact is that they, too, are effective.

In addition, the circumstances under which troops are likely to encounter anthrax are quite different from those that existed during the domestic attacks.

First of all, the domestic incidents were unexpected, whereas on the battlefield, military personnel will be prepared for the prospect of a chemical or biological attack.

Secondly, those exposed to anthrax from the letter attacks were unprotected. Troops on the battlefield will wear chemical protective suits that should largely prevent contamination.

Third, doctors at military aid stations will be looking for signs of chemical or biological agents. They will therefore be ready to immediately administer the proper treatment.

Finally, the domestic anthrax victims were largely older individuals (and one seven-month old infant) who were less likely to have vigorous immune systems. In contrast, most military personnel are relatively young and in prime physical condition, making them better able to resist the disease and respond to treatment.

Taken together, these factors raise a serious question as to whether the risks associated with the anthrax disease might not be greater than the risks our soldiers will face on the battlefield.

But it is not just our fighting men and women who may be placed at risk.

The Department of Defense has established a series of priorities regarding who will get the vaccine first, beginning with elite service members such as pilots, Special Forces, Navy Seals and Army Rangers, and then our top Infantry units – in other words, the “teeth” of our military establishment. If they are adversely effected by the vaccine – even for a short time – then the entire nation is left defenseless because those we rely on to protect America will be unable to do so! It is difficult to believe that the very officials who are responsible for America’s security would endanger it merely to satisfy some bureaucratic whim, but that seems to be exactly what is happening!

Our brave young men and women are willing to place their lives in jeopardy in the defense of freedom. It is unforgivable that officials of their own government would knowingly add to the risks they face and in so doing jeopardize the safety of every American citizen as well! It is time that they put the national interest ahead of their bureaucratic agenda.