The Anthrax VaccineTime and time again over more than two centuries, America’s young people have been called to defend the cause of freedom. In each instance, they have come forward, without fear or reservation, to do what is right. Today they are again fighting on foreign shores both in Iraq and Afghanistan trying to assure to others the same benefits of liberty enjoyed by citizens of the United States. Like their predecessors, they have chosen to subordinate their own well being and safety to the greater good. There can be little doubt that their unselfish sacrifice deserves the gratitude of the protected.

But it deserves something else as well. It deserves honesty and that, in at least one respect, is something that they are not getting.

Anthrax Vaccine Immunization Program

Three years ago, this column first raised the alarm over the mandatory administration of the Anthrax vaccine to members of the Armed Forces. Although the Department of Defense claimed that its Anthrax Vaccine Immunization Program or AVIP posed no serious health threat to the troops and, more important, was necessary to protect the troops against the threat of biological weapons – other voices had raised concerns.

Not the least of these was the troops themselves.

Indeed, during the initial period following initiation of the AVIP program hundreds of service members went so far as to face court-martial rather than be immunized.

Ultimately, the controversy found its way into the courts.

On December 22, 2003, U.S. District Court Judge Emmet G. Sullivan issued a temporary injunction halting the AVIP program because the FDA had failed to approve the vaccine for inhalation Anthrax, the form associated with biological weapons. Two weeks later, however, he lifted the injunction when the FDA issued the necessary approval. In lifting the ban, though, Judge Sullivan called the timing of the FDA ruling “highly suspicious.”

The Judge’s skepticism was more than evident in an exchange with Shannen Coffin, a Justice Department lawyer representing the Pentagon:

“Only after issuance of an injunction, up pops a federal rule, and you’re telling me it’s coincidental?” the Judge asked.

“I’d stand on a stack of Bibles and tell you it’s coincidental.” Coffin insisted.

“That’s an amazing coincidence.” Judge Sullivan replied.

The legal wrangling, however, was not over.

Six service members, whose identity was concealed to protect against retaliation, still had an ongoing suit against the mandatory vaccination program based on different facts. They still had not had their day in court, and quite a day it would be.

On October 27, 2004, ten months after Judge Sullivan had been forced to reinstate the vaccination program by the FDA’s oddly timed ruling, he again ordered a halt to the program. This time his decision was based on the failure of the FDA to allow appropriate public comment when it approved the Anthrax vaccine the previous year.

In his decision, U.S. District Court Judge Emmet G. Sullivan said:

“The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all – public scrutiny.”

The service member’s lawyer, Mark Zaid was ecstatic stating:

“It validates our position of six years that the program was illegal and ill-conceived from day one.”

Still, the Department of Defense continued to maintain that there was no problem insisting that:

“DoD remains convinced that the (vaccination program) complies with all legal requirements and that the Anthrax vaccine is safe and effective.”

Judge Sullivan was not so sure. Moreover, he was sure that there were many citizens who shared his doubts and who had not been given the opportunity to express them. In his decision he said:

“While some individuals may have submitted comments as part of a citizen petition, it is clear to this court that if the status of the Anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency.”

With the new injunction in place, the Defense Department had no choice but to make taking the vaccine voluntary. Service members soon demonstrated their doubts, with more than half refusing vaccination.

But the battle was far from over.

The Pentagon continued to press for approval of the Anthrax vaccine asserting that it was safe and effective. What made their insistence all the more difficult to understand was the fact that there was a substantial body of evidence to suggest that the Anthrax vaccine was anything but safe and effective.

In one study of soldiers at Ft. Bragg, North Carolina, 44 percent of those vaccinated suffered an adverse reaction. In another study performed at a U.S. military facility in Korea, between 72 percent and 74 percent of all women vaccinated had adverse reactions as did between 42 percent and 44 percent of the men.

Nor was the military the only branch of government that had developed data questioning the safety of the Anthrax shots.

The Government Accounting Office (GAO), the official investigative arm of the Congress, conducted a study of Air National Guard pilots and aircrew members who had been vaccinated and found that 37 PERCENT had SERIOUS adverse reactions and that an astounding 84 PERCENT had some sort of adverse reaction.

Perhaps the most important data developed by the GAO was that almost ONE-FIFTH of those vaccinated had SYSTEMIC reactions, the most serious kind. These reactions can have effects that linger for months, years, or even a lifetime!

Remember, the rate of adverse effects found by the GAO was 100 TIMES that claimed by the vaccine’s manufacturer!

What is perhaps most disturbing about the Pentagon’s insistence on vaccinating the troops is that the rationale for administering this dangerous drug no longer exists!

The reason that the Defense Department wanted our service members vaccinated was the strong belief that they might face biological weapons in Iraq.

Now, no matter what you might have read in the press, there really was good reason for military leaders to have this concern.

During the Iran-Iraq War in the 1980s, Saddam Hussein used chemical weapons against his opponent, and was trying to develop biological weapons – especially Anthrax – as well. Following that conflict, he also used weapons of mass destruction – again poison gas – against the Kurds in Northern Iraq, killing at least 100,000. Moreover, during the first Persian Gulf War, stores of chemical weapons were discovered.

There was a substantial body of evidence that in the years following the first Persian Gulf War he was continuing to try to develop chemical, biological and even nuclear weapons. So the concern was valid. As it turned out, however, it was also based on bad information.

Interrogations of Iraqi scientists revealed a bizarre truth: They were so fearful of retribution in the event of failure that they vastly overstated the degree of progress they were making in the development of chemical, nuclear and biological weapons to their superiors. Indeed, in large degree their whole program to develop weapons of mass destruction was a sham, concocted to keep them from earning the Iraqi dictator’s wrath.

Therefore, the major reason for insisting that all troops be inoculated: the potential that their enemy would use biological weapons against them was no longer present. Despite this fact, the Pentagon continued to insist on vaccination, and therein lies the problem.

No one would argue against vaccinating troops, even if there were a substantial risk to their health, if there was a reasonable certainty that they would be exposed to weapons grade Anthrax. Given the virulence of such biological weapons and the high probability that without the vaccination many of those exposed would die, it made sense. But now that the threat no longer exists – if it ever did – there is no reason to vaccinate them if a substantial risk is involved.

Moreover, the experience with the Anthrax attacks that took place in the United States following the September 11 attack on the World Trade Center has demonstrated that if treated immediately with high-powered antibiotics such as Cipro, the effects of exposure can be overcome.

Of course, if, as the Pentagon has maintained, the risk of adverse effects is low, then it might still be prudent to vaccinate the troops on the chance that someone might develop and use Anthrax against them. Indeed, this is exactly the argument a parade of high-ranking officers has made to Congress over the past several years when called upon to testify on the subject.

But now we know that they have not been telling the truth!

The Newport News, Virginia, Daily News recently published the results of an investigation into the Pentagon’s Anthrax vaccine program that revealed the stunning and outrageous truth: the Pentagon has been hiding the facts about the vaccine’s dangers for more than a decade!

The article notes how, in their periodic appearances before Congress, the Pentagon Brass has always said that there were fewer than 100 cases of adverse effects involving hospitalization or serious illness from the Anthrax vaccine during the period between 1998 and 2000. They also insisted that their official policy was that any serious illness or hospitalization associated with the vaccine had to be reported within 24 hours. As the Daily News discovered, there was a reason why the numbers were so low: THEY COOKED THE BOOKS!

The way they did this was to limit the types of illnesses doctors were allowed to report as adverse effects from the vaccine. By deliberately understating the number of adverse effects, they were able to create the impression that the vaccine was much safer than was actually the case.

Now we must be clear here. We are not talking about a difference of a few hundred cases or even a few thousand. Rather, we are talking about an adverse effect rate fully 200 TIMES as high as the Pentagon reported. Instead of less than 100 cases of serious adverse effects, there were ALMOST 21,000!!! AND THOSE ARE JUST THE MOST SERIOUS CASES!!!

Further, in some cases, the types of reactions that went unreported were not just serious, they were a death sentence. For example, three cases of amyotrophic lateral sclerosis, or ALS, commonly referred to as Lou Gehrig’s Disease, went unreported.

The Pentagon argues that a statistical analysis of the incidence of the various illnesses and other adverse effects experienced by service members who were vaccinated were within normal limits. Other medical experts, however, do not agree.

One of the main criticisms stems from the fact that the adverse effects experienced involve a complex set of symptoms, but the statistical analysis reviewed symptoms individually. Moreover, the Pentagon stopped keeping records of adverse events in 2000, even though the effects of the vaccine might be long-term. What is perhaps most disturbing about the discontinuation of the Anthrax vaccine monitoring program is that it failed to meet the standards set by the National Institute of Medicine, which recommends a minimum of five years of surveillance.

Meanwhile, veterans who were forced to take the vaccine continue to experience problems. Among the most common are neuropathy – a tingling in the feet arms and hands, chronic pain in the joints and other symptoms of arthritis and difficulty in concentrating. Other more serious problems include things such as ALS.

In the face of such complaints, how could the military brass continue to tell Congress there was no problem?

The answer is simple, they played word games.

Testifying at a congressional hearing, Lt. General G. Robert Claypool, who at the time was the Deputy Assistant Secretary of Defense for Health Operations Policy said:

“The duty to report adverse medication events has been codified for many years. The joint regulation requires submission of a form, VAERS-1 for all adverse events resulting in more than 24 hours of lost duty time or any period of hospitalization. These requirements represent a higher standard than in comparable civilian community health care settings.”

That certainly is an impressive statement, but there’s a catch. He said that all hospitalizations related to adverse medication events had to be reported, not ALL HOSPITALIZATIONS. But if a particular symptom or health problem is not classified as a recognized “adverse event” then it need not be reported.

In some cases it may well be that the hospitalizations not reported were in fact not related to the vaccine. But we will never know if no attempt is made to determine where the truth lies. Still, it would seem impossible, after five years, to discover the truth. Things, however, are not always what they seem.

In addition to the VAERS system, the military also maintains another database: the Defense Medical Surveillance System or DMSS. It is the most exact and comprehensive database of its kind. The DMSS is capable of tracking and accessing every item of medical information on every member of the Armed Forces: every shot, doctor visit, hospitalization or other medical treatment. The VAERS system pales in comparison.

So why not access and analyze this data to put the vaccine debate to rest once and for all?

The Pentagon argues that they cannot figure out how to access the data and still protect patient privacy.

Officials at the National Institute of Medicine have one thing to say about this claim: NONSENSE!

One Institute official put it succinctly:

“We use these kinds of data sets in Medicaid and Medicare all the time. There are technological solutions.”

Indeed, the type of epidemiological research access to the DMSS records would allow is exactly what is needed to get to the truth. Moreover it is in the Pentagon’s interest to find out if the vaccine is dangerous.

As military technology has become more complex, the cost of training members of the Armed Forces has become increasingly expensive. It can cost anywhere from a hundred thousand dollars to train an infantryman to millions of dollars to train a fighter pilot or Special Forces soldier. But it is not just the money. It also takes time – years in some instances – to fully train military personnel for some specialties and it is the most highly trained service members that are likely to be the first deployed. It is therefore foolish on many levels to risk their becoming incapacitated by an unsafe vaccine.

So why does the military continue to resist scrutiny?

Some observers believe it is a matter of control:

“If you let independent people have the data, you run the risk of losing control. In combat, letting things get out of control gets people killed, so loss of control is a very sensitive issue.”

This may be true, but so is needlessly causing illness or injury to those who volunteer to defend their nation. Yet that is exactly what is about to happen.

On December 19, 2005, the FDA issued a ruling that recognized the Anthrax vaccine as “safe and effective” against all forms of the disease. This once again opens the door to a resumption of the military’s mandatory vaccination program. If it is resumed, our service personnel will once again face the dilemma of taking a vaccine that poses unknown and potentially fatal side effects or ending their military careers. It is a choice they should not have to make.