FDA ruling on PB ignores scientific facts

“Gulf War veterans and scientist are justifiably distressed at the government decision to ignore the scientific evidence regarding this drug. Documents and scientific studies conducted over the last 12 years have clearly shown this drug is both experimental and harmful,” said Michael Woods, President of the NGWRC.

“Citizens and soldiers alike should demand an explanation of this ruling. The Department of Defense and the Department of Veterans Affairs have both concluded through previous studies that PB could not be ruled out as a factor in the illnesses Gulf War veterans currently suffer from. While the drug may be approved for civilians who have the neuromuscular disease called myasthenia gravis, it has never been shown to be either effective or safe for the military application against Soman,” said Steve Robinson, Executive Director of the NGWRC.

In fact, studies have shown that PB’s effectiveness against Soman is questionable. Prescribing PB as a pretreatment is a guess and is not proven effective by scientific fact.

Second, PB’s dosing for effectiveness is variable in each individual and would require individual evaluation due to the genetics and the size of the person receiving the dose.

Third, PB is known to cause muscle damage in the animal studies cited by the FDA with even one dose.

Fourth, PB may be in part responsible for Persian Gulf Illness. This fact cannot be denied and has been emphasized by DoD, the Department of Veterans Affairs, RAND, the Institute of Medicine, the VA Research Advisory Committee on Gulf War Illnesses and veterans.

Fifth, PB can increase the effect of Sarin gas on anyone exposed. Thus, in allowing this use, the FDA, DOD, Congress, the President and ICN Pharmaceuticals are allowing a questionable protection against Soman and also increasing the likelihood that troops will be more susceptible to Sarin and possible complications after the war.

It is possible that those who made the decision think they have chosen the lesser of two evils with the troops protection in mind but ignoring the facts surrounding the risk of PB use is completely irresponsible behavior for all concerned.

It is unfortunate that, on the eve of a potential war with Iraq, the FDA has approved another drug that is known to have harmed veterans of the last Gulf War.

The NGWRC will continue to support the troops of the next Gulf War by asking tough questions when they arise. We will also continue to fight for the rights, treatment and fair compensation of veterans of the last Gulf War.

Soldiers will be forced to take this drug if ordered, regardless of the potential damage.

Once again our government is putting soldiers in another type of “Harms Way,” which could have been prevented. This ruling, in combination with equipment deficiencies, is most likely the impetus for soldiers saving their sperm prior to deployment.

In 2002 FDA and the Pentagon succeeded in their three year effort to get Congress to approve a change the Food Drug and Cosmetic Act to allow animal efficacy tests to suffice for licensure of Biological Warfare (BW) drugs/vaccines. So, the use of PB for protection in a BW context is no longer considered an experiment. This lowers the political liability associated with its use.

(See Public Law 107-188, H.R. 3448, Sec. 123).

According to the law, the use of animal tests to prove efficacy for biodefense products is supposed to depend upon a proven correlate of immunity, for a particular drug/vaccine and a particular pathogen, between the animal models and humans. It is unclear whether the US Army has actually fulfilled this requirement for PB; they have attempted to do so with anthrax since filing an investigational new drug application in 1996 — and have thus far been unsuccessful.

The question is, did FDA follow the provisions of the new law?

First, safety in humans must be proven.

Second, the new “animal efficacy rule” is explained here:

FDA Press release


Final Rule (download here)


Quoting from the Final Rule:

FDA can rely on the evidence from animal studies to provide substantial evidence of the effectiveness of these products when:

1. There is a reasonably well-understood pathophysiological mechanism for the toxicity of the chemical, biological, radiological, or nuclear substance and its amelioration or prevention by the product;

2. The effect is demonstrated in more than one animal species expected to react with a response predictive for humans, unless the effect is demonstrated in a single animal species that represents a sufficiently well-characterized animal model (meaning the model has been adequately evaluated for its responsiveness) for predicting the response in humans;

3. The animal study endpoint is clearly related to the desired benefit in humans, which is generally the enhancement of survival or prevention of major morbidity; and

4. The data or information on the pharmacokinetics and pharmacodynamics of the product or other relevant data or information in animals and humans is sufficiently well understood to allow selection of an effective dose in humans, and it is therefore reasonable to expect the effectiveness of the product in animals to be a reliable indicator of its effectiveness in humans.

Any letter to FDA should demand that FDA demonstrate that each of these criteria has been met.

Further, it is unlikely that any of the testing was done by any entity other than the Army. Relying on the entity that wants to use PB for the science to substantiate its use is an inherent conflict of interest.

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