Avoiding Liability: The Drug Licensing Game the FDA Plays With The Department of Defense

From 2003:

Click here to learn about 3 unusual licensing decisions, which circumvented liability for injuries caused by the following drug and vaccines:

Example 1: Pyridostigmine bromide (aka PB or NAPS tablets).

Example 2: Smallpox vaccine.

Example 3: Anthrax vaccine. "Fully licensed" for the first 520,000 military recipients

FDA documents show that "licensed" anthrax vaccine never demonstrated human efficacy

CDC, which performed some vaccine tests, acknowledged in 1968 that, "As to the efficacy of the vaccine, we have no real method of determining the protection afforded." FDA records show that in 1969 the ad hoc committee to license anthrax vaccine found a lack of "scientific evidence for efficacy of the vaccine." The committee chairman, Dr. Margaret Pittman, then noted, "Michigan has filed all required information and material for license except the results of an adequately controlled clinical investigation that establishes efficacy." Michigan was asked to conduct such a trial, but there is no evidence it was ever carried out. This demonstrates that the vaccine was never proven effective in humans.

Potency of the vaccine has been a continuous headache for the manufacturers. Many different potency standards have been submitted to FDA over the years. The potency assay kept changing because it could never be demonstrated to accurately reflect the potency of the product. One license amendment for potency was submitted in 1978. More were submitted prior to the first Gulf War. As recently as May 2001 Bioport was still submitting amendments to the potency test.

Therefore, FDA should have pulled the vaccine's license, since anthrax vaccine was unable to meet FDA standards for potency and human efficacy from the time the license was first issued. It means that FDA has never known whether or how much the vaccine will protect against anthrax.

"Improvement Needed in FDA’s Postmarket Decisionmaking and Oversight Process" -- GAO

Why is anthrax vaccine still on the market if it is as bad as this website claims? The reason has to do with gross failures of regulation at FDA. The Government Accountability Office said it better than I can, in a March 2006 report:

"FDA lacks clear and effective processes for making decisions about, and
providing management oversight of, postmarket safety issues. The process
has been limited by a lack of clarity about how decisions are made and about
organizational roles, insufficient oversight by management, and data
constraints. GAO observed that there is a lack of criteria for determining
what safety actions to take and when to take them."

('Postmarket' means after a drug has been given a license and is being sold to consumers, in contrast to the process of establishing safety of the drug in order to license it, for which FDA's process is generally more standardized.)

The bottom line is that FDA is totally politicized, and several doctors and scientists concerned about safety have been attacked by their superiors, as well as being prevented from giving talks and publishing papers. There has been ample evidence of this in the media and medical journals over the past several years.

Featured Quote

December 24, 2001
Dr. D.A. Henderson, Health and Human Services's director of public health preparedness, said,
"If this were a vaccine which… had no associated reactions [and]
would work very well, that would be one thing, but this vaccine does have
reactions associated with it, so there's a negative side to it."