Human Subject Protection Army Researchers' Plan Seeks Exemption From FDA Experimental Product Safety Rules

[Guest guest]

BNA is a subscription only DC Beltway trade publication...note his terminology:

" ...the experimental anthrax vaccine... "

 

Army Proposal to use U.S. Soldiers as Human Test Subjects

M. Alexander Otto

Bureau of National Affairs

http://www.bna.com/press/guest/aotto.htm

Posted 2/28/2004 11:45:00 AM

 

The U.S. Department of Defense (DoD and the Federal Drug Administration (FDA)

are facing a tough lawsuit by soldiers questioning the safety of the

experimental anthrax vaccine. In response, DoD and FDA want a new drug category

and bypass human test subject rules. This plan by DoD and FDA represents a major

attempt to undermine the health and safety rights of soldiers. Congress must

stop the DoD and FDA plan. We urge readers to familiarize themselves with the

Nuremberg Code that prohibits using humans as experimental test subjects unless

there is informed consent and the right to refuse.

 

 

 

Human Subject ProtectionArmy Researchers' Plan Seeks Exemption >From FDA

Experimental Product Safety Rules

Under a plan proposed by U.S. Army human research regulators, the Department of

Defense could ignore key Food and Drug Administration safety standards when

administering experimental products to soldiers, according to an October

memorandum recently obtained by BNA from the U.S. Army Medical Research

Institute of Infectious Diseases' Office of Human Use and Ethics.

 

Under current FDA rules, experimental drugs and devices only can be used in

well-controlled clinical trials that test safety and efficacy.

 

That means the principal investigator must supervise the administration of the

product and serious side effects must be reported to FDA within seven days,

neither of which are practical in combat situations, according to the

memorandum, dated Oct. 11, 2002.

 

Investigational products also must carry labels that state " Caution: New

Drug-Limited by Federal (or United States) Law to Investigational Use. "

 

" This label can lead the war fighter to question the safety and/or effectiveness

of the product and may threaten operational objectives, " according to the memo.

New FDA Category

The plan would exempt the military from the clinical trial requirement. Instead,

a joint military and FDA panel would review the safety and efficacy of the

agent, determine whether a clinical trial is feasible, identify ethical

obligations, and approve the product under a new FDA category: " licensed for

contingency. "

 

The category would be reserved for " products unlikely to receive FDA approval

under current rules but that have sufficient human safety and animal efficacy

experience to permit military … use. " The memo noted, however, that the

military often fields products that have not been tested in humans " because of

the great danger to individuals of conducting human clinical efficacy trials. "

 

" DoD should continue to conduct trials when ethically appropriate and when time

and resources permit compliance with the [Federal] Food, Drug and Cosmetic Act, "

the five-page memo stated.

 

Some of the content for this position paper was added to the DOD Medical

Department legislative agenda, Dr. Arthur O. Anderson told BNA. Anderson is

chief of the USARMIID Office of Human Use and Ethics and Department of Clinical

Pathology. He co-authored the memo with Chris Beardmore, an administrator in the

Office of Human Use and Ethics.

Advocate Skeptical

The move would resolve ongoing conflict with FDA about the use of experimental

products. Following the Gulf War and action in Bosnia, DOD was criticized for

failing to report adverse events, properly label and track investigational

products, and ask soldiers' permission before administering experimental agents.

 

Dr. Meryl Nass, an advocate for soldiers injured by anthrax vaccine, botulinum

toxin, nerve gas antidote, and other experimental products, takes a dim view of

the initiative. It is part of an ongoing DOD campaign to free the military from

basic human subject protections, she said.

 

Soldiers are subject to military discipline if they refuse an experimental

product. Those injured have no recourse; soldiers cannot sue DOD for injuries

received while in the service, Nass noted.

 

 

karl theis jr

 

 

http://groups.msn.com/exposureofthetruth