Military proposes serious relaxation of IND regulations

Military proposes serious relaxation of IND regulations

Tue, 28 Jan 2003

We are rapidly approaching The Brave New World. FDA bureaucrats are attempting to institutionalize a double standard in human experimentaion by resorting to a strategy of doublespeak. A Department of Defense memo states: “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 Nuremberg Code of 1947 applies to ALL human beings–including military personnel.

The DOD and FDA would establish different standards for some Americans–in this case military personnel who are being singled out for “special treatment” with drugs whose safety no one knows because they have never been tested in clinical trials.

To accomplish this the FDA is creating a “new category” of drug approval for unlicensed drugs. 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 new category would eliminate FDA labeling requirements that alert people about the experimental nature of the product.

The FDA’s cynical rationale defies logic: “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.”

Meryl Nass, MD., board member of The Alliance for Human Research Protection is on the mark when she told BNA: “It is part of an ongoing DOD campaign to free the military from basic human subject protections.”

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Bureau of National Affairs Army Researchers’ Plan Seeks Exemption From FDA Experimental Product Safety Rules By M. Alexander Otto

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 can only 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, to properly label and track investigational products, and to 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.

Copyright 2003, The Bureau of National Affairs, Inc., Washington, D.C.

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