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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