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OPERATION DESERT SHIELD INFORMED CONSENT WAIVER FOR EXPERIMENTAL DRUGS

Executive Summary

OPERATION DESERT SHIELD INFORMED CONSENT WAIVER FOR EXPERIMENTAL DRUGS is challenged in a lawsuit filed Jan. 11 by the Public Citizen Health Research Group in the D.C. federal court. The suit is filed on behalf of an anonymous serviceman stationed in Saudi Arabia and his wife, and it names HHS Secretary Sullivan, and Secretary of Defense Richard Cheney as co-defendants. In the complaint, HRG argues that "the use of these drugs, whose safety and effectiveness have not been established, violates the Constitution and two federal statutes, and is arbitrary and capricious because it involves involuntary experiments upon unwitting and unwilling military personnel where it is entirely feasible to inform them of the risks and request their consent." HRG's filing of the suit follows the Dec. 21 publication of rule change to allow FDA to waive combat soldiers' right to informed consent on the grounds that "obtaining informed consent from military personnel for the use of an investigational new drug or biologic is not feasible in in certain battlefield or combat- related situations." The lawsuit cites one unapproved vaccine that is expected to be administered to military personnel and two other drugs that are expected to be used for unlabeled indications, both without recipients' explicit consent. An informed consent waiver was granted Dec. 30 for pentavalent Botulinum toxoids, a vaccine against the botulism toxins that might be used in germ warfare. Developed by the Centers for Disease Control, the vaccine has been in use for over 30 years among scientists and laboratory technicians whose work exposes them to botulism toxins. However, presumably because of the limited marketplace for such a treatment, it has never been intended as a candidate for commercial licensing. The Salk Institute and Michigan Department of Public Health have contracted with the army to produce supplies of the product for Desert Shield. ICN Pharmaceutical's Mestinon (pyridostigmine bromide), a drug with an approved indication for the treatment of myasthenia gravis, also received an informed consent waiver for use as a nerve gas antidote one week later, on Jan 8. At a Jan. 11 press conference in Washington, D.C. HRG Directory Sidney Wolfe, M.D. predicted that the military will provide Desert Shield soldiers with 30 mg Mestinon tablets (one half the normal dose recommended for myasthenia gravis) as part of their combat gear. In the event of nerve gas attack, they would self-administer these tablets in combination with an injectable or aerosol form of another nerve gas antidote (atropine sulfate) which recently received FDA approval. The third investigational drug which may be granted an informed consent waiver is a topical skin protectorant called Multi Shield. This ointment was first developed for cosmetic purposes by the Hanover, Mass.-based company Interpro. However, early this fall the U.S. Army obtained its own IND for use of the product as a defense against chemical skin irritants. In animal studies, Multi Shield has shown "some efficacy" in protecting against skin blistering agents such as mustard and nitrogen gas, according to a Department of Defense spokesman. An informed consent waiver for Multi Shield is still pending, but sources at Inter-pro Cosmetics report that their firm, under the supervision of FDA, has already begun producing large stockpiles of the ointment for use in the Middle East.(ITEM 150)EDITORS' NOTE: "The Pink Sheet" (Nov. 26, p. 12) mistakenly stated that supplies of the Army's newly approved aerosol form of atropine sulfate would be be manufactured by 3M Pharmaceuticals. The Army has since reported that though "3M Pharmaceuticals did develop the aerosol for an NDA sponsored by the U.S. Army Office of the Surgeon General, the firm that will produce the atropine aerosol for the Department of the Defense has not yet been decided."
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