The FDA adopted the Interim Rule on the eve of the Persian Gulf War in order to allow the military to use two experimental drugs, pyridostigmine bromide tablets and botulism toxoid vaccine, in response to the threat of chemical or biological warfare. Public Citizen first challenged the Interim Rule in Doe v. Sullivan, a case in which the District of Columbia Circuit Court held that the Interim Rule was within the discretionary authority of the FDA. The Interim Rule is still part of the FDA’s regulations and may be invoked to authorize involuntary use of experimental drugs on troops without informed consent in future military operations.
The petition argues that since the FDA adopted the Interim Rule substantial information has come to light that suggests the Rule was an “unwise departure” from the strict FDA guidelines dealing with informed consent and the limited instances in which it may be waived. The petition points to the following information, revealed in Congressional hearings and government studies on the use of experimental drugs during the War, as evidence that the Rule should be repealed:
When the FDA approved the Rule, it mandated that the military provide all military personnel receiving the experimental drugs with information about the possible side effects of the drugs. The DOD, however, failed to comply with these requirements, and, as a result, the drugs were administered without giving troops information on their effects, even though the FDA considered such information essential to waiving informed consent.
The DOD failed to keep records to identify the troops on whom these experimental drugs were used, and did not keep complete records on the side effects experienced by these troops. The lack of recordkeeping has prejudiced the ability of military personnel to obtain effective medical treatment.
Studies on the safety and effectiveness of these experimental drugs cast doubt on the DOD’s and FDA’s assurances that there was sufficient evidence on the drugs’ effects to justify requiring troops to take the drugs during the Gulf War. These studies include DOD animal studies that indicate that the tablets distributed to troops as a pretreatment for use against nerve gas were ineffective against certain types of nerve gas (sarin and VX) and, indeed, may have made the troops more vulnerable to injury if these nerve agents were used.
In its Interim Report, the Presidential Advisory Committee on Gulf War Veterans’ Illnesses noted that toxicologic studies conducted by the government have identified both of the experimental drugs used on the Gulf War veterans as possible causes of the Gulf War Syndrome that plagues so many veterans. “Even if the experimental drugs were not the cause of the medical problems associated with Gulf War Syndrome,” the petition states, “the fear and uncertainty that these drugs may be a contributing factor highlight how the Interim Rule threatens soldiers’ right of personal autonomy.”
While Public Citizen, the National Veterans Legal Services Program and the National Gulf War Resource Center urge the FDA to repeal the Interim Rule, they request that, at a minimum, the FDA issue a Notice of Proposed Rule Making. This will provide the public, as well as Gulf War veterans, with the opportunity to comment on the consequences of waiving informed consent in light of the Persian Gulf experience.
Public Citizen is a non-profit public interest membership organization dedicated to the study and promotion of public health and safety and consumer welfare through lobbying, litigation, research and publications. Since its founding by Ralph Nader in 1971, Public Citizen has fought in Congress, before regulatory agencies, and in the courts for safe, affordable and effective drugs and medical devices, for responsible controls over the delivery of health care, and for informed consent and consumer access to health care information.
The National Veterans Legal Services Program (NVLSP) is an independent, nonpartisan, nonprofit organization devoted to increasing the national understanding of the plight of America’s forgotten veterans and their families while working to support the interests of needy veterans. NVLSP achieves its mission through education, advocacy, litigation and public policy programming. Telephone 202-265-8305.
The National Gulf War Resource Center, Inc., is a national non-profit educational and research organization founded to support grassroots efforts to assist veterans and family members affected by health consequences of the Persian Gulf War. Our membership consists of twenty-two community based, family oriented organizations in the United States and United Kingdom and represent a consensus view of the Gulf War veterans’ community. Telephone 202-628-2700 ext.162.