The Department of Defense and RAND announced today the release of a policy review concerning the use of investigational new drugs (INDs) during the Gulf War. In this review of the literature released today by the special assistant for Gulf War illnesses, Bernard Rostker, entitled "Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense," RAND reports on the topic of IND use to protect military personnel.
The report reviews,
- The history of the Food and Drug Administration's "interim rule," an exception to the general requirements for informed consent of the participants taking an investigational drug,
- The deliberations between the Defense Department and the FDA in 1990 and the litigation that followed in 1991,
- The actual Gulf War experience with pyridostigmine bromide and botulinum toxoid,
- The work of the Presidential Advisory Committee on Gulf War Veterans' Illnesses.
The review thoroughly addresses the ethical question raised by the waiver of informed consent as authorized by the interim rule and analyzes subsequent issues identified by the FDA in its 1997 request for comments.
"We commissioned this scientific review of the literature because of the continuing concerns of veterans," said Rostker. "Some veterans believe the use of investigational new drugs may have caused their illnesses. During the Gulf War, troops received very little information regarding the use of investigational new drugs. The required record-keeping was poor and administration was inconsistent from unit to unit. This clearly is an area that required a closer look."
During the writing of RAND's review in 1998, the issue of authority for waiving informed consent was decided by legislation. Now, by statute, the president - with full knowledge of the relevant congressional committees - is the final authority for such waivers. RAND concludes that questions of implementation must now be clarified and notes that although policymaking in the shadow of war may involve careful deliberation, it is better to have an adequate policy in place beforehand. The policy needs to be broad enough to respond to a number of contingencies and yet narrow enough to avoid misuse or confusion.
RAND is a non-profit institution working to improve policy and decision-making through research and analysis. Its 50 years of experience and long history of working with the Department of Defense make the organization very well qualified to carry out this type of research.
This paper, as well as the first RAND literature review released last year on oil well fires and another on depleted uranium released today is posted on the DoD website, GulfLINK, at http://www.gulflink.osd.mil. Literature reviews dealing with chemical and biological weapons, pesticides, pyridostigmine bromide, immunizations, infectious diseases and stress are still in preparation and are expected to be released over the next year. As each report is released, it will be posted on GulfLINK.