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Executive Summary

DRUG EXPERIMENTS IN NURSING HOMES WILL BE SUBJECT OF HEARINGS by the Housde Commerce/Health Subcmte., according to subcmte. staff. The hearings are likely to focus on charges that elderly residents of nursing homes did not give adequate voluntary informed consent prior to drug trials. The allegations were recently publicized by the Natl. Council of Senior Citizens (NCSC) in a report entitled "Abusing the Elderly: Drug Experimentation in Nursing Homes." HCSC Exec Director William Hutton submitted the report to Health Subcmte. Chairman Waxman (D-Calif.) with a request that the subcmte. "initiate an investigation to ascertain whether genuinely voluntary and informed consent is possible to achieve in a nursing home environment; whether human experimentation in nursing homes should be prohibited, except under highly restrictive conditions; or what other mechanism can be established to protect the rights of the elderly in nursing homes." The report, based on FDA documents, cites alleged violations, including "the lack of informed and voluntary consent by persons to be used as test subjects for experimental drugs; the lack of initial and continuing review by an Institutional Review Cmte.; the inappropriate selection of persons for drug experiments, thus exposing them to unnecessary risks; and the unreported use of drugs by test subjects concomitantly with the drug under study, thus exposing the test subject to greater risks while at the same time invalidating the study." The drugs involved in the studies cited by the report include USV's Arlidin, Schering's Paxipam, and Lederle's Loxitane. In a May 20 response to the NCSC statement, FDA issued a "Talk Paper" in which it explained that the alleged drug testing abuses occurred in clinical trials that ended before 1981 and that the agency "has implemented several safeguards for all subjects of clinical studies." Furthermore, FDA maintained that, although "individual treatments in some cases were clearly inappropriate and some of the physicians involved were barred from further testing of investigational drugs, the studies themselves involved testing of drugs of potential benefit to patients." The agency noted that institutional review board and informed consent regs were revised in 1981 and that through the Bioresearch Monitoring Program 59 physicians have been disqualified from clinical investigations and another 14 have been restricted from "some or all kinds of" clinical studies. FDA also referred to its proposed clinical investigator and sponsor-monitor regs. The proposed status of those regs could be another peg for the Hill hearing. The sponsor-monitor and clinical investigator regs have been pending since 1977 and 1978, respectively. Hutton's letter to Waxman states that while the council agrees "that drugs to be used by the elderly should be tested on the elderly," it doubts "that free, full voluntary and informed consent as required by law is possible for elderly patients in many -- if not most -- nursing homes." Additionally, he cited a comment from FDA Scientific Investigations Director Frances Kelsey, MD, to a 1984 meeting of the Drug Information Assn. She said: "In general, nursing homes do not provide the environment necessary to conduct adequate and well-controlled and much needed clinical trials."

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