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Abstract
Because of recent news reports and public concern that has followed about past testing LSD in human subjects, possibly without their informed consent, FDA has issued an informational statement about the currently permitted use of this drug for research purposes only. LSD is classified as having no currently accepted therapeutic use, but FDA permits specified research with this drug on human subjects under carefully controlled conditions. At the present time five medical institutions are authorized by FDA to conduct research programs involving the use of LSD with human subjects. These programs are being conducted under FDA's procedures for investigational new drugs, the conditions of which provide a safeguard for the protection of the human subjects. FDA records indicate there have been about 170 legitimate research projects with LSD over the past 10 years, but most are no longer active. The institutions currently authorized to conduct research programs with LSD and the nature of the research program are alcoholism and psychotherapy, Veterans Administration Hospital, Topeka, KS; alcoholism, Vista Flill Psychiatric Foundation, San Francisco, CA; psychosis (patients with special problems), Medical College of Birmingham, Birmingham, AL; psychotherapy in chronic LSD users, Langley Porter Neuropsychiatric Institute, San Francisco, CA; evaluation of LSD in narcotics users and LSD training experience program for mental health-related professionals (total of two programs), Maryland Psychiatric Institute, Baltimore, MD. All programs proposing to use LSD in humans must be reviewed, before FDA action, by an outside advisory committee operating under joint sponsorship of FDA and the National Institute of Drug Abuse. The committee is made up of recognized experts from major medical research institutions. FDA in most cases trees with the committee's findings in approving or disapproving an application. The sponsors of the proposed test are investigated beforehand by the Department of Justice's Drug Enforcement Administration. All such programs must provide for protection of patients, followup care, and informed consent by the patient or responsible guardian. Each investigating institution must maintain a review panel to evaluate the usefulness of the proposed study and assure protection of patients. Drug investigations conducted by the military arms of the Federal Government are exempted from FDA procedures for investigational new drugs under a 1974 memorandum of understanding between FDA and the Department of Defense that permits the military to classify such investigational programs for purposes of national security. The memorandum provided exemptions based on experience between 1964 and 1974 which indicated that military researchers have adhered to FDA standards, adequately protected human subjects, did not compromise the intent of the Food, Drug, and Cosmetic Act's protection requirements, and that certain conditions required before 1974 were no longer necessary.
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