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Regulation of human research with LSD in the United States (1949-1987)

Abstract

Human research with hallucinogens such as lysergic acid diethylamide (LSD) has been ongoing in the USA since 1949. During the 1960s, LSD was investigated for a variety of psychiatric indications, including the following: as an aid in treatment of schizophrenia; as a means of creating a “model psychosis”; as a direct antidepressant; and as an adjunct to psychotherapy. Studies with all drugs, including LSD, have always been conducted under federal regulatory controls, including the 1938 Food Drug and Cosmetic Act (FDCA; which ensured the safety of drugs) and the 1962 Kefauver-Harris Amendments to the FDCA (which described appropriate scientific methodology and ensured drug efficacy). This paper details how the 1962 Amendments introduced numerous safety and efficacy requirements that must be in satisfied during clinical drug research—and how human studies conducted with LSD in the 1960s struggled with their fulfillment. Information is provided from Senate hearings, case law, and interviews with key investigators. Examples are also drawn from scientific papers and symposia published during and since that period, with a focus on information from clinical studies conducted with LSD by psychiatrist Albert Kurland at the Spring Grove State Hospital, near Baltimore, MD. While Kurland largely conformed with these new regulations, other investigators often fell short of complying with scientific standards and federal requirements. Thus, the human hallucinogen studies of the 1960s are best understood as providing pilot data on safety and efficacy, as well as testable hypotheses for current hallucinogen studies conducted under modern scientific and regulatory standards.

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Notes

  1. This system will be familiar to any current cannabis researcher whose non-NIH funded study protocol was required to go before a modern version of the PHS committee in order to obtain botanical marijuana from the National Institute on Drug Abuse (NIDA). (NIDA was originally founded in 1973 within NIMH, after it had rejoined NIH). This modern iteration of the PHS committee had representatives from NIDA and FDA, but was abolished in 2015 in a federal effort to streamline marijuana research.

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Acknowledgements

The author gratefully acknowledges the valuable discussion and comments regarding this paper provided by Dr. Silvia Calderon (Controlled Substance Staff, FDA), Dr. John Swann (FDA Historian), Ms. Nancy Sager (Office of Regulatory Policy, FDA), Dr. Steven Grant (NIDA), Drs. Richard Yensen and Donna Dryer (Orenda Institute), Dr. William Richards (Johns Hopkins University), Dr. Laura Helft (Howard Hughes Medical Institute), and Mr. Jules Asher (NIMH Press Office).

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Correspondence to Katherine R. Bonson.

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Bonson, K.R. Regulation of human research with LSD in the United States (1949-1987). Psychopharmacology 235, 591–604 (2018). https://doi.org/10.1007/s00213-017-4777-4

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Keywords

  • Hallucinogen
  • LSD
  • Clinical
  • Regulation