Prohibited or regulated ? LSD psychotherapy and the United States Food and Drug Administration

Matthew Oram

History of Psychiatry, 2016, 27, (3), 290-306.

Doi : 10.1177/0957154X16648822

Abstract

Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s. This has commonly been explained through the increase in prohibitive federal regulations during the 1960s that aimed to curb the growing recreational use of the drug. However, closely examining the Food and Drug Administration’s regulation of LSD research in the 1960s will reveal that not only was LSD research never prohibited, but that the administration supported research to a greater degree than has been recognized. Instead, the decline in research reflected more complex changes in the regulation of pharmaceutical research and development.

Keywords : Drug Amendments of 1962, drug regulation, Food and Drug Administration, LSD psychotherapy, psychiatry

 

At a US congressional hearing in May 1966, Senator Robert F. Kennedy questioned Food and Drug Administration (FDA) commissioner James Goddard on the recent decline in the number of approved research programs exploring the medical potential of the hallucinogenic drug lysergic acid diethylamide (LSD). In April the drug’s manufacturer, Sandoz Pharmaceuticals, had voluntarily withdrawn its sponsorship of LSD research, and subsequently the number of research programs had dropped from 70 down to nine. After ascertaining from Goddard that the FDA had considered all these programs worthwhile, Kennedy criticized the administration for doing too little to ensure their continuation: ‘if they were worth while I would think you would let them continue … If it was helpful [research] 6 months ago, why is it not helpful now?’ (Senate Subcommittee on Executive Reorganization, 1966: 59).

First synthesized in Switzerland in 1938, LSD had arrived in the USA in 1949, and had quickly become the object of widespread clinical research (Hofmann, 2009; Rinkel, 1957). Many psychiatric researchers had found the drug useful in facilitating various forms of psychotherapy, particularly in the treatment of neuroses and alcoholism. Indeed, research in the 1950s in Canada had reported an unprecedented 50% improvement rate with chronic, treatment-resistant alcoholics (Smith, 1958). However, during the 1960s growing public recreational use of LSD had made the drug the object of increasing public, medical and political concern. Indeed, Kennedy’s hearings, entitled ‘Organization and Coordination of Federal Drug Research and Regulatory Programs: LSD’, were one of three sets that year to focus significant attention on the drug.1

Kennedy described the problem of fairly and effectively regulating LSD as a ‘classic example’ of the difficulties of balancing the interests of ‘Government and science’ (Senate Subcommittee on Executive Reorganization, 1966: 3). Historians and other commentators have primarily explained the decline in LSD psychotherapy research in the USA in the 1960s, towards its complete demise in the mid-1970s, as an outcome of the government backlash against the non-medical use of LSD: increasingly strict regulation of LSD either intentionally or unintentionally ended legitimate research (Doblin, 2000; Dyck, 2008; Hewitt, 2002; Lee and Shlain, 1985; Novak, 1997; Stevens, 1987). From this position, psychiatry lost a potentially significant treatment and research tool due to the US government’s failure to regulate LSD in a way that rationally balanced the risks associated with its abuse with the potential benefits to public health that could result from its responsible medical use.

LSD research first came under government control in 1963, after the Kefauver-Harris Drug Amendments of 1962 amended the 1938 Federal Food, Drug, and Cosmetic Act,2 significantly reforming the regulation of pharmaceutical research and development in the USA. Among other provisions, the amendments introduced FDA oversight over all pre-market clinical drug research. In the same year, the first major national controversy over LSD erupted, when Harvard psychologists Timothy Leary and Richard Alpert were fired from the university following concerns that their research with psychedelics had devolved into heavy informal use of the drugs among themselves, their colleagues, students and associates (Stevens, 1987). With the growth of an LSDinfused youth counterculture in the mid-1960s, the federal government began enacting strict regulatory controls designed to curb recreational use of the drug. The Drug Abuse Control Amendments of 1965 prohibited all but personal possession and government-approved research with LSD. In 1968 a further amendment was passed criminalizing personal possession, and in 1970 the Controlled Substances Act placed LSD in Schedule I – its most prohibitive regulatory category – along with heroin and marijuana.

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2016 - Oram - LSD psychotherapy and the United States Food and Drug Administration