The Therapeutic Nightmare: The Battle Over the World’s most Controversial Sleeping Pill (1999)

“This book examines the politics of the pharmaceutical industry’s testing of sleeping pills, government’s regulation of them, and the role of the medical profession in promoting and prescribing their use. John Abraham and Julie Sheppard provide a brief history of the development of sleeping ‘medications’ from opium and alcohol in the 19th century to barbiturates in the 1930s to 1950s before focusing on the modern era of benzodiazepines first developed during the 1960s and marketed from the 1970s onwards. Concerns about the risks of dependence from taking benzodiazepines started to surface during the 1980s. However, Abraham and Sheppard’s study reveals issues about the therapeutic value of benzodiazepines reaching far beyond dependence. Taking the highly controversial benzodiazepine sleeping pill, Halcion, as a case study, they probe deeply into the manufacturer’s strategy in developing the drug, including the recruitment of medical opinion leaders and the role of the medical-industrial complex, and the regulators’ decision-making processes about whether and how to permit the drug on to the market and remain there, despite evidence of adverse effects on patients. The research underpinning the book was conducted over a period of four years and draws on interviews with various stakeholders and extensive in-depth documentary analysis, including of internal company and government documents made public through court proceedings, which would not normally ever see the light of day. This book explains why patients have come to be exposed to Halcion’s risks and examines the corporate interests of the manufacturers, the professional interests of the scientists and medical researchers, and the interests of patients in safe and effective sleep medications. It reveals how these contending forces shape the regulatory decision-making about drug safety and efficacy.”

“Brilliantly documents how the flawed drug industry/government axis allows Halcion and other dangerous, but real, nightmares to be approved and widely used. The book’s lessons, if learned and acted upon, can prevent further disasters of this kind occurring.” Public Citizen

“Provides a rigorous but accessible analysis of the story behind Halcion. It shows how the supposedly technical evaluation of the drug has in fact been captured by wider socio-political interests. John Abraham and Julie Sheppard make a compelling argument for greater transparency in drug regulation.”
Andrew Webster, Professor of Sociology of Science and Technology, University of York, UK

“A detailed and comprehensive book on a major drug debacle and an important contribution to the drug safety literature.”
Thomas J Moore, Professor of Health Policy, Georgetown University