How do drugs get to the market? What controls are there and what procedures for monitoring their effects? And how adequate are the regulators in protecting public health when new drugs have serious side effects? The Therapeutic Nightmare tells the story of the sleeping pill Halcion - a story which is far from over. First marketed in the 1970s, Halcion has been taken by millions of patients around the world. For many years it has been associated with serious adverse effects such as amnesia, hallucinations, aggression and, in extreme cases, homicide. Thirteen years after its first release, it was banned by the British government. It remains on sale in the United States and many other countries. 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 medication. It reveals how these contending forces shape the regulatory decision-making process about drug safety. As the number of new drugs and health products grows, a major challenge facing regulators and the medical profession is how to put the interests of public health decisively and consistently above the commercial interests of the drugs industry, while becoming more accountable to patient and consumer organizations.
'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 from occurring ' Sidney M Wolfe, MD, Director, Public Citizen's Health Research Group.
'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. The authors make a compelling argument for greater transparency in drug regulation' Andrew Webster, Professor of Sociology of Science and Technology, University of York, and author of Science, Technology and Society.
'A detailed and comprehensive report of a major drug debacle, and an important contribution to the drug safety literature' Thomas I Moore, author of Prescription for Disaster: the Hidden Dangers in Your Medicine Cabinet.
Introduction 1. The Nature of Tranquillizing Drugs 2. The Political Control of Medicines 3. The Rise of Halcion: Getting Approval 4. Sounding the Retreat: The Accumulation of Post-Marketing Problems 5. Legal Challenge and Loss of Faith: British Medicines 6. How the West was Won: Keep Taking the Tablets in the United States 7. Prescription for Change: The Science and Politics of Medicines