Charles Medawar presented at a U of T conference organised by Edward Shorter. Medicines out of Control? draws on the SSRI antidepressant case history to describe a system of medicines’ control tainted by secrecy and conflicts of interest, barely accountable to the public, lacking in common sense and losing sight of the meaning of health. Subtitled Antidepressants and the Conspiracy of Goodwill, this book reveals a demonstrably chaotic system of drug evaluation, driven by the almost unquestioned assumption that health is the product of greater ‘disease awareness’ and more new drugs. These trends reflect the growing dominance of global and market values that now threaten to turn pharmaceutical medicine into something of a polluting enterprise, deeply damaging to the atmosphere of health. Alas, this is no more obvious than global warming to the driver of your average car. Medicines out of Control? is an attempt to promote a complete rethink about what medicines contribute to health, and the basis of decision-making about drug benefits, risks and harm. --- from the publisher Read the first chapter online at socialaudit.org.uk Reviews " … beautifully written, painstakingly researched, thoroughly referenced, powerfully and persuasively argued, and eerily up to date." Lancet (Professor Joe Collier) 26 June 2004. "It is a carefully substantiated and elegantly written indictment of the drug companies that make SSRIs, explaining why their claims for the benefits of these drugs are unfounded, and who has hidden this information from us and how. It is a classic exposé and an essential corrective to the 1990s bestsellers on antidepressants …" Prospect (Cheryll Barron), October 2004 "Readers will either love this remarkable work or fume at it. Few will be neutral. This is the authors’ intention. In the preface they tell us that the book is being ‘offered for peer-review and consultation, and is meant to promote comment and debate’." Essential Drugs Monitor, Autumn 2004 " … I recommend this book to physicians of any specialty, particularly those in primary care or psychiatry. It is sobering, challenging and thought-provoking. The title asks a question that we must keep asking ourselves ... I would also recommend Medicines Out of Control? for medical trainees early in their career. Ideally, however, a reading of the book would be accompanied by a mentor-led group discussion, as its message is so different from what is being received elsewhere, especially at the pharmaceutical-sponsored luncheons into which medical students are quickly initiated. That would be a shame, for those who are ignorant of history are condemned to repeat it." CMAJ (Professor E. Jane Garland), November 23, 2004; 171 (11). "This is an unusually interesting book … As a whole, the narrative compels readers to re-examine their views on drug treatment of depression … This book is, nevertheless, a polemic and as such gives only one side of the argument… Despite these reservations, there is enough in this book to cause an adjustment of opinion in most readers. Few will have their minds changed but most will find themselves more open to the possibilities expressed in this book." Pharmaceutical Journal (David Taylor) 4 September 2004. "It is essential reading for anyone who works in the area of drug regulation and control, and equally essential for those people who share a concern about decision making processes and inappropriate power in the world. It is written by authors with a genuine love for language, who have made a somewhat dry topic area into one of excitement and at times, sinister intrigue." Pacific Health Dialogue (Prof Murray Bailey), Autumn 2004. " … a magisterial history and analysis of the antidepressant crisis by two leading campaigners, Charles Medawar and Anita Hardon, in Medicines Out of Control?" The Observer (Cheryll Barron), 26 September 2004. " … When you have devoured this book, and you absolutely must, see how far you think they have made their case. The evidence is there for the prosecution, and is convincing. Will the defence open its case, please?" International Journal of Risk & Safety in Medicine 16 (2004) 147–148 (Professor I. Ralph Edwards) "The authors’ conclusion – that the community created by new information technology should be adapted and adopted by the medical profession, especially in the case of drugs for the mind – seems not only sensible but obvious. Will the pharmaceutical industry respond? Is it in their best interests to do so? ….Perhaps our best hope is for vigilant and painstaking whistle-blowers of which the authors … are formidable examples" Nature (John Cornwell), 12 August 2004 "The treatment of depression has seldom been more controversial. The safety of new antidepressants is subject to radical reappraisal, while an unpleasant question looms: can we really trust scientific evidence? Medawar and Hardon give a detailed analysis of this quagmire, massively annotated with footnotes and verbatim quotations ..." British Medical Journal (Sean A Spence), 4 November 2004. "This book is not for the faint-hearted. It is in small type, heavily referenced (30 pages of references) and has extensive footnotes (on some pages the footnotes occupy more space than the text). However, as a chronicle of the complexity of the development and use of drugs in modern medicine it makes fascinating reading" Australian Prescriber "To my mind, neither the unevenness nor the unabashed political purpose of the book undermines its call to think hard and clearly about what Edward Shorter has called the Age of Prozac … Beyond the mysterious ‘conspiracy of goodwill’ that has formed the antidepressant era, Medawar and Hardon raise important questions about regulation of drugs". Journal of the Royal Society of Medicine (Professor Carl May), July 2004. "... this House hails the publication of the book 'Medicines Out of Control' as a remarkable account of history repeating itself over the last 150 years in the promotion of anti-depression drugs; congratulates Mr Charles Medawar and Anita Hardon for revealing mountainous evidence of incompetence and inaction by regulatory authorities and profit-driven pharmaceutical giants …." Paul Flynn MP: Early Day Motion for debate, House of Commons, 17 March 2004 See also Multinational Monitor, July/August 2004 Pharmaceutical Technology Europe, 1 May 2004) Scribe (J Int Society for Pharmacoepidemiology), 7, 2 2004 Other excerpts and reviews have appeared in French, Italian, Spanish and Dutch [1], [2], [3] Table of Contents 1. Medicines out of Control? The case history - Crisis unfolding - Of science and common sense - Role of the Pharmas - Medicalisation and ‘disease awareness’ - Government regulation of medicines - Scientific standards - Iatrogenesis - Towards resolution 2. Sedative hell Alcohol - From opium to morphine - Freud, denial and cocaine - Non-narcotic solutions - Ordeal by bromides - Enter the barbiturates - Addiction false and true 3. Tranquillisers Librium and Valium - Benzos versus barbiturates - Measuring tranquilliser effectiveness - Methodology of denial - The trouble with Ativan - Xanax and Halcion - Slouching towards understanding 4. Drugs to defeat depression Origins of antidepressants - First steps in treating depression - Growing the antidepressant market - Do antidepressants work? - Testing the efficacy of the SSRIs - The risk of dependence - Changing the meaning of dependence - Pennies begin to drop 5. From secrecy to common sense The Medicines Control Agency - Official secrecy - Growth of the Internet - Attempts at withdrawal - The meaning of ‘discontinuation’ - FDA preoccupation with ‘abuse’ - In praise of transparency 6. Explaining the Pharmas Drug innovation - US gravitational pull - Blockbuster imperatives - Influence at work - Reputations - Pharmas and world health - Pharmas and the WHO 7. Medicalisation and ‘disease awareness’ Direct-To-Consumer drug advertising - Direct to Europe promotion - The British Way - G10 and the pharmaceutical review - The European Parliament steps in - Public-Private postscript 8. Regulatory dependence Origins of drug control - Figureheads in US drug regulation - UK-style drug control - Commercial sponsorship of government regulation - A footnote on European medicines control - Dossiers and dosage - Limitations of regulatory scrutiny - Adverse drug reaction reporting - Self-regulation? 9. Scientifically tested and approved Medicines Control Agency reviews - Reliability of evidence from drug trials - Clinical research practice - Scientific integrity - Placebo factors and beyond - Organisms in organisations 10. Iatrogenesis Illich on iatrogenesis - Clinical iatrogenesis - Misplaced emphasis on numbers of ADRs - Analysis of paroxetine Yellow Cards - Yellow Cards on suicidal behaviour - Medicalisation 11 The story so far Parliamentary limitations - SSRIs and children - Seroxat label transformation - Unsuitable for publication - Yellow Card prohibition? - Towards 2004 DISCUSSION: Doing more with less - First principles of reform - Health for one and all? References Glossary and notes |