Drug Trial Secrets tells the story of the most famous clinical drug trial of all time — the only trial to lead to a fraud charge, as well as the biggest drug company fine in history.
GlaxoSmithKline paid for Study 329, the clinical trial of their antidepressant Paxil (paroxetine) in the 1990s, and the resulting research was published in the Journal of the American Association of Child Adolescent Psychiatry. The article claimed the drug was effective and safe — even though GSK knew from the research that Paxil didn't work for children and was harmful. In 2004, New York State charged the company with fraud because of this publication. It wouldn't be until 2012 when the Department of Justice also charged GSK with fraud and failure to report safety data that GSK settled and paid a giant $3 billion fine.
But perhaps the most important result was that independent researchers were given access to the full, original records of the clinical trial and relating documents. David Healy and his co-authors spent thousands of hours re-analyzing the raw data, and in this book they describe exactly how GSK and the medical professionals who claimed authorship of the journal article manipulated the data to produce the false result they wanted. They also document the battle they finally won to get the British Medical Journal to publish a re-write of the original study — thirteen years later!
A gripping true-crime narrative, Drug Trial Secrets will leave readers with many questions about the reliability of drug company trials and research by medical professionals funded by drug companies.
About the authors
DAVID HEALY is Reader in Psychological Medicine at the University of Wales College of Medicine and Visiting Professor of Medicine at the University of Toronto. He received his medical degree from University College Dublin and was a Clinical Research Associate at the University of Cambridge. Former Secretary of the British Association for Psychopharmacology, Healy is author of more than 120 peer reviewed articles and more than a dozen books, including The Antidepressant Era (Harvard) and The Creation of Psychopharmacology (Harvard).
JOANNA LE NOURY is a Senior Research Fellow at Bangor University, and the first author on the Restored Study 329. She lives in Llanfairfechan, Wales.
DEE MANGIN is the David Braley and Nancy Gordon Chair of Family Medicine at McMaster University and creator of TaperMD, an online tool to assist patients having a medication review with their doctors. She lives in Dundas, Ontario.
JULIE WOOD was an accountant until one of her sons committed suicide on an SSRI . With her husband, Peter, she then helped set up RxISK.org and created the Study329.org website. She lives in Toronto, Ontario.