Study 329, which was a trial of paroxetine for depression in adolescents, is often held up as the poster child for fraud in clinical trials of psychiatric drugs. In Children of the cure: Missing data, lost lives and antidepressants, David Healy, Joanna Le Noury and Julie Wood painstakingly detail the entire sordid affair, including efforts to get the study retracted and to reanalyse the patient-level data. However, they do so with a larger purpose in mind. Study 329 is not presented as an aberration, but rather as emblematic of a systemic failure in modern medicine (or at least in psychiatry), which leads to prescribing practices that do great harm.
I suspect the title of this book by David Healy, Joanna Le Noury, and Julie Wood, was inspired by the Stephen King horror story Children of the Corn. In the Stephen King story, it is the children who are evil. In Dr. Healy’s book, it is the adults who are perpetrating evil by exaggerating benefits and minimizing harm of antidepressant use in children. A Review of Children of the Cure by David Antonuccio, Ph.D.
Children of the Cure is first a deep dive into the fraudulent reporting of “Study 329,” the clinical trial of Paxil (paroxetine) that launched an epidemic of drug-induced suicides by children and adolescents in the United States and many other countries. It is an indictment of Paxil’s manufacturer, Glaxo Smith Kline (GSK) and the many doctors who were paid to have their names appear on a study that was ghost-written by GSK. A review by Jim Gottstein, author of The Zyprexa Papers
“I tried killing myself thirty times.” So says Vickie, a nurse from Philadelphia who was first prescribed Paxil at the age of ten for something called “social anxiety disorder.” For the past several years, I have borne witness to people like Vickie – wonderful, creative, caring people – who were turned into burned-out shells of their former selves after getting hooked on antidepressants and other psychiatric drugs. Most of these people began taking these drugs for the most banal reasons you could imagine… By Patrick D Hahn @Patrickhahn
Children of the Cure should send shock waves throughout a pharmaceutical industry hell-bent on promoting drugs at any cost and waken up those whose main interests lie in the safeguarding of the general public.
Never before has a book been unleashed on the market which unmasks the lengths a British pharmaceutical company will go to ensure that young children are caught up in the unsavoury shenanigans of ghosting and distorting clinical trial data just to increase sales of a drug called Paroxetine.
A Riff and Review by Annie Bevan
Children of the Cure, at last, gives patients and their relatives the documented truth about how Pharma really operates, how the regulators and guideline makers are not quite the safeguarders of our health that so many of us long believed them to be. And worst of all, the influence the medical journals have on our health by sleight of hand. So many of us did begin to wonder, after appalling experiences about which we were never taken seriously. But in this book we have a talisman, something to generously give to our GPs, full of facts which cannot any longer be discounted. We cannot be brushed away with lies and obfuscations any more. A much needed, carefully researched and documented book which definitely should save lives.
In 1993, a proposal was developed to study the drug for use in adolescent “depression”, and Study 329 was launched. Study 329 did not show a clear benefit compared to placebo, and some study participants suffered serious side effects. The researchers played these down by coding suicidality as lability, and overlooking certain adverse events altogether.
Children of the Cure offers either a fairy tale or an epic take (pay your money and make your own call) on Study 329 – the most famous clinical trial in medicine. There are other takes on what happened in the pipeline from the more academic Illusions of Evidence-Based Medicine by Jureidini and McHenry to Paul Scott’s The Malcharist, which may be satire or may be all too real, difficult to tell, and a compelling screenplay. These books complement Jim Gottstein’s The Zyprexa Papers.
“During my research, I found hundreds of cases of Seroxat-induced “suicide.” I then came across a notorious study that GSK had carried out in the late 90s, a study they termed “329.” The study’s outcome had been posted in a journal online, and all seemed to be well and good. It appeared that Seroxat showed remarkable efficacy in children and adolescents. Why then were children and adolescents dying violent deaths whilst taking it, I wondered?
~ Bob Fiddaman, activist and blogger on drug-related injuries
The story is depressing and tragic, one of many similar tales that have appeared in the past two decades. Clinicians have the skills to assess new treatments, but their independence and financial support must be assured by independent non-industry sources. Children of the Cure is a frightening and tragic story that warrants governmental and public attention. A book review by Max Fink, M.D., Professor of Psychiatry and Neurology Emeritus
StonyBrook University College of Medicine
When Samizdat published Children of the Cure on Amazon, there was discomfort in some quarters. The discomfort was practical for some. Mark Carter from Auckland told us it would take 154 NZ dollars to buy two copies and have then posted to him – he had to go through Amazon.com as Amazon.com.au for some strange reason does […]
Children of the Cure tells the story of the only Medical Study that has two publications in the academic literature—telling precisely the opposite story—and how no one is bothered by this. Study 329 was a clinical study that began in 1994 giving a new antidepressant to teenagers. It has become the most famous clinical trial ever, leading to a fraud charge, a $3 billion fine, and a Black Box Warning.
Buy Book: Children of the Cure