Children of the Cure

Children of the Cure

Missing Data, Lost Lives and Antidepressants

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. Despite now knowing that all trials of antidepressants done in children are negative, sales of these drugs to children and adolescents continue to increase dramatically.

Study 329 was ghost-written, as are all trials of all drugs you might take. The data on what happened to the teenagers in this trial are inaccessible, as are the data from all trials of all drugs you might take. Children of the Cure tells the story of the only pharma company trial where independent researchers have had access to the data and the struggle to publish their findings—a struggle in which medical journals were as difficult as Big Pharma.

The efforts to hide the truth and ways in which it was hidden and pressures blocking publication hold true for every treatment you or your family or friends may be taking.

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.

This book is written by three members of the team—David Healy, Joanna Le Noury and Julie Wood—who have been behind writing the study and creating the website that hosts a set of documents pharmaceutical companies never expected you would get to see.

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PREFACE

This Book Is Not a Game

Every day of the week, many of us take a pill, it might be an antibiotic, a pill for skin or heart problems or an antidepressant. This story about ghost-writing and the hiding of clinical trial data, especially the data on what can go wrong on a pill, applies to every pill you might take.

But no-one tells you that you run these risks, and they don’t tell the doctor prescribing a drug to you.

Instead, you and your doctors will find experts far and wide heaping scorn on the idea that anything could possibly go wrong on a prescription drug. These experts, bedecked though they might be with impressive credentials, rarely if ever have more expertise on working out if a drug causes an adverse event than you do. Few of them have any training in how to detect an adverse event.

This is a story about a chain of events in which someone like you—with no background in whether a drug could cause suicide or homicide—helped pierce the screen of fake expertise that companies hide behind. In this case the story hinges on a study in children of the selective serotonin reuptake inhibiting (SSRI) antidepressant paroxetine, branded as Paxil in the United States, Seroxat in the United Kingdom and a range or related names—Aropax, Deroxat—elsewhere.

It’s a story that makes clear that motivation and common sense can be worth more than “expertise.”

It is also a true story. Truth is stranger than fiction because fiction has to make sense.

In the interests of truth, it is sometimes necessary to leave holes in a story. In March 2004, at the height of concerns that what were then new wonder antidepressants might cause children to commit suicide, it looked as if the U.S. Food and Drug Administration (FDA) was going to claim there was no problem. However, Michelle Anderson from the office of Senator Chuck Grassley (R-Iowa) called a senior FDA honcho and immediately after her call, FDA gave the press an hour’s notice of a briefing at which they effectively put a Black Box Warning on antidepressants.

What was said during that call? Was it a threat to expose the private peccadillos of the boss of FDA? The peccadillos of others are in here and how they play into this story, but we don’t know what Andersen said.

After Black Box Warnings stained the SSRI antidepressants, Lady Macbeth like, senior FDA figures, working closely with trusted experts, spent over a decade trying to wash the stain away, in a manner that suggests the apparatus you think is there to look after you has no interest in truth, and many of those involved would prefer to see you dead than admit they got something wrong.

This is a true story about lies. In the case of suicide or homicide on SSRIs, the lie that fooled many for two decades was that concerns about antidepressants stemmed from pressure by the Church of Scientology. This lie was invented by or for Eli Lilly, the makers of Prozac. The lie was more potent than the Prozac it was invented to defend—a wonderful symbol of the fact that by the 1990s what were once pharmaceutical companies had become marketing companies—better at producing fictions than the medicines we desperately need.

Close to the entire medical literature you and your doctor rely on is now a lie in a different sense. It’s a shame to reveal the denouement of a book before you get to the last page but here it is—if you think clinical trials should reveal truth in a way fiction doesn’t you’ve lost touch with what is happening. The clinical trials at the heart of the evidence supposed to keep us safe are fictions. Company abilities to get away with this depend on being able to keep trial data filed away in places as inaccessible as the resting place of the Lost Ark.

This book’s website comes with the only set of company Clinical Trial data that you, your doctor or others can access—not an absolutely complete set but enough for anyone to join us in the hunt for clues as to the best version of Study 329 and to a version of the story in this book with the least holes.

Nothing you will read here is juiced up. No scenes have been invented to make the story flow. This book is not a game.

Note: Interviews, references, videos, and transcripts cited in this book are available on Study329.org. See endnotes for details.

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