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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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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Skip Murgatroyd says
Just ordered a copy from Amazon. Can’t wait read it! David Healy once again shows that he is a force to be reckoned with!
Tom Benjamin says
This 329 study paved the way for more scrutiny of drug and therapy approvals. There will be increased pressure for speedy and less-stringent approval mechanisms for treatments, particularly if they have some electromagnetic or other technical appeal. The irony is that many of these studies and meta-analyses have stated right on the front page and in the abstract that the treatments did not actually beat placebo. High rates of spontaneous remission were known in the psychotherapy field and cited in 60s textbooks, yet this is now portrayed as though it were a problem standing in the way of new and exciting cures. This review and restorative work is important and those who do it forsake the more prestigious and lucrative career paths open to those who downplay negative evidence and ‘get on with it’, measured by how much grant money they can spend pursuing the elusive next big things. Stay tuned for more such restorative work.
Bill Bradford says
I am familiar with the Study 329 story. I’m a survivor of the LIES of the pseudoscience drug racket and social control mechanism known as “psychiatry”, which is really nothing more than 21st century Phrenology with potent neurotoxins. I was given SSRI’s as an adult. Thank God I got off them before they made me even more dangerous than they did. Money and power are only just “stuff”, neutral in theory. But when we allow the love of money and power to take over, EVIL ALWAYS RESULTS. As difficult to read in detail as I know it will be, still, I’m looking forward to reading this book. Sadly, “Study 329” is not an aberration, but merely an example of the norm…. May your book see widespread reading by MANY people….
Larry D. Sasich says
RESTORING STUDY 329
Paroxetine and Study 329: what we already knew and
Larry D Sasich pharmacist
Burlington, ON, Canada L7S 1Z5
The re-analysis of Study 329 using the Restoring Invisible and
Abandoned Trials (RIAT) protocol missed crucial aspects of
patient drug safety.1-3
The fact that paroxetine had not been shown to be safe and
effective in paediatric patients was made publicly available on
the Food and Drug Administration website in 1998,4 three years
before the publication of Study 329.2 The professional product
label for paroxetine since the mid-2000s contains a box warning,
the strongest type of safety alert the FDA requires, stating that
the drug is not approved for use in paediatric patients.5
More disturbing than the results of the Study 329 re-analysis is
the continued prescribing of drugs such as paroxetine in
populations for which there is no evidence of benefit. Prescribers
must recognise that the phrase “safe and effective” has two
meanings. The one in common usage can be used in medical
journal articles with impunity and the regulatory meaning
requires rigorous review of the evidence submitted to support
the approval of, or the use of, a drug in a specific population.
Prescribing decisions may be based on commercial rather than
scientific sources of information.6 Prescribers are inundated
with promotional materials. However, there is no defence for
prescribing drugs that have not been shown to be beneficial
when publicly available FDA summaries based on rigorous
evaluations of the known evidence support avoiding a drug in
It is questionable whether re-analysis of Study 329 trial 14 years
after the original study was published will have a positive impact
on patient safety. Promoting and placing the information from
FDA regulatory summary documents in the hands of patients
and their parents may better serve public safety.
Competing interests: None declared.
Full response at: http://www.bmj.com/content/351/bmj.h4320/rr-0.
1 Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of
paroxetine and imipramine in treatment of major depression in adolescence. BMJ
2015;351:h4320. (16 September.)
2 Keller MB, Ryan ND, Strober M, et al. Efficacy of paroxetine in the treatment of adolescent
major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry
3 Doshi P, Dickersin K, Healy D, et al. Restoring invisible and abandoned trials: a call for
people to publish the findings. BMJ 2013;346:f2865.
4 Dubitsky GM. Food and Drug Administration review and evaluation of paroxetine controlled
released tablets. 1998. http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-936_Paxil_
5 Apotex. Professional product label: Paxil CR (paroxetine). 2015. http://dailymed.nlm.nih.
6 Avorn J, Chen M, Hartley R. Scientific versus commercial sources of influence on the
prescribing behavior of physicians. Am J Med 1982;73:4-8.
Cite this as: BMJ 2015;351:h5411
© BMJ Publishing Group Ltd 2015
For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
BMJ 2015;351:h5411 doi: 10.1136/bmj.h5411 (Published 14 October 2015)