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ore than a decade ago, a published study touted the benefits of using the Celexa antidepressant to treat children and teens. A recent analysis, however, alleged the study had numerous problems — notably, there was no difference between the drug and a placebo. And so, the researchers and several other academics want the medical society and the journal that published the study to issue a retraction.

In a letter sent Tuesday to the American Psychiatric Association, the researchers maintain the original 2004 study, which was published in the American Journal of Psychiatry, contained “gross misrepresentations” about the safety and effectiveness of the drug. They also allege the study reflected the “pervasive influence” of the marketing objectives of Forest Laboratories, the Celexa manufacturer, since the drug was never approved for use in youngsters.

The researchers wrote that procedural deviations in the study were not reported; negative outcomes were not reported; side effects were misleadingly analyzed; and drafts of the study were prepared by company employees and outside ghostwriters. These points were highlighted in their analysis of the 2004 study, which was published last May in the International Journal of Risk & Safety in Medicine.

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“We believe that the unretracted … article represents a stain on the high standard of the American Journal of Psychiatry and the American Psychiatric Association,” they wrote to APA president Dr. Maria Oquendo. “Neither the AJP nor the APA can claim to be a leader in scientific research and moral integrity, while failing to redress this article that negligently misrepresents scientific findings.”

An APA spokeswoman did not respond when asked whether the organization will consider issuing a retraction.

The researchers maintain a retraction is warranted because the study “continues to be cited uncritically in the psychiatric literature” as evidence that Celexa is effective in treating adolescent depression. “Our main concern is that children and adolescents are continuing to be at risk of harm unnecessarily because well-intentioned physicians have been misled,” they wrote the APA.

Some of the issues raised by the researchers have been previously known. In 2011, Forest, which was later acquired by Allergan, paid $313 million to resolve criminal and civil charges. Federal authorities alleged the company conducted an illegal promotional scheme to create a wider market for the medicine by persuading doctors to prescribe the pill for children and adolescents.

In preparing their analysis, however, the researchers further cited internal Forest documents that became available only as the result of ongoing litigation over the marketing of Celexa and Lexapro, another antidepressant sold by Forest. They argue the documents reveal additional details about the study data. We should note that four of the 16 researchers who signed the letter to the APA have worked as research consultants to one of the law firms that filed the litigation.

The demand for a retraction follows years of controversy over the extent to which some drug makers manipulated clinical studies in order to broaden the market for their medicines.

In perhaps the most notorious case, GlaxoSmithKline four years ago paid $3 billion to resolve civil and criminal charges of preparing, publishing, and distributing a misleading journal article about the use of its Paxil antidepressant in youngsters. The pill had not been approved for that use and the study cited by federal authorities had been ghostwritten.

The Celexa study, in fact, had similarly caused a stir after the federal government became involved in litigation over the marketing. In a 2009 response to the growing fracas, the American Journal of Psychiatry issued a statement indicating that while Forest acknowledged hiring an outside medical writer to work with study authors, the journal was satisfied that the authors satisfied the necessary requirements to have their names listed on the study.

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The journal also noted Forest admitted not disclosing that it was aware of troubling data from a study by Lundbeck, which had licensed Celexa to Forest. The data showed increased risk of suicide in children and adolescents who were treated with the pill. In its 2009 statement, the Journal added that this omission would be noted as a comment on the paper going forward.

Two months ago, the researchers said they contacted AJP editor in chief Robert Freedman to request a retraction, but he wrote back to say that he would not retract the article. The APA spokeswoman sent us a copy of the 2009 statement, but did not respond to further questions.

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  • A recent review, within the past 5 years, of the methodology and statistical analysis of published articles showed that 75% should not have been published. This was 5% better than the previous study in 1980 of 80%! Needless to say we all must be cautious about what we read. Our clinical experience is far better than any “study” coming down from above because figures don’t lie but lie’s do figure!

  • I am no fan of the pharmaceutical industry, or for that matter of any of our many government-supported monopolies. However, I am disturbed by this article because it smacks of propaganda with some hidden agenda. It even sounds like the stuff put out by the Scientology cult! In this article, full of inflammatory innuendos, the author, Ed Silverman, repeatedly refers to “the researchers,” a mysterious group of anonymous individuals whose reasons for acting are never addressed.

  • As a psychiatrist clinician, teacher and researcher, I am of two minds about this. My initial reaction was “well this is only one of MANY examples, and that’s why I teach residents to analyze the methodology of a study carefully, and pursue linked articles on pubmed rather than practicing based on an abstract, or a summary in a secondary source (alone). So let it stay, along with the inumerable subsequent articles confirming its fallacy.” But then, the issue here is essentially research misconduct. This may not be detectable even on the most careful reading. Therefore, I believe there is a much greater good to this letter: the refusal to retract Wagner et al (2004), given the evidence published by Jureidini, Amsterdam & McHenry (2015), represents a clear valuation of power/status/status quo/reputation/etc OVER the welfare of patients or scientific integrity on the part of the AJP/APA. Thus I agree that a published retraction is in order, even if–or better, because–this may increase the likelihood of additional similar cases coming to light.

  • As a clinician I find most all antidepressants make children worse–especially. at ‘therapeutic doses. I’ve seen 4 cases in a year. The drug companies just keep doing studies until they find one they like and ignore dozens of others.

    • Precisely. Pharma gets unlimited bites of the apple, doing as many studies as needed to find two positive studies they can cobble together for FDA approval. If you’ve been around long enough you may remember the drug buspirone, the first non benzodiazepine anxiolytic and one of the first dependent on foreign data for approval. Bristol Myers Squibb performed 20 controlled clinical trials of Buspar, the score card read 18 negative and two “positive”. I put that in quotes because the second “positive” study was a tiny 20 patient study out of Germany. The drug got approved because FDA was desperate to approve anything that wasn’t a BZ. You may also be in the school that believes there is no such thing as pediatric bipolar disorder. I happen to believe the diagnosis only exists because pharma gave millions of dollars to guys like Biederman to establish research institutes and essentially fabricate new DSM diagnoses out of whole cloth in return for the luchre all to willingly coughed up by pharma to get their newly minted diagnoses and the drug sales that follow.

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