More 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.
“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 (AGN), 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 (GSK) 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.
The journal also noted Forest admitted not disclosing that it was aware of troubling data from a study by Lundbeck (HLUYY), 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.