After more than 20 years of criticism and calls for retraction, a journal has placed an expression of concern on a study of the antidepressant Paxil in teens that critics say has led to unwarranted and potentially harmful prescribing of the drug to youth.
The 2001 paper, published in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP), reported findings from a randomized trial known as “Study 329,” which concluded the antidepressant Paxil was safe and effective in kids ages 12 to 18.
In 2012, Paxil maker GlaxoSmithKline agreed to pay $3 billion to settle civil and criminal charges that included “unlawful promotion” of the drug for adolescents, for whom the product was never approved, and allegations the company “participated in preparing, publishing and distributing a misleading medical journal article” — the JAACAP paper. A reanalysis in 2015 found the drug was “ineffective and unsafe” for the age group studied.
Despite these actions and other calls for retraction, the paper received its first mark this September, shortly after a lawsuit was filed against the journal’s owner, the American Academy of Child and Adolescent Psychiatry, and Elsevier, which publishes the title.
JAACAP “is publishing this expression of concern in order to alert readers to concerns that have been raised about the article,” the September 30 notice reads. “Further review is underway, and an expression of concern will continue to be associated with the article until an outcome is reached.”
JAACAP would not comment on why it issued the expression of concern now, referring us to the AACAP. Rob Grant, director of communications for the group, said the academy “cannot comment on the details of an ongoing review process.”
“AACAP and its journals take the responsibility to investigate concerns very seriously,” Grant wrote in an email to us. The expression of concern “is an interim measure while the evaluation process continues,” he added.
In an email, a spokesperson for Elsevier said the publisher had no additional comment about the expression of concern, and that Elsevier does not comment on legal proceedings.
Martin B. Keller, first author on the original paper and a professor emeritus of psychiatry and human behavior at Brown University in Providence, Rhode Island, did not return messages seeking comment.
Critics of Study 329 called the expression of concern a long time coming.
“It’s great that there’s an expression of concern. It’s the first step forward after 20 years of intermittent but frequent complaining,” said Jon Jureidini, a researcher at the University of Adelaide in South Australia and a coauthor of the 2015 reanalysis of Study 329.
Jureidini said he and others have worked for years to get JAACAP to retract the paper to no avail, including devoting a website to the movement. The paper has been cited 451 times, according to Clarivate’s Web of Science, including by researchers citing the work in a positive light, Jureidini said.
Jureidini said he thinks the expression of concern was likely triggered by a recent lawsuit against AACAP and Elsevier. In a complaint filed September 8 in the Superior Court of the District of Columbia, attorney George W. Murgatroyd III argued the journal is violating the D.C. Consumer Protection Procedures Act by continuing to “publish, distribute, and sell a fraudulent scientific article that contains material facts” that mislead the public and endanger adolescent mental health and safety. AACAP and Elsevier are profiting from the article by charging readers $41.50 on the JAACAP website and $33.39 on Elsevier’s ScienceDirect website to buy access to the paper, according to the complaint.
Murgatroyd, who previously represented families whose children died by suicide after taking Paxil, is suing AACAP “in his capacity as a private attorney general acting on behalf of the general public,” according to the complaint.
The complaint contains other allegations about the paper, including that the article was ghostwritten (a charge the authors have denied), that many of its authors didn’t disclose “extensive conflicts of interest,” and that at least 10 of the 22 authors made no substantial contribution to the work, a claim put forth in a 2008 article by Jureidini.
The suit seeks relief in the form of a “retraction of the Keller article along with corrective notice and reasonable attorneys’ fees and costs.”
Murgatroyd said he, too, believes the expression of concern is a response to pressure from the pending lawsuit.
“The mechanism of self-correction isn’t working,” he told us. “When they don’t self-correct, somebody’s got to step in and say, either you do it or the court is going to make you do it.’ There is nothing good about that article. It’s evil. It promoted drugs to kids who killed themselves. There’s nothing worse than that. You can’t allow something like that to stand.”
Peter Doshi, a senior editor for The BMJ who has been critical of Study 329 for at least a decade, called the expression of concern “devoid of detail.” The stated rationale for the notice is “to alert readers to concerns that have been raised about the article,” but it omits any mention of what those concerns are, Doshi said.
Doshi founded Restoring Invisible and Abandoned Trials (RIAT), an initiative that aims to address bias in clinical trials by reporting unpublished results and re-publishing misreported trials. He and colleagues with RIAT identified Study 329 as “a misreported trial in need of restoration,” which led to the 2015 reanalysis. Doshi wrote an editorial in The BMJ that accompanied it.
Doshi said many unanswered questions remain about the journal’s review into the study.
“What I’d like to know: How is this new review being carried out, by whom — the editor? the ethics committee? someone else? ” Doshi said. “What is its scope? Will its findings be published, and when can we expect conclusions?”
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