A Leading Medical Journal is Likely to Retract a Significant Study from 2001 Showing Safety in Prescribing Paxil, an SSRI, to Children and Adolescents

The study, which was published in the Journal of the American Academy of Child & Adolescent Psychiatry, made upbeat claims that Paxil was safe and effective for young people. But the underlying data were later found to be misleading because they distorted results, and the study downplayed information that some patients experienced serious side effects, such as suicidal thoughts.  Meanwhile, GSK, which sold the pill, had attempted to use the findings as a marketing tool to persuade doctors to write more prescriptions, even though Paxil was not approved to treat teens at the time. In fact, the Food and Drug Administration never approved Paxil for this population and issued a warning about suicidal thoughts for this type of antidepressant, known as a selective serotonin reuptake inhibitor, or SSRI.  Fast forward to 2012, when the Paxil marketing figured prominently in a high-profile settlement that the company reached with Department of Justice. GSK agreed to pay $3 billion to resolve criminal and civil charges for “fraudulent promotion” of certain medicines and its failure to report certain safety data, among other things. For many, the episode was the epitome of egregious pharmaceutical marketing.

At the heart of the scandal, though, was the Paxil study, given that depression is a widespread mental health problem and that the pharmaceutical industry had targeted the illness for its potential to be a huge moneymaker. Like blood pressure and cholesterol, depression was one of the so-called me-too therapeutic categories that numerous drug companies targeted in hopes of a large and long-running payout.  Health care organizations screening for depression are skipping a critical question Despite the controversy, the journal never responded to several calls for a retraction that began in 2006. By then, lawsuits were filed against GSK, and internal company documents revealed efforts to manipulate the study findings and that the drugmaker also relied on ghostwriters. By 2010, though, the study was cited in 153 other journal articles. Today, there are 913 citations.  The most recent bid for a retraction was made this month by an attorney, George Murgatroyd III, who has represented a dozen families whose children died by suicide or were severely injured in an attempt to kill themselves after taxing Paxil, according to a lawsuit he filed in Superior Court in Washington, D.C. He took this step after writing the journal in June seeking a retraction.

Murgatroyd claimed the American Academy of Child & Adolescent Psychiatry and Elsevier, the publishing company, violated D.C. consumer protection laws by distributing the article “as if it were valid scientific literature. It is not. The article is a promotional piece masquerading as medical science.” As a result, “vulnerable consumers” were harmed and physicians have been “misled,” the lawsuit stated.  Separately, Murgatroyd wrote us that the article “is a blight and offends all the families who lost their children due to Paxil induced suicidality.” He added that the medical society and publisher continue to profit from the sale of the article, despite the long-standing concerns with the content, and that he recently purchased a copy for $41.50 from the journal website. A spokesperson for the medical society wrote that “AACAP is currently reviewing the article, which was published over two decades ago. While AACAP cannot comment on the details of an ongoing ethical review process, AACAP and its journals take the responsibility to investigate ethical concerns very seriously and manage such concerns in accordance with research integrity recommendations and guidelines established by the Committee on Publication Ethics.”  We asked the spokesperson whether a retraction is being considered, but there was no reply. On its website, the Committee on Publication Ethics, a U.K. charity, posted that “journals should always consider concerns about the integrity and research presented in articles that arise at any time and should not avoid issuing a retraction or an expression of concern simply on the basis of the age of the article.” We asked Elsevier for comment and will update you accordingly.

Meanwhile, a 2022 version of the Paxil product monograph — a document that describes the properties and indications of a drug — that GSK released in Canada noted “controlled clinical studies in depression failed to demonstrate efficacy and do not support the use” in treating children under 18 with depression. It also mentions a higher incidence of adverse events related to emotional changes, “including self-harm.”  One researcher who has followed the saga maintained that a retraction was long overdue.  “This article is still being built into guidelines. And most people don’t know its fraudulent,” said David Healy, a former psychiatry professor at Bangor University in Wales, who runs RxISK.org, a website that gathers information about the side effects of medicines. “Editors are the point people in all this.  If they don’t respond to physician input, and in this case they didn’t, we have a wild west.” Healy was also a member of a team of researchers who a decade ago reanalyzed the study and found Paxil was not safe or effective in adolescents. Their findings, which were published in The BMJ, broke with scientific custom and signaled a new era in scientific publishing, because different journals published different interpretations of the same study. 

“This study was fraudulent. It was ghostwritten and was a negative trial spun as safe and effective, which led to thousands of kids put” on the medicine, Healy said. “And the trials in this age group show no benefit with an excess of harms. And the black box [label] warnings [were added] seemingly to no effect. … And all the time, [the journal] may be actively complicit in this, rather than innocents duped by GSK.”