The Journal of the American Academy of Child and Adolescent Psychiatry says they refuse to retract a study known as Study 329, even though following a lawsuit with GlaxoSmithKline the controversial study involving Paxil was proven to be misleading and distorted.
One global nonprofit Healthy Skepticism expressed concern that the study, which identified the drug Paxil as an effective combatant of depression in children, “seriously misrepresented both the effectiveness and the safety” of the drug. They say that the study’s continued citation was harmful to children, since some children committed suicide after being prescribed Paxil.
Last summer, GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs, failing to report safety data and reporting false prices. One infraction, in particular, concerned this controversial study, further leading some to believe that it is without question that the study be retracted.
The feds claimed the GSK participated in preparing, publishing and distributing what was called a “misleading medical journal article” because the results misreported that a Paxil clinical trial demonstrated efficacy in treating depression in patients under age 18, when the study failed to demonstrate efficacy.
Prosecutors accused GSK sales representatives of then using the article to promote the use of the drug for depressed youth. Sales reps invited prescribing psychiatrists to luxury resorts for “Paxil forum meetings” where they were treated to fancy dinners and free entertainment like sailing trips and balloon rides.
Reports of teens committing suicide while taking Paxil began surfacing in 2003, and the FDA discovered that 10 of the 93 Paxil patients in Study 329 had attempted suicide or thought about it, versus one out of the 87 patients on placebo. In 2004, the FDA added a black-box warning on the drug’s label about the increased risk of suicidal thoughts in teens who take it.
After the settlement with GSK, however, several detractors hoped this presented a fresh opportunity to convince the journal to issue a retraction. Unfortunately, as of yet this has not been the case. The journal has again declined to do so, according to an e-mail exchange with an academic who has previously pushed for retraction.
In a Dec. 21, 2012, e-mail, AACAP editor-in-chief and Yale University psychiatry professor Andres Martin wrote that the “journal’s editorial team undertook a thorough evaluation of the article, the legal settlement and related materials. The authors of the article were contacted and asked to respond to the questions and concerns raised by the settlement.
“After a comprehensive and extensive review, the journal editors found no basis for retraction or other editorial action,” he wrote about what he called a “lengthy” review. His e-mail was addressed to Jon Jureidini, a psychiatry professor at the University of Adelaide in Australia.
Martin was responding to a letter that Jureidini wrote last summer, seeking a retraction. “Given the clear misrepresentations present in the article, it would be appropriate for the journal to withdraw it immediately. Decisive action would benefit the psychiatric and general community, given that this paper inappropriately exaggerates the efficacy of paroxetine in young patients. It would also be beneficial to the journal’s reputation,” Jureidini wrote.
Brown University has joined the journal refusing to retract the study.[hr]