Ten years after its publication, a study by Professor of Psychiatry and Human Behavior Martin Keller continues to generate concern in the medical community due to its alleged link to child suicide.
Last month, the global nonprofit Healthy Skepticism wrote to the University requesting support for its efforts to retract Keller's article — commonly known as Study 329 — from the Journal of the American Academy of Child and Adolescent Psychiatry.
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. The authors added that the study's continued citation was harmful to children, since some children committed suicide after being prescribed Paxil.
The letter follows several ethical examinations of Study 329, including a BBC documentary, the book "Side Effects" by former Boston Globe reporter Alison Bass and an investigation by the Senate Finance Committee. Those inquiries led to allegations that the authors of the study — who had received funds from Paxil's parent company GlaxoSmithKline — suppressed the findings on the drug's connection to suicidal tendencies because they would adversely affect profits.
Keller, the lead author, was also accused of allowing the study to be ghostwritten by a GlaxoSmithKline affiliate. In June 2009, he stepped down as chair of the psychiatry department, citing personal reasons, but he retained his professorship. Keller did not respond to multiple requests for comment for this story.
Citing confidentiality reasons, Dean of Medicine and Biological Sciences Edward Wing also declined to comment.
But the University is harming itself by staying silent in the face of the accusations, said Clinical Associate Professor of Medicine Roy Poses '73 MD'78. "There ought to be a public response. If these allegations are false or wrong, that ought to be made clear. If they're true, then there ought to be some action."
Following the October letter, President Ruth Simmons wrote to Healthy Skepticism that Wing would be in touch soon, said Jon Jureidini, one of the co-authors of the letter and a clinical professor at the University of Adelaide in Australia. Wing has not yet responded.
Though Jureidini said he is waiting for a response before he plans any future actions, he "won't necessarily give up" if the University refuses to support retracting the study.
"I can't imagine how you could review this case and not find misconduct," Jureidini said. He added that the arrival of a new president at Brown could provide an opportunity to ask the University again.
University research policies state that when charges are brought against a researcher, the University must decide whether to pursue a formal investigation. If the investigation reveals misconduct, the researcher can face suspended privileges, and their papers may be withdrawn. If misconduct is not found, the University takes steps to restore the researcher's reputation.
But even if University officials found evidence of misconduct, they would likely ignore them, since Keller's research has provided a steady source of University funding, according to Paul Thacker, an investigator at the Project On Government Oversight. Thacker, who also participated in the Senate inquiry, said he does not think the University should continue to receive any federal funding if it does not publicly address the Keller case.
Thacker added that the University has prioritized discussion of less important issues over the years, citing the Steering Committee on Slavery and Justice formed in 2003. The University "spent all this time tearing themselves up about some sort of peripheral involvement in slavery," he said. "Nobody is walking around today who is being harmed by slavery. There are people who are walking around today who are harmed by this study."
Bass, who has continued to report on Study 329 following the publication of "Side Effects," said though pinpointing specific examples would be difficult, "there's no question there were adolescents and children who became suicidal and tried to kill themselves — and in some cases, succeeded in killing themselves — because the doctors were misled."
Pointing to the accusations of ghostwriting, Bass added that there is a double standard in the University not taking action against Keller, because students who plagiarize face expulsion.
When she was working for the Boston Globe, Bass also authored an article about conflicts of interest in Keller's research, examining payments Keller received from pharmaceutical companies.
Though the University revised its conflict of interest policies in 2009, those changes were simply "window dressing," wrote Leemon McHenry, a co-author of Healthy Skepticism's letter, in an email to The Herald. McHenry, a researcher at California State University, Northridge, speculated that in practice, the University would likely prioritize the wishes of companies like GlaxoSmithKline over its ethical standards.
The University held a forum Tuesday to hear faculty perspectives on its current conflict of interest policy.