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U. will not back retraction of prof’s study

Allegations of a false study have led to ethical investigation of a former professor’s drug research

The Journal of the American Academy of Child and Adolescent Psychiatry will not retract a controversial study authored in 2001 by former Brown professor Martin Keller, according to a letter written by Andres Martin, the journal’s editor, last month.

The Keller study, commonly referred to as Study 329, concluded that the drug Paxil was an effective treatment for adolescent depression. The study has been criticized for distorting data to reach its conclusion, The Herald  previous reported. Its authors have come under attack for their financial ties to Paxil parent company GlaxoSmithKline and have been accused of having the article ghostwritten by a GSK affiliate, The Herald reported. The Senate Finance Committee, a former Boston Globe medical writer, the BBC and, most recently, the Department of Justice have been among those to subject the study to ethical investigations in the 12 years since it was initially published.

The JAACAP conducted an internal investigation of the study following the Department of Justice’s lawsuit against GSK last summer but concluded the study was sound, according to Martin’s letter. In a $3 billion settlement, GSK admitted to selling several misbranded drugs, one of which was Paxil.

In the plea agreement, the Department of Justice said the promotion of Paxil was based on Keller’s “false and misleading” study. GSK entered into the plea without agreeing to the accusations set forth in it, according to a transcript of the plea hearing, and the company specifically denied the claim that the study was “false and misleading” in a letter to the Chronicle of Higher Education last October.

Martin’s letter was addressed to Jon Jureidini, a professor at the University of Adelaide in Australia and a member of the nonprofit Healthy Skepticism. Jureidini had written to Martin requesting that the JAACAP retract the study.

A Healthy Skepticism representative had also written to the University in 2011, requesting support for the group’s request to have Keller’s article retracted. Dean of Medicine and Biological Sciences Edward Wing replied that the University would not support the retraction effort. A Healthy Skepticism representative wrote again to President Christina Paxson in September, asking that the University reconsider its position in light of the GSK settlement. The Herald received copies of each letter from Healthy Skepticism.

The group did not receive a response from Paxson, Jureidini said.

“The University conducted a thorough and impartial review of Dr. Keller’s involvement in Study 329 more than a decade ago,” Marisa Quinn, vice president for public affairs and University relations, wrote to The Herald in an email. “The decision by the Journal of the American Academy of Child and Adolescent Psychiatry does not suggest that any further action by the University is warranted.”

The University previously said the GSK settlement did not mandate additional investigation into Keller’s research, The Herald reported in September.

Keller, a former professor of psychiatry and human behavior, stepped down from his chair position in 2009 and resigned from his professor position last summer. He could not be reached for comment.

Despite Martin’s response, members of Healthy Skepticism plan to continue efforts to have the study retracted, said Leemon McHenry, a member of Healthy Skepticism and co-author of the letters to the University. McHenry is also a faculty member at California State University in Northridge.

“The fact that we’ve got these people that keep denying what’s obvious to most people and what’s obvious to the Department of Justice seems like some conspiracy theory to me,” McHenry said. “I’m not sure what to make of it.”

But the number of adolescent suicides resulting from prescriptions of Paxil encourages the study’s critics to push for retraction.

“The false and misleading statements in the paper are still being cited by other authors as the truth, and the paper is still being used to market Paxil for teenagers,” said David Egilman, the clinical professor of family medicine at Alpert Medical School who had initially approached the University about possible misconduct by Keller. “And as a result, some teenagers are committing suicide.”

Martin did not return a request for comment.



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