Pharma notes psychiatrist Martin Keller's authorship of fraudulent study but his university declines to take action

September 15, 2012

The University will not take action against former Professor of Psychiatry and Human Behavior Martin Keller, despite acknowledgment by pharmaceutical giant GlaxoSmithKline that Keller co-authored a fraudulent study advocating adolescent use of the antidepressant Paxil.

In a record-breaking $3 billion settlement this July, GSK pleaded guilty to selling the misbranded prescription drugs Paxil, Wellbutrin and Avandia. According to the plea agreement, GSK’s promotion of Paxil was largely based on Keller’s “false and misleading” article, published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry.

Since the article’s publication, the ethics of the study—commonly referred to as Study 329—have been scrutinized in a book, a BBC documentary and a Senate Finance Committee investigation. Critics have said the study inappropriately characterized the drug’s effectiveness while downplaying the risk of adolescent suicide associated with Paxil—a significantly larger number of patients treated with Paxil had “a possibly suicidal event” than patients treated with a placebo did, according to the government complaint against GSK. The complaint also claimed that Keller’s article was ghostwritten by GSK representatives.

Following allegations of research misconduct, the University conducted an internal investigation into Keller’s article but has never publicly discussed its findings, citing confidentiality. “The fact that Professor Keller has continued to be chair and continued research and continued to get grants speaks for itself,” then-Provost David Kertzer ’69 P’95 P’98 told The Herald in 2009.

“The University has fully reviewed this issue, and there is nothing that emerged from the recent announcement by the U.S. Department of Justice regarding (Keller’s) research that would prompt any further reviews of the paper by the University,” wrote Edward Wing, dean of medicine and biological sciences, in an email to The Herald.

Keller, who stepped down as chair of the psychiatry department in 2009 but stayed on as a professor, announced his retirement earlier this year and stepped down in July. Pending approval from the National Institutes of Health, the University will transfer his grants to multiple investigators, Wing wrote, calling this a “standard practice” at Brown. Keller did not respond to multiple requests for comment.

The government’s charges against GSK came under the interstate commerce clause. According to a government official speaking anonymously, the government cannot charge the individual researchers who co-authored the study because the research was not funded by federal dollars, the Chronicle of Higher Education reported last month.

When Study 329 was initially conducted, researchers found that Paxil did not perform better than placebos on the measures the researchers had outlined beforehand. In internal documents, GSK called the results of the study “commercially unacceptable,” according to the government complaint. After viewing the results, the company introduced additional measures on which Paxil performed better than the placebo.

Paxil would soon become one of the 10 most prescribed drugs in the country, according to the plea agreement. As part of its promotion of Paxil, GSK would regularly invite physicians to conferences in resort locations, providing fine dining and expensive forms of entertainment, according to the government complaint.

Keller acknowledged in 2006 that over the years, he had received tens of thousands of dollars from GSK and its affiliates.

In recent years, groups such as the Project on Government Oversight have written to the University requesting that action be taken against Keller.

The global nonprofit Healthy Skepticism wrote to administrators last year, requesting the University’s help in an effort to have the article retracted. Wing responded that the University would not support a retraction, adding that the University takes allegations about faculty research very seriously.

Healthy Skepticism plans to write the University again this year, in the hopes that a new president might be more inclined to support its efforts, said Jon Jureidini, a professor at the University of Adelaide in Australia who co-authored last year’s letters.

Source: Sahil Luthra, "U. forgoes action against prof after study fraud," The Brown Daily Herald, September 14, 2012.