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Discredited Paxil Study Clouds GlaxoSmithKline, Brown University

Paxil bottle with pills spilling out

GlaxoSmithKline executives have been implicated in manipulating a now defunct study indicating Paxil is safe for adolescents.

The story of GlaxoSmithKline's fraudulent actions didn't end with the record $3 billion settlement the company agreed to in early July 2012. Instead, the pharmaceutical manufacturer remains under fire for its role in illegally marketing its blockbuster antidepressant Paxil. At issue is a study GlaxoSmithKline orchestrated that misreported data from a clinical trial and that has yet to be corrected.

GlaxoSmithKline was accused of aggressively promoting the use of Paxil in children, which the U.S. Food and Drug Administration (FDA) did not approve. In an attempt to take some of the market from Eli Lilly and Co. -- which manufactures Prozac, the only antidepressant the FDA deems safe for kids younger than 12 -- executives at GlaxoSmithKline reportedly helped tweak a medical journal article to suit their purpose.

Paxil Study Discredited

In 2001, the Journal of the American Academy of Child and Adolescent Psychiatry stated that Paxil was “generally well tolerated and effective for major depression in adolescents.” The study has since been discredited by other scientists who found the outcomes had been combined, only selective results were reported, and ghostwriters authored the paper.

The paper, Study 329, has never been retracted, however, and its authors did not face sanctions. The universities they represented did not even issue a public acknowledgement of the danger their academics created when they published a fabricated study. Furthermore, the lead author of the study, Martin Keller, was allowed to quietly retire from his academic position at Brown University at the end of June and maintain the title of emeritus professor of psychiatry and human behavior.

It's clear the university hopes the issue will be abandoned over time, but health care professionals and researchers are not about to let that happen. Dr. Jon Jureidini and Leemon McHenry, who have written papers debunking Study 329, continue to ask Brown University’s current president, Christine H. Paxson, to take action against Keller.

Even Dr. Roy Poses, a clinical associate professor of medicine at Brown, criticizes his own administration for trying to bury the issue. "The appearance of continued stonewalling, now going on for years, can easily be interpreted to imply that the institution has something really big and bad to hide," he wrote on his blog.

GlaxoSmithKline's Fraudulent Actions

The U.S. Department of Justice certainly believed that GlaxoSmithKline's fraudulent actions were serious and blatantly harmful. “[The] multibillion-dollar settlement is unprecedented in both size and scope,” said James M. Cole, the deputy attorney general. “It underscores the administration’s firm commitment to protecting the American people and holding accountable those who commit health-care fraud.”

Still, scientists and doctors worry that if the study is not retracted, patients may suffer when doctors prescribe medicines such as Paxil based on fraudulent studies.

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