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Doctor Pleads Guilty to Research Fraud Involving Vioxx and Celebrex

By Pharmaceutical Processing | February 23, 2010

BOSTON (AP) — A doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex pleaded guilty Monday to one count of federal health care fraud.

An attorney for Dr. Scott Reuben said the anesthesiologist will have to repay $361,932 in research grants and forfeit assets worth at least $50,000 as penalty for his conduct following a plea hearing in U.S. District Court.

Prosecutors alleged the former chief of acute pain at Baystate Medical Center in Springfield sought and received research grants from pharmaceutical companies but never performed the studies. They said he fabricated patient data and submitted information to anesthesiology journals that unwittingly published it.

Reuben, a 51-year-old Longmeadow resident, took leave after the hospital said last year that a routine review found that some of his research was not approved by an internal hospital review board. Further investigation found 21 papers published in anesthesiology journals between 1996 and 2008 in which Reuben made up some or all of the data, the hospital said.

The hospital asked the journals to retract the studies, some of which reported favorable results from painkillers including New York-based Pfizer Inc.’s Bextra, Celebrex and Lyrica and Whitehouse Station, New Jersey-based Merck & Co. Inc.’s Vioxx. The studies also claimed Wyeth’s antidepressant Effexor could be used as a painkiller. (Wyeth is now part of Pfizer.)

Vioxx and Bextra, among a class of painkillers known as Cox-2 inhibitors, were pulled from the market amid mounting evidence they raised the risk of heart attack, stroke and death. Celebrex is still on the market. Lyrica is a treatment for fibromyalgia, a syndrome characterized by chronic muscle pain and fatigue.

Reuben’s attorneys, Paul Cirel and Ingrid Martin, said in a statement released Monday that Reuben was suffering from a serious a bipolar disorder that was only accurately diagnosed in 2008 and had no financial motive when he committed the offenses.

“Dr. Reuben’s bipolar disease explains but is not an excuse or a defense for his conduct. However, his alternating periods of mania and depression fueled his misconduct and adversely affected his ability to halt his wrongful behaviors in the area of research,” the statement said. “Reuben has admitted his wrongdoing and wishes to apologize to his family, to his colleagues, to the medical community and to the pharmaceutical companies that funded his research.”

Monday’s guilty plea is part of Reuben’s efforts to cooperate with the medical community and with law enforcement, the statement said. Reuben has agreed to not practice medicine and to make full restitution to the pharmaceutical companies that funded his research, it said.

Between 2002 and 2007, Pfizer gave five research grants to Reuben, who was a member of the company’s speakers bureau, giving talks about its drugs to colleagues. The company has said it was not involved in the conduct of Reuben’s studies or in the interpretation or publication of the results.

The investigation was first reported by the trade publication Anesthesiology News.

The journal Anesthesia & Analgesia retracted 10 of Reuben’s studies last February. The journal Anesthesiology said last year that it retracted three.

Reuben faces up to 10 years in prison, to be followed by three years of supervised release and a $250,000 fine. Sentencing is scheduled for May 24.

 

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