Doctors Behaving Badly: Painkiller research faker cuts deal with feds

Scott Reuben, a Massachusetts anesthesiologist, had landed a job as the chief of acute pain at Baystate Medical Center in Springfield. He also had published dozens of papers in academic journals touting the benefits of painkillers made by drug giants Pfizer and Merck.

His work became a key part of the clinical case used to promote COX-2 inhibitors as the newest and best wave of pain drugs in the 1990s and early 2000s. To get a sense of his importance, look at this internal Merck memo that cites his work among just 11 foundational studies that helped establish Vioxx, or rofecoxib, as the market leader. It was approved by the FDA for acute pain in 1999, and the company had high hopes for its expansion into other areas, including colon cancer prevention.   

From early on, there were signs that Vioxx had dangerous cardiovascular side effects, but Merck kept coming up with new studies that downplayed the risk. Finally, in 2004, a Merck-sponsored clinical trial, rather hopefully codenamed APPROVe, showed that Vioxx increased patients' relative risk of heart attacks and strokes. Merck voluntarily pulled Vioxx from the market in September 2004. Bextra, another COX-2 inhibitor promoted by Reuben, was pulled from the market in 2005, and Celebrex, Pfizer's other COX-2 and another Reuben favorite, was slapped with a severe warning label by the FDA.

Perhaps the bad news caused Reuben's employers at Baystate to wonder about all those glowing reports he had written. They put together a peer review panel of other Baystate physicians to look at his studies. In March 2009, the hospital took the rare step of asking medical journals to retract 21 studies that Reuben co-authored between 1996 and 2008. They said the studies, later listed by the journal Anesthesia & Analgesia, were based on fake data.

"Dr. Reuben deeply regrets that this happened," Reuben's attorney, Ingrid Martin, told The Wall Street Journal. "Dr. Reuben cooperated fully with the peer review committee. There were extenuating circumstances that the committee fairly and justly considered."

His apology didn't quite cut it with federal prosecutors in Boston. They filed a health care fraud charge against him. Prosecutors said that, in order to be paid a $74,000 grant from Pfizer to test the painkiller Celebrex, Reuben told the company that he had treated 200 patients. The charge says:

In fact, Reuben had not enrolled any patients into that study and the results reported both to Pfizer and to the Anesthesia and Analgesia Journal and in turn to the public were wholly made up by Reuben.

In Springfield last month, The Republican reported that Reuben made a plea deal with prosecutors. Under the deal, he would have to forfeit to the federal government $50,000 in earnings from the pharmaceutical companies. He will be forced to pay $420,000 to the drug companies as restitution. He has yet to be sentenced and could spend as many as 10 years in prison.

Final question: How did scientists at Pfizer and Merck miss the problems with Reuben's results? Why did it take a hospital to blow the whistle? Let's hope the plea deal doesn't stop this information from ultimately surfacing.