Questions About Retracted Studies Could Hurt Perception of Painkillers

March 12, 2009 07:30 AM
by Cara McDonough
A prominent pain doctor allegedly faked 21 studies about various drugs. With several questionable studies released in recent years, who can consumers trust?

Colleagues Are Shocked

Scott S. Reuben, former chief of acute pain at Baystate Medical Center in Springfield, Mass., faked 21 medical studies claiming to show benefits from certain painkillers, according to the hospital.

Reuben’s studies showed favorable results from various medications, including painkillers like Pfizer Inc.’s Bextra and Merck & Co.’s Vioxx, which have since been withdrawn, as well as other drugs, including Pfizer's Celebrex and Lyrica. He also claimed he found Wyeth's antidepressant Effexor XR useful as a painkiller.

Reuben had been a paid speaker for Pfizer's medicines, and the pharmaceutical company paid for some of his research, reports The Wall Street Journal. There is no evidence that he had any financial deals with Wyeth.
Pfizer representatives said the findings were “very disappointing” and Jacques E. Chelly, the head of acute interventional postoperative pain service at the University of Pittsburgh Medical Center, said he was “shocked” by the news, as Reuben was so well respected. 

Consumers may be shocked by the findings as well.  While questionable, or flat-out phony, pharmaceutical studies aren’t the norm, they certainly aren’t unheard of.

Investors recently filed a lawsuit against pharmaceutical companies Schering-Plough Corp. and Merck & Co., saying that the companies did not disclose test results showing that Vytorin, a drug they jointly produce, does not unclog arteries any better than an older, less expensive drug.

In 2008, the two companies did publically admit that a two-year study found Vytorin—made up of two older drugs, Zetia and Zocor—cleared plaque from arteries no better than Zocor alone, but investors claim that the results should have been released sooner.

Questions surrounded the drug Vioxx as well. The painkiller was eventually withdrawn in 2004 because of a study that connected the drug to heart attack risk, bringing a rash of lawsuits from patients.

But that wasn’t the only controversy attached to the drug; in 2008, researchers said that a study by Merck & Co. that said the painkiller was easier on the stomach than an older drug was “a marketing tool used to boost sales,” Bloomberg reported at the time. The study—called the “Advantage” study—was crafted to get physicians to prescribe Vioxx, and “was marketing masquerading as science,'' said researcher Kevin Hill, of Harvard Medical School in Boston.

As for Reuben’s reportedly faked studies, his attorney Ingrid Martin said that the doctor “deeply regrets that this happened.” She said he has fully cooperated with the peer review committee on this issue, and that there were “extenuating circumstances that the committee fairly and justly considered,” although she did not explain what the circumstances were.

Whatever the reason for the bogus results, the recalled studies will have a big impact on the pain relief field. "Doctors have been using (his) findings very widely," said Dr. Steven Shafer, editor of Anesthesia and Analgesia, which retracted 10 of Reuben’s studies last month.

The news will not, however, have any effect on the drugs’ regulatory status because Reuben’s studies were not submitted to the U.S. Food and Drug Administration or to European authorities.

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Related Topic: Painkiller use

Strong narcotics used as painkillers, such as drugs with ingredients including fentanyl, hydromorphone, methadone, morphine, oxycodone and oxymorphone, may soon be more tightly regulated.

The FDA announced in February that it is launching a campaign against the use of certain narcotics, pointing to a growing misuse of painkillers over the past decade. Reports show that misuse of the products, including accidental overdoses, has grown significantly in the past 10 years.

The FDA’s announcement means that the opioid-type painkillers prescribed to 3.7 million Americans may soon be harder to get. But many patients say prescription painkillers have saved them from a life of chronic pain.

Reference: Prescription drugs


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