Dispute raises concerns on drug-funded studies

updated 7:03 p.m. ET Feb. 22, 2006

WASHINGTON - Dr. Aubrey Blumsohn was stunned: Research results were submitted to a scientific meeting under his name, yet the British bone specialist insists he not only hadn’t written or reviewed the report, he wasn’t sure it was accurate.

The incident turned into a public feud when Blumsohn charged that the U.S. drug company paying for the study rebuffed his attempts to analyze the data.

It’s the latest in a string of controversies about pharmaceutical industry control of medical research, from hidden antidepressant risks to the undercounting of heart attacks in a critical study of the painkiller Vioxx.

Whoever pays for medical research — not necessarily the scientists who do the work — controls what doctors, and the public, learn about its outcome. Scientific journals, including one that published some of the reports Blumsohn now questions, are grappling anew with how to ensure that they print complete results.

“This is a major problem, for both researchers and scientific journals,” said Dr. Joseph Lorenzo of the American Society for Bone and Mineral Research, which has convened a task force to consider whether extra steps are needed to protect against “hidden biases” in industry-funded research.

It’s an important question, considering that the pharmaceutical industry provides about 70 percent of the financing for studies of medications in the United States.

Questions about that research started making headlines in 2004, when a Food and Drug Administration reanalysis of industry antidepressant studies concluded those drugs sometimes increase the risk of suicide in children.

Risks downplayed
Then Merck & Co. pulled its arthritis drug Vioxx off the market, after research found long-term use doubled the risk of heart attacks. Critics say the risk was downplayed until then — and last December, the New England Journal of Medicine revealed that it had published a 2000 Merck study that failed to disclose some heart attacks, making the drug appear less risky than later determined.

Reeling from bad publicity, the industry pledged to do better at revealing results of clinical trials. Editors of leading medical journals attempted to force them to do so, by declaring they would no longer publish results of any studies that hadn’t been listed in a public registry. And Sen. Charles Grassley, R-Iowa, is pushing for legislation to mandate full disclosure.

But Blumsohn, in a Capitol Hill visit arranged by the watchdog Government Accountability Project, is raising questions of more subtle influence — which Procter & Gamble, the company that funded his work, disputes.

P&G hired his lab at Sheffield University to analyze samples from thousands of women who used its osteoporosis drug Actonel. The goal: to determine what rate of bone renewal gives the most protection against fractures.

MORE FROM HEALTH CARE

Health care Section Front

Uninsured ER patients twice as likely to die   NYT: Drug firms raise prices ahead of reform Report: Health bill would reduce senior care Secretive front group battles health bill Medicare paid $47 billion in suspect claims Tough choices on abortion coverage Few Americans make end-of-life wishes known Sources: Reid eyes payroll tax rise on high earners How would the House abortion limits work? Bill Clinton urges passage of health care bill Health care Section Front   Add Health care headlines to your news reader: