Healthy Skepticism Library item: 17436

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Publication type: news

Olmos D
Glaxo Avandia Study Spurs Journal to Urge Review Rule (Update1)
Bloomberg.com 2010 Mar 23
http://www.bloomberg.com/apps/news?pid=20601202&sid=a0VxQPo__m0g

Full text:

Industry-sponsored drug research should be analyzed by scientists without ties to the company developing a product, said an editorial in the Journal of the American Medical Association.

The authors cited a GlaxoSmithKline Plc study of its diabetes drug Avandia as a “disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial,” in today’s editorial. Academic researchers should have “full access” to study data, and medical journal editors should require an independent statistical analysis before publishing company-funded research, wrote Catherine DeAngelis, editor of the journal, and Phil Fontanarosa, executive deputy editor.

The authors cited a report released Feb. 20 by U.S. Senators Max Baucus and Charles Grassley that said London-based Glaxo rushed a company-sponsored study on Avandia into publication in 2007 to refute other research linking the drug to heart attacks. The report said Glaxo attempted to undermine the scientific steering committee on its sponsored study and failed to acknowledge fully Avandia’s significant heart risks.

“It is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance,” DeAngelis and Fontanarosa wrote in the editorial. “This approach would add powerful support to the fundamental principle that physicians must first do no harm.”

The editors said their journal follows the guidelines it is urging.

‘Unjust’ Commentary

Mary Anne Rhyne, a Glaxo spokeswoman, said the editorial and commentary “unjustly challenges the motives of physician scientists” involved in Glaxo’s Avandia study. Both an interim and final analysis of the Avandia data were “independently verified” at the London School of Hygiene and Tropical Medicine, Rhyne said today in an e-mail.

The journal also published a commentary from Steven Nissen, chairman of cardiology at the Cleveland Clinic, who published a separate 2007 study that linked Avandia to a 43 percent increase in risk for heart attacks. Nissen wrote in today’s journal that independent review of study data “is an essential step” to safeguard against companies influencing researchers’ evaluations.

“If all the raw data is in the hands of the investigators, they are able to independently, without company involvement, come to their own conclusions about the efficacy and safety of the therapy,” Nissen said in a telephone interview.

Drug and medical device companies have contended that data from studies they fund are “their proprietary property, and they should not be required to share it with anybody,” Nissen said.

The drugmaker is facing more than 2,000 lawsuits filed on behalf of Avandia users in state and federal courts across the country.

The U.S. Food and Drug Administration said Feb. 22 that it is reviewing data from Glaxo’s Avandia study and that it has scheduled a meeting of outside advisers in July to discuss the diabetes drug. The agency has told patients that they should not stop taking the medication unless their doctors recommend otherwise.