Quoted from http://www.bloomberg.com/apps/news?pid=20601124&sid=aNNloBopUC9g
Glaxo Avandia Study Spurs Journal to Urge Review Rule
By David Olmos
March 23 (Bloomberg) -- 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.”