Avandia inspires JAMA call to reform

The latest brouhaha over Avandia isn't just a tempest in a teapot. It has actually touched off calls for journal-publication reform. In the wake of a U.S. Senate committee report criticizing Avandia-maker GlaxoSmithKline's handling of data on the drug, JAMA editors are arguing that all industry-sponsored trials should come under the scrutiny of independent scientists, not just researchers with financial ties to the drugmaker in question.

Moreover, academic researchers should get "full access" to data from company-sponsored studies, the journal's editors write. And medical journals should require an objective, independent statistical analysis before they agree to publish company-funded research, they say. "This approach would add powerful support to the fundamental principle that physicians must first do no harm," their editorial states.

For its part, GSK defended its handling of the Avandia trials, saying that its analyses of data on the drug were independently vetted by the London School of Hygiene and Tropical Medicine, Bloomberg reports. In a prepared statement emailed to reporters, the company says the JAMA editorial and commentary "unjustly challenge the motives of physician scientists" and "mischaracterizes" company-funded research on Avandia.

This is just the latest dustup over the diabetes drug since a New England Journal of Medicine meta-analysis found increased heart-attack risk among patients using it. Since then, it's been a saga of FDA hearings, safety warnings, slipping sales, and now, a critical Senate report. As CNBC points out, Avandia's sales came in at $721 million last year, down from $2.5 billion before the NEJM study.

- see the JAMA extract
- read the CNBC piece
- check out the story from Bloomberg