The new analysis of Avandia safety data has made its debut. Verdict: The GlaxoSmithKline ($GSK) diabetes drug does not increase cardiovascular risk. What's that, you say? Wasn't Avandia pulled from the market in Europe and restricted in the U.S. for those very risks?
Indeed. But the FDA is convening a new advisory panel next week to reopen the books on that study, known as RECORD. FDA required Glaxo to commission a re-adjudication of the study, and that task was performed by the Duke Clinical Research Institute, using data provided by the drugmaker. And it's this re-adjudication that's now seeing the light of day.
As Forbes reports, the institute's researchers concluded that "there was no evidence of treatment effect on all-cause mortality or cardiovascular plus unknown mortality." Moreover, the Avandia patients didn't have a statistically significant increase in heart attack or stroke, either, though there was a numerical difference, with higher incidence of heart attack and lower incidence of stroke.
Of course, FDA reviewers and the agency's expert advisers have already weighed the RECORD data and raised plenty of questions about the conduct of the study. It was after that panel meeting in 2010 that Avandia was put on the short leash in the U.S. and pulled off the market in Europe.
This time around, the advisory committee includes different members--and doesn't include one of Avandia's fiercest critics, Dr. Steve Nissen of the Cleveland Clinic. He has publicly questioned the re-adjudication and the integrity of the data Duke used to draw conclusions. How the new panelists will view the data remains to be seen. Stay tuned for more next week.
- read the Forbes article