Is FDA putting new Avandia risk data under wraps?

GlaxoSmithKline's (NYSE: GSK) diabetes drug Avandia has received a lot of bad press recently. The latest: The FDA may be delaying publication of a new Avandia study underscoring significant risks targeted by previous independent research, Pharmalot reports.  The study compared outcomes among 227,571 Medicare patients taking either Avandia or Takeda's Actos.  Researchers, including co-author and FDA reviewer David Graham, found that Avandia increased stroke risk by 27 percent, heart failure by 25 percent and death by 13 percent over three years as compared with Actos.

While you'd think the FDA would want to expose such a significant safety issue, Graham's supervisors haven't given him permission to release these results for publication--despite repeated requests. Seemingly out of patience, Graham wrote a letter late last month to FDA Commissioner Margaret Hamburg, arguing that it's critical to get this information out to the public and scientific community as soon as possible.

"JAMA is very interested in our manuscript and we would like to submit it before next Friday, June 4. Gerald Dal Pan, my supervisor is prepared to sign the clearance form (the paper has a disclaimer and does not represent an official FDA position) but won't unless Dr. Woodcock and Dr. Jenkins approve. He is afraid to act, even though he is the "clearing official," the letter states (as quoted by Pharmalot).

"My CMS co-authors are also anxious to submit the manuscript and feel that they have a duty to their customers, Medicare patients, to bring these results to public notice in a scientific journal as soon as possible," the letter adds. "The idea of being blocked from doing this by a sister Agency is a source of concern to them and to me.

No word yet on whether the agency will get off the dime.

- read this Pharmalot piece