Avandia: Lessons Learned By FDA Panel Head
6 CommentsBy Ed Silverman // August 8th, 2007 // 5:04 pm
Cliff Rosen, an endocrinologist at St. Joseph Hospital in Bar Harbor, Maine, chaired last week’s FDA advisory committee meeting on Avandia. This week, he writes a perspective piece in The New England Journal of Medicine, which last May initiated the ruckus by publishing a meta-analysis showing the diabetes med increased the risk of heart attacks by 43 percent. As the proverbial dust settles, Rosen offers a few take-away messages from the circus for improving the drug-approval process:
Lesson One - Make sure you understand the disease, the studies used to evaluate the treatments are properly chosen and designed, and maintain approval standards at all cost. This is contrast to what was characterized as the “basic plot of the (Avandia) story: a new ‘wonder drug,’ approved prematurely and for the wrong reasons by a weakened and underfunded government industry subjected to pressure from industry has caused undue harm to patients.”
Lesson Two - Post-marketing observational studies, no matter how large or independent, can be inconclusive and are no substitute for the costly, but most likely, insightful safety and efficacy follow-up studies. “In the long run,” Rosen writes, “these efforts will save time, money and energy.”
Lesson Three - There’s an urgent need to change the ‘regulatory pathway’ for Type 2 diabetes drugs to make clinical outcomes, and not surrogates, the primary endpoints.
None of these are new concepts, but Rosen is trying to tell us that, as far as he’s concerned, the Avandia controversy managed to bring several of the most pressing issues surrounding drug approval into stark relief. You can read the complete perspective piece here.
Chris
Ed,
I don’t have a subscription so can go only by your piece but as I remember when Avandia was approved, I think in 1998 or 99, there wasn’t as much knowledge of Type 2 diabetes as now. There was one drug approved- Rezulin - but study designs were still evolving as researchers began to understand the condition better. I suppose now different designs would be used but then it was still an imperfect science. It seems a little harsh that Dr Rosen describes the Avandia story as reported: the FDA could have asked all the questions they wanted and taken as long as they needed, especially with the concerns that arose around Rezulin.My recollection is that SB used the same NDA (application process) used by all other companies and were just as much in the hands of FDA as the rest. It’s not always accurate to portray FDA as under-resourced and at the mercy of pharma companies - there are plenty of companies that suffered tremendously because FDA held up their applications during the same period. Interesting piece all the same, with or without Monday morning quarter-backing.
Chris
The quarterbacking being from Dr Rosen of course, not Professor Pharmalot…
Ed Silverman
Hi Chris,
Professor? Hardly. But yes, I was merely summarizing someone else’s editorial. I don’t often run editorials written by others, by the way, but I chose this because of the topic, the news value and the author. And I decided not to offer my own comments, simply because I’m curious to see reactions to his thoughts, instead of my own. He chaired the panel; I didn’t.
All best
ed
Chris
Hi Ed,
I know - that’s why I sent the second message to clarify (I thought) the intent and object of my first comment. I was addressing my comments to Dr Rosen’s position which you quoted in your post. I thought the post was worthy of comment.
Chris
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