Wednesday, July 19, 2006

Still more about Ketex (telithromycin) and a glimpse into the FDA

The July 19,2006 edition of "Morning Edition" on NPR revealed internal e-mails from the FDA concerning the discussions about the approval-or continuing approval-process for Ketex. Dr. David Graham who will be remembered for his role in the Vioxx issue was quoted as saying ( I paraphrase) -Ketex offers no unique benefits relative to other drugs in its class and other drugs with the same type of hepatotoxicity profile as Ketex were removed from the market by the FDA-such drugs as Rezulin and Trovan.So he is saying that the benefit do not trump the risks.Incidentally, Dr. Graham was actively involved in the recall of those two drugs as well as others.

I've written before about the vigorous promotional effort to sell Ketex as an antibiotic that purportedly offers a mechanism to mitigate the development of microbial resistance.Ghost writers and thought leaders put forth the effort that in part have apparently lead to Ketex developing a respectable market share.

It will be interesting to see if this media-induced transparency will lead the FDA to reconsider its position. There are now 4 fatal liver toxicity cases in the U.S. and the public is being made aware of Dr. Graham's argument for not continuing approval and reminded that a clinical trial that was supposed to demonstrate safety was riddled with fraud and fictional patients.

1 comment:

Sid Schwab said...

Dr Gaulte: the comment notification doesn't seem to work on my blog, so I just discovered your post about Charlie Wilson. I love hearing about the people in my book; it's been one of the really nice things about having written. Thanks for visiting, and do come back. As a fellow retired doc, I look here as well. Unfortunately, your posts are erudite enough that I've so far felt I had nothing to add. But I'll be back