UPDATED: 11.22.09 @ 9:30 am EST -- With an uncanny sense of prescience, this morning, a commenter at David's site wrote -- in part -- thus:
. . . .I think the most critical issue in the evaluation of new drugs is post-market monitoring, which inexplicably has only been recognized as an important FDA empowerment recently. Obviously new things show up when the patients number in the millions rather than hundreds. . . .
Indeed. The commenter bevMD is clearlly correct. And in that regard, watch this space, tomorrow afternoon.
This carefully-written new blog is going to become a "must read" for all of us who are serious about trying to constructively address what we see as pharma's current shortcomings. [It will also serve as a great backdrop for a pair of (in my opinion) rather shocking commentaries, to come out on this coming Monday afternoon, regarding Merck's marketing of a certain drug.] Do go read it all, but here is a snippet:
. . . .I'll write about other ways of manipulating results in future posts, but for today I want to comment on one pernicious effect of this behavior -- I have come to distrust and then dislike the companies that provide the (often useful) drugs I must use on patients. When the new HDL-raising drug torcetrapib went down in flames a few years ago, I was actually pleased: I was furious with Pfizer for having tried to get torcetrapib approved in a way that would have only marketed it in a combo pill with atorvastatin. Objectively, it makes no sense that I should be happy at the failure of a drug that would have helped my patients had it worked.
Pharma not only tries to manipulate the interpretation of results of trials, in the design, analysis, and publication phases, they apparently also try to sow doubt about existing competitors. Adriane Fugh-Berman wrote in 2005 about how she was recruited to be the author on a ghost-written manuscript intended to highlight the importance of herbal interactions in patients on warfarin (interactions that Dr. Fugh-Berman felt were overstated). The company recruiting her was presumably working for AstraZeneca, the manufacturer of ximelgatran. Ximelgatran, a direct thrombin inhibitor that aimed to replace warfarin, was eventually withdrawn from the market in Europe (never approved in the US) because of hepatotoxicity. . . .
Do go read David's -- his conclusions may surprise you. They did, me -- pleasantly.
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