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Politics : Politics for Pros- moderated -- Ignore unavailable to you. Want to Upgrade?

To: LindyBill who wrote (133798)	8/22/2005 4:48:19 PM
From: carranza2	Read Replies (1) \| Respond to of 793698

The problem with immunizing drug manufacturers if the drug is FDA approved is that there is no post-approval requirement that the information concerning the results of the clinical trials be made public. After approval, there is also no requirement for public dissemination of negative safety information, which is exactly what happened with Vioxx. It appears that both Merck and the FDA knew of the post-approval problems with Vioxx for years. How can it be fair, then, to allow Merck to skate on a bunch of heart attacks and strokes solely on the basis of FDA approval if it knew of the problem? I would go along with immunizing the drug companies but only if they can show that after the drug approval takes place, they are as clean as a whistle, i.e., didn't have any idea of any problems and acted responsibly once they knew of one. A blanket rule immunizing them if they get FDA approval is in my view as crazy as the Angleton verdict. Plus, I'd make the clinical trial findings public so that the consumer can decide for himself to the extent possible. Something not mentioned inthe Vioxx hoopla is the role of the MD, who stands as a sort of sophisticated gatekeeper guiding and advising the patient. Merck changed the package insert info to reflect problems but it is well known that the typical consumer doesn't read or understand them because of their complexity. Shouldn't the MD as the presumed expert have some responsibility, too?