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To: Ariella who wrote (915)6/23/1998 10:03:00 AM
From: NeuroInvestment  Read Replies (1) | Respond to of 1491
 
That is the logical conclusion, though one can never assume a rational bureaucratic weighing of risk/benefit issues. The other two factors that go unaddressed in this furor are:1) the fact that post-market surveillance receives a tiny proportion of FDA resources, and yet it is only that kind of broadband real-world utilization that can reveal the fullrange of potential problems. Pharmaceutical manufacturers have been reluctant to get behind upramped postmarket monitoring because they like to feel that, once they have surmounted all the obstacles to marketing approval, that they will not have to constantly defend their products. But enhanced post-marketing review to my mind would be a more reasonable tactic than slowing the pipeline of reviews pre-approval. 2)It also speaks to physician failure, and the fact that the FDA sometimes ends up acting 'in loco parentis' for prescribers who deliberately or negligently violate safety limits on drugs. This is true for those who prescribed Duract for more than 10 days, just as it was true for those who prescribed fluramine anorectics to patients who were not clinically obese.

This should not affect HU-211 given the lack of other treatment alternatives, and its (thus far) risk to benefit profile. However, this kind of publicity gives the conservative wing of the FDA ammunition to slow a nascent reform process which I believe is still predominantly in the best interest of consumers. NeuroInvestment (www.neuroinv.com)