September 23, 2010

A new class of drugs – not exactly safe but dangerous enough to deny access

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JS

September 25, 2010 at 9:42 am

I think that analysis is naive at best.
“What we’re seeing emerge — remember there are now about 30 of these programs in existence — is a new class of drugs. They are not exactly safe, but not so dangerous that we would deny them to physicians or patients who really want to have them.”
There are no “safe” drugs and there never have been, there are only drugs with acceptable and unacceptable risk, and the acceptability of the risk depends on the nature of the potential benefit conveyed, which in turn depends on the circumstances and even the values of the individual for whom the drug is being prescribed. Where’s the moral high ground in complaining categorically that there should be no effort to try to accommodate these complexities?
There are problems with the REMS strategy, and it’s worth discussing how it can be improved. But bemoaning that the FDA is even attempting to move away from black and white decisions into a middle-ground that can be more flexible is just foolish.

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