succumbing to peer pressure

Saturday, November 20, 2004

More of the same at the FDA

"I would argue the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenseless," said Graham, associate director for science in the FDA's Office of Drug Safety.
Committee Chairman Charles Grassley, an Iowa Republican, said he worried the FDA was "far too cozy" with drug companies and an independent drug safety office might be needed.
Graham said he felt pressured by supervisors to water down his findings, from a study of patient insurance records, that Vioxx users had a 50 percent greater chance of heart attack and sudden cardiac death than people who took Pfizer Inc.'s rival Celebrex.
Vioxx was the second example this year of the FDA not respecting its own scientists, Grassley said. Another FDA reviewer, Dr. Andrew Mosholder, had warned antidepressants were linked to suicidal behavior in youth, but supervisors initially kept him from making those views public.

Although I have to admit, I don't think Vioxx is the scariest thing out there, and having skimmed the studies that resulting in Vioxx getting yanked from the shelves, it's my personal opinion that the group of people at a significantly elevated risk of heart attack is a pretty specific subset of the population. Of course, that subset deserves to be warned, and shouldn't be taking the drug, but I'm not convinced that Merck was wildly endangering the entire population in quite the same way that Graham is arguing. Nevertheless, I think this is indicative of the crap I mentioned in my summary of the APHA meeting - our federal regulatory agencies are in bed with the very same people they're supposed to be protecting us from. I wouldn't really trust any of these agencies very much.


Anonymous Anonymous said...

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NEW YORK (Reuters) - Merck & Co. MRK.N on Thursday said first-quarter profit fell 15 percent following the withdrawal of its arthritis drug Vioxx last year. Link to original article
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10:07 PM  

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