April 14, 2005
Bextra(r)
You didn't expect me to keep quiet about Bextra, did you?
The FDA have pulled this compound because of a one in a million risk of severe toxicity. Dr. Gilbert Ross has an National Review Online piece. recounting those who lose in the regulation:
So Bextra is gone, joining Vioxx on the pharmaceutical museum shelf. Of course, there is a theoretical possibility that one or both of these drugs, and the unique benefits they hold for many, may someday return. Meanwhile, what about the many thousands of patients who got relief of pain and no untoward effects? Too bad — they have been regulated out of the picture. Bextra’s only a “me-too” drug, after all, and one person in a million may get a skin condition, so out it goes. Activists have advocated, regulators have regulated, and patients will now pay the price. The choice to use this drug in appropriate populations — in bygone days, a choice made between doctor and patient — is no longer to be an option. Someday, regulators and consumers will learn that nothing is risk-free.
Of course another loss is $1.3 Billion in revenue for Pfizer, plus countless resources for compliance, and extreme exposure to lawsuits.
Wouldn't this money be better spent, say finding a cure for MS? Or better recovery from stroke?