Arrivederci Bextra

Dr. Gilbert Ross, the executive and medical director of the American Council on Science and Health, has an article at National Review Online reviewing the removal of Bextra from the market by Pfizer.

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.

The skin condition referred to, Stevens-Johnson Syndrome, is a severe delayed hypersensitivity reaction that causes almost burn-like blistering and affects the eyes as well.  It is rare and unpredictable, occurring in 1-2 patients per million; it is associated with a number of drugs, not just Bextra.  The ones most commonly cited are antibiotics such as sulfa drugs - which are still on the market.

Earlier when the controversy arose with Celebrex, Vioxx and Bextra I made the point (below) that Dr. Ross made here (above).

Problems in medicine are never as straightforward as the public would like.  There is, with any medical intervention, a balancing act.  What are the risks involved in the proposed care vs. the risks of alternatives, and what are the benefits of each.  In the case of Celebrex and Vioxx (and Bextra for that matter) there appears to be a higher risk of heart problems.  But for many arthritis sufferers these were very effective drugs that were also otherwise very well tolerated.  Thousands die each year from gastrointestinal bleeding often attributed to NSAID use, and these drugs had a reduced risk profile for that complication.

Nothing in medicine is risk-free.  Nothing.

UPDATE: On the other hand, maybe this is the real problem.