The announcement that Merck will withdraw its popular painkiller Vioxx (rofecoxib) from the US marketplace generated all kinds of shudders: the Dow Jones industrial average, of which Merck is a component, dropped sharply as Merck stock fell by twenty-seven percent; Merck's hopes of finding new applications for the drug instantly evaporated; and the civil-court system is gearing up for scores of Vioxx-related lawsuits.

The problem with Vioxx is that in a clinical trial to test its effectiveness against the recurrence of colon polyps, it produced an increased risk of what the industry calls "cardiovascular events," a polite term for heart attacks and strokes. Those who took Vioxx for 18 months or more suffered twice as many such "events" as those who were given a placebo.

I've never taken Vioxx, but this matters to me because Vioxx is one of a class of drugs called COX-2 Selective Inhibitors. (COX is an abbreviation for the fatty acid cyclooxygenase; a drug designed to inhibit COX-2 blocks the development of the cyclooxygenase-2 variant, thus retarding the synthesis of prostaglandins that affect inflammation.) Among non-steroidal anti-inflammatory drugs, the COX-2 inhibitors were noted for their reduced effect on the gastrointestinal system: aspirin, the best-known NSAID, is known to have moderate to serious stomach effects if taken in large quantities, and some painkillers of this genre wreak even more havoc on the GI system. Two other major COX-2 inhibitors are sold in the US: Celebrex (celecoxib) and Bextra (valdecoxib). I have never gotten any consistent results from Celebrex, but an occasional Bextra does shut down the pain in my arthritic knee. And if Vioxx has a tendency to produce unwanted cardio "events," maybe drugs that work similarly might have the same tendency.

Or maybe not. Then again, Bextra has side effects of its own. Indeed, every drug has some potential for unwanted results to accompany the wanted results. And while the Vioxx numbers looked bad — about 3.5 percent of patients in this particular clinical trial suffered cardiovascular problems with Vioxx — patients taking the dummy medication suffered the same problems at a rate of 1.9 percent. In pharmaceuticals, as elsewhere in life, there ain't no such thing as a free lunch.

Merck, on balance, was right to pull Vioxx from the shelves; while the publicity is bad, it would have been much worse had they waited for the FDA to order a recall. Still, it should be remembered — but probably won't be, at least among the general public — that just about anything you put into your mouth, be it a $3 Vioxx tab, a two-cent aspirin, or a Kellogg's Pop-Tart, has a measurable risk factor, and the only way to avoid risk completely is to drop dead.

The Vent

#407
  1 October 2004

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 Copyright © 2004 by Charles G. Hill