The pain's not going away, but the drugs are

That's the word as the Cranky Economist finally catches up to yet another pharmaceutical story that has been brewing for the past few days. The FDA is forcing Pfizer to take Bextra (an arthritis drug that resembles Vioxx) off the market, citing some of the same cardiac risks that led to Merck's decision to pull Vioxx last fall.

Merck yanked Vioxx, you may recall, after a study found that the drug was responsible for a somewhat increased risk of heart problems among its users. A perfectly reasonable decision in this litigious world in which we live in (to paraphrase McCartney), although in a "perfect world" sort of way it was dubious. Merck's sin was arguably in over-marketing the drug. Sure, it (and other Cox-2 inhibitors like it) probably do increase heart risk. But that risk was worth it to the small subset of arthritis patients for whom traditional medicines like naproxen (Aleve) and ibuprofen (Advil) were causing stomach ulcers. The real problem with Vioxx wasn't that Merck was selling a dangerous drug; the problem was that too many of the wrong people were buying it.

As the Forbes article linked above suggests, there may have been an added wrinkle with Bextra -- its connection to a rare skin reaction -- that might have influenced the FDA's decision as much as the worry over heart woes. But at the end of the day, one has to wonder whether hyper-sensitivity to risk fueld by a hyperactive trial bar might not be influencing some of the thinking here. Within a week of Merck's announcement last fall, I remember seeing ads on TV by some scurrilous trial lawyer trawling for Vioxx clients. I have to wonder, are we whittling away our ability to make sensible trade-offs when it comes to medical care?

Which is not to be too down on the FDA -- the agency has generally been very effective at protecting American consumers. If memory serves, for example, Thalidomide was never approved for use in the U.S. But if the panel appointed to study the issue was split almost down the middle, and the panelists most likely to encounter patients who could benefit from these drugs determined that the trade-offs were worthwhile, one starts to ask what's going on here.