Healthy Skepticism Library item: 139

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

New Doubts About Celebrex
THE NEW YORK TIMES 2004 Dec 18

Full text:

Let’s hope that Pfizer isn’t falling into the same mind-set that Merck demonstrated when it stonewalled for years over the safety of its popular arthritis drug, Vioxx, only to yank it from the market when a convincing study found it raised the risk of cardiovascular problems. Yesterday Pfizer announced the results of a government-sponsored clinical trial, which showed that its own best-selling arthritis drug, Celebrex, more than doubled or tripled the risk of heart attacks, strokes and cardiovascular deaths, depending on the dosage.

The company found all sorts of ways to express uncertainty over the meaning of these findings, calling them “unexpected” and inconsistent with its own similar trial and other data. It pledged immediate steps to “fully understand” the results. Yet even before any more data comes in, it seems clear that patients and doctors must confront the possibility that this overhyped class of drugs, known as COX-2 inhibitors, may raise the risk of heart problems while offering at best only limited benefits for some patients. The Food and Drug Administration, notoriously weak in policing drugs already on the market, must step in to reduce the dangers.

Vioxx and Celebrex became blockbusters thanks to heavy promotional campaigns that propelled sales far beyond reason. The ads typically implied that the drugs provided exceptional pain relief, but in truth careful clinical trials showed that they were no better in that regard than such common pain relievers as Advil, Motrin and Aleve.

The presumed advantage of COX-2 inhibitors was that they might cut the rate of gastrointestinal side effects like ulcers and bleeding. But the evidence of any benefit is skimpy and seems to be offset by the heart risks that have driven Vioxx from the market. Those risks have also led to required new label warnings about Bextra, Pfizer’s other entry in the class, and left Celebrex under a cloud. This is a bizarre turn of events for drugs taken by millions of Americans in the belief that they were safer and more effective than older painkillers.

Pfizer said it would not pull Celebrex off the shelves, a stance that is not surprising given the profits generated by the drug, and the widespread belief in the industry that Merck only compounded its legal and financial problems by withdrawing Vioxx. But if Vioxx was risky enough for Merck to remove from the market, one wonders why Celebrex should not be yanked as well.

The best hope for an honest assessment of the risks of Celebrex lies with the F.D.A. and its expert advisory committees. The agency has been sharply criticized of late for failing to protect the public adequately against unsafe drugs, especially after the drugs are already on the market. Its own reputation will be on the line as it ponders how tough to get about Celebrex in coming days.