Dying for Pfizer

Last week's New England Journal of Medicine has three research reports on COX-2 inhibitors, all of which find that they approximately double the risk of heart attacks and strokes, and editorials on the subject by God-Editor Jeffrey Drazen and by Susan Okie. This story has gotten plenty of coverage in the corporate media, (and it's been a bit of an obssession here as well) but there's full tale hasn't been heard by most people.

The FDA first approved COX-2 inhibitors in 1999, at a time when there was in fact no evidence that they offered any benefits over aspirin. Remember that the idea was that they would do the work of aspirin-like drugs (called NSAIDS) without the risk of gastrointestinal side effects. In 2000, two studies came out on the long-term safety of COX-2 inhibitors, one of which showed benefit while the other did not. But the one that showed benefit also showed an increased risk of heart attacks compared with people who took an NSAID. But no trials had been designed to look for adverse effects of these drugs -- obviously. The drug companies pay for the studies, and they were interested in getting the drugs approved and on the market. Instead of following up on the question of cardiovascular risk, the companies started testing the drugs for new uses -- prevention of colon cancer, and management of postoperative pain.

Meanwhile, the companies -- Merck and Pfizer -- launched an advertising blitz. We all remember the buff old folks winning the ballroom dancing competition and practicing their martial arts technique. They sold more than $5 billion worth of COX-2 inhibitors every year for the next five years. Then, in late 2004, Merck noticed that people in an ongoing clinical trials who were taking Vioxx were having about twice as many heart attacks and strokes as the control group. It took an independent review panel to tell Pfizer that it's Celebrex was doing the same thing. Both companies fought to keep the drugs on the market, and won, but they were forced to stop the advertising.

Where was the FDA in all this? The FDA's drug approval process is paid for by the drug companies. It is focused on getting drugs approved and on the market, not on protecting the public. FDA scientist David J. Graham told a Senate hearing in November that the FDA was incapable of protecting the public. When he confirmed that Vioxx increases the risk of heart attacks, his superiors ordered him to change his conclusions, which were "inconsistent with the FDA's position on the drug's safety."

He refused. He went public.

The lesson? Science works, the truth is out there. But people, motivated by greed, will lie. And if you're feeling too stiff to play golf or clean the house today, take two aspirin.