Celebrex -- the next poison pill?

Flash: Celebrex becomes the latest aspirin substitute linked to increased risk of heart attacks.

Pfizer this morning announced it has stopped a clinical trial for its billion-dollar painkiller Celebrex because it triggered two-and-a-half times more heart attacks than placebo.

It is becoming increasingly clear that heart problems associated with everyday painkillers called Cox-2 inhibitors (Vioxx, Celebrex, Bextra) are what pharmacologists call a "class effect." Every Cox-2 inhibitor on the market has now been linked to increased risk of heart attacks or strokes.

In September Merck pulled Vioxx from the market because of its link to heart problems -- evidence that scientists knew as early as 2001. And a recent review of published literature about Bextra showed a similar link.

It's interesting to note that Pfizer decided to release this information on Friday. In the world of politics, that's the day when savvy politicians release bad news because Saturday's papers get the smallest readership of the week.

But no public relations strategy can rescue the drug industry or its handmaidens in government from the firestorm that is about to break. U.S. consumers have spent billions of dollars for these "super aspirins" in recent years. When they were launched in the late 1990s, it was considered one of the best marketing campaigns ever by industry insiders. Millions of arthritic seniors threw away their over-the-counter ibuprofen bottles in favor of a $90 per month prescription medicine.

Now, a scant five years later, we have the results of that massive transfer of wealth to the makers of these drugs: tragedy for thousands of families (most of whom have no idea why mom or dad suddenly dropped dead from a heart attack) and increased health care costs to care for survivors of those heart attacks and strokes.

And what was the ostensible benefits of these drugs? They were supposed to save people from the occasional ulcers that resulted from taking either aspirin or other arthritis painkillers like ibuprofen and naproxyn.

It's important to remember that this alleged problem was wildly overstated from the start. Fewer than 6,000 people a year die from perforated ulcers or other forms of gastro-intestinal diseases, according to the Centers for Disease Control. And most of these deaths have nothing to do with taking painkillers.

Yet in news article after news article touting the new "super aspirins," reporters uncritically passed along the claim that an estimated 16,500 died each year from taking traditional pain pills. Where did they get that number? From a single academic study funded by the companies selling the newer drugs.

Indeed, if one looks closely at the Merck trial that led to claims that it helped solve the ulcer problem, one sees that the number of reduced ulcers (not deaths from ulcers, but just ulcers) was roughly comparable to the increase in heart attacks and other serious coronary problems.

One can only hope that when an FDA advisory committee meets in February to discuss the Cox-2 issue, they'll include some economic analysis of this public health fiasco. Conservatives like to subject regulations that cost industry money to cost-benefit analysis. What's that ratio when it is all costs and no benefit?

Posted by gooznews at December 17, 2004 11:30 AM