October 04, 2004
Redux Vioxx
In the wake of Merck's decision to recall Vioxx because it caused heart problems in an unacceptably high percentage of patients, one can only hope doctors and the millions of people on similar drugs will begin asking serious questions about their need for this class of drugs. Vioxx is a COX-2 inhibitor, a drug class that's no better at providing pain relief than over-the-counter ibuprofen or naproxen.
The promise of the COX-2 inhibitor class was that it would eliminate the gastrointestinal side effects associated with taking some painkillers. About two to four percent of chronic users (many elderly arthritis sufferers pop pain pills all day long) get ulcers, GI bleeding and other problems with their digestive tracts. That's about twice the rate of the rest of the population.
According to studies funded by the drug industry, anywhere from 7,500 to 16,500 people a year die from peptic ulcers and other side effects of these so-called non-steroidal anti-inflammatory drugs (NSAIDs). This statistic was duly reported in today's New York Times (log-in required). In theory, the COX-2s did not have such side effects.
However, neither Merck nor Pfizer, the two companies that have brought COX-2s to market, have proved that assertion. The Food and Drug Administration requires Pfizer's Celebrex and Bextra to carry the same warning on their labels as the older generation of NSAIDs. And while Merck's Vioxx proved somewhat less dangerous than naproxen in a 2002 clinical trial (it was the same trial that provided early warning that the drug caused heart problems), the reduction in side effects wasn't so much better than it could shake the GI bleeding warning for seniors.
Moreover, by looking beyond the drug industry-funded studies, one discovers that pain reliever-caused ulcers may not be the huge problem the industry claims it is. This morning, I visited the Centers for Disease Control's National Center for Health Statistics, which publishes annual data on what Americans die from. In 2001, the last year for which data is available, about 2.4 million Americans died.
Guess how many of those died from all forms of gastro-intestinal distress, including severe peptic ulcers? Under 5,000. And there can be no doubt that a few of those exploding stomachs were caused by something other than painkillers -- like binge drinking, for instance. (It is said that Alexander the Great died at 33 from a peptic ulcer that burst after an all night party.)
So it turns out that the drug industry's vaunted R&D labs turned out a non-solution to a minor problem. But COX-2 inhibitors worked as well as ibuprofen for pain relief. So the drug companies' marketers swung into action. They turned Celebrex and Vioxx into two of the biggest selling drugs on the market.
The result? Many seniors now pay nearly $3 a pill for the same pain relief they used to get for ten cents. And who could blame them? After watching a full evening of commercials showing frisky seniors frolicking through fields of flowers after taking this new pain reliever, no wonder they "asked their doctor" for the pricey wonder drug.
So, what a few years ago cost the health care system and seniors a few hundred million dollars a year has been turned into a $6 billion a year market. It's so lucrative that there are no less than seven new COX-2 inhibitors in the industry pipelines.
And you know who's paying for all that R&D? Current drug consumers like you and me, our insurers and all those seniors who spend too many nights watching too many commercials promising them something the drug companies can't deliver. And in 2004, Medicare will start picking up part of the tab.
What a colossal waste.