Wednesday, November 10, 2004

Pfizer/Bextra joins Merck/Vioxx on the COX2 firing line

The New York Times > Business > New Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks

A weak retrospective study suggests Bextra is a disaster. If it were the only such study the appropriate action would be warning labels and more studies. However, in the context of Vioxx, this suggests Bextra should be withdrawn from the market. I'd be amazed if Bextra is on the market a month from now.

So what about Celebrex? It doesn't seem to be much safer on the stomach than well known NSAIDs. It's far more expensive. It's cousins look bad.

It's hard to believe any COX2 inhibitor is going to remain on the market in a year -- at least for their primary indications (arthritis, etc). They may turn out to be good drugs for other conditions where the risk/benefit ratio is better.

There are four interesting questions:

1. Did the pharmas cover up problems? Did they follow reporting requirements? What's their moral (if not legal) culpability if they aggressively market drugs about which their own scientists may have significant reservations?

2. What's with the pharmas anyway? They did a lot to suppress the release of worrisome data on SSRIs. Has the rise of patient-focused marketing completely corrupted the industry?

3. Was the FDA corrupt? It used to be a fairly reputable agency, but now it's run by Bush appointees. Their stated mission has been to be friendlier to the manufacturers and to accelerate drug development. Now we have the SSRI scandal, the Vioxx scandal, and the flu-vaccine scandal. Maybe Eliott Spitzer needs to litigate against the FDA?

4. Will Bush put in place a liability cap to save Merck?

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