Sunday, November 14, 2004

NYT tackles some of the big pharma questions

The New York Times > Business > Dangerous Data: Despite Warnings, Drug Giant Took Long Path to Vioxx Recall
But a detailed reconstruction of Merck's handling of Vioxx, based on interviews and internal company documents, suggests that actions the company took - and did not take - soon after the drug's safety was questioned may have affected the health of potentially thousands of patients, as well as the company's financial health and reputation.

The review also raises broader questions about an entire class of relatively new painkillers, called COX-2 inhibitors; about how drugs are tested; and about how aggressively the federal Food and Drug Administration monitors the safety of medications once they are in the marketplace...

...Five times as many patients taking Vioxx had heart attacks as those taking naproxen.

In a separate NYT article there's a discussion about lowering the cost of drug development by changing how innovation is funded in the US.

These are big questions, the NYT deserves credit for tackling them. Is it just my imagination, or are they doing more of these research-intensive pieces lately?

The most interesting question is how intimate the relationship between the FDA and manufacturers has become. How many key people move between the FDA and manufacturing? How do key donations affect legislators? Eliott Spitzer must be watching closely.

PS. A fivefold relative increase in MI risk is an enormous increase. It's curious that such a large effect didn't emerge earlier. Is there something about patients who can't tolerate NSAIDS (and thus end up on Vioxx) that makes them also prone to MI?

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