Different River

”You can never step in the same river twice.” –Heraclitus

February 22, 2005

COX-2 update

Filed under: — Different River @ 3:53 pm

An FDA advisory panel voted to recommend that all three COX-2 inhibitors be allowed to stay on the market. (Background here.)

Basically, the argument is that while the risks are higher then previously thought, they may still be outweighed by the benefits for some patients. They are going to put stronger warnings on the labels, and it’s (quite reasonably) expected that sales of these drugs will be lower than they were before these risks became known.

This sounds to me like the right outcome. For a long time, the FDA has focused too much on risks and not enough on benefits, and has implicitly assumed that the risk-benefit trade-off is the same for all patients with a given disease. It’s time they start putting this decision inthe hands of doctors and patients, and this decision is a step in that direction.

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