BusinessWeek's Interview with FDA's Richard Pazdur

Here's some must reading this morning.

Anyone interested in the cancer drug approval process at the Food and Drug Administration should read this interview posted yesterday on the BusinessWeek website. Richard Pazdur, chief of the FDA's oncology drug division, has some interesting things to say about the differences between big and small companies that are trying to get new cancer drugs approved, and his emotional response to desperate cancer patients who want access to unproven experimental therapies.

But most importantly (from a scientific point of view), here's what he had to say about efforts by some companies to salvage drug candidates that have failed in achieving their primary endpoint, which is usually prolonged survival:

One of the problems we've had is people coming to us after a drug fails because they've invested millions and millions of dollars into a drug; and then it's, "How can we salvage this?" In other words, failing your primary endpoint and then trying to salvage a trial by looking at subgroups of patients. That's akin to shooting an arrow and having it land on a wall and then drawing a target around it. It's an attempt to resurrect a trial that has failed.

Pazdur has been a frequent target of Wall Street Journal editorials, whose editors seem to have one ear permanently cocked in the direction of the cancer quackery that has always flourished on the fringes of modern medicine. It's nice to see that he hasn't lost his bearings, or his courage in standing up for scientific principles at the FDA.