FDA speaks up a little more often

I'm away from home and I did something really, really bad to my back. I could hardly tie my boots this morning (boots needed; it is snowing like stink up here). One of my fellow scientists took one look at me and said, "I guess you need some Vioxx." Then he laughed. Since I hardly know this person I don't think he was trying to kill me -- he wouldn't have laughed, then, I'm guessing. But Vioxx has killed some other people before the FDA finally acknowledged it could do that. They were soundly (and appropriately) criticized for keeping too quiet. Now, it seems, some are complaining because they aren't being quiet enough. Their response?

If it seems as though the Food and Drug Administration has been issuing a new drug safety warning almost every week, that's because, for the past three months, it has. Since early November, the agency has sent out 14 advisories, more than it has issued in some entire years. Wall Street health-care analyst Les Funtleyder recently quipped that the agency should have a color coding system, as the Department of Homeland Security does, so consumers could determine the severity of the risk.

The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.

"We are trying to act in a responsible way," Seligman says. (Washington Post)

Let's see. The FDA is now issuing advisories because they are trying to act responsibly? Which means . . . Oh, well. I guess we should be glad they're doing it and not carp about the obvious point that if the only thing that's different know is that they are acting responsibly then before . . . But has the pendulum swung too far in the other direction?

[FDA critics Rep. John Dingell (D-Mich.), head of the House Energy and Commerce Committee,] calls the recent increase in public communications "a quantum improvement." Marc J. Scheineson, a former FDA deputy commissioner, agrees. "There was certainly too little information back then,'' he says. Now, the problem is the opposite, he says, "so patients and their doctors will need to filter the news.''

I'm sure Dingell was (mis)using the qualifier "quantum" in the sense of qualitative change, but in fact a quantum is a very small change, not a very large one (that's what you get when you mix physics with pedantry). I agree with both senses. As for former FDA deputy commissioner Scheineson, there seems to be a missing link in his argument, the one that evaluates whether the warnings are both accurate and sufficient. How do we know this apparent increase isn't just scratching the surface of a Big Pharma problem that got out of control because the Bush FDA for the first 7 years of his term in office exercised no control?

Poor FDA. They can't seem to please anyone. That's what happens when you lose credibility and respect.