Thursday, May 22, 2008

Quick hits

Karl Rove has an interesting take on the Obama diplomacy debate. His position would also seem to be supported by this column in today's New York Times.

Meanwhile, here is an article about cancer drug approval that should send everyone into a white-hot rage:
Since 2005 the FDA has approved 18 new cancer drugs, many of them breakthrough products. But the pipeline contains hundreds more that will never get to market because corporate developers aren't able, or willing, to come up with the money, time, and patients necessary to establish acceptable data. A Tufts University review found that only 8% of experimental cancer drugs end up receiving FDA approval, compared with 20% of medicines for all other diseases.

The FDA knows there's a problem. In 2004 it announced with much fanfare an effort, dubbed the Critical Path Initiative, to make clinical trials more productive. But the initiative never got much funding and little has been heard since. Outside the agency, academic and industry researchers who come up with creative ideas for evaluating
drugs routinely complain that the FDA is too conservative to embrace new methods.

The agency's caution may be prudent. But its critics say regulators are too wary of congressional scrutiny in the wake of the debacle involving Merck's (MRK) painkiller Vioxx. Ever since that drug was pulled off the market in 2004 amid safety concerns, the FDA has come under withering attacks in Washington, and overall drug approvals have plummeted. "It's always far easier to say no to a drug than yes,"says Dr. David Kessler, director of the FDA from 1990-97 and now a professor at University of California at San Francisco. "But there are times when the public interest requires that the agency step out of its role solely as a policeman and put into practice those things that might advance the public health."
Look, cancer kills. If a patient wants to try an experimental treatment they should be able to without government interference. It's their life. From a more practical perspective, if you're staring death in the face anyway then a few possible side effects shouldn't be much of a deterrence.

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