Chess Game at the FDA

Science  28 Oct 2005:
Vol. 310, Issue 5748, pp. 589
DOI: 10.1126/science.1121473

I am seriously tempted to offer my help to the president in selecting someone to become the next commissioner of the U.S. Food and Drug Administration (FDA). Things have gotten so desperate that the Bush administration might even welcome help from me. After all, I had the job once—even worked for a president who was somewhat evangelical. And after the soap opera they've just put on, it's hard to believe that the new incumbent will last any longer than the last one, or the one before that. So they might turn to me for help—it's really that bad!

Before we plod through the painful recent history of this agency, I remind readers that it was once in respectable shape. A trusted, highly professional agency responsible for regulating about 25 cents of every consumer dollar spent in America, it was also a model for developing new drug approval processes in other countries. Of course, it was no stranger to controversy. Some critics thought that meeting its regulatory requirements added costs and slowed the progress of medical innovation. Others thought it played softball with the pharmaceutical industry, risking the lives of Americans by approving inadequately tested drugs. I've been asked whether the FDA doesn't actually slow the rate of medical innovation. Of course it does! The question is whether the risk of delaying therapies is fairly well balanced against the risk of adverse drug reactions. There is no agreed standard for finding that point of perfect social utility, and the FDA has usually done reasonably well, annoying equally its passionate critics on both right and left.


Now, to recent history: Late in his first term, President Bush made a promising move by appointing Mark McClellan, a Stanford economics professor and physician, as the FDA commissioner. The applause had barely died down when McClellan was moved to Baltimore to run the Centers for Medicare and Medicaid Services. Many thought this exile was preparation for his appointment as secretary of Health and Human Services (HHS) when Tommy Thompson left. But Thompson hung in there, and by the time his post was vacant, Michael Leavitt was moved in to HHS from the Environmental Protection Agency. In chess, this move—maneuvering powerful back-row pieces to change their locations—is called “castling.” It is becoming increasingly familiar to followers of this administration's personnel policies.

The vacancy at the FDA remained under the acting leadership of Lester Crawford for months until President Bush finally nominated him for commissioner. In my time, Les was a good head of the Bureau of Veterinary Medicine at the agency. But “acting” is never a great job, and his Senate confirmation as commissioner was put on hold by several senators. They wanted his promise to make the “Plan B” morning-after contraceptive easier for consumers to get by moving it from prescription-only to over-the-counter access, as an FDA Advisory Committee had recommended. Eventually, Crawford promised to do so and was confirmed. Meanwhile, a new deputy commissioner was added at the FDA: Scott Gottlieb, a Wall Street drug stock analyst and former American Enterprise Institute scholar. Who picked him isn't clear.

Crawford resigned a scant 2 months after his Senate confirmation, citing age as a reason (at 67?), leaving Plan B still in limbo and of course leaving the FDA slot open once again. You remember castling? Well, the president castled an old Texas friend, National Cancer Institute (NCI) Director Andrew von Eschenbach, right into the interim FDA job. It wasn't quite castling, however, because castling requires the castled piece to move, and von Eschenbach was initially slated to hold both posts! Many insiders were shocked because the NCI develops drugs and sends clinical trials to the FDA, affording an endless opportunity for conflicts of interest.

But hold on. After 2 days, the job-sharing idea disappeared, and it was announced that the NCI would be left in the hands of Deputy Director John Niederhuber, a highly respected surgeon. From this act of the soap opera, two conclusions can be drawn. First, from the reversal, we can gain reassurance that the administration is subject to occasional attacks of embarrassment. Second, the quality of the NCI's new leadership reminds us of baseball Hall of Famer Casey Stengel's mangled version of the old saying: It's an ill wind that blows nobody no good.

Oops! I should have mentioned earlier that the main use of castling in chess is to protect the king.

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