Hey The FDA Did Something Good!

This would be the second time I have written something good about the FDA. I wrote favorably about Dr. Mark McClellan's appointment to be Food and Drug Administration commissioner. Dr. McClellan tried his best with the giant bureaucracy and I was sad to see him leave.

Yet, there is a bright moment at the FDA under acting FDA Commissioner Lester Crawford. The WSJ Ed page points out (paid site) that at a three day hearing, those who would keep a drug off the market for fear of whom it would harm were forced to account for those whom it could help.

Particular credit here goes to acting FDA Commissioner (now the official nominee for the job) Lester Crawford, for convening an unprecedented three days of open hearings on the issue. Cox-2 critics -- including the FDA's own David Graham, who has been feted as heroic in the press -- were given a fair hearing. But in front of the panel of distinguished outside statisticians and clinicians (read: doctors who actually treat patients), he came off as less than fully scientific and, well, a bit uncaring.

Dr. Graham's case against the acceptability of any increased cardiovascular risk for Cox-2s rests on the relatively small percentage of patients who develop full-blown stomach ulcers from older pain medicines like naproxen and ibuprofen. But that small percentage still means a high absolute number (15,000-plus) of deaths annually from gastrointestinal bleeding. And it utterly misses the point that most vulnerable patients never develop ulcers because stomach discomfort causes them to drop their medications long beforehand. Dr. Graham's implicit advice to the pain patients who can't tolerate those drugs: Grin and bear it.

Grin and bear it. Unless you died of colon cancer while the FDA was dreaming up more hurdles for Erbitux. The drug was finally approved, but 15,000 people died and Sam Waksal and Martha Stewart went to prison. Another day's work for the FDA.

Pharmaceuticals Posted by jk at February 22, 2005 11:11 AM