IT IS DIFFERENT WHEN IT IS YOUR WIFE. I have argued in a number of posts that the FDA has given too much importance the “gold standard” of randomized controlled experiments and not enough importance to saving patients’ lives. The consequence is that delays are imposed on drug approvals. For example, I said here: “When the life of a loved one is at stake, perhaps you don’t want to wait for a gold standard review.”
Gardiner Harris wrote an article in the New York Times (January 2) which reported that the oncology chief of the FDA for the last 16 years, in response to the death of his wife from cancer, has changed his approach to regulation with a view to speeding up drug approvals. (The headline on the article is “F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval.” Harris says: “In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process.”