Some years back, I worked with the former Dean of the Yale Medical School on a foundation project. We good naturedly drove each other crazy. We agreed on strategy and the content in a report. Let’s go with it, I urged. “Not yet, he said, I want so-and-so to approve it and ten vet it in the group. You are a creature of process, I said a bit derisively. I am a journalist. We are creatures of product and want to get it out there.
I found the man a bit condescending and asked if he knew how I could be sure he was a doctor. He looked at me blankly. You are arrogant, I said, and I can’t read your writing. He loved it and has repeated the exchange over the years. Clever, perhaps, but there is a point. One reason medical research moves with the speed of molasses on a cold day is that oversight is carried to ridiculous ends.
The sick are impatient and want trials and treatment instantly. That is not going to happen. On the other hand, the FDA never makes a decision in a week, month or year if they can extend it out to double that. They are risk averse to the tenth power, unable, it seems, to distinguish between reasonable risk and recklessness. Suffering patients chomp at the bit , and bureaucrats go to lunch.
Oversight is important. Few question that. But many would like to see a streamlined system where FDA and IRBs (investigational review boards, which examine safety and liability) swallow hard and put us out of our misery. There is no such thing as being one hundred percent, guaranteed safe. Get real, and think of the waiting patient. We are going to die of old age before regulators make a decision.