The FDA

by
Robert Waldmann
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I am back complaining about the FDA as I have in The Ethics of Clinical Trials and 10 years earlier Clinical Trial Ethics (an aside — I had forgotten the old post and Google reminded me that I have been banging this drum for a decade).

Now I have a lot of company, because of the pandemic. Many people (including the ex FDA director Gottlieb retweeted by a Senator Brian Schatz) argue that the extreme circumstances imply that delays that are normally acceptable aren’t acceptable in this case. I really should read these 5 pages written by the former Director of the FDA and the Former Director of the Center for Medicare and Medicaid Services . I’m going to give an (erasable) hostage to fortune, guessing that my comment will be “I told you so during January 2019” . Actually I just advocated expanded access, which is just one of their proposals.

I agree that policy which works in normal times is not appropriate during a pandemic. Small c conservatism implies accepting the status quo until one is sure a reform is an improvement. It is irrelevant when the status quo is not an option, because a virus is spreading. Crazy small c conservatism implies sticking to business as usual as if it implies staying in a steady state, as if the virus (and global warming) are willing to wait for us to make up our minds. This is important. However, I have also asserted that current policy was bad policy during normal times. I stand by that view.

Before going on, I should note that the FDA is doing amazing things within the limits of current law. A vaccine trial started (with vaccine in someone’s deltoid) less than two months after the Sars Cov2 sequence was published. This included the FDA approving the trial with record speed. Similarly, the time from the emergence of Covid 19 to phase III trials of many drugs (including Remdesivir and hydroxychloroquine) must have broken records. The staff and director of the FDA are dedicated, committed and moving bureaucratic mountains.

Still, I think that current law and policy are wrong. I think that it is time to make this case, because the FDA delayed testing for Covid 19 in the USA. The technical problem with one reagent in the CDC test kit should not have caused 3 weeks of delay. Two of them were due to the FDA not the CDC.

I think that the FDA should have the power to give temporary authorization of sale and prescription of a medicine during clinical trials. That is based on the experience of patients who have had compassionate access to Remdesivir, I think the FDA should say it is approved unless and until the clinical trials yield negative results.

A problem with this is that it might become difficult to recruit a control group for trials. I think that it is better to unfairly single out some people and tell them they have to risk getting the Placebo than to impose that cost (in expected value) on everyone. I think the current policy is Pareto inferior to the policy I proposed in “The Ethics of Clinical Trials”.

Also I am certain that I will not be able to convince anyone of the morality of my proposal. I guess I should not even bring it up during a crisis. I think that, right now, the FDA can authorise use of Remdesivir which Gilead must provide free of charge. I’m guessing that approach would work and save hundreds of thousands or millions of lives. My guess might be wrong, but the cost of being wrong is now known to be small, because it is clear that Remdesivir is fairly safe.