Two Cheers for the FDA

Only two because the FDA did play an important role in the US Covid 19 testing fiasco.

the first cheer is for extreme speed in approving phase 1 trials of candidate vaccines (vaccine in a person within 2 months of publication of the Sars Cov2 sequence) and phase III trials of Remdesivir (results leaking already) and hydroxychloroquine.

The second and even louder cheer is for the expanded access to Remdesivir policy. I actually predicted that this wouldn’t happen. I was wrong. I guessed there would be consideration of compassionate use in individual cases. I think the reason there is a systematic program is that the FDA and Gilead (the manufacturer) were overwhelmed with requests.

In particular, I note that one onlusion criterion is eligibility for a clinical trial. If one is eligible then one must risk getting the placebo. The logic is that people have the right to standard of care but do not have the right to an experimental drug which is more likely to help than to harm them. I argue for this logic here.

On the other hand, an exclusion criterion is “Requiring invasive mechanical ventilation (e.g., via endotracheal intubation or tracheostomy)”. This doesn’t make much sense. There is good reason to think that antivirals are useful especially if given early before the cytokine storm breaks. I think part of the logic here is first do no harm so an experimental drug can be used only on people who have very poor chances without it (the death rate of the intubated is roughly 66%). Also I guess Remdesivir will soon be in short supply (I think they have enough for 140,000 patients now and basically everyone in the world will want some).

So the expanded access is radical, but I don’t think it is radical enough.