The FDA strikes again

The WSJ briefly reports that President Trump has “considered issuing an executive order greatly expanding the use of investigational drugs against the new coronavirus, but was met with objections from Food and Drug Administration scientists who warned it could pose unneeded risks to patients[.]” The Journal report bears on our push to raise awareness of possible therapies and get some action on them. Our friend Brian Sullivan comments:

I am not sure why the FDA would object to expediting trials of drugs that have already been approved for other diseases or recognizing the legitimacy of their use as off-label options for patients whose disease is progressively worsening. The safety profile of these approved drugs is generally well understood.

Yes, these drugs have side effects that will pose some health risks to some patients – they are not suitable for every patient. But doctors make treatment decisions every day that factor in the tradeoff between a therapy’s potential side effects and its potential benefits.

In cases where patients have a very poor prognosis, doctors often prescribe drugs off-label as a last resort. That is exactly what took place in the treatment of the US’s first patient, as you posted on Power Line. Patient 1 should be very thankful the FDA wasn’t in charge of his care.

Most likely, the FDA is applying the same, very unhelpful, regulatory logic that led them to block deployment of new virus tests. The FDA is used to operating on their own timeline in situations where delays are either not noticed or don’t cause significant downsides. This is a different situation, and a different decision framework is required.

The White House team needs cover to override the FDA. A group of respected infectious disease experts needs to step up and make the case for us to go all-in to evaluate a range of treatment options. They should also publish treatment protocols that include use of already approved drugs most suitable for off-label use in patients with the most advanced disease.

UPDATE: I have posted the video of this morning’s White House press conference below. There is one question about the Journal report (at 43:00) and there are two questions on the propriety of attributing the virus to China. President Trump states that he hasn’t seen the Journal article but that “we are making a lot of progress therapeutically.” There was no follow-up question on the subject of possible therapies or regulatory relief.

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