Bureaucratic Red Tape Delays Compassionate Use Basis

By Marty Makary MD

If we wanted to, we could instantly slash daily Covid death rates in HALF (or more) with one pill.

Professor, Johns Hopkins University School of Medicine, Johns Hopkins Carey Business School, Editor-in-Chief, MedPage Today

I’m not sure how we can tell a dying Covid patient today that there is a drug that can dramatically reduce your chance of dying, and there are 8.5 million of these pills already pre-produced by Merck, but we can’t give it to you.

If we wanted to, we could instantly slash daily Covid death rates in HALF (or more) with one pill. As I explain in tomorrow’s WSJ, we need to get Merck/Ridgeback’s new Molnupiravir to people who are dying right now on a compassionate use basis just as monoclonal antibodies and convalescent plasma were given to many Americans on a compassionate use basis before an EUA was issued.

This is a powerful drug for Covid. In the phase III RCT, the antiviral dramatically reduced hospitalizations & death by 50%. In fact, no one died who got the drug and they stopped the trial early because of the profound effect of the drug.

To get an expanded access protocol activated by the FDA, Merck has to agree to make the drug available through this mechanism (they haven’t indicated they will), doctors have to set up a protocol (this is a lot of red tape) and the FDA has to approve it (they are being passive despite they are the authors of the regulator hurdles for compassionate use).

The real issue is why is there so much regulatory red tape process to give patients a ‘Right To Try’ during a health emergency. We could instantly cut the daily Covid death rate from 2,000 deaths/day to 1,000/day or even hundreds (depending on how the drug plays out in a larger population).

I’m not sure how we can tell a dying Covid patient today that there is a drug that can dramatically reduce your chance of dying, and there are 8.5 million of these pills already pre-produced by Merck, but we can’t give it to you. Even thought death may be imminent. In terms of the survival benefit, this drug blows the regeneron therapy out of the water (yet it can be used with it) and it has an impecciable safety profile.

We need to push all stakeholders to move quick to make Molnupiravir available on a compassionate use basis.

Opinion | The FDA Can Save Thousands of Lives Today

wsj.com

 

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