The FDA can save thousands of lives today

The Emergency Use Clearance (EUA) from the FDA can take months. But the FDA could allow compassionate use of molnupiravir now by activating what’s called an expanded access protocol, before the drug is formally evaluated. There is a precedent. Last year, the FDA activated the recovery plasma protocol months before issuing a formal EUA. The agency also cleared the administration of monoclonal antibodies to President Trump and other officials last year before this therapy received a formal EUA.

The molnupiravir pills are ready to use. The government has pre-purchased 1.7 million courses of treatment. The drug does not require refrigeration and is easy to ship. These pills are on a shelf as Americans die in hospitals.

Molnupiravir was so effective in its randomized controlled trial that researchers stopped accepting new participants. The observed survival benefit of the drug was spectacular: no Covid patient who received molnupiravir died, compared to eight deaths in the placebo group. When a drug has such profound benefits, it is considered unethical to continue giving a placebo to sick subjects. However, medical practitioners cannot administer molnupiravir to a sick patient due to a regulatory barrier.

Compassionate use does not prevent further study. The drug could be administered widely according to a protocol, and the results could be followed closely, as was done with convalescent plasma. These results may help inform FDA review, pending full approval.

Public health officials may be hesitant to talk about therapies whose promise could give people an excuse to avoid vaccination. It is a legitimate concern. I have had to explain to vulnerable patients that they should not rely on monoclonal antibodies as a substitute for vaccination. But we can strongly encourage vaccination and be frank about the treatment data at the same time. Such honesty would also help restore the damaged credibility of public health.

Early data indicates molnupiravir is the biggest scientific breakthrough against Covid since vaccines. He officially passed the formal medical evidence test. The pill is a lifeline that doctors can throw at the more than 1,000 Americans who drown every day. Will the FDA take action to save lives today?

Dr Makary is Professor at Johns Hopkins University School of Medicine, Editor-in-Chief of Medpage Today and author of “The Price We Pay: What Broke American Healthcare And How To Fix It.”