The FDA Can Save Thousands of Lives Today

‘Compassionate use’ of molnupiravir would dramatically reduce Covid-19’s toll

By Marty Makary. He is a professor at the Johns Hopkins University School of Medicine.

"With the stroke of a pen, the Food and Drug Administration could save thousands of Covid patients’ lives. Data released last week showed that the new antiviral pill molnupiravir, made by Merck and Ridgeback Biotherapeutics, is safe and reduces the risk of the direst outcomes (hospitalization or death) by 50%. It works by directly blocking replication of the virus, is effective against variants, and can be used in combination with other Covid therapies.

The FDA’s emergency-use authorization (EUA) can take months. But the FDA could allow compassionate use of molnupiravir now by activating what is known as an expanded-access protocol, ahead of the drug’s formal evaluation. There is a precedent. Last year, the FDA activated the protocol for convalescent plasma months before it issued a formal EUA. The agency also allowed monoclonal antibodies to be given to President Trump and other officials last year before that therapy was granted a formal EUA. 

Molnupiravir pills are ready to go. The government has prepurchased 1.7 million treatment courses. The medication doesn’t require refrigeration and is easy to ship. These pills are sitting on a shelf as Americans are dying in hospitals.

Molnupiravir was so effective in its randomized controlled trial that researchers stopped accepting new participants. The drug’s observed survival benefit was dramatic: No Covid patient who received molnupiravir died, compared with eight deaths in the placebo group. When a drug shows such profound benefits, it’s considered unethical to continue to give sick subjects a placebo. Yet practicing physicians can’t give molnupiravir to any sick patient because of a regulatory barrier. 

Compassionate use doesn’t preclude further study. The drug could be administered broadly on a protocol, and outcomes could be tracked closely, as was done with convalescent plasma. Those results can help inform the FDA’s review, pending full approval.

Public-health officials may be hesitant to talk about therapeutics whose promise could give people an excuse to avoid vaccination. That’s a legitimate concern. I’ve had to explain to vulnerable patients that they shouldn’t rely on monoclonal antibodies as a substitute for getting vaccinated. But we can strongly encourage vaccination and be candid about the data on therapeutics at the same time. Such honesty would also help restore the damaged credibility of public health.

The early data indicate that molnupiravir is the greatest scientific advancement against Covid since the vaccines. It has officially passed the formal test of medical evidence. The pill is a life preserver that doctors can throw to the 1,000-plus Americans drowning each day. Will the FDA act to save lives today?"