RE: Staggering comments on Merck's pill1 Dec 2021 05:53
“I just want to emphasize that I think it’s a pretty minimal benefit,” said Sally Hunsberger, a statistician at the Biometrics Research Branch of the National Institute of Allergy and Infectious Diseases, who voted no. “I don’t really think we know what groups this is benefiting, if it’s benefiting.”
With the efficacy of the drug far from a slam dunk, the safety profile of the pill became a central point of debate. Molnupiravir works by scrambling the genome of the coronavirus, resulting in catastrophic errors that disable it.
Some committee members said they feared that the drug’s mechanism could result in a more fearsome version of the virus.
“I voted no. It was an easy vote for me to vote no. … There were more questions than answers. I think the potential for this drug to drive some very challenging variants into the public is a major, major concern,” said James E.K. Hildreth, president of Meharry Medical College.
Molnupiravir has not yet been tested against the omicron variant, but because it works in a different way than vaccines and monoclonal antibodies that train their firepower on the coronavirus spike protein, it is expected to hold up against a wide range of variants.
Merck scientists have been testing the drug against every new variant, and have begun working on omicron, said Nicholas Kartsonis, senior vice president of clinical research for infectious diseases and vaccines at Merck. “We expect, based on what we know about the omicron variant, that molnupiravir would be effective against this particular variant,” he said.
But one committee member cautioned against assuming that the drug would be more variant-proof than vaccines or other treatments.
“If we take a look at the omicron variant and see the number of mutations that virus has, I think in many ways we don’t really understand which direction the virus may even be going in terms of changing,” said W. David Hardy, a scientific and medical consultant at Charles R. Drew University of Medicine and Science, who voted yes. “To assume this drug … is going to work when the monoclonals don’t is a big jump. We have no assurance of that.”
Even people who voted in favor of the drug pointed out that it would not be first in line if other options existed.
“If there is an alternative therapy that’s efficacious, like monoclonal antibodies currently or a future medication, that would be the priority,” said Uma M. Reddy, an obstetrician and maternal fetal medicine specialist at Yale School of Medicine, who voted yes.
A second oral pill regimen — it was developed by Pfizer — is also being reviewed by the FDA. That drug could offer advantages that will make it the choice of physicians: It was more effective at preventing hospitalization and death, and doesn’t carry safety concerns about its potential to cause mutations. In contrast, those fears led many committee members to say they would not prescribe the Merck drug to pregnant patients.