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SALT LAKE CITY — A University of Utah Health infectious diseases doctor said Wednesday it was a difficult decision to vote against recommending authorization of the first pill treatment for COVID-19 as one of the experts on a federal Food and Drug Administration advisory committee.
But Dr. Sankar Swaminathan, chief of the U. Health Division of Infectious Diseases, said there wasn't enough data to rule out the possibility of potential birth defects from the Merck treatment, known as molnupiravir.
The antiviral pill narrowly received the endorsement of the FDA panel by a 13-10 vote on Tuesday. If the recommendation for emergency use authorization is accepted by federal authorities, the pill treatment could be available within weeks.
A similar pill from Pfizer is expected to be reviewed shortly. The new treatments are seen as an easy-to-use alternative to costly monoclonal antibody infusions that are used to help keep high-risk COVID-19 patients from needing hospitalization.
With the first U.S. case of the latest COVID-19 variant, omicron, reported in California Wednesday, there's new urgency to expanding treatments. The Biden administration has agreed to purchase more than $2 billion worth of the pills, which are already in production.
Swaminathan, though, said he'd like to know more about the treatment.
"The drug works by causing changes in genetic material," he said. "It's really an unusual mechanism of action." Known as a mutagen, similar to many chemotherapy drugs, Swaminathan said concerns were raised the pill could cause mutations in human DNA.
Merck data based on animal testing showing that was unlikely "could have been stronger," he said.
"Some of us were uncomfortable that that really ruled out the drug causes changes in DNA," Swaminathan said, that could lead to fetal issues "but also the possibility for long-term effects such as cancer."
Calling that risk worrisome but theoretical, the doctor said he hopes he's "wrong and the drug proves to be completely safe and highly effective. But we didn't have enough evidence of that to convince me of that yesterday."
Related:
Expert adviser panel narrowly recommends Merck's at-home COVID-19 pill for FDA authorization
A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck's antiviral pill to treat COVID-19.Pregnant women were excluded from the pill's clinical trials, and they are not expected to be prescribed the treatment unless a doctor determines there are extenuating circumstances, he said.
Other issues included a drop from 50% to 30% in the pill's effectiveness at keeping patients with the virus out of the hospital, based on a final analysis of the clinical trial. When Merck announced the initial results in October, the pill was seen as a pandemic game-changer.
"That raises a red flag," Swaminathan said, calling the efficacy "modest."
The scope of the pill's likely use also worried him.
"The government's bought millions of doses. So we're talking about potentially millions of people potentially getting this drug, right? That's what bothered me a little bit. We're not just talking about hospitalized patients that might go on a ventilator," the doctor said.
So "if there's a very small chance that it could cause birth defects," he said he felt that risk might outweigh the benefit of the treatment. "But that's a judgment call and I could easily see how other people felt differently."
Swaminathan's advice to Utahns? Talk to their doctors about the risk.
"This is something where the discussion needs to be had as to exactly how much risk there is, and whether there's enough risk that it's worth taking a drug that really only has been used in 1,400 people, and for which much of the committee had reservations about both its efficacy and safety," he said.
Still, the pills "might be helpful. It's one more potential tool to use in people at high risk who are not pregnant, for example," Swaminathan said.
Asked if he would take the pill treatment or recommend it to someone close to him, the doctor said he "wouldn't rule it out automatically, but I probably would consider all of the alternatives, including monoclonal antibodies."
