Merck & Co.'s COVID-19 pill Lagevrio may be helping to generate and spread new variants, according to a new study. These mutant spin-offs could possibly turn out to be potentially more contagious and deadly than the virus the drug was originally supposed to combat.

What's the background?

Molnupiravir, sold as Lagevrio, is an antiviral drug from Merck & Co. and Ridgeback Biotherapeutics. It is supposed to prevent RNA viruses from replicating by inducing mutations in the virus genome during replication. The National Institutes of Health claimed that this pill had "shown antiviral activity against SARS-CoV-2 in vitro and in clinical trials."

Dr. Elizabeth Duke, a Fred Hutch research associate who oversaw one molnupiravir trial, told Kaiser Health News in September 2021, "You could give it to everyone in a household, or everyone in a school. Then we’re talking about a return to, maybe, normal life."

By November 2021, the Biden administration had already committed to purchasing $2.2 billion worth of Merck's drug.

The pill received an Emergency Use Authorization from the Food and Drug Administration on Dec. 23, 2021, just days after the New York Times reported that the drug "can insert errors in DNA, which could in theory harm a developing fetus, sperm cells or children."

Since receiving the blessing from the Biden administration, the drug has sold widely and generated significant profits.

According to Reuters, Merck & Co. reported "higher-than-expected" fourth-quarter earnings on Thursdsay, largely due to the sale of its molnupiravir pill in Asia. The pharmaceutical company made $825 million on the pill in Q4 alone.

Mutant pill

The NIH stated in September 2022 that as "a mutagenic ribonucleoside antiviral agent, there is a theoretical risk that molnupiravir will be metabolized by the human host cell and incorporated into the host DNA, leading to mutations. Molnupiravir has been evaluated in 2 in vivo rodent mutagenicity assays. One study produced equivocal results. In the other study, there was no evidence for mutagenicity."

A cluster of human patients reportedly now reportedly know that the risk previously downplayed as "theoretical" is anything but.

A new preprint study by British and American researchers at the Francis Crick Institute, the Imperial College in London, and at other esteemed institutions has revealed that mutations linked to Merck's pill have been found in viral samples taken from dozens of patients, reported Bloomberg.

The researchers suggested that patients treated with molnupiravir "might not fully clear SARS-CoV-2 infections, with the potential for onward transmission of molnupiravir-mutated viruses."

"We find that a specific class of long phylogenetic branches appear almost exclusively in sequences from 2022, after the introduction of molnupiravir treatment, and in countries and age-groups with widespread usage of the drug," said the study. "Our data suggest a signature of molnupiravir mutagenesis can be seen in global sequencing databases, in some cases with onwards transmission."

The researchers indicated that "sequencing data suggest that in at least some cases, viruses with a large number of molnupiravir-induced substitutions have been transmitted to other individuals."

According to the study, Lagevrio-induced mutations have been found among groups of patients, the largest group analyzed consisting of 21 people.

Not only is Merck's profitable drug reportedly resulting in the transmission of brand-new forms of the virus, the researchers indicated that the trajectory of "variant generation and transmission is difficult to predict."

Jonathan Li, a virologist at Harvard Medical School, told Bloomberg, "There’s always been this underlying concern that it could contribute to a problem generating new variants. ... This has largely been hypothetical, but this preprint validates a lot of those concerns."

Merck denies that its profitable drug is a mutant pill.

"There is no evidence to indicate that any antiviral agent has contributed to the emergence of circulating variants," claimed Robert Josephson, a spokesman for the company. "Based on available data we do not believe that Lagevrio (molnupiravir) is likely to contribute to the development of new meaningful coronavirus variants."

It is unclear what mutant forms of the virus Josephson and his company might ultimately come to regard as "meaningful."

Risky business

Theo Sanderson, a geneticist at the Crick Institute who led the study, suggested to Bloomberg, "These effects are visible in these databases. ... It appears that people are being treated, some of them aren't clearing their infections, and some are passing them on."

Ryan Hister, an American researcher attached to the study, suggested that it is far too risky to continue using Merck's drug.

Michael Lin, an antiviral drug researcher at Stanford University, happens to agree.

"There’s no evidence that any of these mutants is worse in any way — not yet — but it’s well agreed that you’re playing with fire if you’re creating random mutations and hoping nothing bad will come of it," said Lin.

Extra to possibly spinning off dangerous variations, the drug has long been associated with other potential hazards.

A May 2021 study on the impact of molnupiravir in hamster cells, published in the Journal of Infectious Diseases, suggested that the drug induced mutations in DNA that could "contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells."

Ahead of its authorization, scientists also expressed concern that the drug could mess with an unborn baby's dividing cells, thereby causing birth defects, reported the New York Times.

Dr. James Hildreth, the president of Meharry Medical College in Tennessee, posed the question during an FDA expert committee meeting on Nov. 30, 2021, "Do we want to reduce the risk for the mother by 30 percent while exposing the embryo and the fetus to a much higher risk of harm by this drug? My answer is no, and there is no circumstance in which I would advise a pregnant woman to take this drug."

Despite Hildreth's opposition, the committee narrowly endorsed the pill and the FDA authorized it. However, the agency did not approve it for people younger than 18 for fear it might adversely impact bone and cartilage growth.

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