Merck’s molnupiravir has certainly received a lot of good press over the past days since the New Jersey-based pharmaceutical company announced its clinical trial demonstrates positive results. They will be expeditiously working to file for an emergency use authorization (EUA) and tap into and try to control what could be as rich as a $10 billion dollar market for early-onset mild COVID-19 home treatment. But if one looks carefully enough, they can find some concerned scientists. For example, a piece at Barron’s authored by Josh Nathan-Kazis expresses concern of a small but concerned group that the drug could cause cancer or birth defects.

TrialSite reported on a Science piece that included quotes from Raymond Schinazi, an Emory University chemist and former founder of Pharmasset, a company developing a similar drug to that of Molnupiravir, which was abandoned in 2003 after the drug’s mutagenic properties came to light.

For our perspective on how Merck marched down the path toward financial glory with this questionable drug can be read here

Does Molnupiravir Pose Risks?

While the developers Ridgeback Biotherapeutics and Merck have downplayed any safety issues and prominent industry, writers such as Derek Lowe share upbeat hopes for the new product taking at face value the data delivered to date. TrialSite notes that the inclusion and exclusion criteria associated with their clinical trial precludes pregnant or breastfeeding women or male and female actively trying to conceive a child. In the case of males, they are requested to “abstain from heterosexual intercourse” in the study.

A prodrug of nucleoside analogue -D-N4 hydroxycytidine (NHC), Molnupiravir has the potential, some scientists share concerns, to possibly be fused into mammalian DNA.  In May Dr. Schinazi and some scientist colleagues published in the Journal of Infectious Diseases that NHC can lead to mutations in animal cell cultures associated with preclinical early-stage lab studies designed to find mutations. 

Merck is on the record that it has undertaken all of this due diligence research and that there is nothing to worry about. However, while Schinazi and some colleagues from the University of North Carolina may have declared that the risk associated with Molnupiravir “may not be zero,” one must consider the clinical trial inclusion and exclusion criteria—clearly, there is concern about offspring.

But one of Dr. Schinazi’s colleagues, Dr. Shuntai Zhou out of UNC’s Swanstrom Lab shared recently “there is a concern that this will cause long-term mutation effects, even cancer.” Declaring that “Biochemistry won’t lie,” Dr. Zhou appears highly confident that “This drug will be incorporated into the DNA.”

Prospect for Access Highly Controlled

Regardless, the drug will be highly controlled thus limiting Merck to exploit the full COVID-19 monetization potential.  For example restrictions on pregnant women and breastfeeding women or those that are actively conceiving a child will be precluded from any label as those who have moderate COVID-19 as recent news in India, if proven correct, indicates the clinical trial there testing the drug isn’t faring as well for moderate patients.

The Medical-Financial-Government Complex

But a confluence of regulatory and government research, academia, and industry along with financiers align to drive the narrative moving forward. TrialSite suggests that some organized cabal is behind the complete trashing of ivermectin-a possible competitor to Molnupiravir. “Nothing will stop this group from aggressively monetizing this crisis” reports Daniel O’Connor, founder of TrialSite. On the other hand, O’Connor shared that “if the drug can help treat people at home safely and make the difference Merck will earn a fortune.” Concerns of price gouging already surface online.

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