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Pills (Attribution: cottonbro, Presented at: WindermereSun.com)

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Dr. Scott Gottlieb, former FDA commissioner, joins CNBC’s “Squawk Box” to discuss Merck’s late-stage data for its oral Covid-19 pill molnupiravir, in the video published on Oct. 1, 2021, “Dr. Scott Gottlieb: Merck’s oral Covid-19 pill is a ‘profound game changer’“, below:              

Upon further investigation of this potential oral antiviral treatment for COVID-19, molnupiravir, there are some concerns about its use and potential long term effects. In a recently published article, Early safety concerns accompanied Merck’s molnupiravir, the first potential oral COVID-19 therapy, it is indicated that more long-term safety data is needed because mutagenic drugs can cause either birth defects or cancer, excerpt in italics below:

There are “persistent side-effect concerns with mutagenic molnupiravir,” as indicated by a Clinical Trials Arena article. Furthermore, Ron Swanstrom, a professor at the University of North Carolina, Chapel Hill, who in January questioned “whether molnupiravir could be metabolized into a precursor of DNA,” and then “enter the host cell nucleus, leading to oncogenesis.”

In theory, mutagenic drugs can cause either birth defects or cancer. The inclusion criteria for the Phase 3 study of molnupiravir required males to refrain from donating sperm and either agree to abstain from sex or use contraception. Females were required to not be pregnant or breastfeeding. Women who were of child-bearing age had to agree to use a highly effective contraceptive method or be abstinent for 28 days from the start of the study intervention. In addition, women of childbearing age must have had a negative highly sensitive pregnancy test within 24 hours before receiving the first dose of medicine.

An August article published in the Journal of Infectious Diseases found that β-D-N4-hydroxycytidine (NHC, initial metabolite of molnupiravir) “displays host mutational activity in an animal cell culture assay, consistent with RNA and DNA precursors sharing a common intermediate of a ribonucleoside diphosphate. These results indicate highly active mutagenic ribonucleosides may hold risk for the host.”

Rick Bright, the former Head of U.S. Biomedical Advanced Research and Development Authority (BARDA), opposed granting additional funding to develop molnupiravir, due to safety concerns related to the drug, and he summarized in Science,  that “similar experimental drugs in this class had been shown to cause reproductive toxicity in animals, and offspring from treated animals had been born without teeth and without parts of their skulls.”

The Science article also quotes the chemist Raymond Schinazi (of Emory University), stating that his previous pharmaceutical company, Pharmasset, abandoned a similar drug in 2003 after discovering its mutagenic properties.

Merck, in April, announced that molnupiravir is not “mutagenic or genotoxic in vivo mammalian systems. The Phase 1 in the first-in-human study confirmed that there were no serious adverse events among molnupiravir recipients. According to the article published in Antimicrobial Agents and Chemotherapy, among those who reported adverse event, 93.3% were mild. Merck expects to produce 10 million courses of treatment using molnupiravir by the end of 2021 and will supply about 1.7 million courses of molnupiravir to the U.S. government upon EAU approval. 

The cost of molnupiravir is about $700 per 5 day course (2 doses day day), estimating at about $1.2 billion purchase agreement at 1.7 million 5-day treatment courses of molnupiravir. There are plans to implement a tiered pricing approach based on World Bank country income criteria. Company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries. 

Dr. Scott Gottlieb, former FDA Commissioner, joins CNBC’s “Squawk Box” to discuss Merck’s highly anticipated Covid-19 pill and the dose commitments the company has made so far, in the video published on Oct. 4, 2021, “Dr. Scott Gottlieb: Merck could seek emergency FDA nod for Covid pill this week“, below:

Is this antiviral a game changer, Oral Antiviral, molnupiravir, in the video published on Oct. 3, 2021, “Antiviral game changer“, below:

In the video published on Oct. 5, 2021, “Ivermectin or Molnupiravir“, below:

In the video above, Dr. Campbell said, “I want both! I am pro-vaccine and I am also pro-antiviral. We don’t want divisions into different camps. That is not helpful. We want to examine what the truth is.”

In the video published on April 3, 2021, “Is New COVID 19 Drug Molnupiravir Better Than Ivermectin? Can Molnupiravir help in Long Haulers?” below:

A pill has cut the risk of hospitalization or death from Covid-19 by half in a study, Merck and Ridgeback Biotherapeutics said. It would become the first oral medicine that fights viral infection for Covid-19 if approved by the US Food and Drug Administration for emergency use authorization. CNN’s John Berman and Dr. Sanjay Gupta discuss, in the video published on Oct. 1, 2021, “Merck: Pill to treat Covid-19 cuts risk of death by half“, below:

Merck is out with new data regarding an antiviral pill to be taken once you show symptoms of COVID-19. The data shows a 50 percent reduction in hospitalizations in deaths, Merck says. Meanwhile, the fight over vaccine and mask mandates has school boards across the country demanding the White House take action, in the video published on Oct. 1, 2021, “Merck: Our Antiviral Pill Reduces COVID-19 Hospitalization And Deaths“, below: