On Molnupiravir and Covid-19 By Mrs Vera West
The new Merck anti-Covid drug, Molnupiravir, has been subject to large-scale media approval. And it would be good if all the positive things said about this drug did not get met by negative ones. Molnupiravir works by integrating itself into the genetic material of the virus, and then causing mutations as the virus replicates, killing it. But, in some lab tests, the drug has also shown the ability to incorporate itself into the genetic material of mammalian cells, thus causing mutations as those cells replicate, theoretically leading to cancer or birth defects.
“In his latest video, John Campbell, Ph.D., compared ivermectin, whose use as a COVID treatment has been widely criticized by mainstream media, with Merck’s new COVID drug, Molnupiravir, which has been the subject of glowing media attention.
Campbell, a UK-based nurse teacher, cited several studies as he compared the two treatments on the basis of effectiveness, safety and cost. He first turned to a paper in the Austin Journal of Pharmacology and Therapeutics, “Drugs Shown to Inhibit SARS-Cov-2 in COVID-19 Disease: Comparative Basic and Clinical Pharmacology of Molnupiravir and Ivermectin.”
The peer-reviewed paper refers to ivermectin as the most studied “repurposed” medication globally, and notes that it is approved by the U.S. Food and Drug Administration and “classified by the World Health Organization (WHO) as an ‘essential’ broad spectrum antiparasitic, antibiotic, and has demonstrated broad antiviral activity against RNA viruses, including HIV, Zika, MERS and coronavirus.”
“And of course, ivermectin also won the Nobel Prize in 2015,” Campbell said.
According to the paper, Campbell said, Molnupiravir — though still going through trials and safety testing — is believed to “work against seasonal and pandemic flu, MERS, coronavirus and SARS-CoV-2.” The paper’s author noted that Molnupiravir does not inhibit inflammation, whereas ivermectin does.
How do the two drugs compare on cost? Ivermectin is exponentially cheaper than Merck’s new Molnupiraravir.
The cost of a complete five-day course of Molnupiravir is $700 — or $70 per pill. That amounts to a 4,000% markup over what it costs Merck to make the drug.
Citing 2013 prices provided by the WHO, Campbell said a five-day course of ivermectin — 10 3mg pills — costs $0.53. (However, at today’s U.S. prices, 10 3mg pills cost about $39).
On effectiveness, Molnupiravir is lacking data. The only publicly available clinical data on Molnupiravir comes from a Merck press statement claiming the new drug is 50% effective against hospitalizations and deaths, when used as an early treatment.
For ivermectin, using publicly available data, Campbell referred to one peer-reviewed study that pegs ivermectin’s effectiveness in early treatment at 62%, and an ongoing meta-analysis which shows ivermectin is 66% effective in early treatment and 86% effective as a prophylactic.
Using VigiBase, a WHO database on pharmaceutical safety data, Campbell showed that out of 3.7 billion doses given of ivermectin there have been only 5,693 reports of adverse events — far fewer, according to Campbell, than the number of adverse event reports associated with amoxicillin and ibuprofen, both widely used and considered safe.
Comparable safety information for Merck’s Molnupiravir is not yet available, as trials and studies are still ongoing. But Campbell did raise concern about Molnupiravir mutagenic properties. He cited the Austin Journal of Pharmacology and Therapeutics paper which states, “there is some concern about the safety of [Molnupiravir’s] NHC-nucleoside triphosphate, which is mutagenic to mammalian cells.”
According to Campbell, Merck denies this is a problem. But the paper suggests, at the very least,” it needs looking into,” Campbell said.”
“As it turns out, all the scientists and doctors who insisted that Merck's "revolutionary" COVID drug molnupiravir is extremely safe weren't faithfully adhering to "the science" after all. Because according to a report published Thursday by Barron's, some scientists are worried that the drug - which purportedly cut hospitalizations in half during a study that was cut short - could cause cancer or birth defects.
So much for having a "strong safety profile," as Dr. Scott Gottlieb claimed in an interview on the day Merck first publicized the research.
It's perfectly understandable why Merck might choose to play down this safety risk: assuming it's approved, the drug is widely expected to be one of "the most lucrative drugs ever" - which is one reason why Merck's shares soared into double-digit territory after the announcement.
As we reported earlier this week, Merck and its "partner" Ridgeback Biotherapeutics will profit immensely by charging customers up to 40x what it costs to make the drug, which Ridgeback originally licensed from Emory University for an "undisclosed sum". The drug was developed with funding from the federal government.
According to Barron's, some scientists who have studied the drug believe that its method of suppressing the virus could potentially run amok within the body.
Some scientists who have studied the drug warn, however, that the method it uses to kill the virus that causes Covid-19 carries potential dangers that could limit the drug’s usefulness.
Molnupiravir works by incorporating itself into the genetic material of the virus, and then causing a huge number of mutations as the virus replicates, effectively killing it. In some lab tests, the drug has also shown the ability to integrate into the genetic material of mammalian cells, causing mutations as those cells replicate.
If that were to happen in the cells of a patient being treated with molnupiravir, it could theoretically lead to cancer or birth defects.
In particular, Raymond Schinazi, a professor of pediatrics and the director of biochemical pharmacology at Emory who studied the drug while it was being developed, and published a number of papers on NHC, the compound that's the active ingredient in the drug. He published a paper that showed the drug can produce a reaction like the one described above, and insisted it shouldn't be given to young people - especially pregnant women - without more data.
Schinazi told Barron’s that he did not believe that molnupiravir should be given to pregnant women, or to young people of reproductive age, until more data is available. Merck’s trials of molnupiravir have excluded pregnant women; the scientists running the trial asked male participants to “abstain from heterosexual intercourse” while taking the drug, according to the federal government website that tracks clinical trials.
Barron's even shared a paper published in the Journal of Infectious Diseases in May by Schinazi and scientists at the University of North Carolina which reported that NHC can cause mutations in animal cell cultures in a lab test designed to detect such mutations - something Merck claims it has tested for. The paper's authors concluded that the risks for molnupiravir "may not be zero".
Merck told Barron's that it has run "extensive tests" on animals which it says show that this shouldn't be an issue. "The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in-vivo mammalian systems," a Merck spokesman said.
Still, scientists and doctors who have studied NHC say that Merck needs to "be careful," and it's not just Schinazi warning about the drug's potential risks.
Dr. Shuntai Zhou, a scientist at the Swanstrom Lab at UNC, said "there is a concern that this will cause long-term mutation effects, even cancer."
Zhou says that he is certain that the drug will integrate itself into the DNA of mammalian hosts. "Biochemistry won’t lie," he says. "This drug will be incorporated in the DNA."
Merck hasn't yet released any data from its animal studies, but the scientists believe that it would take long-term studies to show that the drug is truly totally safe.
"Proceed with caution and at your own peril," wrote Raymond Schinazi, a professor of pediatrics and the director of the division of biochemical pharmacology at the Emory University School of Medicine, who has studied NHC for decades, in an email to Barron’s.
Analysts are already warning that these questions about the drug's safety suggest the reaction in Merck's shares was a little "overblown", to say the least. Investors apparently were so eager for a new "pandemic panacea" (now that the mRNA jabs have proven to be much less effective than advertised) that they didn't ask too many questions about safety, or even question the paucity of data. One analyst for SVB Leerink Dr. Geoffrey Porges described investors' reaction from Friday as "wishful thinking".
Even once the FDA authorizes the drug, Dr. Porges believes it will come with strict limitations on who can and can't use it. "I think it is effectively going to be a controlled substance", Dr. Porges said, adding that the risks to pregnant women, or women who may soon become pregnant, could present thorny problems for the FDA's advisory committee reviewing the drug.
Given that the safety risks of the drug seem well-documented already, Wall Street's gushing about the drug's prospects - "it really is THAT good", one analyst insisted - seems like an idiotic blunder in retrospect. The product of what one might call "magical thinking".”
The entire Covid culture is subjected to such magical thinking.
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