Merck Releasing "Phenomenal" Test Results For Experimental COVID Pill

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"This Is A Game-Changer" - Merck Releasing "Phenomenal" Test Results For Experimental COVID Pill

ZH | OCT 01, 2021 - 07:45 AM


Looks like Merck just beat Pfizer to the punch.

Merck announced Friday that an experimental COVID pill it has developed reduced hospitalizations and deaths by 50% in people recently infected with COVID.

The company will soon ask health officials in the US and abroad to authorize use of the drug.

The news came as a welcome surprise to the public, although COVID cases are already waning in the US and in hard-hit economies in Asia, the drug could create "a real therapeutic advance" that could dramatically decrease the risk of death from COVID.

If approved (and odds are it will be) the drug would be the first treatment for COVID. Some compared it to tamiflu, in that patients should take it within 5 days of COVID infection (like those infected with the flu are instructed to take tamiflu early).

Former FDA Director Dr. Scott Gottlieb told CNBC that the trial results are clearly "profoundly" positive, even though researchers decided to stop the trial early because the drug showed significant success, meaning it would be unethical to keep giving patients placebos. To test the drug, they needed to test more than 700 unvaccinated people in a global study. The people were all considered in the "high risk" category due to factors like age, and other characteristics from their "health profile".

Per the results, 7% of volunteers in the group that received the drug were hospitalized, and none of them died, compared with a 14% rate of hospitalization and death (include eight who died) in the placebo group.

According to Dr. Gottlieb, "this is a phenomenal result. This is a profound game-changer that we have an oral pill that had this kind of effect on patients who are already symptomatic."

Dr. Gottlieb also pointed out that the team that developed the drug "also invented the first successful antibody against ebola so this is a very good drug-development team."

"And remember we have two other drugs in development one by Pfizer (where Dr. Gottlieb serves on the board) and the other by Roches," he said.

Patients won't be taking the drug for very long, typically around five days, which means "the safety profile is probably pretty good," Dr. Gottlieb said.

Per the NYT, "the Merck pill’s efficacy was lower than that of monoclonal antibody treatments, which mimic antibodies that the immune system generates naturally when fighting the virus. Those drugs have been in high demand recently, but they are expensive, are typically given intravenously, and have proved cumbersome and labor-intensive for hospitals and clinics to administer. Studies have shown that they reduce hospitalizations and deaths 70 to 85 percent in similar high-risk Covid patients."

The Merck drug is significantly chemically different from the Pfizer drug that's in its final round of studies, which means there's the possibility of creating a cocktail of anti-viral treatments for COVID. Merck has said it can produce 10MM pills by the end of this year, and Dr. Gottlieb said he expects they'll ramp up production quickly by partnering with other companies.

Merck partnered with a small firm called Ridgeback Biotherapeutics to develop the drug, which is called Molnupiravir. While the study results haven't yet been peer reviewed, at least one independent group of medical experts have given the research their blessing.

"This is a milestone in the fight against COVID," Dr. Gottlieb said.

So, is the prospect of a return to "normality" really on the table? I suppose we're about to find out.

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"Proceed With Caution At Your Own Peril" - Merck's COVID 'Super Drug' Poses Serious Health Risks, Scientists Warn

ZH - adapted | OCT 08, 2021 


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 i********” 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".