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Merck’s new COVID drug, Molnupiravir, is dangerous and unproven
OP-ED
DANIEL HOROWITZNovember 22, 2021
First it was lockdowns, then masks, then a series of failed shots and boosters, with a side-dish of remdesivir killing people in hospitals while blocking lifesaving treatments. Now, the same forces within big pharma are about to unleash their first outpatient drug on us. Are we really to believe that this will suddenly be the first pristine COVID product from big pharma that actually helps rather than harms us? Color me skeptical, especially based on what we know about Merck's supposed wonder drug, Molnupiravir.
First, it's important to note that the medical establishment has made it clear they will not touch a repurposed drug so long as it's off-patent. However, they have no problem using repurposed drugs that are expensive and unsafe as they did with remdesivir (which was repurposed from the Ebola virus) after it killed so many people and had to be pulled from trial. Well, Molnupiravir is also a repurposed drug. Wait for it … Molnupiravir is actually repurposed from a horse drug!
Merck's Molnupiravir, also known as (EIDD-2801), was originally co-developed by Ridgeback Biotherapeutics LP and a biotech company owned by Emory University in 2003 to treat equine encephalitis and was later purchased by Merck to be used for coronavirus. There is nothing novel about the drug. It is a nucleotide analogue that introduces errors in the viral RNA at the time of replication after to cause mutations. The problem with mutagenic drugs is that they are known both to cause side effects, such as cancer and birth defects, in the individual, as well as spawn mutations in the virus — not coincidently similar to the leaky vaccines currently being used.
The reason drugs like ivermectin that work "accidentally" against viruses are so much safer is precisely because they don't attempt to go after the virus in an offensive way, running the risk of damaging good cells and causing mutations. It's actually a good thing that they are not traditional anti-virals and work in a defensive way. The reason we have so few anti-virals in the first place is because they are dangerous to the patient, sort of like chemotherapy.
Merck is asking for federal emergency use authorization at the same time the federal government has signed a $1.2 billion contract with them based on a single safety study conducted by ... you guessed it ... the very entity itself. Interestingly enough, the study participants were bizarrely told to abstain from "heterosexual intercourse" during the trial, a rare and interesting distinction for a trial protocol in an anti-viral therapeutic. But, in fact, they understood that this technology, which works similar to chemotherapy, is not safe for women of childbearing age who want to have children in the future. As Dr. Simon Clarke, associate professor in cellular microbiology at the University of Reading, said, the specific instructions on heterosexual sex "suggests that the drug has the potential to cause birth defects should someone become pregnant."
Much like vaccines, anti-viral agents have to be formulated perfectly. If they fail to fully kill the virus, they run the risk of having the virus mutate and becoming more virulent, akin to shooting at the king and missing.
Also, in the same way anti-virals attack the genetic makeup of the viruses, they have the potential to damage the hosts as well, just like we see with anti-cancer drugs. "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" last month.
After the body ingests Molnupiravir, it produces a compound called NHC (N-hydroxycytidine). Schinazi, who works at the university that originally developed the drug, co-authored a paper in the Journal of Infectious Diseases a few months ago warning that NHC caused mutations in animal cell cultures. Schinazi used to own a biotech company that once attempted to pursue this drug, but abandoned it in 2003 once it was discovered it's mutagenic tendencies.
Barron's also interviewed Dr. Shuntai Zhou, another author of the study and a scientist at the Swanstrom Lab at UNC, who claims he warned Merck last year about their initial findings.
"There is a concern that this will cause long-term mutation effects, even cancer," Zhou says.
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."
What impact it will have when it's there is unknown, given the various systems human cells use to limit the impact of mutations.
Well, that sounds like a drug we want to dive into headfirst while we have safe, cheap, and effective alternatives.
Merck disputes these claims and suggest their studies show otherwise. But are we really to once again place our blind trust in a company that stands to make billions when known molecular biological principles should caution us against proceeding forward with this technology? Why would we spend billions on an untested drug with a dangerous mechanism of action when safe, off-patent, repurposed drugs already work better without the risk?
In another violation of informed consent, Merck was given $356 million in taxpayer funding at the beginning of the pandemic to develop this already-developed drug, despite opposition at the time from former director of the Biomedical Advanced Research and Development Authority (BARDA) Rick Bright. He warned 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."
It is simply indefensible to pursue a drug like this when we already have established, effective, less expensive drugs that are actually safe. Even on side of efficacy, it's becoming harder to take Merck's press released "study" at face value. Two Indian companies that contracted with Merck have already pulled out of the deal because they believe it has no efficacy against moderate COVID-19 infections. Merck had already suspended its trials on Molnupiravir for hospitalized COVID patients, but in October, Aurobindo Pharma Ltd and MSN Laboratories pulled their studies after the drug failed to yield positive results with those who already had a moderate version of the virus.
The fact that Merck is seeking approval to make this drug a standard of care after their trial only followed up on safety data for 29 days in the human trials is unprecedented. The results of their human "trial" were never published in a peer-reviewed journal, the same as a press release released only on their website. "Merck says" their drug is safe and effective is in line not just for approval in the free market, but for government purchases of over a billion dollars' worth of doses.
In the preprinted results of the study by Ridgeback employees last December, they made mention of toxicity in the bone marrow found in the dogs that were part of the animal trial. Interestingly enough, when the study was published in an actual journal several months later, the reference to toxicity in the bone marrow disappeared. However, in the approval paper from the U.K.'s Medicines and Healthcare Products Regulator Agency, they mention, "Reversible, dose-related bone marrow toxicity affecting all haematopoietic cell lines was observed in dogs at ≥17 mg/kg/day (0.4 times the human NHC exposure at the recommended human dose (RHD))." That is not a large enough dose to achieve toxicity.
Shockingly, the U.K. regulator also concedes that "Carcinogenicity studies with molnupiravir have not been conducted," even though long term cancer risks are always a concern with nucleotide analogues. The agency also revealed that "No clinical interaction studies have been performed with molnupiravir."
Sadly, from everything we have seen with the shots and with remdesivir, the less safety data that is available, the more likely the FDA is to approve the drug — in violation of 100 years of standard protocols for drug approval.
FDA approves Keytruda monotherapy in adjuvant RCC:
https://finance.yahoo.com/news/fda-approves-merck-keytruda-pembrolizumab-114500052.html
Guilt by association!
FDA to meet with MRK for its COVID antiviral pill, on 11-30-21 --
The committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-30-2021-antimicrobial-drugs-advisory-committee-meeting-announcement-11302021-11302021
AS I SAID BEFORE "Cancer causing Molnupiravir is a FLOP, Merck should pull this toxic poison from the market immediately before too much damage is done. Massive class action lawsuits are coming Merck's way if they don't."
SHAME ON MERCK FOR PUSHING THIS DANGEROUS DRUG ON THE UNSUSPECTING PUBLIC!!!!
MRK IS GOING LOWER.... A LOT LOWER!!!!
SELL BEFORE ITS TOO LATE!!!!
Was there news that caused that drop?
I had a TON of puts that would have expired worthless today!
Largest % gain of the year for me!
Awaiting the SEC's letter asking me to explain my trade...
I bailed @ 89 but hope to grab again some day. :)
TIMMMMMBBBBBBEEEEEERRRRRRR!!!!!!!!
<THUD>
Thanks for the tip.
Sure... who cares about cancers... THERE IS MONEY TO BE MADE!
Huge uptrend this week going into earnings….. they have a lot working for them and with another variant, the pill will get fast tracked
It's going to be tough for MRK to garner much market share in this market (#msg-166441220).
CDC's Advisory Committee Backs Pneumococcal Vaccine From Pfizer, Merck
ACIP endorses PFE’s Prevnar-20 for_adults_65+_or_19+_ with_medical_conditions:
https://www.businesswire.com/news/home/20211020006069/en
ACIP also endorsed MRK’s V114 for the same patient pool—but only if followed by Pneumovax. Requiring only one shot—and having broader serotype coverage—is a clear marketing edge for PFE in what will be a very large market.
Because it moved up on fake news! Of course it is headed back down!
DOW UP OVER 500 POINTS AND MRK IS ***RED***!!!!!!!!
Make sure to take your VIX with your Ivermectin!
Ten days have passed since Merck dropped its bombshell announcement about Molnupiravir, its "revolutionary" anti-viral that purports to lessen severe COVID and death by half in vulnerable unvaccinated patients.
But as scientists warn about potential unexamined safety issues with molnupirvavir, analysts at Goldman Sachs are reminding clients that Merck is hardly alone in the race to produce an effective antiviral that could function like the Tamiflu of COVID.
Looking ahead to Q42021 and on to Q12022, Goldman is looking forward to drug readouts from Roche, Pfizer, Shionogi and others developing oral antivirals. Goldman's discussions with clients about the potential influence of antiviralls "...indicate that key questions about oral antivirals largely center on: 1) clinical differentiation among the various programs; 2) data and approval timelines, supply, and pricing; and 3) the potential for pediatric and prophylactic use. Within, we size up the market potential and TAM with our market model and frame key upcoming readouts for the late stage programs. We also provide a list of upcoming catalysts in the category."
For investors seeking "exposure to the antiviral theme", Goldman recommends 1) Roche, as preclinical data for its AT-5227 suggest "differentiation" vs. molnupiravir, 2) Shionogi, whose S-217622 represents an alternative to RNA polymerase therapies, and 3) Divi's Labs, which will ride molnupiravir's coattails.
So a few kids will be born without teeth and without parts of their skulls... is that a problem if Merck can make money?
Cancer causing Molnupiravir is a FLOP, Merck should pull this toxic poison from the market immediately before too much damage is done. Massive class action lawsuits are coming Merck's way if they don't.
Molnupiravir is a prodrug of nucleoside analogue ß-D-N4-hydroxycytidine (NHC), which could potentially be incorporated in mammalian DNA.
One study determined there was evidence that the drug could potentially drive mutagenesis in both viral RNA and mammalian DNA. “It seems unlikely that a short course of therapy would spare the host from this exposure because both RNA precursors that affect the virus and DNA precursors that would affect the host pass through the common ribonucleoside diphosphate intermediate,” concludes an article in the Journal of Infectious Diseases.
SVB Leerink analyst Dr. Geoffrey Porges predicts that FDA would restrict who has access to the drug over safety concerns, according to Barron’s.
In the Phase 3 trial of the drug, the side effects of COVID-19 are apparently worse than that of molnupiravir as patients in the placebo group were more likely to withdraw early than recipients of the drug.
An August article published in the Journal of Infectious Diseases found that ß-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.”
Last year, the former Head of U.S. Biomedical Advanced Research and Development Authority (BARDA) Rick Bright opposed granting additional funding to develop the drug, partly over safety concerns related to the drug. In a complaint summarized in Science, Bright wrote 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 Emory University chemist Raymond Schinazi who stated that his previous pharmaceutical company, Pharmasset, abandoned a similar drug in 2003 after discovering its mutagenic properties.
“When someone is infected by a virus, it makes the cells in their body produce copies of itself. This drug works by causing the machinery that reproduces Covid-19’s genetic material to make mistakes, thereby stopping effective replication. That mode of action could cause problems with our own cells, and while reports are that the drug is well tolerated, we still don’t have full details of any side effects. It’s worth noting that people involved in the trial were instructed to abstain from heterosexual sex or use contraception. While this is routine practice with some other medicines, such as cancer chemotherapy, it suggests that the drug has the potential to cause birth defects should someone become pregnant.
“This news is positive, but we must not be carried away. It would be good for the 50% of patients that it could save from getting seriously ill, but not so much for those who are still hospitalised, despite taking it. There’s currently no way of knowing which group someone will be in. It’s worth remembering that another drug, dexamethasone, was found to save around a third of people who would have died with severe Covid-19, but its clinical introduction did not prevent nearly 100,000 deaths in the UK in the past twelve months.
"Proceed with caution at your own peril, said one scientist who studied the primary ingredient in molnupiravir. Another warned that "biochemistry won't lie": "there is a concern that this will cause long-term mutation effects, even cancer."
Exactly correct!
Anyone who is dumb enough to take this shit will find themselves staring in the mirror in a few years after getting a cancer diagnosis asking themselves "What was I thinking"?
It isn't even like this is a theory... it WILL happen to many people!
It is different... much different!
During the height of the "pandemic", with no known medications available, they decided to give the current vaxes an EUA and take a gamble.
There is no reason to take the same gamble on this cancer tablet!
Cancers take years to grow...
This pill will cause cancers... it prevents your immune system from removing cancer cells before they can cause a problem!
The immune system kills spontaneous blood cancer cells every day!
MRK under heavy accumulation since last week -- eyes on the prize.
Long term data? Yeah the covid vaccines had tons of long term data...not
MRK is trading up on misinformation!
The pill data is being spun... the FDA isn't that stupid!
The risks are long term (cancer), and without long term data, it cannot be approved. There are equally effective drugs that have a proven safety profile.
$MRK high estimate of 107.00
Microwave ovens are safe... phones are not.
People need their phones, they don't need the Merck poison!
Microwaves and phones cause cancer too. I dont see the use of those going down.
I am very well researched in Aspartame, and while many people have side effects from it (myself included) medical research does not include cancer among them...
In general, the American Cancer Society does not determine if something causes cancer (that is, if it is a carcinogen), but we do look to other respected organizations for help with this. Based on current research, some of these organizations have made the following determinations:
The US Food and Drug Administration (FDA) has concluded that “the use of aspartame as a general purpose sweetener… is safe.”
The European Food Safety Authority (EFSA) has stated, “Studies do not suggest an increased risk associated with aspartame consumption for… leukaemia, brain tumours or a variety of cancers, including brain, lymphatic and haematopoietic (blood) cancers.”
Though research into a possible link between aspartame and cancer continues, these agencies agree that studies done so far have not found such a link.
Lol that is not what they thought caused cancer. It's aspartame and other artificial sweeteners and drinks like diet coke. The point is you could argue practically anything causes cancer. It's worthless information. We all live and are more likely to already have the genetics that will give us cancer. What we consume barely changes genetics.
Diet Coke does not cause cancer.
Saccharin (not in Diet Coke) was thought to be carcinogenic. It has since been proven otherwise.
Molnupiravir WILL cause cancer!
It suppresses the body's ability to clean up cancer cells in our bodies... which our bodies do normally and constantly!
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