An advisory panel to the US Food and Drug Administration has voted to grant urgent approval of Merck’s COVID-19 oral drug molnupiravir (Lagevrio) – but by a narrow margin.first The vote of 13 to 10 said a lot about the panel’s confidence in the treatment, as well as many of the safety and effectiveness concerns raised by the panel.
Merck reported in an October 2021 press release that their antiviral medication has reduced the risk of hospitalization and death in COVID-19 patients by 50%. However, that is based on data from 386 patients. When the full analysis was published, including data from 710 patients, efficacy was significantly reduced.
Among those who received the drug, the rate of hospitalization or all-cause death was 6.8%, compared with 9.7% in the placebo group – a relative risk reduction of just 30%.2 Some panelists reported that variability in data was poorly explained,3 and it only represents a concern among experts who have raised serious concerns about Merck’s COVID-19 pill.
The placebo worked better than the drug in the second half of the trial
In an addendum released on November 22, 2021, the FDA stated that it was aware of “top-of-the-line safety and efficacy outcomes from all 1,433 randomized participants.”4 The data showed that patients receiving placebo had better outcomes than patients receiving molnupiravir.
As noted in a commentary in the BMJ, “Sufficient data show more hospitalizations among patients receiving molnupiravir (6.2%) than among those receiving placebo (4.7%) ) and caused Merck to adjust the benefit of preventing hospitalization by 30%. ”5
Furthermore, the trial was stopped early after interim results showed eight deaths in the placebo group compared with zero in the molnupiravir group. However, the interim results paint a very different picture – one death per group was recorded.6 BMJ reports:7
“When asked why the trial participants subsequently showed different results from those in the interim analysis, a physician representing Merck told the panelists that the group then included patients were older, were more likely to be female and recruited from Europe, and more likely to carry the delta variant. However, he said, the drop in efficiency at the end of the trial period ‘didn’t really affect us.’
Dr. Pierre Kory, a member of the team that established the COVID-19 Critical Care Working Group (FLCCC) Frontline to Advance Early Treatments for COVID-19, pleaded with the US government to consider Extensive data on the drug ivermectin to prevent COVID-19, keep people with initial symptoms from progressing and help critically ill patients recover – to no avail.8,9
However, the FDA went ahead and granted an emergency use authorization (EUA) for Merck’s questionable drug. Kory tweeted her disappointment at the decision:ten
“There is no love for Pharma for these unscrupulous acts now and in history. But I can HOPE. Hope is now gone: Second half of Merck’s trial: a placebo is better than a drug. Noisy. Even FDA admit weak & risky drugs.. while approving? EUA for IVM [ivermectin] please (I can DREAM too)”
Fauci: Merck’s COVID Drug ‘Impressive’
In October, Dr Anthony Fauci welcomed molnupiravir, calling it “crucially important” and praising its results so far. “It’s a pill that’s given by mouth, so you don’t need anything special other than taking it the way you would take any pill. And the results are actually quite impressive,” he told CNN’s “State of the Union.”11
It’s unclear if Fauci will change her mind now that the results are less than stellar, but the US government is ready for about 3.1 million courses, which it bought for about 2.2 billion. dollars.twelfth Officials have touted the ease of the drug, which is taken at home, orally, every 12 hours for five days.13
Merck plans to produce 10 million packs of the drug by the end of 2021,14 but the FDA panel’s endorsement of the drug is even more curious given that more effective treatment options – namely monoclonal antibodies – have been authorized. As noted in the BMJ:15
“The United States has authorized three monoclonal antibody cocktails, which have been shown to be over 60% effective in preventing hospitalization, and the FDA generally does not approve drugs that are less effective than those already in use.”
Red flags: Molnupiravir works by causing viral mutations
Not only were efficacy concerns raised, but several FDA panelists raised red flags — safety concerns were also expressed. Molnupiravir works by integrating into the viral genome, activating mutations that eventually kill the virus. However, a pill that triggers mutations in a virus can cause mutations in mammalian cells, putting them at risk for cancer and birth defects.16
The risks are so severe that the drug is only recommended for adults, due to the risks that the drug may pose to growing children, including increased growth plate thickness observed in the studies above. animal.17 Pregnant women and those wishing to become pregnant were excluded from the trials, and male subjects were unable to donate sperm for one month after their last dose. Modern Discontent reports:18
“People should recall the problem with thalidomide in the 1960s, a drug used to treat morning sickness in pregnant women that scientists later discovered was teratogenic and caused many other abnormalities. congenital. For this reason, molnupiravir should not be used under any circumstances in pregnant women with concerns about teratogenicity. ”
Finally, the FDA panel did not recommend approval of the drug for children or those who are breastfeeding, due to the risk of embryotoxicity, bone and cartilage toxicity, and mutagenicity.19
Molnupiravir can drive away the mutation
Molnupiravir’s mechanism of action – promoting genetic mutations – is problematic in itself, since the coronavirus spike protein is inherently rapidly mutating. In the Merck phase II trial, the SARS-CoV-2 mutant protein exhibited 72 nucleotide conformational changes, while the placebo mutant protein had only 9 such changes.
In fact, some of those changes could make viruses more infectious, resistant to vaccines and treatments, and release mutations into the environment.20 FDA board member James Hildreth, president of Meharry Medical College in Tennessee, voted against licensing molnupiravir for this reason.
He said, “Even if the probability is very low, 1 in 10,000 or 100,000, this drug could produce an escaped mutant whose vaccines we don’t include, which would be catastrophic for Around the world.”21 William Haseltine, founder and chair of the Department of Biochemical Pharmacology at Harvard, raised similar concerns in Forbes, stating:22
“My suspicions are based on two main concerns. The first is the drug’s mutagenic potential and the possibility that its use can lead to birth defects or cancerous tumors. The second is a much greater and potentially deadly danger: the drug has the ability to supercharge the SARS-CoV-2 mutants and create a more virulent variant in the world. “
We’re Heading for a ‘World-Class Catastrophe’
Haseltine explained that in pre-pandemic studies, molnupiravir was tested against pathogenic coronaviruses such as MERS-CoV. Not only are coronaviruses resistant to drugs, but they continue to survive and replicate even in the presence of a large number of mutations in every gene and protein.
In the lab, treated viruses replicate slightly more slowly than untreated viruses; however, in the real world, this drug can be devastating in unexpected ways, especially since many people may not complete the full course of the drug.
At suboptimal doses, that is, if someone doesn’t take the drug for all five days or misses a few doses here and there, it can create a prime environment for the transmission of the mutated virus. Haseltine told Forbes:23
“It’s more likely that in the real world, people won’t take enough medication. A series of studies on adherence to daily oral antibiotics show that many patients – about 40% – do not complete the full course of treatment.
At these suboptimal concentrations, molnupiravir can have the unfortunate effect of generating mutations in all viral genes and proteins, including spikes, but not necessarily killing it. .
The drug’s makers, Merck and Ridgeback, as well as the FDA are investigating whether molnupiravir is safe for individual use in people at high risk of mild to moderate disease and whether its benefits outweigh the risks. greater than any potential hazard.
But they should also identify the broader danger and how to prevent the drug from creating new and more dangerous variants globally. SARS-CoV-2 has shown remarkable ability to mutate and survive under pressure.
The drugmakers, Merck and Ridgeback, are entering into licensing agreements that allow the drug to be manufactured and sold widely in more than 105 countries, which means, if approved by regulatory authorities, we will soon have very little control over drug administration. and dose distribution. We are likely headed for a world-class disaster. ”
Are there other options?
There are early treatments for COVID-19 that can save lives, but they are not widely available in the media. Dr. Peter McCullough recommends that you get early treatment if you have COVID-19, whether you’ve had the shot or not.24
McCullough’s early treatment regimen initially included a nutritional supplement pack of zinc, vitamin D, vitamin C, and quercetin. While you are recuperating at home, open windows and let in plenty of fresh air and ventilation. If symptoms persist or worsen, your doctor recommends calling your doctor and ordering monoclonal antibody therapy.
Progressive treatment includes anti-infectives such as HCQ or ivermectin, antibiotics, steroids, and blood thinners. If your doctor refuses to treat COVID-19 in its early stages, finding a new medication and/or going to a telemedicine clinic would be helpful, as “the pre-hospitalization period is the time when there is a chance that you will get sick. treatment association”. You can also download McCullough and colleagues’ “Guide to Treating COVID at Home” by McCullough and colleagues.25
The FLCCC I-MASK+ protocol can also be downloaded in full,26 provides you with step-by-step guidance on how to prevent and treat early symptoms of COVID-19. The FLCCC also has early home treatment and prevention procedures, known as I-MASS, that include ivermectin, vitamin D3, a multivitamin, and a digital thermometer to monitor your body temperature. in the prevention phase and ivermectin, melatonin, aspirin and antiseptic mouthwash for early treatment at home.
Family or close contacts of a COVID-19 patient can receive ivermectin (18 milligrams, then repeat dose in 48 hours) for post-exposure prophylaxis.27 Their protocols are translated into 23 different languages to provide free, broad access to this life-saving information, including how to get ivermectin,28 which the FLCCC hopes will be formally adopted into national or international COVID-19 treatment guidelines in the near future.
