The advisory council of the US Food and Drug Administration voted to urgently approve Merck’s oral pill against COVID-19 molnupiravir (Lagevrio) – but with only a small difference.1 The 13 to 10 vote speaks volumes about the commission’s confidence in the treatment, as well as the numerous concerns about the effectiveness and safety expressed by the commission.
In a press release in October 2021, Merck reported that their antiviral drug had led to a 50% reduction in the risk of hospitalization and death among patients with COVID-19. However, this was based on data from 386 patients. When a full analysis was published, which included data from 710 patients, efficacy dropped significantly.
Among those who received the drug, the rate of hospitalization or death from all causes was 6.8%, compared with 9.7% in the placebo group – a relative risk reduction of only 30%.2 Several panelists reportedly said the change in data was poorly explained,3 and represents just one concern expressed by experts raising serious flags about the Merck pill against COVID-19.
Placebo outperformed the drug in the second half of the study
In an addendum released on November 22, 2021, the FDA stated that they became aware of the “safety and efficacy results on top of all 1433 randomized participants”.4 The data showed that patients taking placebo fared better than those taking molnupiravir.
As noted in a comment in the BMJ, “Full data showed more hospitalizations among patients taking molnupiravir (6.2%) than among those taking placebo (4.7%) and led Merck to revise the benefit of prevention admission to 30%. ”5
Furthermore, the study was terminated early after the provisional results showed eight deaths in the placebo group compared to zero in the molnupiravir group. However, the subsequent results gave a completely different picture – one death was recorded in each group.6 BMJ reported:7
“When asked why later study participants showed such different results than those in the interim analysis, the doctor representing Merck told panelists that the later group included older patients, more likely to be women and recruited from Europe, and more likely to will have elderly patients. delta variant. But, he said, the drop in efficiency at the end of the test ‘does not suit us’.
Dr. Pierre Kory, who is part of the COVID-19 Critical Care Working Working Group (FLCCC) to improve early treatment for COVID-19, asked the U.S. government to review extensive data on ivermectin to prevent COVID-19, prevent advancing those with early symptoms and helping critically ill patients recover – to no avail.8,9
Nevertheless, the FDA has continued to grant emergency approval (EUA) for Merck’s highly questionable drug. Kory tweeted his horror at the decision:10
“There is no LOVE for pharmacy given the reckless behavior now and historically. But I can HOPE. Hope is now ruined: the second half of Merck’s study: a placebo is better than a cure. Alas. Even the FDA admits that the drug is weak and risky … while it approves? EUA for IVM [ivermectin] please (I can also DREAM) ”
Fauci: Merck’s pill against COVID ‘impressive’
In October, Dr. Anthony Fauci welcomed molnupiravir, calling it “extremely important” and praising its results so far. “It’s a pill that is given by mouth, so you don’t need anything special other than taking the pill the way you take any pill. And the results are really impressive, “he told CNN” State of the Union “.11
It is unclear whether Fauci has changed his mind given the less than stellar results now available, but the U.S. government is already on the hook for about 3.1 million odds, which it bought for about $ 2.2 billion.12 Officials praised the lightness of the pill, which is taken at home, orally, every 12 hours for five days.13
Merck plans to produce 10 million servings of the drug by the end of 2021.14 but drug approval by the FDA panel is even more interesting given that more effective treatment options – namely monoclonal antibodies – have already been approved. As stated in the BMJ:15
“The U.S. has already approved three monoclonal antibody cocktails, which have shown efficiencies above 60% in preventing intake, and the FDA generally does not approve drugs that are less effective than those already in use.”
Red Flag: Molnupiravir works by causing viral mutations
Not only have concerns about performance led to red flags for some of the FDA panelists – security concerns have also been expressed. Molnupiravir works by integrating into the genetic makeup of the virus, triggering mutations that ultimately kill the virus. A pill that triggers mutations in the virus could potentially trigger mutations in mammalian cells, however, posing a risk of cancer and birth defects.16
The risks are serious enough that the drug is recommended for adults only, because of the risks it could pose to growing children, including the increased thickness of the growth plate recorded in animal studies.17 Pregnant women and those expecting pregnancy were excluded from the study, and men were unable to donate sperm one month after the last dose. Modern Dissatisfaction Report:18
“People should be reminded of the problem with thalidomide from the 1960s, a drug used to treat morning sickness in pregnant women that scientists later discovered was teratogenic and caused many birth defects. Therefore, molnupiravir should never be used in pregnant women who are concerned about possible teratogenicity. ”
Finally, the FDA panel did not recommend the approval of the drug for infants or lactating women, due to the risk of embryo-fetal toxicity, bone and cartilage toxicity, and mutagenicity.19
Molnupiravir could encourage mutants to flee
The mechanism of action of molnupyvir – causing genetic mutations – is in itself problematic, given the spike protein of the coronavirus, which is already mutating rapidly. During Merck’s phase II study, the spiky protein SARS-CoV-2 showed 72 structural changes in the nucleotide, while the spiky protein in the placebo group had only nine such changes.
The reality is that some of these changes could make the virus more infectious, more resistant to vaccines and treatments, and release mutants that have escaped into the environment.20 FDA commission member James Hildreth, president of Meharry Medical College in Tennessee, voted against approving molnupiravir for that reason.
He said: “Even if the probability is very low, 1 in 10,000 or 100,000, that this drug would cause a mutant to escape which vaccines we have are not covered, it would be catastrophic for the whole world.”21 William Haseltine, who founded and chaired the Department of Biochemical Pharmacology at Harvard, expressed similar concerns at Forbes, citing:22
“My doubts are based on two key concerns. The first is the potential mutagenicity of the drug and the possibility that its use could lead to birth defects or cancerous tumors. The second danger is far greater and potentially far more deadly: the drug’s potential to amplify SARS-CoV-2 mutations and release a more virulent variant in the world. ”
We are heading towards a ‘world class catastrophe’
Haseltine explained that during prepandemic studies, molnupiravir was tested for pathogenic coronaviruses such as MERS-CoV. Not only have coronaviruses managed to become drug-resistant, but viruses have continued to survive and replicate even with a large number of mutations in each gene and protein.
In the laboratory, treated viruses replicated somewhat more slowly than untreated viruses; however, in the real world drugs are likely to wreak havoc in unintentional ways, especially because many people may not complete the entire course of the drug.
In suboptimal doses, ie if someone does not take the drug for five days or misses a dose here and there, this can create the first environment for the transmission of mutated viruses. Haseltine told Forbes:23
“There’s a good chance that in the real world people won’t take the whole course of pills. A series of studies on adherence to daily oral antibiotics suggests that many patients – as many as 40% – fail to complete the entire course of treatment.
At these suboptimal concentrations, molnupiravir could have the unfortunate effect of introducing mutations into every gene and protein of the virus, including the spike, but it does not necessarily kill it.
Drug manufacturers Merck and Ridgeback, as well as the FDA, are investigating whether molnupiravir is safe for personal use in high-risk people with mild to moderate disease and whether its benefits outweigh any potential risks.
But they should also determine the wider danger and how to prevent the drug from releasing new and more deadly variants around the world. SARS-CoV-2 has already shown remarkable ability to mutate and survive under pressure.
The drug manufacturers, Merck and Ridgeback, are signing licensing agreements that would allow the drug to be manufactured and sold in more than 105 countries, which means that if approved by regulators, we will soon have very little control over drug use and delivered doses. We are potentially heading for a world-class catastrophe. ”
Are there other options?
There are early treatments for COVID-19 that could save lives, but they are not widespread in the media. Dr. Peter McCullough recommends that you require early treatment if you have COVID-19, regardless of whether you received the vaccine or not.24
McCullough’s early treatment regimen initially included a nutritional package of zinc, vitamin D, vitamin C, and quercetin. While you are recovering at home, open the windows and bring enough fresh air and ventilation into your home. If symptoms persist or worsen, it is recommended to call a physician and require monoclonal antibody therapy.
Treatment progresses with the inclusion of anti-infectives such as HCQ or ivermectin, antibiotics, steroids and blood thinners. If your doctor refuses to treat COVID-19 in the early stages, find a new one and / or visit a telemedicine clinic to help, as the “pre-hospital phase is a time of therapeutic opportunity”. You can also download McCullough and his colleague’s “COVID Home Treatment Guide”.25
The FLCCC I-MASK + protocol can also be downloaded in full,26 giving you step-by-step instructions on how to prevent and treat the early symptoms of COVID-19. The FLCCC also has protocols for prevention and early treatment at home, called I-MASS, which include ivermectin, vitamin D3, multivitamin and digital thermometer to monitor body temperature during prevention and ivermectin, melatonin, aspirin and antiseptic mouthwash. early treatment at home.
Home or close contacts of patients with COVID-19 may take ivermectin (18 milligrams and then repeat the dose in 48 hours) for post-exposure prevention.27 Their protocols have been translated into 23 different languages to allow wide, free access to this life-saving information, including how to get ivermectin,28 which the FLCCC hopes will be formally adopted in the national or international guidelines for the treatment of COVID-19 in the near future.