FDA Panel Recommends Merck Covid Pill, Despite ‘More Questions Than Answers’
The U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee on Tuesday voted narrowly, 13 to 10, to recommend Emergency Use Authorization (EUA) of Merck’s five-day pill to treat COVID.
The drug, molnupiravir, sold under the brand name Lagevrio and developed with Ridgeback Biotherapeutics, is an antiviral medication that inhibits the replication of certain RNA viruses, including SARS CoV-2.
Potential patients would take an 800-milligram pill every 12 hours for five days after COVID symptoms begin. The FDA and Centers for Disease Control and Prevention must both sign off before the drug is granted EUA and made available to the public.
The FDA panel “recommended Merck’s treatment be authorized for people with COVID who are at high risk of becoming severely ill. That would most likely cover tens of millions of Americans who are older or have medical conditions such as obesity, diabetes or heart disease,” The New York Times reported.
Molnupiravir was given in clinical trials to people allegedly infected with the variants Delta, Mu and Gamma, according to The Times. Dr. Nicholas Kartsonis, a Merck executive, said that with the newly discovered variant, Omicron, “we expect based on what we know … that molnupiravir would be effective.”
Just a few days prior to the vote, study data was released showing the effectiveness of the treatment declining from earlier data. According to The Hill:
“The drug manufacturer filed for an Emergency Use Authorization last month after its study suggested molnupiravir reduced the risk of hospitalization by 50%. But updated data from Friday showed a 30% reduction in hospitalizations among more participants.”
The federal government in June signed a $1.2 billion contract with Merck while the experimental treatment was still in clinical trials, according to ABC News. That contract was to purchase treatments for 1.7 million people. But the government has since increased that contract, agreeing to purchase “3.1 million courses of the drug, with the option to purchase more,” The Hill reported.
Panel recommends Merck COVID pill, despite ‘more questions than answers’
A number of FDA panelists, including some who voted to recommend the molnupiravir, expressed hesitation about the drug.
According to CNBC:
“Many members of the advisory committee described the vote as a difficult one, in which they had to carefully weigh the risks and benefits of a drug that could help those most at risk but raised many unanswered questions. Several committee members recommended that Merck’s emergency use authorization be revisited and potentially withdrawn if another treatment becomes available later.”
Dr. David Hardy, who voted to recommend the drug, said there’s a “need for something like this” but admitted the “efficacy of this product is not overwhelmingly good.”
Lindsey Baden, the committee’s chairman, made similar statements calling it “an incredibly difficult decision” with “more questions than answers.”
Dr. Sankar Swaminathan, who voted against recommendation, said more research was needed on how the drug will affect human DNA and the potential for it to cause birth defects.
“The risk of widespread effects on potential birth defects, especially delayed effects on the male, have not been adequately studied,” Swaminathan said.
Dr. James Hildreth expressed concerns with mutant variants escaping, telling the panel:
“Even if the probability is very low, 1 in 10,000 or 100,000, that this drug would induce an escape mutant from which the vaccines we have do not cover, that could be catastrophic for the whole world actually.”
Molnupiravir was already approved in the UK even as similar concerns were expressed.
Dr. William Haseltine, a virologist formerly at Harvard University, told the publication Science:
“You are putting a drug into circulation that is a potent mutagen at a time when we are deeply concerned about new variants. I can’t imagine doing anything more dangerous…. If I were trying to create a new and more dangerous virus in humans, I would feed a subclinical dose [of molnupiravir] to people infected.”
Too many unknowns and potential risks?
As new treatments garner approval despite questionable data, public health officials continue to reject, and in some cases prohibit the use of, older, safe and well-known drugs.
Studies have shown the safety and efficacy of inexpensive drugs, such as oral hydroxychloroquine and povidone-iodine throat spray and ivermectin and doxycycline monotherapy, for treating COVID.
In fact, doctors who have treated COVID patients from the beginning have reported successful results with drugs that have been readily available and in use for years.
Dr. Meryl Nass, a member of Children’s Health Defense (CHD) scientific advisory board, in an email told The Defender:
“We are witnessing another FDA charade, as its Pharma-connected advisory committee members narrowly voted to authorize molnupiravir.
“Plucked from the antiviral boneyard, molnupiravir went through a series of transfers that magically converted it from a failed drug developed at taxpayer expense to a blockbuster drug for Merck and its partner, Ridgeback.”
Molnupiravir reduced hospitalizations by only 30%, is clearly less useful than monoclonal antibodies and works “nowhere near as well as multiple other drugs for COVID,” Nass said.
Nass said molnupiravir’s mechanism of action is inducing mutations — in viruses, but “maybe in us too, as postulated by several FDA committee members.”
“It’s simply another dangerous drug that will help the federal health agencies look like they are doing something, while doing nothing to curtail the pandemic,” Nass said. “And because it is being authorized, instead of being licensed, anyone injured by the drug cannot sue for damages and is unlikely to collect any benefits.”
Mary Holland, CHD president and general counsel, told The Defender:
“There are many problems with Merck’s new cash cow — Merck doesn’t know if it will drive new mutant variants; Merck hasn’t tested the drug on vaccinated people, who will get it; and the drugmaker doesn’t know if it will be effective against new variants.
“The biggest problem, though, is the continued governmental, medical and media suppression of existing, off-patent drugs, including ivermectin and hydroxychloroquine. These products are known to be safe, effective, affordable and available. Authorizing Merck’s new bonanza while suppressing safer, more effective, less expensive alternatives points up the abject failure of the FDA to protect public health.”
Follow the money?
The answer to why this new drug is being authorized for emergency use may very well come down to the incentives.
Ivermectin is actually produced by Merck, but because of government rules Merck would be unable to profit off the drug.
“Due to generic drug substitution rules at pharmacies, Merck could spend millions of dollars to get a COVID-19 indication for ivermectin and then effectively get zero return,” according to David Henderson and Charles Hooper. “What company would ever make that investment? Ivermectin is an old, cheap, off-patent drug. Merck will never make much money from ivermectin sales.”
Dr. Pierre Kory, chief medical officer for Front Line COVID-19 Critical Care Alliance, told LifeSiteNews:
“We plan on giving money to a drug company for a drug that is in no way going to surpass what we already have available right now and can be used. That money should instead be given to supply ivermectin to the country. This is a colossal waste of taxpayer money.”
American taxpayers funded the development of molnupiravir through a $19 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), according to The Intercept.
The cost to produce one molnupiravir treatment is $17.74 to Merck but the purchase contract to the U.S. government is $712 per treatment, The Intercept reported.
Meanwhile, Merck expects to make up to $7 billion in profit from the drug for which U.S. taxpayers funded the development and production.
Similar profit motives were apparent in the approval of remdesivir. Despite concerns addressed by the World Health Organization, the NIAID’s Director Dr. Anthony Fauci was calling it the “standard of care” as drug company Gilead’s initial sales projections from the drug last year were $3 billion.
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Big Pharma’s Five Major Minions that Everyone, Vaxxed or Unvaxxed, Must Oppose
This is not an “anti-vaxxer” article, per se. It’s a call for everyone to wake up to the nefarious motives behind vaccine mandates, booster shots, and condemnation of freedom.
The worst kept secret in world history SHOULD be that the unquenchable push for universal vaccinations against Covid-19 has little if anything to do with healthcare and everything to do with Big Pharma’s influence over the narrative. Unfortunately, that secret has stayed firmly hidden from the vast majority of people because of the five major minions working on behalf of Big Pharma.
What’s even worse is the fact that Big Pharma’s greed is merely a smokescreen to hide an even darker secret. We’ll tackle that later. First, let’s look at the public-facing ringleaders behind the vaccine push, namely Big Pharma. But before we get into their five major minions, it’s important to understand one thing. This is NOT just an article that speaks to the unvaccinated. Even those who believe in the safety and effectiveness of the vaccines must be made aware of agenda that’s at play.
Let’s start with some facts. The unvaccinated do NOT spread Covid-19 more rampantly than the vaccinated. Even Anthony Fauci acknowledged the viral load present in vaccinated people is just as high as in the unvaccinated. This fact alone should demolish the vaccine mandates as it demonstrates they have absolutely no effect on the spread of the disease. But wait! There’s definitely more.
This unhinged push to vaccinate everyone defies science. Those with natural immunity may actually have their stronger defenses against Covid-19 hampered by the introduction of the injections which fool the body into creating less-effective antibodies. Moreover, the push to vaccinate young people is completely bonkers. The recovery rate for those under the age of 20 is astronomical. Children neither contract, spread, nor succumb to Covid-19 in a statistically meaningful way. What they DO succumb to more often than Covid-19 are the adverse reactions to the vaccines, particularly boys.
All of this is known and accepted by the medical community, yet most Americans are still following the vaccinate-everybody script. It requires pure cognitive dissonance and an overabundant need for confirmation bias to make doctors and scientists willingly go along with the program. Yet, here we are and that should tell you something.
Before I get to the five major minions of of Big Pharma, I must make the plea for help. Between cancel culture, lockdowns, and diminishing ad revenue, we need financial assistance in order to continue to spread the truth. We ask all who have the means, please donate through our GivingFuel page or via PayPal. Your generosity is what keeps these sites running and allows us to expand our reach so the truth can get to the masses. We’ve had great success in growing but we know we can do more with your assistance.
Who does Big Pharma control? It starts with the obvious people, the ones who most Americans believe are actually behind this push. Our governments at all levels as well as governments around the world are not working with Big Pharma. They are working for Big Pharma. Some are proactive as direct recipients of cash. Others may oppose Big Pharma in spirit but would never speak out because they know anyone who does has no future in DC.
This may come as a shock to some, but it’s Big Pharma that drives the narrative and sets the agenda for the “experts” at the CDC, FDA, WHO, NIH, NIAID, and even non-medical government organizations.
Most believe it’s the other way around. They think that Big Pharma is beholden to the FDA for approval, but that’s not exactly the case. They need approval for a majority of their projects, but when it comes to the important ones such as the Covid injections, Big Pharma is calling the shots. They have the right people in the right places to push their machinations forward.
That’s not to say that everyone at the FDA is in on it. Big Pharma only needs a handful of friendlies planted in leadership in order to have their big wishes met. We have seen people quitting the FDA in recent weeks for this very reason. The same can be said about the other three- and five-letter agencies. Too many people in leadership have been bribed, bullied, or blackmailed into becoming occasional shills for the various Big Pharma corporations. Some have even been directly planted by Big Pharma. That’s the politics of healthcare and science that drives such things as Covid-19 “vaccines.”
Read the rest of this story, but please be sure to donate first if you can.
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