Blaze News investigates: Long before COVID, Merck allegedly lied about mumps vaccine in MMR II

Blaze News investigates: Long before COVID, Merck allegedly lied about mumps vaccine in MMR II



Litigation against pharmaceutical giant Merck regarding one of its common childhood vaccines has lingered in the court system for more than a decade even though there has been seemingly little dispute about the veracity of the fraud claims against it.

Blaze News reviewed court documents related to the Merck cases and spoke with one attorney as well as several individuals who have put together a feature film, "Protocol 7," about the allegations made in them. According to this evidence, it appears that Merck knew about problems with the mumps component of its measles, mumps, and rubella vaccine, often referred to as MMR II, in the 1990s and has spent significant resources in the decades since to cover up those problems rather than admit the truth or improve the vaccine's quality.

Merck's attorneys did not respond to Blaze News' request for comment.

A 'voice to children who have none': Context of 'Protocol 7'

The allegations dramatized in "Protocol 7" were first made by Merck employee whistleblowers in 2001 and in a federal complaint under the False Claims Act filed under seal in 2010 and made public in 2013. In 2024, questioning the government pitch about vaccines is no longer taboo, thanks in large part to the controversial COVID-19 vaccines. But skepticism about vaccines was not always so socially acceptable.

Just ask Dr. Andrew Wakefield, a British former physician and the writer, director, and executive producer of "Protocol 7." Wakefield was stripped of his medical license and shunned by many in the medical community as a "disgraced anti-vaxxer" after he suggested in the 1990s that children take separate vaccines for measles, mumps, and rubella, perhaps a year apart, because of a possible link between MMR and autism.

Wakefield told Blaze News that he doesn't much mind the attempts to ostracize him. "My production team and I have both moral and professional obligations to give voice to children who have none," he said. "Contrived and dishonest allegations against me only serve to strengthen my resolve."

Wakefield now lives in Austin, Texas, and recently appeared on BlazeTV's "Sara Gonzales Unfiltered" to talk about his experiences promoting vaccine safety and informed consent. A portion of that interview can be viewed below. Subscribe to BlazeTV for other such original content.

'Like a cold': Children and the mumps virus

Between measles, mumps, and rubella, a mumps vaccine would likely be the hardest to sell to parents if there were no MMR II on the CDC's childhood immunization schedule. For one thing, a mumps infection is rare and poses only a low risk to children. Children who do contract the disease likely experience swollen glands, muscle pain, and a fever for a week or less.

Even the CDC website admits: "Some people who get mumps have very mild symptoms (like a cold), or no symptoms at all and may not know they have the disease."

Of course, low risk does not mean risk-free, and one of the most significant risks mumps presents to children is deafness. According to Dr. Robert Malone, who became a household name in recent years because of his public criticism of the COVID vaccines but who also lent his expertise to the whistleblowers in the Merck case, "Mumps has historically been one of the leading causes of childhood deafness." Dr. Wakefield told Blaze News that, though deafness is a frightening possibility with childhood mumps, such incidents are "rare."

Once children go through puberty, however, a mumps infection becomes considerably more dangerous. Males may develop an inflammation of their testes, increasing their chances of sterility. Women who contract mumps while pregnant have "a spontaneous abortion rate of up to 25%," Malone said. In rare cases, adults who contract mumps may even develop meningitis or encephalitis, otherwise known as inflammation of the brain.

'96%' effective: Merck's MMR II vaccine

The dramatic increase in risk that mumps poses once children have aged into and beyond puberty is precisely why Wakefield calls Merck's alleged fraud regarding its MMR II vaccine so "insidious." Before 1968, nearly every child experienced a case of mumps, he said, most of which were mild and "easily treated with antibiotics." Such infections also caused children to naturally develop mumps antibodies that fortified them against re-infection in the future.

In theory, a mumps vaccine would accomplish the same end, but Wakefield, the Merck whistleblowers, and others believe that MMR II has not lived up to its billing regarding mumps. In fact, Wakefield told Blaze News that MMR II has largely been "impotent" and "ineffective" at creating sufficient mumps antibodies in children, thus leaving them at risk of a more severe mumps infection as adults.

Nevertheless, Merck first received a license for a composite measles, mumps, and rubella vaccine in 1978 and began manufacturing it en masse to sell those vaccines to the CDC, which then added MMR to its list of recommended childhood immunizations. Merck and the CDC both recommend that the first dose be administered when a child is between 12 and 15 months, and a second dose should be given when the child is between 4 and 6 years old.

According to Merck's MMR II product insert, updated within the last year, "96%" of the children who were injected with MMR II in its "clinical studies" exhibited "neutralizing antibodies" for the mumps virus. In other words, the vaccine is 96% effective at guarding recipients against mumps infection, the company asserts.

Screenshot of Merck product label

'Out of compliance': Signs of trouble

By the mid-1990s, though, Merck allegedly learned that the MMR II vaccine could not maintain minimum potency throughout its advertised two-year shelf life. According to whistleblowers' allegations in court documents filed last November, Merck employees admitted at some point that MMR II was "misbranded," "out of compliance," and needed "immediate corrective action" to avoid a product recall.

What followed was a clinical trial that allegedly involved unethical and illegal interventions to doctor the testing and data in a failed attempt to maintain the 96% efficacy threshold. This clinical trial became internally known as Protocol 007.

The fraud allegedly perpetrated by Merck employees during Protocol 007 was brought to light by Stephen Krahling and Joan Wlochowski, former Merck virologists who came forward as whistleblowers.

Constitutional lawyer and adviser to the "Protocol 7" film Jim Moody noted that Krahling and Wlochowski are more than just whistleblowers. In court documents, they are referred to as relators, and Moody told Blaze News that as insiders who closely observed the fraud, their testimony carries significant weight in court.

"A paradigmatic relator is a close or a firsthand observer of the fraud," Moody told Blaze News. "... The courts like these firsthand relators [because these] people were in on it, if you will, saw it."

Such direct witness testimony "resolves issues about credibility" regarding the accusations because they are based on eyewitness testimony rather than, say, a "statistical analysis" of big data in state or national records, Moody explained.

'The callousness [of] this fraud': Protocol 007

According to the allegations made by Krahling and corroborated by Wlochowski, Protocol 007 quickly devolved into a series of attempts to cook the data to justify the assertion that MMR II was at least 95% effective at creating mumps antibodies in children. Wakefield told Blaze News that independent testing puts the number somewhere between 60% and 70%, and such reduced effectiveness would almost certainly end the CDC's continued purchase of MMR II, which amounts to about $100 million per year.

To avoid such financial and reputational catastrophe, the first step some Merck scientists allegedly took was to increase the sensitivity of the plaque reduction neutralization tests, which are commonly used to determine vaccine efficacy. They reportedly achieved this increased PRNT sensitivity by testing MMR II against a weakened, lab-generated strain of the mumps virus, even though a naturally occurring and more potent strain was required by law. Even with the more sensitive PRNTs, however, the Merck team apparently could not verify that the MMR II vaccine was 95% effective even against the weakened mumps strain.

The next move Merck researchers allegedly made was to inject rabbits with human antibodies and then take blood from these rabbits to create a glue that would then be added to the PRNTs, a kind of blood and antibody laundering, if you will.

The glue apparently worked — in fact, it worked too well because it created an additional problem: pre-positives on the test plates. In this case, pre-positives are samples of blood taken from children who have never been exposed to the mumps disease or received a dose of the vaccine and thus should have no mumps antibodies but who appeared to exhibit such antibodies nonetheless. As these pre-positive blood samples have already demonstrated antibodies before receiving a vaccine injection, they cannot help but verify vaccine efficacy.

At this point in Protocol 007, either out of frustration or desperation, some Merck employees allegedly decided to stop monkeying with the tests and instead change the numbers recorded in the data to reflect the desired result.

A Merck supervisor cited in court documents reportedly testified: "My goal and my understanding ... was to have [a test] that would allow us to have the capability of measuring 95 percent seroconversion ... without considering the impact on accuracy."

This alleged fraud was not just minor tweaking, court documents showed. Nor was it the result of carelessness or haste.

"Relator Joan Wlochowski testified that she witnessed counting sheets being discarded by lab staff" in connection with Protocol 007, and one Merck lab executive admitted under oath that he discarded many of the Protocol 007 testing plates before "anyone from quality assurance" could verify that they had been properly recorded, Dr. Malone noted in his report.

Indeed, a transcript from a 2017 deposition shows that the lab executive testified: "As best I recall, my understanding of this was that retention of the plates was not a requirement. That the plaque counting sheet was the primary source of the data and the [testing] plates were not -- wasn't required to retain them as the primary data source."

Dr. Wakefield told Blaze News that to add interest and intrigue to the movie "Protocol 7," he and the other writers actually added a "moral quandary" for the character representing this Merck lab executive that he might not have experienced in real life. Otherwise, Wakefield said they risked audiences becoming suspicious that the malfeasance of the Merck figures had been exaggerated.

Moody, legal adviser to the film, indicated to Blaze News that Merck's culpability cannot be overstated.

"The case itself revealed multiple instances, repeated instances of over and over and over again of other frauds," he insisted. "... It's just the callousness by which this fraud was done that makes [Merck], in my view, the extent of the villain that they are."

'Raw data is being changed': The FDA inspects Merck lab

As the licenser of vaccines, the FDA has a keen interest in vaccine data and efficacy as well.

In August 2001, Krahling, one of two relators in the cases against Merck, contacted the FDA to report the fraud he had allegedly witnessed, even though his superior had reportedly threatened him with termination, and he was also allegedly threatened with possible jail time if he came forward. The FDA then alerted Merck about possible deficiencies in the data collected in the Merck executive's lab, court documents said.

The FDA also made an "unannounced" visit to the lab within days of Krahling's report, though Wakefield and his fellow filmmakers indicated that an FDA source may have tipped Merck off about the visit. In any case, the result of the visit was damning for the company.

"Raw data is being changed with no justification," said an FDA Form 483 signed by Debra Bennett and Dr. Kathryn Carbone, according to court documents. An FDA Form 483 is issued "when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts," the agency's website states.

In addition to problems with the raw data, that FDA form also noted potential problems with the Merck executive's lab, the "spreadsheets used to determine questionable results and retesting of clinical samples," and the "notebooks" that logged the individuals "performing each task."

'Materiality': Merck litigation focused on money

Despite the alarming report from the FDA, Merck continued to manufacture MMR II and sell it to the CDC. So in 2010, nearly a decade after the FDA inspection at the Merck lab, relators Krahling and Wlochowski sued Merck under the False Claims Act, which relates to occasions in which the government may have been monetarily defrauded, Moody — a false claims lawyer — told Blaze News.

The case has languished in the court system for the past 14 years, but both sides eventually tried to propel it toward a resolution by filing a summary judgment, which allows one or both sides to argue to a judge that they are entitled to win without submitting the case to a jury because there is allegedly no dispute on the facts or law.

A summary judgment hearing was then held in the Merck case in January 2023, but Merck's legal team did not really seize the opportunity to defend the company against the allegations of fraud. Instead, the "most obvious and undisputable ... reason to grant summary judgment for Merck," Merck attorney Jessica Ellsworth argued at the hearing, was "materiality," a transcript showed. Ellsworth explained materiality in this case to be whether the "CDC would have made different purchasing choices in the Vaccine for Children Program" had it known about the alleged problems with MMR II.

Ellsworth claimed plaintiffs offered "no non-speculative evidence that CDC would have made any different purchasing choices related to M-M-R II based on Relators’ opinions about a research study known as Protocol 007." She also called any suggestion to the contrary "speculation" and "innuendo."

District Judge Chad Kenney of the Eastern District of Pennsylvania agreed, ruling last July that "considering the totality of the circumstances, no reasonable jury could conclude that the alleged false claims were material to the CDC’s purchasing decisions."

That failed False Claims Act case as well as a separate antitrust class action against Merck are now both in the hands of the Third Circuit Court of Appeals and will be decided jointly. Oral arguments in the appeals cases could be held as early as next month.

Lead attorneys for relators Krahling and Wlochowski did not respond to Blaze News' request for comment.

'Vigorously dispute': Merck issues a formal response

While Merck's attorneys focused on materiality as the basis of their defense of Merck in court and have never actually responded to the allegations of fraud publicly, Merck has issued a defense of sorts for MMR II and its research and development. That defense came in response to allegations from former FDA Commissioner Dr. David Kessler, who served as an expert witness for relators Krahling and Wlochowski.

In addition to restating concerns regarding Protocol 007, in a letter dated August 2019, Kessler expressed concerns about incidents of "low mumps potency" MMR vaccinations. In the four short years between 1995 and 1999, Merck reportedly estimated that it had issued 23 million such "low mumps potency" MMRs. After analyzing the same data based on "Merck's methodology for identifying the 23 million doses," Kessler claimed he found that the number was actually closer to 60 million.

Kessler, who described himself as "a strong proponent of vaccines," worried that 60 million "doses of potentially sub-potent vaccine" might "shake the public's confidence in vaccines generally and measles, mumps and rubella vaccine specifically." Nonetheless, Kessler recommended that Merck and/or the government inform patients that they had received an ineffective mumps vaccine, undertake further studies and medical monitoring, and consider developing a new mumps vaccine.

In return, Merck issued a letter that boasted about MMR's overall success at reducing measles, mumps, and rubella infections. The letter also indicated that many of the alleged potency problems associated with the vaccines manufactured before September 1999 could be attributed to a change in "interpreting the potency label claim." "This change was not related to product performance, nor did it present a clinical issue or otherwise create a basis for clinical concern," Merck asserted.

Screenshot of Merck letter

Elsewhere in its response letter, Merck did mention Protocol 007, claiming to "vigorously dispute[] each and every one of Dr. Kessler’s contentions about the propriety of Protocol 007" and insisting that such contentions were based on "plaintiffs’ complaint in the pending litigation." Not only has the FDA known about "concerns" regarding Protocol 007 since at least 2010, Merck's letter claimed, but the FDA had actually "examined" those concerns "in detail ... while Protocol 007 was being designed, performed, analyzed, and supplied to support a Prior Approval Supplement."

Composite screenshot of Merck letter

Wakefield told Blaze News that such assertions still do not explain "the multiple outbreaks of mumps in highly vaccinated populations." Merck's attorneys did not respond to Blaze News' request for comment.

'As many as 94 percent of those who contracted the illness had been vaccinated"

While cases against Merck have lumbered about in the court system, mumps outbreaks have made a minor resurgence in America. In 2016 and 2017, a period that a 2021 NBC News article called the "peak" of this resurgence, 37 states and Washington, D.C., experienced small pockets of outbreaks that resulted in 9,000 reported mumps cases, a tremendous jump from the 231 cases reported in 2003.

NBC News further noted that two-thirds of all reported mumps cases between 2007 and 2019 occurred in people who had aged beyond adolescence — meaning the disease put them at acute risk — and "as many as 94 percent of those who contracted the illness had been vaccinated."

Though no direct link has been made between possible issues with the MMR II vaccine and the increases in mumps cases, Dr. Wakefield and the rest of the "Protocol 7" team believe that because Merck allegedly altered so much key data decades ago, without testing, it's nearly impossible now to determine whether adults who received MMR II as children since the time of Protocol 007 continue to have immunization against mumps — if they ever had immunization in the first place.

According to Wakefield, those children who received an ineffective dose of MMR II would be "in danger of catching mumps as a teenager and older, when mumps is a much more serious disease."

The CDC recommends that "adults who do not have presumptive evidence of immunity should get at least one dose of MMR vaccine." Some may require two doses, the agency says.

While the CDC continues to recommend and purchase MMR II from Merck, the agency has quietly put a competing MMR from GlaxoSmithKline on the schedule and is starting to switch purchases, the "Protocol 7" team told Blaze News.

'Doubts ... cannot be allowed to exist': Big Pharma set up for success

Like all major pharmaceutical companies, Merck seemingly enjoys the benefit of the doubt from the U.S. government. Since at least the early 1980s, the federal government has been openly worrying about public trust in vaccines manufactured by Merck and others, claiming that such vaccines are the safest way to achieve herd immunity for many dangerous diseases.

A June 1984 federal register discussing the polio vaccine went so far as to say that "any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation's public health objectives."

The polio immunization program "depends on" "maintaining public confidence," the register continued, so the FDA ought not to revoke the polio vaccine license based on "deficiencies in the lots" used to test the polio vaccine's efficacy.

Screenshot of federal register

Within a few years of that federal register about the polio immunization program, pharmaceutical manufacturers like Merck gained the added benefit of immunity against vaccine injury tort liability in most individual cases, thanks once again to the federal government. U.S. Code provides that "no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Critics of the COVID vaccines released at the tail end of the Trump administration pointed to even broader protections granted to the industry under the 2005 Public Readiness and Emergency Preparedness Act and the COVID emergency declarations, noting that because of such far-reaching immunity, Pfizer, Moderna, and Johnson & Johnson likely would never be held financially responsible for injuries and death caused by the COVID vaccines. The only exception the PREP Act offers against this blanket immunity is "willful misconduct."

'That's winning': Finally, open dialogue about vaccines

The sharp divide regarding the efficacy of the COVID shots stands in stark contrast to the general acceptance of MMR in most parts of the Western world. But even though billions of doses of COVID shots have been administered worldwide in the past few years, Dr. Wakefield still sees the controversy over COVID vaccines as, in some respects, a victory for vaccine safety and open debate more broadly.

"The majority of adults, certainly in [America], will not get any booster," he told Blaze News. "They said, 'We're done. We're not doing any more.' ... So we now have gone from a handful of people ... who've tried to talk about [vaccine safety] to a majority of the adult population, certainly in this country and essentially the world.

"And that's winning."

However, Moody noted somberly that the change in discourse came in large part because of "constantly shifting and evasive government positions, outright lies, and a near-complete lack of transparency and cover-up of injury and death data."

Still, millions of American children have received the MMR II vaccine without experiencing any adverse side effects or ever developing mumps. Wakefield, Moody, and the others who spoke with Blaze News reiterated that they are not against all vaccines. They simply want consumers, especially parents, to have all the information they need to make the best decisions for themselves and their families and to be able to make these decisions without pressure or coercion from the government, the manufacturers, or the public. They also call for a repeal of blanket immunity for vaccine manufacturers and swift and generous no-fault compensation for all the victims of what they call "the war against disease."

In Wakefield's words, "It's all about informed choice."

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What this canceled doctor just revealed about Big Pharma is “so spicy, so juicy,” you can’t miss it



On this special episode of “Sara Gonzales Unfiltered,” your favorite spicy Latina invites former G.I. surgeon and medical researcher Dr. Andrew Wakefield — who Wikipedia labels as a “fraudster, discredited academic, [and] anti-vaccine activist” — to challenge the mainstream narrative surrounding Big Pharma.

Also joining the show is Matthew Marsden, BlazeTV contributor and star of Wakefield’s new film, "Protocol-7,” which is a bombshell “whistleblower story” that chronicles the true events of the lawsuit against Merck for the firm’s allegedly harmful MMR vaccine.

Together, the three discuss what Sara calls “epic levels of Big Pharma corruption.”

So, how did Dr. Wakefield become “Big Pharma's number one enemy?”

Simple. He spoke the truth even when the truth was inconvenient.

Turns out when you “confront government policy and you threaten pharmaceutical industry profiteering,” you “take a relatively promising medical career and flush it down the toilet,” says Dr. Wakefield, adding that he’s been embroiled in this battle for “30 years now.”

The longstanding narrative surrounding Dr. Wakefield is that he claimed “vaccines cause autism.”

However, that’s not even close to the full story.

“In 1995, I started getting calls from parents saying my child was perfectly well ... and then they had an MMR vaccine, then they had a seizure, and they were never the same again; the lights went out, and they were ultimately diagnosed with autism,” he tells Sara.

While Dr. Wakefield was not trained in matters related to autism, parents continued to call him because their children were simultaneously experiencing painful “intractable bowel problems,” which was within his scope of practice.

However, “The doctors and nurses I talked to dismissed this. They said, ‘This is just autism, get used to it, put them in a home, forget about them, move on, [and] have another child.”’

Thankfully, instead of silently complying, Dr. Wakefield “put together a big team of eminent doctors and the world's leading pediatric gastroenterologists at the time.”

“We investigated these children, and the parents were absolutely right,” he says. “The children had an inflammatory bowel disease, and when we treated that bowel disease as we might treat Crohn's disease or colitis with anti-inflammatories, then not only did the bowel symptoms get better, but they started speaking again.”

“We did it 183 times before I left the Royal Free [Hospital], and it happened virtually every single time.”

When it had become clear “that the medical profession was wrong on virtually every count” related to the effects of its vaccines, Dr. Wakefield suggested “dissociating these vaccines into their component parts ... given perhaps by separation of one year.”

In other words, he never suggested not taking vaccines but rather just taking them separately in order to better study the effects of each individual vaccine.

So while he drew “no conclusions,” made “[no] definitive statements,” and per protocol, suggested a “more detailed study” based on the case series he’d drawn up, his words were twisted and manipulated, eventually leading to his expulsion from the medical field altogether.

To hear more of Dr. Wakefield’s story, as well as the details of his film “Protocol 7,” watch the clip below.

Or head over to get.blazetv.com/sara for the full, 100% uncensored, and FREE episode.


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Canceled doctor discusses new movie exposing alleged lies about mumps vaccine with BlazeTV's Sara Gonzales



Sara Gonzales, host of BlazeTV's "Sara Gonzales Unfiltered," sits down with a British doctor who was canceled decades ago because he dared to question a common vaccine.

In 1993, Andrew Wakefield was a doctor specializing in gastroenterology in London when he began to have doubts about the childhood vaccine known as MMR, which stands for measles, mumps, and rubella. Around that time, Wakefield claimed parents began contacting him, complaining that their children began showing frightening symptoms following their MMR vaccination.

"I started getting calls from parents saying, 'My child was perfectly well. They had speech and language interaction with their siblings, they were developing normally healthy, and then they had an MMR vaccine, and they had a seizure and they were never the same again," Wakefield recalled to Gonzales.

Those children were often then diagnosed with autism, prompting concerns about a possible link between vaccinations in general and autism. But Wakefield did not want parents to ditch vaccines altogether. Rather, he wanted children to receive three separate vaccines — one for measles, mumps, and rubella — perhaps a year apart.

The British government took a different view, Wakefield claimed. "If we allowed parents the choice [to have separate vaccines], it would destroy our MMR program," officials allegedly told Wakefield.

Merck, the pharmaceutical company which manufactures MMR, likewise withdrew the individual vaccines in the U.S., he said.

The retaliation against Wakefield was swift and fierce. He eventually lost his medical license and was shunned by many in the medical community. Wakefield chronicled his fight against MMR in the 2016 documentary "Vaxxed: From Cover-up to Catastrophe."

Wakefield has now directed a second feature film about vaccines called "Protocol-7." The title, he told Gonzales, relates to the protocol apparently used by Merck to mislead parents about the efficacy of its mumps vaccine. "It is a way of misrepresenting the results — which they ultimately give to the FDA — that ... seeks to show that their vaccine is doing something that they say on the product-insert it's doing, but in reality is not doing," he explained.

"Protocol-7" stars Rachel G. Whittle as Lexi Koprowski, a small-town lawyer who begins demanding answers after her adoptive son starts evincing signs of autism following a mumps vaccination. The case against Merck, which she initiated, has been tied up in the courts for nearly 15 years.

Actor Matthew Marsden, who plays Dr. Jay in the movie, also joined Wakefield and Gonzales to discuss his role as well as his experiences in Hollywood after he chose not to take the COVID vaccine a few years ago, claiming he was treated as "the antichrist" and "an idiot."

Though the lockdowns and vaccine mandates were a dark period in recent memory, Wakefield believes the alleged lies surrounded the COVID vaccines will ultimately prove to be Big Pharma's "biggest mistake." "When I started, there were a handful of people worldwide who were prepared to talk about [problems with vaccines]," he said. "Now, ... more than half the adult population of the world are refusing to take the booster doses of the [COVID] vaccine."

Marsden agreed. "I think that if ever a good thing could have come out of COVID, it's that people are more receptive to movies like ['Protocol 7], that they will listen to other people's stories," he claimed.

Wakefield also wants to encourage parents to trust their instincts regarding vaccines and other forms of medical treatment for their children. "[The] main element of the movie was about the power of a mother's intuition," Wakefield said.

"She has to trust in her innate instinct as a mother to do what is best for her child and by proxy every child in the world."

"Protocol-7" is expected to be released soon.

"It is explosive," Gonzales said of "Protocol-7." "It's going to make your blood boil, but it is information that you need to know."

The episode of "Sara Gonzales Unfiltered" featuring Wakefield and Marsden drops Thursday evening at 7 p.m. for BlazeTV subscribers. Click here to subscribe today and enjoy this and other original content.

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'You're playing with fire': Damning study indicates Merck & Co.'s COVID-19 drug Lagevrio is responsible for new mutations of the virus in patients



Merck & Co.'s COVID-19 pill Lagevrio may be helping to generate and spread new variants, according to a new study. These mutant spin-offs could possibly turn out to be potentially more contagious and deadly than the virus the drug was originally supposed to combat.

What's the background?

Molnupiravir, sold as Lagevrio, is an antiviral drug from Merck & Co. and Ridgeback Biotherapeutics. It is supposed to prevent RNA viruses from replicating by inducing mutations in the virus genome during replication. The National Institutes of Health claimed that this pill had "shown antiviral activity against SARS-CoV-2 in vitro and in clinical trials."

Dr. Elizabeth Duke, a Fred Hutch research associate who oversaw one molnupiravir trial, told Kaiser Health News in September 2021, "You could give it to everyone in a household, or everyone in a school. Then we’re talking about a return to, maybe, normal life."

By November 2021, the Biden administration had already committed to purchasing $2.2 billion worth of Merck's drug.

The pill received an Emergency Use Authorization from the Food and Drug Administration on Dec. 23, 2021, just days after the New York Times reported that the drug "can insert errors in DNA, which could in theory harm a developing fetus, sperm cells or children."

Since receiving the blessing from the Biden administration, the drug has sold widely and generated significant profits.

According to Reuters, Merck & Co. reported "higher-than-expected" fourth-quarter earnings on Thursdsay, largely due to the sale of its molnupiravir pill in Asia. The pharmaceutical company made $825 million on the pill in Q4 alone.

Mutant pill

The NIH stated in September 2022 that as "a mutagenic ribonucleoside antiviral agent, there is a theoretical risk that molnupiravir will be metabolized by the human host cell and incorporated into the host DNA, leading to mutations. Molnupiravir has been evaluated in 2 in vivo rodent mutagenicity assays. One study produced equivocal results. In the other study, there was no evidence for mutagenicity."

A cluster of human patients reportedly now reportedly know that the risk previously downplayed as "theoretical" is anything but.

A new preprint study by British and American researchers at the Francis Crick Institute, the Imperial College in London, and at other esteemed institutions has revealed that mutations linked to Merck's pill have been found in viral samples taken from dozens of patients, reported Bloomberg.

The researchers suggested that patients treated with molnupiravir "might not fully clear SARS-CoV-2 infections, with the potential for onward transmission of molnupiravir-mutated viruses."

"We find that a specific class of long phylogenetic branches appear almost exclusively in sequences from 2022, after the introduction of molnupiravir treatment, and in countries and age-groups with widespread usage of the drug," said the study. "Our data suggest a signature of molnupiravir mutagenesis can be seen in global sequencing databases, in some cases with onwards transmission."

The researchers indicated that "sequencing data suggest that in at least some cases, viruses with a large number of molnupiravir-induced substitutions have been transmitted to other individuals."

According to the study, Lagevrio-induced mutations have been found among groups of patients, the largest group analyzed consisting of 21 people.

Not only is Merck's profitable drug reportedly resulting in the transmission of brand-new forms of the virus, the researchers indicated that the trajectory of "variant generation and transmission is difficult to predict."

Jonathan Li, a virologist at Harvard Medical School, told Bloomberg, "There’s always been this underlying concern that it could contribute to a problem generating new variants. ... This has largely been hypothetical, but this preprint validates a lot of those concerns."

Merck denies that its profitable drug is a mutant pill.

"There is no evidence to indicate that any antiviral agent has contributed to the emergence of circulating variants," claimed Robert Josephson, a spokesman for the company. "Based on available data we do not believe that Lagevrio (molnupiravir) is likely to contribute to the development of new meaningful coronavirus variants."

It is unclear what mutant forms of the virus Josephson and his company might ultimately come to regard as "meaningful."

Risky business

Theo Sanderson, a geneticist at the Crick Institute who led the study, suggested to Bloomberg, "These effects are visible in these databases. ... It appears that people are being treated, some of them aren't clearing their infections, and some are passing them on."

Ryan Hister, an American researcher attached to the study, suggested that it is far too risky to continue using Merck's drug.

Michael Lin, an antiviral drug researcher at Stanford University, happens to agree.

"There’s no evidence that any of these mutants is worse in any way — not yet — but it’s well agreed that you’re playing with fire if you’re creating random mutations and hoping nothing bad will come of it," said Lin.

Extra to possibly spinning off dangerous variations, the drug has long been associated with other potential hazards.

A May 2021 study on the impact of molnupiravir in hamster cells, published in the Journal of Infectious Diseases, suggested that the drug induced mutations in DNA that could "contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells."

Ahead of its authorization, scientists also expressed concern that the drug could mess with an unborn baby's dividing cells, thereby causing birth defects, reported the New York Times.

Dr. James Hildreth, the president of Meharry Medical College in Tennessee, posed the question during an FDA expert committee meeting on Nov. 30, 2021, "Do we want to reduce the risk for the mother by 30 percent while exposing the embryo and the fetus to a much higher risk of harm by this drug? My answer is no, and there is no circumstance in which I would advise a pregnant woman to take this drug."

Despite Hildreth's opposition, the committee narrowly endorsed the pill and the FDA authorized it. However, the agency did not approve it for people younger than 18 for fear it might adversely impact bone and cartilage growth.

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New York will prioritize non-white people when distributing lifesaving COVID treatments



As COVID-19 rips through New York, the state government has decided to prioritize non-white people to receive COVID-19 treatments because of "longstanding systemic health and social inequities."

Last week, New York’s Department of Health released a document titled: "Prioritization of Anti-SARS-CoV-2 Monoclonal Antibodies and Oral Antivirals for the Treatment of COVID-19 During Times of Resource Limitations Introduction." The memo provides a hierarchy of who should receive the limited supplies of monoclonal antibodies as well as the new oral antiviral pills — Pfizer's Paxlovid and Merck's molnupiravir — that were approved by the U.S. Food and Drug Administration last week under Emergency Use Authorization.

New York state offers a framework on which individuals should receive priority for COVID-19 treatments based on "risk factors," which include those who are immunocompromised, those who are aged 65 or older, and those who are overweight.

There is also a "note" that states that any COVID-infected people who are non-white should receive priority for treatment over white people because of "inequities."

"Non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19," New York’s Department of Health states.

NY State Department of Health warns they don't have enough Paxlovid or Monoclonal Antibody Treatment and white people need not apply. http://www.mssnyenews.org/wp-content/uploads/2021/12/122821_Notification_107774.pdf\u00a0\u2026pic.twitter.com/MwBtjv2pDx
— Karol Markowicz (@Karol Markowicz) 1640916049

Erin Silk, a spokesperson for the New York Department of Health, told Fox News, "Systemic poverty, which has clearly proven to be a risk factor in populations in New York State and nationwide, is added to the algorithm of prioritization similar to all other risk factors. It is merely mentioned as a factor that increases risk."

The spokesperson noted that the state's "prioritization guidance comes directly from the CDC," adding "Race nor ethnicity would disqualify an individual from receiving treatment."

The Centers for Disease Control and Prevention states, "Race and ethnicity are risk markers for other underlying conditions that affect health, including socioeconomic status, access to health care, and exposure to the virus related to occupation, e.g., frontline, essential, and critical infrastructure workers."

The New York City Department of Health also recommends that race should be considered when prioritizing who receives monoclonal antibodies and oral antiviral pills for COVID-19.

"Consider race and ethnicity when assessing individual risk, as longstanding systemic health and social inequities may contribute to an increased risk of getting sick and dying from COVID-19," the memo to providers reads.

In May, Dr. Anthony Fauci claimed that the COVID-19 pandemic exposed "the undeniable effects of racism" in America.

"Now, very few of these comorbidities have racial determinants," said the chief medical adviser to President Joe Biden. "Almost all relate to the social determinants of health dating back to disadvantageous conditions that some people of color find themselves in from birth regarding the availability of an adequate diet, access to health care, and the undeniable effects of racism in our society."

FDA authorizes pills to treat COVID — but there's a catch



As concern over COVID -19 rises with the spread of the Omicron variant, a new form of treatment for the virus has arrived in the form of oral tablets, but there’s a catch: The medication must be taken quickly to be effective.

The FDA issued an emergency use authorization last week for oral pills made by Pfizer and Merck to treat the virus. Both Pfizer’s Paxlovid and Merck’s molnupiravir are designed to treat people with mild to moderate symptoms who are at risk of hospitalization or death, according to the FDA.

However, the FDA advises that the pills should be taken as soon as possible to be effective.

Both medications should be taken within a five-day window of the initial development of symptoms, according to a report from the Associated Press. Paxlovid comes in three-pill doses that must be taken twice a day for five days. Some pharmacies should be able to test a patient and prescribe the medication in the same visit, according to the AP. Patients hospitalized for COVID after being prescribed Paxlovid should complete the five-day treatment unless otherwise directed by their doctors, according to a fact sheet released by the FDA.

Pfizer's and Merck's treatments are both effective at reducing hospitalization or death as a result of a COVID infection, according to the FDA studies; however, Pfizer's treatment is considered to be far more effective. Pfizer's treatment has shown an 88% effectiveness rate at reducing hospitalization and death, according to the FDA studies. Molnupiravir has not been approved for individuals younger than 18. The FDA expressed concern that molnupiravir may affect bone and cartilage growth in patients under the age of 18. The FDA said that Paxlovid, on the other hand, may be taken by children as young as 12 or who weigh about 88 pounds, according to a statement released Wednesday. Paxlovid is not recommended for patients with kidney or liver problems.

“If you wait until you have started to get breathless, you have already to a large extent missed the window where these drugs will be helpful,” Duke University infectious disease specialist Dr. Cameron Wolfe told the AP, stressing the importance of taking the medication as soon as possible.

Some health professionals have expressed concern that the pills may have serious life-threatening side effects if taken by individuals who are currently taking many common medications, including but not limited to blood thinners; anti-seizure medications; drugs for irregular heart rhythms, high blood pressure, and high cholesterol; and antidepressants, according to NBC.

“Some of these potential interactions are not trivial, and some pairings have to be avoided altogether,” Peter Anderson, professor of pharmaceutical sciences at the University of Colorado Anschutz Medical Campus, told NBC on Sunday.

The Biden administration announced in November that it would purchase 10 million courses of Paxlovid to combat COVID-19. The plan will cost about $5 billion, according to the Washington Post.

Horowitz: The indefensible approval of Pfizer and Merck drugs compared to the snubbing of ivermectin



Later this week, the FDA plans to approve, as the first outpatient COVID drugs, therapeutics that are extremely dangerous and unproven, even as the agency goes to war against cheap, safe, and proven drugs with a track record of no serious adverse events. The approval is as shocking as it is revealing and should serve as a warning to those who don’t believe the FDA would approve vaccines that aren’t safe and effective.

We already know that every drug the FDA has approved so far for inpatient treatment has an FDA “black box warning” for serious adverse events. At present, the only approved drugs in-patient are remdesivir, baricitinib, and tofacitinib. None of them have demonstrated any efficacy over a year of their use, and remdesivir is known to cause liver toxicity and renal failure. Baricitinib (brand name Olumiant) has an FDA black box warning for blood clots, of all things! Tofacitinib (brand name Xeljanz) has a black box warning for “serious infections and malignancy.” Now, let me introduce you to the first candidates for outpatient treatment: Merck’s molnupiravir (brand name Lagevrio) and Pfizer’s Paxlovid.

I’ve already written extensively on molnupiravir. Even the FDA advisory committee admitted that the drug poses a risk of birth defects, is mutagenic, has a dangerous mechanism of action, and was never studied for carcinogenicity, and its second-phase trial showed greater “efficacy” in the placebo group than the trial group. Even the mainstream media has warned that the drug really is not up to snuff, yet shockingly, the FDA is set to give it approval, as if basic safety and efficacy facts no longer matter. This move in itself, in conjunction with what we know about the approved inpatient drugs, should tell you everything you need to know about the juxtaposition of the vaccine approval to the war on ivermectin and hydroxychloroquine and the refusal to approve or encourage the use of numerous other safe and effective drugs.

But what about Pfizer’s Paxlovid? Doesn’t that have a safer mechanism of action, similar to that of ivermectin? And wasn’t it proven 89% effective in reducing mortality and hospitalization?

Efficacy of Pfizer’s Paxlovid

Unlike Merck’s drug, which has a known dangerous mechanism of action as a nucleotide analogue, Paxlovid is more of a defensive drug as a 3CL protease inhibitor. Dr. Ryan Cole, a clinical and anatomic pathologist who has studied the replication process of SARS-CoV-2 and its treatments in more depth than almost anyone on the planet, explains the mechanism as follows:

When COVID replicates inside our cells, part of the process is formation of a long string of amino acids within our cell’s ribosome (hijacked by the virus to use as a protein manufacturing site), forming a chain of proteins called a polyprotein. In order for the proteins to form the parts of the virus, this chain must be clipped and broken down into the viral protein parts. An enzyme called a protease does this cutting and clipping. Paxlovid is a protease inhibitor, meaning it binds to this enzyme “scissors” and keeps the cutting from happening, so the virus cannot reassemble.

Sounds terrific, right?

Here’s the problem. Do you know what else is also the most effective protease inhibitor on the market? Ivermectin. And it also has at least 19 other mechanisms of action, which include anti-coagulant (inhibits CD147 receptor binding) and anti-inflammatory (decreases IL-6 and other inflammatory cytokines) modes of action. Paxlovid has none of these mechanisms. So why would we rely on an expensive drug with one of ivermectin’s 20 mechanisms of action – yes, 20 – that does not have an established safety profile when we can use an off-patent drug with the safest profile imaginable and mechanisms that work even in advanced stages? Also, Cole explains that because Paxlovid only has one mechanism of action, “viruses can eventually mutate around this mechanism.” Dr. John Campbell offers a superb presentation on the similarities and differences, showing why ivermectin is superior to Paxlovid.

Consider that earlier this year, a study in Nature of dozens of potential protease inhibitors against SARS-CoV-2 found ivermectin to be the only one to fully bind the 3LC enzyme. Out of 13 off-target drugs tested, “only ivermectin completely blocked (>80%) the 3CLpro activity at 50 µM concentration.”

So now that we are championing this mode of action, why wouldn’t we exalt the cheaper, more established medicine that is also an anti-coagulant and anti-inflammatory and that has shown the ability to turn around even some patients on ventilators? At best, Paxlovid would likely only work during the first three days of onset of symptoms, which is how the trial was conducted.

Moreover, as anyone who treats this virus will tell you, Delta has been a game changer. This virus is so aggressive and novel in the way it enters the cells and replicates, there is no drug alone without adjuncts that will achieve 89% success against mortality. It’s complete bull. Ivermectin likely achieved that level of success in the original strain, but with Delta, even the most ardent supporters will tell you it needs several adjuncts to keep more people out of the hospital. There is no way Paxlovid with one mechanism of action can achieve 89% success when the king of 3CL protease inhibition can’t do that with several other modes of action.

Now, we all hope that Omicron will completely vanquish Delta and thus will be easier to treat. But why not go with a drug (and more importantly, combo of several drugs) that is safer and has more mechanisms of action? As Cole warns, “A protease inhibitor is only useful when used early when the virus is replicating. We know the Delta and Omicron variants replicate very quickly, so protease inhibitors are only potentially helpful in the first few days of infection.”

Paxlovid contains a dangerous AIDS drug

We haven’t even discussed the safety problems. While the new drug itself in Paxlovid, although unproven, is probably not as dangerous as Merck’s drug, the media has failed to inform the public that it’s combined with AIDS drug, ritonavir.

Why is it combined with the AIDS drug? According to Cole, “In order to work, the protease inhibitor has to last long enough in the body. Another protease inhibitor, ritonavir, usually part of an HIV regimen, is used to prevent the rapid breakdown of Paxlovid.”

Incidentally, in the Nature study of various antiviral drug efficacy against 3CL protease binding, ritonavir had less than 20% success, while ivermectin achieved 85%.

Typically, whenever a pharmaceutical company produces a combo drug, it must conduct separate clinical trials on each component and demonstrate to the FDA why the combination is necessary. But in the pandemic, all rules have been thrown out the window when it comes to Pfizer. No such trial was conducted. Why is this a problem?

According to Cole, “Ritonavir is not without its side effects, which can include life-threatening liver inflammation, pancreatitis, and heart arrhythmias. It may also cause nausea, diarrhea, dizziness, confusion, high cholesterol, high blood sugar, stomach or intestinal bleeding, numb hands and feet, a skin rash, as well as countless other side effects.” The FDA has issued a black box warning for many serious contraindications with ritonavir.

Can you come up with a non-sinister explanation as to how our government will not only approve, but purchase this untested and dangerous product while declaring war on its broader, safer, cheaper, and more established counterpart? If you do, I have some remdesivir to sell you at $3,000 a pop, but unfortunately it won’t cover your kidney transplant.

Horowitz: The despicable and indefensible approval of Merck’s dangerous COVID drug



The FDA has refused to even explore approval of cheap, safe, and effective repurposed drugs for 20 months, despite mounds of evidence from studies vouching for their efficacy and safety. So, naturally, now that the agency is on track to issue an emergency use authorization to the first outpatient drug for COVID, this one must be the greatest thing since penicillin, right? Wrong! In fact, the drug is so dangerous and has so many known and unknown side effects that the FDA advisory committee members basically admitted this was a “difficult” decision and that they could rescind the authorization later on. This decision makes their rejection of ivermectin, fluvoxamine, nitazoxanide, and hydroxychloroquine all the more indefensible.

If you liked remdesivir, you will surely like Merck’s molnupiravir, which was developed with the help of the same entities guarding its approval based on flawed data produced by the company itself that is making over $1 billion off the federal government. No conflict of interest whatsoever!

Although the fix was in because no drug produced by Merck or Pfizer – no matter how dangerous – will ever be turned down, the approval was as revealing as it was appalling. The fact that the vote even by these compromised hacks was 13-10 demonstrates just how problematic molnupiravir likely is out of the gate.

Yesterday, the FDA’s Antimicrobial Drugs Advisory Committee voted 13-10 to approve molnupiravir at 800 milligrams twice a day for five days of COVID treatment for people in at-risk categories. It still needs official approval from the FDA and the CDC before it can be used, but the fix has long been in.

As CNBC reports, even those who voted for the drug admitted that it was a difficult decision and asked to revisit the authorization down the road. They conceded, as I have warned, that this drug can be mutagenic and cause birth defects, in addition to the fact that Merck’s own manipulated data show the efficacy is very modest.

“Given the large potential population affected, the risk of widespread effects on potential birth defects, especially delayed effects on the male, has not been adequately studied,” warned Dr. Sankar Swaminathan, an infectious disease specialist at the University of Utah School of Medicine, who voted no.

As CNBC reports:

The FDA and Merck both recommended against using the drug in kids and pregnant women. Molnupiravir was found to be lethal to embryos in pregnant rats, also causing birth defects and reducing fetal body weight. It also caused other defects that interfered with bone growth in young pups, along with other abnormalities, the data shows.

Just like the vaccines and remdesivir, this drug hits the triple crown – fails on efficacy, causes injury, and also induces mutants and viral escape, possibly making the virus worse. In the FDA’s briefing document on the drug for yesterday’s meeting, it states clearly that “there are potential safety concerns pertaining to MOV, including embryofetal toxicity, bone and cartilage toxicity, and mutagenicity.” They also observe that there is evidence molnupiravir “may increase the rate of changes in the viral spike protein, which, in theory, could enhance SARS-CoV-2 spike protein evolution."

“Of particular interest, in some participants, MOV treatment was associated with amino acid changes at sites/regions of spike that are likely under immune or other evolutionary pressure," warns the onetime gatekeeper that has now become a collaborator with Big Pharma. This sounds an awful lot like Dr. Geert Vanden Bossche’s warning about the vaccines placing evolutionary pressure on the virus, which likely resulted in making it more durable this year than in 2020. “Collectively, these analyses indicate MOV treatment may increase the rate of emergence of SARS-CoV-2 populations with amino acid changes in the viral spike protein, consistent with its mutagenic mechanism of action,” warns the FDA.

Nonetheless, Dr. Michael Green, a pediatric transplant specialist at University of Pittsburgh School of Medicine Division of Infectious Diseases, said the lack of available therapies swayed him and others to vote to approve the drug.

The problem is that after incurring such unknown risk for a drug that has never succeeded and has known safety problems, the efficacy is very modest. Even Merck’s own trial shows barely any efficacy for Delta, and we all know by now how reliable the data can be from the manufacturer itself!

The FDA approves Molnupiravir by 13 votes to 10.\n\nIf you're hit by Delta, Merck's trial data show with a 95% confidence that your risk of hospitalization or death is:\n\n\u2022 reduced by 7.8% or increased by 2.9% (absolute)\n\n\u2022 reduced by 57% or increased by 42% (relative), p=0.41pic.twitter.com/lyLNLVaCv4
— Covid19Crusher (@Covid19Crusher) 1638313433

Even more bizarrely, after Merck announced a 50% reduction in hospitalizations from the first phase of its trial announced in October, just last week the company announced that the combined efficacy is down to 30%. As some have pointed out, that raises serious concerns as to what has happened with the drug’s trial, given that the data from just phase 2 would indicate negative efficacy for the drug, with 4.7% hospitalized in the placebo group compared to 6.2% in the molnupiravir group.

Also, remember that it has already bombed out in terms of efficacy for moderate COVID and never had the potential to work in late stages because it is not anti-inflammatory like ivermectin. The FDA concedes up front that there is zero proven benefit after day five of symptoms.

So, we are trading so much risk of injury and making the virus worse for a short window of potentially modest efficacy at a cost of $700 per person. If this is the standard for approval during an emergency, how on earth could the FDA refuse to greenlight drugs that have already established a robust safety profile for decades when independent studies from people who don’t stand to benefit show much greater efficacy and for a broader spectrum of disease at a cheaper price?

COMPARAISON IVERMECTIN (8,53\u20ac)-vs-MOLNUPIRAVIR(600\u20ac)..pic.twitter.com/shyhoVUNQU
— telephonearabe (@telephonearabe) 1635666126
Revision of the previous post. More precise now.\n\nSources:\nhttps://www.fda.gov/media/154422/download\u00a0\u2026\nhttps://www.fda.gov/media/154419/download\u00a0\u2026\nhttps://www.fda.gov/media/154421/download\u00a0\u2026\nhttps://merck.com/news/merck-and-ridgebacks-molnupiravir-an-oral-covid-19-antiviral-medicine-receives-first-authorization-in-the-world/\u00a0\u2026\nhttps://ema.europa.eu/en/news/ema-issues-advice-use-lagevrio-molnupiravir-treatment-covid-19\u00a0\u2026\nhttps://pm.gov.au/media/australia-secures-access-additional-covid-19-treatment\u00a0\u2026\nhttps://kpkesihatan.com/2021/11/03/kenyataan-akhbar-kpk-3-november-2021-hasil-dapatan-kajian-keberkesanan-rawatan-ivermectin-untuk-pesakit-covid-19-berisiko-tinggi-i-tech-study/\u00a0\u2026\nhttps://clinicaltrials.gov/ct2/show/NCT04920942\u00a0\u2026pic.twitter.com/KMuNLRuOeU
— Massimaux (@Massimaux) 1638269686

The FDA and NIH are willing to give a drug known for birth defects with low efficacy to women of childbearing age outpatient but won’t even allow a Nobel Prize-winning drug safer than Tylenol as a last resort to someone dying.

Just rinsing your nose and mouth with Betadine at the onset of symptoms or preventively works better than this drug, according to Merck’s own data.

Povidone-iodine vs. Molnupiravirpic.twitter.com/64fyTJpfGP
— Massimaux (@Massimaux) 1635004644

Again, why would our government refuse to recommend any of these therapeutics and treatments but continue to support remdesivir and now approve molnupiravir, two dangerous and likely ineffective drugs? And what does that tell us about the process and transparency behind the FDA’s perceived safety and efficacy of the vaccines?

There are no innocuous answers to these questions.

Janet Cragan, a medical officer at the CDC and a panelist on the FDA advisory committee, bizarrely conceded at Tuesday’s meeting that “there are definite concerns about the potential effects of this drug on the embryo and the fetus,” but then said she has problems denying the drug to people! “I don’t think you can ethically say it’s OK to give this drug in pregnancy. [But] I’m not sure you can tell a pregnant women who has Covid-19 that she can’t have the drug if she has decided that’s what she needs.”

Well, how about denying the safest drugs around to everyone with COVID for the past 20 months???!!!

Roy Baynes, the Merck executive at the meeting, even had the nerve to suggest that it’s not for the FDA to tell doctors not to use the drug even in pregnant women! “But I think the idea here is that ultimately the physician is the best position to determine the relative risk-benefit for their patients,” said Baynes.

With its eight mechanisms of action against COVID and award-winning safety profile established for decades, ivermectin trounces molnupiravir in every consideration. As a 2017 article published in Nature’s Journal of Antibiotics observed, “Few, if any, other drugs can rival ivermectin for its beneficial impact on human health and welfare." The authors noted that "ivermectin is continuing to surprise and excite scientists, offering more and more promise to help improve global public health by treating a diverse range of diseases, with its unexpected potential as an antibacterial, antiviral and anti-cancer agent being particularly extraordinary.” They fortuitously predicted, “Essentially, a unique, multifaceted ‘wonder’ drug of the past and present may yet become an even more exceptional drug of the future." Sadly, our government is denying that future and that of several other important safe, off-patent drugs.

Anyone who can’t see the conflict of interest in this powerful juxtaposition is willfully blind to the irremediable corruption in the NIH, the CDC, and the FDA.

Horowitz: The media misses the lesson of Africa and COVID in plain sight



There is nowhere for the priests of Covidstan to run or hide from the failure of their prized injections. Cases in Europe are worse than ever, and America has now racked up more deaths than in 2020, when zero vaccines existed. But reality can hit these people in the face and they will still never admit that all of the human interventions failed.

As Europe battles its fifth wave and even East Asian countries begin to face serious waves of the virus, the AP wrote an article last week claiming that something "mysterious" is going on in much of continental Africa, as these African nations appear to have dodged the pandemic.

But there is something "mysterious" going on in Africa that is puzzling scientists, said Wafaa El-Sadr, chair of global health at Columbia University. "Africa doesn't have the vaccines and the resources to fight COVID-19 that they have in Europe and the U.S., but somehow they seem to be doing better," she said.
Fewer than 6% of people in Africa are vaccinated. For months, the WHO has described Africa as "one of the least affected regions in the world" in its weekly pandemic reports.

No kidding! Contrast that with Europe, where cases are now worse than at any time in the U.S., despite nearly every adult vaccinated in many continental European countries.

2 months into vaccine passports and with ~90% of adults at least partially vaccinated, cases in The Netherlands are up 942% and they\u2019re going back to lockdowns.\n\nIt\u2019s amazing the consistency with which governments will double down on failure to avoid acknowledging realitypic.twitter.com/8XA8cK9vuQ
— IM (@IM) 1637526866

Perhaps the Africans don't have enough money to pay for the rope to hang themselves with leaky vaccines, counterproductive lockdowns, and failed therapeutics like remdesivir. They can't afford to spend $3,000 per dose to have people's kidneys fail and instead are using cheap anti-malaria and anti-parasitic drugs.

Yes, it's true that Africans are younger and the countries' data is less reliable, but that cannot account for the fact that COVID deaths have been nearly nonexistent in many of these countries. Those explanations offered by the AP simply cannot bridge the gap.

Curiously, the AP posits that perhaps "past infection with parasitic diseases" as well as exposure to malaria might make people in these countries more immune to the virus. "On Friday, researchers working in Uganda said they found COVID-19 patients with high rates of exposure to malaria were less likely to suffer severe disease or death than people with little history of the disease."

Gee, why would that be? What about the pathophysiology of those diseases would make people immune to a virus? After all, we have been lectured by those so vociferously against hydroxychloroquine and ivermectin that there can't possibly be cross-relation between the immune response to a parasitic infection and the response to a viral infection.

Could it possibly be the fact that those countries happen to constantly treat themselves with drugs like ... the one that begins with the I and the one that begins with the H?

Since 1987, Merck has been funneling several hundred million doses of ivermectin per year through the Mectizan Donation Program, which includes all of the central African countries. How are the Mectizan countries doing?

And these are the countries @Merck donates Mectizan (=Ivermectin for Human use) to. Do the math.pic.twitter.com/35lAB65tq0
— Mira Moerma (@Mira Moerma) 1630477067

Now, obviously, there are multiple factors involved in the success of these countries, likely including their lack of international travel. However, it is laughable for the media to entertain parasitic infections as a contributing factor without mentioning the two drugs being used to treat COVID that are commonly used in those countries to treat parasitic infections. What is also clear is that the vaccines simply play no role in determining the trajectory of this pandemic — at least not a positive one.

In another part of the world, there is also mounting evidence that ivermectin has helped accelerate a decline in cases. While the Far East has not incurred much death from the virus, those countries have been hit by the recent Delta wave since the summer. Japan was experiencing its sharpest peak of the pandemic, but appears to have enjoyed a steeper and quicker decline since August than any other Asian country.

Tokyo in particular is kicking COVID's ass with IVM - fewest hospitalized since before pandemic. Come on world, wake up wake up wake uppic.twitter.com/nelPEDy9AG
— Pierre Kory, MD MPA (@Pierre Kory, MD MPA) 1637551626

While it's hard to prove causation at this point, it's also hard to overlook the fact that on Aug. 13, Dr. Haruo Ozaki, chairman of the Tokyo Metropolitan Medical Association, spoke favorably of the drug at a press conference.

Tokyo Medical Association Chairman Haruo Ozaki, August 13 2021pic.twitter.com/ANgEbdm1Rn
— Joe (@Joe) 1629731785

"In Africa, if we compare countries distributing ivermectin once a year with countries which do not give ivermectin ... I mean, they don't give ivermectin to prevent COVID, but to prevent parasitic diseases ... but anyway, if we look at COVID numbers in countries that give ivermectin, the number of cases is 134.4 per 100,000, and the number of deaths is 2.2 in 100,000."

"Now, African countries which do not distribute ivermectin: 950.6 cases per 100,000 and 29.3 deaths per 100,000," Ozaki added.

"I believe the difference is clear."

A week later, Ozaki told the Yomiuri Shimbun, which is the largest circulating newspaper in the world, that he had recommended the use of the drug to the Japan Olympic Committee during the Olympics.

Ironically, Japan is the birthplace of ivermectin. In the 1970s, Dr. Satoshi Omura, a Japanese biochemist, discovered the bacteria specimen in the soil that led to the development of ivermectin, along with Dr. William Campbell, a Merck scientist. The two of them won the Nobel Prize for physiology in 2015 for this discovery.

Although ivermectin is not officially recommended by the Japanese government, it is one of the only countries where doctors and citizens have gotten a positive vibe from their government on its use.

Then, of course, there is Uttar Pradesh, the largest state in India, which has crushed its curve to the point that the virus is not just in low circulation, but essentially eradicated since June.

Typically, even when a COVID wave subsides, there is a persisting minimum baseline of cases and deaths, especially after 2-3 months. In Uttar Pradesh, on the other hand, the numbers are remarkable and have held up for a year. Obviously, a lot of the decline was likely due to built-up immunity, but it doesn't account for the fact that the cases didn't just decline to a low level, but essentially flatlined for months. Remember, this is an Indian state with a population of 240 million people. We are seeing similar trends in other Indian states that used ivermectin. The drug is so cheap and available in India that many Americans are buying ivermectin from Indian vendors oversees. (See Juan Chamie's Substack for a compelling district-by-district analysis of Uttar Pradesh's epidemiological curve.)

It is simply unheard of in any other country that experienced a large wave to then go for six straight months with essentially no cases. And again, when cases were eradicated, these Indian states had a very low vaccination rate. Almost nobody was vaccinated in the spring, and even at the end of October, just 15% were fully vaccinated in Uttar Pradesh. A similar trend has played out in Chiapas, Mexico.

No, none of this alone shows empirically that ivermectin itself is a magic pill, but what it does show is that if we are willing to pour billions of dollars and coercion into an ineffective and dangerous injection, why wouldn't we spend a fraction of those funds researching cheap, safe repurposed drugs?

Horowitz: Merck rejects ivermectin for COVID treatment after getting $1.2 billion gov’t contract for expensive, unproven drug



For those trying to follow the science and the law, it's been impossible to ascertain a modicum of consistency in the government's COVID response. However, when you follow the money, everything officials are doing (as well as what they are not doing) makes perfect sense.

The same government that has the power to use COVID to shut down our lives and our breathing also has the power to determine to which pharmaceutical company it will send billions of taxpayer dollars, a decision that is governed 100% by money and politics, not by sound medicine. We already understand why the vaccine companies have been funding a war against cheap, effective therapeutics such as hydroxychloroquine and ivermectin, but many have wondered why Merck would oppose a drug that the company itself has made for many years.

On Feb. 4, Merck came out with a shocking statement warning against the use of ivermectin to treat COVID. The statement claimed there was "no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies" and that there was "a concerning lack of safety data in the majority of studies."

This was quite a bizarre assertion given that 59 studies, including 30 randomized controlled trials, have shown the drug to be extremely effective at all stages of the virus. The statement regarding safety concerns was even more ludicrous given that nearly 4 billion doses of this drug have been dispensed for parasitic ailments, it won the Nobel prize, and it is listed among the WHO's most essential drugs. There is no logical reason why someone would somehow begin experiencing dangerous side effects if he happens to use ivermectin for COVID instead of for scabies or river blindness.

Nonetheless, Merck's statement served as a strong blow to the use of ivermectin, because Merck was a large dispenser of this drug. After all, why would the company dump on its own drug?

Well, now we have an answer. On June 9, Merck announced that it had entered into a procurement agreement. Merck will receive approximately $1.2 billion to supply approximately 1.7 million courses of molnupiravir to the United States government. Molnupiravir is a new drug Merck is currently evaluating in a Phase 3 clinical trials to serve as the wonder drug to treat COVID. The estimated cost of the drug per treatment is $700!

So now we can understand why the company would swap out its own drug that has already been proven safe and effective for something new and experimental. Without the government sending a penny to Merck, I can buy a lifesaving dose of ivermectin for just $26 through GoodRX.

Well, that's if the pharmacy would actually dispense it to me and a doctor would prescribe it to me. We can now understand why Big Pharma has colluded with big government to pressure doctors and pharmacists away from prescribing and dispensing ivermectin. This historic business deal would be moot.

Also, let us not forget that expedited approval of experimental new drugs runs into the same problem as the experimental vaccines. Approval for "Emergency Use Authorization" can be granted by the FDA only if there is "no adequate, approved, and available alternative to the product for diagnosing, preventing or treating" a disease. That's why already-approved drugs like ivermectin have to vanish from discussion. Can you imagine how much ivermectin the feds could have dispensed for a fraction of the cost of expensive experimental drugs and mRNA shots?

What is particularly disturbing is that it appears that molnupiravir contains some of the same molecular qualities as ivermectin, which makes you wonder if Merck knows that ivermectin is effective and just sought a more expensive drug that could be marketed as exclusive and new for COVID, thereby justifying another budget blowout by Washington policymakers.

One of several antiviral qualities to ivermectin is that it disrupts viral RNA-dependent RNA polymerase (RdRp) enzymes. Two Italian doctors in a study published in Nature described the process as follows:

The RdRP residing in nsp12 is the centerpiece of the coronavirus replication and transcription complex and has been suggested as a promising drug target as it is a crucial enzyme in the virus life cycle both for replication of the viral genome but also for transcription of subgenomic mRNAs (sgRNAs) [34]. Ivermectin binds to the viral rdrp and disrupts it. The highly efficient binding of ivermectin to nsp14 confirms its role in inhibiting viral replication and assembly. It is well known that nsp14 is essential in transcription and replication.

Dr. Pierre Kory, the president ofFrontline Covid19 Critical Care Alliance and one of the most prominent advocates of ivermectin, believes that the new drug developed by Merck acts in a similar way.

Merck’s new drug shares molecular similarities to #Ivermectin. And why wouldn’t it? IVM is in a COVID-19 superstar… https://t.co/8IP8xyQJ7g

— Frontline Covid-19 Critical Care (@Covid19Critical) 1623756897.0

Dr. Syed Mobeen, who hosts a daily medical show and often hosts Dr. Kory for discussions about COVID treatment, told me that "it seems that molnupiravir is a copy of one of Ivermectin's mechanisms."

"This mechanism is to disrupt the SARS-COV-2 virus' RNA-dependent RNA polymerase (RdRp) enzyme," said Dr. Mobeen, who runs a medical education center. "Copying this mechanism will give Merck a way to earn from an existing cheap drug's action by relabeling it; however, I believe that molnupiravir will continue to be less effective as studies show that ivermectin has more mechanisms to disrupt the SARS-COV-2 replication and spread. Hence, ivermectin will continue to be a superior choice over molnupirivir or other RdRp disrupters."

Aside from disrupting the viral RdRp, ivermectin supporters believe the cheap drug inhibits the spike protein from binding to the ACE2 enzyme and disrupts the importin alpha and beta.

Merck has yet to explain why its new drug would be more cost effective and score better in a risk-benefit analysis than ivermectin. Just over the weekend, a Cochrane-standard (the highest level review) meta-analysis of ivermectin against COVID-19 by Bryant-Lawrie, which has been published in the American Journal of Therapeutics, concluded that the "apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally."

Thus, with a non-invasive, cheap, and safe drug that doesn't require one to lock down or wear a mask, we could largely solve the problem. Why would the medical establishment not take yes for an answer? As the study concludes:

Ivermectin is not a new and experimental drug with an unknown safety profile. It is a WHO "Essential Medicine" already used in several different indications, in colossal cumulative volumes. Corticosteroids have become an accepted standard of care in COVID-19, based on a single RCT of dexamethasone.1 If a single RCT is sufficient for the adoption of dexamethasone, then a fortiori the evidence of 2 dozen RCTs supports the adoption of ivermectin.
Now we know, in the case of Merck, there are 1.2 billion reasons why not. For some of the larger special interests, that number is exponentially higher and is all backed by the Fed's printing press and guaranteed by the media they have paid and influenced. Welcome to science and medicine.