Merck’s Molnupiravir News
Today news of Merck’s Molnupiravir is dominating the narrative. In dramatic fashion they are stopping the trial recruitment and plan to file an EUA. While this is fantastic news people can’t be blinded by the Merck aura and have to dig into the news to truly understand the ramifications. This is a drug with known mutagenicity. Ironically Merck’s inclusion criteria in ALL their clinical trials required participants to not have sex. This includes the clinical trial for prophylaxis. Perhaps they want to avoid the potential of birth defects so this drug is clearly not going to appeal to anyone building a family or engaging in intercourse.
The drug is using the virus’s propensity to mutate against itself by tricking the replication machinery to pump out reproduction errors until the virally infected cell collapses. The last thing the FDA wants to do is approve a drug that brings the rise of a new class of variants. It’s unclear if Merck tested patients for new variants that are more likely to rise up in patients who have the longest active infections. Merck isn’t simply going to get a pass on this from the FDA. Based on the commentary in the Merck press release it’s unclear if Merck even knows if their drug is safe. Essentially they talk about the incidence of drug-related adverse events as the same, but didn’t provide any color on what these events were.
The euphoria from this news announcement isn’t looking at the fine print of the trial design of the study. Recruitment required at least one underlying medical condition like obesity, old age (>60 years), diabetes, or heart disease. Looking at this patient population was needed to obtain statistical significance because too many with no underlying conditions just get better on their own. The trial could have been a failure otherwise. Another factor contributing to Merck’s success is a smaller than expected stratification of Delta variant infections. Only 40% of the clinical trial had Delta variant patients. People need to consider that a majority of the data was from the alpha variant which means that if Merck doesn’t segregate the data by variant they are trying to pull the wool over our eyes to hide how weak the data really is.
Merck also took precautions to go after the unvaccinated population. Now Pfizer’s drug is following in the same footsteps going after the unvaccinated with at least one underlying medical condition. Todos Medical’s drug Tollovir doesn’t have any of these exclusion criteria in their clinical trial which is probably why it’s the best in class of the oral antivirals. Ironically it’s available right now if you don’t mind reverse engineering the dosage and taking a couple of pills.
The excitement surrounding Molnupiravir is that it will flatten the curve and it may very well do that in the unvaccinated people that are altered early, with at least one underlying condition, that don’t want to have sex. Please raise your hand if you fit in that demographic and compare that to just about anyone at risk of Covid-19 (vaccinated, unvaccinated, multiple underlying conditions, or healthy).
Returning to Normalacy
While many people in America are hoping that the vaccines will help restore normalcy, the brutal reality is that vaccines are failing. A breakthrough infection is a failure of the vaccine, plain and simple. The pivot that it prevents symptoms and death is quickly turning into a myth. So how does the government reconcile these misleading expectations while maintaining control of the situation? Doubling down or tripling down with failed policies through spin master Fauci seems to be the modus operandi. To be clear, these vaccines do offer a level of protection, but people are getting breakthroughs in record numbers because the government hasn’t done a good job educating the public on the true limitations of the vaccines. Unvaccinated people can spread disease the same way vaccinated people can. The divisive talking point that this is a “pandemic of the unvaccinated” is just not completely true.
From HIV/AIDS to COVID-19: Vaccines Fail to Impress
The government has a very flawed strategy that the vaccines will fix all. The chief architect of this is none other than Anthony Fauci. Many might forget his track record during the AIDS Epidemic. In 1996 he was the National Institute of Allergy and Infectious Diseases (NIAID) director and his plan was a vaccine.
In Fauci’s presentation of his strategy to the NIAID, he was
“optimistic that a useful HIV vaccine can be developed, despite economic, ethical, and cultural constraints. The ideal vaccine will likely occur in stages and ultimately be able to prevent initial infections as well as subsequent disease, be well-tolerated, and provide protection against exposure at mucosal surfaces and through blood.”
Does that sound familiar? But first, let’s recap how that worked out. Here we sit, 25 years later, with no HIV vaccine. What we do have is Highly Active Antiretroviral Therapy (HAART) which is an antiviral therapy for HIV. This therapy was first introduced in 1996. This is the same year he made his statements about the promise of vaccines. It was his criticisms and singular focus on vaccines that stymied development of much more effective therapeutics in HIV. One of those HIV therapies that was left for dead during Fauci’s previous reign was PRO 140 which is now known as leronlimab. In 2006, PRO140 received fast track approval as a viral entry inhibitor for HIV. Clinical trial results showed no side effects and that its effects were long lasting, two extremely desirable traits that eluded other HAART regimens, which were very poorly tolerated and only worked for some time until HIV found a way around them and reared its ugly head. After reporting excellent Phase 2 clinical trial results in 2008 that showed a 1.77 mean log reduction in viral load, the drug development stopped because the trial designs needed for regulatory approval were prohibitive and lengthy. This was another Fauci shift to a long term strategy of Antiretroviral Interruption. Interruption as a strategy was extraordinarily misguided since compliance with the HAART regimen is the best means to consistently suppress viral load and prevent mutations that cause drug resistance.
There are many critics of Fauci, but there seems to be one undeniable truth that everyone can agree upon. For the past 25+ years, Fauci has had no new ideas. His robotic answer to a pandemic is a vaccine (HIV through COVID-19). As the body count rises, people are seeing through the stale thinking and realize that many promising therapies never even entered into his calculus which is why Americans are losing faith and confidence in him. This skepticism seemed to come to a climax when Fauci appeared for an interview with Hugh Hewitt. He was pressured to resign because of the loss of confidence in him, but he pushed back saying that his flip flopping was a result of rapidly evolving data. This obscugative answer demonstrates just how out of touch he is because the unvaccinated Americans and at-risk Americans want therapeutic alternatives versus just ”trust me and take the vaccine.”
From HIV Epidemic to COVID-19 Pandemic: Leronlimab Holds the Answer
One very promising drug called leronlimab is threatening to unravel Faucis 25+ year reign as the top authority. In the next 6-to-9 months CytoDyn, the drug developer, is planning on filing a biologic license application (BLA) for HIV, and in the next 3 months is planning to file for emergency use authorization (EUA) for critically-ill COVID-19 patients in Brazil. Leronlimab addresses both viral outbreaks, but that’s not where the train stops. In the next month they are looking to file for breakthrough designation (BTD) in triple-negative breast cancer (TNBC). There are also a multitude of other diseases the company intends to spearhead with leronlimab, but these will come later.
Typically, HAART therapy uses multiple drugs in combination to block HIV replication and mutation. However, in HIV, leronlimab, which is not a toxic HAART therapy, showcased unbeatable efficacy as a monotherapy, where it had a 95% responders rate and no adverse effects. This is about as good as any HIV therapy gets. In treating critically ill COVID-19, which are patients on the brink of death, on ventilators fighting for their lives, the drug had an 82% improvement in mortality at day 14 (p=.023). Finally, in cancer, the company reported a whopping 600% increase in progression free survival (PFS) compared to standard of care and as such CytoDyn (CYDY) is requesting the aforementioned Breakthrough Therapy Designation (BTD). Despite all these remarkable milestones and metrics, the drug isn’t approved and had to go to the Brazilian regulatory agency (ANVISA) to get approval to do a trial down there because the FDA needed “more data.” However, this need for “more data” is chicanery because the company hit a more restrictive endpoint of 14 day mortality instead of the easier to reach 28 day mortality, and the company dosed once a week for two weeks, not four, according to authorities who advised them.
Therapy Ignorance Costing American Lives and Trillions of Dollars
This adherence to “the rules” has cost hundreds of thousands of lives. Now these are Fauci’s rules, and he has a proclivity toward big pharma vaccines. This means that only vaccines exist in his universe and that therapeutics need to take a back seat. He could have easily funded many NIH studies of therapeutics but that didn’t happen. In fact, the government only spent $12 billion on vaccines in 2020 through Operation Warp Speed, while other government agencies like BARDA left therapeutics in the dust due to Fauci’s inability to recognize their importance and act upon that. All it would have taken is a few billion dollars to fund and expedite manufacturing of a wide range of therapeutics to save people’s lives and reduce fear of getting sick. Compare that to the $2.3 trillion spent in stimulus due to the widespread shutdowns and it really becomes laughable that therapeutics took the back seat. Following the money and people will realize that it all got sucked up in vaccination funding and very little if any trickled down to therapeutics. When leronlimab gets approval later this year in Brazil, Fauci will have no defense for not approving a safe drug with a 6-year pristine safety profile that potentially improved the mortality by ~90%. On just this one drug, the blood on his hands is hundreds of thousands of lives. But it is clear that he is a talking head—a politician first and doctor second—and that he will likely just make an attempt to save face.