The second-half negative efficacy during the trial was impressive, but seems to be more a factor of the placebo group suddenly performing better while Molnupiravir severe outcome rate was steady. Doesn't seem to matter. The drug probably doesn't make a huge difference to infection outcomes, it's just a scapegoat for the cancers that the Covid-vaccinated were already going to get anyway.
Wouldn't it imply that Molnupiravir was either inhibiting a better immune response or that viral evolution (for molnupiravir resistance) is taking place even faster?
Wouldn't it matter if the average person not being treated might be getting better trained with viral variants resistant to our current treatments while those being treated are contributing to a "persistence" of severity even in a background of lowering severity without intervention?
I've not look too closely, but it mirrors some of the same problems we have with inoculation.
If Molnupiravir actually works as advertised, it implies that viral replication is shut down for a guaranteed 7% severe outcome rate; whereas in the placebo group outcomes depend on the more random fates of infection (without proper therapeutics). Additionally, there is no way for the virus to evolve resistance. The pill as advertised sabotages gene expression throughout the body. Viruses are genes that need to be expressed to proliferate.
I have my doubts that it works as advertised. It might not do anything at all, given the trial result. Or the mechanism might be inhibition of glycerophospholipid formation and glycosylation which both require CTP and which the virus requires to make envelope and spike protein. The whole thing is probably Kabuki to hide vaccine-induced cancer, like I said.
Hey Brian, I thought about what you were saying and tried to make it fit with what I had in mind along with Jestre's observation that changing composition of the treated and untreated groups over time is sufficient to explain the difference.
I agree with his observation that the underlying effect size is difficult to parse without a sense of what the risk factors are and even more so when one of the subgroups could be an increased risk of both severe covid and treatment failure and we just don't know the baseline since it's the first trial.
I think that obesity is basically a fake co-morbidity developed to try and explain away things which can't be. Obesity is the climate change of medicine in the sense that if the treatment fails, blame it on a loose measurement of height and weight ratio. I could add 330 sumo wrestlers to the placebo and make every prophylactic drug fail against infection prevention and it would be credited to obesity rather than cardio-vascular health.
But since event rate did fall by 2x and Cancer patients were added to treatment arm, it's probably hard to say if the treatment totally fails without knowing the underlying event rate and risk by co-morbidity. COPD was 3x more before, so perhaps these made the absolute risk fall less than placebo as covid went out of season?
Cancer is treated with immunosuppressants? Though, it's a bit funny that these mRNA transfections seemingly act as immunosuppressants and (anecdotally) cause rampant cancer regressions to begin with, whereas Molnupiravir is more akin to intracellular chemotherapy in its aggressive attack of host metabolism (if the theoretical mechanism is in fact valid).
For example decreasing inhibitory cytokines in specific Breast Cancers? Or whatever was happening to Colin Powell but that might be special cases due to transplant related immunosuppression and then cancer.
A blunted innate immune response would promote infection until there is an adaptive immune response and molupiravir or any anti-viral would help in this situation. But if a mutant learns over a consistent period of time what types of pressures and cascades follow, it's likely to survive and transmit. These variants could be nastier because they now can infect relatively healthier cancer patients who are not immunosuppressed.
Right, transplants I get. In so far as the virus can replicate despite M, it will just be those who dodged the bullet. Not those who were resistant to it. Some of these might include mutated but still viable / transmissible viruses, but also bear in mind that transmission might take place well before treatment IRL, implying no selection pressure from treatment. This supports being more concerned about the immunosuppressed who can harbor chronic infection but they were already a mutation factory and it didn't seem to result in any new variants (Omicron actually being from mice)
The Organic Consumers Association and National Vaccine Information organisation today got excluded from Paypal. They can no longer get donation through Paypal. That desparate is the government to get the poison in all that they try to cut off everyone who does not comply.
Thanks, great analysis. One of the things I worry about not knowing is why a specific cohort in the Pfizer trial was 18% smaller in size from the placebo when that cohort had a -20.5 vaccine efficacy. It's very suspicious that randomization lead this kind of distribution. Perhaps it's expected given 22 thousand had to be randomized and very few people were baseline Sars-cov-2 positive but this group had the highest incidence density and lowest efficacy. Not represented well in the trials, while we live in a world where the efficacy in this group matters because most of the world is in this group now. Just like you showed how at risk groups can be gamed by randomizing morbidity, I'm of the opinion that something was wrong with the trial randomization for Pfizer where this crucial group was kind of small for Pfizer or people differentially dropped out.
Unfortunately, we have convinced people that randomized control trials are the end-all-be-all of science. The "gold standard". People that don't know any better are convinced they cannot be wrong but there are many areas like data collection, the randomization process, placebo used, length of study, size of study, variables studied, etc that leave plenty of room for "scientists" to impact the final results. With the Pfizer study, people were not getting regular testing and testing was left to the discretion of doctors regardless of symptoms. It's important to pick up on little discrepencies like this because there is more than 100 billion reasons for Pfizer to manipulate the results at any point they can.
Yes, that and the greater "reactogenicity" (their word in FDA document not mine) seen in the cohort with history of previous coronavirus infection at baseline meant that those extra patients in the first seven days in the Pfizer group with Covid like symptoms but not SARS-COV-2 positive, 409 vs 207 - suggests that a friendly doctor could decide based on WHO's revised guidelines about "False positives" in January, that their was no need to test these people. That basically means that if this cohort was most likely to be positive just after vaccine and we claim those types of positives are false positives but they were true positives, the trial efficacy can't be trusted.
"Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo "
It's more than just a coincidence. I think if Pfizer knew about a higher chance of Covid positivity in the treatment group, they'd certainly not go the extra mile to make sure they can test people in time.
Overall. If you look at Moderna Asymptomatic cases at unblinding and this Admission from Pfizer, it's not clear what efficacy these products have.
Early on, I really wanted to put myself in the FDA's shoes. Could the potential for negative efficacy in the first 7 days be random? Maybe. But they approved the vaccines for EUA on basically the same difference. The fact that VE improved later is besides the point. They should have considered the fact that if it was not random, it would spike cases in the real world. It turns out it was not random and cases spiked and the spikes were sustained throughout the entire year because of slow vaccine rollouts. When it turned out us skeptics were right about not having medium or long term data, and the vaccine essentially "wears off", there was no accountability in their part. Regulators around the world did not pick up on it and it led to 2021 being a far worse year. They doubled down time and time again and even pretended the negative VE were the unvaccinated. The handling of this entire vaccine rollout was atrocious and evil. The molnupiravir EUA with data this awful is proof they haven't even done a lessons learned. Or maybe they knew all along and it is just a sign of corruption and decay.
Molnupiravir or Paxlovid will help generate a steady source of mutants that boosters can select, promote and breed within vaccinees and the next Del-Micron whatever will be an event or recombination and reactivation from a previously ill patients or child who was given the first dose. I bet something like this happened in South Africa after they started pumping the teens with Covid-Attractor (vaccine) on October 20th in Guateng. This pattern will repeat itself as it did with Remdesivir, AZ interaction in India which likely selected for Delta variants after many months of sitting on the sidelines.
This approval is as shocking as "Covid Vax" approval. A potentially very dangerous, novel treatment that barely works, was approved despite a split decision. Patients followed up only for 29 days.
FDA needs to be disbanded.
Thanks for doing hard work and writing an excellent article.
The second-half negative efficacy during the trial was impressive, but seems to be more a factor of the placebo group suddenly performing better while Molnupiravir severe outcome rate was steady. Doesn't seem to matter. The drug probably doesn't make a huge difference to infection outcomes, it's just a scapegoat for the cancers that the Covid-vaccinated were already going to get anyway.
Wouldn't it imply that Molnupiravir was either inhibiting a better immune response or that viral evolution (for molnupiravir resistance) is taking place even faster?
Wouldn't it matter if the average person not being treated might be getting better trained with viral variants resistant to our current treatments while those being treated are contributing to a "persistence" of severity even in a background of lowering severity without intervention?
I've not look too closely, but it mirrors some of the same problems we have with inoculation.
If Molnupiravir actually works as advertised, it implies that viral replication is shut down for a guaranteed 7% severe outcome rate; whereas in the placebo group outcomes depend on the more random fates of infection (without proper therapeutics). Additionally, there is no way for the virus to evolve resistance. The pill as advertised sabotages gene expression throughout the body. Viruses are genes that need to be expressed to proliferate.
I have my doubts that it works as advertised. It might not do anything at all, given the trial result. Or the mechanism might be inhibition of glycerophospholipid formation and glycosylation which both require CTP and which the virus requires to make envelope and spike protein. The whole thing is probably Kabuki to hide vaccine-induced cancer, like I said.
Hey Brian, I thought about what you were saying and tried to make it fit with what I had in mind along with Jestre's observation that changing composition of the treated and untreated groups over time is sufficient to explain the difference.
I agree with his observation that the underlying effect size is difficult to parse without a sense of what the risk factors are and even more so when one of the subgroups could be an increased risk of both severe covid and treatment failure and we just don't know the baseline since it's the first trial.
I think that obesity is basically a fake co-morbidity developed to try and explain away things which can't be. Obesity is the climate change of medicine in the sense that if the treatment fails, blame it on a loose measurement of height and weight ratio. I could add 330 sumo wrestlers to the placebo and make every prophylactic drug fail against infection prevention and it would be credited to obesity rather than cardio-vascular health.
But since event rate did fall by 2x and Cancer patients were added to treatment arm, it's probably hard to say if the treatment totally fails without knowing the underlying event rate and risk by co-morbidity. COPD was 3x more before, so perhaps these made the absolute risk fall less than placebo as covid went out of season?
I think drug pressure can lead to vaccine and drug resistance and made a small note how but happy to be corrected if incorrect. https://almostwrong.substack.com/p/treatments-against-evolution-of-resistance
Cancer is treated with immunosuppressants? Though, it's a bit funny that these mRNA transfections seemingly act as immunosuppressants and (anecdotally) cause rampant cancer regressions to begin with, whereas Molnupiravir is more akin to intracellular chemotherapy in its aggressive attack of host metabolism (if the theoretical mechanism is in fact valid).
For example decreasing inhibitory cytokines in specific Breast Cancers? Or whatever was happening to Colin Powell but that might be special cases due to transplant related immunosuppression and then cancer.
A blunted innate immune response would promote infection until there is an adaptive immune response and molupiravir or any anti-viral would help in this situation. But if a mutant learns over a consistent period of time what types of pressures and cascades follow, it's likely to survive and transmit. These variants could be nastier because they now can infect relatively healthier cancer patients who are not immunosuppressed.
Right, transplants I get. In so far as the virus can replicate despite M, it will just be those who dodged the bullet. Not those who were resistant to it. Some of these might include mutated but still viable / transmissible viruses, but also bear in mind that transmission might take place well before treatment IRL, implying no selection pressure from treatment. This supports being more concerned about the immunosuppressed who can harbor chronic infection but they were already a mutation factory and it didn't seem to result in any new variants (Omicron actually being from mice)
The Organic Consumers Association and National Vaccine Information organisation today got excluded from Paypal. They can no longer get donation through Paypal. That desparate is the government to get the poison in all that they try to cut off everyone who does not comply.
Aren’t these also required to be taken with another drug or three?
I like how you boil it down: garbage. I have no doubt. Thanks for your work.
Thanks, great analysis. One of the things I worry about not knowing is why a specific cohort in the Pfizer trial was 18% smaller in size from the placebo when that cohort had a -20.5 vaccine efficacy. It's very suspicious that randomization lead this kind of distribution. Perhaps it's expected given 22 thousand had to be randomized and very few people were baseline Sars-cov-2 positive but this group had the highest incidence density and lowest efficacy. Not represented well in the trials, while we live in a world where the efficacy in this group matters because most of the world is in this group now. Just like you showed how at risk groups can be gamed by randomizing morbidity, I'm of the opinion that something was wrong with the trial randomization for Pfizer where this crucial group was kind of small for Pfizer or people differentially dropped out.
Unfortunately, we have convinced people that randomized control trials are the end-all-be-all of science. The "gold standard". People that don't know any better are convinced they cannot be wrong but there are many areas like data collection, the randomization process, placebo used, length of study, size of study, variables studied, etc that leave plenty of room for "scientists" to impact the final results. With the Pfizer study, people were not getting regular testing and testing was left to the discretion of doctors regardless of symptoms. It's important to pick up on little discrepencies like this because there is more than 100 billion reasons for Pfizer to manipulate the results at any point they can.
Yes, that and the greater "reactogenicity" (their word in FDA document not mine) seen in the cohort with history of previous coronavirus infection at baseline meant that those extra patients in the first seven days in the Pfizer group with Covid like symptoms but not SARS-COV-2 positive, 409 vs 207 - suggests that a friendly doctor could decide based on WHO's revised guidelines about "False positives" in January, that their was no need to test these people. That basically means that if this cohort was most likely to be positive just after vaccine and we claim those types of positives are false positives but they were true positives, the trial efficacy can't be trusted.
"Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo "
From the December 2020 Emergency Use Application.
https://www.fda.gov/media/144245/download
It's more than just a coincidence. I think if Pfizer knew about a higher chance of Covid positivity in the treatment group, they'd certainly not go the extra mile to make sure they can test people in time.
Overall. If you look at Moderna Asymptomatic cases at unblinding and this Admission from Pfizer, it's not clear what efficacy these products have.
Early on, I really wanted to put myself in the FDA's shoes. Could the potential for negative efficacy in the first 7 days be random? Maybe. But they approved the vaccines for EUA on basically the same difference. The fact that VE improved later is besides the point. They should have considered the fact that if it was not random, it would spike cases in the real world. It turns out it was not random and cases spiked and the spikes were sustained throughout the entire year because of slow vaccine rollouts. When it turned out us skeptics were right about not having medium or long term data, and the vaccine essentially "wears off", there was no accountability in their part. Regulators around the world did not pick up on it and it led to 2021 being a far worse year. They doubled down time and time again and even pretended the negative VE were the unvaccinated. The handling of this entire vaccine rollout was atrocious and evil. The molnupiravir EUA with data this awful is proof they haven't even done a lessons learned. Or maybe they knew all along and it is just a sign of corruption and decay.
Molnupiravir or Paxlovid will help generate a steady source of mutants that boosters can select, promote and breed within vaccinees and the next Del-Micron whatever will be an event or recombination and reactivation from a previously ill patients or child who was given the first dose. I bet something like this happened in South Africa after they started pumping the teens with Covid-Attractor (vaccine) on October 20th in Guateng. This pattern will repeat itself as it did with Remdesivir, AZ interaction in India which likely selected for Delta variants after many months of sitting on the sidelines.
See how naive profiteering helps sustain pandemics. Read this: https://www.livemint.com/science/health/the-dangerous-failure-to-stop-tainted-remdesivir-11640197634967.html
Thank you for this article!
I read a tweet by James Hildreth who voted no.
This approval is as shocking as "Covid Vax" approval. A potentially very dangerous, novel treatment that barely works, was approved despite a split decision. Patients followed up only for 29 days.
FDA needs to be disbanded.
Thanks for doing hard work and writing an excellent article.
If I tried to advance this "cure" they would put me away.