Our government spent billions of dollars on this medicine based on Pfizer's say-so that it worked. Actually, it was never convincingly clear Paxlovid™ did anything useful at all.
Good stuff/great summary of all of the studies and the shenanigans. I am a 36 yr pharma employee - my expertise is not in vaccines but have significant depth in regulatory affairs (working directly with FDA) across multiple therapeutic areas. I think covid has added a significant layer of skepticism across the board including hospital admissions, drugs, costs, politics, policies, etc. It's really created serious rot in some areas.
One point of clarification I will share is that practically all studies that support an NDA/BLA approval are conducted by (and paid for by) the applicant....in this case, Pfizer. Many companies do receive federal or private grants for R&D, but by and large, the applicant/sponsor pays for them (who else would invest that kind of dough with the risk involved?) That may suggest sponsors are up to no good but I can tell you from my 36 yrs, I had only an occasional rare exposure to that (I retired at SVP level) and in those cases, Right beat Wrong. What FDA should do now is remove Paxlovid from the market - it does not work as the most recent study showed. The bugling and genuflecting around this drug is mind-boggling and adds further to the deep skepticism.
Thanks for this - a friend of mine from out herein Longmeadow is the chief of transplant medicine there at “ Man’s Greatest Hospital” - say hi for me.
I’ll add my voice and those of my wife and her parents to the “very helpful” column of an anecdotal tally of Paxlovid recipients, but who the he’ll knows if it’s the placebo effect or not.
The 20.8% number of rebound Covid scares the shit out of me, though, and makes me wonder if Pfizer (I’m no fan of those asshat sociopaths) has figured out a way to pay themselves for the “vaccine”. Kind of reminds me of the old Mad magazine cartoon of kids with a lemonade stand advertising “Lemonade 5 cents” with fine print below saying “Antidote $5”!
Pharmaceuticals are one thing that should be left to government. Research drugs that are really needed and keep the patents as open sourced so anyone is free to make it, globally, and probably special labs in the US the way generic drugs are made now. Sciebtists involved in the developmebt would get a cut, I imagine, but much if not most of the basic research is conducted in universities with government money now.
(2 of 2) Fortunately only small amounts of supplemental vitamin D3 are required. https://vitamindstopscovid.info/00-evi/#00-how-much includes Prof. Sunil Wimalawansa's recommendations https://www.mdpi.com/2072-6643/14/14/2997 for vitamin D3 supplemental intake to attain at least the 50 ng/mL (125 nmol/L = 1 part in 20,000,000 by mass) circulating 25-hydroxyvitamin D, which the immune system needs to function properly. As he noted in a recent FLCCC webinar, these are ratios of body weight, with higher ratios for those suffering from obesity: https://odysee.com/@FrontlineCovid19CriticalCareAlliance:c/Weeekly_Webinar_Aug16_2023:d?t=3386 This is because people suffering from obesity convert less vitamin D3 into circulating 25-hydroxyvitamin D than normal-weight people.
The average daily vitamin D3 intake should be:
70 to 90 IU / kg body weight for those not suffering from obesity (BMI < 30).
100 to 130 IU / kg body weight for obesity I & II (BMI 30 to 39).
140 to 180 IU / kg body weight for obesity III (BMI > 39).
For 70 kg (154 lb) without obesity, this is about 0.125 milligrams (5000 IU) a day. This takes several months to attain the desired > 50 ng/mL circulating 25-hydroxyvitamin D. This is 8 or more times what most governments recommend. "5000 IU" sounds like a lot, but it is a gram every 22 years - and pharma grade vitamin D costs about USD$2.50 a gram ex-factory. Only a handful of factories worldwide make pharmaceutical grade vitamin D3 - and none are owned by major pharmaceutical companies.
If most or all people had at least 50 ng/mL circulating 25-hydroxyvitamin D, there would be little flu (no flu or COVID-19 season) and no pandemic spread of COVID-19. Sepsis, which kills 11 million people a year, worldwide, would be rare. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32989-7/
This page also explains how 25-hydroxyvitamin D is used by immune cells in intracrine (within each cells) and paracrine (to nearby cells) signaling. These are unrelated to hormonal signaling. Neither vitamin D3 nor 25-hydroxyvitamin D are hormones. They are not signaling molecules. 1,25-dihydroxyvitamin D calcitriol functions, in the bloodstream, as a hormone by which the parathyroid gland, osteocytes and the kidneys regulate calcium-phosphate-bone metabolism. The calcitriol produced in immune cells, when an individual cell detects a cell-type specific conditions, works not as a hormone, but as an intracrine or paracrine agent, to change the behaviour of that cell along (intracrine signaling) or nearby cells (paracrine signaling) in ways which are specific to each cell type.
Bill Grant agreed with my suggestion that, very approximately, half of human ill-health would disappear if everyone had sufficient 25-hydroxyvitamin D to run their immune systems properly. Far from the equator, at least in winter, most people who do not supplement vitamin D3 properly have 25 ng/mL or less circulating 25-hydroxyvitamin D. Those with brown or black skin have even less. Inadequate 25-hydroxyvitamin D is far the most important, easily correctable, cause of the generally poorer health of Americans with brown or black skin. Likewise in all countries far from the equator.
(1 of 2) By far the most important early or late treatment for COVID-19, for the great majority of the population whose circulating 25-hydroxyvitamin D level is below 50 ng/mL (125 nmol/L = 1 part in 20,000,000 by mass) is to boost that level, as rapidly as possible, well over 50 ng/mL. This is because the immune system cannot function properly with lower levels.
Without recent extensive ultraviolet-B radiation on ideally white skin, or proper vitamin D3 supplementation (in quantities well above the minuscule amounts recommended by governments, such as 0.015 mg 600 IU / day), most people have 30 ng/mL, 20 ng/mL or less - and some have only 5 ng/mL.
2014 research by doctors at Massachusetts General Hospital showed that with 50 ng/mL or more pre-operative 25-hydroxyvitamin D (as measured in "vitamin D" blood tests), the risk, separately, of hospital acquired infections and surgical site infections was about 2.5%. https://jamanetwork.com/journals/jamasurgery/fullarticle/1782085
The risk of infection rose dramatically in proportion to how far below 50 ng/mL the pre-operative 25-hydroxyvitamin D level was. With 18 ng/mL preoperative circulating 25-hydroxyvitamin D, which is common for many people who have not had a lot of ultraviolet B exposure on ideally white skin, and who do not supplement vitamin D3 properly, the risk of each type of infection rose to 25%.
This shows that serious and potentially deadly weakness in the immune system - here regarding the bacterial pathogens which cause both types of post-operative infection - is caused by 25-hydroxyvitamin D levels which are normal in most countries. See discussion and clearer, combined, graphs at: https://vitamindstopscovid.info/00-evi/#00-50ngmL.
The same weakness, due to inadequate 25-hydroxyvitamin D, also applies to responses against cancer cells, viruses and fungi. Furthermore, the risk of excessive, self-destructive, inflammatory (indiscriminate cell destruction) immune responses *rises* with lower 25-hydroxyvitamin D levels. It is - or should be - very well know that COVID-19 severity, harm and death is caused by lower 25-hydroxyvitamin D.
Death from COVID-19 is caused by the combination of immune system failure to tackle the viral infection and, when this reaches the lungs, responding with excessive inflammatory responses which damage the capillaries and other blood vessels there, leading to fluid leakage which fills the alvioli (pneumonia) and to hypercoagulative blood (in response to this vascular damage) which causes microclots all over the body, including the lungs, heart, brain, spinal cord and other organs.
A single bolus dose of 10 mg (400,000 IU) vitamin D3 cholecalciferol (for 70 kg 154 lb body weight, without obesity) will boost circulating 25-hydroxyvitamin D levels safely over 50 ng/mL, but this takes several days due to the need for hydroxylation in the liver. (Very approximately 1/4 of ingested vitamin D3 goes into circulation as 25-hydroxyvitamin D.)
If given upon diagnosis or initial hospitalisation, this would have saved most of those who were killed or seriously harmed by COVID-19, as well as greatly reducing viral shedding and so transmission.
The best approach is a single oral dose of about 0.014 mg calcifediol per kg body weight. For average weight adults, this is 1 milligram. Calcifediol *is* 25-hydroxyvitamin D. This goes straight into circulation and raises circulating levels within 4 hours. This, and bolus vitamin D3 if calcifediol is not available, is recommended by New Jersey based Professor of Medicine, Sunil Wimalawansa in his 2022 article in Nutrition: "Rapidly Increasing Serum 25(OH)D Boosts the Immune System, against Infections - Sepsis and COVID-19": https://www.mdpi.com/2072-6643/14/14/2997. See also: https://vitamindstopscovid.info/00-evi/#4.7 . The FLCCC adopted his recommendations in 2022. Unfortunately, calcifediol is difficult to obtain, except in Spain, Italy and some nearby countries.
Except for those few people who already have 50 ng/mL 25-hydroxyvitamin D, one of these treatments is by far the most important intervention for COVID-19 - even more than ivermectin or any of the other inexpensive treatments listed at https://c19early.org and especially the vastly profitable, not very safe, ineffective, government promoted, treatments of Molnupiravir, Paxlovid or numerous narrowly targeted monoclonal antibodies.
More importantly, everyone (except perhaps a few who have very high levels of UV-B skin exposure, which damages DNA and so raises the risk of skin cancer) should be supplementing sufficient vitamin D3 to attain at least 50 ng/mL circulating 25-hydroxyvitamin D all year round.
There's very little vitamin D3 in food - fortified or not - or multivitamins. There's no such thing a "vitamin D rich food" in respect of attaining 50 ng/mL 25-hydroxyvitamin D. However, some foods can help attain the much lower 20 ng/mL level required for bone health, which many doctors mistakenly consider to be adequate for overall health.
Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19
Published April 3, 2024 in NJEM
1296 participants who underwent randomization and were included in the full analysis population, 1288 received at least one dose of nirmatrelvir–ritonavir (654 participants) or placebo (634 participants) and had at least one postbaseline visit.
The median time to sustained alleviation of all targeted signs and symptoms of Covid-19 was 12 days in the nirmatrelvir–ritonavir group and 13 days in the placebo group (P=0.60).
I've had covid 3 times. #1 in Feb. 2020. My doctor thought it was bronchitis and when it got worse I got doxycycline. I was very sick and didn't feel 100% well until June of that year. The next 2 times I got covid I took paxlovid. Symptoms went away within 8 hours. Purely anecdotal - doesn't prove anything, there could be many explanations. But at age 70 I'm not sure I want to risk not taking it. The last time I got covid (March, this year), I went downhill pretty fast before I was able to get the paxlovid. Who knows.
Thank you for this important information. Sadly, I wouldn't, and doubt you would, count on the pharmaceutical captured people in governments to "finally reform the corrupt, secretive, dysfunctional system of conducting medical randomized trials."
Powerful, maddening, final paragraph - well summarized. Trying to imagine how that could play out. If insiders reveals the corruption, they are ostracized, labeled, and cast out. Whistleblowers cast as kooks. If outsiders shine light on it, they are marginalized, demonized, and dismissed as a crack pot nobodies by the implicated government/industry officials. Then, the elite media (aristocracy protectors™️) either 1) ignore it, if they can -or- 2) come in and “clean up” the mess, like mob henchmen wiping down a scene where a hit took place. Spin the situation away from the corrupt power players and onto any red herring they can trot out. Standard hack magician misdirection play. Nothing to see here - move along.
Thank you! Keep exposing the corruption.
Very well thought out and expressed. Thank you sir!
Good stuff/great summary of all of the studies and the shenanigans. I am a 36 yr pharma employee - my expertise is not in vaccines but have significant depth in regulatory affairs (working directly with FDA) across multiple therapeutic areas. I think covid has added a significant layer of skepticism across the board including hospital admissions, drugs, costs, politics, policies, etc. It's really created serious rot in some areas.
One point of clarification I will share is that practically all studies that support an NDA/BLA approval are conducted by (and paid for by) the applicant....in this case, Pfizer. Many companies do receive federal or private grants for R&D, but by and large, the applicant/sponsor pays for them (who else would invest that kind of dough with the risk involved?) That may suggest sponsors are up to no good but I can tell you from my 36 yrs, I had only an occasional rare exposure to that (I retired at SVP level) and in those cases, Right beat Wrong. What FDA should do now is remove Paxlovid from the market - it does not work as the most recent study showed. The bugling and genuflecting around this drug is mind-boggling and adds further to the deep skepticism.
Thanks for this - a friend of mine from out herein Longmeadow is the chief of transplant medicine there at “ Man’s Greatest Hospital” - say hi for me.
I’ll add my voice and those of my wife and her parents to the “very helpful” column of an anecdotal tally of Paxlovid recipients, but who the he’ll knows if it’s the placebo effect or not.
The 20.8% number of rebound Covid scares the shit out of me, though, and makes me wonder if Pfizer (I’m no fan of those asshat sociopaths) has figured out a way to pay themselves for the “vaccine”. Kind of reminds me of the old Mad magazine cartoon of kids with a lemonade stand advertising “Lemonade 5 cents” with fine print below saying “Antidote $5”!
Pharmaceuticals are one thing that should be left to government. Research drugs that are really needed and keep the patents as open sourced so anyone is free to make it, globally, and probably special labs in the US the way generic drugs are made now. Sciebtists involved in the developmebt would get a cut, I imagine, but much if not most of the basic research is conducted in universities with government money now.
Hi Matt - I came to a different conclusion, unpopular as that is right now among the stone casters:
https://mccormickmd.substack.com/p/in-defense-of-paxlovid
(2 of 2) Fortunately only small amounts of supplemental vitamin D3 are required. https://vitamindstopscovid.info/00-evi/#00-how-much includes Prof. Sunil Wimalawansa's recommendations https://www.mdpi.com/2072-6643/14/14/2997 for vitamin D3 supplemental intake to attain at least the 50 ng/mL (125 nmol/L = 1 part in 20,000,000 by mass) circulating 25-hydroxyvitamin D, which the immune system needs to function properly. As he noted in a recent FLCCC webinar, these are ratios of body weight, with higher ratios for those suffering from obesity: https://odysee.com/@FrontlineCovid19CriticalCareAlliance:c/Weeekly_Webinar_Aug16_2023:d?t=3386 This is because people suffering from obesity convert less vitamin D3 into circulating 25-hydroxyvitamin D than normal-weight people.
The average daily vitamin D3 intake should be:
70 to 90 IU / kg body weight for those not suffering from obesity (BMI < 30).
100 to 130 IU / kg body weight for obesity I & II (BMI 30 to 39).
140 to 180 IU / kg body weight for obesity III (BMI > 39).
For 70 kg (154 lb) without obesity, this is about 0.125 milligrams (5000 IU) a day. This takes several months to attain the desired > 50 ng/mL circulating 25-hydroxyvitamin D. This is 8 or more times what most governments recommend. "5000 IU" sounds like a lot, but it is a gram every 22 years - and pharma grade vitamin D costs about USD$2.50 a gram ex-factory. Only a handful of factories worldwide make pharmaceutical grade vitamin D3 - and none are owned by major pharmaceutical companies.
If most or all people had at least 50 ng/mL circulating 25-hydroxyvitamin D, there would be little flu (no flu or COVID-19 season) and no pandemic spread of COVID-19. Sepsis, which kills 11 million people a year, worldwide, would be rare. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32989-7/
More research on vitamin D and dementia: https://vitamindstopscovid.info/00-evi/#3.3. This section cites and discusses the impact of low 25-hydroxyvitamin D in the mother, and so the developing child on autism, ADHD, mental retardation, preeclampsia, pre-term birth and low birth weight: https://vitamindstopscovid.info/00-evi/#3.2 .
This page also explains how 25-hydroxyvitamin D is used by immune cells in intracrine (within each cells) and paracrine (to nearby cells) signaling. These are unrelated to hormonal signaling. Neither vitamin D3 nor 25-hydroxyvitamin D are hormones. They are not signaling molecules. 1,25-dihydroxyvitamin D calcitriol functions, in the bloodstream, as a hormone by which the parathyroid gland, osteocytes and the kidneys regulate calcium-phosphate-bone metabolism. The calcitriol produced in immune cells, when an individual cell detects a cell-type specific conditions, works not as a hormone, but as an intracrine or paracrine agent, to change the behaviour of that cell along (intracrine signaling) or nearby cells (paracrine signaling) in ways which are specific to each cell type.
For decades the pharmaceutical industry has suppressed proper understanding of the importance of vitamin D. Dr Pierre Kory recently told Tucker Carlson that "They are terrified of vitamin D." https://nutritionmatters.substack.com/p/dr-pierre-kory-talks-with-tucker has a transcript of this part of the interview: https://twitter.com/TuckerCarlson/status/1768033041568727391. Dr Kory cites long-time vitamin D researcher, Bill Grant PhD's 2018 article: "Vitamin D acceptance delayed by Big Pharma following the Disinformation Playbook": http://orthomolecular.org/resources/omns/v14n22.shtml.
Bill Grant agreed with my suggestion that, very approximately, half of human ill-health would disappear if everyone had sufficient 25-hydroxyvitamin D to run their immune systems properly. Far from the equator, at least in winter, most people who do not supplement vitamin D3 properly have 25 ng/mL or less circulating 25-hydroxyvitamin D. Those with brown or black skin have even less. Inadequate 25-hydroxyvitamin D is far the most important, easily correctable, cause of the generally poorer health of Americans with brown or black skin. Likewise in all countries far from the equator.
(1 of 2) By far the most important early or late treatment for COVID-19, for the great majority of the population whose circulating 25-hydroxyvitamin D level is below 50 ng/mL (125 nmol/L = 1 part in 20,000,000 by mass) is to boost that level, as rapidly as possible, well over 50 ng/mL. This is because the immune system cannot function properly with lower levels.
Without recent extensive ultraviolet-B radiation on ideally white skin, or proper vitamin D3 supplementation (in quantities well above the minuscule amounts recommended by governments, such as 0.015 mg 600 IU / day), most people have 30 ng/mL, 20 ng/mL or less - and some have only 5 ng/mL.
2014 research by doctors at Massachusetts General Hospital showed that with 50 ng/mL or more pre-operative 25-hydroxyvitamin D (as measured in "vitamin D" blood tests), the risk, separately, of hospital acquired infections and surgical site infections was about 2.5%. https://jamanetwork.com/journals/jamasurgery/fullarticle/1782085
The risk of infection rose dramatically in proportion to how far below 50 ng/mL the pre-operative 25-hydroxyvitamin D level was. With 18 ng/mL preoperative circulating 25-hydroxyvitamin D, which is common for many people who have not had a lot of ultraviolet B exposure on ideally white skin, and who do not supplement vitamin D3 properly, the risk of each type of infection rose to 25%.
This shows that serious and potentially deadly weakness in the immune system - here regarding the bacterial pathogens which cause both types of post-operative infection - is caused by 25-hydroxyvitamin D levels which are normal in most countries. See discussion and clearer, combined, graphs at: https://vitamindstopscovid.info/00-evi/#00-50ngmL.
The same weakness, due to inadequate 25-hydroxyvitamin D, also applies to responses against cancer cells, viruses and fungi. Furthermore, the risk of excessive, self-destructive, inflammatory (indiscriminate cell destruction) immune responses *rises* with lower 25-hydroxyvitamin D levels. It is - or should be - very well know that COVID-19 severity, harm and death is caused by lower 25-hydroxyvitamin D.
Death from COVID-19 is caused by the combination of immune system failure to tackle the viral infection and, when this reaches the lungs, responding with excessive inflammatory responses which damage the capillaries and other blood vessels there, leading to fluid leakage which fills the alvioli (pneumonia) and to hypercoagulative blood (in response to this vascular damage) which causes microclots all over the body, including the lungs, heart, brain, spinal cord and other organs.
A single bolus dose of 10 mg (400,000 IU) vitamin D3 cholecalciferol (for 70 kg 154 lb body weight, without obesity) will boost circulating 25-hydroxyvitamin D levels safely over 50 ng/mL, but this takes several days due to the need for hydroxylation in the liver. (Very approximately 1/4 of ingested vitamin D3 goes into circulation as 25-hydroxyvitamin D.)
If given upon diagnosis or initial hospitalisation, this would have saved most of those who were killed or seriously harmed by COVID-19, as well as greatly reducing viral shedding and so transmission.
The best approach is a single oral dose of about 0.014 mg calcifediol per kg body weight. For average weight adults, this is 1 milligram. Calcifediol *is* 25-hydroxyvitamin D. This goes straight into circulation and raises circulating levels within 4 hours. This, and bolus vitamin D3 if calcifediol is not available, is recommended by New Jersey based Professor of Medicine, Sunil Wimalawansa in his 2022 article in Nutrition: "Rapidly Increasing Serum 25(OH)D Boosts the Immune System, against Infections - Sepsis and COVID-19": https://www.mdpi.com/2072-6643/14/14/2997. See also: https://vitamindstopscovid.info/00-evi/#4.7 . The FLCCC adopted his recommendations in 2022. Unfortunately, calcifediol is difficult to obtain, except in Spain, Italy and some nearby countries.
Except for those few people who already have 50 ng/mL 25-hydroxyvitamin D, one of these treatments is by far the most important intervention for COVID-19 - even more than ivermectin or any of the other inexpensive treatments listed at https://c19early.org and especially the vastly profitable, not very safe, ineffective, government promoted, treatments of Molnupiravir, Paxlovid or numerous narrowly targeted monoclonal antibodies.
More importantly, everyone (except perhaps a few who have very high levels of UV-B skin exposure, which damages DNA and so raises the risk of skin cancer) should be supplementing sufficient vitamin D3 to attain at least 50 ng/mL circulating 25-hydroxyvitamin D all year round.
There's very little vitamin D3 in food - fortified or not - or multivitamins. There's no such thing a "vitamin D rich food" in respect of attaining 50 ng/mL 25-hydroxyvitamin D. However, some foods can help attain the much lower 20 ng/mL level required for bone health, which many doctors mistakenly consider to be adequate for overall health.
Those darn studies. It’s difficult enough for insides to spot bad research sometimes and nearly impossible for laypersons to call foul.
latest study showing paxlovid is useless:
https://www.nejm.org/doi/full/10.1056/NEJMoa2309003
Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19
Published April 3, 2024 in NJEM
1296 participants who underwent randomization and were included in the full analysis population, 1288 received at least one dose of nirmatrelvir–ritonavir (654 participants) or placebo (634 participants) and had at least one postbaseline visit.
The median time to sustained alleviation of all targeted signs and symptoms of Covid-19 was 12 days in the nirmatrelvir–ritonavir group and 13 days in the placebo group (P=0.60).
I've had covid 3 times. #1 in Feb. 2020. My doctor thought it was bronchitis and when it got worse I got doxycycline. I was very sick and didn't feel 100% well until June of that year. The next 2 times I got covid I took paxlovid. Symptoms went away within 8 hours. Purely anecdotal - doesn't prove anything, there could be many explanations. But at age 70 I'm not sure I want to risk not taking it. The last time I got covid (March, this year), I went downhill pretty fast before I was able to get the paxlovid. Who knows.
Brilliant article. Thank you for your great writing and thoughtful, clear analysis.
Thank you for this important information. Sadly, I wouldn't, and doubt you would, count on the pharmaceutical captured people in governments to "finally reform the corrupt, secretive, dysfunctional system of conducting medical randomized trials."
Powerful, maddening, final paragraph - well summarized. Trying to imagine how that could play out. If insiders reveals the corruption, they are ostracized, labeled, and cast out. Whistleblowers cast as kooks. If outsiders shine light on it, they are marginalized, demonized, and dismissed as a crack pot nobodies by the implicated government/industry officials. Then, the elite media (aristocracy protectors™️) either 1) ignore it, if they can -or- 2) come in and “clean up” the mess, like mob henchmen wiping down a scene where a hit took place. Spin the situation away from the corrupt power players and onto any red herring they can trot out. Standard hack magician misdirection play. Nothing to see here - move along.