I trust those 2 doctors despite not ever meeting them. Of course meeting them has nothing to do with their integrity, knowledge and leadership. I've followed both for a long time and have weighed their thoughts and proof about a myriad of thing and I see excellent knowledge being grounded with common sense. I am very excited to sit back, with my popcorn and Milk Duds and watch how it all plays out.
Give time for 2 very intelligent people, whose advice I would follow, who are like two policemen in the middle of a bar brawl trying to stop the mayhem and at the same time analyze the evidence for cause!! I'm going to be patient, supportive and hopeful.
I would be more inclined to "give them a chance" if Makary and Prasad were more transparent. For example, in the video Prasad makes a totally unfounded statement that Covid vaccines were never tested against placebo. That is blatantly untrue and feels like a pander to the anti-vax crowd. I would feel better if they acknowledged that the initial vaccines from Moderna, Pfizer, and Astra Zeneca saved millions of lives in the US and around the world.
I certainly support a change in the ways Covid vaccines are evaluated, but I believe that it will primarily discourage companies from developing more vaccines which may be the goal and maybe we don't even need more. As an immunologist who spent half of my career in academic research and then moved into industry, I suspect that the endpoints chosen will not provide significantly greater understanding of what is important for protective (not necessarily sterilizing) immunity. Because the "success' is based solely on antibody responses and not T cell responses which appear to be much longer lasting and much broader than antibody responses, new studies should include sufficiently large sub-studies of SARS-CoV2 T cell immunity at baseline and several weeks after vaccination. That might help answer the question of whether boosters are even helpful at all. In addition, unless you have a fairly good balance with respect to Covid vaccine AND infection history at baseline, the results could be wildly skewed. I am now 75 and have no intention of getting another booster after having the initial vaccination and booster, followed by yearly shots for 2 more years and 3 documented Covid infections over that time (after vaccination). I suspect my T cell immunity is strong enough to protect me now.
If the FDA leadership wants to "speak with clarity and humility" about Covid vaccines, they should also condemn scams like those recently promoted by Meghan McCain touting a company making a “detox” supplement for individuals who were vaccinated years ago and now regret it.
Finally, I found it appalling that at the end of the video they brazenly advertised vacant positions at FDA. I guess they don't know or don't remember that DOGE-directed layoffs at the FDA have had significant consequences in areas related to food safety, medical devices, and drug oversight. Have the FDA leaders been actively engaged in rehiring those competent people who were hastily dismissed?
Dr. Makary’s recent self-assured comments about seed oils and “babies with general body inflammation” due to infant formula are surprising.
Nutrition research is tough and imprecise. Social determinants heavily confound research into the latest trendy molecules -be they vilified or praised by the media.
If Dr. Makary is quick to redact COVID-19 vaccine recommendations due to lack of RTCs and placebo trials, he should be cautious in vilifying single molecules as the culprit for “general body inflammation” unless he has overwhelming evidence to prove it.
If I am to “Give the New FDA Leadership a Chance,” I ask that they use their platform and national media exposure responsibly.
Sounds like a start, but just one improved replacement part in a big machine lubricated by industry money. Grafted onto a larger politico-economic machine. I wonder how much can be done by a few individuals at the top of the FDA without presidential, legislative, and judicial help. Laws against the revolving door and U.S. Treasury funding (from a tax on Big Pharma and Big Devices?) instead of user fees would be a start. The list is long. See PharmedOut.org, "What Needs to Change at the FDA?"
Pharma will only clear the bar for approval that the FDA demands. To expect otherwise is to rely on something counter to human nature.
Set a low bar, get lower quality studies. As Dr. JMM notes, see device approvals of recent years.
So it is a breath of fresh air that Drs. M and P will be setting a higher bar. And I’m looking forward to the better quality studies this new reality will engender.
J .Askin made a VERY important comment above that the mRNA platform should be referred to as a gene therapy product rather than a vaccine. It is my understanding the FDA requires shedding studies on gene therapy products. Will these shedding studies be required? Please ask!
I believe it is extremely irresponsible to approve first and test later. The Covid gene therapy products should be pulled from the market completely and properly tested. To do otherwise, is irresponsible and dangerous. I am very disappointed.
Finally, in reference to the statement, ‘the pharmaceutical company agrees’, who is the regulator here???
A search on the FDA website reveals the following definition of Gene Therapy Products (GTPs) provided by the FDA in documents related to their development and regulation:
“Gene therapy products are all products that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids, viruses, or genetically engineered microorganisms.” FDA. 2015, 2020
By the FDA definition, integration into the host genome is not necessary to meet their GTP designation (note the “or” in the FDA definition). Liposome delivered mRNA to the cell cytoplasm that then instructs the cell ribosomes to make a protein (faux spike) is not much different than DNA created mRNA leaving the nucleus and instructing those same ribosomes to make a protein.
Interestingly, as late as early 2020, the modified mRNA drug platform, if used as a “vaccine”, was apparently considered to be a gene therapy product. Moderna, in its Q2 2020 SEC filing, stated that “currently, mRNA is considered a gene therapy product by the FDA” (and would, presumably, be regulated as such). BioNTech is the Pfizer partner in the Covid mRNA drugs and Ugur Sahin is the founder of BioNTech. In a 2014 article he stated “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy”.
“is not much different…” ….IS still different, isn’t it? Point is, even you have shied away from claiming they’re one and the same.
“Of transferred genetic material” is the key phrase in what you quoted. mRNA by definition is not “genetic material”. (We seem to agree that “integrating into host genome” is irrelevant to this discussion).
I would like to see both sides of the argument. Steve, please provide the same analysis to the ‘vaccine’ definition…the old one, not the revised one used to fit the Covid ‘product’. Thank you.
At the risk of sounding overly esoteric, I have said many times that FDA approval = business deal made. I still feel that way. My hope is that the latest leadership can’t be easily bought, but in government that clearly happens.
I haven't watched/listened, but "They also “convinced” the company to perform a proper placebo-controlled RCT for the vaccine in patients age 50-65 this year" is not what I expected. I was expecting the manufacturer to take their ball and go home!
PS JMM: As someone who worked in an academic group trying to apply EBM to medical devices and phone apps - it's bananas.
"we will learn so much from that trial: efficacy, safety, frequency of COVID hospitalizations in the placebo arm, for instance."
Sorry, this just isn't true. People should especially know better after the available auditing of the seminal trials have shown such clear signs of extensive fraud. Pfizer's trial has received much more attention than Moderna's (1). If Prasad of all people doesn't get wise to the fraud during his tenure, then I see little hope for modern medicine.
The industry is full of hopelessly bad actors and no amount of getting them to do more "science-like activities" will eliminate the fraud. At minimum, total raw data transparency is needed. Yet you can still do plenty of fraud even in that scenario. I side with Peter Gotzsche. Industry should not conduct their own trials, patents need to basically be ended, and a completely non-profit system needs to be established (2). It's not even a question of feasibility. A bird in the bush is worth more than a hundred dead birds in the hand. And it is feasible. All it requires is buy-in. And buy-in is obtained by universal recognition of the irresolvable inability of industry to not commit fraud. And universal recognition can be obtained by Makary and Prasad making sure full formal audits of the two seminal covid vax trials take place, laying bare the fact that the "highest-quality" science we have is in fact disgustingly unacceptable.
(1)
Many serious issues in the publicy-available raw data have been described. These include clear evidence of widespread unblinding, suppression of serious adverse events, imbalanced testing, questionable laboratory practices, a bait-and-switch of what product they actually tested versus what was authorized, imbalanced comorbidities, an unnatural time distribution of deaths, potential neglect of a cardiovascular death signal, gross data manipulation, and a host of other anomalies.
The FDA Direct “podcast” conversations have been great and are a welcome change. But dissatisfaction with leadership is not simply a vaxx vs anti-vaxx argument. The problem is the mRNA platform being referred to and promoted as a “vaccine” rather than the Gene Therapy Products that they are. One only needs to consider DOSE, DISTRIBUTION, and DURATION (of action) to understand the problem of these drugs being used to create an immune response. What is the quantity (dose) of the faux spike protein created by a person’s cells? No one knows. What is the duration of action of the faux spike protein? Reported now to be months to perhaps 1-2 years. Distribution? Lipid nanoparticles carry the mRNA everywhere in the body. The mRNA products are genetic drugs and should undergo the appropriate testing rigor reserved for gene therapy products, not the more lax vaccine testing protocols. They should not be referred to as “vaccines” which provides them an innocence connotation they have not earned or deserve.
Are you unaware of the plasmid DNA contamination (with the SV40 promotor) which is inside the LNPs, discovered by Kevin Mckernen, et al?
Deep sequencing of the Moderna and Pfizer bivalent vaccines identifies contamination of expression vectors designed for plasmid amplification in bacteria
Dude... this is like 2 year old information at this point. You are out here confidently defending the mRNA technology, and you are unaware that the manufacturing process changes AFTER clinical trial (in order to scale up production, e. coli bacteria was used to replicate the RNA, thanks to the SV40 promotor), which resulted in large quantities of DNA fragments included within the LNP.
This is a big deal because, as you have defended, public health officials said that the mRNA can't integrate with your DNA / nucleus - this fact is true. The issue is that the random plasmid DNA will be brought across the cell membrane via the LNP, then can integrate with the nucleus thanks to the SV40 promotor. You need to understand Kevin Mckernen's findings, the implication is huge.
Vinay is prohibited from commenting but I am nearly certain I heard he and Marty say that FDA will bolster safety surveillance, which is a) vitally important for public health, and b) needed to restore trust. I am optimistic that they will make progress in this regard.
I trust those 2 doctors despite not ever meeting them. Of course meeting them has nothing to do with their integrity, knowledge and leadership. I've followed both for a long time and have weighed their thoughts and proof about a myriad of thing and I see excellent knowledge being grounded with common sense. I am very excited to sit back, with my popcorn and Milk Duds and watch how it all plays out.
Give time for 2 very intelligent people, whose advice I would follow, who are like two policemen in the middle of a bar brawl trying to stop the mayhem and at the same time analyze the evidence for cause!! I'm going to be patient, supportive and hopeful.
I would be more inclined to "give them a chance" if Makary and Prasad were more transparent. For example, in the video Prasad makes a totally unfounded statement that Covid vaccines were never tested against placebo. That is blatantly untrue and feels like a pander to the anti-vax crowd. I would feel better if they acknowledged that the initial vaccines from Moderna, Pfizer, and Astra Zeneca saved millions of lives in the US and around the world.
I certainly support a change in the ways Covid vaccines are evaluated, but I believe that it will primarily discourage companies from developing more vaccines which may be the goal and maybe we don't even need more. As an immunologist who spent half of my career in academic research and then moved into industry, I suspect that the endpoints chosen will not provide significantly greater understanding of what is important for protective (not necessarily sterilizing) immunity. Because the "success' is based solely on antibody responses and not T cell responses which appear to be much longer lasting and much broader than antibody responses, new studies should include sufficiently large sub-studies of SARS-CoV2 T cell immunity at baseline and several weeks after vaccination. That might help answer the question of whether boosters are even helpful at all. In addition, unless you have a fairly good balance with respect to Covid vaccine AND infection history at baseline, the results could be wildly skewed. I am now 75 and have no intention of getting another booster after having the initial vaccination and booster, followed by yearly shots for 2 more years and 3 documented Covid infections over that time (after vaccination). I suspect my T cell immunity is strong enough to protect me now.
If the FDA leadership wants to "speak with clarity and humility" about Covid vaccines, they should also condemn scams like those recently promoted by Meghan McCain touting a company making a “detox” supplement for individuals who were vaccinated years ago and now regret it.
Finally, I found it appalling that at the end of the video they brazenly advertised vacant positions at FDA. I guess they don't know or don't remember that DOGE-directed layoffs at the FDA have had significant consequences in areas related to food safety, medical devices, and drug oversight. Have the FDA leaders been actively engaged in rehiring those competent people who were hastily dismissed?
Dr. Makary’s recent self-assured comments about seed oils and “babies with general body inflammation” due to infant formula are surprising.
Nutrition research is tough and imprecise. Social determinants heavily confound research into the latest trendy molecules -be they vilified or praised by the media.
If Dr. Makary is quick to redact COVID-19 vaccine recommendations due to lack of RTCs and placebo trials, he should be cautious in vilifying single molecules as the culprit for “general body inflammation” unless he has overwhelming evidence to prove it.
If I am to “Give the New FDA Leadership a Chance,” I ask that they use their platform and national media exposure responsibly.
Sounds like a start, but just one improved replacement part in a big machine lubricated by industry money. Grafted onto a larger politico-economic machine. I wonder how much can be done by a few individuals at the top of the FDA without presidential, legislative, and judicial help. Laws against the revolving door and U.S. Treasury funding (from a tax on Big Pharma and Big Devices?) instead of user fees would be a start. The list is long. See PharmedOut.org, "What Needs to Change at the FDA?"
https://www.researchgate.net/publication/363697711_What_Needs_to_Change_at_the_FDA
Pharma will only clear the bar for approval that the FDA demands. To expect otherwise is to rely on something counter to human nature.
Set a low bar, get lower quality studies. As Dr. JMM notes, see device approvals of recent years.
So it is a breath of fresh air that Drs. M and P will be setting a higher bar. And I’m looking forward to the better quality studies this new reality will engender.
J .Askin made a VERY important comment above that the mRNA platform should be referred to as a gene therapy product rather than a vaccine. It is my understanding the FDA requires shedding studies on gene therapy products. Will these shedding studies be required? Please ask!
I believe it is extremely irresponsible to approve first and test later. The Covid gene therapy products should be pulled from the market completely and properly tested. To do otherwise, is irresponsible and dangerous. I am very disappointed.
Finally, in reference to the statement, ‘the pharmaceutical company agrees’, who is the regulator here???
mRNA has nothing to do with “gene therapy”.
A search on the FDA website reveals the following definition of Gene Therapy Products (GTPs) provided by the FDA in documents related to their development and regulation:
“Gene therapy products are all products that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids, viruses, or genetically engineered microorganisms.” FDA. 2015, 2020
By the FDA definition, integration into the host genome is not necessary to meet their GTP designation (note the “or” in the FDA definition). Liposome delivered mRNA to the cell cytoplasm that then instructs the cell ribosomes to make a protein (faux spike) is not much different than DNA created mRNA leaving the nucleus and instructing those same ribosomes to make a protein.
Interestingly, as late as early 2020, the modified mRNA drug platform, if used as a “vaccine”, was apparently considered to be a gene therapy product. Moderna, in its Q2 2020 SEC filing, stated that “currently, mRNA is considered a gene therapy product by the FDA” (and would, presumably, be regulated as such). BioNTech is the Pfizer partner in the Covid mRNA drugs and Ugur Sahin is the founder of BioNTech. In a 2014 article he stated “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy”.
“is not much different…” ….IS still different, isn’t it? Point is, even you have shied away from claiming they’re one and the same.
“Of transferred genetic material” is the key phrase in what you quoted. mRNA by definition is not “genetic material”. (We seem to agree that “integrating into host genome” is irrelevant to this discussion).
I would like to see both sides of the argument. Steve, please provide the same analysis to the ‘vaccine’ definition…the old one, not the revised one used to fit the Covid ‘product’. Thank you.
I don’t think I understand your question.
The fact that mRNA has no effect on , and is not the same as, DNA (ie genetic material) is cellular biologic reality.
At the risk of sounding overly esoteric, I have said many times that FDA approval = business deal made. I still feel that way. My hope is that the latest leadership can’t be easily bought, but in government that clearly happens.
I haven't watched/listened, but "They also “convinced” the company to perform a proper placebo-controlled RCT for the vaccine in patients age 50-65 this year" is not what I expected. I was expecting the manufacturer to take their ball and go home!
PS JMM: As someone who worked in an academic group trying to apply EBM to medical devices and phone apps - it's bananas.
Excellent and enlightening pod cast by FDA leadership- I agree with nearly all of this - thanks for shouting it out
"we will learn so much from that trial: efficacy, safety, frequency of COVID hospitalizations in the placebo arm, for instance."
Sorry, this just isn't true. People should especially know better after the available auditing of the seminal trials have shown such clear signs of extensive fraud. Pfizer's trial has received much more attention than Moderna's (1). If Prasad of all people doesn't get wise to the fraud during his tenure, then I see little hope for modern medicine.
The industry is full of hopelessly bad actors and no amount of getting them to do more "science-like activities" will eliminate the fraud. At minimum, total raw data transparency is needed. Yet you can still do plenty of fraud even in that scenario. I side with Peter Gotzsche. Industry should not conduct their own trials, patents need to basically be ended, and a completely non-profit system needs to be established (2). It's not even a question of feasibility. A bird in the bush is worth more than a hundred dead birds in the hand. And it is feasible. All it requires is buy-in. And buy-in is obtained by universal recognition of the irresolvable inability of industry to not commit fraud. And universal recognition can be obtained by Makary and Prasad making sure full formal audits of the two seminal covid vax trials take place, laying bare the fact that the "highest-quality" science we have is in fact disgustingly unacceptable.
(1)
Many serious issues in the publicy-available raw data have been described. These include clear evidence of widespread unblinding, suppression of serious adverse events, imbalanced testing, questionable laboratory practices, a bait-and-switch of what product they actually tested versus what was authorized, imbalanced comorbidities, an unnatural time distribution of deaths, potential neglect of a cardiovascular death signal, gross data manipulation, and a host of other anomalies.
https://openvaet.substack.com/p/pfizerbiontech-c4591001-trial-audit
https://wherearethenumbers.substack.com/p/anomalous-patterns-of-mortality-and
https://modarnlife.substack.com/p/at-investigators-discretion
(2)
https://pmc.ncbi.nlm.nih.gov/articles/PMC5817403/
https://pmc.ncbi.nlm.nih.gov/articles/PMC6084335/
https://multipolar-magazin.de/artikel/never-trust-trials?utm_source=chatgpt.com
The FDA Direct “podcast” conversations have been great and are a welcome change. But dissatisfaction with leadership is not simply a vaxx vs anti-vaxx argument. The problem is the mRNA platform being referred to and promoted as a “vaccine” rather than the Gene Therapy Products that they are. One only needs to consider DOSE, DISTRIBUTION, and DURATION (of action) to understand the problem of these drugs being used to create an immune response. What is the quantity (dose) of the faux spike protein created by a person’s cells? No one knows. What is the duration of action of the faux spike protein? Reported now to be months to perhaps 1-2 years. Distribution? Lipid nanoparticles carry the mRNA everywhere in the body. The mRNA products are genetic drugs and should undergo the appropriate testing rigor reserved for gene therapy products, not the more lax vaccine testing protocols. They should not be referred to as “vaccines” which provides them an innocence connotation they have not earned or deserve.
What are you talking about?
mRNA works at ribosomal level in cellular cytoplasm. Your “genes” are in your DNA within the cellular nucleus.
Are you unaware of the plasmid DNA contamination (with the SV40 promotor) which is inside the LNPs, discovered by Kevin Mckernen, et al?
Deep sequencing of the Moderna and Pfizer bivalent vaccines identifies contamination of expression vectors designed for plasmid amplification in bacteria
https://anandamide.substack.com/p/curious-kittens
Never heard of this before.
Let’s say there was “plasmid DNA contamination” during the production process of certain mRNA vaccines.
How does that bridge the gap to “mRNA vaccine is gene therapy”?
You can her Kevin discuss his findings (and the implications ) here at the 38 minute mark
https://open.spotify.com/episode/31dxPErTCKv0b3os2TbrV2
Dude... this is like 2 year old information at this point. You are out here confidently defending the mRNA technology, and you are unaware that the manufacturing process changes AFTER clinical trial (in order to scale up production, e. coli bacteria was used to replicate the RNA, thanks to the SV40 promotor), which resulted in large quantities of DNA fragments included within the LNP.
This is a big deal because, as you have defended, public health officials said that the mRNA can't integrate with your DNA / nucleus - this fact is true. The issue is that the random plasmid DNA will be brought across the cell membrane via the LNP, then can integrate with the nucleus thanks to the SV40 promotor. You need to understand Kevin Mckernen's findings, the implication is huge.
Dude, my point has been that “mRNA is not gene therapy”….which is the contention of the original commenter on this thread.
I’m here defending biologic reality.
I’m not interested in all the wingnut conspiracy stuff of the antivax crowd.
If there are manufacturing irregularities, the initial commenter can say that, and that’s fine. But don’t obfuscate that with biologic nonsense.
Vinay is prohibited from commenting but I am nearly certain I heard he and Marty say that FDA will bolster safety surveillance, which is a) vitally important for public health, and b) needed to restore trust. I am optimistic that they will make progress in this regard.
Good Job !
Agree!!