An investigation into clinical trial documents reveals how the FDA used statistical sleight of hand to make a serious safety signal in Moderna’s flu vaccine disappear.
“Testifying at the hearings was Wayne Ray, PhD, professor of preventive medicine at Vanderbilt University, who had just published research in the New England Journal of Medicine suggesting that patients on antipsychotics like Seroquel showed double the risk of a “sudden, fatal, pulseless condition, or collapse.”104 The article was titled “Atypical Antipsychotic Drugs and the Risk of Sudden Cardiac Death.” [2009]. Asked by Tom Laughren, director of the FDA's Division of Psychiatry Products, why AstraZeneca's own drug trials didn't “pick up a difference in sudden cardiac death,” Ray replied that AstraZeneca's methodology suffered from “Simpson's paradox,” pooling data from all clinical trials into one large data set with no allowances for the differences in the trials. It is the same distortion that made drugs like Vioxx look safe, said Ray.105“ (Rosenberg M. Born with a junk food deficiency: how flaks, quacks, and hacks pimp the public health. Prometheus Books, 2012).
Another great investigation and article Maryanne. The FDA’s conduct here is plainly indefensible, and it’s hard to avoid the conclusion that they colluded with the manufacturer to conceal that safety signal in order to push an unsafe product onto the market.
re '.. I cannot work out if the FDA reviewers are lazy, incompetent, or corrupt. Maybe it’s all 3...'
Can I suggest politically driven - we are being treated by politicians rather than medics. We saw it during the Covid shots, all countries in lockstep and now with mRNA manufacturing plants, driven by politicians; Biden's pre-emptive pardon for Fauci - he must have been doing Biden's bidding who would have been lobbied by pharma. The economy is everything if you want to get re-elected and receive political funds provided by industry.
I note that pharma was conspicuous by its absence in the recent Sen Paul Committee interrogating Fauci. A committee of politicians who would not want to attract attention to pharma's input, for fear of damaging the cash cow.
WSJ Saturday 8th August 2026. FDA reconsiders Replimune a melanoma drug now that Makary has gone. NB the last words in the quote below ' ....anger among ........Members of Congress...'
'Replimune said Friday that the Food and Drug Administration has agreed to reconsider its treatment for metastatic melanoma on an expedited basis. This bodes well for patients with melanoma and other diseases who were casualties of the prior FDA regime’s arbitrary drug rejections.
And now we have mRNA raising its ugly head in a less than proprietary manner, supported by the FDA.
It has got to be political influence, Govts are responsible for the economy as well as the health of the nation - one must have priority and I can see which one.
The mRNA platform should not be used for the general population. I could see it being used in cancer patients who have no other options that outside of that no
Thank, Maryanne! Will the people really fall in line again? Well! I will start warning my friends. I have one who asks me what I think and doesn’t get them. My brother has ALS thanks to believing the narrative. Maybe my sister can get through to him! This time!
Putting aside the absurdity of approving this dangerous injection which was meant for cancer therapy and is mislabeled as a vaccine, where does a pharmaceutical company get 40,000 adults over age 50 to agree to participate in a study where it may possibly result in getting synthetic mRNA in lipid nanoparticles injected into oneself after the COVID debacle? Answer: I believe most of these study participants are professionals who make a living at allowing pharmaceutical companies to turn them into lifelong guinea pigs. What do we know about the health of these subjects, and how they compare to the average American who is not a pin cushion for whatever experimental injection big Pharma wants to trick us into injecting into ourselves? How reliable is any data that comes from pharmaceutical companies anyway, and when it is being done on people who are likely to have health characteristics quite different from the average citizen, based on their repeated exposure to experimental pharmaceutical toxins, how reliable would the results be anyway, even if the methodology and data analysis were sound? I raise this question because 40,000 subjects seems to be an incredible number given the terrible risks of take COVID-19 injections, which so many people now know about, and which would seemingly make such numbers difficult to muster.
The smaller trials recruited mostly from the US, but the pivotal trial of 40,000 people was conducted across 301 clinical trial sites, recruiting participants from 11 different countries. Most were from North America -- the rest recruited from Europe and Asia. Moderna has a separate company running the trials on its behalf. For the elderly participants, many obviously have multiple health problems, so if someone falls off the perch after vaccination, Moderna's investigators will simply rule that the death was due to pre-existing conditions rather than the vaccine. I imagine that happens all the time. Sad - but its' a reality. It happened with the Covid vaccines, I'm sure.
Hi Maryanne, can I go back to this one. To be non judgemental, do we have a case of the older generation of virologists and public health officials being overawed by a generation of saving lives with spectacular results eg polio, MMR, diptheria etc. This undoudtely spurred a mentality to vaccinate all and be blind to adverse reactions. Pehaps they felt that the variabilty of reactions by individual immune systems could never predict adverse reactions. Not like drugs which mostly act on defined metabolic pathways and adverse reactions are more readily detected. This approval of Moderna's vaccine borders on criminal. Where was the ACIP? To continue with your latest posts on COVID19, big pharma is up to their usual tricks of side stepping adverse reactions and the FDA is complicit. Too many revolving doors?
I think the mentality is that they cannot fathom vaccines causing harm, so even if they have little or no efficacy, they’re still considered a safe bet.
Fantastic reporting MD. Been a fan of yours since I was a kid watching Catalyst on the ABC. During COVID it all made sense what happened to you during your report on statin's that went contrary to what pharma and other captured agencies wanted to hear. I hold you in the highest regard for your scientific literacy and journalistic integrity throughout the past several years. Happy to have gone from free reader to subscriber this month.
Thank you for doing the deep dive to uncover the lies that are found within the so called “gold standard” clinical studies of drug companies, Maryanne. This is the reason there is a loss of trust by the American people.
Why would the FDA approve a vaccine with numerous safety concerns described in your article? I would love to get your thoughts. I can only speculate the FDA thinks the benefits outweigh the harms. Also considering the bias built in to the entire vaccine enterprise including trials, studies, peer review, journals, regulatory process, health care conflicts of interest and legal shields for pharma ... I will default to the "do no harm strategy" for myself.
How does pharma do it and get away with it? They fund regulatory agencies as well as a bunch of other stuff, which gives them control. They fund medical departments at Universities, if one doctor speaks out against a pharma product (like in the cases of Bridle, Oliveri , Healy and Buckhaults, pharma steps in and threatens to pull funding if the university doesn’t get rid of the “offender.” It’s not just a firing but a lesson to along with the firing, where life for the offender gets destroyed, as Bridle explained it, “it’s like a nuclear bomb went off over my head.” They also destroy the person’s credibility to teach them a lesson. Reagan, opened this door wider with the prep act, which now makes them untouchable. Their methods work as all of these doctors have been rendered silenced. All regulatory agencies receive funding under a different name. The ACIP was disbanded for “stepping out.” Like me before this covid mess, I had no idea to the extent of the corruption.
I used to get a yearly flu shot but stopped after the covid shot injury. My close friend who had an adverse reaction to a flu shot maybe 8 or 10 years ago, where her face swelled up and became allergic to a host of things. Of course she was told the flu shot didn’t cause it which demonstrates the complete faith in a false god. She continues to get the flu shots to this day as well as about 8 covid shots. After reading this post, I want to send it to her. I have this feeling of urgency to warn people but really what’s the point. She was fine after all the covid shots so I understand where she’s coming from. It’s all so frustrating that not one group can take down this corrupt, powerful enterprise.
Drug manufacturers have a fiduciary obligation to their shareholders. The FDA has an obligation to protect the public. Pharma gets away with it because the FDA allows it. 😞
You’re right. We know that the top of the FDA is littered with corrupted people. The FDA may have some good honest people but have to toe the line or be removed. It’s all so sickening. Thank you.
re ' ...The FDA has an obligation to protect the public...'
The issue is the word 'protect' - it can't be total protection because that's not possible all drugs can cause harm. It's a question of where the line between harm and benefit is drawn and that is moveable while still claiming to protect the public, albeit at a lower level. And even then it will be a subjective population level decision which is not necessarily relevant to the individual.
ABPI ( Ass British Pharma Industries) their Code of Practice states that 'safe' should not be used to describe a drug unless the word is qualified. Perhaps 'protect' also needs a qualifier because at the moment it gives the impression of total protection.
Personally, I think the research papers and approvals are not worth the paper they are printed on.
Yes, as a citizen (or journalist) the single NEJM journal article costs US$55, which gives you access to the study and appendix…. That is where the bodies are buried.
Some are free. But the publishing companies that own these journals have astronomical profit margins. Big Pharma pays the journal millions to buy study reprints, which its sales reps then distribute to doctors as marketing material.
Efficacy RRR is a marketing metric on It’s own just like the COVID mRNA at 90% when we find out the Absolute Risk Reduction ARR was only 0.8% just like this mRNA flu injection is only 0.8% absolutely better than the normal flu injection but with the downside risk of 6 times the number of adverse conditions that will disrupt your daily life.
As simple as those facts are they provide enough informed consent for anyone with enough intelligence to understand those metrics which could be a doctor advising a patient/client, that you’d be bonkers to take it.
That’s without discussing and reviewing all the other dangerous genetic and metabolic disruption it can cause as well as organ and gland and vascular cellular death from this LNP technology invading your cells in the human body.
“Testifying at the hearings was Wayne Ray, PhD, professor of preventive medicine at Vanderbilt University, who had just published research in the New England Journal of Medicine suggesting that patients on antipsychotics like Seroquel showed double the risk of a “sudden, fatal, pulseless condition, or collapse.”104 The article was titled “Atypical Antipsychotic Drugs and the Risk of Sudden Cardiac Death.” [2009]. Asked by Tom Laughren, director of the FDA's Division of Psychiatry Products, why AstraZeneca's own drug trials didn't “pick up a difference in sudden cardiac death,” Ray replied that AstraZeneca's methodology suffered from “Simpson's paradox,” pooling data from all clinical trials into one large data set with no allowances for the differences in the trials. It is the same distortion that made drugs like Vioxx look safe, said Ray.105“ (Rosenberg M. Born with a junk food deficiency: how flaks, quacks, and hacks pimp the public health. Prometheus Books, 2012).
Yep! 🎯
Another great investigation and article Maryanne. The FDA’s conduct here is plainly indefensible, and it’s hard to avoid the conclusion that they colluded with the manufacturer to conceal that safety signal in order to push an unsafe product onto the market.
I cannot work out if the FDA reviewers are lazy, incompetent, or corrupt. Maybe it’s all 3 🤷🏻♀️
re '.. I cannot work out if the FDA reviewers are lazy, incompetent, or corrupt. Maybe it’s all 3...'
Can I suggest politically driven - we are being treated by politicians rather than medics. We saw it during the Covid shots, all countries in lockstep and now with mRNA manufacturing plants, driven by politicians; Biden's pre-emptive pardon for Fauci - he must have been doing Biden's bidding who would have been lobbied by pharma. The economy is everything if you want to get re-elected and receive political funds provided by industry.
I note that pharma was conspicuous by its absence in the recent Sen Paul Committee interrogating Fauci. A committee of politicians who would not want to attract attention to pharma's input, for fear of damaging the cash cow.
WSJ Saturday 8th August 2026. FDA reconsiders Replimune a melanoma drug now that Makary has gone. NB the last words in the quote below ' ....anger among ........Members of Congress...'
'Replimune said Friday that the Food and Drug Administration has agreed to reconsider its treatment for metastatic melanoma on an expedited basis. This bodes well for patients with melanoma and other diseases who were casualties of the prior FDA regime’s arbitrary drug rejections.
Marty Makary resigned earlier this month as FDA commissioner after the agency’s rejection of treatments for rare and debilitating diseases sparked anger among patients, doctors and Members of Congress. .....' https://www.wsj.com/opinion/fda-replimune-reversal-rp1-melanoma-kyle-diamantas-af92b345
And now we have mRNA raising its ugly head in a less than proprietary manner, supported by the FDA.
It has got to be political influence, Govts are responsible for the economy as well as the health of the nation - one must have priority and I can see which one.
Data torturing..
Imagine years ago suggesting that one day your vaccine control..was another vaccine..
Speed of $science$...
The mRNA platform should not be used for the general population. I could see it being used in cancer patients who have no other options that outside of that no
Bunch of Bloviating Bum Holes 💩
Thank, Maryanne! Will the people really fall in line again? Well! I will start warning my friends. I have one who asks me what I think and doesn’t get them. My brother has ALS thanks to believing the narrative. Maybe my sister can get through to him! This time!
Dr Matthew Phillips has research on ALS which may be of interest:
https://www.youtube.com/watch?v=6cqa9OVNthM
You watch , the Australian TGA will also approve this product as they are even more incompetent, lazy and corrupted.
For sure 😖
Putting aside the absurdity of approving this dangerous injection which was meant for cancer therapy and is mislabeled as a vaccine, where does a pharmaceutical company get 40,000 adults over age 50 to agree to participate in a study where it may possibly result in getting synthetic mRNA in lipid nanoparticles injected into oneself after the COVID debacle? Answer: I believe most of these study participants are professionals who make a living at allowing pharmaceutical companies to turn them into lifelong guinea pigs. What do we know about the health of these subjects, and how they compare to the average American who is not a pin cushion for whatever experimental injection big Pharma wants to trick us into injecting into ourselves? How reliable is any data that comes from pharmaceutical companies anyway, and when it is being done on people who are likely to have health characteristics quite different from the average citizen, based on their repeated exposure to experimental pharmaceutical toxins, how reliable would the results be anyway, even if the methodology and data analysis were sound? I raise this question because 40,000 subjects seems to be an incredible number given the terrible risks of take COVID-19 injections, which so many people now know about, and which would seemingly make such numbers difficult to muster.
The smaller trials recruited mostly from the US, but the pivotal trial of 40,000 people was conducted across 301 clinical trial sites, recruiting participants from 11 different countries. Most were from North America -- the rest recruited from Europe and Asia. Moderna has a separate company running the trials on its behalf. For the elderly participants, many obviously have multiple health problems, so if someone falls off the perch after vaccination, Moderna's investigators will simply rule that the death was due to pre-existing conditions rather than the vaccine. I imagine that happens all the time. Sad - but its' a reality. It happened with the Covid vaccines, I'm sure.
Hi Maryanne, can I go back to this one. To be non judgemental, do we have a case of the older generation of virologists and public health officials being overawed by a generation of saving lives with spectacular results eg polio, MMR, diptheria etc. This undoudtely spurred a mentality to vaccinate all and be blind to adverse reactions. Pehaps they felt that the variabilty of reactions by individual immune systems could never predict adverse reactions. Not like drugs which mostly act on defined metabolic pathways and adverse reactions are more readily detected. This approval of Moderna's vaccine borders on criminal. Where was the ACIP? To continue with your latest posts on COVID19, big pharma is up to their usual tricks of side stepping adverse reactions and the FDA is complicit. Too many revolving doors?
sorry, we do not save lives. We extend life expectancy.
I think the mentality is that they cannot fathom vaccines causing harm, so even if they have little or no efficacy, they’re still considered a safe bet.
Fantastic reporting MD. Been a fan of yours since I was a kid watching Catalyst on the ABC. During COVID it all made sense what happened to you during your report on statin's that went contrary to what pharma and other captured agencies wanted to hear. I hold you in the highest regard for your scientific literacy and journalistic integrity throughout the past several years. Happy to have gone from free reader to subscriber this month.
Thank you so much CuriousBean…. Grateful to have your support. 🙏
Thank you for doing the deep dive to uncover the lies that are found within the so called “gold standard” clinical studies of drug companies, Maryanne. This is the reason there is a loss of trust by the American people.
Maryanne, Best reporting on this that I have seen...as expected. Keep it up! R
Thanks Dr K 🙌
Why would the FDA approve a vaccine with numerous safety concerns described in your article? I would love to get your thoughts. I can only speculate the FDA thinks the benefits outweigh the harms. Also considering the bias built in to the entire vaccine enterprise including trials, studies, peer review, journals, regulatory process, health care conflicts of interest and legal shields for pharma ... I will default to the "do no harm strategy" for myself.
Why? As I mentioned earlier on this thread, reviewers are either lazy, incompetent or corrupt — or some combination of the three.
Thanks for the direct answer.
How does pharma do it and get away with it? They fund regulatory agencies as well as a bunch of other stuff, which gives them control. They fund medical departments at Universities, if one doctor speaks out against a pharma product (like in the cases of Bridle, Oliveri , Healy and Buckhaults, pharma steps in and threatens to pull funding if the university doesn’t get rid of the “offender.” It’s not just a firing but a lesson to along with the firing, where life for the offender gets destroyed, as Bridle explained it, “it’s like a nuclear bomb went off over my head.” They also destroy the person’s credibility to teach them a lesson. Reagan, opened this door wider with the prep act, which now makes them untouchable. Their methods work as all of these doctors have been rendered silenced. All regulatory agencies receive funding under a different name. The ACIP was disbanded for “stepping out.” Like me before this covid mess, I had no idea to the extent of the corruption.
I used to get a yearly flu shot but stopped after the covid shot injury. My close friend who had an adverse reaction to a flu shot maybe 8 or 10 years ago, where her face swelled up and became allergic to a host of things. Of course she was told the flu shot didn’t cause it which demonstrates the complete faith in a false god. She continues to get the flu shots to this day as well as about 8 covid shots. After reading this post, I want to send it to her. I have this feeling of urgency to warn people but really what’s the point. She was fine after all the covid shots so I understand where she’s coming from. It’s all so frustrating that not one group can take down this corrupt, powerful enterprise.
Drug manufacturers have a fiduciary obligation to their shareholders. The FDA has an obligation to protect the public. Pharma gets away with it because the FDA allows it. 😞
You’re right. We know that the top of the FDA is littered with corrupted people. The FDA may have some good honest people but have to toe the line or be removed. It’s all so sickening. Thank you.
re ' ...The FDA has an obligation to protect the public...'
The issue is the word 'protect' - it can't be total protection because that's not possible all drugs can cause harm. It's a question of where the line between harm and benefit is drawn and that is moveable while still claiming to protect the public, albeit at a lower level. And even then it will be a subjective population level decision which is not necessarily relevant to the individual.
ABPI ( Ass British Pharma Industries) their Code of Practice states that 'safe' should not be used to describe a drug unless the word is qualified. Perhaps 'protect' also needs a qualifier because at the moment it gives the impression of total protection.
Personally, I think the research papers and approvals are not worth the paper they are printed on.
Can you explain a paywall? Does that mean you have to pay to read a journal?
Yes, as a citizen (or journalist) the single NEJM journal article costs US$55, which gives you access to the study and appendix…. That is where the bodies are buried.
At one time they were free to read. Not many regular folk read journals, but to have to pay for it now, will reduce the number. Sad.
Some are free. But the publishing companies that own these journals have astronomical profit margins. Big Pharma pays the journal millions to buy study reprints, which its sales reps then distribute to doctors as marketing material.
This is new to me, I didn’t know the sales reps then distributes the study reprints to doctors. It’s scandalous and truly frightening. Thank you.
I wish I could say I’m surprised. Buuuuut, not so much.
Efficacy RRR is a marketing metric on It’s own just like the COVID mRNA at 90% when we find out the Absolute Risk Reduction ARR was only 0.8% just like this mRNA flu injection is only 0.8% absolutely better than the normal flu injection but with the downside risk of 6 times the number of adverse conditions that will disrupt your daily life.
As simple as those facts are they provide enough informed consent for anyone with enough intelligence to understand those metrics which could be a doctor advising a patient/client, that you’d be bonkers to take it.
That’s without discussing and reviewing all the other dangerous genetic and metabolic disruption it can cause as well as organ and gland and vascular cellular death from this LNP technology invading your cells in the human body.