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.
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.
Bunch of Bloviating Bum Holes 💩
“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! 🎯
Data torturing..
Imagine years ago suggesting that one day your vaccine control..was another vaccine..
Speed of $science$...
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.
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.