This may just be an odd way of thinking about it but If public health policy is to be based on science then there needs to be full transparency. Without it there is no distinction between basis health policy on science versus basing it on religious belief. If the US wants to continue to separate church and state then its 'science' based policies cannot rely on the faith of citizens. Without the data the madates/polcies and law are void.
Nov 15, 2023·edited Nov 15, 2023Liked by Tracy Beth Høeg, MD, PhD
Thank you for all you do. You are truly a rare type of clear-thinking and courageous clinician/researcher. My brief input: One big problem (as I see it) is that our 'so-called' health system in the USA is actually a "disease-management system". It is even evident in the the name of the CDC (i.e. center for "disease control' as opposed to center for health promotion) The primary goal in this so-called healthcare system is revenue of course. Profits are the greatest when there is just enough disease present in the society to maximize the need (perceived or actual) for various so-called health care services. That said, the most powerful players in this system don't want everyone in society to be too sick, because someone has to work and produce economic wealth so that the healthcare system can then extract and/or transfer this wealth to themselves via their ingenious multi-stream approach (testing, detection, pharmaceuticals, surgical interventions, etc.) IMHO, we need a massive paradigm shift to focus on health promotion as opposed to disease management. But this will never succeed unless/until we agree upon a clear and rational definition of the word "Health" (which has not happened yet, IMHO). Health should be our goal, health should be our destination, health should be what we aspire to. We should be striving for health individually and collectively. But you can not aspire to something if you do not clearly know what it is or if folks/institutions do not agree on the definition. I would love to see the state of Florida adopt the following definition: "Health- The presence of proper function from the cellular (micro) level to the social (macro) level." If the state of Florida could somehow adopt this definition and declare a "first principle", then what would flow from that would be more of a true healthcare system, wherein health is the objective. Thank you for reading. :-)
The website originally said it would be published in early 2023 (data collection was completed well over a year ago). After I asked where the study was, they removed the completion date from the website. I have emailed the authors multiple times - they always say that they have lots of data to work through but are almost finished, or that they are finished but awaiting publication. Nothing so far.
Interesting. Thanks. I was not aware of this and also wonder what the hold up is, though they do say "long term outcomes" but if the authors say they are analyzing the data, they must be done collecting it. This will be a good study once they make the results available since there were 323 people with myo/pericarditis. That in itself is telling considering the population of New Zealand is only 5 million, right?
On the trial registry site it says that they finished data collection on the 10th October 2022. I had this from them in July 2023:
"Thank you for your email. We appreciate that you have been waiting some time for the results of the study. The study has now concluded and is currently undergoing a robust review process. We will inform you when it is finalised and published.
We appreciate your patience."
And then September:
"The study has now completed and it is undergoing peer review. We aim to update study participants latest by the end of the year, but hope to do so
as soon as review has concluded.
Thank you for your patience."
I downloaded the full Medsafe Adverse Events dataset a while back, and graphed just the peri/myo numbers (https://splendidmarvellous.substack.com/p/new-zealand-pfizer-vaccine-safety). We were seeing significantly higher than expected rates, particularly in the under 60s. While this data was publicly available at the time, there were certainly no media going through it and checking it, which is a real shame.
Nice job with your substack. I got censored on Twitter the same data June 10th Peter Doshi basically said the same thing I did which is especially given myocarditis risks we could not say with certainty the benefit of the vaccine in healthy children outweighed the risk. Our group reported myocarditis rates of 192/million post dose 2 boys 12-15 using VAERS https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1. Same experience: the media was not interested in the numbers, only in attacking us. Interesting NZ had more similar rates post dose 2 as dose 1. I bet that is because it was on people's radars in NZ since you guys were behind us in recommending it to young people and your population was more aware of the myocarditis risk and thought of reporting it.
I shudder to think what the true numbers might be. Our doctors were heavily censored here. The Medical Council warned them they were not to say anything which might discourage vaccine uptake. Several doctors were struck off (eg for suggesting that it had not been tested in pregnant women yet). When my fit, healthy 12yo niece developed symptoms consistent with myo, her GP diagnosed her as having reflux and 'puberty' and put her on omeprazole. She was crook for quite some time. No cardio workup beyond an ecg. I hear many similar stories.
Much gratitude to people like you and Doshi who have really stuck their necks out in defence of both science and people.
The paper below provides evidence in support of your points regarding problems with the FDA, journal review of clinical trial results, and others. Please read and contact the authors for clarification.
Michels et al. 2023. Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial. International Journal Vaccine Theory, Practice, and Research 3(1): 973-1009. https://doi.org/10.56098/ijvtpr.v3i1.85
Thanks this is really interesting. I had heard this mentioned but had not seen the study. I appreciate that link. It looks like the difference in the death rate occurs after the switch to using some process 2 vaccine. (right after EUA)
Apparently not. We have reviewed the lot numbers and it isn’t likely that Process 2 vaccine was used with the exception of the 252 subjects who were in the limited Process 2 trial in early November.
We (the authors of the paper) are looking at explanations for why there were more AEs for unblinded placebos. We are also questioning why there was such a high rate of AEs in the placebo arm. 0.3 ml of saline should not cause much more than a sore injection site if that.
Good point. Yes only 252 receiving process 2 should not have created the difference but wasn't there a higher rate of AEs among those receiving process 2, but perhaps not deaths? Re the placebo AEs, weren't they reporting all AEs and not just those the investigators felt were due to the vaccine/placebo. One would need to know the background rate of all of the AEs. I remember I calculated that for Bell's palsy with the initial Pfizer trial and the vaccine arm had a much higher Bell's palsy rate than expected background rate. For that reason I recommended if people were going to be vaccinated they choose Moderna over Pfizer. But then my whole calculus changed in the spring when we learned about myocarditis and the fact the vaccines were only transiently effective against infection
We are working from Pfizer's 6-Month Interim Report of Adverse Events. It's a PDF document that we converted to Excel file that could be searched. The PDF is over 3600 pages. We assume that all of the AEs reported to Pfizer are in this file.
The first 6,000 subjects enrolled in the trial were given phones and asked to report daily on a select list of "reactogenic events" like sore arm, fever, fatigue, etc. After this first 6,000 subjects, the subjects had to report doctor visits, telemedicine, hospitalization, etc. The protocol described this and I'd have to go back as read it to be sure what the subjects were told. In the 6-Month Report, Pfizer would review each report and decide whether it was related to the vaccine. Unless it was within the first 4-7 days, Pfizer said it was unrelated. So, all AEs were reported and Pfizer decided later whether they were related. From my understanding, the decision of whether an AE is related to the treatment is not a decision of the trial sponsor. It should be done at the close of the trial by statisticians. Read our paper. We say this.
Yes, there was a Bell's palsy signal. We planned to get to this in future manuscripts. Pfizer said in their EUA and in Polack et al that the numbers were too small. We would not agree. The problem is that the analysis requires that there be a placebo control. It is not appropriate to compare frequency to the population in 2019. Read our paper for the explanation. Unblinding the placebo destroyed this trial. There was no ethical reason to unblind. Read the paper. The FDA gave them permission to unblind!
In all seriousness, why not take the next logical leap and question why we need an FDA or CDC? Just like airplanes wouldn’t start falling from the sky if we abolished the US FAA, because airlines would be forced to regulate themselves and prove to the public that their planes are safe, pharmaceutical “regulation” wouldn’t vanish, it would necessarily transform to better serve patients and the medical community.
Great article. I would add that we need rule of law in healthcare. Consumers should have access to prices for medical services up front. No more rampant price fixing and discrimination based on whether you have insurance or what plan you have. These illegal practices must be prosecuted immediately. Also, no more charging U.S. consumers massively inflated drug prices far beyond what consumers in other nations pay for the same drug. In other words, stop the criminal racket that is U.S. healthcare. This is very unlikely to happen since the healthcare industry has purchased our elected politicians who serve their owners and not the people. One can at least hope for a miracle though before the nation fiscally collapses due to massively inflated healthcare costs and borrowing massively to pay for it. Thank you.
Hi, first of all, I would like to thank you for everything you have done for the past 4 years to open people’s eyes and get them to critically think about the Covid narrative and the mandated vaccines. I opened a Twitter account in 2020. Your account was one of the first accounts I followed. Your posts really opened my eyes to main stream media, the lies I had willingly excepted for decades, and subsequently pushed me to do my own research and find alternative sources of the news.
We chose not to vaccinate for Covid, because I have had two heart surgeries in the past and knew that no one had researched my specific issue and how this vaccine would affect it.
This choice became very divisive. My family was not invited to a family wedding and not included in many gatherings.
I was angry for a long time and then chose to turn that anger into courage (after a visit to St Augustine Florida) and found a group in Minnesota, called Team Humanity that supports Minnesotans who have been injured by the Covid vaccine.
My volunteer job is to write stories on Substack of the vaccine injured. I have two stories that I think you would find interesting.
The first one is of Brandon. Brandon was mandated to take the vaccine by his work and then was injured. He turned his anger also into courage and ran for mayor of his small town in Minnesota and passed a healthcare freedom resolution.
Suzanna started Minnesota Team Humanity after suffering from a life altering vaccine injury She has spoke at many local and national political rallies. She believes that vaccine injury should not be a political issue and therefore Minnesota Team Humanity lives in the purple zone so to speak-not political, not blue or red-vaccine injury is a humanity issue.
I am including two links. The first is to the story I wrote about Suzanna and her injury and starting Team Humanity. The second is an essay that we published for her this week about the loneliness that happens when you are vaccine injured.
Thank you for reading their stories. Like your reporting MN Team Humanity is trying to inform people of the true stories of Americans, not the narrative.
Public Health should be educating public re dangers of chronic daily use of cannabis especially in youth. Many youth under age 25 are vaping high concentrate from waking until bedtime. This is currently normalized in our society. CDC has obligation to warn against this practice and specify exact risks including paranoia, delusions, psychotic episodes, worsening anxiety and depression, sleep disruption, ADHD type symptoms, tolerance and addiction. How many recent mass shooters were chronic daily users of cannabis? Many people do not know that cannabis use is absolute contraindication during pregnancy. Most health care providers and therapists do not even ask about much less quantify cannabis usage in their patients. They would likely be shocked! We desperately need a public health campaign regarding the dangers of cannabis.
The recent multi-year drop in US life expectancy has real causes that need to be understood.
Absolutely amazing write up Tracy. You continue to be a beacon.
That list of studies that the fda just refuses to comment on is so blatantly criminal, it baffles me how this is even possible.
Keep up the fantastic work.
This may just be an odd way of thinking about it but If public health policy is to be based on science then there needs to be full transparency. Without it there is no distinction between basis health policy on science versus basing it on religious belief. If the US wants to continue to separate church and state then its 'science' based policies cannot rely on the faith of citizens. Without the data the madates/polcies and law are void.
Thank you for all you do. You are truly a rare type of clear-thinking and courageous clinician/researcher. My brief input: One big problem (as I see it) is that our 'so-called' health system in the USA is actually a "disease-management system". It is even evident in the the name of the CDC (i.e. center for "disease control' as opposed to center for health promotion) The primary goal in this so-called healthcare system is revenue of course. Profits are the greatest when there is just enough disease present in the society to maximize the need (perceived or actual) for various so-called health care services. That said, the most powerful players in this system don't want everyone in society to be too sick, because someone has to work and produce economic wealth so that the healthcare system can then extract and/or transfer this wealth to themselves via their ingenious multi-stream approach (testing, detection, pharmaceuticals, surgical interventions, etc.) IMHO, we need a massive paradigm shift to focus on health promotion as opposed to disease management. But this will never succeed unless/until we agree upon a clear and rational definition of the word "Health" (which has not happened yet, IMHO). Health should be our goal, health should be our destination, health should be what we aspire to. We should be striving for health individually and collectively. But you can not aspire to something if you do not clearly know what it is or if folks/institutions do not agree on the definition. I would love to see the state of Florida adopt the following definition: "Health- The presence of proper function from the cellular (micro) level to the social (macro) level." If the state of Florida could somehow adopt this definition and declare a "first principle", then what would flow from that would be more of a true healthcare system, wherein health is the objective. Thank you for reading. :-)
Thanks for this comment, John. Interesting idea.
Studies not followed through must be a global thing. In NZ we were promised this study: https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-side-effects-and-reactions/covid-19-vaccine-myocarditis-and-pericarditis-study
The website originally said it would be published in early 2023 (data collection was completed well over a year ago). After I asked where the study was, they removed the completion date from the website. I have emailed the authors multiple times - they always say that they have lots of data to work through but are almost finished, or that they are finished but awaiting publication. Nothing so far.
Interesting. Thanks. I was not aware of this and also wonder what the hold up is, though they do say "long term outcomes" but if the authors say they are analyzing the data, they must be done collecting it. This will be a good study once they make the results available since there were 323 people with myo/pericarditis. That in itself is telling considering the population of New Zealand is only 5 million, right?
I do wonder if they ever will release it.
On the trial registry site it says that they finished data collection on the 10th October 2022. I had this from them in July 2023:
"Thank you for your email. We appreciate that you have been waiting some time for the results of the study. The study has now concluded and is currently undergoing a robust review process. We will inform you when it is finalised and published.
We appreciate your patience."
And then September:
"The study has now completed and it is undergoing peer review. We aim to update study participants latest by the end of the year, but hope to do so
as soon as review has concluded.
Thank you for your patience."
I downloaded the full Medsafe Adverse Events dataset a while back, and graphed just the peri/myo numbers (https://splendidmarvellous.substack.com/p/new-zealand-pfizer-vaccine-safety). We were seeing significantly higher than expected rates, particularly in the under 60s. While this data was publicly available at the time, there were certainly no media going through it and checking it, which is a real shame.
Nice job with your substack. I got censored on Twitter the same data June 10th Peter Doshi basically said the same thing I did which is especially given myocarditis risks we could not say with certainty the benefit of the vaccine in healthy children outweighed the risk. Our group reported myocarditis rates of 192/million post dose 2 boys 12-15 using VAERS https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1. Same experience: the media was not interested in the numbers, only in attacking us. Interesting NZ had more similar rates post dose 2 as dose 1. I bet that is because it was on people's radars in NZ since you guys were behind us in recommending it to young people and your population was more aware of the myocarditis risk and thought of reporting it.
I shudder to think what the true numbers might be. Our doctors were heavily censored here. The Medical Council warned them they were not to say anything which might discourage vaccine uptake. Several doctors were struck off (eg for suggesting that it had not been tested in pregnant women yet). When my fit, healthy 12yo niece developed symptoms consistent with myo, her GP diagnosed her as having reflux and 'puberty' and put her on omeprazole. She was crook for quite some time. No cardio workup beyond an ecg. I hear many similar stories.
Much gratitude to people like you and Doshi who have really stuck their necks out in defence of both science and people.
The paper below provides evidence in support of your points regarding problems with the FDA, journal review of clinical trial results, and others. Please read and contact the authors for clarification.
Michels et al. 2023. Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial. International Journal Vaccine Theory, Practice, and Research 3(1): 973-1009. https://doi.org/10.56098/ijvtpr.v3i1.85
Thanks this is really interesting. I had heard this mentioned but had not seen the study. I appreciate that link. It looks like the difference in the death rate occurs after the switch to using some process 2 vaccine. (right after EUA)
Apparently not. We have reviewed the lot numbers and it isn’t likely that Process 2 vaccine was used with the exception of the 252 subjects who were in the limited Process 2 trial in early November.
We (the authors of the paper) are looking at explanations for why there were more AEs for unblinded placebos. We are also questioning why there was such a high rate of AEs in the placebo arm. 0.3 ml of saline should not cause much more than a sore injection site if that.
Good point. Yes only 252 receiving process 2 should not have created the difference but wasn't there a higher rate of AEs among those receiving process 2, but perhaps not deaths? Re the placebo AEs, weren't they reporting all AEs and not just those the investigators felt were due to the vaccine/placebo. One would need to know the background rate of all of the AEs. I remember I calculated that for Bell's palsy with the initial Pfizer trial and the vaccine arm had a much higher Bell's palsy rate than expected background rate. For that reason I recommended if people were going to be vaccinated they choose Moderna over Pfizer. But then my whole calculus changed in the spring when we learned about myocarditis and the fact the vaccines were only transiently effective against infection
We are working from Pfizer's 6-Month Interim Report of Adverse Events. It's a PDF document that we converted to Excel file that could be searched. The PDF is over 3600 pages. We assume that all of the AEs reported to Pfizer are in this file.
The first 6,000 subjects enrolled in the trial were given phones and asked to report daily on a select list of "reactogenic events" like sore arm, fever, fatigue, etc. After this first 6,000 subjects, the subjects had to report doctor visits, telemedicine, hospitalization, etc. The protocol described this and I'd have to go back as read it to be sure what the subjects were told. In the 6-Month Report, Pfizer would review each report and decide whether it was related to the vaccine. Unless it was within the first 4-7 days, Pfizer said it was unrelated. So, all AEs were reported and Pfizer decided later whether they were related. From my understanding, the decision of whether an AE is related to the treatment is not a decision of the trial sponsor. It should be done at the close of the trial by statisticians. Read our paper. We say this.
Yes, there was a Bell's palsy signal. We planned to get to this in future manuscripts. Pfizer said in their EUA and in Polack et al that the numbers were too small. We would not agree. The problem is that the analysis requires that there be a placebo control. It is not appropriate to compare frequency to the population in 2019. Read our paper for the explanation. Unblinding the placebo destroyed this trial. There was no ethical reason to unblind. Read the paper. The FDA gave them permission to unblind!
Good work. Stick with it.
In all seriousness, why not take the next logical leap and question why we need an FDA or CDC? Just like airplanes wouldn’t start falling from the sky if we abolished the US FAA, because airlines would be forced to regulate themselves and prove to the public that their planes are safe, pharmaceutical “regulation” wouldn’t vanish, it would necessarily transform to better serve patients and the medical community.
Great article. I would add that we need rule of law in healthcare. Consumers should have access to prices for medical services up front. No more rampant price fixing and discrimination based on whether you have insurance or what plan you have. These illegal practices must be prosecuted immediately. Also, no more charging U.S. consumers massively inflated drug prices far beyond what consumers in other nations pay for the same drug. In other words, stop the criminal racket that is U.S. healthcare. This is very unlikely to happen since the healthcare industry has purchased our elected politicians who serve their owners and not the people. One can at least hope for a miracle though before the nation fiscally collapses due to massively inflated healthcare costs and borrowing massively to pay for it. Thank you.
Hi, first of all, I would like to thank you for everything you have done for the past 4 years to open people’s eyes and get them to critically think about the Covid narrative and the mandated vaccines. I opened a Twitter account in 2020. Your account was one of the first accounts I followed. Your posts really opened my eyes to main stream media, the lies I had willingly excepted for decades, and subsequently pushed me to do my own research and find alternative sources of the news.
We chose not to vaccinate for Covid, because I have had two heart surgeries in the past and knew that no one had researched my specific issue and how this vaccine would affect it.
This choice became very divisive. My family was not invited to a family wedding and not included in many gatherings.
I was angry for a long time and then chose to turn that anger into courage (after a visit to St Augustine Florida) and found a group in Minnesota, called Team Humanity that supports Minnesotans who have been injured by the Covid vaccine.
My volunteer job is to write stories on Substack of the vaccine injured. I have two stories that I think you would find interesting.
The first one is of Brandon. Brandon was mandated to take the vaccine by his work and then was injured. He turned his anger also into courage and ran for mayor of his small town in Minnesota and passed a healthcare freedom resolution.
Suzanna started Minnesota Team Humanity after suffering from a life altering vaccine injury She has spoke at many local and national political rallies. She believes that vaccine injury should not be a political issue and therefore Minnesota Team Humanity lives in the purple zone so to speak-not political, not blue or red-vaccine injury is a humanity issue.
I am including two links. The first is to the story I wrote about Suzanna and her injury and starting Team Humanity. The second is an essay that we published for her this week about the loneliness that happens when you are vaccine injured.
Thank you for reading their stories. Like your reporting MN Team Humanity is trying to inform people of the true stories of Americans, not the narrative.
Warmly, Lindsay
776a7e49-4705-44ed-bd10-52c7f6f5a031_1080x1596.jpeg
Brandon
teamhumanity.substack.com
f6e86f4b-e7c2-4871-bb55-fbf6cff1f986_1600x1200.jpeg
Neighbors Helping Neighbors…
teamhumanity.substack.com
b9083fca-226d-4273-9052-46a8775afb4f_4256x2832.jpeg
A Cure for Loneliness=Team Humanity
teamhumanity.substack.com
I find it strange he would not pull expert MDs etc from out state. I have second home in Fl, DeSantis is not always how he projects himself.
Public Health should be educating public re dangers of chronic daily use of cannabis especially in youth. Many youth under age 25 are vaping high concentrate from waking until bedtime. This is currently normalized in our society. CDC has obligation to warn against this practice and specify exact risks including paranoia, delusions, psychotic episodes, worsening anxiety and depression, sleep disruption, ADHD type symptoms, tolerance and addiction. How many recent mass shooters were chronic daily users of cannabis? Many people do not know that cannabis use is absolute contraindication during pregnancy. Most health care providers and therapists do not even ask about much less quantify cannabis usage in their patients. They would likely be shocked! We desperately need a public health campaign regarding the dangers of cannabis.