Summary The Informed Consent Action Network (ICAN) has forced the FDA to release data from the Pfizer trial, this includes mortality, adverse event, and demographic data (health and age). The data paints a picture of unequivocally non-random patterns in a data set that should be random except for the impact of the vaccine being studied.
Anyone know what the placebo was? Pharma have a habit of using another vaccine as a placebo and not an inert substance because it obscures safety signals.
Extremely similar (and alarming) patterns as those discussed here for Pfizer are ALSO present in the Moderna clinical trial mortality results: early mortality appeared to favor the vaccine, but after a few months excess deaths started accumulating in the vaccine arm relative to the placebo arm (before the trials were quickly unblinded). Those CONSISTENT results between Pfizer and Moderna are key. Also, just like for Pfizer as discussed in this article, the OLDER age group is where the excess all-cause vaccine deaths relative to placebo occurred in the Moderna trial as well (contrary to popular belief).
Also, don't forget the breakdown of CAUSE OF DEATH between the vaccine and placebo arms, which is also very consistent between the Pfizer and Moderna trials. The fact that "total deaths are similar between vaccine and placebo arms" is dangerously misleading, because the CAUSE OF DEATH breakdown between vaccine and placebo arms is NOT similar. For Pfizer and Moderna combined:
COVID deaths: 2 vaccine vs. 5 placebo (-60%)
non-COVID deaths: 29 vaccine vs. 25 placebo (+16%)
cardiovascular deaths: 16 vaccine vs. 11 placebo (+45%)
Overall: 4 more non-COVID deaths, 3 less COVID deaths (bluntly put, 4 KILLED FOR EVERY 3 SAVED)
Oct 20, 2023Liked by Martin Neil, Tore A. Gulbrandsen
Excellent and important piece, thanks.
"fraudulent or systematic data manipulation" is indeed a thought one can entertain after looking at this trial. See also this work by Josh Guetzkow & myself, re strangely missing increments.
The issue if the data manager is compromised is that every guarantee we're supposed to have from GCP falls. We need an independent and transparent audit of ICON.
"Another theoretically possible explanation – if one really wants to stretch the imagination and engage in conspiratorial ideation – would be fraudulent or systematic data manipulation. But let us leave speculations aside for a moment and have a closer look at what the data says about differences between the two arms."
Hat tip setting aside speculation to wade through the numbers so folks like me who assume criminal liars are always lying have your hard work to cite & back it up! Kudos & thanks <3
Oct 20, 2023·edited Oct 22, 2023Liked by Tore A. Gulbrandsen
Tore, thank you for this analysis of these previously hidden data. I have three questions.
1) In your conclusions you state:
"Furthermore, we have seen that prior health status is different between the two arms..."
I believe you meant to say that prior health status is different between the two arms of those who suffered an adverse event. Am I correct? If so, the significant finding here is the increased incidence of adverse events among placebo recipients (15% more according to your calculations). That is indeed indicative of a non-inert placebo or a reassignment from the therapy group to the control (or both). With more adverse events occurring in placebo recipients, as inexplicable as it is, we would expect there to be more in each subgroup categorized by health status, right?
2) Can you please clarify and unpack this a bit more:
"If the healthy people were selected to the vaccine arm, then why are 81 of the cases in the placebo arm people with “No Medical History” while only 56 cases in the vaccine arm are people with no medical history? Surely it should be the other way around if the healthy people were selected to the vaccine arm? And if the placebo was not inert at all, then we would expect similar rates between the two arms, not elevated solely in the placebo arm."
Are you pointing out the paradoxically higher rate of adverse events in people who got the placebo, or are you suggesting that something else is going on here? Why would we expect similar rates if the placebo was "not inert at all"? Wouldn't depend on how toxic the placebo was compared to the vaccine?
3) Did you find anything peculiar about the distribution of SAEs in general (not just the cardiac related ones)?
I am interested in the general question as to why so many placebo recipients developed an SAE (Serious Adverse Event). These SAEs, by definition and description, are serious indeed. Pfizer claimed that 0.5% of placebo recipients, who were generally young and healthy like all participants, suffered a SAE in the initial observational period which lasted an average of only six weeks. This seems unimaginable to me. This finding allowed the investigators and regulators to excuse the 0.6% rate of SAEs in the treatment arm.
I would like to point to the fact that not less than 100 subjects were said to have been randomised but not exposed.
Even with 44k randomised, 100 appears to be a lot. 100 subjects could almost every variable turn into a misleading direction; think of the "only" 38 deaths. And these 100 do not occur in any table (except the disposition) and in almost no listing, at least not in any listing readable for us.
Hence, shifts could have occurred not only between the randomization groups, but, for me more likely, between the vax group and the pool of not exposed subjects.
I would encourage you to take a closer look to the "Randomised but exposed" people. There were in fact 100! As to my opinion far too much, even for 44k randomised.
The point here is: You hardly find these people. The CSR provides nearly no details. The listings are also empty. These cases appear as lost from the earth.
Please consider these 100 cases. They could move almost every variable in a bad direction - or vice versa to neutrality.
"The observed patterns cannot be the result of random occurrence. The only explanation compatible with all the non-random patterns is that the records of vaccine recipients suffering adverse events and death were changed, moving them to the placebo arm after the event."
This is incredible. We're talking CRIMINAL FRAUD here. All corporate officers of Pfizer need to be arrested an prosecuted.
About 6 months ago I read that it is possible that the placebo could have things in it that could cause harm and not contain the control substance. is that true and if so, could that be the thing causing problems for the placebo group?
Thanks so much for your revealing analysis! I have one little quibble and one question.
1. You write: "the initial death rate during the first 80 days might represent the background death rate". That's likely still too high: apparently there were one or more deaths from vaccination within three weeks.
Good Post! I was looking long and hard at the person time in this study too. As Tore says, there should be way less person years for the placebo than the vaxxed. But if you look at pfizers 6 month study in the NEJM, they record them as both the same. Is it possible for them to be so stupid? Then we have the report that 2 of the placebo deaths occurred after they had been unblinded and given the juice. But they were still counted as placebo. Does this explain the bump up in deaths occurring at 80-100 days? That's around the time the placebo were getting the juice. Did they share the deaths around to make it look balanced? Were there also deaths in the vax arm in the first few weeks after vax that were eliminated because they occurred before the vax had built up full strength (ie from 1 dose to 7 days after dose 2)?
With all these anomalies the only thing to do is throw your hands in the air and call them out for BS...And it's not like pfizzer hasn't got a history for that.
There could be a simpler explanation. They say they used saline as a placebo but did not. As in so many vaccine trials, they could have used another vaccine, or the « carrier » (LNP’s without RNA)
Anyone know what the placebo was? Pharma have a habit of using another vaccine as a placebo and not an inert substance because it obscures safety signals.
Wow, that is quite the allegation.
Thank you!
Extremely similar (and alarming) patterns as those discussed here for Pfizer are ALSO present in the Moderna clinical trial mortality results: early mortality appeared to favor the vaccine, but after a few months excess deaths started accumulating in the vaccine arm relative to the placebo arm (before the trials were quickly unblinded). Those CONSISTENT results between Pfizer and Moderna are key. Also, just like for Pfizer as discussed in this article, the OLDER age group is where the excess all-cause vaccine deaths relative to placebo occurred in the Moderna trial as well (contrary to popular belief).
Also, don't forget the breakdown of CAUSE OF DEATH between the vaccine and placebo arms, which is also very consistent between the Pfizer and Moderna trials. The fact that "total deaths are similar between vaccine and placebo arms" is dangerously misleading, because the CAUSE OF DEATH breakdown between vaccine and placebo arms is NOT similar. For Pfizer and Moderna combined:
COVID deaths: 2 vaccine vs. 5 placebo (-60%)
non-COVID deaths: 29 vaccine vs. 25 placebo (+16%)
cardiovascular deaths: 16 vaccine vs. 11 placebo (+45%)
Overall: 4 more non-COVID deaths, 3 less COVID deaths (bluntly put, 4 KILLED FOR EVERY 3 SAVED)
Pfizer: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf – Table S4
Moderna: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2113017/suppl_file/nejmoa2113017_appendix.pdf – Table S26
Summary paper: https://www.cell.com/iscience/fulltext/S2589-0042(23)00810-6
Excellent and important piece, thanks.
"fraudulent or systematic data manipulation" is indeed a thought one can entertain after looking at this trial. See also this work by Josh Guetzkow & myself, re strangely missing increments.
https://openvaet.substack.com/p/pfizerbiontech-c4591001-trial-the
The issue if the data manager is compromised is that every guarantee we're supposed to have from GCP falls. We need an independent and transparent audit of ICON.
"Another theoretically possible explanation – if one really wants to stretch the imagination and engage in conspiratorial ideation – would be fraudulent or systematic data manipulation. But let us leave speculations aside for a moment and have a closer look at what the data says about differences between the two arms."
Hat tip setting aside speculation to wade through the numbers so folks like me who assume criminal liars are always lying have your hard work to cite & back it up! Kudos & thanks <3
Tore, thank you for this analysis of these previously hidden data. I have three questions.
1) In your conclusions you state:
"Furthermore, we have seen that prior health status is different between the two arms..."
I believe you meant to say that prior health status is different between the two arms of those who suffered an adverse event. Am I correct? If so, the significant finding here is the increased incidence of adverse events among placebo recipients (15% more according to your calculations). That is indeed indicative of a non-inert placebo or a reassignment from the therapy group to the control (or both). With more adverse events occurring in placebo recipients, as inexplicable as it is, we would expect there to be more in each subgroup categorized by health status, right?
2) Can you please clarify and unpack this a bit more:
"If the healthy people were selected to the vaccine arm, then why are 81 of the cases in the placebo arm people with “No Medical History” while only 56 cases in the vaccine arm are people with no medical history? Surely it should be the other way around if the healthy people were selected to the vaccine arm? And if the placebo was not inert at all, then we would expect similar rates between the two arms, not elevated solely in the placebo arm."
Are you pointing out the paradoxically higher rate of adverse events in people who got the placebo, or are you suggesting that something else is going on here? Why would we expect similar rates if the placebo was "not inert at all"? Wouldn't depend on how toxic the placebo was compared to the vaccine?
3) Did you find anything peculiar about the distribution of SAEs in general (not just the cardiac related ones)?
I am interested in the general question as to why so many placebo recipients developed an SAE (Serious Adverse Event). These SAEs, by definition and description, are serious indeed. Pfizer claimed that 0.5% of placebo recipients, who were generally young and healthy like all participants, suffered a SAE in the initial observational period which lasted an average of only six weeks. This seems unimaginable to me. This finding allowed the investigators and regulators to excuse the 0.6% rate of SAEs in the treatment arm.
Thank you.
Excellent analysis!
I would like to point to the fact that not less than 100 subjects were said to have been randomised but not exposed.
Even with 44k randomised, 100 appears to be a lot. 100 subjects could almost every variable turn into a misleading direction; think of the "only" 38 deaths. And these 100 do not occur in any table (except the disposition) and in almost no listing, at least not in any listing readable for us.
Hence, shifts could have occurred not only between the randomization groups, but, for me more likely, between the vax group and the pool of not exposed subjects.
Excellent!
I would encourage you to take a closer look to the "Randomised but exposed" people. There were in fact 100! As to my opinion far too much, even for 44k randomised.
The point here is: You hardly find these people. The CSR provides nearly no details. The listings are also empty. These cases appear as lost from the earth.
Please consider these 100 cases. They could move almost every variable in a bad direction - or vice versa to neutrality.
"The observed patterns cannot be the result of random occurrence. The only explanation compatible with all the non-random patterns is that the records of vaccine recipients suffering adverse events and death were changed, moving them to the placebo arm after the event."
This is incredible. We're talking CRIMINAL FRAUD here. All corporate officers of Pfizer need to be arrested an prosecuted.
I don't know if you saw the press release of Pfizer. They admit finally of the serious side affects in this document.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-amends-us-government-paxlovid-supply-agreement-and?utm_source=substack&utm_medium=email
About 6 months ago I read that it is possible that the placebo could have things in it that could cause harm and not contain the control substance. is that true and if so, could that be the thing causing problems for the placebo group?
Thanks so much for your revealing analysis! I have one little quibble and one question.
1. You write: "the initial death rate during the first 80 days might represent the background death rate". That's likely still too high: apparently there were one or more deaths from vaccination within three weeks.
In Pfizer's original report, one death in the vaccination group was misreported as withdrawn and thus not counted (unclear if it was counted here). See https://infocheckers.org/wiki/Blog:Pfizer_omitted_at_least_one_vaccine_trial_death
And as also mentioned there, it looks as if one vaccinated who died shortly after (probably due to vaccination) was moved to placebo.
2. "This data represents an ordered sequence (ordered by frequency)" ? What sequence, what frequency? Please clarify.
Good Post! I was looking long and hard at the person time in this study too. As Tore says, there should be way less person years for the placebo than the vaxxed. But if you look at pfizers 6 month study in the NEJM, they record them as both the same. Is it possible for them to be so stupid? Then we have the report that 2 of the placebo deaths occurred after they had been unblinded and given the juice. But they were still counted as placebo. Does this explain the bump up in deaths occurring at 80-100 days? That's around the time the placebo were getting the juice. Did they share the deaths around to make it look balanced? Were there also deaths in the vax arm in the first few weeks after vax that were eliminated because they occurred before the vax had built up full strength (ie from 1 dose to 7 days after dose 2)?
With all these anomalies the only thing to do is throw your hands in the air and call them out for BS...And it's not like pfizzer hasn't got a history for that.
Statistical analysis of official data from Israel: All-cause mortality, stroke, cardiac arrest, PE, GBS, cancer, infant mortality, sarcoidosis.
https://israelab.substack.com/p/index
There could be a simpler explanation. They say they used saline as a placebo but did not. As in so many vaccine trials, they could have used another vaccine, or the « carrier » (LNP’s without RNA)
Another stellar contribution to finding the truth. Thanks so much !