I blocked a commenter on their thread as they have been abusive and redundant.
They voiced 2 complaints.
Unless the vials are straight from Pfizer the whole study has custodial bias.
True. But straight from Pfizer has its own bias in that can cherry pick what they share.
We need to know what is in the field and Pfizer hasn’t been very religious on storage conditions for these new products. They changed the cold chain. The vials were sealed and showed no evidence of being tampered with.
The only question is age and RNA degradation.
The evidence against degradation is that the RNA integrity isn’t much worse than what Pfizer describes in public documents.
If the vials we degraded, we see worse RNA integrity than the TGA documents and we don’t see that.
2)second comment was attempting to be a spicey gotcha. The EMA doc above has a date of Nov. 2020. They claim this means Pfizer fixed everything after this.
What they fail to appreciate is the section that demonstrates Pfizer already had low RNA integrity lots in the trial and they make note of having to delete that data from the trial.
We also know the manufacturing for the trial was in flux between synthesized DNA and the migration to plasmids in ecoli.
So low quality shots made it into people and those results were omitted from the trial and the detractors of this work don’t care.
Well, that's embarrassing but not surprising. There was no way they could get these 'vaccines' out in a short time frame using proper manufacturing and distribution practices. I'm no biochemist, but I know enough about various disciplines of engineering to scoff at the claims of high quality manufacturing.
"The Next Gen Sequencing data exist but is largely hidden and only summarized."
Now that is bad news. Why didn't regulators ask for the results of modern sequencing? I've actually worked a little bit with reads from various machines, but as a software engineer building cloud computing infrastructure. Those files are large but I assume that there are a bunch of common tools that can be used to analyze them efficiently. You have to wonder about the regulators as well, since they allowed this.
Apr 30, 2023·edited May 1, 2023Liked by Anandamide
Anandamide, what you are experiencing is nothing unusual. You talk about the "three lettered cathedrals".
Well, I'm an old enough dinosaur to have been long time personal friends with Dr J Anthony Morris, and known Bernice Eddy. Those names might not mean much to you, but both were employees of the then three lettered cathedrals called DBS, which was later transformed into the FDA. Which was merely a matter of changing from spots to stripes and leaving the same criminals in charge. The DBS then the FDA, sequestered both into fenced in corners because their work showed the opposite of what the relevant heads were spouting at the time. We are talking about a time period from 1960 right through to 1976. Both Tony and Bernice were determined to fight the system. There were other scientists employed at the time, also finding contrarian science, but none of them chose to fight. Tony told me their names though... most of those took severance and went and lived a real life, but Tony chose to stay and fight.
He could at least sleep at night, knowing that his work was correct and he told the truth.
In 2010, some doctors decided to indulge in something similar to what you are facing now. Being personal friends of Dr Morris, I decided to weigh in, with the result that the interchanges not only became a blog but were all sent to Dr Morris and his lawyer.
Not that that meant anything to the Priestly Pillocks, who came from the research school of Ignorami.
You might find the blog somewhat amusing, and to know that you have entered the Hall of (in) fame (y) of the really truthful scientists, the likes of which your critics wouldn't have had the brains to emulate:
In Max Schmeling's data from Denmark, the largest "tell" is the big clear space between the blue and green dots. Does this pattern look random uncontrolled? Or does it look like a specific experimental design?
Dear Kevin, you mention a “T7→Kozak region” - because I looked at other documents and never found which RNA polymerase is used. Is it T7? Which makes me really wonder why there are elements of SV40. Or is the plasmid truly ‘dual usage’ for in vitro and in mammalian cell use? Or was it a case of being sloppy to have such a plasmid?
The double standards in this whole debacle are astounding. When did the onus change to the people having to prove its unsafe as opposed to Pharma proving it’s safe? This is way above my knowledge base but thanks for allowing me to get the gist of the deception 🙏
GMP seems to be rather like GLP - Good Laboratory Practices - for which the Chief Scientist from Australia's food regulatory authority was happy to stand up and praise as regulatory Gold Standard. Yet, Monsanto made its own statements on whether they complied with GLP, inside the front cover of their application documents, where they acknowledged they didn't follow GLP, GLP which is at least 10 years out of date of state of the art science.
But your compilation above is bald and shocking.
I don't think that batch graph is about GMP - that looks more like intentional batch variation to me. Yellow for the media and politicians, green for the masses, and a few bits of blue here and there to try something out.
Quality piece of writing and work. I wonder how many of those questions/objections raised by the EMA have been answered or satisfactorily addressed by the Manufacturer as of May 2023?
As a complete lay person with only limited knowledge of blotgate (I was aware it was being discussed but found it largely impenetrable), I obviously struggled with this. But understood enough to know it's significantly damning. How can this analysis be used to be damning beyond Twitter & substack? I'd like to share it (amongst similarly 'lay' folk) so could anyone provide a precis I could use? (I fear anything I could come up with wouldn't do it justice or I'd just literally say something stupid). Thankyou 🙏🏼
Communicating with the masses on these subjects is extremely difficult. I spent 6 or 7 years researching and writing on GM crop Blotgates. The regulatory assumption is that one (GM) gene = one protein. Much like one (mRNA) strand = one spike protein. But when one looks at a blot for GM crop protein that is meant to be of a specific size, detected with an antibody that is meant to be specific for that single protein, finding instead a number of lines on the blots indicating many detected proteins at many different weights, the lie is laid out before the Regulator's eyes. Despite this the regulators will stand up and laud the GM company for meeting their standards. Not just for one crop - every crop. This has been said, and a review published in science, yet I haven't found a way to bring it to the public. In fact, by the time the review was published, I was exhausted.
There was a time where it looked like we could be successful, advised to think about how new Regulation could look in Australia. But health regulation sits within massive global arrangements.
There's
the Laws, national and international
the International Agreements - WTO/WHO
the Good Lab/Manufacturing Practices
the Regulatory standards
the Regulatory review
all set up by the companies and the extreme power interests/moguls behind them, for which the Regulators are only gatekeepers.
The Rich gods are playing. The aim is only to profit from products for which they are reasonably safe from being sued (in the short term) for major visible disaster. The slow decline of public health is of no consequence to their profits at all. I would circumvent wherever possible - stay out of the way - avoid - step around - encourage all to do likewise.
Really good insight, thanks. I think all the regulators are set up that way. To protect industry, rather than the public. Doesn't matter if we are talking OGTR, TGA, APVMA, or ARPANSA.
Absolutely! I had direct experience with the health regulators FSANZ, APVMA, OGTR and even AQIS. I expected the TGA would be the same (or possibly worse), and it hasn't surprised at all. Nonetheless I can barely comprehend how brazen they are.
I did 10 years on GM crops; the most shocking thing.... FSANZ allocated the task of post-market surveillance (the job of assessing whether the FSANZ approval was appropriate) to the crop developers themselves, ie Monsanto, Bayer, Syngenta, Dow. Monsanto was expected to do post market studies to check their crops have actually been safe to eat, and notify FSANZ if not.
Yes, it's in accordance with how the TGA & its "user pays" system operates. The sponsors provide data, assessors may ask for clarification, then usually rubber stamp approvals. The whole system is absurd, but to the average person who doesn't look too closely, it appears to be solid.
I'm sure there are good people within these agencies (& also within the corporates), but if they speak up or voice concerns they get moved on pretty quickly. I'm aware of people like Chapela, Martineau, Heinemann, Carman/Seralini, Rommens, Pusztain, who have blown the whistle on biotech. It was crushing to see how they were maligned by the powers behind the scenes.
I researched as a volunteer with the MADGE Australia network, publishing releases/briefing papers/reports from 2008 to 2011, but they may have stopped maintaining the site (madge.org.au).
I struggle with converting piles of information into coherent units for the public. We weren't alone with that - it seemed to be as hard for the pro-GM'ers to carry their message. The public began with the idea that genetically manipulating their food wouldn't be good (I was working for and on the side of the public) and they were never convinced. However the GM companies used the media to create doubt, promoting pseudo-beneficial crops (golden rice, high omega 3 oils etc), people felt a bit bad denying 'beneficial' crops, and the threatening lobbyists had the ear/wallets of the politicians.
This vaccine thing is a large step further on.... vax refusers have been so demonised that people are too scared to even wonder/question about their safety and efficacy, even quietly in their own minds, such that these heinous forces managed to carry the Direct Injection of latest experimental genetic inventions.
I remember coming across Latham & his site years ago. Great work they do. I was familiar with Madge too. I was reading loads of resources regarding GM at that time. Druker's Altered Genes Twisted Truth I thought was incredible (sad). USRTK have done amazing work too. So have many others. But then, the other side has money & influence (even though they try to paint the concerned & critical voices as a well funded danger!) & through the likes of Entine's GLP are able to propagate the worldview that GM is "substantially equivalent" to conventional breeding, which from my understanding was why the term GE was changed to GMO (to facilitate this public perception) & basically diss anything organic or regenerative based. And the academic institutions were targeted.
Would you remember by any chance around 2015 or maybe 2017 there was a Cornell student called Robert Schooler who set up a short conference at Cornell & invited people to speak on the subject? I think he called it GMO WTF (that was his youtube channel). I vividly remember watching a talk that had Latham & Michael Hansen. I wish I had downloaded a copy of it, because it was priceless. Such good information from Hansen. Those talks that were video recorded have disappeared from the web. Or at least I haven't been able to find them.
I blocked a commenter on their thread as they have been abusive and redundant.
They voiced 2 complaints.
Unless the vials are straight from Pfizer the whole study has custodial bias.
True. But straight from Pfizer has its own bias in that can cherry pick what they share.
We need to know what is in the field and Pfizer hasn’t been very religious on storage conditions for these new products. They changed the cold chain. The vials were sealed and showed no evidence of being tampered with.
The only question is age and RNA degradation.
The evidence against degradation is that the RNA integrity isn’t much worse than what Pfizer describes in public documents.
If the vials we degraded, we see worse RNA integrity than the TGA documents and we don’t see that.
2)second comment was attempting to be a spicey gotcha. The EMA doc above has a date of Nov. 2020. They claim this means Pfizer fixed everything after this.
What they fail to appreciate is the section that demonstrates Pfizer already had low RNA integrity lots in the trial and they make note of having to delete that data from the trial.
We also know the manufacturing for the trial was in flux between synthesized DNA and the migration to plasmids in ecoli.
So low quality shots made it into people and those results were omitted from the trial and the detractors of this work don’t care.
Well, that's embarrassing but not surprising. There was no way they could get these 'vaccines' out in a short time frame using proper manufacturing and distribution practices. I'm no biochemist, but I know enough about various disciplines of engineering to scoff at the claims of high quality manufacturing.
"The Next Gen Sequencing data exist but is largely hidden and only summarized."
Now that is bad news. Why didn't regulators ask for the results of modern sequencing? I've actually worked a little bit with reads from various machines, but as a software engineer building cloud computing infrastructure. Those files are large but I assume that there are a bunch of common tools that can be used to analyze them efficiently. You have to wonder about the regulators as well, since they allowed this.
Regulators are, and have always been, for these new technologies, only there in name. I learnt that about global health regulators over GM crops.
Anandamide, what you are experiencing is nothing unusual. You talk about the "three lettered cathedrals".
Well, I'm an old enough dinosaur to have been long time personal friends with Dr J Anthony Morris, and known Bernice Eddy. Those names might not mean much to you, but both were employees of the then three lettered cathedrals called DBS, which was later transformed into the FDA. Which was merely a matter of changing from spots to stripes and leaving the same criminals in charge. The DBS then the FDA, sequestered both into fenced in corners because their work showed the opposite of what the relevant heads were spouting at the time. We are talking about a time period from 1960 right through to 1976. Both Tony and Bernice were determined to fight the system. There were other scientists employed at the time, also finding contrarian science, but none of them chose to fight. Tony told me their names though... most of those took severance and went and lived a real life, but Tony chose to stay and fight.
He could at least sleep at night, knowing that his work was correct and he told the truth.
In 2010, some doctors decided to indulge in something similar to what you are facing now. Being personal friends of Dr Morris, I decided to weigh in, with the result that the interchanges not only became a blog but were all sent to Dr Morris and his lawyer.
Not that that meant anything to the Priestly Pillocks, who came from the research school of Ignorami.
You might find the blog somewhat amusing, and to know that you have entered the Hall of (in) fame (y) of the really truthful scientists, the likes of which your critics wouldn't have had the brains to emulate:
https://www.beyondconformity.co.nz/hilary-s-desk/on_the_matter_of_dr_anthony_j_morris
Almost amusing.
In 2010 the Cochrane Collaboration had apparently not yet been subverted.
Nicely done. I am directing all of my self accolading “scientific” friends a link to this post.
In Max Schmeling's data from Denmark, the largest "tell" is the big clear space between the blue and green dots. Does this pattern look random uncontrolled? Or does it look like a specific experimental design?
Dear Kevin, you mention a “T7→Kozak region” - because I looked at other documents and never found which RNA polymerase is used. Is it T7? Which makes me really wonder why there are elements of SV40. Or is the plasmid truly ‘dual usage’ for in vitro and in mammalian cell use? Or was it a case of being sloppy to have such a plasmid?
They do use T7 polymerase.
The SV40 is the promoter for the Kan gene. They could have used AmpR which is a bacterial promoter but chose one that is both mammalian and bacterial.
Not a good look if there are genome integration risks.
The double standards in this whole debacle are astounding. When did the onus change to the people having to prove its unsafe as opposed to Pharma proving it’s safe? This is way above my knowledge base but thanks for allowing me to get the gist of the deception 🙏
GMP seems to be rather like GLP - Good Laboratory Practices - for which the Chief Scientist from Australia's food regulatory authority was happy to stand up and praise as regulatory Gold Standard. Yet, Monsanto made its own statements on whether they complied with GLP, inside the front cover of their application documents, where they acknowledged they didn't follow GLP, GLP which is at least 10 years out of date of state of the art science.
But your compilation above is bald and shocking.
I don't think that batch graph is about GMP - that looks more like intentional batch variation to me. Yellow for the media and politicians, green for the masses, and a few bits of blue here and there to try something out.
Quality piece of writing and work. I wonder how many of those questions/objections raised by the EMA have been answered or satisfactorily addressed by the Manufacturer as of May 2023?
Note, they already had needles in arms when this document was written. The EMA makes note of the poor RIN lots making it into the trial. Whoops
Well now we know my Marion Gruber and Phillip Krause resigned from the FDA.
Can someone explain to this novice how "Blotgate is vindicated"?
The EMA raised the same concerns over the western blots being unconvincing proof of translational fidelity
As a complete lay person with only limited knowledge of blotgate (I was aware it was being discussed but found it largely impenetrable), I obviously struggled with this. But understood enough to know it's significantly damning. How can this analysis be used to be damning beyond Twitter & substack? I'd like to share it (amongst similarly 'lay' folk) so could anyone provide a precis I could use? (I fear anything I could come up with wouldn't do it justice or I'd just literally say something stupid). Thankyou 🙏🏼
Communicating with the masses on these subjects is extremely difficult. I spent 6 or 7 years researching and writing on GM crop Blotgates. The regulatory assumption is that one (GM) gene = one protein. Much like one (mRNA) strand = one spike protein. But when one looks at a blot for GM crop protein that is meant to be of a specific size, detected with an antibody that is meant to be specific for that single protein, finding instead a number of lines on the blots indicating many detected proteins at many different weights, the lie is laid out before the Regulator's eyes. Despite this the regulators will stand up and laud the GM company for meeting their standards. Not just for one crop - every crop. This has been said, and a review published in science, yet I haven't found a way to bring it to the public. In fact, by the time the review was published, I was exhausted.
There was a time where it looked like we could be successful, advised to think about how new Regulation could look in Australia. But health regulation sits within massive global arrangements.
There's
the Laws, national and international
the International Agreements - WTO/WHO
the Good Lab/Manufacturing Practices
the Regulatory standards
the Regulatory review
all set up by the companies and the extreme power interests/moguls behind them, for which the Regulators are only gatekeepers.
The Rich gods are playing. The aim is only to profit from products for which they are reasonably safe from being sued (in the short term) for major visible disaster. The slow decline of public health is of no consequence to their profits at all. I would circumvent wherever possible - stay out of the way - avoid - step around - encourage all to do likewise.
Really good insight, thanks. I think all the regulators are set up that way. To protect industry, rather than the public. Doesn't matter if we are talking OGTR, TGA, APVMA, or ARPANSA.
Absolutely! I had direct experience with the health regulators FSANZ, APVMA, OGTR and even AQIS. I expected the TGA would be the same (or possibly worse), and it hasn't surprised at all. Nonetheless I can barely comprehend how brazen they are.
I did 10 years on GM crops; the most shocking thing.... FSANZ allocated the task of post-market surveillance (the job of assessing whether the FSANZ approval was appropriate) to the crop developers themselves, ie Monsanto, Bayer, Syngenta, Dow. Monsanto was expected to do post market studies to check their crops have actually been safe to eat, and notify FSANZ if not.
Yes, it's in accordance with how the TGA & its "user pays" system operates. The sponsors provide data, assessors may ask for clarification, then usually rubber stamp approvals. The whole system is absurd, but to the average person who doesn't look too closely, it appears to be solid.
I'm sure there are good people within these agencies (& also within the corporates), but if they speak up or voice concerns they get moved on pretty quickly. I'm aware of people like Chapela, Martineau, Heinemann, Carman/Seralini, Rommens, Pusztain, who have blown the whistle on biotech. It was crushing to see how they were maligned by the powers behind the scenes.
Did you publish anything about your experiences?
They're all wonderful scientists/human beings - I know a couple personally. There are a lot more. I did the review with virologist Dr Jonathan Latham (of BioSRP - independentsciencenews.org) and environmental scientist Dr Angelika Hilbeck, published here: https://www.tandfonline.com/doi/full/10.1080/02648725.2017.1357295
I researched as a volunteer with the MADGE Australia network, publishing releases/briefing papers/reports from 2008 to 2011, but they may have stopped maintaining the site (madge.org.au).
I struggle with converting piles of information into coherent units for the public. We weren't alone with that - it seemed to be as hard for the pro-GM'ers to carry their message. The public began with the idea that genetically manipulating their food wouldn't be good (I was working for and on the side of the public) and they were never convinced. However the GM companies used the media to create doubt, promoting pseudo-beneficial crops (golden rice, high omega 3 oils etc), people felt a bit bad denying 'beneficial' crops, and the threatening lobbyists had the ear/wallets of the politicians.
This vaccine thing is a large step further on.... vax refusers have been so demonised that people are too scared to even wonder/question about their safety and efficacy, even quietly in their own minds, such that these heinous forces managed to carry the Direct Injection of latest experimental genetic inventions.
Thanks for all you did & do.
I remember coming across Latham & his site years ago. Great work they do. I was familiar with Madge too. I was reading loads of resources regarding GM at that time. Druker's Altered Genes Twisted Truth I thought was incredible (sad). USRTK have done amazing work too. So have many others. But then, the other side has money & influence (even though they try to paint the concerned & critical voices as a well funded danger!) & through the likes of Entine's GLP are able to propagate the worldview that GM is "substantially equivalent" to conventional breeding, which from my understanding was why the term GE was changed to GMO (to facilitate this public perception) & basically diss anything organic or regenerative based. And the academic institutions were targeted.
Would you remember by any chance around 2015 or maybe 2017 there was a Cornell student called Robert Schooler who set up a short conference at Cornell & invited people to speak on the subject? I think he called it GMO WTF (that was his youtube channel). I vividly remember watching a talk that had Latham & Michael Hansen. I wish I had downloaded a copy of it, because it was priceless. Such good information from Hansen. Those talks that were video recorded have disappeared from the web. Or at least I haven't been able to find them.
All the best,