Pfizer has asked a federal court to let it intervene in a high-profile case that has seen U.S. drug regulators try to slow-walk disclosure of data on Pfizer’s COVID-19 vaccine.
Pfizer says it supports disclosing the data but wants to ensure that information exempt from disclosure under the Freedom of Information Act (FOIA) is not “disclosed inappropriately.”
astoundingly, the FDA itself is supporting this.
their lawyers are supporting this.
this is a federal agency whose ostensible job is to safeguard your health and to ensure the safety and efficacy of the drugs you use.
this is the agency that has rushed programs of unprecedented size through with outlandishly little data, incredible opacity, and allowed on an emergency basis the fastest drug rollout in human history.
when asked for the data, they requested 75 years to provide it.
The FDA later asked a judge to give it 75 years, but the judge rejected the request and ordered the regulator to produce 55,000 pages a month, which would give it about eight months to fully disclose the records.
the failure of these vaccines to generate sterilizing immunity and stop spread has been astonishing. their side effect profile is magnitudes worse than any other ever approved. the very math and definitions that underpinned their studies and underpins their public health reporting to this day was and remains a bayesian rig job that all by itself can make harm and immunosuppression look like vaccine efficacy.
and despite all this, the FDA whose job it allegedly is to protect we the people from predation by unscrupulous food and drug companies is seeking to hide the data, not to free it.
all bureaucracies ultimately evolve to become their own primary constituencies. they serve themselves and their institutional benefit first and foremost.
well, at least until they become completely captured. then the cops join the criminals. and make no mistake, the FDA has been captured. i have never seen anything remotely like the last two years. the top vaccine people quit in disgust.
and now the FDA are siding with pfizer and inviting them in to help in the cover up.
they are protecting their own misbehavior in service of big pharma. this is not the role they were supposed to play and it looks doubly bad for them given the way that gottleib quit in mid term to join the pfizer board of directors. this is a revolving door that would make even wall street and the federal reserve blush.
the FDA have forgotten what their job is.
they have forgotten whom they are supposed to serve and they are lining up to line their pockets instead.
we need the courts to step in and stop this evidence tampering and to appoint some impartial ombudsman to oversee it.
letting pfizer control the redaction of these documents is like letting the fox commission investigate the henhouse murders.
we’re going to get back something that looks like this:
and that is not what we need.
we need a full and frank forensic accounting from end to end of what was known, what was done, and what all the outcomes were including and especially the ones the dropped from the study due to definitional manipulation.
this is a huge issue affecting 100’s of millions of people.
According to our leaders, not only do we need a massive cover-up for the cover-up, we need less information. Berenson sent a warning this morning about Substack now being under pressure. The WaPo is publishing an article about how Substack is a major outlet of misinformation that is tearing the world apart. Substack is first on the list, (if you don't count the already censored Google, FB, IG, You Tube, Parler, etc.) -the powers that be will shake them down until they are sawdust. Then Telegram, and the lesser threats of NY Post and Daily Mail. Taking down the media is priority number one.
Also, Bari Weiss, who I once liked, posted her Substack this morning, stating that the vaccines "have been literal lifesavers" and that "[d]espite the conspiracy theories in some corners of the web or on Fox News, there is simply zero evidence that they are killing people; that they are harming people in large numbers; or that this is all some malicious plot by Big Pharma. There is overwhelming proof that these vaccines prevent serious illness." (But I ask again, where is that?)
Which I find ironic given the fact that she is a staunch, if not maniacal, supporter of Jews and Israel, which is now suffering terribly as a result of too many vaccines. So fuck Bari Weiss, and more to the point, shame on her.
Bad Cat, I hope you keep a list of email addresses from your Substack following, just in case.
Postscript: I failed to mention that 95% of the comments to Bari directly disagreed with her stance on vaccines and questioned her journalistic integrity, rightly so.
Lawyer Aaron Siri, whose firm is involved in this case, wrote about this on his Substack. Super fun footnote to his firm's opposition is this: "Reflecting the issues with this product, the FDA failed to send a representative to a federal court hearing in this matter on December 14th because of the 'FDA’s protocols' regarding COVID-19. Meaning, despite the FDA’s claim the vaccine is 'effective,' the FDA is apparently still scared to send a representative to the hearing. Its actions speak volumes and cast serious doubt on its words."
Gato, can you make your logo available in some printed form? I just want to put it on my fridge to keep me cheered up. But I'd buy a hat too. or a bumpersticker. or something. Thank you.
We need ALL THE PEOPLE to say NO NO NO !!!! We will not take ANY of your products (vaccines or otherwise) until you have provided FULL DISCLOSURE.
No more boosters
No more to kids (pull them from schools if necessary)
Boycott any Pfizer products on the market: Advil, Bextra, Celebrex, Diflucan, Lyrica, Robitussin and Viagra, Chapstick -- buy the products of their competitors instead - or no name brand
This is a criminal entity and needs to be treated as such.
Here's another interesting article that questions the vaccines safety. Four chemistry professors sent a list of questions to BioNTech founder Ugur Sahin. They are concerned about possible quality issues with the vaccine.
I hope the court can stop them or the data may be gone forever. I wish someone in the FDA would have a coming to Jesus conversion and speak the truth. Where are the whistleblowers when we need them? Oh, wait, we have them (DOD whistleblowers) but they, too, are being silenced because the media won't report on it.
I get the impression the FDA, when it believes it has a pandemic on its hands, essentially allows itself to go into "state of war" conditions where deceit is not only allowed, but encouraged. Malone talked about this -- that any information that increases vaccine hesitancy can be suppressed even if it's true. The other part of "war time" conditions is that the elites allow their own predetermined level of collateral casualty. Your kid was paralyzed by the clot shot? "Thank you for serving your country. (Without the rights of a wounded veteran, of course).
In terms of that collateral damage question: we all know this vaccine has created far more death and injury than any other, but it's also been mandated in some quarters. What is the _rate_ of casualty for this vaccine versus previous vaccines?
OMG, absolutely inappropriate to allow Pfizer to “help” redact their own documents. They will redact anything that discloses how dangerous the jabs are! If the fda needs help, hire an independent panel to do the work.
Most, if not all, regulatory agencies have been defanged by lobbying and the revolving door and general pro-corporatist political pressure (the EPA springs to mind), but to my knowledge, the FDA is the only one that is also DIRECTLY funded by the industry it purports to 'regulate'*. The CDC, in its turn, accepts multimillion-$ "gifts," strings and all, from its lazily overseen industries., AND HOLDS PATENTS in that same industry (so, in that particular sphere, the CDC actually IS the industry). The CDC/FDA also may be the only agencies that allow lawyered-up behemoth monopolies to run their own studies and sequester the resulting data. Explains a lot, I think.
*About 45% of the FDA's budget, or $2.7 billion, comes from "industry user fees ( = legal bribes)"
Several months ago, at a seminar or whatnot, Charlie Kirk was asked (I paraphrase), "What would have to happen for us to reach the point for which the Founders included the Second Amendment in the Bill of Rights?"
Charlie deflected the question, instead calling for all peaceful means.
Yeah, that's great, Charlie, as far as it goes. But there came a point when our forebears realized that dumping tea in Boston Harbor just wasn't gonna get the job done.
Pfizer isn't going anywhere no matter what they find. It's happened before, it will happen again. Too many stakeholders with too much at stake to take them down, everyone in the gov knows this; that's why they are helping them hide.
For years many of us have called the FDA the "Federal Death Authority" for erecting barriers to entry that are insurmountable to all but the large, favored few big pharma companies, thus slowing development to a crawl and causing the deaths of countless people.
I have friends in the medical device business that tell me that it takes at least $100 million to get a new device through the bureaucracy and to market, making it all but impossible for disrupting, upstart companies to improve everyone's lives like in the computer/internet space.
And, of course and as usual, the founding story of the FDA and its predecessors, to protect people from "snake oil" and such, is complete mythology.
Private rating and certification agencies, like UL, would not be subject to regulatory capture and bureaucratic mission creep, and instead would have an economic incentive to stay neutral and accurate lest its competitors outshine it.
The FDA should have been abolished decades ago, and it certainly should be now.
What astonishes me is that this article, with the damning links, and countless others like it, have ZERO impact on this dispelling the Diabolical Disorientation happening right before our eyes!
The "errors" and blunders ALWAYS go in ONE direction: in favor of Bigger Gov't, Pfizer & Company, and Depotism & Cruelty.
This is how you turn half the country into conspiracy theorists. This is like the Warren Commission. Only thing left is to stack the commission with Fauci and some Pfizer reps to adjudicate a magic bullet (aka vaxx) theory.
Has any authoritarian regime ever been reasoned out of power? I'm no history buff, but I don't remember seriously bad actors changing their ways in the face of overwhelming evidence or logical discussion of their malfeasance. This is the uncomfortable fact that we are avoiding because ". . .mankind are more disposed to suffer, while evils are sufferable, than to right themselves by abolishing the forms to which they are accustomed." And we all know how that declaration ended. So we hope and pray that maybe the courts, maybe the November elections, maybe Omicron, maybe legal actions, maybe an act of God.
The rot goes so deep and the vax obsession is quite astounding. I was just reading a supposedly, proper scientific article discussing long-term immunity to sars cov2. In the initial paragraph it recommended that naturally-infected and recovered get vaccinated (for unclarified reasons) yet in the same article clearly demonstrated that natural infection is both broader and longer lasting than the 'vaccines' (transfections). Like anyone who's been reading about basic immunology over the last year would already know. But seriously, they can't let these bloody transfections go. They're obsessed with these shots and antibody levels. It's their 'precious' and must be protected at all costs, to hell with everything else. This FDA move is yet another example of that.
This is BULLSHIT! I used to respect the FDA but no more. I spent nearly four decades working in preclinical pharmaceutical research. But now I am glad I am no longer a part of it, because I would have a hard time looking in the mirror. 75 years to release documents? What are they hiding? What are they thinking of? This is not the same industry I spent most of my life working in.
The FDA flying monkeys want to secure a job with Big Pharma after they leave their jobs at the FDA. Totally corrupted, totally compromised. Abolish the FDA, CDC, etc., and DONT start over! Americans will be healthier.
They're afraid of facing criminal prosecution and hoping to put it off until most of us are dead. But they're fools to want to because if they don't face judgment for their crimes against humanity in courts of law, they will eventually face rough justice at the hands of humanity, and it won't be pretty.
You do have to ask: Where is the American Medical Association? Where is the American Academy of Pediatrics? My family doc is terrific, but what has become of the professional organizations? Why aren't they demanding disclosure?
Sooner or later, someone in some lab in a different country than the US, will tae a long hard look at what's in that shot. Then they will do some tests of their own. And then the cat will be out of the bag anyway.
I mean, it's not as if the US presidents (with one recent exception) has been making friends around the world the past 20 yeras, is it? There's an incredible amount of bile out there, not against the people(s) of the USA but against the [redacted] on top.
China, perhaps if tensions concerning Taiwan can't be solved with Biden appeasing Xi. Or Russia. Remember the time a president 'drew a red line' in the sand before Putin? Remember what Putin did immediately after that? Or Iran, no lost love there. Or some other nation with a bone to pick.
Just speculating of course but all it takes is one lab in a nation that has zero reason to fear the US or comply with the shenanigans of US businesses.
Redaction is routinely done for clinical trial data to protect against the accidental release of information that might identify participants.
I don't seek to defend Pfizer's attempts to keep their data out of the public domain, but this is actually a genuine issue - let me give you an example from a report I worked on some time ago. Female actress found dead by swimming pool at Hollywood mansion with over 20 OTC drugs in her system. Cause of death not established at time of report.
I am not well up on Hollywood actresses but immediately knew who it was.
Remember, any release of this data at all is quite a recent initiative. The agencies have also chosen the most cumbersome and challenging system you could imagine. Instead of wholesale redaction of CSR Section 16 listings and patient narratives (and equivalents from the submission dossiers), everything has to be released, but with painstaking removal of any individual patient potentially identifying information.
Some sponsors take pro-active approaches to this, for example in listings giving subject ages by range in 5-year intervals. I understand and support the desire for public availability of data but this reduces the scientific value of the study (85 years is very different to 90 years in medicine). A different approach is needed, and one that wouldn't take so much time, one that balances the public interest in accessible clinical trial data and the public interest in people not being put off participation in clincial trials because of potential publication and identification of sensitive medical information.
Hi! New subscriber here. I read a part of one of your articles on Cecilia Hecht (sp?) post. I liked what I read and came here to subscribe. Thank-you for the information and standing for freedom of speech/the "press."
Every single person from the top to some TBDL level at the FDA needs to be fired. And then let's decide whicb ones are to be prosecuted for attempted evidence tampering.
I'll bet anything there's a clause in the secret contract with Pfizer that this be delegated to them. Refusal, means the government forfeits a military base!
I'm not sure why you're "astounded" by the FDA's actions. I'd be "astounded" if they actually acted in a way that suggested integrity and the public interest.
The agencies are all corrupted by Big Corp/Big Pharma money. It's too late: the die is cast. Only a clear out of the Augean stables will change things... but we will all suffer in the process.
I have a question that I think deserves a serious answer. No msm reporter will ever ask it of an FDA or Pfizer official with a camera rolling, but maybe we can get Rand Paul to do it.
Why would Pfizer data underlying a government promoted, funded and mandated drug be subject to redaction? Since any competitor’s drug developed through theft of “proprietary information” would have to go through FDA’s approval process and the US Patent Office, that theft of technology could be stopped in its tracks. It’s highly unlikely that the pharmacist in the strip mall is a threat to business. And China already has access to the technology because their scientists are on the research teams.
I know what the obvious snarky answers would be, because I’ve thought of them myself. So is there really a legitimate reason for this cloaking of the information behind the stuff they want to stick in our veins?
I really try to resist conspiratorial thinking, but may be the FDA's claim that it was going to take them 75 years was just a setup to let Pfizer step in and "help".
They're only supposed to redact personally identifiable data. At the Ron Johnson hearing the other day, one of the doctors or researchers held up some papers of FOIA documents that were almost completely big black boxes. Is there more of that in our future?
...and that is not what we need.
According to our leaders, not only do we need a massive cover-up for the cover-up, we need less information. Berenson sent a warning this morning about Substack now being under pressure. The WaPo is publishing an article about how Substack is a major outlet of misinformation that is tearing the world apart. Substack is first on the list, (if you don't count the already censored Google, FB, IG, You Tube, Parler, etc.) -the powers that be will shake them down until they are sawdust. Then Telegram, and the lesser threats of NY Post and Daily Mail. Taking down the media is priority number one.
Also, Bari Weiss, who I once liked, posted her Substack this morning, stating that the vaccines "have been literal lifesavers" and that "[d]espite the conspiracy theories in some corners of the web or on Fox News, there is simply zero evidence that they are killing people; that they are harming people in large numbers; or that this is all some malicious plot by Big Pharma. There is overwhelming proof that these vaccines prevent serious illness." (But I ask again, where is that?)
Which I find ironic given the fact that she is a staunch, if not maniacal, supporter of Jews and Israel, which is now suffering terribly as a result of too many vaccines. So fuck Bari Weiss, and more to the point, shame on her.
Bad Cat, I hope you keep a list of email addresses from your Substack following, just in case.
Postscript: I failed to mention that 95% of the comments to Bari directly disagreed with her stance on vaccines and questioned her journalistic integrity, rightly so.
And yet not a single health care, physician, or nursing association has spoken up in support of the immediate release of the data.
Do hospital systems even want to see the actual data? Are there any physician scientists out there who are curious what the data shows?
I can’t wrap my brain around the fact that these groups are comfortable just taking Pfizer at their word.
The fact that they are is killing every last shred of trust I have in the health care system.
Lawyer Aaron Siri, whose firm is involved in this case, wrote about this on his Substack. Super fun footnote to his firm's opposition is this: "Reflecting the issues with this product, the FDA failed to send a representative to a federal court hearing in this matter on December 14th because of the 'FDA’s protocols' regarding COVID-19. Meaning, despite the FDA’s claim the vaccine is 'effective,' the FDA is apparently still scared to send a representative to the hearing. Its actions speak volumes and cast serious doubt on its words."
Siri's post is here: https://aaronsiri.substack.com/p/fda-asks-the-court-to-delay-first
Gato, can you make your logo available in some printed form? I just want to put it on my fridge to keep me cheered up. But I'd buy a hat too. or a bumpersticker. or something. Thank you.
“the FDA have forgotten what their job is.” Please tell me a time when they knew what their job was?
We need ALL THE PEOPLE to say NO NO NO !!!! We will not take ANY of your products (vaccines or otherwise) until you have provided FULL DISCLOSURE.
No more boosters
No more to kids (pull them from schools if necessary)
Boycott any Pfizer products on the market: Advil, Bextra, Celebrex, Diflucan, Lyrica, Robitussin and Viagra, Chapstick -- buy the products of their competitors instead - or no name brand
This is a criminal entity and needs to be treated as such.
Here's another interesting article that questions the vaccines safety. Four chemistry professors sent a list of questions to BioNTech founder Ugur Sahin. They are concerned about possible quality issues with the vaccine.
https://www.berliner-zeitung.de/news/chemiker-zu-impfstoff-woher-kommt-der-grauton-li.208305
English version
https://poal.co/s/Health/498505
I hope the court can stop them or the data may be gone forever. I wish someone in the FDA would have a coming to Jesus conversion and speak the truth. Where are the whistleblowers when we need them? Oh, wait, we have them (DOD whistleblowers) but they, too, are being silenced because the media won't report on it.
This is literally life or death. They want to give the smallest of us multiple shots of god-knows-what. It's our future on the line.
I get the impression the FDA, when it believes it has a pandemic on its hands, essentially allows itself to go into "state of war" conditions where deceit is not only allowed, but encouraged. Malone talked about this -- that any information that increases vaccine hesitancy can be suppressed even if it's true. The other part of "war time" conditions is that the elites allow their own predetermined level of collateral casualty. Your kid was paralyzed by the clot shot? "Thank you for serving your country. (Without the rights of a wounded veteran, of course).
In terms of that collateral damage question: we all know this vaccine has created far more death and injury than any other, but it's also been mandated in some quarters. What is the _rate_ of casualty for this vaccine versus previous vaccines?
OMG, absolutely inappropriate to allow Pfizer to “help” redact their own documents. They will redact anything that discloses how dangerous the jabs are! If the fda needs help, hire an independent panel to do the work.
Most, if not all, regulatory agencies have been defanged by lobbying and the revolving door and general pro-corporatist political pressure (the EPA springs to mind), but to my knowledge, the FDA is the only one that is also DIRECTLY funded by the industry it purports to 'regulate'*. The CDC, in its turn, accepts multimillion-$ "gifts," strings and all, from its lazily overseen industries., AND HOLDS PATENTS in that same industry (so, in that particular sphere, the CDC actually IS the industry). The CDC/FDA also may be the only agencies that allow lawyered-up behemoth monopolies to run their own studies and sequester the resulting data. Explains a lot, I think.
*About 45% of the FDA's budget, or $2.7 billion, comes from "industry user fees ( = legal bribes)"
https://easyhealthoptions.com/cdc-bed-big-pharma/
Several months ago, at a seminar or whatnot, Charlie Kirk was asked (I paraphrase), "What would have to happen for us to reach the point for which the Founders included the Second Amendment in the Bill of Rights?"
Charlie deflected the question, instead calling for all peaceful means.
Yeah, that's great, Charlie, as far as it goes. But there came a point when our forebears realized that dumping tea in Boston Harbor just wasn't gonna get the job done.
END. REGULATORY. CAPTURE. NOW.
Feds found Pfizer too big to nail
By Drew Griffin and Andy Segal, CNN Special Investigations Unit
April 2, 2010 4:44 p.m. EDT
https://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/?hpt=Sbin
Pfizer isn't going anywhere no matter what they find. It's happened before, it will happen again. Too many stakeholders with too much at stake to take them down, everyone in the gov knows this; that's why they are helping them hide.
Because honest do-gooders always want stuff redacted or hidden for 75 years. Pfizer is just so damn bashful.
It's obvious they are criminals trying desperately to cover up what they've done. And they will get away with it, my prediction.
Well, to paraphrase Berenson:
"Government gonna government."
For years many of us have called the FDA the "Federal Death Authority" for erecting barriers to entry that are insurmountable to all but the large, favored few big pharma companies, thus slowing development to a crawl and causing the deaths of countless people.
I have friends in the medical device business that tell me that it takes at least $100 million to get a new device through the bureaucracy and to market, making it all but impossible for disrupting, upstart companies to improve everyone's lives like in the computer/internet space.
And, of course and as usual, the founding story of the FDA and its predecessors, to protect people from "snake oil" and such, is complete mythology.
Private rating and certification agencies, like UL, would not be subject to regulatory capture and bureaucratic mission creep, and instead would have an economic incentive to stay neutral and accurate lest its competitors outshine it.
The FDA should have been abolished decades ago, and it certainly should be now.
Pfizer, Fauci, Gates = EVIL
What astonishes me is that this article, with the damning links, and countless others like it, have ZERO impact on this dispelling the Diabolical Disorientation happening right before our eyes!
The "errors" and blunders ALWAYS go in ONE direction: in favor of Bigger Gov't, Pfizer & Company, and Depotism & Cruelty.
Facts be damned.
Must be some pretty damning stuff in there.
This is how you turn half the country into conspiracy theorists. This is like the Warren Commission. Only thing left is to stack the commission with Fauci and some Pfizer reps to adjudicate a magic bullet (aka vaxx) theory.
Has any authoritarian regime ever been reasoned out of power? I'm no history buff, but I don't remember seriously bad actors changing their ways in the face of overwhelming evidence or logical discussion of their malfeasance. This is the uncomfortable fact that we are avoiding because ". . .mankind are more disposed to suffer, while evils are sufferable, than to right themselves by abolishing the forms to which they are accustomed." And we all know how that declaration ended. So we hope and pray that maybe the courts, maybe the November elections, maybe Omicron, maybe legal actions, maybe an act of God.
Comrade: who needs transparency when you can have a government-funded mandatory subscription model? https://yuribezmenov.substack.com/p/how-to-build-a-killer-business
The rot goes so deep and the vax obsession is quite astounding. I was just reading a supposedly, proper scientific article discussing long-term immunity to sars cov2. In the initial paragraph it recommended that naturally-infected and recovered get vaccinated (for unclarified reasons) yet in the same article clearly demonstrated that natural infection is both broader and longer lasting than the 'vaccines' (transfections). Like anyone who's been reading about basic immunology over the last year would already know. But seriously, they can't let these bloody transfections go. They're obsessed with these shots and antibody levels. It's their 'precious' and must be protected at all costs, to hell with everything else. This FDA move is yet another example of that.
Why don't we just privatize the courts. Let Pfizer run its own legal system, appoint its own judges.
But they only asked for 75 yrs for their study on the safety of it all
This is BULLSHIT! I used to respect the FDA but no more. I spent nearly four decades working in preclinical pharmaceutical research. But now I am glad I am no longer a part of it, because I would have a hard time looking in the mirror. 75 years to release documents? What are they hiding? What are they thinking of? This is not the same industry I spent most of my life working in.
The FDA flying monkeys want to secure a job with Big Pharma after they leave their jobs at the FDA. Totally corrupted, totally compromised. Abolish the FDA, CDC, etc., and DONT start over! Americans will be healthier.
Just when you say…it can’t get worse!!!
They're afraid of facing criminal prosecution and hoping to put it off until most of us are dead. But they're fools to want to because if they don't face judgment for their crimes against humanity in courts of law, they will eventually face rough justice at the hands of humanity, and it won't be pretty.
Sketchy. Very sketchy. 🤔
kakistocracy
kăk″ĭ-stŏk′rə-sē, kä″kĭ-
noun
1 Government by the least qualified or most unprincipled citizens.
2 Government by the worst men in the state: opposed to aristocracy, government by the best men.
3 Government by the worst men.
The American Heritage® Dictionary of the English Language, 5th Edition.
These people are running the world. For a long time now.
All while they're murdering kids. Surprise!
It's starting to feel like the whole thing (government agencies) will require being torn down & rebuilt.
demand a halt to pfizer jabs until all data has been released.
You do have to ask: Where is the American Medical Association? Where is the American Academy of Pediatrics? My family doc is terrific, but what has become of the professional organizations? Why aren't they demanding disclosure?
Sooner or later, someone in some lab in a different country than the US, will tae a long hard look at what's in that shot. Then they will do some tests of their own. And then the cat will be out of the bag anyway.
I mean, it's not as if the US presidents (with one recent exception) has been making friends around the world the past 20 yeras, is it? There's an incredible amount of bile out there, not against the people(s) of the USA but against the [redacted] on top.
China, perhaps if tensions concerning Taiwan can't be solved with Biden appeasing Xi. Or Russia. Remember the time a president 'drew a red line' in the sand before Putin? Remember what Putin did immediately after that? Or Iran, no lost love there. Or some other nation with a bone to pick.
Just speculating of course but all it takes is one lab in a nation that has zero reason to fear the US or comply with the shenanigans of US businesses.
Thank you Gato for addressing this issue. This information is the foundation for truly informed consent regarding the vaccines. On a lighter note:
The Real Reason FDA Wants 75 years to Release Covid Vaccine Data
https://narrowpath.substack.com/p/the-real-reason-fda-wants-75-years?r=171xjv&utm_campaign=post&utm_medium=web&utm_source=direct
Was there ever a better example of regulatory capture?
Metaphorically: The FDA is Big Pharma's pimp and they don't care that the prostitutes they are pimping are knowingly spreading venereal diseases.
Redaction is routinely done for clinical trial data to protect against the accidental release of information that might identify participants.
I don't seek to defend Pfizer's attempts to keep their data out of the public domain, but this is actually a genuine issue - let me give you an example from a report I worked on some time ago. Female actress found dead by swimming pool at Hollywood mansion with over 20 OTC drugs in her system. Cause of death not established at time of report.
I am not well up on Hollywood actresses but immediately knew who it was.
Remember, any release of this data at all is quite a recent initiative. The agencies have also chosen the most cumbersome and challenging system you could imagine. Instead of wholesale redaction of CSR Section 16 listings and patient narratives (and equivalents from the submission dossiers), everything has to be released, but with painstaking removal of any individual patient potentially identifying information.
Some sponsors take pro-active approaches to this, for example in listings giving subject ages by range in 5-year intervals. I understand and support the desire for public availability of data but this reduces the scientific value of the study (85 years is very different to 90 years in medicine). A different approach is needed, and one that wouldn't take so much time, one that balances the public interest in accessible clinical trial data and the public interest in people not being put off participation in clincial trials because of potential publication and identification of sensitive medical information.
Hi! New subscriber here. I read a part of one of your articles on Cecilia Hecht (sp?) post. I liked what I read and came here to subscribe. Thank-you for the information and standing for freedom of speech/the "press."
Every single person from the top to some TBDL level at the FDA needs to be fired. And then let's decide whicb ones are to be prosecuted for attempted evidence tampering.
I'll bet anything there's a clause in the secret contract with Pfizer that this be delegated to them. Refusal, means the government forfeits a military base!
Most crime goes unpunished.
Governments know this, they're the ones committing most of the crime.
I'm not sure why you're "astounded" by the FDA's actions. I'd be "astounded" if they actually acted in a way that suggested integrity and the public interest.
The agencies are all corrupted by Big Corp/Big Pharma money. It's too late: the die is cast. Only a clear out of the Augean stables will change things... but we will all suffer in the process.
I have a question that I think deserves a serious answer. No msm reporter will ever ask it of an FDA or Pfizer official with a camera rolling, but maybe we can get Rand Paul to do it.
Why would Pfizer data underlying a government promoted, funded and mandated drug be subject to redaction? Since any competitor’s drug developed through theft of “proprietary information” would have to go through FDA’s approval process and the US Patent Office, that theft of technology could be stopped in its tracks. It’s highly unlikely that the pharmacist in the strip mall is a threat to business. And China already has access to the technology because their scientists are on the research teams.
I know what the obvious snarky answers would be, because I’ve thought of them myself. So is there really a legitimate reason for this cloaking of the information behind the stuff they want to stick in our veins?
I really try to resist conspiratorial thinking, but may be the FDA's claim that it was going to take them 75 years was just a setup to let Pfizer step in and "help".
They're only supposed to redact personally identifiable data. At the Ron Johnson hearing the other day, one of the doctors or researchers held up some papers of FOIA documents that were almost completely big black boxes. Is there more of that in our future?