The regulator states the study "does not belong to the FDA," despite it being conducted at FDA labs, with FDA resources, by students under the supervision of FDA staff.
Young people talk of socialism but in the past four years I never heard the globalists running things do anything constructive or show any concern for the masses nor did I hear politicians explain just what their "socialism" was going to be.
I do know that suburban homes went from $300,000 to $600,000.
We all are living with ridiculously high food prices.
I hope people wake up. The Great Reset has destroyed just like it intended to do.
It's probable that there are scientists within the FDA who object to way the regulator handles things...they're more difficult to access for comment because the media department puts a wall around them.
I wonder how many employees in these regulatory organisations are waiting for change at the top? A turn around could happen quickly if key manipulators with conflicts of interest are removed
Yes, me too; I'm very interested to see if RFK Jr. gets confirmed and secondly, to see what he is able to accomplish regarding the "malevolence." Perhaps it is likely that the FDA scientists who supervised the students plan on remaining at the FDA and those responsible for cooking up the absurdly lazy response have already packed their bags and sent out their CV's to Big Pharma?
"We know that they are lying, they know that they are lying, they even know that we know they are lying, we also know that they know we know they are lying too, they of course know that we certainly know they know we know they are lying too as well, but they are still lying."
(Paraphrase of a number of quotes from a number of sources)
When I responded to your report regarding this study last week Maryanne, I suggested that it would be interesting to be on the end of the telephone line, between senior representatives of the FDA and their paymasters, Big Pharma. Never, in my wildest nightmares, did I presume that all that was required, to ensure that the FDA got back into Big Pharma's good books, was just to state that a study that was overseen by their scientists, a study that used "product" held by them, and a study that was done in one of their laboratories, was absolutely nothing to do with them, whatsoever, and that therefore, following that "clarification" all would be well with the world!
On what planet have these idiots at the FDA arrived from? Under what principles of honour, integrity and ethics have they been schooled?
The FDA's comments are exactly similar to a parent, whose child, lives in the same house, whose wife gave birth to that child, whose name is on the child's birth certificate, stating in a family court of law that he has no responsibility for the child, as it is not his, and expecting the judge to agree with him! Such blatant arrogance, ignorance and stupidity would be laughed out of court, particularly when the judge informed the parent that tests showed that he shared the same DNA as the child.
The FDA's statement just adds another level of incredulity, to the whole Big Pharma story. A level that, with everything that has been revealed and understood about this discredited industry in recent years, one really could not believe could be "attained". But, like each and every other time that we have been left totally gobsmacked, by the newest revelations that come about, we must once again give this industry immense credit for taking the story to a level that no sane individual could ever think was at all possible!
In all honesty, I would suggest that, due to the level of fiction and fantasy that pervades the hierarchy of these entities, like the FDA, the senior executives should apply for positions at Disney World where their tall stories would manifest into some quite wonderful exhibits!
FDA misbehaved before by NOT referring to real scientific statistically proven evidence but what they call RWE (Real-world evidence)
In your report MaryAnne you commented about FDA relying on billions of successful vaccines worldwide and that is an absolute cop out - your smoking example good
I looked up the full approval of Paxlovid from EUA in May 2023
Take time to look at this
“
EXECUTIVE SUMMARY
Pfizer, the applicant, submitted the New Drug Application (NDA) for PAXLOVID (nirmatrelvir tablets; ritonavir tablets) in June 2022. The applicant is seeking an indication for COVID-19 treatment among high-risk patient regardless of their vaccination status, similar to the PAXLOVID indication for its Emergency Use Authorization (EUA). The clinical review team considers the clinical trial data submitted for the NDA sufficient to support the benefit of PAXLOVID as COVID-19 treatment in the Omicron era, regardless of vaccination status. The Division of Antivirals requested an assessment of the publicly available literature on observational real-world evidence (RWE) studies to determine whether the RWE contradicts the trial conclusions.
The literature search conducted by Division of Epidemiology II (DEPI II) on January 30, 2023, identified 22 RWE studies that evaluated PAXLOVID effectiveness in outpatient COVID-19 populations. Seventeen of the 22 published studies were excluded from in-depth DEPI II review as they included overlapping study populations with the reviewed RWE studies, were based on insufficient longitudinal data in the data sources and/or were unable to account for potential bias introduced by index time selection. The five remaining studies included in our in-depth review were cohort studies conducted in non-hospitalized COVID-19 patients during the Omicron era. Two studies were based on nation-wide or territory-wide electronic health records (EHR) of hospitals and outpatient clinics in Israel and China (Hong Kong); one study used province-wide integrated health care data from Quebec, Canada; two studies used EHR and administrative claims data from the U.S. Veterans Health Administration and an integrated healthcare system in a single U.S. state. All studies evaluated the risk of COVID-19-related hospitalization, or all-cause hospitalization between PAXLOVID-treated COVID-19 patients and those who were not treated with PAXLOVID.
The reviewed RWE studies consistently reported that PAXLOVID use is associated with a reduction in the risk of worsening COVID-19 outcomes in broader populations than those included in the pivotal trials - with respect to age, underlying "high-risk" comorbidities and COVID-19 vaccination status in Omicron era. However, the information available for the reviewed R WE studies is insufficient to determine their quality.
DEPI II determined that the results of the five reviewed studies did not contradict the findings of those trials. Given the lack of information to determine quality, DEPI II recommended against using the results of the available R WE studies to support or refute effectiveness of PAXLOVID treatment in non-hospitalized COVID-19 patients, especially among specific patient subgroups.”
The quiet full authorisation in August 2024 by TGA would have had to use FDA mutual agreement “evidence” as no other full trials have been conducted.
In the same way that a particular brand of mRNA vaccine has been delivered in Australia and the world, Paxlovid with its poor standard population non statistical evidence has been prescribed many times in Australia. Think of the criteria of aboriginals over 50 and say what evidence?
Really, is anyone surprised? The big fat investments in this technology holds sway. I’m really interested in the story behind the supervisors. Did they go it alone? Did they get into trouble? Will they be fired? How did they come to their decision to research this extremely controversial and career ending project? I’m sure there’s a story there. So many people are hanging their hats on the new administration to expose this corruption. I, personally don’t think it’s going to move the needle one iota. Don’t forget Bourla had dinner with trump within the last month. I’m sure bourla/ pfizer did what they do best. Pay off people for their silence. The fda making a “factual” statement that definitely has indoctrinated the masses about the millions of live’s saved can’t be proven. There was never, ever any independent data collection on the injuries. The stats were skewed. No diagnostic tests ergo there is no evidence to support the lie. People don’t know that and will willingly believe the deception.
I cannot hardly wait until, 20 Jan 25
Young people talk of socialism but in the past four years I never heard the globalists running things do anything constructive or show any concern for the masses nor did I hear politicians explain just what their "socialism" was going to be.
I do know that suburban homes went from $300,000 to $600,000.
We all are living with ridiculously high food prices.
I hope people wake up. The Great Reset has destroyed just like it intended to do.
Don't hold your breath!
Is there a massive rift between "leadership" of captured institutions and their best scientists?
It's probable that there are scientists within the FDA who object to way the regulator handles things...they're more difficult to access for comment because the media department puts a wall around them.
Behold - The Emperor's New Vaccine ! ...and the bravery of DocM and co in calling them out !
FDA = Fools Denying Actuality
TGA = Toadies Grovelling to Americans 🙊
"Big Tobacco and the Seven Dwarfs -- Swearing Under Oath to Lie"
https://www.youtube.com/watch?v=MJBaBJawnSY
I think it takes a mix of laziness and malevolence for the FDA to behave this way. I'm so curious to see if this changes in the new administration.
I wonder how many employees in these regulatory organisations are waiting for change at the top? A turn around could happen quickly if key manipulators with conflicts of interest are removed
Yes, me too; I'm very interested to see if RFK Jr. gets confirmed and secondly, to see what he is able to accomplish regarding the "malevolence." Perhaps it is likely that the FDA scientists who supervised the students plan on remaining at the FDA and those responsible for cooking up the absurdly lazy response have already packed their bags and sent out their CV's to Big Pharma?
With over a billion doses of the French Fries delivered, no safety concerns have been identified, says spokesman Ronald McDonald
🤡 😆 😂 🤣 👍
The first rule of Fight Club - do not talk about Fight Club, keep all things secret.
The 2nd rule of Fight Club - see rule #1.
The FDA (and TGA) will continue to use DEI in all things, i.e. Deflect, Evade, Indemnify.
Things are getting really interesting now, roll on Jan 20.
It beggars belief that the FDA is so deceitful and publishes lies. Of course it was their study.
And they won't even address the findings. "We don't comment on individual studies"...what BS!
"We know that they are lying, they know that they are lying, they even know that we know they are lying, we also know that they know we know they are lying too, they of course know that we certainly know they know we know they are lying too as well, but they are still lying."
(Paraphrase of a number of quotes from a number of sources)
When I responded to your report regarding this study last week Maryanne, I suggested that it would be interesting to be on the end of the telephone line, between senior representatives of the FDA and their paymasters, Big Pharma. Never, in my wildest nightmares, did I presume that all that was required, to ensure that the FDA got back into Big Pharma's good books, was just to state that a study that was overseen by their scientists, a study that used "product" held by them, and a study that was done in one of their laboratories, was absolutely nothing to do with them, whatsoever, and that therefore, following that "clarification" all would be well with the world!
On what planet have these idiots at the FDA arrived from? Under what principles of honour, integrity and ethics have they been schooled?
The FDA's comments are exactly similar to a parent, whose child, lives in the same house, whose wife gave birth to that child, whose name is on the child's birth certificate, stating in a family court of law that he has no responsibility for the child, as it is not his, and expecting the judge to agree with him! Such blatant arrogance, ignorance and stupidity would be laughed out of court, particularly when the judge informed the parent that tests showed that he shared the same DNA as the child.
The FDA's statement just adds another level of incredulity, to the whole Big Pharma story. A level that, with everything that has been revealed and understood about this discredited industry in recent years, one really could not believe could be "attained". But, like each and every other time that we have been left totally gobsmacked, by the newest revelations that come about, we must once again give this industry immense credit for taking the story to a level that no sane individual could ever think was at all possible!
In all honesty, I would suggest that, due to the level of fiction and fantasy that pervades the hierarchy of these entities, like the FDA, the senior executives should apply for positions at Disney World where their tall stories would manifest into some quite wonderful exhibits!
At the end of Nineteen Eighty-Four, Winston Smith traces 'with his finger in the dust on the table: 2 + 2 = 5'.
As many have said before, to those in power 1984 was not a novel - it was an instruction manual.
Indeed. Broadbent said you couldn’t make this up! But the FDA did.
FDA misbehaved before by NOT referring to real scientific statistically proven evidence but what they call RWE (Real-world evidence)
In your report MaryAnne you commented about FDA relying on billions of successful vaccines worldwide and that is an absolute cop out - your smoking example good
I looked up the full approval of Paxlovid from EUA in May 2023
Take time to look at this
“
EXECUTIVE SUMMARY
Pfizer, the applicant, submitted the New Drug Application (NDA) for PAXLOVID (nirmatrelvir tablets; ritonavir tablets) in June 2022. The applicant is seeking an indication for COVID-19 treatment among high-risk patient regardless of their vaccination status, similar to the PAXLOVID indication for its Emergency Use Authorization (EUA). The clinical review team considers the clinical trial data submitted for the NDA sufficient to support the benefit of PAXLOVID as COVID-19 treatment in the Omicron era, regardless of vaccination status. The Division of Antivirals requested an assessment of the publicly available literature on observational real-world evidence (RWE) studies to determine whether the RWE contradicts the trial conclusions.
The literature search conducted by Division of Epidemiology II (DEPI II) on January 30, 2023, identified 22 RWE studies that evaluated PAXLOVID effectiveness in outpatient COVID-19 populations. Seventeen of the 22 published studies were excluded from in-depth DEPI II review as they included overlapping study populations with the reviewed RWE studies, were based on insufficient longitudinal data in the data sources and/or were unable to account for potential bias introduced by index time selection. The five remaining studies included in our in-depth review were cohort studies conducted in non-hospitalized COVID-19 patients during the Omicron era. Two studies were based on nation-wide or territory-wide electronic health records (EHR) of hospitals and outpatient clinics in Israel and China (Hong Kong); one study used province-wide integrated health care data from Quebec, Canada; two studies used EHR and administrative claims data from the U.S. Veterans Health Administration and an integrated healthcare system in a single U.S. state. All studies evaluated the risk of COVID-19-related hospitalization, or all-cause hospitalization between PAXLOVID-treated COVID-19 patients and those who were not treated with PAXLOVID.
The reviewed RWE studies consistently reported that PAXLOVID use is associated with a reduction in the risk of worsening COVID-19 outcomes in broader populations than those included in the pivotal trials - with respect to age, underlying "high-risk" comorbidities and COVID-19 vaccination status in Omicron era. However, the information available for the reviewed R WE studies is insufficient to determine their quality.
DEPI II determined that the results of the five reviewed studies did not contradict the findings of those trials. Given the lack of information to determine quality, DEPI II recommended against using the results of the available R WE studies to support or refute effectiveness of PAXLOVID treatment in non-hospitalized COVID-19 patients, especially among specific patient subgroups.”
The quiet full authorisation in August 2024 by TGA would have had to use FDA mutual agreement “evidence” as no other full trials have been conducted.
In the same way that a particular brand of mRNA vaccine has been delivered in Australia and the world, Paxlovid with its poor standard population non statistical evidence has been prescribed many times in Australia. Think of the criteria of aboriginals over 50 and say what evidence?
Agree, the claim that "billions of doses have been given so it must be same" is utterly stupid.
This is the full doc website https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217188Orig1s000OtherR.pdf?utm_source=chatgpt.com
This is a nice, concise article. Has anyone determined what could go on having this plasmid DNA in one's body?
Really, is anyone surprised? The big fat investments in this technology holds sway. I’m really interested in the story behind the supervisors. Did they go it alone? Did they get into trouble? Will they be fired? How did they come to their decision to research this extremely controversial and career ending project? I’m sure there’s a story there. So many people are hanging their hats on the new administration to expose this corruption. I, personally don’t think it’s going to move the needle one iota. Don’t forget Bourla had dinner with trump within the last month. I’m sure bourla/ pfizer did what they do best. Pay off people for their silence. The fda making a “factual” statement that definitely has indoctrinated the masses about the millions of live’s saved can’t be proven. There was never, ever any independent data collection on the injuries. The stats were skewed. No diagnostic tests ergo there is no evidence to support the lie. People don’t know that and will willingly believe the deception.