5 ms·

Will there be confirmed better oversight than with Pfizer's 12-15 year old clinical trial, re: Maddie De Garay's story? https://youtu.be/L2GKPYzL_JQ https://yo

by loceng 5y ago

Will there be confirmed better oversight than with Pfizer's 12-15 year old clinical trial, re: Maddie De Garay's story? https://youtu.be/L2GKPYzL_JQ https://youtu.be/L2GKPYzL_JQ - "How many more adverse effects have been covered up during the trials? - Maddie de Garay's story."

walterbell 5y ago
The Maddie de Garay story is tragic and history will not look kindly on the unnecessary censorship of an injured child in Pfizer's original clinical trial. They could have used that incident as an opportunity to demonstrate the protocols for investigation and prevent of similar injuries. It's promising that there will be slightly higher regulatory standards for the Omicron vaccine: clinical trial in humans must be completed before approval and clinical trial data must be submitted at the same time, i.e. no 75-year delays. > the debate appears to have shifted with the European Medicines Agency (EMA) saying on Friday that international regulators now preferred clinical studies to be carried out before approval of a new vaccine ... Inclusion of clinical trial data in the regulatory filings may have an impact on the delivery of initial batches.
- loceng 5y ago
  Don't you think everyone in society would be shocked to also know that, aside from suppressing her severe adverse reactions, they only tracked participants for 7 days - along with other blatantly obvious problems with the vaccine trial designs?
  - walterbell 5y ago
    Yes, we need more transparency on all the trials, e.g. comparing methodology and benchmarking against standard practices. Justifications for corner cutting in 2020 trials should not apply to 2022+ trials. If this issue were more widely understood, there would be several open-source repos aggregating "lessons learned" and public info about the trials, across countries and vendors.
    - loceng 5y ago
      It's interesting that you're minimizing the gross lack of integrity as simply corner cutting - there isn't a single valid reason for that. Anything counter-mainstream narrative is suppressed, so that is part of the problem to your "if this issue were more widely understood" - the scientific process, conversation, has been highly suppressed over these last 2 years. A major British medical journal just demanded that the raw trial data be released - but will it even be untampered with - like the Maddie De Garay situation insinuates happens widespread since there were no, and still no, government health agencies who have sounded an alarm - or caught it and put a hold on the vaccine release for different age groups until uncompromised trials were completed? The system capture here is so obvious it's blinding.
      - walterbell 5y ago
        Step 1 is to remove plausible deniability, e.g. urgency being used to bypass existing controls, and restore some systemic control. Ultimately we will need new systems to prevent this from happening again, at many levels of governance. There are many nested challenges, e.g. system/regulatory capture is not new, but can you think of a single historical example with pervasive lockstep censorship across media, industry and government in multiple countries? Did government relief/stimulus funding distort incentives for health outcomes, e.g. ineffective high-fee ventilators vs. early treatment with existing drugs? Even in the face of lockstep censorship, as truth/facts surfaced in 2020-2021, why did no organized presentation achieve widespread public visibility? Without an accurate threat model (e.g. infiltration of health freedom groups, https://ccsfreedom.org/ https://ccsfreedom.org/), truth will not be sufficient to prevail against organized opposition.
cguess 5y ago
FYI this guy is extremely anti-vax and what he was saying was roundly condemned. https://www.theguardian.com/australia-news/2021/dec/07/liberal-senator-gerard-rennicks-vaccine-claims-condemned-by-health-officials-in-covid-inquiry https://www.theguardian.com/australia-news/2021/dec/07/liber...
- loceng 5y ago
  And what are your thoughts, not fed to you by a mainstream narrative, on the contents of what Maddie De Garay shared about her and her daughter's experience in the Pfizer trial - or is ~10 minutes plus the time to think and write about it too much effort for you to dedicate to such an important issue such as integrity?

by loceng 5y ago

walterbell 5y ago

The Maddie de Garay story is tragic and history will not look kindly on the unnecessary censorship of an injured child in Pfizer's original clinical trial. They could have used that incident as an opportunity to demonstrate the protocols for investigation and prevent of similar injuries. It's promising that there will be slightly higher regulatory standards for the Omicron vaccine: clinical trial in humans must be completed before approval and clinical trial data must be submitted at the same time, i.e. no 75-year delays. > the debate appears to have shifted with the European Medicines Agency (EMA) saying on Friday that international regulators now preferred clinical studies to be carried out before approval of a new vaccine ... Inclusion of clinical trial data in the regulatory filings may have an impact on the delivery of initial batches.

loceng 5y ago
Don't you think everyone in society would be shocked to also know that, aside from suppressing her severe adverse reactions, they only tracked participants for 7 days - along with other blatantly obvious problems with the vaccine trial designs?
- walterbell 5y ago
  Yes, we need more transparency on all the trials, e.g. comparing methodology and benchmarking against standard practices. Justifications for corner cutting in 2020 trials should not apply to 2022+ trials. If this issue were more widely understood, there would be several open-source repos aggregating "lessons learned" and public info about the trials, across countries and vendors.
  - loceng 5y ago
    It's interesting that you're minimizing the gross lack of integrity as simply corner cutting - there isn't a single valid reason for that. Anything counter-mainstream narrative is suppressed, so that is part of the problem to your "if this issue were more widely understood" - the scientific process, conversation, has been highly suppressed over these last 2 years. A major British medical journal just demanded that the raw trial data be released - but will it even be untampered with - like the Maddie De Garay situation insinuates happens widespread since there were no, and still no, government health agencies who have sounded an alarm - or caught it and put a hold on the vaccine release for different age groups until uncompromised trials were completed? The system capture here is so obvious it's blinding.
    - walterbell 5y ago
      Step 1 is to remove plausible deniability, e.g. urgency being used to bypass existing controls, and restore some systemic control. Ultimately we will need new systems to prevent this from happening again, at many levels of governance. There are many nested challenges, e.g. system/regulatory capture is not new, but can you think of a single historical example with pervasive lockstep censorship across media, industry and government in multiple countries? Did government relief/stimulus funding distort incentives for health outcomes, e.g. ineffective high-fee ventilators vs. early treatment with existing drugs? Even in the face of lockstep censorship, as truth/facts surfaced in 2020-2021, why did no organized presentation achieve widespread public visibility? Without an accurate threat model (e.g. infiltration of health freedom groups, https://ccsfreedom.org/ https://ccsfreedom.org/), truth will not be sufficient to prevail against organized opposition.

cguess 5y ago

FYI this guy is extremely anti-vax and what he was saying was roundly condemned. https://www.theguardian.com/australia-news/2021/dec/07/liberal-senator-gerard-rennicks-vaccine-claims-condemned-by-health-officials-in-covid-inquiry https://www.theguardian.com/australia-news/2021/dec/07/liber...

loceng 5y ago
And what are your thoughts, not fed to you by a mainstream narrative, on the contents of what Maddie De Garay shared about her and her daughter's experience in the Pfizer trial - or is ~10 minutes plus the time to think and write about it too much effort for you to dedicate to such an important issue such as integrity?