Interesting Twitter Account.
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@lufins-dad said in Interesting Twitter Account.:
There was also the whole testing drugs on Nigerian Kids thing back in 2007 I believe? Numerous allegations of fraudulent data from clinical trials in the past doesn’t help…
The problem with this particular conspiracy theory is that Pfizer isn't a black box. COVID is the medical discussion of the world right now. Doctors, scientists, statisticians, etc., etc. are studying everything involving the virus, including one of the most widely-distributed vaccines.
If you'd like to claim that Pfizer is shady AF, that's fine but it's nowhere near enough to debunk the effectiveness of their vaccines. Be prepared to have to make qui bono accusations against every independent researcher on the planet for any "they're hiding the numbers" claims to be taken seriously.
@aqua-letifer said in Interesting Twitter Account.:
@lufins-dad said in Interesting Twitter Account.:
There was also the whole testing drugs on Nigerian Kids thing back in 2007 I believe? Numerous allegations of fraudulent data from clinical trials in the past doesn’t help…
The problem with this particular conspiracy theory is that Pfizer isn't a black box. COVID is the medical discussion of the world right now. Doctors, scientists, statisticians, etc., etc. are studying everything involving the virus, including one of the most widely-distributed vaccines.
From the link…
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:
Participants placed in a hallway after injection and not being monitored by clinical staff
Lack of timely follow-up of patients who experienced adverse events
Protocol deviations not being reported
Vaccines not being stored at proper temperatures
Mislabelled laboratory specimens, and
Targeting of Ventavia staff for reporting these types of problems.
Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”
The Brad
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@axtremus said in Interesting Twitter Account.:
@jolly said in Interesting Twitter Account.:
@axtremus said in Interesting Twitter Account.:
@jolly said in Interesting Twitter Account.:
Because I distrust Pfizer immensely.
Based on what?
You distrust only Pfizer, or also Moderna and Johnson & Johnson too?You do know about Pfizer, don't you?
Please, share your reasons for distrusting Pfizer.
Illegal activity
@jolly said in Interesting Twitter Account.:
@axtremus said in Interesting Twitter Account.:
@jolly said in Interesting Twitter Account.:
@axtremus said in Interesting Twitter Account.:
@jolly said in Interesting Twitter Account.:
Because I distrust Pfizer immensely.
Based on what?
You distrust only Pfizer, or also Moderna and Johnson & Johnson too?You do know about Pfizer, don't you?
Please, share your reasons for distrusting Pfizer.
Illegal activity
What illegal activity?
Kindly cite specific cases. -
https://abcnews.go.com/Business/pfizer-fined-23-billion-illegal-marketing-off-label/story?id=8477617
“Cry havoc and let slip the DOGE of war!”
Those who cheered as J-6 American prisoners were locked in solitary for 18 months without trial, now suddenly fight tooth and nail for foreign terrorists’ "due process". — Buck Sexton
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@aqua-letifer said in Interesting Twitter Account.:
@lufins-dad said in Interesting Twitter Account.:
There was also the whole testing drugs on Nigerian Kids thing back in 2007 I believe? Numerous allegations of fraudulent data from clinical trials in the past doesn’t help…
The problem with this particular conspiracy theory is that Pfizer isn't a black box. COVID is the medical discussion of the world right now. Doctors, scientists, statisticians, etc., etc. are studying everything involving the virus, including one of the most widely-distributed vaccines.
From the link…
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:
Participants placed in a hallway after injection and not being monitored by clinical staff
Lack of timely follow-up of patients who experienced adverse events
Protocol deviations not being reported
Vaccines not being stored at proper temperatures
Mislabelled laboratory specimens, and
Targeting of Ventavia staff for reporting these types of problems.
Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”
@lufins-dad said in Interesting Twitter Account.:
In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”Yes.
My point is, if there's a problem with the vaccines, it will be made public.
As for the rest, yes, I for one am extremely surprised that in light of an immediate need for the most sought-after product in the entire world, some recordkeeping corners were cut.
Please love yourself.
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Cutting corners is one thing. I want to know if certain data subsets were suppressed.
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@jolly said in Interesting Twitter Account.:
Cutting corners is one thing. I want to know if certain data subsets were suppressed.
There is absolutely no way that kind of information will be kept from the entire world in perpetuity.
Please love yourself.
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@jolly said in Interesting Twitter Account.:
https://abcnews.go.com/Business/pfizer-fined-23-billion-illegal-marketing-off-label/story?id=8477617
OK, let‘s suppose the case that resulted in the $2.3B fine in 2009 gives you a reason to distrust Pfizer. But Pfizer is not the only COVID-19 vaccine provider in the world. There is also Moderna and Johnson & Johnson, to name just a couple more. Do you distrust only Pfizer or all the other COVID-19 vaccine providers too?
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@jolly said in Interesting Twitter Account.:
Cutting corners is one thing. I want to know if certain data subsets were suppressed.
There is absolutely no way that kind of information will be kept from the entire world in perpetuity.
@aqua-letifer said in Interesting Twitter Account.:
@jolly said in Interesting Twitter Account.:
Cutting corners is one thing. I want to know if certain data subsets were suppressed.
There is absolutely no way that kind of information will be kept from the entire world in perpetuity.
Of course not. Now, tell me how the Wuhan Lab investigation is coming.
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@aqua-letifer said in Interesting Twitter Account.:
@jolly said in Interesting Twitter Account.:
Cutting corners is one thing. I want to know if certain data subsets were suppressed.
There is absolutely no way that kind of information will be kept from the entire world in perpetuity.
Of course not. Now, tell me how the Wuhan Lab investigation is coming.
@jolly said in Interesting Twitter Account.:
@aqua-letifer said in Interesting Twitter Account.:
@jolly said in Interesting Twitter Account.:
Cutting corners is one thing. I want to know if certain data subsets were suppressed.
There is absolutely no way that kind of information will be kept from the entire world in perpetuity.
Of course not. Now, tell me how the Wuhan Lab investigation is coming.
- We don't have any jurisdiction in China. That's not even remotely the same thing.
- Even that wasn't kept under wraps. The only people still in the dark about this are the same people who are reinventing pronouns at the federal level.
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Countries and multinational corporations can finagle statistics at will. Now, if Pfizer chose to ignore or misplace a few numbers in the tally, how would you know?
I've never been through a national tally, but I've seen the paperwork involved in regional raw data. It is reams of paper. Would be very easy to shave some percentage points anyway you wanted to take them.
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Countries and multinational corporations can finagle statistics at will. Now, if Pfizer chose to ignore or misplace a few numbers in the tally, how would you know?
I've never been through a national tally, but I've seen the paperwork involved in regional raw data. It is reams of paper. Would be very easy to shave some percentage points anyway you wanted to take them.
@jolly said in Interesting Twitter Account.:
I've never been through a national tally, but I've seen the paperwork involved in regional raw data. It is reams of paper. Would be very easy to shave some percentage points anyway you wanted to take them.
We're talking government workers here.
But even still, you can't hack into a nation's worth of health records at minute clinics, doc's offices and hospitals and wipe out patient cases. If the vaccine's really that problematic, it'll get found out.
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@lufins-dad said in Interesting Twitter Account.:
In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”Yes.
My point is, if there's a problem with the vaccines, it will be made public.
As for the rest, yes, I for one am extremely surprised that in light of an immediate need for the most sought-after product in the entire world, some recordkeeping corners were cut.
@aqua-letifer said in Interesting Twitter Account.:
@lufins-dad said in Interesting Twitter Account.:
In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”Yes.
My point is, if there's a problem with the vaccines, it will be made public.
As for the rest, yes, I for one am extremely surprised that in light of an immediate need for the most sought-after product in the entire world, some recordkeeping corners were cut.
This goes beyond corners being cut. The real issue isn't even Pfizer to my mind. It's the lack of oversight from the FDA. It's one thing for them to miss something during the largest international and multinational pharmaceutical effort ever expended. It's quite another thing to ignore and not investigate documented reports of problems at one of the labs.
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@aqua-letifer said in Interesting Twitter Account.:
@lufins-dad said in Interesting Twitter Account.:
In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”Yes.
My point is, if there's a problem with the vaccines, it will be made public.
As for the rest, yes, I for one am extremely surprised that in light of an immediate need for the most sought-after product in the entire world, some recordkeeping corners were cut.
This goes beyond corners being cut. The real issue isn't even Pfizer to my mind. It's the lack of oversight from the FDA. It's one thing for them to miss something during the largest international and multinational pharmaceutical effort ever expended. It's quite another thing to ignore and not investigate documented reports of problems at one of the labs.
@lufins-dad said in Interesting Twitter Account.:
The real issue isn't even Pfizer to my mind. It's the lack of oversight from the FDA.
Dude are you serious?
This is the very same organization that, for decades, conservatives have—rightly—mocked for being so monolithic that they "wouldn't approve aspirin in this day and age." I've heard that here, many, many times. And it's correct.
But now, in the midst of a global pandemic, in which the one thing everyone on the planet wants most and right now is a workable vaccine, the problem is that the FDA played it too fast and loose?
I'm not saying they didn't, I'm saying how could they not? If not in this way, then it would have been something else. With thousands of balls in the air and unprecedented pressure to just get on with it, you're gonna drop some balls.
Please love yourself.
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@lufins-dad said in Interesting Twitter Account.:
The real issue isn't even Pfizer to my mind. It's the lack of oversight from the FDA.
Dude are you serious?
This is the very same organization that, for decades, conservatives have—rightly—mocked for being so monolithic that they "wouldn't approve aspirin in this day and age." I've heard that here, many, many times. And it's correct.
But now, in the midst of a global pandemic, in which the one thing everyone on the planet wants most and right now is a workable vaccine, the problem is that the FDA played it too fast and loose?
I'm not saying they didn't, I'm saying how could they not? If not in this way, then it would have been something else. With thousands of balls in the air and unprecedented pressure to just get on with it, you're gonna drop some balls.
@aqua-letifer Agree with you. The US FDA is the "gold standard" in product/process development approval in the food and drugs area.
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@lufins-dad said in Interesting Twitter Account.:
The real issue isn't even Pfizer to my mind. It's the lack of oversight from the FDA.
Dude are you serious?
This is the very same organization that, for decades, conservatives have—rightly—mocked for being so monolithic that they "wouldn't approve aspirin in this day and age." I've heard that here, many, many times. And it's correct.
But now, in the midst of a global pandemic, in which the one thing everyone on the planet wants most and right now is a workable vaccine, the problem is that the FDA played it too fast and loose?
I'm not saying they didn't, I'm saying how could they not? If not in this way, then it would have been something else. With thousands of balls in the air and unprecedented pressure to just get on with it, you're gonna drop some balls.
@aqua-letifer said in Interesting Twitter Account.:
@lufins-dad said in Interesting Twitter Account.:
The real issue isn't even Pfizer to my mind. It's the lack of oversight from the FDA.
Dude are you serious?
This is the very same organization that, for decades, conservatives have—rightly—mocked for being so monolithic that they "wouldn't approve aspirin in this day and age." I've heard that here, many, many times. And it's correct.
But now, in the midst of a global pandemic, in which the one thing everyone on the planet wants most and right now is a workable vaccine, the problem is that the FDA played it too fast and loose?
I'm not saying they didn't, I'm saying how could they not? If not in this way, then it would have been something else. With thousands of balls in the air and unprecedented pressure to just get on with it, you're gonna drop some balls.
Ever work with the FDA?
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@aqua-letifer said in Interesting Twitter Account.:
@lufins-dad said in Interesting Twitter Account.:
The real issue isn't even Pfizer to my mind. It's the lack of oversight from the FDA.
Dude are you serious?
This is the very same organization that, for decades, conservatives have—rightly—mocked for being so monolithic that they "wouldn't approve aspirin in this day and age." I've heard that here, many, many times. And it's correct.
But now, in the midst of a global pandemic, in which the one thing everyone on the planet wants most and right now is a workable vaccine, the problem is that the FDA played it too fast and loose?
I'm not saying they didn't, I'm saying how could they not? If not in this way, then it would have been something else. With thousands of balls in the air and unprecedented pressure to just get on with it, you're gonna drop some balls.
Ever work with the FDA?
@jolly said in Interesting Twitter Account.:
@aqua-letifer said in Interesting Twitter Account.:
@lufins-dad said in Interesting Twitter Account.:
The real issue isn't even Pfizer to my mind. It's the lack of oversight from the FDA.
Dude are you serious?
This is the very same organization that, for decades, conservatives have—rightly—mocked for being so monolithic that they "wouldn't approve aspirin in this day and age." I've heard that here, many, many times. And it's correct.
But now, in the midst of a global pandemic, in which the one thing everyone on the planet wants most and right now is a workable vaccine, the problem is that the FDA played it too fast and loose?
I'm not saying they didn't, I'm saying how could they not? If not in this way, then it would have been something else. With thousands of balls in the air and unprecedented pressure to just get on with it, you're gonna drop some balls.
Ever work with the FDA?
No, but they're enormous and bureaucratic AF.
