"The important thing is not to stop questioning." - Albert Einstein
If it's good enough for Al, who am I to say otherwise.
If it's good enough for Al, who am I to say otherwise.
Covid Vaccine
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How Pfizer Hid Nearly 80% of COVID Vaccine Trial Deaths From Regulators
According to an analysis, published this month in the International Journal of Vaccine Theory, Practice, and Research, of Pfizer-BioNTech COVID-19 vaccine clinical trial data, the vaccine makers hid fatality data from regulators in order to qualify for Emergency Use Authorization.Pfizer-BioNTech delayed reporting vaccine-associated deaths among BNT162b2 clinical trial participants until after the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the product.
The vaccine makers also failed to account for a large number of subjects who dropped out of the trial.
Together, these strategies kept regulators and the public ignorant of a 3.7-fold increase in cardiac deaths among subjects who received the vaccine, according to analysis in the International Journal of Vaccine Theory, Practice, and Research....
The authors revealed “inconsistencies” between data presented in Pfizer-BioNTech’s 6-month interim report and subsequent publications by Pfizer-BioNTech trial site administrators:
“Most importantly, we found evidence of an over 3.7-fold increase in the number of deaths due to cardiac events in the BNT162b2 vaccinated individuals compared to those who received only the placebo.”
This means that 79% of relevant deaths were not recorded in time to be included in Pfizer’s regulatory paperwork.
By not including relevant subject deaths in the case report, Pfizer obscured cardiac adverse event signals, allowing the EUA to proceed unchallenged.
Forensic analysis of the 38 subject deaths in the 6-Month Interim Report of the Pfizer/BioNTech BNT162b2 mRNA Vaccine Clinical Trial
Abstract
The analysis reported here is unique in that it is the first study of the original data from the Pfizer/BioNTech BNT162b2 mRNA vaccine clinical trial (CA4591001) to be carried out by a group unaffiliated with the trial sponsor. Our study is a forensic analysis of the 38 trial subjects who died between July 27, 2020, the start of Phase 2/3 of the clinical trial, and March 13, 2021, the data end date of their 6-Month Interim Report. Phase 2/3 of the trial involved 44,060 subjects who were equally distributed into two groups and received Dose 1 of either the BNT162b2 mRNA vaccinated or the Placebo control (0.9% normal saline). At Week 20, when the BNT162b2 mRNA vaccine received Emergency Use Authorization from the U.S. FDA, subjects in the placebo arm were given the option to be BNT162b2 vaccinated. All but a few accepted. Surprisingly, a comparison of the number of subject deaths per week during the 33 Weeks of this study found no significant difference between the number of deaths in the vaccinated versus placebo arms for the first 20 weeks of the trial, the placebo-controlled portion of the trial. After Week 20, as subjects in the Placebo were unblinded and vaccinated, deaths among this still unvaccinated cohort of this group slowed and eventually plateaued. Deaths in the BNT162b2 vaccinated subjects continued at the same rate. Our analysis revealed inconsistencies between the subject data listed in the 6-Month Interim Report and publications authored by Pfizer/BioNTech trial site administrators. Most importantly, we found evidence of an over 3.7-fold increase in number of deaths due to cardiovascular events in BNT162b2 vaccinated subjects compared to Placebo controls. This significant adverse event signal was not reported by Pfizer/BioNTech. Potential sources of these data inconsistencies are identified.
Well, this is just their opinion, going to need addresses and phone numbers.
We should call the PR department at IU Health. They need to be made aware.
they deserve to know
For over HALF A CENTURY the liberals have championed the evils of the pharmaceutical companies… I’ve heard the gospel of the evils of Pfizer among others from them since my young days in the 80’s…
It took one politically driven media narrative to utterly flip that position….
It took one politically driven media narrative to utterly flip that position….
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Big govt runs big pharma now and they can't have enough big govt now. That wasn't the case awhile back. Pure lemmings now. Amazing how effective their tactics were in utterly brainwashing a huge chunk of the population and creating government dependence.
The pattern I've been seeing is Trogs inability to process a large amount of information. He's lost after 2 sentences, gives up and resumes his tired talking points.
That is a common trait among liberals.
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pFucking pFizer pFraud.
You could see it a mile away if you bothered to open your eyes.....they kept changing all their clinical trials data--publicly--someone here defending them actually posted the site--so what the hell did the pFDA do?
Enabled the greatest pFraud of all time.
You could see it a mile away if you bothered to open your eyes.....they kept changing all their clinical trials data--publicly--someone here defending them actually posted the site--so what the hell did the pFDA do?
Enabled the greatest pFraud of all time.
We’ll get to see their trial results in only 71 more years.
I recall all the Question Authority bumper stickers.
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Yeah, but that is not data from the CDC. Surely the CDC or FDA will publish data on American excess deaths showing that these guys are way off base.
I mean the American excess deaths would be over 100000 per week if that was the case.
Huh? Wait, whaaaaat? Horsepaste for the win.
People who received hydroxychloroquine were less likely to die than those who did not, according to a new study.
Just 0.8 percent of patients at a facility in France who received hydroxychloroquine (HCQ) and an antibiotic died, compared to 4.8 percent of patients who did not receive the drug combination, French researchers reported on Nov. 1.
"This study represents the largest single-center study evaluating HCQ-AZ in the treatment of COVID-19. Similarly, to other large observational studies, it concludes that HCQ would have saved lives," Dr. Didier Raoult, with Aix-Marseille Universite in Marseille, and his co-authors wrote.
The paper was published in the journal New Microbes and New Infections. It was released as a preprint earlier this year, but withdrawn because authors said they have changed their "analytic strategies."
Researchers examined records from 30,423 patients with COVID-19 who were treated at another institution in Marseille, IHU Méditerranée Infection. They included all adults who tested positive for COVID-19 and who were treated in the hospital as an inpatient or an outpatient between March 2, 2020, and Dec. 31, 2021.
The study set ended up with 30,202 patients because treatment information was not available for the 221 others.
Most of the patients received off-label prescriptions of hydroxychloroquine and azithromycin (AZ), a common antibiotic.
Of the set, 23,172 patients received the drug combination. The other 7,030 did not.
Among those who received the drugs, 191, or 0.8 percent, died. Among those who did not, 344, or 4.8 percent, passed away.
Those who received HCQ and AZ were more likely to survive regardless of whether they were inpatients or outpatients.
The biggest effect was recorded in outpatients aged 50 to 89.
Limitations of the study included drawing from records from a single center. Funding came in part from the French government.
HCQ has been cleared in both France and the United States for decades but not for treating COVID-19.
Dr. David Boulware, an infectious disease doctor at the University of Minnesota Medical School, said that clinical trial data do not support using HCQ against the illness.
"Hydroxychloroquine has not been shown to have any benefit in randomized clinical trials," Dr. Boulware, who was not involved in the new study, told The Epoch Times in an email.
"There is zero antiviral effect in humans, and zero reduction in hospitalization among 11 randomized clinical trials pooled together," he added, referring to a metanalysis he co-authored that was published in January. Dr. Boulware also helped carry out a randomized trial examining HCQ as a prophylaxis in people who were exposed to COVID-19, and found it did not prevent illness or confirmed infection.
The group also criticized smaller trials with similar findings as underpowered, including a trial in France that was stopped due to enrollment issues.
"In contrast, several large observational retrospective studies published in the literature, including a total of 47,516 patients report a benefit of using HCQ on the mortality of COVID-19 patients," the authors said, pointing to studies from France, Iran, and Spain.
They said the number of patients in the observational studies outweighs the number of patients in the randomized trials and support using HCQ as an early treatment.
Dr. Boulware said that observational data can suffer from serious problems, pointing to a response in 2020 to an observational U.S. paper that reported an association between HCQ with AZ and lower mortality among hospitalized patients.
Dr. Raoult and his co-authors acknowledged the limitations of observational data but lamented what they see as a dearth of clinical trials that use proper dosing.
"Unfortunately, few if any of the RCTs that have attempted to demonstrate the efficacy of HCQ on COVID-19 patients were run with an appropriate methodology," they wrote.
"Inadequate target (late treatment), excessive dosage of the drug, or inappropriate study power were the main troubles. While observational studies have also confounding factors, as discussed above, significant effect estimate differences between RCTs and observational studies are more likely to be linked to the quality of the study than to its design," they added, referencing a Cochrane Review that there was little difference between observational studies and clinical trials.
"In any case, since the epidemic has now vanished, it is no longer possible to conduct RCTs," they concluded. "Only observational studies can bring any more insights to support policy makers with repositioning of hydroxychloroquine in the treatment of COVID-19."
Dr. Raoult was director of the facility at which the patients were seen, but retired in 2022 after a French agency investigation found issues at the facility with regulation compliance. Several of his papers have since been retracted.
Dr. Raoult did not respond to a request for comment.
The new study came about a month after researchers in Belgium reported in another observational study that HCQ with AZ reduced COVID-19 mortality among hospitalized patients.
"Our study suggests that, despite the controversy surrounding its use, treatment with hydroxychloroquine and azithromycin remains a viable option," Dr. Gert Meeus, a nephrologist with AZ Groeninge Hospital, and other researchers wrote.
That group offered similar concerns regarding trials as the French group, including over the dosing levels.
https://www.sciencedirect.com/science/article/pii/S2052297523001075 <-----THE STUDY
Hydroxychloroquine Associated With Lower COVID-19 Mortality: Study
The French study included 30,202 patients.People who received hydroxychloroquine were less likely to die than those who did not, according to a new study.
Just 0.8 percent of patients at a facility in France who received hydroxychloroquine (HCQ) and an antibiotic died, compared to 4.8 percent of patients who did not receive the drug combination, French researchers reported on Nov. 1.
"This study represents the largest single-center study evaluating HCQ-AZ in the treatment of COVID-19. Similarly, to other large observational studies, it concludes that HCQ would have saved lives," Dr. Didier Raoult, with Aix-Marseille Universite in Marseille, and his co-authors wrote.
The paper was published in the journal New Microbes and New Infections. It was released as a preprint earlier this year, but withdrawn because authors said they have changed their "analytic strategies."
Researchers examined records from 30,423 patients with COVID-19 who were treated at another institution in Marseille, IHU Méditerranée Infection. They included all adults who tested positive for COVID-19 and who were treated in the hospital as an inpatient or an outpatient between March 2, 2020, and Dec. 31, 2021.
The study set ended up with 30,202 patients because treatment information was not available for the 221 others.
Most of the patients received off-label prescriptions of hydroxychloroquine and azithromycin (AZ), a common antibiotic.
Of the set, 23,172 patients received the drug combination. The other 7,030 did not.
Among those who received the drugs, 191, or 0.8 percent, died. Among those who did not, 344, or 4.8 percent, passed away.
Those who received HCQ and AZ were more likely to survive regardless of whether they were inpatients or outpatients.
The biggest effect was recorded in outpatients aged 50 to 89.
Limitations of the study included drawing from records from a single center. Funding came in part from the French government.
HCQ has been cleared in both France and the United States for decades but not for treating COVID-19.
Dr. David Boulware, an infectious disease doctor at the University of Minnesota Medical School, said that clinical trial data do not support using HCQ against the illness.
"Hydroxychloroquine has not been shown to have any benefit in randomized clinical trials," Dr. Boulware, who was not involved in the new study, told The Epoch Times in an email.
"There is zero antiviral effect in humans, and zero reduction in hospitalization among 11 randomized clinical trials pooled together," he added, referring to a metanalysis he co-authored that was published in January. Dr. Boulware also helped carry out a randomized trial examining HCQ as a prophylaxis in people who were exposed to COVID-19, and found it did not prevent illness or confirmed infection.
Mixed Evidence
Dr. Raoult and his co-authors acknowledged that several large randomized trials have found no benefits for HCQ against COVID-19, including a World Health Organization trial. But they said that the largest, funded by the World Health Organization and and United Kingdom government, suffered from "significant methodological problems," including high dosing during the first 24 hours.The group also criticized smaller trials with similar findings as underpowered, including a trial in France that was stopped due to enrollment issues.
"In contrast, several large observational retrospective studies published in the literature, including a total of 47,516 patients report a benefit of using HCQ on the mortality of COVID-19 patients," the authors said, pointing to studies from France, Iran, and Spain.
They said the number of patients in the observational studies outweighs the number of patients in the randomized trials and support using HCQ as an early treatment.
Dr. Boulware said that observational data can suffer from serious problems, pointing to a response in 2020 to an observational U.S. paper that reported an association between HCQ with AZ and lower mortality among hospitalized patients.
Dr. Raoult and his co-authors acknowledged the limitations of observational data but lamented what they see as a dearth of clinical trials that use proper dosing.
"Unfortunately, few if any of the RCTs that have attempted to demonstrate the efficacy of HCQ on COVID-19 patients were run with an appropriate methodology," they wrote.
"Inadequate target (late treatment), excessive dosage of the drug, or inappropriate study power were the main troubles. While observational studies have also confounding factors, as discussed above, significant effect estimate differences between RCTs and observational studies are more likely to be linked to the quality of the study than to its design," they added, referencing a Cochrane Review that there was little difference between observational studies and clinical trials.
"In any case, since the epidemic has now vanished, it is no longer possible to conduct RCTs," they concluded. "Only observational studies can bring any more insights to support policy makers with repositioning of hydroxychloroquine in the treatment of COVID-19."
Dr. Raoult was director of the facility at which the patients were seen, but retired in 2022 after a French agency investigation found issues at the facility with regulation compliance. Several of his papers have since been retracted.
Dr. Raoult did not respond to a request for comment.
The new study came about a month after researchers in Belgium reported in another observational study that HCQ with AZ reduced COVID-19 mortality among hospitalized patients.
"Our study suggests that, despite the controversy surrounding its use, treatment with hydroxychloroquine and azithromycin remains a viable option," Dr. Gert Meeus, a nephrologist with AZ Groeninge Hospital, and other researchers wrote.
That group offered similar concerns regarding trials as the French group, including over the dosing levels.
https://www.sciencedirect.com/science/article/pii/S2052297523001075 <-----THE STUDY
This is coming back to bite them, even though no one will admit it. A drug that has been around since the '50's and safely used for arthritic inflammation and lupus for years suddenly became demonized as horse medicine when treating a condition with an off label use, solely for political and perhaps more importantly economic gain of those involved.
I personally dispensed thousands of tablets of Plaquenil over the years without incident, no deaths, no lawsuits. How could that possibly be?
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Well, this is certainly just anecdotal with zero scientific evidence.
I'm actually shocked this was in my newsfeed.
I'm actually shocked this was in my newsfeed.
What the actual ****? Yahoo! News reporting a heart-felt article about someone damaged severely by the vaccines??? Is the tide turning?
"Health Care systems everywhere recommend the ShOtZ!!! Eeettt that SHattt SaMMich!!!" /Floggy
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Who cares? What does his Health System advise on their website? That is all that matters
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The health officials - Fauci, Birx, NIH officials, the lemmings at the WHO - dismissing Hydroxychloroquine as a safe and effective treatment for Covid need to be punished. Those people used their positions of authority to spread lie. Their lies killed people as the French study shows. Killed A LOT of people.
The government lackeys who retired should have their pensions reduced, the currently employed should be fired.
I'll go further. This is a gallows-level offense. They killed people.
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Or it’s an article from The Telegraph which was ordered to correct two Covid misinformation claims in the past.At least you acknowledge the tide is against you - the first step in realizing that you’re delusional.
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At least you acknowledge the tide is against you - the first step in realizing that you’re delusional.
"That article is from [put in name of source here]. That publication issued a [retraction/correction/clarification/other step used on one or two of its 5,000 articles over the past 10 years/make up something] so it cannot be trusted. [Accuse other side of what you do dozens of times per week, such as project or engage in delusional behavior, then insert emoji here; recommendations are LOL guy or Crying-laughing guy]"
- Leftist Guide to Avoid Addressing Facts Showing Lefties' Argument Is As Usual 100% Wrong
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