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Wednesday, January 11, 2023

FDA Commissioners Say the Agency Needs Ways to Fight Online “Misinformation”

 

Former and current Food and Drug Administration (FDA) commissioners said that the agency needs partners to fight public health misinformation and that patient advocates, clinicians, industry, and academic leaders have a role to play.

The commissioners made the comments at the 2023 Innovations in Regulatory Science Summit, an event that was organized by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).


“I actually believe that misinformation is the leading cause of death right now in the US because whether we’re looking at COVID or chronic disease, people are making bad choices driven by the information that they get,” said FDA Commissioner Robert Califf, as reported by regulatory focus. “We were just not prepared for what broad access to the internet would do to communication channels.”


Califf said that the academic community was not doing enough to combat misinformation and that their criticism of the FDA is having unintended consequences.


“As a public agency, we need to be critiqued but I think often the people that are doing the critiquing assume that the agency’s going to be there in the future in the way that they expect it to be there,” Califf said. “So, they’re critiquing it to make it better. But to a lot of unsuspecting people that hear it, it just completely erodes their belief in the institution.”

Mark McClellan, who served as an FDA commissioner from 2002 to 2004 said, “Realistically, FDA needs help.” He acknowledged that there is currently a lack of trust in public health agencies and officials. However, people still trust their doctors, community leaders, and others that are “close to their experience.”

Scott Gottlieb, a Pfizer board member who served as a commissioner from 2017 to 2019, said the fast response to misinformation is crucial and touted the idea of allowing the industry to counter misinformation about products.
“We’ve seen FDA weigh in, admirably, around some dangerous disinformation on specific products,” he said. “But that can’t be the business of the FDA.”


He suggested that the FDA should create a limited safe harbor to allow sponsors to directly counter misinformation. He added that the FDA would determine how and what the sponsors can respond to.


“I think sponsors need to have the ability to defend their products in the marketplace of ideas when there’s true misinformation,” Gottlieb said.


Gottlieb was under fire this week after it was revealed that Gottlieb had been flagging tweets to Twitter...

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Twitter censored tweets after pressure from Pfizer director

A newly released email from the Twitter Files has revealed that Twitter censored a tweet from Dr. Brett Giroir, a board member at the biopharmaceutical company Altesa Biosciences, after it was flagged by Scott Gottlieb, a board member at the pharmaceutical giant Pfizer.

Gottlieb and Giroir both currently serve on the boards of several pharmaceutical companies and have backgrounds in public health. Gottlieb is a former Food and Drug Administration (FDA) commissioner while Giroir is a former Assistant Secretary for Health and former acting Commissioner of the FDA.


Pfizer produces Covid vaccines whereas Altesa Biosciences develops drugs to combat Covid.


In the August 27, 2021 email, which was published by journalist Alex Berenson, Gottlieb complained to Todd O'Boyle, a senior manager on Twitter's Public Policy team, about a tweet from Giroir that claimed natural immunity to Covid-19 was superior to vaccine immunity.


"This is the kind of stuff that's corrosive," Gottlieb wrote. "Here he draws a sweeping conclusion off a single retrospective study in Israel that hasn't been peer reviewed. But this tweet will end up going viral and driving news coverage."

According to Berenson, O'Boyle forwarded Gottlieb’s email to Twitter's Strategic Response team — a team that was tasked with handling complaints from Twitter's most important employees and users.

Berenson said that O'Boyle didn't mention that Gottlieb was a Pfizer board member in this email and instead wrote, “Please see this report from the former FDA commissioner.”


An analyst from Twitter's Strategic Response team quickly found that the tweet didn't violate any of Twitter's "misinformation" rules, according to Berenson. However, the tweet was still slapped with a "Misleading" label and had its replies, shares, and likes disabled after Gottlieb's complaint.

This label and the restrictions still haven't been removed, even though several high-ranking health officials, such as former White House Covid response coordinator Dr. Deborah Birx, have since questioned the effectiveness of Covid vaccines when it comes to preventing infections.

Berenson also claimed that one week later, on September 3, 2021, Gottlieb complained about a tweet from Covid lockdown and vaccine skeptic Justin Hart.


The Hart tweet that Gottlieb reportedly complained about stated: "Sticks and stones may break my bones but a viral pathogen with a child mortality rate of ~0% has cost our children nearly three years of schooling."

Berenson alleged that Gottlieb complained about this tweet when the Pfizer Covid vaccine "would soon be approved for children 5 to 11."

However, Berenson said that this time, Twitter refused to act.


Previous Twitter email releases have revealed that during the same month that Gottlieb was complaining about Giroir's tweet, he also flagged one of Berenson's articles to Twitter. Berenson was temporarily suspended from Twitter days after Gottlieb flagged his article.


Gottlieb responded to the revelations about him flagging Giroir's tweet by claiming that the publication of this email was a "selective disclosure" of his "private communications with Twitter" and that it had stoked "the threat environment" and instigated "more menacing dialogue, with potentially serious consequences."


Giroir accused Gottlieb of scheming with Twitter to "apparently put corporate interests first not public health."

Tuesday, January 10, 2023

Monday, January 9, 2023

Sunday, January 8, 2023

Was the Buffalo Bills Athlete's Heart Attack Related to the Mandatory Injection?

More Than 270 Deaths in US Athletes After Vaccination: Peer-Reviewed Letter

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Over 270 athletes and former athletes in the United States have died from cardiac arrests or other serious issues after taking COVID-19 vaccines, according to data from a recent peer-reviewed letter to the editor.

Authored by structural biologist Panagis Polykretis, and board-certified internist and cardiologist Dr. Peter McCullough, the letter’s cited data found that from 2021 to 2022, at least 1,616 cardiac arrests or other major medical issues have been globally documented in vaccinated athletes, with 1,114 of those being fatal.

The global data also showed that between 2021 to 2022, former and current American athletes made up 279 of the mortalities.

Athletes have a lower chance of cardiac arrest and sudden cardiac death as compared to nonathletes. A 2016 U.S. study calculated that nonathletes, compared to athletes, have a 29 times higher chance of sudden cardiac death.

One of the reasons is because “athletes are screened out for the common causes of sudden death on the playing field,” McCullough told The Epoch Times.

Players are screened for hypertrophic cardiomyopathy, which makes up almost 50 percent of sudden cardiac deaths in athletes, as well as other less common heart abnormalities.

The intensive screening is what makes competitive-level sports safer than everyday sporting activities, McCullough argued.

Sudden Cardiac Deaths in Athletes Increased After Vaccination

McCullough pointed to a European study that tracked sudden cardiac deaths in European athletes over 38 years from 1966 to 2004. The study reported 1,101 sudden cardiac deaths over the interval, which Polykretis estimated would be around 29 deaths per year.

In the United States, it is estimated that 100 to 150 athletes die every year from sudden death.

The data cited in the letter, however, showed that in 2022 alone, over 190 deaths from cardiac arrests or other factors have been reported in current and former athletes.

This does not include the deaths of athletes with unknown vaccine statuses and those whose names did not make it into the media.

McCullough said looking at the data, “there’s no doubt,” that sudden cardiac deaths have increased following vaccinations.

However, since most of the sudden cardiac deaths in the media are of professional competitive players, McCullough added that collecting data from athletes in colleges, high schools, and other international leagues would give a more comprehensive picture.

He pointed to studies that have shown high myocarditis increases following COVID-19 vaccinations.

Prior to the pandemic, a 2017 study in Finland found that myocarditis rates were 19.5 per million for children 15 years of age and younger. Another 2012 Japanese study on pediatric admissions reported even lower rates of 2.6 cases per million in children aged 1 month to 17.

In the data released by the Centers for Disease Control (CDC) and Prevention in June 2021 (pdf), researchers expected myocarditis rates in vaccinated 12- to 17-year-old males to be 63 cases per million. By the following year, researchers at the CDC noted that myocarditis numbers in young males were exceeding the background rates (pdf).

A study by researchers from Kaiser Permanente (pdf), published in August 2022, estimated myocarditis would be 186 cases out of a million, after a second dose of vaccine in 12- to 17-year-old children. In males, this number was raised to 377 cases out of a million.

However, in prospective studies, one Thai study found that 2.3 percent of children who received two shots of mRNA doses had a heart injury. Another study evaluated 777 health care workers who were boosted and 2.8 percent reported a heart injury.

This means that if the results are extrapolated, around 25,000 people per million could suffer from heart injuries after two or three doses of COVID-19 vaccinations, according to McCullough.

“I’m very concerned,” said McCullough, “This is a public health problem. I think it is incumbent upon individuals to disclose the vaccine status.”

“We see the report of public figures or athletes one after another, dying suddenly, with no explanation. It’s incumbent upon the families, the medical staff, the doctors, and the reporters to disclose the vaccine status. They are investigational vaccines, and they are linked to death in peer-reviewed studies.”

A German autopsy study evaluated 25 people who died unexpectedly within 20 days of being vaccinated. Four of the individuals were found with myocarditis without any other disease signal that may have caused the unexpected death.

The authors concluded that their autopsy studies indicated that deaths were due to cardiac failure, and that myocarditis could be “a potentially lethal complication following mRNA-based anti-SARS-CoV-2 vaccination.”

It should also be noted that myocarditis events have also been reported in unvaccinated COVID-19 patients in 2020, and studies have shown that the virus can cause heart damage. But it is debatable if the heart injuries patients experience are caused by myocarditis or some other reasons.

study published in April 2022 found that increases in myocarditis and pericarditis are statistically insignificant among unvaccinated individuals after COVID infection. The researchers evaluated around 197,000 unvaccinated patients, and there were 9 and 11 cases of myocarditis and pericarditis, respectively.

A French study that tracked cardiac arrests in athletes pre-pandemic from 2005 to 2018 also found that the rate of cardiac arrests in sports has remained constant, while survivability of these events has increased due to help from bystanders.

Correction: This article has been updated to clarify the source of the data is a peer-reviewed letter. The Epoch Times regrets the errors.

Marina Zhang is a health writer for The Epoch Times, based in New York. She mainly covers stories on COVID-19 and the healthcare system and has a bachelors in biomedicine from The University of Melbourne. Contact her at marina.zhang@epochtimes.com.

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