A Department of Justice attorney has been caught admitting in an undercover video that the FDA’s campaign against the use of ivermectin for COVID-19 treatment was not only misguided but also an overreach of its authority.
In December 2021, the Food and Drug Administration (FDA) issued a stern warning to Americans: “Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.”
This statement, which came during the height of the COVID-19 pandemic, was not only controversial but also deeply flawed, as the FDA had previously praised the drug in other contexts.
Ivermectin, a drug that had been safely used in humans since 1966, had been vilified by the FDA during the pandemic, despite its earlier successes in treating various diseases and even being administered to African migrants by the agency itself back in 2015.
Yet, in the face of mounting evidence—105 controlled studies showing a 61% lower risk in early COVID-19 treatment—the FDA clung to its erroneous position, interested in promoting its agenda than in protecting public health.
A group of courageous doctors, refusing to be silenced, filed a federal lawsuit against the U.S. Department of Health and Human Services (HHS) and the FDA, challenging the agencies’ unlawful attempts to block ivermectin’s use in treating COVID-19.
The lawsuit, filed in the U.S. Southern District of Texas in Galveston, asserts that the FDA overstepped its authority and interfered unjustifiably with medical practice.
Among the plaintiffs were Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter, who accused the FDA of launching a campaign of misinformation. The doctors pointed out that while the FDA had approved ivermectin for human use long before the pandemic, the agency suddenly began spreading falsehoods about its safety when COVID-19 struck.
They argued that this shift in narrative was part of a broader strategy to promote unproven vaccines while suppressing effective treatments.
During the court proceedings, the FDA’s lawyers shockingly admitted that the agency’s recommendations against Ivermectin were only advice and were not mandatory when they told people to “stop” taking Ivermectin for COVID-19.
Isaac Belfer, a lawyer representing the FDA, said, “The cited statements were not directives,” said Isaac Belfer, one of the lawyers. “They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
“They use informal language, that is true… It’s conversational but not mandatory,” he continued.
The lawsuit resulted in a significant victory for the doctors, with the FDA being forced to remove its social media posts and consumer advisories against the use of ivermectin for COVID-19.
Belfer, caught on undercover camera by Project Veritas, confessed that the FDA’s actions were an overreach.
“So, what the agency has done… [is] unquestionably beyond its authority. Making a recommendation of what drugs to take or not to take, that’s the practice of medicine. And FDA can’t practice medicine,” Belfer told Project Veritas.
“I think going forward they’ll [FDA] probably be a bit more careful. They [the doctors] got an opinion that was good for them. That kind of limited FDA’s authority. It’s not okay to… actually tell people, ‘You should not take this drug,’” he added.
Drs Apter and Bowden told Project Veritas that suppression of ivermectin led to a prolonged pandemic, and potentially millions in excess COVID deaths.
Apter: “It’s not unreasonable to think that there have been a million unnecessary deaths from COVID in the United States because of the public health agency suppression of effective early treatment with repurposed inexpensive medications.”
Bowden: “If more people had access to early treatment in the form of ivermectin, monoclonal antibodies, hydroxychloroquine… we could have nipped the pandemic in the bud.”
I'm not a medical expert, and neither is the fauch.
Thanks Fauci, CDC, FDA, NIH. You hurt the youth because of COVID LIES.
On last Tuesday’s edition of NBC’s “Hallie Jackson Reports,” host Hallie Jackson discussed a new study on the learning loss caused by COVID school closures and acknowledged that politics played a role in school closure policies, but also stated that people under 20 were “not necessarily less likely to spread” the virus and “experts we spoke with say the impact on stopping the spread depends on the school.”
Jackson said, “New research finding what does happen: The shutdowns coming at a steep cost to students, start with the learning loss, a study led by researchers at Harvard and Stanford found school districts that spent most of the 2020-2021 school year remote saw students fall more than half a grade behind in math on average, more than districts that spent most of the year in-person. Lower-income students ended up hurt the most, whether they went back to school sooner or stayed mostly at home that year. Politics also playing a role, Republican-led states re-opening faster than those run by Democrats.”
She added, “Question is, did closures slow COVID down? Data we now have shows people under 20 were half as likely to catch COVID, but not necessarily less likely to spread it. And experts we spoke with say the impact on stopping the spread depends on the school.”
She then played video of Pediatrics-Infectious Diseases Professor at the University of Colorado School of Medicine Dr. Sean O’Leary stating, “By the summer of 2020, we did have some data from — primarily from Europe showing that kids could be safely in school. But again, circumstances, some schools were able to do that. Other schools just simply could not do it.”
Jackson then stated, “But the academic damage is done. And even now, national test scores from spring 2023 show students 3rd through 8th grade overall have not rebounded from what they lost in math.”
CDC hiding the truth.
Image credit: Raed Mansour, Flickr
FDA and the CDC knew, but the CDC never released the facts. The CDC Drafted a Vaccine-Related Myocarditis Alert but Never Sent It. I did an article the other day about how the FDA report on the dangers of the Vaccine was and no one paid attention.
Now we find out that the CDC Drafted a Vaccine-Related Myocarditis Alert but for some reason, kept it secret and never released it.
WHOOPSIE: The CDC drafted a vaccine-related myocarditis alert but never sent it.
“The CDC started receiving reports of post-vaccination myocarditis in January 2021 and either failed to detect or ignored a safety signal for myocarditis… pic.twitter.com/SCVaLw9xEN
“The CDC started receiving reports of post-vaccination myocarditis in January 2021 and either failed to detect or ignored a safety signal for myocarditis and the mRNA shots the following month … The agency also hid a warning from Israel, the country that first vaccinated young people, who face the highest risk of myocarditis from COVID-19 vaccination.”
Rather than disseminating the myocarditis risk via the Health Alert Network (HAN), a platform that would have actually alerted the public, the CDC chose to bury the details in a document titled “Clinical Considerations.”
WHO, CDC, FDA, and the NIH, You have no one to blame but yourself. Now as we enter what’s called the cold and flu season, the four organizations that have given us a renewal of the little chicken sky is falling.
Ever since 2020 these organizations have been all over the map with what to do or how to do things when it comes to COVID. Tony the Fauch was the ringleader in all of this.
Now we’re hearing about this new Chineese virus that again has the world in a panic Some say that the recent cases of this virus is what showed up in Ohio and Massachutes.
Of course China and the CDC are saying that it’s just a case of ‘white lung syndrome’. Now this virus is attacking mostly children. Anyone seeing another lockdown?
WASHINGTON, DC – MARCH 9: CDC Director Rochelle Walensky speaks during a news conference at HHS headquarters March 9, 2023 in Washington, DC. Secretary of the Department of Health and Human Services Xavier Becerra and other agency heads discussed President Joe Biden’s fiscal year 2024 budget request for the Department of Health and Human Services. (Photo by Drew Angerer/Getty Images)
Now they’re claiming we can’t trust the Vaers database they themselves set up.
U.S. health authorities have responded to the warning from Florida’s surgeon general about a spike in reports of adverse events following COVID-19 vaccination.
Drs. Rochelle Walensky and Robert Califf claimed in the response that Dr. Joseph Ladapo, the surgeon general, was misleading the public by focusing on the increase in adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).
“The claim that the increase of VAERS reports of life-threatening conditions reported from Florida and elsewhere represents an increase of risk caused by the COVID-19 vaccines is incorrect, misleading, and could be harmful to the American public,” Walensky and Califf said in the missive.
The COVID-19 vaccines were given emergency authorization in late 2020. Under the emergency authorizations, vaccine companies and healthcare workers are required to report certain adverse events through VAERS, “so more reports should be expected,” Walensky and Califf said.
“Most reports do not represent adverse events caused by the vaccine and instead represent a preexisting condition that preceded vaccination or an underlying medical condition that precipitated the event,” they said.
They did not cite any studies or other research to support the claim.
While anyone can lodge reports with the system, authorities request medical records and other documentation in an effort to verify reports of certain events. Out of 1,826 reports of heart inflammation after Pfizer or Moderna vaccination in adults through May 26, 2022, for instance, the CDC verified 72 percent.
The CDC also identified hundreds of safety signals for the Moderna and Pfizer COVID-19 vaccines through analyzing VAERS data in 2022, according to records obtained by The Epoch Times. A safety signal is a possible sign of a side effect. Only a handful of adverse events are definitely caused by the vaccines, according to the CDC, including myocarditis, or heart inflammation, and severe allergic shock.
Ladapo said in February that in Florida, the number of reports to VAERS after the COVID-19 vaccines were authorized spiked by 1,700 percent, while the increase in vaccine administration rose by just 400 percent.
“We have never seen this type of response following previous mass vaccination efforts pushed by the federal government,” Ladapo said in a letter to Walensky and Califf.
“These findings are unlikely to be related to changes in reporting given their magnitude, and more likely reflect a pattern of increased risk from mRNA COVID-19 vaccines,” he added, calling for “unbiased research … to better understand these vaccines’ short- and long-term effects.” The Pfizer and Moderna vaccines both use messenger RNA (mRNA) technology.
Florida officials pointed to a study that found in the original clinical trials that the vaccinated were more at risk of serious adverse events, as well as otherpapers that found an increased risk of adverse events after COVID-19 vaccination.
Florida currently recommends against COVID-19 vaccination for young, healthy males who have been shown to be at the highest risk of myocarditis. Vaccinating the population “doesn’t make any sense” from a risk-benefit standpoint, Ladapo, appointed by Republican Florida Gov. Ron DeSantis, told The Epoch Times. The heart inflammation causes serious problems and can even lead to death in some cases.
Food and Drug Administration (FDA) Commissioner Robert Califf testifies during a Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee hearing on Capitol Hill in Washington on April 28, 2022. (Kevin Dietsch/Getty Images)
Officials Differ
Walensky and Califf, both appointed by Democrat President Joe Biden, told Ladapo that their reference information supports vaccinating virtually all people aged 6 months and older with not only a primary series of the COVID-19 vaccine, but boosters.
“Based on available information for the COVID-19 vaccines that are authorized or approved in the United States, the known and potential benefits of these vaccines clearly outweigh their known and potential risks,” they said. “Multiple well conducted, peer-reviewed, published studies and demonstrate that the risk of death, serious illness and hospitalization is higher for unvaccinated individuals for every age group.”
The officials cited studies from the CDC, including papers published by the agency’s quasi journal. According to the CDC, some papers published by the journal aren’t peer reviewed. All of the studies are shaped by agency officials to align with its messaging, which during the pandemic has been aggressively pro-vaccination, even as awareness of confirmed and possible side effects has grown.
The messaging was on display in the letter.
“As the leading public health official in state, you are likely aware that seniors in Florida are under-vaccinated, with just 29% of seniors having received an updated bivalent vaccine, compared to the national average of 41% coverage in seniors,” Walensky and Califf said. “It is the job of public health officials around the country to protect the lives of the populations they serve, particularly the vulnerable. Fueling vaccine hesitancy undermines this effort.”
The officials said that they “stand firmly behind the safety and effectiveness of the mRNA COVID-19 vaccines, which are fully supported by the available scientific data.”
“Staying up to date on vaccination is the best way to reduce the risks of death and serious illness or hospitalization from COVID-19. Misleading people by overstating the risks, or emphasizing the risks without acknowledging the overwhelming benefits, unnecessarily causes vaccine hesitation and puts people at risk of death or serious illness that could have been prevented by timely vaccination,” the officials continued.
The letter came after the CDC’s recent risk-benefit assessment of the new, updated boosters was criticized by independent medical professionals for downplaying risks and exaggerating benefits.
Florida Surgeon General Dr. Joseph Ladapo. (York Du/The Epoch Times)
Reaction
Walensky’s and Califf’s response to Ladapo featured citations to flawed studies, Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, told The Epoch Times via email, “The CDC routinely conducts cross-sectional studies and inappropriately analyzes them as if they were case-control studies, which substantially overestimates their reported vaccine efficacy measures.
“In this letter, these doctors cherry pick studies and ignore, for example, reliable Public Health UK data showing the exact opposite of what they claim,” Risch said.
“As much as they claim that the VAERS data are not quantitatively useful, these data indeed show a major COVID-19 vaccine rollout-period mortality signal that cannot be ignored or handwaved away by the lack of a population reference. These agencies continuously proclaim their data monitoring of several other information sources, yet they have not been transparent with these data,” he added.
Risch noted that insurance data shows a jump in COVID-19 deaths after the vaccines were authorized and that, according to a recent survey, many Americans know of at least one person who has suffered an adverse event after vaccination.
“FDA and CDC have lost credibility with much of the American public, and accusing Dr. Ladapo of misinformation when they themselves are the official purveyor of misinformation is unconscionable,” Risch said.
Nikki Whiting, a spokeswoman for Ladapo, said that the surgeon general would be sending a response letter to the officials.
“The response from the federal government is just another redundant display of the same apathetic talking point of ‘safe and effective.’ Googling their fact sheets would have achieved the same result,” she told The Epoch Times in an email.
“While the Feds gaslight the American public, Florida pushes for the truth. Three inquiries remain unanswered: 1. Access to raw patient-level data to allow for unbiased research. 2. Adequate attention surrounding the risks detected by numerous researchers around the world. 3. Public transparency from the CDC, FDA, and Big Pharma.”
