Tag Archives: FDA

CDC Aware of Hundreds of Safety Signals for COVID Jab, by Dr. Joseph Mercola

Posted on January 23, 2023 | Leave a comment

The CDC and FDA have released their data that indicate the Covid vaccines were certainly not safe. From Dr. Joseph Mercola at theburningplatform.com:

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Story at-a-glance

  • In September 2022, The Epoch Times asked the U.S. Centers for Disease Control and Prevention to release its Proportional Reporting Ratio (PRR) data mining results. The CDC refused. A Freedom of Information Act (FOIA) request has now forced the release of these data, and they are stunning
  • The CDC’s PRR monitoring has identified several hundred safety signals, including for Bell’s palsy, blood clots, pulmonary embolism and death. In individuals aged 18 and older, there are 770 safety signals for different adverse events, and more than 500 of them have a stronger safety signal than myocarditis and pericarditis
  • In the 12- to 17-year-old age group there are 96 safety signals, and in the 5- to 11-year-old group there are 66, including myocarditis, pericarditis, ventricular dysfunction, cardiac valve incompetency, pericardial and pleural effusion, chest pain, appendicitis and appendectomies, Kawasaki’s disease and vitiligo
  • The proportions of deaths, which were only provided for the 18-plus age group, was 14% for the COVID jabs compared to 4.7% for all other vaccines
  • The FDA is also required to perform safety monitoring, using empirical Bayesian data mining. The Epoch Times asked the FDA to release its monitoring results in July 2022 but, like the CDC, the FDA refused, only to admit in December 2022 they’d confirmed the Pfizer shot was linked to pulmonary embolism

In September 2022, The Epoch Times asked the U.S. Centers for Disease Control and Prevention to release its Proportional Reporting Ratio (PRR) data mining results. PRR1 measures how common an adverse event is for a specific drug compared to all the other drugs in the database.

According to the standard operating procedures2,3 for the Vaccine Adverse Event Reporting System (VAERS), which is run jointly by the CDC and the Food and Drug Administration, the CDC is required to perform these data mining analyses.

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Health Care Workers Cry Foul On FDA Claiming It Didn’t Prohibit Ivermectin For COVID-19, by Katie Spence

Posted on January 5, 2023 | 1 comment

The FDA’s cover-their-ass lie on its Ivermectin policy is exposed. From Katie Spence at The Epoch Times via zerohedge.com:

Dr. Yusuf Saleeby has practiced medicine for more than 30 years. He serves patients in South Carolina and until recently had never faced an investigation from his state medical board.

File photo: A package of ivermectin tablets. (Natasha Holt/The Epoch Times)

But after Saleeby started prescribing ivermectin to his patients, he was reported to the board, which opened an investigation, despite the state’s attorney general’s promise that his office wouldn’t prosecute doctors who prescribed off-label medications.

Jennifer Wright, a nurse practitioner and clinical director who practices in Florida, but can prescribe across state lines, told The Epoch Times she received a letter from the Office of the Attorney General of New York ordering her not to prescribe ivermectin.

“You know, basically threatened me. If I don’t stop prescribing, then they’re going to fine me,” Wright said about the letter, which threatened legal action with fines of up to $5,000 per violation.

The letter stated that the Food and Drug Administration only authorized ivermectin for use in humans when treating “parasitic worms and head lice and skin conditions like rosacea.”

The citation in the letter appears to be from an FDA advisory issued in March 2021 titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”

That advisory and other anti-ivermectin messaging from the FDA are now the subject of a lawsuit brought by three doctors against the agency. The doctors argue that the FDA illegally interfered with their ability to treat patients. The suit was dismissed but an appeal has been filed by the plaintiffs.

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The Truth About Ivermectin, by Marina Zheng

Posted on November 22, 2022 | Leave a comment

Ivermectin works against Covid and many other diseases. From Marina Zheng at The Epoch Times via zerohedge.com:

Ivermectin has been hailed as a “wonder drug” and, according to the UNESCO World Science Report, a critical component of “one of the most triumphant public health campaigns ever waged in the developing world.”

A healthcare worker holds a bottle of ivermectin in Colombia on July 21, 2020. (Luis Robayo/AFP via Getty Images)

However, since the onset of the COVID-19 pandemic, the National Institutes of Health (NIH) and affiliated health authorities have vociferously recommended against ivermectin as a potential treatment for the virus.

Though the Food and Drug Administration (FDA) has approved ivermectin for human use in treating conditions caused by parasites, it has also insisted that ivermectin “has not been shown to be safe or effective” when it comes to treating COVID-19.

In a social media message that has gone viral, the FDA labeled it as a drug for horses and not fit for human consumption: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

The post made headlines and was one of the FDA’s most successful social media campaigns. Yet, research findings seem to contradict the public health organization’s recommendations.

A growing body of research shows that ivermectin is an essential treatment for COVID-19. Many doctors have praised the drug for its broad yet effective antiparasitic, antiviral, antibacterial, anti-inflammatory, anti-cancer, and autophagic properties.

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The secret is there are no secrets, by Alex Berenson

Posted on August 3, 2022 | Leave a comment

The FDA had no idea whether the most recent boosters were going to be either safe or effective. From Alex Berenson at alexberenson.substack.com:

New Food and Drug Administration documents show the agency knew almost nothing about how well mRNA boosters might work when it okayed them. It was mainly using public Israeli data like everyone else.

Anyone paying attention in August 2021 could see the rush to approve mRNA Covid boosters was politically driven and didn’t have much data behind it.

Now we have proof from the inside.

Emails released last week by the Food and Drug Administration show the agency’s vaccine regulators felt heavy pressure from the White House and senior FDA officials to approve boosters.

By itself, that fact is not a huge surprise. The two top vax regulators, Drs. Marion Gruber and Philip Krause, announced their resignations in late August 2021 and within weeks spoke out publicly against widespread booster shots.

No, the most frightening revelation in the emails isn’t the political machinations they reveal. It’s how they explode the myth of FDA omniscience, that the agency somehow had knowledge unavailable to the public to help it understand if boosters might work.

In reality, the emails show the opposite. (The FDA released them in response to a Freedom of Information Act request from the conservative group Judicial Watch, which has done great work using FOIA to unearth government documents on Covid.)

As Gruber and other top FDA officials discussed what to do about boosters, they had almost no data on the safety or efficacy of a third shot. Their most useful estimates of vaccine efficacy came from Israeli studies using the same figures from the Israeli health care system that I had begun highlighting in July on Twitter.

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FDA Colluded With Moderna to Bypass COVID Vaccine Safety Standards, Documents Reveal, by Megan Redshaw

Posted on July 13, 2022 | Leave a comment

Ostensibly a regulatory agency, the FDA has become a subsidiary of the big drug companies. From Megan Redshaw at childrenshealthdefense.org:

According to Alexandra Latypova, an ex-pharmaceutical industry executive, documents obtained from the U.S. Department of Health and Human Services on Moderna’s COVID-19 vaccine suggest the U.S. Food and Drug Administration and Moderna colluded to bypass regulatory and scientific standards used to ensure products are safe.

According to an ex-pharmaceutical industry and biotech executive, documents obtained from the U.S. Department of Health and Human Services (HHS) on Moderna’s COVID-19 vaccine suggest the U.S. Food and Drug Administration (FDA) and Moderna colluded to bypass regulatory and scientific standards used to ensure products are safe.

Alexandra Latypova has spent 25 years in pharmaceutical research and development working with more than 60 companies worldwide to submit data to the FDA on hundreds of clinical trials.

After analyzing 699 pages of studies and test results “supposedly used by the FDA to clear Moderna’s mRNA platform-based mRNA-1273, or Spikevax,” Latypova told The Defender she believes U.S. health agencies are lying to the public on behalf of vaccine manufacturers.

“It is evident that the FDA and NIH [National Institutes of Health] colluded with Moderna to subvert the regulatory and scientific standards of drug safety testing,” Latypova said.

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FDA Duplicity on Covid-19 Vaccines, by Steve McCann

Posted on February 9, 2022 | Leave a comment

Nothing is more corrupt than a completely captured government agency. From Steve McCann at americanthinker.com:

Perhaps the most important long-term fallout of the Chinese Coronavirus pandemic has been the exposure of the venality and politicization within the Food and Drug Administration (FDA) as well as other federal health agencies such as the Centers for Disease Control (CDC).

Nothing personifies this corruption more than the FDA’s absurdly close ties to the pharmaceutical companies.  Thus, their refusal to recognize proven inexpensive therapeutics and their unorthodox approach in licensing certain Pfizer and Moderna mRNA Covid-19 — vaccines that are not offered for sale in the United States.

What was the FDA’s and the pharmaceutical companies’ endgame in this process?  Was it to gaslight the American people in order to sell vaccines and achieve mass vaccinations?   Was their motive to protect the pharmaceutical companies from exposure to liability and a tsunami of litigation?  Was it so the FDA could more easily approve these vaccines for children who are not at risk of Covid-19?  Or all the above?

In August of 2021, the FDA, to great media fanfare, granted permanent approval for a Pfizer Covid-19 vaccine.  The catch: it was for a vaccine that was not available to Americans.  What the FDA approved and licensed is Pfizer’s Comirnaty vaccine, not the Pfizer-BioNTech vaccine that has been continuously in use under Emergency Use Authorization (EUA) since December of 2020.  Manufacturers of medicines sold under an EUA are immunized from legal liability.

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How evil do you have to be to suddenly pull treatment from ailing Florida COVID patients? By Monica Showalter

Posted on January 28, 2022 | 1 comment

The Covid commissars are doing everything in their power to suppress any preventative or treatment that is not vaccines, Remdesivir, or ventilators. People are dying as a result of this criminal idiocy. From Monica Showalter at americanthinker.com:

Is Joe Biden trying to top the vile, cruel record of blue-state governors such as New York’s Andrew Cuomo, who seeded COVID patients into the nursing homes?

It sure looks like it, given his strange, sudden, and absolute shutdown of monoclonal antibody treatments on patients who are being successfully treated with the therapy in Florida.  For vulnerable, sick people waiting in line for it, including those right up to the date of scheduled treatment, tough luck — go to the back of the line, and see if you can find some other treatment, and hope your COVID does not progress to the morgue.

That’s what Joe Biden is offering Florida, a red state that voted against him in 2020, that maybe, just maybe, he’d like to punish a little, not just for not voting for him, but to erase its record of success on COVID.  He seems to be out to punish Florida by ensuring that Florida’s COVID death count ascends to those of his favored blue states.  Whatever Joe’s motive here, there are no honorable answers as we explore this.

According to Fox News:

The Florida Department of Health announced that it is closing all monoclonal antibody treatment sites in the state after the U.S. Food and Drug Administration rescinded emergency-use authorizations for two particular treatments for COVID-19.

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FDA Now Wants 75 Years to Release Pfizer Vaccine Documents, by Michael Nevradakis, Ph.D.

Posted on December 13, 2021 | Leave a comment

The FDA went through the documents in question in 108 days to approved Pfizer’s vaccine application but it will take them 75 years to release the same documents to the public. Smells fishy. From Michael Nevradakis, Ph.D. at lewrockwell.com:

“ … it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.”

The U.S. Food & Drug Administration (FDA) now says it needs 75 years — up from the 55 years the agency initially requested — to fully release redacted versions of all documents related to the agency’s approval of Pfizer’s Comirnaty COVID-19 vaccine.

In a legal brief filed Dec. 7, the FDA said 59,000 additional pages of documents, not included in the agency’s earlier filings, need to be processed. The agency did not offer an explanation for why those documents initially were overlooked.

The agency said it can release an initial batch of approximately 12,000 pages by the end of January. Past that date, the FDA said it can process and disclose only 500 pages of documents per month.

This would mean the entire cache of documents would not be fully released until 2096. The FDA’s initial timeline would have meant the release of the documents would not be completed until 2076, or 55 years from now.

The FDA did not divulge the criteria it will use to select the initial 12,000 pages of documents, or how the agency will prioritize the release of those pages, or of additional pages going forward.

The documents in question stem from a Freedom of Information Act (FOIA) request filed in August by Public Health and Medical Professionals for Transparency (PHMPT).

In its FOIA request, the group asked the FDA to release “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.

In a filing submitted to a federal judge in November, the U.S. Department of Justice (DOJ), arguing on behalf of the FDA, initially claimed the agency could process some 329,000 pages of documents at a rate of only 500 pages per month, in order to have time to redact legally exempt material.

According to the DOJ, such material includes “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.”

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Legal Push: Vaccine Data Transparency at the FDA, by Aaron Kheriaty, MD

Posted on November 24, 2021 | Leave a comment

The FDA wants to wait 55 years before it releases its date on Pfizer’s Covid-19 vaccines. That puts the data right up there with the CIA files on the Kennedy assassination as something the Establishment really really wants to hide. From Aaron Kheriaty, MD, at aaronkheriaty.substack.com:

In response to my FOIA request for the data relied upon for the Pfizer vaccine approval, the FDA indicated in would release it all… by the year 2076 (yes, you read that right).

Along with 30 other academic physicians and scientists I submitted a Freedom of Information Act (FOIA) request to the FDA for the Pfizer vaccine data. This week, in response, the FDA claimed that it will take them 55 years to release this data, though it only took them 108 days to review this same data for the vaccine approval process. Here’s the full story, along with the initial commentary in the press on the FDA’s absurd response.

In previous posts I’ve described my legal action pushing the CDC to acknowledge natural immunity and describing their telling response to a FOIA request we submitted. Keep in mind that the CDC is the federal agency that makes recommendations on the use of vaccines after they are approved, whereas the FDA is the federal agency responsible for approving vaccines (as well as medications and medical devices) for use. Both agencies, along with the NIH (and Anthony Fauci’s NAIAD division of NIH), report to the HHS Secretary, Xavier Becerra—a lawyer with no public health experience whose previous term as Attorney General of my home state of CA was disastrous.

But back to the FDA story. In September I organized 30 distinguished academic physicians and scientist colleagues to form Public Health and Medical Professionals for Transparency. This group included, among other luminaries, my friends Harvey Risch of Yale, Andrew Bostom of Brown, Joseph Ladapo of UCLA (who has since been appointed Surgeon General of Florida), Paul Alexander, formerly of HHS and WHO, Aditi Bhargava of UCSF, and other scientists from the U.S., Canada, Denmark, Australia, Germany, and the University of Oxford in the U.K.

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The FDA’s War Against The Truth On Ivermectin, by David R. Henderson and Charles L. Hooper

Posted on October 21, 2021 | Leave a comment

The FDA radically toned down its online warnings about Ivermectin after David R. Henderson, Charles L. Hooper, and the Wall Street Journal called them out. From Henderson and Hooper at aier.org:

On July 28, the Wall Street Journal ran our article “Why Is the FDA Attacking a Safe, Effective Drug?” In it, we outlined the potential value of the antiparasitic drug ivermectin for Covid-19, and we questioned the FDA’s vigorous attack on ivermectin. Many people praised us and many criticized us. We had clearly covered a sensitive subject. It didn’t help that one of the studies we referenced was retracted shortly before we submitted our article. Within hours of learning that fact, we sent a mea culpa to the Journal’s editors. They acted quickly, adding a note at the end of the electronic version and publishing our letter. It’s important to address two criticisms of our work. The first is that we exaggerated the FDA’s warning on ivermectin. The second is that Merck’s stance on ivermectin proved that even the company that developed ivermectin thought that it doesn’t work for Covid-19.

First, we didn’t exaggerate the FDA’s warning on ivermectin. Instead, the agency changed its website after our article was published, probably to reflect the points we made. Second, Merck had two incentives to downplay ivermectin’s usefulness against the novel coronavirus. We’ll explain both points more fully.

Ivermectin was developed and marketed by Merck & Co. while one of us (Hooper) worked there years ago. Dr. William C. Campbell and Professor Satoshi Omura were awarded the 2015 Nobel Prize for Physiology or Medicine. They earned it for discovering and developing avermectin. Later Campbell and some associates modified avermectin to create ivermectin. Merck & Co. has donated four billion doses of ivermectin to prevent river blindness and other diseases in areas of the world, such as Africa, where parasites are common. The ten doctors who are in the Front Line Covid-19 Critical Care Alliance call ivermectin “one of the safest, low-cost, and widely available drugs in the history of medicine.” Ivermectin is on the WHO’s List of Essential Medicines and ivermectin has been used safely in pregnant women, children, and infants.

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