Tag Archives: FDA

The secret is there are no secrets, by Alex Berenson

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

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

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

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.

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

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

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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Horse-Bleep: How 4 Calls on Animal Ivermectin Launched a False FDA-Media Attack on a Life-Saving Human Medicine, by Mary Beth Pfeiffer and Linda Bonvie

There has never been such an ungrounded and intense official effort to prevent the use of a proven safe and effective human drug. From Mary Beth Pfeiffer and Linda Bonvie at rescue.substack.com:

Our investigative reporters dug up the FDA memos documenting the start of a propaganda campaign, and got The New York Times to correct its false reporting.

The Propaganda That Started The Big Lie:

In a hokey tweet on August 21, the U.S. Food and Drug Administration told Americans the obvious: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

Everyone knew what “it” was: an animal form of the drug ivermectin that folks were said to be using, widely, for covid-19. Don’t, said FDA.

Within two days, 23.7 million people had seen that Pulitzer-worthy bit of Twitter talk. Hundreds of thousands more got the message on Facebook, LinkedIn, and from the Today Show’s 3 million-follower Instagram account.

“That was great!” declared FDA Acting Commissioner Janet Woodcock in an email to her media team. “Even I saw it!” For the FDA, the “not-a-horse” tweet was “a unique viral moment,” a senior FDA official wrote to Woodcock, “in a time of incredible misinformation.”

There was one problem, however. The tweet was a direct outgrowth of wrong data—call it misinformation—put out the day before by the Mississippi health department. The FDA did not vet the data, according to our review of emails obtained under the Freedom of Information Act and questions to FDA officials. Instead, it saw Mississippi, as one email said, as “an opportunity to remind the public of our own warnings for ivermectin.”

The story behind the tweet that went ’round the world shows how a myth was born about a safe, if now controversial, human drug that was FDA-approved for parasitic disease  in 1996  and bestowed the Nobel Prize in Medicine in 2015. It is a story in which the barest grain of truth morphed into an anything-goes media firestorm.

It began with one sentence in a Mississippi health alert on reports to the state’s poison control center: At least 70% of the recent calls have been related to ingestion of livestock or animal formulations of ivermectin purchased at livestock supply centers.” In the thick of a fierce covid wave in the American South, no official at the FDA, or reporter for that matter, seemed to ask: 70 percent of what? Instead, government and media joined forces against a public health threat that, in retrospect, was vastly exaggerated.

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The Coordinated Attack on Ivermectin Is a Crime Against Humanity, by Louie Gohmert

The official concerted attacks on Ivermectin and Hydroxychloroquine to withhold cheap and effective medications from people who either want to prevent Covid or who have it and want to cure themselves, especially when the alternatives are ineffective and dangerous vaccines, is indeed a crime against humanity. From Louie Gohmert at amgreatness.com:

Make no mistake, the evil, deadly, coordinated globalist attacks we are currently witnessing on ivermectin will go down in history as a vicious crime against humanity.

Just as we saw with hydroxychloroquine last summer, government alphabet agencies, the medical industrial complex, and their willing accomplices in the media have recently made it clear that there is yet another safe, effective treatment for COVID-19 they wish to torpedo. It’s the latest naughty word which will get you censored on social media and mocked and belittled by late-night “comedians”: ivermectin.

While ivermectin has been used by certain brave doctors around the world to treat COVID-19 for over a year now, it only recently became the target of a multi-pronged attack, with the U.S. government, the media, and Big Pharma all playing important roles in the deadly dystopian disinformation campaign against the drug. As more Americans became aware of ivermectin’s efficacy against COVID-19, like clockwork the government and its propaganda arm in the press jumped in to discredit it, referring to the drug snidely as a “horse dewormer.” 

We watched the FDA embarrass itself with its ridiculing tweet telling people “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” while linking to an agency article on why people should not use ivermectin to treat or prevent the China Virus. We saw Rolling Stone magazine forced to admit that its recent story about Oklahoma hospitals being overwhelmed by patients who overdosed on ivermectin was completely false.

Omar Marques/SOPA Images via Getty Images

Pharmaceutical company Merck, which produces ivermectin, discredited its use for COVID by irresponsibly stating, “We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.” It is worth noting that Merck and Pfizer are developing their own oral antivirals that would directly compete with the cheap and effective ivermectin. These antivirals, unlike ivermectin, would be patented, creating the potential for pharmaceutical companies to rake in billions of dollars from their use.

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The Meaning of the FDA Resignations, by Jeffrey A. Tucker

A couple of staffers at the FDA suffered an attack of integrity. From Jeffrey A. Taylor at brownstone.org:

How significant is it that the two top FDA officials responsible for vaccine research resigned last week and this week signed a letter in The Lancet that strongly warns against vaccine boosters? This is a remarkable sign that the project of government-managed virus mitigation is in the final stages before falling apart.

The booster has already been promoted by top lockdown advocates Neil Ferguson of Imperial College and Anthony Fauci of NIH, even in the face of rising public incredulity toward their “expert” advice. For these two FDA officials to go on record with grave doubts – and their perspective is certainly backed by the unimpressive booster experience in Israel – introduces a major break in the narrative that the experts in charge deserve our trust and deference.

What’s at stake here? It’s about more than the boosters. It’s about the whole experience of taking away the control of health management from individuals and medical professionals and handing it over to modelers and government officials with coercive power.

From the first week of March 2020, the US embarked on a wild experiment in virus mitigation, deploying a series of measures with a sweep and scope that had never previously been attempted, not in modern times and not even in ancient times. The litany of controls and tactics is long. Many of these measures survive in most parts of the US. The retail landscape is still filled with plexiglass. We are still invited to sanitize ourselves when going indoors. People still mask up in proximity to others. The “Karens” of the world are still actively shaming and denouncing anyone suspected of non-compliance.

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