Tag Archives: FDA

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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CDC/FDA Smoking Gun of Smoking Guns, by Jon Rappoport

Has the SARS-Cov-2 virus ever been isolated? If so, where is the scientific evidence? If not, then how can tests measure it and treatments treat it? From Jon Rappoport at lewrockwell.com:

They confess: they had no virus when they concocted the test for the virus; they “contrived” a model by pretending to find what they wanted to find; it’s called a self-fulfilling prophecy

This is the con and the crime that drove millions of lives, and economies, into ruin

he CDC has issued a document that bulges with devastating admissions.

The release is titled, “07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing.” It begins explosively:

“After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.”

Many people believe this means the CDC is giving up on the PCR test as a means of “detecting the virus.” The CDC isn’t saying that at all.

They’re saying the PCR technology will continue to be used, but they’re replacing what the test is looking FOR with a better “reference sample.” A better marker. A better target. A better piece of RNA supposedly derived from SARS-CoV-2.

CDC/FDA are confessing there has been a PROBLEM with the PCR test which has been used to detect the virus, starting in February of 2020—right up to this minute.

In other words, the millions and millions of “COVID cases” based on the PCR test in use are all suspect. Actually, that statement is too generous. Every test result of every PCR test should be thrown out.

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The Lies Must Stop, by Raúl Ilargi Meijer

Reading the fine print on the FDA’s recent “approval” of the Pfizer vaccine reveals a convoluted state of affairs that’s deliberately being used to get people to take the shot. From Raúl Ilargi Meijer at theautomaticearth.com:

The FDA. the U.S. Food and Drug Administration, announced on Monday that it gave full approval to a vaccine. But it didn’t. Or rather, it did, but the approval is for a vaccine that doesn’t exist. Or rather, it exists, but it’s not being produced. Or rather, it’s being produced, but under different names and with different legal statuses.

The FDA is playing a game with Americans, in order to get them to submit to being vaccinated. And this has to stop. No more. The role of the FDA is to protect people, not cajole them into politically desired but illegal actions. Below are 3 -bullet points of- articles about the (non-) approval. One from Peter Doshi, senior editor at The BMJ, and a powerful foe to the FDA, one from Robert Kennedy jr, and one from Jill Malone, wife of Dr. Robert Malone.

But first, yet another lie -BIG, not noble- from Anthony Fauci, as told to Anderson Cooper. There is no approval for “the Pfizer product”, and Fauci knows that very well. Or rather, there is approval for a Pfizer product that is not available to anyone. And that should never have been approved the way it was in the first place, but that’s another story. Still, Fauci said it.

In theory, if he were called on it (but of course he won’t be by any reporter he talks to), he could say that the products are the same anyway. But he won’t say that, because he realizes full well that they have different legal statuses; they are “legally distinct” in the words of the FDA. So Fauci can’t say they are the same. Even if it’s just a matter of a different label on a vial.

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With Pfizer Likely to Get FDA Approval Monday It’s Worth Remembering Pfizer and Moderna Lost The Clinical Trial Control Group Testing Vaccine Efficacy and Safety, by sundance

You can’t conduct a randomly controlled trial if you “decontrol” the control group before the trial is complete. From sundance at theconservativetreehouse.com:

According to the New York Times and multiple media outlets, Pfizer is expected to get full FDA approval today.  “The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.” (read more)  With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:

The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine.  However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated.  Almost all the control group were then given the vaccine.

Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues.  Without a control group there is nothing to compare the vaccinated group against.  According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:

(Via NPR) […] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.  “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots. (read more)

Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost under the auspices of  “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.

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Does the FDA think these data justify the first full approval of a covid-19 vaccine? by Peter Doshi

The FDA has never approved a drug or vaccine with as short a testing period, plethora of documented adverse side effects (including death), and incomplete testing as it just did with Pfizer’s Covid-19 vaccine. From Peter Doshi at blogs.bmj.com:

The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi

On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”

But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”

The 20 page preprint matters because it represents the most detailed public account of the pivotal trial data Pfizer submitted in pursuit of the world’s first “full approval” of a coronavirus vaccine from the Food and Drug Administration. It deserves careful scrutiny.

The elephant named “waning immunity”

Since late last year, we’ve heard that Pfizer and Moderna’s vaccines are “95% effective” with even greater efficacy against severe disease (“100% effective,” Moderna said).

Whatever one thinks about the “95% effective” claims (my thoughts are here), even the most enthusiastic commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s advisory committee last December.

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FDA — Captured and Corrupt, by Joseph Mercola

Two important points. The FDA is captured and corrupt, but it is no different than most government agencies. From Joseph Mercola at lewrockwell.com:

If you’re like most people, you probably assume that the U.S. Food and Drug Administration is funded by the U.S. government and therefore isn’t catering to private industries.

The agency itself certainly tries to present itself as independent from the industries it regulates but, in reality, legal loopholes have led to the FDA receiving money from, and being captured and corrupted by, private interests.

While the FDA itself does not accept corporate money, it does receive money funneled via a nonprofit foundation, which in turn receives money from other nonprofits funded by private interests. It’s really all a façade because the end result is the same. Those donating the money ultimately end up with the ability to pull strings, when needed.

The Reagan-Udall Foundation

As explained by NPR1 back in 2012, the Reagan-Udall Foundation is a nonprofit foundation created by Congress in 2007 to support scientific research that is of interest to the FDA. According to NPR:2

“The idea was that this foundation could do things the FDA can’t. It would raise money from private sources, fund research in areas where the FDA lacks expertise, and organize collaborations involving industry, patient groups and academia.”

As explained in a 2008 article3 in the Journal of the National Cancer Institute, the creation of the Reagan-Udall Foundation was part of a larger plan to establish a private-public partnership to facilitate the Critical Path Initiative.

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US Paying Billions for Free COVID-19 Vaccines, by Joseph Mercola

Beyond a shadow of a reasonable doubt the government is in the pocket of the drug industry. From Joseph Mercola at lewrockwell.com:

July 22, 2020, Pfizer struck a $1.95 billion deal with the U.S. Department of Health and Human Services and the Department of Defense to provide Americans with 100 million doses of its COVID-19 vaccine, for free, with an option for 500 million additional doses.1 The agreement is part of Operation Warp Speed.

Pfizer/BioNTech have also inked a deal with the U.K. government for 30 million initial doses.2 The vaccine, currently known only as BNT162, developed in partnership with the German company BioNTech, requires two doses, which means the initial batch for the U.S. would cover 50 million people. The deal hinges on the vaccine clearing Phase 3 human trials.

According to a July 22, 2020, press release,3 Phase 2b/3 safety and efficacy trials were expected to begin at the end of July. The company expects seeking a regulatory review by the U.S. Food and Drug Administration in October 2020, which would allow them to manufacture the 100 million doses by the end of the year.

The BNT162 vaccine is based on BioNTech’s proprietary mRNA technology. BioNTech is the market authorization holder for the mRNA technology worldwide, and will own all the trademarks for the vaccine.5 According to Pfizer’s press release:6

“The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. On July 1st, Pfizer and BioNTech announced preliminary data7 from BNT162b1, the most advanced of the four mRNA formulations.

The data demonstrates that BNT162b1 is able to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19 … Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported.”

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Health Care Laws Should Be Abolished, by Doug Casey

Government is the cause, free markets are the solution for the health care “crisis.” From Doug Casey at caseyresearch.com:

How to reform the U.S. “health care” system is a continuing topic in the news. I put that phrase in quotes because it’s a misnomer. You don’t insure your health – that can’t be done. You can only insure that the costs of medical care, if your health fails, will be covered. Saying “health care” makes people think that someone else will magically assure their health, which is impossible. Collectivists like to use the phrase as part of their continuing war on what words mean, and how people think.

Health is something you do for yourself with proper diet, exercise, and lifestyle decisions. Medical care is something very different; it’s what you need for acute trauma or disease. People want good health, but all insurance can give them is hospitals, doctors, and medicines – all of which are scary.

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FDA Policies Kill, by Walter E. Williams

People die when the drug gatekeepers refuse to allow in safe, beneficial new drugs. From Walter Williams at lewrockwell.com:

Among the U.S. Food and Drug Administration’s responsibilities are approval and regulation of pharmaceutical drugs. In short, its responsibility is to ensure the safety and effectiveness of drugs. In the performance of this task, FDA officials can make two types of errors — statistically known as the type I error and type II error. With respect to the FDA, a type I error is the rejection or delayed approval of a drug that is safe and effective — erring on the side of over-caution — and a type II error is the approval of a drug that has unanticipated dangerous side effects, or erring on the side of under-caution.

Let’s examine the incentives of FDA officials. If FDA officials err on the side of under-caution and approve a drug that has unanticipated dangerous side effects, the victims of their mistake will be highly visible. There may be congressional hearings, embarrassment to the agency and officials fired.

It’s an entirely different story if FDA officials err on the side of over-caution and either disapprove or delay the approval of a drug that is both safe and effective. In that case, the victims will be invisible. They will have no idea that their suffering could have been eliminated, or in the case of death, their loved ones will have no idea why they died. Their suffering and/or death will be chalked up to the state of medicine rather than the status of an FDA drug application. Their doctor will simply tell them there’s nothing more that can be done to help them. The FDA officials go scot-free.

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