Tag: fda

RFK Jr. Declares War on Big Pharma: Vows to Clear Out ‘Entire Departments’ at the FDA in Push for Health Reform

Robert F. Kennedy Jr., known for his relentless stance against corporate influence in health policy, is now taking direct aim at the entrenched bureaucracies within the U.S. health agencies.

As a possible future Trump administration appointee, RFK Jr. has laid out a plan to rid the FDA and other key federal agencies of the deeply-rooted corruption that prioritizes corporate profits over public health.

Recall that Trump said that if he is elected, Kennedy will work on “health and women’s health ” and the nation’s food supply.

“Robert F. Kennedy Jr. we have. And he’s going to work on health and women’s health and all of the different reasons, because we’re not really a wealthy or a healthy country,” Trump said during his rally in Nevada.

“I told Bobby, ‘I want you to take care of health, I want you to look at the food and the food supply and what we put on the food and all sorts of — you can look at, but let me handle the oil and gas, Bobby,’” Trump added.

In Kennedy’s crosshairs are not only the FDA but also the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Department of Agriculture (USDA).

On Saturday, Robert Kennedy Jr. announced that the Trump administration would advise all U.S. water systems to remove fluoride from tap water on day one.

“On January 20, the Trump White House will advise all U.S​. water systems to remove fluoride from public water,” Kennedy wrote. “Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease. President ​Donald Trump and First Lady Melania Trump want to Make America Healthy Again.”

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FDA Knows That China and India Drug Quality Is Poor, But Independently Collects and Tests Only about 0.001%

Quality control errors during pharmaceutical manufacturing are unfortunately common occurrences. The majority (around 50%) of employees that work in pharmaceutical manufacturing tend to have duties which are safety/quality-control related, but apparently even that isn’t enough. 

Even with a major focus on quality, there is still an estimated 2-3σ (sigma) level of imprecision when it comes to pharmaceutical manufacturing. That corresponds to 66,807 to 308,537 defects per 1,000,000 opportunities. But with pharmaceutical development being so complicated, there could be more than 1,000,000 “opportunities” for error. 

The above listed error calculation – while alarming enough – was referenced in small-molecule pharmacology. However, increasingly complex pharmaceuticals (such as today’s widely used biotechnological products, including GLP-1 diabetes/weight loss or mRNA products for Covid-19) have molecular weights that can be thousands times larger than small molecule compounds. That could mean an even greater opportunity for error. 

The FDA is abundantly aware of pharmaceutical fragility and potential quality shortcomings, including at the highest levels of its leadership. 

In fact, Dr. Michael Kopcha, the current Director of the FDA’s Office of Pharmaceutical Quality (OPQ), wrote and published the above published Six Sigma calculation, lamenting the imprecise nature of pharmaceutical manufacturing – back in 2017. 

Any alteration in structure that occurs during manufacturing has the potential to vastly change a compound’s clinical activity, including a change from therapeutic drug into a poison.

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FDA Approves AstraZeneca No-Needle At-Home ‘Live’ Virus Flu Vaccine with 90% Shed Rate

AstraZeneca subsidiary MedImmune, LLC, the manufacturer of FluMist, anticipates that FluMist will be available for the 2026 influenza season as well.

FluMist, which is sprayed into the nose, is now approved for the alleged prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age.

Each refrigerated FluMist sprayer contains a single 0.2 mL dose with “live” attenuated influenza virus (10^6.5–7.5 FFU) from three strains: A/Norway (H1N1), A/Thailand (H3N2), and B/Austria (B/Victoria lineage).

Alarmingly, the FDA package insert indicates that the vaccinated can shed (or transmit) the vaccine virus onto the unvaccinated, potentially infecting them.

“Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients,” the document reads.

Vaccine virus shedding within 28 days of FluMist vaccination was studied in two multi-center trials: Study MI-CP129 (200 healthy participants aged 6 to 59 months) and Study FM026 (344 healthy participants aged 5 to 49 years).

In both studies, nasal samples were collected daily for the first 7 days, then every other day through Day 28.

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FDA Brushed Off Concerns About DNA Fragments in Gardasil’s HPV Vaccine

Over the last two years, cancer genomic experts have raised concerns about the presence of residual DNA fragments in the mRNA COVID-19 vaccines, saying that it has the potential to increase the risk of developing cancer.

This mirrors the concerns raised several years ago about the safety of the Gardasil human papillomavirus (HPV) vaccine, manufactured by Merck & Co.

In 2011, Sin Hang Lee, a pathologist and 30-year veteran in DNA analysis, made the startling discovery of synthetic DNA fragments in several vials.

“I was shocked to find DNA fragments in the HPV vaccine because DNA is not supposed to be there,” Lee recalls.

“They use DNA to make the vaccine, but then it is supposed to be chopped up and removed in the manufacturing process,” he said.

Lee, an internationally recognized expert in molecular gene detection, carefully documented his findings in a report that was sent to the U.S. Food and Drug Administration (FDA) for review.

The FDA investigated.

On Sept. 23, 2011, the FDA’s Center for Biological Evaluation and Research (CEBR) responded by saying it had evaluated the concerns in Lee’s report, and determined that the Gardasil vaccine was “safe and effective.”

The FDA did acknowledge that Lee found residual DNA in the vaccine, but said it was “expected” and “inevitable” in products that are manufactured using recombinant technology.

The agency also said it remained confident that the residual DNA was “not a risk to vaccine recipients.”

“The presence of residual DNA is not a safety factor as defined by US regulations, and is not required to be included in Gardasil’s labeling,” wrote the FDA.

The following month (Oct. 21, 2011) the FDA quietly updated its website to reflect the presence of DNA fragments in the vaccine, assuring the public there was “no safety risk.”

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Millions Of Americans With Depression Could Be Eligible For Psilocybin Therapy If Approved By FDA, Study Shows

As many as 6 in 10 people currently receiving treatment for depression in the U.S. could qualify for psilocybin-assisted therapy if the treatment were approved by the Food and Drug Administration. That’s according to a recent study in the journal Psychedelics that highlights the broad impact that could result from wider clinical availability of the entheogen.

“Our findings suggest that if the FDA gives the green light, psilocybin-assisted therapy has the potential to help millions of Americans who suffer from depression,” Syed Fayzan Rab, an MD candidate at Emory University, and the study’s lead author, said in statement about the report. “This underscores the importance of understanding the practical realities of rolling out this novel treatment on a large scale.”

The study, authored by a three-person team from Emory, the University of Wisconsin and UC Berkeley and published last month, sought to estimate the upper, midrange and lower boundaries of current depression patients—including both major depressive disorder (MDD) and treatment-resistant depression (TRD)—who would likely be eligible for the psychedelic treatment. Its low-end figure is 24 percent, the midrange estimate is 56 percent and the upper boundary is 62 percent of current patients.

Overall, the report gives a range of estimates on the number of depression patients who’d qualify for psilocybin therapy, with between 4.7 million and 6.6 million MDD patients and between 1.4 million and 1.9 million TRD patients potentially eligible.

“These ranges highlight the potential variability in our estimates based on changes in the assumptions underlying comorbidity prevalence, emphasizing both the robustness and the uncertainty inherent in our projections,” the paper says.

Behind the wide range of estimates are open questions about who would be eligible for psilocybin-assisted therapy (PSIL-AT). For example, authors said the variance was “largely influenced by the removal of alcohol and substance use disorders as exclusion criteria” as well as analysis of other comorbidities that may or may not affect patient eligibility.

Other issues involve the degree to which healthcare providers would dispense psilocybin for off-label use (meaning for conditions other than depression), whether treatment is covered by insurance and whether other psychedelics—for example LSD—become available as alternatives to psilocybin.

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Court Confirms Merck Lied on Mumps Vaccine Label — But Lets Drugmaker Off the Hook in Antitrust Lawsuit

An appeals court this week ruled that even though Merck misrepresented critical data to the U.S. Food and Drug Administration (FDA) to gain approval for its updated mumps vaccine — and even though the FDA knew about the false claims — because the agency approved the vaccine anyway, Merck can’t be held responsible for unfairly hurting competitors.

The ruling stems from a class action lawsuit brought by a group of physicians and physicians groups who alleged Merck violated the Sherman Antitrust Act by making false claims about the efficacy of its mump vaccine on the product’s label in order to stifle competition and maintain a monopoly in the marketplace.

The Sherman Antitrust Act prohibits companies from conspiring to create a monopoly.

The U.S. 3rd Circuit Court of Appeals didn’t dispute the plaintiffs’ allegations that Merck lied to the FDA about the vaccine’s efficacy.

However, citing the Noerr-Pennington doctrine, the court ruled that because the FDA took no action against Merck after discovering the false claims, it was the FDA’s decision — not Merck’s fraud — that injured competitor GSK and the physicians and physicians groups who bought the ineffective vaccine at inflated prices.

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The COVID “vaccine” is an intentional effort at world genocide

Never before have there been children, young adults, athletes in their prime, entertainers, dropping dead “cause unknown” following vaccination.

Of course, the cause is known.  The leading doctors and medical scientists of our time–which excludes health agency bureaucrats, such as Fauci, who serve as marketing agents for Big Pharma and corrupt, politicized state medical boards and HMOs–have explained why and how the mRNA “vaccines,” which are not vaccines, kill, destroy the immune system, and cause health injuries.  What is not known is why some die immediately after receiving the deadly substance, others a month later, and others remain, so far, alive.  Some researchers think the content of the “vaccines” differed by lot, and some think some of the jabs were placebos for the purpose of producing an uninjured cadre to tout the safety of the jabs.  

Professor Michel Chossudovsky has collected here — https://www.globalresearch.ca/the-covid-killer-vaccine-people-are-dying-all-over-the-world-its-a-criminal-undertaking/5800358 — a number of videos documenting the widespread sufferings and deaths of the vaccinated.  It is not the unvaccinated who are “mysteriously” dropping dead all over the world.  It is the vaccinated.  

Yet the coverup continues.  The western media–a collection of whores–are at work covering up for themselves as well as for Fauci, Biden, Bill Gates, Big Pharma, the FDA, NIH, CDC, and the utterly corrupt and irresponsible medical profession.  Big Pharma and the FDA continue to push jabbing babies with the killer vaccine, and there are still parents so utterly stupid and insouciant that they participate in the murder of their own children.

With people all over the world so stupid and so blindly trusting of authority, we can see why the Satanic Bill Gates and Satanic Klaus Schwab are confident that they can succeed in reducing the world population and effecting their Great Reset.

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Bombshell Court Order: FDA Admits Graphene Oxide Found in Pfizer mRNA Vaccines – Confidential Docs Exposed!

The Covid-19 vaccines have been at the centre of a heated debate since their introduction, with many questions and concerns raised about their safety and effectiveness.

Speculation has also been rife that the Covid-19 injections may contain traces of Graphene Oxide, a highly toxic and conductive substance.

Medicine regulators, with the support of the Mainstream Media, have repeatedly denied these claims.

But they were lying to you.

Because recent evidence has emerged that confirms the presence of Graphene Oxide, a highly toxic and conductive substance, in the Pfizer vaccine. And it has come from the US Food and Drug Administration (FDA) which has been forced to publish the confidential Pfizer documents by order of the Federal Court in the USA.

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Another Government Lie? The Overwhelming Evidence that Tobacco does NOT Cause Cancer

One medical “fact” that the majority of people living in western countries today accept as “true”, is that smoking cigarettes leads to lung cancer, and that tobacco is a toxic substance.

But is it true? Can we trust our government when it comes to health advice? Have they ever lied to us in the past about health or diseases?

First, think about it logically. People have smoked tobacco for hundreds, if not thousands of years.

U.S. Government “experts” figured out only in 1964 that cigarettes caused cancer and were bad for health, as the Surgeon General put out a warning declaring that cigarettes were bad for one’s health.

Was there actually any evidence or credible science to back this up, or were other interests in play behind this warning?

Fortunately, if one decides to search out the evidence themselves, there is plenty of evidence and research to show the opposite, that tobacco does not cause cancer, and that as a natural plant, it actually has some therapeutic properties, which at one time seemed to be well-known.

I want to state up front that I do not smoke cigarettes, and never have (I never enjoyed them, even when I was in high school and most of my friends smoked them), and that I have no economic ties at all to the tobacco industry.

Neither am I recommending that anyone should either start smoking tobacco, or quit smoking tobacco.

That is an individual choice, and my sole interest is in publishing the truth, and giving further reasons why it is unwise to trust our current medical system and the government alphabet agencies that protect them, rather than protecting the health of the American public.

If there are indeed therapeutic properties to tobacco, such as relieving neurological disorders like Parkinson’s Disease, Big Pharma would have plenty of motivation to suppress that information in favor of their pharmaceutical patented drugs.

Also, cancer has always been the largest money-maker in the pharmaceutical industry, and there is plenty of evidence that cancer is a modern disease caused by pharmaceutical products, especially most recently as a known side-effect of the experimental COVID shots, so they need alternative products to blame for the ever-increasing cancer rates that bring in $billions to Big Pharma, while continuing to propagate the lie that there are no cures for cancer, when in fact there are many, but all of them are banned by the FDA.

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FDA ‘Unquestionably’ Overstepped Authority With War on Ivermectin, DOJ Attorney Admits

The attorney who defended the U.S. Food & Drug Administration (FDA) when doctors sued the FDA over its anti-ivermectin social media posts during the COVID-19 pandemic admitted the FDA’s war against ivermectin was a mistake and an abuse of governmental authority, according to an investigation by Project Veritas.

The nonprofit, which focuses on exposing corruption through undercover video, on Aug. 27 released footage of U.S. Department of Justice (DOJ) attorney Isaac Belfer telling an undercover Project Veritas journalist that what the FDA did was “unquestionably beyond its authority.”

Although Belfer defended the FDA’s actions in court, he told the Project Veritas journalist that there was a “legitimate problem” with the agency’s actions.

“If you remember during the pandemic,” Belfer said, “FDA issued some tweets that said, ‘You are not a horse. You are not a cow. Stop it with ivermectin.’ … They’ll often use tweets to pursue a broader agenda.”

In this instance, the tweets were part of a larger agenda of discouraging people from using ivermectin — a drug the FDA approved in 1996 for treating several diseases — to treat COVID-19.

But the FDA “really shouldn’t be saying, ‘Don’t take this drug,’” Belfer said, because the FDA — as a federal agency — can do only what it has statutory authorization from Congress to do.

The FDA is authorized to provide information about drugs, but it cannot recommend what drugs to take or not take. “That’s the practice of medicine and the FDA can’t practice medicine,” Belfer said.

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