Tag: fda

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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FDA Lets Chemical Companies Decide if Recycled Plastics Are Safe for Food Containers

Recycled content in food packaging is increasing as sustainability advocates press manufacturers to cut their use of virgin plastic.

Since 1990, the U.S. Food and Drug Administration (FDA), the agency responsible for ensuring food contact materials are safe, has approved at least 347 voluntary manufacturer applications for food contact materials made with recycled plastic, according to a database on its website.

Approvals have tripled in recent years, from an average of 7 to 8 per year through 2019, to 23 per year since then, and they continue to climb. The FDA has already approved 27 proposals through June this year.

Other than Coca-Cola, most manufacturers seeking approval are petrochemical giants such as Eastman Chemicals, Dupont and Indorama; and lesser-known plastic packaging manufacturers, including many from China, India and other countries.

The end buyers of the recycled materials aren’t included in the FDA database, but many popular brands are using recycled content. Cadbury chocolate bars come in a wrapper marketed as 30% recycled “soft plastic packaging.”

The Coca-Cola Co. in North America reports it sells soft drinks in 100% recycled PET (polyethylene terephthalate) bottles, while General Mills says its Annie’s cereal boxes use a liner made from 35% recycled plastic film.

Increasing recycled content in packaging may be good news for the planet, but researchers say the FDA has a lax approval process for plastic food packaging that hasn’t kept pace with the science on chemical hazards in plastics.

The agency’s approval process for recycled plastics is voluntary and ignores the potential risk of chemical mixtures, researchers told Environmental Health News (EHN). Companies can seek guidance on their recycling process, but they are not required to.

In addition, the FDA relies on manufacturers’ test data when it approves materials, leaving companies essentially in charge of policing themselves. Meanwhile, some studies show that recycled plastic can harbor even more toxic chemicals — such as bisphenol-A (BPA), phthalates, benzene and others — than virgin plastic.

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FDA Lets Chemical Companies Decide if Recycled Plastics Are Safe for Food Containers

Recycled content in food packaging is increasing as sustainability advocates press manufacturers to cut their use of virgin plastic.

Since 1990, the U.S. Food and Drug Administration (FDA), the agency responsible for ensuring food contact materials are safe, has approved at least 347 voluntary manufacturer applications for food contact materials made with recycled plastic, according to a database on its website.

Approvals have tripled in recent years, from an average of 7 to 8 per year through 2019, to 23 per year since then, and they continue to climb. The FDA has already approved 27 proposals through June this year.

Other than Coca-Cola, most manufacturers seeking approval are petrochemical giants such as Eastman Chemicals, Dupont and Indorama; and lesser-known plastic packaging manufacturers, including many from China, India and other countries.

The end buyers of the recycled materials aren’t included in the FDA database, but many popular brands are using recycled content. Cadbury chocolate bars come in a wrapper marketed as 30% recycled “soft plastic packaging.”

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FDA Approves New COVID Vaccines — for Virus Strains ‘Largely Faded From Circulation’

The U.S. Food and Drug Administration (FDA) approved updated mRNA COVID-19 vaccines manufactured by Pfizer and Moderna which target the currently dominant Omicron variant KP.2 strain of SARS-CoV-2, the agency announced Thursday.

The new shots are recommended for all people ages 6 months and older. However, according to the FDA, the new vaccines remain under emergency use authorization (EUA) for people between ages 6 months and 11 years.

According to NBC News, the new vaccines could be available within days.

The vaccines were approved even though their clinical trial data have not been released. Manufacturers claim that “testing in animals shows the shots trigger neutralizing antibodies,” The Epoch Times reported.

According to MedPageToday, the new vaccines “are manufactured using a similar process as previous formulas of these vaccines” and “the FDA assessed manufacturing and nonclinical data” in its approval process.

NBC News quoted a Pfizer spokesperson who said the data the company submitted to the FDA indicates a “substantially improved” immune response against the currently circulating COVID-19 variants.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement, “Vaccination continues to be the cornerstone of COVID-19 prevention.”

“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality,” Marks said.

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Watchdog pushes for investigation of FDA official’s conflict of interest

A disturbing article in the New York Times reveals that while a senior Food and Drug Administration (FDA) official, Jeff Shuren, M.D., J.D., was in charge of regulating medical devices, his wife’s powerful Washington law firm was representing their manufacturers.

Despite ethics rules barring Shuren, the director of the FDA’s Center for Devices and Radiological Health, from working on matters involving clients of his wife’s law firm, he did not always fully recuse himself, according to the report. In July, Shuren announced that he was transferring to the FDA’s Office of the Commissioner, and will leave the agency later this year.

Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, calls on the Office of Inspector General at the Department of Health and Human Services (DHHS) to launch an investigation amid news of these allegations. He released the following statement:

“The revelations about Dr. Shuren, the former director of the FDA’s Center for Devices and Radiological Health, are very troubling. There are long-standing concerns that the FDA’s regulation of medical devices has been too friendly to industry under Shuren’s leadership and has not prioritized patient safety and the effectiveness of novel medical devices. The Office of Inspector General at DHHS should formally investigate the allegations in the New York Times article. And the FDA must appoint a new director of the Center for Devices and Radiological Health who has no conflicts of interest and prioritizes patients’ interests.”

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