Tag: fda

DEA Calls For Increased DMT Production In 2025 To Support Development Of FDA-Approved Psychedelic Drug

The Drug Enforcement Administration (DEA) is increasing the 2025 quota for the legal production of DMT in the U.S., saying it agrees with requests for the adjustment to “support legitimate research and scientific efforts” to develop a Food and Drug Administration- (FDA) approved drug based on the psychedelic.

In a notice set to be published in the Federal Register on Tuesday, DEA cited “additional quota applications and comments from DEA-registered manufacturers,” justifying the increase for the psychedelic compound.

DEA released initial quotas for the production of Schedule I and Schedule II controlled substances for research purposes in September. At the time, it called for an increase in the manufacturing of the psychedelics ibogaine, psilocybin and psilocyn, while continuing to maintain stable quotas for other substances such as marijuana, THC and MDMA.

But following a public comment period, it raised the production goal for DMT from 11,000 grams to 20,000 grams.

It’s not clear how close researchers are to developing a DMT-based drug, but several companies have indicated their intent to bring the psychedelic to market, pending regulatory approval.

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Just how far does the malfeasance of the FDA extend? Clinical trials of psychiatric drugs show negative outcomes – more chemical drugs are required to treat side effects

The Reality of Psychiatric Medications

Mental health conditions are often treated with pharmaceuticals, but are these products really as “safe and effective” as public health officials, healthcare professionals and drug manufacturers claim them to be?

David Wayne, psychiatric nurse, returns to “Pediatric Perspectives” to spill the beans on the true risks associated with common medications for depression, anxiety and related diagnoses.

The information contained in this episode is for informational purposes only. No material is intended to be a substitute for professional medical advice, diagnosis or treatment.”

The interview is wide-ranging and covers treatments such as anti-psychotic and anti-depressant drugs, as well as SSRI’s and Serotonin (and impotency).

Of note are the failed clinical trials and side effects that require ever more chemical drugs that are just as bad, with their own harmful side effects.

Aaron Siri pointed out the clinical trial detail in the package inserts of vaccines such as Hep B.

It looks like the same information on bad trial outcomes applies to psychiatric drugs.

The information is in the package inserts – from (dodgy) memory – I think these details are in section 6,

There are many reports of the deteriorating mental health of Americans. These “leaves rustling in the wind” could mean that these mental health issues and other physical issues, are caused by chemicals in psychiatric drugs.

All “approved” by the FDA as “safe and effective”.

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FDA must disclose more COVID-19 vaccine records, US judge rules

A federal judge has ordered the U.S. Food and Drug Administration to publicly disclose more information underpinning its authorization of COVID-19 vaccines, after failing to persuade the court to end the public records lawsuit.

In a ruling, opens new tab on Friday, U.S. District Judge Mark Pittman in Fort Worth, Texas, ordered the agency to produce its “emergency use authorization” file to a group of scientists who wanted to see licensing information that the FDA relied on to approve the Pfizer-BioNTech coronavirus vaccine.

“The COVID-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine,” wrote Pittman, appointed in 2019 by then-President Donald Trump.

The lawsuit, filed in late 2021, attracted attention after the FDA said it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency, the group that brought the case.

The FDA declined to comment.

Attorney Aaron Siri, representing the Public Health and Medical Professionals for Transparency, welcomed Pittman’s order.

“The FDA clearly lacks confidence in the review that it conducted to license Pfizer’s COVID-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review,” Siri said.

He said the agency was “hiding from the court and the plaintiff one million pages of clinical trial documents from the COVID-19 vaccine clinical trials.”

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The Coming Sea Change at Trump’s FDA: Towards an Era of Safety and Public Transparency for Medical Devices

It has been over a decade since my late-wife, Dr. Amy Josephine Reed, was harmed and killed by a poorly regulated medical device, known as the Power Morcellator. The sheer force of Dr. Reed’s voice, as a Harvard Medical School faculty member and a physician-scientist — and the injustice it uncovered to countless other women like her — became a bellwether case that demonstrates an ongoing and severe safety failure operational in the medical device regulatory space at FDA.

Of course, this safety failure in the FDA’s medical device regulatory arm, the Center for Devices and Radiological Health (CDRH), is hardly unique to that center. Industry and conflicted academic “experts,” not patients, play an outsized role in governing and corrupting almost all of the FDA’s centers. But, certainly, the source of the safety failure at CDRH is crystallized in the dangerous regulatory regime that the agency center utilizes to clear the vast majority of medical devices for the US healthcare marketplace: The 510(k).

At a legislative level, CDRH’s 510(k) regulatory regime was not designed to ensure the safety or efficacy of the medical devices it regulates — a fact that is well known to most public health experts and FDA regulators themselves. CDRH’s 510(k) does not use anything even remotely resembling an “evidence-based” framework to provide clearance to thousands of new medical devices annually used in the care of patients across the US and abroad.

Even more problematic is that the medical device industry pays the FDA for the 510(k) clearances obtained. In other words, almost the entire 510(k) clearance apparatus at CDRH is literally funded by the medical device industry — the very industry that stands to gain the most from the 510(k) clearances it funds. This is a serious conflict of interest in the healthcare space, and should not pass ethical muster — even when the argument is that such payments from industry to government are saving taxpayer dollars. The moment the industry starts paying to keep the FDA’s centers’ lights on is when the industry, not the people, will have an outsized voice in governing the agency that is regulating it.

Worse yet, the CDRH personnel whose 510(k)-related activities are funded by medical device makers exert virtually no real scrutiny over the manufacturer’s claims in their 510(k) applications for market clearance — either because their “reviews” are deliberately superficial and nominal, or because they are grossly incompetent from an expert perspective. It is literally true that the overwhelming majority of medical devices that seek 510(k) clearance for use in the US marketplace are granted them, without difficulty and at mach speed, by any reasonable standard — and although these devices are literally directly engaging the most vulnerable of America’s citizens: patients who trust American healthcare at their most vulnerable!

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FDA May Move To Ban Red Dye 3 from Food

The Food and Drug Administration (FDA) may move to ban artificial dye Red 3, otherwise known as erythrosine, from foods within the next few weeks.

Jim Jones, deputy commissioner for human foods at the agency, told a Senate meeting that the FDA is in the process of deciding a ban, in response to a petition.

“With Red 3, we have a petition in front of us to revoke the authorization board, and we’re hopeful that in the next few weeks we’ll be acting on that petition,” Jones said.

Red 3 is a colouring derived from petroleum that is widely used in foods and drinks, although it has been banned in cosmetics since 1990 after studies suggested it caused cancer in lab animals.

“There is simply no reason for this chemical to be in our food except to entice and mislead consumers by changing the color of their food so it looks more appealing,” said Rep. Frank Pallone in a statement, in response to the news.

“With the holiday season in full swing where sweet treats are abundant, it is frightening that this chemical remains hidden in these foods that we and our children are eating.”

Red 3 has been a target of Robert F. Kennedy Jr., who has been nominated as the next head of Health and Human Services by president-elect Trump.

Kennedy has vowed to clean up the food supply, the reform the system of food-additive regulation and ensure independence between regulators and industry.

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Food and Drug Administration Defends Refusal To Approve Flavored E-Cigarettes Before the Supreme Court

The Supreme Court heard the Food and Drug Administration’s (FDA) appeal in Food and Drug Administration v. Wages and White Lion Investments, LLC on Monday. The case concerns the FDA’s requirement for scientific studies to approve premarket tobacco applications (PMTAs) for flavored electronic cigarette (e-cigarette) manufacturers and distributors. The FDA’s requirement contradicts data and years of its own guidance for the end of reducing an exaggerated epidemic of underage nicotine use.

Concerns about rampant teen nicotine use are common. They are also commonly exaggerated. NPR originally claimed that “the percentage of high school kids who reported daily vaping of e-cigarettes jumped from 9.7% in 2014 to 30% in 2023.” (The outlet has since printed a correction.) What the FDA and CDC’s 2023 National Youth Tobacco Survey actually said was that 29.9 percent of high schoolers currently using e-cigarette were daily users; only 10 percent of all high schoolers were current users, (down from 14.1 percent in 2022), 90.3 percent of whom used flavored products. If “e-cigarettes have filled the vacuum” left by smoking, as former FDA deputy commissioner William Schultz says to NPR, the vacuum is not as large as people are led to believe.

The 2024 National Youth Tobacco Survey shows that this figure has fallen even further: from 10 percent to 7.8 percent. E-cigarettes have become increasingly unpopular with middle school and high school students despite sales increasing 47 percent from 2019 to 2023. More than 80 percent of this is attributable to flavored products, according to data from the CDC Foundation and Truth, a nonprofit public health organization committed to preventing youth nicotine addiction.

E-cigarettes are not the only product inappropriate for consumption by middle schoolers and high schoolers, alcohol is too. Despite the popularity of Pink Whitney, Fireball, Mike’s Hard Lemonade, and other sugary, colorful alcoholic drinks among high schoolers, federal regulators allow these products to be manufactured and distributed. The prohibition of such goods to adults would be unwarranted, not to mention infeasible. Nonetheless, the paternalistic Family Smoking Prevention and Tobacco Control Act of 2009, which grants the FDA the authority to regulate tobacco and nicotine products, restricts what kinds of tobacco products adults may consume.

The Act explicitly “prohibits a cigarette or any of its components from containing…any artificial or natural flavor (other than tobacco or menthol) or any herb or spice (including strawberry, grape, orange, clove, cinnamon, and vanilla.” The law also directs the Secretary of Health and Human Services of the FDA to establish the Center for Tobacco Products and to, among various responsibilities, “develop an action plan to enforce restrictions on the promotion and advertising of menthol and other cigarettes to youth.”

But the Act also “prohibits the secretary from: imposing unduly burdensome requirements” on manufacturers and importers. This provision is problematic for the FDA’s wholesale denial of PMTAs to flavored nicotine products. In the Fifth Circuit’s January 2024 opinion, Judge Andrew Oldham explains that the FDA “sent manufacturers of flavored e-cigarette products on a wild goose chase” by imposing new testing requirements after “promulgat[ing] hundreds of pages of guidance documents” between 2018 and 2020.

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The FDA’s War Against America’s Health

In 1906, the first FDA (Food and Drug Administration) was created in response to massive public protests against adulterated food and drugs (e.g., rotting food partially preserved with food additives or counterfeit consumer products). To stop it, food industry lobbyists attempted every tactic imaginable, eventually taking over the Department of Agriculture and in time forcing the dedicated public servant leading it (Harvey Wiley) to quit. Because of this, many toxic food additives Wiley fought against gained “generally recognized as safe” (GRAS) status and remain in use today.

•The handicapping of the FDA came to a head in 1962, when thalidomide was just barely prevented from devastating America’s children, prompting Congress to give the FDA much broader powers to police the safety and efficacy of drugs.

•Unfortunately, this law backfired, as the FDA created an impossible to reach standard of efficacy that it selectively enforced to protect the pharmaceutical industry and simultaneously began utilizing increasingly brazen (and illegal) police tactics against anyone promoting effective natural therapies.

•Because of this, many life-changing medical therapies (discussed throughout this article) were blacklisted by the FDA and faded into obscurity. This, along with the FDA’s tendency to push unsafe and ineffective therapies (e.g., vaccines or antidepressants) onto the market regardless of how much data argued against doing so, led to the FDA becoming the most protested agency in the federal government.

•Nonetheless, every attempt to fix the FDA failed. In this article, I will review the structural issues that have perpetually caused the FDA to succumb to incompetence and corruption. I propose potential solutions that can utilize the unprecedented window created by the Make America Healthy Again movement to end the FDA’s war against America’s health.

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Trump’s FDA Pick Thinks Marijuana Is A ‘Gateway Drug’ That Causes Heart And Mental Health Problems

President-elect Donald Trump’s pick to run the Food and Drug Administration (FDA) is a medical marijuana skeptic, promoting claims that cannabis use is linked to cardiovascular issues and mental health problems for youth. He has also suggested that marijuana is a gateway drug.

Marty Makary, a surgeon and medical commentator, has been selected to serve as FDA commissioner in the incoming Trump administration—a critical role as far as federal cannabis policy is concerned.

While the Robert F. Kennedy Jr., the president-elect’s choice for secretary of the U.S. Department of Health and Human Services (HHS) that oversees FDA supports ending marijuana prohibition and legalizing certain psychedelics for therapeutic purposes, Makary has been critical of cannabis use.

In September, he said that “people think marijuana today is the marijuana of hippies and that it’s entirely safe—but marijuana today is roughly 20 times more potent.”

“Even though it may have lower health complications in adults, that may not be true for adolescents where their mind is still developing,” he said on the mindbodygreen podcast. “The drug may have a different impact on young, healthy teenagers.”

“Some studies have found that among teenagers who use marijuana the risk of a psychosis diagnosis later in life goes way up—as many as 25 percent of people who consume it,” Makary said in the comments, which were first flagged by Cultivated Media, adding that he’s “not making a statement about the legalization or non-legalization,” but “to suggest that it is entirely safe is not consistent with the real scientific literature.”

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FDA Approves Long-Awaited Clinical Trial Of Smoked Marijuana To Treat PTSD In Veterans

After years of delays, researchers are set to move forward on a landmark clinical trial meant to evaluate the efficacy of smoked medical marijuana to treat post-traumatic stress disorder (PTSD) in military veterans. The study is being funded with tax revenue from legal cannabis sales in Michigan.

The Multidisciplinary Association for Psychedelic Studies, or MAPS, announced this week that the U.S. Food and Drug Administration (FDA) granted approval for Phase 2 of the research, what MAPS described in a press release as “a randomized, placebo-controlled study of 320 Veterans suffering from moderate to severe PTSD who have previously used cannabis.”

The group said the study “is designed to investigate the inhalation of high THC dried cannabis flower, versus placebo cannabis, with the daily dose being self-titrated by participants.” It’s meant to reflect consumption patterns already happening across the country and study “the ‘real-world’ use of inhaled cannabis to understand its potential benefits and risks in treating PTSD.”

The project is years in the making, MAPS said, noting that it encountered numerous issues in clearing the research with FDA that only recently were resolved.

“After 3 years of negotiations with the FDA, this decision opens the door to future research into cannabis as a medical treatment, offering hope to millions,” the organization said.

“These data are critical to inform patients, medical providers, and adult-use consumers when considering cannabis in treatment plans for the management of PTSD, pain, and other serious health conditions,” the group’s press release said, “yet regulatory obstacles have historically made it difficult or impossible to conduct meaningful research on the safety and effectiveness of cannabis products typically consumed in regulated markets.”

MAPS said that over the years, it responded to five partial clinical hold letters from FDA that halted the study’s progress.

“On August 23, 2024, MAPS responded to the FDA’s fifth clinical hold letter by submitting a Formal Dispute Resolution Request (FDRR) to resolve the continued scientific and regulatory disagreement with the Division on four key issues,” according to the organization: “1) the proposed THC dose of the cannabis flower product, 2) smoking as a delivery method, 3) vaping as a delivery method, and 4) the enrollment of cannabis naïve participants.”

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FDA approves Gates-backed bird flu vaccine trial: ‘Disaster waiting to happen’

The FDA has approved the first phase of human trials for a self-amplifying mRNA bird flu vaccine developed by Arcturus Therapeutics, funded by the US government and the Gates Foundation. This vaccine, targeting the H5N1 virus, introduces an enzyme prompting cells to produce more mRNA, leading to sustained antigen production, which experts warn could lead to prolonged immune activation and unknown health risks.

Epidemiologist Dr. Nicolas Hulscher described the FDA’s approval as an opportunity for Arcturus to “experiment with injecting humans with H5N1 bird flu replicon mRNA.” The clinical study is funded by the Biomedical Advanced Research and Development Authority (BARDA), a division of HHS focused on pandemic preparedness. Arcturus also recently received a $928,563 grant from the Gates Foundation, which has long supported mRNA research.

Arcturus claims self-amplifying mRNA vaccines can provide immunity with smaller doses. However, Hulscher warned that even a small dose might be more hazardous due to the vaccine’s self-replicating nature, as the extent of antigen production cannot be precisely measured or controlled.

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