Tag: fda

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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Arcturus Therapeutics is seeking approval from the FDA to go ahead with self-replicating bird flu vaccine trials

Self-amplifying RNA (“saRNA”), also termed self-replicating RNA (“srRNA”), and self-amplifying mRNA (“sa-mRNA” or “samRNA”) are synonymous terms. Both refer to a synthetic mRNA molecule engineered to replicate itself within host cells.  Vaccines using this self-replicating technology are also called “replicon” vaccines.

In November 2023, Japan approved the use of the first saRNA vaccine against covid.  The vaccine is called Kostaive and is also known as ARCT-154 or, in Vietnam, VBC-COV19-154. It is a CSL and Arcturus Therapeutics vaccine.  At the time of the approval, researchers were hopeful that this was only the beginning for saRNA treatments for infectious diseases and even cancers.  The vaccine, which the Japanese are referring to as the “third atomic bomb,” began to be rolled out in Japan in October 2024 as part of its autumn covid vaccination programme.

There is only explicit mention of Kostaive using STARR mRNA technology. However, it is likely that the Kostaive “vaccine” uses both of Arcturus Therapeutics’ proprietary technologies: STARR (self-transcribing and replicating RNA) mRNA technology and LUNAR (lipid-mediated universal RNA delivery) delivery system.

LUNAR is a nanoparticle delivery system that enables the efficient and targeted delivery of mRNA to cells. STARR is a self-replicating RNA platform that combines with LUNAR to drive “therapeutic” protein expression.

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FDA Greenlights New Bill Gates-Funded ARCT-2304 Self-Replicating samRNA ‘Pandemic’ H5N1 Bird Flu Jab

Arcturus Therapeutics, a company specializing in mRNA-based pharmaceuticals, quietly announced Monday that the U.S. Food and Drug Administration (FDA) has granted approval for its Investigational New Drug (IND) application for ARCT-2304, a self-amplifying mRNA (sa-mRNA) injection targeting the H5N1 avian influenza “bird flu” virus.

The FDA has recently come under fire for “failing to meet safety requirements” and “failing to prioritize scientific data quality delivered from FDA laboratories,” according to the U.S. House of Representatives Committee on Energy and Commerce.

The new Arcturus trial, funded by the Biomedical Advanced Research and Development Authority (BARDA), aims to assess ARCT-2304’s efficacy in preventing pandemic influenza and plans to enroll around 200 healthy adults across the United States.

“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process,” said Joseph Payne, President & CEO of Arcturus Therapeutics in a press release.

“The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.”

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Big Pharma CEO’s Call Emergency Meeting After RFK Jr. Vows To Gut Corrupt FDA

The top five CEOs of major pharmaceutical companies appear to be in ‘panic mode’ and have reportedly convened an emergency meeting following Donald Trump’s historic election win.

Following Trump’s election victory, RFK Jr warned that entire departments of the Food and Drug Administration would “have to go”.

Jamel Holley, a New Jersey assemblyman and advisor to Robert F. Kennedy, Jr. said: “Sources tell me top five CEOs of pharmaceutical companies are holding an emergency teleconference at 1 PM. A lawyer has confirmed that everyone is in a state of panic!”

InfoWars reports: Additionally, Holley noted that major pharma stocks are sliding due to an “increasing threat environment” thought to be represented by Kennedy’s role in reforming public health agencies during the next Trump administration.

Kennedy said Wednesday he aims to drastically cut “entire departments” in the Food and Drug Administration, which regulates products related to public health and safety in the U.S.

“The nutrition department of the FDA has to go. They’re not doing their job. They’re not protecting our kids. Why do we have Froot Loops in this country that have 18 or 19 ingredients, and you go to Canada and it’s got two or three?” he asked MSNBC.

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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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