Tag: fda

FDA Admits COVID Vaccine Leads to ‘Significiantly Elevated’ Risk of Seizure in Toddlers

Toddlers and young children are at a “significantly elevated” risk of seizure after taking the COVID-19 vaccine, according to the latest research by the Food and Drug Administration (FDA).

Researchers found that children experienced a 2.5-fold increase in febrile seizures within 24 hours of receiving a Moderna shot compared to the same children between eight to 63 days post-vaccination. There were 88 febrile seizures after the Pfizer vaccination among the study group.

The report states:

In this self-controlled case series that included participants aged 2-5 years from three commercial insurance databases, the incidence rate ratio of febrile seizures was significantly elevated in the 0-1 days following mRNA-1273 administration. Absolute risk was small.

The incidence of febrile seizures was elevated immediately following vaccination with the monovalent mRNA-1273 COVID-19 vaccine in children aged 2-5 years. Based on the current body of evidence, the safety profile of monovalent mRNA vaccines remains favorable for use in young children.

The findings raise further concerns about the various vaccines, which have led to a variety of serious side effects despite being touted by the medical establishment as “safe and effective.”

Keep reading

The Era of Informed Consent is Over

In a significant blow to patient autonomy, informed consent has been quietly revoked just 77 years after it was codified in the Nuremberg Code.

On the 21st of December 2023, as we were frantically preparing for the festive season, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a final ruling to amend a provision of the 21st Century Cures Act. This allowed 

…an exception from the requirement to obtain informed consent when a clinical investigation poses no more than a minimal risk to the human subject…

This ruling went into effect on January 22nd, 2024, which means it’s already standard practice across America. 

So, what is the 21st Century Cures Act? It is a controversial Law enacted by the 114th United States Congress in January 2016 with strong support from the pharmaceutical industry. The Act was designed to

…accelerate the discovery, development, and delivery of 21st-century cures, and for other purposes [?]…[emphasis added]

Some of the provisions within this Act make for uncomfortable reading. For example, the Act supported: 

High-risk, high-reward research [Sec. 2036].

Novel clinical trial designs [Sec. 3021]

Encouraging vaccine innovation [Sec. 3093].

This Act granted the National Institutes of Health (NIH) legal protection to pursue high-risk, novel vaccine research. A strong case could be made that these provisions capture all the necessary architecture required for much of the evil that transpired over the past four years.

Overturning patient-informed consent was another stated goal of the original Act. Buried under Section 3024 was the provision to develop an

Informed consent waiver or alteration for clinical investigation.

Scholars of medical history understand that the concept of informed consent, something we all take for granted today, is a relatively new phenomenon codified in its modern understanding as one of the critical principles of the Nuremberg Code in 1947. It is inconceivable that just 77 years after Nuremberg, the door has once again opened for state-sanctioned medical experimentation on potentially uninformed and unwilling citizens.  

Keep reading

New Study Finds One Dose of LSD Could Effectively Treat Anxiety in Many Patients

After years of criminalization and marginalization, scientists have begun looking at LSD’s medical benefits more closely, so much so that the Food and Drug Administration just issued a groundbreaking stamp of approval. 

Biopharmaceutical company Mind Medicine announced March 7 that the FDA has awarded “breakthrough therapy” status to its trial of patients using MM120 (lysergide D-tartrate) to treat anxiety. MindMed chief medical officer Daniel Karlin explained what the trial approval means going forward. “A breakthrough designation is a recognition that a drug has demonstrated evidence of clinical efficacy in meeting an unmet medical need with morbidity and mortality associated with it,” he told CNN. The move allows the FDA to “engage more closely in drug development” and speeds up the road to final approval as the agency is involved throughout the process. 

MM120 is the codename for MindMed’s lysergide D-tartrate compound, which resembles and delivers similar effects to lysergic acid diethylamide, known more commonly as LSD. In its ongoing trial, which kicked off in 2022, MindMed has so far found that a single dose of MM120 led to a 48-percent rate of remission from generalized anxiety disorder after 12 weeks following the drug’s administration. Scientists also noted significantly improved clinical signs of generalized anxiety disorder among 65 percent of patients within three months. 

“The clinical improvement for many patients was more than double what we see with today’s standard of care,” Karlin said. “This occurred at all levels of anxiety, from moderate all the way up to severe.”

Keep reading

FDA Loses its War on Ivermectin: Agrees to Remove All Related Social Media Content and Consumer Advisories on Ivermectin Usage for COVID-19

In December 2021, the FDA warned Americans not to use Ivermectin, which “is intended for animals” to treat or prevent COVID-19.

“Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous,” FDA said at the time.

This was a very controversial statement at the time since the FDA pushed the drug on African migrants back in 2015, and the drug was praised in several scientific journals.

There have now been 101 Ivermectin COVID-19 controlled studies that show a 62% lower risk in early treatment in COVID-19 patients.

A group of brave doctors had filed a federal lawsuit against the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) over the agencies’ unlawful attempts to block the use of ivermectin in treating COVID-19.

The lawsuit, filed in the U.S. Southern District of Texas in Galveston, argues that the FDA has overstepped its authority and unjustifiably interfered with their medical practice.

The plaintiffs, Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter, are contesting the FDA’s portrayal of ivermectin as dangerous for human consumption. They note that the FDA has approved ivermectin for human use since 1996 for a variety of diseases. However, they allege that with the advent of the COVID-19 pandemic, the FDA began releasing documents and social media posts discouraging the use of the anti-viral drug for COVID-19 treatment.

“We’re suing the FDA for lying to the public about ivermectin,” said Dr. Bowden.

Keep reading

Ground cinnamon sold at discount stores is tainted with lead, FDA warns

Ground cinnamon sold by U.S. discount retailers is contaminated with high levels of lead and should be discarded, federal health officials said Wednesday.

The U.S. Food and Drug Administration said cinnamon sold by stores including the Dollar Tree and Family Dollar contains lead at levels that could be unsafe for people, particularly children, with prolonged exposure to the spice. The agency urged suppliers to recall the products voluntarily.

Cinnamon products included in the agency’s safety alert include the La Fiesta brand sold by La Superior and SuperMercados; Marcum brand sold by Save A Lot stores; MK brands sold by SF Supermarket; Swad brand sold by Patel Brothers; El Chilar brand sold by La Joya Morelense; and Supreme Tradition brand sold by Dollar Tree and Family Dollar stores.

“Removing the ground cinnamon products in this alert from the market will prevent them from contributing elevated amounts of lead to the diets of children,” the alert said.

Keep reading

FDA Official Says Agency Is ‘Actively’ Exploring CBD Regulations As It Continues To Monitor Kratom

The Food and Drug Administration (FDA) is “actively” exploring a potential regulatory framework for CBD, with plans to prioritize the issue in the next year, a top official says. Meanwhile, the agency is also investigating issues related to kratom.

FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak discussed the agency’s cannabis and kratom interests during a webinar hosted by the Alliance for a Strong FDA this month.

Asked about issues that are “top of mind” for the agency in 2024 and where officials hope to engage with Congress, Trzeciak said that later this year or next year FDA wants to address setting up “an appropriate regulatory framework for CBD.”

Later in the conversation, the FDA official was asked specifically about how the agency is “prioritizing” its work on cannabis and kratom regulations, and she said officials are taking a number of factors into consideration as they work to address the substances.

“In almost every neighborhood you go to, you can see stores on the corners that are marketing CBD and kratom and others,” she said. “And one of the things that we have been thinking through here at FDA, using CBD as an example, is what does the regulatory framework for those products look like?”

“Based on what we know about CBD in particular, we do not think that those products would be able to meet the safety standards that we have in place for foods and dietary supplements today,” she said, referencing the agency’s position after it declined to enact regulations for the non-intoxicating cannabinoid that was legalized under the 2018 Farm Bill.

“What can we do in terms of regulatory tools to ensure that this product is going to be marketed that consumers are clearly aware of what the product is, what is in it and making sure that we have basic information about the marketplace?” Trzeciak said. “I like to think of it as the common regulatory tool that we have across the other products that we regulate.”

She added that FDA wants to “work with Congress on this effort,” including possible rulemaking around CBD product labeling and packaging.

“For example, how can we ensure that the agency knows if there are adverse events that are being reported, so we can identify those trends, making sure that the product is being manufactured or produced in a way that’s safe and quality?” she said.

Kratom reform advocates say the deputy commissioner’s comments represent a “shift” in the agency’s policy perspective on the issue. Historically, FDA hasn’t engaged in the kratom debate as actively as other agencies such as the National Institute on Drug Abuse (NIDA).

Keep reading

US Officials Concede No Active Surveillance On Long-Term Effects Of COVID-19 Vaccines

In a Feb. 15 hearing by the Select Subcommittee on the Coronavirus Pandemic, U.S. health officials side-stepped a question when asked whether the U.S. Food and Drug Administration (FDA) is actively conducting extended safety surveillance on those who received early COVID-19 vaccines.

Rep. Nicole Malliotakis (R-N.Y.) asked Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, whether the FDA is conducting active surveillance and if there are any specific health markers they’re studying that may signal trends requiring further inquiry.

“Every time we go through and do the safety surveillance, we start back, and it goes back to 2020. In some cases where we’re looking for certain things, we might use a different window, but indeed, we have to look from the beginning of the period of surveillance. I can turn it over to Dr. Jernigan because he can speak for CDC [Centers for Disease Control and Prevention] in that regard,” Dr. Marks said.

“So with regard to myocarditis, we certainly have been monitoring the issue with various different data systems. I think the most recent data really demonstrates that you’re about eight times less likely to get myocarditis if you’re vaccinated compared to those that are unvaccinated,” Dr. Daniel Jernigan, director of the National Center for Emerging and Zoonotic Infectious Diseases at the CDC responded.

Rep. Malliotakis told Jernigan she wanted to know about “everything,” not just myocarditis.

Dr. Jerrigan asked her to repeat the question, and she asked again whether the FDA was conducting extended safety surveillance on early recipients of COVID-19 vaccines.

“Most of the reports that we get of adverse events are in the few weeks following the vaccination,” Jernigan said. In terms of monitoring these over time, Jernigan said the agency has “vaccine effectiveness” systems in place at the CDC.

Neither Jernigan nor Marks referenced any active surveillance initiatives being undertaken by their agencies to monitor people who received the original COVID-19 vaccines for long-term health effects.

“There is no system in place for long-term vaccine safety surveillance in this country,” Ms. Liz Willner, founder of OpenVAERS, told The Epoch Times.

Keep reading

Conspiracy Theory Debunker Finds Real Conspiracies

The 2023 book Misbelief by Dan Ariely belongs to a genre I would label “debunking Covid conspiracy theories.” The book is meant to explore the thought process of people who subscribe to conspiracy theories, especially about Covid and the Covid vaccines. 

Thus I was surprised to encounter in the book two stories in which the author uncovered real conspiracies to hide information about Covid from the public. 

Ariely, a professor of psychology at Duke University, played a bit part in promoting Covid lockdowns around the world. By his own description, he worked 

…on projects related to Covid-19 with the Israeli government and a bit with the British, Dutch, and Brazilian governments as well…I was mostly working to try to get the police to use rewards to incentivize good mask-wearing behavior and observance of social distancing instead of using fines… (p. 4) 

The first genuine conspiracy he describes involved the US Food and Drug Administration (FDA) manipulating data in the Vaccine Adverse Events Reporting System (VAERS).

The second involved a newspaper editor-in-chief refusing to report about vaccine side effects observed by a hospital. The author reports these situations matter-of-factly, and even gives the conspirators the benefit of the doubt, saying maybe they did the right thing! 

Let’s look at the VAERS conspiracy (recounted on pp. 274-276). Ariely says he got this information directly from a person who works “in the information technology department of the FDA.” The agency, according to the story, determined that: 

…foreign powers, mostly Russian and Iranian, had found a way to spread disinformation using VAERS. So when the FDA identified cases that had clearly come from such sources, it removed them from the system…

Not only did it delete this data, but it did so silently. Ariely only found out by accident: Parents of vaccine-injured children maintained their own copy of the VAERS data, downloaded from the FDA site. They noticed that cases appearing in their downloaded data later disappeared from the government copy of the database, and they told Ariely about this. 

Supposedly the FDA tried to keep these actions secret because it “did not want to announce to the foreign powers that it was onto them,” the FDA employee told him. But to anyone reasonably well-versed in information technology, keeping such acts secret is an obvious mistake. The bad guys will figure out what is going on; the folks we are trying to protect are left in the dark about possible mischief affecting data they rely on. And that’s the most charitable assessment of their actions. It could be worse: the FDA might have removed valid information inadvertently (putting aside possible nefarious intentions at this point). How might that come about? 

Keep reading

COVID Vaccine Shedding Is ‘Real,’ FDA and Pfizer Documents Are Proof: Clinicians

The topic of COVID-19 vaccine shedding has long been controversial; now, some doctors say it is real.

“Shedding is unfortunately real,” said Dr. Pierre Kory at the Front Line COVID-19 Critical Care Alliance (FLCCC) conference in Phoenix, Arizona, in early February. “The FDA (U.S. Food and Drug Administration) knows that.”

Dr. Kory is a co-founder of the FLCCC, a non-profit advocacy group founded by physicians for the treatment of COVID-19, long COVID, and postvaccine syndromes. He is also the co-founder of the Leading Edge Clinic and has treated over a thousand long-COVID and postvaccine patients.

Mainstream fact-checkers have largely denied shedding on the basis of definition. The commonly cited definition comes from the U.S. Centers for Disease Control and Prevention (CDC) website, which defines shedding as the release of viruses, bacteria, and their components from live vaccines.

While mRNA and adenovirus vaccines are not live vaccines, they function similarly to gene therapy products.

All gene therapy products pose a risk of shedding, according to the FDA.

Keep reading

FDA Grants Priority Review Of MDMA-Assisted Therapy For PTSD, Psychedelics Drug Development Company Says

The Food and Drug Administration (FDA) has agreed to review MDMA-assisted therapy as a potential treatment option for post-traumatic stress disorder (PTSD), and the application has been granted priority status, according to the psychedelics-focused drug development company that’s leading the effort.

About two months after Lykos Therapeutics (formerly MAPS Public Benefit Corporation) submitted the new drug application (NDA) for MDMA in combination with psychotherapy, FDA granted it priority review last week and has set a target date for determination by August 11, the company announced on Friday.

If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with talk therapy and other supportive services.

“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” Lykos CEO Amy Emerson said in a press release. “We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”

Keep reading