Tag: fda

DISTURBING FDA LOOPHOLE ALLOWS SCIENTISTS TO DO EXPERIMENTS ON HUMANS WITHOUT INFORMED CONSENT

An FDA rule change published on December 21, 2023 solidifies that scientists are allowed to conduct human experiments without informed consent, as long as the research poses “minimal risk” and includes “appropriate safeguards to protect the rights, safety, and welfare of human subjects.” Investigation by ICAN’s legal team revealed that efforts to undermine informed consent protections have long been in the works, going back to at least 1962. ICAN has filed a FOIA request to dig deeper into this violation of one of our most basic human rights.

Informed consent is one of the bedrocks of human rights. It requires that (1) you be fully informed of the risks and benefits of any intervention or procedure and (2) that you consent to participate without coercion of any kind. Unfortunately, it turns out that Congress and our federal health authorities have been working to weaken informed consent protections for over 60 years!

On the heels of FDA’s new draft guidance which further weakens the already paltry clinical trial requirements for vaccine approval, FDA is once again implementing rules that take aim at informed consent protections. On December 21, 2023, FDA issued a final rule that “allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects.”

An investigation by ICAN’s attorneys revealed that back in 1962, Congress passed an amendment to the Food, Drug, and Cosmetics Act which directed HHS to create regulations that required researchers to “obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings.” (Emphasis added.)

In 1981, both the FDA and HHS issued updated federal regulations regarding “The Protection of Human Subjects.” HHS’s regulations for example “exempt[ed]  broad categories of research which normally present little or no risk of harm to subjects,” such as “study of data, documents, records and specimens.”

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FDA Says ‘No Safety Signals’ Linking White Blood Clots To COVID Shots, Despite Embalmer Survey Suggesting Otherwise

White clots in people’s arteries are “really happening” — so why isn’t the phenomena being openly discussed in the public sphere? political commentator Russell Brand asked during a recent episode of his “Stay Free” podcast.

Brand showed viewers a clip of prominent medical commentator John Campbell, Ph.D., interviewing former Air Force Major Thomas Haviland.

Haviland conducted a 2023 survey of 269 embalmers across four major countries and three continents.

According to the survey, more than 70% of embalmers found strange fibrous white blood clots — clots they were not finding pre-pandemic — in significant percentages of corpses in 2023.

Haviland also conducted a similar survey in late 2022 that revealed 66% of embalmers began finding the unusual clots in mid-2021, suggesting a temporal link to the rollout of COVID-19 vaccines, which began earlier that year.

The topic is largely going undiscussed by mainstream news outlets, Brand said, although at least GB News interviewed Campbell to talk about the “white stringy rubbery clots.”

“You’re not really hearing it discussed to the degree that it perhaps ought,” Brand said, “if it is as prevalent as is suggested.”

For instance, Brand cited a Feb. 21 BNN Breaking article that reported Thai neurologist Dr. Thiravat Hemachudha had initially discussed the topic in a Facebook post — but swiftly chose to “cease public discussions on the topic.”

Thiravat is chief of the Thai Red Cross Emerging Infectious Diseases Health Science Centre and a proponent of COVID-19 vaccines.

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FDA Not Interested In Reports Of Unusual Blood Clots In Cadavers Around The World Since Covid Pandemic

“Full Measure” host Sharyl Attkisson looks into reports of unknown blood clots being found in cadavers around the world since the COVID-19 pandemic.

“No matter what’s causing this, whether it’s the virus, the vaccine, or whether it’s Cheerios or a bad box of Cracker Jacks, something has to be farmed out what’s causing it, because it’s obviously a change in the blood,” said former Air Force major Tom Haviland.

“The FDA did offer a response to Full Measure,” reported Sharyl Attkisson. “The FDA and the Centers for Disease Control and Prevention (CDC) place a high priority on vaccine safety and are committed to our vaccine safety monitoring program. The FDA has not identified any safety signals for fibrous blood clots with COVID-19 vaccines.”

She added: “They also stated that since the observations were made on cadavers, it ‘falls outside of the FDA’s regulatory purview.'”

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SHOCKING: USA has recorded over 1 Million Excess Deaths among the over 65’s since the FDA “approved” the COVID-19 Vaccine

The FDA granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, making it the first COVID-19 vaccine to receive such authorization in the United States.

Following that, the Moderna COVID-19 vaccine received EUA on December 18, 2020, and the Janssen (Johnson & Johnson) COVID-19 vaccine received EUA on February 27, 2021.

The elderly were offered the COVID-19 vaccine first and the number of excess deaths recorded was astounding. During the first 20 weeks of 2021 150,085 excess deaths were recorded among people aged over 65’s compared to the 2015 to 2019 five-year average.

Then from week 21 to week 40 of 2021, an astounding 165,387 excess deaths were recorded among people aged 65 and over. This brought the total excess deaths from week 1 to week 40 of 2021 to 315,472 among those most likely to get the COVID-19 vaccine.

The remainder of 2021 saw 133,268 excess deaths recorded. Bringing the total excess deaths for the year among the over 65’s to 448,740.

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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.”

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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.  

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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.”

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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.

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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.

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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).

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