Tag: fda

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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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.

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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? 

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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.

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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.”

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The Loosening of Rules on Informed Consent

On January 22, 2024, amendments to the Food and Drug Administration (FDA) regulations (21 CFR 50) covering Institutional Review Boards (IRBs) were finalized and implemented. The amendments added a new section 50.22 that allows for exceptions to informed consent requirements for minimal risk research. 

While the addition of section 50.22 harmonizes FDA IRB regulations with the Dept of Health and Human Services (DHHS) IRB regulations (known as the Common Rule: 45 CFR 46) that are administered by the Office for Human Research Protections (OHRP), the handling of the Covid shots over the past 3-4 years should raise red flags. 

Currently, I am chair of an IRB at a private-not-for-profit outpatient healthcare agency that does research in which vulnerable populations are recruited. As such, I’m well aware that the foundational documents from which the OHRP developed the regulatory framework under which IRBs operate are the Nuremberg Code and the Belmont Report. 

Back in October 2023, my first Brownstone post, Where is the Office for Human Research Protections, asked the question as to how the approval of a Phase 3 research pharmaceutical product (mRNA vaccines) could be done without the formal involvement of IRBs. Specifically, the Nuremberg Code, covering informed consent, and the Belmont Report, covering among other elements, bodily autonomy, which are foundational to oversight of human subject research, and the requirement for a data and safety monitoring plan were completely discarded. Was the OHRP consulted for its input, and if not, did anyone from OHRP express concern? Given that these protections were put in place in response to medical atrocities (the Holocaust and the Tuskegee experiments), you’d think that they’d be sacrosanct. Think again!

While not providing a direct answer to the question I posed, Debbie Lerman’s posts, Covid mRNA Vaccines Required No Safety Oversight and Covid mRNA Vaccines Required No Safety Oversight: Part Two, and Sasha Latypova’s post, EUA Countermeasures Are Neither Investigational nor Experimental, provided a detailed roadmap as to the actions that were actually taken in implementing Emergency Use Authorization (EUA) for the Covid shot. To me, the most significant finding was that the legality of using EUA in civilian populations is rather tenuous, at best. 

With the foregoing as a backdrop, let’s get into the nuts and bolts of the new FDA regulations, noting that in addition to being chair of an IRB, I am also a retired physician, who has been in the healthcare field for 50 years. This includes 19 years of direct patient care in a rural setting as a Board Certified Internist, 17 years of clinical research at a private-not-for-profit outpatient healthcare agency, and over 35 years of involvement in public health, and health systems infrastructure and administration. As such, I bring a breadth of training, knowledge, and experience to this matter that is fairly unique.

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CRIMINAL FDA DECLARES INFORMED CONSENT NULL AND VOID

If we’ve learned one thing over the last three years, it’s that abiding by centuries-old medical ethics, like asking questions, is what White Supremacists™ and domestic terrorists do.

Via the soon-to-be-memory-holed American Medical Association webpage on informed consent:

“Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.

The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention.”

That was then.

This is now, when respecting the Science™ requires that you shut your filthy masked mouth and do whatever corporate media news actors and Public Health™ technocrats tell you to do.

Via Federal Register:

“The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule 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. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.”

Branch COVIDians surely don’t care about any of this, as they gave up long ago exercising their former right to be fully informed of medical experimentation risks anyway. In fact, they brag about their ignorance and apathy and doglike obedience as if they are virtues.

Listen to the New York NAACP lady explain:

“We must take the vaccine. Now, I’m going to tell you a personal story off script. So, today right after this I am going to have an infusion, and I’m going to have an infusion because I want to make sure that the cancer that was in my body does not return. I’m not asking what’s in the infusion, I’m not looking up all of the ingredients in the infusion, I am sticking out my arm and I am taking the infusion, and that’s what we have to do.” [seal-like clapping from the masked retards behind her]

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Hemp Industry Pushes Congress To Hold FDA Accountable With Hearing On CBD Regulation Inaction

A coalition of hemp industry organizations are calling on a House committee to hold a hearing addressing the ongoing lack of Food and Drug Administration (FDA) regulations for products made with constituents of the crop such as CBD.

In a letter addressed to House Energy and Commerce Committee leaders, 28 state and national  nonprofits focused on hemp and dietary supplements said that “the time for a hearing has never been riper” to examine regulatory pathways that FDA could enact to allow for the lawful marketing of hemp products for humans and animals.

“In the more than five years since the legalization of hemp through the 2018 Farm Bill, in spite of a designated annual appropriation, the FDA has taken no meaningful steps toward the regulation of hemp—whether it be animal feed or extracts for human consumption like CBD,” the groups said.

FDA said last year that, after an extensive review, it determined that it lacked necessary authority to establish regulations for the hemp and CBD market, stating that it will require additional congressional support.

“Meanwhile, thousands of unregulated products continue to be sold, causing great consumer confusion and advantaging bad actors via-a-vis good faith manufacturers who want to play by the rules and offer healthy products,” the letter says.

The House Energy and Commerce and Senate Health, Education, Labor and Pensions (HELP) Committee responded to FDA’s inaction last summer by putting out a Request for Information (RIF) from experts on the best path forward for regulating hemp, with hundreds of respondents sharing their perspective and recommendations.

“By now, your staff has had months to review and consider these recommendations,” the organizations said in the new letter, adding that “Energy & Commerce must weigh in for there to be meaningful action.”

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