Tag: fda

Fifth Circuit sides with ivermectin-prescribing doctors in their quarrel with the FDA

Three doctors who prescribed ivermectin for Covid-19 patients have valid claims that the Food and Drug Administration overstepped its authority with a campaign warning people not to take the drug, a Fifth Circuit panel ruled Friday, reinstating the trio’s lawsuit against the agency.

Drs. Robert Apter and Mary Talley Bowden say between them they have treated or consulted more than 9,000 Covid patients and they each have a patient survival rate of more than 99%, despite regularly prescribing them ivermectin off-label to treat the respiratory illness.

But the doctors say pharmacies stopped filling their prescriptions for the drug — which the FDA approved in 1996 for human use to treat parasitic diseases caused by round worms and black flies — after the FDA launched a public relations campaign in spring 2021 sounding the alarm that people were being hospitalized after self-medicating with large doses of the drug intended for deworming livestock that they had purchased over the counter.

The FDA also sent letters to the Federation of State Medical Boards and National Association of Boards of Pharmacy warning against the use of ivermectin to treat Covid-19 with a link to an agency advisory that said taking it in high dosages is dangerous.

Apter and Talley Bowden, along with Dr. Paul Marik, sued the FDA, the Department of Health and Human Services and the agencies’ leaders in Galveston federal court in June 2022. They claimed the FDA had exceeded its authority and violated the Administrative Procedure Act by interfering with their practice of medicine — regulation of which, they contended, falls to states.

The FDA’s campaign, coupled with their advocacy of ivermectin, caused them problems: A major Houston hospital system forced Talley Bowden to resign her privileges; Apter was referred to physician regulatory boards of Arizona and Washington state for discipline; Marik was forced to resign from his post at Eastern Virginia Medical School, where he was a medical professor and chief of pulmonary and critical care.

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Former Trump Drug Czar Says Top Federal Officials Stopped FDA From Scheduling Kratom Amid Concern About Agency’s ‘Bias’

As the U.S. Food and Drug Administration (FDA) under the Trump administration prepared to propose federal restrictions on kratom, a number of top officials intervened, criticizing the agency’s “bias” and stopping it “on the spot” from moving ahead with scheduling, a former White House drug czar said in a new interview.

“They did not give—did not have—the entire facts. They didn’t have the science,” said Jim Carroll, who served as director of the Office of National Drug Control Policy, or drug czar, under President Donald Trump from 2018 to 2021. “FDA did not paint the entire picture. Maybe they didn’t have the entire picture, but everyone else did.”

Carroll, who now works as a private lawyer and consultant, made the comments during a discussion with Mac Haddow, senior fellow at the American Kratom Association (AKA), during the National Conference of State Legislatures summit in Indianapolis earlier this month.

The former White House official said that as the Trump administration was considering whether to schedule kratom under the Controlled Substances Act, around 2018, FDA gave a presentation to his office that misstated the drug’s risk profile and potential benefits.

The agency was “talking about kratom being an opioid. We know that’s wrong, it’s flat-out wrong,” Carroll said. “They said that it’s highly addictive. Johns Hopkins [and] other medical, independent researchers have said it’s no more addictive than a cup of coffee in the morning, which I had before this interview.”

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How the FDA approved an antipsychotic that failed to show a meaningful benefit but raised the risk of death

In trials, brexpiprazole failed to provide a clinically meaningful benefit and it increased mortality, but the FDA fast tracked its approval and the sponsor predicts $1bn in annual sales. Robert Whitaker investigates the first licensed antipsychotic for treating agitation in elderly patients with dementia

For years, health officials have tried to rein in the prescribing of atypical antipsychotics to elderly patients with dementia. The practice has been entirely “off label” yet widespread. The US Food and Drug Administration reports that around 60% of patients with Alzheimer’s dementia in residential care have received an off-label prescription for an antipsychotic, benzodiazepine, antidepressant, or anti-epileptic drug. After a 2005 FDA warning that cited a 60-70% increased risk of death associated with antipsychotic drug use, the US Centers for Medicare and Medicaid Services established the National Partnership to Improve Dementia Care in Nursing Homes, a public-private collaboration that sought to “reduce the use of antipsychotics” and “enhance the use of non-pharmacological approaches.”1

But a May 2023 FDA approval of the antipsychotic brexpiprazole for agitation in patients with Alzheimer’s dementia may reverse all of this. At a cost of around $1400 (£1102; €1280) a month, the manufacturers Otsuka and Lundbeck, which jointly brought the “first in class” approval to market, are forecasting an additional $1bn in annual sales of Rexulti.2

Serious questions remain, however, about the harm-benefit balance of Otsuka and Lundbeck’s drug. The drug carries a “boxed warning”—the FDA’s most serious type of warning, informing prescribers of increased mortality. And among four efficacy evaluations across the three prelicensure clinical trials, the highest efficacy observed was a 5.3 point improvement over placebo on a 174 point scale. In the two trials that assessed quality of life, no benefit for either the patient or the caregiver was demonstrated.

“The small benefits do not outweigh serious safety concerns,” said Nina Zeldes, health researcher at the consumer advocacy organisation Public Citizen, addressing the FDA’s advisory committee at its 14 April meeting before the approval.3 “Like other antipsychotics, this is a drug that can kill patients without providing a meaningful benefit.”4

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The Unforgivable Ivermectin Swindle

This month, lawyers for the Food and Drug Administration admitted in a U.S. court that doctors “do have the authority to prescribe ivermectin to treat COVID”, an admission that stands at stark odds with a multiple year campaign to misinform, misalign and tarnish the reputation of one of the world’s most successful drugs, which could have been used to save hundreds of thousands of lives during the pandemic.

“FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID. So they are not interfering with the authority of doctors to prescribe drugs or to practice medicine,” Ashley Cheung Honold, lawyer representing the FDA said this month.

I know this likely isn’t the case for my regular readers, but if you’re new to the blog and you happen to be one of those people who still doesn’t quite understand that you are routinely lied to by the media and the billionaires that run our country, I can think of no better indoctrination than the travesty of a fraud that was just perpetrated on the American people regarding ivermectin.

For those who haven’t followed the story, during the course of the Covid pandemic, it was revealed that ivermectin – a drug that has been administered billions of times to humans and is on the World Health Organization’s list of Essential Medicines – was found in numerous clinical trials to have efficacy in early treatment of Covid-19. If you’re looking for a primer on this, here is a website that aggregates all of the clinical trials and here is a discussion with Bret Weinstein and Dr. Pierre Kory that serves as a great introduction to the topic.

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FDA creates path for psychedelic drug trials

Federal regulators are laying out guidance for psychedelic drug trials for the first time, in a move that could encourage the mainstreaming of substances like magic mushrooms and LSD as behavioral health treatments.

Why it matters: Psychedelics are turning into a multi-billion industry and gaining widespread acceptance after decades of concerns about recreational use of the products — and the high risk for misuse. But research to date has largely been backed by private sponsors.

Driving the news: The Food and Drug Administration on Friday released first-ever draft guidance outlining considerations — including trial conduct, data collection and subject safety — for researchers looking into psychedelic treatments for a variety of conditions, including PTSD, depression and anxiety.

  • The agency filed the 14-page document two days after a bipartisan coalition in Congress led by Rep. Dan Crenshaw (R-Texas) introduced legislation directing the issuance of clinical trial guidelines.
  • It also came as 10,000 attendees and hundreds of exhibitors converged on Denver for what was billed as the “largest psychedelic conference in history,” with guests ranging from New York Jets quarterback Aaron Rodgers to National Institute of Mental Health director Joshua Gordon.

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FDA warns stores to stop selling Elf Bar, the top disposable e-cigarette in the US

The Food and Drug Administration on Thursday said it has sent warning letters to dozens of retailers selling fruit- and candy-flavored disposable e-cigarettes, including the current best-selling brand, Elf Bar.

It’s the latest attempt by regulators to crack down on illegal disposable vapes that have poured into U.S. stores in recent years.

Last month, the FDA issued orders allowing customs officials to seize shipments of Elf Bar, Esco Bar and two other brands at U.S. ports. None of the products have received FDA authorization and they come in flavors like cotton candy, which regulators say can appeal to teenagers.

In the latest action, the FDA said it issued warnings to 189 convenience stores, vape shops and other retailers.

“We’re not going to stand by as bad actors are profiting off the sale of illegal products that are addicting our nation’s youth,” Brian King, the FDA’s tobacco center director, said in an interview. “Today’s action is just part of our long-standing efforts to address those products, particularly flavored disposable products.”

The FDA has tried for years to regulate the multibillion-dollar vaping industry, but separate data released by government researchers Thursday shows unauthorized e-cigarettes continue to launch.

The Centers for Disease Control and Prevention analysis showed the number of e-cigarette brands in the U.S. grew from 184 in early 2020 to 269 by late 2022.

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Elon Musk’s Neuralink Gets FDA Approval to Study Brain Implants in Humans

Elon Musks’s neurotechnology company Neuralink announced on Thursday it has obtained approval from the U.S. Food and Drug Administration (FDA) to carry out a clinical study of brain implants in humans.

It marks the first in-human clinical study for the company.

“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company said in a statement.

“Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!” it added, without providing further details about the trial.

Musk, in response, wrote on Twitter: “Congratulations Neuralink team!”

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Miscarriages and Dead Infants Were Described in a Secret FDA Review but Hidden From The Public

A new document was released to ICAN this April, thanks to a FOIA legal action that compelled the government to provide Pfizer documents they tried to keep secret for 75 years. Indeed, they had a good reason to hide it.

That document is called “PREGNANCY AND LACTATION CUMULATIVE REVIEW.” Many findings in it validate several concerns of COVID vaccine skeptics.

Pfizer identified 458 pregnancies where mothers were vaccinated (with and without adverse events).

Of the 673 case reports identified in the search, 458 involved BNT162b2 exposure during pregnancy (mother/fetus) and 215 involved exposure during breast-feeding.

In 210 out of the 458 cases, maternal exposure … was reported either with no associated AEs or with AE off-label use/product use issue for either the mother or the baby.

What happened to those pregnancies?

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FDA Presses Forward on Anti-Aging Supplement Ban

In a letter recently made public on the federal docket, the FDA has restated the position it announced in October 2022 that NMN does not meet the definition of a dietary supplement because, in the agency’s view, it was studied as a drug before it was ever sold in or as a supplement. The FDA is clearly gearing up for a ban of this critical anti-aging supplement. We need a strong, sustained grassroots response from the natural health community to protect access to this supplement; we also need to support changes in this law that threatens many other natural compounds from being turned into drugs.

The letter, dated January 23, 2023 but made public on March 29, 2023, is in response to a “new dietary ingredient” notification filed by Effepharm, Ltd., in November 2022 with additional information submitted in January 2023. The letter reiterates the FDA’s position that NMN is not a legal supplement due to the back-channel at the FDA that we’ve described many times before.

For supplements that are considered “new” under the law—that is, they weren’t sold “in or as a supplement” before 1994—companies must submit a notification to the FDA with studies to prove that it is safe before that ingredient can be marketed—this is referred to as a “new dietary ingredient” (NDI) notification. But here’s the issue: if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives an NDI notification on it from a supplement company, it can no longer be sold as a supplement.

This back-channel is threatening the existence of a number of important supplements. The pyridoxamine version of vitamin B6 was banned through this mechanism; CBD and NAC are also in jeopardy due to this loophole. We’ve explained previously that this provision inherently favors drug companies. IND applications are confidential. A drug company can file an IND on an ingredient and sit on it for years. Meanwhile, an innovative supplement company could develop that nutrient into a great product, do the studies to comply with the FDA’s ridiculous notification process, and then create a market for that product—and then the drug company can swoop in with their IND, kick the supplements out of the market, and create a monopoly. 

Last month, ANH-USA filed a Citizen’s Petition with our allies, the Natural Products Association, calling for the FDA to issue a regulation stating that NMN is a lawful dietary supplement. You can read our previous coverage for more detail on the arguments contained in that submission.

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FDA Commissioner Dr. Robert Califf says “regulation” is needed to target “misinformation”

In an interview with CNBC, FDA Commissioner Dr. Robert Califf said that online misinformation was harming the life expectancy of people, there is a need for “better regulation” on how to handle health misinformation and that “specific authorities at FDA, FTC, and other areas are going to be needed.”

“We know more and more about misinformation. It relates back to this life expectancy,” Califf said. Why aren’t we using knowledge of diet? It’s not that people don’t know about it. Why aren’t we using medical products as effectively and efficiently as our peer countries? A lot of it has to do with choices that people make because of the things that influence their thinking. The COVID vaccines and the antivirals give us an easy way to talk about it, but this is not limited to those areas. In heart disease, so many people don’t take their medicines, even though they’re now generic and very low-cost, often [they’re] deluded into taking things that are sold over the Internet that aren’t effective.”

According to the FDA commissioner, one of the solutions is telling the “truth is a louder volume.”

“In the good old days, when I was a practicing cardiologist, for the most part, people developed products, they got through the FDA, the label determined what was talked about, the Internet didn’t exist, you advertised in medical meetings and journals. There was sort of a hierarchy of information that went through the prescriber or the implanter in the case of devices to the patient. Of course, the problem in that system is it left a lot of people out. We now know about that. Now, everyone’s included because everyone’s connected to the Internet. But we can put out a statement about what we’ve determined based on the highest level of evidence, within ten minutes, someone who’s thought ten minutes about it can reach a billion people. And there’s nothing that restricts them from telling things that are not true. This has always existed. … But they couldn’t reach so many people,” he explained.

He added that there isn’t enough regulation on health information and that is “impacting our health in very detrimental ways.” As such, he thinks “there is a real need for better regulation of how to deal with this complex information.”

Califf noted that the FDA already has regulatory authority over advertisements content on tech platforms. But he feels the agency could do it better.

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