Tag: fda

American Lung Association Demands the FDA Mislead the Public About Vaping

The Food and Drug Administration (FDA) should abandon any efforts to inform the public that vaping is safer than smoking, says the American Lung Association (ALA).  

Numerous public surveys show a consistent, widespread misperception that vaping nicotine is just as or more dangerous than smoking cigarettes. The problem is so extensive that correcting these false beliefs forms part of the FDA’s Center for Tobacco Products (CTP) 5-year strategic plan. 

Writing in the journal Addiction, Brian King, the head of CTP, stated: “Opportunities exist to educate adults who smoke cigarettes about the relative risks of tobacco products.” To that end, among the five goals listed as part of CTP’s plan is a commitment to inform the public that not all tobacco products are created equally, with cigarettes being the most dangerous and others, such as e-cigarettes, being far less harmful. 

The pledge to provide accurate information about the risks of different nicotine products is long overdue and in line with the public health communications of peer countries such as Canada, New Zealand, and the U.K. (The U.K. even has vape shops in hospitals, and some smokers are offered free vapes to help them quit.)

But in their comments on CTP’s strategic plan, the ALA, which proclaims its commitment to a world free of lung disease, demands the FDA “remove language from the description for this goal that references informing adults about the relative risk of tobacco products” and that “CTP should have no part in the industry’s efforts to sustain addiction through the failed and flawed notion that adult smokers should switch to e-cigarettes.”

Despite ALA’s protestations, the idea that e-cigarettes are effective for smoking cessation is not a tobacco industry notion. According to the prestigious Cochrane Review, e-cigarettes are more effective than nicotine patches or gums in helping smokers quit. In essence, the ALA is asking the FDA to withhold accurate information from the public that could save lives. The recommendations sparked strong reactions from those who believe safer alternatives to cigarettes are a no-brainer from a public health perspective.

“This is highly ironic, given the extent to which the Lung Association and other tobacco control organizations went to punish the tobacco industry for lying to the public and hiding critical health information,” writes Michael Siegel, a visiting professor at the Tufts University School of Medicine. “It is also unethical because it violates the public health code of ethics, which calls for honesty and transparency in public health communications. We do not hide critical health information from the public.”

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FDA Refuses to Provide COVID-19 Vaccine Safety Data to US Senator

U.S. officials are refusing to provide COVID-19 vaccine safety data to a U.S. senator.

Sen. Ron Johnson (R-Wis.) asked the U.S. Food and Drug Administration (FDA) for the results of analyses on data from the Vaccine Adverse Event Reporting System in January. The request came after the U.S. Centers for Disease Control and Prevention (CDC) said none of the safety signals it identified for the COVID-19 vaccines were “unexpected.”

The two agencies have run different types of analyses on the system’s reports, which are primarily made by health care professionals.

The first time the agency ran analyses using the method for the COVID-19 vaccines, in 2022, hundreds of signals were triggered, files obtained by The Epoch Times show.

The FDA in 2021 started a different type of analysis, called Empirical Bayesian (EB) data mining.

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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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