Tag: fda

Indonesia’s President Urges Biden To Lift FDA’s Kratom Import Restrictions, Advocacy Groups Say

In a meeting with President Joe Biden this week, the president of Indonesia urged the administration to lift a Food and Drug Administration (FDA) alert that broadly restricts imports of kratom to the U.S., according to a pair of advocacy groups.

Indonesia is one of the primary international exporters of kratom, a plant native to Southeast Asia that’s used for pain relief, managing the symptoms of opioid withdrawal and other purposes. The plant is currently unscheduled under U.S. law, but FDA issued an import alert in July that has seriously limited kratom imports from Canada, Indonesia, Malaysia and the Philippines.

Indonesian President Joko Widodo met with Biden for a bilateral meeting at the White House on Monday. According to the American Kratom Association (AKA) and the Kratom Coalition, Widodo used the opportunity to request administrative action to remove the FDA restrictions, emphasizing the economic and environmental consequences of the current kratom import policy for Indonesia.

The White House referred Marijuana Moment’s request for comment to the National Security Council (NSC). A spokesperson for NSC said they have “nothing to add on the Leaders’ conversation beyond the joint statement and fact sheet released on Monday” that do not explicitly mention kratom.

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Free the Meds: 5 Drugs You Should Be Able To Buy Over the Counter

The Food and Drug Administration (FDA) approves not only which drugs can go to market but also whether they require a prescription from a doctor. The agency gets this power from the Durham-Humphrey Amendment of 1951. Meant to protect patients, the law has turned into a license to make life difficult. Here are five low-risk drugs that the FDA could make available over the counter today.

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FDA finds potential ‘safety signal’ of seizures in 2-5 yr olds after getting Covid-19 shots

A new preprint study led by the U.S. Food and Drug Administration (FDA) has detected a potential “safety signal” for seizures and convulsions in young children after receiving the monovalent Pfizer or Moderna mRNA Covid-19 vaccines.

Researchers observed the condition in children ages 2-4 for the Pfizer vaccine, and ages 2-5 for the Moderna vaccine.

The total number of cases was 72, with over 50% meeting the definition for febrile seizures.

The median time between vaccination and seizures or convulsions was two days, with 32% occurring the day of or the day after vaccination. All seizures and convulsions took place within seven days of vaccination.

The signal emerged through near real-time surveillance of more than 4 million vaccinated children.

The researchers of the preprint study cautioned that the results “should be interpreted carefully given study limitations.”

The study also identified a myocarditis/pericarditis safety signal in mostly male children 12-17 years old.

However, since each of these conditions were a “known adverse outcome,” according to the researchers, they did not conduct any further follow-up.

Data for the study were collected through health claims records from CVS Health, Optum and Carelon Research, which participate in the FDA’s Center for Biologics Evaluation and Research, and supplemented with data from state and local immunization information systems databases.

The study covered reports through January, February or March of this year — as little as 6 months after the approval of vaccinations for younger children.

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FDA Authorizes New Covid-19 Shots From Pfizer, Moderna

Now that only the most mentally unstable liberals are demanding that the government protect them from near certain death by forcing them to wear face diapers that don’t – and have never – worked, on the afternoon of September 11 US drug regulators – many of whom are undoubtedly hoping to get a job offer at either Pfizer or Moderna as soon as they quit the public sector – authorized new COVID-19 vaccines to try to counter the poor effectiveness the current slate provide.

The U.S. Food and Drug Administration (FDA) cleared shots from Moderna and Pfizer that will be available to Americans as young as 6 months of age later this month. It’s a different question if anyone will take said shots following the recent newsflow suggesting that the side effects of the covid shots are far more dangerous than the so-called “vaccine” which doesn’t actually prevent infection.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, a top FDA official, said in a statement. 

“We very much encourage those who are eligible to consider getting vaccinated.”

The FDA approved the Moderna and Pfizer vaccines for people aged 12 and older. Regulators granted emergency authorization for the shots for people aged 6 months to 11 years of age. There was no mention of Novavax, whose vaccine is also available in the United States.

The shots target XBB.1.5, a subvariant of the Omicron virus variant. That subvariant has already largely been displaced by newer strains, including EG.5, according to the U.S. Centers for Disease Control and Prevention (CDC).

The authorizations came despite a lack of data from clinical trials.

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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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