Tag: fda

If Opiates Are Killing Americans, Why Won’t the FDA Let Us Try an Alternative?

For more than a decade, patients who’ve needed certain controlled medications have suffered from ill-advised, untenable policies the U.S. government has instituted, allegedly to mitigate the ever-surging numbers of drug overdose deaths. These policies have been a dismal failure on multiple fronts: Not only have deaths continued to surge, but the terrifying intrusion of the Drug Enforcement Administration (DEA) into the practice of medicine has had a chilling effect on patients and their physicians. 

As the DEA relentlessly tightens production quotas on medications for pain and ADHD, it has begun tracking every pill, making doctors increasingly reluctant to prescribe any controlled drugs and leaving many patients in a lurch. Perhaps worse, DEA production quotas have caused the back-order of multiple drugs—an increasingly common burden for patients, even those fortunate to have doctors willing to risk a DEA drug bust for simply doing their job.

The ill and disabled suffer the most. Virtually all patients who have diseases or chronic pain conditions will say that the emergency department is the single worst place to go for relief from severe pain. Doctors and hospitals are often more concerned about law enforcement looking over their shoulders than patient care. Patients desperate for pain relief often turn to street drugs, where they fall victim to counterfeit pills that contain fentanyl (or worse) instead of a legal opioid. 

By contrast, doctors in Australia, Canada, the United Kingdom, and throughout Europe have been using a fixed-dose, inhaled general anesthesia medicine that effectively reduces acute pain—a medication denied to Americans by a seemingly indifferent Food and Drug Administration (FDA). 

Doctors commonly used methoxyflurane (Penthrane) as a general anesthetic in the 1960s and 1970s. But, because it had toxic effects on the liver and kidneys, anesthesiologists gradually stopped using it and turned to safer anesthetics. In 2005, the FDA removed methoxyflurane from the market.

However, an Australian company, Medical Developments International, has been marketing a lower-dose, self-administered, single-use nasal inhaler version of methoxyflurane for 30 years. Its brand name is Penthrox, though many people refer to it as the “green whistle,” because of the package it comes in. People living in Europe have had access to the green whistle since 2015, and Canadian patients have had it since 2018. 

In 2020, a randomized controlled clinical trial in the U.K. demonstrated that the drug saved an average of 71 minutes in providing pain relief to accident and emergency department patients. Likewise, a 2020 Australian trial found that a methoxyflurane inhaler “was associated with clinically significant lower pain scores compared to standard therapy.” While it may cause drowsiness in some people, methoxyflurane at this low dose has few adverse effects, such as liver and kidney toxicity, and there are no reported cases of addiction or abuse. 

In 2022, the FDA finally lifted its “clinical hold” on methoxyflurane nasal inhalers and has allowed its manufacturer to resume FDA-supervised clinical trials. Unfortunately, this is an unnecessary waste of time.

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FDA is a front organisation: There are no technicians in the buildings, no equipment and no sample testing occurs

Katherine Watt has been corresponding with a reader who is researching the history of US public health and regulatory agencies.  Records before 1973 are difficult to locate.  However, what has become clear is that the origins of these agencies are not what they make them out to be.

Why are they lying about their origins?  Because, Watt says, “they have maintained a bunch of empty office buildings that serve only as mailing addresses … There are no technicians in the buildings, there’s no equipment and no sample testing occurs.”

Katherine Watt is a mom, Catholic, and paralegal from Pennsylvania, USA. On her Substack page ‘Bailiwick News’ she documents how, since at least World War II, US Congress has been waging war on the people by passing legislation which makes it easier and easier for them to be destroyed – legally – by the pharmaceutical industry.

One of Watt’s Substack readers is researching the pre-1972 statutory and regulatory history of some of the USA’s public health agencies, including the National Institutes of Health (“NIH”) and the Food and Drug Administration (“FDA”).

The reason why 1972 is relevant is that in that year the regulation of biological products transferred from the NIH Division of Biologics Standards to the FDA Bureau of Biologics.  “In 1973, FDA published a consolidated set of biological product manufacturing non-regulations in the Federal Register,” Watt explained.

“Administrative rule-making by FDA since 1973 is relatively easy to locate,” she said.  However, “administrative rule-making by NIH prior to 1973 is more difficult to locate.”

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1 In 3 Kids Have Elevated Levels Of Lead In Blood, As FDA Investigates Lead-Tainted Fruit Pouches

Many parents turn to fruit pouches whenever their children ask for a quick snack. These travel-friendly, resealable snacks are made from fruit purees designed to take the edge off your child’s hunger in a pinch.

They come in eye-catching and attractive packaging and are sweetened to suit kids’ flavor preferences.

But fruit pouches aren’t as great as they seem to be. Aside from being an inferior substitute for real fruits and fresh fruit juices, these seemingly harmless snacks can mess up your child’s health, as they are found to be contaminated with extremely high levels of lead.

FDA recalls three brands of fruit pouches due to lead contamination

In October 2023, the FDA warned parents and guardians to avoid buying WanaBana apple cinnamon fruit puree pouches, after it was discovered that the snacks contained high levels of lead.

According to the FDA:

“Parents and caregivers of toddlers and young children who may have consumed WanaBana apple cinnamon fruit puree pouches should contact their child’s healthcare provider about getting a blood test.

“Lead is toxic to humans and can affect people of any age or health status. Protecting children from exposure to lead is important to lifelong good health.”

Healthy Holistic Living reported that at least seven cases of severe lead poisoning linked to these fruit pouches were identified in more than five states, including Arizona, Louisiana, Maryland, Missouri and North Carolina.

WanaBana then voluntarily recalled their fruit puree pouches, which were sold in grocery chains like Dollar Tree as well as online retailers like Amazon.

Following these findings, the FDA also issued a recall for two more brands of fruit pouches — Schnucks cinnamon-flavored applesauce pouches and variety pack, and Weis cinnamon applesauce pouches.

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‘Time to Ground the Plane’: FDA Advisers Recommend JN.1 COVID Vaccines Despite Growing Evidence of Cancer Risks

In a unanimous 16-0 vote, the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee today recommended a monovalent JN.1-lineage vaccine composition for 2024-2025 Formula for COVID-19 vaccines.

The JN.1 variant has been most dominant this year, Reuters reported.

Last year, the agency’s committee recommended COVID-19 vaccines targeting XBB.1.5, a subvariant of Omicron that dominated the U.S. from November 2021 to 2022.

The committee today also discussed which specific strains within the JN.1-lineage group — such as subvariants KP.2 and KP.3 — the vaccines should target. The FDA said it will later issue an official recommendation to manufacturers about what subvariants it wants to target within the JN.1-lineage group.

David Wiseman, Ph.D., a bioscience researcher, told the committee that in recommending continued COVID-19 vaccination, the FDA may be putting the U.S. public’s health at risk. “Based on the totality of evidence, it is reasonable to believe that the product [COVID-19 vaccines] may be unsafe,” he said.

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Despite progress in data transparency, the FDA still keeps its data secret

History shows that hiding clinical trial data can be deadly.

Vioxx is a well-known example of how the US drug regulator withheld important information about the harms of the drug for over three years, before it was withdrawn from the market and tens of thousands of people died as a consequence.

Numerous initiatives have been launched over the past two decades to improve access to trial data after it became evident that what was reported in peer-reviewed journals was often cherry-picked and misleading.

Eminent scientists have succeeded in gaining access to trial data from the European and Canadian drug regulators, but a recent analysis published in the Journal of Law, Medicine, & Ethics, found that the US FDA still lags behind others when it comes to data transparency.

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FDA detects surge in seizures and heart failure in children who were subjected to COVID-19 jabs

After years of ignoring serious safety signals with the COVID-19 vaccines, the Food and Drug Administration (FDA) finally commissioned a safety study and took a closer look at two serious adverse events that affect young children and adolescents: heart inflammation and seizures.

In a large cohort study involving over 4 million inoculated children, the FDA detected a surge in seizures for children ages 2 to 5. The agency also found a surge in myocarditis and pericarditis in children ages 12 to 17.

“Statistical signals were detected for myocarditis or pericarditis after BNT162b2 vaccination in children aged 12 to 17 years and seizure after vaccination with BNT162b2 and mRNA-1273 in children aged 2 to 4 or 5 years,” the study authors wrote.

Children permanently injured, without scientific rationale or legal recourse

The Pfizer (BNT162b2) and Moderna (mRNA-1273) COVID-19 “vaccines” are responsible for surges in heart inflammation and heart failure in children across the United States. These serious, life-threatening vaccine injuries were predicated on the false belief that children would either die without the jabs or would spread an infection that could kill their elders if they didn’t succumb to the jabs.

Practically every public health entity, institution, and false authority demanded that children be subject to this experiment, and now millions of parents are realizing that they were manipulated into a scam of diabolical proportions.

Of the 73 million American children aged 6 months to 17 years, approximately 26.2 million have completed the primary series of a FDA-licensed COVID-19 vaccine. Another 5.5 million U.S. children had received at least one dose of the primary series.

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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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