Wednesday, January 29, 2025
Saturday, March 23, 2024
FDA Loses its War on Ivermectin: Agrees to Remove All Related Social Media Content and Consumer Advisories on Ivermectin Usage for COVID-19.
(IT’S TOO DAMN LATE … HOW MANY PEOPLE DID THE FDA KILL … KNOWINGLY, AS IVERMECTIN HAS BEEN USED FOR DECADES TO PREVENT AND TREAT HUMAN ILLNESSES? THEY ARE CULPABLE IN THE SERIOUS ILLNESS AND DEATHS OF THOUSANDS.)
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.
Claims were made that the initial article misrepresented the law by stating the FDA’s official stance against Ivermectin use without mentioning that doctors were allowed to administer the medicine.
U.S. law is cited in the complaint, including the provision that the FDA “may not interfere with the authority of a health care provider to prescribe or administer any legally marked device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”
On Thursday, the U.S. Food and Drug Administration (FDA) reportedly agreed to remove all its previous social media posts and consumer advisories that specifically addressed the use of ivermectin for the treatment or prevention of COVID-19.
“FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history. This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship,” Dr. Bowden wrote on her social media.
The plaintiffs have recently received the signed court order and are preparing to issue a press release about it later today.
The Gateway Pundit previously reported that during a hearing, the agency’s lawyers argued that the FDA was only giving advice and it was not mandatory when it told people to “stop” taking Ivermectin for COVID-19.
“The cited statements were not directives,” said Isaac Belfer, one of the lawyers. “They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
“They use informal language, that is true… It’s conversational but not mandatory,” he continued.
However, the statement from the lawyer contradicted the FDA’s social media post, stating, “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” and another tweet says, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”
Both tweets displayed the title of “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and included a link to that publication.
Last year, Doctors Mary Talley Bowden, Paul Marik, & Robert Apter appeared in the Fifth Circuit Court of Appeals as part of their lawsuit.
“The FDA is not your doctor. Yesterday we took them to court to remind them of that,” Dr. Bowden wrote.
“A pharmacist cites CDC and US FDA as why she will continue to deny filling prescriptions for ivermectin. On Tuesday, the FDA’s attorney declared the FDA has no problem with doctors prescribing ivermectin off-label. It’s time for them to make a formal announcement and set the record straight,” Bowden wrote on Thursday.
During the oral argument, Ashley Cheung Honold, a Department of Justice lawyer representing the FDA stated that the agency “explicitly recognizes” that doctors do have the authority to administer ivermectin to treat COVID.
“”FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” said Honold.
“FDA made these statements in response to multiple reports of consumers being hospitalized, after self-medicating with ivermectin intended for horses, which is available for purchase over the counter without the need for prescription,” Honold said.
“In some contexts, those words could be construed as a command,” Ms. Honold said. “But in this context, where FDA was simply using these words in the context of a quippy tweet meant to share its informational article, those statements do not rise to the level of a command.”
“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,” she said.
It can be recalled that Houston Methodist launched an investigation into Bowden and suspended her for defying health authorities and exercising free speech.
The hospital excoriated Bowden for “using her social media accounts to express her personal opinions about the COVID-19 vaccine and treatments,” NBC News reports. The suspension barred the physician from admitting or treating patients at the hospital.
Bowden repeatedly warned that it is “wrong” to mandate the experimental mRNA vaccines and continuously touted Ivermectin as a safe and effective treatment amid threats from public health officials against prescribing the drug.
Bowden was forced to resign. In her resignation letter, Bowden doubled down on the efficacy of Ivermectin.
“I have worked hard to provide early treatment for victims of COVID-19. My efforts have been successful. I have treated more than 200 COVID-19 patients, including many with co-morbidities, and none of these patients have required hospitalization. This is a testament to the success of my treatment methods,” she wrote. “Throughout this pandemic, there has been no FDA-approved treatment for COVID. Therefore I have done my best to care for patients and save lives in the absence of a clear scientific consensus.”
“Early treatment must still be part of any strategy for patient care. That is why physicians and hospitals should pay more attention to medications such as Ivermectin, which significant research and my clinical experience indicate is effective,” she continued. “I have decided to part ways with Houston Methodist because of the accusation that I have been spreading “dangerous information.” This is false and defamatory. I do not spread misinformation, and my opinions are supported by science. There is substantial evidence for the efficacy of Ivermectin in treating COVID-19, and no evidence for serious or fatal side effects associated with the doses used to treat COVID-19.”
https://www.thegatewaypundit.com/2024/03/fda-loses-its-war-ivermectin-agrees-remove-all/?utm_source=rss&utm_medium=rss&utm_campaign=fda-loses-its-war-ivermectin-agrees-remove-all
Sunday, November 19, 2023
Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products.
SILVER SPRING, Md., Nov. 16, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products until they come into compliance with federal regulations and requirements under the Federal Food, Drug, and Cosmetic Act.
The U.S. District Court for the District of Utah, Central Division has entered two consent decrees of permanent injunction against Evig LLC, of St. George Utah, and the company's CEO, Douglas Lex Howard, as well as Premium Production LLC, of St. George, Utah, and its Manager, Ryan Petersen.
Tuesday, August 22, 2023
I WILL NOT COMPLY. I NEVER HAVE AND NEVER WILL. I DON'T KNOW ANYONE WHO REGRETS REFUSING THE "VACCINE."
Prepping for Masking 2.0, Fear Pro, Obedience Plus, and the ‘even scarier than last time’ variants.
They’re just testing everyone to see if you’ve been paying attention or are you a sheep wearing blinders.
An Atlanta college has become the first since the government declared the pandemic over to mandate masks for students and staff just days after classes began.
Morris Brown College, a private liberal arts school, is requiring students and employees to wear face masks in hallways and lecture halls for two weeks due to 'reports of positive cases among students.'
Second verse, same as the first ... a little bit louder and a little bit worse ...
Meanwhile, in an editorial published by the American College of Physicians (ACP), Government doctors and public health experts in Seattle have called for face coverings to be made compulsory in all healthcare facilities once more.
They argue that hospital patients are at a higher risk of dying from or being seriously ill with Covid and would benefit from the 'reduce[d] risk for Covid contracted in the hospital among patients and health care workers.'
In other words, hospitals are full of germs. So we want to make sure people die alone and in pain again because of THIS germ.
And here's what they are basing it on ...
The World Health Organization and the Centers for Disease Control and Prevention are tracking a new, highly mutated lineage of the virus that causes COVID-19.
Six cases in four countries have been detected since late July. Scientists are keeping an eye on the new lineage, named BA.2.86, because it has 36 mutations that distinguish it from the currently-dominant XBB.1.5 variant.
So far there is no evidence that BA.2.86 spreads faster or causes more serious illness than previous versions. The CDC said its advice on protecting yourself from COVID remains the same.
Let me repeat the salient part: SIX cases in FOUR COUNTRIES. Six cases out of how many millions of people? Long story short, there's no proof that any of the new stuff is worse than the old stuff. BUT everyone should panic, get new experimental shots, and replay all of the crap that didn't work the first time.
Moderna said preliminary trial data suggest its latest version of the vaccine shows promise against Eris and a related variant called Fornax, which has begun to circulate in the U.S.
Pfizer Inc. has said its updated COVID-19 shot showed neutralizing activity against the Eris subvariant in a study conducted on mice.
And again with the mice. How many this time? One or two?
The mind boggles that they are trying this again.
Do you trust the CDC? … the WHO? Moderna? … Pfizer? … Their version of Science™? …
Are you a moron? Or are you wanting to see if “died suddenly” was just a “conspiracy theory?”
Oh, and if you’re wondering if it’s true what you’ve been hearing with all them memes saying that the FDA has approved ivermectin for use against Covid … you should never trust the governments stance on anything that solves the problem quickly, effectively, and cost efficient.
From the FDA:
"Although FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use," the agency said in a post on X, formerly known as Twitter, Friday.
Other major health organizations advising against use of ivermectin for COVID-19 include: the World Health Organization, European Medicines Agency, Infectious Diseases Society of America, and the U.S. National Institutes of Health.
Monday, August 14, 2023
120,000 American Children ‘Died Suddenly’ after Covid Shots Rollout.
A bombshell new report from the U.S. Centers for Disease Control and Prevention (CDC) has revealed that a staggering 120,000 American children have “died suddenly” following the public rollout of the mRNA Covid shots.
Throughout 2021, Democrat President Joe Biden’s administration and then-chief medical advisor Dr. Anthony Fauci insisted that the shots were “safe and effective” and necessary for protecting kids from the virus, despite children only showing mild symptoms if any at all.
On December 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine was granted emergency use authorization (EUA) for administration in individuals 16 years of age and older by the U.S. Food and Drug Administration (FDA).
On May 10, 2021, the FDA expanded the EUA for the use of the shots to include adolescents 12 through 15 years of age.
On June 17, 2022, the FDA authorized emergency use of the mRNA Covid vaccines from Moderna and Pfizer-BioNTech to include use in children down to 6 months of age.
Just over a year on, the report, which was quietly released by CDC with little attention from the corporate media, has revealed that nearly half a million children and young adults have now died since the injections were approved for use on most children.
Over 118,000 of those deaths are suspected to be linked to the Covid vaccines’ side effects.
Despite the staggering death toll revealed in the report, it has been met with a deafening silence from the corporate media.
Meanwhile, the establishment media is consumed with get-Trump reporting and distracting the public with propaganda on the war in Ukraine and the alleged “climate crisis.”
Compared to other countries, the U.S. Government has been slow when it comes to publishing relevant and up-to-date data.
The delays make it difficult to analyze the consequences of rolling out the experimental mRNA injections to the public.
However, the latest data from the CDC has just been published by the Organisation for Economic Co-operation and Development (OEC).
The OEC is an intergovernmental organization with 38 member countries.
It was founded in 1961 to stimulate economic progress and world trade.
The OEC hosts a wealth of data on excess deaths, including data from the CDC that isn’t easily available to the American people.
You can view the data for yourself here: https://stats.oecd.org/index.aspx?queryid=104676
The figures that have been provided to the OEC by the CDC show excess deaths among American children and young adults aged 0-44 across the country by week in 2020 and 2021.
The official figures reveal that there was a slight increase in excess deaths among children and young adults when the alleged Covid pandemic hit the U.S. in early 2020.
However, with the introduction of a Covid injection, one would have expected deaths to have fallen significantly among the age group in 2021.
Instead, however, the opposite happened.
Excess deaths among children and young adults were significantly higher every single week in 2021 than they were in 2020 except for weeks 29 and 30.
But then in week 31, something drastic happened to cause excess deaths to skyrocket among children and young adults.
And official figures provided by the CDC, unfortunately, show that trend has continued in 2022.
The most recent data released by the CDC covers up to week 40, the week ending October 9th, and it should be noted that the last few weeks of data are subject to change.
But 2022 has also been a significant year for excess deaths among children and young adults.
The CDC has confirmed that there have been 7,680 more excess deaths among children and young adults in 2022 so far than there were during the same time frame in 2020 at the height of the Covid pandemic.
The year 2021, was by and far the worst, however, with 27,227 more excess deaths by week 40 following the roll-out of the Covid-19 injection than what occurred in 2020 at the height of the pandemic.
But the most concerning figures reveal that the overall number of deaths and excess deaths among children and young adults spiked since the roll-out of the Covid injections.
Nearly half a million people aged 0 to 44 have sadly died since week 51 of 2020.
This has resulted in an astonishing 117,719 excess deaths against the 2015-2019 five-year average.
If we are to believe the official narrative that Covid-19 is a deadly disease, then we could perhaps agree that 231,987 children and young adults up to the age of 44 dying in 2020 resulting in 40,365 excess deaths was an unfortunate consequence of this disease.
But if the official narrative were true, that Covid injections are “safe and effective,” there wouldn’t be soaring increases in deaths among children and young adults in both 2021 and 2022.
We know millions of Americans were coerced into getting the injections.
And we know millions of parents were coerced into forcing their children to also get the same injections.
The data provided by the CDC, which has been incredibly hard to find, only gives us clues as to this being the case with so many deaths among young Americans.
However, further data published by the UK government confirms it.
One of the pieces of evidence confirming this is a report published on the 6th of July 2022, by the UK’s Office for National Statistics (ONS), which is a UK government agency.
As Slay News reported, official UK government figures show the overwhelming number of people who died from Covid had received three or more shots of mRNA vaccines for the virus.
The UK government quietly released the official figures for Covid deaths in 2022.
The data reveals that the triple+ vaccinated population accounted for 92% of Covid-19 deaths throughout the entirety of 2022.
The figures also show that 9 in every 10 Covid deaths in England over the past two years had received three or more of the shots.
https://slaynews.com/news/120000-american-children-died-suddenly-covid-shots-rollout/
Thursday, June 1, 2023
FDA Bans Farmers from Caring for Their Own Animals Without Costly Vet Approval.
For the last, oh, I don’t know… forever… ranchers and farmers large and small have taken care of their livestock with antibiotics and antimicrobials that were available at farm stores. These medicines treat common illnesses and infections that people who own large animals and livestock are very familiar with and qualified to treat. They have been trusted to do so for as long as these medicines have been available. The first chicken antibiotics were introduced in 1948. Since then, there has been no call nor reason to regulate these items. Many farmers and ranchers tend to many of their animals’ veterinary needs, which is a part of being a responsible animal handler who needs to keep costs down.
It would be ridiculous to take a chicken to the vet. When chickens are sick, you consult with other chicken owners and go buy the needed items to make them well again. It was a good system.
But NOW, the unelected, unaccountable, faceless, nameless, power-hungry monarchs at the FDA have decided that none of our farmers, ranchers, or hobbyists will be allowed to have those medicines anymore without visiting the vet for a prescription. This will cost the farmers tens of thousands of dollars a year in added vet bills, which they will then pass onto the consumer, forcing prices even higher during a time of record inflation.
There was no debate in Congress, no federal law passed, no chance for a town hall or public debate, no reading of a bill, no commercials warning the public so they could stop this encroachment on liberty and sanity. We have been informed by federal decree that this is now our new reality.
The U.S. Food and Drug Administration (FDA) released new antibiotic guidance pertaining to animal drugs containing medically-important antimicrobials for use in companion and food production animals that are currently approved for over-the-counter (OTC) marketing.
Under the guidance, FDA stated several antibiotics familiar to ranchers and other livestock owners will no longer be available OTC.
The intent of the new antibiotic guidance is to ensure animal drugs that contain antimicrobials important for humans are not being overused or used incorrectly, said Texas Farm Bureau (TFB) Associate Director of Commodity and Regulatory Activities Tracy Tomascik.
“There are many antibiotics used in both human and animal medicine, and there’s concern that overuse or misuse of those medicines can contribute to antimicrobial resistance,” he said. “FDA has been updating its antimicrobial medication guidelines for several years now. This is the latest update in a string of changes to the way ranchers can access medication for livestock use.”
This starts in June of this year. Some have suggested that this is a move to keep people from buying Ivermectin, which has been shown in studies to improve COVID symptoms. It doesn’t matter why they did it; the bigger problem is that no federal agency should be able to institute any sweeping federal mandate without input from the people it affects. This is tyranny.
But perhaps worse than this shocking display of federal f*ckery through the executive branch exercising immense power it should not have is the fact that our representatives are shocked and confused at how this happened. Rep. Thomas Massie (R-Ky.) replied to a tweet discussing this new rule claiming ignorance. “I mean no slight to you by my reply, but I don’t recall voting on this recently. Was this done at the state level? Too many rules are implemented by agencies these days.”
What the FDA has done by instituting this new rule is an attack on liberty itself. It should cause people to flood the streets in protest of a government that is so big it is now openly hostile to the people it claims to serve. This is not representative government. America is broken and I’m not sure anyone in any position of power is serious about stopping it.
https://pjmedia.com/columns/megan-fox/2023/05/26/fda-bans-farmers-from-caring-for-their-own-animals-without-costly-vet-approval-n1698371
Tuesday, May 23, 2023
GET THE MILK. THE WHOLE MILK. NOTHING BUT THE MILK.
For some reason, milk has been under attack. Some critics are saying don’t drink milk, it’s unneeded, unnatural, and bad for you. That couldn’t be further from the truth.
Thousands of scientific studies have documented the benefits of drinking milk. Don’t be misled by alarming headlines or passionate critics. Get the full story about milk. Nutrition is a science, not a point of view. See what the real experts are saying about milk, one of the most naturally nutrient-rich beverages you can find.
Some are avoiding dairy milk or replacing it with an alternative. But it’s tough to make up for the nutrients that real milk provides, which is particularly troubling for growing kids, who will likely suffer the most.
Learn the facts.
THIS IS HERESY
No cow needed: Oat and soy can be called milk, FDA proposes.
Soy, oat, almond and other drinks that bill themselves as “milk” can keep using the name, according to draft federal rules released Wednesday.
Food and Drug Administration officials issued guidance that says plant-based beverages don’t pretend to be from dairy animals, and that U.S. consumers aren’t confused by the difference.
Dairy producers for years have called for the FDA to crack down on plant-based drinks and other products that they say masquerade as animal-based foods and cloud the real meaning of “milk.”
Under the draft rules, the agency recommends that beverage makers label their products clearly by the plant source of the food, such as “soy ‘milk’” or “cashew ‘milk.’”
The rules also call for voluntary extra nutrition labels that note when the drinks have lower levels of nutrients than dairy milk, such as calcium, magnesium or vitamin D. They would continue to allow labels that note when plant-based drinks have higher levels. Fortified soy ‘milk’ is the only plant-based food included in the dairy category of U.S. dietary guidelines because of its nutrient levels.
The new guidelines are aimed at providing consumers clear nutrition information, FDA Commissioner Dr. Robert Califf said in a statement. The draft rules do not apply to nondairy products other than beverages, such as yogurt.
The National Milk Producers Federation, an industry trade group, applauded the call for extra nutrition information on drink labels, but said they rejected the FDA’s conclusion that plant-based drinks can be called milk because it’s a “common and usual name.”
The Good Food Institute, a group that advocates for plant-based products, objected to the extra labeling in a statement, saying “the guidance misguidedly admonishes companies to make a direct comparison” with cow’s milk, even though key nutrients are already required to be listed.
In recent years, the number of plant-based drinks has exploded to include dozens of varieties, including cashew, coconut, hemp and quinoa-based beverages. Although the drinks are made from the liquid extracts of plant materials, they are frequently labeled, and described, as “milks.”
In the U.S., almond ‘milk’ is the most popular variety, but oat ‘milk’ has been seeing the fastest growth. Still, nondairy sales are dwarfed by traditional milk. Sales of refrigerated cow’s milk grew to $12.3 billion in the 52 weeks ending Jan. 28, compared to $2.5 billion for nondairy ‘milk,’ according to NielsenIQ.
In the past, lawmakers in dairy states have tried to get bills passed that would require the FDA to enforce a federal standard that defines “milk” as the product of “milking one or more healthy cows.”
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Yeah, I know this is fake BUT IT DOES realistically reflect the amount of faith that I think you should put in ANYONE of the Muslim 'fa...