Joel S. Hirschhorn shares jaw-dropping quote from federal attorney defending FDA in lawsuit
By now millions of Americans well-informed about the pandemic know that the cheap, safe and effective generic medicine ivermectin (IVM) was blocked for wide-scale use from the very beginning by the federal government. It was a critical but medically wrong tactic within the wait-for-the-vaccine strategy. Preventing early use of IVM has surely killed and harmed hundreds of thousands of Americans. A few courageous doctors have successfully been using IVM during the pandemic, but most feared punishment as they lost their medical freedom.
Now comes a mind-boggling statement from an attorney defending the Food and Drug Administration (FDA) in a lawsuit brought by three doctors. The following statement should be copied and used by both doctors and individuals to freely prescribe and use IVM in the earliest stage of COVID infection as an antiviral. It always should have been seen as an alternative to experimental, unsafe and ineffective COVID vaccines.
“The cited statements were not directives. 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,” Isaac Belfer, a lawyer defending FDA, told the court. “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.”
Imagine that! So, let truth prevail. Let national access to IVM begin!
Here is the whole story.
Because of a credible lawsuit, the federal government now is lying in a most amazing way. It says it really did not say what it has been saying for more than two years.
Federal lawyers recently argued in a Texas courtroom – and apparently with straight faces – that the government’s war on ivermectin during the COVID-19 pandemic was a figment of our collective imagination. What a load of BS. From the very beginning of the pandemic Anthony Fauci made sure to block wide use of IVM.
The doctors who have sued the FDA maintain that the agency wrongfully interfered with their ability to treat their patients with claims that IVM was useless to stop or cure COVID. And they were correct. Medical freedom was intentionally killed.
The FDA is being sued by Dr. Paul Marik of Virginia, Dr. Mary Bowden of Texas and Dr. Robert Apter of Arizona. The three plaintiffs claim the FDA illegally prohibited them from prescribing the drug to their patients. This was true for both patients seen in doctors’ offices and in hospitals.
Yet during a hearing earlier this month, the Biden administration’s lawyers maintained the agency’s rejection of IVM was simply a “recommendation.”
If attorney Belfer’s assertion is true, it raises a very urgent question: On what legal grounds did hospitals all over the United States (where most COVID deaths have occurred) refuse to administer IVM to severely ill COVID-19 patients, even when patients and their family members begged for the drug to be administered? Many lawsuits were used by families to get deathbed patients access to IVM. But only a few succeeded, and in several cases patients walked out of the hospital in a few days. Hospitals used enormous resources to fight these cases.
If ivermectin was not prohibited by the FDA or any other U.S. medical authority for treating COVID-19, why did Dr. Marik’s hospital prohibit him from administering the drug to his dying patients? Why was Dr. Bowden reported to the Texas Medical Board for disciplinary action when she prescribed it? Why did many pharmacists fear losing their licenses if they filled IVM prescriptions for treating COVID-19?
Because the FDA did block the medication, with the help of Fauci at NIH and the CDC.
Here are multiple examples of how IVM was blocked.
On the FDA’s official Twitter account, the agency wrote a post with the headline, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” An accompanying tweet stated, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
Another post, later on, added, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”
The FDA created an actual Q&A webpage devoted to IVM. The first question: “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.” The government was not content with blocking access to IVM. It also wanted to cut demand for it.
That answer also noted, “While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19. You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.”
The website also suggested ivermectin might be a “fraudulent” COVID treatment. Talk about intentional misinformation.
In response to the FDA’s argument, the plaintiffs’ lawyer, Jared Kelson, replied that the FDA “clearly convey(ed) that this is not an acceptable way to treat these patients.”
IVM became a favorite and repeated target of criticism from leftists, especially after former President Donald Trump suggested it might work – as many, many studies and clinical experience in a number of countries, such as India, showed. It must be administered early enough and at a high enough dose.
Liberals ridiculed Trump and other advocates of the drug for prescribing people a “horse dewormer.” People who suggested online that IVM could be used for COVID saw their accounts blocked or eradicated for spreading “misinformation.”
In August 2021, Fauci told CNN of IVM, “Don’t do it; there’s no evidence whatsoever that it works and it could potentially have toxicity … with people who have gone to poison control centers because they’ve taken the drug at a ridiculous dose and wind up getting sick,” he said. “There’s no clinical evidence that indicates that this works.” These were simply lies. Just another example that everything Fauci supported was WRONG.
Last year, Republican Sen. Rand Paul noted that “hatred for Trump” had “deranged these people so much that they’re unwilling to objectively study” IVM as a possible treatment.
Now, in a classic case of gaslighting, the government proclaims it never told anyone not to use the drug. Still more reason for the public NOT to trust the government.
As the FDA lawyer Belfer told U.S. District Judge Jeffrey Brown, the statements on IVM “did not set agency policy,” and “simply provide(d) nonbinding recommendations to consumers.” Sure. What FDA actually did killed many Americans.
What many patients and their families asked for was to be allowed to try the drug (FDA-approved for river blindness, elephantiasis, and scabies) for COVID. The patients and their kin gladly indemnified the hospitals and arranged to have their independent doctor deliver and administer the drug. Nevertheless, here are the ugly truths:
Hospital administrators absolutely refused to grant this wish. At best, they said they were following federal guidance against using IVM.
Hospital attorneys fought tooth and nail against using IVM to treat critically ill COVID patients, doing everything in their power to challenge patient lawsuits and appeal court orders to administer the drug. They disregarded many studies and reports showing that IVM worked.
Even when hospital doctors acknowledged that the patients were dying, they insisted it was better to let the disease take its natural course rather than allow patients to try ivermectin. Pure malpractice.
Even when patients’ families succeeded in getting a court order to administer the drug, most hospitals still refused, even at the risk of being held in contempt of court. They were content with patients dying.
No matter what is now being said as some type of excuse for killing people, what should remain a priority is criminally prosecuting Anthony Fauci. SOURCE
I wholeheartedly agree that Anthony Fauci should be prosecuted for Mass Murder. This man is a monster. He is no better than Hitler’s man, Josef Mengele!
However, since the onset of the COVID-19 pandemic, the National Institutes of Health (NIH) and affiliated health authorities have vociferously recommended against ivermectin as a potential treatment for the virus.
In a social media message that has gone viral, the FDA labeled it as a drug for horses and not fit for human consumption: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
A portrait of William Campbell and an illustration describing his work displayed on a screen during a press conference of the 2015 Nobel Medicine Prize. William Campbell and Satoshi Omura won the Nobel Medicine Prize for their discoveries of treatments against parasites—Avermectin, which was modified to Ivermectin. (JONATHAN NACKSTRAND/AFP via Getty Images)
Though its broad antiparasitic functions are not well understood, it is known that ivermectin penetrates parasites’ nervous systems, turning off their neurons’ actions, possibly deactivating and killing them.
As part of a donation campaign launched in 1988 by Merck & Co., Inc., the manufacturer of ivermectin, the drug was used in Africa to treat river blindness. Also called onchocerciasis, river blindness is a tropical disease caused by Onchocerca volvulus worms. It is the second-most common cause worldwide of infectious blindness.
The Onchocerca worms mature in the skin of an infected individual (“the host”). After mating, female worms can release into the host’s skin up to 1,000 microfilariae a day; the female worms live for 10 to 14 years. The presence of these worms can lead to scarring in the tissues and, when microfilariae invade the eye, can cause visual impairment or complete loss of vision.
When Merck distributed ivermectin in areas hardest hit by the disease, treatment benefited the residents’ overall health and led to economic recovery. Ivermectin replaced previous drugs that had devastating side effects.
Ivermectin has also proven effective against lymphatic filariasis, known as elephantiasis. Parasitic worms transmitted through the bite of an infected mosquito can grow and develop in lymphatic vessels, which regulate the body’s water balance. When certain vessels are blocked, the areas—typically the legs and genitals—can swell, with the legs enlarging to elephant-like stumps.
The World Health Organization listed ivermectin as an essential drug and has advised many countries to run annual campaigns to rid people of these parasites. Such recommendations are a solid testament to ivermectin’s safety.
For their work, including the discovery of avermectin, in 2015, Omura and Campbell were among three recipients of the Nobel Prize in Physiology or Medicine.
It is an indispensable drug for the underdeveloped world, with about 3.7 billion doses administered as part of global campaigns during the past 30 years. To this day, ivermectin remains a staple drug of tropical areas and an essential drug in treating onchocerciasis, lymphatic filariasis, strongyloidiasis, and scabies.
Prophylaxis intervenes in the first phases of COVID-19 infection, which is mainly asymptomatic, when the virus replicates to increase its viral load—symptom onset occurs after the viral load peaks.
Ivermectin can be effective in the early stages of infection. Outside the cells, ivermectin can attach to parts of the virus, immobilizing it and preventing it from entering and infecting human cells.
Ivermectin can also enter the cell to prevent the virus from replicating. SARS-CoV-2 needs cell replication machinery to make more of the virus; ivermectin attaches and blocks a protein critical to this process, preventing viral production.
Additionally, ivermectin can be absorbed from the skin and stored in fat cells for a long time.
“Because it’s lipid soluble, it is stored and slowly released, [so] once you’ve taken a prophylactic dose, and I think it’s like the cumulative dose of about 400mg, that your risk of getting COVID is close to zero and you can actually stop it for a while,” said Dr. Paul Marik, a widely published critical care specialist with 500 peer-reviewed papers to his name, in an interview with The Epoch Times.
Dr. Paul Marik in Kissimmee, Fla. on Oct. 14, 2022. (The Epoch Times)
Marik co-founded the Front Line COVID-19 Critical Care Alliance (FLCCC), a group of physicians formed in the early days of the pandemic and dedicated to treating COVID-19. According to interviews, many of the group’s doctors have successfully treated COVID-19 with ivermectin. The organization’s other co-founder, Dr. Pierre Kory, has written a book about ivermectin’s use and controversy during the pandemic.
Dr. Sabine Hazan, a gastroenterologist with 22 years of experience in clinical research, told The Epoch Times that she would advise ivermectin use for only a short time in critical patients rather than recommending the use of it as a prophylaxis.
Continuous use of ivermectin—as with all drugs—can make the body dependent on the drug rather than working to fix itself.
2. Ivermectin for Early and Acute COVID
Many peer-reviewed studies have found that ivermectin, when used by itself or in conjunction with other therapies in symptomatic patients, reduces ventilation time, time for recovery, and the risk of progressing to severe disease. (pdf 1, pdf 2, pdf 3)
This is likely due to ivermectin’s anti-inflammatory role in multiple pathways, achieved by clearing out the viral particles by immobilizing them, reducing inflammation, and improving mitochondrial action.
Suppose the early viral replication is not controlled and cleared out soon enough by the body’s immune system. In that case, the infection can become severe or even hyperinflammatory, possibly leading to systemic organ failures.
Ivermectin can also directly interact with immune pathways, suppressing inflammation and reducing the chances of developing a cytokine storm. A cytokine storm occurs when the immune system is hyperactive and hyperinflammatory. Though ivermectin can help to clear out the virus and its particles, the inflammatory state of the tissues and the organs can often cause more damage than the virus itself.
Ivermectin also likely improves gut health, which plays an essential role in immunity by preventing bacteria and viruses from infecting people via the gut.
In a published study, Hazan hypothesized that ivermectin helps COVID-19 patients by increasing the levels of Bifidobacteria—a beneficial bacteria—in the gut.
As the CEO and founder of her own genetic sequencing research laboratory, ProgenaBiome, Hazan noticed that the Bifidobacteria levels in her stools would increase after she took ivermectin. Critical COVID patients would have “zero Bifidobacteria,” which can often be a sign of poor health.
“When people die of COVID, they die from the cytokines—they couldn’t breathe anymore. It’s almost like an anaphylactic reaction. So when you give them ivermectin at the moment they’re about to crash, you’re boosting the Bifidobacteria [and increasing their oxygen],” Hazan said.
She explained that ivermectin is a fermented product of Streptomyces bacteria. Streptomyces are within the same group Bifidobacteria are from, which may explain why ivermectin temporarily boosts Bifidobacteria.
Ivermectin also helps with mitochondrial function. During severe COVID-19, patients often experience pulmonary dysfunctions due to lung inflammation, reducing oxygen flow. This can cause stress to the mitochondria, leading to fatigue, and, when severe, may cause cell and tissue death. Ivermectin has been shown to increase energy production, indicating that it is beneficial to the mitochondria.
Furthermore, Ivermectin can bind to the spike protein—a distinctive structural feature of the COVID virus which has a crucial role in its pathogenesis. In systemic disease, the spike protein can enter the bloodstream and bind to red blood cells to form blood clots. Ivermectin can prevent blood clots from forming in the body.
3. Ivermectin for Long COVID and Post-Vaccine Symptoms
The number of studies supporting ivermectin to treat long COVID and post-COVID-19 vaccine symptoms is limited. However, doctors treating these conditions have observed successful results with ivermectin.
Researchers found that in patients reporting long COVID symptoms—including coughing, brain fog, headaches, and fatigue—ivermectin alleviated their symptoms.
Mechanistically, ivermectin can improve autophagy. This process is usually switched off during COVID-19 infections. By switching autophagy back on, ivermectin can help cells clear remnant viral proteins out, returning stability to the cell.
Like acute and severe COVID-19, chronic spike protein triggers inflammation, and ivermectin can reduce such responses by suppressing inflammatory pathways and lessening the damage to tissues and blood vessels.
The Changing Public Health Messaging on Ivermectin
The NIH’s stance on ivermectin has changed several times.
Early in the pandemic, there was little information on ivermectin as a potential treatment for the virus.
The first study that mentioned ivermectin as a potential COVID-19 treatment came from Australia in April 2020. Researchers administered ivermectin to SARS-CoV-2-infected monkey kidney cells in the laboratory and found the drug beneficial in very high doses. However, the researchers concluded that further study was needed. Many health agencies, including the NIH, the CDC, and other global health regulators concluded that ivermectin could kill the virus only at toxic levels.
Even now, NIH’s statement on ivermectin for COVID-19 reads: “Ivermectin has been shown to inhibit replication of SARS-CoV-2 in cell cultures. However, pharmacokinetic and pharmacodynamic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans.”
The study’s lead author, Dr. Jean-Jacques Rajter, is a critical care doctor specializing in pulmonary medicine.
Rajter gave a testimony (pdf) of his findings to the Senate Committee on Homeland Security & Governmental Affairs in December 2020.
The day after he saw the Australian study, one of his COVID patients dramatically deteriorated from breathing normally at room oxygen levels to requiring intubation. The patient’s son pleaded with Rajter to save his mother using whatever options were available. Dr. Rajter recognized that hydroxychloroquine would be ineffective in the advanced stages of COVID. After much deliberation, Dr. Rajter tried ivermectin.
“The patient deteriorated as expected for about 12 more hours but stabilized by 24 hours and improved by 48 hours. After this, two more patients had similar issues and were treated with the ivermectin-based protocol. Based on experience, these patients should have done poorly, yet they all survived,” the testimony read.
More clinical studies were published, showing the benefits of ivermectin as a prophylactic treatment. (pdf 1, pdf 2).
The findings encouraged the use of ivermectin among doctors desperate to find a cure.
Meanwhile, by October 2020, research into COVID-19 vaccines and the use of remdesivir to treat the virus was already in full swing.
According to the FDA, specific criteria should be met for the EUA (Emergency Use Authorization) to be granted for vaccines and medications, including that there are “no adequate, approved, and available alternatives.”
Some doctors say that if ivermectin’s use for COVID had been approved, it would have made the EUAs for vaccines and remdesivir null and void.
Following the Australian study, the FDA published a statement, “FAQ: COVID-19 and Ivermectin Intended for Animals,” highlighting the use of ivermectin in animals and advising against the use of ivermectin for COVID-19.
The NIH also discouraged the use of ivermectin, albeit briefly. On Jan. 14, 2021, the NIH changed its statement, writing that there was no evidence to recommend or disapprove the use of ivermectin. However, in April 2022, the statement changed to strongly disapproving of using ivermectin.
“We [Marik, Kory, and Dr. Andrew Hill, a virologist and consultant to the WHO] had a conference with NIH in January of 2021. We presented our data, and Andrew Hill presented the data he had done…there were a number of studies at that point, which were very positive,” said Marik.
Yet using the FDA’s statement against ivermectin to ban its use in COVID-19 cases would be considered an overreach. Since the FDA approved ivermectin in 1996, this made the drug acceptable for off-label use.
“The fact that it’s not FDA approved for COVID is irrelevant because the FDA endorses the use of off-label drugs at the clinician’s discretion,” said Marik.
As an ironic side effect of the messaging on ivermectin, people suddenly found themselves unable to access ivermectin, and some turned to veterinary-grade ivermectin.
Though veterinary ivermectin is the same product as medicinal ivermectin, the manufacturing standard is not the same as it is for human-grade pharmaceuticals.
Contradictory Research and Campaigns
Though the initial research in 2020 showed promising results for ivermectin, published studies reported conflicting findings by the following year.
The NIH has funded many studies on the effectiveness of ivermectin, the most recent being ACTIV-6.
Individuals can participate in the study once they develop COVID by selecting ivermectin from four other drugs. The drug was sent to them via mail. This method means that some people in the study could have recovered by the time they received the ivermectin.
There are some controversies regarding this study.
The first is that the authors changed the primary endpoints during the study, which is heavily frowned upon as it can affect the validity and reliability of the outcome.
Initially, the primary endpoint was the number of deaths, hospitalizations, and symptoms reported at day 14.
This was changed to the number of deaths, hospitalizations, and symptoms by day 28. In the actual published study, there was another change, with the endpoint being duration of COVID-19 symptoms.
A rapid review published by the Massachusetts Institute of Technology (MIT) implied that the endpoints were changed because, by the time the study commenced, there were far fewer events of death and hospitalizations; as a result, there would not be enough data for a reliable comparison.
Indeed, the data at the ACTIV-6 livestream showed that the ivermectin group reported only one death; this death would not be considered relevant to the research because the patient was hospitalized and died before he took ivermectin.
There were also further implementations in the study that could impact the observed effectiveness of the drug.
On average, this study’s participants received treatment six days after first reporting symptoms. Patients needed to report eligible symptoms and test positive for COVID-19 before receiving drugs. Due to this added time, about seven percent of the participants had no symptoms by the time ivermectin arrived.
Despite these negative findings for ivermectin, there is still some evidence that may demonstrate that ivermectin can be useful in treating COVID-19.
In the abstract, the authors concluded that taking ivermectin had “a posterior probability of benefit of .91,” this is another way of writing that ivermectin had a 91 percent probability of being more beneficial than placebo.
The percent of probability is below 95 percent, making the benefit of ivermectin insignificant.
Slides from the ACTIV-6 presentation on a statistically significant secondary endpoint findings.
Another secondary endpoint showed that by day 14, ivermectin already had a statistically significant 27 percent benefit with 98 percent probability of efficacy.
The FDA and NIH did not respond for comments by press time. SOURCE
To family members of all those whose lives were cut short by Covid 19, this article comes too late and brings much sorrow and anger. Questions of why this therapeutic was not given to those who doctors knew were dying remain unanswered.
My husband and I have not had any of the Jabs. We have family coming to visit in less than two weeks. These family members are triple vaxxed and boosted, but have had Covid a few times. One of those times was very recent. We have Ivermectin which was prescribed for us by a doctor from Frontline Doctors. We will be taking the Ivermectin as a prophylaxis a few days before they arrive.
VERY INTERESTING THAT AFTER I POSTED THIS ARTICLE, DAILYMAIL.CO.UK TOOK THEIR STORY DOWN!! YOU WILL SEE IF YOU CLICK ON THE LINK. FURTHERMORE, THEY ARE PUTTING OUT THE EXACT OPPOSITE OF WHAT THEIR ORIGINAL ARTICLE SAID. SEEMS TO ME THAT THERE IS SOME THREATENING HAPPENING BEHIND THE SCENES.THE GLOBALISTS ARE A BUNCH OF MOBSTERS!
Drug used to treat lice and scabies could cut Covid deaths by up to 75%, research suggests
New study suggests ivermectin cuts Covid infections by around 75 per cent
More than 30 trials globally found the drug caused improvements in treatment
The study is set to be published in the US journal Frontiers of Pharmacology
A cheap and safe drug widely used against parasites cuts Covid infections, hospitalisations and deaths by about 75 per cent, a study shows.
More than 30 trials across the world found that ivermectin causes ‘repeated, consistent, large magnitude improvements in clinical outcomes’ at all stages of the disease.
The peer-reviewed study, to be published in the US journal Frontiers of Pharmacology, says the evidence is so strong that the drug – used to treat head lice and scabies – should become a standard therapy everywhere, so hastening the global recovery.
Study co-author Professor Paul Marik, director of emergency and pulmonary care at the Eastern Virginia Medical School in the US, said: ‘The data is overwhelming – we are in a pandemic, and this is an incredibly effective way to combat it. If we use ivermectin widely, our societies can open up.’
More than 30 trials across the world found that ivermectin causes ‘repeated, consistent, large magnitude improvements in clinical outcomes’ at all stages of the disease (stock image)
Other medications have been touted as effective treatments for combating coronavirus, only for trials to dash hopes – notably with hydroxychloroquine, the anti-malarial drug.
An earlier study by Professor Andrew Hill of Liverpool University also concluded that ivermectin cuts death rates by around three-quarters.
He recommended there should be larger trials before it was approved by UK regulators. A new trial of ivermectin as a Covid treatment is due to start shortly at Oxford University.
Dr Tess Lawrie, director of the Evidence-Based Medicine Consultancy in Bath, convened an online summit of international experts last weekend to discuss the new data. It included evidence that widespread use of ivermectin in parts of India and South America has led to a big reduction in infections and deaths.
The peer-reviewed study, to be published in the US journal Frontiers of Pharmacology, says the evidence is so strong that the drug – used to treat head lice and scabies – should become a standard therapy everywhere, so hastening the global recovery (file image)
Yesterday Dr Lawrie submitted a 97-page report to the World Health Organisation, urging it immediately to recommend ivermectin to treat Covid.
The drug, taken in tablet form or as drops, is licensed in Britain only as a treatment for parasitic worms, head lice and scabies.
It has been used by hundreds of millions of patients over the past 30 years, mainly in developing countries, and at around £50 per patient – less in some countries – is far cheaper than other new Covid treatments, such as the rheumatism drug tocilizumab, which costs £1,000 per patient.
The UK’s Medicines and Healthcare Regulatory Agency said it was aware of the global study into the use of ivermectin to treat Covid-19 and that its evidence would be reviewed.
Since publication of this article Frontiers in Pharmacology reversed its provisional decision to publish the paper on which it was based, saying ‘this paper does not offer an objective nor balanced scientific contribution to the evaluation of ivermectin’. Subsequently a revised version of the paper was peer-reviewed again and published by the American Journal of Therapeutics.Source
I thought of my neighbor and friend, Donna, when I read this. She was begging the doctors and nurses in the hospital to give her Ivermectin or HCQ. They flat out refused and within a week they put her on the ventilator and she died that very day.
I really do not know how these health workers sleep at night knowing that they took part in the mass murdering of patients.