Should off-label drugs be allowed in the fight against COVID-19?
The bad news about COVID-19 continues to pour in. The “Delta variant” now makes up 98 percent of COVID cases in Washington, Dr. Alan Melnick of Clark County Public Health shared last Friday. Case rates now exceed levels in January, prior to mass inoculation by the three “EUA approved” vaccinations. “Delta is a game-changer,” he said.
“Israel’s Grim COVID Data Suggests Vaccines Alone Won’t Stop Pandemic” read one major news headline. They are perhaps the most vaccinated nation in the world. Yet vaccines designed when the original “alpha” variant was the only known type of COVID-19 don’t appear to solve the crisis as the number of “breakthrough” cases continue to rise.
Prescribing off-label or repurposed drugs is common. It accounts for 10 to 20 percent of all prescriptions written, although the practice is more common in specific patient populations like children and the elderly. “Physicians also might be more likely to prescribe off-label medications for patients facing life-threatening or terminal medical conditions for which there are limited or no FDA-approved alternatives,” states the AMA Journal of Ethics.
Clark County resident Nicole Wubben’s son is a lineman in Texas. Most of his work is outdoors. Yet he came in contact with a coworker who had COVID-19.
His entire family came down with the sickness COVID-19 triggers. In the midst of being treated for heat exhaustion, COVID hit him hard. The entire family was prescribed a regimen of drugs and vitamins which included ivermectin.
A week after receiving the drugs, her son is doing much better. His family is recovering too. They are all grateful for the medical care they received, and especially “the wonder drug” ivermectin.
Last month, the Food and Drug Administration (FDA) issued a press release warning people about the use of the antiparasitic drug ivermectin. News reports hyped people going to the hospital for taking the “horse medication.” In Mississippi two people were reported to end up in a hospital for wrongly taking the version of ivermectin meant for livestock. According to an Aug. 20 press release, that was not true. “No hospitalizations due to ivermectin toxicity have been directly reported to the Mississippi Poison Control Center or the Mississippi State Department of Health.”
Clark County Public Health dutifully followed Washington DOH guidance with the following.
“Ivermectin is an antiparasitic drug used commonly in humans and animals. Ivermectin tablets are approved by the FDA at very specific doses for some parasitic worms, and there are topical formulations for head lice and skin conditions like rosacea. But ivermectin is not an anti-viral (a drug for treating viruses).
“Evidence to-date shows ivermectin is ineffective against treating the COVID-19 and the side effects can be potentially dangerous. Using formulations intended for animals, which are often higher concentration, could lead to overdoses.”
Yet in Israel, an Aug. 2 news headline says “Double-blind study shows ivermectin reduces disease’s duration and infectiousness • FDA and WHO caution against its use.” In June, Oxford University began an in depth study of ivermectin. They reported that ivermectin is a broad spectrum antiparasitic that reduced SARS-CoV-2 replication in laboratory studies.
The U.S. media followed with a barrage of anti-ivermectin stories. “The Centers for Disease Control and Prevention (CDC) issued a new health advisory Thursday reiterating that ivermectin does not treat or prevent COVID-19. The drug, which is commonly used to treat parasites in humans and animals, is selling out at veterinary stores and has become a common prescription request across the U.S.”
Yet in 2019, the CDC advocated for the use of ivermectin treatment on immigrants. They advised the International Organization for Migration (IOM) physicians who screen the refugees for departure, and U.S. doctors who treat them upon arrival, to prescribe “all Middle Eastern, Asian, North African, Latin American, and Caribbean refugees” with ivermectin and albendazole.
Over the weekend, Rolling Stone magazine had to issue a “correction” about a false story published Friday, reporting hospitals in Oklahoma were being overrun with people who had taken the livestock version of ivermectin. “Oklahoma hospital system denies claim of gunshot victims left to wait as staff overwhelmed with horse dewormer overdoses” one local TV news station reported.
The story turns out to have been based on the claims of one doctor — claims that Rolling Stone and other media sources never checked.
The FDA approved the Pfizer-BioNTech vaccine, now named Comirnity for use in August. However, the FDA does not prohibit physicians from prescribing drugs off-label. Congress has repeatedly taken legal steps to prevent the FDA from interfering with the practice of medicine.
Yet protests continue to increase against Gov. Jay Inslee’s vaccine mandates. Seattle’s Jason Rantz shared “mass resistance arises as Washington makes it nearly impossible to get vaccine exemptions.”
Whom to believe
The politicians and heads of public health agencies have pledged to “follow the science.” Are they following the science when it comes to ivermectin and other off-label drugs? Whom should you believe?
According to many, the battle against ivermectin is because of federal restrictions contained in the Emergency Use Authorization (EUA) regulations. They prohibit new, not fully tested drugs from use if there are other “adequate, approved and available alternatives.” Big pharma would rather sell you $3,000 per dose remdesivir than $1-2 ivermectin, fluvoxamine, or hydroxychloroquine.
Daniel Horowitz said of ivermectin: “to suggest that it is not safe is a scandalous lie.” He went on: “precisely at the time when the shots are wearing off, the FDA not only quasi-approved the vaccine, but picked the leakiest of all to greenlight and also authorized emergency use of a third shot … of the same failed substance.”
The National Institutes of Health (NIH) currently says “both chloroquine and hydroxychloroquine increase the endosomal pH, which inhibits fusion between SARS-CoV-2 and the host cell membrane.” Yet the FDA revoked hydroxychloroquine EUA for COVID in June 2020.
Hatred of former President Donald Trump has kept researchers from looking into the antiparasitic drug ivermectin and other drugs to treat COVID-19, Kentucky Sen. Rand Paul told constituents last week.
“The hatred for Trump deranged these people so much that they’re unwilling to objectively study it,” Paul said to constituents in a Northern Kentucky suburb just south of Cincinnati. “So someone like me that’s in the middle of it, I can’t tell you because they will not study ivermectin. They will not study hydroxychloroquine without the taint of their hatred for Donald Trump.”
It’s also why they don’t research hydroxychloroquine, he said, an anti-malarial drug touted by Trump as a treatment.
An Ohio Judge ordered a hospital to treat a ventilated COVID-19 patient with ivermectin. Judge Gregory Howard ruled last week that West Chester Hospital, part of the University of Cincinnati’s health network must “immediately administer ivermectin” to patient Jeffrey Smith following his doctor’s prescription of 30 mg of ivermectin for 21 days, the Ohio Capital Journal reported.
In India and other poor countries, ivermectin has demonstrated amazing results. These include parts of Peru, Paraguay, Colombia, Argentina and Brazil; and in Panama, Namibia, Zimbabwe, Slovakia and Indonesia. Ivermectin reduced hospitalizations in Mexico City up to 76 percent, while a door-to-door campaign obliterated it in the state of Chiapas. These trends follow organized efforts to try ivermectin, are no coincidence.
Yet in the U.S. the barrage of bad press has triggered “ivermectin reluctance” on a level that rivals “vaccine reluctance,” creating horrible situations like this.
Facing intubation next, Tyrrell had had enough. “I’m terminal, if you unplug that [oxygen] machine, I’m going to die,” he told a doctor. “I asked him, after he’d already given me everything else, if I could take ivermectin.”
“You might as well drink bleach,” the doctor responded.
Stephen Tyrrell is alive today because he got ivermectin. “It saved my life,” he said. The 51-year-old Florida man spent 104 days in two hospitals and in rehab facilities. For his first 38 days in the hospital, his insurance company paid $385,000.
In anatomy of a failed policy, multiple success stories are laid side by side with awful tales such as mentioned above. Doctors are pressured by healthcare systems and government regulators, who in turn are pressured by politicians and their corporate sponsors.
Rather than support actual outpatient care, this is what we get from alleged protectors of U.S. public health, including the Food and Drug Administration, National Institutes of Health, and Centers for Disease Control, states Mary Beth Pfeiffer.
- Willful ignorance of the science supporting ivermectin – or any early treatment for that matter.
- Demonization of this safe FDA-approved drug, used on 250 million people annually, as fit only for animals.
- Speedy acceptance of drugs like woefully ineffective remdesivir in a system rife with conflicts of interest.
- A fantastical supposition that there is one way out of COVID: Vaccines.
- Greatly enriched pharmaceutical companies thanks to taxpayer largesse and something called the Emergency Use Authorization.
That statute in U.S. law allowed millions to be inoculated with a hot-off-the-presses, unapproved vaccine, as long as one explicit caveat was met: “there are no adequate, approved, and available alternatives.”
Of course, we know there were alternatives all along. Drugs to treat COVID have been sacrificed to vaccines.
CLICK TO PLAY VIDEO. Dr. Pierre Kory of the Front-Line COVID-19 Critical Care Alliance addresses a Senate committee and answers questions about the use and effectiveness of ivermectin.
In Israel, a recent news headline reports “$15 drug gets COVID patients off oxygen support in under week – study.” Fenofibrate is an FDA-approved oral medication. The results were published on Researchsquare.com and are currently under peer review. The UK study showed the drug reduced COVID infection by up to 70 percent.
Other existing drugs might have relegated COVID to a manageable outpatient disease by the first half of 2021. There are promising generics: ivermectin primarily but also fluvoxamine, hydroxychloroquine, budesonide and protocols that employ them with zinc, Vitamin D and more, reported Pfeiffer.
The news and potential benefits of these alternatives have been suppressed around the globe. “Countries – mainly, but not all, in the first world — have caved under pressure to conform to the U.S.-hatched strategy of expensive vaccines paid for by the government,” she says. Big pharma approves.
Dr. Pierre Kory broke the news in the U.S. last December, but has been vilified in the media. Nonetheless, he and his team continue their efforts to explore “repurposed drugs” via the Frontline Covid Critical Care Alliance (FLCCC).
In spite of suppression by major media outlets, the efforts of Dr. Kory, Dr. Paul Marik, Dr.G. Umberto Meduri, Dr. Joseph Varon, Dr. Jose Iglesias and their team of physicians is getting shared.
On Aug. 19, Matt Walsh shared an extensive story on ivermectin with his newspaper empire of 425,000, in a piece titled The battle for ivermectin. He introduces them to Michael Capuzzo.
Capuzzo is a former reporter for The Philadelphia Inquirer and The Miami Herald and the author of the New York Times bestsellers Close to Shore and The Murder Room. He is cofounder and editor of Mountain Home magazine.
Capuzzon has produced the single most complete story on the battle over ivermectin — a 10,000 word tome that truly tells as many sides of the story as is possible. Written in May, “The drug that cracked covid” is an amazing tale, a “must read” for people wanting to more fully understand what is happening.
He shared the following last week in an article titled: Believe It: A Top Old School Journalist Stands Up for Ivermectin and Free Speech.
“What’s so frightening about little ivermectin that The New York Times must daily drive stakes through its heart? And start again the next day with the garlic and the spike and hammer because the little pill keeps jumping from the casket, whispering it’s inconvenient, unstoppable truths?
“… A drug typically used to treat parasitic worms,” the Times lead paragraph states (except better known in human medicine as eradicating elephantiasis and river blindness in Africa in one of the great humanitarian achievements in medical history) “…that has repeatedly failed in clinical trials to help people infected with the coronavirus” (except in the 58 randomized and observational controlled trials of 10,200 people showing it strongly reduces transmission, time to recovery, hospitalization, and death). “The only functional strategy we have for getting control of COVID-19 is vaccination,” Dr. Irwin Redlener of Columbia University told the Times…(except in Mexico City, and many other places on Earth with brown and black and poor people the Times simply ignores, where the IMSSS Health Agency collapsed the pandemic with ivermectin, when 50,000 patients treated early with it compared to 70,000 not treated found a 75 percent reduction in need for hospitalization.) A show of hands, please: Is none of this news? Ivermectin propaganda is a whole new discipline, as robust as Victorian poetry or 20th Century fiction, and there’s no time to cover it all here.
“A counterbalance to the media slaying of ivermectin is Matt Walsh, owner of a group of award-winning newspapers and a fiercely ethical Old School journalist. He has had enough.”
Read more:
- Study: Risk for getting COVID rises with each shot
A new report from the Epoch Times warns that the more COVID shots an individual has taken, the higher the risk of getting COVID. - ‘That’s a scandal’: CDC knew COVID shots caused deaths, but lied with public denials
A new report from the Epoch Times reveals its investigation shows that the CDC knew of the links between the COVID shots and death – and lied about them. - FDA agrees to remove anti-ivermectin posts off the internet in lawsuit settlementThe Food and Drug Administration has reportedly settled a lawsuit brought by three doctors who accused the health regulator of interfering with their ability to practice medicine and prescribe Ivermectin to treat COVID.
- No good news about student learning on 4-year anniversary of COVID school closuresFour years ago this month, schools nationwide shut down as COVID-19 numbers skyrocketed and students were sent home for what was initially planned to be two weeks.
- NBA Hall-of-Famer among plaintiffs in lawsuit over WA state COVID-19 restrictionsNBA Hall-of-Famer John Stockton of Spokane is among the plaintiffs suing over alleged free-speech sanctions levied against health care providers who spoke out against state restrictions imposed during the COVID-19 pandemic.
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