Amid a flood of media reports conflating a veterinary version of the drug ivermectin with one for human use that is touted worldwide by physicians and in more than 100 scientific studies as a safe and effective treatment for COVID-19, a 74-year-old Vietnam War veteran died in Texas after a hospital refused to administer the drug in defiance of a court order, according to the family.
Pete Lopez was put on a ventilator Aug. 19 at Memorial Hermann Sugar Land Hospital near Houston after testing positive for COVID-19, reported the local Fox affiliate. The hospital issued a statement explaining it could not comment on specific cases but said in part: “It is important to note that physicians diagnose and treat patients consistent with best medical practices. … The FDA has not authorized or approved Ivermectin for the treatment or prevention of COVID-19. Data currently available does not demonstrate that Ivermectin is safe or effective against COVID-19 infection.”
Gabrielle Snider, a granddaughter of Lopez, told the news station the hospital “took away from my grandfather and us, his family, the opportunity to know whether or not that drug would have worked for him.”
On Monday, an Ohio judge reversed a previous decision from another judge, ruling a hospital no longer had to give a COVID-19 patient ivermectin after it was prescribed to him by a licensed physician, WBNS-TV in Columbus, Ohio, reported
Common Pleas Judge Michael Oster said in the order that “public policy should not and does not support allowing a physician to try ‘any’ type of treatment on human beings.”
Julie Smith, the wife of COVID-19 patient Jeffery Smith, sued West Chester Hospital after the hospital refused to treat her husband with ivermectin. The hospital appealed the decision, arguing against that while the doctor was licensed he was not board certified, and the Federal Drug Administration has warned against using ivermectin to treat COVID-19.
But Jeffery Smith already had received 13 days of doses, and the hospital said they are ready to take him off the ventilator soon.
“Julie has won this case; I don’t care what this judge says,” one of her lawyers, Ralph Lorigo told WBNS. “We are believers he’s going to survive because of ivermectin.”
‘Overriding the judgment of fully qualified physicians’
Last Friday, the Texas Medical Board and Texas State Board of Pharmacy issued a joint statement Sept. 3 supporting physicians who prescribe drugs off-label, the repurposing of drugs approved by the FDA.
The boards said they “do not endorse or prohibit
any particular prescribed drugs or treatment for COVID-19 that meet the standard of care.”
“Drugs are permitted to be prescribed off-label. It is the professional judgement of each physician to write their prescriptions while meeting all applicable federal and state statutes and rules,” the statement said. “Similarly, each pharmacist must use their professional judgement in dispensing valid prescriptions while meeting all applicable federal and state statutes and rules.”
Ivermectin is a prescription for humans. Stop the lies. https://t.co/WjkBCe1TAe
— Mercedes Schlapp (@mercedesschlapp) September 7, 2021
The American Medical Association, however, has advised doctors to stop prescribing ivermectin to COVID patients.
The American Association of Physicians and Surgeons has pushed back on the AMA’s determination. In a letter Saturday to AMA President Dr. Gerald Harmon, AAPS Executive Director Dr. Jane Orient charged the AMA is “contradicting the professional judgment of a very large number of physicians, who are writing about 88,000 prescriptions per week.”
“AMA claims that ivermectin is dangerous and ineffective despite the safe prescription of billions of doses since 1981, and the mostly favorable results of 63 controlled studies in COVID-19,” she wrote.
Orient noted the AMA doesn’t recommend any early treatments for COVID-19, and AAPS members “would appreciate clarification of the AMA’s stand.”
- What are the criteria for advocating that pharmacists override the judgment of fully qualified physicians who are responsible for individual patients?
- What are the criteria for forbidding off-label use of long-approved drugs, which constitute at least 20 percent of all prescriptions?
- On what basis does AMA demand use only within a clinical trial for ivermectin, but call for virtually universal vaccination outside of controlled trials, despite FDA warnings of potential cardiac damage in healthy young patients, and no information about long-term effects?
“We believe that these questions get to the heart of issues of physician and patient autonomy, as well as scientific principles such as the need for a control group in experiments,” Orient wrote.
The FDA warned in August 2020 of “consumers who may self-medicate by taking ivermectin products intended for animals.”
“People should never take animal drugs,” the agency helpfully informed citizens.
One day later, the National Institutes of Health published a guideline that “recommends against the use of ivermectin for the treatment of COVID-19, except in a clinical trial.”
But in its consumer guidance, the FDA admitted it has not reviewed data on the use of ivermectin to treat or to prevent COVID-19, pointed out the Front Line COVID-19 Critical Care Alliance, which describes itself as “a group of highly published, world-renowned critical care physicians and scholars.”
“However, the agency felt compelled to use language to discourage any discourse and interest in using Ivermectin as a front-line treatment of COVID-19,” the FLCCC said.
“To do this is to ignore the growing body of scientific evidence from peer-reviewed research, over 40 medical trials, and results from Ivermectin’s use in medical settings worldwide, showing the safe and effective use of the drug in fighting COVID-19.”
The WHO stated March 31 that the “current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive,” and until more data is available, “recommends that the drug only be used within clinical trials.”
In terms of safety, the American Journal of Therapeutics published a study finding that of the 4 billion doses of ivermectin administered since 1998, only 28 cases of serious neurological adverse events have been recorded. Ivermectin has been administered safely to pregnant women, children and infants, the study found.
Meanwhile, the political influence on the ostensibly independent FDA was spotlighted this week when two top agency vaccine officials resigned amid pressure from the White House to approve COVID-19 booster shots.
The push for boosters comes amid the vaccines’ diminishing efficacy. An Israeli study published in July found the Pfizer shot was only 39% effective against the delta variant, which comprised the majority of cases. And a study published Aug. 24 by researchers in Israel, one of the world’s most vaccinated nations, found natural immunity from a COVID infection is 27 times more effective than immunity from the Pfizer-BioNTech mRNA vaccine.
Media recently have been reveling in mockery of people taking ivermectin for COVID, giving the false impression that they are using the horse dewormer.
The Associated Press had to issue a correction to an article published in late August that claimed 70% of calls made to the Mississippi Department of Health were from people who had ingested the livestock version of Ivermectin, the Daily Wire reported.
Epidemiologist Dr. Paul Byers said the number of calls to poison control about ivermectin was about 2%.
One week ago, Rolling Stone and Rachel Maddow repeated an Oklahoma doctor’s claim to media that the emergency rooms in the state were overwhelmed by patients who had taken the livestock version of Ivermectin, forcing gunshot victims to wait.
But the hospital highlighted in the story said the doctor had not worked there for more than two months, and it had not had any cases of ivermectin ingestion.
The inventors of the FDA-approved version of ivermectin for human consumption won a Nobel Prize for their effort. Touted as a “wonder drug” in the Journal of Antibiotics, ivermectin was shown in both in-vitro and in-vivo studies long before the COVID-19 pandemic to have strong antiviral as well as antiparasitic properties.
And since the spring of 2020, ivermectin – which is on the World Health Organization’s list of essential medicines and is being administered to refugees entering the U.S. – has been the subject of 113 published studies presenting statistically significant evidence indicating it is safe and effective for both treating and preventing COVID-19. Among them are 73 peer-reviewed studies, with 63 comparing treatment and control groups. Significantly, a June 2020 study found ivermectin inhibits the replication of SARS-CoV-2 in-vitro.
And based on promising results in human trials, the University of Oxford is studying ivermectin in the U.K.’s PRINCIPLE trial, the world’s largest clinical trial of possible COVID-19 treatments.
Recently, the American Journal of Therapeutics published a paper analyzing 18 randomized controlled treatment trials of ivermectin in COVID-19 that found “large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance.”
“Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin,” the researchers said, referring to the drug’s ability to prevent the disease. “Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of COVID-19 has been identified.”
A metanalysis of studies published one month ago by the American Journal of Therapeutics found “moderate-certainty” evidence that “large reductions in COVID-19 deaths are possible using ivermectin.”
And ivermectin – already widely used in low- and middle-income countries to treat worm infections – has been touted by government officials in treating COVID-19. In May, the government of India’s most populated state, Uttar Pradesh, said its early, widespread use of ivermectin helped to keep the number of COVID cases and deaths low. The health department for the state, which has a population of more than 230 million, introduced ivermectin on Aug. 6, 2020, as a treatment and a prophylaxis for health workers and others in close contacts with COVID patients. Uttar Pradesh has been averaging only 24 cases and 0-2 deaths per day in recent months, ranking last in cases per capita among India’s 36 states.
In Africa, according to a study, areas where ivermectin was distributed in recent years to populations to combat river blindness have significantly lower levels of mortality caused by COVID-19.
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