AUSTIN (KXAN) — The American Medical Association is calling for the “immediate end” to the use of the drug ivermectin to treat COVID-19, and it’s asking doctors to stop prescribing it for that purpose.
The buzz around it surged again Wednesday after comedian and podcast giant Joe Rogan claimed he was using it to treat his own infection.
Ivermectin is used to treat parasites in animals, and sometimes humans, but it’s not an anti-viral and, more importantly, it’s not approved by the Food and Drug Administration for COVID-19 treatment. It can be taken topically or orally if prescribed by a doctor for its intended use, otherwise, potential side effects can be severe, including neurologic disorders, seizures, coma and even death.
“We have seen patients that have delayed their necessary and appropriate presentation to a hospital because they’re taking this cocktail that has been sold and promoted to them as highly effective,” said Dr. Mark Casanova, a Texas Medical Association COVID-19 Task Force member.
Casanova said not only does taking the drug for unauthorized uses pose risks for side effects, but it causes patients to have a false sense of security.
Casanova said side effects include nausea and vomiting.
“Ivermectin is designed to, both in livestock and in humans, to treat gastrointestinal stomach bugs; basically worms and other such parasites,” Casanova explained. “So it stands to reason that it’s really concentrating on things that are growing in the intestinal tract that don’t belong.”
Texas’ state health department reports poison control centers already had more than triple the ivermectin exposure calls than they did all of last year.
Tom Schnorr, owner of Austin Compounding Pharmacy and pharmacist-in-charge, said he’s been filling ivermectin prescriptions for months, though the decision goes against the FDA, the Centers for Disease Control and Prevention, National Institutes of Health and now, the AMA.
Schnorr said the orders have spiked for about three weeks now, going from 70 prescriptions a day for ivermectin to 250 a day. That’s nearly 2,500 patients so far this year, he said.
“And none of them have ever, have ever had a need to go to the hospital,” Schnorr said, though he admits he doesn’t have a system to check in with each patient.
Schnorr points to studies that have not yet been peer-reviewed or screened by other medical professionals.
“I get beat on by a lot of my fellows saying, ‘Tom, there’s no, you know, there’s no double-blind, crossover, peer-reviewed studies.’ There’s about 64 well-thought-out reviews on the FLCCC.net website,” he said.
Schnorr is not a doctor, but he offers “COVID-19 advice” to patients online. You can also download an ivermectin order form from his website. Schnorr said listed are suggested drugs to prevent and treat the virus.
At least two of the drugs listed, ivermectin and fluvoxamine, are not approved treatments for COVID-19.
He said he and his wife take ivermectin once a week, and he even recommends doctors prescribe it as a prevention for children who have returned to in-person learning.
Schnorr is vaccinated and says he has gotten COVID-19 twice. He says he was taking ivermectin when he caught the virus the second time but thinks it helped him recover quickly.
Medical experts and the CDC say there’s next to zero data showing any benefits of taking the drug for COVID-19, but that’s not stopping even doctors from prescribing it.
The Texas Medical Board told KXAN it doesn’t ban any drug or treatment for physicians who may be prescribing ivermectin.
“The off-label use of drugs as an alternative therapy for COVID-19 patients is permissible,” a spokesperson wrote in an email to KXAN.
They added that, as is the case with any alternative therapy, physicians have to provide full disclosure of treatment options, side effects and obtain informed consent.
The FDA reports that between early July and Aug. 13, over 88,000 prescriptions were dispensed in the U.S., but pre-pandemic, roughly 3,600 prescriptions were dispensed per year. That’s in addition to the people buying doses at livestock stores and taking potentially dangerous amounts intended for large animals.
The CDC warns: “Ivermectin is not authorized or approved by FDA for prevention or treatment of COVID-19. The National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines Panel has also determined that there are currently insufficient data to recommend ivermectin for treatment of COVID-19.”
Nevertheless, misleading information and false claims about ivermectin’s effectiveness have proliferated across social media and among some right-wing news organizations.
Several notable conservative personalities have promoted the medication, including Fox News hosts Tucker Carlson and Laura Ingraham. Last week, Republican Kentucky Sen. Rand Paul claimed researchers’ “hatred for former President Donald Trump” has kept them from studying ivermectin despite Trump only ever promoting the anti-malaria drug hydroxychloroquine, another drug not shown to be an effective COVID-19 treatment.
Wisconsin Republican Sen. Ron Johnson has also promoted ivermectin, prompting the suspension of his YouTube account for violation of Google’s medical misinformation policies.
Misinformation/Disinformation
Studies on ivermectin as COVID-19 treatment do exist and some testify to the drug’s efficacy. But right now, that data is overwhelmingly considered inconsistent, questionable and/or inconclusive. Medical experts say the data affirming ivermectin is minuscule compared to the amount indicating its uselessness.
A July review of 14 ivermectin studies concluded these studies were small and “few are considered high quality.” The researchers say they’re uncertain about the efficacy and safety of the drug and that “reliable evidence” doesn’t support using ivermectin for COVID-19 treatment outside of well-designed randomized trials.
These are their reasons:
- Low numbers of participants in studies
- Imprecise or even skewed methods: some studies compared use of ivermectin to other unproven drugs like hydroxychloroquine. Comparisons were also made based on different criteria among the two drugs
- Some studies had different interpretations of the results
- The authors say that some studies were excluded from the review completely due to high risk of bias. They found about one-third of study results currently available were at a high risk of bias. Most results were ruled to have at least some concern about bias
- Narrow confidence intervals (CIs) in findings: meaning how much confidence there was in results falling within a certain range. While findings among these studies may indicate that ivermectin may be effective, the probability is slim.
Meanwhile, an oft-cited Australian study found ivermectin killed the virus, but several scientists have since explained humans most likely aren’t capable of ingesting or processing the amounts of ivermectin used during the experiment.
Thirty-one other ivermectin studies are underway currently, while 18 others are awaiting review.
Earlier this month, Together Trial, a large-scale ivermectin clinical trial (which is not yet peer-reviewed) ended with the conclusion that the drug had “no effect whatsoever” on whether its 1,500 patients needed to go to emergency rooms or be hospitalized.
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 NIH. Additionally, pharmaceutical company Merck, a manufacturer of ivermectin, says there’s “no meaningful evidence” to support its use in this way.
Meanwhile, Dr. Anthony Fauci, the nation’s top infectious disease expert, said last week: “Don’t do it. There’s no evidence whatsoever that it works and it could potentially have toxicity because people have taken ridiculous dosages and they wind up getting sick. There’s no clinical evidence that indicates that this works.”
National surge in usage
Nevertheless, ivermectin use goes on — and continues grabbing headlines because of it.
Usage has spiked so much that the FDA was forced to put out a warning weeks ago reading: “You are not a horse. You are not a cow. Seriously, ya’ll. Stop it.”
Dr. Matthew Payne told the Washington Post he’s been meeting many patients in his Oklahoma hospital who distrusted the proven-effective COVID-19 vaccines but trusted ivermectin.
“There is surprise and shock when they initially get sick and have to come to the hospital,” Payne said. “They’ll say, ‘I’m not sure why I feel so bad. I was taking the ivermectin,’ and I will say, ‘It doesn’t do any good.’”
Due to an increase in search traffic for the drug, Amazon said it will block some autocomplete search responses for ivermectin, USA Today reports. While the retail giant will still autocomplete searches that begin with “iv” to “ivermectin for horses” and “ivermectin paste,” it will instead redirect to a message advising against human usage of the drug for COVID-19 treatment.
Last week, a judge in Butler County, Ohio, ruled in favor of a woman who demanded the hospital treating her husband for COVID-19 give him ivermectin, the Ohio Capital Journal reports. Butler County Judge Gregory Howard ordered West Chester Hospital to give 51-year-old Jeffrey Smith 30 milligrams of ivermectin every day for the next three weeks.
In her lawsuit, Smith’s wife, Julie Smith, claims she offered to sign documents releasing all other parties, doctors and the hospital from all liability related to the dosage. The hospital declined.
Smith says her husband, who has been on a ventilator for weeks, has a very slim chance of survival and that she’s willing to try anything to keep him alive.
“The FLCCC”
Smith’s lawsuit references the work of Dr. Fred A. Wagshul, who is a founding member of the Front Line COVID-19 Critical Care Alliance, a group of doctors that are promoting the use of ivermectin for COVID-19 treatment.
The FLCCC is behind the website covid19criticalcare.com, which purports to offer “prevention and treatment protocols for COVID-19.” In addition to the use of ivermectin, which the FLCCC calls its “core” preventative measure, it has indicated that a person can gargle with mouthwash, take vitamins and administer nasal drops containing iodine.
Chief among the FLCCC’s resources on ivermectin is a review published in the American Journal of Therapeutics. It’s co-authored by one member of the alliance and relies to some degree (at least 15.5%, according to academic journal Nature) on a non-peer-reviewed preprint that was withdrawn due to “ethical concerns.”
That paper allegedly studied a large sample size of COVID-19 symptomatic people and found that ivermectin significantly reduced symptoms and deaths. But academics and critics found issues related to plagiarism and data manipulation, Nature reports.
The FLCCC Alliance says “vaccination is part of the solution” for ending the COVID-19 pandemic, although vaccines are not listed in its preventative protocol plan. The group does say people should follow public health authority recommendations, including “vaccinations as appropriate.”
The group’s treatment protocol for hospitalized patients reads: “If administered early, this formula of FDA-approved, safe, inexpensive, and readily available drugs can eliminate the need for ICU beds and mechanical ventilators and return patients to health.”
Nevertheless, the FDA has not approved ivermectin for COVID-19 treatment.
The FLCCC says its information is for educational purposes only and is not a substitute for diagnosis or treatment plans from a licensed medical professional.
The alliance lists a disclaimer on its website, reading: “IF YOU ARE DISSATISFIED WITH ANY OF THE CONTENT OR MATERIALS ON OUR WEBSITE, OR ANY SERVICES OR INFORMATION AVAILABLE THROUGH THE WEBSITE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE ACCESSING AND USING OUR WEBSITE.”
“At the end of the day, do we want to take… de-wormer… to try to prevent something, or wear a mask that comes at a much lower cost and get a vaccine that’s free?” said Casanova.
The CDC urges and reminds Americans that the currently available COVID-19 vaccines, including Pfizer (now fully FDA-approved), Moderna and Johnson & Johnson, are safe and effective. Booster shots are currently underway and under discussion. While vaccines do not ensure you won’t become infected with COVID-19, they have significant real-world data confirming they prevent severe illness and hospitalization.