The truth about Ivermectin?

Why do Americans keep taking ivermectin for COVID despite FDA warnings? Hundreds of doctors continue to prescribe it.

Adrianna Rodriguez, USA TODAY

Wed, February 2, 2022, 11:51 AM

Contrary to scientific evidence and warnings from health agencies, hundreds of doctors nationwide continue to prescribe ivermectin – encouraged by a little-known national group of physicians – to prevent and treat COVID-19.

During the omicron wave they've been busier than ever, writing tens of thousands of prescriptions.

Many of the doctors follow treatment guidelines set by an organization called the Front Line COVID-19 Critical Care Alliance, which promotes the controversial drug along with other unproven therapies.

The alliance has been gaining momentum, appearing in conservative media outlets and serving as an inspiration for proposed legislation in various states to force acceptance of the anti-parasitic as a legitimate COVID-19 treatment.

The group's protocol is a laundry list of ivermectin and other prescription drugs, over-the-counter medications, vitamin supplements and herbs, none of which have been scientifically proven to work against COVID-19.

Dr. Paul Marik, a pulmonary and critical care specialist who co-founded and now chairs the FLCCC, said the group was created at the start of the pandemic when little was known about treating COVID-19 and early intervention was needed.

“We developed a protocol for the early treatment of COVID-19,” he said. “Why wait until the patients have severe pulmonary disease? They can’t breathe. They’re dying to be treated. This is stupidity.”

But two years into the pandemic, health experts say science has yielded proven therapies and effective vaccines that prevent hospitalizations and death.

“There’s a group of physicians who will abandon the science in order to satisfy the unscientific demands of patients,” said Dr. Gregory Poland, professor of medicine and infectious diseases and director of the Mayo Clinic's Vaccine Research Group. “It’s disinformation. You’re failing to use proven therapies in favor of disproven therapies, and that’s wrong.”

Dr. Miriam Merad, director of the Precision Immunology Institute at Mount Sinai’s Icahn School of Medicine, called the drug cocktail "terrifying" and "frankly, dangerous."

Although ivermectin for humans is not dangerous when used as directed, health experts say the danger lies in choosing it over COVID-19 vaccination or verified treatments.

“It's a bunch of lies,” Merad said, "and it’s embarrassing for our profession.”

What is ivermectin?

The American Medical Association and the American Academy of Allergy, Asthma and Immunology declined to comment on the FLCCC Alliance and the actions of associated doctors. The American College of Physicians, the American Board of Allergy and Immunology and the American Academy of Family Physicians did not respond to USA TODAY’s request for comment.

Professional organizations may not want to engage in discussions about ivermectin, health experts say.

“Most of us have really repudiated its use for COVID-19. It’s frustrating that people continue to prescribe it and direct people away from proven therapies. ... I don’t know what more we can do,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

"The fact is this has become more of a political crusade now rather than a scientific one,” he said. “It’s out of the realm of scientific discussion.”

Ivermectin is approved by the Food and Drug Administration in tablet form for people to treat some parasitic infections. The drug also comes in a paste or can be injected to treat or prevent parasites in animals.

The drug wasn’t frequently used in Americans before the pandemic because ivermectin is prescribed to treat specific parasites not common in the U.S, said Laurel Bristow, infectious disease clinical researcher at Emory University. But fueled by desperation and disinformation, it caught on as an alternative COVID-19 treatment, particularly among those who refused to be vaccinated.

By summer, poison control centers saw a fivefold increase in calls related to ivermectin compared with pre-pandemic levels, according to the Centers for Disease Control and Prevention. Data from the American Association of Poison Control Centers shows ivermectin poison cases increased 212% from Jan. 1, 2021, to Sept. 21.

In some cases, people were self-medicating with ivermectin intended for livestock and required emergency care. “You are not a horse. You are not a cow,” the FDA said in an advisory in August. “Seriously, y’all. Stop it.”

US COVID-19 map: Tracking cases and deaths

Yet doctors continued to prescribe it, and insurance companies continued to pay for it. A study published in JAMA Network this month estimated private and Medicare plans may have paid nearly $2.5 million for ivermectin prescriptions in the week of Aug. 13 alone.

“Spending on inexpensive drugs like ivermectin can add up pretty quickly,” said lead author Dr. Kao-Ping Chua, assistant professor of pediatrics at the University of Michigan Medical School. “Insurers may be aware that this may be happening, but they may simply be reluctant to do anything about it for public relations purposes.”

Because ivermectin prescriptions have tracked with case counts, he suspects more are being dispensed now than in August.

In response to questions about why it covered ivermectin prescriptions, the Centers for Medicare & Medicaid Services told USA TODAY it sent out a memo in December warning of potential fraud associated with the drug. It's unclear why it took so long for CMS to sound the alarm or what other action was taken.

Free masks are arriving at pharmacies: Here's when N95 masks can be picked up at stores.

Despite the government warnings, FLCCC Alliance members continued to push ivermectin for COVID-19, appearing on conservative media outlets, talk shows and podcasts. Last week, U.S. Sen. Ron Johnson, R-Wis., invited FLCCC founders to a roundtable in Washington, D.C., to promote ivermectin. The five-hour discussion was hosted on Rumble, a YouTube alternative popular among conservatives that doesn't censor content.

In an email sent Monday to members of the FDA, Dr. Hooman Noorchashm, a physician, immunologist and public health advocate, pleaded for the Biden administration to take action.

"It is critically important for the United States government to urgently determine the legal legitimacy of the 'non-profits' involved with marketing these, at best controversial 'early treatment' wares," he wrote. "I do believe that this all amounts to a very severe national public health security threat."

The FDA told USA TODAY it does not discuss ongoing investigations as a general policy but said the "safety and efficacy of ivermectin for the prevention or treatment of COVID-19 has not been established."

How the FLCCC Alliance helped keep ivermectin alive

Dr. James P. Johnston, a concierge doctor who runs a telemedicine platform for COVID-19 patients, told USA TODAY that with COVID-19 cases on the rise, he has been prescribing ivermectin to about 40 people a day.

“It’s been a huge, huge boost to my practice,” he said.

Dr. Benjamin Marble, a former ER doctor and founder of another COVID-19 telemedicine platform, says he and about 20 other doctors working for his site have written more than 100,000 ivermectin prescriptions for COVID-19. The consultation is free, but after the prescriptions are sent, the site asks patients for a $125 donation.

Before prescribing any medications, many of the doctors listed on the FLCCC's website charge patients a consultation fee of $50 to $300.

"We’re trying to help as many people as we can," said Marble, who is based in Florida.

Both doctors say they look to the FLCCC protocol for guidance and "science-based recommendations." The Public Readiness and Emergency Preparedness Act, amended during the pandemic, allows physicians to prescribe, dispense or administer COVID-19 therapeutics across state lines no matter where they are licensed.

When Larry Hetu, 38, of Gulf Breeze, Florida, contracted COVID-19 in July, he reached out to Marble, a friend he met through the Republican Party. Hetu said he was unvaccinated because he mistrusted the government and wanted to avoid the hospital at all costs. He paid about $300 for his entire treatment, which included ivermectin and other medications included in the FLCCC protocol.

"I heard about it but I’m not too much into medicine, so I didn’t understand exactly what it was," Hetu said. "So, I relied on (Marble's) judgement."

Across the country, conservative lawmakers are pushing for ivermectin to become an accepted COVID-19 treatment.

In Indiana, Republican Rep. Curt Nisly has filed a bill that would allow doctors and registered nurses to write a standing order for the drug and prohibit pharmacies that fill it from providing information discouraging its use for COVID-19.

Nisly cited FLCCC Alliance co-founder Dr. Pierre Kory, who said a treatment that includes ivermectin could reduce COVID-19 deaths by about 75%. There is no evidence to support the claim, health experts say.

Vaccinated and test positive?: What to know about omicron, COVID for this holiday season.

In Kansas, a group of legislators is pushing a bill that would make it easier for doctors to prescribe ivermectin for off-label use. Pharmacists would be required to fill such prescriptions even if they believe the drug would be dangerous to patients. Physicians and pharmacists would be immune from civil liability.

The Federation of State Medical Boards said it strongly opposes efforts to limit medical board authority and investigate harm to patients.

"If passed, these bills would ultimately endanger patients and their ability to seek recourse if harmed by a physician," said federation spokesperson Joe Knickrehm.

Steve Stites, chief medical officer at The University of Kansas Health System, called the situation "messy."

"This is politics, unfortunately, and not health care," he said in a media briefing last week. "And when politics gets involved in health care, it kind of gets a little messy."

What does the science say?

On Monday, Japanese trading and pharmaceutical company Kowa Co. Ltd said ivermectin showed an “antiviral effect" against omicron and other coronavirus variants in nonclinical research, Reuters reported, but it has not been approved by the Japanese government to treat COVID-19.

Doctors who prescribe ivermectin insist the practice is supported by such findings.

Members of the alliance frequently cite a study from Brazil – co-written by one of its founding members – that showed ivermectin significantly reduced COVID-19 hospitalization and death, and another from Mexico that they say found ivermectin can improve recovery and lessen severe disease.

Health experts say these observational studies were poorly designed, relied on subjective measures for success and left room for bias. They also appeared in lesser-known journals that lack rigorous peer-review.

Many more randomized, controlled trials – the gold-standard for clinical research – have shown ivermectin is not effective at preventing or treating COVID-19. A meta-analysis of 23 trials controlling for bias found it had no effect on survival, hospitalization, the risk of mechanical ventilation or recovery.

Merck, the manufacturer of ivermectin, said last year that the drug has “no meaningful evidence of clinical activity or clinical efficacy in patients with COVID-19” and that there’s “a concerning lack of safety data in the majority of studies.”

In medicine, drugs are frequently used "off-label" to treat other conditions when there is evidence they work.

“We should be evaluating whether existing drugs can be repurposed for COVID treatment,” Chua said. “It’s just that the efficacy (for ivermectin) has not been established by these trials to date.”

In June, the National Institutes of Health launched a randomized, controlled trial to see whether ivermectin, along with two other drugs, can be repurposed to reduce COVID-19 symptoms. Bristow, who is involved in the large study, urged Americans who are interested in the drug to enroll in the trial to ensure safe use, get compensated and "contribute to the library of scientific knowledge." Final results are expected in March 2023.

The FLCCC does not plan any clinical trials on the group's medication protocol in part because it changes based on the "fluid nature of treating COVID-19," Marik said.

After numerous rigorous studies, the FDA has authorized or approved several therapies proven to treat or prevent the worst effects of COVID-19, including two antiviral pills authorized by the FDA in December. There is also one monoclonal antibody, sotrovimab, that remains effective against omicron.

The supply of these regulated therapeutics is limited for now, but health experts say the most powerful tool against severe illness and death from COVID-19 is safe, free and widely available: the authorized vaccines.

“There’s enough data out there to show if the vaccines are not working," Merad said. "So I wonder, who has the bias here?”

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: Ivermectin for COVID: US doctors continue to prescribe unproven drug