As ivermectin goes over the counter, some pharmacists worry about a lack of guidance

NBC News

4 hours ago

Boise, Idaho, pharmacist Matt Murray has no choice but to disappoint the handful of people who call him every day asking for a drug used to treat parasitic worms.
He could give them the medication, called ivermectin, but only with a doctor's note.
The callers aren't in the throes of an active intestinal worm infestation, Murray said. They simply want access to the pills without having to see a doctor first.
'A lot of people are calling, asking, 'Do you guys have it for sale? Can I buy it? How do I get it?'' said Murray, the director of operations for the independent Customedica Pharmacy. 'Not so much, 'How does it work? What is it for?''
The volume of such calls has increased sharply since mid-April, when Idaho Gov. Brad Little, a Republican, signed a bill into law mandating that ivermectin be available to anyone who wants it over the counter.
While the law technically says that pharmacists like Murray can sell the drug over the counter, the Food and Drug Administration hasn't approved it to be used this way.
'I don't feel that we could just sell prescription ivermectin,' Murray said. 'It's not designed or packaged for retail sale.'
That hasn't stopped frenzied social media claims about ivermectin's supposed 'miraculous' abilities to cure everything from Covid to cancer.
'Ivermectin eliminated the cancer on the skin of my shoulder and it only took 3 weeks,' one person wrote on X. 'It's also working wonders on my eczema,' another wrote on the platform.
Ivermectin has never been formulated or labeled specifically for over-the-counter use, like aspirin or an antacid. Without proper guidance, there is concern that people could overdose on the medication.
Interest in using drugs or experimental treatments in unapproved ways has gained steam with Robert F. Kennedy Jr.'s appointment as head of the Department of Health and Human Services. Kennedy recently said on a podcast that people should have access to controversial alternative therapies like stem cells and chelation therapy to remove heavy metals from the body. The FDA has warned that neither should be used without oversight from a doctor.
The hype has prompted lawmakers in 16 states, including Idaho, to propose and in some cases pass legislation to make the pills readily available for anyone without a prescription. While health insurance covers many prescription drugs, including ivermectin, it doesn't cover over-the-counter medicines.
This year, two other GOP-led states — Arkansas and Tennessee — passed over-the-counter ivermectin laws.
NBC News called 15 independent pharmacies in those states, plus Idaho, to ask whether pharmacists could provide ivermectin without a prescription.
Not a single one said they'd sell the drug over the counter, despite the new laws.
All, however, appeared to be sympathetic to the request. One pharmacist in Arkansas took the time to explain that he needed to wait until the FDA provided guidance on over-the-counter ivermectin.
Until then, he and all the others said, over-the-counter access to ivermectin would have to wait.
Pharmacists say that just because over-the-counter ivermectin is written into law doesn't mean it should be made available to anyone who asks for it. They still rely on federal health guidance.
'Most over-the-counter drugs, especially ones that were prescriptions at one point, go through some FDA approval process,' Murray said. 'In that process, it gets decided what the labeling is going to say,' including warnings and directions.
Republican lawmakers in Alabama, Georgia, Kentucky, Louisiana, Maine, Minnesota, Mississippi, New Hampshire, North Carolina, North Dakota, Pennsylvania, South Carolina and West Virginia have also proposed bills to make ivermectin available over the counter.
Nearly all would simply permit health care providers and pharmacists to distribute ivermectin without a prescription.
Most, like the one proposed in Alabama, would also protect pharmacists from any possible disciplinary action such as fines or license suspension from pharmacy licensing boards for dispensing it.
Maine's proposed legislation specifically permits ivermectin to be sold to people who want to try it for Covid, cancer or the flu.
Mississippi's bill would limit over-the-counter ivermectin to anyone 18 and older.
The drug likely wouldn't be placed on store shelves, but be kept behind pharmacy counters, much like some cold medicines.
Even if states do pass laws protecting pharmacists from disciplinary action, like the proposed legislation in Alabama, Murray said that he and his colleagues remain concerned.
'If you dispense something that doesn't have directions or safety precautions on it, who's ultimately liable if that causes harm?' Murray said. 'I don't know that I would want to assume that risk.'
The Food and Drug Administration warns that taking large doses of ivermectin 'can be dangerous' and cause vomiting, diarrhea, low blood pressure, seizures, coma and even death. The drug could also interact with other medications like blood thinners, the FDA says.
A spokeswoman for CVS Health said that while its pharmacies are able to dispense ivermectin with a prescription, they are 'not currently selling ivermectin over the counter' in any state.
Walgreens declined to comment.
What ivermectin is — and isn't
Ivermectin was discovered by Japanese biochemist Satoshi Ōmura in the 1970s, first as a veterinary drug and then as a groundbreaking treatment for dangerous and disfiguring tropical diseases such as river blindness, as well as tapeworms, scabies and other worm-related infections. Hundreds of millions of people in mostly underdeveloped countries have used it safely with minimal side effects, such as fatigue or diarrhea, for decades.
During the pandemic, the true benefit of the drug got twisted and distorted amid a social media frenzy. When mainstream doctors and scientists insisted that ivermectin didn't treat Covid, mostly conservative groups embraced it in direct opposition to public health officials.
Podcaster Joe Rogan told his tens of millions of followers that ivermectin worked to cure him of Covid in 2021, prompting many people to seek out the drug as a way to treat mild or moderate cases of the virus.
While there was early hope that ivermectin could ease Covid symptoms, it didn't treat respiratory viruses. It still doesn't.
Ivermectin has also been touted as a cancer cure. On the same podcast, actor Mel Gibson claimed ivermectin had wiped out Stage 4 cancer in three of his friends.
Gibson offered no proof. Some cancer patients believed the promises, with potentially devastating results.
'I tried that last year,' Scott Adams, the creator of the 'Dilbert' comic strip, wrote on X, 'to no effect.' Adams, a vocal Donald Trump supporter, revealed in May that he'd been diagnosed with advanced prostate cancer. 'There are claims of it working, but I am aware of no patient who benefitted from it.'
Adams asked his social media followers to stop inundating him with advice to take ivermectin.
Adams wrote that his 'odds of survival have probably jumped from zero to 30%' because he decided on a different treatment and will be 'working with top doctors in the field.'
When one person pleaded with him in the comments not to discourage people from trying ivermectin, the cartoonist didn't play around: 'Your advice could kill people if they delay other treatments.'
There's simply no evidence that ivermectin treats cancer, said Dr. Harold Burstein, a breast oncologist at Dana-Farber Cancer Institute in Boston. He knows because he's looked for it, without success.
Since the Rogan podcast featuring Gibson aired, Burstein has had an uptick in patients asking him about ivermectin. He scoured the medical literature looking for any shred of indication that the drug could be useful to his patients.
'There are exactly zero published clinical trials in a human being on whether ivermectin does or doesn't treat cancer,' Burstein said. 'I can assure you that if any oncologist in America had seen' a benefit to ivermectin, he said, 'they would have been eager to write it up.'
Some scientists are indeed trying to figure out whether ivermectin has any impact on cancer outcomes. Researchers at Cedars-Sinai Medical Center in Los Angeles have begun a preliminary study combining ivermectin with an immunotherapy drug for patients with metastatic triple-negative breast cancer. Final results aren't expected anytime soon.
Doctors tried to make ivermectin 'work'
Ivermectin is manufactured in the U.S. by Merck. The company said in a statement that ivermectin should only be used within the approved FDA framework.
'The use of ivermectin is not supported beyond the doses and populations indicated in the regulatory agency-approved prescribing information,' a Merck spokesperson wrote in an email.
Despite the growing push for over-the-counter ivermectin, there's no sales data available for how many people are buying the pills.
Focusing on making ivermectin available without a doctor's prescription is the latest in a trend of mostly conservative politicians sidestepping expert medical advice. Utah and Florida, for example, recently banned community water fluoridation, despite decades of widespread evidence that it drastically reduces tooth decay.
Dr. Hugh Cassiere, director of critical care services for South Shore University Hospital, part of Northwell Health in New York, said, 'This is about constituents who either heard, read or saw something on social media and now have an idea that this is something good. They're going right to their congressman or senator to demand access.'
'That's not how medicine should work,' he said.
Scientists did, in fact, study whether ivermectin helped people with Covid.
Dr. Adrian Hernandez, a cardiologist with the Duke Clinical Research Institute in Durham, North Carolina, led a large research project that ultimately showed ivermectin had no benefit in treating acute Covid.
'It's always great that legislators care about the health of the state,' Hernandez said. 'But ivermectin didn't help patients get better any faster.'
Hernandez's study was posted on a preprint server called medRxiv in 2022. Studies posted on the site are considered preliminary because they haven't been peer-reviewed.
A second 2022 paper published by the New England Journal of Medicine found that Covid patients treated with ivermectin weren't any less likely to be hospitalized than people who didn't get the drug.
A third study that did suggest a benefit was later retracted because it contained fraudulent data, according to the publisher.
None of this stopped many from demanding access to the drug. During the pandemic, hospitals reported a spike in patients who had been poisoned after taking veterinary-grade ivermectin intended for livestock. Two deaths in New Mexico were linked to the drug.
Even the FDA warned that high doses of ivermectin can cause seizures, coma and death. 'You are not a horse. You are not a cow. Seriously, y'all. Stop it,' the FDA tweeted on Aug. 21, 2021. The controversial post was later deleted but can still be accessed through web archives.
A Merck spokesperson said the drug shouldn't be used for anything other than clearing parasitic infestations.
Northwell Health's Cassiere said medications, especially ivermectin, should only be used after talking with a qualified health care provider, no matter how politicians vote.
'If you're not an expert, if you did not go to medical school, nurse practitioner school, physician assistant school, and don't have the proper training, then you should not be recommending therapies outside of that expertise,' he said.
'Are you going to get a bank loan at the deli on the corner? I don't think so.'