Ivermectin (IVM) will now be sold over the counter (OTC) in at least one state, with other states in the process of granting that status.
Gov. Sarah Huckabee Sanders of Arkansas signed Senate Bill 189 into law on March 25, approving ivermectin for use without a prescription.
Idaho’s SB 1211, a similar bill, was passed with overwhelming support and sent to Gov. Brad Little within four days of introduction.
Another similar bill, HB 278, is making its way through the Alabama legislature but is under delay in the House Health Committee.
Other states have passed laws protecting physicians’ ability to prescribe ivermectin and other treatments off label.
Pandemic Deceit
Ivermectin became widely known for its demonization during the COVID-19 pandemic. After IVM became a well-known alternative treatment for COVID-19, the U.S. Food and Drug Administration opposed its use for that purpose.
The drug was originally used to treat parasitic worms, leading to false claims that it was intended only for animals. Researchers William C. Campbell and Satoshi Ōmura earned a Nobel Prize for their discoveries in treating humans with the therapy.
‘Perfect’ OTC Candidate
“Ivermectin is a perfect candidate to be moved to over-the-counter status,” said Charles L. Hooper, president and cofounder of Objective Insights, Inc., a health care consulting firm. “It is very safe. It has been dosed more than 4 billion times around the world, and it has been safely used in pregnant women, children, and infants.”
Hooper was an employee at Merck when Campbell helped discover ivermectin.
“Those who argue against Rx-to-OTC switches for drugs claim that patients will misuse or abuse the OTC drugs,” said Hooper. “But patients can misuse and abuse Rx drugs.
“With ivermectin, some are concerned that it would be used for viruses such as SARS-CoV-2, the virus that causes COVID-19, but ivermectin has been shown to work against SARS-CoV-2, so this is an unscientific, paternalistic, and patronizing position,” said Hooper.
Conflicting Priorities
The Food and Drug Administration (FDA) should focus on safety but not efficacy, says Hooper.
“Efficacy is much harder, and more expensive, than safety to demonstrate in clinical trials,” said Hopper. “And what is the typical result? Something like: ‘20 percent of those who got the placebo improved while 50 percent of those who got the active drug improved.’
“Patients and doctors can already understand this,” said Hooper. “Why do we need the FDA to tell us that 50 percent versus 20 percent is good enough?”
In addition, “no one can know what effect a certain patient will get,” Hooper said.
Vaccine Favoritism
Public health bureaucrats pushed for development and distribution of vaccines during the pandemic, and they discouraged use of readily available treatments, says Jeffrey A. Singer, M.D., a senior fellow at the Cato Institute and author of Your Body, Your Health Care.
“I think many in the public health community developed an almost visceral opposition to the idea of people self-medicating with ivermectin,” said Singer.
“Public health officials were biased toward a vaccine-related solution to the COVID pandemic and believed that discovering a drug can treat COVID infections would impede emergency use authorization of a newly developed vaccine,” said Singer. Studies of the effectiveness of ivermectin in treating COVID-19 have been inconclusive, Singer says.
Officials “also objected to people doing their due diligence and exercising their right to self-medicate without first receiving approval from credentialed experts,” said Singer. “This paternalism persists post-pandemic.”
FDA Option
The public can ask the FDA to classify ivermectin as OTC nationwide, says Singer.
“The FDA commissioner has the authority to unilaterally reclassify ivermectin as OTC,” said Singer. “And the commissioner can consider requests from any interested party, including pharmacists and patients, to reclassify a drug as OTC.”
The agency, however, “has tended to defer to the pharmaceutical manufacturers and won’t reclassify without their request,” said Singer.
Current FDA Commissioner Marty Makary, M.D. “might be more receptive to requests by professional or patient advocacy groups,” said Singer.
Makary discussed his views on drug policy and the dangers of medical groupthink in a September 20, 2024 Cato Institute panel co-hosted by Singer.
Agency Agendas
Doctors care far more about patient choice and autonomy than government agencies do, says Singer.
“Clinicians have marinated in the ethics of informed consent and respect for autonomy,” said Singer. “Unfortunately, the government doesn’t respect autonomy.
“Lawmakers on the federal and state level must repeal laws that let the government control what medications we can take, what kinds of health care professionals we can consult, what kinds of treatments we can undergo, and what kinds of substances we can consume,” said Singer.
More prescription drugs should be classified as OTC, says Devon Herrick, a health care economist.
“More Rx drugs should be switched to over the counter,” said Herrick. “A way for this to happen would be to allow pharmacists to authorize more drugs directly to patients,” said Herrick.
There are many such “behind the counter” drugs, such as pseudoephedrine, cough syrups, insulin, and emergency contraception.
OTC Lowers Costs
Consumers benefit when drugs are approved for OTC sales, not just because of access, but cost.
“OTC drugs are generally a lot cheaper than Rx drugs,” said Hopper. “In one example, the OTC drugs were priced at 10 percent of the Rx equivalents.
“Most pharmaceuticals are under-prescribed and underused,” said Hopper. “There are many chronic conditions for which drugs have shown tremendous benefits, but for which only a fraction of the patients who would benefit actually get the beneficial drugs. OTC makes drugs easier to acquire.”
Harry Painter ([email protected]) writes from Oklahoma.
Harry Painter ([email protected]) writes from Brooklyn, New York.
