State legislators are expanding medications people can get over the counter (OTC), bypassing pesky (and expensive) medical visits and trampling expertise once thought exclusively within the purview of the medical profession. Ivermectin has been the poster child for “medical freedom” since the COVID pandemic and this new campaign—the price may be your health.
Last week, the North Carolina legislature cleared a bill allowing pharmacists to dispense Ivermectin for humans without a prescription. The bill now heads to the State Senate. If passed, North Carolina will join Arkansas, Idaho, and Tennessee allowing Ivermectin to be procured OTC; thirteen states have similar legislation pending.
Meet the Miracle Horse Dewormer
Ivermectin is an FDA-approved drug, tested for safety and effectiveness in treating two intestinal parasitic conditions, intestinal strongyloidiasis and onchocerciasis, available by prescription only. Topical forms are FDA-approved to treat external parasites like head lice and certain skin conditions. However, its most common use is as a horse-dewormer paste readily available without a prescription.
During the early stages of the COVID pandemic, Ivermectin was touted as a miracle cure or snake oil, often depending on perspective and political party; the drug became politicized as an “’ anti-establishment alternative’ to vaccination.” Demand went wild. According to the CDC, prescriptions skyrocketed to 88,000 from a pre-pandemic weekly baseline of 3,600, notwithstanding strong cautionary advice from the FDA and CDC. [1]
While mainstream medicine warned that Ivermectin’s use for COVID is dangerous and presented serious side effects and drug interactions (including blood thinners and several antibiotics), the warnings went unheeded. Calls to poison-control centers spiked as individuals self-medicated. When physicians refused to prescribe the drug for COVID, people corralled the OTC veterinary version– some died, ostensibly from improper use or overdose. Some physicians saw a market niche; their “prescribing services” retained by those who hadn’t been examined and weren’t patients. Judges allowed physicians without hospital accreditation to prescribe the drug for hospitalized patients, bypassing hospital and licensing rules.
Nevertheless, the drug remained within the control of physicians, who were still charged with and held accountable for accurate diagnosis, assessing risks, determining dosage, side-effects, and drug interactions, and providing informed consent. Until now.
The Medical Freedom Movement on Steroids
COVID has vivified the medical freedom movement – which stresses autonomy in an individual’s right to make personal health decisions unfettered by governmental interference, even when these decisions may be at odds with population or public health concerns. The movement’s mantra surfaced in those contesting vaccines and their mandates and those irked by inability to procure Ivermectin to treat COVID.
Now, various legislatures are taking the mantra one step further, endowing the “medically free” with the knowledge and expertise to self-determine if Ivermectin is “right” for them and their children and determine their dosage. All without physician intervention or oversight.
The State Police Power
While we commonly think of the FDA or CDC as the primary health regulators, the Founding Fathers delegated the right to regulate health and safety to the states, e.g., via licensing physicians under its police power. For drugs, the responsibility is shared between the state and the feds. However, all medications sold, whether by prescription or over the counter, must be approved by the FDA.
Based on submitted safety and efficacy profiles, compliance with a rigorous three-phase clinical testing protocol, and post-marketing reports and testing, the FDA approves drugs for a specific use and a specific cohort, e.g., children, adults, men, or women. A physician, however, is not limited to prescribing these drugs for use or populations beyond their FDA designation. This is called “off-label” usage. The state may impose additional restrictions, for example, limiting the number of prescriptions for controlled substances and narcotics.
OTC- Drugs Without a Prescription
Some drugs are available over the counter, i.e., without a prescription, but these drugs also must be FDA-approved. The FDA clearance protocol assures that an ingredient in an OTC drug is safe, effective, and suitable for consumer-mediated use, including ensuring that the consumer can understand the instructions for use.
The federal government can also impose additional health-related restrictions on OTC drugs, such as limiting the amount purchased or the placement of a drug behind the pharmacist’s counter and requiring age identification, such as for ephedrine, pseudoephedrine, and phenylpropanolamine under the Combat Methamphetamine Epidemic Act of 2005.
In some instances where the safety and efficacy of a prescription drug have become clear over time, the FDA may reassign a prescription drug to OTC status. It’s not simple or instantaneous, as the FDA writes,
“The Rx-to-OTC switch process involves rigorous review and approval by the FDA. And the process can look slightly different, depending on whether it’s a full or partial switch.”
About 13 medications have made the switch from prescription-only to OTC.
Let the People Prescribe for Themselves
The North Carolina proposed law designates prescription Ivermectin as an OTC drug, bypassing the FDA protocol, experience, and methods to assure it is suitable and safe for the layperson to self-prescribe. The legislation, in the name of medical freedom, removes the physician from diagnosis and treatment, conferring it wholescale on the individual consumer assumed to be fully competent to diagnose, self-administer the drug, assess the side-effects, risks, and drug interactions- all in the name of medical freedom.
The sponsoring legislator seems to think Ivermectin is just like an all-purpose bathroom cleaner:
“[Ivermectin] is a multipurpose drug, and it’s not my job to tell people how to use it. We want to give medical freedom to the people who choose a safe and effective drug.”
- Rep. Jonathan Almond sponsor HB618.
Mainstream medical practitioners (and the FDA) strongly disagree. Dr. Dan Uslan, Chief of Infectious Diseases for UCLA Health, writes,
“Ivermectin is potentially a very toxic drug. There have been lots of cases of liver problems and liver failure, severe GI upset, and even things like seizure and coma.”
A drug that generated controversy for its off-label prescription use will now be freely available without FDA approval or even an age restriction. Nor does it appear that the labeling will become more patient-friendly, although the side effects, including “skin rash [necessitating hospitalization], nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, confusion), sudden drop in blood pressure, and liver injury (hepatitis),” will remain. [2]
No Redress for the Medically Freed
When things go wrong with medications used in treating our illnesses, we often depend on the tort system to right them. Those remedies will be unavailable here.
- No doctor is involved; there can be no malpractice suit.
- Pharmacists, who often can advise a patient on specific drug interactions, are granted civil and criminal immunity in the new bill.
- The legislators purveying this magic medicine with abandon are generally also immune from suit. No wonder there seems to be no soul-searching as to the dangers unleashed.
Worse, perhaps, are the optics. When reaching for an OTC drug, we rightfully presume there is FDA testing for efficacy and safety. But with Ivermectin sitting next to Claritin, solely blessed by your local legislator, the consumer will be blind-sided into falsely believing the drug has FDA approval for consumer use without medical advice.
Under the banner of "medical freedom,” lawmakers without medical knowledge are, in effect, “practicing medicine without a license.” Doesn’t this freedom subject the citizenry to the dangers from which we expect the government to protect us? When the consequences hit, there would be no doctor, pharmacist, or lawmaker held accountable. Just a grieving family, an empty pharmacy counter, and a bitter reminder that freedom without responsibility is a license to harm.
[1] Advice for which they were sued for overstepping their mandate.
[2] Apparently, the direct link to the FDA statement has been removed by the “increased transparency” provided by the new administration
