Idaho Legislature Votes to Make Ivermectin an Over-the-counter Medication

Kyle Pfannenstiel has excellent reporting in yesterday’s issue of the Idaho Capital Sun Idaho Legislature approves ivermectin deregulation, sending bill to governor • Idaho Capital Sun about the Idaho Legislature approving a measure to overrule federal law that requires ivermectin to be dispensed to humans pursuant to a prescription, which these Legislators believe will allow ivermectin to be sold over-the-counter in Idaho pharmacies and stores.

Here is the pertinent section of the bill that was just approved by the Idaho House and Senate:

“Notwithstanding any law to the contrary, ivermectin suitable for human use may be sold or purchased as an over-the-counter medication in this state without a prescription or consultation with a health care professional.”

The clause, “Notwithstanding any law to the contrary” might have been glossed over by those who don’t love legal jargon as much as I do or know what laws might be to the contrary, but there is an important law to the contrary – The Food, Drug, and Cosmetic Act that was enacted by the U.S. Congress.

The Durham-Humphrey Amendment divided drugs and medications into two categories: those that can only be sold and dispensed pursuant to a prescription and over the counter (OTC) medications that may be sold for self-administered use without the clinical oversight of a physician. The FDA has been delegated the authority to make the assignment of these two categories to those medications that can be legally sold in the U.S.

The Food, Drug, and Cosmetic Act has long been considered to be the supreme law of the land (that means overriding any state laws that are in conflict with the statute) and to displace states from this area of regulation that would otherwise lead to a patchwork of laws across the country. It has made sense to most of us that this would be the case as it allows for a concentration of expertise in a federal agency (the FDA) to undertake the lengthy and complicated issue of reviewing the basic science, animal and subsequent human studies of safety and efficacy for the myriad classes of medications to determine whether they are safe and effective, the appropriate indications for their use, the proper dosing and what side effects and adverse effects must be listed for health care professionals and for patients. I know of no states that would have this degree of expertise and infrastructure to both conduct the initial applications of medications and the post-marketing surveillance.

On the other hand, I did not fall out of my chair when I learned that the Idaho Legislature was considering this bill given what appears to me to be growing anti-science sentiment and a growing appetite to challenge federal laws by enacting state laws that are in conflict – a legal strategy that previously would have been sure to fail and considered a waste of taxpayer dollars, but more recently seems increasingly more plausible after EMTALA (the Emergency Medical Treatment and Active Labor Act) was found not to mean what its plain text says and what those of us who have studied it for almost 40 years always thought it meant.

Frankly, I fully expect one (or both) of two things to happen that will make the issue of Idaho law (assuming the governor does not veto the bill) in this instance being struck down a purely academic question and not one that sees the light of day in our hallowed halls of justice. First, I fully expect Dr. Martin Makary, the newly confirmed head of the FDA, who infamously pronounced that the U.S. would achieve herd immunity to SARS-CoV-2 and the pandemic would be over in just over one year (April of 2021), under the leadership of RFK, Jr., Secretary of HHS, will pronounce a recategorization of ivermectin to over-the-counter status. Second, even if I am wrong in my prediction, I cannot imagine a scenario where the current administration would attempt to enforce federal law and prevent Idaho from implementing this law. Without legal action by the federal government, there would be no case to be challenged in the courts.

Putting legal analysis to the side, there are so many disturbing issues about this latest action of the Idaho Legislature. These are not serious legislators and I will explain why below.

1. It would seem plain and obvious that if the legislature had never before entered into the field of regulating (rather deregulating) prescription medications and decided that this was now an area ripe for state regulation that it might want to hold some hearings, listen to some expert opinions, consider the implications of doing so (process, precedent-setting, legal, etc.), but that apparently didn’t happen. So, is the legislature going to embark on a review of all medications and make their own determinations as to whether they should be prescription or over-the-counter? If not, what will be the criteria for selecting which medications they will review? What criteria will they use? What expertise will they rely on? Personally, I have not felt that we need more government, more cost to taxpayers, and a legislature that needs to find more things with which to consume itself continuing its inching towards being a full-time job.
2. It would also seem plain and obvious that if the legislature is now going to undertake classifying medications, that it might want to hear from experts on the specific medications in question, let’s say maybe the board of pharmacy or maybe, in the case of ivermectin, some infectious disease experts? But as Mr. Pfannenstiel reported, “Idaho lawmakers didn’t hear public feedback on the bill from doctors, pharmacists or health care professionals.” That kind of makes me think that perhaps they merely want to pass something to score political points, but don’t want to be inconvenienced by hearing all the reasons that this might be a really bad idea or harm Idahoans. In fact, one only needed to listen in to the discussion to be aghast at all the misinformation and baseless claims made that would lead one to believe that ivermectin is nearly a cure-all, despite the very limited role for this medication in the evidence-based treatment of illness.
3. Of course, to the extent that the legislature is intending this to be their one and only foray into regulating medications, this is a problem of their own making. It was appalling to the medical community that the legislature actually promoted disinformation early on in the pandemic in giving unprecedented access to anti-vaccine messaging and late in the pandemic by introducing bills that would likely impair our response to future pandemics. (As an aside, the legislature is now recognizing the serious physician shortage such that it is contemplating the need to purchase a medical school while at the same time failing to have any insight that these anti-science/anti-medicine actions are undermining their stated objective of recruiting and retaining more physicians in Idaho).

It is a common strategy of antivax organizations to promote unproven preventatives and treatments to people to give them more confidence in refusing vaccination. Ivermectin was promoted on the flimsiest of data as a preventative against COVID-19 in the same way that vitamin A is now being touted as a preventative against measles. The problem is that well-designed, high-quality studies show that neither works. In the case of ivermectin, Idaho emergency room and critical care physicians often dealt with families who brought in a family member critically ill with COVID-19 only to learn that the assurances they received from a coordinated network of doctors touting their telehealth services for patients to receive ivermectin at a hefty cost were baseless. And, now Texas parents of children hospitalized for severe measles are learning that vitamin A not only did not prevent their unvaccinated child from getting measles, but that doctors are now having to address the harms the children have suffered as a result of vitamin A overdoses as well.

As Mr. Pfannenstiel points out in his article, “The U.S. Food and Drug and Administration, or FDA, hasn’t approved ivermectin to treat or prevent COVID-19, saying the federal agency finds existing clinical trial data don’t show “ivermectin is effective against COVID 19 in humans.” There are multiple high-quality studies that all support this conclusion, and I have previously provided and written about many of them on this blog.

• The Legislature has pursued a number of bills that limit, restrict or even prohibit the use of a number of the tools that are available to address a future pandemic. There certainly are reasons to rethink a number of the approaches undertaken in the course of combating the COVID-19 pandemic. But, can anyone point to a committee or work group that has undertaken a review of our pandemic response and assimilated a list of lessons learned? Can anyone point to one bill that the legislature has introduced, held hearings on, and passed into law that would strengthen our pandemic preparedness? Please let me know if so, because I am not aware of anything as to either of these strategies that would seem to be the work of a serious legislature that wants to use real life lessons to help protect our state and its citizens.

How strong were the arguments of lay persons in favor of this bill? Let’s look at a couple:

1. According to Mr. Pfannenstiel, “Supporters argue making ivermectin more widely available for human use would avoid people buying versions of the drug intended for animals, and it would make human use safer by providing more information on appropriate doses.” This is illogical. First, the legislature didn’t buy analogous arguments for marijuana (and, by the way, I personally believe rightly so), so there is a problem of internal inconsistency. Second, the reason people were buying animal versions of ivermectin is because the state stood back and allowed certain physicians to promote disinformation that ivermectin would work and reputable physicians wouldn’t prescribe it because it was not safe and effective for the prevention or treatment of COVID-19.

Human use of a medication at appropriate doses does not make it safer if there is no benefit from taking the medication at any dose. Deceiving the public as to the benefits of ivermectin and then making it more available by making it over-the-counter does not protect Idahoans nor does it serve public health. In fact, given the implied claims of these disinformation doctors and appallingly some public health board members that ivermectin was essentially 100 percent effective in preventing SARS-CoV-2 infection and severe disease not only promoted the use of a medication that has potential adverse effects, while offering no benefit, but also gave many of these deceived Idahoans a sense of invincibility that actually increased their exposures and risks of infection mistakenly thinking that they couldn’t be infected while taking the medication.

• In one example provided by Mr. Pfannenstiel, “Rep. Faye Thompson, R-McCall, said she recently went to a local feed store hoping to buy ivermectin for herself and her family to use, but stopped out of confusion over the appropriate dose.” This touches on the other issue that terrifies me about making ivermectin over-the-counter. I do believe that competent adults should be able to make foolish and irresponsible decisions if that is what they want and it won’t harm someone else. But, I fear that the fact that these same adults are already thinking that it is a brilliant idea to buy medications intended for animals for their children from a local feed store will mean they will give these over-the-counter medications to their children for inappropriate uses. Given that ivermectin is being already being touted by some of the disinformation doctors as a treatment for bird flu (a potentially lethal infection in children), a preventative and treatment for cancer, and God knows what all else, I fear that parents will resort to ivermectin rather than seeking medical care for a prompt diagnosis and effective treatment for potentially dangerous threats to the health of Idaho children. This would be a travesty.

Lest the reader of this blog post believe that this bill was just some fringe element of the Republican party, Mr. Pfannenstiel reported that this bill received bipartisan support, including only one vote against it in the House. One Democratic Representative that I had the impression was thoughtful offered his support of the bill on the basis that there are people who think ivermectin works comparing it to medical marijuana for the treatment of pain. I don’t know a single reputable physician or pharmacist that believes we should make all medications that people think works for something over-the-counter when the evidence clearly shows they are wrong.

I could go on much longer, but let me close with one horrifying thought. Mr. Pfannenstiel reported about one Idaho Senator giving credence to the notion that ivermectin is close to being a cure-all stating that “Some people will use it like taking vitamins.”