Ross MarchandPeople are accustomed to long and unnecessary doctor’s visits to receive a diagnosis and then have a prescription given to them. The process is tedious, costly, and in some cases, unnecessary.
That old dynamic may be changing, as many come to realize the absurdity of locking away therapies behind the counter. Recently, health care and biotech writer Alex Kesin wrote to Department of Health and Human Services Secretary Robert F. Kennedy Jr. urging him to reclassify statins (which reduce blood cholesterol levels) as over-the-counter (OTC) medications.
However, statins are just one of many medications that shouldn’t require physician approval. Patients should have the freedom and flexibility to take relatively safe medications that can save or better their lives.
In making his pitch for OTC statins, Kesin notes, “Say only 1% of the 130 million U.S. adults aged 40-75 grab an OTC statin. … you avert ~14,000 heart attacks and strokes.” The risks of this strategy are minimal. “Serious muscle injury from statins occurs in <0.1% of users; hepatotoxicity is an order of magnitude rarer.” The consumer and taxpayer savings of preventing heart attacks with OTC statins could easily reach into the billions of dollars.
Asthma patients would also benefit from a similar OTC push for a medication called albuterol. Albuterol (a fast-acting bronchodilator) is widely used to treat asthma, and its safety profile supports over-the-counter availability. Its use is generally well-tolerated over long periods of time, and common side effects (e.g., nervousness, coughing, throat irritation) are very rarely emergency situations. It’s when patients don’t have access to asthma medications like albuterol that trouble ensues.
According to a 2014 analysis in Allergy and Asthma Proceedings, “In 1,095 adult ED [Emergency Department] patients with acute asthma, we found that 30 [percent] ran out of their inhaled asthma medications before the ED visit.” Given that 25 million Americans have asthma, the switch could be lifesaving. While critics raise concerns about overuse, missed diagnoses, or poor asthma management, these concerns are surely outweighed by access in severe episodes (which do claim lives).
A less-rigid regulatory approach would also benefit cancer patients. Ondansetron (brand name Zofran), a 5-HT3 receptor antagonist used to treat nausea and vomiting, has a strong safety record and high tolerability for even the most vulnerable patients. Originally approved in the U.S. in 1991 for chemotherapy-induced nausea, ondansetron is now widely prescribed off-label for pregnancy-related nausea, viral gastroenteritis, and post-operative nausea. Patients have noticed its miraculous ability in whisking away nausea in as little as thirty minutes.
Similar to statins and albuterol, ondansetron is generally well-tolerated and side effects (e.g., headaches, fatigue, dry mouth, malaise, and constipation) are relatively mild. Numerous clinical studies confirm its minimal sedative effect, especially compared to older OTC medications such as diphenhydramine (brand name Benadryl), which carries more pronounced cognitive and anticholinergic side effects.
The main argument for limiting OTC access appears to be the association between ondansetron and a rare but potentially fatal heart condition called QT prolongation. But, this arrhythmia onset is exceedingly uncommon after taking the medication, and there isn’t a link at all for certain age groups. Surely, patients could simply be warned about the risk through prominent labeling rather than having to schedule a doctor’s visit. If doctors and policymakers trust patients to use NSAIDs (nonsteroidal anti-inflammatory drugs) and sleep aids responsibly, access to ondansetron shouldn’t be such a hassle.
Medications such as statins, albuterol, and ondansetron have saved and improved millions of lives with minimal side-effects.
While no drug is perfect, policymakers must weigh the manageable harms of less physician direction against the significant problems posed by lack of access. Statins should be just the start of a large push to reclassify safe and effective medications as over the counter. These changes could usher in a whole new era of improved and expedited health care, resulting in significant savings for consumers and taxpayers.
Ross Marchand is a senior fellow for the Taxpayers Protection Alliance.
Anyone who has suffered side-effects from statins might read this article and conclude Mr. Kesin has not, himself, suffered any side-effects and his advice is a form of pimping for an industry that at times overlooks patient health in favor of increased revenue. The current statin market is somewhere between $15B – $20Billion. Those kinds of numbers distort reality. Statins are not benign, they have side effects and interactions with other drugs. Tylenol is OTC but it is not, by any measure, harmless. Making drugs OTC cuts medical system costs in certain ways, maybe, but it overlooks national health and the costs of treating side-effects. I thought that’s where RFK Jr. was headed, toward a new American paradigm that favors a more limited drug regime, and that begs a much reduced fanfare for drug taking, in general. Making something OTC does not contribute to that goal. The national objective should be to reduce drug use and dependency, improve citizens’ health, not increase the ease of access and quantities of drugs sold.
Instead of taking a statin, people should research lecithin. There’s some good research out there on lecithin and cholesterol.
I can think of a number of meds that could be OTC, but statins? Statins are not without potential significant side effects. Is it possible statins are mentioned because patients are becoming reluctant to use statins and the drug makers think an OTC option would boost revenue?
Yes, yes and yes of course.