Ivermectin, Luvox and Mixed Messages on the Pandemic

There have been many confusing and mixed messages in the public discussion on the medications ivermectin and Luvox as treatments for the pandemic. I'd like to explain why this is and offer my recommendation for using these medications.

Our Medical and Media "Tower of Babel"

To make sense of the widely divergent messages being heard related to addressing the virus, it's critical to understand the different "languages" being used, which depend on the context of the discussion.

FDA Hurdles

For example, FDA regulations prohibit a company from making claims that a potential disease treatment is effective, unless it has gone through the FDA $100 million to $2.4 billion regulatory testing process. Until this happens, by the FDA definition the treatment is "unproven," and it will declare it to be so no matter how solid the scientific evidence. This is what, because of a deadly quirk in our laws, Congress requires the FDA to do, which contributes to countless deaths and unnecessarily massive health costs.

Why? It is virtually impossible for anything low cost (i.e., not patentable) to make it through this FDA gauntlet. No matter how safe or effective it is, this regulatory quirk is why the FDA considers virtually all natural or generic medication treatments to be "unproven" for new indications. No one can or will pay these fees.

This is what is occurring with ivermectin and Luvox.  The pandemic does allow some "special dispensations," but the FDA generally still warns against anything that doesn't carry its unaffordable stamp of approval.

NIH Hurdles

The NIH has a different language. They speak a language that requires the scientific certainty found in very large prospective randomized double-blind placebo-controlled studies. These are very expensive to conduct, and so are usually only done when justified by being very expensive treatments that are likely to produce very big profits.

In the NIH view, until such a study has been run, even if numerous well-done studies show very strong clinical benefit, their language is that there is "no proof" of efficacy. So, while this strong (to the point of overly rigid) criterion creates a certain certainty for things they say do work, it also dramatically limits the availability of safe and research-proven treatments. Simply put, this approach markedly favors very expensive and profitable treatments. So, when the NIH says something works, it likely does. But when they say there is "no proof" (by their definition), in real terms that is often a very misleading and, ironically, unscientific statement. So countless effective, safe and low-cost treatments go unused — essentially because they are inexpensive.

So both the FDA and NIH share the quirk that the more expensive a potential treatment, the more likely it is to get through their difficult gauntlets for approval. This is the case even when the expensive treatment's clinical benefit is modest and toxicity high, which is one reason why we have the most expensive (but likely not the best) healthcare system in the world.

Physicians have a different language and responsibility. Some physicians simply parrot what the FDA and NIH say. This is because they misunderstand the language issues. From my perspective as a physician, my role is to evaluate the available research data, and then factor in the treatment cost and safety to determine a risk-benefit assessment. Basically, does the research and clinically-shown effectiveness, cost, and safety warrant recommending a given treatment?

Ivermectin is incredibly safe, having been used in countless millions of people for decades. At the recommended dose of 1 mg of ivermectin per 10 pounds of body weight up to 180 pounds, and by using the free GoodRx website or smartphone app to get discounts on medication, the total cost of treatment is only $12. So, the risks and downsides are negligible, while the benefits in a number of studies have consistently been profound. (Download this study to see an example and this review of the research that shows its efficacy in COVID-19.)  

Mortality was significantly lower in the ivermectin group (13.3% vs. 24.5%). This translates to death rates being 84% higher in the untreated group. Seeing these kinds of findings with essentially no safety risk and a cost of only $12, many physicians doing a cost-benefit analysis find that this clearly leads them to recommend ivermectin. I recommend ivermectin in my patients who I suspect of having COVID-19.

Meanwhile, in 2 studies using the old, low-cost and known to be safe OCD medication called Luvox (luvoxamine), the COVID-19 progression was stopped in its tracks, with zero deaths. In one prospective placebo-controlled study, 0 of 80 people required hospitalization vs. 4 of 72 in the placebo group. Here is one study on the Luvox done at my old alma mater, Washington University.

In another study of 113 people with early COVID-19, Luvox was offered by the physician. The 0 of 65 workers who took the medication needed hospitalization, while 6 of 48 workers who turned down fluvoxamine had to be hospitalized. Two required intensive care, and one died, the study found.

Unproven? No proof? To me this depends on how these terms are defined.

At the end of the day, when considering safe and low-cost options, the choice of treatment needs to rest with the individual after discussing the research with their physician. My job is to inform people of why they are hearing different messages; what the research shows the benefit, safety and cost to be; and what I recommend based on the research.