Ohio Gov. Mike DeWine did the right thing in directing Ohio’s Board of Pharmacy to rescind its recent order prohibiting pharmacists from filling certain prescriptions for use of hydroxychloroquine for COVID-19. DeWine’s act was unusual, but not as unusual as the unprecedented pharmacy board action that triggered it. The board’s action could have led people to think that hydroxychloroquine, also known as HCQ, must be an unusually dangerous drug. In fact, it is an unusually safe drug.
Let’s discuss this safety.
An old drug, HCQ was licensed by FDA 65 years ago. It carries FDA “indications” for treatment of lupus, rheumatoid arthritis, and malaria, but has long been used “off-label” for other conditions for which it lacks a government-recognized indication. So, is off-label prescribing illegal? Or, at least, disreputable? Not at all. Off-label prescribing by physicians is as old as FDA “labeling” itself. According to the Department of Health and Human Services, 20 percent of all prescriptions are off-label. Indeed, off-label prescribing is often medically indicated.
HCQ was originally licensed to treat malaria, an uncommon disease in the U.S., but almost half the world’s people live in areas where malaria is endemic. Since 1955, at least 100 million of these people have been treated with hydroxychloroquine to prevent malaria. They took the drug for years at a time. Because of this, and also because of other on-and-off-label uses of this drug, hydroxychloroquine, far from being a novel agent, is among the world’s most prescribed drugs. The 65 years of extensive, long-term use of HCQ also implies extensive and well-established knowledge of the safety of this medicine. One of us has prescribed HCQ for 44 years for both on-label and off-label reasons. The drug has been used to treat lupus and rheumatoid arthritis for over half a century.
Like nearly every drug, HCQ can have side effects. Overall, however, the safety profile of this medicine is better than that of many drugs. Yet, the off-label use of hundreds of those drugs does not seem to interest the pharmacy board. It can be taken during pregnancy, by breastfeeding women, by children, by the elderly, and by people who are immunocompromised. It is not addictive or sold out of car windows. Unlike more than 600 other drugs, hydroxychloroquine’s Package Insert contains no ‘Black Box Warning’ to alert medical professionals of “potentially serious adverse reactions” associated with its use. After 65 years it would be mighty fishy if one appeared next week. (Most drugs have no such warning.)
In some countries, HCQ is available without a prescription. It’s instructive to compare the safety of HCQ with Tylenol. Available in groceries and convenience stores, etc., Tylenol can cause liver failure when used to excess. It does this with surprising frequency and it causes more deaths than hydroxychloroquine by a very wide margin.
Now let’s touch on the likely benefit of HCQ for treatment of COVID-19. Six weeks ago, the Henry Ford Hospital system in Michigan, in a study of more han 800 patients, reported that hydroxychloroquine cut the death rate of seriously ill COVID-19 patients in half — if the drug was started within three days of hospitalization. There were no deaths from HCQ side effects in this study — including the recently “touted” and disingenuously exaggerated cardiac kind. The obstructionist story that HCQ has a New York Times-sized risk of making your ticker run fast and furious is false. Long experience proves beyond an honest doubt that the actual incidence of this, in comparison to the drug’s vastly extensive worldwide use, is practically infinitesimal.
About the same time, the large Mt. Sinai system in New York reported that hydroxychloroquine use was associated with a statistically significant reduction in COVID-19’s death rate in hospitalized patients, compared with otherwise similar patients who did not receive HCQ. The reduction in death rate was of about the same magnitude as that reported in Detroit by the Ford Hospital System. The Mt. Sinai study included over 6,000 patients. Again, there weren’t any deaths attributable to HCQ in this large group of patients (yes, there were zero deaths of the hyped-up cardiac kind warned of in the faux-alarm fires) – but the study results do indicate that a significant number of lives were saved by HCQ. Also, New York University Hospital reported that adding zinc to HCQ treatment of hospitalized patients confirmed prior observations that a large, additional, statistically significant reduction in the death rate is observed in COVID-19 patients treated with both agents compared to HCQ alone.
Henry Ford Hospital, Baylor University’s Scott and White Clinic, and Yale epidemiology professor Harvey Risch, to name but a few, are publicly advocating that the FDA endorse not only inpatient use of HCQ but also use in the outpatient world where clinical evidence and common sense both strongly suggest it is likely to be more effective.
The clinical experts calling for outpatient use of HCQ in this pandemic believe the key thing is to start this drug early before patients with COVID-19 get really sick and end up in the hospital. Visit c19study.com, to find a frequently updated database, currently displaying 71 reports of studies, including those referred to above, in which HCQ was used to treat COVID-19. (By early August the managers of this database began to get malicious threats. They were victimized by attempts to remotely erase the entire database. Those who resort to such tactics are acting for political or economic purposes, not medical ones. They’re not afraid that HCQ won’t work; they’re afraid it will. However, c19study.com remains up and running; you can dig into the truth about HCQ yourself.
It’s a good thing President Trump brought HCQ to the attention of the American people as a possible treatment for COVID-19. “Big Pharma” is apparently not interested in inexpensive solutions to this crisis, or even in inexpensive partial solutions. Apparently, the federal government’s health care bureaucracy isn’t either.
We encourage readers to remember this: 65 years of extensive, long term use of hydroxychloroquine in more than 100 million people trumps any safety trial, randomized or otherwise, none of which, in any case, have shown a significant rate of serious adverse events from recommended doses of hydroxychloroquine, doses mentioned on the product insert.
Finally, we note that hydroxychloroquine is on the World Health Organization’s List of Essential Medicines. Both Governor DeWine and FDA Commissioner Stephen Hahn have recently opined that prescribing hydroxychloroquine is a matter best decided between doctors and their patients. Going forward, we think it is essential that the Ohio Board of Pharmacy not obstruct treatment choices made by COVID-19 patients in consultation with their physicians.