The debate over the use of hydroxychloroquine rages on as COVID-19 cases in the United States exceed 6,000,000 and deaths approach 200,000.
From many respected corners of the medical and regulatory establishment, we have been led to believe, emphatically, that the case for HCQ is now closed. Many studies are cited as evidence that giving HCQ to COVID-19 patients is, at best, ineffective and, at worst, harmful.
But take a closer look because, as usual, the devil is in the details. The patient population in these studies is tremendously varied. In many instances, the medication was used on critically ill patients with advanced disease, or it was given to healthy adults with early or asymptomatic disease. In the case of the former, it is likely too late for these drugs to help. In the case of the latter, treatment is not needed, since those patients will likely recover with no symptoms or with relatively mild ones. There is little justification for the use of HCQ in these populations.
Yet curiously absent amid repeated indictments of HCQ is this critical discovery, hiding in plain sight: Studies have repeatedly shown that HCQ combined with azithromycin (with or without zinc) has yielded positive results in one specific population: high-risk patients (over 60, diabetes, obesity, etc.) receiving the treatment before progression of the disease into the lungs.
When these patients received the combination therapy prior to hospitalization, shortly after, or even before a confirmed COVID-19 diagnosis, they had more rapid viral clearance, lower hospitalization rates, fewer intubations, and lower mortality. High-risk patients should discuss this potential treatment with their physician well in advance of contracting COVID-19 so that, should symptoms occur, a course of early treatment with HCQ will already have been mutually agreed upon.
The benefit of using a combination therapy of HCQ, azithromycin, and zinc in the earliest stages of the COVID-19 illness is not surprising. The three components interact to block the virus from entering the cells of the respiratory system and reproducing. They also stimulate the body to produce virus-killing proteins and hormones and help to mediate some of the symptoms. They are most effective early in the course of the disease when the infection is limited to the upper respiratory system. Once the virus reaches the lungs the disease becomes very difficult to treat.
The endless debate over the safety of these drugs for use in COVID-19 patients is nonsensical. A search of the Food and Drug Administration’s publicly available adverse events database shows that over the last 50 years, of the billions of uses of HCQ around the world, there have only been 202 reported cases of cardiac-related deaths. This is an astounding safety record! And even if one were to assume that 95% of cardiac-related deaths have not been reported, it’s still a vanishingly small percentage of total uses. Azithromycin has an even better safety record, and zinc is a nonprescription vitamin supplement.
Physicians treating COVID-19 patients should tune out the politics of HCQ and “follow the science.” HCQ, combined with azithromycin and zinc, has shown safety and efficacy in high-risk patients treated early in their disease. Moreover, because this therapy can be used very early in the disease progression, long before other treatments are used, it removes the dilemma of “treatment A vs. treatment B.” A patient can later be given other, more aggressive treatments if the early use of HCQ does not deliver the desired reduction in symptoms and virus load.
There is, of course, a small population for which HCQ or azithromycin should not be prescribed due to preexisting conditions. But, other than these few exceptions, widespread adoption of this drug regimen, in the right patient population, will save many lives and should be strongly recommended, indeed encouraged, by our medical and regulatory establishments.
Given the safety profile and apparent benefit of using HCQ in the right patient population, why has the drug become so bitterly contested? It is hard to understand why the FDA has yet to issue an emergency use authorization for HCQ and azithromycin in the above-described population. People are dying.
Alan C. Herman earned his Ph.D. in microbiology from Duke University and did his post-doctoral work in oncogenic virus structure. From 2011 to his retirement in 2018, he served as chief scientific officer for Coherus Biosciences.
