The drug doesn't come without a certain set of risks, and no one knows if it can effectively treat COVID-19.
The president and some of his close advisors — desperate for a COVID-19 cure — are asking “What do you have to lose?” by taking hydroxychloroquine (HCQ), a strong medication never adequately tested for efficacy or safety in COVID-19 patients. The correct answer to the president’s question, which he doesn’t seem to want to hear, is that we have our lives to lose.
The president acknowledges “I’m not a doctor” but this raises the question “What do doctors know about the drug recommended by the president?" Most doctors are aware that HCQ can be effective for patients with malaria, arthritis or lupus. If they were to follow the president’s suggestion and prescribe it for COVID-19 patients, they would also like to know that it will benefit some of those patients, at least.
This drug hasn't proven to be successful in treating viral illnesses
What is known? HCQ has been tested previously in several viral illnesses but never found effective. Importantly, there is no evidence whatsoever that HCQ can prevent COVID-19, and there is only anecdotal evidence that it improves the course of the disease. The reports that it can reduce the measurable levels of the virus in patients are seriously flawed, lack a valid control group and were released to the public with little, if any, scientific review. Proper clinical trials with HCQ are underway, but these will take months. In summary, doctors do not know if HCQ or any other drug now being tested is effective or will have any medical benefit.
Without any assurance of benefit, what do you have to lose? Most doctors rely on the FDA-approved label to evaluate the “risk” side of the benefit/risk equation for each presciption. The drug label for HCQ, and its close relative Chloroquine, are very clear about their risks and both contain a page and a half of stark warnings that include the possibility of blindness due to retinal injury, loss of consciousness due to low blood sugar, suicidal behavior, heart failure, potentially lethal interactions with other drugs, lethal heart rhythm disturbances and yes, death. When doctors prescribe HCQ, they expect that the risk of these potentially tragic side effects will be outweighed by some benefit.
Doctors are also trained to use their medical skills to evaluate the patient’s overall condition as part of the risk/benefit equation for a drug and to take appropriate measures to mitigate any risks. They know that some patients are at greater risk of developing side effects than others. Unfortunately, the patients at greatest risk for most of HCQ’s serious side effects are the same as the very sickest COVID-19 patients, e.g. those on respirators with low blood oxygen levels and with disturbances in body chemistry.
Continuous ECG monitoring is one of the methods used to prevent potentially lethal cardiac effects of HCQ and chloroquine. In many ICUs, computerized decision support systems monitor the patient’s electronic chart and send advisories to physicians when a drug’s risk exceeds safe thresholds. However, these surveillance tools are not generally available outside of the hospital and could not protect those who might try to prevent COVID-19 by taking HCQ.
Special exceptions are made for emergencies
Pandemics and other public health tragedies alter the usual norms and requirements of medical practice. When a life is in danger, physicians may decide to prescribe an unproven drug and monitor the patient for any potentially serious side effects. To enable such use, the FDA has “approved” the careful use of HCQ under an Emergency Use Authorization (EUA). It should be emphasized that the FDA did not approve HCQ as either safe or effective to treat or prevent COVID-19. Recognizing the unique situation doctors are facing, the FDA’s emergency authorization is for the “unapproved use of hydroxychloroquine” supplied from the nation’s stockpile but only for hospitalized adults and adolescents “for whom a clinical trial is not available, or participation is not feasible”.
The FDA’s EUA Fact Sheet should be carefully read by anyone contemplating prescribing or taking HCQ. Also, the public should know that the FDA is working hard to correct a problem at some public websites that post drug labels. Labels for 15 of the 49 products containing HCQ are out of date and do not contain the warnings found in the currently approved HCQ label or in the FDA’s Fact sheet.
In this crisis, our political leaders are grasping at straws and encouraging hope. When faced with a national medical crisis such as a pandemic, I encourage our leaders to defer to the medical and scientific experts who have the knowledge, skills and training to save lives and to not encourage unnecessary or unfounded risks with our lives and our safety.
Dr. Raymond L. Woosley is a professor of medicine at The University of Arizona, College of Medicine-Phoenix. He is the president of the Arizona Center for Education and Research on Therapeutics. Follow him on Twitter: @RayWoosley