At a restaurant industry executive event a little while ago, President Donald Trump stated that he was taking hydroxychloroquine or “the hydroxy” as he called it, in an effort to prevent COVID-19 infection. He also said many frontline workers—presumably referring to nurses, doctors and emergency medical technicians—were also taking the drug.
Over the last few months while working in the intensive care unit, I have seen the devastating effects of COVID-19 infection on both the young and the old, on those with no prior medical problems and those with preexisting conditions. But as a critical care doctor taking care of critically ill COVID-19 patients, I do not know anyone who’s taking hydroxychloroquine to reduce the likelihood of catching COVID-19, and I would certainly not recommend it at this point.
To be clear, the effectiveness of the drug against COVID-19 is unknown. There are several ongoing clinical trials evaluating its effectiveness in both outpatient and inpatient settings, in both the prevention and treatment of COVID-19 infection. But preliminary research suggests that it may be unsafe, at least for routine use outside a hospital. The Food and Drug Administration has issued an official warning about it. For the president of the United States to advocate repeatedly for unproven therapies is extremely concerning and irresponsible from someone in his position of power and influence.
While hydroxychloroquine has been around for several years in the treatment of malaria and lupus, it is not harmless. A recent clinical trial was stopped early because of an elevated number of deaths in hospitalized patients receiving high doses of the medicine in hospitalized patients with COVID-19 infection. Hydroxychloroquine can cause abnormalities in heart rhythm, and with long-term use may lead to heart failure and vision loss. Average Americans do not have the privilege of a personal physician who offers daily cardiac monitoring and daily COVID-19 testing.
Yet the assertions continue. Sean Conley, Trump’s personal physician, stated in a recent memo referring to the president taking daily hydroxychloroquine that “the potential benefit from treatment outweighed the relative risks.” To my knowledge, there is no study showing any benefit of daily hydroxychloroquine use in people who are COVID-19 negative. The National Institutes of Health reports current clinical trials have studied up to a 10-day course of treatment in patients with COVID-19 infection.
Historically, scientists and physicians, in the quest to do good, have prescribed treatments that have been at best ineffective and at worst, deadly. In the 1918 influenza pandemic, doctors recommended an extreme amount of aspirin for symptom relief, which led to a spike of deaths due to aspirin poisoning. Many of the deaths in October 1918 are now thought to have been due to such overdoses, and not the flu itself.
Drugs that work in test tubes or petri dishes under ideal conditions have often been shown to be ineffective in human trials. In the Ebola outbreak of 2014–2016, an antiviral drug, remdesivir, was highly touted as the miracle drug against Ebola due to monkey trials, however ultimately failed a landmark clinical trial in humans.
Of note, remdesivir is again gaining scientific and media interest, and is now thought to be a promising drug in the treatment of COVID-19. The FDA has issued an emergency use authorization, allowing its use in the treatment of severely ill patients pending final results from three ongoing clinical trials. However, while we must remain optimistic that remdesivir will be the answer we seek in ridding the world of this awful virus, we must temper our optimism before we have adequate data, especially knowing that there is still a lot about this virus that we are yet to understand.
There is also a sprint to find a new coronavirus vaccine. As with any vaccine, the goal is to train the body to recognize a COVID-19 infection and attack the virus in the early stages of infection. This would either stop an infection in its tracks or, at the very least, reduce the severity of an infection. As of May 27, 10 vaccines were in the clinical stages of evaluation, with 115 vaccines racing through the preclinical stages. Some adenovirus vaccines show some promise, with the most prominent being China’s CanSino and ChAdOx1 from Oxford University.
Vaccines are not without risk, however. In a recent poll of Americans by the Associated Press-NORC Center for Public Affairs Research, about half of respondents overall (but only 25 percent of black and 37 percent of Hispanic respondents) planned to get a COVID-19 vaccine if it became available. The major factors for reluctance were fear of side effects, followed by the fear of contracting coronavirus infection from the vaccine itself.
Some of this general American hesitation regarding vaccine side effects can be traced back to the 1976 swine flu vaccine. The threat of a major influenza outbreak led to a hastily created attenuated live-virus vaccine, which was coupled by a push by the American government to vaccinate most of the population. Unfortunately, this vaccine was directly responsible for at least 450 cases of Guillain-Barré syndrome (GBS), a rare neurological disorder causing paralysis and, in some cases, breathing difficulties leading to ventilator dependence. The pandemic never materialized, however, and most of the people infected with the flu that year had mild symptoms. This reminds us that in the race to develop a vaccine, governments, companies and regulatory bodies must ensure that the highest scientific standard is upheld to protect rather than harm the general public.
Our scientific knowledge of the virus itself is growing rapidly. We now know that it affects more than just the lungs; it also can lead to blood clots, “COVID toes,” heart failure, kidney failure and stroke. A few months ago, most thought that children were relatively immune to this virus, but now know that children can also suffer from multiorgan failure and even death.
Social distancing has slowed the spread of the virus, and countries around the world are slowly reopening. The world does not need a second surge of hospitalizations and deaths due to unproven medical therapies rather than the virus itself.
For the safety and health of everyone, the goal of science and medicine should be, as always: first, do no harm.