Doctors should follow the evidence for promising therapies. Instead they demand certainty.
By Joseph A. Ladapo
Fear and panic are central impediments to competent decision-making during a crisis. As Covid-19 cases and hospitalizations rise around the country, creating an atmosphere of crisis, political leaders are reaching for last spring’s lockdown playbooks. Their grave tone conveys an air of inevitability, as if politicians have no choice but again to restrict civil liberties, limit social gatherings, and cripple businesses that survived the initial lockdowns. But there’s a better way: following the evidence for early treatment of Covid-19.
The health system would be less burdened if more patients were treated before they require hospitalization, and there are promising therapeutic options that patients can administer themselves at home. This was the subject of a Nov. 19 hearing before the Senate Homeland Security and Governmental Affairs Committee.
Testimony from the hearing underscored an important issue: Too many doctors have interpreted the term “evidence-based medicine” to mean that the evidence for a treatment must be certain and definitive before it can be given to patients. Because accusing a physician of not being “evidence based” can be a career-damaging allegation, fear of straying from the pack has prevailed, favoring inertia and inaction amid uncertainty about Covid-19 treatments.
For diseases with established treatment options, holding out for certainty may be prudent. But when options are limited and there are safe treatments with evidence for effectiveness, holding out for certainty can be catastrophic. Requiring a high degree of certainty during a crisis may elevate the augustness of medical organizations and appease the sensibilities of medical professionals, but it does nothing for patients who need help.
The penchant for certainty is visible in the frequently updated treatment guidelines for Covid-19 from the National Institutes of Health. These guidelines were developed by scientists around the country, but because of a mentality that is biased toward virtually irrefutable evidence, no distinction is made for treatments with evidence for effectiveness that falls below the mark of certainty. This framework almost certainly has contributed to many avoidable deaths during this pandemic.
Take the antidepressant fluvoxamine. A high-quality, randomized clinical trial of 152 patients published in the Journal of the American Medical Association found that zero patients treated with fluvoxamine within seven days of the onset of symptoms experienced clinical deterioration compared with 8% of patients receiving a placebo.
Another randomized trial of 200 health-care workers and other adults at high risk of exposure found that 2% of those treated with the antiparasitic ivermectin developed Covid-19 compared with 10% of patients in a control group. A meta-analysis of five randomized clinical trials showed that early use of hydroxychloroquine reduced infection, hospitalization and death by 24%. All of these findings were statistically significant. These medications have been used for decades and have safety profiles comparable to other commonly prescribed medications. This includes hydroxychloroquine, a medication routinely prescribed to pregnant women and breast-feeding mothers.
Uncertainty may remain, but all three medications have demonstrated at least a reasonable likelihood of success when used in early Covid-19 illness or for prevention. Other promising agents include the plant-based compound quercetin—which is being studied in a clinical trial and was used by Sen. Ron Johnson, chairman of the Homeland Security Committee, after his Covid-19 diagnosis in October—and the congestion medication bromhexine, which reduced death rates among hospitalized patients in a randomized study published by BioImpacts.
While some health officials dismiss nonrandomized studies, the Cochrane organization, an international leader in evidence-based medicine, published a review of several hundred studies showing that randomized clinical trials and nonrandomized studies of treatments generally yield similar findings. Modern epidemiologic and statistical methods can usually overcome biases inherent in nonrandomized study designs.
The most auspicious path forward is for local and state governments, research institutions, community clinics and Covid-19 testing sites to provide patients with access to promising outpatient treatments while collecting data about health outcomes. With almost 200,000 new Covid-19 cases daily in the U. S., uncertainty about effectiveness could be resolved within a few weeks. Until then, it is up to patients to demand outpatient treatment. Political leaders have largely been silent, and most physicians have been telling Covid-19 patients to quarantine and hope for the best rather than prescribing early treatment.
As California Gov. Gavin Newsom recently demonstrated with his festive dinner party at a Napa Valley restaurant, asking human beings not to socialize is neither realistic nor healthy. Attempting to shame them into cooperating runs counter to fundamental tenets of public health. And while masks may be effective in crowded or poorly ventilated indoor settings, the recent randomized trial of mask use in Denmark—along with Covid-19 case trends in California, New York and other states that have had mask mandates in place for months—should disabuse anyone of the illusion that mask mandates will quell the crisis.
Treating high-risk patients with Covid-19 at home using safe medications is the most promising public-health strategy for preventing hospital overcrowding and death. These treatments are widely available and can be combined with other measures. What Americans need in this crisis is clear-eyed policy inspired by imagination and a genuine desire to protect the vulnerable—rather than fueled by fear or partisan political agendas.
Dr. Ladapo is an associate professor at UCLA’s David Geffen School of Medicine.