Greg Elliott: Do the studies before prescribing medicines for COVID-19

This Monday, April 6, 2020, photo shows an arrangement of hydroxychloroquine pills in Las Vegas. President Donald Trump and his administration kept up their out-sized promotion Monday of an malaria drug not yet officially approved for fighting the new coronavirus, even though scientists say more testing is needed before it’s proven safe and effective against COVID-19. Trump trade adviser Peter Navarro championed hydroxychloroquine in television interviews a day after the president publicly put his faith in the medication to lessen the toll of the coronavirus pandemic. (AP Photo/John Locher)

Years ago, I benefited from my medical education. Not all facts taught then stood the test of time, but the wisdom of my teachers was timeless.

For example, Theodore Woodward, M.D., shared two “pearls." First, “All medicines are poisons,” was a caution to pay attention to the potential for a medicine to do more harm than good. He also told me to “Believe half of what you read, and half of what you hear,” a caution to read and listen carefully.

Both pearls resonate as I observe the controversy over hydroxychloroquine to treat COVID-19.

Let’s start with “All medicines are poisons.” Examples of this principle abound. Warfarin reduces strokes caused by blood clots that form in the hearts of patients with atrial fibrillation. But warfarin is dangerous if not used properly. The same can be said of opioids, which, used properly, alleviate suffering, but, when widely marketed and used without safeguards, cause premature deaths.

Unfortunately, some medications offer none of the benefits of properly managed warfarin or opiates, but they can cause serious harm. My own professional life bears witness to the scourge of “fen-phen,” promoted as a treatment for obesity in the mid-1990s.

The promise of pills to treat obesity combined with the financial incentives of a huge market proved more than a few thoughtful doctors could derail. Many physicians carefully avoided prescribing fen-phen. Other physicians, wanting to do something to help, generously prescribed fen-phen, even though scientific studies documenting health benefits were unavailable. Ultimately, research showed fenfluramine to be a poison which caused a rare fatal lung disease or damaged heart valves in susceptible patients. Fenfluramine took many lives prematurely.

Now consider, “Believe half of what you read, and half of what you hear.” Much has already been written and said about hydroxychloroquine to treat COVID-19. Statements about hydroxychloroquine currently play out on a much larger stage than warfarin, opioids or fen-phen ever did. The president speaks of potential benefits of hydroxychloroquine for COVID-19. The evidence of benefit is shallow, leading Dr. Anthony Fauci to say that “We still need to do the definitive studies to determine whether any intervention … is truly safe and effective.”

This week the Centers for Disease Control updated their guidance, saying, “There are no drugs or other therapeutics approved by the U.S. Food and Drug Administration to prevent or treat COVID-19.”

Studies are underway. This month investigators at Intermountain Healthcare and University of Utah Health opened two studies of hydroxychloroquine treatment for COVID-19. These studies will help determine whether hydroxychloroquine is beneficial or just adds risks to those with COVID-19.

These studies also safeguard patient selection, monitor for known and unknown adverse effects and protect patients with oversight by safety committees. These protections are important, as illustrated by early closure of a COVID-19 trial in Brazil after deaths associated with heart arrhythmias.

Some advocate rapid deployment of hydroxychloroquine, including “off label” prescription of hydroxychloroquine to treat COVID-19. Earlier this month, Utah legislators approved a “right to try” bill to shield Utah physicians from liability when they prescribe medications to COVID-19 patients off label.

Despite the right to try, Utah physicians should not prescribe hydroxychloroquine for COVID-19 when the benefit remains unproven. The lesson of fenfluramine underscores another pearl passed on by another wise teacher.

“Greg”, he said, “I keep a book on when the right thing to do is to do nothing.” The right thing to do now is to do nothing, i.e. do not prescribe hydroxychloroquine off-label. Instead, follow the advice of Fauci and, “do the definitive studies to determine whether any intervention, not just this one, is truly safe and effective.”

Greg Elliott

Greg Elliott, M.D, MACP, is a Utah physician, professor of internal medicine at the University of Utah and the medical director for graduate medical education at Intermountain Healthcare. The opinions and content expressed here are solely my own and do not represent the views or opinions of Intermountain Healthcare or the University of Utah.