A decade or more after European studies suggested that chewing an aspirin within an hour of experiencing chest pain and other heart attack symptoms quickly began to dissolve blood clots in coronary arteries to restore blood flow to the heart, few American cardiologists were acting on this life-saving information.
Why? Controlled clinical trials in the U.S. hadn’t yet determined whether the benefit of preventing permanent heart damage or death outweighed the risk of a bleeding ulcer or triggering anaphylaxis—a rare, life-threatening allergic reaction to aspirin.
Even people with no medical training intuitively understand that in the throes of a heart attack that is depriving the heart and brain of oxygenated blood, a bleeding ulcer is not going to be listed as the cause of death—and doctors wouldn’t recommend this emergency intervention to patients for whom it is contraindicated.
But an over-abundance of caution caused avoidable death and disability before it became standard protocol to tell patients to call 911 and to chew on an aspirin while waiting for the ambulance to arrive. Seems silly, right?
Well, it’s déjà vu all over again, when it comes to treating patients hospitalized with coronavirus and at risk of dying from severe respiratory complications.
During the daily briefings of the White House Coronavirus Task Force, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, repeatedly referred to reports from frontline clinicians that the combination of the anti-malarial drug hydroxychloroquine and the antibiotic azithromycin can completely clear coronavirus from the body within six days as “anecdotal” evidence.
The coronavirus pandemic is a medical story, not a political story. Yet, there are no medical journalists in the White House Briefing Room. To a medical journalist, “anecdotal” evidence is what doctors in the field are reporting. To a political journalist, “anecdotal” evidence is unsubstantiated hearsay.
Fauci knew—or should have known—that political journalists would report his characterization of clinical reports on the safety and efficacy of hydroxychloroquine and azithromycin (HCQ+AZ) not as something “you hear out there” but as the president overhyping (or “lying” about) the benefits of the treatment.
Over and over again, Fauci also gave the false impression that the experimental treatment regimen would not, or could not, be given to severely ill patients before data from large-scale, randomized double-blind clinical trials becomes available: “My job as a scientist is . . . to prove without a doubt that a drug is not only safe, but it actually works.”
All well and good, but a clinician’s job is to save lives. And in the midst of a burgeoning global pandemic when speed is of the essence, field experience with two drugs whose safety profiles are well understood suffices to treat patients who are likely to die. For this reason, the FDA-approved chloroquine and remdesivir, an Ebola treatment, for “compassionate use.” Both drugs can be administered immediately to patients who have serious or life-threatening cases of coronavirus.
The combination of HCQ+AZ could cause abnormal heart rhythms and would not be given to patients with known atrial flutter or atrial fibrillation. Research suggests one alternative for these patients: The combination of chloroquine and zinc, which can stop the virus from replicating.
“Anecdotal” evidence typically prompts new, off-label uses (not FDA-approved) of available medications that eventually become standard treatment after the controlled clinical studies are done. For instance, doctors used HCQ off-label to treat lupus, rheumatoid arthritis, scleroderma, and sarcoidosis, and this is now standard treatment for these conditions.
Making the perfect the enemy of the good, Fauci was dismissive both of clinical use of HCQ+AZ in China and South Korea, but also of small clinical trials in China and in France. The World Health Organization just announced a large global trial of HCQ+AZ, remdesivir, and a combination of HIV drugs lopinavir and ritonavir, but it also will not meet Fauci’s exacting methodological standards.
And like President Trump, New York Governor Andrew Cuomo is optimistic enough about these results to have secured 10,000 doses of HCQ+AZ from the FDA, and will reportedly launch a clinical trial on the recommendation of Howard Zucker, the state’s health commissioner. This trial, too, will be quick and dirty, but it will quickly yield actionable “anecdotal” evidence.
There is one critical clinical trial Fauci should have initiated as soon as it became apparent hospitals nationwide lacked adequate supplies of face masks and shields, gloves, gowns, and other personal protective equipment to handle the pandemic: The prophylactic administration of HCQ to frontline healthcare personnel in coronavirus hot spots.
Doctors and nurses at one hospital in Seattle, Los Angeles, and New York City could be given the anti-malarial drug to see whether they are more resistant to coronavirus infection than their counterparts at another hospital in those cities not taking it.
After 50 years in Washington, Fauci has become an overly-cautious bureaucrat: “It probably would be several weeks and maybe longer before we know whether [containment measures] are having an effect.”
No, we will know by mid-April whether the rate of infection has been significantly slowed by taking bold action to augment containment with widespread clinical use of HCQ+AZ to cure hospitalized patients and reduce the length of time they can pass on the infection to others, as well as to prevent infection in those caring for them.
Not taking these steps will unnecessarily prolong the pandemic, which will unnecessarily prolong and deepen the adverse economic effects of federal and state containment efforts.
None of the White House correspondents at last Friday’s Coronavirus Task Force briefing had the wit to ask Fauci, “If your wife were lying in a hospital bed and is in danger of dying from coronavirus complications, would you give her hydroxychloroquine and azithromycin?”
It would be the medical journalist’s equivalent of CNN’s Bernard Shaw opening the second presidential debate between Vice President George H.W. Bush and Governor Michael Dukakis in 1988, by asking, “Governor, if Kitty Dukakis were raped and murdered, would you favor an irrevocable death penalty for the killer?”