The United States is still dealing with more than 10,000 COVID-19 deaths per month. This is unacceptably high. Why this death rate has not instilled a sense of urgency at the FDA is baffling to me. Is it really ‘COVID-19 fatigue’? Or might it be because older adults and the frail account for 90% of those deaths? Whatever the reason, the FDA has failed to act in a timely way, and neither of the above reasons justifies ignoring available science and tools.
More than two months ago, a group I once chaired — the Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) — convened to review an Emergency Use Authorization (EUA) for sabizabulin, a COVID-19 therapeutic drug specifically targeted to help hospitalized, severely ill patients.
The PADAC was presented with data showing that over a period of 18 months, in conjunction with guidance from the FDA, sabizabulin was tested in a double-blind placebo clinical trial format against the toughest possible population — those already hospitalized with moderate to severe COVID-19.
In fact, the clinical trial results were so remarkably positive that an FDA-independent review pane made up of representatives from the University of Maryland, Cleveland Clinic and Mayo Clinic stopped the Phase 3 trial early due to overwhelming clinical efficacy and convincing safety, declaring that it would be unethical to continue to give hospitalized patients (who were receiving the customary standard of care) a placebo that had little to no effect at preventing patient deaths.
Since last June, the FDA staff has been aware that patients receiving sabizabulin experienced a relative reduction in mortality of more than 50%, without any significant adverse effects caused by interactions with drugs regularly taken by that population. Six months later, in November, the PADAC reviewed that clinical trial data showing a significant number of these severely ill, hospitalized older adults taking the drug could be saved over those receiving the accepted standard of care.
One might believe that this compelling data would have been acted upon quickly. Alas, that has not been the case. When one of the FDA reviewers was prompted by a PADAC member on the timing of an FDA decision, the response was, “What’s the rush?” Such bureaucratic indifference typically wears a more discerning public mask, but the apparent disdain and apathy toward the families of those who were dying of COVID-19 were on full display. Frankly, I think several of the PADAC members didn’t fully understand the difference between reviewing an application under the guidelines for an emergency use authorization and one outside of an emergency declaration.
I firmly believe that the FDA approval process should be based on scientific data, yet I’ve never reviewed a proposed drug application where that data was as comprehensive or as “perfect” as I might like. I had to balance the data we had with the human benefit and ethical factors that every physician understands. Patients’ well-being should come first. That is why I don’t understand what is taking the FDA so long to act.
Today’s most serious COVID-19 challenge isn’t vaccination rates, testing, or travel bans, but rather the deployment of effective treatments for hospitalized patients who comprise the most vulnerable members of society and older adults. Too many people are still dying of COVID-19, and we need therapeutics such as sabizabulin that have demonstrated significant potential to safely prevent death and, based on mechanism of action, are expected to be effective against all virus variants.
As a physician who has dedicated his life to saving people, I know that even a single death that could have been prevented is unacceptable — period. And therefore, the FDA needs to act quickly, hopefully, to give families assurance that their loved ones are not being ignored.
• Dr. Erik R. Swenson is a professor of medicine, physiology and biophysics at the University of Washington, and a former chairman of the FDA’s Pulmonary-Allergy Drugs Advisory Committee.