Despite these sacrifices to battle the pandemic, the U.S. continues to lead the world in total confirmed Covid-19 cases and Covid-19 fatalities. As of September 9, the Coronavirus Resource Center at John Hopkins University estimates that nearly 6.4 million confirmed cases of Covid-19 with about 190,500 fatalities. With many universities, schools, and state governments trying to reopen, additional outbreaks are likely on the horizon.
As the public grows more frustrated with sacrificing their personal and economic liberty to combat the pandemic, entrepreneurial scientists and healthcare providers have worked tirelessly to help patients battle the virus. And their efforts have led to another treatment breakthrough.
The Food and Drug Administration recently issued an Emergency Use Authorization (EUA) for the use of convalescent blood plasma to help treat Covid-19. The treatment method involves extracting blood plasma from patients who recovered or are recovering from Covid-19 and inject it into patients more seriously affected by the virus. When successful, the plasma boosts the patient’s immune system, which allows them to battle Covid-19.
The treatment’s EUA grants medical professionals the authority to provide treatment for patients outside of clinical trials. It also adds to a growing list of Covid-19 treatment options, providing hope during troubling times.
But blood plasma’s emergency approval has also generated widespread concern that the procedure is unproven. In the FDA’s own words, blood plasma treatment for Covid-19, “does not yet represent a new standard of care based on the current available evidence.”
This perceived lack of evidence has provoked prominent government health officials to demand more clinical trials before using the procedure to treat Covid-19. As Dr. H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases, expressed last month in a New York Times interview that many of his colleagues, “are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that.”
It is true that when a treatment, drug, or medical device receives a EUA, it forgoes the typical FDA approval process to reach patients and healthcare professionals more quickly. Thus, it forgoes some clinical trials “prove” its effectiveness. Unfortunately, waiting on the results of extensive clinical trials during a public health crisis requires time, which many Covid-19 patients do not have.
But the bigger question at hand isn’t whether the information obtained through clinical trials is “important,” it is whether drug producers and healthcare professionals can find safe and effective treatments absent the FDA’s approval process.
Evidence from the ongoing pandemic strongly suggests they can.
In early March 2020, a variety of regulatory barriers set in place by the FDA and other agencies caused a critical shortage of Covid-19 test kits to diagnose patients. To quickly expand the supply of test kits, the FDA instituted an “umbrella EUA” approach, enabling laboratories and Covid-19 test developers to create and offer their own tests without requiring the agency’s permission. Producers were allowed to submit evidence of their test kits’ effectiveness and receive an EUA afterwards.
Covid-19 test kit EUAs multiplied quickly. As of August, the FDA granted over 140 EUAs for Covid-19 testing-kits. The test-kits were also consistently reliable, with only two test kits losing their EUA as of July. Perhaps more importantly, a less rigorous approach to granting EUAs helped take the United States from a crippling testing shortage to having “more Covid-19 tests than it knows what to do with.”
Blood plasma treatment for Covid-19 tells a similar story. Although the FDA’s EUA is recent, medical professions have been using blood plasma to combat Covid-19 for months. As of late August, more than 70,000 Covid-19 infected patients have received blood plasma treatment. A study of 35,000 patients receiving convalescent blood plasma to treat Covid-19 had faced a lower likelihood of death.
As I have frequently stressed, complex public health problems rarely have clear solutions. Rather, they present us with challenging tradeoffs. Granting treatments and other medical goods EUAs comes with the cost of less clinical trials to demonstrate their effectiveness.
Fortunately, the innovativeness and responsiveness of healthcare providers leave us in capable hands. Blood plasma treatments are just the latest example.