Earlier this week researchers in the U.K reported that the inexpensive and commonly‐used steroid dexamethasone reduced the fatality rate of COVID-19 patients on ventilators by 30 percent. This wonderful news makes a lot of sense to health care practitioners.
As we learn more about the workings of the novel coronavirus we now understand that many of the most critical cases result from an over‐reaction of the patient’s immune system (called a “cytokine storm”) causing inflammation and destruction of tissues and organs that can ultimately lead to death. Steroids have long been employed to counteract acute and chronic immune and hyperimmune responses. Aware of this, many clinicians managing critically ill COVID-19 patients who continue to deteriorate have “intuitively” resorted to steroids in a last‐ditch effort to rescue them. The results from these clinical trials in the U.K. validate that intuition and provide hope that we can further reduce COVID-19’s fatality rate.
Dexamethasone for the treatment of COVID-19 patients is yet another example of an off‐label use of a drug. The Food and Drug Administration has not approved the drug for the treatment of COVID-19, but clinicians are never prohibited from using a drug in ways not listed on the FDA‐approved label.
The discovery of this off‐label use for dexamethasone was devoid of politics or central planners. It resulted from clinicians applying their shared knowledge and experience to a new challenge and then reporting their findings.
Compare the dexamethasone story with that of hydroxychloroquine. Aware of in vitro and anecdotal clinical evidence that the anti‐inflammatory and anti‐malarial drug hydroxychloroquine, with or without the antibiotic azithromycin, might combat COVID-19 infection, President Trump touted the drug in a March 13 press conference as a potential “game changer,” and subsequently announced that he is taking it prophylactically.
When the FDA Commissioner stated that hydroxychloroquine was not approved for use in COVID-19 infections, it set off a firestorm in the press. This, in turn, led governors in several states to forbid the off‐label use of hydroxychloroquine for COVID-19 infections except under government‐approved circumstances—a major intrusion of political leaders into the normal practice of medicine.
But the politicization did not stop there. Within a couple of weeks the FDA issued an Emergency Use Authorization to create a national strategic stockpile of hydroxychloroquine (and its related drug, chloroquine) for the treatment of COVID-19 infections.
While a debate still rages among many clinicians, the emerging evidence from clinical trials of hydroxychloroquine treatment for COVID-19 has been generally discouraging. As a result, on June 15, the FDA revoked the Emergency Use Authorization. Now the Department of Health and Human Services finds itself saddled with a national strategic stockpile of 63 million doses of hydroxychloroquine and 2 million doses of chloroquine. And stockpiles created in more than 20 states are similarly in limbo. Florida’s governor purchased 1 million doses that have never been used.
As a physician, I cannot state with any confidence if hydroxychloroquine is effective for treating COVID-19. But I have stated vociferously that decisions regarding the off‐label use of any drug to treat any condition should be up to health care practitioners and their patients. Politics and central planning only lead to negative unintended consequences.
In the case of hydroxychloroquine, politics and central planning impeded empirical treatment and the collection of evidence on its use in COVID-19 infections. It also distorted the production and supply of hydroxychloroquine and caused needless, wasteful stockpiling.
Meanwhile, empiric use and clinical trials of off‐label dexamethasone for COVID-19 has been uninvolved with politics. Perhaps we should be grateful that President Trump hadn’t heard about it.