Most recent policies aimed at mitigating the spread of the novel coronavirus within the United States focus on preventing the transmission of the virus with methods like social distancing, school closures, and paid sick leave. But what drugs are available to treat people once they are infected with the virus? What about drugs that prevent transmission in the first place?
Given that the first cases of COVID-19 emerged less than four months ago, the FDA has not yet approved any drug to specifically treat the novel virus. Even globally, no drug has been proven to effectively treat COVID-19. Clinical trials to evaluate the safety and efficacy of new treatments can take years, though the FDA has mechanisms in place to speed up the process when necessary to “treat serious or life-threatening conditions.” President Trump has publicly called for the agency to do just that for two antiviral drugs, a generic antimalarial drug called hydroxychloroquine and Gilead Sciences’ Remdesivir, which was originally developed as a treatment for SARS and MERS.
The president’s claim at a press conference on Thursday that these two therapies were “essentially approved” to treat COVID-19 is misleading. Neither drug has been approved by the FDA to treat COVID-19, and neither will be approved to treat COVID-19 until months from now, if at all.
As of now, Remdesivir has not been approved by the FDA to treat any condition, let alone COVID-19. A randomized clinical trial of Remdesivir conducted by the National Institute of Allergy and Infectious Diseases is currently underway with patients with laboratory-confirmed novel coronavirus, but it’s still unclear whether the drug effectively fights the virus in human subjects. Some positive anecdotes have emerged, but as of today, there is no solid causal evidence on whether Remdesivir effectively treats COVID-19.
The president’s statement is a bit more accurate in the context of hydroxychloroquine, a generic drug that has been approved for use in the U.S. to treat malaria and other conditions for decades. Aside from some promising anecdotal evidence, though, hydroxychloroquine has not yet been proven definitively to treat COVID-19. Doctors are technically permitted to prescribe hydroxychloroquine off-label, meaning to treat a different condition or indication than the condition the FDA approved it to treat, which applies to patients with COVID-19. Reports of increases in demand for the drug seem to indicate that physicians are doing just that.
But this spike in prescriptions has led to shortages of the drug, causing dire consequences for patients that need the drug for other conditions such as lupus. In response, Teva Pharmaceutical Industries and Novartis have committed to donating millions of pills to hospitals and pharmacies across the country, and Mylan announced that it will ramp up its production of the drug.
It’s crucial to note that no peer-reviewed clinical evidence exists to support the effectiveness of hydroxychloroquine as a treatment for COVID-19. Physicians are either prescribing the drug to coronavirus patients based on hunches or stockpiling the drug in anticipation of forthcoming research. These off-label prescriptions, based only on doctors’ intuition, could prevent patients with lupus from accessing a drug that they need to survive.
Aside from hydroxychloroquine and Remdesivir, there are quite a few new drugs entering preclinical and Phase I testing to treat COVID-19, though these therapies have little to no documented evidence supporting their safety and efficacy as of now. Some companies are trying to engineer treatments for the virus using antibodies from recovered patients, though these drugs are also still in the early stages of development.
Antiviral treatments like hydroxychloroquine and Remdesivir are not vaccines, though, and some experts aren’t mincing words about the necessity of finding one. In a recent article in The Atlantic, Dr. Aaron Carroll and Dr. Ashish Jha stated that “we need to pour vast sums of intellectual and financial resources into developing a vaccine that would finally bring this nightmare to a close.” The National Institutes of Health announced on Monday that clinical trials had begun in Seattle to test a potential vaccine, a messenger RNA-based therapy that “has shown promise in animal models.” As even President Trump admits, though, “it’s still a long process.” And vaccine development absolutely needs to be thorough in order to prevent harmful complications and anti-vaccination sentiments.
One way to bypass the long process of conducting clinical trials to obtain FDA approval for a new drug, however, is to direct doctors to prescribe existing drugs for the off-label purpose of treating COVID-19. But a substantial body of evidence on the safety and effectiveness of a drug needs to be developed for off-label prescriptions to be advisable or even ethical. That’s why researchers at the Quantitative Biosciences Institute at the University of California are testing existing FDA-approved drugs to try to find an already on-market product that can double as a treatment for COVID-19. It’s also why some promising clinical trials are underway in China to test whether favipiravir, a flu drug, could double as a COVID-19 treatment.
Physicians should always keep the murky ethics of off-label prescribing in mind. But as this pandemic continues to devastate human lives and economies across the globe, though, it’s definitely worth considering whether some risks need to be taken to go on the offensive against the pandemic.