Can an anti-malarial drug touted by the White House fight the acute version of the coronavirus infection? Yesterday, HHS Secretary Alex Azar announced that the FDA had granted physicians in the US an emergency authorization to prescribe chloroquine and hydroxychloroquine to certain patients with COVID-19 symptoms, based on initial successes with them in Europe. HHS will begin accepting tens of millions of doses for distribution to the “hot spots” around the nation:
Scientists in America and around the world have identified multiple potential therapeutics for #COVID19, including chloroquine and hydroxychloroquine. President Trump is taking every possible step to protect Americans from the coronavirus and provide them with hope.
— Secretary Alex Azar (@SecAzar) March 30, 2020
The Food and Drug Administration on Sunday issued an emergency use authorization for hydroxychloroquine and chloroquine, decades-old malaria drugs championed by President Donald Trump for coronavirus treatment despite scant evidence.
The agency allowed for the drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” HHS said in a statement, announcing that Sandoz donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine.
The move was supported by the White House, part of a larger Trump-backed effort to speed the use of anti-malaria drugs as a potential therapy for a virus that has no proven treatment or cure. FDA already has allowed New York state to test administering the medication to seriously ill patients, and some hospitals have added it to their treatment protocols.
Most other news outlets offer the same veneer of skepticism as Politico does here. Just because Trump talks about it, however, does not make it less valuable nor this decision more political. It’s a step toward allowing the science to dictate strategy rather than allowing the red tape to hamstring both.
A little skepticism is warranted, to be sure, but not about the decision to try this strategy. It’s not a vaccine, nor is it likely a “cure,” in the normal sense. It’s a treatment, and it’s still more aspirational than established. French and Italian doctors have seen some significant success in prescribing the two forms of chloroquine in conjunction with azithromycin, an antibiotic which appears to help fight off respiratory complications. Just how the two work to fight COVID-19 is not yet well known, nor is it clear that it produces better results than other methods. No normal effectiveness study has been done, Dr. Anthony Fauci noted earlier this month, but there’s also no time in which to do it:
Dr. Anthony Fauci, the government’s top infectious disease expert, said during a press briefing earlier this month that much of what is known about the drug is based on “anecdotal reports.”
“It was not done in a controlled clinical trial, so you really can’t make any definitive statement about it,” he said.
The two drugs have one big advantage in this situation, however. They have both already been tested for lethality by the FDA and approved for other uses. At the minimum, doctors know how to use both without killing their patients or introducing new complications, plus it appears that this need not replace other treatments for COVID-19. There’s simply not enough time to do the kind of double-blind longitudinal study normally required by the FDA, a process which takes years rather than weeks or days. In the midst of a pandemic, it’s also questionable in an ethical sense to withhold the medicine just to get a control sample for such a study. In this case, we will know how well this works by deploying it to the sick and determining their rate of recovery in comparison to other treatments.
Is this the way we want to evaluate new medicines? Not normally, but these are not normal times, nor are they new medicines. They are established medicines with known parameters for use that will at the very least do no additional harm. We don’t have five years to test out new treatments in the midst of a pandemic. It’s not an optimal method, but in an emergency it’s a low-risk decision, and kudos to HHS and FDA for recognizing that.