The Trump administration’s fitful response to COVID-19 has failed to meet the moment, one in which a pandemic the likes of which has not been seen in a century threatens the well-being and livelihood of millions of Americans. As this issue of Chain Drug Review was about to go to press, more than 6.9 million people in this country had been infected with the novel coronavirus and 201,920 had died from the disease, according to Johns Hopkins University. The U.S. accounted for more than 20% of global cases in both categories, despite having less than 5% of the world’s population.
Within the overarching emergency, another crisis looms that could, if not promptly addressed, have an adverse impact on public health long after medical science has conquered COVID-19. The inconsistent messaging, contradictory information and lack of a coordinated national response to the outbreak has served to erode trust in the institutions designed to protect and promote the health of Americans. Led by the president, and radiating out to the White House Coronavirus Task Force, the Food and Drug Administration, the Centers for Disease Control and Prevention and, to a lesser extent, the National Institutes of Health, the administration has often confused the public, giving Americans good reason to be skeptical about official guidance.
One doesn’t have to look too far into the history of the pandemic to grasp the problem. Early on, during the weeks after the first COVID-19 case in the U.S. was confirmed on January 20, government experts said it was not necessary for people to wear face masks in public places. That position has long since been debunked, with most government officials — with the notable exception of the president — now consistently recommending masks as the best way to slow the spread of the disease. A case can be made that government experts should get a pass on the issue, since COVID-19 is, indeed, a novel form of coronavirus. That defense doesn’t pertain to subsequent reversals.
President Trump repeatedly touted the value of hydroxychloroquine, a drug use to treat malaria, lupus and arthritis, in the fight against coronavirus. Despite widespread doubts in the medical and scientific communities, the FDA in late March issued an emergency use authorization for utilization of the drug to treat patients. The decision was overturned in mid-June after clinical trials failed to demonstrate that hydroxychloroquine helped those patients, and might even cause additional health problems. A similar scenario played out in August, when the president and FDA Commissioner Stephan Hahn talked up convalescent blood plasma as a treatment, making claims about its effectiveness that Hahn subsequently walked back, although an EUA for it remains in effect.
The height of folly occurred in April, when Trump, speaking at a press briefing, suggested that sunlight or disinfectant should be explored as possible cures for coronavirus. “So, supposing we hit the body with a tremendous — whether it’s ultraviolet or just very powerful light,” he said, addressing Dr. Deborah Birx, the federal government’s coronavirus response coordinator. “I think you said that hasn’t been checked but you’re going to test it. And then I said, supposing you brought the light inside of the body, which you can do either through the skin or in some other way. And I think you said you’re going to test that too. Sounds interesting.
“And then I see the disinfectant where it knocks it out in a minute. One minute. And is there a way we can do something like that, by injection inside or almost a cleaning? So it’d be interesting to check that.”
Numerous additional examples of incomplete or misleading statements about COVID-19 from the administration, including the CDC’s flip-flops on when people need to be tested and airborne transmission of the virus, could be cited. Taken together, the missteps and misinformation (some of which one can’t help but think were influenced by political considerations) serve to undermine American’s trust in a health care system already plagued by chronic problems of access, quality and cost.
Restoring confidence — and doing so quickly — is imperative. Trump has promised a COVID-19 vaccine by Election Day, and scientists, both inside and outside the government, are cautiously optimistic that one will be approved late this year or early next. Americans must be able to count on the FDA to be guided strictly by science when determining if one or more vaccine candidates are safe and effective.
The agency last month took some steps that could help quiet public unease, drafting stringent guidelines for granting an EUA for a COVID-19 vaccine. Phase 3 trials of vaccine candidates from Moderna, AstraZeneca, and Pfizer and BioNTech are already well under way, and Johnson & Johnson has also initiated Phase 3 testing. Reports indicate that, under the proposed FDA guidelines, one or more of them would have to prove at least 50% effective, and that participants in the clinical trials be tracked for two months after receiving the final dose. That methodology would conflict with Trump’s timetable.
The president wasted no time in raising doubts about the FDA’s plans. Characterizing the draft guidelines as a political move, Trump asserted that the rules must be approved by the Department of Health and Human Services and the White House, where science seems to be a secondary consideration.
One recent survey found that only 51% of Americans are willing to be immunized; a second showed that 35% have little or no trust in a vaccine. That is an enormous problem. When the pharmaceutical industry comes up with a solution, it won’t be of any use unless people are willing to be immunized. For that to happen, Americans must have faith that government health experts are giving them the straight story.