It wasn’t exactly what you’d call a triumph for science. During an April coronavirus press briefing, President Trump tossed out the idea of using disinfectants and sunlight to treat COVID-19 patients.
Reacting to a study, presented by William Bryan, undersecretary for science and technology at the Department of Homeland Security, that found sun exposure and cleaning agents like bleach have an adverse effect on the coronavirus (when used on surfaces), Trump posed the question about whether the chemicals could be used in a treatment.
The president later walked back his remarks, but several websites and social media posts took them out of context. “The briefing transcript shows that Trump did not say people should inject themselves with bleach or alcohol to treat the coronavirus. He was asking officials on the White House coronavirus task force whether they could be used in potential cures,” pointed out the Poynter Institute’s PolitiFact website.
Still, Reckitt Benckiser, Lysol’s marketer, wound up issuing a statement that, “under no circumstances” should its disinfectant products be administered into the human body. And the episode shall forever be known as Trump’s “Lysol moment.”
This controversy was the latest instance of the president trying to seem like a man of action in the face of the crisis but, in his usual way, stepping into a firestorm. Take the earlier brouhaha over antimalarial drug hydroxychloroquine to treat patients with COVID-19.
At a March 31 briefing, Trump suggested using hydroxychloroquine to treat patients with the virus. “I think it’s not a bad idea to do it, but that’s up to the doctors,” he said, adding on April 5, “What do you have to lose?” even though no new evidence of efficacy had emerged.
For those comments, the president was excoriated in the media and, ultimately, overruled by an expert medical panel, which recommended against doctors using a combination of hydroxychloroquine and azithromycin for the treatment of COVID-19 patients due to potential toxicities. The panel was convened by the National Institutes of Allergy and Infectious Diseases (NIAID), which is led by Dr. Anthony Fauci, who also leads the White House coronavirus task force.
Not to equate a proven antimalarial drug like hydroxychloroquine with a toxic cleaning agent like Lysol, but both controversies (the former more so than the latter) reignited a long-running disagreement, expressed by The Wall Street Journal thusly: “the dispute between ‘proven’ treatments and taking risks for people at death’s door.”
In other words, with doctors in emergency rooms across the country at the end of their rope due to a lack of a treatment or vaccine for Covid, can we in good conscience wait for “definitive” evidence, or should we be focused on throwing everything we’ve got at this pathogen?
There seemed to be little of that tension with remdesivir, the Gilead antiviral drug originally developed for Ebola which was recently endorsed for use against coronavirus. And not merely because, as the WSJ opined, the drug “remains a step ahead of the debunker brigades.” In a White House press briefing last week, it was Dr. Fauci himself who released promising data from a placebo-controlled trial suggesting that remdesivir sets a new standard of care for treating the illness caused by COVID-19.
The I.V. antiviral was associated with shorter hospitalizations and a trend toward improved mortality, according to a statement later issued by the NIAID, which sponsored the trial of 1,060 subjects. Although the reduction in death didn’t reach statistical significance, Dr. Fauci said, the NIAID will continue to follow those patients, and subsequent peer review of the data could suss out a clearer benefit.
As expected, two days later the FDA made the decision to authorize emergency use of the drug.
Nevertheless, in a kind of real-time peer review, many analysts and medical experts rightly pointed out that remdesivir is no silver bullet. Questions also swirled about its ability to reduce viral load and there was no small amount of confusion, given that a Chinese study, published in The Lancet the same day as Dr. Fauci’s briefing, came to the opposite conclusion: Based on a study of 237 patients, “remdesivir was not associated with statistically significant clinical benefits,” the Chinese researchers wrote.
Let’s remember that drug development, like much of scientific inquiry, is usually done incrementally, sometimes glacially. Take 1987’s introduction of azidothymidine, the first antiretroviral drug for treatment of HIV/AIDS, which Dr. Fauci referenced during his remdesivir press briefing.
Over the course of the next decade, AZT, as it was known, led to better treatment and a new standard of care that could be paired with other antiretrovirals. Indeed, four additional reverse transcriptase inhibitors and the first protease inhibitors were approved by the FDA from 1988 to 1995.
However, the death toll from AIDS didn’t plateau until about a decade after that new standard of care’s debut. Data from the National Center for Health Statistics show deaths in the U.S. due to AIDS climbed from about 13,000 in 1987 to just over 41,000 a year in 1995. Monotherapy slowed viral replication and disease progression but added only months to life and had severe side effects. HIV rapidly developed resistance to this single drug.
It wasn’t until 1995, the year following approval of Roche’s saquinavir, that the death rate began to fall. That was also the year Merck and the NIAID began a trial of a three-drug combination, but it was complex – with multiple tablets, complicated schedules and the need for extensive monitoring – not to mention pricey.
AIDS activists staged a Wall Street demonstration to protest profiteering by pharma – especially AZT’s maker, Burroughs Wellcome – and the Reagan administration’s mishandling of the AIDS crisis. Patients wanted faster access to potential treatments, despite high-minded opposition, from the media and political spheres.
Shortly after their sit-in, the FDA said it would shorten its drug-approval process. Single-tablet treatments eventually replaced the multi-drug regimens, and the side effects were minimized. Access to, and pricing for, such therapy evolved.
Today we look back on the AZT case study and that tumultuous time period as a situation where the public, drugmakers and the FDA rebalanced the drug risk-benefit equation during a health crisis. Then, as now, the equation is being tested.
I would hope that the editorialists at the august WSJ are not urging that we set aside our reliance on sound science, just that sentiment ought to lean toward doing everything possible to get a safe and effective treatment as soon as possible. Or, as they expressed it, pushing back on what they see as “overreliance on certitude in science and medicine.”
Many of the treatments being repurposed for use in coronavirus may not work out. There are still hydroxychloroquine clinical trials under way, which will yield an answer as to any proven benefit. One expert, former FDA commissioner Dr. Scott Gottlieb, told CNBC that any benefit is probably modest or we would have seen a more robust treatment effect by now.
Remdesivir is still enjoying the halo of Dr. Fauci’s White House data readout. Until trials fully come to fruition, it remains our best hope. Social distancing may be able to flatten the curve, but we need the biopharma industry to step up and develop the kind of medical technology that will really allow us to gain the upper hand.
By next fall, predicted Dr. Gottlieb, we may indeed have a more expanded arsenal with which to wage war against this pandemic: a combination therapy with remdesivir as the backbone, tens of millions of doses of an experimental vaccine that can be deployed in case of a new pandemic hotspot, and widespread antigen testing.
Until then, there may be other Trump Lysol moments, but the search must go on.
