Scott Gottlieb, MD, former Commissioner of the U.S. Food and Drug Administration (FDA), had some advice for attendees of the 37th Annual Miami Breast Cancer Conference in his keynote address at the meeting. While his formal presentation pertained to innovations in oncology drug development and approvals, Dr. Gottlieb also weighed in on the potential spread of the novel coronavirus, or COVID-19.
Scott Gottlieb, MD
“It’s a good time to channel your inner misanthrope,” he said, and embrace social distancing measures, as case counts are expected to quickly rise once widespread testing for the virus is finally in place. An examination of epidemiology data shows a distinct spike in reported respiratory illnesses across the country, he noted. Much of this may stem from the well—but worried—seeking unnecessary medical care. “Clearly something else is happening,” he noted—potentially wider transmission than has been acknowledged so far.
“I think we’re facing some difficult months ahead,” said Dr. Gottlieb. “There’s a lot of speculation about just how bad this disease is. Most of the modeling we’ve seen coming out—looking at South Korea, Italy, and certain parts of China—suggests the mortality rate will be about 1%, which is significantly more than the seasonal flu, which is about 0.1%.”
South Korea is now reporting a lower case-fatality rate of 0.6%, with most cases diagnosed in the past 10 days. But the lag between diagnosis and death is 3 to 6 weeks, noted Dr. Gottlieb, “So as people move through the process of developing more severe and critical illness,” this number should rise.
Although China is seeing some success in containment, it is a result of societal restrictions and “a human cost that is untenable” in the United States, said Dr. Gottlieb. On the opposite end of the spectrum, Iran seems to be putting forth little effort at containment, allowing the virus to “burn through their population.”
“We’re going to have to figure out what [the] American approach is to this and how we start to take more aggressive mitigation steps. We’re losing a pretty narrow window to step in,” he said, adding that new “hot spots” are cropping up, including New York, Boston, Chicago, and Washington, DC.
“We’re going to have to figure out what [the] American approach is to this and how we start to take more aggressive mitigation steps. We’re losing a pretty narrow window to step in."— Scott Gottlieb, MD
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“We really haven’t stepped in with the kind of mitigation step and social distancing in these hot spots that you’d want to see to break the chain of transmission. I think this week is really going to be critical as we start to turn over the card with more cases,” he said.
The other challenge has been the creation and adequate use of effective testing. “The diagnostics just were not in place,” he said. “In an ideal world, we would be doing what the Netherlands is doing: testing indeterminate cases of influenza [the flu]. If someone shows up with flu-like symptoms, gets swabbed, and shows up negative for the flu—but still has a significant respiratory disease—they’ll then get tested for the coronavirus,” he noted. “We had no sentinel surveillance.”
Testing strategies are evolving and improving, with wider adoption expected within the next week, and novel treatments are being developed. There is also a need to enhance social distancing tactics, mitigation methods, and protection of the most vulnerable citizens.
“Until we can get to the other side of this and push down the steepness of the curve, …let’s hope we have a therapeutic by the fall,” he concluded.
Dr. Gottlieb was the 23rd Commissioner of the FDA, serving from 2017 to 2019.