Gottlieb: More coronavirus kits coming, but so is crisis

2020 03 13 23 58 1361 United States Flag 400

More kits to diagnose the coronavirus are going to be available soon, but that doesn't mean the U.S. is out of the woods, according to Dr. Scott Gottlieb, former commissioner of the U.S. Food and Drug Administration (FDA). Gottlieb spoke at a webinar on March 13 hosted by Accumen and WIRB-Copernicus Group (WCG).

In fact, the U.S. is just at the beginning of an epidemic spread of the virus, Gottlieb said.

"If you think about the situation in South Korea and Italy, 90% of cases in those countries were diagnosed in the last 10 to 12 days," he said. "This virus moves quickly."

Increased testing capacity in the coming week will be, in part, due to the FDA's action: Also on March 13, it issued an emergency use authorization (EUA) to Roche Molecular Systems for its cobas SARS-CoV-2 test -- 24 hours after the company submitted its application. Roche prepositioned its test so that labs could begin testing immediately after the EUA was received. And President Donald Trump announced a national state of emergency on March 13 that will help increase the production of coronavirus test kits.

"We're going to have broader diagnostic screening next week [due to the Roche test]," Gottlieb said. "The test allows for tens of thousands of patients to be tested daily."

The insufficient testing capability has been both well-documented and frustrating, according to Dr. Paul Biddinger, director of the Center for Disaster Medicine at Massachusetts General Hospital, who also participated in the webinar.

"It's extraordinary how different the U.S. capability has been compared to almost anywhere else," he said. "We've had capacity of 23 tests per 1 million people, the lowest of any industrialized country, compared to 2,800 tests per 1 million people in Guangdong, China, and 3,600 per 1 million people in South Korea. When you look at our testing capability, it's hard to say we have a good handle on how much disease is in the U.S. -- we don't know, because we haven't been able to test."

Even with increased testing capacity, more needs to be done, according to Gottlieb. The goal of mitigating the spread of the disease is to flatten the infection peak and therefore put less burden on the healthcare system. That's where social distancing measures and rethinking how hospitals operate during the crisis come in.

"The purpose of social distancing is to keep the peak of the epidemic below which the healthcare system gets exhausted," Gottlieb said. "Flattening the peak means that the total time of the epidemic is longer, but the number of cases is more manageable. Social distancing efforts as of now have been ad hoc by state, and we need a more systematic approach."

It's imperative that the burden on the healthcare system is reduced, he said.

"Hospitals should put off elective procedures," he said. "And there's no reason for a hospital to be having a JCAHO audit right now."

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