3/13/20
The COVID-19 outbreak has been a confusing time for Americans, but one thing has been glaringly clear: The U.S. is way behind when it comes to testing people for the coronavirus. Despite the fact that last week, Vice President Mike Pence promised that “roughly 1.5 million tests” would soon be available, an ongoing Atlantic investigation can confirm that only 13,953 tests have been conducted nationally. By comparison, South Korea, which has one of the largest outbreaks outside China, is testing nearly 20,000 people per day. Testing is essential for identifying people who have been infected and for understanding the true scope of the outbreak. But when the initial test from the Centers for Disease Control and Prevention was rolled out to state public-health laboratories in early February, one of its components was discovered to be faulty. Since then, academic, clinical, and other laboratories have struggled to get or make new tests and diagnose patients. Interviews with laboratory directors and public-health experts reveal a Fyre-Festival-like cascade of problems that have led to a dearth of tests at a time when America desperately needs them. What happened?
• The Food and Drug Administration has a protocol called emergency use authorization, or EUA, through which it clears tests from labs around the country for use in an outbreak. Former FDA officials I spoke with said that during past outbreaks, EUAs could be granted in just a couple of days. But this time, the requirements for getting an EUA were so complicated that it would have taken weeks to receive one. Clinical labs were not allowed to begin testing at all before they had received the EUA, even if they had already internally made sure their tests worked.
• Labs and companies need samples of the virus itself in order to make their tests, but delays in getting access to samples further slowed down the test-development process. The coronavirus originated in China, and as several microbiologists told me, the Chinese government does not allow specimens to be shipped outside its borders.
• The U.S. health-care system is broken up into state and county public-health laboratories, which have different equipment than academic research institutions, which have different equipment than hospitals that diagnose patients. So the same test won’t necessarily work in different places. We don’t have a nationalized health-care system where you put the same equipment in all the hospitals. We have all these independent hospital systems with their own equipment in their own labs.
• For months, President Trump has made light of the coronavirus, telling attendees at a Black History Month reception, for instance, that perhaps the virus could miraculously disappear. He claimed on Twitter that the U.S. has done a “great job” handling the outbreak. Such a cavalier attitude seems unlikely to have motivated health officials to take things seriously. There’s reportedly been tension and infighting between the president and his HHS secretary, Alex Azar, as well as between the FDA and the CDC. Vice President Mike Pence, who has no background in public health, repeatedly sidelined Azar from the coronavirus-response task force, and the White House appears to be blaming Azar for any failures in its coronavirus response. There was a huge amount of infighting about who could or who should lead this, and there was a sense that a lot of people [inside HHS] weren’t considering it a major threat.
