Red Tape Stymied Testing and Made the Coronavirus Pandemic Worse.

Author:Bailey, Ronald

THE UNITED STATES is home to the most innovative biotech companies and university research laboratories in the world. That should have provided us with a huge advantage with respect to detecting and monitoring emerging cases of COVID-19 caused by the coronavirus pandemic. Public health officials had the opportunity to slow, if not contain, the outbreak: By tracing the contacts of diagnosed people and quarantining those who in turn tested positive, they could have severed the person-to-person chains of disease transmission.

South Korea demonstrates that such a campaign can work. While both countries detected their first cases of COVID-19 on January 20, the trajectories in the U.S. and South Korea have since sharply diverged. By the beginning of March, South Korea had "flattened the curve"--that is, substantially reduced the number of people being diagnosed each day with coronavirus infections--whereas the United States was still struggling to do so when this article went to press six weeks later.

South Korean health officials met on January 27 with private biomedical companies, urging them to develop coronavirus diagnostic tests and assuring them of speedy regulatory approval. The first commercial test was approved in that country a week later. South Korea's now-famous drive-through testing sites were soon testing tens of thousands for the virus. By the first week in March, the country had tested more than 150,000 people, compared to just 2,150 in the United States. Testing and contact tracing helped daily diagnosed cases in South Korea peak at 909 on February 29.

In stark contrast, officials at the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) stymied private and academic development of diag nostic tests. Much to the contrary, the CDC required that public health officials use only a diagnostic test designed by the agency. That test--released on February 5--turned out to be contaminated by a reagent that made it impossible for outside labs to tell if the virus was present in a sample or not. The CDC's insistence on top-down centralized testing meant there were no available alternatives, which greatly slowed down disease detection just as the infection rate was accelerating.

This massive bureaucratic failure is a big part of why a larger proportion of Americans than of South Koreans will...

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