The United States is home to the most innovative biotech companies and university research laboratories in the world. That fact should have given our country a huge advantage with respect to detecting and monitoring emerging cases of COVID-19 caused by the new coronavirus outbreak.
Instead, as The New York Times reports in a terrific new article, officials at the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) stymied private and academic development of diagnostic tests that might have provided an early warning and a head start on controlling the epidemic that is now spreading across the country.
As the Times reports, Seattle infectious disease expert Dr. Helen Chu had, by January, collected a huge number of nasal swabs from local residents who were experiencing symptoms as part of a research project on flu. She proposed, to federal and state officials, testing those samples for coronavirus infections. As the Times reports, the CDC told Chu and her team that they could not test the samples unless their laboratory test was approved by the FDA. The FDA refused to approve Chu's test on the grounds that her lab, according to the Times, "was not certified as a clinical laboratory under regulations established by the Centers for Medicare & Medicaid Services, a process that could take months."
In the meantime, the CDC required that public health officials could only use the diagnostic test designed by the agency. That test released on February 5 turned out to be badly flawed. The CDC's insistence on a top-down centralized testing regime greatly slowed down the process of disease detection as the infection rate was accelerating.
A frustrated Chu and her colleagues began testing on February 25 without government approval. They almost immediately detected a coronavirus infection in a local teenager with no recent travel history. Chu warned local public health officials of her lab's finding and the teenager's school was closed as a precaution. The teen's diagnosis strongly suggested that the disease had been circulating throughout the western part of Washington for weeks. We now know that that is likely true.
Did the FDA and CDC functionaries commend Chu for being proactive? Not at all. Washington state epidemiologist Scott Lindquist recalled, "What they said on that phone call very clearly was cease and desist to Helen Chu. Stop testing." On February 29, the FDA finally agreed to unleash America's vibrant biotech companies and academic labs by allowing them to develop and deploy new tests for the coronavirus that causes COVID-19.
The Times notes:
The Seattle Flu Study illustrates how existing regulations and red tape—sometimes designed to protect privacy and health—have impeded the rapid rollout of testing nationally, while other countries ramped up much earlier and faster. Faced with a public health emergency on a scale potentially not seen in a century, the United States has not responded nimbly.
Due to red tape, the coronavirus outbreak in the U.S. will be worse than it should have been.