"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.
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."
https://reason.com/2020/03/11/how-g...ting-and-made-the-coronavirus-epidemic-worse/
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.
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."
https://reason.com/2020/03/11/how-g...ting-and-made-the-coronavirus-epidemic-worse/
