The public health challenge of our generation is right in front of us. SARS-CoV-2 appears to be the Andromeda strain that public health workers fear to see emerging. After many years of working at the Centers for Disease Control and Prevention, I’m perplexed, and saddened, that the agency seems to be sitting on the sidelines for this pandemic and is not building on the accumulated skills and experience from its past.
Nobody dismisses the worsening crisis or its ability to deal a potentially deadly blow to health systems and economies around the world. Health care providers throughout the U.S., emulating those in other countries, are improvising protective equipment. Bandanas are the new N95 face masks. Clinicians and other providers wait days or weeks to get the results of nasal swabs collected at great risk from patients suspected to have Covid-19. From nurseries to universities, from small businesses to large corporations, nearly everybody is, or likely will soon be, quarantined, locked down, and rightfully scared.
For decades, the CDC has been at the forefront of responding quickly to new and emerging disease threats. During previous outbreaks, teams of responders have been quickly deployed in the U.S., at the request of one or more states, as well as in remote and sometimes socially unstable places at the request of foreign governments. The mission of these teams is to guide and support local, national and international public health response efforts.
In the spring of 1993, an unknown disease was detected in the Four Corners region of Colorado, Utah, Arizona, and New Mexico. A CDC team was dispatched to the area. In just a few weeks, CDC scientists had not only identified and described a new hantavirus, but they also created a diagnostic test for laboratories. By the end of 1993, patients were found in multiple states and tens of thousands of blood samples had been run in one of CDC’s laboratories.
During the 2014-2016 Ebola outbreak, the CDC enlisted thousands of responders from the U.S. and various affected African countries, and staffed a laboratory first in Kenema, and then in Bo, Sierra Leone that conducted more than 16,000 Ebola tests under difficult local conditions.
Over the decades, CDC workers developed many new diagnostic assays during emergencies to respond promptly to new or orphan diseases.
Annual funding cycles and conflicting priorities have challenged the CDC’s ability to maintain expertise and replenish human resources. New layers of bureaucracy, created in the late 2000s, fostered increased top-down regulation, slowing or blocking initiative and innovation. Productivity declined as research and clinical laboratories were saddled with strict and complicated Clinical Laboratory Improvement Amendments (CLIA) rules and an insistence on FDA-approved tests — even for tests developed and run only in CDC reference laboratories.
Each year supervisors must take mandatory leadership training courses regardless of their demonstrated skills and experience. Instead of mentoring younger generations at the bench, laboratory managers and leaders spend much of their time in the office to working on time-consuming lab-related paperwork and seeking clearer explanations of new regulations….
The use of other diagnostic assays for SARS-CoV-2, including one recommended by the World Health Organization, were blocked in the U.S. by the Food and Drug Administration, pending the Emergency Use Authorization. The belated recognition by the Department of Health and Human Services and the U.S. government of the gravity of the Covid-19 outbreak resulted in new requests and rules for the Atlanta-based CDC. The inevitable politicization of the response added further challenges. The CDC is, after all, a governmental agency….
Inexplicably, offers by CDC laboratorians to volunteer for the Covid-19 response and support the coronavirus laboratory with added manpower were refused by CDC administrators, who seem incapable of understanding the dire situation occurring outside the organization’s gates, hiding behind cumbersome regulations developed for peacetime settings…