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.

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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.

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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 CDC’s inability to respond quickly to a pandemic like Covid-19 shouldn’t come as a surprise. It was ill-prepared to develop and distribute laboratory tests, not only to state laboratories — which the CDC had done previously, albeit for rare and infrequent diseases — but also to commercial laboratories, a completely different and uncharted task.

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.

Despite these and many other challenges, numerous CDC scientists, young and old, seasoned and newly hired, have responded to the Covid-19 call. Hundreds of civil servants, Commissioned Corps officers, and contactors are staffing 24/7 the CDC’s Emergency Operations Center or are deployed in the field. The center’s coronavirus laboratory is working long hours to keep up with testing samples, reporting results, and fielding requests from everybody.

Starting this week, all “nonessential” CDC staff and those not already involved in the response were asked to prepare for an extended period of telework. This also covers a large number of laboratory personnel, most of whom can’t do the daily bench work from home. The potential impact of this on the CDC and the CDC Covid-19 response could be tremendous.

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.

One might argue that all CDC staff are essential staff. Although many of them could or would prefer to work from home for personal reasons, laboratorians should be in the lab. Most want to help fight this pandemic, from running the current coronavirus assays to developing and testing new ones, testing virus inactivation methods, evaluating much-needed safety protocols, and adding their expertise in outbreaks and laboratory work to the response.

In a rapidly changing situation like Covid-19, scientific questions arise frequently, and only synergy between researchers will keep up with the demands.

Peace time rules and regulations are not well-adapted to an actual “war” situation, which is how many see Covid-19. These rules and regulations must be adapted by leaders who understand the reality of rapidly evolving outbreaks and the need to act expediently.

With its considerable laboratory resources, the CDC should be able to test thousands of samples every day. Confirmation from CDC labs lets clinicians and health institutions better manage the situation, instead of being forced to remain in the dark. Early detection of infection in a patient will expedite correct management, diminish the risk of transmission, allow enrollment in therapeutic clinical trials, and increase chances of survival.

This CDC surge laboratory capacity could be reduced later on when hospital and commercial laboratories will be able to take up the slack in diagnostic testing.

In these difficult times, many CDC workers are looking for leaders such as Walter Dowdle, a CDC scientist and key visionary leader. He pledged to the American people that CDC will base all of its public health decision on the highest quality scientific data, openly and objectively derived, and to place the benefits of society above the benefits of the institution.

We need — today not tomorrow — the emergence of many more such leaders within the CDC.

Pierre E. Rollin, M.D., worked for the CDC for 27 years, retiring in 2019 as epidemiology team lead of the Viral Special Pathogens branch.

  • I do not pretend to know anything about this subject or how to fix the Wuhan epidemic (I am not trying to be snide but it came from Wuhan, and it started there for a reason, the live wildlife markets, and we generally called emerging diseases by the place they were first found in the past. But mostly because the wildlife markets are a hazard the Chinese government allowed to exist long after the SARS outbreak proved how dangerous they are )

    I am not defending any particular political philosophy but it seems like this is an example of the extreme power of the FDA causing a huge failure.

    We hear all the time about the FDA banning some medicine, even on an experimental basis, which apparently reputable scientists and doctors believe can help patients who are so far gone the risks are not really relevant. Years ago I had a guy tell me his horse died, while there was an experimental treatment which might have worked but he could not get it, in the US, because of the FDA. A HORSE.

    I am shocked to hear the FDA was actually blocking the CDC in the CDC’s own lab work – one would not have thought that was even legally possible.

    It seems to me the legal basis for the FDA control is weak to begin with – Remdesivir was developed, and I guess is still being made, by a company in California – it could be used in California, on California residents, without having any effect on any other state – so why should the FDA have any power at all to prevent that under our Constitution? They seem to be far too powerful – and i know there is plenty of quackery and it’s harmful – but my attitude is, I can mostly avoid the quacks by doing research – and I do not have to become an opiod addict-it is kind of simple, just do not take too many opioids – so let me have my medicines and treatments.

    In general, I believe you want more than one entity involved in dealing with a big problem – if, for example, California – larger and richer than many countries – probably better able to deal with the epidemic than Spain or Italy in many ways- more biotech is here is my guess – had it’s own CDC – which could not be prevented from taking action by FDA blocking it – it could test it’s own drugs and vaccines as it wished on volunteers – my guess is that would have helped a great deal in this.

    I know flaky wishful thinking like “I think this (drug combo only supported by a tiny number of anecdotal reports) is going to be a game changer” is not going to help, but the extremely conservative “We are going to need 18 months for a vaccine” is insane in a war. What the US did in WW2 is put out probably thousands of contracts for new devices – new fighters, bombers, ships, torpedoes, etcetera – within a few months – sometimes days – and let the contractors go at it. And they got some defective machines which killed a lot of people before they were rejected or improved – but they also got better stuff within a fairly short period of time – I know CDC and FDA are not sitting on their hands but they seem to not be willing to take the “risks” which are not really risks at all considering what is going to happen if we do not come up with the stuff we need sooner rather than later.

  • The CDC failed because it failed to identify the real problem. The problem was not to create the perfect test….it was to create a good-enough test that was scalable, cost-efficient, and fast. Having too many false-positives was not a problem….it simply would mean too many people would be quarantined. Having a complicated test that could only be run by CDC (too their standards), which took days to complete, and which could only process a few thousand cases was the problem.

  • Is this due in part to the Washington administration not including the CDC in their team?

    • No. The centralization of testing into the CDC in the event of pandemics was done in the Obama Administration, not by Trump. It was a power grab by the FDA/CDC. In the early part of the Wuhan Flu epidemic they were actually directing the FBI to shut down independent tests developed by virologists in the State of Washington —and they did. Unfortunately the CDC compounded their hubris by rolling out a faulty time consuming test leaving the US far behind other countries in testing capabilities.

      So yes, you can blame “the administration”. But which one?

  • Thank you Pierre. We could easily triple the number of laboratorians and laboratories working on this outbreak.

  • Is the problem because the CDC is a highly conflicted organization where shareholder values are the driving force behind everything these days? 30% of CDC funding comes from private industry but something is clearly amiss here and the focus has narrowed to the sectors with greatest profit potential. These certainly aren’t Lyme and tick-borne diseases, neglected tropical diseases, new antibiotics, new vaccines etc. The effort now seems to be in profitable treatment business models rather than cures or prevention.

    The CDC is acting like a quasi government. Decisions are mede by a powerful few behind closed doors with no transparency. Medicine is a self-regulating profession which s fine as long as they are being altruistic. It’s time to consider some level of civilian oversight. The CDC gave Lyme disease and all procedures around it to the private 11,000 member IDSA society who have rejected all science that doesn’t agree with dogma.

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