Covid-19: Why Health Emergencies Are Too Important To Be Left To Government Agencies

I wrote this on March 6th, 2020 - back when I thought more testing was what was needed! Haha! Good times! I guess it’s good to be reminded that I don’t always see the whole picture. Anyway, the larger point here is still very true, and I think critically important going forward:

(Originally published on ThinkSpot, March 6, 2020)

We often hear that a centralized state is needed for situations like what we may (or may not) be facing now: An outbreak of a serious disease that is very contagious and could affect thousands or even millions of people across a nation or even the globe. The argument goes something like this: A fast, coordinated, response is needed in emergencies like this, the private sector is ill-equipped to muster such a response on short notice in response to a crisis, so we need to call in the state, and give it whatever power it asks for. 

As is so often the case in response to such arguments, it is precisely the opposite that is true. The CDC's response to Covid-19 provides a good illustration of this. 

As ProPublica reports:

"The CDC designed a flawed test for COVID-19, then took weeks to figure out a fix so state and local labs could use it. New York still doesn’t trust the test’s accuracy"

Because the CDC and the FDA control who may create and distribute tests, independent labs were prevented from producing tests to fill the void created by CDC incompetence:

"There are other ways to expand the country’s testing capacity. Beyond the CDC and state labs, hospitals are also able to develop their own tests for diseases like COVID-19 and internally validate their effectiveness, with some oversight from the federal Centers for Medicare and Medicaid Services. But because the CDC declared the virus a public health emergency, it triggered a set of federal rules that raises the bar for all tests, including those devised by local hospitals.

"So now, hospitals must validate their tests with the FDA — even if they copied the CDC protocol exactly. Hospital lab directors say the FDA validation process is onerous and is wasting precious time when they could be testing in their local communities"

To clarify: Because Covid-19 was declared to be a public health emergency, more restrictive rules were put in place making creating tests even more difficult.

This has led to a real shortage of needed testing kits, and as a consequence, wildly inaccurate estimates of the number of people who have been infected in the US.

According to ProPublica:

"Doctors at the University of California, Davis Medical Center, where (a patient who may have been the first known to have been infected inside of the US) is being treated, said testing was delayed for nearly a week because the patient didn’t fit restrictive federal criteria, which limits tests only to symptomatic patients who recently traveled to China"

And individuals have posted accounts online of having severe symptoms, seeking testing for Covid-19, and being turned away because they don't meet the stringent criteria. 

So, because of the CDC's inability to produce a sufficient quantity of functioning tests, and because it and the FDA forcibly prevent others from doing so, we now cannot have even a decent estimate of the number of cases in the US, and therefore can have no ideawhat the case-fatality rateis. It is not unusual to underestimate the number of infected people in a new outbreak, but the CDC's centralized control of testing has made this problem much worse.

Last Saturday, according to ProPublica, the FDA "announced an 'accelerated policy … to achieve more rapid testing capacity in the United States...'" Academic hospital labs will now have more freedom to use their own diagnostics. However it is unclear as to whether these labs will be able to distribute their tests to others. Back in early February, UC San Francisco's Dr. Charles Chiu, and the biotech company Mamoth Biosciences, were working on a CRISPR-based test–but were stalled by CDC roadblocks.

From The Mercury News:

"For the San Francisco team, the next step is to demonstrate that CRISPR diagnostic kit is effective in living coronavirus-infected cells. They’re waiting to acquire cells from the CDC or state. Thus far, they’ve only been able to study the virus by analyzing the genetic code published by Chinese scientists. Research, thus far, has been conducted in synthetic cells designed in the lab.

"Competitive tests are also in development by other companies, such as the Cambridge-based biotech company Sherlock Biosciences. It uses CRISPR-based technology developed by Feng Zhang and his colleagues at the Broad Institute of MIT and Harvard."Currently all potential coronavirus specimens are sent to U.S. CDC labs in Atlanta.

"The government’s test uses a large, expensive and sophisticated tool called Reverse Transcriptase PCR (RT-PCR), which measures the amount of viral RNA, a chain of cells that carry genetic information, in a patient’s sputum, serum or blood."It takes time to ship a patient’s sample to Atlanta, then process it and release results. To help expedite detection, the government is improving and standardizing its test and plans to release it to a limited number of state health departments. But still that test will take time.

 "That’s one reason why news about suspected cases has been slow to confirm"

Another group–the Seattle Flu Study (an initiative by the Brotman Baty Institute for Precision Medicine) –was able to develop their own test for Covid-19, but the only reason they were able to get around the govt. prohibition on non-state entities working to solve this problem is that they did it under the guise of "research." Their test uncovered one of the first cases of community transmission in Washington State.

From StatNews:

"Frustrated by the lack of testing resulting from the problem with the CDC-developed kit, the Seattle Flu Study began using an in-house developed test to look for Covid-19 in samples from people who had flu-like symptoms but who had tested negative for flu. That work — permissible because it was research — uncovered the Snohomish County teenager"

Whatever the severity of COVID-19 turns out to be (without accurate infection numbers, we can't possibly know), it is abundantly clear that centralized government power cannot be part of any sensible response to it. The CDC's stranglehold on testing has only served to stifle efforts to get more and better tests out to the people who need them, and to prevent us from finding out vital information about this virus in a timely way. The best thing the CDC and FDA could do now would be to get out of the way.