Bottom line: It is normal for the US government to develop its own disease testing under CDC. Experts in CDC are typically very good at it. But in the case of coronavirus, the US government developed a flawed test, creating lengthy delays in testing and in parallel left obstacles in place that would have shortened the delay. Meanwhile, U.S. government officials have repeatedly misled the public and policy makers. In total, more than 8 weeks were lost due to policy failure. This post explains and documents this remarkable policy failure.
At the fourth press conference of the White House Coronavirus Task Force on March 17, the president was asked the following:
Q: Could you just respond to something, Mr. President, before you leave, on what Jon was saying? You’ve — you’ve called for people to leave politics out of this. Joe Biden said, “The World Health Organization offered testing kits that they had available to the United States and to give it to us now. We refused it. We didn’t want to buy them.” PolitiFact says the WHO never made that offer. Can you tell us what actually happened?
The first response came from the President who spoke about a range of things, but then passed on responsibility for response to others. Dr. Deborah Birx was first:
Yeah, so I tried to cover this in the answer when I talked about quality of kits. And our quality analysis runs through the FDA. So all of these platforms, we have asked people to submit. And we’ve asked states to quality control. So, I mean, the — anybody could submit their test to us. We don’t buy tests that haven’t been quality controlled and they show us the data. Either show us the data upfront or show us the data after they’ve been running them.
Because quality testing for our American people is paramount to us. It doesn’t help to put out a test where 50 percent or 47 percent are false positives. Imagine what that would mean to the American people. Imagine their level of concern now in telling people that they’re false positive.
We take the same approach to HIV. Imagine telling someone they were positive to HIV and they weren’t. So that is our bottom line: the customer, the American people first. And so any of these groups can submit their testing kits through our regulatory processes, but without that and without a plan, we are not going to accept tests that have not been studied by us.
This response was both evasive and misleading.
- It is true that the US typically requires approval of such tests through the FDA. But that is misleading. The so-called “WHO test” was actually developed in Germany, and submitted to the WHO on January 17th (PDF), less than one week after the Chinese government had posted the genome of the virus.
- Neither the WHO nor Germany would have submitted that test to U.S. authorities for approval, in any case. According to New York Times interviews with CDC and WHO: “For countries that are unable to make the tests or buy them from other countries, the W.H.O. asks academic or government laboratories to make tests. It then delivers them to poor and middle-income countries at low or no cost, paying for them out of emergency funds or loans from institutions like the World Bank.” (Note: This also means that Biden’s claim was incorrect.)
- The US has ample capability to develop its own tests and wouldn’t need to rely on other countries. According to a WHO spokesperson: “To our knowledge, no discussions occurred between WHO and CDC (or other USG agencies) about WHO providing COVID-19 tests to the US. This is consistent with experience since the US does not ordinarily rely on WHO for reagents or diagnostic tests because of sufficient domestic capacity.”
Admiral Brett Giroir, Assistant Secretary for Health and head of the Public Health Service and official responsible for testing, played along with the silly charade: “When I became involved in the testing world, I called as senior officials at the WHO as I could find to understand what the situation was. And as far as I can tell from sources that should know, no one ever offered a test that we refused.” Of course, not. That is not how it works and it is safe to say the Admiral knows that.
To quickly return to Birx — her discussion of tests needing to be submitted to FDA is irrelevant — that is not how things work. Her second point, suggesting that a test — presumably by context referring to the tests used by the WHO — is 50% or 47% false positive is incredibly misleading. She later backtracked on this claim, when asked by the New York Times: “Late on Tuesday night, Dr. Birx confirmed that although she was responding to a question about the W.H.O. test, she was referring to a study of an early diagnostic test used in China.”
In fact, that study of a test developed in China that Birx was referring to was actually retracted in the days following. The larger point however is that Birx was discussing a test that was not being used by the WHO, and not relevant at all to the question she was responding to — highly misleading.
Here is how the discussion of the tests by the White House Task Force was summarized by the president (following the comments Goroir saying “no one ever offered us a test that we refused”):
THE PRESIDENT: That’s what I heard too.
ADMIRAL GIROIR: This was a — this is a research-grade test, right? Research-grade test that was never submit- —
SECRETARY AZAR: It was not approved.
ADMIRAL GIROIR: Not approved, not submitted to the FDA, that was supplied in tens of thousands of quantities to 100 countries in the world, okay?
So I think there’s a lot that people are saying about this that’s just based on rumor and myth. Nothing was offered that we refused. It was a research test that was not approved. And again, there was a small number that we have greatly surpassed in a very short period of time.
THE PRESIDENT: So, number one, nothing was offered. Number two, it was a bad test. Otherwise, it was wonderful.
A shocking degree of misinformation and spin.
What actually happened is that the initial U.S. test, developed by CDC encountered problems in its manufacture. This was explained by FDA Commissioner Stephen Hahn on March 7:
[I]n the U.S., the CDC is typically the first developer of a diagnostics for an emergency because they have access to clinical specimens and viral samples before other developers. They work to make this material available for other developers to use in validation of their tests. The CDC test can and often does become the basis for tests that other developers create. The CDC test is an incredibly important tool during a public health emergency response.
In this case, once the CDC had access to clinical specimens, and similar to past emergencies, the FDA immediately began working with our public health partners at the CDC to support the development of the CDC diagnostic test, including working with the CDC through their emergency use authorization process.
There were manufacturing problems with the CDC test. While those issues have been resolved, at the time, this created complications for expanding access for public health laboratories and other developers who might use the CDC test as the basis for development of their own test.
The initial CDC test was published on January 24, just over a week after the German researchers had published their version. This test was initially limited to use only at CDC labs. By February 6, CDC began sharing the tests with state laboratories.
Then, on February 12, in a press briefing with Dr. Nancy Messonnier, CDC announced that some states had identified that were problems with the CDC tests (emphasis added):
Now I’d also like to update you on our diagnostic test kits. As you know, this is a dynamic, rapidly evolving situation, and our response continues to be based on the latest science. We continue to be flexible to meet the public health challenges that the virus presents, and clearly a success is the CDC rapid development of a diagnostic and rapid deployments to the states, which was clearly important to try to bring the testing closer to patients to avoid delays that have been inherent in sending samples to CDC. When the state receives these test kits, their procedure is to do quality control themselves in their own laboratories. Again, that is part of the normal procedures, but in doing it, some of the states identified some inconclusive laboratory results. We are working closely with them to correct the issues and as we’ve said all along, speed is important, but equally or more important in this situation is making sure that the laboratory results are correct. During a response like this, we know things may not always go as smoothly as we would like. We have multiple levels of quality control to detect issues just like this one. We’re looking into all of these issues to understand what went wrong, and to prevent these same things from happening in the future.
With the CDC test delayed by another two weeks, on February 28, the FDA announced “a policy regarding laboratories using tests they develop and validate before FDA has issued an Emergency Use Authorization (EUA) for their test in order to achieve more rapid testing capacity in the United States” (PDF).
The CDC test submitted to the WHO (here in PDF) carries a date of March 15 which 57 days — 8 weeks — after the coronavirus test from Germany was submitted to the WHO. Meantime, the delay in the CDC coronavirus test meant that the US needed to quickly allow the creation of a mishmash of tests across the nation.
The New York Times concluded, correctly: “Public health officials are warning that no one knows how deeply the virus will spread, in part because the federal government’s flawed rollout of tests three weeks ago has snowballed into an embarrassing fiasco of national proportions.”