President Donald Trump has made a truly cynical and potentially deadly calculation. Fearing political harm from a continuing economic downtown more than he fears causing unnecessary loss of lives from the COVID-19 pandemic, he is determined to push an early re-opening of businesses, stores, and institutions regardless of the risks.
He repeatedly has been advised by experts that the economy can be safely be re-started only when there are sufficient rapid-result test kits available to do much more widespread testing than is now being done. Such testing is needed so that the extent of the virus in the community is known and that people with COVID-19 can be identified and isolated. He also knows that there still are nowhere near enough test kits to do that.
Instead of accepting the obvious federal responsibility for the shortage of tests, however, he alternatively denies the shortage and seeks to thrust the responsibility for it onto the states. I.e., there is no shortage, but if there is a shortage it is the states’ fault. Two days ago, he tweeted this:
“Governors, get your states testing programs & apparatus perfected. Be ready, big things are happening. No excuses!”
Trump is fully aware that he is pressing for actions that will kill people. He believes, however, that by creating the false narrative that states are responsible for any failure to do sufficient testing he can blame the loss of life attributable to a premature relaxing of restrictions on the governors. Even for Trump zealots, this may prove to be one big lie too many.
The approval, manufacture, and distribution of a sufficient number of diagnostic test kits to bring the pandemic under control is and always has been a responsibility of the federal government.
Assuming an argument can be made about state and local responsibility for having sufficient numbers of ventilators, masks, and other ordinary medical supplies on hand to meet a national emergency (it can’t, by the way), there is no argument about the approval and production of sufficient diagnostic tests for a newly-discovered disease. It is a process controlled by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) and is unquestionably part of the necessary federal response to a pandemic that has been declared a national emergency.
Trump’s general dithering as the pandemic evolved has been well-documented by the New York Times, Washington Post and other news sources. The lack of urgency in the federal response was especially problematic when it came to the approval and production of test kits. It is worth reviewing how the the test kit problem began, because it illustrates just how outrageous it is for Trump to suggest that he is going to hand over to state governors a problem that his administration created and still has not solved.
A superb, detailed account of how the federal government fumbled the testing ball, and how we made mistakes that South Korea avoided, was published by Reuters on March 18th. It’s absolutely essential reading for anyone interested in understanding where we went wrong with the testing. I’ve summarized the highlights of the missteps below.
The CDC runs into a problem, and the delays begin.
Chinese authorities first detected an outbreak of a “novel,” or new type of, coronavirus in December 2019 in Wuhan province. On January 11, 2020, Chinese scientists posted the genome of the new virus on an open website.
Within a week, German virologists produced the first diagnostic test. It was approved by the World Health Organization (WHO) and by February 6th the WHO had shipped 250,000 diagnostic tests to 70 laboratories around the world. By the end of February more than 1.4 million tests had been sent to nearly 60 countries, not including the United States.
The CDC did not authorize the WHO test for use in the United States, following its standard practice of producing its own test for a new virus to ensure accuracy and reliability. Unfortunately, shortly after the CDC began distributing its own test kits on February 5th, local labs reported that the CDC tests were producing inconsistent results. It turned out that the test kits were faulty and had to be replaced. Valuable time was lost.
The FDA compounds the problem, and the delays continue.
The first confirmed case of COVID-19 in the United States was diagnosed in Washington State on January 20th. By February 24th, still lacking usable tests from the CDC, health officials in Washington and elsewhere grew desperate. The Association of Public Health Laboratories sent a letters to Dr. Stephen Hahn, the FDA commissioner, asking him to use his legal discretion to waive standard approval protocols and allow state and local public health laboratories to create their own tests for the virus. He initially declined to do so.
On February 29th, however, the FDA relented and announced a new policy to make it easier for hospital laboratories to develop their own tests. We now know that many public and private laboratories had been chomping at the bit since early January to develop tests.
Olfert Landt, head of the German lab that developed the first diagnostic test for COVID-19, believes that the United States waited too long before using private companies to develop the tests. He stated that the pandemic was too big and moving too fast for the CDC to develop its own test in time. “There are ten companies in the U.S. who could have developed the tests for them,” Landt said. “Commercial companies will run to an opportunity like this.”
South Korea has a regulatory system similar to ours. During the outbreak of another coronavirus in 2015, MERS, it had learned a deadly lesson about the need to get test kits in the hands of clinicians quickly. The lesson, of which American epidemiologists were aware, was that routine approval procedures were too slow to deal with a coronavirus. The South Koreans were determined not to repeat the mistake with COVID-19 that they made with MERS in 2015.
South Korea had its first diagnosed case of COVID-19 on the same day as the United States, January 20th. On January 27th, South Korean officials met with representatives of 20 medical companies at a train station, urging them to begin work on developing tests for COVID-19, promising quick regulatory approval.
A week after the meeting, South Korea’s CDC approved one company’s diagnostic test. An approval process that normally takes up to a year-and-a-half in South Korea took one week. Another company soon followed. By the end of February, South Korea had drive-through screening centers and the ability to test thousands of people daily.
South Korea used its ability to do quick and widespread testing, along with an extensive program of contact tracing, to identify and isolate those in the community infected with the virus. It’s ability to slow the spread of the virus through those measures dramatically decreased the incidence of and death toll from the disease and allowed officials to avoid severe restrictions on businesses and schools, softening the impact of the pandemic on the economy.
Why did we fail where South Korea succeeded?
South Korea acknowledged that its expedited approval of testing sacrificed accuracy for speed, but correctly believed the need for speed was paramount; using reasonably accurate tests was better than forcing public health officials to fly completely blind. As manufacturers developed more accurate tests, the early test kits were replaced with the more accurate ones.
The FDA eschewed South Korea’s approach, and erred on the side of caution. Alberto Gutierrez, who led the FDA’s office overseeing diagnostic testing from 2009 to 2017, explained that the agency proceeds with caution because it sees itself as the last line of defense against opportunistic companies looking to cash in on threats to public health, claiming that “the FDA had good intentions.”
“There is money to be made in an emergency, and a lot of people try to take advantage of that,” Gutierrez told Reuters. “The problem the FDA faces is, do you let it become the Wild West?”
Good intentions are one thing, the bigger picture in controlling a pandemic caused by a deadly and rapidly spreading virus is quite another, and it’s hard to believe that the Wild West was worse than what is going on now. In defending the FDA’s slow, cautious approach, Dr. Deborah Birx, the State Department official coordinating the White House COVID-19 task force, stated last month that a less reliable test can result in “false negatives,” meaning test results erroneously indicating that people with the disease do not have it.
That is true, but having no test means that far more people with the disease will go undiagnosed. Did the FDA simply let the perfect become the enemy of the good, somehow failing to recognize that time was of the essence and that waiting for the “perfect” test would cripple efforts to contain the pandemic? It seems doubtful; I believe that there is more to it than that.
Dr. Robert Redfield, head of the CDC, made clear that it was the FDA that called the shots on approval of testing by private labs. A lot of the blame for the slow roll out of test kits therefore fell on Dr. Stephen Hahn, Trump’s appointee who took over as commissioner of the FDA on December 17, 2019.
Dr. Joshua Sharfstein is a former principal deputy commissioner of the FDA as well as a former Secretary of the Maryland Department of Health. Although he agreed that the FDA should have moved more quickly to authorize public and private labs to develop and use their own tests, he did not put all of the blame on the FDA. “The FDA can design an approach to support the public health strategy, but someone has to tell FDA the public health goal,” he said.
Scharfstein also referred to the pandemic response team on the National Security Council under the leadership of Admiral Timothy Ziemer that Trump eliminated in 2018 when discussing how a lack of leadership from the White House may have affected the FDA:
“People talk about, like, why does it matter that they closed the White House office on pandemic preparedness? This is one reason.”
It is not clear that the absence of Ziemer and his team, competent and experienced as they were, would have made any difference. Since Scharfstein made his comments we have learned from the New York Times the extent to which Trump’s stubborn refusal to take the pandemic more seriously, despite the pleas of advisers and other experts, delayed the federal response.
Trump was heavily invested in his boast that the partial ban he placed on travel from China on January 31st had succeeded in preventing a serious outbreak of COVID-19 in the United States. On February 24th, the same day that the Association of Public Health Laboratories sent its frantic letter to Hahn urging him to green light approval of test kits because the window was closing on the opportunity to contain the outbreak of the virus in the United States, Trump tweeted the following:
“The Coronavirus is very much under control in the USA. We are in contact with everyone and all relevant countries. CDC & World Health have been working hard and very smart. Stock Market starting to look very good to me!”
The Trump administration received its first formal notification of the outbreak of the coronavirus in China on January 3rd and within days United States intelligence agencies were warning about the threat in the President’s Daily Brief. Seventy days later, on March 13th, Trump declared the pandemic a national emergency. The Washington Post described in detail how the intervening 70 days, which could have been used to ramp up the federal response, largely were squandered.
In summary, I find it hard to believe that it was nothing more than the failure of the FDA to recognize the urgency of the situation that caused it to move so slowly. We may not know until Trump leaves office, or at least until subpoenas are issued and testimony taken under oath, whether Trump had a personal hand in the FDA’s laggardly response to the pandemic, but the agency’s actions seem remarkably consistent with Trump’s own lackadaisical approach to the emergency.
We do know that Trump has never even acknowledged the need for widespread testing, for reasons at which we can only guess. And we also know that the delay in making tests widely available already has caused many deaths, and will cause many more.
Why is the distribution of test kits still lagging behind need?
Given the almost universal agreement among experts that society cannot safely be “re-opened” until testing is much more widely available, you might think that 1) there would be specific production goals for additional tests based on the number of tests needed to lift restrictions, and 2) a concrete plan for meeting those production goals, with a timeline.
If you think that, then you haven’t been watching Trump’s pandemic briefings. One of my many frustrations with those briefings is that reporters have not been pressing Trump on this issue.
Trump has consistently denied that there is a test kit shortage. That denial pretty much rules out Vice President Pence and his task force initiating a discussion on the extent of the shortage and how to address it, even though the shortage of test kits remains the biggest impediment to bringing the pandemic under control, short of a vaccine.
And it also means that there is a conspicuous absence on the stage during the pandemic briefings: Someone with knowledge of the scope of the test kit problem, and the expertise to know how to solve it. Drs. Fauci and Birx are experts on the control of the disease, not on the logistics of manufacturing and distributing test kits. The closest thing to a medical logistics expert that we’ve heard from so far is Jared Kushner. Need I say more.
I believe that one of the reasons that Trump is ducking this issue is that closer scrutiny will reveal another major mistake involving the failure to use the Defense Production Act. As noted above, Olfert Landt, head of the German lab that developed the first diagnostic test for COVID-19, believed that commercial American companies would have jumped at the opportunity to develop and manufacture tests if the FDA had authorized them to do so from the start.
We don’t know if that ultimately occurred, but even if it did, I believe that it would have been prudent for the federal government to step in via the Defense Production Act to do the procurement. That would have assured a specific level of production, stabilized the supply chain, eliminated price gouging, and enabled distribution of the tests where most needed.
Using the Defense Production Act may still prove to be necessary. We have received so little useful information on the test kit shortage that it is hard to know. I believe that we are being kept in the dark by design.
Is Trump serious about exercising powers that he doesn’t have?
Today Trump doubled down on his incorrect claim that he has the power to overrule state governors and lift restrictions on public gatherings, workplace closures, etc., tweeting:
“For the purpose of creating conflict and confusion, some in the Fake News Media are saying that it is the Governors decision to open up the states, not that of the President of the United States & the Federal Government. Let it be fully understood that this is incorrect…It is the decision of the President, and for many good reasons.”
I doubt that even his slimy Attorney General, William Barr, has told him that this is true. The president has no such power under our federalist system.
Trump wants it to appear as if he is the one trying to save the economy, but without accepting responsibility for the consequences of reopening schools, stores, and businesses too early. If governors push back on reopening, he will accuse them of promoting an economic downturn to hurt him at the polls. If they do reopen, and it turns out that they did so too soon, he will blame them for being unprepared with their “testing programs.”
I may be wrong, but I believe this time Trump is being too clever by half. His mistakes and the mistakes of his administration are too well-documented to bullshit his way out the mess he has made of the federal pandemic response. People are dying, and that tends to make us finally sit up and pay attention.