Coronavirus testing requires 'wartime effort' from federal leadership, former FDA commissioner says

At multiple White House briefings, President Trump has touted the number of coronavirus tests being performed in the United States, repeatedly making the false claim that the U.S. has performed more tests per capita than any other country. And while the total number of tests being performed on a daily basis has increased, reaching over 2.5 million completed tests by April 10 according to the COVID Tracking Project, that number is far less than the White House had promised in early March — and far fewer than the number needed to safely lift lockdowns across the U.S., according to experts.

“It’s not necessary, but it would be a good thing to have,” Trump said at a press conference on April 9 when asked about having a nationwide testing system. “Do you need it? No. Is it a nice thing to do? Yes. We’re talking about 325 million people, and that’s not going to happen, as you can imagine.”

But many disagree — including Dr. David Kessler, the former commissioner of the Food and Drug Administration and author of Fast Carbs, Slow Carbs: The Simple Truth about Food, Weight, and Disease.

“We underestimated the virus at the beginning. We underestimated the extent of the virus. We can’t underestimate the extent of the testing we need,” Kessler told Yahoo News. He is a member of the team advising presumptive Democratic presidential nominee Joe Biden on the coronavirus pandemic. But Kessler, who has served as FDA commissioner in both Republican and Democratic administrations, insists that this is not a partisan issue.

“The answer is — in the absence of a vaccine and a therapeutic — testing, testing, testing. It’s our only tool against this virus,” Kessler said.

Kessler argues that the level of mobilization of efforts to produce and distribute more tests needs to be on par with a wartime effort, and that one person needs to be responsible for orchestrating that effort — though Kessler says he has yet to see that role adequately filled.

“Right now, we need one person who reports directly to the president who can ensure that all resources — from that swab, that specimen kit, to that big machine sitting somewhere in a laboratory somewhere in the United States — that that entire spectrum of what’s necessary can be mustered with an efficiency that you need to basically scale up in a wartime effort,” Kessler said. “There are a lot of well-intentioned people trying to do pieces of this puzzle, pieces of this effort. But no one really understands, regrettably, what it takes from beginning to end, who is leading this effort, this real expertise.”

“The administration will say they have Admiral Giroir. He’s doing that. But he’s not commandeered the resources as in a wartime effort,” Kessler continued. “When I see all the large laboratory machines running 24/7, where we’re getting all the specimens collected and have enough swabs, then we’re going to be able to open up this country.”

WASHINGTON, DC - APRIL 06: (2nd L-R) U.S. Vice President Mike Pence, President Donald Trump, Assistant Secretary for Health Admiral Brett Giroir and Dr. Deborah Birx, coronavirus response coordinator, speak to reporters following a meeting of his coronavirus task force in the Brady Press Briefing Room at the White House on April 06, 2020 in Washington, DC. (Photo by Chip Somodevilla/Getty Images)
WASHINGTON, DC - APRIL 06: (2nd L-R) U.S. Vice President Mike Pence, President Donald Trump, Assistant Secretary for Health Admiral Brett Giroir and Dr. Deborah Birx, coronavirus response coordinator, speak to reporters following a meeting of his coronavirus task force in the Brady Press Briefing Room at the White House on April 06, 2020 in Washington, DC. (Photo by Chip Somodevilla/Getty Images)

Adm. Brett P. Giroir, a medical doctor and assistant secretary for health at the U.S. Department of Health and Human Services, is a member of Trump’s coronavirus task force and was appointed “testing czar” on March 12, which put him in charge of coordinating testing efforts among public health service agencies. His area of responsibility encompasses the complete set of diagnostic testing activities, including the customer and patient experience, specimen collection, logistics, testing, result return and supply chain.

“A key priority is to ensure that patients, doctors and hospitals can access tests seamlessly and with maximum ease, and Dr. Giroir will lead efforts to execute on that goal,” HHS Secretary Alex Azar said in a statement.

“I have a lot of respect for Admiral Giroir,” Kessler added. “And I think they are trying. But at this point, there has to be a plan to reopen this country, and that requires putting into place the specifics of how we’re going to get literally millions of tests done a week. That’s not been solved. They have increased the testing. I applaud that. But they’re off so far by an order of magnitude. They have to scale up the efforts. And they’re going to have to take a more assertive role faster, bringing to bear the kind of resources, these big machines, running them 24/7, pushing these companies to do what they’ve never done before but they’re willing to do.”

A report released by the U.S. Department of Health and Human Services Office of Inspector General, which surveyed 323 hospitals across 46 states, the District of Columbia and Puerto Rico from March 23 to 27, found that hospitals reported severe shortages of testing supplies and extended waits for test results. Hospitals said that they were unable to keep up with COVID-19 testing demands because they lacked complete kits or the individual components and supplies needed to complete tests.

“I don’t know the inspector general, I don’t know that person,” Giroir said at a White House briefing on April 6 when asked about the report. “I tell you one thing I have a problem with. If there was such a problem that she knew about or he knew about on March 23rd and 24th, why did I find out about the test from them on the news media at 8 o’clock this morning? If there was a problem, I think you’re ethically obliged to tell me where that is so we can interact with it like I do every single day. But that’s a discussion for the future. I think testing is really in a good position right now.”

Earlier that same day, Giroir was asked on the “Today” show about the report and why the U.S. has been lagging behind other countries in testing.

“We are really going hospital to hospital to try to assure that the tests are available and I’m meeting with hospital associations from all the metroplex areas and there’s no question that testing is tight. But there are enough tests out there for people who need the test to get the test,” Giroir said.

Widespread testing is considered by public health experts to be a crucial precursor to lifting lockdowns. By determining which individuals are infected and need to self-isolate, those who are tested and found to be uninfected can return to everyday public activities without forcing the entire population to stay home.

“We’re going to need, obviously, to test anyone who’s symptomatic. But that alone is not going to be enough. We’re going to need very strong surveillance testing in this country,” Kessler said.

Currently, testing is being prioritized for those exhibiting symptoms, with hospitals reporting confusing guidance on who qualifies for testing that varies by state. But the need for more testing is underlined by the number of asymptomatic cases. At a press conference on April 5, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, estimated that between 25 percent and 50 percent of all coronavirus carriers exhibit no symptoms and may be unwittingly spreading the disease. But Fauci conceded that there is no way to know for certain how many “silent carriers” exist until widespread testing is performed.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, attends a Coronavirus Task Force news conference at the White House in Washington, D.C., U.S., on Friday, April 10, 2020. President Donald Trump said he'll introduce on Tuesday a council of doctors and business people who will advise his government on how to reopen the economy following the coronavirus outbreak. Photographer: Kevin Dietsch/UPI/Bloomberg
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, attends a Coronavirus Task Force news conference at the White House in Washington, D.C., U.S., on Friday, April 10, 2020. President Donald Trump said he'll introduce on Tuesday a council of doctors and business people who will advise his government on how to reopen the economy following the coronavirus outbreak. Photographer: Kevin Dietsch/UPI/Bloomberg

“I don’t have any scientific data to say that,” Fauci said. “You know when we’ll get the scientific data? When we get those antibody tests out there and we really know what the penetrance is. Then we can answer the questions in a scientifically sound way.”

Fauci has also said that a different kind of test, for the presence of antibodies in the blood, signifying a previous exposure to the virus, is an important step towards being able to lift lockdowns. People who test positive for antibodies are presumed to be protected from re-infection with the virus, although questions remain about the degree and persistence of that immunity.

“As we look forward, as we get to the point of at least considering opening up the country as it were, it’s very important to appreciate and to understand how much that virus has penetrated this society," Fauci told CNN on April 10. “Because it’s very likely that there are a large number of people out there that have been infected, have been asymptomatic and did not know they were infected."

Fauci says antibody tests could be available “within a week or so.”

There are approved tests for the presence of active infection, although the U.S. got off to a slow start and the promise by President Trump on March 6 that “anybody who wants a test gets a test” isn’t close to being fulfilled. A test introduced by Abbott in late March is able to deliver positive or negative results within minutes, and can be performed in a doctor’s office or emergency room without waiting for tests to be sent out to a lab.

But deploying tests has been delayed by a lack of testing supplies, like the swabs needed to collect testing samples. The HHS inspector general report found that many hospitals said they were competing with other providers for limited supplies. National coordination could help ease that problem.

“The new Abbott test is terrific, but it’s not going to be available in enough quantity to test the millions and millions of people that are going to be surveyed to make sure we can open up this country,” Kessler told Yahoo News. “I am sure that Abbott is ready to put an additional assembly line, it wants to make as many machines as it can. But that machine has certain limitations. The parts are custom designed. They come from all around the world.”

Medical workers test patients at a drive-through Covid-19 testing center at Bergen New Bridge Medical Center in Paramus, New Jersey, U.S., on Friday, April 10, 2020. Photographer: Michael Nagle/Bloomberg
Medical workers test patients at a drive-through Covid-19 testing center at Bergen New Bridge Medical Center in Paramus, New Jersey, U.S., on Friday, April 10, 2020. Photographer: Michael Nagle/Bloomberg

Drive-through testing centers have also been touted by the White House, but they exist on only a limited scale. This is partially a consequence of the shortage of personal protective equipment for health care workers who administer those tests, with hospitals reluctant to send their employees into a test line unprotected. Now, with the creation of swab testing that can be self-administered, the risk for health care workers at these locations is lower.

Kessler says the testing availability will be important even as the U.S. eases back into normal life.

“We’re going to be playing whack-a-mole for some time,” Kessler said. “But the real question is, can we act quick enough before those little outbreaks become a major epidemic?”

“We can’t make the same mistake twice.”

This is what testing for COVID-19 is like.

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