The Trump administration figures who’ve led the federal government’s coronavirus response have escaped the wrath — and even the questions — of Congress.
Until now. On Tuesday, Anthony Fauci, Robert Redfield, Stephen Hahn, and Brett Giroir are set to testify before the Senate’s main health committee. They’ll come face to face (or Zoom-to-face) with lawmakers who’ve been outspoken in their criticisms of the Trump administration’s coronavirus response, including Sens. Elizabeth Warren (D-Mass.), Bernie Sanders (I-Vt.), and Patty Murray (D-Wash.).
It’s the first major, in-person congressional hearing on the issue in months. And it’s the first time that members of the Trump administration’s coronavirus task force have been summoned before the members of Congress who, at least theoretically, are supposed to be conducting oversight over the White House’s response to a pandemic that has killed nearly 80,000 Americans to date.
It will not be your conventional congressional hearing, with some masked senators sitting 6 feet apart and others joining by video from their home states. Over the weekend, the Trump administration also announced that its witnesses would testify remotely after being exposed to White House staff who tested positive for Covid-19. Senators, instead, will turn to video chat to grill the four high-ranking officials: Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases; Robert Redfield, the director of the Centers for Disease Control and Prevention; Stephen Hahn, the commissioner of the Food and Drug Administration; and Brett Giroir, the assistant health secretary whom the Trump administration has appointed its de facto “testing czar.”
The breadth of that slate will give lawmakers the chance to press for answers about some of the most controversial aspects of the Trump administration’s response: testing shortages, emergency drug approvals, drug access, and the widespread mixed messaging about social distancing and reopening policies.
One missing voice, however, will be the administration’s top health care official: Alex Azar, who the president replaced as task force chair in February, and who has been criticized recently for, among other issues, the controversial reassignment of Rick Bright, a high-ranking official helping to oversee vaccine development.
If we had the opportunity, here’s what STAT reporters would ask the assembled guests on Tuesday.
What are the three biggest mistakes the United States has made in its response to date and what have you done to fix them?
An epic fail in the development and approval of tests to identify people infected with Covid-19 meant the country was blind to how soon person-to-person transmission started in the United States, how quickly it progressed, and how far it spread. The CDC has been roasted for its faulty test; the FDA’s role in this fiasco seems not to have earned it the same level of opprobrium.
But having been too slow to issue Emergency Use Authorizations to commercial tests when the CDC’s failed, the FDA appeared to reverse course entirely when antibody tests became available, allowing manufacturers to push out unauthorized tests without EUAs. Many, in the words of former CDC Director Tom Frieden, are junk.
Are those the big mistakes? Or is it the silencing of the CDC, which in other pandemics and disease outbreaks has been a trusted source of science-based advice? Was it moving to ease movement restrictions before epidemic curves have flattened? Before operations to test suspected cases and trace their contacts were in place? Before plans were drawn up to outline what the signals would be for resuming social distancing, if cases start to soar again?
— Helen Branswell
In the pandemic preparedness planning you have done throughout your careers, did it ever occur to you that the country that would be the hardest hit by a pandemic would be the United States?
The numbers are stark and they are embarrassing. The population of the United States makes up only 4.25% of the global population, but this country has the most Covid-19 cases and deaths by a large measure.
Nearly one-third — 32% — of all confirmed cases and 28% of all reported deaths have occurred in the United States.
Former CDC Director William “Bill” Foege said this about the U.S. response last week: “We’re all immersed in this country right now in a remedial course in humility. Why would anyone come to us for advice on how to handle this virus? It would make no sense.”
— Helen Branswell
In the past week, we’ve seen chaos and confusion as the federal government, Gilead Sciences, and the pharmaceutical wholesaler AmerisourceBergen have attempted to distribute remdesivir, the drug that’s showing promise as a Covid-19 treatment, to hospitals around the country. How did the federal government decide which hospitals would receive remdesivir, and why has that process become so incomprehensible?
STAT reported last week that roughly two dozen hospitals received remdesivir, though there appeared to be little rhyme or reason to how they were selected. The drug, which is seen as among the most promising therapeutics that could be used to treat Covid-19, recently received an Emergency Use Authorization from the Food and Drug Administration, and many coronavirus patients — and the physicians treating them — have scrambled for access.
On Friday, President Trump reportedly empowered Deborah Birx, the White House’s coronavirus response coordinator, to oversee remdesivir distribution — but it remains largely unclear what transpired in the 48 hours prior, when doctors and hospitals around the country said publicly that they couldn’t figure out how to get their hands on the medicine.
— Lev Facher
If the relaxation of social distancing measures and the reopening of businesses leads to an upsurge in transmission, what is the plan for dealing with it? How likely is it that areas would have to go back into some form of shutdown?
Going into lockdown a second (or third) time is going to be a lot harder than it was the first time. People for whom this pandemic has been financially ruinous are not going to easily agree to sacrifice again if it looks like another shutdown is needed as the country waits for vaccines to become available.
The public isn’t being prepared for this possibility. There appears to be no national plan, no agreement about what would trigger a return to social distancing, school closures (if they have reopened), a new ban on in-restaurant dining.
What is the plan? Is there a plan?
— Helen Branswell
What led the Trump administration to select the University of Washington’s IHME model as a tool in guiding its Covid-19 response? Did reliance on that model, which has been widely criticized, help or hurt?
Throughout its coronavirus response, the Trump administration has publicly cited projections from the University of Washington’s Institute for Health Metrics and Evaluation — even as epidemiologists have warned the model’s not well-suited for the task.
The White House’s initial projection that between 100,000 and 240,000 Americans would die from Covid-19 was based in part on IHME numbers, and President Trump’s late-April agitation to begin a return to normalcy came as the projection showed as few as 60,000 Americans would die — a milestone that, tragically, we’ve long since blown past.
The model currently projects that Covid-19 will claim 134,000 American lives by August. That number, of course, has ticked higher as numerous states have rushed to reopen their economies, moves that public health experts project will result in increased rates of infection and, therefore, more death.
— Lev Facher
Advice to the public on how to protect themselves has been contradictory — there have been mixed messages, for example, on issues as simple as whether Americans should wear masks. How can people trust what they hear from officials?
Public health officials, especially at the top levels of government, have sometimes offered conflicting messages about proper social distancing protocol.
It was only in early April, for example, that the CDC and the White House suggested that even asymptomatic people should wear masks in public — and even then, the U.S. recommendations were at odds with the WHO, which recommends that only sick people and their caretakers wear masks. The U.S. recommendations, moreover, aren’t mandatory. Even when he announced the White House recommendation, Trump said, “This is voluntary. I don’t think I’m going to be doing it.” And during a visit to the Mayo Clinic in Minnesota last month, Vice President Mike Pence was photographed visiting recovered Covid-19 patients without a mask.
Different states and even different cities have further conflicting policies about mask usage. Massachusetts, for instance, now has a statewide policy urging masks or face coverings in public, but California residents are subject to such a policy based on the city or county they live in.
The mixed messages raise serious questions about who is in charge and which advice Americans should follow, especially as states begin to reopen their economies and, potentially, as people consider traveling from one jurisdiction to another.
— Shraddha Chakradhar
Already, there are credible projections that suggest a second wave of the coronavirus pandemic could be worse than the first. Are you ignoring those projections?
Winter is coming, and with it a likely resurgence of Covid-19 that could mirror what we are living through now or something even more monstrous. Before the kind of herd immunity we need against the coronavirus takes hold — something above 50% of the population as opposed to the estimated 5% we have now — a return to normal seems to make more dismal projections more likely.
Without a vaccine or treatments beyond remdesivir, much less adequate testing to contain current infections, the second wave seems like something to anticipate, not minimize. What plans do you have to prepare?
— Elizabeth Cooney
Questions for the NIH’s Fauci
Why is the White House encouraging states to lift restrictions when they haven’t met the White House’s own guidance for reopening? Why did the White House, as reported by the Associated Press, shelve a CDC report that outlined how and when to safely reopen? What are you saying to the president about that?
More than half of states are starting to lift the stay-at-home policies they imposed to try to get control of viral spread in their communities. But new daily cases have plateaued at a level that experts say makes it likely that transmission could explode once more if lockdown restrictions are eased. Epidemiologists say overall cases need to be brought down to levels that authorities can track and manage before we reopen more businesses and restaurants.
Last month, the White House indicated it held a similar view. Its recommendations for when a state could lift shelter-in-place rules included such milestones as a decrease in cases for 14 days and getting below a certain rate of positive tests among everyone who was tested. Many states that are tiptoeing into reopening have not hit these benchmarks. The administration said decisions about reopening ultimately lie with states, but why is White House cheering the lifting of restrictions? What will happen should cases take off again?
— Andrew Joseph
How much of the full remdesivir trial data have you seen? How soon do you expect the data to be released? Why shouldn’t we be concerned there are disappointments when the NIAID data is finally released?
Right now, we have only preliminary results from a press release from the company behind the drug, Gilead, and no further way to understand who may not be helped by remdesivir or why.
Data are important. Complete clinical trial results are needed so that doctors and other researchers can truly understand the extent to which a drug really works, how it helps patients and how it doesn’t help patients. Perhaps a drug helps certain groups of patients more than other patients, so what might the data say about that? And then there are potential side effect issues.
Instead, we have what is known as top-line findings, but nothing that really answers these questions. This means doctors in the trenches lack complete understanding of what they are giving patients and what to expect. Moreover, the results were released the same day that a study in the Lancet found the drug doesn’t help. This needs to be reconciled. It creates a confusing picture.
There are members of the White House’s coronavirus task force who understand these concerns. Beyond the need to urgently get treatments to patients during a pandemic, we still need to know what we are dealing with when medicines are rushed out the door. The administration failed to address these concerns by not releasing more data or guaranteeing the data is released within a certain period of time.
— Ed Silverman
Questions for the CDC’s Redfield
You’ve been forced to the sidelines during the task force briefings and the agency you lead has been sidelined for the past two months in terms of communicating to the public. What can you do to restore the public leadership role that Americans have come to expect from the CDC?
As we said last month, the CDC has been largely invisible in this outbreak. And the visibility it has had — see botched test rollout above — has scarred the agency’s reputation in the eyes of the public.
Without a strong CDC playing a central role in conveying fact-based information to the public — information that is not strained through a political filter — Americans will be at greater risk as this virus continues to move through communities. What are you doing to restore the CDC to its central role?
— Helen Branswell
Questions for the FDA’s Hahn
The president has boasted about his ability to direct the FDA’s actions. How can we trust the FDA to be an impartial regulator?
During the coronavirus pandemic, Trump has made no bones about telling the head of the FDA what he thinks is good public health policy. On March 29, for example, Trump took to Twitter to push the FDA to issue a regulatory authorization for a mask decontamination system from the company Battelle. And on March 19, he tried to declare, via fiat from the White House briefing room podium, that the unproven Covid-19 treatment, hydroxychloroquine, was now FDA-approved. There have been reports, too, of Trump’s inner circle pushing the FDA to dole out special treatment to other unproven Covid-19 treatments.
FDA Commissioner Stephen Hahn has publicly insisted there has been no political pressure on the FDA from the White House. But he’s appeared willing to take the president’s orders to heart. Battelle was issued an emergency authorization within hours of Trump’s tweet, and hydroxychloroquine did eventually secure a limited FDA approval.
A president putting pressure on the FDA isn’t an altogether new phenomena. In fact, FDA commissioners dating back to the 1980s have publicly pushed for the FDA to be made an independent agency to avoid exactly this scenario. But with a president so willing to publicly exert pressure, and an FDA commissioner so unwilling to call that behavior out as unacceptable, how can the public depend on the FDA to put science over politics?
— Nicholas Florko
Why is there still an EUA for hydroxychloroquine?
The FDA’s March 28 decision to issue an Emergency Use Authorization for hydroxychloroquine was controversial, since the evidence supporting use of the drug was notoriously scant and these authorizations are only supposed to be doled out to drugs where it is “reasonable to believe” a product “may be effective” and “the known and potential benefits outweigh the known and potential risks.”
The FDA has said that it was staring down a multimillion-dose donation of the drug and issued an EUA to allow the government to accept the donation and put it in the national stockpile. “Given the circumstances, I would say we did the best we could,” FDA drug center chief Janet Woodcock told STAT.
But since issuing that EUA, the situation has rapidly changed. Several studies have since cast doubt on the drug’s effectiveness. Just last week, an observational study of more than 1,000 patients published in the New England Journal of Medicine found that hydroxychloroquine was no better at preventing intubation and death than the existing standard of care. Another observational, retrospective analysis conducted by the Department of Veterans Affairs and academic researchers even found that the drug was associated with higher mortality rates.
The FDA took an extraordinary step in April and warned patients against using the drug because it may cause “serious heart rhythm problems.”
The treatment outlook is also wildly different than it was just a few weeks ago when FDA issued this authorization. Namely, the FDA has since issued an EUA for Gilead’s remdesivir, which is widely considered to be the best treatment option so far for patients dying of Covid-19.
So, if the FDA knows hydroxychloroquine can have some potentially deadly side effects, evidence is mounting it isn’t effective to treat Covid-19, and there’s another drug available, why does the drug still have FDA’s stamp of approval?
— Nicholas Florko
Why can’t the FDA strike the balance on regulating tests?
In the early days of the pandemic, as the CDC ran into problems distributing its in-house diagnostic test to other labs, the FDA wouldn’t allow academic labs and private companies to roll out their own diagnostic tests. The delays and limits with testing handcuffed the U.S. response, leaving federal and local public health officials unable to follow the virus as it spread through the country. It falsely painted a rosy picture that the country did not have much transmission. And it created a testing hole that only now is being filled in. The FDA eventually shifted its stance and allowed tests beyond the CDC’s to be used.
Then came a problem from the other end of the regulatory spectrum, this time with antibody tests — blood tests that are used to identify people who had previously contracted the virus, even if they were never diagnosed during the active infection. The FDA allowed manufacturers to start selling their tests without first showing they performed up to accuracy thresholds (no test is perfect). This led to a flood of unreliable tests on the market and confused consumers. This month, the FDA changed that policy as well, requiring manufacturers to submit accuracy data.
So in one case, the FDA was too restrictive, and in the other, it was too lax. Why did that happen and how will you strike a better balance going forward?
— Andrew Joseph
Questions for HHS’ Giroir
President Trump said last week that testing is “overrated,” but outside experts across the political spectrum have said there still aren’t enough tests to safely reopen schools and businesses. Does the president believe testing is the key to reopening the economy, and if so, why is he pushing for states without sufficient testing capacity to reopen?
Here are two views of the testing picture, both gloomy.
In late April, a state-by-state analysis by Harvard researchers and STAT found that 31 states and the District of Columbia were doing too little testing to identify most infected people in a timely manner. Ten states would need to increase their daily testing totals by at least 10,000 to get there. That includes the hard-hit New York, which would have to perform more than 100,000 more tests a day.
An early May analysis by the Associated Press gauged how well states were doing compared to a benchmark mentioned at a recent White House briefing for how many tests, swabs, and other materials states would get: enough to test 2.6% of their populations. Using the slightly lower measure of 2% later confirmed by HHS, fewer than half of states are testing at that level. Many states already moving to reopen, including Colorado, South Carolina, and Texas, have failed to test 2% of their residents.
How can states reopen before testing hits even the lower mark?
— Elizabeth Cooney