WASHINGTON - White House trade adviser Peter Navarro is leading a Trump administration effort to demand the Food and Drug Administration reverse course and grant a second emergency authorization for the antimalarial drug hydroxychloroquine to treat covid-19, the disease caused by the coronavirus.
Navarro, armed with a controversial new study that he says shows the drug's effectiveness, is being cheered on by President Donald Trump, who has long touted the drug as a "game changer" and even used himself as a possible preventive measure. Trump praised the study on Twitter earlier this week, urging the FDA to "Act Now." The campaign also has been promoted by Rudolph W. Giuliani, the president's lawyer, and Laura Ingraham's show on Fox News.
But Navarro, an economist known more for his aggressive approach to trade issues and China policy than for his medical credentials, faces serious challenges as he denounces what he calls "media-induced hydroxy hysteria." Scientists have widely criticized the new study, by Detroit's Henry Ford Health System, as flawed. In addition, just weeks ago the FDA revoked its emergency authorization for hydroxychloroquine after major studies found the medication wasn't effective for covid-19. And the unexpected revival of a politically fraught issue comes as FDA Commissioner Stephen Hahn tries to shake off criticism he sometimes seems overly deferential to Trump.
"A reversal [on hydroxychloroquine] would be widely seen as bending to the political will of the White House and the hit to Dr. Hahn's credibility would be profound," said Steven Joffe, a medical ethicist at the University of Pennsylvania.
The FDA's response to this pressure will be closely watched, not only because the White House has already been criticized for pushing to influence the CDC's guidelines for the pandemic, but also because the agency will take the lead in approving a vaccine for the coronavirus, a decision that could potentially affect millions. Health experts say it is important for the agency, which was criticized for its initial decision to okay hydroxychloroquine in March, to guard its credibility as it prepares to make these landmark decisions for a public sometimes skeptical of vaccines.
The tug-of-war on hydroxychloroquine also is seen by many as a test for the FDA's Hahn. While sympathetic about his difficult position, some health experts say he appears too willing at times to placate Trump. Just last Sunday, Hahn declined repeated opportunities on two different television shows to dispute Trump's statement that 99 percent of covid-19cases are harmless. On CNN, he said he didn't want to "get into who is right and who is wrong."
Hahn did not want to get into a distracting debate about the president's statement, according to an administration official who spoke on the condition of anonymity to discuss internal deliberations.
Navarro says his goal is simple: At a time when the virus is surging in many parts of the country, there are 60 million millions of doses of hydroxychloroquine in the Strategic National Stockpile that can't be distributed unless the FDA issues an emergency authorization. He asserted the Henry Ford study shows the drug works when used as an early treatment and said the FDA should take action "within days, not weeks or months" so he could send the shipments.
Trump has told aides that he sees the Detroit study as "vindication" of his position and wants the drug sent to hospitals across the country, in the words of another senior administration official who spoke on the condition of anonymity to discuss internal deliberations.A number of Trump political aides, along with the Republican National Committee and campaign officials, have also promoted the Detroit study.
Navarro said if the Detroit data is backed up by subsequent studies, "there is blood on the media's hands" for sowing doubts about the drug.
Navarro has loudly clashed with medical experts, including Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, over hydroxychloroquine and has become obsessed with promoting the drug, advisers say. While he is viewed by many colleagues as bombastic, sometimes uninformed and temperamental, he has maintained a close adviser spot in Trump's game-of-thrones White House by embracing and promoting issues like hydroxychloroquine and tariffs.
The FDA initially gave emergency use authorization to hydroxychloroquine in March based on scant evidence. The agency in April issued a safety warning about potential cardiac problems before withdrawing its approval last month.
The Henry Ford study, which involved more than 2,400 patients hospitalized between March and May, found death rates were 50 percent lower among the patients treated with hydroxychloroquine, the authors said. They also noted the drug posed no safety problems.
Henry Ford officials said the results were different from other studies that didn't show effects from the drug because they treated patients soon after they were hospitalized and used different dosages. They said they asked the FDA for emergency authorization for hydroxychloroquine "for a clearly defined list of clinical uses," including trials. The health system declined to make the authors available and the FDA said it would not comment on any pending submission.
"The FDA needs to very carefully and quickly consider the Detroit request - China virus cases are rising, Americans are dying, and hydroxychloroquine appears to be a very effective weapon when used in early treatment with virtually no downside risk," Navarro said. He said he had talked to someone at the FDA about the issue but declined to identify the person.
But the Henry Ford study has been sharply criticized by scientists who said it shouldn't be used to change policy. It was an observational study, considered much less rigorous than a randomized trial, in which patients are randomly assigned to receive a treatment or not. And its results fly in the face of three major randomized trials that have found hydroxycloroquine is not effective in treating or preventing covid-19.
Critics also noted that twice as many of the Henry Ford patients who received hydroxychloroquine also got a steroid - which has been shown to benefit covid-19 patients - compared to those who didn't get hydroxychloroquine. That made it hard to know which drug benefited the patients, they said. The authors made statistical adjustments to account for that, but other scientists said the methodology wasn't clear and that it is very hard to correct studies in that way.
"You want to look at the totality of the data," said Eric Topol, director of the Scripps Research Translational Institute. "The totality is overwhelmingly in the opposite direction. You have to conclude with the Henry Ford study is an outlier and there's some kind of confounder that is skewing the data and not representing the truth."
Doctors can still prescribe the drug for covid-19 because it is approved for other illnesses. But Navarro said that the FDA's safety warning and withdrawal of the emergency authorization had effectively killed demand. "In my discussions with the FDA, they seemed unaware of the massive depressive effect their decisions have had on use of the medicine," he said.
Peter McCullough, an internist at Baylor University Medical Center, said he agreed with Navarro that the FDA should change its position. "This is the public health crisis of the century and doctors should not have barriers,"he said, noting that some state medical boards are making it hard for doctors to prescribe the drug.
In recent interviews, Giuliani, the president's lawyer, said the studies discounting hydroxychloroquine are bogus. "They've thrown cold water on it because they are academics," he said, adding he has taken the drug three times without side effects.
Test results so far have been "silly," he said, adding that a police officer friend and others in New York have succeeded after taking it. "They don't know what they're talking about," he said of doctors warning against it.,
Hahn, who declined to be interviewed for this story, has said repeatedly that the FDA makes its decisions based on science and data and that he has never felt political pressure to take any specific action. He has said the agency will continue to make decisions based on those factors, not political ones.
Any decision about reauthorizing hydroxychloroquine will be made by FDA career scientists, said an administration official who spoke on the condition of anonymity to discuss internal processes.
Many scientists said they doubted the FDA would move to reauthorize hydroxychloroquine based on the Detroit study, considering the price the agency might pay in credibility.
"When future coronavirus vaccines come up for FDA approval, the public should have full confidence that the FDA will make the correct decision to protect the public health by ensuring that vaccines are safe and effective," said David Boulware, an infectious-disease specialist at the University of Minnesota Medical School who conducted one of the major clinical trials on hydroxychloroquine.
Peter Lurie, a former top FDA official during the Obama administration, agreed it was unlikely hydroxychloroquine would be reauthorized. "That would be an about face of an about face," he said. Referring to the Washington suburb where the agency is located, he added, "White Oak will be suffering from dizziness if that keeps happening."
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The Washington Post's Ariana Eunjung Cha contributed to this story.
They raced to shut down their economies in March, and many opened them just as quickly in May.
Now, governors across the country are facing growing pressure from public health experts and local leaders to reimpose stay-at-home orders as the only way to regain control of coronavirus outbreaks that threaten to overwhelm hospitals and send the death count spiraling.
The push appeared to receive a boost from Anthony Fauci, the nation's top infectious-disease official, who suggested in comments released late Wednesday that struggling states "should seriously look at shutting down."
He took a more measured approach on Thursday, emphasizing that stay-at-home orders should remain a last resort and suggesting a pause in reopening plans instead.
So far, that has been the preferred method for governors seeking to arrest climbing caseloads while not alienating a virus-weary public. Yet, with scant evidence of progress in states across the Sun Belt - and beyond - experts are increasingly concluding that more drastic measures are necessary.
"Stay-at-home is a blunt instrument," said Farshad Fani Marvasti, director of public health at Arizona State University. "But when you're leading the world in new cases and things don't seem to be getting better, you may have to use that blunt instrument."
Studies have found that orders that closed nonessential businesses and forbid nonessential travel or gatherings prevented millions of coronavirus cases nationwide when they were imposed this spring. Researchers have also found such orders could have saved tens of thousands of lives had they been implemented earlier.
But with the economy reeling from a prolonged shutdown, and President Donald Trump agitating for a quick reopening, governors across the country lifted restrictions in May. That was despite the fact that most had not met the White House's own criteria for determining when it was safe to ease up.
Now, with caseloads hitting new peaks, the process for some states has been thrown in reverse.
Nationwide, more than a dozen states have paused their reopenings this summer as case numbers have climbed. Another half-dozen have rolled back previously announced reopenings. Several have reimposed bans on bars, which have been particularly hospitable spots for the virus to circulate.
Yet the majority of states have pressed ahead with reopenings.
As case numbers in the U.S. surge, that has unnerved public health experts who see a disaster in the making.
Fauci told the Wall Street Journal in a podcast released Wednesday that some states "went too fast" with their reopenings and suggested that the solution may be to go back to square one.
"I think any state that is having a serious problem, that state should seriously look at shutting down," he said in remarks that appeared to contradict Trump's push for the country's reopening to continue.
During an appearance Thursday, Fauci dialed back his remarks, saying that a "complete shutdown" would be "obviously an extreme."
"I would hope we don't have to resort to shutdown," he said at an event hosted by the Hill newspaper. "I think it would not be viewed very, very favorably, even by the states and the cities involved. So rather than think in terms of reverting back down to a complete shutdown, I would think we need to get the states pausing in their opening process."
But other public health specialists insist a pause is not enough, and that the U.S. won't be able to reopen to the extent that many other countries have until it learns how to do so safely.
"We see the hurricane coming. In some places, it's already here," said Thomas Tsai, a Harvard health policy researcher and surgeon. "The question is whether you're going to evacuate your citizens from the path."
The evidence so far, Tsai said, suggests not.
"We're watching this unfold and we're frozen," he said.
At the Harvard Global Health Institute, with which Tsai is affiliated, researchers recently put together a national tracker to assess the severity of the outbreak in all 50 states.
As of Thursday, 15 of them were in a state of "accelerated spread," meaning that stay-at-home orders should at least be considered, along with aggressive testing and tracing programs.
Another five - Arizona, Florida, Louisiana, South Carolina and Georgia - were flashing red. In those states, the outbreaks are so advanced that researchers say stay-at-home is no longer optional. It should be mandatory.
In all five, however, governors have waved off suggestions that people should be again told to stay at home, citing the economic costs of keeping people out of work.
In Arizona, cumulative deaths topped 2,000 on Thursday and daily hospitalizations hit another high. Gov. Doug Ducey, a Republican, has urged people to stay home when possible, and he has reinstated closures of bars, water parks, movie theaters and gyms.
But so far, that hasn't been sufficient. The case counts continue to rise in a way that public health experts say is reminiscent of the exponential growth that the world's worst-hit places experienced earlier this year, before stay-at-home orders kicked in.
"We don't want to become another New York, another Italy," said Marvasti. "But that's where we're headed. We need to learn our lesson from these places."
Steve Adler, the mayor of Austin, has come to the same conclusion. In Texas's capital city, cases have been surging and hospitals have been filling up.
This week, new coronavirus admissions surpassed an average of 70 per day - the low end of the trigger that health authorities had set for shutting down nonessential businesses, ending indoor restaurant dining and banning gatherings outside the home.
The situation, Adler said, is "precarious in terms of our ability to meet the intensive care surge that we could be facing."
A slowed growth rate has bought the city more time to consider whether a shutdown is truly necessary. But Adler said it remained an option he would need to consider.
"I have to do everything I can to protect the city," he said.
Authorities in Houston and Dallas have also asked for the authority to shut down, citing the pressure on hospitals and concern that there may not be enough medical staff to treat the sick.
Standing in their way, however, is Texas Gov. Greg Abbott, a Republican, who has maintained that he alone has the authority to issue stay-at-home orders. And he has been a steadfast opponent, despite record caseloads - more than 10,000 new cases of the virus were reported Tuesday.
"To shut things down completely back into lockdown mode, that would really force Texans into poverty," Abbott said this week.
A return to stay-at-home orders could have severe political consequences. Although surveys showed strong support for such measures in the spring, a second round would inevitably spawn a backlash.
"People are tired of this and they're tired of the same message and they're tired of this disease," said Karen Landers, assistant state health officer in Alabama. "The weather looks nice and it's, 'Why should I be worried about sickness?' "
Alabama is one of at least five states that hit a single-day high of new cases Thursday. Nationally, the seven-day average was 52,820, up more than 7,100 cases from the same time last week, according to data tracked by The Post.
Many governors, Abbott included, have argued that targeted measures will be more effective than a blanket shutdown.
In Missouri, which reopened rapidly in early May, case numbers have risen sharply since mid-June. At least some of that increase has stemmed from increased testing. But there have also been significant outbreaks, including at meat processing plants in the state's southwest - with cases extending into the broader community.
But state health director Randall Williams said that rather than focus on shutdowns, the state's attention has been on "boxing in" hot spots with aggressive testing and isolation for those infected. He said promotion of social distancing, hand washing and mask wearing would also help to stem the spread.
In southwest Missouri, a conservative area where resistance to masks has run high, many have cited the president's example in refusing to wear one. But attitudes may be shifting as the peril posed by covid-19 hits home: The city council in Joplin, the region's hub, rejected a mandatory mask ordinance last week, only to reverse course Wednesday night and approve one.
Michigan health director Robert Gordon said his office, too, was focused on changing behavior and getting the public to follow medical advice.
"Part of it is what are the rules on the books. Equally important is what are people doing, whatever those rules are," Gordon said.
Gov. Gretchen Whitmer, a Democrat, who authorized some of the strictest stay-at-home rules nationwide before lifting them in June, has signaled that she won't be afraid to reimpose restrictions. Last week, she halted the state's reopening, and ordered bars to again be shuttered for indoor service.
Gordon said the difficulty in bringing down case numbers will only increase, with schools seeking to reopen next month and the weather forcing more people indoors in the fall.
A return to stay-at-home, he said, was the last resort. But it wasn't unimaginable, either.
"Our job is to do absolutely everything in our power," he said, "so we don't have to go back to that."
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The Washington Post's John Wagner, Joshua Partlow, Kim Bellware and Jacqueline Dupree contributed to this report.