WASHINGTON — The Food and Drug Administration’s abrupt decision this week to revoke an emergency waiver for two malaria drugs promoted by President Trump as potential “game changers” against the coronavirus has left 66 million doses stranded in the federal stockpile — and officials do not yet know what they will do with them.
The F.D.A.’s withdrawal on Monday of its “emergency use authorization” for chloroquine and hydroxychloroquine did not go over well at the White House, where top aides to Mr. Trump had rushed in March to fill the federal stockpile. That included accepting a donation from the pharmaceutical giant Bayer of three million tablets from a factory in Pakistan that had not been certified by the F.D.A. as safe.
“This is a Deep State blindside by bureaucrats who hate the administration they work for more than they’re concerned about saving American lives,” Peter Navarro, Mr. Trump’s trade adviser, who helped distribute 19 million hydroxychloroquine pills, fumed in an interview Monday night.
Medical experts across the country — including those who are researching hydroxychloroquine — on Tuesday applauded the F.D.A.’s withdrawal of the waiver after it concluded the drugs’ potential benefits did not outweigh their risks.
An F.D.A. spokesman said the White House and Health and Human Services Secretary Alex M. Azar II were made aware of the decision before it was announced. But Mr. Navarro’s anger seemed to capture the futility of the administration’s headlong efforts to yield to the president’s wishes and rush the two drugs into use, yet another example of how politics and science have collided in Mr. Trump’s Washington.
Besides Mr. Navarro, the internal debate over the malaria drugs included a well-known cast of characters: Mr. Trump, who took hydroxychloroquine for two weeks and insisted on Monday that it “certainly didn’t hurt me”; Dr. Anthony S. Fauci, the government’s top infectious disease expert; Rick Bright, who said he was ousted from his position as head of a federal research agency after complaining that Bayer’s chloroquine was not safe; and various Fox News personalities.
“They had a flimsy basis for the E.U.A. in the first place,” Dr. Peter Lurie, the president of the Center for Science in the Public Interest, said, using the abbreviation for emergency use authorization. “It’s quite clear they were strong-armed into it by Navarro himself and others — not excluding radio, television talk show hosts, the president’s pals and some doctor in New York. And now they’ve got mud on their faces because they’ve belatedly come to their senses and done the right thing.”
In the end, none of the chloroquine was ever distributed from the stockpile; doctors preferred hydroxychloroquine, which is newer and has fewer side effects, they say. But its prospects as a treatment for Covid-19 also look dim.
As of Monday, the government has distributed 31 million tablets of hydroxychloroquine to state and local health departments, hospitals and research institutions; 63 million tablets remain, according to Carol Danko, a spokeswoman for the Department of Health and Human Services. Officials are working with the companies that donated the drugs to “determine the available options” for the products.
Dr. Bright, writing on Twitter on Monday night, offered his own idea: “The drugs should never have been brought into our country and should be destroyed. It took far too long for HHS to revoke this EUA.”
The frantic effort that led to the F.D.A.’s emergency waiver began in mid-March, just days after Mr. Trump declared the coronavirus pandemic a national emergency, according to emails from Dr. Bright’s whistle-blower complaint, some not previously made public, as well as interviews with people involved.
Patients lay dying on gurneys in hospital corridors in New York, governors pleaded with the federal government to send masks and other supplies, and physicians had no treatments. A French doctor, Didier Raoult, stoked interest in hydroxychloroquine with a video promoting it for Covid-19. A cryptocurrency investor, James Todaro, and a New York lawyer, Gregory Rigano, wrote a paper about the drugs, which took off on Twitter, prompting the Fox News host Laura Ingraham to invite Mr. Rigano to appear on her show.
In New York, Dr. Vladimir Zelenko, a self-described “simple country doctor,” was giving coronavirus patients a three-drug cocktail that included hydroxychloroquine — and claiming that all had survived without need for hospitalization. (A federal prosecutor recently opened an investigation into Dr. Zelenko’s claims.)
With the Republican right, including Ms. Ingraham, Sean Hannity, Tucker Carlson and other Fox News personalities promoting hydroxychloroquine, Mr. Trump chimed in. By March 17, Bayer had offered the White House three million doses of chloroquine, which was discovered in the 1930s and is derived from the bark of the quinine tree.
Some versions of chloroquine are approved in the United States. Bayer’s was not. Top officials at Dr. Bright’s former agency, known as the Biomedical Advanced Research and Development Authority, or BARDA, were not enthusiastic about the donation; “in vitro,” or test tube, studies were not promising, they said.
“Not a lot of enthusiasm based on just vitro data,” Robert Johnson, an agency official, wrote in an email to a top aide to Dr. Robert Kadlec, the assistant secretary of health for preparedness and response. “Chloroquine has been shown to have in vitro effects on other microbes, but that has not panned out to clinical benefit.”
Dr. Kadlec and his aides, however, were insistent, the emails show. They wanted the chloroquine donation distributed widely as part of a clinical trial that would be sponsored by BARDA, with the National Institutes of Health providing the ethics panel, known as an “institutional review board,” overseeing the trial. At the same time, the technology giant Oracle was developing a platform that, the White House hoped, could serve as a vehicle for doctors to enter data about the drug.
On March 23, the F.D.A.’s top lawyer, Stacy Amin, dashed off an urgent email.
“Can we please start moving forward on BARDA sponsoring the chloroquine I.N.D.,” she wrote, referring to an “investigational new drug” application, documents that accompany a clinical trial. “The president is announcing this tonight and I believe the W.H. would like it set up by tomorrow with data to flow into the Oracle platform,” she added, referring to the White House.
By that time, other companies had donated tens of millions of tablets of hydroxychloroquine, which is approved in the United States and often used to treat lupus, rheumatoid arthritis and other autoimmune disorders, as well as for malaria prevention.
But top F.D.A. officials, as well as Dr. Fauci, took a dim view of the clinical trial idea — and especially the Oracle platform, which they viewed as unworkable, according to three people involved in the decision-making. Dr. Bright, too, was balking; if the drugs had to be accepted into the national stockpile, he wanted their distribution tightly controlled.
Dr. Janet Woodcock, who heads the F.D.A.’s Center for Drug Evaluation and Research, ultimately decided to issue the emergency use authorization, but only for hospitalized patients who could not participate in clinical trials. In a recent interview, Dr. Kadlec said there was no pressure from the White House.
“Everything that was done here was trying to do something consistent with the president’s well-established policy of right-to-try and the secretary’s efforts to explore every opportunity to find appropriate measures,” he said. “Contrary to the recent narrative that said we don’t care about science, we do.”
The waiver was issued on March 28. Less than a month later, the F.D.A. issued a warning about the drugs, citing “reports of serious heart rhythm problems in patients with Covid-19 treated with hydroxychloroquine or chloroquine.”
Frequently Asked Questions and Advice
Updated June 16, 2020
What is pandemic paid leave?
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
Does asymptomatic transmission of Covid-19 happen?
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
What’s the risk of catching coronavirus from a surface?
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
How does blood type influence coronavirus?
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
How many people have lost their jobs due to coronavirus in the U.S.?
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
Will protests set off a second viral wave of coronavirus?
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
My state is reopening. Is it safe to go out?
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
What are the symptoms of coronavirus?
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
How can I protect myself while flying?
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
How do I take my temperature?
Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.
Should I wear a mask?
The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
What should I do if I feel sick?
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
How do I get tested?
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
In announcing Monday’s withdrawal of the waiver, the F.D.A. said its “continued review of the scientific evidence” led officials to conclude that the two drugs are “unlikely to be effective in treating Covid-19” for the uses described in the waiver. That, combined with the concerns about cardiac effects, led to the decision, the agency said.
Representative Greg Walden of Oregon, the top Republican on the House Energy and Commerce Committee, which oversees the F.D.A., expressed support for the decision.
“I trust Dr. Hahn; I think he follows the science,” Mr. Walden said, referring to Dr. Stephen Hahn, the F.D.A. commissioner, who will testify before his committee next week. “Emergency use is a powerful tool in his toolbox. Without better data, I think it made sense to turn it off.”
The decision does not prevent doctors from prescribing hydroxychloroquine, also available through pharmacies, on their own, though it will probably discourage them from doing so. More than 50 clinical trials — including two large-scale studies conducted by the National Institutes of Health — of hydroxychloroquine are underway in the United States.
Mr. Navarro insisted that the F.D.A. would have “blood on its hands” if any of those studies showed hydroxychloroquine was effective. Dr. Lurie, of the Center for Science in the Public Interest, said the opposite, calling the agency’s decision a triumph of “sound science” over “base political instincts.”
Dr. Adrian Hernandez, who directs the Clinical Research Institute at Duke University School of Medicine and has enrolled 550 health care workers in a clinical trial to study whether hydroxychloroquine is effective as a prophylactic, agreed. But the controversy over the drug has discouraged participation, he and other researchers have said.
“We should only be using these types of drugs within clinical trials until proven useful,” Dr. Hernandez said, adding, “From a policy perspective, the E.U.A. was a complete failure.”