New drug gets OK for the severely ill

Intensive care units at head of line

WASHINGTON — The Food and Drug Administration on Friday issued an emergency use authorization that will allow doctors to use Gilead Sciences’ remdesivir to treat patients who are seriously ill with covid-19 and hospitalized.

The authorization allows the antiviral drug, which is administered intravenously, to be used to treat the disease in adults and children hospitalized with severe disease, which is defined as patients with low blood oxygen levels or needing oxygen therapy or a mechanical ventilator. The limited authorization allows the agency to bring products to market without full data on their safety and efficacy.

President Donald Trump announced the Gilead authorization during a meeting in the Oval Office with FDA Commissioner Stephen

Hahn and Gilead Chief Executive Officer Daniel O’Day. The FDA then immediately released a statement detailing the decision.

The action comes two days after Dr. Anthony Fauci, the nation’s top infectious-disease expert, announced that trial data showed the drug had a “clear-cut, significant, positive effect in diminishing the time to recovery.”

“That is really quite important,” said Fauci, director of the National Institute of Allergy and Infectious Diseases, which is overseeing a study of more than 1,000 patients in the United States and around the world.

O’Day, in a news release, said the authorization “opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of covid-19.” The company has already provided the drug to thousands of patients through clinical trials and its own compassionate use program.

Gilead said it would coordinate with the government to prioritize cities and hospitals most heavily affected by coronavirus infections for distribution. Hospitals with intensive care units, which treat the most severely ill patients, will get the drug first, the company said.

Doctors will not use the drug on people with covid-19 who are at home, said Dr. Paul Goepfert, an infectious-disease doctor at the University of Alabama, Birmingham and a trial site investigator for the NIAID remdesivir study.

The drug was found in the trial, which began in late February, to reduce hospital stays from 15 days to 11 days. Reaching the stage where it can be routinely provided to patients in a little more than two months “has to be one of the fastest findings for this kind of drug development ever,” Goepfert said.

Gilead has said it plans to have enough doses for 140,000 people by the end of the month, a supply that could be extended if a finding in a separate Gilead trial holds up — that a five-day course of treatment may be as effective as a 10-day course.

Gilead has said it believes it can produce 1 million courses of treatment by the end of the year.

Possible side effects of remdesivir include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, sweating and shivering.

Trump said Friday that he’s hoping the total number of covid-19 deaths in the United States will be below 100,000, which he acknowledged is a “horrible number.” As of Friday, there were more than 1.1 million cases and 65,000 deaths in the U.S., according to Johns Hopkins University.

FAUCI TESTIMONY BLOCKED

In other news from Washington, the White House is blocking Fauci from testifying before a House subcommittee investigating the outbreak and response, arguing that it would be “counterproductive” for him to appear next week while in the midst of participating in the government’s responses to the pandemic.

The White House issued a statement about Fauci’s testimony shortly after The Washington Post published a story Friday quoting a spokesman for the House Appropriations Committee, who said the White House was refusing to allow Fauci to appear at a subcommittee hearing next week.

“While the Trump administration continues its whole-of-government response to covid-19, including safely opening up America again and expediting vaccine development, it is counterproductive to have the very individuals involved in those efforts appearing at congressional hearings,” said White House spokesman Judd Deere. “We are committed to working with Congress to offer testimony at the appropriate time.”

In fact, Fauci is expected to appear at a Senate hearing related to testing the following week, said a senior administration official who spoke on condition of anonymity to discuss internal planning.

“It’s not muzzling, it’s not blocking, it’s simply trying to ensure we’re able to balance the need for oversight, the legitimate need for oversight, with their responsibilities to handle covid-19 work at their respective agencies and departments,” said the official, who noted that health risks entailed in moving around in public places were also a factor.

A spokeswoman for Fauci did not immediately respond to a request for comment.

The House Appropriations subcommittee will instead hear from Thomas Frieden, who led the Centers of Disease Control and Prevention during the Obama administration, said committee spokesman Evan Hollander.

SCATTERED REOPENINGS

Meanwhile, more than a dozen states let restaurants, stores or other businesses reopen Friday in the biggest oneday push yet to get their economies up and running again.

People in Louisiana could eat at restaurants again but had to sit outside at tables 10 feet apart with no waiter service. Maine residents could attend church services as long as they stayed in their cars. And a Nebraska mall reopened with plastic glass barriers and hand-sanitizing stations, but few shoppers.

In much of Colorado, people could get their hair cut and shop at stores again, though stay-at-home orders remained in place in Denver and surrounding counties. Wyoming let barbershops, nail salons, gyms and day care centers reopen. In Maine, golf courses, hairdressers and dentists opened.

Hotels near South Carolina beaches opened and state parks unlocked their gates for the first time in more than a month.

Texas’ reopening got underway with sparse crowds at

shopping malls and restaurants allowing customers to dine in, though only at 25% capacity in most places. A video posted on social media showed a city park ranger in Austin getting shoved into the water Thursday while asking people in a crowd to keep 6 feet apart from each other. Police charged a 25-year-old man with attempted assault.

Around the country, protesters have demanded governors reboot the battered economy. More than 100 people chanted and carried signs in front of Chicago’s Thompson Center, where Gov. J.B. Pritzker has an office, to call for an end to the statewide lockdown.

Essential workers planned to strike nationwide Friday to demand safer conditions, while other groups planned rallies against tight stay-at-home orders they say are crippling the U.S. economy.

Demonstrations were planned in New York, Washington, Los Angeles and other cities. Protesters asked consumers not to cross picket lines or use those companies’ services for the day in solidarity.

Meanwhile, nurses were planning to take to the streets outside more than 130 hospitals in 13 states to protest a lack of personal protective equipment and the punishments they endure when they speak out about the problem. More than 60 nurses across the country have died of covid-19, organizers said.

New Mexico Gov. Michelle Lujan Grisham invoked the state’s Riot Control Act as she sealed off all roads to nonessential traffic in the city of Gallup, population 70,000, to help control a surging coronavirus outbreak in the former trading post on the outskirts of the Navajo reservation.

In the hardest-hit corner of the U.S., New York Gov. Andrew Cuomo said schools and colleges will remain closed through the rest of the academic year. The order, which applies to 4.2 million students statewide, continues a shutdown that had been set to expire May 15.

The last patients left New York City’s Jacob K. Javits Convention center Friday after a total of 1,095 patients were treated there as the coronavirus ravaged the city during April.

The daily count of patients who enter hospitals across the state for treatment of covid-19 has been hovering around 900 to 1,000, a number that is down from more than 3,000 at the beginning of April but is still troubling, Cuomo said.

In Washington state, where the nation’s first covid-19 case was confirmed in January, Gov. Jay Inslee said Friday that he is extending the state’s stay-athome order through at least May 31 and that he will ease the restrictions in four stages.

REOPENING CALLED RISKY

Fauci warned local leaders to avoid “leapfrogging” critical milestones in an effort to reopen their economies as the pandemic continues.

“Obviously you could get away with that, but you’re making a really significant risk,” Fauci said Thursday evening on CNN.

Fauci, who has repeatedly cautioned against prematurely easing restrictions, said he already noticed that some states and cities are not adhering to the steps laid out in the White

House’s recently issued guidance on reopening — a plan that administration officials say will now replace the expired federal social distancing measures.

“If you follow the guidelines, there’s a continuity that’s safe, that’s prudent and that’s careful,” he said.

But if governors rush to reopen when they aren’t ready, Fauci cautioned that the move would probably only set back the progress their states have made.

“There’s no doubt in my mind that when you pull back mitigation, you’re going to start seeing cases crop up here and there,” he said. “If you’re not able to handle them, you’re going to see another peak, a spike, and then you almost have to turn the clock back to go back to mitigation.”

“The discretion is given to the governors, they know their states. The mayors know their cities, so you want to give them a little wiggle room,” he said. “But my recommendation is don’t wiggle too much.”

While Fauci acknowledged

that some local leaders are following the guidance, he said “others are taking a bit of a chance.”

“I hope they can actually handle any rebound that they see,” he added.

OTHER NATIONS EMERGING

Elsewhere around the world, Beijing’s Forbidden City, the imperial palace turned museum that is one of China’s biggest tourist attractions, started welcoming visitors again, and Bangladesh began reopening factories.

Across Europe and Asia, millions of workers marked May Day, or international labor day, struggling without jobs or worried they don’t have enough workplace protections against the virus.

In Turkey, police in Istanbul detained at least 15 people, including trade union leaders who tried to stage a May Day march in defiance of coronavirus lockdown rules and a ban on demonstrations at a historic square.

The Confederation of Progressive Trade Unions of Turkey

tweeted that its chairman, Arzu Cerkezoglu, and several other union leaders were detained Friday while going to lay wreaths of carnations at Taksim Square.

Images showed police officers and demonstrators wearing masks and face guards engaged in tense encounters that involved close physical contact.

The Istanbul governor’s office issued a statement saying the demonstrators were later released.

Taksim Square holds symbolic value for Turkey’s labor movement. During a 1977 May Day event, 34 people were killed there when shots were fired into the crowd from a nearby building.

Information for this article was contributed by Laurie McGinley, Christopher Rowland, Mark Berman, Colby Itkowitz, Erica Werner, Allyson Chiu and Mike DeBonis of The Washington Post; and by Janet McConnaughey, Grant Schulte, Christopher Weber, Marina Villeneuve, Karen Matthews, Carolyn Thompson and Zeynep Bilginsoy of The Associated Press.