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The White House accuses the F.D.A. of partisan foot-dragging on Covid-19 treatments. Critics cry foul.
The White House is mounting an extraordinary public pressure campaign on the Food and Drug Administration to speed up its reviews of potential treatments and vaccines for the coronavirus.
It may already be having an effect. On Sunday evening, President Trump is holding a news conference at 5:30 p.m. Eastern time with the director of the F.D.A., Dr. Stephen M. Hahn, about what the White House is calling “a major therapeutic breakthrough.” A senior administration official familiar with the plans said Mr. Trump was expected to announce emergency F.D.A. authorization of convalescent plasma as a treatment for Covid-19.
The F.D.A. was preparing last week to issue that authorization, but backed off after several top federal health officials, including Dr. Anthony S. Fauci, argued that the evidence for the treatment was still too weak, requiring more analysis of the data, according to two senior administration officials.
Dr. Scott Gottlieb, a former F.D.A. commissioner, characterized the likely announcement as an “incremental” step. Convalescent plasma — taken from patients who have recently recovered — is already widely available and has been used by 70,000 patients across the country.
Emergency authorization, he said on the CBS program “Face the Nation” on Sunday, would probably increase access to the treatment and allow plasma manufacturers to recoup their costs, but would not be a game changer.
The administration’s campaign emerged this weekend. Appearing on Sunday talk shows, Mark Meadows, the White House chief of staff, amplified an accusation Mr. Trump made on Twitter Saturday, when the president claimed that a “deep state” at the F.D.A. was intentionally slow-walking approval of new therapies to harm him politically.
Without evidence, Mr. Trump asserted that the agency, which is responsible for approving new medicines, was “hoping to delay the answer until after November 3rd” — Election Day — and he urged its officials to “focus on speed, and saving lives!”
The tweet prompted backlash from Democrats and some health experts, who warned that the president was trying to short-circuit the safeguards that regulators rely on to ensure that drugs and treatments are safe and effective.
Nancy Pelosi, the House speaker, called Mr. Trump’s claim “very dangerous.”
“Even for him,” she said Saturday at a news conference, “it went beyond the pale, in terms of how he would jeopardize the health and well-being of the American people, accuse the F.D.A. of politics, when he is the one who has tried to inject himself in the scientific decisions of the administration.”
“Staggeringly dangerous,” Holden Thorp, the editor in chief of the journal Science, tweeted in response to the president’s statement. Referring to Dr. Hahn, the F.D.A. commissioner, he wrote, “We need @SteveFDA to stay strong.”
Mr. Trump’s handling of the pandemic has cost him politically, and criticism of him on that point was a major theme of the Democratic National Convention last week. With the Republican National Convention beginning on Monday, his team is under pressure to shift the narrative.
Dr. Gottlieb also used his talk show appearance to defend the F.D.A. and its employees, saying that rigorous science, not politics, guides the approval process for potential vaccines.
“I firmly reject the idea that they would slow up anything, or accelerate anything for that matter, based on any kind of political consideration, and any consideration, other than what’s best for the public health and a real sense of mission to patients,” Dr. Gottlieb said.
Mr. Meadows, meanwhile, sidestepped questions about Mr. Trump’s charge of political bias, saying the president was merely keeping the pressure on career bureaucrats to deliver treatment breakthroughs.
“He had to make sure that they felt the heat,” Mr. Meadows said on “This Week” on ABC. “If they don’t see the light, they need to feel the heat, because the American people are suffering.”
On “Fox News Sunday,” Mr. Meadows cited Mr. Trump’s coming announcement.
It “should have been made several weeks ago,” Mr. Meadows said. “It was a fumble by a number of people in the federal government.” Mr. Meadows said Mr. Trump was not trying to “cut corners,” but had “a real frustration with some of the bureaucrats who think they can just do this the way they normally do it.”
“We’re facing unprecedented times, which require unprecedented action,” he said. “The president is right to call it out.”
Florida follows California in hitting 600,000 cases, and Texas is right behind.
Florida on Sunday became the second state to surpass 600,000 reported coronavirus cases since the beginning of the pandemic, joining California, which crossed that threshold on Aug. 14, according to a New York Times database.
Texas, with 599,277 reported cases and more than 5,000 daily cases recorded during the past week, is expected to reach 600,000 cases within the next day.
Texas and Florida, which rank as the second and third most populated states behind California, experienced a surge of infections this summer after state officials eased lockdown measures.
New cases in all three states, however, have been decreasing in recent weeks, with Florida recording a 40 percent drop in its seven-day average compared to the average two weeks earlier. The decline in Texas has been less dramatic, with a 22 percent decrease during the same period. The caseload decrease in California was 7 percent.
Reported deaths, however, still remain high in all three states. Florida recorded 106 new deaths on Saturday, for a total of 10,324 since the beginning of the pandemic. Texas had 167 deaths, for a total of 11,650, and California counted at least 153 new deaths on Aug. 22, for a total of 12,141.
A giant motorcycle rally in South Dakota is over. Positive test results are starting to come in.
As bikers prepared to inundate the South Dakota city of Sturgis this month, there were warnings that the motorcycle rally, a two-week event that attracts hundreds of thousands of people annually, could spur the spread of the coronavirus.
In the days since it ended last Sunday, there are troubling signs that it did.
On Tuesday, South Dakota health officials announced that a patron who spent five hours at One-Eyed Jack’s Saloon during the rally had since tested positive for the virus. On Thursday, they said an employee of a tattoo parlor who had worked five 16-hour shifts in five days had also tested positive. Then on Friday, the news arrived that another person who patronized three local saloons had also tested positive.
And public health officials in two neighboring states, Minnesota and Nebraska, attributed dozens of cases to the rally and warned people who had attended to monitor themselves for symptoms and get tested.
Even before the first bikers arrives for the rally, cases in South Dakota had slowly been trending upward.
At the beginning of July, the state was averaging 52 cases a day; by Saturday the average over the previous 7 days had reached 145, according to a New York Times database.
On Saturday, the state set a record Saturday with 251 new coronavirus cases.
Gov. Kristi Noem, a Republican, never issued a stay-at-home order and has refused to sign a statewide mask ordinance. She also hosted President Trump’s Independence Day rally at Mount Rushmore, a packed event without social distancing and few masks.
Large gatherings have continued, and have even been encouraged by local officials throughout the state despite repeated incidents.
Attendees of the Sitting Bull Stampede Rodeo in Mobridge in July, a Big & Rich Concert in Sioux Falls at the beginning of August and now the Sturgis motorcycle rally have all tested positive for the virus.
In China, where the pandemic began, life is starting to look normal. Check out the pool party.
In Shanghai, restaurants and bars in many neighborhoods are teeming with crowds. In Beijing, thousands of students are heading back to campus for the fall semester. In Wuhan, where the coronavirus emerged eight months ago, water parks and night markets are packed elbow to elbow, buzzing as before.
While the United States and much of the rest of the world are still struggling to contain the coronavirus, life in many parts of China has in recent weeks become strikingly normal. Cities have relaxed social distancing rules and mask mandates, and crowds are again filling tourist sites, movie theaters and gyms.
“It no longer feels like there is something too frightful or too life-threatening out there,” said Xiong Xiaoyan, who works at a paint manufacturer in the southern province of Guangdong.
Now, after months of travel restrictions and citywide testing drives, locally transmitted cases of the virus in China are near zero, according to official data. On Sunday, China reported no new locally transmitted cases for the seventh consecutive day. The 12 new infections it reported were all imported, bringing China’s total number of confirmed cases to 84,951, with at least 4,634 deaths.
China could still face a Covid-19 resurgence, experts warn, especially as the weather cools and people spend more time indoors.
“They still need to be cautious,” said David Hui, the director of the Stanley Ho Center for Emerging Infectious Diseases at the Chinese University of Hong Kong. “Mass gatherings and mass celebrations should not be encouraged.”
Lebanon imposes a new lockdown as cases spike in the wake of the Beirut port explosion.
Lebanon imposed a partial lockdown on Friday after a dramatic spike in virus cases in the aftermath of the devastating Aug. 4 explosion at the Beirut port.
“We have reached the brink of the abyss and we no longer have the luxury of time,” the health minister, Dr. Hamad Hassan, said on Friday, warning that hospitals were nearing capacity, according to Lebanon’s National News Agency.
The country has recorded 3,241 cases in the last seven days, according to a New York Times database, bringing its total cases to 10,952, in a population of about 5.5 million, or 160 cases per 100,000 people. One hundred and thirteen people have died, 21 of them in the last seven days.
The rules include a curfew from 6 p.m. to 6 a.m., with exceptions for disaster relief efforts around the port. Markets, gyms, restaurants and other public spaces were ordered to close until the lockdown ends on Sept. 7.
Lebanon had initially been able to contain the virus with a lockdown first imposed in mid-March, which eased in stages starting in June.
But cases had been rising in the weeks before the explosion, which killed more than 170 people, injured more than 6,000, and displaced more than 300,000. The blast’s cause is under investigation, but it was fueled by an enormous cache of ammonium nitrate that had been stored at the port for years, even after officials were warned of the danger it posed. And even before the pandemic, the country was paralyzed by an economic crisis that left hospitals facing shortages.
The blast rendered three hospitals inoperable, damaged three others, along with many clinics, and destroyed many medical supplies, according to the World Health Organization, which warned that the health care system and work force were under severe strain. Two of the damaged hospitals had been treating Covid-19 patients.
Officials had stressed the threat of a virus resurgence, as the calamity often made social distancing impossible. In the days after the blast, the displaced moved in with family and friends, mourners gathered, people flocked to damaged areas to clean up, and angry protests against the ruling elite erupted — and were met with tear gas — in central Beirut.
As tropical storms bear down, those in their path are urged to heed the virus in their preparations.
With Hurricane Marco and Tropical Storm Laura continuing to churn in the Caribbean this weekend, prompting warnings and watches for several countries, Gov. John Bel Edwards of Louisiana has urged residents to be mindful of the pandemic as they made their emergency preparations.
“Covid-19 does not become less of a threat because of tropical weather,” said Mr. Edwards, who advised people to include face masks and hand sanitizer in their emergency kits.
The governor declared a state of emergency on Friday, and requested a federal emergency declaration from the White House on Saturday, as he warned that Marco and Laura were forecast to affect the state in quick sequence early this week.
Marco was about 325 miles south-southeast of the northwest of the western tip of Cuba on Sunday morning, with maximum sustained winds of 75 miles per hour, and moving north-northwest near 14 miles per hour, according to the National Hurricane Center. It is expected to strengthen to bring dangerous storm surges to the Gulf Coast, and is on track to approach southeastern Louisiana on Monday.
On Sunday, Laura was lashing parts of the Dominican Republic and Haiti with heavy rains and “life-threatening” flash flooding, the center said. Laura’s center is forecast to move near or over Cuba as it crosses the southeastern Gulf of Mexico.
The storm is expected to produce three to six inches of rain in Puerto Rico and the U.S. Virgin Islands, with some areas getting as much as eight inches, the hurricane center said. Cuba is expected to receive similar rainfall amounts. The Dominican Republic and Haiti may get up to eight inches of rain, with as much as 12 inches across the southern areas.
Marco may strengthen over the weekend but begin to weaken by Monday or Tuesday, the hurricane center said. The storm is expected to produce one to four inches of rain, with some isolated amounts of six inches, across the eastern portions of Mexico, forecasters said.
Dennis Feltgen, a meteorologist with the National Hurricane Center, on Friday quashed public speculation that the storms would collide and form a single monster storm. “They cannot merge,” he said. “They actually repel each other because of the rotations.”
In California, prisoners’ release amid the pandemic has drained a controversial firefighting corps.
Inmates from state prisons have helped California fight fires for decades, playing a crucial role in containing the blazes striking the state with more frequency and ferocity in recent years.
This past week, though, hundreds of inmate firefighters were absent from the fire lines. They had already gone home, part of an early release program initiated by Gov. Gavin Newsom to protect them from the coronavirus.
That has highlighted the state’s dependence on prisoners in its firefighting force and complicated its battle against almost 600 fires, many of which continued burning across Northern California this weekend.
The virus has exposed countless examples of inequality across the United States, and the use of inmate firefighters shows how the pandemic’s consequences have reached deep into unexpected corners of society. In California, the presence of inmates has been the difference between having the resources to save homes from wildfires — or not.
To critics, the prison program is exploitative and should be replaced with proper public investment in firefighting. To others, it is an essential part of the state’s response to what has become an annual wildfire crisis.
Across the United States there have been 112,436 infections of inmates and correctional officers, and 825 have died, according to a New York Times database. In four of the six prisons that train incarcerated firefighters, there have been more than 200 infections each among inmates and staff members, according to the database.
The state’s main firefighting agency is pleading for more personnel, and Mr. Newsom has requested more firefighters from as far away as the East Coast and Australia.
Waits stretch up to 12 hours at Austria’s border as vacationers return from the Balkans.
After travelers reported wait times of up to 12 hours at Austria’s southern border with Slovenia overnight because of restrictions aimed at slowing the coronavirus, the Austrian authorities loosened the controls on Sunday morning.
An enormous traffic jam had formed as many Central and Western Europeans returned from vacations in the Balkans by car. Those in each vehicle, including people passing through Austria to other countries, were required by the Austrian health authorities to stop and fill out a registration form.
One vacationer from Bavaria, in southern Germany, told the German news media that he had arrived at the congested border at 5:30 p.m. on Saturday and then not been able to enter Austria until 7:30 a.m. on Sunday.
Caught off guard, the Slovenian and Austrian authorities did not provide assistance to stuck drivers, and the atmosphere during the wait grew tense and aggressive, according to Austrian media reports. Before the pandemic, the border was mostly open, with many drivers not even having to slow down when crossing the national border.
On Sunday morning, the governor of the Austrian state of Kärnten ordered border police officers to perform only spot checks at the crossing, which quickly reduced the wait time.
Austria reported 265 new coronavirus cases on Friday; Germany, to which many of the travelers caught up in the border delay were returning, recorded 2,034 new cases.
Nearly 40 percent of infections currently registered in Germany are thought to have been brought back by returning vacationers.
New York City restaurants face ‘apocalyptic’ times.
Restaurants in New York City, which were devastated by the pandemic shutdown in the spring, remain in crisis as a ban on indoor service continues, despite nearly 10,000 eateries having set up outdoor seating since July.
Though outdoor dining has been a hit with patrons and provided a tenuous lifeline, restaurant owners say they are operating at a fraction of regular seating capacity. Many remain open only because of the federal paycheck protection program, which supports payroll, and because they have not paid full rent in months.
Hanging in the balance is a vital New York City industry that before the pandemic employed more than 300,000 people, including recent immigrants, musicians, artists, writers and actors who help define the city as a cultural hub.
Last week, New York City restaurants were doing about 23 percent of last year’s volume in terms of people seated, according to data from Resy, the reservation app. The previous week it was 18 percent. In mid-July, it was 10 percent.
Gabriel Stulman said that Bar Sardine, one of his nine Manhattan restaurants, was doing 30 percent of normal business and that its landlord had refused to negotiate on rent. Without additional government relief, he predicted that many restaurants would close in the coming months if indoor dining remains barred.
“I don’t want to be dramatic, but this is apocalyptic for the industry,” he said. “If it’s not safe to open, I understand that — I’m a team player. But you got to do something about my rent, my payroll. You got to answer these questions.”
Large social gathering leads to lawmakers’ resignations in Ireland.
Ireland’s fragile governing coalition was in turmoil this weekend in the wake of a parliamentary golf club dinner that was held in violation of the country’s social distancing guidelines and resulted in several high-profile resignations.
The coalition parties’ leaders said they had agreed to recall Parliament early from its six-week summer recess to deal with the matter, and that Prime Minister Micheal Martin would make a formal request to the legislature on Monday.
The Golf Society event, held on Wednesday in a hotel in western Ireland, was attended by more than 80 guests, despite rules limiting most indoor gatherings to 50 people.
Among those in attendance was Phil Hogan, a longtime Irish lawmaker who is the European Union’s trade commissioner — a position that puts him at the forefront of the bloc’s Brexit negotiations with Britain, one of Ireland’s most significant trading partners.
Both Mr. Martin and the leader of Mr. Hogan’s party, Deputy Prime Minister Leo Varadkar, have urged the commissioner to “consider his position” after attending the Golf Society dinner.
The governing coalition, formed in June four months after a tight election, is the first time in Ireland’s history that its two main political parties have forged an alliance, having been staunch rivals since their formation after the country’s civil war nearly a century ago.
The Golf Society dinner has already led to the resignation of the agriculture minister, Dara Calleary, and the deputy chairman of Ireland’s Senate, Jerry Buttimer, both of whom were in attendance. Also present was a Supreme Court judge.
The head of Ireland’s state tourism agency also resigned last week after it was revealed that he had gone on vacation in Italy, despite a marketing campaign from his own agency urging people not to take trips abroad.
Ireland had reported nearly 28,000 coronavirus cases as of Sunday morning, and over 700 deaths.
Why antibody tests may not help you much.
Getting an antibody test now to see whether you had the coronavirus months ago is pointless, according to guidelines issued this past week by a major medical society.
Many tests are inaccurate, some look for the wrong antibodies, and even the right antibodies fade away, said experts at the Infectious Diseases Society of America, which issued the guidelines.
Because current tests cannot determine whether someone is immune, the society said, they “cannot inform decisions to discontinue physical distancing or lessen the use of personal protective equipment.”
With few exceptions, antibody testing should be used only for population surveys, not for diagnosing illness in individuals, the panel said.
Moreover, “if you live in a low-prevalence area, you have a much higher likelihood of getting a false-positive test, meaning you may think you are protected but you aren’t,” said Dr. Angela M. Caliendo, a testing expert at Brown University’s Alpert Medical School and a member of the society’s expert panel.
Despite the flaws of antibody tests, recent studies of patients who definitely were infected suggest that they have long-lasting immunity and that it is very unlikely that they will become reinfected.
That may be because white blood cells known as B and T cells, which are “primed” to recognize and attack the coronavirus, remain in circulation long after antibodies have faded away. B and T cells are not analyzed by common antibody tests.
Reporting was contributed by Nicholas Bogel-Burroughs, Derrick Bryson Taylor, Nicholas Fandos, Tess Felder, Rebecca Halleck, Andew Jacobs, Thomas Fuller, Rebecca Griesbach, Javier C. Hernández, Sharon Otterman, Elisabetta Povoledo, Katie Rogers, Christopher F. Schuetze, Maura Turcotte, Albee Zhang and Karen Zraick.
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