WASHINGTON — When senior officials of the Food and Drug Administration held a morning conference call on Tuesday, they received a sober warning from the agency’s head, Dr. Stephen Hahn, who had just spoken to the White House: “All he said, “crazy” Is spreading and continues to work to fight this epidemic.
There are many distractions. President Trump is working hard to overturn the election results. His only public statement about the coronavirus in recent days is to express his indignation that good news about vaccines does not appear until after election day-even if the new daily infection volume exceeds 1
With the increase in the number of viruses, Vice President Mike Pence canceled the holiday at the last minute of the week, but his White House Coronavirus Task Force was almost silent. The White House Chief of Staff, Mark Meadows, who was infected with the virus, announced last month: “We will not control this epidemic.” He said the focus should be on the long-term goal of developing vaccines and treatments.
At the same time, the national emergency reserve strategy national inventory is only 115 million N95 masks, far below the 300 million N95 masks that the government had hoped to accumulate before winter. , Said in a recent interview, although he added that the government is continuing to expand its supply of protective equipment.
The epidemic caught the United States off guard in March, but epidemiologists warned people that the autumn and winter waves would last for several months, because people were forced to enter indoors, schools resumed attending classes in person, and Americans were tired of counting. Preventive measures of the month. However, the shortage of personal protective equipment has returned, especially in rural hospitals, nursing homes and private medical institutions, where these people cannot use the supply network that serves the large hospital chain.
Dr. Shikha Gupta, executive director of Get Us PPE, is a voluntary work aimed at providing available supplies to healthcare providers. He said that 70% of those who sought help from the organization last month reported that they were entirely a critical piece of equipment.Mask Gloves and disinfectant wipes top the list.
She said: “The medical staff were exhausted and frustrated. It was really hard to believe that November 10th felt like mid-March.” “The number of cases we encountered was the highest ever, and we also Encountered the same problem that has existed since the first day.”
The governors once again competed with large hospital chains for scarce equipment. Nursing homes are solving the problem of shortage of staff, which prevents hospitals from providing care for patients. In Wisconsin, the situation is so severe that health officials are considering a plan to train family members of nursing home residents to fill facilities that lack sufficient workers.
John Sauer, chairman of the Wisconsin LeadingAge Association, said: “We have come up with all the ideas we can think of, but we do need bold action by the federal government.” Nursing facilities. “We cannot solve this problem alone.”
Compared with the beginning of the pandemic, the situation in the United States is better now. Both the state and the hospital have their own inventory, and Admiral Polochik said that the federal government has achieved its goal of buying 153,000 ventilators.
However, as the country enters what may be the worst phase of the pandemic, the Trump administration is still largely disengaged. President-elect Biden tried to assume the leadership mantle, use the appointment of the Coronary Advisory Committee, and wear a mask to appeal to all Americans, but until he took office on January 20, he had no power to mobilize the federal response.
“1,000 people die every day, it’s like two jumbo jets falling from the sky,” said Dr. Carlos Del Rio, an infectious disease expert at Emory University, who worked with the White House coronavirus response coordinator Deborah L. Dr. Birx is closely related. “If two jumbo jets fall from the sky every day and kill everyone, don’t you think everyone will panic? But somehow, we didn’t do it. Somehow, as a country, we don’t feel anger.”
“We need Churchill,” he added. “We need someone to enter a vacuum and lead the country.”
White House spokesperson Brian Morgenstern said that Mr. Trump and his administration are “still focused on saving lives,” citing their efforts to produce vaccines and therapeutics. He added that the task force “always keeps in touch with state and local officials” to provide assistance when needed.
But Mr. Trump is at war with his own health officials. Pharmaceutical maker Pfizer announced on Monday that he was furious after early clinical trial data showed that its coronavirus vaccine was more than 90% effective. A senior government official said in a conversation with Dr. Hann Hahn that the president accused the company and the Food and Drug Administration of conspiring to delay news that might increase his chances of reelection.
The aides said that the president thinks that Pfizer may have announced the success of its clinical trial before November 3, but deliberately chose to keep this news, and may not contaminate the company’s vaccine in order to finally save Trump’s re-election. bid. White House aides were particularly angry when Mr. Biden publicly stated that his public health advisers knew about Pfizer’s performance on Sunday, while aides said the news had reached the White House.
Apart from Mr. Trump’s Twitter feed, the Federal Bullying Forum-an important part of an effective infectious disease response-has largely remained silent. The government’s chief infectious disease expert, Dr. Anthony S. Fauci, said in an interview on Tuesday that the vaccine will “change the rules of the game” over time.
He said that vaccines are not a panacea. Unless the dose is widely available (perhaps by mid-2021), the United States is in a “dilemma”, which requires Americans to wear masks and social distancing, and avoid crowding. Set up, especially indoors.
Dr. Fauci said: “My message to the American public is: Persevere, aid is coming, vaccines are coming, we all need to be united.”
The vacancy in Washington’s leadership has exacerbated state anxiety.
Casey Katims, a federal liaison for Washington State Governor Jay Inslee, said: “In the fall and winter, we are facing a severe situation.”
In Ohio, Republican Gov. Mike DeWine cancelled the regular Tuesday afternoon virus press conference and instead planned to speak statewide on Wednesday evening because local officials reported daily cases More than 6,500, nearly 1,000 Saturdays more than the recorded record.
In North Dakota, Governor Doug Burgum said this week that the state’s hospitals are full, and even medical staff who are positive for the virus but not showing symptoms can treat coronavirus patients specifically Work in the ward.
“Leadership is important,” said Dr. Howard Markel, a professor of medical history at the University of Michigan, who helped formulate the federal social isolation policy during the George W. Bush administration. “What your leaders do, such as showing off their masks or holding unmasked parties, will almost encourage people to do so.”
Dr. del Rio said that federal health officials, such as the Secretary of Health Alex M. Azar II or the Director of the Centers for Disease Control and Prevention, Dr. Robert R. Redfield, must start holding daily press conferences to provide public health guidance.
Without leadership, local officials felt they were struggling. According to an analysis by University of Chicago researchers R. Tamara Konetzka and Rebecca J. Gorges, from the end of May to late October, the number of new cases per week among nursing home residents increased fourfold, and the number of deaths more than doubled in 20 states.Centers for Disease Control and Prevention
“The depressing news is that nothing has changed since spring,” Professor Konezka said.
Even many large hospital chains that claim to have sufficient medical equipment continue to operate in crisis mode. This usually means requiring employees to reuse respirator masks that are to be discarded after each use.
Deborah Burger, president of National Nurses United, the largest organization of registered nurses, said that the CDC lacks clear guidelines that allow hospitals to set their own standards for reusing disposable protective equipment. The use of staff and patients increases the risk of infection.
She said: “We have been in the pandemic for 11 months, and the government has still not adequately addressed the safety issues of medical staff and the community.” “I have been a nurse for more than 45 years, but I have never seen anything like this. Just like we are in” Twilight zone “Same as in.”
The White House has focused its attention on the government’s “Warp Warp Speed”, a rapid vaccine and therapy development program, and its coronavirus task force has reduced its workload, holding rote memorizations in the situation room every week. However, instead of celebrating Pfizer’s news on Monday, the government launched a series of condemnations.
Trump said in a Twitter message on Monday that Pfizer deliberately delayed announcing its good news, and the US Food and Drug Administration also supported this delay.
Witnessed by senior management, at a meeting of the Coronavirus Task Force on Monday afternoon, Mr. Azar and Dr. Hann confronted Pfizer’s announcement and expressed the coordination between FDA and Pfizer and its detailed vaccine The guide postponed news of the breakthrough. Change found.
He questioned Dr. Hahn’s timetable and requested urgent approval of Pfizer vaccine.
The president’s allies suspected that Pfizer might have obtained the results of the trial earlier, but chose not to. In fact, Pfizer initially planned to ask for results from an independent safety monitoring committee when taking Covid-19 among 32 clinical trial participants who received the vaccine or placebo. That will be the first barometer of the company’s effectiveness.
Pfizer officials said, but a few weeks ago, FDA regulators suggested that they are unlikely to issue emergency use authorization for Pfizer vaccine based on a trial of only 32 cases and nearly 44,000 people.
Pfizer decided to wait for more cases. By the end of last week, 94 subjects had tested positive for Covid-19, which appeared to be sufficient to meet FDA requirements. The company said an early analysis showed that the vaccine is more than 90% effective.
Pfizer has stated that it hopes to apply for an emergency use authorization in late November, and experts hope that the FDA will make a decision as early as mid-December. But Pfizer said it only produced a few million doses, and experts hope the government can step in to speed up production. The second vaccine manufacturer Moderna will soon seek FDA review of its clinical trial results.
On Monday, the FDA granted emergency authorization to Eli Lilly and Company for antibody treatment similar to the treatment Trump gave him shortly after he contracted the coronavirus. The company uses a limited dose and only authorizes newly infected patients who are not hospitalized.
Some in the agency gave Dr. Hahn’s Tuesday warning to his senior staff about “crazy” warnings, which indicated that the president might fire him. Others said that the commissioner only acknowledged the fact that the days after the election will be difficult.
Washington reported Sheryl Gay Stolberg, Sharon LaFraniere and Noah Weiland, and New York reported Andrew Jacobs.Report contributed by Maggie Haberman and Jo Becker Katie Thomas from New York, Chicago and Sheila Kaplan from San Francisco.