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How accurate are the coronavirus tests used in the U.S.?Months into the outbreak, no one really knows how well many of the screening tests work, and experts at top medical centers say it is time to do the studies to find out.When the new virus began spreading, the Food and Drug Administration used its emergency powers to OK scores of quickly devised tests, based mainly on a small number of lab studies showing they could successfully detect the virus.That’s very different from the large patient studies that can take weeks or months, which experts say are needed to provide a true sense of testing accuracy.The FDA’s speedy response came after it was initially criticized for delaying the launch of new tests during a crisis and after the Centers for Disease Control and Prevention stumbled in getting its own test out to states.But with the U.S. outbreak nearly certain to stretch on for months or even years, some experts want the FDA to demand better evidence of the tests’ accuracy so doctors know how many infections might be missed.There have been more than 2 million confirmed coronavirus cases in the U.S. and more than 115,000 deaths, according to data compiled by Johns Hopkins University. Cases in nearly half of U.S. states are rising.In recent weeks, preliminary findings have flagged potential problems with some COVID-19 tests, including one used daily at the White House. Faulty tests could leave many thousands of Americans with the incorrect assumption that they are virus-free, contributing to new flare-ups of the disease as communities reopen.“In the beginning, the FDA was under a lot of pressure to get these tests onto the marketplace,” said Dr. Steven Woloshin of Dartmouth College, who wrote about the issue in the New England Journal of Medicine last week. “But now that there are plenty of tests out there, it’s time for them to raise the bar.”The FDA said in a statement that it has already asked multiple test makers to do follow-up accuracy studies, although it didn’t say for how many of the more than 110 authorized screening tests. The agency also said it is tracking reports of problems. Accuracy has also been an issue with blood tests that look for signs of past infections.No screening test is 100% accurate. So details on accuracy are routinely provided for tests of all types, including seasonal flu, hepatitis, HIV and cancers. For example, rapid flu tests are known to miss 20% or more of all cases, a factor doctors weigh when treating patients who have symptoms but test negative.For now, most COVID-19 tests in the U.S. don’t give data on real-world performance, including how often the tests falsely clear patients of infection or falsely detect the virus. That information is lacking for all but a few of the roughly 80 commercial screening tests available, according to an Associated Press review.The government’s emergency authorization process “requires a lower level of evidence,” the agency said. Makers need only show that a test “may be effective” instead of the usual requirement to demonstrate “safety and effectiveness.” They would have to meet that higher threshold once the U.S. government declares the emergency over.Many of the commercial test makers submitted results from 60 samples, the minimum number required and mostly used lab-produced specimens of the virus. The FDA now recommends the use of nasal swabs or other real samples from people screened for coronavirus.Experts say larger patient studies patients are needed to assess a test’s true performance.Lab testing bears little resemblance to actual — sometimes imperfect — conditions at hospitals, clinics and testing sites noted Dr. Robert Kaplan of Stanford University.“You’re testing people in parking lots, the patients themselves are extremely anxious and often unable to follow instructions,” said Kaplan, a former associate director of the National Institutes of Health.Kaplan and others say those differences could explain why some tests are not performing as expected.Last month, the FDA warned doctors of a potential accuracy problem with Abbott Laboratories’ rapid ID Now test, which delivers results in roughly 15 minutes. The test has been lauded by President Donald Trump and used to screen the president, his staff and visitors to the White House.The FDA alert followed a preliminary report by New York University that found Abbott’s test missed between a third to one-half of infections caught by a rival test in patients screened for the virus.Abbott rejected the findings, saying the researchers did not follow the instructions for using its test. The company pointed to alternate patient studies, including its own, that have found the test successfully detects between 91% and 95% or more of virus cases when compared to other tests.But similar problems with ID NOW’s accuracy have been flagged in preliminary reports by researchers at Stanford University, Loyola University and the Cleveland Clinic.For now, the FDA is requiring Abbott to conduct follow-up studies in several different patient groups.The FDA’s emergency standards “are still high but there is a significant difference in the body of work that what would go into a submission under the normal process,” said Abbott vice president John Hackett. “Our normal process takes years to bring these out.”Requiring bigger studies of all coronavirus tests could provide valuable information, but it could also strain the FDA’s already stretched staff and resources, said Dr. Daniel Schultz, former director of the FDA’s medical device center.Dr. Colin West of the Mayo Clinic worries doctors and patients have put too much confidence in the current crop of tests, when an unknown number of patients with COVID-19 are likely receiving false negative results.Even a modest error rate can have grave consequences during an outbreak like COVID-19. West gives the example of a test that is 95% accurate at detecting the virus and is used on 1 million people. That would still result in 50,000 people being incorrectly told that they don’t have the virus.“The negative test does not mean that I’m off the hook,” West said. “We just need to maintain that level of vigilance until we have a better sense of how good these tests really can be.”___Follow Matthew Perrone on Twitter: @AP_FDAwriter.___Follow AP pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6604
In an election year in the middle of a global coronavirus pandemic, a new study finds the majority of Americans, about 80 percent, are confident in-person polling places will be run safely.Survey respondents also seem to agree that it is important for Americans to learn who won the election within a day or two of Election Day, about 82 percent, but only about 50 percent feel confident this will actually happen.Other questions asked on a recent Pew Research Center study appear to have strong partisan divisions.When it comes to being confident about in-person versus mail-in ballots being counted, overall 90 percent of respondents feel good about in-person ballots being counted as voters intended.The confidence in mail-in ballots being counted as voters intended differs; just 37 percent of those who support President Donald Trump say they are confident in mail-in ballots, compared to 77 percent of those who support Democratic presidential nominee Joe Biden.These feelings lead to a 30-point difference in which supporters are planning to cast their ballot in person on Election Day; 50 percent of Trump supporters say they will vote in-person, while just 20 percent of Biden supporters say they will.Roughly 20 percent of both Trump supporters and Biden supporters reported they had already voted or planned to vote in-person during their state’s early voting.The sides also differ on their feelings about how Election Day will be administered around the country. About 90 percent of all survey participants have confidence in their local community elections to be run well.However, 72 percent of Biden supporters feel confident about elections around the country and just 50 percent of Trump supporters feel confident about elections being run well around the country.The survey was conducted the first week of October, talking to more than 11,900 American adults. 1884

House Speaker Nancy Pelosi is questioning President Donald Trump’s fitness to serve, announcing legislation Thursday that would create a commission to allow Congress to intervene under the 25th Amendment to the Constitution and remove the president from executive duties.Just weeks before the Nov. 3 election, Pelosi said Trump needs to disclose more about his health after his COVID-19 diagnosis. She noted Trump’s “strange tweet” halting talks on a new coronavirus aid package — he subsequently tried to reverse course — and said Americans need to know when, exactly, he first contracted COVID as others in the White House became infected. On Friday, she plans to roll out the legislation that would launch the commission for review.“The public needs to know the health condition of the president,” Pelosi said, later invoking the 25th Amendment, which allows a president’s cabinet or Congress to intervene when a president is unable to conduct the duties of the office.Trump responded swiftly via Twitter.“Crazy Nancy is the one who should be under observation. They don’t call her Crazy for nothing!” the president said.The president’s opponents have discussed invoking the 25th Amendment for some time, but are raising it now, so close to Election Day, as the campaigns are fast turning into a referendum on Trump’s handling of the coronavirus pandemic. More than 210,000 Americans have died and millions more infected by the virus that shows no signs of abating heading into what public health experts warn will be a difficult flu season and winter.Trump says he “feels great” after being hospitalized and is back at work in the White House. But his doctors have given mixed signals about his diagnosis and treatment. Trump plans to resume campaigning soon.Congress is not in legislative session, and so any serious consideration of the measure, let alone votes in the House or Senate, is unlikely. But the bill serves as a political tool to stoke questions about Trump’s health as his own White House is hit by an outbreak infecting top aides, staff and visitors, including senators.In a stunning admission, Senate Majority Leader Mitch McConnell said Thursday that he had stopped going to the White House two months ago because he disagreed with its coronavirus protocols. His last visit was Aug. 6.“My impression was their approach to how to handle this was different from mine and what I insisted we do in the Senate, which is to wear a mask and practice social distancing,” McConnell said at a campaign stop in northern Kentucky for his own reelection.On Friday, Pelosi along with Rep. Jamie Raskin, D-Md., a constitutional law professor, plan to roll out the legislation that would create a commission as outlined under the 25th Amendment, which was passed by Congress and ratified in 1967 as way to ensure a continuity of power in the aftermath of President John F. Kennedy’s assassination.It says the vice president and a majority of principal officers of the executive departments “or of such other body as Congress” may by law provide a declaration to Congress that the president “is unable to discharge the powers and duties of his office.” At that point, the vice president would immediately assume the powers of acting president.Trump abruptly halted talks this week on the new COVID aid package, sending the economy reeling, his GOP allies scrambling and leaving millions of Americans without additional support. Then he immediately reversed course and tried to kickstart talks.It all came in a head-spinning series of tweets and comments days after he returned to the White House after his hospitalization with COVID-19.First, Trump told the Republican leaders in Congress on Tuesday to quit negotiating on an aid package. By Wednesday he was trying to bring everyone back to the table for his priority items — including ,200 stimulus checks for almost all adult Americans.Pelosi said Thursday that Democrats are “still at the table” and her office resumed conversations with top negotiator Treasury Secretary Steven Mnuchin.She said she told Mnuchin she was willing to consider a measure to prop up the airline industry, which is facing widespread layoffs. But that aid, she said, must go alongside broader legislation that includes the kind of COVID testing, tracing and health practices that Democrats say are needed as part of a national strategy to “crush the virus.”Normally, the high stakes and splintered politics ahead of an election could provide grounds for a robust package. But with other Republicans refusing to spend more money, it appears no relief will be coming with Americans already beginning early voting.Democrats have made it clear they will not do a piecemeal approach until the Trump administration signs off on a broader, comprehensive plan they are proposing for virus testing, tracing and other actions to stop its spread. They have scaled back a trillion measure to a .2 trillion proposal. The White House presented a .6 trillion counter offer. Talks were ongoing when Trump shut them down.“There’s no question that the proximity to the election has made this much more challenging,” McConnell said.___Associated Press writers Bruce Schreiner in Frankfort, Kentucky, and Laurie Kellman and Pamananda Rama in Washington contributed to this report. 5313
If you've ever had a surgical procedure, you know it can often mean a high hospital bill. Now, more people are turning to surgery centers for a lower cost.Sandi Bowen is one of those people.Something as simple as picking out a shirt is more challenging for Bowen than she ever thought it'd be. On Easter, she found a lump in her breast. Doctors told her it was cancer."It was very very very confusing," Bowen says. "It still is. It brings tears to my eyes, because I don't understand how I got it."Instead of a lumpectomy, she decided to remove her entire breast. And instead of going to a hospital for breast reconstruction, Bowen opted for the Kaiser Permanente Ambulatory Surgery Center, where she got the surgery. In less than 24 hours, she was back home recovering. "I felt very special," Bowen says. "They were there every time I moved. They came in and talked to me, even goofed around with me."Dr. Mike Sawyer, the director at the center, says they've worked hard to address concerns regarding patient care."If it's a patient that just needs physicians to kind of come to the bedside, and maybe we have to have some kind of intervention, we're able to do that because are here and we are present," Dr. Sawyer says. "On site, as they say. If it's really something that requires a higher level of care, that again allows us to do a pretty quick transfer process over to one of our partner hospitals."Compared with hospitals, Kaiser Permanente says its patients are seeing an average cost savings of 30 percent on their procedures. It can be anything from simple orthopedic procedure to joint procedures.However, Dr. Sawyer says there are important questions you need to ask before determining if a surgery center is the best option for you."Does your physician feel comfortable with this operation there?" Dr. Sawyer says. "Have you and your physician discussed all the ramifications of that procedure? And then what sort of plans does that ambulatory surgery center have if you were required a higher level of care?" 2037
I believe we should abolish the Electoral College and select our president by the winner of the popular vote, same as every other office.But while it still exists, I was proud to cast my vote in New York for Joe Biden and Kamala Harris. pic.twitter.com/th9qebu9ka— Hillary Clinton (@HillaryClinton) December 14, 2020 330
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