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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
If you’re tuning into the new “Looney Tunes Cartoons” on HBO Max, you may notice a slight edit made to the classic show’s “wabbit” hunter.In the 2020 reboot, producers decided that Elmer Fudd would no longer carry a gun in his endless pursuit of Bugs Bunny. Neither will any other characters for that matter.“We’re not doing guns,” showrunner Peter Browngardt told The New York Times.Browngardt said other forms of “Looney Tunes” violence is still baked into the show, whether that involve sticks of dynamite, intricate booby traps, falling anvils or bank safes.“But we can do cartoony violence — TNT, the Acme stuff. All that was kind of grandfathered in,” Browngardt added.It seems Elmer Fudd may have a new weapon on choice in the show, In a scene titled “Dynamite Dance,” he’s seen chasing Bugs with a scythe before the famous bunny outsmarts him with sticks of dynamite.Producers of the show are wrapping production on the first 1,000 minutes of cartoons, which comes to about 200 cartoons in all, The Times reports.The “Looney Tunes” reboot premiered on HBO Max on May 27, with a total of 30 shorts in 10 episodes. 1128
HUNTINGTON BEACH, Calif. (AP) — Wildlife officials say a goose is recovering after being found with a large arrow through its neck at the same Southern California park where a goose and a gull swallowed prescription pills last month.The Los Angeles Times reported Monday that the goose flew around with the arrow in its neck for a week before it was finally captured at Carr Park in Huntington Beach.The arrow was removed and the bird was given antibiotics, IV fluids and painkillers. It's expected to fully recover.Shortly before Christmas, a Canadian goose and a ring-bill gull had their systems flushed after eating pills — including sedatives — that someone dumped in the park. Both birds have recovered after being treated at a wildlife center.Officials don't know whether the two incidents are related. 816
House Democrats held a heated debate Tuesday over a push to impose term limits?on some of their leaders, ultimately deciding to table the discussion until incoming freshmen members can take part in the conversation next month."There's some strong feelings in the room, but we're not going to deal with it today," Rep. Debbie Dingell of Michigan said while leaving the caucus meeting.House Minority Leader Nancy Pelosi of California, as she seeks to shore up support for her speaker bid, is in active conversations with Rep. Ed Perlmutter of Colorado, a leader of the small group of Democrats attempting to block her from the speakership because they want to see new leaders at the top.Perlmutter and his allies are pushing for Pelosi to back a proposal for term limits on senior Democratic leadership positions. While the talks at one point also included term limits for lower-level leadership roles and committee chairs, sources close to the discussion say the conversation has narrowed to a focus on the top three leadership positions.Broadly, the idea of term limits is a contentious topic among Democrats, where a divide exists between those eager to see a new generation of leaders and those who say seniority and experience matter.Incoming House Majority Leader Steny Hoyer of Maryland, who's been in Congress for three decades and served as majority leader when Democrats last held power, passionately decried the idea of term limits on Tuesday.Hoyer said six times that he doesn't support term limits and noted he had repeatedly cosponsored legislation in the past that called for repealing term limits for the presidency."I'm against term limits, because I have a term limit. It's a two-year term limit," Hoyer told reporters. "Every year the citizens that I represent and the members in this House have to re-up my contract."Asked how he feels about Pelosi entertaining the idea of term limits in her negotiations, Hoyer was frank."She's not negotiating for me," he said.Multiple Democrats said the debate in the caucus meeting Tuesday was a broad discussion over the idea of term limits in general, rather than any specific proposal with positions and a set number of terms in mind.Emerging from the meeting, many members expressed some openness to the idea but wanted to see a concrete proposal first."I don't think it's a bad idea. I don't see any downside," said Rep. Bill Pascrell, a New Jersey Democrat. "It keeps people looking forward. I tend to support it right now.""My conceptual thought on this, I think the American people hired us to be the majority in part to bring some change to Congress," said Rep. Raja Krishnamoorthi, an Illinois Democrat. "And therefore we have to figure out how we can put more people in positions of responsibility so they can gain skills to assume leadership in the future."Pelosi, Hoyer and Rep. James Clyburn of South Carolina have been the top three House Democrats for more than a decade, and the trio was recently nominated by the caucus to maintain their positions in the next Congress -- despite some opposition in the party to their long-running places at the top.If Pelosi ultimately supports some sort of term limit, it's unclear how many votes she would win among her detractors, but it could potentially help her get close to or over the 218-vote threshold she needs to win the speakership on the floor.Pelosi, who explored the idea of term limits for committee chairs in 2015, told reporters last week she was "sympathetic" to the concerns of those who'd like to see limits but said it was a matter to be debated by the caucus.Even if Pelosi supports a proposal, it would need to be voted on by the entire caucus, which is already divided on the broader idea of term limits.Some of that opposition can be seen in the Congressional Black Caucus."The CBC has had, it's no secret, a long history of supporting seniority," said Rep. Joyce Beatty of Ohio, who recently elected vice chairwoman of the caucus. "Let's not change the rules when you have women who have finally gotten there, when you have African-Americans -- and why do we make a big deal at this point in time in history that we want to change the rules?"Noting the concerns voiced in Tuesday's meeting, Beatty said she felt confident that "Pelosi will work in the best interest of the entire caucus and not just a minority of the caucus."Rep. Cedric Richmond of Louisiana, chairman of the Congressional Black Caucus, said he's against all term limits, describing the idea as "a solution to a problem that doesn't exist.""She's talking to those guys, but that doesn't mean the caucus has to vote for it," Richmond said, referring to Perlmutter and his allies. "And I think that all she's committing is that she'll support it or something, so we'll see what happens. But at some point those guys got to put all this silliness to bed so we can start governing."While term limits is an idea that could potentially get some Pelosi opponents on board for her speaker bid, others say they won't be deterred from seeking a change at the top.Rep. Kurt Schrader, an Oregon Democrat who's an outspoken critic of Pelosi, said term limits wouldn't be enough to tamp down his quest to see her go."I don't see it happening, frankly," he said of the term limits idea. "Blowback has been significant, as you might imagine. I'm anticipating that we still have the votes to stop her from becoming speaker." 5439
IMPERIAL BEACH (KGTV) — Some South Bay parents are upset after they say their elementary school abruptly canceled an annual Christmas tradition out of deference to families who do not observe the holiday.For years, students at Oneonta Elementary School in Imperial Beach had a December assembly featuring Christmas decorations, Christmas songs and a visit from Santa.This year’s December assembly was held Friday without a Christmas show. Teachers learned of the change Wednesday, according to 6th grade parent Jose Cariman.“No notice to the parents. No notice to the teachers, no advance notice for anything,” he said. “What are they teaching [the students]? Are they teaching them that Christmas is not allowed to be celebrated?”RELATED:San Diego students get 'epic' Christmas surprise from officersPadres players surprise San Diego elementary school students with new bikesVideo from the assembly in 2018 shows children in Santa hats singing Christmas songs on a stage decorated with the words “Merry Christmas” in at least four languages.6th grade student Alexis Sandoval said she was disappointed by the change, particularly for her younger siblings.“It was just super sad because we’re always used to having a nice, fun Christmas party, and now we just can’t have a party for some reason,” she said, noting the school began scaling back aspects of its holiday celebration last year.Oneonta has a new principal, David Trautman, who joined the school in July 2018, according to his LinkedIn page. Trautman declined to comment and referred questions to the South Bay Union School District.RELATED:Sweetwater Union High School District approves interim budget with million shortfallSan Marcos parents sound off against superintendent's hires“South Bay Union School District is dedicated to ensuring that all students, families, and staff feel welcome and included on our campuses and at all District facilities,” Superintendent Katie McNamara said in a statement.McNamara said the district serves a diverse community with a variety of beliefs, both religious and secular, and provided the following guidance to school employees before the holiday season: “While teaching about religious holidays is a permissible part of the educational program, celebrating religious holidays is not allowed in public schools.”“During the time of the year when major religious holidays are celebrated, it is important to remember that not everyone shares the beliefs of the majority,” she added.Miriam Martinez, a parent of a 2nd grader, said she doesn’t understand why some schools in SBUSD went forward with Christmas-themed assemblies when the celebration at Oneonta was canceled. “It’s upsetting because they look forward to it. And it’s unfortunate because not all of us can afford to take them to the mall to see Santa. So some of the kids just do it at school. This is where they get to tell Santa their Christmas list,” she said.A district press release mentions an event at Mendoza Elementary called “Irish You a Merry Christmas.” The event was sponsored by outside groups and held on a Saturday. A district spokesperson did not directly respond to a question about end-of-year assemblies at other schools. “Schools and classrooms have been decorated and are reflective of seasonal themes and many schools have had numerous festive programs,” McNamara said in the statement.Cariman and Martinez said they’d like to see Oneonta handle Christmas like it handles Halloween: parents who don’t want to participate can opt out, and bring their child to school late. Here is the full statement from Superintendent Katie McNamara: 3629