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  • In bid to rapidly expand coronavirus testing, U.S. agency abruptly changes rules

    President Trump calls on reporters at a press conferences at the White House

    After severe criticism of how the United States was handling coronavirus testing, the Food and Drug Administration announced at a press conference with President Donald Trump that it was changing how it regulated newly developed diagnostic assays.

    REUTERS/Joshua Roberts

    The Food and Drug Administration (FDA) today recommended a dramatic shift in how it implements regulations that control whether laboratories can use diagnostic kits created in-house to test for infections of COVID-19. “We issued a policy this morning that allows us to have a lot of flexibility around the development of diagnostic tests,” FDA Commissioner Stephen Hahn said at a White House briefing with President Donald Trump this afternoon. “We expect this policy to have a significant impact.” The change could greatly expand the number of laboratories able to do coronavirus testing.

    The U.S. government has come under severe criticism for not providing nearly enough tests needed to understand the extent of spread in the population. A test kit produced and distributed by the U.S. Centers for Disease Control and Prevention (CDC) was shelved after state and local labs trying it out discovered it contained a faulty reagent. As a result, many labs that have the capability to test themselves have not been allowed to do so.

    The new recommendations focus on “high-complexity testing laboratories” that are certified under federal rules known as Clinical Laboratory Improvement Amendments. This group of facilities includes many hospital labs, like the one where epidemiologist Michael Mina works at Brigham and Women’s Hospital. “Essentially it’s opening up a clear and concise avenue for labs like the one at Brigham and Women’s,” Mina says. “It’s what I’ve been advocating for a month now.”

  • The United States badly bungled coronavirus testing—but things may soon improve

    CDC’s laboratory test kit for coronavirus 2 (SARS-CoV-2)

    A faulty reagent in a test kit distributed by the U.S. Centers for Disease Control and Prevention has hampered efforts to find and confirm COVID-19 cases.

    CENTERS FOR DISEASE CONTROL AND PREVENTION

    Speed is critical in the response to COVID-19. So why has the United States been so slow in its attempt to develop reliable diagnostic tests and use them widely?

    The World Health Organization (WHO) has shipped testing kits to 57 countries. China had five commercial tests on the market 1 month ago and can now do up to 1.6 million tests a week; South Korea has tested 65,000 people so far. The U. S. Centers for Disease Control and Prevention (CDC), in contrast, has done only 459 tests since the epidemic began. The rollout of a CDC-designed test kit to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the country eager to test more suspected cases—and test them faster—have been unable to do so. No commercial or state labs have the approval to use their own tests.

    In what is already an infamous snafu, CDC initially refused a request to test a patient in Northern California who turned out to be the first probable COVID19 case without known links to an infected person.

  • Canada’s ‘dynamic’ plan to protect endangered right whales rests on robots

    A North Atlantic right whale caught in fishing gear

    New regulations in Canada should reduce the number of right whales getting tangled up in fishing gear.

    Nick Hawkins/Minden Pictures

    With only about 400 North Atlantic right whales remaining, the Canadian government is stepping up its efforts to keep them safe, even as it tries to keep the nation’s lucrative snow crab and lobster fisheries in business. Officials yesterday announced the nation’s latest plan for reducing the number of these behemoths being hit by ships or tangled up in fishing nets. It calls for regulating fishing and shipping in a larger area than in previous years but aims to restrict most activities only after a whale has been spotted nearby. Those “dynamic” restrictions will rest, in part, on data collected by robotic submarines equipped with sensors that can detect right whale calls, as well as airborne drones doing visual surveys.

    Right whales (Eubalaena glacialis), which breed off Florida and head north to summer off New England and northeastern Canada, have in recent years been shifting where they hang out. More of the whales have been appearing in Canada’s Gulf of St. Lawrence, likely because of a warming ocean. As they migrate and feed, they can get hit by ships or tangled in fishing gear, problems that are taking an increasing toll on this vulnerable population, which has been declining since 2010. Since 2017, 30 whales have died this way, says Kristen Monsell, an attorney for the Center for Biological Diversity.

    The Canadian government responded in 2018 by closing some fishing areas and slowing ships down while whales were present and investing $1 million to help rescue whales in trouble (such as by cutting away entangling nets). Last year, it confined those restricted areas to where 90% of the whales had been spotted 2 years earlier—but by the end of that season, it had imposed dynamic restrictions across the entire Gulf of St. Lawrence. Under the dynamic regulations, fishing is prohibited, and ship speeds are reduced for 2 weeks in areas where a whale is spotted. If there is a second sighting within that period, the area is closed to fishing and shipping through mid-November. In 2020, dynamic restrictions will be in place across both the Gulf of St. Lawrence and the Bay of Fundy to the south.

  • Singapore claims first use of antibody test to track coronavirus infections

    A traveler, wearing a protective facemask amid fears about the spread of the COVID-19 novel coronavirus, walks past the Rain Vortex display at Jewel Changi Airport in Singapore on February 27, 2020.

    A traveler wearing a protective facemask at Changi Airport in Singapore. The city has not seen COIVD-19 cases exploding yet.

    Roslan RAHMAN/AFP via Getty Images

    In what appears to be a first, disease trackers in Singapore have used an experimental antibody test for COVID-19 to confirm that a suspected patient was infected with the coronavirus. The patient was one of two people who together formed a missing link between two clusters of cases that each occurred in a Singaporean church.

    Researchers around the world are racing to develop antibody tests, also called serological tests, that can confirm whether someone was infected even after their immune system has cleared the virus that causes COVID-19. The group that developed the test, at Duke-NUS Medical School in Singapore, is among the front-runners, although its assay has to be validated before it is taken into production and deployed widely.

    Current tests for SARS-CoV-2, the virus that causes COVID-19, look for genetic material of the virus, for instance in saliva or nasal, oral, or anal swabs, using the polymerase chain reaction (PCR). They have one huge drawback: They only give a positive result when the virus is still present. The tests can’t identify people who went through an infection, recovered, and cleared the virus from their bodies.

  • Interior Department moves to impose new rules on use of science in decision-making

    waterfall in Yosemite National Park

    New rules could govern which scientific studies the Department of the Interior allows to inform its efforts to manage some 200 million hectares of land, including national parks like Yosemite.

    Unsplash

    Originally published by E&E News

    The Interior Department is moving closer to further entrench a policy that it calls “Promoting Open Science” but that critics call misguided and political.

    Following up on a secretarial order issued in October 2018, department officials are in the process of developing a formal rule governing the use of science.

  • A single ‘paper mill’ appears to have churned out 400 papers, sleuths find

    illustration of papers flying off a roll printer
    3d imagination/shutterstock.com

    Online sleuths have discovered what they suspect is a paper mill that has produced more than 400 scientific papers with potentially fabricated images. Some journals are now investigating the papers.

    Elisabeth Bik, a microbiologist–turned–research integrity expert based in San Francisco, along with other “forensic detectives,” identified the potentially problematic papers, which they think came from a single source. They say the papers contain western blot images—used in molecular biology to visualize the presence of proteins—that contain remarkably similar background patterns and unusually neat bands lacking smears, stains, or dots, which often appear in such images.

    “We think that these western blots are not real,” says Bik, who wrote about the case on her blog on 21 February. “Most of them have a very similar layout so we realized these are all coming from the same stable.”

  • Missing clinical trial data must be made public, federal judge says

    a doctor using a stethoscope on a young patient

    Sponsors of clinical trials must report missing data from hundreds of trials from 2007–17.

    Halfpoint/iStock.com

    Drug companies, device manufacturers, and universities must turn over missing data from hundreds of clinical trials conducted in the United States from 2007–17, a federal judge ruled this week. The ruling from the Southern District of New York says government agencies including the National Institutes of Health, the U.S. Department of Health and Human Services, and the Food and Drug Administration (FDA) for years misinterpreted a law requiring them to collect and post data to ClinicalTrials.gov, a publicly accessible government database.

    If it is upheld, the ruling would make it harder for drug companies to keep unfavorable results from the public, and it could offer vital information for patients and doctors, STAT reports. Still unclear is how quickly the agencies might move to fill in the 10-year gap in compliance—and what the consequences would be for clinical trial sponsors that don’t comply.

  • Budget cut threatens novel social science research program at Department of Defense

    Afghan security forces keep watch near the site of a suicide attack in Kabul, Afghanistan February 11, 2020

    Afghan security forces trained by the U.S. military keep watch near the site of a suicide attack in Kabul this month.

    Omar Sobhani/REUTERS

    The U.S. Department of Defense (DOD) wants to kill a unique social science research program that has helped it understand nontraditional threats to national security, from the rapid growth of China’s technological prowess to the mind of a suicide bomber.

    DOD’s $740 billion budget request for fiscal year 2021 drops core funding for the $20 million Minerva Research Initiative. Michael Griffin, DOD undersecretary for research and engineering, put Minerva on the chopping block as part of a review by Defense Secretary Mark Esper that identified some $5 billion worth of programs deemed less essential to DOD’s mission. Griffin, who oversees a $16.5 billion research budget, has made developing hypersonic weapons his top priority, and DOD watchers say Minerva doesn’t meet Griffin’s definition of what his office should be funding.

    “The current undersecretary doesn’t believe that Minerva is science,” says a Democratic congressional staffer familiar with the program. “He thinks it’s soft, and his priorities are elsewhere.”

  • ‘A completely new culture of doing research.’ Coronavirus outbreak changes how scientists communicate

    Researchers at the Pasteur Institute

    Researchers at the Pasteur Institute in Lille, France, at work on the new coronavirus on 20 February.

    SYLVAIN LEFEVRE/GETTY IMAGES

    On 22 January, Dave O’Connor and Tom Friedrich invited several dozen colleagues around the United States to join a new workspace on the instant messaging platform Slack. The scientists, both at the Wisconsin National Primate Research Center, had seen news about a new disease emerging in China and realized researchers would need a primate model if they were going to answer some important questions about its biology. “We put out a call to a bunch of investigators and basically said: ‘Hey, let’s talk,’” O’Connor says. The idea is to coordinate research and make sure results are comparable, Friedrich adds. (They named the Slack workspace the Wu-han Clan, a play on the hip-hop group Wu-Tang Clan.)

    The Wu-han Clan is just one example of how the COVID-19 outbreak is transforming how scientists communicate about fast-moving health crises. A torrent of data is being released daily by preprint servers that didn’t even exist a decade ago, then dissected on platforms such as Slack and Twitter, and in the media, before formal peer review begins. Journal staffers are working overtime to get manuscripts reviewed, edited, and published at record speeds. The venerable New England Journal of Medicine (NEJM) posted one COVID-19 paper within 48 hours of submission. Viral genomes posted on a platform named GISAID, more than 200 so far, are analyzed instantaneously by a phalanx of evolutionary biologists who share their phylogenetic trees in preprints and on social media.

    “This is a very different experience from any outbreak that I’ve been a part of,” says epidemiologist Marc Lipsitch of the Harvard T.H. Chan School of Public Health. The intense communication has catalyzed an unusual level of collaboration among scientists that, combined with scientific advances, has enabled research to move faster than during any previous outbreak. “An unprecedented amount of knowledge has been generated in 6 weeks,” says Jeremy Farrar, head of the Wellcome Trust.

  • The coronavirus seems unstoppable. What should the world do now?

     Residents wait to be given access to shop in a supermarket in small groups of forty people on February 23, 2020 in the small Italian town of Casalpusterlengo

    Residents of Casalpusterlengo, an Italian town under lockdown, line up to enter a supermarket.

    MIGUEL MEDINA/AFP via Getty Images

    The global march of COVID-19 is beginning to look unstoppable. In just the past week, a countrywide outbreak surfaced in Iran, spawning additional cases in Iraq, Oman, and Bahrain. Italy put 10 towns in the north on lockdown after the virus rapidly spread there. An Italian physician carried the virus to the Spanish island of Tenerife, a popular holiday spot for northern Europeans, and Austria and Croatia reported their first cases. Meanwhile, South Korea’s outbreak kept growing explosively and Japan reported additional cases in the wake of the botched quarantine of a cruise ship.

    The virus may be spreading stealthily in many more places. A modeling group at Imperial College London has estimated that about two-thirds of the cases exported from China have yet to be detected.

    The World Health Organization (WHO) still avoided using the word “pandemic” to describe the burgeoning crisis today, instead talking about “epidemics in different parts of the world.” But many scientists say that regardless of what it’s called, the window for containment is now almost certainly shut. “It looks to me like this virus really has escaped from China and is being transmitted quite widely,” says Christopher Dye, an epidemiologist at the University of Oxford. “I’m now feeling much more pessimistic that it can be controlled.” In the United States, “disruption to everyday life might be severe,” Nancy Messonnier, who leads the coronavirus response for the U.S. Centers for Disease Control and Prevention, warned on 25 February. “We are asking the American public to work with us to prepare for the expectation that this is going to be bad.”

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