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Archive for the ‘Legal Issues Genetic Medicine’ Category

The Error of Fighting a Public Health War With Medical Weapons – WIRED

Saturday, January 2nd, 2021

Heres the wild part, the most 2020 thing about 2020: That schismthat conflict between public health and private well-being, between personal liberties and communal gainis as old as pandemics. The germ of the idea was, in fact, the idea of the germ.

In the mid-1800s, physicians and scientists were starting to come around to the long-gestating idea that diseases could be caused by wee, invisible critters that jumped from person to persona contagium animatum, as 16th-century thinkers put it. They didnt know what viruses or bacteria were, but they knew something was carrying illness.

The contagionists had their opposite number: scientists who in 1948 the researcher Edwin Ackerknecht famously called anticontagionists. Oh, they believed that some diseases spread by some agent, person-to-person. Smallpox and syphilis, maybe. Those were contagious. But they werent epidemicsyellow fever, cholera, or the plague, things that seemed to spread seasonally, or in specific places, or only among specific kinds of people. Nobody knew how. They didnt know anything about food- and waterborne pathogens, about differences between viruses and bacteria, about surface-borne fomites that transmitted disease in some cases, while exhaled droplets and aerosols might in others. Absent any of that? Well, maybe it was something atmospherica cloud of illness, a miasma, maybe even the filth of poverty and pre-sanitation cities. (Its telling that scientists are still fighting over the idea of an airborne contagium animatum, even today.)

But the anticontagionists knew one thing for sure. Those big three epidemicswith typhus thrown in sometimes, toowere the things that had, since the 14th century, caused governments to take population-scale measures to control them. That meant quarantines, travel restrictions, business closureswhat today we might call lockdowns. And that made the anticontagionists nuts. They said that lockdowns, then as now, were bad for business; losses incurred as a result outweighed those caused by the epidemic itself. In the midst of the 19th centurys Industrial Revolution, anything that inhibited business was an inhibition of freedom itself. Quarantines meant, to the rapidly growing class of merchants and industrialists, a source of losses, a limitation to expansion, a weapon of bureaucratic control that it was no longer willing to tolerate, Ackerknecht wrote. Contagionism would, through its associations with the old bureaucratic powers, be suspect to all liberals, trying to reduce state interference to a minimum. Anticontagionists were thus not simply scientists, they were reformers, fighting for the freedom of the individual and commerce against the shackles of despotism.

Also, by saying that disease came from lack of sanitation and poor hygiene, the pro-filth contingent was sometimes quietly and sometimes loudly associating disease with ethnicity and socioeconomic status. It was immunological social Darwinism; if poor and nonwhite people got sick first, or more often, that proved to some reformers that those people made bad personal choices (rather than indicating a failure of the systems around them). In that light, identifying filth as the generator of epidemics paved the way for the hygiene movement, showed the moral and physical superiority of unpoor whites, and provided a rationale for slum clearance and residential zoning laws. Squint at redlining and you see not just the geography of racism but also a colonial cordon sanitaire.

To be fair, as one historian notes, the (paltry) science of miasmas did suggest that quarantines would actually make epidemic diseases worse, because they amplified the confinement and lousy conditions that spread the disease. And if you read miasma as the conditions that make a disease spread, well, thats also the point Im trying to make, so yeah. These were good-faith scientific arguments that also happened to be politically motivated economic and philosophical ones, tinged by racism.

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The Error of Fighting a Public Health War With Medical Weapons - WIRED

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Moderna, Pfizer vaccine trials were the highest of quality: vaccine expert – Yahoo Money

Saturday, January 2nd, 2021

The Guardian

Republicans say they will reject presidential electors from states where Trump campaign contested results unless audit completedTed Cruz of Texas, Ron Johnson of Wisconsin and nine other Republican US senators or senators-elect said on Saturday they will reject presidential electors from states where Donald Trump has contested his defeat by Joe Biden, unless and until [an] emergency 10-day audit of such results is completed.The move is largely symbolic and unlikely to overturn the presidential election. Nonetheless, it adds to a sense of deepening crisis affecting US democracy.Trump has refused to concede, though Biden won more than 7m more votes nationally and took the electoral college by 306-232, a margin Trump called a landslide when he won it over Hillary Clinton in 2016.The Trump campaign has lost the vast majority of more than 50 lawsuits it has mounted in battleground states, alleging electoral fraud, and before the supreme court.On Friday, a federal judge dismissed a suit lodged by a House Republican which attempted to give the vice-president, Mike Pence, who will preside over the certification of the electoral college result on Wednesday, the power to overturn it.Nonetheless, the senators and senators-elect who issued a statement on Saturday followed Senator Josh Hawley of Missouri in committing to challenging the result.Objections are also expected from a majority of House Republicans. Objections must be debated and voted on but as Democrats control the House and the Senate majority leader, Mitch McConnell, and other senior Republicans have voiced opposition, the attempt to disenfranchise a majority of Americans seems doomed to fail.On Saturday, Senator Lisa Murkowski of Alaska said she would vote to certify the results, writing: The oath I took at my swearing-in was to support and defend the constitution of the United States, and that is exactly what I will do. Pat Toomey of Pennsylvania, a state where Trump has sued, said he would vigorously defend our form of government by opposing this effort to disenfranchise millions of voters in my state and others.But Cruz and Johnson were joined by Senators James Lankford (Oklahoma), Steve Daines (Montana), John Kennedy (Louisiana), Marsha Blackburn (Tennessee) and Mike Braun (Indiana). Senators-elect Cynthia Lummis (Wyoming), Roger Marshall (Kansas), Bill Hagerty (Tennessee) and Tommy Tuberville (Alabama) also signed on.The election of 2020, they said, like the election of 2016, was hard fought and, in many swing states, narrowly decided. The 2020 election, however, featured unprecedented allegations of voter fraud, violations and lax enforcement of election law, and other voting irregularities.No hard evidence for such claims has been presented. Federal officials including former attorney general William Barr and Christopher Krebs, a cyber security chief fired by Trump, have said the election was secure.Regardless, the senators said Congress should immediately appoint an electoral commission, with full investigatory and fact-finding authority, to conduct an emergency 10-day audit of the election returns in the disputed states. Once completed, individual states would evaluate the commissions findings and could convene a special legislative session to certify a change in their vote, if needed.The senators made reference to the contested election of 1876, which ended in the appointment of such a commission.We should follow that precedent, they said. Most well-informed observers would suggest otherwise, given that process put an end to post-civil war Reconstruction and led to the institution of racist Jim Crow laws across the formerly slave-owning south.In August, the Pulitzer-winning historian Eric Foner told the Guardian: The election of 1876 would not have been disputed at all if there hadnt been massive violence in the south to prevent black people from voting and voter suppression like we have today. Now, voter suppression is mostly legal.Presciently, given baseless claims that voting under a pandemic was abused by Democrats, he added: Today, I can certainly see the Trump people challenging these mail-in ballots: Theyre all fraudulent, they shouldnt be counted. Challenging peoples voting.Cruz, like Hawley, is prominent among Republicans expected to run for president in 2024, and thus eager to appeal to supporters loyal to Trump. On Saturday, Christine Pelosi, daughter of House speaker Nancy Pelosi and a member of the Democratic National Committee, referred to the bitter 2016 primary when she tweeted: Ted Cruz is defending Trumps assaults on democracy with more energy than he defended his own family against Trumps assaults on his wife and father.The Democratic strategist Max Burns wrote: The exact same Senate GOP that refused to allow a single witness during President Trumps impeachment trial now wants to call a bunch of witnesses to investigate Joe Bidens 2020 victory.Biden did not immediately comment. In Congress, the Connecticut senator Richard Blumenthal branded the statement pathetic, un-American and an attack on our democracy. Amy Klobuchar, from Minnesota, said Biden will be inaugurated on 20 January, and no publicity stunt will change that.Trump did not immediately comment but his campaign tweeted: THANK YOU! The Arizona congressman Paul Gosar hailed the senators as patriots.But there was also criticism from the right. Joe Walsh, a former congressman who ran against Trump in 2020, wrote: They cite ZERO evidence of voter fraud Donald Trumps single greatest legacy is the destruction of truth.Walsh added: These Republicans know this is bad for the country. But they dont care. They believe its good for them politically. They are placing their own interests before the countrys interests.With unintended irony or simple bad faith the senators and senators-elect said their allegations are not believed just by one individual candidate. Instead, they are widespread. Reuters/Ipsos polling, tragically, shows 39% of Americans believe the election was rigged. That belief is held by Republicans (67%), Democrats (17%), and Independents (31%). Whether or not our elected officials or journalists believe it, that deep distrust of our democratic processes will not magically disappear. It should concern us all. And it poses an ongoing threat to the legitimacy of any subsequent administrations.Marc Elias, a leading Democratic elections lawyer, said of the senators: History will remember and curse them for their cowardice and treachery.

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Moderna, Pfizer vaccine trials were the highest of quality: vaccine expert - Yahoo Money

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Celebrate the new year with this New Year’s Eve fireworks show in SF – Yahoo News

Saturday, January 2nd, 2021

The Telegraph

Donald Trump was dealt a stinging rebuke by Republican senators last night as Congress overrode his veto of a sweeping defence bill. It was the first time in Mr Trump's four years as president that Congress had blocked his veto power. Many Republican senators joined Democrats in an 81-13 vote to override, well over the two thirds majority required. As a result the annual $740 billion National Defense Authorization Act to fund the military in 2021 will become law. Mr Trump had called the result, which was expected, a "disgraceful act of cowardice" and the Republican leadership in Congress "weak". The bill will provide a three per cent pay raise for US troops and included elements relating to defence policy, troop levels, weapons systems and military construction. Mr Trump had vetoed it, arguing it allowed for the renaming of military bases that honour Confederate generals, and that it limited his ability to bring troops home from Afghanistan and Germany. He also tried to link passage of the bill to measures targeting social media companies. Throughout Mr Trump's term Republican senators had been highly reluctant to break so publicly with him. He had vetoed eight previous bills and none were overridden. But with less than three weeks left in office Mr Trump's influence with Republican senators appeared to have receded markedly. Mitch McConnell, the Republican leader in the Senate, said: "It's time for us to deliver this bill. It's our chance to remind brave service members and their families that we have their backs." It came as Republicans also faced a deepening split over Mr Trump's last ditch attempt to overturn the US presidential election result. Over 140 Republicans in the House of Representatives may be ready to back a move not to certify the outcome at a joint session of Congress on Jan 6, it emerged. But even with that level of support the attempt to block the result still had no chance of success. Mr McConnell privately urged colleagues to accept the election result, and called his own vote on Jan 6 the "most consequential I have ever cast". In an open letter Ben Sasse, the Republican senator from Nebraska, accused colleagues of "playing with fire". He said: "Lets be clear what is happening here. We have a bunch of ambitious politicians who think theres a quick way to tap into the presidents populist base without doing any real, long-term damage. But theyre wrong. "Adults dont point a loaded gun at the heart of legitimate self-government." The move to oppose the election results was ignited by Josh Hawley, a Republican senator from Missouri. He will object, forcing a two-hour debate, followed by a vote in the Senate, and in the House of Representatives. The session in Congress will take place a day after two run-off races in Georgia, which will determine whether Republicans or Democrats control the Senate. David Perdue, one of two Republican candidates, announced he would spend the final days of the campaign in quarantine after possible exposure to the coronavirus. Meanwhile, it emerged that staffing changes were to be made to the Secret Service's presidential detail when Joe Biden takes office on Jan 20. Mr Biden's camp was said to have expressed concerns that current agents might be politically supportive of Mr Trump. Mr Trump cut short a trip to Florida and headed back to Washington on New Year's Eve. In a New Year video message he hailed "historic victories" on the economy and fighting the pandemic. He said: "We have to be remembered for what's been done." In the final weeks of his term the president was also facing an ongoing battle with Republicans in Congress, including Mr McConnell, after he called for an increase in stimulus cheques to Americans. He also faced growing friction with Iran.

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Celebrate the new year with this New Year's Eve fireworks show in SF - Yahoo News

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The movie industry will strengthen again around April or May: Screenvision CEO – Yahoo Money

Saturday, January 2nd, 2021

The Guardian

Republicans say they will reject presidential electors from states where Trump campaign contested results unless audit completedTed Cruz of Texas, Ron Johnson of Wisconsin and nine other Republican US senators or senators-elect said on Saturday they will reject presidential electors from states where Donald Trump has contested his defeat by Joe Biden, unless and until [an] emergency 10-day audit of such results is completed.The move is largely symbolic and unlikely to overturn the presidential election. Nonetheless, it adds to a sense of deepening crisis affecting US democracy.Trump has refused to concede, though Biden won more than 7m more votes nationally and took the electoral college by 306-232, a margin Trump called a landslide when he won it over Hillary Clinton in 2016.The Trump campaign has lost the vast majority of more than 50 lawsuits it has mounted in battleground states, alleging electoral fraud, and before the supreme court.On Friday, a federal judge dismissed a suit lodged by a House Republican which attempted to give the vice-president, Mike Pence, who will preside over the certification of the electoral college result on Wednesday, the power to overturn it.Nonetheless, the senators and senators-elect who issued a statement on Saturday followed Senator Josh Hawley of Missouri in committing to challenging the result.Objections are also expected from a majority of House Republicans. Objections must be debated and voted on but as Democrats control the House and the Senate majority leader, Mitch McConnell, and other senior Republicans have voiced opposition, the attempt to disenfranchise a majority of Americans seems doomed to fail.On Saturday, Senator Lisa Murkowski of Alaska said she would vote to certify the results, writing: The oath I took at my swearing-in was to support and defend the constitution of the United States, and that is exactly what I will do. Pat Toomey of Pennsylvania, a state where Trump has sued, said he would vigorously defend our form of government by opposing this effort to disenfranchise millions of voters in my state and others.But Cruz and Johnson were joined by Senators James Lankford (Oklahoma), Steve Daines (Montana), John Kennedy (Louisiana), Marsha Blackburn (Tennessee) and Mike Braun (Indiana). Senators-elect Cynthia Lummis (Wyoming), Roger Marshall (Kansas), Bill Hagerty (Tennessee) and Tommy Tuberville (Alabama) also signed on.The election of 2020, they said, like the election of 2016, was hard fought and, in many swing states, narrowly decided. The 2020 election, however, featured unprecedented allegations of voter fraud, violations and lax enforcement of election law, and other voting irregularities.No hard evidence for such claims has been presented. Federal officials including former attorney general William Barr and Christopher Krebs, a cyber security chief fired by Trump, have said the election was secure.Regardless, the senators said Congress should immediately appoint an electoral commission, with full investigatory and fact-finding authority, to conduct an emergency 10-day audit of the election returns in the disputed states. Once completed, individual states would evaluate the commissions findings and could convene a special legislative session to certify a change in their vote, if needed.The senators made reference to the contested election of 1876, which ended in the appointment of such a commission.We should follow that precedent, they said. Most well-informed observers would suggest otherwise, given that process put an end to post-civil war Reconstruction and led to the institution of racist Jim Crow laws across the formerly slave-owning south.In August, the Pulitzer-winning historian Eric Foner told the Guardian: The election of 1876 would not have been disputed at all if there hadnt been massive violence in the south to prevent black people from voting and voter suppression like we have today. Now, voter suppression is mostly legal.Presciently, given baseless claims that voting under a pandemic was abused by Democrats, he added: Today, I can certainly see the Trump people challenging these mail-in ballots: Theyre all fraudulent, they shouldnt be counted. Challenging peoples voting.Cruz, like Hawley, is prominent among Republicans expected to run for president in 2024, and thus eager to appeal to supporters loyal to Trump. On Saturday, Christine Pelosi, daughter of House speaker Nancy Pelosi and a member of the Democratic National Committee, referred to the bitter 2016 primary when she tweeted: Ted Cruz is defending Trumps assaults on democracy with more energy than he defended his own family against Trumps assaults on his wife and father.The Democratic strategist Max Burns wrote: The exact same Senate GOP that refused to allow a single witness during President Trumps impeachment trial now wants to call a bunch of witnesses to investigate Joe Bidens 2020 victory.Biden did not immediately comment. In Congress, the Connecticut senator Richard Blumenthal branded the statement pathetic, un-American and an attack on our democracy. Amy Klobuchar, from Minnesota, said Biden will be inaugurated on 20 January, and no publicity stunt will change that.Trump did not immediately comment but his campaign tweeted: THANK YOU! The Arizona congressman Paul Gosar hailed the senators as patriots.But there was also criticism from the right. Joe Walsh, a former congressman who ran against Trump in 2020, wrote: They cite ZERO evidence of voter fraud Donald Trumps single greatest legacy is the destruction of truth.Walsh added: These Republicans know this is bad for the country. But they dont care. They believe its good for them politically. They are placing their own interests before the countrys interests.With unintended irony or simple bad faith the senators and senators-elect said their allegations are not believed just by one individual candidate. Instead, they are widespread. Reuters/Ipsos polling, tragically, shows 39% of Americans believe the election was rigged. That belief is held by Republicans (67%), Democrats (17%), and Independents (31%). Whether or not our elected officials or journalists believe it, that deep distrust of our democratic processes will not magically disappear. It should concern us all. And it poses an ongoing threat to the legitimacy of any subsequent administrations.Marc Elias, a leading Democratic elections lawyer, said of the senators: History will remember and curse them for their cowardice and treachery.

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The movie industry will strengthen again around April or May: Screenvision CEO - Yahoo Money

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Congress overrides Donald Trump’s veto of a defense policy bill in the first such rebuke of his presidency – Yahoo News

Saturday, January 2nd, 2021

The Telegraph

Donald Trump was dealt a stinging rebuke by Republican senators last night as Congress overrode his veto of a sweeping defence bill. It was the first time in Mr Trump's four years as president that Congress had blocked his veto power. Many Republican senators joined Democrats in an 81-13 vote to override, well over the two thirds majority required. As a result the annual $740 billion National Defense Authorization Act to fund the military in 2021 will become law. Mr Trump had called the result, which was expected, a "disgraceful act of cowardice" and the Republican leadership in Congress "weak". The bill will provide a three per cent pay raise for US troops and included elements relating to defence policy, troop levels, weapons systems and military construction. Mr Trump had vetoed it, arguing it allowed for the renaming of military bases that honour Confederate generals, and that it limited his ability to bring troops home from Afghanistan and Germany. He also tried to link passage of the bill to measures targeting social media companies. Throughout Mr Trump's term Republican senators had been highly reluctant to break so publicly with him. He had vetoed eight previous bills and none were overridden. But with less than three weeks left in office Mr Trump's influence with Republican senators appeared to have receded markedly. Mitch McConnell, the Republican leader in the Senate, said: "It's time for us to deliver this bill. It's our chance to remind brave service members and their families that we have their backs." It came as Republicans also faced a deepening split over Mr Trump's last ditch attempt to overturn the US presidential election result. Over 140 Republicans in the House of Representatives may be ready to back a move not to certify the outcome at a joint session of Congress on Jan 6, it emerged. But even with that level of support the attempt to block the result still had no chance of success. Mr McConnell privately urged colleagues to accept the election result, and called his own vote on Jan 6 the "most consequential I have ever cast". In an open letter Ben Sasse, the Republican senator from Nebraska, accused colleagues of "playing with fire". He said: "Lets be clear what is happening here. We have a bunch of ambitious politicians who think theres a quick way to tap into the presidents populist base without doing any real, long-term damage. But theyre wrong. "Adults dont point a loaded gun at the heart of legitimate self-government." The move to oppose the election results was ignited by Josh Hawley, a Republican senator from Missouri. He will object, forcing a two-hour debate, followed by a vote in the Senate, and in the House of Representatives. The session in Congress will take place a day after two run-off races in Georgia, which will determine whether Republicans or Democrats control the Senate. David Perdue, one of two Republican candidates, announced he would spend the final days of the campaign in quarantine after possible exposure to the coronavirus. Meanwhile, it emerged that staffing changes were to be made to the Secret Service's presidential detail when Joe Biden takes office on Jan 20. Mr Biden's camp was said to have expressed concerns that current agents might be politically supportive of Mr Trump. Mr Trump cut short a trip to Florida and headed back to Washington on New Year's Eve. In a New Year video message he hailed "historic victories" on the economy and fighting the pandemic. He said: "We have to be remembered for what's been done." In the final weeks of his term the president was also facing an ongoing battle with Republicans in Congress, including Mr McConnell, after he called for an increase in stimulus cheques to Americans. He also faced growing friction with Iran.

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Congress overrides Donald Trump's veto of a defense policy bill in the first such rebuke of his presidency - Yahoo News

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Why was the UK first to authorize a coronavirus vaccine? – CNN

Friday, December 4th, 2020

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CNN's Dr. Sanjay Gupta has answers.","duration":"02:27","sourceName":"CNN","sourceLink":"","videoCMSUrl":"/video/data/3.0/video/health/2020/12/02/sanjay-gupta-covid-19-vaccine-safety-orig-dp.cnn/index.xml","videoId":"health/2020/12/02/sanjay-gupta-covid-19-vaccine-safety-orig-dp.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201202170652-vacine-safety-gupta-large-169.jpg","videoUrl":"/videos/health/2020/12/02/sanjay-gupta-covid-19-vaccine-safety-orig-dp.cnn/video/playlists/coronavirus/","description":"Will the vaccine have negative long-term effects? Is the vaccine being rushed out too fast? Will life go back to normal after it's released? CNN's Dr. Sanjay Gupta answers questions about the safety of the Covid-19 vaccines.","descriptionText":"Will the vaccine have negative long-term effects? Is the vaccine being rushed out too fast? Will life go back to normal after it's released? CNN's Dr. Sanjay Gupta answers questions about the safety of the Covid-19 vaccines."},{"title":"High-ranking officials ignore their own Covid-19 advice","duration":"03:13","sourceName":"CNN","sourceLink":"https://www.cnn.com/","videoCMSUrl":"/video/data/3.0/video/health/2020/12/04/high-ranking-officials-coronavirus-guidelines-dnt-tsr-todd-vpx.cnn/index.xml","videoId":"health/2020/12/04/high-ranking-officials-coronavirus-guidelines-dnt-tsr-todd-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201201144213-41-holidays-coronavirus-unf-1129-washington-large-169.jpg","videoUrl":"/videos/health/2020/12/04/high-ranking-officials-coronavirus-guidelines-dnt-tsr-todd-vpx.cnn/video/playlists/coronavirus/","description":"CNN's u003ca href="https://www.cnn.com/profiles/brian-todd-profile" target="_blank">Brian Toddu003c/a> reports on high-ranking officials, including Austin, Texas, Mayor Steve Adler and Governor Gavin Newsom (D-CA), going against their own Covid-19 guidelines. ","descriptionText":"CNN's u003ca href="https://www.cnn.com/profiles/brian-todd-profile" target="_blank">Brian Toddu003c/a> reports on high-ranking officials, including Austin, Texas, Mayor Steve Adler and Governor Gavin Newsom (D-CA), going against their own Covid-19 guidelines. "},{"title":"California issues stay-at-home order to battle Covid-19 surge","duration":"02:18","sourceName":"CNN","sourceLink":"http://www.cnn.com","videoCMSUrl":"/video/data/3.0/video/politics/2020/12/03/california-coronavirus-stay-at-home-order-hill-pkg-vpx-tsr.cnn/index.xml","videoId":"politics/2020/12/03/california-coronavirus-stay-at-home-order-hill-pkg-vpx-tsr.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201203123552-california-covid-testing-1202-large-169.jpg","videoUrl":"/videos/politics/2020/12/03/california-coronavirus-stay-at-home-order-hill-pkg-vpx-tsr.cnn/video/playlists/coronavirus/","description":"California Gov. Gavin Newsom announced a new stay-at-home order that will take hold in regions where hospitals are feeling the squeeze on capacity to treat the incoming surge of Covid-19 patients. CNN's Erica Hill reports.","descriptionText":"California Gov. Gavin Newsom announced a new stay-at-home order that will take hold in regions where hospitals are feeling the squeeze on capacity to treat the incoming surge of Covid-19 patients. CNN's Erica Hill reports."},{"title":"Funeral home manager: It keeps getting worse by the day","duration":"03:30","sourceName":"CNN","sourceLink":"https://www.cnn.com","videoCMSUrl":"/video/data/3.0/video/health/2020/12/03/funeral-homes-slammed-coronavirus-pandemic-jose-amezcua-intv-nr-vpx.cnn/index.xml","videoId":"health/2020/12/03/funeral-homes-slammed-coronavirus-pandemic-jose-amezcua-intv-nr-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201203161821-funeral-homes-slammed-coronavirus-pandemic-jose-amezcua-intv-nr-vpx-00000119-large-169.jpg","videoUrl":"/videos/health/2020/12/03/funeral-homes-slammed-coronavirus-pandemic-jose-amezcua-intv-nr-vpx.cnn/video/playlists/coronavirus/","description":"Funeral homes across the country are scrambling to keep up with the u003ca href="http://www.cnn.com/world/live-news/coronavirus-pandemic-12-03-20-intl/index.html" target="_blank">soaring coronavirus death tollu003c/a>. In El Paso, Texas, the city's largest funeral home, Sunset Funeral Homes, has far exceeded its average annual number of services. CNN's u003ca href="http://www.cnn.com/profiles/brooke-baldwin-profile" target="_blank">Brooke Baldwinu003c/a> speaks with manager Jose Amezcua about how the pandemic changed their operations.","descriptionText":"Funeral homes across the country are scrambling to keep up with the u003ca href="http://www.cnn.com/world/live-news/coronavirus-pandemic-12-03-20-intl/index.html" target="_blank">soaring coronavirus death tollu003c/a>. In El Paso, Texas, the city's largest funeral home, Sunset Funeral Homes, has far exceeded its average annual number of services. 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Hear her story from CNN affiliate WPIX."},{"title":"Watch nurse's desperate plea after household falls ill with coronavirus","duration":"06:44","sourceName":"CNN","sourceLink":"http://www.cnn.com","videoCMSUrl":"/video/data/3.0/video/health/2020/12/03/nurse-sofia-burke-ctn-intv-family-covid-19-vpx.cnn/index.xml","videoId":"health/2020/12/03/nurse-sofia-burke-ctn-intv-family-covid-19-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201202230314-nurse-sofia-burke-large-169.jpg","videoUrl":"/videos/health/2020/12/03/nurse-sofia-burke-ctn-intv-family-covid-19-vpx.cnn/video/playlists/coronavirus/","description":"CNN's Don Lemon talks with nurse Sofia Burke, where 7 of the 8 household members have been stricken with coronavirus.","descriptionText":"CNN's Don Lemon talks with nurse Sofia Burke, where 7 of the 8 household members have been stricken with coronavirus."},{"title":"Alabama mom raising 12 kids after sister died from Covid-19","duration":"01:42","sourceName":"wbrc","sourceLink":"https://www.wbrc.com/","videoCMSUrl":"/video/data/3.0/video/us/2020/12/03/mom-raising-12-kids-after-sister-die-coronavirus-pkg-vpx.wbrc/index.xml","videoId":"us/2020/12/03/mom-raising-12-kids-after-sister-die-coronavirus-pkg-vpx.wbrc","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201202193233-alabama-mom-large-169.jpg","videoUrl":"/videos/us/2020/12/03/mom-raising-12-kids-after-sister-die-coronavirus-pkg-vpx.wbrc/video/playlists/coronavirus/","description":"Alabama woman Francesca McCall is now u003ca href="https://www.cnn.com/2020/12/02/us/coronavirus-sister-raising-12-kids-trnd/index.html" target="_blank">taking care of 12 childrenu003c/a> after losing her younger sister, Chantale McCall, to Covid-19.","descriptionText":"Alabama woman Francesca McCall is now u003ca href="https://www.cnn.com/2020/12/02/us/coronavirus-sister-raising-12-kids-trnd/index.html" target="_blank">taking care of 12 childrenu003c/a> after losing her younger sister, Chantale McCall, to Covid-19."},{"title":"He works in a Covid-19 unit in a parking garage. Trump called it fake","duration":"04:21","sourceName":"CNN","sourceLink":"http://www.cnn.com/","videoCMSUrl":"/video/data/3.0/video/politics/2020/12/03/nevada-dr-larry-keeperman-coronavirus-parking-garage-unit-trump-ebof-sot-vpx.cnn/index.xml","videoId":"politics/2020/12/03/nevada-dr-larry-keeperman-coronavirus-parking-garage-unit-trump-ebof-sot-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201202195944-dr-larry-keeperman-vpx-large-169.jpg","videoUrl":"/videos/politics/2020/12/03/nevada-dr-larry-keeperman-coronavirus-parking-garage-unit-trump-ebof-sot-vpx.cnn/video/playlists/coronavirus/","description":"As the coronavirus pandemic grows more dire across the US, Dr. Larry Keeperman treats patients in a Covid-19 unit run out of a parking garage in Nevada. After Keeperman tweeted a photo of the unit, President Donald Trump called it "fake" and echoed his false claims about the Nevada election results. Keeperman responds to Trump in an interview with CNN's Erin Burnett.","descriptionText":"As the coronavirus pandemic grows more dire across the US, Dr. Larry Keeperman treats patients in a Covid-19 unit run out of a parking garage in Nevada. After Keeperman tweeted a photo of the unit, President Donald Trump called it "fake" and echoed his false claims about the Nevada election results. Keeperman responds to Trump in an interview with CNN's Erin Burnett."},{"title":"Covid-19 vaccine trial volunteer describes side effects","duration":"03:04","sourceName":"CNN","sourceLink":"http://www.cnn.com/","videoCMSUrl":"/video/data/3.0/video/health/2020/12/02/moderna-coronavirus-vaccine-trial-volunteer-side-effects-gupta-pkg-lead-vpx.cnn/index.xml","videoId":"health/2020/12/02/moderna-coronavirus-vaccine-trial-volunteer-side-effects-gupta-pkg-lead-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201202171822-yasir-batalvi-moderna-trial-gupta-vpx-large-169.jpg","videoUrl":"/videos/health/2020/12/02/moderna-coronavirus-vaccine-trial-volunteer-side-effects-gupta-pkg-lead-vpx.cnn/video/playlists/coronavirus/","description":"CNN's Dr. Sanjay Gupta talks with Moderna Covid-19 vaccine trial participant Yasir Batalvi about the side effects he's experienced.","descriptionText":"CNN's Dr. Sanjay Gupta talks with Moderna Covid-19 vaccine trial participant Yasir Batalvi about the side effects he's experienced."},{"title":"'It's so hard': Pandemic taking a toll on frontline workers","duration":"03:16","sourceName":"CNN","sourceLink":"https://www.cnn.com/?refresh=1","videoCMSUrl":"/video/data/3.0/video/health/2020/12/02/frontline-workers-colorado-covid-19-pandemic-kafanov-dnt-newday-vpx.cnn/index.xml","videoId":"health/2020/12/02/frontline-workers-colorado-covid-19-pandemic-kafanov-dnt-newday-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201202081657-kafanov-colorado-frontline-workers-large-169.jpg","videoUrl":"/videos/health/2020/12/02/frontline-workers-colorado-covid-19-pandemic-kafanov-dnt-newday-vpx.cnn/video/playlists/coronavirus/","description":"CNN's u003ca href="http://www.cnn.com/profiles/lucy-kafanov" target="_blank">Lucy Kafanovu003c/a> speaks with two frontline workers in Colorado about the hardships of being in the medical field during the coronavirus pandemic.","descriptionText":"CNN's u003ca href="http://www.cnn.com/profiles/lucy-kafanov" target="_blank">Lucy Kafanovu003c/a> speaks with two frontline workers in Colorado about the hardships of being in the medical field during the coronavirus pandemic."},{"title":"'It's a huge move': Dr. Gupta on UK's vaccine approval","duration":"02:52","sourceName":"CNN","sourceLink":"https://www.cnn.com/","videoCMSUrl":"/video/data/3.0/video/health/2020/12/02/uk-pfizer-biontech-coronavirus-vaccine-approval-gupta-sot-newday-vpx.cnn/index.xml","videoId":"health/2020/12/02/uk-pfizer-biontech-coronavirus-vaccine-approval-gupta-sot-newday-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201202073620-gupta-vaccine-sot-newday-vpx-large-169.jpg","videoUrl":"/videos/health/2020/12/02/uk-pfizer-biontech-coronavirus-vaccine-approval-gupta-sot-newday-vpx.cnn/video/playlists/coronavirus/","description":"The United Kingdom has become the u003ca href="https://www.cnn.com/2020/12/02/uk/pfizer-coronavirus-vaccine-uk-intl-hnk/index.html" target="_blank">first Western nation to approve a Covid-19 vaccine,u003c/a> a landmark moment in the coronavirus pandemic that paves the way for the first doses to be rolled out across the country. CNN's u003ca href="https://www.cnn.com/profiles/sanjay-gupta-profile" target="_blank">Dr. Sanjay Guptau003c/a> discusses.","descriptionText":"The United Kingdom has become the u003ca href="https://www.cnn.com/2020/12/02/uk/pfizer-coronavirus-vaccine-uk-intl-hnk/index.html" target="_blank">first Western nation to approve a Covid-19 vaccine,u003c/a> a landmark moment in the coronavirus pandemic that paves the way for the first doses to be rolled out across the country. CNN's u003ca href="https://www.cnn.com/profiles/sanjay-gupta-profile" target="_blank">Dr. Sanjay Guptau003c/a> discusses."},{"title":"CNN looks into how China plans to ship Covid-19 vaccines ","duration":"03:04","sourceName":"CNN","sourceLink":"https://www.cnn.com/","videoCMSUrl":"/video/data/3.0/video/world/2020/12/02/china-coronavirus-vaccine-distribution-aircraft-culver-pkg-intl-vpx.cnn/index.xml","videoId":"world/2020/12/02/china-coronavirus-vaccine-distribution-aircraft-culver-pkg-intl-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201201230900-china-vaccine-distibution-aircraft-culver-pkg-vpx-large-169.jpg","videoUrl":"/videos/world/2020/12/02/china-coronavirus-vaccine-distribution-aircraft-culver-pkg-intl-vpx.cnn/video/playlists/coronavirus/","description":"CNN received exclusive access to infrastructure preparations at Shenzhen Airport in southern China where Alibaba's logistics and shipping unit, Cainiao, has prepared climate-controlled storage chambers and aircraft cabins to distribute Covid-19 vaccines to parts of the Middle East, Africa and Latin America as soon as China's Central Government approves them. ","descriptionText":"CNN received exclusive access to infrastructure preparations at Shenzhen Airport in southern China where Alibaba's logistics and shipping unit, Cainiao, has prepared climate-controlled storage chambers and aircraft cabins to distribute Covid-19 vaccines to parts of the Middle East, Africa and Latin America as soon as China's Central Government approves them. "},{"title":"Infectious disease expert on new quarantine time: This is a smart move","duration":"01:05","sourceName":"CNN","sourceLink":"https://www.cnn.com/","videoCMSUrl":"/video/data/3.0/video/health/2020/12/02/michael-osterholm-coronavirus-quarantine-time-cdc-ctn-vpx.cnn/index.xml","videoId":"health/2020/12/02/michael-osterholm-coronavirus-quarantine-time-cdc-ctn-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201201235549-michael-osterholm-ctn-12-1-2020-vpx-large-169.jpg","videoUrl":"/videos/health/2020/12/02/michael-osterholm-coronavirus-quarantine-time-cdc-ctn-vpx.cnn/video/playlists/coronavirus/","description":"The CDC will soon issue new guidelines decreasing coronavirus quarantine time from 14 to 7-10 days, two senior administration officials told CNN. CNN's Don Lemon discusses with infectious disease expert Michael Osterholm. ","descriptionText":"The CDC will soon issue new guidelines decreasing coronavirus quarantine time from 14 to 7-10 days, two senior administration officials told CNN. CNN's Don Lemon discusses with infectious disease expert Michael Osterholm. "},{"title":"Here's what you need to know about getting the Covid-19 vaccine","duration":"03:16","sourceName":"CNN","sourceLink":"https://www.cnn.com/","videoCMSUrl":"/video/data/3.0/video/health/2020/12/01/what-you-need-to-know-about-getting-coronavirus-vaccine-todd-tsr-pkg-vpx.cnn/index.xml","videoId":"health/2020/12/01/what-you-need-to-know-about-getting-coronavirus-vaccine-todd-tsr-pkg-vpx.cnn","videoImage":"//cdn.cnn.com/cnnnext/dam/assets/201201181444-coronavirus-vaccine-dnt-todd-tsr-12012020-large-169.jpg","videoUrl":"/videos/health/2020/12/01/what-you-need-to-know-about-getting-coronavirus-vaccine-todd-tsr-pkg-vpx.cnn/video/playlists/coronavirus/","description":"CNN's u003ca href="https://www.cnn.com/profiles/brian-todd-profile" target="_blank">Brian Toddu003c/a> reports on what we need to know about the safety, side effects and timelines of the Covid-19 vaccine. ","descriptionText":"CNN's u003ca href="https://www.cnn.com/profiles/brian-todd-profile" target="_blank">Brian Toddu003c/a> reports on what we need to know about the safety, side effects and timelines of the Covid-19 vaccine. "}],'js-video_headline-featured-1hpthb6','',"js-video_source-featured-1hpthb6",true,true,'coronavirus');if (typeof configObj.context !== 'string' || configObj.context.length

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Why was the UK first to authorize a coronavirus vaccine? - CNN

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How the pandemic enabled a robot revolution – Politico

Friday, December 4th, 2020

Future Pulse is a new weekly newsletter exploring the rapidly changing world of health care and technology. We call out fads from real advances, chronicle experimentation and investigate the tension between innovation, regulation and privacy. Join the conversation!

JUST WHAT THE ROBOT ORDERED: At several Texas health networks, a friendly-looking robot with a mechanical arm and blinking lights for eyes can be seen whirring around the hospital floor, ferrying lab samples and protective gear for nursing staff. At Bostons Brigham & Womens this summer, a roaming four-legged robot with mounted infrared cameras loped into the emergency department to take patients vital signs. At Los Angeles Adventist Health White Memorial, seven devices the size of mini-fridges zip around to disinfect patient rooms with UV light.

Whether theyre restocking supply rooms or taking patients heart rates, the roving machines could help contain the coronavirus spread by cutting down on possible exposure between staff and patients, health system leaders say. The systems were already in the early stages of piloting robots before the pandemic, but the crisis has generated more interest than ever, robotics experts tell us. The big question is whether to rush to automate is pushing aside viable existing technologies

What were trying to do is introduce ways of really preserving safety of health care personnel by having assistance ... in doing tasks that can essentially be handed off to a robot, says MIT assistant professor Giovanni Traverso, part of the research team that sent Boston Dynamics dog-like robot named Spot into Brigham & Womens exam rooms to measure vital signs like temperature and blood pressure.

Rich Pedroncelli/AP Photo

Stopped at the door: Still, there are lots of mundane challenges some robots havent been able to overcome, like walking up stairs or opening certain types of doors. For robots in general, the standard doorknob is still going to be most challenging, says Andrew Rossi of Diligent Robotics, which created the Moxi robot used in the Texas health systems.

And anytime the robots are deployed to a new health system, they have to be programmed with new instructions. We have to understand what elevators they use and how they badge in and out of doors and then we have to make adjustments, Rossi said.

Theres much to learn before health systems go all in with robots, MITs Traverso said. His team is exploring whether Boston Dynamics Spot, which retails for about $75,000, is worth the investment. Theyre also considering patients comfort levels with the robot caregivers, which Traverso admits might be a little jarring. In general, though,people are curious and kind of fascinated by this robot, he says.

A simpler approach?: And the biggest question remains is the high-tech way ultimately the better way?

I think we need to further expand our understanding and exposure to robots and see them in different settings, Traverso says. The main question is, do we need that level of sophistication, or are there simpler systems?

Welcome back to Future Pulse, where we explore the convergence of health care and technology. Share your news and feedback: @dariustahir, @ravindranize, @ali_lev, @katymurphy.

Next week, POLITICO will feature a special edition Future Pulse newsletter at the Milken Institute Future of Health Summit. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators determined to confront and conquer the most significant health challenges. Covid-19 has exposed weaknesses across our health systems, particularly in the treatment of our most vulnerable communities, driving the focus of the 2020 conference on the converging crises of public health, economic insecurity, and social justice.

Michael Anne Kyle @michaelannica "Being in year 5 of a PhD in health policy, I have spent a very large amount of time thinking about waste, moral hazard, unnecessary utilization, consumer decision-making, etc. And yet this week I went to the ED for a broken toe."

The percentage of telehealth visits for mental health services rose in most regions this year, possibly due to increased stress, FAIR Health's president Robin Gelburd says. Variation could be due to differences in substance use disorder diagnoses.

A periodic feature delivering insights from health and tech leaders on how the pandemic is changing the medical system.

Its been less than a year since Chinese scientists shared the Covid-19 genetic sequence, allowing the sprint for a vaccine to commence. Now, states have until the end of this week to tell the federal government how they plan to distribute shots that could be shipped within 24 hours of FDA authorization.

Experts told us they have a multitude of concerns over how the vaccines are allocated to states, wholl get the shots first, and misinformation spreading online.

This is the first time in the history of our country where we are launching multiple novel vaccines all at once that have different dosing, complex scheduling and challenging transport, storage and administration requirements, says Vivian Riefberg, former co-lead of McKinseys U.S. health care practice and now professor of practice at University of Virginias Darden School of Business. Combine this with at least 50 different high level distribution plans (each state) using a range of inexperienced and experienced health care professionals in delivering these products. Then add to that overall market confusion for consumers about the various products. Will we have the right coordinated logistics and campaign to ensure the vast majority of people have timely access and take the vaccine?

David Blumenthal, president of the Commonwealth Fund, which has studied states immunization track records, said his big concern is that many states may not have the resources they need to implement an emergency population-wide immunization plan. Commonwealths research, he said, found huge variation across states in their past success in vaccinating their populations against influenza and other infectious diseases. States also display considerable differences in their ability to immunize populations of color, who suffer disproportionately from Covid-19.

We should leverage primary care providers, who have built trusting relationships with their patients, to educate the public and administer vaccines, says Farzad Mostashari, CEO of Aledade and a former national coordinator for health IT in the Obama administration. As front line workers, they should also be prioritized to receive the vaccines themselves. My biggest concern is that distribution may leave out smaller independent practices, especially in rural and underserved areas where their participation is needed most.

Im less concerned about the nuts and bolts of physical distribution, says Robert Wachter, professor and chair of the Department of Medicine at University of California, San Francisco. Im more concerned about misinformation about side effects ... When you vaccinate 200 million people, a fair number of them will have strokes, cancer or heart attacks in the months after vaccination. Some will spin these into vaccine side effects.

Paul Barrett, deputy director of the NYU Stern Center for Business and Human Rights, worries that the drumbeat of false information online will discourage vaccination. Even before Covid-19, a loud chorus of anti-vaxxer activists, some of whom wrapped their views in various conspiracy theories, had become prominent on the major social media platforms, he said. The coming Covid-vaccination push will almost certainly provoke this contingent into redoubling their activities.

GOOGLES LATEST BID FOR HOSPITAL AND PATIENT DATA: The tech giants forays into health care havent always been welcomed: Its data-collection partnership with the hospital chain Ascension is still under HHS investigation for potential violations of the health privacy law HIPAA. But POLITICO's Mohana Ravindranath writes Googles cloud business is now marketing itself as a technical facilitator for hospitals and insurers, as part of the broader push to share patient data between electronic health records and apps.

Google executives say the effort can relieve hospitals and insurers from the burden of doing a huge technical undertaking on their own. Beyond that, the company is prodding the industry to think bigger about how the digital overhaul can improve patient care, said Google Clouds global health care director Aashima Gupta. This could include new ways to analyze clinical data or building apps that could help patients manage their condition.

Patients may want better access to their health data, but its not clear if theyll trust this latest venture to safeguard theirs. Asked whether shes seen pushback from providers wary of Silicon Valleys expansion into health care, Gupta stressed the company aimed to be sensitive to the needs of clinicians and patients alike. "Consumers are demanding better ways to access their data," she said.

THE PROMISE AND PITFALLS OF AI: Artificial intelligence has been eyed as an easy fix for a health care system facing strain from the pandemic, an aging population and rising costs. Still, the technology raises ethical, legal, economic, and social questions policymakers must confront in order to realize its full potential, concludes a new report to Congress.

Jacquelyn Martin/AP Photo

The Government Accountability Office and the National Academy of Medicine in a joint inquiry acknowledge that AI has shown promise in predicting health outcomes, recommending treatment and helping to record clinical notes, among other tasks. But significant challenges persist. For instance, the technical experts building these tools cant always rely on high-quality data, potentially perpetuating bias that affects patient care. And how these systems work arent always transparent to patients or clinicians, which can undermine trust.

Given those trade-offs, the report offers six paths for Congress and federal regulators to consider, though it offers no recommendations. These include allowing the technology to flourish without government intervention (though GAO noted this could also increase disparities) and working with outside groups to encourage better data sharing and AI testing. Authors noted that groups with proprietary data and technology might be reluctant to participate.

TRUMP ADMIN CEMENTS VIRTUAL CARE CHANGES: The federal Medicare agency on Tuesday approved expanded coverage of telehealth services, ensuring some pandemic policies will last beyond the public health emergency period. Medicare will pay for 60 more telehealth services, though the changes wont do much for patients outside rural areas when the emergency declaration is lifted. Medicare payment law generally restricts telehealth coverage to patients in rural areas, unless Congress makes a change.

Alcoholics Anonymous goes to Zoom, reports the New York Times.

Science Magazine probes HHSs controversial coronavirus data system, alleges discrepancies.

STAT delves into a new artificial intelligence feat from the folks at Google DeepMind: folding proteins.

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How the pandemic enabled a robot revolution - Politico

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The mink link: How COVID-19 mutations in animals affect human health and vaccine effectiveness – The Conversation CA

Tuesday, November 24th, 2020

The importance of commercially raised animals in the COVID-19 pandemic has received much attention in the past few weeks, when a new variant of SARS-CoV-2 was detected in farmed mink. Unfortunately, mink tend to be relatively susceptible to respiratory infections, and these can readily spread through mink farms due to high-density housing.

Data from the Netherlands earlier in the pandemic have revealed that mink can be readily infected with SARS-CoV-2 and then pass the virus to humans. In Denmark, 214 people people have been infected by a variant of SARS-CoV-2 that is presumed to have mutated in Danish mink. Over 200 mink farms had tested positive for SARS-CoV-2, and at least five different mink variants of the virus have been detected so far.

These events initiated a mass culling of farmed mink in that country (although this was limited due to legal issues), and cast a spotlight on the disturbing scenario of human-to-mink-to-human transmission of SARS-CoV-2, with potential for the virus to change in mink prior to re-infecting people.

Specifically, this latest occurrence unveils the possibility that mink can serve as an alternate host to promote mutations of SARS-CoV-2, which can be passed back to humans and other animals, both domestic and wild and potentially placing the wild mustelid (minks, ferrets and related species) population at risk.

We are researchers in the fields of virology, immunology and pathology. Our research programs bridge human and animal health and study the transmission of viruses, immune responses to viruses, how viruses cause diseases, and developing strategies such as vaccines to prevent infectious diseases. The recent news linking mink to the current pandemic highlights the importance of research at the interface of animal and human health.

Since the start of the COVID-19 pandemic, the world has learned much about virology, as well as the concept of One Health. At the core of One Health is the idea that human and animal health are intertwined in a shared environment, and that we need to broaden our perspectives beyond human health alone.

Indeed, animals have been at the centre of this pandemic from the beginning. Overwhelming evidence suggests that this coronavirus (SARS-CoV-2), which causes COVID-19, originated from bats. There is debate about whether an intermediate animal host might have harboured additional changes to SARS-CoV-2 to produce the current virus that spreads efficiently person to person. The leading candidate for this is a scaly anteater known as a pangolin.

What is known for sure is that changes to coronaviruses can occur over time due to inherent and purposeful errors in these viruses ability to copy their genetic codes. This allows a virus to make small changes over time and is an efficient way for them to adapt to new environments.

One of the recently identified Danish mink strains is particularly concerning because changes in the genome occurred in what is called the viruss spike protein, which it uses to enter human cells. These changes have been detected in 12 human cases related to this particular mink variant. Fortunately, this change does not seem to correlate with worse clinical outcomes, based on a small number of cases.

The spike protein is also the primary target of natural and vaccine-induced immune responses to the virus. In theory, if SARS-CoV-2 mutates too much, the immunity derived from the parental virus, acquired either by natural infection or vaccination, could become less effective against the new strain.

The good news is that, so far, theres no evidence that the mink-derived SARS-CoV-2 mutant can bypass natural or vaccine-induced immunity. Fortunately, our immune systems are designed to generate antibodies against multiple parts of the spike protein. This means that if only a small part of the spike protein is mutated, antibodies against other parts of the protein should still confer at least some protection.

The fact that SARS-CoV-2 can change highlights the need for vaccines that not only induce protective antibodies but that can also elicit robust T cell responses, which is the other major mechanism by which our immune systems can kill viruses. Like antibodies, T cells will target multiple parts of viral proteins, thereby increasing the chance of maintaining immunity against non-mutated regions of the proteins.

It might also be important to consider making vaccines that target more than one of the proteins from SARS-CoV-2. Its very difficult for a virus to make major changes to multiple proteins without compromising its fitness.

Read more: Training our immune systems: Why we should insist on a high-quality COVID-19 vaccine

The other issue that the mink SARS-CoV-2 brings to the forefront of the vaccine development effort is the need for vaccines that are plug-and-play. These are vaccine technologies where the viral protein the vaccine is designed to target can be readily swapped with a different version of the viral protein.

Once approved by health regulators as being safe and efficacious against a highly pathogenic coronavirus, such technologies could, in theory, be rapidly modified to target emerging mutant viruses; akin to the annual flu vaccine that gets modified every year to target emerging influenza virus variants.

With mink being confirmed only recently as a possible reservoir for SARS-CoV-2, more research is urgently needed to inform rationally based decisions to cull millions of these animals. Even if mass cullings continue, it is unlikely that mink farms will be completely phased out at the global level in the near future. So the question becomes how do we manage the potential threat to human health of SARS-CoV-2 in mink over the long term?

First, enhanced biosecurity measures should be implemented on mink farms.

Second, screening of farmed mink for coronaviruses should be added to the surveillance programs of animal health regulatory agencies, with this information made available to human health regulators.

Third, consideration could be given to tailoring COVID-19 vaccines for animal reservoirs, which would now include farmed mink. These recommendations would not only reduce the potential spread of coronaviruses from mink to humans, it would simultaneously address SARS-CoV-2-related health issues for mink. Indeed, mink can develop COVID-19 after becoming infected with SARS-CoV-2 and it can sometimes be severe and lethal, with no effective current treatment.

Unless future evidence suggests otherwise, it may be best to stay the course with current vaccine development programs with the goal of getting multiple technological platforms approved for use in humans. Then these platforms can be readily modified, akin to the annual influenza vaccine, to target emerging mutant viruses, if warranted.

Simultaneously, public health agencies with any interest in promoting human health should expand their visions to include the health and surveillance of domestic animals and wildlife at the point where human and veterinary medicine interface.

In the case of SARS-CoV-2, humans are currently the largest reservoir of the virus on Earth, and the threat of spillover from human hosts to farmed animals and wildlife species is now made evident. This is an opportune time to take stock in our relationships with animals and the natural world and take action to ensure health for all and this biosphere we share.

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The mink link: How COVID-19 mutations in animals affect human health and vaccine effectiveness - The Conversation CA

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How vaccines get made and approved in the US – The Albany Herald

Tuesday, November 24th, 2020

COVID-19 and its wide-ranging impacts on the lives of nearly everyone on the planet have brought vaccines to the forefrontif a suitable vaccine can be found and widely distributed, then life could perhaps resume some semblance of normalcy. People around the world are waiting impatiently for news of vaccine trials from companies such as Pfizer, Moderna, and AstraZeneca.

Already there have been some promising developments. On Nov. 16, Moderna released the results of a study that showed their vaccine has a 94% rate of effectiveness. While the results of their 30,000-person Phase 3 trial have not yet been published, researchers said that the results show that the vaccine is safe and effective. On Nov. 18,Pfizer and its partner BioNTech announced it concluded its Phase 3 study (which began July 27) and determined their vaccine is95% effective. Pfizer and BioNTech will submit arequest forEmergency Use Authorization by the FDA as soon as possible and plans to share their data with global regulatoryagencies.

The news from both companies has given people hope that the SARS-CoV-2 virus that causes COVID-19 can eventually be controlled. However, there is also mistrust surrounding vaccines, and often a lack of understanding about how they are created, how they are tested, and how safe they are. If people dont trust the vaccine, then people wont take it, and the pandemic could go on longer.

Some of this lack of trust comes from a lack of information or misinformation. In order to demystify vaccines and the vaccine manufacturing and approval process in the United States, Stacker consulted the Food & Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and other public health sources to better understand and explain vaccines to the general public.

After going through these authoritative health information sources, Stacker identified some key terms to help readers better understand the types of vaccines and how they work, and then listed the many steps involved in the creation, approval, and distribution of new vaccines in the U.S. We then created a list of 30 key terms and steps, showing how intensive and precise the vaccine creation and approval process is, and ultimately that vaccines are safe and effective tools for fighting disease.

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How vaccines get made and approved in the US - The Albany Herald

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Legalization votes bring worries of increased youth marijuana use, but evidence remains murky – AberdeenNews.com

Tuesday, November 24th, 2020

One major concern of South Dakotans who opposed legalization of medical and recreational marijuana was that it could lead to an epidemic of youth use of the drug.

Drug-abuse prevention advocates and law enforcement officials said greater availability of marijuana would almost certainly lead to an increase of use among children and teens whose brains are still developing.

Despite their concerns, however, research conducted by the federal Centers for Disease Control and Prevention and the National Institutes of Health has not found an increase in the regular use of marijuana among youths in Oregon, Washington or Colorado, the states where marijuana legalization has been most extensively studied.

Colorado, for example, has a lower overall youth marijuana use rate than the U.S. as a whole. And in all three states, as in the rest of the U.S., there has been a long-term decline in the regular use of marijuana among youths.

Those statistics provide little comfort, however, for those in South Dakota who are on the front lines of the battle to prevent drug abuse by youth.

Marijuana use is associated with poorer performance in school, increased risk for mental health disorders and other negative behavior outcomes for youth, said Maureen Murray, director of mental health and prevention services at Youth and Family Services in Rapid City.

It is concerning because legalization makes people think that using marijuana is safe and doesnt have consequences, and teens dont need to hear that, Murray said. We have very significant concerns with teens.

South Dakota voters approved statewide ballots measures on Nov. 3 that have set the stage for legalization of both medicinal and recreational marijuana in July. Marijuana would be legal only for those 21 and over. South Dakota was one of four new states to legalize recreational marijuana bringing the total to 15. Medical marijuana will soon be legal in 36 states.

Regular marijuana use is defined in surveys as respondents having used the drug at least once during the 30 days before they took the survey. Research has shown that regular and heavy use of marijuana among teens carries the most risk for long-term negative effects.

National surveys such as the biennial Youth Risk Behavior Survey have shown small declines in the number of youths regularly using both marijuana and alcohol over the past decade. South Dakota has generally followed the national trend, with surveys showing a decline in regular youth marijuana use from 17.8% of youths surveyed in 2011 compared to only 16.5% in 2019.

Colorado, where recreational marijuana has been legal since 2014, also has seen declines in youth marijuana use. From 2011 to 2019, the youth use rate dropped from 22% in 2011 to 20.1% in 2019. Prevention experts say national and state education programs and prevention efforts have played a big role in declines in youth marijuana use.

Concerns over marijuana legalization among the South Dakota drug-abuse prevention community range from worries over use by motorists to the potential for women to harm children by using marijuana while pregnant or breastfeeding, said Darcy Jensen, executive director of Prairie View Prevention Services. Jensen is a licensed addiction counselor and a leader of the Coalition for a Drug Free South Dakota.

Members of the coalition met Nov. 12 to begin planning a response to marijuana legalization, Jensen said. Though reform was badly needed in how marijuana and other drug use has been treated by the criminal justice system, full legalization of marijuana was not the best way to fix those problems and may lead to new issues, Jensen said.

I dont know that this was a place that I would want South Dakota to be in, but we are, so we need to find ways to counter it, and continue to provide positive prevention education, Jensen said.

Legalizing marijuana causes new social and health problems, Jensen said, citing reports from Colorado showing that the number of traffic fatalities in which a driver tested positive for marijuana increased from 18% in 2013 to 32% in 2017.

Meanwhile, the rate of marijuana-related hospitalizations has risen sharply from an average of 1,440 per 100,000 hospitalizations annually from 2010 to 2013 to 3,517 last year. But perhaps most concerning, Jensen said, was that the number of suicide victims found to have marijuana in their bloodstreams increased.

A closer look at Colorado data reveals a nuanced, inconclusive picture of marijuana legalization. In 2018 the state Department of Public Safety published a comprehensive report on impacts of marijuana legalization. The report shows that while Colorado has seen an increase in its number of traffic fatalities, eight states with similar populations and traffic patterns that had not legalized marijuana also saw similar increases in traffic deaths. Pinning the rise in Colorado traffic deaths solely on marijuana legalization was not possible, the report said.

Furthermore, Colorados rising number of marijuana-related hospitalizations might have been influenced by changes in how hospitals track diagnoses. The healthcare industry in 2015 updated the diagnosis codes used for billing, creating many new coding categories. More codes meant doctors had more options to indicate whether they believe a patient had been using marijuana prior to being hospitalized, the 2018 Colorado public safety report said.

Suicide rates in Colorado have increased less only slightly, from 19.7% in 2012 to 20.5% in 2016. The rate of Colorado suicide victims testing positive for marijuana has nearly doubled from 11.8% in 2012 to 22.3% in 2016. Nationally, about 22.4% of suicide victims tested positive for marijuana in 2016, data that includes states where marijuana is not legal, according to a 2018 CDC report.

Still, experts studying youth marijuana use and the effects of marijuana on brain development say that South Dakotas drug-abuse prevention advocates are right to be concerned about legalization. While there does not appear to have been sharp increases in the number of children and teens using marijuana in states that have legalized, legalization remains a relatively new concept and longitudinal studies are few.

Little evidence exists to show that legalizing marijuana for medical purposes causes an increase in youth use of the drug. There also is little evidence, so far, that legalizing marijuana for recreational use leads to an increase in the overall number of children smoking or otherwise ingesting the drug. Instead, research shows adult use typically rises with legalization.

Once medical cannabis laws or medical marijuana laws are enacted, we usually see increases in use in adults ages 26 and older. But we dont see any increases in use among adolescents, which is good, said Dr. Silvia Martins, director of the Substance Use Epidemiology Unit at Columbia University. Regarding recreational legalization of cannabis, most of the research has shown that increases in use is mainly among adults.

A September 2019 report from the National Institutes of Health found that Colorado has seen no increase in the number of adolescents using marijuana since legalization for adults 21 and over in 2014. The biennial Youth Risk Behavior Survey found that in 2019, Colorados estimated rate of youth marijuana use of 20.1% was lower than the national rate of 21.7%.

An October 2019 report from the CDC found that marijuana use among students in 10th and 12th grades in Washington state did not significantly change from the year 2000 to 2016. For students in 8th grade, the regular marijuana use rate fell by half, from 12% in 2000 to 6% in 2016. In Washington, legal sales of recreational marijuana began in 2014.

Still, researchers such as Martins caution that there has not been enough research into how legalizing recreational use of marijuana affects youth drug use to draw major conclusions.

At most, researchers have only had a few years of data to study, Martins said. Most of the data on population-wide youth marijuana use come from anonymous surveys of students administered in schools such as the Youth Risk Behaviors Survey. States conduct the survey in schools during odd-numbered years, and its results are reported to the CDC. Public health officials use the survey to monitor such things as drug and alcohol abuse among adolescents.

In Colorado, there have only been two Youth Risk Behavior Surveys conducted since legal sales of recreational marijuana began, one in 2017 and one in 2019.

Another potential factor in youth marijuana use is how children growing up watching their parents and other adults use marijuana will view the drug. Parents can have a strong influence on their childrens choices, said Magdalena Cerda, director of the Center for Opioid Epidemiology and Policy at New York Universitys Grossman School of Medicine.

Previous studies have found that if your parents use drugs, then the likelihood of you using drugs is going to be higher, Cerda said. Whether that is because you think it is more acceptable, or it is because drugs are more available to you, or because of something else entirely, is relatively unclear. But I would say that is a concern.

Another 10 years could pass before the normalizing effect of legalizing marijuana shows up in surveys of high school students, she said.

Researchers have identified some troubling trends among youths who regularly use marijuana. A few studies have found increases in Cannabis Use Disorder among youths who regularly use marijuana in states that have legalized recreational sales of the drug, Cerda said. Cannabis Use Disorder is generally diagnosed when someone cant quit using despite trying, starts having trouble at work or school due to marijuana use, or gives up social activities due to use of marijuana.

That is obviously a concern because dependence on cannabis actually has an effect on your life, on your interactions with others and on your work, Cerda said. Essentially, a cannabis addiction, particularly for adolescents, can have long-term effects.

Marijuana use has been associated with an increase in a persons risk for developing a mental health disorder, said J. Cobb Scott, an assistant professor of psychology at the University of Pennsylvania Perelman School of Medicine. There also is evidence that using marijuana can lead to psychotic episodes in people who already have schizophrenia. Psychotic episodes can lead to involuntary hospitalization, homelessness or suicide, Scott said.

One significant risk of marijuana use is in youths and young adults who potentially are at risk of schizophrenia or depression, said Scott, who has spent years researching how marijuana use affects brain function and mental health.

But just because someone who has mental illness has a history of marijuana use doesnt mean the drug caused the illness, Scott said. Researchers have attempted to prove marijuana use causes mental illness but have had mixed results.

A 2019 study of how marijuana use contributed to the prevalence of psychosis in adults in Europe, published in the medical journal The Lancet, found that people using high potency marijuana every day were five times more likely to develop psychosis than people who didnt use the drug. But a 2016 study of data collected by the National Epidemiological Survey on Alcohol and Related Conditions found no link between marijuana use and mental health disorders.

Theres evidence both ways right now, Scott said. And what we dont have is a lot of epidemiological evidence. We have seen increased use of cannabis over the last 15 years or so, but we dont have the hugely increased rates of psychosis that you might expect if that relationship were really strongly causal.

Part of the difficulty in pinning down whether or not marijuana can cause psychosis is that most of the research into how marijuana affects people has been observational. Researchers have essentially had to wait for people to start using the drug on their own before marijuanas effect on them can be studied. Because researchers are not controlling who uses the drug or how much theyre using, and are often not recording their subjects medical histories or IQ levels before they start using marijuana, it can be hard to know for sure the significance of the drugs impacts.

Drawing conclusions from observational research requires large sample sizes being studied over several years, Scott said.

Some of the best evidence of marijuanas effect on brain development and mental health comes from a study conducted in New Zealand. In the study, researchers followed more than 1,000 people from the age of eight until they turned 38.

The New Zealand researchers found that subjects who developed an addiction to marijuana and began using it heavily before turning 18 and remained addicted to the drug for many years lost an average of six Intelligence Quotient points. People who started using marijuana as adults did not lose any IQ points, the study found.

An ongoing study being conducted by the U.S. National Institutes of Health, called the Adolescent Brain Cognitive Development study, should give scientists a much better understanding of how marijuana affects young brains. The study will follow more 10,000 children aged 9 and 10 for a decade. Researchers will collect information on the children using brain scans, genetic and psychological tests, academic records and surveys. The study began in 2015.

One area where there is strong evidence of marijuanas effects on people is cognitive function, or how well a persons brain works. Many studies have shown that frequent cannabis use can impact cognitive functioning in specific areas, including memory and behavior, Scott said. Marijuanas cognitive effects, though, tend to wear off fairly quickly after someone quits using the drug.

A couple of larger studies have shown that heavy use starting before the age of 18, and going on pretty consistently for a number of years, may cause long term changes in cognitive functioning. But that is a very small group of people, Scott said.

Still, South Dakotans should be concerned about marijuana use among teenagers, Scott said. There are too many unknowns about the drugs effect on brain development. Studies of rats, for example, have shown that marijuana can affect the development of important parts of the brain such as the hippocampus, which plays a significant role in learning and memory.

We know that the brain continues to develop through the teenage years and into the mid-20s, Scott said. And we know that any psychoactive substance like cannabis can potentially affect brain development.

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Your daily 6: Third vaccine looks effective, no single ‘word of the year’ and Trump team called ‘a national embarrassment’ – Ravalli Republic

Tuesday, November 24th, 2020

HARTFORD, Conn. (AP) Jury duty notices have set Nicholas Philbrook's home on edge with worries about him contracting the coronavirus and passing it on to his father-in-law, a cancer survivor with diabetes in his mid-70s who is at higher risk of developing serious complications from COVID-19.

Philbrook and his wife, Heather Schmidt, of Camarillo, California, have been trying to convince court officials that he should be excused from jury duty because her father lives with them. But court officials told him that is not a valid reason and he must appear in court early next month.

"My main concern is you still have to go into a building, you still have to be around a set number of people," said Philbrook, 39, a marketing company editor. "In an enclosed space, how safe are you? It just doesn't feel like a right time still to be doing that kind of stuff on a normal basis."

People across the country have similar concerns amid resurgences of the coronavirus, a fact that has derailed plans to resume jury trials in many courthouses for the first time since the pandemic started.

Within the past month, courts in Hartford, Connecticut, San Diego and Norfolk, Virginia, have had to delay jury selection for trials because too few people responded to jury duty summonses. The non-response rates are much higher now than they were before the pandemic, court officials say.

Judges in New York City, Indiana, Colorado and Missouri declared mistrials recently because people connected to the trials either tested positive for the virus or had symptoms.

"What the real question boils down to are people willing to show up to that court and sit in a jury trial? said Bill Raftery, a senior analyst with the National Center for State Courts. "Many courts have been responsive to jurors who have said that they're not comfortable with coming to court and doing jury duty and therefore offering deferrals simply because of concerns over COVID."

Also this month, state court systems in Connecticut, New York and New Jersey and courts in Denver, Colorado, were among those to suspend all jury trials because of rising virus rates. On Friday, federal officials announced that about two dozen U.S. district courts across the county have suspended jury trials and grand jury proceedings because of virus outbreaks and too few people showing up for jury duty.

Courts are under pressure to resume trials because of the case backlogs piling up during the pandemic.

A few courts have held trials in person and by video conference. Although video conferences may appear to be the best bet, many criminal defense lawyers oppose them because it's harder to determine witness credibility and to see if jurors are paying attention, said Christopher Adams, a lawyer in Charleston, South Carolina, and president of the National Association of Criminal Defense Lawyers.

"For almost everybody, there is no compelling need for trials to go forward during the pandemic," he said, adding that most courts are not holding jury trials at the moment.

Adams said another concern is how representative juries would be if trials went ahead the virus' impact and the level of concern about it across different demographics, such as Black, Latino and elderly populations that are dying at higher rates, could affect who feels safe to serve jury duty.

"What we can't allow is to have trials where there's not a fair cross section of the community represented," he said.

But many criminal defense lawyers are pointing to a major issue with not holding trials defendants who are detained while awaiting trial. Although jails and prisons across the country have released thousands of low-risk inmates because of concerns about the virus, many people remain locked up in pretrial detention.

A case in federal court in Hartford, Connecticut, offers a glimpse of how the virus can upend proceedings.

In October, 150 people were summoned for jury duty for the trial of Amber Foley, who is fighting child pornography charges and demanding her constitutional right to a speedy trial. It would be the first criminal trial in Connecticut, in state or federal court, since the pandemic began.

Only about half the potential jurors showed up and many others were excused for various reasons including concerns about COVID-19. Only 19 people were left, short of the 31 people estimated to be needed to pick a jury of 12 and one alternate juror.

And then, two court security officers tested positive for the virus, forcing the temporary closure of the courthouse for cleaning and prompting Judge Vanessa Bryant's law clerk to go into isolation and get tested because of contact with the officers.

Bryant decided last week to postpone Foley's jury selection until mid-January. Like judges in other parts of the country, she ruled the interests of public health outweigh those of a speedy trial.

"Despite every effort being made by the Court, the Court must reluctantly conclude that it is unable to empanel a representative jury from the 200 prospective jurors summoned without jeopardizing the safety of all trial participants," Bryant wrote in a ruling.

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Your daily 6: Third vaccine looks effective, no single 'word of the year' and Trump team called 'a national embarrassment' - Ravalli Republic

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Cybersecurity depends on the user – Modern Diplomacy

Friday, November 20th, 2020

The UN is calling for authoritative scientific information and research to be made freely available, to accelerate research into an effective vaccine against the COVID-19 virus, help counter misinformation, and unlock the full potential of science.

Arguing that no-one is safe until everyone is safe, the World Health Organization (WHO) has, for several months, been urging countries and scientists to collaborate, in a bid to bring the pandemic under control. This has involved the creation, alongside governments, scientists, foundations, the private sector and other partners, of a groundbreaking platform to accelerate the development of tests, treatments and vaccines.

In October, the head of the agency, Tedros Ghebreyesus Adhanom, alongside human rights chief Michelle Bachelet, and Audrey Azoulay, Director-General of science, culture and education agency UNESCO, issued a call for Open Science, describing it as a fundamental matter of human rights, and arguing for cutting-edge technologies and discoveries to be available for those who need them most.

But what exactly does Open Science mean, and why does the UN insist on making it more widespread?

Open Science has been described as a growing movement aimed at making the scientific process more transparent and inclusive by making scientific knowledge, methods, data and evidence freely available and accessible for everyone.

The Open Science movement has emerged from the scientific community and has rapidly spread across nations. Investors, entrepreneurs, policy makers and citizens are joining this call.

However, the agency also warns that, in the fragmented scientific and policy environment, a global understanding of the meaning, opportunities and challenges of Open Science is still missing.

Open Science facilitates scientific collaboration and the sharing of information for the benefit of science and society, creating more and better scientific knowledge, and spreading it to the wider population.

UNESCO has described Open Science as a true game changer: by making information widely available, more people can benefit from scientific and technological innovation.

Because, in a world that is more inter-connected than ever before, many of todays challenges do not respect political or geographic borders, and strong international scientific collaboration is essential to overcome the problems. The COVID-19 pandemic is a prime example.

We also have the tools to make it happen: with digitalization becoming ever more widespread, it is far easier than ever before to share scientific knowledge and data, which are needed to enable decisions that can lead to overcoming global challenges to be based on reliable evidence.

In this global health emergency, thanks to international collaboration, scientists have improved their understanding of the coronavirus with unprecedented speed and openness, embracing the principles of Open Science. Journals, universities, private labs, and data repositories have joined the movement, allowing open access to data and information: some 115,000 publications have released information related to the virus and the pandemic, and more than 80 per cent of them can be viewed, for free, by the general public.

Early in the pandemic, for example, Chinese scientists readily shared the genome of the virus, jumpstarting all following research into the virus, and the diagnostic testing, treatments, and vaccines that have since been developed.

Finally, the crisis has underlined the urgent need to bring science closer to decision making and to society as a whole. Fighting misinformation and promoting evidence-based decision-making, supported by well-informed citizens, has proven to be of vital importance in the fight against COVID 19.

To ensure that Open Science truly meets its potential, and benefits both developed and developing countries, UNESCO is taking the lead in building a global consensus on values and principles for Open Science that are relevant for every scientists and every person independently of their place of origin, gender, age or economic and social background.

The future UNESCO Recommendation on Open Science is expected to be the international instrument to set the right and just standards for Open Science globally, which fulfil the human right to science and leave no one behind.

In a statement released on World Science Day for Peace and Development, celebrated on 10 November, Ms. Azoulay said that widening the scope of Open Science will help science to unlock its full potential, making it more effective and diverse by enabling anyone to contribute, but also to bring its objectives in line with the needs of society, by developing scientific literacy in an informed citizenry who take responsibility and are involved in collective decision-making.

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It’s Been Exactly One Year Since the First Case of COVID Was Found in China – Newsweek

Friday, November 20th, 2020

One year ago, a mysterious illness emerged in Wuhan, China, marking the start of the coronavirus pandemic that has now killed more than 1.25 million people around the world and infected tens of millions more.

In March, the South China Morning Post published an article based on Chinese government data that showed the first known case of COVID-19 can be traced back to November 17, 2019possibly a 55-year-old individual from Hubei province, although "patient zero" has yet to be confirmed.

Chinese authorities did not officially identify the first case of the new disease until December 8, 2019.

Over the weeks that followed, medical staff in Wuhan treated dozens of patients suffering from pneumonia of unknown cause. The patients were treated for a range of unexplained symptoms including high fever, coughing and respiratory problems.

Among these individuals were an elderly couple who sought treatment at Hubei Provincial Hospital of Integrated Chinese and Western Medicine on December 26. A doctor at the hospital who attended to the couple, Zhang Jixian, later told Chinese state-run news agency Xinhua in April that the illness "looked like flu or common pneumonia."

But CT scan images revealed lung abnormalities that were not characteristic of either of these diseases.

Zhang had worked as a medical expert during the SARS outbreak that originated in China in 2003, which went on to kill more than 800 people around the world. Given her experience with this epidemiccaused by a pathogen in the coronavirus familyshe was attuned to the possibility that the elderly couple's illnesses could represent a new infectious disease.

Once the doctor had seen the couple's CT scans, she requested that their son be examined as well.

"At first their son refused to be examined. He showed no symptoms or discomfort, and believed we were trying to cheat money out of him," Zhang told state news agency Xinhua at the time.

Eventually, the son agreed to be examined, with his CT scans showing that he had the same lung abnormalities that were detected in his parents. "It is unlikely that all three members of a family caught the same disease at the same time unless it is an infectious disease," Zhang said.

On December 27, another patient arrived at the hospital suffering from a fever and cough who also turned out to have the same lung abnormalities as the three family members. Blood tests of this fourth patient and the family revealed that they were suffering from viral infections, although the exact cause of their symptoms was unclear, with influenza tests producing a negative result.

Zhang subsequently submitted a report to officials at the hospital reporting the discovery of a new "viral disease." At this point, it was still not clear whether or not the illness could be transmitted between people, but the doctor speculated it was "probably infectious."

Becoming increasingly concerned, Zhang placed the four patients in a provisional quarantine area in the hospital and ordered medical staff to wear personal protective equipment.

On December 29, three more patients arrived presenting with similar lung abnormalities, prompting the hospital to launch an internal investigation headed by a panel of experts, Chinese newspaper the Workers' Daily reported in February.

All of these patients were found to have been exposed to the Huanan Seafood Wholesale Market in Wuhanas did the fourth patient to arrive at Hubei Provincial Hospital with the mystery illness.

Hubei Provincial Hospital's internal investigation found that the unknown pneumonia cases were unusual and warranted further investigation, with medical staff reporting the situation to local health authorities on December 29.

This prompted a field investigation by the Wuhan Center for Disease Control and Prevention (CDC.) The investigation was aimed at uncovering more patients with pneumonia with potential links to the market.

On the same day, six of the seven patients with the new disease at Hubei Provincial were transferred to another medical centerthe Wuhan Jinyintan Hospitalwhich specializes in the treatment of infectious diseases.

The Wuhan CDC search turned up several additional cases and on December 30, health authorities from Hubei province reported the pneumonia cluster to the Chinese CDC. At this point, the Wuhan Municipal Health Commission sent out an alert, informing its affiliated institutions about how to respond to a possible outbreak of infectious pneumonia.

On the last day of 2019, the commission released the first public messaging regarding the pandemic, briefing Wuhan residents about a viral pneumonia outbreak. It reported a total of 27 confirmed cases, seven of which were in critical condition. The early evidence of the outbreak had also been reported on ProMEDone of the largest publicly available emerging disease reporting systems in the world.

While there was still no evidence of human-to-human transmission and the cause of the pneumonia was yet to be determined, Wuhan authorities advised people to wear face masks and avoid crowded areas.

The public health announcement was reported by local and national media in China, and was later picked up by a handful of international news outlets. Meanwhile, rumors were circulating on Chinese social media that the outbreak could be linked to the SARS virus.

"The cause of the disease is not clear," the state-run People's Daily newspaper said in a post on Chinese social media site Weibo. "We cannot confirm it is what's being spread online, that it is SARS virus. Other severe pneumonia is more likely."

China sent experts to Wuhan to conduct an investigation, take samples from the patients who were suffering from the new disease and support the control effort. Authorities had so far isolated all the patients and their close contacts were also being supervised.

By January 2, 41 patients had been admitted to hospital with the new disease, all of whom were relocated to the Jinyintan Hospital. Retrospective research conducted later in 2020 would find that the number of people infected by this point was significantly higher than this figure suggests.

According to the Chinese CDC, initial laboratory tests from patients suffering from the viral pneumonia were negative for 26 common respiratory pathogens. It was not until January 7 that Chinese scientists confirmed that a novel coronavirus, dubbed 2019-nCoV, was the cause of the mysterious pneumonia outbreak.

On January 24, a group of Chinese scientists published a report in The Lancet examining the 41 cases that had been admitted to hospital by January 2.

The paperthe first peer-reviewed, publicly available scientific study on the outbreakfound that 27 of these patients had been exposed to the Huanan seafood market, which had been shut down by Chinese authorities on January 1.

Thirteen of these patients were admitted to an ICU and six died, indicating a high mortality rate at the time. The study also found that the symptom onset date of the first patient identified was December 1, 2019.

The researchers admitted that there were still "major gaps" in their knowledge of the virusincluding where it originated.

Frederick Hayden, an infectious disease specialist and emeritus professor at the University of Virginia, who co-authored a Lancet editorial accompanying the Chinese study, told Newsweek that he first heard about the new illness when he spotted the ProMED Posting on December 30, 2019.

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He quickly sent off emails to colleagues in Chinaincluding one of his previous collaborators, Bin Cao, at the China-Japan Friendship Hospital in Beijingto try and get more information.

"Obviously, I was concerned. I didn't know if it was possibly another SARS event, or a novel virus. In the very beginning, there were statements that it wasn't being transmitted from person to person. Of course, that was subsequently proven to be completely inaccurate. Based on discussions with Cao Bin early in January, it was clear that there was human transmissibility and that it could cause very severe disease. They were taking care of critically ill patients at the time."

Shangxin Yang, a microbiologist from UCLA Health, who has colleagues, family and friends near the coronavirus' epicenter in Wuhan, told Newsweek he had started hearing rumors in late December on Chinese social media that SARS had reappeared in the country. A Beijing-based health care company claimed it had detected the SARS virus in the analysis of a sample taken from a Wuhan patient who was actually infected with the novel coronavirus.

The detection of SARS, which was shared on social media by doctors, later turned out to be incorrect, with the company mistaking the novel coronavirus for SARS due to its very close genetic similarity.

"Obviously, it was very questionable at the timea lot of people were sceptical because SARS had disappeared for more than 10 years, since 2003," Yang said. "A reappearance of SARS would definitely be something shocking."

Yang didn't take the rumors of a new SARS outbreak very seriously until the end of the year, when he saw an image posted on Chinese social media showing a notice from Wuhan authorities in a local hospital alerting medical staff of the emerging pneumonia outbreak.

"I saw that and thought, 'that looks really real,' and I remember jumping out of bed. On one hand, you have a company who's using genetic sequencing to report this as SARS and on the other hand, you have authorities putting out this notice to all hospitals in Wuhan asking them to report any cases like that directly to local public health officials.

"It's then I realized it was a true outbreak. Whether it was a reemergence of SARS or a novel virus, at that time, I wasn't entirely sure, but I realized it's for real."

The graphic below, provided by Statista, shows the countries worst hit by the pandemic.

Over the course of January, international media took an increasing interest in the growing coronavirus outbreak as the virus spread around the world.

On January 12, China publicly shared the genetic sequence of the novel coronavirus. And just a day later, officials in Thailand confirmed a case of COVID-19the first outside China itself.

By January 20, the virus had spread all around China and to a handful of other countries including Japan, Thailand, South Korea and the United States, as governments scrambled to respond to the outbreak.

Chinese authorities locked down Wuhana city of 11 million peopleon January 23 as panic and confusion spread. COVID-19 cases were reported in Singapore and Vietnam for the first time, with the total confirmed global figure soaring past 500. At least 17 people had died from the new disease at this point.

The world watched on as China began building an emergency hospital in Wuhanwhich was completed in just 10 dayswhile images emerged of officials in personal protective equipment checked the temperatures of residents in Chinese cities.

By January 28, a delegation from the World Health Organization led by its Director-General Tedros Adhanom Ghebreyesus arrived in China to meet with the country's leadership and learn about the response of the authorities, as well as provide assistance.

Just two days later, with thousands of new cases confirmed in China, the WHO declared a "public health emergency of international concern" as the U.S. government warned Americans not to travel to China, and urged those in the country leave. Later in the year, on March 11with the virus now confirmed on every continent except Antarcticathe WHO declared that the COVID-19 outbreak was now a pandemic.

Long before the COVID-19 outbreak started, experts had been warning of the risks of a deadly global pandemic. In September 2019, shortly before the novel coronavirus emerged, a team of international scientists said in a report that efforts to prepare for such an event were "grossly insufficient." A year on, and lessons have been learned the hard way, with the future trajectory of the pandemic still far from certain.

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Risks and benefits of an AI revolution in medicine – Harvard Gazette

Thursday, November 12th, 2020

If you start applying it, and its wrong, and we have no ability to see that its wrong and to fix it, you can cause more harm than good, Jha said. The more confident we get in technology, the more important it is to understand when humans can override these things. I think the Boeing 737 Max example is a classic example. The system said the plane is going up, and the pilots saw it was going down but couldnt override it.

Jha said a similar scenario could play out in the developing world should, for example, a community health worker see something that makes him or her disagree with a recommendation made by a big-name companys AI-driven app. In such a situation, being able to understand how the apps decision was made and how to override it is essential.

If you see a frontline community health worker in India disagree with a tool developed by a big company in Silicon Valley, Silicon Valley is going to win, Jha said. And thats potentially a dangerous thing.

Researchers at SEAS and MGHs Radiology Laboratory of Medical Imaging and Computation are at work on the two problems. The AI-based diagnostic system to detect intracranial hemorrhages unveiled in December 2019 was designed to be trained on hundreds, rather than thousands, of CT scans. The more manageable number makes it easier to ensure the data is of high quality, according to Hyunkwang Lee, a SEAS doctoral student who worked on the project with colleagues including Sehyo Yune, a former postdoctoral research fellow at MGH Radiology and co-first author of a paper on the work, and Synho Do, senior author, HMS assistant professor of radiology, and director of the lab.

We ensured the data set is of high quality, enabling the AI system to achieve a performance similar to that of radiologists, Lee said.

Second, Lee and colleagues figured out a way to provide a window into an AIs decision-making, cracking open the black box. The system was designed to show a set of reference images most similar to the CT scan it analyzed, allowing a human doctor to review and check the reasoning.

Jonathan Zittrain, Harvards George Bemis Professor of Law and director of the Berkman Klein Center for Internet and Society, said that, done wrong, AI in health care could be analogous to the cancer-causing asbestos that was used for decades in buildings across the U.S., with widespread harmful effects not immediately apparent. Zittrain pointed out that image analysis software, while potentially useful in medicine, is also easily fooled. By changing a few pixels of an image of a cat still clearly a cat to human eyes MIT students prompted Google image software to identify it, with 100 percent certainty, as guacamole. Further, a well-known study by researchers at MIT and Stanford showed that three commercial facial-recognition programs had both gender and skin-type biases.

Ezekiel Emanuel, a professor of medical ethics and health policy at the University of Pennsylvanias Perelman School of Medicine and author of a recent Viewpoint article in the Journal of the American Medical Association, argued that those anticipating an AI-driven health care transformation are likely to be disappointed. Though he acknowledged that AI will likely be a useful tool, he said it wont address the biggest problem: human behavior. Though they know better, people fail to exercise and eat right, and continue to smoke and drink too much. Behavior issues also apply to those working within the health care system, where mistakes are routine.

We need fundamental behavior change on the part of these people. Thats why everyone is frustrated: Behavior change is hard, Emanuel said.

Susan Murphy, professor of statistics and of computer science, agrees and is trying to do something about it. Shes focusing her efforts on AI-driven mobile apps with the aim of reinforcing healthy behaviors for people who are recovering from addiction or dealing with weight issues, diabetes, smoking, or high blood pressure, conditions for which the personal challenge persists day by day, hour by hour.

The sensors included in ordinary smartphones, augmented by data from personal fitness devices such as the ubiquitous Fitbit, have the potential to give a well-designed algorithm ample information to take on the role of a health care angel on your shoulder.

The tricky part, Murphy said, is to truly personalize the reminders. A big part of that, she said, is understanding how and when to nudge not during a meeting, for example, or when youre driving a car, or even when youre already exercising, so as to best support adopting healthy behaviors.

How can we provide support for you in a way that doesnt bother you so much that youre not open to help in the future? Murphy said. What our algorithms do is they watch how responsive you are to a suggestion. If theres a reduction in responsivity, they back off and come back later.

The apps can use sensors on your smartphone to figure out whats going on around you. An app may know youre in a meeting from your calendar, or talking more informally from ambient noise its microphone detects. It can tell from the phones GPS how far you are from a gym or an AA meeting or whether you are driving and so should be left alone.

Trickier still, Murphy said, is how to handle moments when the AI knows more about you than you do. Heart rate sensors and a phones microphone might tell an AI that youre stressed out when your goal is to live more calmly. You, however, are focused on an argument youre having, not its physiological effects and your long-term goals. Does the app send a nudge, given that its equally possible that you would take a calming breath or angrily toss your phone across the room?

Working out such details is difficult, albeit key, Murphy said, in order to design algorithms that are truly helpful, that know you well, but are only as intrusive as is welcome, and that, in the end, help you achieve your goals.

For AI to achieve its promise in health care, algorithms and their designers have to understand the potential pitfalls. To avoid them, Kohane said its critical that AIs are tested under real-world circumstances before wide release.

Similarly, Jha said its important that such systems arent just released and forgotten. They should be reevaluated periodically to ensure theyre functioning as expected, which would allow for faulty AIs to be fixed or halted altogether.

Several experts said that drawing from other disciplines in particular ethics and philosophy may also help.

Programs like Embedded EthiCS at SEAS and the Harvard Philosophy Department, which provides ethics training to the Universitys computer science students, seek to provide those who will write tomorrows algorithms with an ethical and philosophical foundation that will help them recognize bias in society and themselves and teach them how to avoid it in their work.

Disciplines dealing with human behavior sociology, psychology, behavioral economics not to mention experts on policy, government regulation, and computer security, may also offer important insights.

The place were likely to fall down is the way in which recommendations are delivered, Bates said. If theyre not delivered in a robust way, providers will ignore them. Its very important to work with human factor specialists and systems engineers about the way that suggestions are made to patients.

Bringing these fields together to better understand how AIs work once theyre in the wild is the mission of what Parkes sees as a new discipline of machine behavior. Computer scientists and health care experts should seek lessons from sociologists, psychologists, and cognitive behaviorists in answering questions about whether an AI-driven system is working as planned, he said.

How useful was it that the AI system proposed that this medical expert should talk to this other medical expert? Parkes said. Was that intervention followed? Was it a productive conversation? Would they have talked anyway? Is there any way to tell?

Next: A Harvard project asks people to envision how technology will change their lives going forward.

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HHS eased oversight of Covid-19 tests though it knew of problems – STAT

Tuesday, November 3rd, 2020

Early in the coronavirus pandemic, management at the North Hill Retirement Community a sprawling high-end campus for older adults in suburban Boston kept a wary eye on how the virus was sweeping through similar facilities with devastating, deadly consequences.

It took precautions to protect its residents, and when the order came down that by mid-July, all of its 400 staff members had to be tested for the virus every week, administrators scanned a list of approved tests provided by the Massachusetts health department and selected a vendor a Boston-based DNA lab named Orig3n that had developed its own test for the novel coronavirus.

North Hill was soon to learn, not all Covid-19 tests are created equal. In a vast, confusing landscape populated by hundreds of different private companies and labs, some tests are proving problematic, especially when used to screen people who have no symptoms of Covid-19. A STAT investigation found that top officials at the U.S. Department of Health and Human Services ended already-minimal oversight of these so-called laboratory developed tests in mid-August, despite being informed that the tests were plagued with quality issues.

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It was just two weeks earlier that North Hills administrators, after going months with only one positive test for Covid-19, had been informed that 19 staff members tested positive for the virus at the same time.

It was really out of the blue, said Ted Owen, North Hill president and CEO. The numbers looked strange to us, that suddenly there would be this big thing.

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State public health investigators were called in to verify the test results, and meanwhile, Owens said, There was a week of absolute pandemonium. Staffers were sent home to nervous families, waiting for symptoms to emerge, while residents and their families waited to see if the virus had spread among the vulnerable, older population of North Hill. In the end, the problem was not a viral outbreak but a testing issue. All 19 of the results were false positives; none of the staffers actually had Covid-19.

North Hills false positives were not isolated. A state investigation in August found 383 false coronavirus positives in that period from Orig3n tests, which had been used by about 60 nursing homes in the state. The state health department suspended Orig3ns testing, demanding the company address contamination and documentation issues. Orig3n told STAT it faults human error for its testing problems.

The Orig3n test is just one of dozens that hospitals, university researchers, and private labs rushed to make as the pandemic spread across the U.S. All these laboratory developed tests, known as LDTs, use the same basic PCR technology to identify genetic material from the coronavirus in patient swabs, but their performance can vary widely. They are being used across the country by states, private employers, sports leagues, and schools to try to manage the pandemic, yet they are something of a black box. Because they fall into a regulatory gray area, nobody outside the labs themselves knows how accurate they are not even the health care providers who use them.

Nor is it clear how many LDTs for Covid-19 are on the market. The Food and Drug Administration doesnt know for sure, but acknowledges the number is not small; the agency has granted emergency authorization to more than 200 diagnostic tests, and LDTs may account for more than half of tests in use, an FDA official estimated. These lab PCR tests are essentially the same as ones sold by manufacturers like Abbott and Roche, but theyre regulated differently and are exempt from oversight by the FDA.

In February, as the coronavirus was starting to spread across the U.S., the FDA began requiring these labs to apply for an emergency use authorization, as it had in previous public health emergencies like the H1N1 flu pandemic in 2009. The bar was set low to get tests on the market fast, labs were allowed to start using them without waiting for FDA sign-off and the standards for approval were far less than would normally be required. Labs merely had to show reasonable accuracy detecting the virus on contrived test samples that werent obtained from actual patients.

Then this summer, the Department of Health and Human Services directed the FDA to stop requiring emergency authorization for this segment of the testing market. The Centers for Medicare and Medicaid Services retained oversight of the labs, but it ensures only that labs meet quality standards, not that specific tests work. The decision meant the FDA has no way to track problems with Covid-19 LDTs including false-positive or false-negative results or even which labs are marketing these tests.

An HHS spokesperson said the decision was made for purely legal reasons, based on its Office of General Counsels determination that the FDA does not have jurisdiction over lab-developed tests.

This deregulatory action ensures compliance with law, is responsive to multiple Trump Administration Executive Orders and better prepares us for future pandemics while maintaining regulatory safeguards for quality and accuracy, HHS chief of staff Brian Harrison said in a statement.

But STAT has learned that before the decision, HHS and its general counsel, Robert Charrow, were alerted to major concerns about many of the LDTs for detecting the coronavirus, which had been identified during the FDAs review process.

Another FDA official, speaking on background, told STAT that data on problems with LDT accuracy and performance were sent by the FDA to HHS at the beginning of August, and were seen by Charrow before the decision to revoke FDA authority over LDTs, announced on Aug. 20. This officialwas on multiple phone calls with FDA colleagues and scientists in which the submission of data to HHS was discussed, including with people who had gathered and compiled the data and who were expressing extreme frustration with HHS for, as they described it, suppressing the data.

The data became public in a September article in the New England Journal of Medicine, in which two FDA officials outlined how the emergency use authorization process enables the agency to track the safety and problems with tests, but HHS earlier knowledge of the data has not been previously reported.

In the first months of the pandemic and testing rollouts, the FDA analyzed 125 EUA requests from laboratories, and found design or validation problems with 82, while several have been denied authorization, wrote FDAs Jeffrey Shuren, director of the Center for Devices and Radiological Health, and Timothy Stenzel, director of the FDA Office of In Vitro Diagnostics and Radiological Health. In most cases, the EUA process allowed the agency to work with labs to correct problems, they noted.

No test is 100 percent accurate and performance can vary within populations, they wrote. Covid-19 diagnostic tests may be less accurate in asymptomatic or low-risk populations and in persons who shed little virus or are early or late in the course of illness.

In a later interview, Shuren said the FDAs oversight role is critical in monitoring tests for safety and accuracy and keeping problematic tests off the market.

The value of FDA oversight of tests is that we are able to review and rely on the science to better understand whether or not a product works and how well it works, he said. If were not reviewing something, we cant do that.

Responding to criticism of the HHS decision, Charrow, the general counsel, said in a statement,It is false to say that this will lead to unregulated, low-quality COVID-19 tests. Every single COVID-19 test in the United States will still be regulated at the federal level. This simply removes an additional regulatory barrier that at most other times is not required.

Alberto Gutierrez, former director of the FDA Office of In Vitro Diagnostics and Radiological Health, who was with the agency for 25 years, said the current chaos in testing could have been prevented if the FDA and HHS were working together to track problems and safety and get the best tests to market.

The problem with LDTs is there are a lot of different laboratories and there are no real standards because the tests are developed by the laboratories, he said. Theres no bar to meet. You have very good laboratories that are very thorough, and you have some that cut corners.

In early October, three Democratic members of the U.S. House Reps. Frank Pallone Jr. of New Jersey, the chairman of the Energy and Commerce Committee, Anna Eshoo of California, and Diana DeGette of Colorado wrote to HHS Secretary Alex Azar, demanding answers about the agencys decision to end FDA oversight and tracking of lab-developed tests. During the Covid-19 pandemic, they said, FDA jurisdiction over LDTs is warranted because as former FDA Commissioner Scott Gottlieb recently wrote, in public health emergencies, diagnostic tests not only diagnose diseases that arent completely understood, but help guide analyses of disease progression and risks to public health.

The testing company at the center of this summers debacle in Massachusetts where it was also deployed to test people who are homeless says it is working to improve its Covid-19 test, which remains off the market there and in other states where it was used, including North Carolina. Weve taken extraordinary steps to work through this challenging time and hope to be able to bring our capacity carefully back online to help address this pandemic, said Orig3n CEO Robin Smith.

Orig3n was granted emergency authorization in April, before HHS dropped the requirement. Under an EUA, test makers are supposed to report to the FDA when things go wrong including false results. But few do. A review of the agencys public database for testing issues shows only 657 reports related to Covid-19 diagnostic tests as of Sept. 30, out of more than 100 million tests performed by that point. This means the vast majority of false Covid-19 results including all of the Orig3n testing errors are simply never reported.

The FDA acknowledges underreporting is rampant, limiting the databases usefulness for spotting problematic tests. Especially for LDTs, it relies on essentially an honor system, expecting labs to report on themselves. Without better tracking and oversight from the federal government, some agency officials told STAT, they fear testing problems will continue as the pandemic worsens through the fall and winter, with patients and medical providers flying blind on which tests can be trusted.

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Who won this years Nobel science prizes? – The Economist

Thursday, October 8th, 2020

Oct 8th 2020

OCTOBERS FIRST week is a nervous time for scientists with serious accomplishments under their beltsfor this is when the phone might ring from Stockholm. Those who give out the Nobel science prizes (the Karolinska Institute for the physiology or medicine award, and Swedens Royal Academy of Science for the awards in physics and chemistry) are known neither for offering the winners more than an hour or twos notice of the public announcement of their success, nor for respecting time zones. New laureates in North America receive the news in the dead of night. That, though, is normally reckoned a small price to pay for what is still seen as sciences most prestigious honour.

Britain being in a more convenient time zone from the Swedish point of view, Sir Roger Penrose, of Oxford University, was not actually asleep when his own phone rang. But he was, he says, in the shower. He was one of three winners of the physics prize, the others being Andrea Ghez and Reinhard Genzel, of the University of Californias Los Angeles and Berkeley campuses respectively. Their prize was for the theoretical explanation and subsequent discovery of some of the strangest objects in the universe: black holes.

Black holes are, famously, so dense that nothing, not even light, can escape their immense gravitational pull. A black holes centre is thought to be a point of infinite density, called a singularity, where the known laws of physics break down. Though the possibility that they existed was hypothesised a century ago, as a consequence of Einsteins general theory of relativity (which is actually a theory of how gravity shapes the structure and contents of the universe), early work suggested that they could form only from the collapse of perfectly symmetrical stars or gas clouds. That is hardly realistic, and Einstein himself doubted that they actually existed.

They therefore remained a theoretical curiosity until 1965, when an as-yet-unknighted Dr Penrose worked out the specifics of how real matter could collapse in a way that would form one. He showed, using a mathematical concept which he called a trapped surface, that even asymmetric, clumpy stars and dust clouds could become black holes. This work provided the tools needed by observational astronomers to go out hunting for them.

By definition, it is impossible to see a black hole directly. Instead, physicists glean insights into them by studying the effect of their gravity on the motion of their stellar neighbours. Dr Ghez and Dr Genzel used this idea to gather evidence that Sagittarius A*a bright source of radio waves at the centre of the Milky Way, Earths home galaxyis actually a supermassive black hole around which all the stars in the galaxy, the Sun included, orbit.

Dr Ghez and her team employed the Keck Observatory telescope, in Hawaii, with its ten-metre-wide primary mirror, to make their observations. Dr Genzels group used a series of eight-metre-wide telescopes high in the mountains of the Atacama desert, in Chile, for theirs. These instruments were all sensitive enough to peer through the clouds of dust that otherwise obscure the heart of the Milky Way.

Over three decades both sets of researchers, working independently, tracked around 30 of the brightest stars at the galactic centre (see chart). A star called S2, for example, takes 16 years to complete an orbit of Sagittarius A*, and, at its closest approach, comes within 17 light-hours of it. These measurements have permitted astronomers to piece together a picture of Sagittarius A* as a black hole of around 4m solar masses, packed into a region of space that is about the size of the solar system.

April 2019 saw the release of the first-ever image of a black hole (Sagittarius A*s local equivalent at the centre of a galaxy called M87, 53m light-years from Earth). This was taken, in radio frequencies, using the Event Horizon Telescope, a collaboration that links eight existing radio telescopes all around Earth and thus permits far higher resolution than any single instrument could manage. As technology improves, the Event Horizon Telescope could also one day provide a more detailed image of the region around Sagittarius A*.

As is often the way, the chemistry prize went for a discovery that might equally well have been handed out for medicineCRISPR-Cas9 gene editing. The winners were Emmanuelle Charpentier of the Max Planck unit for the science of pathogens, in Berlin, and Jennifer Doudna of the University of California, Berkeley.

CRISPR-Cas9 is derived from a bacterial defence mechanism that snips small sequences of DNA from viral interlopers and copies them into a bacteriums own genome, thus creating a scrapbook by which to recognise such aggressors, should they come again. The laureates prize is not, though, for the mere discovery of a novel bacterial immune system. It is for the adaptation of that discovery into the most important gene-editing tool yet inventedone that is already helping to design disease-resistant crops and new therapies for cancer, and which may, perhaps, end hereditary disease in human beings.

If an organisms collective DNA can be thought of as the book of its life, CRISPR-Cas9 allows for any specific sequence of words within that book to be identified, selected, removed and replaced. This is done by creating a molecule called a guide RNA, which matches a target DNA sequence, and pairing it with an enzyme, Cas9, that is capable of snipping the DNA helix at this point. Then, if so desired, a new piece of DNA can be inserted.

The laureates path to Stockholm began at a caf in Puerto Rico in 2011. That was when Dr Charpentier, who had discovered intriguing and unexplained RNA fragments in a bacterium, engineered a meeting with Dr Doudna, an expert in the DNA-snipping capability of Cas proteins. Since this collaboration bore fruit in 2012, progress has been rapid. By February 2013 Feng Zhang of the Broad Institute in Cambridge, Massachusetts and George Church of Harvard Medical School had independently demonstrated the techniques effectiveness in mouse and human genomes, paving the way for the treatment of human diseases. Clinical trials are now under way to test its power against sickle-cell anaemia and certain cancers, with animal experiments showing promising results in the treatment of muscular dystrophy.

There has also been controversy. In 2018 He Jiankui of the Southern University of Science and Technology, in Shenzhen, China, announced the birth of twin girls whose embryos he had edited with the help of CRISPR-Cas9. Dr Hes stated goal was to induce immunity to HIV, by disabling the gene for a protein which that virus uses to gain admission to cells. This was too much for the authorities. Even ignoring the issues of consent involved when a procedure is carried out on an embryo, making genetic edits so early in life means that they will be incorporated into germ cells, and thus passed down the generations. That raises serious ethical questions, and what Dr He did was declared illegal by the Chinese government. Dr He is now in prison.

Nor is germ-line editing the only controversy surrounding CRISPR-Cas9. A further complication concerns who gets the patents that will monetise it. The University of California and the Broad have been involved for years in a legal battle over the matter. By giving the prize to Dr Doudna and Dr Charpentier the Royal Academy of Science may have put its thumb on the scales. In picking them it has also, for the first time, awarded a Nobel science prize to an all-female group. Dr Charpentier, via a phone link to the room where the announcement was made, said I hope this provides a positive message to young girls. Women in science can also be awarded prizes. But more importantly, women in science can also have an impact.

Regardless of which category it truly fits into, the creation of CRISPR-Cas9 was a high-end piece of technowizardy. The actual prize for medicine, however, went for a piece of old-fashioned medical detective workthe identification of hepatitis C, a virus that causes life-threatening liver infections and is passed on by exposure to contaminated blood. Though other widespread diseases, such as malaria and HIV/AIDS, gain more attention, the World Health Organisation (WHO) reckons that around 70m people are infected with hep C and that it kills 400,000 people a year. Hep C has also, in the past, turned the business of blood transfusion into a lottery, since there was no way to tell whether a particular batch of blood harboured it. That this is no longer the case is, in no small measure, thanks to the work of this years laureatesHarvey Alter, Michael Houghton and Charles Rice.

Dr Alters work came first. In the 1960s he was a colleague of Baruch Blumberg, who discovered the hepatitis B virus (for which he won a Nobel prize in 1976). Hepatitis viruses are labelled, in order of discovery, by letters of the alphabet. A, a waterborne pathogen, causes an acute infection that passes after a few weeks and induces subsequent immunity. The effects of B and C, though, are chronic and may result eventually in cirrhosis and cancer. Blumbergs discovery led him to a vaccine for hep B, and also meant that blood intended for transfusion could be screened. But it became apparent that such screened blood still sometimes caused hepatitis, albeit at lower rates. Since hep A was also being screened for by this time, that suggested a third virus awaited discovery.

In 1978 Dr Alter, then working at Americas National Institutes of Health, proved this was true by injecting into chimpanzees blood from recipients of transfusions screened for the known viruses who had nevertheless developed hepatitis. These animals sometimes then went on to develop the illness. It took until 1989 to clone the new virus. That was done by Dr Houghton, who was then working at Chiron, a Californian biotechnology firm subsequently bought by Novartis, a Swiss pharmaceutical giant.

Dr Houghton amplified viral genetic material drawn randomly from chimpanzees infected with the as-yet-unidentified virus and tested this against antibodies from infected humans. Antibodies are proteins crafted by the immune system to stick specifically to parts of particular pathogens. By looking at which chimpanzee-derived material the antibodies in question attached themselves to, Dr Houghton was able to isolate the virus and identify it as a type of flavivirus, a group that also includes yellow fever and dengue. He also thus provided a way of screening blood intended for transfusion.

Dr Rice, working at Washington University, in St Louis, Missouri, eliminated lingering uncertainties about whether the flavivirus Dr Houghton had identified was the sole cause of hep C. Attempts to use cloned, purified versions of it to infect chimpanzees had not worked, leading to doubts about whether it was acting alone. Dr Rice identified part of the viral genome which looked crucial to the process of infection, but was highly mutable. He suspected that this mutability was hindering successful infection in the laboratory, and was able to eliminate it by genetic engineering. The stabilised virus was, indeed, infectious to chimps.

The consequence of all this is that blood for transfusion can now be screened routinely for hep C, and drugs to treat it have now been developed. Unfortunately, this has not stopped the march of the illness. Those in rich countries have benefited. Deaths in Britain, for example, fell by 16% between 2015 and 2017. But the wider picture is grim. Some countries, such as Egypt, have recently done well. Others, less so.

One reason is that, besides transfusion, hep C is spread by drug users sharing needles. It can also be spread sexually. This stigmatises it in the eyes of some. And unlike HIV/AIDS, which spreads in similar ways but quickly developed a political lobby to find a treatment once it was discovered, no one spoke up at the beginning for those suffering from the effects of hep C.

That is starting to change. In 2016 the WHO published a strategy for the elimination of all forms of hepatitis. The tools are there to do this. Whether the will to use them also exists remains to be seen.

This article appeared in the Science & technology section of the print edition under the headline "They walked in looking like dynamite"

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Patent and Patient Rights in COVID-19: Is the Right to Exclusivity a Hamlet Question? – The Leaflet

Thursday, October 8th, 2020

Today the judicial authority may be faced with balancing patent rights and patients rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life, writes J. PRABHA SRIDEVAN.

THERE cannot be a better moment than now, the year of COVID-19, to place my argument, that the right to health and ergo the right to a life with dignity is way ahead of the right that the patented invention obtains to the owner. An open letter has been addressed by heads of States and others to the World Health Organization (WHO), Our world will only be safer once everyone can benefit from the science and access a vaccine and that is a political challenge.Now is not the time to allow the interests of the wealthiest corporations and governments to be placed before the universal need to save lives, or to leave this massive and moral task to market forces. It is equally a judicial challenge.

I argue that the right to life which logically means the right of access to medicine and the right to health, inheres in every human being and is not bestowed under any grant, and is unlimited by time. But the patent right is one granted by the State to the inventor as a quid pro quo allowing the owner to enforce and protect his right for a period at the end of which the owner shall transfer the technology and the invention comes to the public space.

In a patent litigation between the right of access to medicine and the right to property, the judge must be the sentinel on the qui vive, not just a sentinel on the alert, but literally qui vive Who shall live or Whose side are you on? Whose entitlement is heavier? Today when even the survival of the world as we know it today, depends literally upon who gets the medicine, I say the right to life is heavier.

Public interest is not an either-or factor in (Indias) Patents Act. The General Principles mentioned in the Act as being applicable to working of patented inventions, unmistakably mentions public health. The criteria for granting compulsory license are also grounded in public interest; compulsory licence can be granted in circumstances of national emergency and extreme urgency; and patents can be acquired by the State for a public purpose. Every country has similar provisions and they have been successfully employed both by the North and the South.

By creating a higher bar for determining non-obviousness, India made sure that incremental innovations did not get canonized as patents and its Section 3(d) stands out as a model of how to use the flexibilities in a way that facilitates access to health. The Supreme Court of India said (W)e shall see how the Indian legislature addressed this concern and, while harmonizing the patent law in the country with the provisions of the TRIPS Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the Developing Countries and the Least Developed Countries). The State contracts with the patentee to enforce and protect the patent rights in return for technology transfer and promotion of technological innovation, for the benefit of not just the owner but also the user, and for the enhancement of social and economic welfare.

The argument of the patent rights holder is that the exclusivity is the reward for the knowledge contributed to the world by their invention. And they must be allowed to recoup it. It is the Money, money, money in Swedish pop group ABBAs words. It is argued that without monetary incentive there will be no innovation. It is argued that the owners have the right to maximise their profits. And since the creators right is a human right too and has been recognised as such, it is not bound to give way to right to health.

Even in the text of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the social objectives like health needs and access to medicine are inbuilt. But however good a covenant or instrument may be, if those who are implementing it are not good, it will prove to be bad. However bad that covenant or statute may be, if those implementing it are good, it will prove to be good. And it is the wise judge who weighs in these objectives in the balance.

The United Nations Human Rights Council has confirmed the primacy of human rights, such as the right to health over trade, intellectual property rights and other bilateral investment or trade agreements. Resolution 32/L.23 reaffirms the importance of access to medicines for all human beings as one of the fundamental human rights and stresses that improved access could save millions of lives every year.

The Constitution of every country contains implicitly or explicitly an assurance that there is a fundamental right to life. This must be expansively construed. The right to life, we acknowledge, encompasses several rights each one of them being basic and fundamental. The(y) are the right to live with dignity, the right to shelter and the right to health. The State is obligated to ensure that these fundamental rights are not only protected but are enforced and made available to all citizens.

How far can the Court stretch its arm to help? Rejecting the argument that courts can only issue declaratory orders, the South Africa Court said, The nature of the right infringed and the nature of the infringement will provide guidance as to the appropriate relief in a particular case. Where necessary this may include both the issuing of a mandamus and the exercise of supervisory jurisdiction.

It is basic that the power to grant carries with it the power not to grant. But without going to that extreme, the judiciary has enough aids to facilitate access.

The Costa Rica-initiated COVID-19 Technology Access Pool (C-TAP) aims to make vaccines, tests, treatments and other health technologies to fight the virus accessible to all. This indicates the importance of access. If the vaccines and other health technologies are manufactured in developed countries, and made available only to the people there, and even within those countries, only to those groups who have access, it would be inviting disaster of a pandemic proportion.

The Nagoya Protocol can be used as a tool. What has been overlooked in the ongoing discussions on IP issues and COVID is that the Nagoya Protocol and its obligations require sharing of benefits arising from the use of genetic resources. Thus, any commercialisation of COVID- related treatment and/or prevention can be argued to be bound by this protocol and its benefit- sharing provisions.

The judicial authority faced with balancing right to life against right to exclusivity and monetary gains has several tools to employ and to innovate solutions.

It is clear that TRIPS had the pious intent of balancing public health. Even if it had got skewed midway, the course can be corrected now. There is sufficient compass guidance within TRIPS for the judicial authority to rule in favour of access.

It is undeniable that adequate access to affordable medicine or treatment to the stricken cannot be facilitated just by a judicial fiat. It needs executive will, and there are bilateral treaties and other tangential statutes that may come in the way of the TRIPS flexibilities having full play. The initiative and the incentive that a willing generic manufacturer can show is another issue. Even the generics, it is feared, may sing the same song. Sales of drugs will naturally be incentivized to focus on those who can pay more, rather than the vast masses who cannot afford much. This not only unnecessarily raises prices, but reduces the possibility of weak patents being challenged. What effect will the present economic slow-down have on the generic manufacturers? This is, in the words of Prof. Shamnad Basheer a decision that calls into consideration issues of economic and political viability. In other words, the problem of access moves beyond the realm of the purely legal into the realms of economics and politics.

The judicial authority will have to choose life. Forced to choose between protecting the essential right to life an unalienable right assured by the Constitution (Art.5) or over ruling it in favour of secondary or financial interests of the State, I understand, as this dilemma is set out, that judicial ethics dictate to the judge only one possible option: to decide in favour of the undeniable right to life. While intellectual property right (IPR) has been termed as a human right, it is undeniably a granted right, and can be ungranted. The right to life and the right of access to health is a far superior right. It is a right we are born with, like the right to dignity, and we cannot be disrobed of that right.

The time has come to innovate and find an alternative to the present patent system, one which does not rest solely on access-denying exclusivity, but one where innovation and access can co- exist. A monopoly today could literally kill millions. Commenting on the judgment of the Australia High Court in DArcy v. Myriad Genetics, it is observed, This judgment raises the question whether a patent regime should allow quality of life to be the commodity of a monopoly.16

Today that commodity will not be just the quality of life but the very continuance of life. The consequences of a pandemic cannot be geographically limited if supply of the cure is so limited. Even a superficial scan of the demography of the most vulnerable argues the case in favour of access. Therefore, the South should present an alternative where both rights can be harmonised without jeopardising lives or diminishing the quality of lives.

This has happened earlier and the South has resisted such corporate and political hegemony that has facilitated the capitalization of health in various forms, and has been of vital importance and ha(s) won significant victories, but ha(s) not managed to transform or reverse the structural appropriation of health by capital.

The judicial authority must infuse itself with a spirit of constitutionalism that depends upon an interpretive, non-technocratic hermeneutics and has emerged as a democratic counter weight to logics of multinational pharmaceutical capital. It shall weigh in the huge public interest factor when orders of injunction are sought for and cannot ignore it. There are dismal examples of when it should not have been granted. One might convincingly argue that a patent right is predominantly a commercial or market-oriented property interest and is therefore compensable in monetary terms. And commercial interests can never take precedence over saving lives.

There is no acceptable data correlating the expenses incurred in inventing a drug and the price at which the drug is sold. The poser of whether there will be any invention without the rights being enforced and monetized is an arguable one. Assuming without conceding that it is so, it is possible to devise a different model of remuneration than the present one. The exclusive private ownership model lends itself to predatory tactics.

Instead we may have other innovative methods like a patent pool working in cooperation with not just countries and international organizations but also the hundreds of researchers, innovators, companies and universities involved. This will help in combating the crisis and earning collectively. It may be time to think of a pervasive compensatory liability regime. It is not that this tension between the two rights has gone unnoticed. The Sub-Commission on the Promotion and Protection of Human Rights adopted Resolution 2000/7 on Intellectual Property Rights and Human Rights which has an antagonistic approach to TRIPS.

The relationship between the private rights and the public health rights should be spatially expanded in tune with the constitutional aspirations rather than narrowly viewed as a private grasp of the patent owning few. The Court shall explore the various models of rewarding or compensating the inventor, but the Court shall and is bound to defer to the always superior claim of the right to health over right to exclusivity. Today Hamlets question must be answered in favor of life.

(Justice Prabha Sridevan is a former Judge of the Madras High Court and Chair of the Intellectual Property Appellate Board of the Government of India. Views are personal. The article was first published in SouthViews.)

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Patent and Patient Rights in COVID-19: Is the Right to Exclusivity a Hamlet Question? - The Leaflet

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FDA Oversight of Laboratory-Developed Tests Continues To Evolve – JD Supra

Thursday, October 8th, 2020

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administrations (FDA) oversight of laboratory-developed tests (LDTs). The administration declared that LDTs, which are a subset of in vitro diagnostic tests (IVDs) developed and used in-house by clinical laboratories, would not be subject to premarket review by the FDA absent formal agency rulemaking. This announcement reversed the position that the FDA staked out in late February 2020, when it issued a guidance document for the industry on the development of IVDs to diagnose COVID-19.

The February guidance set expectations regarding the analytical and clinical validation of IVDs used to address the pandemic and included most complex LDTs intended to diagnose the disease. The FDA published a second policy in March allowing for independent authorization of LDTs by states and expounded on these policies again in May.

The FDAs oversight of LDTs in the context of COVID-19 promulgated with little fanfare given the exigencies of the pandemic represented yet another turn in the agencys mercurial relationship with these controversial diagnostics that dates back more than four decades. Because the administration and the Department of Health and Human Services has now rescinded the FDAs prior guidance, laboratories must decide whether to voluntarily seek an emergency use authorization from the FDA for their LDTs, which would provide the tort protections associated with all such authorized countermeasures, or to proceed without it. Longer term, the future and degree of FDA oversight of LDTs will remain uncertain until either the FDA undertakes a formal rulemaking process or Congress takes legislative action.

IVDs are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, according to the FDA. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. The FDA began regulating them as medical devices when Congress amended the Food, Drug and Cosmetic Act in 1976 to create the comprehensive regulatory scheme providing for the risk-based medical device classification system and premarket review process that exists today. Components of IVDs, such as antibodies, specific receptor proteins, ligands, nucleic acid sequences and other analyte-specific reagents, are also subject to FDA oversight as medical devices. Most of the hundreds of IVDs on the market today have been cleared by the FDA as Class II medical devices, which are sold to laboratories across the country.

The disconnect in this area is that, at the same time the FDA developed a robust regulatory process for premarket review of IVDs, it adopted a decidedly laissez faire approach to regulation of LDTs, a subset of IVDs that are designed, manufactured and used within a single laboratory for clinical use. The FDA perceived LDTs as low risk due to their limited number and primary use in rare disease contexts. Accordingly, LDTs were not subject to the agencys robust premarket evaluations of analytical and clinical validity. Analytical validity focuses on whether a test can accurately and reliably measure what it claims to measure, whereas clinical validity focuses on whether the measurement is predictive of a certain state of health. The result is a bifurcated market, in which IVDs developed for commercial sale are held to rigorous FDA standards while homegrown tests developed for the same uses inside the developers lab are not.

The FDAs oversight of laboratory-developed tests in the context of COVID-19 represented yet another turn in the agencys mercurial relationship with these controversial diagnostics that dates back more than four decades.

Medical and technological advances over the past four decades have driven the development of LDTs to cover a wide range of conditions, including human papillomavirus, Lyme disease, whooping cough, certain cancers and heart disease. The growth of the LDT industry has led to concerns among stakeholders about whether current regulatory oversight of LDTs, led primarily by the Centers for Medicare and Medicaid Services (CMS), is sufficient to ensure their safety and effectiveness. Reports of inaccuracies in cervical cancer testing led to the enactment of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which extended federal regulations to all laboratories performing testing on human specimens for the purpose of diagnosis or treatment. Under the CLIA, CMS evaluates the analytical but not clinical validity of LDTs during accreditation surveys of laboratories. These surveys are conducted on a biennial basis, so it may take up to two years after an LDT has been offered for clinical use before its analytical validity is confirmed by regulators.

In July 2010, the FDA announced its intent to reconsider its long-standing policy of enforcement discretion with respect to LDTs after identifying issues with several high-risk LDTs and hosted a public workshop to gather feedback from industry stakeholders. Four years later, the FDA issued draft guidance proposing a regulatory framework for LDTs. It followed up a year later with a report on 20 case studies of potential and actual patient harm arising from inaccurate or unreliable LDTs that supported the need for increased LDT oversight. Members of the lab and diagnostic industry pushed back against the FDAs new position, asserting the FDA had no right to regulate LDTs in the first place. They argued LDTs were clinical rather than medical devices and that regulation would constitute an intrusion into the practice of medicine. Industry stakeholders were also concerned that FDA oversight would stifle innovation, raise costs for laboratories and limit patient access to LDTs they deemed vital to public health.

In January 2017, the FDA announced it would not finalize the guidance and invited Congress to address the issue. To advance the discussion, however, the FDA published a position paper synthesizing feedback it received from stakeholders as well as its own views on appropriate oversight that would balance the need for innovation with the need for assuring the safety and effectiveness of LDTs. The FDA proposed an approach in which agency oversight would be phased in over several years based on risk. The proposal would grandfather tests already on the market and exempt from most oversight LDTs that are low risk or intended for rare diseases, forensic use, public health surveillance and so-called traditional tests that use components that are legally marketed for clinical use and whose output is the result of manual interpretation by a qualified laboratory professional, without the use of automated instrumentation or software for intermediate or final interpretation. All other tests, including modified versions of grandfathered tests, would be subject over time to adverse event and malfunction reporting, premarket clearance and approval, and CLIA-based quality requirements. The FDA reserved the right to take action against any LDT, even those exempted from the phased-in requirements, in the event of deceptive promotion or inadequate validation.

Many stakeholders interpreted the FDAs announcement as a retreat to the long-standing position of enforcement discretion while it turned the issue over to Congress to resolve. The reality was less clear, however, as the agency continued to assert its jurisdiction over LDTs in certain circumstances. In October 2018, FDA issued a guidance warning that many genetic tests on the market that claim to predict a patients response to specific medications had not been reviewed by the agency and might not be supported by requisite scientific or clinical evidence. In April 2019, the FDA issued a warning letter to Inova Genomics Laboratory alleging that its genetic tests, which were offered for the same purpose, were adulterated and misbranded, and posed a significant public health concern because they had not been adequately validated. Notably, the FDA rejected Inovas assertions that the company was operating within an LDT Exemption by explaining that no exemption existed and that the agency never created a legal carve out from its premarket review processes for LDTs. The agency also asserted that it retained the discretion to take action against LDTs when appropriate despite its long-standing policy of exercising enforcement discretion. The FDAs unpredictable approach toward LDTs left members of the lab and diagnostic industry unsettled and anxious about federal challenges to the legality of their tests.

Facing the COVID-19 pandemic, the FDA took another step toward more complete oversight when it included LDTs in its polices for other IVDs intended to diagnose the disease. The position was no doubt fueled by the FDAs desire to ensure a measure of analytical and clinical validity for all complex tests used to diagnose the disease, given the obvious exigencies and public health equities at issue. However, the Trump administrations August 19 announcement formally rescinds guidance and other informal statements from the agency concerning premarket review of LDTs. The move frees developers of LDTs to act without FDA pre-review, which offers a measure of clarity for the market but also triggers concern from public health experts who believe now is the time for more oversight, not less.

Against this backdrop, there may be greater pressure than ever on Congress to take up the issue. Lawmakers have made several attempts at determining the future of LDT regulation. A draft bipartisan bill released in March 2017 outlined a regulatory framework for LDTs based in part on a proposal by the Diagnostic Test Working Group, a coalition of industry stakeholders. After feedback from the FDA, lawmakers unveiled a new bill, the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act, in December 2018. On March 5, 2020, lawmakers introduced a revised VALID Act with bipartisan sponsorship.

The VALID Act would create a new regulatory framework to govern the development and use of all in vitro clinical tests (IVCTs), which would include both IVDs and LDTs. The proposal would replace the three-tiered system used to regulate other medical devices with a two-tiered system consisting of low- and high-risk tests (although the legislation would allow the FDA to develop special controls for certain high-risk tests, which could evolve into a third tier of moderate-risk devices). The legislation would require premarket evaluation and compliance with quality system regulations unless an exemption applied. Like the FDAs 2017 proposal, the act would exempt low-risk tests such as those intended to treat rare diseases and some LDTs that are already in use. Current LDTs not eligible for grandfathering under the act would be handled under special transitional provisions. The legislation also includes a precertification program intended to reduce regulatory burdens and provide priority review/breakthrough concepts. The program is modeled after those that exist today for other medical products to support expedited development and review of novel tests or tests intended to treat a life-threatening or irreversibly debilitating human disease or condition.

Whether and when Congress will act on the legislation is unclear. The current controversy surrounding COVID-19 testing is sure to put a spotlight on this issue, and the VALID Act has bipartisan support in committees of jurisdiction in both chambers. But the United States is heading toward another presidential election, and the current Congress has been notably partisan. The Medical Device User Fee Amendments must be renewed in September 2022, and that must-pass legislation is a likely vehicle for enactment of the VALID Act if it is not taken up beforehand. Some form of the legislation certainly could move in the next year, but the window is tight given the election and the other pandemic-related causes, which will take priority.

In the meantime, industry stakeholders should closely monitor developments in the LDT space. LDTs and related genetic tests play a significant role in health care decision-making, and a new regulatory framework will have major implications for the future of these products. But critical questions remain, including whether Congress will take action and whether the FDA will eventually act if Congress does not. Whether the FDA intends to respond to the August 19 announcement by initiating a rulemaking or formally modifying its 2017 position is unclear. The FDA likely will wait for the outcome of the election and take stock of its options then. Regardless of how, if at all, a more defined regulatory framework for LDTs ultimately crystallizes, the latest announcement makes clear that lasting guidance is necessary for all parties to navigate the world of LDTs with some measure of certainty, both during COVID-19 and beyond.

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FDA Oversight of Laboratory-Developed Tests Continues To Evolve - JD Supra

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One Sperm Donor. 36 Children. A Mess of Lawsuits. – The Atlantic

Tuesday, September 15th, 2020

I discussed the case of Donor 9623 with Dov Fox, a professor of health law at the University of San Diego. Fox covered the lawsuits in his book, Birth Rights and Wrongs, and he has spent the past year diving even deeper into the case of Donor 9623interviewing parents who were deceived, children coming to terms with their genetic inheritance, and eventually the donor himself for a new Audible podcast.

Read: IVF mix-ups have broken the definition of parenthood

Fox and I have spoken before about the ways embryo mix-ups and other examples of reproductive technology gone awry confound the law and the very notion of parenthood. Tens of thousands of babies are born with the help of reproductive technology every year in the U.S., yet fertility clinics and sperm banks remain surprisingly unregulated. Mistakes, when they happen, have deeply existential consequences. Before the podcasts release last week, we talked again about Donor 9623 and how courts try to make sense of the uncomfortable idea of wrongful birth, a term that he argues makes no sense.

This interview has been edited for length and clarity.

Sarah Zhang: In your book, you covered several cases where reproductive technology gone wrong poses these really hard questions: white parents who were inseminated with the wrong donor sperm and ended up with a Black child, parents who had aborted based on an incorrect fetal diagnosis, a surrogate who didnt want to relinquish the child. What specifically drew you to this case of Donor 9623 so much that you wanted to do a whole podcast about it?

Dov Fox: I thought this case was really gray. It wasnt that there was just an obvious loophole in the legal framework or the law hadnt caught up to the advances in technology. It raised really deep, hard, fundamental questions about human existence, with an eye to the future of gene editing and embryo screeningwhat it means to be a parent and what is reasonable for would-be parents to expect. Thats an uncomfortable place for judges and for lawmakers.

This was one of the very largest and most international sperm banks that shipped to tens of thousands of parents in dozens of countries all over the world. This is an especially popular donor for more than a decade. And there were so many parts of his history that were concealed or misrepresentedhis health and his criminal record and his educational background.

Zhang: You say this is an uncomfortable place for judges and lawmakers, and while wrongful-birth lawsuits get a lot of attention, they havent been very successful in court in the U.S. Why is that?

Fox: A lot of courts that say no to wrongful-birth claims say its about protecting the individual children. And theres intuitive appeal to this idea. God, how awful would it sound to the child to learn that their life, their existence, is wrongfulthat their parents didnt want them, dont want them, wanted a different kid instead, dont love them. Thats not what parents intend, but that doesnt necessarily mean that it doesnt express that, whether to their kids or to other groups who have the very condition that their kids have.

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Nebraska Medical Bill initiative blocked from entering the November ballots – Cannabis Health Insider

Tuesday, September 15th, 2020

Gray mold on cannabis plants is a sign of a fungal disease called Botrytis blight. It appears as a thick blanket of webs on the plants and causes severe damage to the buds during growth and even after harvest.

In most cannabis plants, gray mold starts growing on the inside of a bud before appearing on the outside. One of the preventative measures that cultivators can take early on is to protect the buds from moisture. Using tents or greenhouse to cover plants can help to attain this.

Other than this, there are a number of other techniques that can help to stop the infection from damaging the plants. Here is a complete guide to prevent and control the infection.

Typically, gray mold causes a discoloration of plant buds and a lot of moisture retention in the leaves. This causes lesions to appear on the plant, advancing into a rot in later stages. The final stage that follows after this is the appearance of the mycelium, or gray mold in the affected plant.

According to experts, if an infection appears to be gray on the outside, it is most probably gray mold. For confirmation, examining a microbial infection under a microscope can provide solid answers.

The good news for cannabis cultivators is that although gray mold is a fairly common fungal disease, it is not aggressive. It does not harm any healthy plant tissue to progress further. In fact, the disease enters the plant through pruning cuts, damages caused by insects or dying tissues of spent leaves.

As mentioned earlier, Botrytis blight does not damage healthy tissue. It enters plants through wounds created by insects. Therefore, one of the first steps to ensure protection from gray mold is to inhibit insects and diseases from attacking the plants.

Like most fungal infections, Botrytis blight flourishes in humid and dark conditions. Just 12 hours of wetness and 90% humidity levels can set the infection in motion.

This is one of the major reasons of mature plants getting infected. The dense leaf and flower growth in mature plants inhibits ventilation, creating ideal conditions for the sporadic growth of the infection.

Opening up plants for more sunlight absorption can discourage the spread of the fungal infection in plants.

Using water management techniques like drip irrigation and proper drainage can be helpful in controlling this problem. Experts also suggest the use of a couple of humidity meters in cultivation facilities for maximum control.

In addition, small tips like watering the plants early in the morning and maximizing time between watering can ensure moisture control in the plants.

End users of cannabis usually consume the plant through inhalation or smoking. This is why using commercial fungicides on the crops for treatment is highly discouraged.

One of the primary ingredients for treating fungal infections is Myclobutanil. A number of studies have found that it turns into Cyanide gas while smoking, posing serious threat to the health of the end user.

Using organic fungicides is an alternate option for crop growers. Using potassium bicarbonate, bacillus amyloliquefaciens and Tetra Crop Control can help to stop the spread of infection if it is spotted early enough.

It is noteworthy that some cannabis strains are naturally mold resistant. Being inhabitants of wet and humid climates, these strains naturally have naturally developed resistance to the infection.

To curb the spread of gray mold, there are a number of techniques that can be applied by growers of cannabis plants.

Removing moldy buds and sterilizing the plants can inhibit the growth of gray mold on other parts.

Sterilizing equipment used in pruning damaged plant parts will ensure infection containment. Proper disposal of damaged parts after solarization will also ensure that the pathogens have been completely destroyed.

Botrytis has a tendency to feed on dying leaves. Therefore, removing any possible habitat can assure the infection does not thrive.

Plucking fan leaves off the plant can also be a possible step towards maintaining ventilation and humidity in its surroundings.

For assuring the best possible mold free harvest, it is important to consider the environment of the drying rooms of the harvested crops.

More often than not, buds are put in drying rooms that are humid or have a polluted airspace. In other cases, storing them while they were not completely dry starts the development of the mold.

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Nebraska Medical Bill initiative blocked from entering the November ballots - Cannabis Health Insider

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