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"title": "Proposition 14: With Just Handful of Cures, California Stem Cell Agency's Fate Is In Hands of Voters",
"headTitle": "Proposition 14: With Just Handful of Cures, California Stem Cell Agency’s Fate Is In Hands of Voters | KQED",
"content": "\u003cp>\u003cem>A Yes vote authorizes the state to sell $5.5 billion in general obligation bonds primarily for stem cell research and the development of new medical treatments in California. A No vote would mean the state’s stem cell research agency will probably shut down by 2023. \u003c/em>\u003c/p>\n\u003cp>In the ramp-up to the 2004 election, a California TV viewer may have come across the popular actor Michael J. Fox urging her to vote Yes on a state proposition. His voice slurred faintly by Parkinson’s disease, he still sounded wry, boyish and familiar.\u003c/p>\n\u003cp>“My most important role lately is as an advocate for patients and for finding new cures for diseases,” said Fox, eyes level with the camera. “California’s Stem Cell Research Initiative 71 will support research to find cures for diseases that affect millions of people, including cancer, diabetes, Alzheimer’s and Parkinson’s.”\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=fK9Eg0GVl7Q\u003c/p>\n\u003cp>Within that 30-second spot, Fox, diagnosed at age 29 with a neurodegenerative disorder that typically does not strike until after 60, used the word “cures” three times.\u003c/p>\n\u003cp>Proposition 71, which passed with 59% of the vote, authorized the sale of $3 billion in bonds to create an agency that funded stem cell research. The successful campaign grew out of a time, in the early 2000s, when the promise of stem cell and regenerative medicine excited both scientists and the public.\u003c/p>\n\u003cp>Whether the project has lived up to that promise is a matter of opinion. How voters view the record of the agency may go a long way in their decision whether or not to replenish the fund, which is fast running out of money, with an additional $5.5 billion to be raised with new bonds authorized by Proposition 14, now on the ballot.\u003c/p>\n\u003cp>\u003cstrong>President Bush – A ‘Demon’ to Attack\u003c/strong>\u003c/p>\n\u003cp>Scientists since the1800s have known about stem cells, which are not yet dedicated to any particular anatomical function and have the potential to become nerve cells, blood cells, skin cells or any other type. They are found in blastocysts, which are human embryos four to five days after fertilization, and in a few areas, such as bone marrow and gonads, in adults.\u003c/p>\n\u003cp>[emailsignup newslettername='science' align='right']In the late 1990s, researchers developed ways to steer the development of these cells, and the possibilities for improving medicine seemed endless. If malfunctioning cells were at the root of a particular disease, could new healthy cells tailored to the job fix what was wrong? Scientists and many members of the public were eager to find out.\u003c/p>\n\u003cp>Anti-abortion groups, however, a key constituency of President George W. Bush, opposed the research, and in 2001 he limited federal funding to a few existing lines of embryonic stem cells, severely curtailing research.\u003c/p>\n\u003cp>Some in the state of California wanted to get around Bush’s restrictions, and Proposition 71 was born.\u003c/p>\n\u003cp>“(T)hey had this demon they could attack in the campaign — the Bush administration,” said David Jensen, author of “California’s Great Stem Cell Experiment,” who also writes the blog \u003ca href=\"http://californiastemcellreport.blogspot.com/\" target=\"_blank\" rel=\"noopener noreferrer\">California Stem Cell Report\u003c/a>. “They could say, ‘This is a great opportunity, and the only way we’re going to get it done is to do it here in California.'”\u003c/p>\n\u003cp>The measure created the California Institute for Regenerative Medicine. The stem cell research agency is unique in the U.S.\u003c/p>\n\u003cp>“No other state has done this kind of level of funding and focus on this kind of thing,” said Jensen. “It’s a really cutting-edge area of science.”\u003c/p>\n\u003cp>\u003cstrong>A Few Successes\u003c/strong>\u003c/p>\n\u003cp>The pace of innovation has been slower than many hoped. As it turned out, grand discoveries were not around the corner, and to date there is no widespread stem cell treatment approved for the public. To date, CIRM has funded more than 64 trials directly and aided in 31 more. Not all have or will result in treatments.\u003c/p>\n\u003cp>But despite the lack of a marquee cure like one for Alzheimer’s or Parkinson’s, the agency has seen some notable triumphs.\u003c/p>\n\u003cp>“Probably one of the most spectacular successes they have certainly so far,” said Jensen, “is clinical trials that have saved the lives of what they say are 40 children.”\u003c/p>\n\u003cp>Those children were born with severe combined immunodeficiency (SCID), commonly known as “bubble baby syndrome,” a rare, generally fatal condition in which a child is born without a working immune system. An \u003ca href=\"https://blog.cirm.ca.gov/2017/07/25/cirm-funded-life-saving-stem-cell-therapy-gets-nod-of-approval-from-fda/\" target=\"_blank\" rel=\"noopener noreferrer\">FDA-approved\u003c/a> gene therapy that grew out of CIRM-funded research can now cure the disease by taking a patient’s own blood stem cells and modifying them to correct the SCID mutation. The altered cells generate new, healthy blood cells and repair the immune system.\u003c/p>\n\u003cp>The FDA has also approved two drugs for rare blood cancers that were developed with CIRM funds.\u003c/p>\n\u003cp>Sandra Dillon, a graphic designer in San Diego, credits one of the drugs with saving her life. She was diagnosed when she was just 28, in 2006. Her doctors told her they would try to manage her symptoms, but that she was going to get progressively sicker.\u003c/p>\n\u003cp>“Even just the idea of a cure or getting better wasn’t even on the table back then,” said Dillon, who is featured in ads for the Yes on 14 campaign.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=Fv6FFQ1ez2w\u003c/p>\n\u003cp>“I remember just praying and begging into the universe, please, someone just look at my disease, please someone help, who is going to look at this thing.”\u003c/p>\n\u003cp>By 2010, Dillon was extremely ill. She connected with a doctor at UC San Diego who received early-stage funding from CIRM and told her she could take part in clinical trials.\u003c/p>\n\u003cp>“For the first time, there was this moment of, ‘Oh, my gosh! There are researchers doing something. And it could help me and I can get access to it.’ It was amazing.”\u003c/p>\n\u003cp>The drug received FDA approval in 2019, and today Dillon’s cancer has retreated to the point where she can live a normal life.\u003c/p>\n\u003cp>“I love that I am not tethered to a hospital anymore. I can go out on long backpacking trips and hiking and surfing,” she said. “I am a completely different person with this drug. And I have a whole future ahead of me.”\u003c/p>\n\u003cp>The original funding raised by Proposition 71 is running out. Proposition 14 would authorize the sale of a new bond to refill the agency piggy bank. Gov. Gavin Newsom, the UC Board of Regents, and scores of patient advocacy groups also support the measure.\u003c/p>\n\u003cp>Many newspaper editorial boards, however, oppose the proposition, including the San Francisco Chronicle, Mercury News and Los Angeles Times.\u003c/p>\n\u003cp>Right now the state still owes about $1 billion toward the debt created by Proposition 71. If Proposition 14 passes, the yearly price tag to pay off the new bond would be about $260 million per year for about 30 years.\u003c/p>\n\u003cp>One of the selling points of the original proposition was the potential for the state to earn big money in royalties from the treatments it helped develop, says Jeff Sheehy, an HIV patient advocate and the only CIRM board member to oppose Proposition 14.\u003c/p>\n\u003cp>“The promises were made that this would pay for itself. We would be able to pay back the bonds with the … money we would get from royalties, etc., etc.”\u003c/p>\n\u003cp>That has not worked out as envisioned: CIRM estimates it has received less than $500,000 in royalties. Early this year, Forty Seven, a company whose therapies were heavily funded by CIRM, \u003ca href=\"https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/gilead-to-acquire-forty-seven-for-49-billion\" target=\"_blank\" rel=\"noopener noreferrer\">sold\u003c/a> to Gilead for $4.9 billion. While millions went to various researchers, neither CIRM nor the state of California received anything.\u003c/p>\n\u003cp>“One of the flaws in the original measure is that we [the agency] cannot hold stock in the products that we develop,” says Sheehy. “And that’s because the California Constitution says that the state of California cannot, as a government entity, hold equity.”\u003c/p>\n\u003cp>Proposition 14 makes it impossible for the state to use profits from its investment on, say, schools or other funding priorities. Instead, any royalties earned must be fed back into programs to make CIRM-funded treatments more affordable.\u003c/p>\n\u003cp>“What it does is it basically takes all of our returns that we get from this and gives it back to the pharmaceutical and biotech companies,” said Sheehy. “It becomes just a blatant giveaway to these companies when we should be requiring access and requiring fair pricing.”\u003c/p>\n\u003cp>Sheehy says he supports medical research, but doesn’t like the state going into more debt to pay for it. The greater the state’s obligations in bond money, which has to be paid back with interest, the less there is in the general fund, and Sheehy says the state has more pressing needs than stem cell research — things like housing, education and transportation.\u003c/p>\n\u003cp>“The biggest and perhaps the most compelling reason why I feel so strongly that this is not a good idea is that we simply cannot afford it,” he said. “If we think this is so important,” asks Sheehy, “why don’t we just don’t pay for [this research] out of the general fund? It would be cheaper.”\u003c/p>\n\u003cp>Opponents of Proposition 14 also point to longstanding complaints of conflicts of interest among the agency board. Most of the $3 billion distributed by the agency has gone to institutions with connections to board members. Critics say the structural conflicts of interest between the board and agency are not addressed in the new measure. Proposition 14 would balloon an already huge board of 29 members to 35.\u003c/p>\n\u003cp>Funding needs for stem cell research also are not as acute as they were back in 2004. The federal National Institutes of Health now \u003ca href=\"https://report.nih.gov/categorical_spending.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">funds\u003c/a> some basic stem cell research, spending about $2 billion a year, with $321 million of that going toward human embryonic stem cell research. The Trump administration has not reinstated the ban, but has added lengthy paperwork and review \u003ca href=\"https://www.sciencemag.org/news/2019/07/trump-administration-releases-details-fetal-tissue-restrictions\" rel=\"noopener noreferrer\" target=\"_blank\">requirements\u003c/a>. And private ventures, like nonprofits started by tech billionaires, are pouring more money into biotech.\u003c/p>\n\u003cp>The problem with assuming that, says Melissa King, executive director of Americans for Cures, the stem cell advocacy group behind the “Yes on 14” campaign, is that CIRM fills a neglected funding need.\u003c/p>\n\u003cp>“The NIH does not fund clinical trials at nearly the rate that CIRM can and has been,” King said.\u003c/p>\n\u003cp>She says that’s important because of what she calls the “Valley of Death,” where promising early-stage research frequently fails to translate into promising treatments that can be tested in clinical-stage research. (What works well in a test tube often does not work well in an organism.) This weeding-out process is costly but necessary. And it’s where CIRM focused a lot of its effort.\u003c/p>\n\u003cp>“The first- and maybe even second-phase clinical trials, it’s very difficult to get those funded,” King said. “It is too much of a risk for business to take on on its own. Venture [capital] isn’t going there. Angel [funding] isn’t going there.”\u003c/p>\n\u003cp>What voters have to ask themselves, says writer Jensen, is whether stem cell funding is “a high priority for the state of California? Different people make different judgments about that.”\u003c/p>\n\u003cp>CIRM supporters say if Prop. 14 doesn’t pass, critical research will stall. Others say federal and private funding will step in and fill the gap.\u003c/p>\n\u003cp>Absent new funding, the institute expects it will wind down operations leading to a complete sundown in 2023.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cem>A Yes vote authorizes the state to sell $5.5 billion in general obligation bonds primarily for stem cell research and the development of new medical treatments in California. A No vote would mean the state’s stem cell research agency will probably shut down by 2023. \u003c/em>\u003c/p>\n\u003cp>In the ramp-up to the 2004 election, a California TV viewer may have come across the popular actor Michael J. Fox urging her to vote Yes on a state proposition. His voice slurred faintly by Parkinson’s disease, he still sounded wry, boyish and familiar.\u003c/p>\n\u003cp>“My most important role lately is as an advocate for patients and for finding new cures for diseases,” said Fox, eyes level with the camera. “California’s Stem Cell Research Initiative 71 will support research to find cures for diseases that affect millions of people, including cancer, diabetes, Alzheimer’s and Parkinson’s.”\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/fK9Eg0GVl7Q'\n title='//www.youtube.com/embed/fK9Eg0GVl7Q'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Within that 30-second spot, Fox, diagnosed at age 29 with a neurodegenerative disorder that typically does not strike until after 60, used the word “cures” three times.\u003c/p>\n\u003cp>Proposition 71, which passed with 59% of the vote, authorized the sale of $3 billion in bonds to create an agency that funded stem cell research. The successful campaign grew out of a time, in the early 2000s, when the promise of stem cell and regenerative medicine excited both scientists and the public.\u003c/p>\n\u003cp>Whether the project has lived up to that promise is a matter of opinion. How voters view the record of the agency may go a long way in their decision whether or not to replenish the fund, which is fast running out of money, with an additional $5.5 billion to be raised with new bonds authorized by Proposition 14, now on the ballot.\u003c/p>\n\u003cp>\u003cstrong>President Bush – A ‘Demon’ to Attack\u003c/strong>\u003c/p>\n\u003cp>Scientists since the1800s have known about stem cells, which are not yet dedicated to any particular anatomical function and have the potential to become nerve cells, blood cells, skin cells or any other type. They are found in blastocysts, which are human embryos four to five days after fertilization, and in a few areas, such as bone marrow and gonads, in adults.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>In the late 1990s, researchers developed ways to steer the development of these cells, and the possibilities for improving medicine seemed endless. If malfunctioning cells were at the root of a particular disease, could new healthy cells tailored to the job fix what was wrong? Scientists and many members of the public were eager to find out.\u003c/p>\n\u003cp>Anti-abortion groups, however, a key constituency of President George W. Bush, opposed the research, and in 2001 he limited federal funding to a few existing lines of embryonic stem cells, severely curtailing research.\u003c/p>\n\u003cp>Some in the state of California wanted to get around Bush’s restrictions, and Proposition 71 was born.\u003c/p>\n\u003cp>“(T)hey had this demon they could attack in the campaign — the Bush administration,” said David Jensen, author of “California’s Great Stem Cell Experiment,” who also writes the blog \u003ca href=\"http://californiastemcellreport.blogspot.com/\" target=\"_blank\" rel=\"noopener noreferrer\">California Stem Cell Report\u003c/a>. “They could say, ‘This is a great opportunity, and the only way we’re going to get it done is to do it here in California.'”\u003c/p>\n\u003cp>The measure created the California Institute for Regenerative Medicine. The stem cell research agency is unique in the U.S.\u003c/p>\n\u003cp>“No other state has done this kind of level of funding and focus on this kind of thing,” said Jensen. “It’s a really cutting-edge area of science.”\u003c/p>\n\u003cp>\u003cstrong>A Few Successes\u003c/strong>\u003c/p>\n\u003cp>The pace of innovation has been slower than many hoped. As it turned out, grand discoveries were not around the corner, and to date there is no widespread stem cell treatment approved for the public. To date, CIRM has funded more than 64 trials directly and aided in 31 more. Not all have or will result in treatments.\u003c/p>\n\u003cp>But despite the lack of a marquee cure like one for Alzheimer’s or Parkinson’s, the agency has seen some notable triumphs.\u003c/p>\n\u003cp>“Probably one of the most spectacular successes they have certainly so far,” said Jensen, “is clinical trials that have saved the lives of what they say are 40 children.”\u003c/p>\n\u003cp>Those children were born with severe combined immunodeficiency (SCID), commonly known as “bubble baby syndrome,” a rare, generally fatal condition in which a child is born without a working immune system. An \u003ca href=\"https://blog.cirm.ca.gov/2017/07/25/cirm-funded-life-saving-stem-cell-therapy-gets-nod-of-approval-from-fda/\" target=\"_blank\" rel=\"noopener noreferrer\">FDA-approved\u003c/a> gene therapy that grew out of CIRM-funded research can now cure the disease by taking a patient’s own blood stem cells and modifying them to correct the SCID mutation. The altered cells generate new, healthy blood cells and repair the immune system.\u003c/p>\n\u003cp>The FDA has also approved two drugs for rare blood cancers that were developed with CIRM funds.\u003c/p>\n\u003cp>Sandra Dillon, a graphic designer in San Diego, credits one of the drugs with saving her life. She was diagnosed when she was just 28, in 2006. Her doctors told her they would try to manage her symptoms, but that she was going to get progressively sicker.\u003c/p>\n\u003cp>“Even just the idea of a cure or getting better wasn’t even on the table back then,” said Dillon, who is featured in ads for the Yes on 14 campaign.\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/Fv6FFQ1ez2w'\n title='//www.youtube.com/embed/Fv6FFQ1ez2w'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>“I remember just praying and begging into the universe, please, someone just look at my disease, please someone help, who is going to look at this thing.”\u003c/p>\n\u003cp>By 2010, Dillon was extremely ill. She connected with a doctor at UC San Diego who received early-stage funding from CIRM and told her she could take part in clinical trials.\u003c/p>\n\u003cp>“For the first time, there was this moment of, ‘Oh, my gosh! There are researchers doing something. And it could help me and I can get access to it.’ It was amazing.”\u003c/p>\n\u003cp>The drug received FDA approval in 2019, and today Dillon’s cancer has retreated to the point where she can live a normal life.\u003c/p>\n\u003cp>“I love that I am not tethered to a hospital anymore. I can go out on long backpacking trips and hiking and surfing,” she said. “I am a completely different person with this drug. And I have a whole future ahead of me.”\u003c/p>\n\u003cp>The original funding raised by Proposition 71 is running out. Proposition 14 would authorize the sale of a new bond to refill the agency piggy bank. Gov. Gavin Newsom, the UC Board of Regents, and scores of patient advocacy groups also support the measure.\u003c/p>\n\u003cp>Many newspaper editorial boards, however, oppose the proposition, including the San Francisco Chronicle, Mercury News and Los Angeles Times.\u003c/p>\n\u003cp>Right now the state still owes about $1 billion toward the debt created by Proposition 71. If Proposition 14 passes, the yearly price tag to pay off the new bond would be about $260 million per year for about 30 years.\u003c/p>\n\u003cp>One of the selling points of the original proposition was the potential for the state to earn big money in royalties from the treatments it helped develop, says Jeff Sheehy, an HIV patient advocate and the only CIRM board member to oppose Proposition 14.\u003c/p>\n\u003cp>“The promises were made that this would pay for itself. We would be able to pay back the bonds with the … money we would get from royalties, etc., etc.”\u003c/p>\n\u003cp>That has not worked out as envisioned: CIRM estimates it has received less than $500,000 in royalties. Early this year, Forty Seven, a company whose therapies were heavily funded by CIRM, \u003ca href=\"https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/gilead-to-acquire-forty-seven-for-49-billion\" target=\"_blank\" rel=\"noopener noreferrer\">sold\u003c/a> to Gilead for $4.9 billion. While millions went to various researchers, neither CIRM nor the state of California received anything.\u003c/p>\n\u003cp>“One of the flaws in the original measure is that we [the agency] cannot hold stock in the products that we develop,” says Sheehy. “And that’s because the California Constitution says that the state of California cannot, as a government entity, hold equity.”\u003c/p>\n\u003cp>Proposition 14 makes it impossible for the state to use profits from its investment on, say, schools or other funding priorities. Instead, any royalties earned must be fed back into programs to make CIRM-funded treatments more affordable.\u003c/p>\n\u003cp>“What it does is it basically takes all of our returns that we get from this and gives it back to the pharmaceutical and biotech companies,” said Sheehy. “It becomes just a blatant giveaway to these companies when we should be requiring access and requiring fair pricing.”\u003c/p>\n\u003cp>Sheehy says he supports medical research, but doesn’t like the state going into more debt to pay for it. The greater the state’s obligations in bond money, which has to be paid back with interest, the less there is in the general fund, and Sheehy says the state has more pressing needs than stem cell research — things like housing, education and transportation.\u003c/p>\n\u003cp>“The biggest and perhaps the most compelling reason why I feel so strongly that this is not a good idea is that we simply cannot afford it,” he said. “If we think this is so important,” asks Sheehy, “why don’t we just don’t pay for [this research] out of the general fund? It would be cheaper.”\u003c/p>\n\u003cp>Opponents of Proposition 14 also point to longstanding complaints of conflicts of interest among the agency board. Most of the $3 billion distributed by the agency has gone to institutions with connections to board members. Critics say the structural conflicts of interest between the board and agency are not addressed in the new measure. Proposition 14 would balloon an already huge board of 29 members to 35.\u003c/p>\n\u003cp>Funding needs for stem cell research also are not as acute as they were back in 2004. The federal National Institutes of Health now \u003ca href=\"https://report.nih.gov/categorical_spending.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">funds\u003c/a> some basic stem cell research, spending about $2 billion a year, with $321 million of that going toward human embryonic stem cell research. The Trump administration has not reinstated the ban, but has added lengthy paperwork and review \u003ca href=\"https://www.sciencemag.org/news/2019/07/trump-administration-releases-details-fetal-tissue-restrictions\" rel=\"noopener noreferrer\" target=\"_blank\">requirements\u003c/a>. And private ventures, like nonprofits started by tech billionaires, are pouring more money into biotech.\u003c/p>\n\u003cp>The problem with assuming that, says Melissa King, executive director of Americans for Cures, the stem cell advocacy group behind the “Yes on 14” campaign, is that CIRM fills a neglected funding need.\u003c/p>\n\u003cp>“The NIH does not fund clinical trials at nearly the rate that CIRM can and has been,” King said.\u003c/p>\n\u003cp>She says that’s important because of what she calls the “Valley of Death,” where promising early-stage research frequently fails to translate into promising treatments that can be tested in clinical-stage research. (What works well in a test tube often does not work well in an organism.) This weeding-out process is costly but necessary. And it’s where CIRM focused a lot of its effort.\u003c/p>\n\u003cp>“The first- and maybe even second-phase clinical trials, it’s very difficult to get those funded,” King said. “It is too much of a risk for business to take on on its own. Venture [capital] isn’t going there. Angel [funding] isn’t going there.”\u003c/p>\n\u003cp>What voters have to ask themselves, says writer Jensen, is whether stem cell funding is “a high priority for the state of California? Different people make different judgments about that.”\u003c/p>\n\u003cp>CIRM supporters say if Prop. 14 doesn’t pass, critical research will stall. Others say federal and private funding will step in and fill the gap.\u003c/p>\n\u003cp>Absent new funding, the institute expects it will wind down operations leading to a complete sundown in 2023.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "UC Berkeley's Jennifer Doudna Shares Nobel Prize in Chemistry for CRISPR",
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"content": "\u003cp>Two scientists won the Nobel Prize in chemistry on Wednesday for developing “molecular scissors” to edit genes, offering the promise of one day curing inherited diseases.\u003c/p>\n\u003cp>Working on opposite sides of the Atlantic, Frenchwoman Emmanuelle Charpentier and American Jennifer A. Doudna came up with a method known as CRISPR-cas9 that can be used to change the DNA of animals, plants and microorganisms. It was only the fourth time that a Nobel in the sciences was awarded exclusively to women, who have long received less recognition for their work than men in the prize’s 119-year history.\u003c/p>\n\u003cp>Charpentier and Doudna’s work allows for laser-sharp snips in the long strings of DNA that make up the “code of life,” enabling scientists to precisely edit specific genes to remove errors that lead to disease in humans — and is already being used for that purpose.\u003c/p>\n\u003cp>“There is enormous power in this genetic tool, which affects us all,” said Claes Gustafsson, chair of the Nobel Committee for Chemistry. “It has not only revolutionized basic science, but also resulted in innovative crops and will lead to groundbreaking new medical treatments.”\u003c/p>\n\u003cp>Gustafsson said that, as a result, any genome can now be edited “to fix genetic damage.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Dr. Francis Collins, who led the drive to map the human genome, said the technology “has changed everything” about how to approach diseases with a genetic cause, such as sickle cell disease.\u003c/p>\n\u003cp>“You can draw a direct line from the success of the human genome project to the power of CRISPR-cas to make changes in the instruction book,” said Collins, director of the National Institutes of Health, which helped fund Doudna’s work.\u003c/p>\n\u003cp>But many also cautioned that the technology raises serious ethical questions and must be used carefully. Much of the world became more aware of CRISPR in 2018, when Chinese scientist He Jiankui revealed he had helped make the world’s first gene-edited babies, to try to engineer resistance to future infection with the AIDS virus. His work was denounced as unsafe human experimentation because of the risk of causing unintended changes that could pass to future generations, and he’s been sentenced to prison in China.\u003c/p>\n\u003cp>In September, an international panel of experts issued a report saying it’s still too soon to try to make genetically edited babies because the science isn’t advanced enough to ensure safety, but they mapped a pathway for countries that want to consider it.\u003c/p>\n\u003cp>“Being able to selectively edit genes means that you are playing God in a way,” said American Chemical Society President Luis Echegoyen, a chemistry professor at the University of Texas El Paso.\u003c/p>\n\u003cp>Charpentier, 51, spoke of the shock of winning.\u003c/p>\n\u003cp>“Strangely enough I was told a number of times (that I’d win), but when it happens you’re very surprised and you feel that it’s not real,” she told reporters by phone from Berlin after the award was announced in Stockholm by the Royal Swedish Academy of Sciences. “But obviously it’s real, so I have to get used to it now.”\u003c/p>\n\u003cp>When asked about the significance of two women winning, Charpentier said that while she considers herself first and foremost a scientist, “it’s reflective of the fact that science becomes more modern and involves more female leaders.”\u003c/p>\n\u003cp>“I do hope that it will remain and even develop more in this direction,” she said, adding that it’s “more cumbersome to be a woman in science than to be a man in science.”\u003c/p>\n\u003cp>Three times a woman has won a Nobel in the sciences by herself; this is the first time an all-female team won a science prize. In 1911, Marie Curie was the sole recipient of the chemistry award, as was Dorothy Crowfoot Hodgkin in 1964. In 1983, Barbara McClintock won the Nobel for medicine.\u003c/p>\n\u003cp>Doudna told The Associated Press of her own surprise — including that she learned she’d won from a reporter.\u003c/p>\n\u003cp>“I literally just found out, I’m in shock,” she said. “I was sound asleep.\u003c/p>\n\u003cp>“My greatest hope is that it’s used for good, to uncover new mysteries in biology and to benefit humankind,” said Doudna, who is affiliated with UC Berkeley and is paid by the Howard Hughes Medical Institute, which also supports AP’s Health and Science Department.\u003c/p>\n\u003cp>The breakthrough research done by Charpentier and Doudna was published in 2012, making the discovery very recent compared to much Nobel-wining research, which is often only honored after decades have passed.\u003c/p>\n\u003cp>Speaking to reporters from the Max Planck Unit for the Science of Pathogens in Berlin, which she leads, Charpentier said despite how recently it was developed, the method is now widely used by scientists researching diseases, developing drugs and engineering new plants.\u003c/p>\n\u003cp>Among the most promising therapies already being developed are for eye diseases and blood disorders, such as sickle cell disease and beta thalassemia, she said. It could also have applications in the growing field of cancer immunotherapy.\u003c/p>\n\u003cp>Developing hardy crops is another promising direction, said Charpentier. “I think this is very important considering the challenge we are facing of climate change,” she said.\u003c/p>\n\u003cp>The Broad Institute at Harvard and MIT have been in a long court fight over patents on CRISPR technology, and many other scientists did important work on it, but Doudna and Charpentier have been most consistently honored with prizes for turning it into an easily usable tool.\u003c/p>\n\u003cp>The prestigious award comes with a gold medal and prize money of 10 million kronor (more than $1.1 million), courtesy of a bequest left more than a century ago by the prize’s creator, Swedish inventor Alfred Nobel. The amount was increased recently to adjust for inflation.\u003c/p>\n\u003cp>On Monday, the Nobel Committee awarded the prize for physiology and medicine for discovering the liver-ravaging hepatitis C virus. Tuesday’s prize for physics honored breakthroughs in understanding the mysteries of cosmic black holes.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The other prizes are for outstanding work in the fields of literature, peace and economics.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Two scientists won the Nobel Prize in chemistry on Wednesday for developing “molecular scissors” to edit genes, offering the promise of one day curing inherited diseases.\u003c/p>\n\u003cp>Working on opposite sides of the Atlantic, Frenchwoman Emmanuelle Charpentier and American Jennifer A. Doudna came up with a method known as CRISPR-cas9 that can be used to change the DNA of animals, plants and microorganisms. It was only the fourth time that a Nobel in the sciences was awarded exclusively to women, who have long received less recognition for their work than men in the prize’s 119-year history.\u003c/p>\n\u003cp>Charpentier and Doudna’s work allows for laser-sharp snips in the long strings of DNA that make up the “code of life,” enabling scientists to precisely edit specific genes to remove errors that lead to disease in humans — and is already being used for that purpose.\u003c/p>\n\u003cp>“There is enormous power in this genetic tool, which affects us all,” said Claes Gustafsson, chair of the Nobel Committee for Chemistry. “It has not only revolutionized basic science, but also resulted in innovative crops and will lead to groundbreaking new medical treatments.”\u003c/p>\n\u003cp>Gustafsson said that, as a result, any genome can now be edited “to fix genetic damage.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Dr. Francis Collins, who led the drive to map the human genome, said the technology “has changed everything” about how to approach diseases with a genetic cause, such as sickle cell disease.\u003c/p>\n\u003cp>“You can draw a direct line from the success of the human genome project to the power of CRISPR-cas to make changes in the instruction book,” said Collins, director of the National Institutes of Health, which helped fund Doudna’s work.\u003c/p>\n\u003cp>But many also cautioned that the technology raises serious ethical questions and must be used carefully. Much of the world became more aware of CRISPR in 2018, when Chinese scientist He Jiankui revealed he had helped make the world’s first gene-edited babies, to try to engineer resistance to future infection with the AIDS virus. His work was denounced as unsafe human experimentation because of the risk of causing unintended changes that could pass to future generations, and he’s been sentenced to prison in China.\u003c/p>\n\u003cp>In September, an international panel of experts issued a report saying it’s still too soon to try to make genetically edited babies because the science isn’t advanced enough to ensure safety, but they mapped a pathway for countries that want to consider it.\u003c/p>\n\u003cp>“Being able to selectively edit genes means that you are playing God in a way,” said American Chemical Society President Luis Echegoyen, a chemistry professor at the University of Texas El Paso.\u003c/p>\n\u003cp>Charpentier, 51, spoke of the shock of winning.\u003c/p>\n\u003cp>“Strangely enough I was told a number of times (that I’d win), but when it happens you’re very surprised and you feel that it’s not real,” she told reporters by phone from Berlin after the award was announced in Stockholm by the Royal Swedish Academy of Sciences. “But obviously it’s real, so I have to get used to it now.”\u003c/p>\n\u003cp>When asked about the significance of two women winning, Charpentier said that while she considers herself first and foremost a scientist, “it’s reflective of the fact that science becomes more modern and involves more female leaders.”\u003c/p>\n\u003cp>“I do hope that it will remain and even develop more in this direction,” she said, adding that it’s “more cumbersome to be a woman in science than to be a man in science.”\u003c/p>\n\u003cp>Three times a woman has won a Nobel in the sciences by herself; this is the first time an all-female team won a science prize. In 1911, Marie Curie was the sole recipient of the chemistry award, as was Dorothy Crowfoot Hodgkin in 1964. In 1983, Barbara McClintock won the Nobel for medicine.\u003c/p>\n\u003cp>Doudna told The Associated Press of her own surprise — including that she learned she’d won from a reporter.\u003c/p>\n\u003cp>“I literally just found out, I’m in shock,” she said. “I was sound asleep.\u003c/p>\n\u003cp>“My greatest hope is that it’s used for good, to uncover new mysteries in biology and to benefit humankind,” said Doudna, who is affiliated with UC Berkeley and is paid by the Howard Hughes Medical Institute, which also supports AP’s Health and Science Department.\u003c/p>\n\u003cp>The breakthrough research done by Charpentier and Doudna was published in 2012, making the discovery very recent compared to much Nobel-wining research, which is often only honored after decades have passed.\u003c/p>\n\u003cp>Speaking to reporters from the Max Planck Unit for the Science of Pathogens in Berlin, which she leads, Charpentier said despite how recently it was developed, the method is now widely used by scientists researching diseases, developing drugs and engineering new plants.\u003c/p>\n\u003cp>Among the most promising therapies already being developed are for eye diseases and blood disorders, such as sickle cell disease and beta thalassemia, she said. It could also have applications in the growing field of cancer immunotherapy.\u003c/p>\n\u003cp>Developing hardy crops is another promising direction, said Charpentier. “I think this is very important considering the challenge we are facing of climate change,” she said.\u003c/p>\n\u003cp>The Broad Institute at Harvard and MIT have been in a long court fight over patents on CRISPR technology, and many other scientists did important work on it, but Doudna and Charpentier have been most consistently honored with prizes for turning it into an easily usable tool.\u003c/p>\n\u003cp>The prestigious award comes with a gold medal and prize money of 10 million kronor (more than $1.1 million), courtesy of a bequest left more than a century ago by the prize’s creator, Swedish inventor Alfred Nobel. The amount was increased recently to adjust for inflation.\u003c/p>\n\u003cp>On Monday, the Nobel Committee awarded the prize for physiology and medicine for discovering the liver-ravaging hepatitis C virus. Tuesday’s prize for physics honored breakthroughs in understanding the mysteries of cosmic black holes.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The other prizes are for outstanding work in the fields of literature, peace and economics.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"headTitle": "FDA Releases Stricter Vaccine Safety Guidelines Despite White House Interference | KQED",
"content": "\u003cp>The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines despite efforts by the White House to block them, clearing the way for requirements that are widely expected to prevent the introduction of a vaccine before Election Day.\u003c/p>\n\u003cp>In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of COVID-19 vaccines.\u003c/p>\n\u003cp>President Donald Trump has repeatedly insisted a vaccine could be authorized before Nov. 3, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.\u003c/p>\n\u003cp>Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.\u003c/p>\n\u003cp>A senior administration official confirmed Monday that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the two-month data requirement, arguing there was “no clinical or medical reason” for it.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But on Tuesday, the FDA posted the guidance on its website, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.\u003c/p>\n\u003cp>FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”\u003c/p>\n\u003cp>The requirements are aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. But FDA has made clear only vaccines that are shown to be safe and effective will be authorized for coronavirus.\u003c/p>\n\u003cp>Former FDA acting commissioner Dr. Stephen Ostroff said the requirements seem reasonable given the agency is in largely “uncharted territory” in terms of considering emergency use of a vaccine. The agency has only previously cleared one vaccine through the method — a decades-old shot that was authorized to prevent anthrax poisoning in 2005.\u003c/p>\n\u003cp>“There really is no margin for error here,” Ostroff said. “Even when you’re talking about limited use of a vaccine there has to be some level of assurance that there isn’t a risk here that would far outweigh the benefit.”\u003c/p>\n\u003cp>Dr. Peter Marks, the head of FDA’s vaccine division, said Tuesday that the two-month follow-up requirement was chosen to be “something reasonably aggressive, but not too conservative — right in the middle.” He spoke at a symposium organized by Johns Hopkins University.\u003c/p>\n\u003cp>Initial doses of vaccines for emergency use would likely be reserved for medical workers and people with health conditions that make them particularly vulnerable to coronavirus. Full FDA approval for the general population will require significantly more data and is not expected until mid-2021.\u003c/p>\n\u003cp>The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. FDA’s Hahn has been attempting to shore up public confidence in the vaccine review process for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective.\u003c/p>\n\u003cp>Pfizer CEO Albert Bourla has stoked excitement by saying that he expects data on whether the company’s candidate works to be ready in late October. But a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.\u003c/p>\n\u003cp>Vaccine development typically takes years, but the U.S. government has invested billions in efforts to accelerate the process and help multiple drugmakers prepare multiple candidates. All the doses will be purchased by the federal government for use vaccinating the U.S. population.\u003c/p>\n\u003cp>Beyond exposing the rift between the White House and FDA, the delay in releasing the guidelines may have had limited practical effect.\u003c/p>\n\u003cp>FDA scientists have been discussing the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.\u003c/p>\n\u003cp>Former FDA Commissioner Scott Gottlieb said Tuesday that drugmakers depend on the FDA’s science-based endorsement to vouch for the safety and effectiveness of their products.\u003c/p>\n\u003cp>“I can’t imagine a circumstance where a sponsor would challenge or seek to undermine the FDA’s role here,” Gottlieb said at the COVID-19 symposium. “This is precisely the moment when we need an objective, neutral arbiter.”\u003c/p>\n\u003cp>Last week, Gottlieb and six other former FDA commissioners blasted the Trump administration for “undermining the credibility” of the agency in a op-ed calling for the release of the then-stalled vaccine guidelines.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests,” the officials wrote.\u003c/p>\n\n",
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"excerpt": "The move follows a multiweek tug-of-war between Trump officials and government scientists over the review and timeline for upcoming vaccines. The FDA guidelines now state that companies must provide two months of safety data from participants before seeking emergency approval.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines despite efforts by the White House to block them, clearing the way for requirements that are widely expected to prevent the introduction of a vaccine before Election Day.\u003c/p>\n\u003cp>In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of COVID-19 vaccines.\u003c/p>\n\u003cp>President Donald Trump has repeatedly insisted a vaccine could be authorized before Nov. 3, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.\u003c/p>\n\u003cp>Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.\u003c/p>\n\u003cp>A senior administration official confirmed Monday that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the two-month data requirement, arguing there was “no clinical or medical reason” for it.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But on Tuesday, the FDA posted the guidance on its website, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.\u003c/p>\n\u003cp>FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”\u003c/p>\n\u003cp>The requirements are aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. But FDA has made clear only vaccines that are shown to be safe and effective will be authorized for coronavirus.\u003c/p>\n\u003cp>Former FDA acting commissioner Dr. Stephen Ostroff said the requirements seem reasonable given the agency is in largely “uncharted territory” in terms of considering emergency use of a vaccine. The agency has only previously cleared one vaccine through the method — a decades-old shot that was authorized to prevent anthrax poisoning in 2005.\u003c/p>\n\u003cp>“There really is no margin for error here,” Ostroff said. “Even when you’re talking about limited use of a vaccine there has to be some level of assurance that there isn’t a risk here that would far outweigh the benefit.”\u003c/p>\n\u003cp>Dr. Peter Marks, the head of FDA’s vaccine division, said Tuesday that the two-month follow-up requirement was chosen to be “something reasonably aggressive, but not too conservative — right in the middle.” He spoke at a symposium organized by Johns Hopkins University.\u003c/p>\n\u003cp>Initial doses of vaccines for emergency use would likely be reserved for medical workers and people with health conditions that make them particularly vulnerable to coronavirus. Full FDA approval for the general population will require significantly more data and is not expected until mid-2021.\u003c/p>\n\u003cp>The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. FDA’s Hahn has been attempting to shore up public confidence in the vaccine review process for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective.\u003c/p>\n\u003cp>Pfizer CEO Albert Bourla has stoked excitement by saying that he expects data on whether the company’s candidate works to be ready in late October. But a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.\u003c/p>\n\u003cp>Vaccine development typically takes years, but the U.S. government has invested billions in efforts to accelerate the process and help multiple drugmakers prepare multiple candidates. All the doses will be purchased by the federal government for use vaccinating the U.S. population.\u003c/p>\n\u003cp>Beyond exposing the rift between the White House and FDA, the delay in releasing the guidelines may have had limited practical effect.\u003c/p>\n\u003cp>FDA scientists have been discussing the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.\u003c/p>\n\u003cp>Former FDA Commissioner Scott Gottlieb said Tuesday that drugmakers depend on the FDA’s science-based endorsement to vouch for the safety and effectiveness of their products.\u003c/p>\n\u003cp>“I can’t imagine a circumstance where a sponsor would challenge or seek to undermine the FDA’s role here,” Gottlieb said at the COVID-19 symposium. “This is precisely the moment when we need an objective, neutral arbiter.”\u003c/p>\n\u003cp>Last week, Gottlieb and six other former FDA commissioners blasted the Trump administration for “undermining the credibility” of the agency in a op-ed calling for the release of the then-stalled vaccine guidelines.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests,” the officials wrote.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "What Is the Prognosis for President Trump?",
"headTitle": "What Is the Prognosis for President Trump? | KQED",
"content": "\u003cp>After dismissing the threat of the COVID-19 pandemic for months, President Trump announced \u003ca href=\"https://twitter.com/realDonaldTrump/status/1311892190680014849\" target=\"_blank\" rel=\"noopener noreferrer\">on Twitter\u003c/a> late Thursday night that he and his wife, Melania, had tested positive for the coronavirus that causes the disease. The White House on Friday said Trump is experiencing “mild” symptoms and that he will \u003ca href=\"https://www.npr.org/2020/10/02/919697784/trump-makes-unannounced-visit-to-walter-reed-following-coronavirus-diagnosis\" target=\"_blank\" rel=\"noopener noreferrer\">work \u003c/a>from Walter Reed hospital “for the next few days.”\u003c/p>\n\u003cp>On KQED’s \u003ca href=\"https://www.kqed.org/forum/2010101880055/president-trump-tests-positive-for-coronavirus\" target=\"_blank\" rel=\"noopener noreferrer\">Forum\u003c/a> radio program Friday, \u003cstrong>Dr. Bob Wachter\u003c/strong>, chair of the Department of Medicine at UCSF, spoke with host Michael Krasny about the prognosis for Trump, what therapeutics may be available to him, and an assessment of the president’s response to the pandemic from a public health perspective.\u003c/p>\n\u003cp>The following has been edited for length and clarity.\u003c/p>\n\u003cp>\u003cstrong>What is the prognosis for someone of President Trump’s age, height and weight, and other characteristics?\u003c/strong>\u003c/p>\n\u003cp>\u003cem>Bob Wachter\u003c/em>: As we go through the checkboxes of what would give you a worse prognosis, he checks off many if not all of them. Older is worse than younger, and once you get up to 74 years old, your chance of dying is somewhere around 100 times greater than if you got it in your 20s. But his chances of survival are quite good; from what we know from public information, his chances of dying are about 1 in 20, though that’s probably about 10 times greater than the average person who gets COVID.\u003c/p>\n\u003cp>[pullquote citation=\"Dr. Bob Wachter, UCSF\"]‘As we go through the checkboxes of what would give you a worse prognosis, he checks off many if not all of them. But his chances of survival are quite good.’[/pullquote]Men do almost twice as poorly as women for reasons that aren’t fully understood. He also meets the clinical definition of obesity in terms of his body mass index. That makes his prognosis three times worse than if he wasn’t obese.\u003c/p>\n\u003cp>Whatever other illnesses he has, and they have not been forthcoming about his medical record, that can only add to the negative prognostic signs. He already comes into this with a fair number of points against him.\u003c/p>\n\u003cp>That doesn’t mean he’s likely to do poorly, but the fact that he has symptoms means that he already is not in the best category: About 40% of people who get the coronavirus are asymptomatic through the entire course of the illness; maybe a little bit less than that because some are presymptomatic.\u003c/p>\n\u003cp>You might say, “the symptoms are mild.” Is that reassuring? I would say not at all. Because he gets tested every day, we know he only got it a couple of days ago. So he’s very early in his course. It would be highly surprising for him to be worse than just mildly symptomatic now. And his period of greatest risk will come in the next seven to 10 days or so.\u003c/p>\n\u003cp>\u003cstrong>What therapeutics is President Trump eligible for? Which ones do you think would help?\u003c/strong>\u003c/p>\n\u003cp>There is no proven treatment for early COVID in terms of preventing the illness from getting worse and leading to a shortness of breath or hospitalization or ultimately respiratory failure.\u003c/p>\n\u003cp>[pullquote]‘It would be highly surprising for him to be worse than just mildly symptomatic [at this stage]. His period of greatest risk will come in the next seven to 10 days or so.’[/pullquote]The only treatments that have been approved are ones that we know work for sure, and they’re only given for patients who are sick and are in the hospital. One is an antiviral drug called remdesivir, \u003cb>\u003c/b>generally only available to people who are already sick and in the hospital. The other is an anti-inflammatory medicine called dexamethasone, which is a form of steroid.\u003c/p>\n\u003cp>There’s a set of therapeutics, which have shown promise in early studies, called monoclonal antibodies. They’re essentially an artificial form of antibodies. It’s very expensive, so it won’t be widely used, but giving it to people before they’re sick enough to need to be hospitalized — and it’s too early to be sure about this — lowers the rate of hospitalization and sickness. My guess is that they will figure out a way to get the president one of those drugs, even though it’s not generally available to the public.\u003c/p>\n\u003cp>There was a lot of discussion on Twitter last night about how even though he’s got these negative prognostic signs — his age, his obesity and being male — he’ll also get the best care in the world.\u003c/p>\n\u003cp>[pullquote]‘As people have mapped out what a pandemic would look like over the last 20, 30, 40 years, there was no scenario in which the federal government would have become part of the problem.’[/pullquote]That might make a difference if it turns out these drugs work and he has access to them, whereas the rest of us wouldn’t. But I can tell you that in my experience and in the literature, there’s no great evidence that VIPs do better. And actually, sometimes they do worse because as you remember from \u003ca href=\"https://www.kqed.org/news/42207/steve-jobs-think-different-philosophy-included-approach-to-cancer-treatment\" target=\"_blank\" rel=\"noopener noreferrer\">Steve Jobs\u003c/a>, sometimes they dictate their own care and it’s not evidence-based. Sometimes the care is somewhat chaotic because everybody is falling over themselves to take care of the patient. And so in terms of the VIP stuff, I wouldn’t think that his odds are any better than the average patient coming into the emergency room at UCSF today.\u003c/p>\n\u003cp>\u003cstrong>Can you talk about the rapid tests they use at the White House?\u003c/strong>\u003c/p>\n\u003cp>They are getting better. A new one has just come out, but I don’t think it’s being used yet at the White House. They do have false negatives.\u003c/p>\n\u003cp>It’s unusual, but there have been false positives with that test as well. It happened with Gov. [Mike] DeWine of Ohio. And so the first positive test that came back from the president last night might’ve been the rapid one. But by now, though they’re really not being transparent at all about this, because we could use a lot more information about the test, I assume he’s had the better, PCR test, and that both tests were positive. I don’t think they would have come out publicly unless they confirmed both tests.\u003c/p>\n\u003cp>I think part of the theme here is that in the environment of the White House, where people were being tested every day, they took that, I believe, as reassurance that nobody around the president could have COVID, and it’s OK, therefore, not to follow the public health guidelines. And that clearly was a mistake.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Joe Biden’s test came back negative. Could it be too early, though, for the test to be definitive?\u003c/strong>\u003c/p>\n\u003cp>The answer is yes. So it will be important that he has follow-up tests. It takes a few days of incubation period for the virus to replicate enough in order to have a positive test. So if the vice president’s exposure was through the debate, having a negative test today is certainly more reassuring than a positive test, but he would not be out of the woods. You’d want to see tests for another several days.\u003c/p>\n\u003cp>Biden’s risk should be extremely low. First of all, he’s been extraordinarily careful for the entire time. In terms of the debate itself, I didn’t see a measurement, but it looked like he was standing 15 to 20 feet away, which is generally, although not 100%, a safe distance.\u003c/p>\n\u003cp>\u003cstrong>What effect do you think this will have on the next planned debates? The next one, conducted in a town hall format, is scheduled for Oct. 15.\u003c/strong>\u003c/p>\n\u003cp>I think they’ll pay more attention to the risk of the virus in any kind of public gathering, so I imagine the rules will be somewhat different in terms of additional spacing. And certainly everybody in the audience will wear masks.\u003c/p>\n\u003cp>You know, it’s a little bit hard to say in terms of future presidential debates, because the president has symptoms now. In general, we say that two weeks after the onset of symptoms, you are no longer infectious, even if you are continuing to test positive.\u003c/p>\n\u003cp>In the beginning, we saw people with persistently positive viral tests for weeks and weeks and wondered if they were still infectious. And the evidence is really quite clear that a couple of weeks out, you’re no longer infectious, even though you may still test positive because you have the virus.\u003c/p>\n\u003cp>But certainly for the next two weeks, the president needs to be in absolutely strict quarantine. It would be public health malpractice to do an in-person debate within a couple of weeks of someone developing the coronavirus.\u003c/p>\n\u003cp>\u003cstrong>In a \u003ca href=\"https://int.nyt.com/data/documenttools/evanega-et-al-coronavirus-misinformation-submitted-07-23-20-1/080839ac0c22bca8/full.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">study\u003c/a> released this week, Cornell University researchers found that President Trump is “likely the \u003ca href=\"https://www.nytimes.com/2020/09/30/us/politics/trump-coronavirus-misinformation.html\" target=\"_blank\" rel=\"noopener noreferrer\">largest driver\u003c/a>” of COVID-19 misinformation. What has been the president’s effect on public health? \u003c/strong>\u003c/p>\n\u003cp>We can feel sympathy for the person and still feel like this pandemic has been mishandled at a national level. And the source of much of that is the president; there’s just no two ways about it.\u003c/p>\n\u003cp>It’s very hard to look at his responses all the way through and see anything good about them. Really, under any estimate that I can come up, with that has cost tens of thousands of lives.\u003c/p>\n\u003cp>We look at San Francisco, which just had its 100th death last week from COVID. If the entire country had our death rate, we would have had 165,000 fewer deaths. In San Francisco, our bodies are exactly the same, and the virus is exactly the same. But in an area where there was good political leadership and where the people wore masks and paid attention to the science, that is the kind of difference that could have been made.\u003c/p>\n\u003cp>I believe that had there been presidential leadership, as I think we would have expected — coming out early saying this is serious, here’s what you need to do, the kind of thing that he obviously knew about according to his \u003ca href=\"https://www.cnn.com/2020/09/09/politics/bob-woodward-rage-book-trump-coronavirus/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">discussions\u003c/a> with Bob Woodward — I believe that we would have had tens of thousands if not 100,000 or more fewer deaths.\u003c/p>\n\u003cp>I try to be fair and say this would have been bad under anyone’s watch. It would’ve been a major challenge to the system, and people would have died. But it didn’t have to be like this and doesn’t have to be like this.\u003c/p>\n\u003cp>You know, as people have mapped out and gamed out what a pandemic would look like over the last 20, 30, 40 years, there was no scenario in which the federal government would have become part of the problem, would have been the source of misinformation, would have shackled the main agency responsible for prevention and educating people about what to do. That was not on the list of things that we needed to worry about.\u003c/p>\n\u003cp>\u003cstrong>What effect do you think President Trump’s contracting the virus will have on public health going forward? \u003c/strong>\u003c/p>\n\u003cp>\u003cb>\u003c/b>If there’s any good that comes out of this, it will be that people who did not take this seriously will take it more seriously. You know, if the president can get it, anybody can get it.\u003c/p>\n\u003cp>There sometimes is this feeling that we’re out of the woods. It’s just clearly not true. The virus hasn’t changed in a material way over the course of eight or nine months, and neither have we. We are all susceptible.\u003c/p>\n\u003cp>What’s remarkable is we know the things that one needs to do to lower your chance of contracting the coronavirus. And unfortunately, the president has doubled down on not doing those things. Obviously we wish him well. But there was a lot of foolish behavior that went into this.\u003c/p>\n\u003cp>A lot will hinge on how he does. If he has a mild case, he may feel a little bit crummy for a few days or a week or so and be back to normal. And you wonder what will come out of the politics of that if he recovers. There is also a decent chance that he will do poorly.\u003c/p>\n\u003cp>\u003cstrong>Can we say that this finally puts to rest the idea that hydroxychloroquine can indeed be a prophylactic? The president took it for weeks and swore by it. \u003c/strong>\u003c/p>\n\u003cp>What puts that idea to rest is the fact that there have been more than a dozen studies on that question. But no, I think it’s hazardous to use single-case patient examples. That’s part of what gets the president in trouble: He sees a case where the patient miraculously got better. And the next thing you know, he’s touting it as a cure. That’s why we need science. The fact that he may have been taking hydroxychloroquine and he still got sick is interesting, but to me not persuasive. What’s persuasive is that it has been massively studied, and the evidence is quite clear that it does not work.\u003c/p>\n\u003cp> \u003c/p>\n\u003cp> \u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>After dismissing the threat of the COVID-19 pandemic for months, President Trump announced \u003ca href=\"https://twitter.com/realDonaldTrump/status/1311892190680014849\" target=\"_blank\" rel=\"noopener noreferrer\">on Twitter\u003c/a> late Thursday night that he and his wife, Melania, had tested positive for the coronavirus that causes the disease. The White House on Friday said Trump is experiencing “mild” symptoms and that he will \u003ca href=\"https://www.npr.org/2020/10/02/919697784/trump-makes-unannounced-visit-to-walter-reed-following-coronavirus-diagnosis\" target=\"_blank\" rel=\"noopener noreferrer\">work \u003c/a>from Walter Reed hospital “for the next few days.”\u003c/p>\n\u003cp>On KQED’s \u003ca href=\"https://www.kqed.org/forum/2010101880055/president-trump-tests-positive-for-coronavirus\" target=\"_blank\" rel=\"noopener noreferrer\">Forum\u003c/a> radio program Friday, \u003cstrong>Dr. Bob Wachter\u003c/strong>, chair of the Department of Medicine at UCSF, spoke with host Michael Krasny about the prognosis for Trump, what therapeutics may be available to him, and an assessment of the president’s response to the pandemic from a public health perspective.\u003c/p>\n\u003cp>The following has been edited for length and clarity.\u003c/p>\n\u003cp>\u003cstrong>What is the prognosis for someone of President Trump’s age, height and weight, and other characteristics?\u003c/strong>\u003c/p>\n\u003cp>\u003cem>Bob Wachter\u003c/em>: As we go through the checkboxes of what would give you a worse prognosis, he checks off many if not all of them. Older is worse than younger, and once you get up to 74 years old, your chance of dying is somewhere around 100 times greater than if you got it in your 20s. But his chances of survival are quite good; from what we know from public information, his chances of dying are about 1 in 20, though that’s probably about 10 times greater than the average person who gets COVID.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "‘As we go through the checkboxes of what would give you a worse prognosis, he checks off many if not all of them. But his chances of survival are quite good.’",
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"content": "\u003cdiv class=\"post-body\">\u003cp>Men do almost twice as poorly as women for reasons that aren’t fully understood. He also meets the clinical definition of obesity in terms of his body mass index. That makes his prognosis three times worse than if he wasn’t obese.\u003c/p>\n\u003cp>Whatever other illnesses he has, and they have not been forthcoming about his medical record, that can only add to the negative prognostic signs. He already comes into this with a fair number of points against him.\u003c/p>\n\u003cp>That doesn’t mean he’s likely to do poorly, but the fact that he has symptoms means that he already is not in the best category: About 40% of people who get the coronavirus are asymptomatic through the entire course of the illness; maybe a little bit less than that because some are presymptomatic.\u003c/p>\n\u003cp>You might say, “the symptoms are mild.” Is that reassuring? I would say not at all. Because he gets tested every day, we know he only got it a couple of days ago. So he’s very early in his course. It would be highly surprising for him to be worse than just mildly symptomatic now. And his period of greatest risk will come in the next seven to 10 days or so.\u003c/p>\n\u003cp>\u003cstrong>What therapeutics is President Trump eligible for? Which ones do you think would help?\u003c/strong>\u003c/p>\n\u003cp>There is no proven treatment for early COVID in terms of preventing the illness from getting worse and leading to a shortness of breath or hospitalization or ultimately respiratory failure.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "‘It would be highly surprising for him to be worse than just mildly symptomatic [at this stage]. His period of greatest risk will come in the next seven to 10 days or so.’",
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"content": "\u003cdiv class=\"post-body\">\u003cp>The only treatments that have been approved are ones that we know work for sure, and they’re only given for patients who are sick and are in the hospital. One is an antiviral drug called remdesivir, \u003cb>\u003c/b>generally only available to people who are already sick and in the hospital. The other is an anti-inflammatory medicine called dexamethasone, which is a form of steroid.\u003c/p>\n\u003cp>There’s a set of therapeutics, which have shown promise in early studies, called monoclonal antibodies. They’re essentially an artificial form of antibodies. It’s very expensive, so it won’t be widely used, but giving it to people before they’re sick enough to need to be hospitalized — and it’s too early to be sure about this — lowers the rate of hospitalization and sickness. My guess is that they will figure out a way to get the president one of those drugs, even though it’s not generally available to the public.\u003c/p>\n\u003cp>There was a lot of discussion on Twitter last night about how even though he’s got these negative prognostic signs — his age, his obesity and being male — he’ll also get the best care in the world.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "‘As people have mapped out what a pandemic would look like over the last 20, 30, 40 years, there was no scenario in which the federal government would have become part of the problem.’",
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"content": "\u003cdiv class=\"post-body\">\u003cp>That might make a difference if it turns out these drugs work and he has access to them, whereas the rest of us wouldn’t. But I can tell you that in my experience and in the literature, there’s no great evidence that VIPs do better. And actually, sometimes they do worse because as you remember from \u003ca href=\"https://www.kqed.org/news/42207/steve-jobs-think-different-philosophy-included-approach-to-cancer-treatment\" target=\"_blank\" rel=\"noopener noreferrer\">Steve Jobs\u003c/a>, sometimes they dictate their own care and it’s not evidence-based. Sometimes the care is somewhat chaotic because everybody is falling over themselves to take care of the patient. And so in terms of the VIP stuff, I wouldn’t think that his odds are any better than the average patient coming into the emergency room at UCSF today.\u003c/p>\n\u003cp>\u003cstrong>Can you talk about the rapid tests they use at the White House?\u003c/strong>\u003c/p>\n\u003cp>They are getting better. A new one has just come out, but I don’t think it’s being used yet at the White House. They do have false negatives.\u003c/p>\n\u003cp>It’s unusual, but there have been false positives with that test as well. It happened with Gov. [Mike] DeWine of Ohio. And so the first positive test that came back from the president last night might’ve been the rapid one. But by now, though they’re really not being transparent at all about this, because we could use a lot more information about the test, I assume he’s had the better, PCR test, and that both tests were positive. I don’t think they would have come out publicly unless they confirmed both tests.\u003c/p>\n\u003cp>I think part of the theme here is that in the environment of the White House, where people were being tested every day, they took that, I believe, as reassurance that nobody around the president could have COVID, and it’s OK, therefore, not to follow the public health guidelines. And that clearly was a mistake.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Joe Biden’s test came back negative. Could it be too early, though, for the test to be definitive?\u003c/strong>\u003c/p>\n\u003cp>The answer is yes. So it will be important that he has follow-up tests. It takes a few days of incubation period for the virus to replicate enough in order to have a positive test. So if the vice president’s exposure was through the debate, having a negative test today is certainly more reassuring than a positive test, but he would not be out of the woods. You’d want to see tests for another several days.\u003c/p>\n\u003cp>Biden’s risk should be extremely low. First of all, he’s been extraordinarily careful for the entire time. In terms of the debate itself, I didn’t see a measurement, but it looked like he was standing 15 to 20 feet away, which is generally, although not 100%, a safe distance.\u003c/p>\n\u003cp>\u003cstrong>What effect do you think this will have on the next planned debates? The next one, conducted in a town hall format, is scheduled for Oct. 15.\u003c/strong>\u003c/p>\n\u003cp>I think they’ll pay more attention to the risk of the virus in any kind of public gathering, so I imagine the rules will be somewhat different in terms of additional spacing. And certainly everybody in the audience will wear masks.\u003c/p>\n\u003cp>You know, it’s a little bit hard to say in terms of future presidential debates, because the president has symptoms now. In general, we say that two weeks after the onset of symptoms, you are no longer infectious, even if you are continuing to test positive.\u003c/p>\n\u003cp>In the beginning, we saw people with persistently positive viral tests for weeks and weeks and wondered if they were still infectious. And the evidence is really quite clear that a couple of weeks out, you’re no longer infectious, even though you may still test positive because you have the virus.\u003c/p>\n\u003cp>But certainly for the next two weeks, the president needs to be in absolutely strict quarantine. It would be public health malpractice to do an in-person debate within a couple of weeks of someone developing the coronavirus.\u003c/p>\n\u003cp>\u003cstrong>In a \u003ca href=\"https://int.nyt.com/data/documenttools/evanega-et-al-coronavirus-misinformation-submitted-07-23-20-1/080839ac0c22bca8/full.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">study\u003c/a> released this week, Cornell University researchers found that President Trump is “likely the \u003ca href=\"https://www.nytimes.com/2020/09/30/us/politics/trump-coronavirus-misinformation.html\" target=\"_blank\" rel=\"noopener noreferrer\">largest driver\u003c/a>” of COVID-19 misinformation. What has been the president’s effect on public health? \u003c/strong>\u003c/p>\n\u003cp>We can feel sympathy for the person and still feel like this pandemic has been mishandled at a national level. And the source of much of that is the president; there’s just no two ways about it.\u003c/p>\n\u003cp>It’s very hard to look at his responses all the way through and see anything good about them. Really, under any estimate that I can come up, with that has cost tens of thousands of lives.\u003c/p>\n\u003cp>We look at San Francisco, which just had its 100th death last week from COVID. If the entire country had our death rate, we would have had 165,000 fewer deaths. In San Francisco, our bodies are exactly the same, and the virus is exactly the same. But in an area where there was good political leadership and where the people wore masks and paid attention to the science, that is the kind of difference that could have been made.\u003c/p>\n\u003cp>I believe that had there been presidential leadership, as I think we would have expected — coming out early saying this is serious, here’s what you need to do, the kind of thing that he obviously knew about according to his \u003ca href=\"https://www.cnn.com/2020/09/09/politics/bob-woodward-rage-book-trump-coronavirus/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">discussions\u003c/a> with Bob Woodward — I believe that we would have had tens of thousands if not 100,000 or more fewer deaths.\u003c/p>\n\u003cp>I try to be fair and say this would have been bad under anyone’s watch. It would’ve been a major challenge to the system, and people would have died. But it didn’t have to be like this and doesn’t have to be like this.\u003c/p>\n\u003cp>You know, as people have mapped out and gamed out what a pandemic would look like over the last 20, 30, 40 years, there was no scenario in which the federal government would have become part of the problem, would have been the source of misinformation, would have shackled the main agency responsible for prevention and educating people about what to do. That was not on the list of things that we needed to worry about.\u003c/p>\n\u003cp>\u003cstrong>What effect do you think President Trump’s contracting the virus will have on public health going forward? \u003c/strong>\u003c/p>\n\u003cp>\u003cb>\u003c/b>If there’s any good that comes out of this, it will be that people who did not take this seriously will take it more seriously. You know, if the president can get it, anybody can get it.\u003c/p>\n\u003cp>There sometimes is this feeling that we’re out of the woods. It’s just clearly not true. The virus hasn’t changed in a material way over the course of eight or nine months, and neither have we. We are all susceptible.\u003c/p>\n\u003cp>What’s remarkable is we know the things that one needs to do to lower your chance of contracting the coronavirus. And unfortunately, the president has doubled down on not doing those things. Obviously we wish him well. But there was a lot of foolish behavior that went into this.\u003c/p>\n\u003cp>A lot will hinge on how he does. If he has a mild case, he may feel a little bit crummy for a few days or a week or so and be back to normal. And you wonder what will come out of the politics of that if he recovers. There is also a decent chance that he will do poorly.\u003c/p>\n\u003cp>\u003cstrong>Can we say that this finally puts to rest the idea that hydroxychloroquine can indeed be a prophylactic? The president took it for weeks and swore by it. \u003c/strong>\u003c/p>\n\u003cp>What puts that idea to rest is the fact that there have been more than a dozen studies on that question. But no, I think it’s hazardous to use single-case patient examples. That’s part of what gets the president in trouble: He sees a case where the patient miraculously got better. And the next thing you know, he’s touting it as a cure. That’s why we need science. The fact that he may have been taking hydroxychloroquine and he still got sick is interesting, but to me not persuasive. What’s persuasive is that it has been massively studied, and the evidence is quite clear that it does not work.\u003c/p>\n\u003cp> \u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "A COVID-19 Vaccine May Be Only 50% Effective. Is That Good Enough?",
"headTitle": "A COVID-19 Vaccine May Be Only 50% Effective. Is That Good Enough? | KQED",
"content": "\u003cp>As we get closer to a COVID-19 vaccine, it’s exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective.\u003c/p>\n\u003cp>Dr. Anthony Fauci, chief of the National Institute of Health and Infectious Disease, has\u003ca href=\"https://www.brown.edu/academics/public-health/fauci\"> tried to set realistic expectations\u003c/a> when discussing the importance of a vaccine. “We don’t know yet what the efficacy might be. We don’t know if it will be 50% or 60%,” Fauci said during a Brown University event in August.\u003c/p>\n\u003cp>“I’d like it to be 75% or more,” Fauci said, but he acknowledged that may not be realistic.\u003c/p>\n\u003cp>The Food and Drug Administration has said that once a vaccine is shown to be safe and at least 50% effective, it could be approved for use in the U.S.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>So What Does 50% Efficacy Mean?\u003c/strong>\u003c/p>\n\u003cp>“When we talk ‘vaccine effectiveness,’ what we’re talking about is, ‘How effective was the vaccine at preventing actual disease?’ ” explains scientist\u003ca href=\"https://www.immunize.org/aboutus/litjen_tan_bio.asp\"> L.J. Tan\u003c/a>, chief strategistof the nonprofit Immunization Action Coalition.\u003c/p>\n\u003cp>In other words, Tan says, “If you vaccinate 100 people, 50 people will not get [the] disease.”\u003c/p>\n\u003cp>This may not sound like an impressive rate of infection prevention, but there are other potential benefits to individuals and the community from getting vaccinated.\u003c/p>\n\u003cp>“It’s possible that the [COVID-19] vaccine will reduce the severity of disease” in the other 50% who do get sick, says physician\u003ca href=\"https://cph.osu.edu/people/wmiller\"> Bill Miller\u003c/a> of The Ohio State University College of Public Health. “It may mean that people are less likely to be hospitalized, require ICU care or die.\u003c/p>\n\u003cp>“That’s certainly the case with the influenza vaccine,” Miller adds. “People who get the vaccine may still get the flu, but, for the most part, their disease is milder than if they hadn’t had the vaccine.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.feinberg.northwestern.edu/faculty-profiles/az/profile.html?xid=16506\">Michael Ison\u003c/a>, an infectious disease physician at the Northwestern University Feinberg School of Medicine, echoes that sentiment. While it’s true that 50 out of 100 people who get the vaccine could still end up getting infected with the coronavirus, “hopefully, the majority will have milder disease,” Ison says. But he cautions there’s a lot to learn in that regard, given that the studies of COVID-19 vaccine candidates are still very much underway.\u003c/p>\n\u003cp>“We really need to get some information from the trials that are ongoing to best understand what the impact will be,” he says. Ison is a member of the research team at Northwestern that is conducting studies on COVID-19 and on influenza vaccines.\u003c/p>\n\u003cp>And here’s the next reality check: The extent to which any vaccine that emerges will help halt the COVID-19 pandemic depends on how many people get the immunization.\u003c/p>\n\u003cp>In order to put this pandemic in the rearview mirror, a large percentage of the population needs to either be vaccinated or gain immunity via an infection with the virus (a much riskier route that \u003ca href=\"https://www.npr.org/sections/health-shots/2020/07/24/894148860/without-a-vaccine-researchers-say-herd-immunity-may-never-be-achieved\">would include many more deaths\u003c/a>).\u003c/p>\n\u003cp>When a large portion of the population has immunity to the virus because of this sort of \u003ca href=\"https://apic.org/monthly_alerts/herd-immunity/\">“herd immunity,”\u003c/a> it’s unlikely to keep spreading. Even people who haven’t been vaccinated (such as very young babies and those with compromised immune systems) are protected once this level of immunity in a population is achieved, because the illness has little opportunity to spread within the community — most people who run into the virus in this scenario are immune.\u003c/p>\n\u003cp>For the coronavirus, Ison says, “‘herd immunity’ is seen when we have somewhere between 60% to 70% of the population having some degree of protection.”\u003c/p>\n\u003cp>So — here’s a little math — if 20% of the U.S. population ends up getting exposed to the virus and developing an infection before we have a vaccine (as is \u003ca href=\"https://www.nytimes.com/2020/04/23/nyregion/coronavirus-new-york-update.html#:~:text=About%2021%20percent%20of%20people,what%20is%20the%20infection%20rate.\">estimated to be the level of immunity in the New York City metro area right now),\u003c/a> then we would still need an additional 40% of the population to gain protection via a vaccine.\u003c/p>\n\u003cp>And in order to get 40% of a population immune through vaccination — if you have a vaccine with 50% efficacy — “you’re going to have to vaccinate 80% of the population,” says \u003ca href=\"https://vaccines.emory.edu/faculty-evc/primary-faculty/del_rio_carlos.html\">Carlos del Rio\u003c/a>, an infectious disease expert at Emory University. “So it’s not going to happen right away.”\u003c/p>\n\u003cp>For starters, Ison says, there are logistical challenges to getting everyone vaccinated, given the mammoth undertaking of manufacturing and distributing a vaccine.\u003c/p>\n\u003cp>“It’s going to take us months to get the entire population vaccinated if they are willing to get vaccinated,” he says — which is \u003ca href=\"https://www.npr.org/2020/09/09/911188375/how-vaccine-skepticism-may-affect-efforts-to-combat-the-coronavirus-pandemic\">another big “if.”\u003c/a> An NPR/PBS/Marist poll in August found that\u003ca href=\"https://www.npr.org/2020/08/14/902265017/poll-biden-expands-lead-a-third-of-country-says-it-wont-get-vaccinated\"> more than a third of Americans — 35% — say they won’t get vaccinated\u003c/a> when a vaccine comes available.\u003c/p>\n\u003cp>What’s more, most of the candidate vaccines now being tested would require two separate doses to trigger their most effective protection, Ison says. So at a minimum, he notes, you’ve got a full month between the two doses of vaccine and a short period of time after the second dose before someone who was been vaccinated would be protected.\u003c/p>\n\u003cp>It’s also still not known how long the immunity gained through any of the current COVID-19 vaccine candidates will last or to what extent the virus might mutate or change in a way that makes that vaccine less effective.\u003c/p>\n\u003cp>“What we will only know once we have the vaccine [approved and rolled out] is how effective it is, how long lasting the protection is and how much pressure it applies to the virus to change, to escape the pressures of the vaccine,” Ison says.\u003c/p>\n\u003cp>Despite all these remaining unknowns, it is safe to say that any such vaccine against the coronavirus could play a significant role in reducing the spread of the virus.\u003c/p>\n\u003cp>“If a vaccine is 50% effective, that’s still good,” Miller says. That means that you have a good possibility of being protected. He says we should think about its effectiveness the way we do about the benefits of cancer treatments, for example.\u003c/p>\n\u003cp>“In some severe cancers, we’d be pretty happy to get a drug that gets us to 50% effectiveness,” he notes.\u003c/p>\n\u003cp>\u003cstrong>Why Do We Need to Test a Proposed Vaccine in So Many People?\u003c/strong>\u003c/p>\n\u003cp>For now, it’s important to see the experimental trials of each vaccine candidate through to the end, Miller says. The phase 3 trials will tell us a lot about the safety of a vaccine as well as its effectiveness.\u003c/p>\n\u003cp>The large studies now underway are being conducted as double-blind, placebo-controlled trials, which is considered the gold standard in scientific research. This means half the participants get the real vaccine and “half the patients get a placebo — a water shot,” Ison says. And nobody — not the researchers nor the participants — will know until after the study is complete who got the placebo and who got the real vaccine.\u003c/p>\n\u003cp>“What we would like to see is that there’s a difference in the rate of COVID-19 — with a much lower rate in patients who get the vaccine than in the patients who get the placebo,” Ison says. But it takes time and a lot of people to see that sort of effect and to answer questions about safety.\u003c/p>\n\u003cp>The vaccine makers are aiming to enroll about 30,000 people in each trial.\u003c/p>\n\u003cp>“Side effects of vaccines [can be] very rare, so you need a lot of people to see if the vaccine causes any unexpected problems,” Miller explains. “These side effects must also be monitored carefully post-marketing to ensure that every important problem is identified.”\u003c/p>\n\u003cp>Ison notes that there’s another benefit to a large study — it helps researchers know how strong the immune response to a vaccine needs to be to be protective.\u003c/p>\n\u003cp>\u003cstrong>Will the Vaccine Protect Older People? And What If I’m Heavy?\u003c/strong>\u003c/p>\n\u003cp>With age, the immune system often mounts a lesser response to vaccination; that’s why, for example, adults 65 and older can opt for a high-dose flu shot — that’s thought to help bolster their protection. And scientists also know from prior research that the flu vaccine is \u003ca href=\"https://www.npr.org/sections/health-shots/2019/11/24/782079520/excess-weight-can-weaken-the-flu-shot\">less effective in people who carry a lot of extra weight\u003c/a>. Ison says it’s too soon to know if obesity or age will be a factor in the immune response to the COVID-19 vaccine candidates now being considered for use.\u003c/p>\n\u003cp>In research results so far, he says, “the small, phase 1 data shows that you can generate antibody responses even in older adults, but it’ll be these larger studies that will tell us [whether] we need to use higher doses or more doses of the vaccine in certain cases.” Results from phase 3 trials of safety and effectiveness are expected in the coming months.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2020 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+COVID-19+Vaccine+May+Be+Only+50%25+Effective.+Is+That+Good+Enough%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>[ad floatright]\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>As we get closer to a COVID-19 vaccine, it’s exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective.\u003c/p>\n\u003cp>Dr. Anthony Fauci, chief of the National Institute of Health and Infectious Disease, has\u003ca href=\"https://www.brown.edu/academics/public-health/fauci\"> tried to set realistic expectations\u003c/a> when discussing the importance of a vaccine. “We don’t know yet what the efficacy might be. We don’t know if it will be 50% or 60%,” Fauci said during a Brown University event in August.\u003c/p>\n\u003cp>“I’d like it to be 75% or more,” Fauci said, but he acknowledged that may not be realistic.\u003c/p>\n\u003cp>The Food and Drug Administration has said that once a vaccine is shown to be safe and at least 50% effective, it could be approved for use in the U.S.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>So What Does 50% Efficacy Mean?\u003c/strong>\u003c/p>\n\u003cp>“When we talk ‘vaccine effectiveness,’ what we’re talking about is, ‘How effective was the vaccine at preventing actual disease?’ ” explains scientist\u003ca href=\"https://www.immunize.org/aboutus/litjen_tan_bio.asp\"> L.J. Tan\u003c/a>, chief strategistof the nonprofit Immunization Action Coalition.\u003c/p>\n\u003cp>In other words, Tan says, “If you vaccinate 100 people, 50 people will not get [the] disease.”\u003c/p>\n\u003cp>This may not sound like an impressive rate of infection prevention, but there are other potential benefits to individuals and the community from getting vaccinated.\u003c/p>\n\u003cp>“It’s possible that the [COVID-19] vaccine will reduce the severity of disease” in the other 50% who do get sick, says physician\u003ca href=\"https://cph.osu.edu/people/wmiller\"> Bill Miller\u003c/a> of The Ohio State University College of Public Health. “It may mean that people are less likely to be hospitalized, require ICU care or die.\u003c/p>\n\u003cp>“That’s certainly the case with the influenza vaccine,” Miller adds. “People who get the vaccine may still get the flu, but, for the most part, their disease is milder than if they hadn’t had the vaccine.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.feinberg.northwestern.edu/faculty-profiles/az/profile.html?xid=16506\">Michael Ison\u003c/a>, an infectious disease physician at the Northwestern University Feinberg School of Medicine, echoes that sentiment. While it’s true that 50 out of 100 people who get the vaccine could still end up getting infected with the coronavirus, “hopefully, the majority will have milder disease,” Ison says. But he cautions there’s a lot to learn in that regard, given that the studies of COVID-19 vaccine candidates are still very much underway.\u003c/p>\n\u003cp>“We really need to get some information from the trials that are ongoing to best understand what the impact will be,” he says. Ison is a member of the research team at Northwestern that is conducting studies on COVID-19 and on influenza vaccines.\u003c/p>\n\u003cp>And here’s the next reality check: The extent to which any vaccine that emerges will help halt the COVID-19 pandemic depends on how many people get the immunization.\u003c/p>\n\u003cp>In order to put this pandemic in the rearview mirror, a large percentage of the population needs to either be vaccinated or gain immunity via an infection with the virus (a much riskier route that \u003ca href=\"https://www.npr.org/sections/health-shots/2020/07/24/894148860/without-a-vaccine-researchers-say-herd-immunity-may-never-be-achieved\">would include many more deaths\u003c/a>).\u003c/p>\n\u003cp>When a large portion of the population has immunity to the virus because of this sort of \u003ca href=\"https://apic.org/monthly_alerts/herd-immunity/\">“herd immunity,”\u003c/a> it’s unlikely to keep spreading. Even people who haven’t been vaccinated (such as very young babies and those with compromised immune systems) are protected once this level of immunity in a population is achieved, because the illness has little opportunity to spread within the community — most people who run into the virus in this scenario are immune.\u003c/p>\n\u003cp>For the coronavirus, Ison says, “‘herd immunity’ is seen when we have somewhere between 60% to 70% of the population having some degree of protection.”\u003c/p>\n\u003cp>So — here’s a little math — if 20% of the U.S. population ends up getting exposed to the virus and developing an infection before we have a vaccine (as is \u003ca href=\"https://www.nytimes.com/2020/04/23/nyregion/coronavirus-new-york-update.html#:~:text=About%2021%20percent%20of%20people,what%20is%20the%20infection%20rate.\">estimated to be the level of immunity in the New York City metro area right now),\u003c/a> then we would still need an additional 40% of the population to gain protection via a vaccine.\u003c/p>\n\u003cp>And in order to get 40% of a population immune through vaccination — if you have a vaccine with 50% efficacy — “you’re going to have to vaccinate 80% of the population,” says \u003ca href=\"https://vaccines.emory.edu/faculty-evc/primary-faculty/del_rio_carlos.html\">Carlos del Rio\u003c/a>, an infectious disease expert at Emory University. “So it’s not going to happen right away.”\u003c/p>\n\u003cp>For starters, Ison says, there are logistical challenges to getting everyone vaccinated, given the mammoth undertaking of manufacturing and distributing a vaccine.\u003c/p>\n\u003cp>“It’s going to take us months to get the entire population vaccinated if they are willing to get vaccinated,” he says — which is \u003ca href=\"https://www.npr.org/2020/09/09/911188375/how-vaccine-skepticism-may-affect-efforts-to-combat-the-coronavirus-pandemic\">another big “if.”\u003c/a> An NPR/PBS/Marist poll in August found that\u003ca href=\"https://www.npr.org/2020/08/14/902265017/poll-biden-expands-lead-a-third-of-country-says-it-wont-get-vaccinated\"> more than a third of Americans — 35% — say they won’t get vaccinated\u003c/a> when a vaccine comes available.\u003c/p>\n\u003cp>What’s more, most of the candidate vaccines now being tested would require two separate doses to trigger their most effective protection, Ison says. So at a minimum, he notes, you’ve got a full month between the two doses of vaccine and a short period of time after the second dose before someone who was been vaccinated would be protected.\u003c/p>\n\u003cp>It’s also still not known how long the immunity gained through any of the current COVID-19 vaccine candidates will last or to what extent the virus might mutate or change in a way that makes that vaccine less effective.\u003c/p>\n\u003cp>“What we will only know once we have the vaccine [approved and rolled out] is how effective it is, how long lasting the protection is and how much pressure it applies to the virus to change, to escape the pressures of the vaccine,” Ison says.\u003c/p>\n\u003cp>Despite all these remaining unknowns, it is safe to say that any such vaccine against the coronavirus could play a significant role in reducing the spread of the virus.\u003c/p>\n\u003cp>“If a vaccine is 50% effective, that’s still good,” Miller says. That means that you have a good possibility of being protected. He says we should think about its effectiveness the way we do about the benefits of cancer treatments, for example.\u003c/p>\n\u003cp>“In some severe cancers, we’d be pretty happy to get a drug that gets us to 50% effectiveness,” he notes.\u003c/p>\n\u003cp>\u003cstrong>Why Do We Need to Test a Proposed Vaccine in So Many People?\u003c/strong>\u003c/p>\n\u003cp>For now, it’s important to see the experimental trials of each vaccine candidate through to the end, Miller says. The phase 3 trials will tell us a lot about the safety of a vaccine as well as its effectiveness.\u003c/p>\n\u003cp>The large studies now underway are being conducted as double-blind, placebo-controlled trials, which is considered the gold standard in scientific research. This means half the participants get the real vaccine and “half the patients get a placebo — a water shot,” Ison says. And nobody — not the researchers nor the participants — will know until after the study is complete who got the placebo and who got the real vaccine.\u003c/p>\n\u003cp>“What we would like to see is that there’s a difference in the rate of COVID-19 — with a much lower rate in patients who get the vaccine than in the patients who get the placebo,” Ison says. But it takes time and a lot of people to see that sort of effect and to answer questions about safety.\u003c/p>\n\u003cp>The vaccine makers are aiming to enroll about 30,000 people in each trial.\u003c/p>\n\u003cp>“Side effects of vaccines [can be] very rare, so you need a lot of people to see if the vaccine causes any unexpected problems,” Miller explains. “These side effects must also be monitored carefully post-marketing to ensure that every important problem is identified.”\u003c/p>\n\u003cp>Ison notes that there’s another benefit to a large study — it helps researchers know how strong the immune response to a vaccine needs to be to be protective.\u003c/p>\n\u003cp>\u003cstrong>Will the Vaccine Protect Older People? And What If I’m Heavy?\u003c/strong>\u003c/p>\n\u003cp>With age, the immune system often mounts a lesser response to vaccination; that’s why, for example, adults 65 and older can opt for a high-dose flu shot — that’s thought to help bolster their protection. And scientists also know from prior research that the flu vaccine is \u003ca href=\"https://www.npr.org/sections/health-shots/2019/11/24/782079520/excess-weight-can-weaken-the-flu-shot\">less effective in people who carry a lot of extra weight\u003c/a>. Ison says it’s too soon to know if obesity or age will be a factor in the immune response to the COVID-19 vaccine candidates now being considered for use.\u003c/p>\n\u003cp>In research results so far, he says, “the small, phase 1 data shows that you can generate antibody responses even in older adults, but it’ll be these larger studies that will tell us [whether] we need to use higher doses or more doses of the vaccine in certain cases.” Results from phase 3 trials of safety and effectiveness are expected in the coming months.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2020 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+COVID-19+Vaccine+May+Be+Only+50%25+Effective.+Is+That+Good+Enough%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>At the beginning of the coronavirus pandemic, there were lots of stories about scrappy manufacturers promising to revamp their factories to start making personal protective equipment in the U.S.\u003c/p>\n\u003cp>Back in the spring, fuel-cell maker Adaptive Energy retooled part of its factory in Ann Arbor, Michigan, to make plastic face shields. Now, 100,000 finished shields are piling up in cardboard boxes on the factory floor — unsold.\u003c/p>\n\u003cp>“We jumped in head first,” said Ranvir Gujral, the company’s principal owner. He added ruefully: “We weren’t the only ones with a brilliant idea of getting our folks back to work and trying to help and manufacture PPE.”\u003c/p>\n\u003cp>Since the coronavirus pandemic began, President Trump and industry officials have talked a lot about the need to ramp up domestic manufacturing of critical protective gear. But six months on, \u003ca href=\"https://www.npr.org/2020/08/19/903612006/yep-masks-and-protective-gear-are-still-hard-get-especially-for-small-buyers\">there are still shortages of all kinds of PPE,\u003c/a> like N95 respirator masks, while face shields are easy to find.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Lack of a Coherent National Plan\u003c/strong>\u003c/p>\n\u003cp>The disconnect can be traced, in part, to the lack of a coherent national plan.\u003c/p>\n\u003cp>When Gujral and other domestic manufacturers saw an opportunity to help protect front-line workers — and to keep their own employees working, many of them shifted gears to make face shields and hand sanitizer, which are relatively simple to produce.\u003c/p>\n\u003cp>But fewer shifted to making N95 masks, which are far more complicated, and they’re in short supply. Nurses and doctors are reusing masks over and over again. Some small medical practices can’t even find supplies they can afford.\u003c/p>\n\u003cp>Still, Trump consistently ignores that reality.\u003c/p>\n\u003cp>“We’ve opened up factories. We’ve had tremendous success with face masks and with shields,” Trump said during a press briefing at the White House last week.\u003c/p>\n\u003cp>The market is, in fact, glutted with face shields. But the U.S. is still far short of the 3.5 billion masks that public health officials say are needed this year.\u003c/p>\n\u003cp>The White House narrative is that the pandemic revealed the danger of relying too much on Chinese suppliers, and that the U.S. has ramped up domestic production significantly, making those early shortages a thing of the past.\u003c/p>\n\u003cp>“We are taking our business out of China. We are bringing it home. We want our business to come home,” Trump said at the Republican National Convention.\u003c/p>\n\u003cp>But in reality, U.S. manufacturers worry the administration is fumbling a chance to bring the PPE industry back home.\u003c/p>\n\u003cp>“We’re not seeing that happen. In fact, we’re behind in manufacturing jobs. We’re importing more PPEs than ever,” said Scott Paul, president of the Alliance for American Manufacturing.\u003c/p>\n\u003cp>\u003cstrong>‘This Administration Has Really Had a Big Firm Focus’\u003c/strong>\u003c/p>\n\u003cp>The White House worked with some big companies, including 3M and Honeywell, to ramp up domestic production of respirator masks. But that was relatively easy for them:\u003c/p>\n\u003cp>3M developed the first N95 mask, so it already has factories and established customers.\u003c/p>\n\u003cp>Even so, 3M and Honeywell haven’t been able to make enough masks as the pandemic wore on and demand only increased.\u003c/p>\n\u003cp>“We’re not tens of millions of masks short. We’re hundreds of millions of masks short of where we need to be,” Paul said. “It would make complete sense to want to scale up some small and midsized manufacturers to help fill in this massive gap.”\u003c/p>\n\u003cp>But the federal government has no plan to help small- and midsized manufacturers move into PPE.\u003c/p>\n\u003cp>“This administration has really had a big firm focus,” said Gary Gereffi, a professor at Duke University and the founding director of the Duke Global Value Chains Center.\u003c/p>\n\u003cp>“We’ve never really fully dealt with the ongoing demand for the basic items — the face masks and the gloves and the gowns,” Gereffi said, partly because the administration has been more focused on discovering a vaccine that could bring the coronavirus outbreak under control.\u003c/p>\n\u003cp>As a result, Gereffi said: “We didn’t have any agency in the government that knew which companies were producing these different products.”\u003c/p>\n\u003cp>That leaves manufacturers like Ranvir Gujral, the factory owner in Michigan, to figure it out on their own. Gujral still wants to help in the pandemic. He’s thinking about retooling his factory in Michigan again, this time to make N95 masks.\u003c/p>\n\u003cp>“We have the machines lined up. We have the raw materials lined up. We have the capital lined up,” Gujral said.\u003c/p>\n\u003cp>What he’s missing is some certainty that his investment will pay off. Gujral’s factory wouldn’t be ready to start cranking out masks until the spring.\u003c/p>\n\u003cp>“Are we going to still have demand? Are these customers still going to come to us?,” he asked. “We don’t want to be left holding the bag.”\u003c/p>\n\u003cp>Gujral says he can’t risk repeating his face shield experience with N95 masks.\u003c/p>\n\u003cp>“This is a big enough move to put us out of business if it doesn’t go well,” he said. “It’s a bet-the-company move.”\u003c/p>\n\u003cp>It’s the same conundrum facing all sorts of industries. Things are made more cheaply overseas, especially in China. So are customers willing to pay a little more for masks that are made in the USA? Or other scarce items, like protective gloves or gowns?\u003c/p>\n\u003cp>“I hear that from across my industry,” said Kimberly Glas, the president of the National Council of Textile Organizations, an industry trade association in Washington. “People aren’t going to make an investment realizing that there’s not a customer at the other end.”\u003c/p>\n\u003cp>Even as the Trump administration downplays the PPE shortages, it has taken steps to try to shore up U.S. manufacturing of drugs and medical supplies. The president signed an executive order last month requiring federal agencies to buy American-made when possible.\u003c/p>\n\u003cp>It’s a good step, said Glas, who worked at the U.S. Commerce Department during the Obama administration. But she says it will take more than that — a real strategic federal plan, or tax incentives — to convince domestic manufacturers to invest.\u003c/p>\n\u003cp>“My fear is a year from now, we will see these supply chains that were heavily dominated in China go back to China fully,” Glas said.\u003c/p>\n\u003cp>And the U.S. will have squandered a chance to bring jobs back onshore, and make America self-sufficient when it comes to protecting against the coronavirus.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2020 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Why+Can%27t+America+Make+Enough+N95+Masks%3F+6+Months+Into+Pandemic%2C+Shortages+Persist&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>[ad floatright]\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>At the beginning of the coronavirus pandemic, there were lots of stories about scrappy manufacturers promising to revamp their factories to start making personal protective equipment in the U.S.\u003c/p>\n\u003cp>Back in the spring, fuel-cell maker Adaptive Energy retooled part of its factory in Ann Arbor, Michigan, to make plastic face shields. Now, 100,000 finished shields are piling up in cardboard boxes on the factory floor — unsold.\u003c/p>\n\u003cp>“We jumped in head first,” said Ranvir Gujral, the company’s principal owner. He added ruefully: “We weren’t the only ones with a brilliant idea of getting our folks back to work and trying to help and manufacture PPE.”\u003c/p>\n\u003cp>Since the coronavirus pandemic began, President Trump and industry officials have talked a lot about the need to ramp up domestic manufacturing of critical protective gear. But six months on, \u003ca href=\"https://www.npr.org/2020/08/19/903612006/yep-masks-and-protective-gear-are-still-hard-get-especially-for-small-buyers\">there are still shortages of all kinds of PPE,\u003c/a> like N95 respirator masks, while face shields are easy to find.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Lack of a Coherent National Plan\u003c/strong>\u003c/p>\n\u003cp>The disconnect can be traced, in part, to the lack of a coherent national plan.\u003c/p>\n\u003cp>When Gujral and other domestic manufacturers saw an opportunity to help protect front-line workers — and to keep their own employees working, many of them shifted gears to make face shields and hand sanitizer, which are relatively simple to produce.\u003c/p>\n\u003cp>But fewer shifted to making N95 masks, which are far more complicated, and they’re in short supply. Nurses and doctors are reusing masks over and over again. Some small medical practices can’t even find supplies they can afford.\u003c/p>\n\u003cp>Still, Trump consistently ignores that reality.\u003c/p>\n\u003cp>“We’ve opened up factories. We’ve had tremendous success with face masks and with shields,” Trump said during a press briefing at the White House last week.\u003c/p>\n\u003cp>The market is, in fact, glutted with face shields. But the U.S. is still far short of the 3.5 billion masks that public health officials say are needed this year.\u003c/p>\n\u003cp>The White House narrative is that the pandemic revealed the danger of relying too much on Chinese suppliers, and that the U.S. has ramped up domestic production significantly, making those early shortages a thing of the past.\u003c/p>\n\u003cp>“We are taking our business out of China. We are bringing it home. We want our business to come home,” Trump said at the Republican National Convention.\u003c/p>\n\u003cp>But in reality, U.S. manufacturers worry the administration is fumbling a chance to bring the PPE industry back home.\u003c/p>\n\u003cp>“We’re not seeing that happen. In fact, we’re behind in manufacturing jobs. We’re importing more PPEs than ever,” said Scott Paul, president of the Alliance for American Manufacturing.\u003c/p>\n\u003cp>\u003cstrong>‘This Administration Has Really Had a Big Firm Focus’\u003c/strong>\u003c/p>\n\u003cp>The White House worked with some big companies, including 3M and Honeywell, to ramp up domestic production of respirator masks. But that was relatively easy for them:\u003c/p>\n\u003cp>3M developed the first N95 mask, so it already has factories and established customers.\u003c/p>\n\u003cp>Even so, 3M and Honeywell haven’t been able to make enough masks as the pandemic wore on and demand only increased.\u003c/p>\n\u003cp>“We’re not tens of millions of masks short. We’re hundreds of millions of masks short of where we need to be,” Paul said. “It would make complete sense to want to scale up some small and midsized manufacturers to help fill in this massive gap.”\u003c/p>\n\u003cp>But the federal government has no plan to help small- and midsized manufacturers move into PPE.\u003c/p>\n\u003cp>“This administration has really had a big firm focus,” said Gary Gereffi, a professor at Duke University and the founding director of the Duke Global Value Chains Center.\u003c/p>\n\u003cp>“We’ve never really fully dealt with the ongoing demand for the basic items — the face masks and the gloves and the gowns,” Gereffi said, partly because the administration has been more focused on discovering a vaccine that could bring the coronavirus outbreak under control.\u003c/p>\n\u003cp>As a result, Gereffi said: “We didn’t have any agency in the government that knew which companies were producing these different products.”\u003c/p>\n\u003cp>That leaves manufacturers like Ranvir Gujral, the factory owner in Michigan, to figure it out on their own. Gujral still wants to help in the pandemic. He’s thinking about retooling his factory in Michigan again, this time to make N95 masks.\u003c/p>\n\u003cp>“We have the machines lined up. We have the raw materials lined up. We have the capital lined up,” Gujral said.\u003c/p>\n\u003cp>What he’s missing is some certainty that his investment will pay off. Gujral’s factory wouldn’t be ready to start cranking out masks until the spring.\u003c/p>\n\u003cp>“Are we going to still have demand? Are these customers still going to come to us?,” he asked. “We don’t want to be left holding the bag.”\u003c/p>\n\u003cp>Gujral says he can’t risk repeating his face shield experience with N95 masks.\u003c/p>\n\u003cp>“This is a big enough move to put us out of business if it doesn’t go well,” he said. “It’s a bet-the-company move.”\u003c/p>\n\u003cp>It’s the same conundrum facing all sorts of industries. Things are made more cheaply overseas, especially in China. So are customers willing to pay a little more for masks that are made in the USA? Or other scarce items, like protective gloves or gowns?\u003c/p>\n\u003cp>“I hear that from across my industry,” said Kimberly Glas, the president of the National Council of Textile Organizations, an industry trade association in Washington. “People aren’t going to make an investment realizing that there’s not a customer at the other end.”\u003c/p>\n\u003cp>Even as the Trump administration downplays the PPE shortages, it has taken steps to try to shore up U.S. manufacturing of drugs and medical supplies. The president signed an executive order last month requiring federal agencies to buy American-made when possible.\u003c/p>\n\u003cp>It’s a good step, said Glas, who worked at the U.S. Commerce Department during the Obama administration. But she says it will take more than that — a real strategic federal plan, or tax incentives — to convince domestic manufacturers to invest.\u003c/p>\n\u003cp>“My fear is a year from now, we will see these supply chains that were heavily dominated in China go back to China fully,” Glas said.\u003c/p>\n\u003cp>And the U.S. will have squandered a chance to bring jobs back onshore, and make America self-sufficient when it comes to protecting against the coronavirus.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2020 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Why+Can%27t+America+Make+Enough+N95+Masks%3F+6+Months+Into+Pandemic%2C+Shortages+Persist&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>Three new studies strongly support using inexpensive and widely available drugs to treat people who are seriously ill with COVID-19. The drugs are steroids, and the research published Wednesday confirms they are proving to be the most effective treatment found to date.\u003c/p>\n\u003cp>Initially, the use of these drugs in COVID-19 was controversial. Some doctors have long used steroids to treat conditions related to COVID-19, namely \u003ca href=\"https://www.nigms.nih.gov/education/fact-sheets/Pages/sepsis.aspx\">sepsis\u003c/a> and \u003ca href=\"https://www.lung.org/lung-health-diseases/lung-disease-lookup/ards\">acute respiratory distress syndrome\u003c/a>.\u003c/p>\n\u003cp>Steroids help tamp down the immune system’s potentially deadly overreaction to an infection. But some doctors worried that steroids could also prevent the body from fighting off the coronavirus effectively.\u003c/p>\n\u003cp>“Giving steroids to COVID-19 could have been quite scary,” \u003ca href=\"https://mirm-pitt.net/our-people/faculty-staff-bios/derek-c-angus-md-mph-frcp-fccm-fccp/\">says Dr. Derek Angus\u003c/a>, a critical care specialist at the University of Pittsburgh Medical Center.\u003c/p>\n\u003cp>In June, \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/06/16/878069587/early-results-show-benefit-of-steroid-for-very-sick-covid-19-patients\">a major study from the U.K\u003c/a>. found that the steroid dexamethasone was a big help. It reduced deaths significantly among the most serious cases of COVID-19 — notably people who needed ventilators or supplemental oxygen.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>That advance was great news, but those findings created a conundrum for Angus and other researchers who were running their own studies of steroids in COVID-19 patients. It no longer felt appropriate to be giving some people steroids and others a placebo.\u003c/p>\n\u003cp>“Essentially overnight, because these findings were so striking, there was this sense among clinicians participating in other clinical trials [that] … we have to stop our trials.”\u003c/p>\n\u003cp>So those studies all ended prematurely. Researchers from three research groups have now published the findings they had gathered in the journal \u003cem>JAMA\u003c/em>. One group is \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770276\">from France\u003c/a>, one is \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770277\">from Brazil\u003c/a>, and the third is \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770278\">an international team\u003c/a> that includes the University of Pittsburgh’s Angus.\u003c/p>\n\u003cp>Taken together, the publication of these studies “represents an important step forward in the treatment of patients with COVID-19,” Drs. Hallie Prescott and Todd Rice \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770275\">wrote in a \u003cem>JAMA\u003c/em> editorial\u003c/a>. The results not only provide further support for the use of dexamethasone, they also back the use of another widely used steroid, hydrocortisone.\u003c/p>\n\u003cp>“I think it’s good news to have a strong, clear signal on what is a widely available, inexpensive class of therapies,” Angus said. He also contrasts these studies with a lot of other research on COVID-19. Many other studies, such as those involving much-hyped anti-malaria drugs, did not randomize their participants or include a comparison group. Such measures — \u003ca href=\"https://himmelfarb.gwu.edu/tutorials/studydesign101/rcts.cfm\">randomized controlled trials\u003c/a> — are the gold standard for medical research.\u003c/p>\n\u003cp>“It is reassuring that we can get randomized trials executed successfully and rapidly in the face of a pandemic,” Angus said, “and it definitely puts us on a surer footing.”\u003c/p>\n\u003cp>Based on these new results and related analysis, the World Health Organization on Wednesday \u003ca href=\"https://www.who.int/publications/i/item/WHO-2019-nCoV-Corticosteroids-2020.1\">updated its guidelines\u003c/a> for steroids. It now recommends them for severely or critically ill COVID-19 patients, such as those on a ventilator, but not for patients with milder disease.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>You can contact NPR science correspondent Richard Harris at \u003c/em>\u003ca href=\"mailto:rharris@npr.org\">\u003cem>rharris@npr.org.\u003c/em>\u003c/a>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2020 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Inexpensive+Steroids+Can+Save+Lives+Of+Seriously+Ill+COVID-19+Patients&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Three new studies strongly support using inexpensive and widely available drugs to treat people who are seriously ill with COVID-19. The drugs are steroids, and the research published Wednesday confirms they are proving to be the most effective treatment found to date.\u003c/p>\n\u003cp>Initially, the use of these drugs in COVID-19 was controversial. Some doctors have long used steroids to treat conditions related to COVID-19, namely \u003ca href=\"https://www.nigms.nih.gov/education/fact-sheets/Pages/sepsis.aspx\">sepsis\u003c/a> and \u003ca href=\"https://www.lung.org/lung-health-diseases/lung-disease-lookup/ards\">acute respiratory distress syndrome\u003c/a>.\u003c/p>\n\u003cp>Steroids help tamp down the immune system’s potentially deadly overreaction to an infection. But some doctors worried that steroids could also prevent the body from fighting off the coronavirus effectively.\u003c/p>\n\u003cp>“Giving steroids to COVID-19 could have been quite scary,” \u003ca href=\"https://mirm-pitt.net/our-people/faculty-staff-bios/derek-c-angus-md-mph-frcp-fccm-fccp/\">says Dr. Derek Angus\u003c/a>, a critical care specialist at the University of Pittsburgh Medical Center.\u003c/p>\n\u003cp>In June, \u003ca href=\"https://www.npr.org/sections/coronavirus-live-updates/2020/06/16/878069587/early-results-show-benefit-of-steroid-for-very-sick-covid-19-patients\">a major study from the U.K\u003c/a>. found that the steroid dexamethasone was a big help. It reduced deaths significantly among the most serious cases of COVID-19 — notably people who needed ventilators or supplemental oxygen.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>That advance was great news, but those findings created a conundrum for Angus and other researchers who were running their own studies of steroids in COVID-19 patients. It no longer felt appropriate to be giving some people steroids and others a placebo.\u003c/p>\n\u003cp>“Essentially overnight, because these findings were so striking, there was this sense among clinicians participating in other clinical trials [that] … we have to stop our trials.”\u003c/p>\n\u003cp>So those studies all ended prematurely. Researchers from three research groups have now published the findings they had gathered in the journal \u003cem>JAMA\u003c/em>. One group is \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770276\">from France\u003c/a>, one is \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770277\">from Brazil\u003c/a>, and the third is \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770278\">an international team\u003c/a> that includes the University of Pittsburgh’s Angus.\u003c/p>\n\u003cp>Taken together, the publication of these studies “represents an important step forward in the treatment of patients with COVID-19,” Drs. Hallie Prescott and Todd Rice \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2770275\">wrote in a \u003cem>JAMA\u003c/em> editorial\u003c/a>. The results not only provide further support for the use of dexamethasone, they also back the use of another widely used steroid, hydrocortisone.\u003c/p>\n\u003cp>“I think it’s good news to have a strong, clear signal on what is a widely available, inexpensive class of therapies,” Angus said. He also contrasts these studies with a lot of other research on COVID-19. Many other studies, such as those involving much-hyped anti-malaria drugs, did not randomize their participants or include a comparison group. Such measures — \u003ca href=\"https://himmelfarb.gwu.edu/tutorials/studydesign101/rcts.cfm\">randomized controlled trials\u003c/a> — are the gold standard for medical research.\u003c/p>\n\u003cp>“It is reassuring that we can get randomized trials executed successfully and rapidly in the face of a pandemic,” Angus said, “and it definitely puts us on a surer footing.”\u003c/p>\n\u003cp>Based on these new results and related analysis, the World Health Organization on Wednesday \u003ca href=\"https://www.who.int/publications/i/item/WHO-2019-nCoV-Corticosteroids-2020.1\">updated its guidelines\u003c/a> for steroids. It now recommends them for severely or critically ill COVID-19 patients, such as those on a ventilator, but not for patients with milder disease.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>You can contact NPR science correspondent Richard Harris at \u003c/em>\u003ca href=\"mailto:rharris@npr.org\">\u003cem>rharris@npr.org.\u003c/em>\u003c/a>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2020 NPR. To see more, visit https://www.npr.org.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Inexpensive+Steroids+Can+Save+Lives+Of+Seriously+Ill+COVID-19+Patients&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"title": "Scientists Look to Convalescent Plasma, Antibody Cloning as Possible COVID Cures",
"headTitle": "Scientists Look to Convalescent Plasma, Antibody Cloning as Possible COVID Cures | KQED",
"content": "\u003cp class=\"p1\">Since early in the pandemic, scientists have said antibodies that the immune system makes to fight the coronavirus could be crucial in finding a cure for COVID-19.\u003c/p>\n\u003cfigure id=\"attachment_1969056\" class=\"wp-caption alignright\" style=\"max-width: 640px\">\u003ca href=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288.jpg\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-large wp-image-1969056\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-1020x1360.jpg\" alt=\"\" width=\"640\" height=\"853\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-1020x1360.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-800x1067.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-160x213.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-768x1024.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-1152x1536.jpg 1152w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-1536x2048.jpg 1536w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288.jpg 1920w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">UCSF expects results from a placebo-controlled trial using COVID-19 convalescent plasma by the end of 2020. \u003ccite>(Dr. Ashok Nambiar/UCSF)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">The FDA recently authorized one of these treatments — \u003ca href=\"https://www.kqed.org/science/1968824/qa-is-convalescent-plasma-therapy-safe-and-effective-as-a-covid-19-treatment\">\u003cspan class=\"s1\">convalescent plasma,\u003c/span>\u003c/a> in which the antibody-rich portion of blood donated by recovered COVID-19 patients is given to people hospitalized with the disease. But the \u003ca href=\"https://www.politico.com/news/2020/08/23/plasma-treatment-coronavirus-fda-trump-400390\">\u003cspan class=\"s1\">approval\u003c/span>\u003c/a>, which came soon after President Donald Trump \u003ca href=\"https://www.politico.com/news/2020/08/19/trump-coronavirus-plasma-therapy-398801\">\u003cspan class=\"s1\">accused\u003c/span>\u003c/a> the agency of moving too slowly on the treatment for political reasons, has prompted pushback from some in the scientific community, who say more research is needed to determine if and how plasma can be effective against COVID-19. Meanwhile, research on another therapy, involving antibodies cloned in the lab, is just getting underway in human subjects.\u003c/p>\n\u003cp class=\"p1\">\u003cb>‘Liquid Gold’\u003c/b>\u003c/p>\n\u003cp class=\"p1\">Plasma, sometimes called “liquid gold” by doctors for its yellow hue and potential therapeutic value, is made by spinning blood to separate antibodies and other proteins from red blood cells.\u003c/p>\n\u003cp class=\"p1\">The use of convalescent plasma in medicine dates back \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4781783/\">\u003cspan class=\"s1\">more than a hundred years\u003c/span>\u003c/a>.\u003c/p>\n\u003cp class=\"p1\">“We’ve used it in infectious diseases from polio to influenza, ebola, etc.,” said UCSF professor of medicine Dr. Peter Chin-Hong.\u003c/p>\n\u003cp class=\"p1\">Chin-Hong, whose team is running a COVID-19 convalescent plasma trial, says that while the treatment is considered relatively low-risk, the FDA’s authorization is too hasty.\u003c/p>\n\u003cp class=\"p1\">“The main reason why it’s the wrong time is that we just don’t have enough data yet to say if it works,” he said.\u003c/p>\n\u003cp class=\"p3\">Early results from a \u003ca href=\"https://www.medrxiv.org/content/10.1101/2020.07.29.20162917v2\">\u003cspan class=\"s1\">Mayo Clinic study\u003c/span>\u003c/a> suggest convalescent plasma may reduce COVID-19 mortality rates. But the study, which is available as a non-peer-reviewed preprint, wasn’t placebo-controlled, and Chin-Hong says results from rigorous clinical trials with COVID-19 convalescent plasma have yet to be published.\u003c/p>\n\u003cp class=\"p4\">\u003ci>“\u003c/i>I think plasma is a great potential intervention,” he said. “I just don’t know where it works best.\u003ci>”\u003c/i>\u003c/p>\n\u003cp class=\"p3\">The \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment\">\u003cspan class=\"s1\">FDA’s authorization\u003c/span>\u003c/a> limits plasma treatment to hospitalized patients, and much of the early application for research purposes has focused on the most severe cases. But Chin-Hong says convelescent plasma may work better early on, before the disease has a chance to progress and patients get seriously ill.\u003c/p>\n\u003cp class=\"p3\">Dr. James Zehnder, director of clinical pathology at Stanford, agrees that the jury is still out on whether plasma can treat the sickest COVID-19 patients. In looking at the natural patterns of how infected patients make antibodies, he says, researchers have seen the most robust antibody response from those who have severe, potentially life-threatening inflammation. In contrast, those who have milder illness tend to have a weaker antibody response.\u003c/p>\n\u003cp class=\"p4\">\u003ci>“\u003c/i>So one question is that if the really sick patients are already making really high levels of antibodies,” Zehnder said, “how does infusing more antibodies help?\u003ci>”\u003c/i>\u003c/p>\n\u003cp class=\"p4\">Results from placebo-controlled trials, Zehnder says, are the gold standard for clinical research, and they will be key in answering questions surrounding COVID-19 convalescent plasma therapy.\u003c/p>\n\u003cp class=\"p1\">Dr. Stuart Cohen, chief of infectious diseases at UC Davis,\u003ci> \u003c/i>worries that a broad rollout of the treatment in the wake of the FDA authorization could jeopardize that research by stifling enrollment.\u003c/p>\n\u003cp class=\"p1\">“If I tell you, you can be on this clinical trial where you could get a placebo and then they say, ‘Well, I saw that this is available already, why don’t you just give it to me?’” Cohen said, “that sort of finishes off any real ability to determine whether this really works or not.”\u003c/p>\n\u003cp class=\"p1\">While he acknowledges doctors are desperate for more tools to try to fight COVID-19, Cohen cautions that the supply of convalescent plasma, which has mostly kept up with the demand for research studies, could be depleted as a result of the FDA authorization.\u003c/p>\n\u003cp class=\"p1\">If doctors all of sudden begin prescribing the drug liberally, Chin-Hong adds, “it may mean that the patients who need it the most may not get it.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"p1\">\u003cb>Cloning Antibodies in the Lab\u003c/b>\u003c/p>\n\u003cp class=\"p3\">Convalescent plasma isn’t the only way researchers are using antibodies from the blood of recovered patients to develop COVID-19 treatments. Scientists are also working to manufacture antibodies in the lab.\u003c/p>\n\u003cp class=\"p3\">“What you can do is you can go into that person who’s a survivor and find the most potent antibody in that person, clone it and then give it to millions of people,” said Dr. Phil Pang, chief medical officer at San Francisco-based \u003ca href=\"https://www.vir.bio/\">\u003cspan class=\"s1\">Vir Biotechnology\u003c/span>\u003c/a>.\u003c/p>\n\u003cp class=\"p3\">These “\u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4284445/\">\u003cspan class=\"s1\">monoclonal antibodies\u003c/span>\u003c/a>,” Pang says, are made by cloning the powerful, neutralizing antibodies that prevent the coronavirus from invading healthy cells.\u003c/p>\n\u003cp class=\"p3\">The FDA first approved this type of treatment in the 1980s. Doctors have used them mainly to help treat cancer patients and people with autoimmune conditions.\u003c/p>\n\u003cp class=\"p3\">Unlike convalescent plasma, Pang says, the supply of monoclonal antibodies isn’t dependent on blood donations and can be scaled up to potentially reach more people. The proteins are typically replicated in the lab using cell lines from hamsters or mice.\u003c/p>\n\u003cp class=\"p3\">“The antibody manufacturing process is now a very well-defined process,” Pang said. “I would say it’s akin to the way in which we can go about manufacturing cars.”\u003c/p>\n\u003cp class=\"p3\">Pang says one of the antibodies Vir has cloned has been shown to neutralize SARS-CoV-2 in a lab. The finding was supported by an \u003ca href=\"https://www.nature.com/articles/s41586-020-2349-y\" target=\"_blank\" rel=\"noopener noreferrer\">article\u003c/a> \u003cspan class=\"s1\">published in \u003ci>Nature\u003c/i>\u003c/span>\u003ci> \u003c/i>in May.\u003cb> \u003c/b>The company recently launched a randomized trial to see if giving a single injection to newly diagnosed COVID-19 patients can help stop the illness from progressing.\u003c/p>\n\u003cp class=\"p3\">The treatment may eventually be able to prevent infection in front-line workers and other at-risk populations exposed to the coronavirus, acting like a short-term vaccine, Pang says.\u003c/p>\n\u003cp class=\"p3\">“A\u003ci> \u003c/i>vaccine works by giving a person to, say, a fragment of a viral protein and hoping that their immune system creates antibodies,” Pang said. “In this case, what we’re saying is let’s just give them the immune response we know or believe will be protective\u003ci>.\u003c/i>”\u003c/p>\n\u003cp class=\"p3\">The \u003ca href=\"https://www.nih.gov/news-events/news-releases/clinical-trials-monoclonal-antibodies-prevent-covid-19-now-enrolling\">\u003cspan class=\"s1\">NIH\u003c/span>\u003c/a> and a host of drug companies, including Regeneron Pharmaceuticals and Eli Lilly, are testing their own COVID-19 monoclonal antibody candidates.\u003c/p>\n\u003cp class=\"p3\">Preliminary results from both Vir’s monoclonal antibody study and UCSF’s convalescent plasma research are expected by the end of 2020.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n",
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"excerpt": "Since early in the pandemic, scientists have said antibodies that the immune system makes to fight the coronavirus could be crucial in finding a cure for COVID-19.",
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"title": "Scientists Look to Convalescent Plasma, Antibody Cloning as Possible COVID Cures | KQED",
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"headline": "Scientists Look to Convalescent Plasma, Antibody Cloning as Possible COVID Cures",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"p1\">Since early in the pandemic, scientists have said antibodies that the immune system makes to fight the coronavirus could be crucial in finding a cure for COVID-19.\u003c/p>\n\u003cfigure id=\"attachment_1969056\" class=\"wp-caption alignright\" style=\"max-width: 640px\">\u003ca href=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288.jpg\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-large wp-image-1969056\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-1020x1360.jpg\" alt=\"\" width=\"640\" height=\"853\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-1020x1360.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-800x1067.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-160x213.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-768x1024.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-1152x1536.jpg 1152w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288-1536x2048.jpg 1536w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/COVID-Plasma2-scaled-e1598660843288.jpg 1920w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">UCSF expects results from a placebo-controlled trial using COVID-19 convalescent plasma by the end of 2020. \u003ccite>(Dr. Ashok Nambiar/UCSF)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">The FDA recently authorized one of these treatments — \u003ca href=\"https://www.kqed.org/science/1968824/qa-is-convalescent-plasma-therapy-safe-and-effective-as-a-covid-19-treatment\">\u003cspan class=\"s1\">convalescent plasma,\u003c/span>\u003c/a> in which the antibody-rich portion of blood donated by recovered COVID-19 patients is given to people hospitalized with the disease. But the \u003ca href=\"https://www.politico.com/news/2020/08/23/plasma-treatment-coronavirus-fda-trump-400390\">\u003cspan class=\"s1\">approval\u003c/span>\u003c/a>, which came soon after President Donald Trump \u003ca href=\"https://www.politico.com/news/2020/08/19/trump-coronavirus-plasma-therapy-398801\">\u003cspan class=\"s1\">accused\u003c/span>\u003c/a> the agency of moving too slowly on the treatment for political reasons, has prompted pushback from some in the scientific community, who say more research is needed to determine if and how plasma can be effective against COVID-19. Meanwhile, research on another therapy, involving antibodies cloned in the lab, is just getting underway in human subjects.\u003c/p>\n\u003cp class=\"p1\">\u003cb>‘Liquid Gold’\u003c/b>\u003c/p>\n\u003cp class=\"p1\">Plasma, sometimes called “liquid gold” by doctors for its yellow hue and potential therapeutic value, is made by spinning blood to separate antibodies and other proteins from red blood cells.\u003c/p>\n\u003cp class=\"p1\">The use of convalescent plasma in medicine dates back \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4781783/\">\u003cspan class=\"s1\">more than a hundred years\u003c/span>\u003c/a>.\u003c/p>\n\u003cp class=\"p1\">“We’ve used it in infectious diseases from polio to influenza, ebola, etc.,” said UCSF professor of medicine Dr. Peter Chin-Hong.\u003c/p>\n\u003cp class=\"p1\">Chin-Hong, whose team is running a COVID-19 convalescent plasma trial, says that while the treatment is considered relatively low-risk, the FDA’s authorization is too hasty.\u003c/p>\n\u003cp class=\"p1\">“The main reason why it’s the wrong time is that we just don’t have enough data yet to say if it works,” he said.\u003c/p>\n\u003cp class=\"p3\">Early results from a \u003ca href=\"https://www.medrxiv.org/content/10.1101/2020.07.29.20162917v2\">\u003cspan class=\"s1\">Mayo Clinic study\u003c/span>\u003c/a> suggest convalescent plasma may reduce COVID-19 mortality rates. But the study, which is available as a non-peer-reviewed preprint, wasn’t placebo-controlled, and Chin-Hong says results from rigorous clinical trials with COVID-19 convalescent plasma have yet to be published.\u003c/p>\n\u003cp class=\"p4\">\u003ci>“\u003c/i>I think plasma is a great potential intervention,” he said. “I just don’t know where it works best.\u003ci>”\u003c/i>\u003c/p>\n\u003cp class=\"p3\">The \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment\">\u003cspan class=\"s1\">FDA’s authorization\u003c/span>\u003c/a> limits plasma treatment to hospitalized patients, and much of the early application for research purposes has focused on the most severe cases. But Chin-Hong says convelescent plasma may work better early on, before the disease has a chance to progress and patients get seriously ill.\u003c/p>\n\u003cp class=\"p3\">Dr. James Zehnder, director of clinical pathology at Stanford, agrees that the jury is still out on whether plasma can treat the sickest COVID-19 patients. In looking at the natural patterns of how infected patients make antibodies, he says, researchers have seen the most robust antibody response from those who have severe, potentially life-threatening inflammation. In contrast, those who have milder illness tend to have a weaker antibody response.\u003c/p>\n\u003cp class=\"p4\">\u003ci>“\u003c/i>So one question is that if the really sick patients are already making really high levels of antibodies,” Zehnder said, “how does infusing more antibodies help?\u003ci>”\u003c/i>\u003c/p>\n\u003cp class=\"p4\">Results from placebo-controlled trials, Zehnder says, are the gold standard for clinical research, and they will be key in answering questions surrounding COVID-19 convalescent plasma therapy.\u003c/p>\n\u003cp class=\"p1\">Dr. Stuart Cohen, chief of infectious diseases at UC Davis,\u003ci> \u003c/i>worries that a broad rollout of the treatment in the wake of the FDA authorization could jeopardize that research by stifling enrollment.\u003c/p>\n\u003cp class=\"p1\">“If I tell you, you can be on this clinical trial where you could get a placebo and then they say, ‘Well, I saw that this is available already, why don’t you just give it to me?’” Cohen said, “that sort of finishes off any real ability to determine whether this really works or not.”\u003c/p>\n\u003cp class=\"p1\">While he acknowledges doctors are desperate for more tools to try to fight COVID-19, Cohen cautions that the supply of convalescent plasma, which has mostly kept up with the demand for research studies, could be depleted as a result of the FDA authorization.\u003c/p>\n\u003cp class=\"p1\">If doctors all of sudden begin prescribing the drug liberally, Chin-Hong adds, “it may mean that the patients who need it the most may not get it.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp class=\"p1\">\u003cb>Cloning Antibodies in the Lab\u003c/b>\u003c/p>\n\u003cp class=\"p3\">Convalescent plasma isn’t the only way researchers are using antibodies from the blood of recovered patients to develop COVID-19 treatments. Scientists are also working to manufacture antibodies in the lab.\u003c/p>\n\u003cp class=\"p3\">“What you can do is you can go into that person who’s a survivor and find the most potent antibody in that person, clone it and then give it to millions of people,” said Dr. Phil Pang, chief medical officer at San Francisco-based \u003ca href=\"https://www.vir.bio/\">\u003cspan class=\"s1\">Vir Biotechnology\u003c/span>\u003c/a>.\u003c/p>\n\u003cp class=\"p3\">These “\u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4284445/\">\u003cspan class=\"s1\">monoclonal antibodies\u003c/span>\u003c/a>,” Pang says, are made by cloning the powerful, neutralizing antibodies that prevent the coronavirus from invading healthy cells.\u003c/p>\n\u003cp class=\"p3\">The FDA first approved this type of treatment in the 1980s. Doctors have used them mainly to help treat cancer patients and people with autoimmune conditions.\u003c/p>\n\u003cp class=\"p3\">Unlike convalescent plasma, Pang says, the supply of monoclonal antibodies isn’t dependent on blood donations and can be scaled up to potentially reach more people. The proteins are typically replicated in the lab using cell lines from hamsters or mice.\u003c/p>\n\u003cp class=\"p3\">“The antibody manufacturing process is now a very well-defined process,” Pang said. “I would say it’s akin to the way in which we can go about manufacturing cars.”\u003c/p>\n\u003cp class=\"p3\">Pang says one of the antibodies Vir has cloned has been shown to neutralize SARS-CoV-2 in a lab. The finding was supported by an \u003ca href=\"https://www.nature.com/articles/s41586-020-2349-y\" target=\"_blank\" rel=\"noopener noreferrer\">article\u003c/a> \u003cspan class=\"s1\">published in \u003ci>Nature\u003c/i>\u003c/span>\u003ci> \u003c/i>in May.\u003cb> \u003c/b>The company recently launched a randomized trial to see if giving a single injection to newly diagnosed COVID-19 patients can help stop the illness from progressing.\u003c/p>\n\u003cp class=\"p3\">The treatment may eventually be able to prevent infection in front-line workers and other at-risk populations exposed to the coronavirus, acting like a short-term vaccine, Pang says.\u003c/p>\n\u003cp class=\"p3\">“A\u003ci> \u003c/i>vaccine works by giving a person to, say, a fragment of a viral protein and hoping that their immune system creates antibodies,” Pang said. “In this case, what we’re saying is let’s just give them the immune response we know or believe will be protective\u003ci>.\u003c/i>”\u003c/p>\n\u003cp class=\"p3\">The \u003ca href=\"https://www.nih.gov/news-events/news-releases/clinical-trials-monoclonal-antibodies-prevent-covid-19-now-enrolling\">\u003cspan class=\"s1\">NIH\u003c/span>\u003c/a> and a host of drug companies, including Regeneron Pharmaceuticals and Eli Lilly, are testing their own COVID-19 monoclonal antibody candidates.\u003c/p>\n\u003cp class=\"p3\">Preliminary results from both Vir’s monoclonal antibody study and UCSF’s convalescent plasma research are expected by the end of 2020.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "Q&A: Is Convalescent Plasma Therapy Safe and Effective as a COVID-19 Treatment?",
"headTitle": "Q&A: Is Convalescent Plasma Therapy Safe and Effective as a COVID-19 Treatment? | KQED",
"content": "\u003cp>The Food and Drug Administration on Sunday issued an emergency authorization for doctors to treat COVID-19 using blood plasma from patients who’ve recovered from the disease.\u003c/p>\n\u003cfigure id=\"attachment_1968851\" class=\"wp-caption alignright\" style=\"max-width: 640px\">\u003ca href=\"https://ww2.kqed.org/app/uploads/sites/35/2029/08/convalescent-plasma-therapy.jpg\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1968851 size-large\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2029/08/convalescent-plasma-therapy-1020x574.jpg\" alt=\"\" width=\"640\" height=\"360\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-1020x574.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-800x450.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-160x90.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-768x432.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-1536x864.jpg 1536w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy.jpg 1600w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Alex Edelman/AFP via Getty Images)\u003c/figcaption>\u003c/figure>\n\u003cp>Below, STAT answers the major questions surrounding convalescent plasma as a COVID-19 treatment and the science supporting its use.\u003c/p>\n\u003cp>\u003cstrong>What is convalescent plasma, and how does it work?\u003c/strong>\u003c/p>\n\u003cp>When people get sick with COVID-19, their immune systems generate antibodies to fight the disease. Those antibody proteins float in their blood plasma — the liquid component of blood that suspends blood cells.\u003c/p>\n\u003cp>Doctors can harvest the plasma, test it for safety, and then purify it to isolate those antibodies. That “plasma-derived therapy,” or “convalescent plasma,” can be injected into another patient sick with COVID-19, and the antibodies it contains can help fight the virus early in an infection until the patient’s own immune system generates its own antibodies in sufficient quantities to beat back COVID-19.\u003c/p>\n\u003cp>\u003cstrong>Does scientific evidence show that convalescent plasma is a safe and effective treatment for COVID-19?\u003c/strong>\u003c/p>\n\u003cp>The Mayo Clinic released data in June that showed plasma treatment was safe following transfusion in a group of 20,000 patients, which included substantial enrollment from Black and Latino patients.\u003c/p>\n\u003cp>A study released Aug. 13 — but not yet peer-reviewed — suggested that using convalescent plasma to treat patients with severe COVID-19 soon after their diagnosis was associated with a lower likelihood of death. But the study had serious scientific limitations that make interpreting the findings difficult.\u003c/p>\n\u003cp>The Mayo Clinic study, which enrolled more than 35,000 patients, showed that patients who received transfusions within three days of their COVID-19 diagnosis had a seven-day death rate of 8.7%, while patients who received plasma treatment after four or more days had a mortality rate of 11.9%. The difference met the standard for statistical significance.\u003c/p>\n\u003cp>The study didn’t include a placebo group for comparison, however, so it’s unclear exactly how impactful the plasma treatment might be. The study was sponsored by the National Institutes of Health and sought to broaden access to convalescent plasma, part of a so-called “expanded access” program not designed to definitively test how well the treatment works, but instead to quickly get it to patients.\u003c/p>\n\u003cp>More rigorous randomized, placebo-controlled studies of convalescent plasma are ongoing.\u003c/p>\n\u003cp>\u003cstrong>What does an emergency use authorization, or ‘EUA,’ mean?\u003c/strong>\u003c/p>\n\u003cp>The FDA has issued a number of emergency authorizations for COVID-19 treatments: Most notably the Gilead Sciences antiviral remdesivir, and for the antimalarial drug hydroxychloroquine, which the agency has since withdrawn.\u003c/p>\n\u003cp>The authorizations mean, effectively, that the agency believes the treatments in question are promising and largely safe, though there’s not yet definitive data supporting their efficacy.\u003c/p>\n\u003cp>An EUA for convalescent plasma would effectively license doctors across the country to begin treating COVID-19 patients with convalescent plasma, but it’s unclear whether it will result in a meaningful expansion in access to the therapy, in part because the supply is limited by the number of recovered patients who donate plasma.\u003c/p>\n\u003cp>The Mayo Clinic study, which relied on an FDA “expanded access” program, was broad enough that it allowed 35,000 patients access to the treatment despite the lack of a formal authorization for its use. It’s unclear whether an EUA will lead to a major increase in the number of doctors capable of using convalescent plasma to treat COVID-19, and the number of patients who will end up receiving the treatment.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Aren’t some patients being treated with convalescent plasma already?\u003c/strong>\u003c/p>\n\u003cp>Yes, through “compassionate use” programs like the Mayo Clinic study, and through more rigorous clinical trials.\u003c/p>\n\u003cp>\u003cstrong>Isn’t the government already advertising convalescent plasma as a COVID-19 treatment?\u003c/strong>\u003c/p>\n\u003cp>Yes. FDA Commissioner Stephen Hahn began encouraging Americans sick with COVID-19 to donate plasma as early as April. The federal government, in fact, has already spent about $8 million on radio and online advertisements encouraging Americans to donate plasma, even though no government agency has formally endorsed its use.\u003c/p>\n\u003cp>President Donald Trump attended a roundtable on donating plasma last month at the American Red Cross national headquarters in Washington, D.C., accompanied by health secretary Alex Azar, Surgeon General Jerome Adams, and Tony Fauci, the director of the National Institute of Allergy and Infectious Diseases.\u003c/p>\n\u003cp>Hahn’s face has even appeared on FDA-branded billboard advertisements that encourage passers-by: “Help us save lives. Donate plasma now.”\u003c/p>\n\u003cp>\u003cstrong>Has there been pushback regarding use of convalescent plasma?\u003c/strong>\u003c/p>\n\u003cp>Yes. The New York Times reported on Wednesday that Fauci and the director of the National Institutes of Health recently intervened to discourage the FDA from issuing an EUA for convalescent plasma, citing concerns over weak data.\u003c/p>\n\u003cp>It’s not clear whether their reported pushback made a difference. Francis Collins, the NIH director, and Fauci are widely respected scientists, but have no authority over FDA.\u003c/p>\n\u003cp>Scientists outside government have cast the convalescent plasma debate as a case study in pandemic-era science — and how the urgency of treating COVID-19 balances against the need for caution and due diligence in developing new medical treatments.\u003c/p>\n\u003cp>“It raises the question of what strength of evidence is necessary to treat during a pandemic,” Harlan Krumholz, director of the Center for Outcomes Research and Evaluation at Yale New Haven Hospital, told STAT recently. “The problem is we have yet to resolve what is sufficient evidence to change the treatment paradigm.”\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2020/08/23/is-convalescent-plasma-safe-and-effective/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n",
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"excerpt": "The FDA Sunday issued an emergency authorization for doctors to treat COVID-19 using blood plasma from patients who’ve recovered from the disease. STAT answers the major questions surrounding convalescent plasma as a treatment and the science supporting its use.",
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"description": "The FDA Sunday issued an emergency authorization for doctors to treat COVID-19 using blood plasma from patients who’ve recovered from the disease. STAT answers the major questions surrounding convalescent plasma as a treatment and the science supporting its use.",
"title": "Q&A: Is Convalescent Plasma Therapy Safe and Effective as a COVID-19 Treatment? | KQED",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration on Sunday issued an emergency authorization for doctors to treat COVID-19 using blood plasma from patients who’ve recovered from the disease.\u003c/p>\n\u003cfigure id=\"attachment_1968851\" class=\"wp-caption alignright\" style=\"max-width: 640px\">\u003ca href=\"https://ww2.kqed.org/app/uploads/sites/35/2029/08/convalescent-plasma-therapy.jpg\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1968851 size-large\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2029/08/convalescent-plasma-therapy-1020x574.jpg\" alt=\"\" width=\"640\" height=\"360\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-1020x574.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-800x450.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-160x90.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-768x432.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy-1536x864.jpg 1536w, https://cdn.kqed.org/wp-content/uploads/sites/35/2029/08/convalescent-plasma-therapy.jpg 1600w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">(Alex Edelman/AFP via Getty Images)\u003c/figcaption>\u003c/figure>\n\u003cp>Below, STAT answers the major questions surrounding convalescent plasma as a COVID-19 treatment and the science supporting its use.\u003c/p>\n\u003cp>\u003cstrong>What is convalescent plasma, and how does it work?\u003c/strong>\u003c/p>\n\u003cp>When people get sick with COVID-19, their immune systems generate antibodies to fight the disease. Those antibody proteins float in their blood plasma — the liquid component of blood that suspends blood cells.\u003c/p>\n\u003cp>Doctors can harvest the plasma, test it for safety, and then purify it to isolate those antibodies. That “plasma-derived therapy,” or “convalescent plasma,” can be injected into another patient sick with COVID-19, and the antibodies it contains can help fight the virus early in an infection until the patient’s own immune system generates its own antibodies in sufficient quantities to beat back COVID-19.\u003c/p>\n\u003cp>\u003cstrong>Does scientific evidence show that convalescent plasma is a safe and effective treatment for COVID-19?\u003c/strong>\u003c/p>\n\u003cp>The Mayo Clinic released data in June that showed plasma treatment was safe following transfusion in a group of 20,000 patients, which included substantial enrollment from Black and Latino patients.\u003c/p>\n\u003cp>A study released Aug. 13 — but not yet peer-reviewed — suggested that using convalescent plasma to treat patients with severe COVID-19 soon after their diagnosis was associated with a lower likelihood of death. But the study had serious scientific limitations that make interpreting the findings difficult.\u003c/p>\n\u003cp>The Mayo Clinic study, which enrolled more than 35,000 patients, showed that patients who received transfusions within three days of their COVID-19 diagnosis had a seven-day death rate of 8.7%, while patients who received plasma treatment after four or more days had a mortality rate of 11.9%. The difference met the standard for statistical significance.\u003c/p>\n\u003cp>The study didn’t include a placebo group for comparison, however, so it’s unclear exactly how impactful the plasma treatment might be. The study was sponsored by the National Institutes of Health and sought to broaden access to convalescent plasma, part of a so-called “expanded access” program not designed to definitively test how well the treatment works, but instead to quickly get it to patients.\u003c/p>\n\u003cp>More rigorous randomized, placebo-controlled studies of convalescent plasma are ongoing.\u003c/p>\n\u003cp>\u003cstrong>What does an emergency use authorization, or ‘EUA,’ mean?\u003c/strong>\u003c/p>\n\u003cp>The FDA has issued a number of emergency authorizations for COVID-19 treatments: Most notably the Gilead Sciences antiviral remdesivir, and for the antimalarial drug hydroxychloroquine, which the agency has since withdrawn.\u003c/p>\n\u003cp>The authorizations mean, effectively, that the agency believes the treatments in question are promising and largely safe, though there’s not yet definitive data supporting their efficacy.\u003c/p>\n\u003cp>An EUA for convalescent plasma would effectively license doctors across the country to begin treating COVID-19 patients with convalescent plasma, but it’s unclear whether it will result in a meaningful expansion in access to the therapy, in part because the supply is limited by the number of recovered patients who donate plasma.\u003c/p>\n\u003cp>The Mayo Clinic study, which relied on an FDA “expanded access” program, was broad enough that it allowed 35,000 patients access to the treatment despite the lack of a formal authorization for its use. It’s unclear whether an EUA will lead to a major increase in the number of doctors capable of using convalescent plasma to treat COVID-19, and the number of patients who will end up receiving the treatment.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Aren’t some patients being treated with convalescent plasma already?\u003c/strong>\u003c/p>\n\u003cp>Yes, through “compassionate use” programs like the Mayo Clinic study, and through more rigorous clinical trials.\u003c/p>\n\u003cp>\u003cstrong>Isn’t the government already advertising convalescent plasma as a COVID-19 treatment?\u003c/strong>\u003c/p>\n\u003cp>Yes. FDA Commissioner Stephen Hahn began encouraging Americans sick with COVID-19 to donate plasma as early as April. The federal government, in fact, has already spent about $8 million on radio and online advertisements encouraging Americans to donate plasma, even though no government agency has formally endorsed its use.\u003c/p>\n\u003cp>President Donald Trump attended a roundtable on donating plasma last month at the American Red Cross national headquarters in Washington, D.C., accompanied by health secretary Alex Azar, Surgeon General Jerome Adams, and Tony Fauci, the director of the National Institute of Allergy and Infectious Diseases.\u003c/p>\n\u003cp>Hahn’s face has even appeared on FDA-branded billboard advertisements that encourage passers-by: “Help us save lives. Donate plasma now.”\u003c/p>\n\u003cp>\u003cstrong>Has there been pushback regarding use of convalescent plasma?\u003c/strong>\u003c/p>\n\u003cp>Yes. The New York Times reported on Wednesday that Fauci and the director of the National Institutes of Health recently intervened to discourage the FDA from issuing an EUA for convalescent plasma, citing concerns over weak data.\u003c/p>\n\u003cp>It’s not clear whether their reported pushback made a difference. Francis Collins, the NIH director, and Fauci are widely respected scientists, but have no authority over FDA.\u003c/p>\n\u003cp>Scientists outside government have cast the convalescent plasma debate as a case study in pandemic-era science — and how the urgency of treating COVID-19 balances against the need for caution and due diligence in developing new medical treatments.\u003c/p>\n\u003cp>“It raises the question of what strength of evidence is necessary to treat during a pandemic,” Harlan Krumholz, director of the Center for Outcomes Research and Evaluation at Yale New Haven Hospital, told STAT recently. “The problem is we have yet to resolve what is sufficient evidence to change the treatment paradigm.”\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2020/08/23/is-convalescent-plasma-safe-and-effective/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n\u003c/div>\u003c/p>",
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"title": "Doctors and Nurses Are Not Doing Okay",
"headTitle": "Doctors and Nurses Are Not Doing Okay | KQED",
"content": "\u003cp class=\"p1\">After five months working shifts at an emergency department in Oakland, Douglas Frey says he’s mentally and physically spent. \u003cspan class=\"s1\">Most days the\u003c/span> tall, athletic-looking 47-year-old nurse\u003cspan class=\"s1\"> ends his shift depleted by what he calls an “undercurrent” of “tension.”\u003c/span>\u003c/p>\n\u003cp class=\"p1\">Every day Frey worries he’ll make a mistake — picking up a contaminated mask, perhaps — and bring the virus home to his two boys and wife, who is immunocompromised. He’s worried about his hospital’s ability to source enough masks and protective gear for him to do his job safely.\u003c/p>\n\u003cfigure id=\"attachment_1968315\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1968315 size-medium\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/IMG_3506-e1597182085426-800x885.jpg\" alt=\"After working many consecutive months both as an ER nurse in Oakland Douglas Frey is emotionally and physically exhausted.\" width=\"800\" height=\"885\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-800x885.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-1020x1129.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-160x177.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-768x850.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-1388x1536.jpg 1388w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426.jpg 1574w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">After working many consecutive months as an ER nurse in Oakland, Douglas Frey is emotionally and physically exhausted. \u003ccite>(Courtesy of Douglas Frey)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p3\">Frey is not alone among medical staff when it comes to pandemic burnout.\u003c/p>\n\u003cp class=\"p3\">The unflappable health care heroes of the current crisis are beginning to crack under the strain. Doctors, nurses and other professionals are not only fighting an intractable virus day after day, they’re also coping with isolation, shifting official guidelines and limited ways to recharge.\u003c/p>\n\u003cp class=\"p1\">A\u003ca href=\"https://onlinelibrary.wiley.com/doi/10.1111/acem.14065\"> \u003cspan class=\"s2\">study\u003c/span>\u003c/a> published in June by researchers from UCSF and other universities showed emergency medicine physicians reporting a median 60% increase in emotional exhaustion and burnout over prepandemic levels.\u003c/p>\n\u003cp class=\"p1\">These workers cited the unavailability of protective gear, inadequate testing and the risk of spreading the virus by discharged patients as their primary concerns. Physicians noted their stress levels have decreased their affection with family members.\u003c/p>\n\u003cp class=\"p1\">The gowns in one recent shipment to Frey’s hospital were so thin that managers encouraged workers to double up when they wore them, he says. But, “Even with two, they’d come off in shreds by the time you got them off.”\u003c/p>\n\u003cp class=\"p1\">Now, he has the opposite problem. The gowns in the current stock are made of thick, impermeable vinyl. He often leaves the hospital soaked in sweat.\u003c/p>\n\u003cp class=\"p1\">Frey’s work frustrations are compounded by the drumbeat of bad news and what he considers to be a lack of cohesive response on the part of political leaders. “I’m exhausted by the fact that every family, store, business, organization, school, city, county and state is having to duplicate efforts to try and figure out what to do,” he said.\u003c/p>\n\u003cp class=\"p1\">And now he’s bracing for a potentially overwhelming wave of patients this fall when COVID-19 collides with cold and flu season.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"p1\">\u003cb>Recipe for More Burnout\u003c/b>\u003c/p>\n\u003cp class=\"p1\">Before the pandemic hit, 42% of more than 15,000 physicians responding to an online survey by the medical news website Medscape \u003ca href=\"https://www.medscape.com/slideshow/2020-lifestyle-burnout-6012460?faf=1\" target=\"_blank\" rel=\"noopener noreferrer\">reported\u003c/a> being burned out. High rates of depression and suicide in the medical profession have long been a \u003ca href=\"https://www.npr.org/sections/health-shots/2018/07/31/634217947/to-prevent-doctor-suicides-medical-industry-rethinks-how-doctors-work\" target=\"_blank\" rel=\"noopener noreferrer\">problem\u003c/a>.\u003c/p>\n\u003cp class=\"p1\">Experts fear the coronavirus crisis will only make those numbers go up.\u003c/p>\n\u003cp class=\"p1\">“When the stress of hospitals gets unbelievably high, it ceases to be a place where we get sustenance, or feel like we’re being helpful,” said Bradley Dreifuss, an emergency medicine physician and public health specialist at the University of Arizona in Tucson. “Instead we feel helpless.”\u003c/p>\n\u003cp class=\"p1\">Dreifuss penned a \u003ci>New York Times\u003c/i>\u003ca href=\"https://www.nytimes.com/2020/06/26/opinion/coronavirus-arizona-hospitals.html\"> \u003cspan class=\"s2\">editorial\u003c/span>\u003c/a> in June to draw attention to health care fatigue. He wrote the article from an Airbnb after nine consecutive shifts. For months he has lived there alone to protect his wife and 10-year-old daughter.\u003c/p>\n\u003cp class=\"p1\">He says many of his colleagues are starting to withdraw emotionally and show increasing levels of cynicism, which inspired him to add mental health services to an initiative he started called\u003ca href=\"https://hcwhosted.org/\"> \u003cspan class=\"s2\">HCW Hosted.\u003c/span>\u003c/a> At first, the online platform connected health care workers with temporary housing, but now doctors and nurses can access mental health support as well.\u003c/p>\n\u003cp class=\"p1\">Dreifuss called the current situation “very, very challenging.”\u003c/p>\n\u003cp class=\"p1\">“COVID patients are much sicker than our typical patients physiologically,” he said. “When you’re working with constrained resources and uncertainty, it makes it a lot worse.”\u003c/p>\n\u003cp class=\"p1\">\u003cb>Extra Burden on Latino Doctors\u003c/b>\u003c/p>\n\u003cp class=\"p1\">The days began to blur together for Dinora Chinchilla, a pulmonologist specializing in critical care in Los Angeles County, where the virus has killed nearly\u003ca href=\"https://www.latimes.com/projects/california-coronavirus-cases-tracking-outbreak/los-angeles-county/\"> \u003cspan class=\"s2\">5,000 \u003c/span>\u003c/a>people.\u003c/p>\n\u003cfigure id=\"attachment_1968316\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1968316 size-medium\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/IMG_9630-800x1067.jpg\" alt=\"Dr. Dinora Chinchilla is finally taking a month after seven consecutive months treating patients in an ICU in Los Angeles county.\" width=\"800\" height=\"1067\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-800x1067.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-1020x1360.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-160x213.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-768x1024.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-1152x1536.jpg 1152w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-1536x2048.jpg 1536w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-scaled.jpg 1920w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Dr. Dinora Chinchilla is finally taking a month off after working seven consecutive months. \u003ccite>(Nicole Cataldi)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">“All I saw was COVID, COVID, COVID,” she said. “I didn’t know Monday from a Saturday. I felt like every day was on repeat.”\u003c/p>\n\u003cp class=\"p1\">She is finally taking a few weeks off to refuel. Many days, when the 39-year-old looked around the intensive care unit, every single patient was connected to a ventilator. Most were older, overweight, diabetic and Latino.\u003c/p>\n\u003cp class=\"p1\">“Seeing how disproportionately COVID has affected the Latino community and being able to be that person for them now is what I always wanted,” said Chinchilla. “But that comes with a big burden.”\u003c/p>\n\u003cp class=\"p1\">As a kid growing up in East L.A., she dreamed of treating low-income families like hers. Bridging that barrier inspires her to work longer shifts than many of her colleagues, she says. Current COVID-19 protocols do not allow visitors inside the hospital, so she has insisted on personally calling the families of Latino patients, because she believes it’s kinder to deliver what is often devastating news directly\u003ci> \u003c/i>rather than through a translator.\u003c/p>\n\u003cp class=\"p1\">“It was just so emotional,” Chinchilla said, fingering the inside of a large silver hoop earring. “I can’t say that I didn’t cry often.”\u003c/p>\n\u003cp class=\"p1\">The heartache didn’t end at work. When Chinchilla unlocked the door to her house, her two young children would run toward her. But she had to head in the opposite direction.\u003c/p>\n\u003cp class=\"p1\">“How sad is that?” she said. “Not being able to hug your child when she’s so happy that you’re home because you’ve been gone for 14 hours.”\u003c/p>\n\u003cp class=\"p1\">Chinchilla didn’t embrace her kids until she scrubbed herself raw in a scalding shower. And, now, even though she’s enjoying slower days at home recovering, her mind won’t relax.\u003c/p>\n\u003cp class=\"p1\">“I feel that sense of duty,” she said. “This is my specialty. This is what I signed up for. I have to be there.”\u003c/p>\n\u003cfigure id=\"attachment_1968318\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1968318\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-800x1067.jpeg\" alt=\"The emergency room where Dr. Victor Cisneros works is running out of beds for patients, many from Latino families like his.\" width=\"800\" height=\"1067\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-800x1067.jpeg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-1020x1360.jpeg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-160x213.jpeg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-768x1024.jpeg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-1152x1536.jpeg 1152w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-1536x2048.jpeg 1536w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907.jpeg 1920w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">The emergency department in Orange County where Dr. Victor Cisneros works is running out of beds for patients, many from Latino families like his. \u003ccite>(Victor Cisneros)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">Victor Cisneros, a 39-year-old emergency department physician, can relate. He treats patients in Orange County. His hospital is running out of beds for patients, many from families just like his.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">“I grew up very underserved,” said Cisneros, smiling. “I come from a very humble family. I’m the first physician, the first person to graduate college.”\u003c/p>\n\u003cp class=\"p1\">He’s originally from Mexico, but now much of his family lives in Los Angeles. Even though they live near each other, social distancing has made it hard for them to feel close. For Cisneros, the lack of physical contact is exacerbated because he lives alone.\u003c/p>\n\u003cp class=\"p1\">“You just feel trapped,” he said. “Because you’re in the ER for 10 hours, which is intense, exhausting. It smells. People are vomiting. There’s blood.”\u003c/p>\n\u003cp class=\"p1\">He used to disconnect from work by working out or going to dinner with friends. But now, his gym is closed and many of his friends don’t want to hang out, knowing he’s around sick people all day.\u003c/p>\n\u003cp class=\"p1\">“So, I’m on a couch in front of a screen by myself. It’s almost like you’re in jail.”\u003c/p>\n\u003cp class=\"p1\">He fears the current situation is not sustainable, especially for physicians who were already burned out. “This is probably the tipping edge for them,” he said.\u003c/p>\n\u003cp class=\"p1\">Doctors aren’t known for seeking help, said Dr. Deborah Marin, a professor of psychiatry at Mount Sinai’s Icahn School of Medicine. “Suffering is kind of part of the profession to some degree,” she said. “But people shouldn’t be suffering.”\u003c/p>\n\u003cp class=\"p1\">Marin directs a new program called the\u003ca href=\"https://icahn.mssm.edu/about/departments/psychiatry/clinical/stress-resilience-personal-growth-center\"> \u003cspan class=\"s2\">Mount Sinai Center for Stress, Resilience, and Personal Growth\u003c/span>\u003c/a>, designed to address mental health issues like depression, anxiety and post-traumatic stress disorder in health care workers.\u003c/p>\n\u003cp class=\"p1\">“The idea is to shore up people’s resilience and be supportive of them,” Marin said. “They need to feel like they’re not in this alone.”\u003c/p>\n\u003cp class=\"p1\">The program includes a hotline, a wellness app and workshops designed to help connect nurses and doctors. She says the most important step is to ask for help, which could mean starting a conversation with a supervisor, friend or a therapist.\u003c/p>\n\u003cp class=\"p1\">Which could be good advice for not just doctors, but all of us.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n",
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"excerpt": "After months of fighting the pandemic, health care workers are breaking under heavy emotional and physical strain. ",
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"subhead": "Coronavirus Crisis Is Burning Out Health Care Workers in California",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"p1\">After five months working shifts at an emergency department in Oakland, Douglas Frey says he’s mentally and physically spent. \u003cspan class=\"s1\">Most days the\u003c/span> tall, athletic-looking 47-year-old nurse\u003cspan class=\"s1\"> ends his shift depleted by what he calls an “undercurrent” of “tension.”\u003c/span>\u003c/p>\n\u003cp class=\"p1\">Every day Frey worries he’ll make a mistake — picking up a contaminated mask, perhaps — and bring the virus home to his two boys and wife, who is immunocompromised. He’s worried about his hospital’s ability to source enough masks and protective gear for him to do his job safely.\u003c/p>\n\u003cfigure id=\"attachment_1968315\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1968315 size-medium\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/IMG_3506-e1597182085426-800x885.jpg\" alt=\"After working many consecutive months both as an ER nurse in Oakland Douglas Frey is emotionally and physically exhausted.\" width=\"800\" height=\"885\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-800x885.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-1020x1129.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-160x177.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-768x850.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426-1388x1536.jpg 1388w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_3506-e1597182085426.jpg 1574w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">After working many consecutive months as an ER nurse in Oakland, Douglas Frey is emotionally and physically exhausted. \u003ccite>(Courtesy of Douglas Frey)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p3\">Frey is not alone among medical staff when it comes to pandemic burnout.\u003c/p>\n\u003cp class=\"p3\">The unflappable health care heroes of the current crisis are beginning to crack under the strain. Doctors, nurses and other professionals are not only fighting an intractable virus day after day, they’re also coping with isolation, shifting official guidelines and limited ways to recharge.\u003c/p>\n\u003cp class=\"p1\">A\u003ca href=\"https://onlinelibrary.wiley.com/doi/10.1111/acem.14065\"> \u003cspan class=\"s2\">study\u003c/span>\u003c/a> published in June by researchers from UCSF and other universities showed emergency medicine physicians reporting a median 60% increase in emotional exhaustion and burnout over prepandemic levels.\u003c/p>\n\u003cp class=\"p1\">These workers cited the unavailability of protective gear, inadequate testing and the risk of spreading the virus by discharged patients as their primary concerns. Physicians noted their stress levels have decreased their affection with family members.\u003c/p>\n\u003cp class=\"p1\">The gowns in one recent shipment to Frey’s hospital were so thin that managers encouraged workers to double up when they wore them, he says. But, “Even with two, they’d come off in shreds by the time you got them off.”\u003c/p>\n\u003cp class=\"p1\">Now, he has the opposite problem. The gowns in the current stock are made of thick, impermeable vinyl. He often leaves the hospital soaked in sweat.\u003c/p>\n\u003cp class=\"p1\">Frey’s work frustrations are compounded by the drumbeat of bad news and what he considers to be a lack of cohesive response on the part of political leaders. “I’m exhausted by the fact that every family, store, business, organization, school, city, county and state is having to duplicate efforts to try and figure out what to do,” he said.\u003c/p>\n\u003cp class=\"p1\">And now he’s bracing for a potentially overwhelming wave of patients this fall when COVID-19 collides with cold and flu season.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp class=\"p1\">\u003cb>Recipe for More Burnout\u003c/b>\u003c/p>\n\u003cp class=\"p1\">Before the pandemic hit, 42% of more than 15,000 physicians responding to an online survey by the medical news website Medscape \u003ca href=\"https://www.medscape.com/slideshow/2020-lifestyle-burnout-6012460?faf=1\" target=\"_blank\" rel=\"noopener noreferrer\">reported\u003c/a> being burned out. High rates of depression and suicide in the medical profession have long been a \u003ca href=\"https://www.npr.org/sections/health-shots/2018/07/31/634217947/to-prevent-doctor-suicides-medical-industry-rethinks-how-doctors-work\" target=\"_blank\" rel=\"noopener noreferrer\">problem\u003c/a>.\u003c/p>\n\u003cp class=\"p1\">Experts fear the coronavirus crisis will only make those numbers go up.\u003c/p>\n\u003cp class=\"p1\">“When the stress of hospitals gets unbelievably high, it ceases to be a place where we get sustenance, or feel like we’re being helpful,” said Bradley Dreifuss, an emergency medicine physician and public health specialist at the University of Arizona in Tucson. “Instead we feel helpless.”\u003c/p>\n\u003cp class=\"p1\">Dreifuss penned a \u003ci>New York Times\u003c/i>\u003ca href=\"https://www.nytimes.com/2020/06/26/opinion/coronavirus-arizona-hospitals.html\"> \u003cspan class=\"s2\">editorial\u003c/span>\u003c/a> in June to draw attention to health care fatigue. He wrote the article from an Airbnb after nine consecutive shifts. For months he has lived there alone to protect his wife and 10-year-old daughter.\u003c/p>\n\u003cp class=\"p1\">He says many of his colleagues are starting to withdraw emotionally and show increasing levels of cynicism, which inspired him to add mental health services to an initiative he started called\u003ca href=\"https://hcwhosted.org/\"> \u003cspan class=\"s2\">HCW Hosted.\u003c/span>\u003c/a> At first, the online platform connected health care workers with temporary housing, but now doctors and nurses can access mental health support as well.\u003c/p>\n\u003cp class=\"p1\">Dreifuss called the current situation “very, very challenging.”\u003c/p>\n\u003cp class=\"p1\">“COVID patients are much sicker than our typical patients physiologically,” he said. “When you’re working with constrained resources and uncertainty, it makes it a lot worse.”\u003c/p>\n\u003cp class=\"p1\">\u003cb>Extra Burden on Latino Doctors\u003c/b>\u003c/p>\n\u003cp class=\"p1\">The days began to blur together for Dinora Chinchilla, a pulmonologist specializing in critical care in Los Angeles County, where the virus has killed nearly\u003ca href=\"https://www.latimes.com/projects/california-coronavirus-cases-tracking-outbreak/los-angeles-county/\"> \u003cspan class=\"s2\">5,000 \u003c/span>\u003c/a>people.\u003c/p>\n\u003cfigure id=\"attachment_1968316\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1968316 size-medium\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/IMG_9630-800x1067.jpg\" alt=\"Dr. Dinora Chinchilla is finally taking a month after seven consecutive months treating patients in an ICU in Los Angeles county.\" width=\"800\" height=\"1067\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-800x1067.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-1020x1360.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-160x213.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-768x1024.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-1152x1536.jpg 1152w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-1536x2048.jpg 1536w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_9630-scaled.jpg 1920w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Dr. Dinora Chinchilla is finally taking a month off after working seven consecutive months. \u003ccite>(Nicole Cataldi)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">“All I saw was COVID, COVID, COVID,” she said. “I didn’t know Monday from a Saturday. I felt like every day was on repeat.”\u003c/p>\n\u003cp class=\"p1\">She is finally taking a few weeks off to refuel. Many days, when the 39-year-old looked around the intensive care unit, every single patient was connected to a ventilator. Most were older, overweight, diabetic and Latino.\u003c/p>\n\u003cp class=\"p1\">“Seeing how disproportionately COVID has affected the Latino community and being able to be that person for them now is what I always wanted,” said Chinchilla. “But that comes with a big burden.”\u003c/p>\n\u003cp class=\"p1\">As a kid growing up in East L.A., she dreamed of treating low-income families like hers. Bridging that barrier inspires her to work longer shifts than many of her colleagues, she says. Current COVID-19 protocols do not allow visitors inside the hospital, so she has insisted on personally calling the families of Latino patients, because she believes it’s kinder to deliver what is often devastating news directly\u003ci> \u003c/i>rather than through a translator.\u003c/p>\n\u003cp class=\"p1\">“It was just so emotional,” Chinchilla said, fingering the inside of a large silver hoop earring. “I can’t say that I didn’t cry often.”\u003c/p>\n\u003cp class=\"p1\">The heartache didn’t end at work. When Chinchilla unlocked the door to her house, her two young children would run toward her. But she had to head in the opposite direction.\u003c/p>\n\u003cp class=\"p1\">“How sad is that?” she said. “Not being able to hug your child when she’s so happy that you’re home because you’ve been gone for 14 hours.”\u003c/p>\n\u003cp class=\"p1\">Chinchilla didn’t embrace her kids until she scrubbed herself raw in a scalding shower. And, now, even though she’s enjoying slower days at home recovering, her mind won’t relax.\u003c/p>\n\u003cp class=\"p1\">“I feel that sense of duty,” she said. “This is my specialty. This is what I signed up for. I have to be there.”\u003c/p>\n\u003cfigure id=\"attachment_1968318\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1968318\" src=\"https://ww2.kqed.org/app/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-800x1067.jpeg\" alt=\"The emergency room where Dr. Victor Cisneros works is running out of beds for patients, many from Latino families like his.\" width=\"800\" height=\"1067\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-800x1067.jpeg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-1020x1360.jpeg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-160x213.jpeg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-768x1024.jpeg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-1152x1536.jpeg 1152w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907-1536x2048.jpeg 1536w, https://cdn.kqed.org/wp-content/uploads/sites/35/2020/08/IMG_7918-scaled-e1597180915907.jpeg 1920w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">The emergency department in Orange County where Dr. Victor Cisneros works is running out of beds for patients, many from Latino families like his. \u003ccite>(Victor Cisneros)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">Victor Cisneros, a 39-year-old emergency department physician, can relate. He treats patients in Orange County. His hospital is running out of beds for patients, many from families just like his.\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cp class=\"p1\">“I grew up very underserved,” said Cisneros, smiling. “I come from a very humble family. I’m the first physician, the first person to graduate college.”\u003c/p>\n\u003cp class=\"p1\">He’s originally from Mexico, but now much of his family lives in Los Angeles. Even though they live near each other, social distancing has made it hard for them to feel close. For Cisneros, the lack of physical contact is exacerbated because he lives alone.\u003c/p>\n\u003cp class=\"p1\">“You just feel trapped,” he said. “Because you’re in the ER for 10 hours, which is intense, exhausting. It smells. People are vomiting. There’s blood.”\u003c/p>\n\u003cp class=\"p1\">He used to disconnect from work by working out or going to dinner with friends. But now, his gym is closed and many of his friends don’t want to hang out, knowing he’s around sick people all day.\u003c/p>\n\u003cp class=\"p1\">“So, I’m on a couch in front of a screen by myself. It’s almost like you’re in jail.”\u003c/p>\n\u003cp class=\"p1\">He fears the current situation is not sustainable, especially for physicians who were already burned out. “This is probably the tipping edge for them,” he said.\u003c/p>\n\u003cp class=\"p1\">Doctors aren’t known for seeking help, said Dr. Deborah Marin, a professor of psychiatry at Mount Sinai’s Icahn School of Medicine. “Suffering is kind of part of the profession to some degree,” she said. “But people shouldn’t be suffering.”\u003c/p>\n\u003cp class=\"p1\">Marin directs a new program called the\u003ca href=\"https://icahn.mssm.edu/about/departments/psychiatry/clinical/stress-resilience-personal-growth-center\"> \u003cspan class=\"s2\">Mount Sinai Center for Stress, Resilience, and Personal Growth\u003c/span>\u003c/a>, designed to address mental health issues like depression, anxiety and post-traumatic stress disorder in health care workers.\u003c/p>\n\u003cp class=\"p1\">“The idea is to shore up people’s resilience and be supportive of them,” Marin said. “They need to feel like they’re not in this alone.”\u003c/p>\n\u003cp class=\"p1\">The program includes a hotline, a wellness app and workshops designed to help connect nurses and doctors. She says the most important step is to ask for help, which could mean starting a conversation with a supervisor, friend or a therapist.\u003c/p>\n\u003cp class=\"p1\">Which could be good advice for not just doctors, but all of us.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "The US Has a Dwindling Number of Months to Contain COVID-19 Before a Winter Surge",
"headTitle": "The US Has a Dwindling Number of Months to Contain COVID-19 Before a Winter Surge | KQED",
"content": "\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">T\u003c/span>\u003c/span>he good news: The United States has a window of opportunity to beat back COVID-19 before things get much, much worse.\u003c/p>\n\u003cp>The bad news: That window is rapidly closing. And the country seems unwilling or unable to seize the moment.\u003c/p>\n\u003cp>Winter is coming. Winter means cold and flu season, which is all but sure to complicate the task of figuring out who is sick with COVID-19 and who is suffering from a less threatening respiratory tract infection. It also means that cherished outdoor freedoms that link us to pre-COVID life — pop-up restaurant patios, picnics in parks, trips to the beach — will soon be out of reach, at least in northern parts of the country.\u003c/p>\n\u003cp>Unless Americans use the dwindling weeks between now and the onset of “indoor weather” to tamp down transmission in the country, this winter could be Dickensianly bleak, public health experts warn.\u003c/p>\n\u003cp>“I think November, December, January, February are going to be tough months in this country without a vaccine,” said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>It is possible, of course, that some vaccines could be approved by then, thanks to \u003ca href=\"https://www.statnews.com/2020/07/30/a-huge-experiment-how-the-world-made-so-much-progress-on-a-covid-19-vaccine-so-fast/\" target=\"_blank\" rel=\"noopener noreferrer\">historically rapid scientific work\u003c/a>. But there is little prospect that vast numbers of Americans will be vaccinated in time to forestall the grim winter Osterholm and others foresee.\u003c/p>\n\u003cp>Human coronaviruses, the distant cold-causing cousins of the virus that causes COVID-19, circulate year-round. Now is typically the low season for transmission. But in this summer of America’s failed COVID-19 response, the SARS-CoV-2 virus is widespread across the country, and pandemic-weary Americans seem more interested in resuming pre-COVID lifestyles than in suppressing the virus to the point where schools can be reopened, and stay open, and restaurants, movie theaters, and gyms can function with some restrictions.\u003c/p>\n\u003cp>“We should be aiming for no transmission before we open the schools and we put kids in harm’s way — kids and teachers and their caregivers. And so, if that means no gym, no movie theaters, so be it,” said Caroline Buckee, associate director of the Center for Communicable Disease Dynamics at Harvard’s T.H. Chan School of Public Health.\u003c/p>\n\u003cp>“We seem to be choosing leisure activities now over children’s safety in a month’s time. And I cannot understand that trade-off.”\u003c/p>\n\u003cp>While many countries managed to suppress the spread of SARS-CoV-2, the United States has failed miserably. Countries in Europe and Asia are worrying about a second wave. Here, the first wave rages on, engulfing rural as well as urban parts of the country. Though there’s been a slight decline in cases in the past couple of weeks, more than 50,000 Americans a day are being diagnosed with COVID-19. And those are just the confirmed cases.\u003c/p>\n\u003cp>To put that in perspective, at this rate the U.S. is racking up more cases in a week than Britain has accumulated since the start of the pandemic.\u003c/p>\n\u003cp>Public health officials had hoped transmission of the virus would abate with the warm temperatures of summer and the tendency — heightened this year — of people to take their recreational activities outdoors. Experts do believe people are less likely to transmit the virus outside, especially if they are wearing face coverings and keeping a safe distance apart.\u003c/p>\n\u003cp>But in some places, people have been throwing COVID cautions to the wind, flouting public health orders in the process. Kristen Ehresmann, director of infectious disease epidemiology, prevention, and control for the Minnesota Department of Health, points to a \u003ca href=\"http://www.citypages.com/news/minnesota-sues-rodeo-for-flouting-coronavirus-rules/571995611\" target=\"_blank\" rel=\"noopener noreferrer\">large, three-day rodeo\u003c/a> that was held recently in her state. Organizers knew they were supposed to limit the number of attendees to 250 but refused; thousands attended. In Sturgis, South Dakota, an estimated quarter of a million motorcyclists were expected to descend on the city this past weekend for an annual rally that spans 10 days.\u003c/p>\n\u003cp>Even on smaller scales, public health authorities know some people are letting down their guard. Others have never embraced the need to try to prevent the spread of the virus. Ehresmann’s father was recently invited to visit some friends; he went, she said, but wore his mask, elbow bumping instead of shaking proffered hands. “And the people kind of acted like … ‘Oh, you drank that Kool-Aid,’ rather than, ‘We all need to be doing this.’”\u003c/p>\n\u003cp>Ehresmann and others in public health are flummoxed by the phenomenon of people refusing to acknowledge the risk the virus poses.\u003c/p>\n\u003cp>“Just this idea of, ‘I just don’t want to believe it so therefore it’s not going to be true’ — honestly, I have not really dealt with that as it relates to disease before,” she said.\u003c/p>\n\u003cp>Buckee, the Harvard expert, wonders if the \u003ca href=\"https://www.statnews.com/2020/04/20/the-months-of-magical-thinking-as-the-coronavirus-swept-over-china-some-experts-were-in-denial-about-what-was-to-come/\" target=\"_blank\" rel=\"noopener noreferrer\">magical thinking\u003c/a> that seems to have infected swaths of the country is due to the fact many of the people who have died were elderly. For many Americans, she said, the disease has not yet touched their lives — but the movement restrictions and other response measures have.\u003c/p>\n\u003cp>“I think if children were dying, this would be … a different situation, quite honestly,” she said.\u003c/p>\n\u003cp>Epidemiologist Michael Mina despairs that an important chance to wrestle the virus under control is being lost, as Americans ignore the realities of the pandemic in favor of trying to resume pre-COVID life.\u003c/p>\n\u003cp>“We just continue to squander every bit of opportunity we get with this epidemic to get it under control,’’ said Mina, an assistant professor at Harvard’s T.H. Chan School of Public Health and associate medical director of clinical microbiology at Boston’s Brigham and Women’s Hospital.\u003c/p>\n\u003cp>“The best time to squash a pandemic is when the environmental characteristics slow transmission. It’s your one opportunity in the year, really, to leverage that extra assistance and get transmission under control,” he said, his frustration audible.\u003c/p>\n\u003cp>Driving back transmission would require people to continue to make sacrifices, to accept the fact that life post-COVID cannot proceed as normal, not while so many people remain vulnerable to the virus. Instead, people are giddily throwing off the shackles of coronavirus suppression efforts, seemingly convinced that a few weeks of sacrifice during the spring was a one-time solution.\u003c/p>\n\u003cp>Osterholm has for months warned that people were being misled about how long the restrictions on daily life would need to be in place. He now thinks the time has come for \u003ca href=\"https://www.nytimes.com/2020/08/07/opinion/coronavirus-lockdown-unemployment-death.html?searchResultPosition=1\" target=\"_blank\" rel=\"noopener noreferrer\">another lockdown\u003c/a>. “What we did before and more,” he said.\u003c/p>\n\u003cp>The country has fallen into a dangerous pattern, Osterholm said, where a spike in cases in a location leads to some temporary restraint from people who eventually become alarmed enough to start to take precautions. But as soon as cases start to plateau or decline a little, victory over the virus is declared and people think it’s safe to resume normal life.\u003c/p>\n\u003cp>“It’s like an all or nothing phenomenon, right?” said Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases. “You all locked down or you get so discouraged with being lockdown that you decide you’re going to be in crowded bars … you can have indoor parties with no masks. You can do all the things that are going to get you in trouble.”\u003c/p>\n\u003cp>Osterholm said with the K-12 school year resuming in some parts of the country or set to start — along with universities — in a few weeks, transmission will take off and cases will start to climb again. He predicted the next peaks will “exceed by far the peak we have just experienced. Winter is only going to reinforce that. Indoor air,” he said.\u003c/p>\n\u003cp>Buckee thinks that if the country doesn’t alter the trajectory it is on, more shutdowns are inevitable. “I can’t see a way that we’re going to have restaurants and bars open in the winter, frankly. We’ll have resurgence. Everything will get shut down again.”\u003c/p>\n\u003cp>Fauci favors a reset of the reopening measures, with a strong messaging component aimed at explaining to people why driving down transmission now will pay off later. Young people in particular need to understand that even if they are less likely to die from COVID-19, statistically speaking, transmission among 20-somethings will eventually lead to infections among their parents and grandparents, where the risk of severe infections and fatal outcomes is higher. (Young people can also develop long-term health problems as a result of the virus.)\u003c/p>\n\u003cp>“It’s not them alone in a vacuum,” Fauci said. “They are spreading it to the people who are going to wind up in the hospital.”\u003c/p>\n\u003cp>Everyone has to work together to get cases down to more manageable levels, if the country hopes to avoid “a disastrous winter,” he said.\u003c/p>\n\u003cp>“I think we can get it under much better control, between now and the mid-to-late fall when we get influenza or we get whatever it is we get in the fall and the winter. I’m not giving up,” Fauci said.\u003c/p>\n\u003cp>But without an all-in effort “the cases are not going to come down,” he warned. “They’re not. They’re just not.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2020/08/10/winter-is-coming-as-flu-season-nears-americas-window-of-opportunity-to-beat-back-covid-19-is-narrowing/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"excerpt": "Americans must use the weeks between now and the onset of “indoor weather” to tamp down coronavirus transmission, experts warn. ",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">T\u003c/span>\u003c/span>he good news: The United States has a window of opportunity to beat back COVID-19 before things get much, much worse.\u003c/p>\n\u003cp>The bad news: That window is rapidly closing. And the country seems unwilling or unable to seize the moment.\u003c/p>\n\u003cp>Winter is coming. Winter means cold and flu season, which is all but sure to complicate the task of figuring out who is sick with COVID-19 and who is suffering from a less threatening respiratory tract infection. It also means that cherished outdoor freedoms that link us to pre-COVID life — pop-up restaurant patios, picnics in parks, trips to the beach — will soon be out of reach, at least in northern parts of the country.\u003c/p>\n\u003cp>Unless Americans use the dwindling weeks between now and the onset of “indoor weather” to tamp down transmission in the country, this winter could be Dickensianly bleak, public health experts warn.\u003c/p>\n\u003cp>“I think November, December, January, February are going to be tough months in this country without a vaccine,” said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>It is possible, of course, that some vaccines could be approved by then, thanks to \u003ca href=\"https://www.statnews.com/2020/07/30/a-huge-experiment-how-the-world-made-so-much-progress-on-a-covid-19-vaccine-so-fast/\" target=\"_blank\" rel=\"noopener noreferrer\">historically rapid scientific work\u003c/a>. But there is little prospect that vast numbers of Americans will be vaccinated in time to forestall the grim winter Osterholm and others foresee.\u003c/p>\n\u003cp>Human coronaviruses, the distant cold-causing cousins of the virus that causes COVID-19, circulate year-round. Now is typically the low season for transmission. But in this summer of America’s failed COVID-19 response, the SARS-CoV-2 virus is widespread across the country, and pandemic-weary Americans seem more interested in resuming pre-COVID lifestyles than in suppressing the virus to the point where schools can be reopened, and stay open, and restaurants, movie theaters, and gyms can function with some restrictions.\u003c/p>\n\u003cp>“We should be aiming for no transmission before we open the schools and we put kids in harm’s way — kids and teachers and their caregivers. And so, if that means no gym, no movie theaters, so be it,” said Caroline Buckee, associate director of the Center for Communicable Disease Dynamics at Harvard’s T.H. Chan School of Public Health.\u003c/p>\n\u003cp>“We seem to be choosing leisure activities now over children’s safety in a month’s time. And I cannot understand that trade-off.”\u003c/p>\n\u003cp>While many countries managed to suppress the spread of SARS-CoV-2, the United States has failed miserably. Countries in Europe and Asia are worrying about a second wave. Here, the first wave rages on, engulfing rural as well as urban parts of the country. Though there’s been a slight decline in cases in the past couple of weeks, more than 50,000 Americans a day are being diagnosed with COVID-19. And those are just the confirmed cases.\u003c/p>\n\u003cp>To put that in perspective, at this rate the U.S. is racking up more cases in a week than Britain has accumulated since the start of the pandemic.\u003c/p>\n\u003cp>Public health officials had hoped transmission of the virus would abate with the warm temperatures of summer and the tendency — heightened this year — of people to take their recreational activities outdoors. Experts do believe people are less likely to transmit the virus outside, especially if they are wearing face coverings and keeping a safe distance apart.\u003c/p>\n\u003cp>But in some places, people have been throwing COVID cautions to the wind, flouting public health orders in the process. Kristen Ehresmann, director of infectious disease epidemiology, prevention, and control for the Minnesota Department of Health, points to a \u003ca href=\"http://www.citypages.com/news/minnesota-sues-rodeo-for-flouting-coronavirus-rules/571995611\" target=\"_blank\" rel=\"noopener noreferrer\">large, three-day rodeo\u003c/a> that was held recently in her state. Organizers knew they were supposed to limit the number of attendees to 250 but refused; thousands attended. In Sturgis, South Dakota, an estimated quarter of a million motorcyclists were expected to descend on the city this past weekend for an annual rally that spans 10 days.\u003c/p>\n\u003cp>Even on smaller scales, public health authorities know some people are letting down their guard. Others have never embraced the need to try to prevent the spread of the virus. Ehresmann’s father was recently invited to visit some friends; he went, she said, but wore his mask, elbow bumping instead of shaking proffered hands. “And the people kind of acted like … ‘Oh, you drank that Kool-Aid,’ rather than, ‘We all need to be doing this.’”\u003c/p>\n\u003cp>Ehresmann and others in public health are flummoxed by the phenomenon of people refusing to acknowledge the risk the virus poses.\u003c/p>\n\u003cp>“Just this idea of, ‘I just don’t want to believe it so therefore it’s not going to be true’ — honestly, I have not really dealt with that as it relates to disease before,” she said.\u003c/p>\n\u003cp>Buckee, the Harvard expert, wonders if the \u003ca href=\"https://www.statnews.com/2020/04/20/the-months-of-magical-thinking-as-the-coronavirus-swept-over-china-some-experts-were-in-denial-about-what-was-to-come/\" target=\"_blank\" rel=\"noopener noreferrer\">magical thinking\u003c/a> that seems to have infected swaths of the country is due to the fact many of the people who have died were elderly. For many Americans, she said, the disease has not yet touched their lives — but the movement restrictions and other response measures have.\u003c/p>\n\u003cp>“I think if children were dying, this would be … a different situation, quite honestly,” she said.\u003c/p>\n\u003cp>Epidemiologist Michael Mina despairs that an important chance to wrestle the virus under control is being lost, as Americans ignore the realities of the pandemic in favor of trying to resume pre-COVID life.\u003c/p>\n\u003cp>“We just continue to squander every bit of opportunity we get with this epidemic to get it under control,’’ said Mina, an assistant professor at Harvard’s T.H. Chan School of Public Health and associate medical director of clinical microbiology at Boston’s Brigham and Women’s Hospital.\u003c/p>\n\u003cp>“The best time to squash a pandemic is when the environmental characteristics slow transmission. It’s your one opportunity in the year, really, to leverage that extra assistance and get transmission under control,” he said, his frustration audible.\u003c/p>\n\u003cp>Driving back transmission would require people to continue to make sacrifices, to accept the fact that life post-COVID cannot proceed as normal, not while so many people remain vulnerable to the virus. Instead, people are giddily throwing off the shackles of coronavirus suppression efforts, seemingly convinced that a few weeks of sacrifice during the spring was a one-time solution.\u003c/p>\n\u003cp>Osterholm has for months warned that people were being misled about how long the restrictions on daily life would need to be in place. He now thinks the time has come for \u003ca href=\"https://www.nytimes.com/2020/08/07/opinion/coronavirus-lockdown-unemployment-death.html?searchResultPosition=1\" target=\"_blank\" rel=\"noopener noreferrer\">another lockdown\u003c/a>. “What we did before and more,” he said.\u003c/p>\n\u003cp>The country has fallen into a dangerous pattern, Osterholm said, where a spike in cases in a location leads to some temporary restraint from people who eventually become alarmed enough to start to take precautions. But as soon as cases start to plateau or decline a little, victory over the virus is declared and people think it’s safe to resume normal life.\u003c/p>\n\u003cp>“It’s like an all or nothing phenomenon, right?” said Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases. “You all locked down or you get so discouraged with being lockdown that you decide you’re going to be in crowded bars … you can have indoor parties with no masks. You can do all the things that are going to get you in trouble.”\u003c/p>\n\u003cp>Osterholm said with the K-12 school year resuming in some parts of the country or set to start — along with universities — in a few weeks, transmission will take off and cases will start to climb again. He predicted the next peaks will “exceed by far the peak we have just experienced. Winter is only going to reinforce that. Indoor air,” he said.\u003c/p>\n\u003cp>Buckee thinks that if the country doesn’t alter the trajectory it is on, more shutdowns are inevitable. “I can’t see a way that we’re going to have restaurants and bars open in the winter, frankly. We’ll have resurgence. Everything will get shut down again.”\u003c/p>\n\u003cp>Fauci favors a reset of the reopening measures, with a strong messaging component aimed at explaining to people why driving down transmission now will pay off later. Young people in particular need to understand that even if they are less likely to die from COVID-19, statistically speaking, transmission among 20-somethings will eventually lead to infections among their parents and grandparents, where the risk of severe infections and fatal outcomes is higher. (Young people can also develop long-term health problems as a result of the virus.)\u003c/p>\n\u003cp>“It’s not them alone in a vacuum,” Fauci said. “They are spreading it to the people who are going to wind up in the hospital.”\u003c/p>\n\u003cp>Everyone has to work together to get cases down to more manageable levels, if the country hopes to avoid “a disastrous winter,” he said.\u003c/p>\n\u003cp>“I think we can get it under much better control, between now and the mid-to-late fall when we get influenza or we get whatever it is we get in the fall and the winter. I’m not giving up,” Fauci said.\u003c/p>\n\u003cp>But without an all-in effort “the cases are not going to come down,” he warned. “They’re not. They’re just not.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2020/08/10/winter-is-coming-as-flu-season-nears-americas-window-of-opportunity-to-beat-back-covid-19-is-narrowing/\" target=\"_blank\" rel=\"noopener noreferrer\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Doctors say the antiviral drug remdesivir is one of the few treatments that benefits patients hospitalized with COVID-19. But the drug, made by Gilead Sciences, can cost more than $3,000 for the full course of treatment, and some hospitals — including several in the Bay Area — say it’s in short supply.\u003c/p>\n\u003cp>\u003ca href=\"https://www.gilead.com/\" target=\"_blank\" rel=\"noopener noreferrer\">Foster City-based Gilead\u003c/a> is currently the only company making remdesivir, and \u003ca href=\"https://www.amerisourcebergen.com/\" target=\"_blank\" rel=\"noopener noreferrer\">AmerisourceBergen\u003c/a> is the sole distributor.\u003c/p>\n\u003cp>On Tuesday, California Attorney General Xavier Becerra \u003ca href=\"https://www.oag.ca.gov/system/files/attachments/press-docs/Remdesivir%20Letter%2020200804.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">sent a letter\u003c/a> to federal health officials, urging them to allow other companies to manufacture and distribute the drug.\u003c/p>\n\u003cp>The letter, which was addressed to top officials at the U.S. Department of Health and Human Services, the National Institutes of Health, and the federal Food and Drug Administration, was endorsed by a bipartisan coalition of 34 state attorneys general.\u003c/p>\n\u003cp>Gilead has \u003ca href=\"https://www.gilead.com/purpose/advancing-global-health/covid-19/working-to-supply-remdesivir-for-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\">announced plans\u003c/a> to make 2 million courses of remdesivir, which can be either six or 10 vials, by the end of the year. Becerra’s letter calls that amount “dangerously low” to handle current or future coronavirus outbreaks.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>He says now is the time to produce more of the drug.\u003c/p>\n\u003cp>“If Gilead is not prepared to do it,” he said, “We have the right to say we’re going to try to do whatever we can, go wherever we must, to ramp up the supply.”\u003c/p>\n\u003cp>\u003cstrong>No ‘Secret Sauce’\u003c/strong>\u003c/p>\n\u003cp>Because the development of remdesivir was supported in part by federal tax dollars, including a $30 million NIH-funded clinical trial, Becerra says there are legal grounds for Washington to intervene.\u003c/p>\n\u003cp>“It’s not as if there’s a secret sauce here,” Becerra told KQED. “Folks know how to make this drug and the taxpayers helped make that drug possible. Let’s get it out there to folks.”\u003c/p>\n\u003cp>Under the \u003ca href=\"https://www.govinfo.gov/content/pkg/STATUTE-94/pdf/STATUTE-94-Pg3015.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Bayh-Dole Act\u003c/a>, the letter says, the federal government could make Gilead license its remdesivir patent to third party manufacturers.\u003c/p>\n\u003cp>An HHS spokesperson wrote in an email that because remdesivir wasn’t, “as a whole,” funded by the federal government, it doesn’t believe the Bayh-Dole Act applies in this case.\u003c/p>\n\u003cp>Gilead said in a statement it was “deeply disappointed” by the letter, and that it misrepresented the overall need for its drug:\u003c/p>\n\u003cblockquote>\u003cp>“One significant factual error is the assertion that all 3.5 million current COVID-19 patients should be treated with remdesivir. This assertion ignores the fact that not all COVID-19 patients are eligible to be treated with remdesivir and, thankfully, many will recover prior to hospitalization and never need the drug.”\u003c/p>\u003c/blockquote>\n\u003cp>Remdesivir was shown in one \u003ca href=\"https://www.kqed.org/science/1963229/government-study-shows-patients-responding-to-coronavirus-treatment-drugmaker-gilead-says\" target=\"_blank\" rel=\"noopener noreferrer\">controlled clinical trial\u003c/a> to reduce median COVID-19 hospital stays by about four days.\u003c/p>\n\u003cp>\u003cstrong>Desperate Hospitals\u003c/strong>\u003c/p>\n\u003cp>Dr. Peter Chin-Hong, an infectious disease specialist at UCSF, says that on Tuesday the hospital was down to two vials of remdesivir, with another shipment expected, but not guaranteed, to arrive soon.\u003c/p>\n\u003cp>Chin-Hong says local hospitals have sent each other vials of remdesivir, when able, so that their COVID-19 patients can get the treatment.\u003c/p>\n\u003cp>“We’re definitely desperate for the drug,” said Chin-Hong. “At the clinical end, health care providers currently in 2020 spend a disproportionate amount of time bartering [the] drug, sourcing the drug, trying to play remdesivir Tetris where we’re constantly figuring out, do we have enough?”\u003c/p>\n\u003cp>With the expectation of another coronavirus surge this winter, Chin-Hong says suppliers need to come together to make more remdesivir.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“The timing of the attorney general’s letter is actually perfect,” he said, “because if we decide to do something now, we could have an impact on that winter surge.”\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Doctors say the antiviral drug remdesivir is one of the few treatments that benefits patients hospitalized with COVID-19. But the drug, made by Gilead Sciences, can cost more than $3,000 for the full course of treatment, and some hospitals — including several in the Bay Area — say it’s in short supply.\u003c/p>\n\u003cp>\u003ca href=\"https://www.gilead.com/\" target=\"_blank\" rel=\"noopener noreferrer\">Foster City-based Gilead\u003c/a> is currently the only company making remdesivir, and \u003ca href=\"https://www.amerisourcebergen.com/\" target=\"_blank\" rel=\"noopener noreferrer\">AmerisourceBergen\u003c/a> is the sole distributor.\u003c/p>\n\u003cp>On Tuesday, California Attorney General Xavier Becerra \u003ca href=\"https://www.oag.ca.gov/system/files/attachments/press-docs/Remdesivir%20Letter%2020200804.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">sent a letter\u003c/a> to federal health officials, urging them to allow other companies to manufacture and distribute the drug.\u003c/p>\n\u003cp>The letter, which was addressed to top officials at the U.S. Department of Health and Human Services, the National Institutes of Health, and the federal Food and Drug Administration, was endorsed by a bipartisan coalition of 34 state attorneys general.\u003c/p>\n\u003cp>Gilead has \u003ca href=\"https://www.gilead.com/purpose/advancing-global-health/covid-19/working-to-supply-remdesivir-for-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\">announced plans\u003c/a> to make 2 million courses of remdesivir, which can be either six or 10 vials, by the end of the year. Becerra’s letter calls that amount “dangerously low” to handle current or future coronavirus outbreaks.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>He says now is the time to produce more of the drug.\u003c/p>\n\u003cp>“If Gilead is not prepared to do it,” he said, “We have the right to say we’re going to try to do whatever we can, go wherever we must, to ramp up the supply.”\u003c/p>\n\u003cp>\u003cstrong>No ‘Secret Sauce’\u003c/strong>\u003c/p>\n\u003cp>Because the development of remdesivir was supported in part by federal tax dollars, including a $30 million NIH-funded clinical trial, Becerra says there are legal grounds for Washington to intervene.\u003c/p>\n\u003cp>“It’s not as if there’s a secret sauce here,” Becerra told KQED. “Folks know how to make this drug and the taxpayers helped make that drug possible. Let’s get it out there to folks.”\u003c/p>\n\u003cp>Under the \u003ca href=\"https://www.govinfo.gov/content/pkg/STATUTE-94/pdf/STATUTE-94-Pg3015.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Bayh-Dole Act\u003c/a>, the letter says, the federal government could make Gilead license its remdesivir patent to third party manufacturers.\u003c/p>\n\u003cp>An HHS spokesperson wrote in an email that because remdesivir wasn’t, “as a whole,” funded by the federal government, it doesn’t believe the Bayh-Dole Act applies in this case.\u003c/p>\n\u003cp>Gilead said in a statement it was “deeply disappointed” by the letter, and that it misrepresented the overall need for its drug:\u003c/p>\n\u003cblockquote>\u003cp>“One significant factual error is the assertion that all 3.5 million current COVID-19 patients should be treated with remdesivir. This assertion ignores the fact that not all COVID-19 patients are eligible to be treated with remdesivir and, thankfully, many will recover prior to hospitalization and never need the drug.”\u003c/p>\u003c/blockquote>\n\u003cp>Remdesivir was shown in one \u003ca href=\"https://www.kqed.org/science/1963229/government-study-shows-patients-responding-to-coronavirus-treatment-drugmaker-gilead-says\" target=\"_blank\" rel=\"noopener noreferrer\">controlled clinical trial\u003c/a> to reduce median COVID-19 hospital stays by about four days.\u003c/p>\n\u003cp>\u003cstrong>Desperate Hospitals\u003c/strong>\u003c/p>\n\u003cp>Dr. Peter Chin-Hong, an infectious disease specialist at UCSF, says that on Tuesday the hospital was down to two vials of remdesivir, with another shipment expected, but not guaranteed, to arrive soon.\u003c/p>\n\u003cp>Chin-Hong says local hospitals have sent each other vials of remdesivir, when able, so that their COVID-19 patients can get the treatment.\u003c/p>\n\u003cp>“We’re definitely desperate for the drug,” said Chin-Hong. “At the clinical end, health care providers currently in 2020 spend a disproportionate amount of time bartering [the] drug, sourcing the drug, trying to play remdesivir Tetris where we’re constantly figuring out, do we have enough?”\u003c/p>\n\u003cp>With the expectation of another coronavirus surge this winter, Chin-Hong says suppliers need to come together to make more remdesivir.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“The timing of the attorney general’s letter is actually perfect,” he said, “because if we decide to do something now, we could have an impact on that winter surge.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"info": "What kind of no sabo word is Hyphenación? For us, it’s about living within a hyphenation. Like being a third-gen Mexican-American from the Texas border now living that Bay Area Chicano life. Like Xorje! Each week we bring together a couple of hyphenated Latinos to talk all about personal life choices: family, careers, relationships, belonging … everything is on the table. ",
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"marketplace": {
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"info": "Our flagship program, helmed by Kai Ryssdal, examines what the day in money delivered, through stories, conversations, newsworthy numbers and more. Updated Monday through Friday at about 3:30 p.m. PT.",
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"masters-of-scale": {
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},
"mindshift": {
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"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>",
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"order": 12
},
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"google": "https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5",
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"onourwatch": {
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"tagline": "Deeply-reported investigative journalism",
"info": "For decades, the process for how police police themselves has been inconsistent – if not opaque. In some states, like California, these proceedings were completely hidden. After a new police transparency law unsealed scores of internal affairs files, our reporters set out to examine these cases and the shadow world of police discipline. On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. Is it the officers, or the public they've sworn to serve?",
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"info": "Our weekly podcast explores how the media 'sausage' is made, casts an incisive eye on fluctuations in the marketplace of ideas, and examines threats to the freedom of information and expression in America and abroad. For one hour a week, the show tries to lift the veil from the process of \"making media,\" especially news media, because it's through that lens that we see the world and the world sees us",
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},
"pbs-newshour": {
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},
"perspectives": {
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"order": 14
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"info": "The economy explained. Imagine you could call up a friend and say, Meet me at the bar and tell me what's going on with the economy. Now imagine that's actually a fun evening.",
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"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/planetmoney.jpg",
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"politicalbreakdown": {
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"title": "Political Breakdown",
"tagline": "Politics from a personal perspective",
"info": "Political Breakdown is a new series that explores the political intersection of California and the nation. Each week hosts Scott Shafer and Marisa Lagos are joined with a new special guest to unpack politics -- with personality — and offer an insider’s glimpse at how politics happens.",
"airtime": "THU 6:30pm-7pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Political-Breakdown-2024-Podcast-Tile-703x703-1.jpg",
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"order": 5
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"possible": {
"id": "possible",
"title": "Possible",
"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
"airtime": "SUN 2pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.possible.fm/",
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"source": "Possible"
},
"link": "/radio/program/possible",
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"spotify": "https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"
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},
"pri-the-world": {
"id": "pri-the-world",
"title": "PRI's The World: Latest Edition",
"info": "Each weekday, host Marco Werman and his team of producers bring you the world's most interesting stories in an hour of radio that reminds us just how small our planet really is.",
"airtime": "MON-FRI 2pm-3pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/The-World-Podcast-Tile-360x360-1.jpg",
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},
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},
"radiolab": {
"id": "radiolab",
"title": "Radiolab",
"info": "A two-time Peabody Award-winner, Radiolab is an investigation told through sounds and stories, and centered around one big idea. In the Radiolab world, information sounds like music and science and culture collide. Hosted by Jad Abumrad and Robert Krulwich, the show is designed for listeners who demand skepticism, but appreciate wonder. WNYC Studios is the producer of other leading podcasts including Freakonomics Radio, Death, Sex & Money, On the Media and many more.",
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