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"content": "\u003cp>You vacuum it, sweep it and wipe it off your furniture. But do you know what it actually is – and how it may affect your health?\u003c/p>\n\u003cp>[pullquote size='small' align='right']Shoe bottoms are gross: 96% of shoes have traces of feces bacteria on their soles, including the antimicrobial resistant C. diff, and over 90% of these bacteria are transferred to floors. Add in cancer-causing toxins from asphalt road residue and endocrine-disrupting lawn chemicals, and the recommendation becomes even clearer – no outdoor shoes inside.[/pullquote]Don’t feel bad if you’re clueless about your dust. Scientists are not that far ahead of you in terms of understanding the sources and health risks of indoor air and particles.\u003c/p>\n\u003cp>That’s an issue, because people spend a lot of time indoors. Indeed, the average American stays within four walls for \u003ca href=\"https://www.nature.com/articles/7500165\">almost 90% of their day\u003c/a>. So knowing more about how your indoor environment affects your health is vital.\u003c/p>\n\u003cp>To better quantify environmental influences on health, researchers have begun using an\u003ca href=\"https://academic.oup.com/ije/article/41/1/24/650703\">“exposome” approach\u003c/a>, which considers every last environmental exposure an individual experiences over a lifetime. Your own exposome includes everything from secondhand smoke when you were a baby to lead exposure in your childhood to particulate matter if you grew up near a major roadway or industrial facility.\u003c/p>\n\u003cp>Dust is a big component of the exposome. What particles are you inhaling and ingesting as you go about your day?\u003c/p>\n\u003cp>\u003ca href=\"https://scholar.google.com/citations?user=MEp4948AAAAJ&hl=en&oi=ao\">I’m a geochemist\u003c/a>, and my lab studies environmental health at the household level. Along with environmental scientist \u003ca href=\"https://scholar.google.com/citations?user=d_ZBfxYAAAAJ&hl=en&oi=ao\">Mark Taylor\u003c/a> at Macquarie University and other international partners, I’m conducting a research project on the indoor exposome.\u003c/p>\n\u003cp>Instead of dumping their vacuum canister into the trash, citizen-scientists put it into a sealable bag and send it off to our lab for analysis. This project, called \u003ca href=\"https://www.360dustanalysis.com/\">360 Dust Analysis\u003c/a>, is one of a number of recent efforts that are starting to crack the code on indoor dust.\u003c/p>\n\u003cfigure id=\"attachment_1943494\" class=\"wp-caption alignnone\" style=\"max-width: 754px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-1943494\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/06/file-20190613-32317-3ujy96.jpg\" alt=\"\" width=\"754\" height=\"566\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/file-20190613-32317-3ujy96.jpg 754w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/file-20190613-32317-3ujy96-160x120.jpg 160w\" sizes=\"(max-width: 754px) 100vw, 754px\">\u003cfigcaption class=\"wp-caption-text\">360 Dust workers unpack a donated sample. \u003ccite>(Gabriel Filippelli/ The Conversation)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>The Dust Is Coming From Inside\u003c/strong>\u003c/p>\n\u003cp>About one-third of household dust is created inside your home. The components differ depending on the construction and age of your home, the climate and the cleaning and smoking habits of occupants, so there’s no standard formula for dust.\u003c/p>\n\u003cp>First, you and your pets generate some of that detritus. Sloughed off human skin cells are part of the debris. So are \u003ca href=\"https://www.jacionline.org/article/S0091-6749(10)00907-3/fulltext\">pet skin cells\u003c/a>, called dander, and dust mites that feed on skin – both of which are strong human allergens.\u003c/p>\n\u003cp>Overall, you can be sure that \u003ca href=\"http://content.time.com/time/health/article/0,8599,1966870,00.html\">your dust also includes some\u003c/a> decomposed insects, food debris (especially in the kitchen), fibers from carpet, bedding and clothes, and particulate matter from smoking and cooking. We hope our 360 Dust Analysis program will help solve more of the riddle of just what else goes into dust.\u003c/p>\n\u003cp>So far, so gross. And there are humanmade chemicals in the mix as well. For decades, manufacturers have chemically treated clothing and furniture with flame retardants and surface protectants. In fact, for some time, the \u003ca href=\"https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Childrens-Sleepwear-Regulations\">flame retardants were required by law\u003c/a> in furniture and children’s sleepwear.\u003c/p>\n\u003cp>But then researchers started identifying them in human blood and tissue, and even newborns showed \u003ca href=\"https://pubs.acs.org/doi/10.1021/acs.est.5b01793\">evidence of exposure in utero\u003c/a>. How did these molecules end up in people’s bodies? Mostly via inhalation or ingestion of indoor dust.\u003c/p>\n\u003cp>\u003cstrong>Health Concerns About What We Put in Our Homes\u003c/strong>\u003c/p>\n\u003cp>Here’s one place new science and new techniques are starting to raise serious health red flags. A flurry of research is currently underway to \u003ca href=\"https://www.nature.com/articles/s41370-018-0113-2\">determine the potential toxicity\u003c/a> of these chemicals in the human system. Scientists are also developing new techniques \u003ca href=\"https://www.nature.com/articles/jes20179\">using wearables\u003c/a>, such as \u003ca href=\"https://greensciencepolicy.org/monitoring-chemicals-in-our-environment-with-wristbands/\">silicone wrist bands\u003c/a>, to determine the relationship between these dust sources and how much of them winds up in a person’s body.\u003c/p>\n\u003cp>A pet-free and fiber-free indoor environment would be one way to reduce the amount and potential toxicity of indoor dust. But there’s an additional concern that’s emerged from recent research: the rise of antimicrobial resistance.\u003c/p>\n\u003cp>Research has linked several indoor disinfection products to antimicrobial resistance. At least one study found that elevated levels of triclosan, a common antimicrobial agent in hand soaps, were correlated with high levels of \u003ca href=\"https://pubs.acs.org/doi/10.1021/acs.est.6b00262\">antibiotic-resistant genes in dust\u003c/a>, presumably from bacteria that live in your home and dust. This relationship is due to repeated partial, but not complete, destruction of bacteria and other microbes that go on to grow and proliferate, carrying resistant genes.\u003c/p>\n\u003cfigure id=\"attachment_1943500\" class=\"wp-caption alignnone\" style=\"max-width: 507px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1943500 size-full\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/06/gettyimages-523835605-170667a.jpg\" alt=\"\" width=\"507\" height=\"338\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/gettyimages-523835605-170667a.jpg 507w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/gettyimages-523835605-170667a-160x107.jpg 160w\" sizes=\"(max-width: 507px) 100vw, 507px\">\u003cfigcaption class=\"wp-caption-text\">Young woman cleaning surfaces with green cleaning products. \u003ccite>(heshphoto/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>The Dust That Comes in From Outside\u003c/strong>\u003c/p>\n\u003cp>To get a full picture of dust sources and hazards, you need to consider the other two-thirds of the indoor dust load, which \u003ca href=\"https://pubs.acs.org/doi/10.1021/es9003735\">actually come from outside\u003c/a>. This dirt and dust is tracked in on shoes and on the feet and fur of pets. It blows in through open windows and doorways and vents. And it \u003ca href=\"https://pubs.acs.org/doi/10.1021/es9003735\">ranges in size and composition\u003c/a> from gritty silt to irritating pollen to the finest of soil particles.\u003c/p>\n\u003cp>One of the most widespread health issues related to outdoor sources is lead. This potent neurotoxin has \u003ca href=\"https://www.elementascience.org/articles/10.12952/journal.elementa.000059/\">accumulated to sometimes extremely high levels\u003c/a> in soils and dust after a century of emissions from industrial sources, vehicles burning leaded gasoline and degraded lead-based paints. The hazard is particularly great in cities and near mining or other industrial point sources of lead.\u003c/p>\n\u003cp>Lead-contaminated soils, and dust generated from them, are tightly linked to \u003ca href=\"https://www.jstor.org/stable/24927721?seq=1#page_scan_tab_contents\">lead poisoning of children\u003c/a>. Owing to their active neural development, \u003ca href=\"https://www.annualreviews.org/doi/10.1146/annurev.med.55.091902.103653\">lead can permanently disable exposed children\u003c/a>.\u003c/p>\n\u003cp>In the drive to prevent lead poisoning, scientists have focused on what they call point sources: relatively easily identifiable things like peeling paint and lead water pipes. Soil and dust exposures are less well known.\u003c/p>\n\u003cp>Researchers have recently found correlations between \u003ca href=\"https://pubs.acs.org/doi/10.1021/es303854c\">lead in air and blood lead levels in children\u003c/a>. Now several lab groups are taking a careful look not just at exposures in outdoor settings but also at how \u003ca href=\"https://pubs.acs.org/doi/10.1021/es9003735\">lead may seep into homes\u003c/a> and become part of the indoor exposome.\u003c/p>\n\u003cp>\u003cstrong>Limit What You Can\u003c/strong>\u003c/p>\n\u003cp>Much as \u003ca href=\"https://science.sciencemag.org/content/187/4176/535\">Freon in refrigerants and other products\u003c/a> caused the \u003ca href=\"https://link.springer.com/chapter/10.1007%2F978-1-4939-6710-0_2\">degradation of Earth’s protective stratospheric ozone layer\u003c/a> and \u003ca href=\"https://www.sciencedirect.com/science/article/pii/S0890623807002377?via%3Dihub\">bisphenol A, a plasticizer used in bottles\u003c/a> and other consumer products ended up in people’s bodies, there’s concern among scientists that “better living through chemistry” might result in a string of \u003ca href=\"https://www.ehn.org/chemical-exposures-are-small-doses-harm-2518446452.html\">unintended human health consequences\u003c/a> in the realm of dust.\u003c/p>\n\u003cp>Taking off outdoor clothing like jackets and adopting a shoeless household policy is one way to reduce indoor exposure to outdoor pollutants. \u003ca href=\"https://www.ciriscience.org/a_96-Study-Reveals-High-Bacteria-Levels-on-Footwear\">Shoe bottoms are gross\u003c/a>: 96% of shoes have traces of feces bacteria on their soles, including the antimicrobial resistant \u003cem>C. diff\u003c/em>, and over 90% of these bacteria are transferred to floors. Add in cancer-causing \u003ca href=\"https://www.tandfonline.com/doi/abs/10.1080/10408444.2018.1528208?journalCode=itxc20\">toxins from asphalt road residue\u003c/a> and \u003ca href=\"https://www.tandfonline.com/doi/full/10.1080/23273747.2016.1148803\">endocrine-disrupting lawn chemicals\u003c/a>, and the recommendation becomes even clearer – no outdoor shoes inside.\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>You vacuum it, sweep it and wipe it off your furniture. But do you know what it actually is – and how it may affect your health?\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "Shoe bottoms are gross: 96% of shoes have traces of feces bacteria on their soles, including the antimicrobial resistant C. diff, and over 90% of these bacteria are transferred to floors. Add in cancer-causing toxins from asphalt road residue and endocrine-disrupting lawn chemicals, and the recommendation becomes even clearer – no outdoor shoes inside.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>Don’t feel bad if you’re clueless about your dust. Scientists are not that far ahead of you in terms of understanding the sources and health risks of indoor air and particles.\u003c/p>\n\u003cp>That’s an issue, because people spend a lot of time indoors. Indeed, the average American stays within four walls for \u003ca href=\"https://www.nature.com/articles/7500165\">almost 90% of their day\u003c/a>. So knowing more about how your indoor environment affects your health is vital.\u003c/p>\n\u003cp>To better quantify environmental influences on health, researchers have begun using an\u003ca href=\"https://academic.oup.com/ije/article/41/1/24/650703\">“exposome” approach\u003c/a>, which considers every last environmental exposure an individual experiences over a lifetime. Your own exposome includes everything from secondhand smoke when you were a baby to lead exposure in your childhood to particulate matter if you grew up near a major roadway or industrial facility.\u003c/p>\n\u003cp>Dust is a big component of the exposome. What particles are you inhaling and ingesting as you go about your day?\u003c/p>\n\u003cp>\u003ca href=\"https://scholar.google.com/citations?user=MEp4948AAAAJ&hl=en&oi=ao\">I’m a geochemist\u003c/a>, and my lab studies environmental health at the household level. Along with environmental scientist \u003ca href=\"https://scholar.google.com/citations?user=d_ZBfxYAAAAJ&hl=en&oi=ao\">Mark Taylor\u003c/a> at Macquarie University and other international partners, I’m conducting a research project on the indoor exposome.\u003c/p>\n\u003cp>Instead of dumping their vacuum canister into the trash, citizen-scientists put it into a sealable bag and send it off to our lab for analysis. This project, called \u003ca href=\"https://www.360dustanalysis.com/\">360 Dust Analysis\u003c/a>, is one of a number of recent efforts that are starting to crack the code on indoor dust.\u003c/p>\n\u003cfigure id=\"attachment_1943494\" class=\"wp-caption alignnone\" style=\"max-width: 754px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-1943494\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/06/file-20190613-32317-3ujy96.jpg\" alt=\"\" width=\"754\" height=\"566\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/file-20190613-32317-3ujy96.jpg 754w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/file-20190613-32317-3ujy96-160x120.jpg 160w\" sizes=\"(max-width: 754px) 100vw, 754px\">\u003cfigcaption class=\"wp-caption-text\">360 Dust workers unpack a donated sample. \u003ccite>(Gabriel Filippelli/ The Conversation)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>The Dust Is Coming From Inside\u003c/strong>\u003c/p>\n\u003cp>About one-third of household dust is created inside your home. The components differ depending on the construction and age of your home, the climate and the cleaning and smoking habits of occupants, so there’s no standard formula for dust.\u003c/p>\n\u003cp>First, you and your pets generate some of that detritus. Sloughed off human skin cells are part of the debris. So are \u003ca href=\"https://www.jacionline.org/article/S0091-6749(10)00907-3/fulltext\">pet skin cells\u003c/a>, called dander, and dust mites that feed on skin – both of which are strong human allergens.\u003c/p>\n\u003cp>Overall, you can be sure that \u003ca href=\"http://content.time.com/time/health/article/0,8599,1966870,00.html\">your dust also includes some\u003c/a> decomposed insects, food debris (especially in the kitchen), fibers from carpet, bedding and clothes, and particulate matter from smoking and cooking. We hope our 360 Dust Analysis program will help solve more of the riddle of just what else goes into dust.\u003c/p>\n\u003cp>So far, so gross. And there are humanmade chemicals in the mix as well. For decades, manufacturers have chemically treated clothing and furniture with flame retardants and surface protectants. In fact, for some time, the \u003ca href=\"https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Childrens-Sleepwear-Regulations\">flame retardants were required by law\u003c/a> in furniture and children’s sleepwear.\u003c/p>\n\u003cp>But then researchers started identifying them in human blood and tissue, and even newborns showed \u003ca href=\"https://pubs.acs.org/doi/10.1021/acs.est.5b01793\">evidence of exposure in utero\u003c/a>. How did these molecules end up in people’s bodies? Mostly via inhalation or ingestion of indoor dust.\u003c/p>\n\u003cp>\u003cstrong>Health Concerns About What We Put in Our Homes\u003c/strong>\u003c/p>\n\u003cp>Here’s one place new science and new techniques are starting to raise serious health red flags. A flurry of research is currently underway to \u003ca href=\"https://www.nature.com/articles/s41370-018-0113-2\">determine the potential toxicity\u003c/a> of these chemicals in the human system. Scientists are also developing new techniques \u003ca href=\"https://www.nature.com/articles/jes20179\">using wearables\u003c/a>, such as \u003ca href=\"https://greensciencepolicy.org/monitoring-chemicals-in-our-environment-with-wristbands/\">silicone wrist bands\u003c/a>, to determine the relationship between these dust sources and how much of them winds up in a person’s body.\u003c/p>\n\u003cp>A pet-free and fiber-free indoor environment would be one way to reduce the amount and potential toxicity of indoor dust. But there’s an additional concern that’s emerged from recent research: the rise of antimicrobial resistance.\u003c/p>\n\u003cp>Research has linked several indoor disinfection products to antimicrobial resistance. At least one study found that elevated levels of triclosan, a common antimicrobial agent in hand soaps, were correlated with high levels of \u003ca href=\"https://pubs.acs.org/doi/10.1021/acs.est.6b00262\">antibiotic-resistant genes in dust\u003c/a>, presumably from bacteria that live in your home and dust. This relationship is due to repeated partial, but not complete, destruction of bacteria and other microbes that go on to grow and proliferate, carrying resistant genes.\u003c/p>\n\u003cfigure id=\"attachment_1943500\" class=\"wp-caption alignnone\" style=\"max-width: 507px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1943500 size-full\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/06/gettyimages-523835605-170667a.jpg\" alt=\"\" width=\"507\" height=\"338\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/gettyimages-523835605-170667a.jpg 507w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/gettyimages-523835605-170667a-160x107.jpg 160w\" sizes=\"(max-width: 507px) 100vw, 507px\">\u003cfigcaption class=\"wp-caption-text\">Young woman cleaning surfaces with green cleaning products. \u003ccite>(heshphoto/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>The Dust That Comes in From Outside\u003c/strong>\u003c/p>\n\u003cp>To get a full picture of dust sources and hazards, you need to consider the other two-thirds of the indoor dust load, which \u003ca href=\"https://pubs.acs.org/doi/10.1021/es9003735\">actually come from outside\u003c/a>. This dirt and dust is tracked in on shoes and on the feet and fur of pets. It blows in through open windows and doorways and vents. And it \u003ca href=\"https://pubs.acs.org/doi/10.1021/es9003735\">ranges in size and composition\u003c/a> from gritty silt to irritating pollen to the finest of soil particles.\u003c/p>\n\u003cp>One of the most widespread health issues related to outdoor sources is lead. This potent neurotoxin has \u003ca href=\"https://www.elementascience.org/articles/10.12952/journal.elementa.000059/\">accumulated to sometimes extremely high levels\u003c/a> in soils and dust after a century of emissions from industrial sources, vehicles burning leaded gasoline and degraded lead-based paints. The hazard is particularly great in cities and near mining or other industrial point sources of lead.\u003c/p>\n\u003cp>Lead-contaminated soils, and dust generated from them, are tightly linked to \u003ca href=\"https://www.jstor.org/stable/24927721?seq=1#page_scan_tab_contents\">lead poisoning of children\u003c/a>. Owing to their active neural development, \u003ca href=\"https://www.annualreviews.org/doi/10.1146/annurev.med.55.091902.103653\">lead can permanently disable exposed children\u003c/a>.\u003c/p>\n\u003cp>In the drive to prevent lead poisoning, scientists have focused on what they call point sources: relatively easily identifiable things like peeling paint and lead water pipes. Soil and dust exposures are less well known.\u003c/p>\n\u003cp>Researchers have recently found correlations between \u003ca href=\"https://pubs.acs.org/doi/10.1021/es303854c\">lead in air and blood lead levels in children\u003c/a>. Now several lab groups are taking a careful look not just at exposures in outdoor settings but also at how \u003ca href=\"https://pubs.acs.org/doi/10.1021/es9003735\">lead may seep into homes\u003c/a> and become part of the indoor exposome.\u003c/p>\n\u003cp>\u003cstrong>Limit What You Can\u003c/strong>\u003c/p>\n\u003cp>Much as \u003ca href=\"https://science.sciencemag.org/content/187/4176/535\">Freon in refrigerants and other products\u003c/a> caused the \u003ca href=\"https://link.springer.com/chapter/10.1007%2F978-1-4939-6710-0_2\">degradation of Earth’s protective stratospheric ozone layer\u003c/a> and \u003ca href=\"https://www.sciencedirect.com/science/article/pii/S0890623807002377?via%3Dihub\">bisphenol A, a plasticizer used in bottles\u003c/a> and other consumer products ended up in people’s bodies, there’s concern among scientists that “better living through chemistry” might result in a string of \u003ca href=\"https://www.ehn.org/chemical-exposures-are-small-doses-harm-2518446452.html\">unintended human health consequences\u003c/a> in the realm of dust.\u003c/p>\n\u003cp>Taking off outdoor clothing like jackets and adopting a shoeless household policy is one way to reduce indoor exposure to outdoor pollutants. \u003ca href=\"https://www.ciriscience.org/a_96-Study-Reveals-High-Bacteria-Levels-on-Footwear\">Shoe bottoms are gross\u003c/a>: 96% of shoes have traces of feces bacteria on their soles, including the antimicrobial resistant \u003cem>C. diff\u003c/em>, and over 90% of these bacteria are transferred to floors. Add in cancer-causing \u003ca href=\"https://www.tandfonline.com/doi/abs/10.1080/10408444.2018.1528208?journalCode=itxc20\">toxins from asphalt road residue\u003c/a> and \u003ca href=\"https://www.tandfonline.com/doi/full/10.1080/23273747.2016.1148803\">endocrine-disrupting lawn chemicals\u003c/a>, and the recommendation becomes even clearer – no outdoor shoes inside.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "Ketamine Cousin Was Approved for Depression Despite Warning Signs",
"headTitle": "Ketamine Cousin Was Approved for Depression Despite Warning Signs | KQED",
"content": "\u003cp>Ketamine is a darling of combat medics and clubgoers, an anesthetic that can quiet your pain without suppressing breathing and a hallucinogenic that can get you high with little risk of a fatal overdose.\u003c/p>\n\u003cp>For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment — prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.”\u003c/p>\n\u003cp>That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug — announced in press releases, celebrated on the evening news and embraced by major health care providers \u003ca href=\"https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5220\" target=\"_blank\" rel=\"noopener\">like the Department of Veterans Affairs\u003c/a>.\u003c/p>\n\u003cp>The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.\u003c/p>\n\u003cp>The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents and interviews with participants, KHN found.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.\u003c/p>\n\u003cp>Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.\u003c/p>\n\u003cp>Esketamine’s trajectory to approval shows — step by step — how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.\u003c/p>\n\u003cp>Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a two-day study during which 30 patients were given esketamine intravenously.\u003c/p>\n\u003cp>\u003ca href=\"https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy\" target=\"_blank\" rel=\"noopener\">“Breakthrough therapy” status\u003c/a> puts drugs on a fast track to approval, with more frequent input from the FDA.\u003c/p>\n\u003cp>Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like, how many drugs must fail before a patient’s depression is considered intractable or “treatment-resistant”? And how many successful clinical trials are necessary for FDA approval?\u003c/p>\n\u003cp>Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.\u003c/p>\n\u003cp>The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Dr. Matthew Rudorfer, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said: “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”\u003c/p>\n\u003cp>But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, the system director of medication safety for Fairview Health Services based in Minneapolis.\u003c/p>\n\u003cp>\u003cstrong>A Nasal Spray Offers a Path to a Patent\u003c/strong>\u003c/p>\n\u003cp>Spravato is available only under supervision at a certified facility, like a doctor’s office, where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.\u003c/p>\n\u003cp>Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.\u003c/p>\n\u003cp>Esketamine is the first new type of drug approved to treat severe depression in about three decades.\u003c/p>\n\u003cp>Although ketamine has been used off-label for years to treat depression and post-traumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and (in some studies) more potent, could be patented as a new drug.\u003c/p>\n\u003cp>Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.\u003c/p>\n\u003cp>Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said: “I am offering real-world proof of efficacy, and that is I am both alive and here today.”\u003c/p>\n\u003cp>The drug did not work “for the majority of people who took it,” Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”\u003c/p>\n\u003cp>\u003cstrong>Concerns About Testing Precedents\u003c/strong>\u003c/p>\n\u003cp>Those considerations apparently helped outweigh several scientific red flags that committee members called out at the hearing.\u003c/p>\n\u003cp>Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid-acting.”\u003c/p>\n\u003cp>The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “\u003ca href=\"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-clinical-evidence-effectiveness-human-drug-and-biological-products\" target=\"_blank\" rel=\"noopener\">each convincing on its own.\u003c/a>” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.\u003c/p>\n\u003cp>To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.\u003c/p>\n\u003cp>What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms compared with the placebo treatment on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.\u003c/p>\n\u003cp>Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.\u003c/p>\n\u003cp>Less than two years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.\u003c/p>\n\u003cp>Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Dr. Erick Turner, a former FDA reviewer who serves on the committee but did not attend the meeting.\u003c/p>\n\u003cp>Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression — even though those who had suicidal ideation with some intent to act in the previous six months, or a history of suicidal behavior in the previous year, were excluded from the studies.\u003c/p>\n\u003cp>In \u003ca href=\"https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2019.19040423\" target=\"_blank\" rel=\"noopener\">a recent commentary in the American Journal of Psychiatry\u003c/a>, Dr. Alan Schatzberg, a Stanford University researcher who has studied ketamine, suggested there might be a link due to “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors.\u003c/p>\n\u003cp>Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Witczak said in an interview. She voted against the drug.\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"https://www.kff.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>\u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a> (KHN) is a national health policy news service. It is an editorially independent program of the \u003ca href=\"http://www.kff.org/\" target=\"_blank\" rel=\"noopener\">Henry J. Kaiser Family Foundation\u003c/a> which is not affiliated with Kaiser Permanente.\u003c/em>\u003c/p>\n\n",
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"excerpt": "The Federal Drug Administration approved a ketamine cousin for patients with intractable depression. But the drug’s manufacturer provided the FDA with only modest evidence it worked.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Ketamine is a darling of combat medics and clubgoers, an anesthetic that can quiet your pain without suppressing breathing and a hallucinogenic that can get you high with little risk of a fatal overdose.\u003c/p>\n\u003cp>For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment — prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.”\u003c/p>\n\u003cp>That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug — announced in press releases, celebrated on the evening news and embraced by major health care providers \u003ca href=\"https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5220\" target=\"_blank\" rel=\"noopener\">like the Department of Veterans Affairs\u003c/a>.\u003c/p>\n\u003cp>The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.\u003c/p>\n\u003cp>The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents and interviews with participants, KHN found.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.\u003c/p>\n\u003cp>Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.\u003c/p>\n\u003cp>Esketamine’s trajectory to approval shows — step by step — how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.\u003c/p>\n\u003cp>Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a two-day study during which 30 patients were given esketamine intravenously.\u003c/p>\n\u003cp>\u003ca href=\"https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy\" target=\"_blank\" rel=\"noopener\">“Breakthrough therapy” status\u003c/a> puts drugs on a fast track to approval, with more frequent input from the FDA.\u003c/p>\n\u003cp>Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like, how many drugs must fail before a patient’s depression is considered intractable or “treatment-resistant”? And how many successful clinical trials are necessary for FDA approval?\u003c/p>\n\u003cp>Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.\u003c/p>\n\u003cp>The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Dr. Matthew Rudorfer, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said: “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”\u003c/p>\n\u003cp>But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, the system director of medication safety for Fairview Health Services based in Minneapolis.\u003c/p>\n\u003cp>\u003cstrong>A Nasal Spray Offers a Path to a Patent\u003c/strong>\u003c/p>\n\u003cp>Spravato is available only under supervision at a certified facility, like a doctor’s office, where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.\u003c/p>\n\u003cp>Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.\u003c/p>\n\u003cp>Esketamine is the first new type of drug approved to treat severe depression in about three decades.\u003c/p>\n\u003cp>Although ketamine has been used off-label for years to treat depression and post-traumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and (in some studies) more potent, could be patented as a new drug.\u003c/p>\n\u003cp>Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.\u003c/p>\n\u003cp>Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said: “I am offering real-world proof of efficacy, and that is I am both alive and here today.”\u003c/p>\n\u003cp>The drug did not work “for the majority of people who took it,” Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”\u003c/p>\n\u003cp>\u003cstrong>Concerns About Testing Precedents\u003c/strong>\u003c/p>\n\u003cp>Those considerations apparently helped outweigh several scientific red flags that committee members called out at the hearing.\u003c/p>\n\u003cp>Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid-acting.”\u003c/p>\n\u003cp>The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “\u003ca href=\"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-clinical-evidence-effectiveness-human-drug-and-biological-products\" target=\"_blank\" rel=\"noopener\">each convincing on its own.\u003c/a>” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.\u003c/p>\n\u003cp>To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.\u003c/p>\n\u003cp>What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms compared with the placebo treatment on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.\u003c/p>\n\u003cp>Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.\u003c/p>\n\u003cp>Less than two years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.\u003c/p>\n\u003cp>Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Dr. Erick Turner, a former FDA reviewer who serves on the committee but did not attend the meeting.\u003c/p>\n\u003cp>Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression — even though those who had suicidal ideation with some intent to act in the previous six months, or a history of suicidal behavior in the previous year, were excluded from the studies.\u003c/p>\n\u003cp>In \u003ca href=\"https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2019.19040423\" target=\"_blank\" rel=\"noopener\">a recent commentary in the American Journal of Psychiatry\u003c/a>, Dr. Alan Schatzberg, a Stanford University researcher who has studied ketamine, suggested there might be a link due to “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors.\u003c/p>\n\u003cp>Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Witczak said in an interview. She voted against the drug.\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"https://www.kff.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a> (KHN) is a national health policy news service. It is an editorially independent program of the \u003ca href=\"http://www.kff.org/\" target=\"_blank\" rel=\"noopener\">Henry J. Kaiser Family Foundation\u003c/a> which is not affiliated with Kaiser Permanente.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "UC Partners With Pharmaceutical Giant on $67 Million CRISPR Lab",
"headTitle": "UC Partners With Pharmaceutical Giant on $67 Million CRISPR Lab | KQED",
"content": "\u003cp>The University of California and the British pharmaceutical giant GlaxoSmithKline on Thursday announced plans to build a new $67 million genetics laboratory focused on the gene-editing technology CRISPR.\u003c/p>\n\u003cp>Scientists at what will be called the Laboratory for Genomics Research, to be built over the next five years in San Francisco’s Mission Bay, will explore how genetic mutations cause disease, while developing new gene therapies and other treatments.\u003c/p>\n\u003cp>The study of human genetics has exploded in the last decade, and scientists can now identify mutations in DNA that cause a wide range of disease, from cancer to Huntington’s to muscular dystrophy.\u003c/p>\n\u003cp>“But turning that into an actionable item where you can develop a therapy has been challenging,” said Jonathan Weissman, a biochemist at UCSF. Weissman is designing the laboratory with UC Berkeley’s Jennifer Doudna, a CRISPR pioneer, and Hal Barron, chief science officer and president of GSK.\u003c/p>\n\u003cp>Weissman hopes the lab will enable researchers to more fully understand genetic differences through the advancement of functional genomics — the study of gene relationships and interactions — that relies on CRISPR technology.\u003c/p>\n\u003cp>CRISPR is so powerful because it targets specific genes with precise edits in DNA.\u003c/p>\n\u003cp>\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1943305 alignright\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-800x531.jpg\" alt=\"\" width=\"800\" height=\"531\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-800x531.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-160x106.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-768x510.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-1020x677.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-1200x797.jpg 1200w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115.jpg 1280w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/p>\n\u003cp>“CRISPR is a great discovery tool that lets us understand why changes in our DNA can cause disease and then give us clues as to how we might be able to intervene to prevent it,” said Weissman.\u003c/p>\n\u003cp>Recent advances in machine learning have given scientists the ability to use powerful computers to analyze the massive amount of data generated by CRISPR applications. The hope is that these supercomputers can help unlock the mysteries of cell biology and rapidly accelerate the discovery of new treatments.\u003c/p>\n\u003cp>“We think that human genetics, functional genomics and machine learning will allow us to identify novel targets that will result in medicines that will have a profound effect ,” said Barron.\u003c/p>\n\u003cp>GSK’s Barron said he hopes the lab will spur advancements in gene therapy at “a pace previously thought impossible.”\u003c/p>\n\u003cp>The lab will employ about 40 people, GSK and UC said, and will be located between UCSF’s Mission Bay campus and the new Warriors \u003ca href=\"http://www.gswconstruction.com/webcam/\">stadium\u003c/a>.\u003c/p>\n\u003cp>\u003cstrong>CRISPR and Ethics\u003c/strong>\u003c/p>\n\u003cp>With CRISPR technology, scientists can modify or add entirely new genes.\u003c/p>\n\u003cp>CRISPR is different from other gene-editing tools in that its applications can alter the DNA of somatic cells and germ cells.\u003c/p>\n\u003cp>Somatic cells are found in organs and tissues and are not passed on through reproduction. Germ cells hold genes that are heritable.\u003c/p>\n\u003cp>Doudna said the focus of the new lab will be on fundamental discovery science, and not on germ cell editing.\u003c/p>\n\u003cfigure id=\"attachment_1943306\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1943306\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-800x565.jpg\" alt=\"\" width=\"800\" height=\"565\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-800x565.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-160x113.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-768x543.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-1020x721.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-1200x848.jpg 1200w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-1920x1357.jpg 1920w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758.jpg 2048w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Jennifer Doudna will spearhead a new CRISPR lab in the Mission Bay neighborhood of San Francisco. speaks onstage at WIRED Business Conference Presented By Visa At Spring Studios In New York City on June 7, 2017 in New York City. (Photo by Brian Ach/Getty \u003ccite>(Brian Ach/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“I don’t think there’s any intention right now to be editing human embryos in the center,” she said. “I think our goal is actually to work on various kinds of disease-related questions that would be addressable using primary cells and tissues.”\u003c/p>\n\u003cp>Last year, controversy swarmed around He Jiankui, a biochemist with Southern University of Science and Technology in Shenzhen, China, who used CRISPR to perform germline editing to modify genes in a human embryo.\u003c/p>\n\u003cp>At the time, Doudna was one of the scientists who quickly criticized Jiankui, telling NPR that his work is a “break from the cautious and transparent approach of the global scientific community’s application of CRISPR-Cas9 for human germline editing.”\u003c/p>\n\u003cp>Doudna has declared a need to confine the use of gene-editing in human embryos to situations in which there is a clear medical need with zero alternative viable approach.\u003c/p>\n\u003cp>Additionally, Doudna says there’s a lot of fundamental research that needs to be done prior to any use of genome editing for clinical purposes in human embryos. “In that regard, the [lab] will play a very important role in stimulating fundamental, curiosity-driven research that needs to be done,” she said. “It will both advance our understanding of the human genome and we’ll also advance the potential in the power of the technology.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The University of California and the British pharmaceutical giant GlaxoSmithKline on Thursday announced plans to build a new $67 million genetics laboratory focused on the gene-editing technology CRISPR.\u003c/p>\n\u003cp>Scientists at what will be called the Laboratory for Genomics Research, to be built over the next five years in San Francisco’s Mission Bay, will explore how genetic mutations cause disease, while developing new gene therapies and other treatments.\u003c/p>\n\u003cp>The study of human genetics has exploded in the last decade, and scientists can now identify mutations in DNA that cause a wide range of disease, from cancer to Huntington’s to muscular dystrophy.\u003c/p>\n\u003cp>“But turning that into an actionable item where you can develop a therapy has been challenging,” said Jonathan Weissman, a biochemist at UCSF. Weissman is designing the laboratory with UC Berkeley’s Jennifer Doudna, a CRISPR pioneer, and Hal Barron, chief science officer and president of GSK.\u003c/p>\n\u003cp>Weissman hopes the lab will enable researchers to more fully understand genetic differences through the advancement of functional genomics — the study of gene relationships and interactions — that relies on CRISPR technology.\u003c/p>\n\u003cp>CRISPR is so powerful because it targets specific genes with precise edits in DNA.\u003c/p>\n\u003cp>\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1943305 alignright\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-800x531.jpg\" alt=\"\" width=\"800\" height=\"531\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-800x531.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-160x106.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-768x510.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-1020x677.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115-1200x797.jpg 1200w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/DESKTOP_CRISPR_171115.jpg 1280w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/p>\n\u003cp>“CRISPR is a great discovery tool that lets us understand why changes in our DNA can cause disease and then give us clues as to how we might be able to intervene to prevent it,” said Weissman.\u003c/p>\n\u003cp>Recent advances in machine learning have given scientists the ability to use powerful computers to analyze the massive amount of data generated by CRISPR applications. The hope is that these supercomputers can help unlock the mysteries of cell biology and rapidly accelerate the discovery of new treatments.\u003c/p>\n\u003cp>“We think that human genetics, functional genomics and machine learning will allow us to identify novel targets that will result in medicines that will have a profound effect ,” said Barron.\u003c/p>\n\u003cp>GSK’s Barron said he hopes the lab will spur advancements in gene therapy at “a pace previously thought impossible.”\u003c/p>\n\u003cp>The lab will employ about 40 people, GSK and UC said, and will be located between UCSF’s Mission Bay campus and the new Warriors \u003ca href=\"http://www.gswconstruction.com/webcam/\">stadium\u003c/a>.\u003c/p>\n\u003cp>\u003cstrong>CRISPR and Ethics\u003c/strong>\u003c/p>\n\u003cp>With CRISPR technology, scientists can modify or add entirely new genes.\u003c/p>\n\u003cp>CRISPR is different from other gene-editing tools in that its applications can alter the DNA of somatic cells and germ cells.\u003c/p>\n\u003cp>Somatic cells are found in organs and tissues and are not passed on through reproduction. Germ cells hold genes that are heritable.\u003c/p>\n\u003cp>Doudna said the focus of the new lab will be on fundamental discovery science, and not on germ cell editing.\u003c/p>\n\u003cfigure id=\"attachment_1943306\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1943306\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-800x565.jpg\" alt=\"\" width=\"800\" height=\"565\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-800x565.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-160x113.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-768x543.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-1020x721.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-1200x848.jpg 1200w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758-1920x1357.jpg 1920w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/06/GettyImages-693524758.jpg 2048w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Jennifer Doudna will spearhead a new CRISPR lab in the Mission Bay neighborhood of San Francisco. speaks onstage at WIRED Business Conference Presented By Visa At Spring Studios In New York City on June 7, 2017 in New York City. (Photo by Brian Ach/Getty \u003ccite>(Brian Ach/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“I don’t think there’s any intention right now to be editing human embryos in the center,” she said. “I think our goal is actually to work on various kinds of disease-related questions that would be addressable using primary cells and tissues.”\u003c/p>\n\u003cp>Last year, controversy swarmed around He Jiankui, a biochemist with Southern University of Science and Technology in Shenzhen, China, who used CRISPR to perform germline editing to modify genes in a human embryo.\u003c/p>\n\u003cp>At the time, Doudna was one of the scientists who quickly criticized Jiankui, telling NPR that his work is a “break from the cautious and transparent approach of the global scientific community’s application of CRISPR-Cas9 for human germline editing.”\u003c/p>\n\u003cp>Doudna has declared a need to confine the use of gene-editing in human embryos to situations in which there is a clear medical need with zero alternative viable approach.\u003c/p>\n\u003cp>Additionally, Doudna says there’s a lot of fundamental research that needs to be done prior to any use of genome editing for clinical purposes in human embryos. “In that regard, the [lab] will play a very important role in stimulating fundamental, curiosity-driven research that needs to be done,” she said. “It will both advance our understanding of the human genome and we’ll also advance the potential in the power of the technology.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "A Doctor's Crusade Against Sharp Limits on Opioids for 'Legacy Patients'",
"headTitle": "A Doctor’s Crusade Against Sharp Limits on Opioids for ‘Legacy Patients’ | KQED",
"content": "\u003cp>About four years ago, Dr. Stefan Kertesz started hearing that patients who had been taking opioid painkillers for years were being taken off their medications. Sometimes it was an aggressive reduction they weren’t on board with, sometimes it was all at once. Clinicians told patients they no longer felt comfortable treating them.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\"> [pullquote]‘I think I’m particularly provoked by situations where harm is done in the name of helping. What really gets me is when responsible parties say we will protect you, and then they call upon us to harm people.’[/pullquote]\u003c/span>\u003c/p>\n\u003cp>Kertesz, a primary care physician who also specializes in addiction medicine, had not spent his career investigating long-term opioid use or chronic pain. But he grew concerned by the medical community’s efforts to regain control over prescribing patterns after years of lax distribution. Limiting prescriptions for new patients had clear benefits, he thought, but he wondered about the results of reductions among “legacy patients.” Their outcomes weren’t being tracked.\u003c/p>\n\u003cp>Now, Kertesz is a leading advocate against policies that call for \u003ca href=\"https://academic.oup.com/painmedicine/article/20/3/429/5218985\" target=\"_blank\" rel=\"noopener noreferrer\">aggressive reductions\u003c/a> in long-term opioid prescriptions or have resulted in forced cutbacks. He argues that well-intentioned initiatives to avoid the mistakes of the past have introduced new problems. He’s warned that clinicians’ decisions are destabilizing patients’ lives and leaving them in pain — and in some cases could drive patients to obtain opioids illicitly or even take their lives.\u003c/p>\n\u003cp>“I think I’m particularly provoked by situations where harm is done in the name of helping,” Kertesz said. “What really gets me is when responsible parties say we will protect you, and then they call upon us to harm people.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>It’s a case that Kertesz, 52, has tried to make with nuance and precision, bounded by an emphasis on the history of overprescribing and the benefits of tapering for patients for whom it works. But against a backdrop of tens of thousands of opioid overdose deaths each year and an ongoing reckoning about the roots of the opioid addiction crisis, it’s the dialectical equivalent of pinning the tail on a bucking bronco. Kertesz’s critics have questioned his motives. He’s heard he’s been called “the candyman.”\u003c/p>\n\u003cfigure id=\"attachment_1942580\" class=\"wp-caption alignright\" style=\"max-width: 615px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-1942580\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/05/kertesz2018.png\" alt=\"\" width=\"615\" height=\"567\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/kertesz2018.png 615w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/kertesz2018-160x148.png 160w\" sizes=\"(max-width: 615px) 100vw, 615px\">\u003cfigcaption class=\"wp-caption-text\">Dr. Stefan Kertesz a leading advocate against policies that call for aggressive reductions in long-term opioid prescriptions or have resulted in forced cutbacks. \u003ccite>(University of Alabama at Birmingham)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“I am really worried that people like Stefan Kertesz, who is trying to champion ‘patient-centered care,’ in some ways are feeding into the same misleading messaging rolled out by Purdue [Pharma] and others that not to prescribe opioids is tantamount to torturing patients,” said Dr. Anna Lembke, the medical director of addiction medicine at Stanford.\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2017/01/17/chronic-pain-management-opioids/\" rel=\"\">The debate is playing out\u003c/a> as doctors try to move beyond their days of overprescribing while responsibly treating chronic pain. It is also playing out in settings like Kertesz’s office here at a Veterans Affairs clinic, where a patient named Jerry Brown, a 63-year-old former boilermaker and carpenter, recently showed up.\u003c/p>\n\u003cp>Brown had a compressed spinal cord and severe neck pain. For more than a decade, dating back to before he started seeing Kertesz, he had been taking about 300 morphine milligram equivalents (MME) of opioids a day — a dosage equivalent to \u003ca href=\"https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">more than three times\u003c/a> the level that clinicians should “avoid or carefully justify,” according to federal officials.\u003c/p>\n\u003cp>Kertesz and Brown tried a 10% dose reduction a few years ago. But Brown became volatile and less active and complained of revived pain, so Kertesz eased back.\u003c/p>\n\u003cp>Kertesz, who treats patients who are or have been homeless, told Brown that he had “incurred risk” with his dose. “Do you know that I wish you hadn’t had your doses increased?” he asked.\u003c/p>\n\u003cp>“Yes,” Brown replied.\u003c/p>\n\u003cp>They could try again to taper the dose to reduce that risk. But Brown had stable housing and activities to keep him busy — he helped his ex-wife out at her home and cleaned up after her Chihuahuas. He had anxiety and sometimes had trouble getting to the clinic because of transportation problems. But there was no evidence he had misused or sold his drugs, or misused other substances.\u003c/p>\n\u003cp>In this case, Kertesz’s takeaway was: “Leave well enough alone.”\u003c/p>\n\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">O\u003c/span>\u003c/span>pioid prescribing has been \u003ca href=\"https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html\" target=\"_blank\" rel=\"noopener noreferrer\">declining since 2012\u003c/a>, though levels remain higher than they were two decades ago. Today, depending on the estimate, anywhere from \u003ca href=\"https://academic.oup.com/painmedicine/article/20/4/724/5301726?utm_content=buffer9586d&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer\" target=\"_blank\" rel=\"noopener noreferrer\">8 million\u003c/a> to \u003ca href=\"https://academic.oup.com/painmedicine/article/20/3/429/5218985\" target=\"_blank\" rel=\"noopener noreferrer\">18 million\u003c/a> Americans take opioids for chronic pain.\u003c/p>\n\u003cp>The interest in reducing their dosages is predicated in part on efforts to minimize patients’ risk of overdose and addiction. But there are other considerations. Enduring opioid use makes people more sensitive to pain, many experts believe. Opioid use has also been associated with anxiety, depression, and other health issues.\u003c/p>\n\u003cp>Plus, as people become dependent, the drugs might just be staving off symptoms of withdrawal that would come without another dose, rather than treating the original source of pain.\u003c/p>\n\u003cp>In short, experts say, long-term opioid use is not good medicine.\u003c/p>\n\u003cp>Kertesz, who is also a professor at the University of Alabama at Birmingham School of Medicine, agrees with all of that. But he believes that lowering dosages will hurt some patients who are leading functional lives on opioids, and that top-down strategies won’t protect them.\u003c/p>\n\u003cp>So, in 2015, when the Centers for Disease Control and Prevention proposed prescribing guidelines for primary care clinicians treating chronic pain, Kertesz grew nervous.\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/pharmalot/2016/03/15/opioids-painkillers-cdc/\">The guidelines\u003c/a>, a set of \u003ca href=\"https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fvolumes%2F65%2Frr%2Frr6501e1er.htm#contribAff\" target=\"_blank\" rel=\"noopener noreferrer\">measured recommendations\u003c/a> finalized in March 2016, suggested clinicians try other therapies for pain before moving to opioids and prescribe only the lowest effective dose and duration of the drugs. (The guidelines do not apply to end-of-life or cancer care.) For patients on high doses, the guidelines said, “If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.”\u003c/p>\n\u003cp>“Our day-to-day practice aligns with nearly all principles laid out in the guideline,” Kertesz wrote in \u003ca href=\"https://medium.com/@StefanKertesz/considering-cdc-s-proposed-2016-guideline-for-prescribing-opioids-for-chronic-pain-a-good-start-e7cf22be40cd\" target=\"_blank\" rel=\"noopener noreferrer\">a comment\u003c/a> he submitted on the draft. But he cautioned the voluntary recommendations could be implemented too stringently by others.\u003c/p>\n\u003cp>“This is a guideline like no other … its guidance will affect the immediate well-being of millions of Americans with chronic pain,” he wrote.\u003c/p>\n\u003cp>After the release of the guidelines, Kertesz started seeing ripple effects. In early 2017, federal officials \u003ca href=\"https://www.politico.com/story/2017/03/docs-warn-that-medicare-crackdown-will-hurt-pain-patients-235917\" target=\"_blank\" rel=\"noopener noreferrer\">unveiled a Medicare proposal\u003c/a> that would have blocked prescriptions higher than 90 MME without a special review. Around the same time, the National Committee for Quality Assurance considered docking clinicians’ scores if they had patients on high doses for long periods.\u003c/p>\n\u003cp>Kertesz, other experts, and \u003ca href=\"https://www.medpagetoday.com/meetingcoverage/ama/76256\" target=\"_blank\" rel=\"noopener noreferrer\">some medical societies\u003c/a> protested such proposals, contending they invoked the CDC guidelines while violating them.\u003c/p>\n\u003cfigure id=\"attachment_1942586\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1942586\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/05/GettyImages-678211-800x525.jpg\" alt=\"\" width=\"800\" height=\"525\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-800x525.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-160x105.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-768x504.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-1020x669.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-1200x787.jpg 1200w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-1920x1260.jpg 1920w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211.jpg 2048w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">The prescription medicine OxyContin is displayed. \u003ccite>(Darren McCollester/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“Most of us wish to see an evolution toward fewer opioid starts and fewer patients at high doses,” Kertesz and colleagues \u003ca href=\"https://medium.com/@StefanKertesz/an-opioid-quality-metric-based-on-dose-alone-80-professionals-respond-to-ncqa-6f9fbaa2338\" target=\"_blank\" rel=\"noopener noreferrer\">wrote in response\u003c/a> to the NCQA plan. “The proposed NCQA measure indulges no such subtleties.”\u003c/p>\n\u003cp>The discussion overall has been hindered by limited research, including evidence for the benefits of forced tapering. But \u003ca href=\"http://www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">as of October 2018\u003c/a>, 33 states had codified some prescription limits into law. Pharmacies and insurers capped prescriptions at 90 MME. Law enforcement agencies warned high prescribers.\u003c/p>\n\u003cp>Some initiatives have focused on avoiding “new starts,” not on tapering legacy patients. But Kertesz and other advocates argued the pressure of all the policies and warnings inculcated an anxiety around prescribing.\u003c/p>\n\u003cp>Chronic pain patients were seen as legally risky and medically complicated, so they had trouble finding providers.\u003c/p>\n\u003cp>Kertesz and his allies raised their concerns in \u003ca href=\"https://www.statnews.com/2017/02/24/opioids-prescribing-limits-pain-patients/\" rel=\"\">the popular\u003c/a> and \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27858590\" target=\"_blank\" rel=\"noopener noreferrer\">academic presses\u003c/a> and at conferences, building momentum over the years. They collected anecdotes from patients who said they had been harmed in some way by dose reductions or involuntary tapers.\u003c/p>\n\u003cp>“It is imperative that healthcare professionals and administrators realize that the Guideline does not endorse mandated involuntary dose reduction or discontinuation,” read \u003ca href=\"https://docs.google.com/document/d/1RzQDSppUKhjiAsEmhW2WbTXlP5V8vJ4M_vBPQLKhK_8/edit\" target=\"_blank\" rel=\"noopener noreferrer\">a March letter\u003c/a> co-authored by Kertesz calling on the CDC to reiterate its recommendations were not binding. The letter continued: “Patients have endured not only unnecessary suffering, but some have turned to suicide or illicit substance use.”\u003c/p>\n\u003cp>More than 300 patient advocates and experts, including three former White House drug czars, signed it.\u003c/p>\n\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">K\u003c/span>\u003c/span>ertesz sees his advocacy work as an extension of several throughlines in his career. For one, he has patients who have been on opioids for years, and he knows the stress clinicians face when renewing a high-dose prescription. He also has a history of arguing for causes that stretches back to writing op-eds for his high school newspaper in Silicon Valley.\u003c/p>\n\u003cp>But his willingness to take on what he sees as injustices does not mean he feels self-assured about doing so.\u003c/p>\n\u003cp>“Every single bit of it involves ambivalence and driving myself crazy,” he said. “Like, am I making a mistake? Am I going to blow up my career?”\u003c/p>\n\u003cp>When Kertesz thinks, he leans forward and pulls his hair back. His obsessive streak extends to both his career and his personal life. (He’s become a fencing fanatic, having taken up the sport less than six years ago.) When he talks about medicine, he pauses mid-conversation to point out whether his statements are based on randomized trials or his own inference. He can appear scatterbrained and is working with a coach to become more structured.\u003c/p>\n\u003cp>“He’s not like a heroic figure on a horse. He’s more like a neurotic figure on a horse,” said Dr. Saul Weiner of the University of Illinois at Chicago, who became friends with Kertesz while working at a hospital in Gabon during medical school.\u003c/p>\n\u003cp>Having tenure has made Kertesz more comfortable being outspoken. And he feels he may have more credibility than other physicians to make this specific case. He is a primary care physician who cares for people who are homeless and, beyond some former stock ownership, has no ties to drug companies, as opposed to a pain specialist who received research funding from them. (Kertesz \u003ca href=\"https://twitter.com/StefanKertesz/status/1120865642062630912\" target=\"_blank\" rel=\"noopener noreferrer\">noted\u003c/a> that he recently packed his own PB&J for a conference, the implication being he’ll avoid even a pharma-funded sandwich spread.)\u003c/p>\n\u003cfigure id=\"attachment_1942524\" class=\"wp-caption alignright\" style=\"max-width: 768px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1942524 size-full\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/05/Saul-and-Stefan-in-Gabon-768x504.jpg\" alt=\"\" width=\"768\" height=\"504\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/Saul-and-Stefan-in-Gabon-768x504.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/Saul-and-Stefan-in-Gabon-768x504-160x105.jpg 160w\" sizes=\"(max-width: 768px) 100vw, 768px\">\u003cfigcaption class=\"wp-caption-text\">Kertesz and Saul Weiner working at a hospital in Gabon in the early 1990s. \u003ccite>(Saul Weiner)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>But other leaders of Health Professionals for Patients in Pain, the group that wrote the March letter calling on the CDC to clarify its guidelines, have projects that are supported by drug companies. They \u003ca href=\"https://healthprofessionalsforpatientsinpain.org/about-us\" target=\"_blank\" rel=\"noopener noreferrer\">disclose as much\u003c/a> on the group’s site, but it’s left the group exposed to the criticism that it’s not wholly removed from the pharmaceutical industry.\u003c/p>\n\u003cp>Kertesz “certainly is very close to people who are being paid by opioid manufacturers,” said Dr. Adriane Fugh-Berman of Georgetown University, who studies the pharma industry’s influence on medicine. “He’s certainly worked with people who have close ties to opioid manufacturers.”\u003c/p>\n\u003cp>Kertesz said that because of the industry’s history of opioid promotion, such criticisms need to be part of the discussion.\u003c/p>\n\u003cp>Fugh-Berman is among the experts who have challenged Kertesz’s most alarming claim: that pain patients are being driven to suicide. They argue advocates are relying on anecdotes more suited to a political candidate’s barnstorming of Iowa than the kind of scientific evidence needed to substantiate claims of a new epidemic. Establishing cause and effect in suicide is complex, and studies have shown \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMra1802148\" target=\"_blank\" rel=\"noopener noreferrer\">an association between opioid use and suicide\u003c/a>.\u003c/p>\n\u003cp>“Where is your evidence of documented suicides from people who are tapered?” Fugh-Berman \u003ca href=\"https://www.youtube.com/watch?v=LR4lpvAZ8sY\" target=\"_blank\" rel=\"noopener noreferrer\">asked Kertesz\u003c/a> following a presentation at a conference last year.\u003c/p>\n\u003cp>Kertesz replied that he had \u003ca href=\"https://www.healthaffairs.org/do/10.1377/hblog20180117.832392/full/\" target=\"_blank\" rel=\"noopener noreferrer\">reviewed medical records\u003c/a> from people who had died by suicide after an opioid reduction. He added a caveat: “You have three things that are potentially simultaneously associated with harm: Pain itself. Opioid dependence, the dependence itself. And the event, however we wish to interpret it clinically — as resurgent pain or untreated opioid dependence — in patients who are having opioids taken away.”\u003c/p>\n\u003cp>Kertesz is now trying to secure funding to study such suicides.\u003c/p>\n\u003cp>Fugh-Berman and Kertesz are often cast as representatives of two fundamentally opposed camps. (Indeed, Stanford’s Lembke and Kertesz are slated \u003ca href=\"https://amersa.org/conference/conference-at-a-glance/\" target=\"_blank\" rel=\"noopener noreferrer\">to square off in a “spicy debate”\u003c/a> at an upcoming medical conference.)\u003c/p>\n\u003cp>Such a framing elides what they agree on. Kertesz emphasizes that opioids were massively overprescribed, that the patients he’s worried about should have never been on these doses, and that many patients will be better off after tapering. Lembke stresses that tapers need to go slowly and that patients should be monitored closely during the process — never pushed out of care.\u003c/p>\n\u003cp>But they disagree on exactly how to go about lowering prescribing and the proportion of patients who can be tapered without compromising quality of life.\u003c/p>\n\u003cp>Lembke argues that top-down policies are required to counter all the incentives clinicians have to keep patients on opioids. She has called for medical centers to establish teams that can guide patients through the process. She also said that some patients should be switched to \u003ca href=\"https://www.statnews.com/2019/04/30/loosen-restrictions-on-prescribing-buprenorphine-addiction-treatment/\">buprenorphine\u003c/a> — an opioid addiction medication that eases withdrawal symptoms — even if they do not meet the diagnosis of opioid use disorder.\u003c/p>\n\u003cp>“To leave them at those doses because it’s too hard, that’s not OK,” she said.\u003c/p>\n\u003cp>Lembke noted that prescription policies typically include exceptions for some patients to remain on high-dose opioids.\u003c/p>\n\u003cp>“There are rare instances where I would agree that maybe the most judicious path is ‘leave well enough alone,’” she said. “But that would be where the patient has to commute four hours to get to my clinic, they have no social support, they have no family, they have no psychological or emotional resources to help them do this hard thing which really from a medical perspective they need to do.”\u003c/p>\n\u003cp>Kertesz takes a different view. He supports doctors who encourage tapers, and \u003ca href=\"https://www.youtube.com/watch?v=u9F-vAVQvGM\" target=\"_blank\" rel=\"noopener noreferrer\">he has spoken\u003c/a> about tapering a patient off her medications against her wishes in one case. But he believes those are choices for clinicians to make, and that overarching policies will lead to mismanaged care.\u003c/p>\n\u003cp>Backing mandatory limits, he said, “assumes that what’s going to happen at the systems level will reflect the best clinician.”\u003c/p>\n\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">L\u003c/span>\u003c/span>ast month, the authors of the CDC guidelines \u003ca href=\"https://www.statnews.com/2019/04/24/cdc-opioid-prescribing-guidelines-misapplied/\">published a paper\u003c/a> that said “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations.” They \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMp1904190?query=featured_home\" target=\"_blank\" rel=\"noopener noreferrer\">called out\u003c/a> “hard limits and abrupt tapering of drug dosages” that their guidance did not endorse.\u003c/p>\n\u003cp>It was what Kertesz and his colleagues had been asking for. But now, they face the more difficult task of \u003ca href=\"https://www.statnews.com/2019/04/26/no-shortcuts-prescribing-opioids-chronic-pain/\" rel=\"\">ensuring every group\u003c/a> that overshot the CDC guidelines corrects course.\u003c/p>\n\u003cp>The national attention Kertesz has received for his efforts felt far removed from the room where he was seeing his patients earlier this month. One was in the midst of a taper experiment, from 40 MME to 35 MME a day. But there was also talk of blood pressure medications and cancer screenings — primary care basics.\u003c/p>\n\u003cp>Then there was Byron, 47. He asked that his last name not be used, but Kertesz and the staff at the clinic called him their Jonah. He had been swallowed up by his addiction and maybe should have died, but here he was, like God had some plan for him.\u003c/p>\n\u003cp>Byron was staying at a recovery home, but he felt listless without the rush of drugs or living on the street, he told Kertesz. Kertesz bumped up his buprenorphine dose, but the existential anguish was a harder problem to address.\u003c/p>\n\u003cp>“At any given moment, any one of us feels unsure about who to be or what to do or how to do it,” Kertesz told him.\u003c/p>\n\u003cp>“You have extra burdens, but you’re not alone,” he continued. “Everyone has times when they don’t have clarity.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2019/05/20/googles-ai-improves-accuracy-of-lung-cancer-diagnosis-study-shows/\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\">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": "A medical doctor becomes a leading advocate against policies that call for aggressive reductions in long-term opioid prescriptions or have resulted in forced cutbacks. ",
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"title": "A Doctor's Crusade Against Sharp Limits on Opioids for 'Legacy Patients' | KQED",
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"headline": "A Doctor's Crusade Against Sharp Limits on Opioids for 'Legacy Patients'",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>About four years ago, Dr. Stefan Kertesz started hearing that patients who had been taking opioid painkillers for years were being taken off their medications. Sometimes it was an aggressive reduction they weren’t on board with, sometimes it was all at once. Clinicians told patients they no longer felt comfortable treating them.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\"> \u003c/p>\u003c/div>",
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"content": "‘I think I’m particularly provoked by situations where harm is done in the name of helping. What really gets me is when responsible parties say we will protect you, and then they call upon us to harm people.’",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/span>\u003c/p>\n\u003cp>Kertesz, a primary care physician who also specializes in addiction medicine, had not spent his career investigating long-term opioid use or chronic pain. But he grew concerned by the medical community’s efforts to regain control over prescribing patterns after years of lax distribution. Limiting prescriptions for new patients had clear benefits, he thought, but he wondered about the results of reductions among “legacy patients.” Their outcomes weren’t being tracked.\u003c/p>\n\u003cp>Now, Kertesz is a leading advocate against policies that call for \u003ca href=\"https://academic.oup.com/painmedicine/article/20/3/429/5218985\" target=\"_blank\" rel=\"noopener noreferrer\">aggressive reductions\u003c/a> in long-term opioid prescriptions or have resulted in forced cutbacks. He argues that well-intentioned initiatives to avoid the mistakes of the past have introduced new problems. He’s warned that clinicians’ decisions are destabilizing patients’ lives and leaving them in pain — and in some cases could drive patients to obtain opioids illicitly or even take their lives.\u003c/p>\n\u003cp>“I think I’m particularly provoked by situations where harm is done in the name of helping,” Kertesz said. “What really gets me is when responsible parties say we will protect you, and then they call upon us to harm people.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>It’s a case that Kertesz, 52, has tried to make with nuance and precision, bounded by an emphasis on the history of overprescribing and the benefits of tapering for patients for whom it works. But against a backdrop of tens of thousands of opioid overdose deaths each year and an ongoing reckoning about the roots of the opioid addiction crisis, it’s the dialectical equivalent of pinning the tail on a bucking bronco. Kertesz’s critics have questioned his motives. He’s heard he’s been called “the candyman.”\u003c/p>\n\u003cfigure id=\"attachment_1942580\" class=\"wp-caption alignright\" style=\"max-width: 615px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-1942580\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/05/kertesz2018.png\" alt=\"\" width=\"615\" height=\"567\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/kertesz2018.png 615w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/kertesz2018-160x148.png 160w\" sizes=\"(max-width: 615px) 100vw, 615px\">\u003cfigcaption class=\"wp-caption-text\">Dr. Stefan Kertesz a leading advocate against policies that call for aggressive reductions in long-term opioid prescriptions or have resulted in forced cutbacks. \u003ccite>(University of Alabama at Birmingham)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“I am really worried that people like Stefan Kertesz, who is trying to champion ‘patient-centered care,’ in some ways are feeding into the same misleading messaging rolled out by Purdue [Pharma] and others that not to prescribe opioids is tantamount to torturing patients,” said Dr. Anna Lembke, the medical director of addiction medicine at Stanford.\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2017/01/17/chronic-pain-management-opioids/\" rel=\"\">The debate is playing out\u003c/a> as doctors try to move beyond their days of overprescribing while responsibly treating chronic pain. It is also playing out in settings like Kertesz’s office here at a Veterans Affairs clinic, where a patient named Jerry Brown, a 63-year-old former boilermaker and carpenter, recently showed up.\u003c/p>\n\u003cp>Brown had a compressed spinal cord and severe neck pain. For more than a decade, dating back to before he started seeing Kertesz, he had been taking about 300 morphine milligram equivalents (MME) of opioids a day — a dosage equivalent to \u003ca href=\"https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">more than three times\u003c/a> the level that clinicians should “avoid or carefully justify,” according to federal officials.\u003c/p>\n\u003cp>Kertesz and Brown tried a 10% dose reduction a few years ago. But Brown became volatile and less active and complained of revived pain, so Kertesz eased back.\u003c/p>\n\u003cp>Kertesz, who treats patients who are or have been homeless, told Brown that he had “incurred risk” with his dose. “Do you know that I wish you hadn’t had your doses increased?” he asked.\u003c/p>\n\u003cp>“Yes,” Brown replied.\u003c/p>\n\u003cp>They could try again to taper the dose to reduce that risk. But Brown had stable housing and activities to keep him busy — he helped his ex-wife out at her home and cleaned up after her Chihuahuas. He had anxiety and sometimes had trouble getting to the clinic because of transportation problems. But there was no evidence he had misused or sold his drugs, or misused other substances.\u003c/p>\n\u003cp>In this case, Kertesz’s takeaway was: “Leave well enough alone.”\u003c/p>\n\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">O\u003c/span>\u003c/span>pioid prescribing has been \u003ca href=\"https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html\" target=\"_blank\" rel=\"noopener noreferrer\">declining since 2012\u003c/a>, though levels remain higher than they were two decades ago. Today, depending on the estimate, anywhere from \u003ca href=\"https://academic.oup.com/painmedicine/article/20/4/724/5301726?utm_content=buffer9586d&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer\" target=\"_blank\" rel=\"noopener noreferrer\">8 million\u003c/a> to \u003ca href=\"https://academic.oup.com/painmedicine/article/20/3/429/5218985\" target=\"_blank\" rel=\"noopener noreferrer\">18 million\u003c/a> Americans take opioids for chronic pain.\u003c/p>\n\u003cp>The interest in reducing their dosages is predicated in part on efforts to minimize patients’ risk of overdose and addiction. But there are other considerations. Enduring opioid use makes people more sensitive to pain, many experts believe. Opioid use has also been associated with anxiety, depression, and other health issues.\u003c/p>\n\u003cp>Plus, as people become dependent, the drugs might just be staving off symptoms of withdrawal that would come without another dose, rather than treating the original source of pain.\u003c/p>\n\u003cp>In short, experts say, long-term opioid use is not good medicine.\u003c/p>\n\u003cp>Kertesz, who is also a professor at the University of Alabama at Birmingham School of Medicine, agrees with all of that. But he believes that lowering dosages will hurt some patients who are leading functional lives on opioids, and that top-down strategies won’t protect them.\u003c/p>\n\u003cp>So, in 2015, when the Centers for Disease Control and Prevention proposed prescribing guidelines for primary care clinicians treating chronic pain, Kertesz grew nervous.\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/pharmalot/2016/03/15/opioids-painkillers-cdc/\">The guidelines\u003c/a>, a set of \u003ca href=\"https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fvolumes%2F65%2Frr%2Frr6501e1er.htm#contribAff\" target=\"_blank\" rel=\"noopener noreferrer\">measured recommendations\u003c/a> finalized in March 2016, suggested clinicians try other therapies for pain before moving to opioids and prescribe only the lowest effective dose and duration of the drugs. (The guidelines do not apply to end-of-life or cancer care.) For patients on high doses, the guidelines said, “If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.”\u003c/p>\n\u003cp>“Our day-to-day practice aligns with nearly all principles laid out in the guideline,” Kertesz wrote in \u003ca href=\"https://medium.com/@StefanKertesz/considering-cdc-s-proposed-2016-guideline-for-prescribing-opioids-for-chronic-pain-a-good-start-e7cf22be40cd\" target=\"_blank\" rel=\"noopener noreferrer\">a comment\u003c/a> he submitted on the draft. But he cautioned the voluntary recommendations could be implemented too stringently by others.\u003c/p>\n\u003cp>“This is a guideline like no other … its guidance will affect the immediate well-being of millions of Americans with chronic pain,” he wrote.\u003c/p>\n\u003cp>After the release of the guidelines, Kertesz started seeing ripple effects. In early 2017, federal officials \u003ca href=\"https://www.politico.com/story/2017/03/docs-warn-that-medicare-crackdown-will-hurt-pain-patients-235917\" target=\"_blank\" rel=\"noopener noreferrer\">unveiled a Medicare proposal\u003c/a> that would have blocked prescriptions higher than 90 MME without a special review. Around the same time, the National Committee for Quality Assurance considered docking clinicians’ scores if they had patients on high doses for long periods.\u003c/p>\n\u003cp>Kertesz, other experts, and \u003ca href=\"https://www.medpagetoday.com/meetingcoverage/ama/76256\" target=\"_blank\" rel=\"noopener noreferrer\">some medical societies\u003c/a> protested such proposals, contending they invoked the CDC guidelines while violating them.\u003c/p>\n\u003cfigure id=\"attachment_1942586\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-1942586\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/05/GettyImages-678211-800x525.jpg\" alt=\"\" width=\"800\" height=\"525\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-800x525.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-160x105.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-768x504.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-1020x669.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-1200x787.jpg 1200w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211-1920x1260.jpg 1920w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/GettyImages-678211.jpg 2048w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">The prescription medicine OxyContin is displayed. \u003ccite>(Darren McCollester/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“Most of us wish to see an evolution toward fewer opioid starts and fewer patients at high doses,” Kertesz and colleagues \u003ca href=\"https://medium.com/@StefanKertesz/an-opioid-quality-metric-based-on-dose-alone-80-professionals-respond-to-ncqa-6f9fbaa2338\" target=\"_blank\" rel=\"noopener noreferrer\">wrote in response\u003c/a> to the NCQA plan. “The proposed NCQA measure indulges no such subtleties.”\u003c/p>\n\u003cp>The discussion overall has been hindered by limited research, including evidence for the benefits of forced tapering. But \u003ca href=\"http://www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">as of October 2018\u003c/a>, 33 states had codified some prescription limits into law. Pharmacies and insurers capped prescriptions at 90 MME. Law enforcement agencies warned high prescribers.\u003c/p>\n\u003cp>Some initiatives have focused on avoiding “new starts,” not on tapering legacy patients. But Kertesz and other advocates argued the pressure of all the policies and warnings inculcated an anxiety around prescribing.\u003c/p>\n\u003cp>Chronic pain patients were seen as legally risky and medically complicated, so they had trouble finding providers.\u003c/p>\n\u003cp>Kertesz and his allies raised their concerns in \u003ca href=\"https://www.statnews.com/2017/02/24/opioids-prescribing-limits-pain-patients/\" rel=\"\">the popular\u003c/a> and \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27858590\" target=\"_blank\" rel=\"noopener noreferrer\">academic presses\u003c/a> and at conferences, building momentum over the years. They collected anecdotes from patients who said they had been harmed in some way by dose reductions or involuntary tapers.\u003c/p>\n\u003cp>“It is imperative that healthcare professionals and administrators realize that the Guideline does not endorse mandated involuntary dose reduction or discontinuation,” read \u003ca href=\"https://docs.google.com/document/d/1RzQDSppUKhjiAsEmhW2WbTXlP5V8vJ4M_vBPQLKhK_8/edit\" target=\"_blank\" rel=\"noopener noreferrer\">a March letter\u003c/a> co-authored by Kertesz calling on the CDC to reiterate its recommendations were not binding. The letter continued: “Patients have endured not only unnecessary suffering, but some have turned to suicide or illicit substance use.”\u003c/p>\n\u003cp>More than 300 patient advocates and experts, including three former White House drug czars, signed it.\u003c/p>\n\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">K\u003c/span>\u003c/span>ertesz sees his advocacy work as an extension of several throughlines in his career. For one, he has patients who have been on opioids for years, and he knows the stress clinicians face when renewing a high-dose prescription. He also has a history of arguing for causes that stretches back to writing op-eds for his high school newspaper in Silicon Valley.\u003c/p>\n\u003cp>But his willingness to take on what he sees as injustices does not mean he feels self-assured about doing so.\u003c/p>\n\u003cp>“Every single bit of it involves ambivalence and driving myself crazy,” he said. “Like, am I making a mistake? Am I going to blow up my career?”\u003c/p>\n\u003cp>When Kertesz thinks, he leans forward and pulls his hair back. His obsessive streak extends to both his career and his personal life. (He’s become a fencing fanatic, having taken up the sport less than six years ago.) When he talks about medicine, he pauses mid-conversation to point out whether his statements are based on randomized trials or his own inference. He can appear scatterbrained and is working with a coach to become more structured.\u003c/p>\n\u003cp>“He’s not like a heroic figure on a horse. He’s more like a neurotic figure on a horse,” said Dr. Saul Weiner of the University of Illinois at Chicago, who became friends with Kertesz while working at a hospital in Gabon during medical school.\u003c/p>\n\u003cp>Having tenure has made Kertesz more comfortable being outspoken. And he feels he may have more credibility than other physicians to make this specific case. He is a primary care physician who cares for people who are homeless and, beyond some former stock ownership, has no ties to drug companies, as opposed to a pain specialist who received research funding from them. (Kertesz \u003ca href=\"https://twitter.com/StefanKertesz/status/1120865642062630912\" target=\"_blank\" rel=\"noopener noreferrer\">noted\u003c/a> that he recently packed his own PB&J for a conference, the implication being he’ll avoid even a pharma-funded sandwich spread.)\u003c/p>\n\u003cfigure id=\"attachment_1942524\" class=\"wp-caption alignright\" style=\"max-width: 768px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1942524 size-full\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/05/Saul-and-Stefan-in-Gabon-768x504.jpg\" alt=\"\" width=\"768\" height=\"504\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/Saul-and-Stefan-in-Gabon-768x504.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/Saul-and-Stefan-in-Gabon-768x504-160x105.jpg 160w\" sizes=\"(max-width: 768px) 100vw, 768px\">\u003cfigcaption class=\"wp-caption-text\">Kertesz and Saul Weiner working at a hospital in Gabon in the early 1990s. \u003ccite>(Saul Weiner)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>But other leaders of Health Professionals for Patients in Pain, the group that wrote the March letter calling on the CDC to clarify its guidelines, have projects that are supported by drug companies. They \u003ca href=\"https://healthprofessionalsforpatientsinpain.org/about-us\" target=\"_blank\" rel=\"noopener noreferrer\">disclose as much\u003c/a> on the group’s site, but it’s left the group exposed to the criticism that it’s not wholly removed from the pharmaceutical industry.\u003c/p>\n\u003cp>Kertesz “certainly is very close to people who are being paid by opioid manufacturers,” said Dr. Adriane Fugh-Berman of Georgetown University, who studies the pharma industry’s influence on medicine. “He’s certainly worked with people who have close ties to opioid manufacturers.”\u003c/p>\n\u003cp>Kertesz said that because of the industry’s history of opioid promotion, such criticisms need to be part of the discussion.\u003c/p>\n\u003cp>Fugh-Berman is among the experts who have challenged Kertesz’s most alarming claim: that pain patients are being driven to suicide. They argue advocates are relying on anecdotes more suited to a political candidate’s barnstorming of Iowa than the kind of scientific evidence needed to substantiate claims of a new epidemic. Establishing cause and effect in suicide is complex, and studies have shown \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMra1802148\" target=\"_blank\" rel=\"noopener noreferrer\">an association between opioid use and suicide\u003c/a>.\u003c/p>\n\u003cp>“Where is your evidence of documented suicides from people who are tapered?” Fugh-Berman \u003ca href=\"https://www.youtube.com/watch?v=LR4lpvAZ8sY\" target=\"_blank\" rel=\"noopener noreferrer\">asked Kertesz\u003c/a> following a presentation at a conference last year.\u003c/p>\n\u003cp>Kertesz replied that he had \u003ca href=\"https://www.healthaffairs.org/do/10.1377/hblog20180117.832392/full/\" target=\"_blank\" rel=\"noopener noreferrer\">reviewed medical records\u003c/a> from people who had died by suicide after an opioid reduction. He added a caveat: “You have three things that are potentially simultaneously associated with harm: Pain itself. Opioid dependence, the dependence itself. And the event, however we wish to interpret it clinically — as resurgent pain or untreated opioid dependence — in patients who are having opioids taken away.”\u003c/p>\n\u003cp>Kertesz is now trying to secure funding to study such suicides.\u003c/p>\n\u003cp>Fugh-Berman and Kertesz are often cast as representatives of two fundamentally opposed camps. (Indeed, Stanford’s Lembke and Kertesz are slated \u003ca href=\"https://amersa.org/conference/conference-at-a-glance/\" target=\"_blank\" rel=\"noopener noreferrer\">to square off in a “spicy debate”\u003c/a> at an upcoming medical conference.)\u003c/p>\n\u003cp>Such a framing elides what they agree on. Kertesz emphasizes that opioids were massively overprescribed, that the patients he’s worried about should have never been on these doses, and that many patients will be better off after tapering. Lembke stresses that tapers need to go slowly and that patients should be monitored closely during the process — never pushed out of care.\u003c/p>\n\u003cp>But they disagree on exactly how to go about lowering prescribing and the proportion of patients who can be tapered without compromising quality of life.\u003c/p>\n\u003cp>Lembke argues that top-down policies are required to counter all the incentives clinicians have to keep patients on opioids. She has called for medical centers to establish teams that can guide patients through the process. She also said that some patients should be switched to \u003ca href=\"https://www.statnews.com/2019/04/30/loosen-restrictions-on-prescribing-buprenorphine-addiction-treatment/\">buprenorphine\u003c/a> — an opioid addiction medication that eases withdrawal symptoms — even if they do not meet the diagnosis of opioid use disorder.\u003c/p>\n\u003cp>“To leave them at those doses because it’s too hard, that’s not OK,” she said.\u003c/p>\n\u003cp>Lembke noted that prescription policies typically include exceptions for some patients to remain on high-dose opioids.\u003c/p>\n\u003cp>“There are rare instances where I would agree that maybe the most judicious path is ‘leave well enough alone,’” she said. “But that would be where the patient has to commute four hours to get to my clinic, they have no social support, they have no family, they have no psychological or emotional resources to help them do this hard thing which really from a medical perspective they need to do.”\u003c/p>\n\u003cp>Kertesz takes a different view. He supports doctors who encourage tapers, and \u003ca href=\"https://www.youtube.com/watch?v=u9F-vAVQvGM\" target=\"_blank\" rel=\"noopener noreferrer\">he has spoken\u003c/a> about tapering a patient off her medications against her wishes in one case. But he believes those are choices for clinicians to make, and that overarching policies will lead to mismanaged care.\u003c/p>\n\u003cp>Backing mandatory limits, he said, “assumes that what’s going to happen at the systems level will reflect the best clinician.”\u003c/p>\n\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">L\u003c/span>\u003c/span>ast month, the authors of the CDC guidelines \u003ca href=\"https://www.statnews.com/2019/04/24/cdc-opioid-prescribing-guidelines-misapplied/\">published a paper\u003c/a> that said “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations.” They \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMp1904190?query=featured_home\" target=\"_blank\" rel=\"noopener noreferrer\">called out\u003c/a> “hard limits and abrupt tapering of drug dosages” that their guidance did not endorse.\u003c/p>\n\u003cp>It was what Kertesz and his colleagues had been asking for. But now, they face the more difficult task of \u003ca href=\"https://www.statnews.com/2019/04/26/no-shortcuts-prescribing-opioids-chronic-pain/\" rel=\"\">ensuring every group\u003c/a> that overshot the CDC guidelines corrects course.\u003c/p>\n\u003cp>The national attention Kertesz has received for his efforts felt far removed from the room where he was seeing his patients earlier this month. One was in the midst of a taper experiment, from 40 MME to 35 MME a day. But there was also talk of blood pressure medications and cancer screenings — primary care basics.\u003c/p>\n\u003cp>Then there was Byron, 47. He asked that his last name not be used, but Kertesz and the staff at the clinic called him their Jonah. He had been swallowed up by his addiction and maybe should have died, but here he was, like God had some plan for him.\u003c/p>\n\u003cp>Byron was staying at a recovery home, but he felt listless without the rush of drugs or living on the street, he told Kertesz. Kertesz bumped up his buprenorphine dose, but the existential anguish was a harder problem to address.\u003c/p>\n\u003cp>“At any given moment, any one of us feels unsure about who to be or what to do or how to do it,” Kertesz told him.\u003c/p>\n\u003cp>“You have extra burdens, but you’re not alone,” he continued. “Everyone has times when they don’t have clarity.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2019/05/20/googles-ai-improves-accuracy-of-lung-cancer-diagnosis-study-shows/\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\">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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"title": "The Half Dome Lottery System Was Supposed to Make the Hike Safer. This Study Says It Hasn’t",
"headTitle": "The Half Dome Lottery System Was Supposed to Make the Hike Safer. This Study Says It Hasn’t | KQED",
"content": "\u003cp>Anyone attempting to summit Yosemite National Park’s iconic Half Dome rock formation during the 2000s would have likely found a bottleneck of hikers along the breathtaking final push up a steep incline of sheer granite.\u003cbr>\n[pullquote size='medium' align='right' citation='Susanne Spano, UCSF']‘The permits were put in place for the right reasons — to make it safer for the people that are participating. It just so happens that there is no safety benefit.’[/pullquote]On a busy day, more than 1,000 people made the climb, and park officials worried that so many hikers using the cables put in place to assist their ascent made for dangerous conditions.\u003c/p>\n\u003cp>“This restriction is needed to provide for visitor safety,” the park service wrote at the time in a \u003ca href=\"https://www.nps.gov/yose/planyourvisit/upload/halfdomemanagement.pdf\">\u003cspan style=\"font-weight: 400;\">policy paper\u003c/span>\u003c/a>. The number of daily visitors was subsequently lowered even more, to 300.\u003c/p>\n\u003cp>But an \u003ca href=\"https://www.wemjournal.org/article/S1080-6032(18)30218-7/fulltext\">\u003cspan style=\"font-weight: 400;\">analysis\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400;\"> of the park’s injury numbers, out this month in the journal \u003c/span>\u003ci>\u003cspan style=\"font-weight: 400;\">Wilderness & Environmental Medicine, \u003c/span>\u003c/i>\u003cspan style=\"font-weight: 400;\">found that the number of accidents involving Half Dome hikers were statistically the same for the five years before and after the park began its permitting policy, despite the fact that up to 66% fewer hikers summited each day. \u003c/span>\u003c/p>\n\u003cp>“Overcrowding does not seem to be the major factor influencing safety,” said Susanne Spano, the study’s lead author and director of the Wilderness Medicine fellowship program at UCSF Fresno. \u003cspan style=\"font-weight: 400;\">“The permits were put in place for the right reasons — to make it safer for the people that are participating. It just so happens that there is no safety benefit.” \u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Researchers found that from 2005 to 2009, before the lottery, Yosemite logged 85 search and rescue incidents, 134 accidents, and 38 major incidents. Between 2011 and 2015, the park saw 54 search and rescue incidents, 156 victims, and 35 major incidents. The park saw a decrease of three deaths, however, from seven to four. \u003c/span>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Long, Steep\u003c/strong>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">At between 14 to 16 miles round trip\u003cstrong>, \u003c/strong>including roughly 5,000 feet of elevation gain, the trek up Half Dome is one of the longest and steepest single-day hikes in the entire national park system, taking about 12 hours.\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">Additionally, the trailhead is easily accessible by car, which makes it a draw for more inexperienced hikers. Other hikes of similar difficulty, like the summit of nearby Mount Whitney (the tallest mountain in the Sierra), are less frequented, requiring more preparation and time in the backcountry. \u003c/span>\u003c/p>\n\u003cp>One stated reason for initiating the permitting system was the crowding on the incline up the summit. But the study in \u003ci>\u003cspan style=\"font-weight: 400;\">Wilderness & Environmental Medicine \u003c/span>\u003c/i>suggests that hikers are mostly getting hurt on the trail before that final leg, according to John Rose, professor of emergency medicine at the UC Davis Medical Center, who was not involved in the study.\u003c/p>\n\u003cp>“[The research] supports the idea that the problem was probably not related to just having too many people on the cable.” Rose cautioned that the \u003ca href=\"https://www.statsdirect.com/help/basics/prospective.htm\" target=\"_blank\" rel=\"noopener\">retrospective \u003c/a>study’s limitations include a small data set.\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Trailhead quotas are often used in national parks to limit the number of visitors and provide opportunities for solitude, but it’s less common for permit policies to be created in order to protect the health of hikers and backpackers. Spano’s research team is unaware of any other program like Yosemite’s.\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">Still, if people are getting hurt, it’s important to figure out why, and the park should consider additional safety measures, says Kathryn Van Waes, executive director of the American Hiking Society. \u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">“It needs to be looked into,” she said, suggesting Yosemite consult safety measures taken by parks with similarly perilous trails. “There are other places with these kinds of dangerous hikes in China, Switzerland and places in South America.” \u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Van Waes suggested that an educational video explaining the dangers of Half Dome , shown as part of the permitting process, could help deter inexperienced hikers. \u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">A more extreme measure would be requiring guides to assist with the climb, she said, acknowledging such a measure would be unpopular with visitors and could create liability concerns. \u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_1941842\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1941842 size-medium\" style=\"font-weight: bold; background-color: transparent; color: #767676;\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-800x600.jpg\" alt=\"\" width=\"800\" height=\"600\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-800x600.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-160x120.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-768x576.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-1020x765.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-1200x900.jpg 1200w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o.jpg 1280w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">A warning sign posted on the trek up to Half Dome in Yosemite National Park. (Mike Wexler/Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>A Tough Ticket\u003c/strong>\u003c/p>\n\u003cp>Spano said one thing possibly contributing to Half Dome injuries is “summit fever,” predicated on the difficulty that average hikers have acquiring permits. \u003cspan style=\"font-weight: 400;\">The park issues them through a preseason lottery in March and daily lotteries during hiking season, normally May to October, when the guide cables are up.\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Now that the opportunity to ascend Half Dome has been curtailed, Spano said, hikers may be pressing on even though they feel fatigued. “You might never have a chance to get back,” she said.\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">In 2017, the success rate for the preseason lottery was as low as 2% for weekend dates and 32% for weekdays, \u003c/span>\u003cspan style=\"font-weight: 400;\">San Francisco Chronicle columnist Tom Stienstra \u003c/span>\u003ca href=\"https://www.sfchronicle.com/travel/article/Yosemite-is-changing-Half-Dome-hiking-permits-13722202.php\">\u003cspan style=\"font-weight: 400;\">reported\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400;\"> in March. Stienstra said that computer programmers “essentially have rigged the online-permit system.” \u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">In 2018, the average success rate improved to 47% on weekdays and 24% on weekends, according to the park’s \u003c/span>\u003cspan style=\"font-weight: 400;\">\u003ca href=\"https://www.nps.gov/yose/planyourvisit/hdpermits.htm\" target=\"_blank\" rel=\"noopener\">lottery statistics\u003c/a>. \u003c/span>This year, the park tinkered with the system in order to curb the selling and transferring of permits, The Mercury News \u003ca href=\"https://www.mercurynews.com/2019/03/13/yosemite-half-dome-permits-available-for-2019/\" target=\"_blank\" rel=\"noopener\">reported\u003c/a>.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Yosemite officials recommend that Half Dome hikers wear boots with traction, protect themselves from the sun, and drink at least a gallon of water. It’s not common for cell phones to work in the backcountry, even though there is some \u003ca href=\"https://www.nps.gov/yose/planyourvisit/internet.htm\">cell reception in the park\u003c/a>, mostly in Yosemite Valley. The park also suggests a hard-and-fast turnaround time — if you haven’t reached the top by midafternoon, you should reverse course so you aren’t hiking by headlamp in the dark. But bring a light just in case.\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003c/p>\n\u003cp>\u003cem>This story originally incorrectly cited the study’s injury statistics as parkwide and not limited to the area above Little Yosemite Valley.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n",
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"excerpt": "In 2010, Yosemite began a permitting lottery for visitors to Half Dome, out of safety concerns due to overcrowding on the trail. But a recent analysis of the park’s injury numbers found that the system did not reduce accidents.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Anyone attempting to summit Yosemite National Park’s iconic Half Dome rock formation during the 2000s would have likely found a bottleneck of hikers along the breathtaking final push up a steep incline of sheer granite.\u003cbr>\n\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>On a busy day, more than 1,000 people made the climb, and park officials worried that so many hikers using the cables put in place to assist their ascent made for dangerous conditions.\u003c/p>\n\u003cp>“This restriction is needed to provide for visitor safety,” the park service wrote at the time in a \u003ca href=\"https://www.nps.gov/yose/planyourvisit/upload/halfdomemanagement.pdf\">\u003cspan style=\"font-weight: 400;\">policy paper\u003c/span>\u003c/a>. The number of daily visitors was subsequently lowered even more, to 300.\u003c/p>\n\u003cp>But an \u003ca href=\"https://www.wemjournal.org/article/S1080-6032(18)30218-7/fulltext\">\u003cspan style=\"font-weight: 400;\">analysis\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400;\"> of the park’s injury numbers, out this month in the journal \u003c/span>\u003ci>\u003cspan style=\"font-weight: 400;\">Wilderness & Environmental Medicine, \u003c/span>\u003c/i>\u003cspan style=\"font-weight: 400;\">found that the number of accidents involving Half Dome hikers were statistically the same for the five years before and after the park began its permitting policy, despite the fact that up to 66% fewer hikers summited each day. \u003c/span>\u003c/p>\n\u003cp>“Overcrowding does not seem to be the major factor influencing safety,” said Susanne Spano, the study’s lead author and director of the Wilderness Medicine fellowship program at UCSF Fresno. \u003cspan style=\"font-weight: 400;\">“The permits were put in place for the right reasons — to make it safer for the people that are participating. It just so happens that there is no safety benefit.” \u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Researchers found that from 2005 to 2009, before the lottery, Yosemite logged 85 search and rescue incidents, 134 accidents, and 38 major incidents. Between 2011 and 2015, the park saw 54 search and rescue incidents, 156 victims, and 35 major incidents. The park saw a decrease of three deaths, however, from seven to four. \u003c/span>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Long, Steep\u003c/strong>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">At between 14 to 16 miles round trip\u003cstrong>, \u003c/strong>including roughly 5,000 feet of elevation gain, the trek up Half Dome is one of the longest and steepest single-day hikes in the entire national park system, taking about 12 hours.\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">Additionally, the trailhead is easily accessible by car, which makes it a draw for more inexperienced hikers. Other hikes of similar difficulty, like the summit of nearby Mount Whitney (the tallest mountain in the Sierra), are less frequented, requiring more preparation and time in the backcountry. \u003c/span>\u003c/p>\n\u003cp>One stated reason for initiating the permitting system was the crowding on the incline up the summit. But the study in \u003ci>\u003cspan style=\"font-weight: 400;\">Wilderness & Environmental Medicine \u003c/span>\u003c/i>suggests that hikers are mostly getting hurt on the trail before that final leg, according to John Rose, professor of emergency medicine at the UC Davis Medical Center, who was not involved in the study.\u003c/p>\n\u003cp>“[The research] supports the idea that the problem was probably not related to just having too many people on the cable.” Rose cautioned that the \u003ca href=\"https://www.statsdirect.com/help/basics/prospective.htm\" target=\"_blank\" rel=\"noopener\">retrospective \u003c/a>study’s limitations include a small data set.\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Trailhead quotas are often used in national parks to limit the number of visitors and provide opportunities for solitude, but it’s less common for permit policies to be created in order to protect the health of hikers and backpackers. Spano’s research team is unaware of any other program like Yosemite’s.\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">Still, if people are getting hurt, it’s important to figure out why, and the park should consider additional safety measures, says Kathryn Van Waes, executive director of the American Hiking Society. \u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">“It needs to be looked into,” she said, suggesting Yosemite consult safety measures taken by parks with similarly perilous trails. “There are other places with these kinds of dangerous hikes in China, Switzerland and places in South America.” \u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Van Waes suggested that an educational video explaining the dangers of Half Dome , shown as part of the permitting process, could help deter inexperienced hikers. \u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">A more extreme measure would be requiring guides to assist with the climb, she said, acknowledging such a measure would be unpopular with visitors and could create liability concerns. \u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_1941842\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"wp-image-1941842 size-medium\" style=\"font-weight: bold; background-color: transparent; color: #767676;\" src=\"https://ww2.kqed.org/science/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-800x600.jpg\" alt=\"\" width=\"800\" height=\"600\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-800x600.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-160x120.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-768x576.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-1020x765.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o-1200x900.jpg 1200w, https://cdn.kqed.org/wp-content/uploads/sites/35/2019/05/3655503955_b3a3fc9015_o.jpg 1280w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">A warning sign posted on the trek up to Half Dome in Yosemite National Park. (Mike Wexler/Flickr)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>A Tough Ticket\u003c/strong>\u003c/p>\n\u003cp>Spano said one thing possibly contributing to Half Dome injuries is “summit fever,” predicated on the difficulty that average hikers have acquiring permits. \u003cspan style=\"font-weight: 400;\">The park issues them through a preseason lottery in March and daily lotteries during hiking season, normally May to October, when the guide cables are up.\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Now that the opportunity to ascend Half Dome has been curtailed, Spano said, hikers may be pressing on even though they feel fatigued. “You might never have a chance to get back,” she said.\u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">In 2017, the success rate for the preseason lottery was as low as 2% for weekend dates and 32% for weekdays, \u003c/span>\u003cspan style=\"font-weight: 400;\">San Francisco Chronicle columnist Tom Stienstra \u003c/span>\u003ca href=\"https://www.sfchronicle.com/travel/article/Yosemite-is-changing-Half-Dome-hiking-permits-13722202.php\">\u003cspan style=\"font-weight: 400;\">reported\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400;\"> in March. Stienstra said that computer programmers “essentially have rigged the online-permit system.” \u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003cspan style=\"font-weight: 400;\">In 2018, the average success rate improved to 47% on weekdays and 24% on weekends, according to the park’s \u003c/span>\u003cspan style=\"font-weight: 400;\">\u003ca href=\"https://www.nps.gov/yose/planyourvisit/hdpermits.htm\" target=\"_blank\" rel=\"noopener\">lottery statistics\u003c/a>. \u003c/span>This year, the park tinkered with the system in order to curb the selling and transferring of permits, The Mercury News \u003ca href=\"https://www.mercurynews.com/2019/03/13/yosemite-half-dome-permits-available-for-2019/\" target=\"_blank\" rel=\"noopener\">reported\u003c/a>.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">Yosemite officials recommend that Half Dome hikers wear boots with traction, protect themselves from the sun, and drink at least a gallon of water. It’s not common for cell phones to work in the backcountry, even though there is some \u003ca href=\"https://www.nps.gov/yose/planyourvisit/internet.htm\">cell reception in the park\u003c/a>, mostly in Yosemite Valley. The park also suggests a hard-and-fast turnaround time — if you haven’t reached the top by midafternoon, you should reverse course so you aren’t hiking by headlamp in the dark. But bring a light just in case.\u003c/span>\u003cspan style=\"font-weight: 400;\">\u003cbr>\n\u003c/span>\u003c/p>\n\u003cp>\u003cem>This story originally incorrectly cited the study’s injury statistics as parkwide and not limited to the area above Little Yosemite Valley.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n\u003c/div>\u003c/p>",
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"headTitle": "Google AI Outperforms Radiologists in Lung Cancer Diagnoses: Study | KQED",
"content": "\u003cp>\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">O\u003c/span>\u003c/span>ne of lung cancer’s most lethal attributes is its ability to trick radiologists. Some nodules appear threatening but turn out to be false positives. Others escape notice entirely, and then spiral without symptoms into metastatic disease.\u003c/p>\n\u003cp class=\"danger-zone\">\u003cspan style=\"font-weight: 400;\">[aside postID='futureofyou_256816' \u003c/span>\u003ci>\u003cspan style=\"font-weight: 400;\">label=\u003c/span>\u003c/i>\u003cspan style=\"font-weight: 400;\">'Has Technology Ruined the Radiology Profession?\u003c/span>\u003cspan style=\"font-weight: 400;\">']\u003c/span>On Monday, however, Google unveiled an artificial intelligence system that — in early testing — demonstrated a remarkable talent for seeing through lung cancer’s disguises.\u003c/p>\n\u003cp class=\"danger-zone\">A \u003ca href=\"http://track.nature.com/track/click/30195101/www.nature.com?p=eyJzIjoicTBxSFlxcFRWaUltRDVsd2FRSGNRRXJNV3JzIiwidiI6MSwicCI6IntcInVcIjozMDE5NTEwMSxcInZcIjoxLFwidXJsXCI6XCJodHRwczpcXFwvXFxcL3d3dy5uYXR1cmUuY29tXFxcL2FydGljbGVzXFxcL3M0MTU5MS0wMTktMDQ0Ny14XCIsXCJpZFwiOlwiZTU3ZWRiYjZkNzc2NDU3Yjg2OThiMDVkMGM1MzgyYmVcIixcInVybF9pZHNcIjpbXCJkYjkwMzZjZDA4Y2JjNGQ3OTdkODVjYjYyOWE4ZWEyZjE1NTNmMzk3XCJdfSJ9\" target=\"_blank\" rel=\"noopener\">study\u003c/a> published in Nature Medicine reported that the algorithm, trained on 42,000 patient CT scans taken during a National Institutes of Health clinical trial, outperformed six radiologists in determining whether patients had cancer. It detected 5% more cancers and cut false positives — when cancer is suspected though a nodule is harmless — by 11% from reviewing a single scan. It performed on par with the radiologists when prior images of patients were also included in the evaluation.\u003c/p>\n\u003cp class=\"\">The results underscore AI’s potential to improve lung cancer screening and help radiologists diagnose malignancies earlier and with greater accuracy — though the research did not show whether the Google system would help patients live longer. Lung cancer is by far the most common killer of Americans among cancers, resulting in about 160,000 deaths in 2018.\u003c/p>\n\u003cp class=\"\">A large \u003ca href=\"https://www.cancer.gov/types/lung/research/nlst\" target=\"_blank\" rel=\"noopener\">NIH study\u003c/a> — the same one that supplied data for Google’s algorithm — established that screening of high-risk patients such as long-term smokers can reduce the risk of death by about 20%, but it also raised concerns about false positives leading to unnecessary testing that can harm patients. It reported that several deaths resulted from false positives that led patients to undergo invasive biopsies and other procedures. Ongoing concerns about the overall accuracy and benefit of screening have led to low rates of such testing. Meanwhile, about 50 percent of lung cancers are diagnosed after they have already spread, when the disease is harder to effectively treat.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Experts who were not involved in the study said Google’s system could make screening much more viable.\u003c/p>\n\u003cp>“These people have a technology that will improve the precision of screening tremendously,” said Dr. Otis Brawley, a professor of oncology and epidemiology at Johns Hopkins University and formerly executive vice president of the American Cancer Society. He said he is generally a skeptic of lung cancer screening, but emphasized that Google’s performance in reducing false positives was a significant step forward.\u003c/p>\n\u003cp>“It’s going to prevent more bad things from happening to people who are being screened,” said Brawley, adding that the system’s strong performance in that regard doesn’t necessarily mean it will save more lives from lung cancer.\u003c/p>\n\u003cp>Google’s system will require more rigorous testing — probably a randomized controlled trial — before it could be put into medical practice. The study was limited to patients who had already been treated, so it is impossible to tell whether the system, when used on new patients, will result in more effective care and better outcomes.\u003c/p>\n\u003cp>Google executives acknowledged that point in the study and an accompanying blog post, adding that they are working with clinical partners to further refine and validate the system. “To do a full assessment of this, you have to work with research organizations and run large-scale trials to understand how this technology will work at scale and on broad populations,” said Daniel Tse, a Google product manager who co-authored the study. He added that the company has had pre-submission discussions with the Food and Drug Administration to discuss approval criteria.\u003c/p>\n\u003cp>Google engineers who developed the AI system emphasized that it is not designed to replace radiologists, but to improve their ability to detect nodules and determine if they are dangerous. Existing computer-aided systems separate nodule detection and diagnosis into different tasks. Google’s system performs both functions, honing in on regions of interest within a scan and providing a risk score that indicates whether a given patient’s nodules are cancerous.\u003c/p>\n\u003cp>The system uses \u003ca href=\"https://towardsdatascience.com/simple-introduction-to-convolutional-neural-networks-cdf8d3077bac\" target=\"_blank\" rel=\"noopener\">convolutional neural networks\u003c/a>, a type of AI architecture, to learn the features of malignancy and point out the problematic areas by analyzing three-dimensional CT scans. That task is difficult and time-consuming for radiologists because they cannot examine three-dimensional scans the way a computer can; they must review hundreds of individual slices of the scan to hone in on problems. But the computer can review all the dimensions at once.\u003c/p>\n\u003cp>“We were able to train the [AI models] over the whole scan at a very high resolution,” said Shravya Shetty, a Google engineer and technical lead on the study. “Although radiologists can look at the slices, there are clear advantages to the model here.”\u003c/p>\n\u003cp>The authors reported that the system’s performance remained consistent when it was exposed to patients outside of the NIH dataset on which it was trained. The system reviewed scans of 1,700 patients from Northwestern Memorial HealthCare in Chicago, and produced similar results in classifying nodules and making diagnoses.\u003c/p>\n\u003cp>Experts said the Google software may be particularly useful for general radiologists, who often review patient lung scans in community hospitals in the U.S. Most lack the expertise of thoracic radiologists who specialize in lung disorders and are concentrated at large academic medical centers.\u003c/p>\n\u003cp>“To be able to make screening available to everyone, it can’t just be done by thoracic radiologists. It has to be done by all radiologists,” said Dr. Jorge Gomez, a medical oncologist at Mount Sinai Health System who serves as a national spokesman for the American Lung Association.\u003c/p>\n\u003cp>At Mount Sinai, he said, thoracic radiologists regularly participate in meetings to discuss patient care and point out the specific aspects of scans that indicate why nodules may or may not be malignant.\u003c/p>\n\u003cp>“That’s an incredible resource to have, and computers might be able to do that well,” he said. “This is a very important study that should prompt somebody with very deep pockets to do a randomized trial.”\u003c/p>\n\u003cp>Tse, the Google product manager, said the company is actively pursuing that work. “We are pushing things forward both internally within Google and with our partners,” he said, adding that he could not yet identify the time frame for the follow-up study.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2019/05/20/googles-ai-improves-accuracy-of-lung-cancer-diagnosis-study-shows/\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com/\">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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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/span>On Monday, however, Google unveiled an artificial intelligence system that — in early testing — demonstrated a remarkable talent for seeing through lung cancer’s disguises.\u003c/p>\n\u003cp class=\"danger-zone\">A \u003ca href=\"http://track.nature.com/track/click/30195101/www.nature.com?p=eyJzIjoicTBxSFlxcFRWaUltRDVsd2FRSGNRRXJNV3JzIiwidiI6MSwicCI6IntcInVcIjozMDE5NTEwMSxcInZcIjoxLFwidXJsXCI6XCJodHRwczpcXFwvXFxcL3d3dy5uYXR1cmUuY29tXFxcL2FydGljbGVzXFxcL3M0MTU5MS0wMTktMDQ0Ny14XCIsXCJpZFwiOlwiZTU3ZWRiYjZkNzc2NDU3Yjg2OThiMDVkMGM1MzgyYmVcIixcInVybF9pZHNcIjpbXCJkYjkwMzZjZDA4Y2JjNGQ3OTdkODVjYjYyOWE4ZWEyZjE1NTNmMzk3XCJdfSJ9\" target=\"_blank\" rel=\"noopener\">study\u003c/a> published in Nature Medicine reported that the algorithm, trained on 42,000 patient CT scans taken during a National Institutes of Health clinical trial, outperformed six radiologists in determining whether patients had cancer. It detected 5% more cancers and cut false positives — when cancer is suspected though a nodule is harmless — by 11% from reviewing a single scan. It performed on par with the radiologists when prior images of patients were also included in the evaluation.\u003c/p>\n\u003cp class=\"\">The results underscore AI’s potential to improve lung cancer screening and help radiologists diagnose malignancies earlier and with greater accuracy — though the research did not show whether the Google system would help patients live longer. Lung cancer is by far the most common killer of Americans among cancers, resulting in about 160,000 deaths in 2018.\u003c/p>\n\u003cp class=\"\">A large \u003ca href=\"https://www.cancer.gov/types/lung/research/nlst\" target=\"_blank\" rel=\"noopener\">NIH study\u003c/a> — the same one that supplied data for Google’s algorithm — established that screening of high-risk patients such as long-term smokers can reduce the risk of death by about 20%, but it also raised concerns about false positives leading to unnecessary testing that can harm patients. It reported that several deaths resulted from false positives that led patients to undergo invasive biopsies and other procedures. Ongoing concerns about the overall accuracy and benefit of screening have led to low rates of such testing. Meanwhile, about 50 percent of lung cancers are diagnosed after they have already spread, when the disease is harder to effectively treat.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Experts who were not involved in the study said Google’s system could make screening much more viable.\u003c/p>\n\u003cp>“These people have a technology that will improve the precision of screening tremendously,” said Dr. Otis Brawley, a professor of oncology and epidemiology at Johns Hopkins University and formerly executive vice president of the American Cancer Society. He said he is generally a skeptic of lung cancer screening, but emphasized that Google’s performance in reducing false positives was a significant step forward.\u003c/p>\n\u003cp>“It’s going to prevent more bad things from happening to people who are being screened,” said Brawley, adding that the system’s strong performance in that regard doesn’t necessarily mean it will save more lives from lung cancer.\u003c/p>\n\u003cp>Google’s system will require more rigorous testing — probably a randomized controlled trial — before it could be put into medical practice. The study was limited to patients who had already been treated, so it is impossible to tell whether the system, when used on new patients, will result in more effective care and better outcomes.\u003c/p>\n\u003cp>Google executives acknowledged that point in the study and an accompanying blog post, adding that they are working with clinical partners to further refine and validate the system. “To do a full assessment of this, you have to work with research organizations and run large-scale trials to understand how this technology will work at scale and on broad populations,” said Daniel Tse, a Google product manager who co-authored the study. He added that the company has had pre-submission discussions with the Food and Drug Administration to discuss approval criteria.\u003c/p>\n\u003cp>Google engineers who developed the AI system emphasized that it is not designed to replace radiologists, but to improve their ability to detect nodules and determine if they are dangerous. Existing computer-aided systems separate nodule detection and diagnosis into different tasks. Google’s system performs both functions, honing in on regions of interest within a scan and providing a risk score that indicates whether a given patient’s nodules are cancerous.\u003c/p>\n\u003cp>The system uses \u003ca href=\"https://towardsdatascience.com/simple-introduction-to-convolutional-neural-networks-cdf8d3077bac\" target=\"_blank\" rel=\"noopener\">convolutional neural networks\u003c/a>, a type of AI architecture, to learn the features of malignancy and point out the problematic areas by analyzing three-dimensional CT scans. That task is difficult and time-consuming for radiologists because they cannot examine three-dimensional scans the way a computer can; they must review hundreds of individual slices of the scan to hone in on problems. But the computer can review all the dimensions at once.\u003c/p>\n\u003cp>“We were able to train the [AI models] over the whole scan at a very high resolution,” said Shravya Shetty, a Google engineer and technical lead on the study. “Although radiologists can look at the slices, there are clear advantages to the model here.”\u003c/p>\n\u003cp>The authors reported that the system’s performance remained consistent when it was exposed to patients outside of the NIH dataset on which it was trained. The system reviewed scans of 1,700 patients from Northwestern Memorial HealthCare in Chicago, and produced similar results in classifying nodules and making diagnoses.\u003c/p>\n\u003cp>Experts said the Google software may be particularly useful for general radiologists, who often review patient lung scans in community hospitals in the U.S. Most lack the expertise of thoracic radiologists who specialize in lung disorders and are concentrated at large academic medical centers.\u003c/p>\n\u003cp>“To be able to make screening available to everyone, it can’t just be done by thoracic radiologists. It has to be done by all radiologists,” said Dr. Jorge Gomez, a medical oncologist at Mount Sinai Health System who serves as a national spokesman for the American Lung Association.\u003c/p>\n\u003cp>At Mount Sinai, he said, thoracic radiologists regularly participate in meetings to discuss patient care and point out the specific aspects of scans that indicate why nodules may or may not be malignant.\u003c/p>\n\u003cp>“That’s an incredible resource to have, and computers might be able to do that well,” he said. “This is a very important study that should prompt somebody with very deep pockets to do a randomized trial.”\u003c/p>\n\u003cp>Tse, the Google product manager, said the company is actively pursuing that work. “We are pushing things forward both internally within Google and with our partners,” he said, adding that he could not yet identify the time frame for the follow-up study.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>The Bay Area has gotten well and truly soaked this year, with some cities near or already surpassing their average rainfall for the entire water year.\u003c/p>\n\u003cp>[pullquote size='medium' align='right' citation='Dr. Kari Nadeau, Stanford University']‘I’ve seen a lot more people come in with very severe symptoms. People calling me in the middle of the night just saying they can’t stop sneezing, and they can’t stop coughing and having mucus congestion. That is different than 10 years ago.’[/pullquote]But what’s good for our water supply can be a pain in the ear, nose and throat for allergy sufferers. All that rain means more plants growing, which also means more pollen, the fine powder produced by plants’ reproductive organs, called the stamen. Pollen is the cause of most seasonal allergies, and the pollen count indicates how much of it is floating around in the air.\u003c/p>\n\u003cp>“This pollen season was particularly bad because it rained so heavily and abruptly stopped, and everything pollinated,” said Dr. Michelle Huffaker, of the Allergy and Asthma Medical Group of the Bay Area. “We experienced an overlap between trees and grasses, with really high burdens of pollen each. That was particularly bad for folks’ symptoms.”\u003c/p>\n\u003cp>For the \u003ca href=\"https://www.aaaai.org/about-aaaai/newsroom/allergy-statistics\">7.8% of U.S. adults\u003c/a> that suffer from hay fever, that means sneezing, congestion, watery eyes and general discomfort, according to the American Academy of Allergy, Asthma, and Immunology, not to mention legions of sneezing, congested, watery-eyed and generally discomforted sufferers.\u003cbr>\n[aside postID=”science_1940604,science_1930023″ label=”Bay Area Pollen Forecast”[/aside]Daniel Mackey, 56, a resident of San Francisco, has struggled with pollen allergies for 20 years. “I’ve never suffered as badly as I did this year,” Mackey said.\u003c/p>\n\u003cp>Ordinarily, he buys loads of antihistamine when his allergies act up, typically in April. That’s usually enough to keep his symptoms at bay.\u003c/p>\n\u003cp>“This year has been far more difficult,” he said. “It just makes your life unmanageable. It does seem to be getting increasingly worse each year, but this year was particularly bad.”\u003c/p>\n\u003cp>For children with difficult-to-control asthma or people that don’t have access to inhalers, medication and other treatment, a bad reaction could mean a trip to the intensive care unit. Although rare, the most dire allergy attacks can be life-threatening.\u003c/p>\n\u003cp>\u003cstrong>Is Global Warming Making Your Allergies Worse?\u003c/strong>\u003c/p>\n\u003cp>Here’s the long-term outlook: Pollen season is starting earlier and lasting longer. That alone could spell trouble for allergy sufferers. But in addition, plants are producing more pollen, so not only is the season lengthening, it’s also more severe.\u003c/p>\n\u003cp>One reason for this unwelcome shift is that climate change is pushing temperatures higher, according to researcher Lewis Ziska, a plant physiologist with the U.S. Department of Agriculture’s research service.\u003c/p>\n\u003cp>“Bottom line, there is a clear effect of temperature increasing the length of the season but also increasing the intensity,” Ziska said.\u003c/p>\n\u003cp>The negative trend in pollen would seem to extend well beyond the Bay Area, according to a recently published \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/30904111\">retrospective\u003c/a> \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/30904111\">study\u003c/a> \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/30904111\">in\u003c/a> \u003cem>Lancet Planet Health. \u003c/em>The study, on which Ziska was the lead author, analyzed at least 20 years of pollen data from 17 locations across the Northern Hemisphere. Twelve of the 17 areas experienced increases in annual pollen count, and 11 of 17 endured a longer season.\u003c/p>\n\u003cp>Additionally, a 2014 study \u003ca href=\"https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0111712\">published\u003c/a> in the journal \u003cem>PLOS On\u003c/em>e suggested that elevated levels of carbon dioxide can increase the amount of pollen some plants produce, by as much as 50% per flower.\u003c/p>\n\u003cp>The researchers, from Harvard and the University of Massachusetts, Amherst, estimated that grass pollen, the scourge of many Bay Area allergy suffers, will increase by up to 200%.\u003c/p>\n\u003cp>“We are concerned about the future; if we consistently see temperature changes, that [is] going to mean enormous consequences in terms of allergy season and for people’s health,” Ziska said.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>That future may have already begun, according to Dr. Kari Nadeau, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University.\u003c/p>\n\u003cp>“I see both adults and kids,” Nadeau said. “I’ve seen a lot more people come in with very severe symptoms. People calling me in the middle of the night just saying they can’t stop sneezing, and they can’t stop coughing and having mucus congestion. That is different than 10 years ago.”\u003c/p>\n\u003cp>\u003cstrong>Spikes Througout the Year\u003c/strong>\u003c/p>\n\u003cp>The Bay Area experiences three pollen spikes throughout the year, says Nadeau.\u003c/p>\n\u003cp>Juniper bushes and cypress, cedar and other trees release pollen beginning in January.\u003c/p>\n\u003cp>Pollen from annual grasses increases in April and into June, followed by a surge in summer weed pollen\u003cstrong>. \u003c/strong>While the ragweed pollen count jumps during the fall months on the East Coast, it’s not as much of a problem in California.\u003c/p>\n\u003cp>Nadeau added that experts typically know the contours of allergy season, with some variation each year. But even that’s changing. “The problem is there’s more and more of these plants that are now secreting these pollen,” Nadeau said.\u003cstrong>\u003cbr>\n\u003c/strong>\u003cbr>\nSan Francisco resident Mackey said his allergies have put a crimp in what is normally an upbeat time of year.\u003c/p>\n\u003cp>“At the advent of spring, normally people are happy,” he said. “For me, it’s a trial for a few weeks. It’s one of those things that you have to experience to know how debilitating it is.”\u003c/p>\n\u003cp>\u003cem>You can find resources for dealing with hay fever and information about allergies at the \u003c/em>\u003cem>American\u003c/em> \u003cem>Academy\u003c/em> \u003cem>of\u003c/em> \u003cem>Allergy\u003c/em>\u003cem>, \u003c/em>\u003cem>Asthma\u003c/em> \u003cem>and\u003c/em> \u003cem>Immunology’s\u003c/em>\u003cem> \u003ca href=\"https://www.aaaai.org/conditions-and-treatments/Virtual-Allergist\">virtual allergist\u003c/a> and the \u003ca href=\"https://acaai.org/allergies/types/hay-fever-rhinitis\">web site\u003c/a> of the \u003c/em>\u003cem>American\u003c/em> \u003cem>College\u003c/em> \u003cem>of\u003c/em> \u003cem>Allergy,\u003c/em> \u003cem>Asthma,\u003c/em> \u003cem>and\u003c/em> \u003cem>Immunology\u003c/em>\u003cem>.\u003cbr>\n\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n",
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"excerpt": "Abundant rain is good for our chronically challenged water supply, but it can be a pain in the ear, nose and throat for allergy sufferers, as more plants means more pollen. And climate change is only making it worse.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>But what’s good for our water supply can be a pain in the ear, nose and throat for allergy sufferers. All that rain means more plants growing, which also means more pollen, the fine powder produced by plants’ reproductive organs, called the stamen. Pollen is the cause of most seasonal allergies, and the pollen count indicates how much of it is floating around in the air.\u003c/p>\n\u003cp>“This pollen season was particularly bad because it rained so heavily and abruptly stopped, and everything pollinated,” said Dr. Michelle Huffaker, of the Allergy and Asthma Medical Group of the Bay Area. “We experienced an overlap between trees and grasses, with really high burdens of pollen each. That was particularly bad for folks’ symptoms.”\u003c/p>\n\u003cp>For the \u003ca href=\"https://www.aaaai.org/about-aaaai/newsroom/allergy-statistics\">7.8% of U.S. adults\u003c/a> that suffer from hay fever, that means sneezing, congestion, watery eyes and general discomfort, according to the American Academy of Allergy, Asthma, and Immunology, not to mention legions of sneezing, congested, watery-eyed and generally discomforted sufferers.\u003cbr>\n\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>Daniel Mackey, 56, a resident of San Francisco, has struggled with pollen allergies for 20 years. “I’ve never suffered as badly as I did this year,” Mackey said.\u003c/p>\n\u003cp>Ordinarily, he buys loads of antihistamine when his allergies act up, typically in April. That’s usually enough to keep his symptoms at bay.\u003c/p>\n\u003cp>“This year has been far more difficult,” he said. “It just makes your life unmanageable. It does seem to be getting increasingly worse each year, but this year was particularly bad.”\u003c/p>\n\u003cp>For children with difficult-to-control asthma or people that don’t have access to inhalers, medication and other treatment, a bad reaction could mean a trip to the intensive care unit. Although rare, the most dire allergy attacks can be life-threatening.\u003c/p>\n\u003cp>\u003cstrong>Is Global Warming Making Your Allergies Worse?\u003c/strong>\u003c/p>\n\u003cp>Here’s the long-term outlook: Pollen season is starting earlier and lasting longer. That alone could spell trouble for allergy sufferers. But in addition, plants are producing more pollen, so not only is the season lengthening, it’s also more severe.\u003c/p>\n\u003cp>One reason for this unwelcome shift is that climate change is pushing temperatures higher, according to researcher Lewis Ziska, a plant physiologist with the U.S. Department of Agriculture’s research service.\u003c/p>\n\u003cp>“Bottom line, there is a clear effect of temperature increasing the length of the season but also increasing the intensity,” Ziska said.\u003c/p>\n\u003cp>The negative trend in pollen would seem to extend well beyond the Bay Area, according to a recently published \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/30904111\">retrospective\u003c/a> \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/30904111\">study\u003c/a> \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/30904111\">in\u003c/a> \u003cem>Lancet Planet Health. \u003c/em>The study, on which Ziska was the lead author, analyzed at least 20 years of pollen data from 17 locations across the Northern Hemisphere. Twelve of the 17 areas experienced increases in annual pollen count, and 11 of 17 endured a longer season.\u003c/p>\n\u003cp>Additionally, a 2014 study \u003ca href=\"https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0111712\">published\u003c/a> in the journal \u003cem>PLOS On\u003c/em>e suggested that elevated levels of carbon dioxide can increase the amount of pollen some plants produce, by as much as 50% per flower.\u003c/p>\n\u003cp>The researchers, from Harvard and the University of Massachusetts, Amherst, estimated that grass pollen, the scourge of many Bay Area allergy suffers, will increase by up to 200%.\u003c/p>\n\u003cp>“We are concerned about the future; if we consistently see temperature changes, that [is] going to mean enormous consequences in terms of allergy season and for people’s health,” Ziska said.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>That future may have already begun, according to Dr. Kari Nadeau, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University.\u003c/p>\n\u003cp>“I see both adults and kids,” Nadeau said. “I’ve seen a lot more people come in with very severe symptoms. People calling me in the middle of the night just saying they can’t stop sneezing, and they can’t stop coughing and having mucus congestion. That is different than 10 years ago.”\u003c/p>\n\u003cp>\u003cstrong>Spikes Througout the Year\u003c/strong>\u003c/p>\n\u003cp>The Bay Area experiences three pollen spikes throughout the year, says Nadeau.\u003c/p>\n\u003cp>Juniper bushes and cypress, cedar and other trees release pollen beginning in January.\u003c/p>\n\u003cp>Pollen from annual grasses increases in April and into June, followed by a surge in summer weed pollen\u003cstrong>. \u003c/strong>While the ragweed pollen count jumps during the fall months on the East Coast, it’s not as much of a problem in California.\u003c/p>\n\u003cp>Nadeau added that experts typically know the contours of allergy season, with some variation each year. But even that’s changing. “The problem is there’s more and more of these plants that are now secreting these pollen,” Nadeau said.\u003cstrong>\u003cbr>\n\u003c/strong>\u003cbr>\nSan Francisco resident Mackey said his allergies have put a crimp in what is normally an upbeat time of year.\u003c/p>\n\u003cp>“At the advent of spring, normally people are happy,” he said. “For me, it’s a trial for a few weeks. It’s one of those things that you have to experience to know how debilitating it is.”\u003c/p>\n\u003cp>\u003cem>You can find resources for dealing with hay fever and information about allergies at the \u003c/em>\u003cem>American\u003c/em> \u003cem>Academy\u003c/em> \u003cem>of\u003c/em> \u003cem>Allergy\u003c/em>\u003cem>, \u003c/em>\u003cem>Asthma\u003c/em> \u003cem>and\u003c/em> \u003cem>Immunology’s\u003c/em>\u003cem> \u003ca href=\"https://www.aaaai.org/conditions-and-treatments/Virtual-Allergist\">virtual allergist\u003c/a> and the \u003ca href=\"https://acaai.org/allergies/types/hay-fever-rhinitis\">web site\u003c/a> of the \u003c/em>\u003cem>American\u003c/em> \u003cem>College\u003c/em> \u003cem>of\u003c/em> \u003cem>Allergy,\u003c/em> \u003cem>Asthma,\u003c/em> \u003cem>and\u003c/em> \u003cem>Immunology\u003c/em>\u003cem>.\u003cbr>\n\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n\u003c/div>\u003c/p>",
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"title": "San Francisco Bay Area Pollen Forecast",
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"content": "\u003cp>The 2019 San Francisco Bay Area pollen season has been \u003ca href=\"https://www.kqed.org/science/1941908/this-years-bay-area-pollen-season-is-really-bad-heres-why\" target=\"_blank\" rel=\"noopener noreferrer\">awful\u003c/a>. Below is the forecast for the area’s pollen levels. The information is pulled from \u003ca href=\"https://www.pollen.com/\" target=\"_blank\" rel=\"noopener noreferrer\">Pollen.com\u003c/a>, a website maintained by \u003ca href=\"https://www.iqvia.com/\" target=\"_blank\" rel=\"noopener noreferrer\">IQVIA\u003c/a>, a health care research firm. The site also provides a \u003ca href=\"https://www.pollen.com/forecast/current/pollen/94141\" target=\"_blank\" rel=\"noopener noreferrer\">real-time pollen forecast\u003c/a>. \u003cspan style=\"font-weight: 400\">You can find resources for dealing with hay fever and pollen allergies \u003c/span>\u003cspan style=\"font-weight: 400\">\u003ca href=\"https://www.aaaai.org/conditions-and-treatments/Virtual-Allergist\" target=\"_blank\" rel=\"noopener noreferrer\">here\u003c/a>\u003c/span>\u003cspan style=\"font-weight: 400\"> and \u003ca href=\"https://acaai.org/allergies/types/hay-fever-rhinitis\" target=\"_blank\" rel=\"noopener noreferrer\">here\u003c/a>. \u003c/span>\u003c/p>\n\u003ctable border=\"0\" width=\"98%\" cellspacing=\"0\" cellpadding=\"0\">\n\u003ctbody>\n\u003ctr>\n\u003ctd>\n\u003ctable border=\"0\" width=\"98%\" cellspacing=\"0\" cellpadding=\"0\">\n\u003ctbody>\n\u003ctr>\n\u003ctd>\n\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe loading=\"lazy\" src=\"https://datawrapper.dwcdn.net/K0nK9/52/\" height=\"305\" width=\"100%\" scrolling=\"yes\" class=\"iframe-class\" frameborder=\"0\">\u003c/iframe>\n\u003c/td>\n\u003c/tr>\n\u003ctr>\n\u003ctd>\n\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe loading=\"lazy\" src=\"https://datawrapper.dwcdn.net/xcGu9/6/\" height=\"100\" width=\"100%\" scrolling=\"yes\" class=\"iframe-class\" frameborder=\"0\">\u003c/iframe>\n\u003c/td>\n\u003c/tr>\n\u003ctr>\n\u003ctd>\n\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe loading=\"lazy\" src=\"https://datawrapper.dwcdn.net/A7xl6/40/\" height=\"400\" width=\"100%\" scrolling=\"yes\" class=\"iframe-class\" frameborder=\"0\">\u003c/iframe>\n\u003c/td>\n\u003c/tr>\n\u003c/tbody>\n\u003c/table>\n\u003c/td>\n\u003c/tr>\n\u003c/tbody>\n\u003c/table>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The 2019 San Francisco Bay Area pollen season has been \u003ca href=\"https://www.kqed.org/science/1941908/this-years-bay-area-pollen-season-is-really-bad-heres-why\" target=\"_blank\" rel=\"noopener noreferrer\">awful\u003c/a>. Below is the forecast for the area’s pollen levels. The information is pulled from \u003ca href=\"https://www.pollen.com/\" target=\"_blank\" rel=\"noopener noreferrer\">Pollen.com\u003c/a>, a website maintained by \u003ca href=\"https://www.iqvia.com/\" target=\"_blank\" rel=\"noopener noreferrer\">IQVIA\u003c/a>, a health care research firm. The site also provides a \u003ca href=\"https://www.pollen.com/forecast/current/pollen/94141\" target=\"_blank\" rel=\"noopener noreferrer\">real-time pollen forecast\u003c/a>. \u003cspan style=\"font-weight: 400\">You can find resources for dealing with hay fever and pollen allergies \u003c/span>\u003cspan style=\"font-weight: 400\">\u003ca href=\"https://www.aaaai.org/conditions-and-treatments/Virtual-Allergist\" target=\"_blank\" rel=\"noopener noreferrer\">here\u003c/a>\u003c/span>\u003cspan style=\"font-weight: 400\"> and \u003ca href=\"https://acaai.org/allergies/types/hay-fever-rhinitis\" target=\"_blank\" rel=\"noopener noreferrer\">here\u003c/a>. \u003c/span>\u003c/p>\n\u003ctable border=\"0\" width=\"98%\" cellspacing=\"0\" cellpadding=\"0\">\n\u003ctbody>\n\u003ctr>\n\u003ctd>\n\u003ctable border=\"0\" width=\"98%\" cellspacing=\"0\" cellpadding=\"0\">\n\u003ctbody>\n\u003ctr>\n\u003ctd>\n\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe loading=\"lazy\" src=\"https://datawrapper.dwcdn.net/K0nK9/52/\" height=\"305\" width=\"100%\" scrolling=\"yes\" class=\"iframe-class\" frameborder=\"0\">\u003c/iframe>\n\u003c/td>\n\u003c/tr>\n\u003ctr>\n\u003ctd>\n\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe loading=\"lazy\" src=\"https://datawrapper.dwcdn.net/xcGu9/6/\" height=\"100\" width=\"100%\" scrolling=\"yes\" class=\"iframe-class\" frameborder=\"0\">\u003c/iframe>\n\u003c/td>\n\u003c/tr>\n\u003ctr>\n\u003ctd>\n\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe loading=\"lazy\" src=\"https://datawrapper.dwcdn.net/A7xl6/40/\" height=\"400\" width=\"100%\" scrolling=\"yes\" class=\"iframe-class\" frameborder=\"0\">\u003c/iframe>\n\u003c/td>\n\u003c/tr>\n\u003c/tbody>\n\u003c/table>\n\u003c/td>\n\u003c/tr>\n\u003c/tbody>\n\u003c/table>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "Worried About 'Designer Babies'? They're Still Only a Fantasy. And That May Never Change",
"headTitle": "Worried About ‘Designer Babies’? They’re Still Only a Fantasy. And That May Never Change | KQED",
"content": "\u003cp>Scientists continue to speak out against the prospect of producing engineered embryos that could lead to “designer babies.”\u003c/p>\n\u003cp>[pullquote align='right']‘You could have done just as well by throwing a dart at the genome and saying, ‘OK, we’re going to look at this gene and see if it’s associated with depression.’[/pullquote]\u003c/p>\n\u003cp>Leaders of the American Society of Gene and Cell Therapy \u003ca href=\"https://www.asgct.org/research/news/april-2019/scientific-leaders-call-for-global-moratorium-on-g\">sent a letter\u003c/a> on April 24 to Alex Azar, the secretary of health and human services, adding their voices to the call for a moratorium on experiments that could alter the genes passed down to future generations.\u003c/p>\n\u003cp>This move follows a \u003ca href=\"https://www.npr.org/sections/health-shots/2019/03/13/701549223/call-for-global-moratorium-on-creating-gene-edited-babies\">widely criticized experiment \u003c/a>in China last year that apparently produced children with edited genomes.\u003c/p>\n\u003cp>The concern is largely ethical. The reality is that biologists probably couldn’t produce designer babies even if they wanted to.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>It turns out that the genetics underlying desirable traits such as athleticism, intelligence and beauty are so complicated it may not ever be possible to make targeted changes.\u003c/p>\n\u003cp>Back in the day of Gregor Mendel, the monk who modified the traits of the pea plants in his 19th century garden, it seemed that traits were based on simple elements (later dubbed “genes”). But by the 1920s, \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/28987627\">it was becoming clear\u003c/a> that human traits involved many genes acting in concert.\u003c/p>\n\u003cp>Still, during the heyday of the Human Genome Project at the end of the 20th century, hopes were high that common diseases might be explained through the interaction of just a handful of genes. You may recall all those stories about scientists hunting “the gene for” various diseases. Hundreds of scientific papers purported to show strong candidates for these critical genes.\u003c/p>\n\u003cp>British comedian John Cleese poked fun at this idea\u003ca href=\"https://www.youtube.com/watch?v=-M-vnmejwXo&feature=youtu.be\"> in a video skit\u003c/a>, where he pointed on a chart to “the gene which we scientists now know makes us eat coconut ice cream after a fish dinner.”\u003c/p>\n\u003cp>But the scientific effort to find genes for common conditions was largely a flop (with a few notable exceptions, such as Alzheimer’s and breast cancer). For example, hundreds of studies over the years have reportedly found genes associated with schizophrenia.\u003c/p>\n\u003cp>“When we look at the 20 most studied genes investigated for schizophrenia, \u003ca href=\"https://www.biologicalpsychiatryjournal.com/article/S0006-3223(17)31772-9/fulltext\">we find basically no evidence\u003c/a> that any of those are associated at levels greater than we’d expect due to chance,” says \u003ca href=\"https://www.colorado.edu/ibg/matthew-keller\">Matthew Keller\u003c/a> at the University of Colorado.\u003c/p>\n\u003cp>His lab also looked at the early claims for genes linked to depression. \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/30845820\">Those, too, went nowhere\u003c/a>.\u003c/p>\n\u003cp>“You could have done just as well by throwing a dart at the genome and saying, ‘OK, we’re going to look at this gene and see if it’s associated with depression,’ ” he says.\u003c/p>\n\u003cp>Instead, scientists found that thousands upon thousands of genes are associated with common diseases and common traits. And most of them have just a tiny influence on the risk of a disease, often just a small fraction of a percent.\u003c/p>\n\u003cp>Human traits, like height, follow the same story.\u003c/p>\n\u003cp>\u003ca href=\"https://profiles.stanford.edu/jonathan-pritchard\">Jonathan Pritchard\u003c/a>, a Howard Hughes investigator at Stanford University, has looked into the genetics of height, which is one of the most thoroughly studied traits. “It quickly became clear there’s huge numbers of variants that affect height,” he says. “We have estimated that it’s probably something like 100,000 variants across the genome, so most of the genome affects height by a small amount.”\u003c/p>\n\u003cp>A few years ago, he suggested that height and presumably other common traits are “omnigenetic,” meaning they involve all of our genes.\u003c/p>\n\u003cp>If that’s the case, each gene must influence many different traits. A gene linked to height might affect the basic mechanism inside many cells. So editing one gene would affect not only height but who knows what else.\u003c/p>\n\u003cp>Pritchard and his colleagues \u003ca href=\"https://www.cell.com/cell/fulltext/S0092-8674(19)30400-3\">published a paper\u003c/a> Thursday that reveals the nature of the variants related to complex traits like height. The genetic variation isn’t in the genes themselves (the DNA code that tells cells what proteins to produce) but in genetic elements that regulate those genes at the same time they influence other tasks.\u003c/p>\n\u003cp>His findings suggest our genes work as an interconnected network. It’s not a predictable machine as much as it is a flock of starlings, which wheels in the sky based on group dynamics.\u003c/p>\n\u003cp>That phenomenon makes our biology a challenge to understand, let alone engineer, Pritchard says. “We find nature as it is, not really as we wish it to be,” he says, a bit wistfully.\u003c/p>\n\u003cp>Pritchard’s concept of omnigenetics is not wholly accepted by his peers.\u003c/p>\n\u003cp>The logical conclusion is that genetics is “such a mush that we can’t understand it,” says \u003ca href=\"https://www.ebi.ac.uk/about/people/ewan-birney\">Ewan Birney\u003c/a> at the European Bioinformatics Institute. “I find that a bit depressing.”\u003c/p>\n\u003cp>Birney still holds out hope that, as we learn more about genetics, clearer mechanisms will emerge.\u003c/p>\n\u003cp>But in any event, there’s no question that complicated traits involve thousands of genes with multiple purposes.\u003c/p>\n\u003cp>“If anybody thinks we can understand how to change genomes to improve things, they don’t have an appreciation for the lack of knowledge that we have,” Birney says.\u003c/p>\n\u003cp>In the case of \u003ca href=\"https://www.npr.org/sections/health-shots/2018/11/28/671375070/facing-backlash-chinese-scientist-defends-gene-editing-research-on-babies\">the rogue Chinese experiment\u003c/a>, the scientist attempted to edit a gene to create a variant that apparently protects people from HIV infection, resulting in the birth of genetically engineered twins. But going back to the idea that genes all play multiple roles, it’s not clear what else this alteration has done to the children.\u003c/p>\n\u003cp>Birney also notes there’s a big difference between engineering a designer baby with desirable characteristics and fixing a genetic flaw. “We’re much better at understanding when things break, and we call those genetic diseases,” Birney says.\u003c/p>\n\u003cp>There, gene editing could be brought to bear. A broken gene could be edited. But there are other options that carry less risk.\u003c/p>\n\u003cp>There is already an effective technology, called preimplantation genetic diagnosis, which allows doctors to look for these single-gene flaws in fertilized eggs and select only those that are free of the genetic disease to be implanted in the mother’s womb.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>This approach is widely regarded as ethical. And the child isn’t a “designer baby,” but ends up with a natural set of genes.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2019 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+Making+A+%27Designer+Baby%27+Would+Be+Easier+Said+Than+Done&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>It turns out that the genetics underlying desirable traits such as athleticism, intelligence and beauty are so complicated it may not ever be possible to make targeted changes.\u003c/p>\n\u003cp>Back in the day of Gregor Mendel, the monk who modified the traits of the pea plants in his 19th century garden, it seemed that traits were based on simple elements (later dubbed “genes”). But by the 1920s, \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/28987627\">it was becoming clear\u003c/a> that human traits involved many genes acting in concert.\u003c/p>\n\u003cp>Still, during the heyday of the Human Genome Project at the end of the 20th century, hopes were high that common diseases might be explained through the interaction of just a handful of genes. You may recall all those stories about scientists hunting “the gene for” various diseases. 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And most of them have just a tiny influence on the risk of a disease, often just a small fraction of a percent.\u003c/p>\n\u003cp>Human traits, like height, follow the same story.\u003c/p>\n\u003cp>\u003ca href=\"https://profiles.stanford.edu/jonathan-pritchard\">Jonathan Pritchard\u003c/a>, a Howard Hughes investigator at Stanford University, has looked into the genetics of height, which is one of the most thoroughly studied traits. “It quickly became clear there’s huge numbers of variants that affect height,” he says. “We have estimated that it’s probably something like 100,000 variants across the genome, so most of the genome affects height by a small amount.”\u003c/p>\n\u003cp>A few years ago, he suggested that height and presumably other common traits are “omnigenetic,” meaning they involve all of our genes.\u003c/p>\n\u003cp>If that’s the case, each gene must influence many different traits. A gene linked to height might affect the basic mechanism inside many cells. So editing one gene would affect not only height but who knows what else.\u003c/p>\n\u003cp>Pritchard and his colleagues \u003ca href=\"https://www.cell.com/cell/fulltext/S0092-8674(19)30400-3\">published a paper\u003c/a> Thursday that reveals the nature of the variants related to complex traits like height. The genetic variation isn’t in the genes themselves (the DNA code that tells cells what proteins to produce) but in genetic elements that regulate those genes at the same time they influence other tasks.\u003c/p>\n\u003cp>His findings suggest our genes work as an interconnected network. It’s not a predictable machine as much as it is a flock of starlings, which wheels in the sky based on group dynamics.\u003c/p>\n\u003cp>That phenomenon makes our biology a challenge to understand, let alone engineer, Pritchard says. “We find nature as it is, not really as we wish it to be,” he says, a bit wistfully.\u003c/p>\n\u003cp>Pritchard’s concept of omnigenetics is not wholly accepted by his peers.\u003c/p>\n\u003cp>The logical conclusion is that genetics is “such a mush that we can’t understand it,” says \u003ca href=\"https://www.ebi.ac.uk/about/people/ewan-birney\">Ewan Birney\u003c/a> at the European Bioinformatics Institute. “I find that a bit depressing.”\u003c/p>\n\u003cp>Birney still holds out hope that, as we learn more about genetics, clearer mechanisms will emerge.\u003c/p>\n\u003cp>But in any event, there’s no question that complicated traits involve thousands of genes with multiple purposes.\u003c/p>\n\u003cp>“If anybody thinks we can understand how to change genomes to improve things, they don’t have an appreciation for the lack of knowledge that we have,” Birney says.\u003c/p>\n\u003cp>In the case of \u003ca href=\"https://www.npr.org/sections/health-shots/2018/11/28/671375070/facing-backlash-chinese-scientist-defends-gene-editing-research-on-babies\">the rogue Chinese experiment\u003c/a>, the scientist attempted to edit a gene to create a variant that apparently protects people from HIV infection, resulting in the birth of genetically engineered twins. 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"title": "Interview: Theranos Whistleblower Erika Cheung Thinks Elizabeth Holmes Should Spend Years in Prison",
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"content": "\u003cp class=\"danger-zone\">\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">S\u003c/span>\u003c/span>he joined Theranos fresh out of the University of California, Berkeley, a self-described “starry-eyed’’ 22-year-old chemist and biologist who saw Elizabeth Holmes as a role model: the CEO who would revolutionize the blood testing industry.\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400;\">[pullquote align='right'] ‘\u003c/span>I think people can be forgiven for mistakes that they’ve made. But at the same time, to set that example, to say that you have lied to your investors, you have lied to your employees, you endangered the lives of tens of thousands of patients. And now, you’re going to just get away with that? What kind of example does that set for other people within this industry?’\u003cspan style=\"font-weight: 400;\">[/pullquote]\u003c/span>\u003c/p>\n\u003cp class=\"danger-zone\">Seven months later, Erika Cheung quit her job as a lab associate at the company and became a disillusioned whistleblower, her life now enveloped by one of the biggest business scandals in American history. She was among those who had made clear to federal regulators that she viewed Holmes as a liar who had put patients at risk. (Holmes, and her company’s former president, Ramesh Balwani, have been \u003ca href=\"https://www.justice.gov/usao-ndca/pr/theranos-founder-and-former-chief-operating-officer-charged-alleged-wire-fraud-schemes\" target=\"_blank\" rel=\"noopener\">indicted on charges of defrauding investors\u003c/a> out of hundreds of millions of dollars as well as deceiving hundreds of patients and doctors.)\u003c/p>\n\u003cp class=\"danger-zone\">In an interview with STAT, Cheung reflected on how she was duped by Holmes, why she believes the disgraced CEO should spend at least five years in prison and how the rifts between her fellow whistleblower Tyler Shultz, and his famous grandfather, George Shultz, went on longer than people know.\u003c/p>\n\u003cp>[aside postid=\"futureofyou_203018\"]Shultz and Cheung, both close friends, have turned their attention since they left Theranos to creating an organization called Ethics in Entrepreneurship in the hope of offering advice for people in the world of technology to sniff out bad players early on. Cheung, now 28, lives in Hong Kong, but was in Boston this week to appear at the Atlantic magazine’s Pulse Summit on Health Care, which was co-sponsored by STAT. Here is a transcript of the interview, which was edited for length and clarity.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003cstrong>Do you think Elizabeth Holmes should go to jail?\u003c/strong>\u003c/p>\n\u003cp>Yes. I’m not the type of person to want to serially punish someone for something that they’ve done. I think people can be forgiven for mistakes that they’ve made. But at the same time, to set that example, to say that you have lied to your investors, you have lied to your employees, you endangered the lives of tens of thousands of patients. And now, you’re going to just get away with that? What kind of example does that set for other people within this industry? That it’s OK to raise a whole bunch of money, put on this theatrical show and now walk away scot-free, versus the Fyre Festival guy. On a much smaller scale, all these partygoers ended up going to this festival; they were in FEMA tents and everything, he got five to six years. (She was referring to Billy McFarland, the founder of the Fyre Festival, who was recently sentenced to six years in prison for promoting a “luxury music festival’’ that bilked its backers.)\u003c/p>\n\u003cp>\u003cstrong>How long do you want to see her locked up? What would make you feel like she’s paying …\u003c/strong>\u003c/p>\n\u003cp>Her dues? For me, honestly, my only agenda in all of this was for them to stop processing patient samples. Everything beyond that I’m going to leave it up to the justice system. I just wish that she would have the common sense to come forward and apologize. In terms of number of years in prison? Definitely more, I suppose, than the Fyre Festival guy.\u003c/p>\n\u003cp>\u003cstrong>What do you make of her being very public these days, out with her \u003c/strong>\u003ca href=\"https://www.vanityfair.com/news/2019/02/inside-elizabeth-holmess-final-months-at-theranos\" target=\"_blank\" rel=\"noopener\">\u003cstrong>reported fiance\u003c/strong>\u003c/a>\u003cstrong> and her dog?\u003c/strong>\u003c/p>\n\u003cp>It’s just weird. It’s just a bit surreal. When you see someone have this situation and pretend that everything is normal. It’s so bizarre.\u003c/p>\n\u003cp>\u003cstrong>Elizabeth Holmes interviewed you to get the job. Did you think anything was off at the beginning?\u003c/strong>\u003c/p>\n\u003cp>Initially I came in starry-eyed. I admired Elizabeth Holmes. She was this female entrepreneur in biotech. Really what she represented to me was that you could work really hard and get to a position of running your own company. There was something very powerful about the mission she was trying to put forward: making health care accessible, affordable, allowing for price transparency when you get your blood diagnostics. It’s not until you look at her as a character in retrospect that you realize the red flags and warning signs of her behavior and her personality and the kind of act that she put on to be the front face of Theranos.\u003c/p>\n\u003cp>\u003cstrong>When did things turn for you?\u003c/strong>\u003c/p>\n\u003cp>Things started to turn for me about a month, two months in. Initially I started in research and development. When things fail in R&D, that’s fine. That’s expected. But about a month in we were starting to get patients that were rolling in from our Walgreens center in Palo Alto. And I had run this patient sample and before I’d run the patient sample, I was running all these quality controls and they kept failing. And failing. Over and over. I was up until 3 a.m. trying to get quality controls to work and they weren’t working. Things weren’t working all the time. They were deleting data as outliers. Untrained staff were making decisions. Upper level management was saying, “Just get the results out,” at any cost. And get it out quickly.\u003c/p>\n\u003cp>\u003cstrong>The better-known whistleblower, your friend Tyler Shultz, knew Holmes much better through his grandfather. (George Shultz was a former secretary of state and investor and champion of Holmes, who sided with her when his grandson started raising doubts.)\u003c/strong>\u003c/p>\n\u003cp>Tyler was a good contact for me to have because he had direct contact with Elizabeth Holmes because of his grandfather. He was eating Thanksgiving dinner with Elizabeth Holmes.\u003c/p>\n\u003cp>\u003cstrong>Are things OK with Tyler and his grandfather?\u003c/strong>\u003c/p>\n\u003cp>Yes. It took a while. A lot longer than I think people realize. It took quite a while. Until seven months ago. I think his grandfather finally realized the truth. They’re finally getting dinner together.\u003c/p>\n\u003cp>But it’s not what it was. It’s hard, right? For George Shultz, this was a legacy investment in a way. This was one of those last final projects that he was investing in.\u003c/p>\n\u003cp>\u003cstrong>It must have been very painful for Tyler.\u003c/strong>\u003c/p>\n\u003cp>Oh, yeah. Can you imagine? Tyler’s dad too. Tyler’s dad had to be put between his own father and his son. Tyler’s dad supported Tyler but really wanted it to end, all the legal battles.\u003c/p>\n\u003cp>\u003cstrong>Are you surprised by all the sustained publicity over Theranos, the major movie projects?\u003c/strong>\u003c/p>\n\u003cp>Yes. It’s blown up into this big story, this big case. One, she got hyped up to this large degree. She was on Fortune, she was considered the youngest billionaire in the United States. And I think rising to the height of everyone treating her as this celebrity and realizing it was on a basis of lies, and not only that it was a company that was around health care. This was people’s lives. It wasn’t developing an app that was like janky you couldn’t get your pizza delivered on time.\u003c/p>\n\u003cp>\u003cstrong>What’s your sense of whether Elizabeth Holmes knowingly committed fraud or deluded herself about her actions?\u003c/strong>\u003c/p>\n\u003cp>It’s hard when you’re dealing with someone who was clearly delusional to really understand what is going on in their head and what they perceive as reality versus what they’ve sort of imagined. Do I think she was out to scam everybody from the very beginning? At lot of people disagree with me, but I don’t think that was the case. I think she went in, at least initially, with good intentions. But she let her ego get in the way. She was more focused on being the next Steve Jobs of health care.\u003c/p>\n\u003cp>\u003cstrong>People have called her a “psychopath.’’\u003c/strong>\u003c/p>\n\u003cp>I don’t know her well enough. But clearly there’s something not right with her. She’s never made an apology. She’s never come forward to the patients and said, “Hey, I’m sorry.”\u003c/p>\n\u003cp>\u003cstrong>When you say she’s “not right,’’ do you look back at any clues that you didn’t pick up on?\u003c/strong>\u003c/p>\n\u003cp>The secrecy. The extreme amount of paranoia of these big medical diagnostic companies going to come after her and destroy her technology. The fact that before you even go in there and interview you have to sign an NDA. Responding to questions, “Well, until you work for the company, that’s trade secrets.”\u003c/p>\n\u003cp>\u003cstrong>Did you see that during your interview with Holmes?\u003c/strong>\u003c/p>\n\u003cp>She just dodged a lot of questions. Like, “Oh, so what kind of technology are you guys using to run the blood samples?” It would always be the case, “Until you work for the company, those are trade secrets — you’ll be able to find out what we’re working on.”\u003c/p>\n\u003cp>\u003cstrong>What’s the most off-the-wall thing you saw Holmes do?\u003c/strong>\u003c/p>\n\u003cp>The lying. Watching her do an article with Fortune or with Forbes, and it would just be such a different picture, just a wildly different picture of what was going on internally in the company versus what was being portrayed in the media. It was so disparate to the reality: Sitting at your lab bench and going, “What is she talking about?”\u003c/p>\n\u003cp>\u003cstrong>What are you doing now?\u003c/strong>\u003c/p>\n\u003cp>I founded a \u003ca href=\"http://ethicsinentrepreneurship.org/\" target=\"_blank\" rel=\"noopener\">nonprofit\u003c/a> basically focused on preventing major scandals from happening, like Theranos.\u003c/p>\n\u003cp>We’re focused on three different stakeholders: providing resources and tools for entrepreneurs, so that at every stage of development they understand the ethical considerations in building a business and in running a business, from hiring to the culture you implement to building your product. We’re working with ethics departments and seasoned lawyers and compliance officers to basically build out the tools to help entrepreneurs.\u003c/p>\n\u003cp>\u003cstrong>How big is your staff?\u003c/strong>\u003c/p>\n\u003cp>We launched six weeks ago. At the moment we have six people. I’m the only full-time. Tyler is coming on board; he helps with introductions and the strategy of the organization. At this point, we’re self-funded and we’re talking to a few investors.\u003c/p>\n\u003cp>\u003cstrong>What are long-standing consequences of the Theranos saga?\u003c/strong>\u003c/p>\n\u003cp>Investors are very cautious. Is this the next Theranos? A lot of people are very discouraged by this whole scenario. What are the implications of having a strong female founder in biotech being associated with the largest and biggest scandal in Silicon Valley to date? What are the unconscious biases that may go against female founders who are very charismatic, who are very good at selling, in terms of approaching investors or selling to customers?\u003c/p>\n\u003cp>\u003cstrong>Do you think this could happen again?\u003c/strong>\u003c/p>\n\u003cp>Yeah. Maybe not in the same style. A lot of people have been very skeptical of the fireworks and show that Silicon Valley puts on about how they’re going to change the world and make an impact in this very grandiose way without necessarily having the evidence to back up how they’re going to do that.\u003c/p>\n\u003cp>As software in general starts to integrate more into regulated industries, we’re going to have to be on high alert of these types of scenarios happening again.\u003c/p>\n\u003cp>\u003cstrong>Now that Holmes is out of the picture, is there a woman founder in the sciences you admire?\u003c/strong>\u003c/p>\n\u003cp>I like Anne Wojcicki from 23andMe. She’s a very kind, strong female leader. She’s very pragmatic. She’s been able to confront these different challenges of building a tech company in a highly regulated space with a certain level of sensibility about her. It’s not that she gets defeated when regulatory challenges come up.\u003c/p>\n\u003cp>\u003cstrong>Your advice to entrepreneurs to do good in the health space?\u003c/strong>\u003c/p>\n\u003cp>There still is a lot of opportunity to solve a lot of problems in health care. And even though Theranos was how not to do things, there are many good ways to do things well and we’re at an exciting period in this convergence between software and computing power and biology and synthetic biology that really we’re going to start seeing a lot of innovation in the health care space.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>This \u003ca href=\"https://www.statnews.com/2019/05/01/from-protegee-to-whistleblower-a-former-theranos-scientist-says-elizabeth-holmes-should-come-forward-and-apologize/\">story\u003c/a> was originally published by \u003ca href=\"https://www.statnews.com\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/p>\n\n",
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"excerpt": "In an interview, Elizabeth Cheung reflects on how she went from starry-eyed to disillusioned at Theranos and why she thinks Elizabeth Holmes, the company's disgraced CEO, should spend at least five years in prison.",
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"content": " ‘\u003c/span>I think people can be forgiven for mistakes that they’ve made. But at the same time, to set that example, to say that you have lied to your investors, you have lied to your employees, you endangered the lives of tens of thousands of patients. And now, you’re going to just get away with that? What kind of example does that set for other people within this industry?’\u003cspan style=\"font-weight: 400;\">",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/span>\u003c/p>\n\u003cp class=\"danger-zone\">Seven months later, Erika Cheung quit her job as a lab associate at the company and became a disillusioned whistleblower, her life now enveloped by one of the biggest business scandals in American history. She was among those who had made clear to federal regulators that she viewed Holmes as a liar who had put patients at risk. (Holmes, and her company’s former president, Ramesh Balwani, have been \u003ca href=\"https://www.justice.gov/usao-ndca/pr/theranos-founder-and-former-chief-operating-officer-charged-alleged-wire-fraud-schemes\" target=\"_blank\" rel=\"noopener\">indicted on charges of defrauding investors\u003c/a> out of hundreds of millions of dollars as well as deceiving hundreds of patients and doctors.)\u003c/p>\n\u003cp class=\"danger-zone\">In an interview with STAT, Cheung reflected on how she was duped by Holmes, why she believes the disgraced CEO should spend at least five years in prison and how the rifts between her fellow whistleblower Tyler Shultz, and his famous grandfather, George Shultz, went on longer than people know.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>Shultz and Cheung, both close friends, have turned their attention since they left Theranos to creating an organization called Ethics in Entrepreneurship in the hope of offering advice for people in the world of technology to sniff out bad players early on. Cheung, now 28, lives in Hong Kong, but was in Boston this week to appear at the Atlantic magazine’s Pulse Summit on Health Care, which was co-sponsored by STAT. Here is a transcript of the interview, which was edited for length and clarity.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003cstrong>Do you think Elizabeth Holmes should go to jail?\u003c/strong>\u003c/p>\n\u003cp>Yes. I’m not the type of person to want to serially punish someone for something that they’ve done. I think people can be forgiven for mistakes that they’ve made. But at the same time, to set that example, to say that you have lied to your investors, you have lied to your employees, you endangered the lives of tens of thousands of patients. And now, you’re going to just get away with that? What kind of example does that set for other people within this industry? That it’s OK to raise a whole bunch of money, put on this theatrical show and now walk away scot-free, versus the Fyre Festival guy. On a much smaller scale, all these partygoers ended up going to this festival; they were in FEMA tents and everything, he got five to six years. (She was referring to Billy McFarland, the founder of the Fyre Festival, who was recently sentenced to six years in prison for promoting a “luxury music festival’’ that bilked its backers.)\u003c/p>\n\u003cp>\u003cstrong>How long do you want to see her locked up? What would make you feel like she’s paying …\u003c/strong>\u003c/p>\n\u003cp>Her dues? For me, honestly, my only agenda in all of this was for them to stop processing patient samples. Everything beyond that I’m going to leave it up to the justice system. I just wish that she would have the common sense to come forward and apologize. In terms of number of years in prison? Definitely more, I suppose, than the Fyre Festival guy.\u003c/p>\n\u003cp>\u003cstrong>What do you make of her being very public these days, out with her \u003c/strong>\u003ca href=\"https://www.vanityfair.com/news/2019/02/inside-elizabeth-holmess-final-months-at-theranos\" target=\"_blank\" rel=\"noopener\">\u003cstrong>reported fiance\u003c/strong>\u003c/a>\u003cstrong> and her dog?\u003c/strong>\u003c/p>\n\u003cp>It’s just weird. It’s just a bit surreal. When you see someone have this situation and pretend that everything is normal. It’s so bizarre.\u003c/p>\n\u003cp>\u003cstrong>Elizabeth Holmes interviewed you to get the job. Did you think anything was off at the beginning?\u003c/strong>\u003c/p>\n\u003cp>Initially I came in starry-eyed. I admired Elizabeth Holmes. She was this female entrepreneur in biotech. Really what she represented to me was that you could work really hard and get to a position of running your own company. There was something very powerful about the mission she was trying to put forward: making health care accessible, affordable, allowing for price transparency when you get your blood diagnostics. It’s not until you look at her as a character in retrospect that you realize the red flags and warning signs of her behavior and her personality and the kind of act that she put on to be the front face of Theranos.\u003c/p>\n\u003cp>\u003cstrong>When did things turn for you?\u003c/strong>\u003c/p>\n\u003cp>Things started to turn for me about a month, two months in. Initially I started in research and development. When things fail in R&D, that’s fine. That’s expected. But about a month in we were starting to get patients that were rolling in from our Walgreens center in Palo Alto. And I had run this patient sample and before I’d run the patient sample, I was running all these quality controls and they kept failing. And failing. Over and over. I was up until 3 a.m. trying to get quality controls to work and they weren’t working. Things weren’t working all the time. They were deleting data as outliers. Untrained staff were making decisions. Upper level management was saying, “Just get the results out,” at any cost. And get it out quickly.\u003c/p>\n\u003cp>\u003cstrong>The better-known whistleblower, your friend Tyler Shultz, knew Holmes much better through his grandfather. (George Shultz was a former secretary of state and investor and champion of Holmes, who sided with her when his grandson started raising doubts.)\u003c/strong>\u003c/p>\n\u003cp>Tyler was a good contact for me to have because he had direct contact with Elizabeth Holmes because of his grandfather. He was eating Thanksgiving dinner with Elizabeth Holmes.\u003c/p>\n\u003cp>\u003cstrong>Are things OK with Tyler and his grandfather?\u003c/strong>\u003c/p>\n\u003cp>Yes. It took a while. A lot longer than I think people realize. It took quite a while. Until seven months ago. I think his grandfather finally realized the truth. They’re finally getting dinner together.\u003c/p>\n\u003cp>But it’s not what it was. It’s hard, right? For George Shultz, this was a legacy investment in a way. This was one of those last final projects that he was investing in.\u003c/p>\n\u003cp>\u003cstrong>It must have been very painful for Tyler.\u003c/strong>\u003c/p>\n\u003cp>Oh, yeah. Can you imagine? Tyler’s dad too. Tyler’s dad had to be put between his own father and his son. Tyler’s dad supported Tyler but really wanted it to end, all the legal battles.\u003c/p>\n\u003cp>\u003cstrong>Are you surprised by all the sustained publicity over Theranos, the major movie projects?\u003c/strong>\u003c/p>\n\u003cp>Yes. It’s blown up into this big story, this big case. One, she got hyped up to this large degree. She was on Fortune, she was considered the youngest billionaire in the United States. And I think rising to the height of everyone treating her as this celebrity and realizing it was on a basis of lies, and not only that it was a company that was around health care. This was people’s lives. It wasn’t developing an app that was like janky you couldn’t get your pizza delivered on time.\u003c/p>\n\u003cp>\u003cstrong>What’s your sense of whether Elizabeth Holmes knowingly committed fraud or deluded herself about her actions?\u003c/strong>\u003c/p>\n\u003cp>It’s hard when you’re dealing with someone who was clearly delusional to really understand what is going on in their head and what they perceive as reality versus what they’ve sort of imagined. Do I think she was out to scam everybody from the very beginning? At lot of people disagree with me, but I don’t think that was the case. I think she went in, at least initially, with good intentions. But she let her ego get in the way. She was more focused on being the next Steve Jobs of health care.\u003c/p>\n\u003cp>\u003cstrong>People have called her a “psychopath.’’\u003c/strong>\u003c/p>\n\u003cp>I don’t know her well enough. But clearly there’s something not right with her. She’s never made an apology. She’s never come forward to the patients and said, “Hey, I’m sorry.”\u003c/p>\n\u003cp>\u003cstrong>When you say she’s “not right,’’ do you look back at any clues that you didn’t pick up on?\u003c/strong>\u003c/p>\n\u003cp>The secrecy. The extreme amount of paranoia of these big medical diagnostic companies going to come after her and destroy her technology. The fact that before you even go in there and interview you have to sign an NDA. Responding to questions, “Well, until you work for the company, that’s trade secrets.”\u003c/p>\n\u003cp>\u003cstrong>Did you see that during your interview with Holmes?\u003c/strong>\u003c/p>\n\u003cp>She just dodged a lot of questions. Like, “Oh, so what kind of technology are you guys using to run the blood samples?” It would always be the case, “Until you work for the company, those are trade secrets — you’ll be able to find out what we’re working on.”\u003c/p>\n\u003cp>\u003cstrong>What’s the most off-the-wall thing you saw Holmes do?\u003c/strong>\u003c/p>\n\u003cp>The lying. Watching her do an article with Fortune or with Forbes, and it would just be such a different picture, just a wildly different picture of what was going on internally in the company versus what was being portrayed in the media. It was so disparate to the reality: Sitting at your lab bench and going, “What is she talking about?”\u003c/p>\n\u003cp>\u003cstrong>What are you doing now?\u003c/strong>\u003c/p>\n\u003cp>I founded a \u003ca href=\"http://ethicsinentrepreneurship.org/\" target=\"_blank\" rel=\"noopener\">nonprofit\u003c/a> basically focused on preventing major scandals from happening, like Theranos.\u003c/p>\n\u003cp>We’re focused on three different stakeholders: providing resources and tools for entrepreneurs, so that at every stage of development they understand the ethical considerations in building a business and in running a business, from hiring to the culture you implement to building your product. We’re working with ethics departments and seasoned lawyers and compliance officers to basically build out the tools to help entrepreneurs.\u003c/p>\n\u003cp>\u003cstrong>How big is your staff?\u003c/strong>\u003c/p>\n\u003cp>We launched six weeks ago. At the moment we have six people. I’m the only full-time. Tyler is coming on board; he helps with introductions and the strategy of the organization. At this point, we’re self-funded and we’re talking to a few investors.\u003c/p>\n\u003cp>\u003cstrong>What are long-standing consequences of the Theranos saga?\u003c/strong>\u003c/p>\n\u003cp>Investors are very cautious. Is this the next Theranos? A lot of people are very discouraged by this whole scenario. What are the implications of having a strong female founder in biotech being associated with the largest and biggest scandal in Silicon Valley to date? What are the unconscious biases that may go against female founders who are very charismatic, who are very good at selling, in terms of approaching investors or selling to customers?\u003c/p>\n\u003cp>\u003cstrong>Do you think this could happen again?\u003c/strong>\u003c/p>\n\u003cp>Yeah. Maybe not in the same style. A lot of people have been very skeptical of the fireworks and show that Silicon Valley puts on about how they’re going to change the world and make an impact in this very grandiose way without necessarily having the evidence to back up how they’re going to do that.\u003c/p>\n\u003cp>As software in general starts to integrate more into regulated industries, we’re going to have to be on high alert of these types of scenarios happening again.\u003c/p>\n\u003cp>\u003cstrong>Now that Holmes is out of the picture, is there a woman founder in the sciences you admire?\u003c/strong>\u003c/p>\n\u003cp>I like Anne Wojcicki from 23andMe. She’s a very kind, strong female leader. She’s very pragmatic. She’s been able to confront these different challenges of building a tech company in a highly regulated space with a certain level of sensibility about her. It’s not that she gets defeated when regulatory challenges come up.\u003c/p>\n\u003cp>\u003cstrong>Your advice to entrepreneurs to do good in the health space?\u003c/strong>\u003c/p>\n\u003cp>There still is a lot of opportunity to solve a lot of problems in health care. And even though Theranos was how not to do things, there are many good ways to do things well and we’re at an exciting period in this convergence between software and computing power and biology and synthetic biology that really we’re going to start seeing a lot of innovation in the health care space.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "Amputations for Black and Latino Diabetics a 'Mega-Disparity'",
"headTitle": "Amputations for Black and Latino Diabetics a ‘Mega-Disparity’ | KQED",
"content": "\u003cp>On his regular rounds at the University of Southern California’s Keck Hospital, Dr. David Armstrong lives a brutal injustice of American health care.\u003c/p>\n\u003cp>[pullquote]In California, of the 82,000 diabetic amputations from 2011 to 2017, people who were black or Latino were more than twice as likely as non-Hispanic whites to undergo amputations related to diabetes, a Kaiser Health News analysis found.[/pullquote]Each week, dozens of patients with diabetes come to him with deep wounds, severe infections and poor circulation — debilitating complications of a disease that has spiraled out of control. He works to save their limbs, but sometimes Armstrong and his team must resort to amputation to save the patient, a painful and life-altering measure he knows is nearly always preventable.\u003c/p>\n\u003cp>For decades now, the American medical establishment has known how to manage diabetes. Even as the number of people living with the illness continues to climb — today, estimated at more than 30 million nationwide — the prognosis for those with access to good health care has become far less dire. With the right medication, diet and lifestyle changes, patients can learn to manage their diabetes and lead robust lives.\u003c/p>\n\u003cp>Yet across the country, surgeons still perform tens of thousands of diabetic amputations each year. It’s a drastic procedure that stands as a powerful example of the consequences of being poor, uninsured and cut off from a routine system of quality health care.\u003c/p>\n\u003cp>“Amputations are an unnecessary consequence of this devastating disease,” said Armstrong, professor of surgery at Keck School of Medicine of USC. “It’s an epidemic within an epidemic. And it’s a problem that’s totally ignored.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>In California, where doctors performed more than 82,000 diabetic amputations from 2011 to 2017, people who were black or Latino were more than twice as likely as non-Hispanic whites to undergo amputations related to diabetes, a Kaiser Health News analysis found.\u003c/p>\n\u003cp>The pattern is not unique to California. Across the country, studies have shown that diabetic amputations vary significantly not just by race and ethnicity but also by income and geography. Diabetic patients living in communities tat rank in the nation’s bottom quartile by income were nearly 39% more likely to undergo major amputations compared with people living in the highest-income communities, according to one \u003ca href=\"https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0134914\">2015 study\u003c/a>.\u003c/p>\n\u003cp>A \u003ca href=\"https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2014.0148\">2014 study\u003c/a> by UCLA researchers found that people with diabetes in poorer neighborhoods in Los Angeles County were twice as likely to have a foot or leg amputated than those in wealthier areas. The difference was more than tenfold in some parts of the county.\u003c/p>\n\u003cp>\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium alignnone\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/california-amputations3.png\" width=\"1024\" height=\"871\">\u003c/p>\n\u003cp>Amputations are considered a “mega-disparity” and dwarf nearly every other health disparity by race and ethnicity, said Dr. Dean Schillinger, a medical professor at the University of California-San Francisco. To begin with, people who are black or Latino are more at risk of diabetes than other groups — a disparity often attributed to socioeconomic factors such as higher rates of poverty and lower levels of education. They also may live in environments with less access to healthy food or places to exercise.\u003c/p>\n\u003cp>Then, among those with the disease, blacks and Latinos often get diagnosed after the disease has taken hold and have more complications, such as amputations. “If you go into low-income African American neighborhoods, it is a war zone,” said Schillinger, former chief of the Diabetes Prevention and Control Program at the California Department of Public Health. “You see people wheeling themselves around in wheelchairs.”\u003c/p>\n\u003cp>Part of the outrage for researchers is that medical science has made so much headway in diabetes treatment. Nationwide, fewer than \u003ca href=\"https://www.ajmc.com/newsroom/diabetic-amputations-may-be-rising-in-the-united-states\">5 adults out of every 1,000 with diabetes\u003c/a> get amputations.\u003c/p>\n\u003cp>But for those who do, the consequences are profound. More than half of amputations in California from 2011 to 2017 occurred among people ages 45 to 64, according to the KHN analysis, meaning many people are left disabled and dependent on others for care during their prime working years.\u003c/p>\n\u003cp>\u003cstrong>From Mother to Son\u003c/strong>\u003c/p>\n\u003cp>Jackson Moss leaned back on his couch and raised his right leg. His wife, Bernadette, sprayed antiseptic on a gaping wound on the sole of his foot before dabbing it with Vaseline and rewrapping it with gauze.\u003c/p>\n\u003cp>A stocky man who used to deliver poultry, Moss, 47, said he had to stop working after his left leg was amputated below the knee about 10 years ago. Later, he lost part of his right foot. With Bernadette’s help, he is trying to save the rest of it.\u003c/p>\n\u003cfigure class=\"wp-caption alignright\" style=\"max-width: 1350px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/amputations-8_1350.jpg\" width=\"1350\" height=\"900\">\u003cfigcaption class=\"wp-caption-text\">Jackson Moss had to stop working after his left leg was amputated below the knee about 10 years ago because of an infected wound that developed in his toe.(Heidi de Marco/California Healthline\u003c/figcaption>\u003c/figure>\n\u003cp>“If I didn’t have my wife, I don’t know where I’d be,” said Moss, who wears a prosthesis on his left leg and uses a wheelchair. “I can’t get around good like I used to.”\u003c/p>\n\u003cp>Moss, who lives in Compton, embodies many of the characteristics of people most likely to get diabetic amputations. He is African American with a relatively low family income: about $30,000 a year from his Social Security disability check and his wife’s job with the county mental health department.\u003c/p>\n\u003cp>Moss has not always received regular medical care. His mother, who also had a leg amputated from diabetes, would take him to the doctor when he was a boy. But he stopped going as an adult. He didn’t have insurance during much of his 20s and 30s. Medical care just wasn’t a priority, he said, until about 25 years ago when his blood sugar shot up so high he passed out at home.\u003c/p>\n\u003cp>After he was diagnosed with Type 2 diabetes, he started seeing a physician more often. He tried to avoid sugar, as his doctor recommended, but bad habits die hard. “It takes a lot to eat right,” he said, “and it costs more.”\u003c/p>\n\u003cp>One day, about 10 years ago, he bumped his toe on the bed. He thought little of it until he developed an infected wound. A fever sent him to the hospital, where his lower leg was removed. A few years later, with his diabetes still poorly controlled, he lost the toes on his other foot.\u003c/p>\n\u003cp>In recent years, Moss and his wife said, health providers have sometimes ignored their concerns. They recalled trips to the emergency room when they had to convince doctors his fever came from a diabetes-related infection. “They wouldn’t take my word,” he said. The couple did not see it as discrimination, more like dismissiveness.\u003c/p>\n\u003cp>Now, Moss goes to a clinic run by Martin Luther King, Jr. Community Hospital, which serves a large Latino and black population in South Los Angeles. On a recent visit, his doctor asked if he was staying off the foot with the wound. “I just get up when I have to go to the restroom and to get in and out of the bed,” Moss responded.\u003c/p>\n\u003cp>Moss hopes someday he will be able to do more — get back to taking his grandsons to Chuck E. Cheese or playing dominoes with friends.\u003c/p>\n\u003cp>“I just sit here all day long,” he said.\u003c/p>\n\u003cfigure class=\"wp-caption alignnone\" style=\"max-width: 1350px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/amputations-9_1350.jpg\" width=\"1350\" height=\"900\">\u003cfigcaption class=\"wp-caption-text\">Moss holds the funeral program for his mother, who also had diabetes.(Heidi de Marco/California Healthline)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>‘The Most Shameful Metric’\u003c/strong>\u003c/p>\n\u003cp>Amputations typically start with poorly controlled diabetes, a disease characterized by excess sugar in the blood. Untreated, it can lead to serious complications such as kidney failure and blindness.\u003c/p>\n\u003cp>People with diabetes often have reduced sensation in their feet, as well as poor circulation. \u003ca href=\"http://mr3health.com/wp-content/uploads/2018/10/nejmra1615439.pdf\">As many as one-third\u003c/a> of people with the most common form — Type 2 — develop foot ulcers or a break in the skin that can become infected.\u003c/p>\n\u003cp>Amputations occur after those infections rage out of control and enter the bloodstream or seep deeper into the tissue. People with diabetes often have a condition that makes it harder for blood to circulate and wounds to heal.\u003c/p>\n\u003cp>The circumstances that give rise to amputations are complex and often intertwined: Patients may avoid doctors because their family and friends do, or clinics are too far away. Some may delay medical visits because they don’t trust doctors or have limited insurance. Even when they seek treatment, some find it difficult to take medication as directed, adhere to dietary restrictions or stay off an infected foot.\u003c/p>\n\u003cp>Californians with diabetes who have a regular place to go for health care other than the emergency room are less likely to get amputations, according to an analysis conducted for Kaiser Health News by the UCLA Center for Health Policy Research. If they have a plan to control their diabetes, they also have less chance of amputation.\u003c/p>\n\u003cp>The analysis shows that many amputations could be avoided with better access to care and better disease management, said Ninez Ponce, director of the center.\u003c/p>\n\u003cp>“It’s the most shameful metric we have on quality of care,” Ponce said. “It is a health equity issue. We are a very rich state. We shouldn’t be seeing these diabetic amputations.”\u003c/p>\n\u003cp>An amputation often leads to a cascade of setbacks: more infections, more amputations, decreased mobility, social isolation. \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/26898398\">Research shows\u003c/a> as many as three-quarters of people with diabetes who have had lower-limb amputations die within five years.\u003c/p>\n\u003cfigure class=\"wp-caption alignnone\" style=\"max-width: 1350px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/amputations-11_1350.jpg\" width=\"1350\" height=\"900\">\u003cfigcaption class=\"wp-caption-text\">Patricia Zamora gets ready to clean the wound on her foot on Nov. 1, 2018. Zamora was first diagnosed with gestational diabetes and eventually with conventional Type 2.(Heidi de Marco/California Healthline)\u003c/figcaption>\u003c/figure>\n\u003cp>The health system bears surprisingly large costs for what remains a relatively uncommon problem. A single lower-limb amputation can cost more than $100,000. By far, government programs — Medicaid and Medicare — pay for the most amputations.\u003c/p>\n\u003cp>Experts say the best bet is to intervene well before they become necessary. People with diabetes are “very much in need of the simplest, basic, cost-effective, easy-to-implement treatments,” said Dr. Philip Goodney, director of the Center for the Evaluation of Surgical Care at Dartmouth.\u003c/p>\n\u003cp>Along with basic measures to control diabetes, regular foot exams are key. The Centers for Disease Control and Prevention estimates somewhere between 11% and 28% of people with diabetes get the recommended podiatric care, a yearly foot exam to check for loss of sensation and blood flow. Under federal rules governing Medicaid, the government program for low-income Americans, such care is optional and not covered by every state.\u003c/p>\n\u003cp>California includes it as an optional benefit, limiting access to such care. An \u003ca href=\"http://healthpolicy.ucla.edu/publications/Documents/PDF/2017/podiatricservices-brief-jun2017.pdf\">analysis\u003c/a> by UCLA researchers estimated that the use of preventive podiatric services saved the Medi-Cal system — California’s version of Medicaid — up to $97 million in 2014, based on avoided hospital admissions and amputations, and that savings could be much greater if more patients had access.\u003c/p>\n\u003cp>\u003cstrong>Fighting for Jesse\u003c/strong>\u003c/p>\n\u003cp>Jesse Guerrero is 12, but already knows what diabetes — and amputations — can do to a family. He has seen how life changed since his mom, Patricia Zamora, had her first surgery. She had to stop working as a group home supervisor. They were evicted and eventually moved into his grandmother’s house in Pomona.\u003c/p>\n\u003cp>Now, they stay home a lot more than they used to. “I want her to get better so we can finally go places,” Jesse said.\u003c/p>\n\u003cp>First diagnosed with gestational diabetes, Zamora, 49, eventually was diagnosed with conventional Type 2. Though her mother has diabetes, she said, she didn’t understand the risks.\u003c/p>\n\u003cfigure class=\"wp-caption alignright\" style=\"max-width: 770px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/amputations-10_1350.jpg?w=770&h=513&crop=1\" width=\"770\" height=\"513\">\u003cfigcaption class=\"wp-caption-text\">Jesse Guerrero helps take care of his mom, who has diabetes. “I want her to get better so we can finally go places,” he says.(Heidi de Marco/California Healthline)\u003c/figcaption>\u003c/figure>\n\u003cp>Her serious troubles started in 2014, when she stubbed her big toe and it turned black and purple. When she finally went to an ER, doctors said it had to be amputated. The next year, after another stumble and another infection, doctors removed the remaining toes on her right foot.\u003c/p>\n\u003cp>Now, she is fighting a third wound and risks losing the limb below her knee. She uses a scooter and wears a boot to keep the pressure off.\u003c/p>\n\u003cp>Many days, she wants to give up.\u003c/p>\n\u003cp>“But I can’t,” she said. “I have Jesse.”\u003c/p>\n\u003cp>His health is also a concern. Though only in middle school, Jesse is overweight, putting him at greater risk for Type 2 diabetes. She recently took away his PlayStation and signed him up for flag football so he would be more active.\u003c/p>\n\u003cp>Jesse, too, is scared.\u003c/p>\n\u003cp>“I don’t want to get my foot cut off,” he said. “I’d rather have a full life than a short one.”\u003c/p>\n\u003cp>\u003cstrong>The Gift of Pain\u003c/strong>\u003c/p>\n\u003cp>As hospitals have seen the impacts — and cost — of amputations, some have made efforts to reduce them. Some, like Keck Hospital, have started limb preservation centers, which use cross-disciplinary teams and technology to treat wounds and help patients improve disease management.\u003c/p>\n\u003cp>Even with a team of specialists, however, saving a limb often depends on patients coming in early rather than waiting until their foot has become dangerously infected. But because their sensation is dulled, they often don’t appreciate the danger.\u003c/p>\n\u003cp>“How do you get someone to come in if they don’t have pain?” Armstrong said. “They need the gift of pain.”\u003c/p>\n\u003cp>One of Armstrong’s patients, Cirilo Delgado, has a wound on his heel that could cost him his lower leg. He already lost a toe.\u003c/p>\n\u003cp>Delgado, 41, knew diabetes ran in his family. His father, 68, has diabetes. His mother, who had diabetes and kidney failure, died at 67. His diabetic sister died at 35 of a heart attack, a possible complication of diabetes.\u003c/p>\n\u003cp>“I saw them die young,” he said. “I don’t want to be the next one.”\u003c/p>\n\u003cp>Like Moss, Delgado didn’t always have insurance. And he didn’t seek care for his diabetes until the symptoms got dire.\u003c/p>\n\u003cp>Delgado used to work at a dry cleaning shop but had to stop because he doesn’t have the balance he once did. His blood pressure fluctuates dangerously, and he needs dialysis three times a week for kidney failure. He has moved in with his father, a truck driver who stopped working to help care for him.\u003c/p>\n\u003cp>In November, doctors used a skin flap from his leg to try to heal his latest wound. He’s praying he doesn’t get another.\u003c/p>\n\u003cp>“I know there’s a prosthesis,” he said, “but it’s not the same as a limb.”\u003c/p>\n\u003cp>\u003cem>To see more, visit \u003ca href=\"http://khn.org/\">Kaiser\u003c/a>\u003ca href=\"http://khn.org/\"> Healt\u003c/a>\u003ca href=\"http://khn.org/\">h\u003c/a>\u003ca href=\"http://khn.org/\"> News\u003c/a>, an editorially independent program of the \u003ca href=\"https://www.kff.org/\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>\u003cem>\u003ca href=\"https://californiahealthline.org\">California Healthline\u003c/a> ethnic media editor Ngoc Nguyen and Kaiser Health News data editor Elizabeth Lucas contributed to this report.\u003c/em>\u003c/p>\n\u003cp>\u003cem>Methodology note: Kaiser Health News analyzed 2011-17 data from California’s Office of Statewide Health Planning and Development (OSHPD) on diabetes patients discharged after lower-limb amputations. OSPHD grouped the amputations into these racial and ethnic categories: white, black, Hispanic and other; and these age groups: under 45, 45-64, 65 and over. To compare amputation rates across groups, KHN calculated crude rates using California population data for each year from the U.S. Census Bureau, and calculated the final age-adjusted rate for each racial/ethnic group using U.S. 2010 population distribution as weights.\u003c/em>\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp> \u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>Each week, dozens of patients with diabetes come to him with deep wounds, severe infections and poor circulation — debilitating complications of a disease that has spiraled out of control. He works to save their limbs, but sometimes Armstrong and his team must resort to amputation to save the patient, a painful and life-altering measure he knows is nearly always preventable.\u003c/p>\n\u003cp>For decades now, the American medical establishment has known how to manage diabetes. Even as the number of people living with the illness continues to climb — today, estimated at more than 30 million nationwide — the prognosis for those with access to good health care has become far less dire. With the right medication, diet and lifestyle changes, patients can learn to manage their diabetes and lead robust lives.\u003c/p>\n\u003cp>Yet across the country, surgeons still perform tens of thousands of diabetic amputations each year. It’s a drastic procedure that stands as a powerful example of the consequences of being poor, uninsured and cut off from a routine system of quality health care.\u003c/p>\n\u003cp>“Amputations are an unnecessary consequence of this devastating disease,” said Armstrong, professor of surgery at Keck School of Medicine of USC. “It’s an epidemic within an epidemic. And it’s a problem that’s totally ignored.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In California, where doctors performed more than 82,000 diabetic amputations from 2011 to 2017, people who were black or Latino were more than twice as likely as non-Hispanic whites to undergo amputations related to diabetes, a Kaiser Health News analysis found.\u003c/p>\n\u003cp>The pattern is not unique to California. Across the country, studies have shown that diabetic amputations vary significantly not just by race and ethnicity but also by income and geography. Diabetic patients living in communities tat rank in the nation’s bottom quartile by income were nearly 39% more likely to undergo major amputations compared with people living in the highest-income communities, according to one \u003ca href=\"https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0134914\">2015 study\u003c/a>.\u003c/p>\n\u003cp>A \u003ca href=\"https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2014.0148\">2014 study\u003c/a> by UCLA researchers found that people with diabetes in poorer neighborhoods in Los Angeles County were twice as likely to have a foot or leg amputated than those in wealthier areas. The difference was more than tenfold in some parts of the county.\u003c/p>\n\u003cp>\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium alignnone\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/california-amputations3.png\" width=\"1024\" height=\"871\">\u003c/p>\n\u003cp>Amputations are considered a “mega-disparity” and dwarf nearly every other health disparity by race and ethnicity, said Dr. Dean Schillinger, a medical professor at the University of California-San Francisco. To begin with, people who are black or Latino are more at risk of diabetes than other groups — a disparity often attributed to socioeconomic factors such as higher rates of poverty and lower levels of education. They also may live in environments with less access to healthy food or places to exercise.\u003c/p>\n\u003cp>Then, among those with the disease, blacks and Latinos often get diagnosed after the disease has taken hold and have more complications, such as amputations. “If you go into low-income African American neighborhoods, it is a war zone,” said Schillinger, former chief of the Diabetes Prevention and Control Program at the California Department of Public Health. “You see people wheeling themselves around in wheelchairs.”\u003c/p>\n\u003cp>Part of the outrage for researchers is that medical science has made so much headway in diabetes treatment. Nationwide, fewer than \u003ca href=\"https://www.ajmc.com/newsroom/diabetic-amputations-may-be-rising-in-the-united-states\">5 adults out of every 1,000 with diabetes\u003c/a> get amputations.\u003c/p>\n\u003cp>But for those who do, the consequences are profound. More than half of amputations in California from 2011 to 2017 occurred among people ages 45 to 64, according to the KHN analysis, meaning many people are left disabled and dependent on others for care during their prime working years.\u003c/p>\n\u003cp>\u003cstrong>From Mother to Son\u003c/strong>\u003c/p>\n\u003cp>Jackson Moss leaned back on his couch and raised his right leg. His wife, Bernadette, sprayed antiseptic on a gaping wound on the sole of his foot before dabbing it with Vaseline and rewrapping it with gauze.\u003c/p>\n\u003cp>A stocky man who used to deliver poultry, Moss, 47, said he had to stop working after his left leg was amputated below the knee about 10 years ago. Later, he lost part of his right foot. With Bernadette’s help, he is trying to save the rest of it.\u003c/p>\n\u003cfigure class=\"wp-caption alignright\" style=\"max-width: 1350px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/amputations-8_1350.jpg\" width=\"1350\" height=\"900\">\u003cfigcaption class=\"wp-caption-text\">Jackson Moss had to stop working after his left leg was amputated below the knee about 10 years ago because of an infected wound that developed in his toe.(Heidi de Marco/California Healthline\u003c/figcaption>\u003c/figure>\n\u003cp>“If I didn’t have my wife, I don’t know where I’d be,” said Moss, who wears a prosthesis on his left leg and uses a wheelchair. “I can’t get around good like I used to.”\u003c/p>\n\u003cp>Moss, who lives in Compton, embodies many of the characteristics of people most likely to get diabetic amputations. He is African American with a relatively low family income: about $30,000 a year from his Social Security disability check and his wife’s job with the county mental health department.\u003c/p>\n\u003cp>Moss has not always received regular medical care. His mother, who also had a leg amputated from diabetes, would take him to the doctor when he was a boy. But he stopped going as an adult. He didn’t have insurance during much of his 20s and 30s. Medical care just wasn’t a priority, he said, until about 25 years ago when his blood sugar shot up so high he passed out at home.\u003c/p>\n\u003cp>After he was diagnosed with Type 2 diabetes, he started seeing a physician more often. He tried to avoid sugar, as his doctor recommended, but bad habits die hard. “It takes a lot to eat right,” he said, “and it costs more.”\u003c/p>\n\u003cp>One day, about 10 years ago, he bumped his toe on the bed. He thought little of it until he developed an infected wound. A fever sent him to the hospital, where his lower leg was removed. A few years later, with his diabetes still poorly controlled, he lost the toes on his other foot.\u003c/p>\n\u003cp>In recent years, Moss and his wife said, health providers have sometimes ignored their concerns. They recalled trips to the emergency room when they had to convince doctors his fever came from a diabetes-related infection. “They wouldn’t take my word,” he said. The couple did not see it as discrimination, more like dismissiveness.\u003c/p>\n\u003cp>Now, Moss goes to a clinic run by Martin Luther King, Jr. Community Hospital, which serves a large Latino and black population in South Los Angeles. On a recent visit, his doctor asked if he was staying off the foot with the wound. “I just get up when I have to go to the restroom and to get in and out of the bed,” Moss responded.\u003c/p>\n\u003cp>Moss hopes someday he will be able to do more — get back to taking his grandsons to Chuck E. Cheese or playing dominoes with friends.\u003c/p>\n\u003cp>“I just sit here all day long,” he said.\u003c/p>\n\u003cfigure class=\"wp-caption alignnone\" style=\"max-width: 1350px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/amputations-9_1350.jpg\" width=\"1350\" height=\"900\">\u003cfigcaption class=\"wp-caption-text\">Moss holds the funeral program for his mother, who also had diabetes.(Heidi de Marco/California Healthline)\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>‘The Most Shameful Metric’\u003c/strong>\u003c/p>\n\u003cp>Amputations typically start with poorly controlled diabetes, a disease characterized by excess sugar in the blood. Untreated, it can lead to serious complications such as kidney failure and blindness.\u003c/p>\n\u003cp>People with diabetes often have reduced sensation in their feet, as well as poor circulation. \u003ca href=\"http://mr3health.com/wp-content/uploads/2018/10/nejmra1615439.pdf\">As many as one-third\u003c/a> of people with the most common form — Type 2 — develop foot ulcers or a break in the skin that can become infected.\u003c/p>\n\u003cp>Amputations occur after those infections rage out of control and enter the bloodstream or seep deeper into the tissue. People with diabetes often have a condition that makes it harder for blood to circulate and wounds to heal.\u003c/p>\n\u003cp>The circumstances that give rise to amputations are complex and often intertwined: Patients may avoid doctors because their family and friends do, or clinics are too far away. Some may delay medical visits because they don’t trust doctors or have limited insurance. Even when they seek treatment, some find it difficult to take medication as directed, adhere to dietary restrictions or stay off an infected foot.\u003c/p>\n\u003cp>Californians with diabetes who have a regular place to go for health care other than the emergency room are less likely to get amputations, according to an analysis conducted for Kaiser Health News by the UCLA Center for Health Policy Research. If they have a plan to control their diabetes, they also have less chance of amputation.\u003c/p>\n\u003cp>The analysis shows that many amputations could be avoided with better access to care and better disease management, said Ninez Ponce, director of the center.\u003c/p>\n\u003cp>“It’s the most shameful metric we have on quality of care,” Ponce said. “It is a health equity issue. We are a very rich state. We shouldn’t be seeing these diabetic amputations.”\u003c/p>\n\u003cp>An amputation often leads to a cascade of setbacks: more infections, more amputations, decreased mobility, social isolation. \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/26898398\">Research shows\u003c/a> as many as three-quarters of people with diabetes who have had lower-limb amputations die within five years.\u003c/p>\n\u003cfigure class=\"wp-caption alignnone\" style=\"max-width: 1350px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/amputations-11_1350.jpg\" width=\"1350\" height=\"900\">\u003cfigcaption class=\"wp-caption-text\">Patricia Zamora gets ready to clean the wound on her foot on Nov. 1, 2018. Zamora was first diagnosed with gestational diabetes and eventually with conventional Type 2.(Heidi de Marco/California Healthline)\u003c/figcaption>\u003c/figure>\n\u003cp>The health system bears surprisingly large costs for what remains a relatively uncommon problem. A single lower-limb amputation can cost more than $100,000. By far, government programs — Medicaid and Medicare — pay for the most amputations.\u003c/p>\n\u003cp>Experts say the best bet is to intervene well before they become necessary. People with diabetes are “very much in need of the simplest, basic, cost-effective, easy-to-implement treatments,” said Dr. Philip Goodney, director of the Center for the Evaluation of Surgical Care at Dartmouth.\u003c/p>\n\u003cp>Along with basic measures to control diabetes, regular foot exams are key. The Centers for Disease Control and Prevention estimates somewhere between 11% and 28% of people with diabetes get the recommended podiatric care, a yearly foot exam to check for loss of sensation and blood flow. Under federal rules governing Medicaid, the government program for low-income Americans, such care is optional and not covered by every state.\u003c/p>\n\u003cp>California includes it as an optional benefit, limiting access to such care. An \u003ca href=\"http://healthpolicy.ucla.edu/publications/Documents/PDF/2017/podiatricservices-brief-jun2017.pdf\">analysis\u003c/a> by UCLA researchers estimated that the use of preventive podiatric services saved the Medi-Cal system — California’s version of Medicaid — up to $97 million in 2014, based on avoided hospital admissions and amputations, and that savings could be much greater if more patients had access.\u003c/p>\n\u003cp>\u003cstrong>Fighting for Jesse\u003c/strong>\u003c/p>\n\u003cp>Jesse Guerrero is 12, but already knows what diabetes — and amputations — can do to a family. He has seen how life changed since his mom, Patricia Zamora, had her first surgery. She had to stop working as a group home supervisor. They were evicted and eventually moved into his grandmother’s house in Pomona.\u003c/p>\n\u003cp>Now, they stay home a lot more than they used to. “I want her to get better so we can finally go places,” Jesse said.\u003c/p>\n\u003cp>First diagnosed with gestational diabetes, Zamora, 49, eventually was diagnosed with conventional Type 2. Though her mother has diabetes, she said, she didn’t understand the risks.\u003c/p>\n\u003cfigure class=\"wp-caption alignright\" style=\"max-width: 770px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https://californiahealthline.org/wp-content/uploads/sites/3/2019/04/amputations-10_1350.jpg?w=770&h=513&crop=1\" width=\"770\" height=\"513\">\u003cfigcaption class=\"wp-caption-text\">Jesse Guerrero helps take care of his mom, who has diabetes. “I want her to get better so we can finally go places,” he says.(Heidi de Marco/California Healthline)\u003c/figcaption>\u003c/figure>\n\u003cp>Her serious troubles started in 2014, when she stubbed her big toe and it turned black and purple. When she finally went to an ER, doctors said it had to be amputated. The next year, after another stumble and another infection, doctors removed the remaining toes on her right foot.\u003c/p>\n\u003cp>Now, she is fighting a third wound and risks losing the limb below her knee. She uses a scooter and wears a boot to keep the pressure off.\u003c/p>\n\u003cp>Many days, she wants to give up.\u003c/p>\n\u003cp>“But I can’t,” she said. “I have Jesse.”\u003c/p>\n\u003cp>His health is also a concern. Though only in middle school, Jesse is overweight, putting him at greater risk for Type 2 diabetes. She recently took away his PlayStation and signed him up for flag football so he would be more active.\u003c/p>\n\u003cp>Jesse, too, is scared.\u003c/p>\n\u003cp>“I don’t want to get my foot cut off,” he said. “I’d rather have a full life than a short one.”\u003c/p>\n\u003cp>\u003cstrong>The Gift of Pain\u003c/strong>\u003c/p>\n\u003cp>As hospitals have seen the impacts — and cost — of amputations, some have made efforts to reduce them. Some, like Keck Hospital, have started limb preservation centers, which use cross-disciplinary teams and technology to treat wounds and help patients improve disease management.\u003c/p>\n\u003cp>Even with a team of specialists, however, saving a limb often depends on patients coming in early rather than waiting until their foot has become dangerously infected. But because their sensation is dulled, they often don’t appreciate the danger.\u003c/p>\n\u003cp>“How do you get someone to come in if they don’t have pain?” Armstrong said. “They need the gift of pain.”\u003c/p>\n\u003cp>One of Armstrong’s patients, Cirilo Delgado, has a wound on his heel that could cost him his lower leg. He already lost a toe.\u003c/p>\n\u003cp>Delgado, 41, knew diabetes ran in his family. His father, 68, has diabetes. His mother, who had diabetes and kidney failure, died at 67. His diabetic sister died at 35 of a heart attack, a possible complication of diabetes.\u003c/p>\n\u003cp>“I saw them die young,” he said. “I don’t want to be the next one.”\u003c/p>\n\u003cp>Like Moss, Delgado didn’t always have insurance. And he didn’t seek care for his diabetes until the symptoms got dire.\u003c/p>\n\u003cp>Delgado used to work at a dry cleaning shop but had to stop because he doesn’t have the balance he once did. His blood pressure fluctuates dangerously, and he needs dialysis three times a week for kidney failure. He has moved in with his father, a truck driver who stopped working to help care for him.\u003c/p>\n\u003cp>In November, doctors used a skin flap from his leg to try to heal his latest wound. He’s praying he doesn’t get another.\u003c/p>\n\u003cp>“I know there’s a prosthesis,” he said, “but it’s not the same as a limb.”\u003c/p>\n\u003cp>\u003cem>To see more, visit \u003ca href=\"http://khn.org/\">Kaiser\u003c/a>\u003ca href=\"http://khn.org/\"> Healt\u003c/a>\u003ca href=\"http://khn.org/\">h\u003c/a>\u003ca href=\"http://khn.org/\"> News\u003c/a>, an editorially independent program of the \u003ca href=\"https://www.kff.org/\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>\u003cem>\u003ca href=\"https://californiahealthline.org\">California Healthline\u003c/a> ethnic media editor Ngoc Nguyen and Kaiser Health News data editor Elizabeth Lucas contributed to this report.\u003c/em>\u003c/p>\n\u003cp>\u003cem>Methodology note: Kaiser Health News analyzed 2011-17 data from California’s Office of Statewide Health Planning and Development (OSHPD) on diabetes patients discharged after lower-limb amputations. OSPHD grouped the amputations into these racial and ethnic categories: white, black, Hispanic and other; and these age groups: under 45, 45-64, 65 and over. To compare amputation rates across groups, KHN calculated crude rates using California population data for each year from the U.S. Census Bureau, and calculated the final age-adjusted rate for each racial/ethnic group using U.S. 2010 population distribution as weights.\u003c/em>\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>\u003ci>Editor’s note: The following story was produced by an Ygnacio Valley High School student for \u003c/i>\u003ca href=\"https://ww2.kqed.org/education/2018/04/18/youth-takeover-of-kqed-news-starts-april-23/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">Youth Takeover\u003c/span>\u003c/i>\u003c/a> week at KQED.\u003c/p>\n\u003cp>As a teenage girl, I know the feeling of not being able to bring up teen pregnancy or talk about sex-related conversations with my parents. For many, the subject is awkward and uncomfortable.\u003c/p>\n\u003cp>This was the case for me, until this year.\u003c/p>\n\u003cp>Before coming to Ygnacio Valley High School, I was never really educated about sex and how to make educated decisions regarding contraception methods. And yet, my parents expect me not to get pregnant.\u003c/p>\n\u003cp>While I am not worried about getting pregnant, something I have observed is that when it happens, the young woman is usually shamed.\u003c/p>\n\u003cp>Our parents should learn how to normalize sex-related conversations. For example, my friend was having unprotected sex. When I asked her why, she said it was because she’s only 14 and doesn’t think she is able to get pregnant. If she had taken a class or had an adult in her life she could talk to, I think she would make educated decisions.\u003c/p>\n\u003cp>These days teens learn misguided or fictional information on social media, websites, even TV. Most teenagers I know use the pull-out method, not knowing they can still get pregnant or end up with a sexually transmitted infection.\u003c/p>\n\u003cp>Here at Ygnacio Valley High School, I applaud Ms. Lamb’s healthy living class, in which she teaches about safe sex, contraception, consent, sexuality, and sexually transmitted illnesses. As a teenage girl, I wish society would normalize teen sex, so that adults and teens would be able to talk about it with less awkwardness. It would make a huge impact on teen pregnancies. And it helps the boys, too, not just the girls. \u003cspan style=\"font-weight: 400\">From talking with my girlfriends, we’ve realized some teenage boys don’t even know how to put on a condom, so sometimes they say they don’t want to use it. \u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">My friends and I don’t always have someone to talk with about how to handle a situation like that. Every teen should have at least one individual who can help them through these confusing years. \u003c/span>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003ci>Editor’s note: The following story was produced by an Ygnacio Valley High School student for \u003c/i>\u003ca href=\"https://ww2.kqed.org/education/2018/04/18/youth-takeover-of-kqed-news-starts-april-23/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">Youth Takeover\u003c/span>\u003c/i>\u003c/a> week at KQED.\u003c/p>\n\u003cp>As a teenage girl, I know the feeling of not being able to bring up teen pregnancy or talk about sex-related conversations with my parents. For many, the subject is awkward and uncomfortable.\u003c/p>\n\u003cp>This was the case for me, until this year.\u003c/p>\n\u003cp>Before coming to Ygnacio Valley High School, I was never really educated about sex and how to make educated decisions regarding contraception methods. And yet, my parents expect me not to get pregnant.\u003c/p>\n\u003cp>While I am not worried about getting pregnant, something I have observed is that when it happens, the young woman is usually shamed.\u003c/p>\n\u003cp>Our parents should learn how to normalize sex-related conversations. For example, my friend was having unprotected sex. When I asked her why, she said it was because she’s only 14 and doesn’t think she is able to get pregnant. If she had taken a class or had an adult in her life she could talk to, I think she would make educated decisions.\u003c/p>\n\u003cp>These days teens learn misguided or fictional information on social media, websites, even TV. Most teenagers I know use the pull-out method, not knowing they can still get pregnant or end up with a sexually transmitted infection.\u003c/p>\n\u003cp>Here at Ygnacio Valley High School, I applaud Ms. Lamb’s healthy living class, in which she teaches about safe sex, contraception, consent, sexuality, and sexually transmitted illnesses. As a teenage girl, I wish society would normalize teen sex, so that adults and teens would be able to talk about it with less awkwardness. It would make a huge impact on teen pregnancies. And it helps the boys, too, not just the girls. \u003cspan style=\"font-weight: 400\">From talking with my girlfriends, we’ve realized some teenage boys don’t even know how to put on a condom, so sometimes they say they don’t want to use it. \u003c/span>\u003c/p>\n\u003cp>\u003cspan style=\"font-weight: 400\">My friends and I don’t always have someone to talk with about how to handle a situation like that. Every teen should have at least one individual who can help them through these confusing years. \u003c/span>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"info": "KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.",
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"order": 8
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},
"link": "https://www.cityarts.net",
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"order": 1
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"title": "Commonwealth Club of California Podcast",
"info": "The Commonwealth Club of California is the nation's oldest and largest public affairs forum. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. This podcast feed is usually updated twice a week and is always un-edited.",
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"source": "Commonwealth Club of California"
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"info": "KQED’s live call-in program discussing local, state, national and international issues, as well as in-depth interviews.",
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"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Forum-Podcast-Tile-703x703-1.jpg",
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"order": 9
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"hidden-brain": {
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"info": "Shankar Vedantam uses science and storytelling to reveal the unconscious patterns that drive human behavior, shape our choices and direct our relationships.",
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"airtime": "SUN 7pm-8pm",
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"source": "NPR"
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"info": "Guy Raz dives into the stories behind some of the world's best known companies. How I Built This weaves a narrative journey about innovators, entrepreneurs and idealists—and the movements they built.",
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"airtime": "SUN 7:30pm-8pm",
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"hyphenacion": {
"id": "hyphenacion",
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"tagline": "Where conversation and cultura meet",
"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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"jerrybrown": {
"id": "jerrybrown",
"title": "The Political Mind of Jerry Brown",
"tagline": "Lessons from a lifetime in politics",
"info": "The Political Mind of Jerry Brown brings listeners the wisdom of the former Governor, Mayor, and presidential candidate. Scott Shafer interviewed Brown for more than 40 hours, covering the former governor's life and half-century in the political game and Brown has some lessons he'd like to share. ",
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"order": 18
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},
"latino-usa": {
"id": "latino-usa",
"title": "Latino USA",
"airtime": "MON 1am-2am, SUN 6pm-7pm",
"info": "Latino USA, the radio journal of news and culture, is the only national, English-language radio program produced from a Latino perspective.",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/latinoUsa.jpg",
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},
"link": "/radio/program/latino-usa",
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"rss": "https://feeds.npr.org/510016/podcast.xml"
}
},
"marketplace": {
"id": "marketplace",
"title": "Marketplace",
"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.",
"airtime": "MON-FRI 4pm-4:30pm, MON-WED 6:30pm-7pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Marketplace-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.marketplace.org/",
"meta": {
"site": "news",
"source": "American Public Media"
},
"link": "/radio/program/marketplace",
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"rss": "https://feeds.publicradio.org/public_feeds/marketplace-pm/rss/rss"
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},
"masters-of-scale": {
"id": "masters-of-scale",
"title": "Masters of Scale",
"info": "Masters of Scale is an original podcast in which LinkedIn co-founder and Greylock Partner Reid Hoffman sets out to describe and prove theories that explain how great entrepreneurs take their companies from zero to a gazillion in ingenious fashion.",
"airtime": "Every other Wednesday June 12 through October 16 at 8pm (repeats Thursdays at 2am)",
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"officialWebsiteLink": "https://mastersofscale.com/",
"meta": {
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"source": "WaitWhat"
},
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"rss": "https://rss.art19.com/masters-of-scale"
}
},
"mindshift": {
"id": "mindshift",
"title": "MindShift",
"tagline": "A podcast about the future of learning and how we raise our kids",
"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>",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg",
"imageAlt": "KQED MindShift: How We Will Learn",
"officialWebsiteLink": "/mindshift/",
"meta": {
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"source": "kqed",
"order": 12
},
"link": "/podcasts/mindshift",
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"google": "https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5",
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