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"disqusTitle": "Was the EpiPen Hack Ethical?",
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"content": "\u003cp>\u003cstrong>Update June 5, 2017 \u003c/strong>\u003c/p>\n\u003cp>From The New York Times Sunday: Charles Duhigg \u003ca href=\"https://www.nytimes.com/2017/06/04/business/angry-about-epipen-prices-executive-dont-care-much.html\" target=\"_blank\" rel=\"noopener noreferrer\">writes\u003c/a> that last year's outrage over Mylan ratcheting up the price of the EpiPen, so that patients\u003ca href=\"http://www.reuters.com/article/us-health-epipen-costs-idUSKBN16Y24O\" target=\"_blank\" rel=\"noopener noreferrer\"> out-of-pocket costs\u003c/a> increased by over 500 percent in a few years, has not resulted in the company lowering the price of the product. Duhigg writes:\u003c/p>\n\u003cblockquote>\u003cp>Mylan has been called out again and again over the years — by the company’s own employees, regulators, patients, politicians and the press — and hasn’t changed, even as revenue has skyrocketed, hitting $11 billion last year. The firm is a case study in the limits of what consumer and employee activism, as well as government oversight, can achieve.\u003c/p>\u003c/blockquote>\n\u003cp>Meanwhile last week, Iowa Republican Sen. Charles Grassley\u003ca href=\"https://www.grassley.senate.gov/news/news-releases/grassley-latest-estimate-taxpayers-overpaid-127-billion-epipen\" target=\"_blank\" rel=\"noopener noreferrer\"> announced\u003c/a> that the government has estimated Mylan may have overcharged Medicaid by as much as $1.27 billion for the EpiPen under the agency's drug rebate program.\u003c/p>\n\u003cp>\u003cstrong>Original post from Jan. 23, 2017\u003c/strong>\u003c/p>\n\u003cp>Should we be free, as individuals, to make and take our own medicine at home? Who’s responsible if we get hurt or die? Do we have to right to do what we wish with our bodies in the interests of survival, healing and self-care? For years, such questions have been at the heart of public health debates over euthanasia – the right to die – and even drug addiction.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>They also lie at the center of the infamous Mylan EpiPen pricing scandal. Last fall, Mylan CEO Heather Bresch appeared before the House Oversight Committee to explain the company’s 548 percent price hike for a simple device that injects a lifesaving anti-allergy hormone, FDA-approved epinephrine.\u003c/p>\n\u003cp>The cost drove desperate allergy patients to seek alternatives, including \u003ca href=\"http://www.thedailybeast.com/articles/2016/09/22/please-do-not-hack-your-own-epipen.html\">the dangerous practice\u003c/a> of shooting epinephrine straight from a vial into a muscle.\u003c/p>\n\u003cp>Enter a new challenger: the pharmaceutical hacking collective \u003ca href=\"https://fourthievesvinegar.org/\">Four Thieves Vinegar.\u003c/a> The group is led by Michael Laufer, a math professor by day at Menlo College in Atherton, California, who shot to internet fame overnight last August when he uploaded a DIY instructional video that went viral, showcasing his homemade version of a copycat EpiPen he called the EpiPencil. \u003ca href=\"https://www.the-parallax.com/2016/09/19/epipencil-hack-costs-fraction-epipen-exclusive/\">His device costs around $35 to construct\u003c/a>– a fraction of Mylan’s $600 brand name dual-pack EpiPen. Anyone can make it at home for personal use, he claims.\u003c/p>\n\u003cp>Laufer isn’t a medical doctor and doesn’t pretend to be. But he’s a numbers guy, well versed in computer science, and has dipped into biology and chemistry. It took him two weeks to research and assemble the plastic components of the EpiPen, an auto injector created by a NASA researcher and marketed in 1980 for $20. Mylan later picked up the patent and has benefited from a monopoly.\u003c/p>\n\u003cfigure id=\"attachment_323237\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-323237\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-800x1013.jpg\" alt=\"Close-up of packaging used in the Epi-Pencil. \" width=\"800\" height=\"1013\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-800x1013.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-160x203.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-768x973.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-1020x1292.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-1920x2432.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-1180x1495.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-960x1216.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-240x304.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-375x475.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-520x659.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Close-up of packaging used in the EpiPencil. \u003ccite>(Four Thieves Vinegar Collective)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Four Thieves Vinegar is named after a folk remedy made from vinegar and spices to ward off bubonic plague. The collective is part of the fast-growing DIY Biology movement, a subculture in which tech meets pharma--a Maker Faire for bio-geeks. In the video, Laufer carefully demonstrates how anyone can do what he did: combine a cheap off-the-shelf needle injector made for diabetics that is easy to buy on the internet, and combine it with a syringe that can be preloaded with a $1 dose of epinephrine.\u003c/p>\n\u003cp>Under fire, Mylan soon released\u003ca href=\"http://newsroom.mylan.com/2016-12-16-Mylan-Launches-the-First-Generic-for-EpiPen-epinephrine-injection-USP-Auto-Injector-as-an-Authorized-Generic\"> a $300 generic of its EpiPen\u003c/a>, but that did little to quiet critics. Georgia Congressman Buddy Carter accused the company of failing to disclose the truth about its profiteering. “There is no transparency, that's the problem here,\" he declared.\u003c/p>\n\u003cp>Leaders also criticized the FDA for its slow-paced approval of generic rivals. Teva Pharmaceutical Industries failed to get approval \u003ca href=\"https://consumerist.com/2016/09/12/teva-will-try-again-to-get-fda-approval-on-epipen-competitor-by-2018/\">for its generic EpiPen\u003c/a> in late 2016, but expects approval by 2018. Meanwhile, CVS Pharmacy has just released a $109.99 generic \u003ca href=\"http://www.pharmacytimes.com/sap-news/cvs-offers-2pack-adrenaclick-for-fraction-of-epipen-price\">two-pack EpiPen called Adrenaclick\u003c/a>. At $55 a pen, it’s close to Laufer’s DIY price -- and provides consumers with a safe, FDA-approved product.\u003c/p>\n\u003cp>That’s exactly what Laufer hoped might happen. As he sees it, his EpiPencil hack was a classic example of The Emperor Has No Clothes: It revealed the actual cost of the plastic auto injector – and showed others how they could make such a device cheaply.\u003c/p>\n\u003cp>It’s a mixed victory, though. The media spotlight gained supporters for Laufer's collective, but also opened him up to criticism. “I get a lot more fan mail then hate mail,” he says, including from parents. But others sharply condemn his actions, and his hacking group’s broader mission: making medicine at home.\u003c/p>\n\u003cp>\u003cstrong>Home Pharma Hacks Raise Safety Questions\u003c/strong>\u003c/p>\n\u003cp>Shortly after Laufer’s hack, the FDA issued a strongly worded warning against its use: “Using unapproved prescription drugs for personal use is a potentially dangerous practice,” an FDA spokesperson \u003ca href=\"http://www.in-pharmatechnologist.com/Regulatory-Safety/US-FDA-warns-against-30-alternative-to-Mylan-s-EpiPen\">told\u003c/a> the website in-PharmaTechnologist. “Unapproved drugs may be contaminated, sub-potent, super-potent or counterfeit.”\u003c/p>\n\u003cp>Critics agree. Yvette d’Entremont, known as SciBabe, is a former chemist-cum-blogger who quickly labeled the EpiPen hack a potential major fail if misused. “It seems like such a bad idea,” she told the Daily Beast. “It’s all fun and games until your product gets contaminated and you get a giant abscess in your muscle.”\u003c/p>\n\u003caside class=\"pullquote alignright\">'I believe in empowering people, in sharing information. We need to talk about alternatives to expensive medication regimens.’\u003ccite>Michael Laufer\u003c/cite>\u003c/aside>\n\u003cp>Contamination and improper dosing can happen with approved drugs too. Epinephrine is a serious drug, used to shock the heart. Laufer defends his device as safe. “In most ways it is equivalent” to Mylan’s EpiPen, he argues, pointing out that it features a safety cap like approved EpiPens, and only carries a single dose.\u003c/p>\n\u003cp>But it’s still untested. And as the father of toxicology himself, Paracelsus, famously warned: all medicine is poison at a certain dose.\u003c/p>\n\u003cp>Oncologist Ezekiel Emanuel, a bioethicist and senior fellow at the Center for American Progress, adds to the chorus of concern, cautioning strongly against using the device.\u003c/p>\n\u003cp>“We have the FDA for a reason. We want to protect the American public from dangerous drugs, which they have no ability to evaluate independently,” he says. “So now we’re going to have some guy who’s going to make a drug and a drug delivery device, put it out there -- no testing, no evaluation of whether it’s safe or effective -- and who the hell knows how many people are going to be hurt -- or not.”\u003c/p>\n\u003cfigure id=\"attachment_323239\" class=\"wp-caption aligncenter\" style=\"max-width: 678px\">\u003cimg class=\"size-full wp-image-323239\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown.jpg\" alt=\"Michael Laufer demonstrates how to lead the Epi-Pencil in a DIY video posted to YouTube.\" width=\"678\" height=\"487\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown.jpg 678w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown-160x115.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown-240x172.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown-375x269.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown-520x374.jpg 520w\" sizes=\"(max-width: 678px) 100vw, 678px\">\u003cfigcaption class=\"wp-caption-text\">Michael Laufer demonstrates the EpiPencil in a DIY video posted to YouTube. \u003ccite>(Anne-christine d'Adesky/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Adds Emanuel: “In this case he may turn out to be lucky and no one’s hurt. But we don’t want that regime.”\u003c/p>\n\u003cp>He said the solution to high pharmaceutical prices was \"not this cockamamie 'let people throw drugs out there untested,'\" but to reduce the market power that drug companies rely on to set prices.\u003c/p>\n\u003cp>\"We give drug companies monopolies through the patent law, and marketing exclusivity,\" he said. \"No other country gives a monopoly and then expects good behavior on pricing.\u003c/p>\n\u003cp>\"So what we’ve done is say, 'Oh we’re giving drug companies monopoly pricing power and then we’re like shocked, shocked they're raising prices.\"\u003c/p>\n\u003cp>Margaret McLean, director of bioethics at the\u003ca href=\"https://www.scu.edu/ethics/focus-areas/bioethics/\"> Markkula Center for Applied Ethics\u003c/a> in Santa Clara, also agrees using Laufer's device could be dangerous. She herself, carries an EpiPen. It carries a higher copay than her other medicines, so she sympathizes with parents who can’t afford even generic versions. But the safety risks remain serious.\u003c/p>\n\u003cp>“There is always user error,” says McLean, citing incorrect dosing as a concern. “That is true with FDA-approved drugs too. But the error is less if I don’t have to draw up the right amount of epinephrine myself. I’m grateful for the standardization and check on the injector itself, and that the dose in there is appropriate for me.” She doesn’t want to worry about bubbles in the syringe, which are very dangerous. “There are a lot of steps here,” she says of Laufer’s DIY epinephrine device, “where sitting at home in your kitchen, never having done this before, it puts you in a higher risk category then buying it from the pharmacy.”\u003c/p>\n\u003cp>Still, she understands the urgent unmet need for affordable EpiPens. “The FDA is not able to move things through in an expeditious way, so people rightly get antsy.”\u003c/p>\n\u003cp>Perhaps surprisingly, Laufer agrees about the warnings on safety. “Chemistry is science. So, yes, it’s a concern. You have to think immediately, ‘What if it’s misused?’ But that’s a first-order reaction,” he says. “Ideologically, I believe that more access to more information is inherently better for everyone.” He supports FDA safety reviews and clinical trial tests for new drugs and devices that are marketed to consumers. But he stresses, he’s not marketing anything.\u003c/p>\n\u003caside class=\"pullquote alignright\">'We have the FDA for a reason. We want to protect the American public from dangerous drugs which they have no ability to evaluate independently.'\u003ccite>Ezekiel Emanuel, Center for American Progress\u003c/cite>\u003c/aside>\n\u003cp>Where Laufer draws a hard line – and marks his battleground -- is the domain of the private individual. “What I’m saying is, here is something you can think about... If you decide you’d like to adopt it, then that’s the whole ethic: Here is an idea, play with it, if you like -- no strings attached.”\u003c/p>\n\u003cp>\u003cstrong>More Drug Hacks On the Horizon\u003c/strong>\u003c/p>\n\u003cp>In his cramped faculty office, Laufer greets visitors with a warm smile, eager to share his mission and rebut critics who, he feels, have misperceptions about the true goals and the impact of his hacking action. Online, he looks like a steampunk rebel hero in a metal-studded leather jacket, rimless glasses shoved high on his forehead. Offline, he’s natty in a dark suit, purple tie and tie pin, and fancy abacus-shaped cuff links befitting a math geek.\u003c/p>\n\u003cp>“I believe in empowering people, in sharing information,” Laufer says, citing his hacker creed. “We need to talk about alternatives to expensive medication regimens.” He compares the need for a cheap drug delivery device like his EpiPencil to IKEA furniture: something that should be easy to make, with simple instructions for the average consumer.\u003c/p>\n\u003cp>What people do with that information is not his business, he declares. “I don’t know if anyone has built it besides me,” he says of the EpiPencil. “I don’t want to know. I believe in giving people information they can use to make important decisions about their self-care. That’s what I can offer.”[contextly_sidebar id=\"ucdOGkeG5JNKwxC6hhmw4jS3XUbH2VRU\"]\u003c/p>\n\u003cp>Anyone who copies a patented device risks running afoul of patent law. It's a form of civil disobedience with life-or-death stakes. That make it easy to justify, according to Laufer's group, whose \u003ca href=\"https://fourthievesvinegar.org/faq\">website asks\u003c/a>, \"If the choices presented to you are to die, because you cannot afford medication, or violate a copyright, which would you choose?\"\u003c/p>\n\u003cp>Four Thieves Vinegar is presently focused on “small batch” chemistry--medicines that are easy to make with at-home equipment. Laufer’s first successful hack was pyrimethamine (brand name Daraprim), a decades-old drug used to treat toxoplasmosis in AIDS, cancer and malaria patients. Turing Pharmaceuticals purchased the patent in August 2015 and, a month later, \u003ca href=\"http://www.cbsnews.com/news/generic-drug-price-increases-5000-percent-overnight/\">hiked the price for a single Daraprim pill overnight\u003c/a> by 5,000 percent, from $13.50 to $750. Turing CEO Martin Shkreli became a Big Pharma pariah. In response, Laufer made a batch of DIY Daraprim for $2 a pill. So did a group of \u003ca href=\"https://qz.com/851416/why-martin-shkreli-and-turings-daraprim-still-costs-750-in-the-us-when-australian-schoolkids-can-make-it-for-2/\">Australian high school students\u003c/a>.\u003c/p>\n\u003cp>Laufer has now set his sights on several drugs he feels urgently merit greater public access, including the\u003ca href=\"http://www.rawstory.com/2016/05/american-women-increasingly-turn-to-diy-abortion-drugs-after-gop-laws-shut-down-health-clinics/\"> abortion drugs RU-486 (Mifepristone) and Misoprostol\u003c/a>; Solvadi, a hepatitis C drug; and Glaxo’s HIV prevention pill, GSK-744. He’s keenly aware his choices remain controversial and politically charged.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Looking ahead, Laufer foresees a future of medicine more like Socrates, less like Big Pharma: “Maybe in not too long, the idea of doing chemistry on a personal and individual level and applying it to medicine will be more commonplace. I like dreaming about that.”\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cstrong>Update June 5, 2017 \u003c/strong>\u003c/p>\n\u003cp>From The New York Times Sunday: Charles Duhigg \u003ca href=\"https://www.nytimes.com/2017/06/04/business/angry-about-epipen-prices-executive-dont-care-much.html\" target=\"_blank\" rel=\"noopener noreferrer\">writes\u003c/a> that last year's outrage over Mylan ratcheting up the price of the EpiPen, so that patients\u003ca href=\"http://www.reuters.com/article/us-health-epipen-costs-idUSKBN16Y24O\" target=\"_blank\" rel=\"noopener noreferrer\"> out-of-pocket costs\u003c/a> increased by over 500 percent in a few years, has not resulted in the company lowering the price of the product. Duhigg writes:\u003c/p>\n\u003cblockquote>\u003cp>Mylan has been called out again and again over the years — by the company’s own employees, regulators, patients, politicians and the press — and hasn’t changed, even as revenue has skyrocketed, hitting $11 billion last year. The firm is a case study in the limits of what consumer and employee activism, as well as government oversight, can achieve.\u003c/p>\u003c/blockquote>\n\u003cp>Meanwhile last week, Iowa Republican Sen. Charles Grassley\u003ca href=\"https://www.grassley.senate.gov/news/news-releases/grassley-latest-estimate-taxpayers-overpaid-127-billion-epipen\" target=\"_blank\" rel=\"noopener noreferrer\"> announced\u003c/a> that the government has estimated Mylan may have overcharged Medicaid by as much as $1.27 billion for the EpiPen under the agency's drug rebate program.\u003c/p>\n\u003cp>\u003cstrong>Original post from Jan. 23, 2017\u003c/strong>\u003c/p>\n\u003cp>Should we be free, as individuals, to make and take our own medicine at home? Who’s responsible if we get hurt or die? Do we have to right to do what we wish with our bodies in the interests of survival, healing and self-care? For years, such questions have been at the heart of public health debates over euthanasia – the right to die – and even drug addiction.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>They also lie at the center of the infamous Mylan EpiPen pricing scandal. Last fall, Mylan CEO Heather Bresch appeared before the House Oversight Committee to explain the company’s 548 percent price hike for a simple device that injects a lifesaving anti-allergy hormone, FDA-approved epinephrine.\u003c/p>\n\u003cp>The cost drove desperate allergy patients to seek alternatives, including \u003ca href=\"http://www.thedailybeast.com/articles/2016/09/22/please-do-not-hack-your-own-epipen.html\">the dangerous practice\u003c/a> of shooting epinephrine straight from a vial into a muscle.\u003c/p>\n\u003cp>Enter a new challenger: the pharmaceutical hacking collective \u003ca href=\"https://fourthievesvinegar.org/\">Four Thieves Vinegar.\u003c/a> The group is led by Michael Laufer, a math professor by day at Menlo College in Atherton, California, who shot to internet fame overnight last August when he uploaded a DIY instructional video that went viral, showcasing his homemade version of a copycat EpiPen he called the EpiPencil. \u003ca href=\"https://www.the-parallax.com/2016/09/19/epipencil-hack-costs-fraction-epipen-exclusive/\">His device costs around $35 to construct\u003c/a>– a fraction of Mylan’s $600 brand name dual-pack EpiPen. Anyone can make it at home for personal use, he claims.\u003c/p>\n\u003cp>Laufer isn’t a medical doctor and doesn’t pretend to be. But he’s a numbers guy, well versed in computer science, and has dipped into biology and chemistry. It took him two weeks to research and assemble the plastic components of the EpiPen, an auto injector created by a NASA researcher and marketed in 1980 for $20. Mylan later picked up the patent and has benefited from a monopoly.\u003c/p>\n\u003cfigure id=\"attachment_323237\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-323237\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-800x1013.jpg\" alt=\"Close-up of packaging used in the Epi-Pencil. \" width=\"800\" height=\"1013\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-800x1013.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-160x203.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-768x973.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-1020x1292.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-1920x2432.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-1180x1495.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-960x1216.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-240x304.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-375x475.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/Epi-Pencil-packaging-sent-by-Laufer-520x659.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Close-up of packaging used in the EpiPencil. \u003ccite>(Four Thieves Vinegar Collective)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Four Thieves Vinegar is named after a folk remedy made from vinegar and spices to ward off bubonic plague. The collective is part of the fast-growing DIY Biology movement, a subculture in which tech meets pharma--a Maker Faire for bio-geeks. In the video, Laufer carefully demonstrates how anyone can do what he did: combine a cheap off-the-shelf needle injector made for diabetics that is easy to buy on the internet, and combine it with a syringe that can be preloaded with a $1 dose of epinephrine.\u003c/p>\n\u003cp>Under fire, Mylan soon released\u003ca href=\"http://newsroom.mylan.com/2016-12-16-Mylan-Launches-the-First-Generic-for-EpiPen-epinephrine-injection-USP-Auto-Injector-as-an-Authorized-Generic\"> a $300 generic of its EpiPen\u003c/a>, but that did little to quiet critics. Georgia Congressman Buddy Carter accused the company of failing to disclose the truth about its profiteering. “There is no transparency, that's the problem here,\" he declared.\u003c/p>\n\u003cp>Leaders also criticized the FDA for its slow-paced approval of generic rivals. Teva Pharmaceutical Industries failed to get approval \u003ca href=\"https://consumerist.com/2016/09/12/teva-will-try-again-to-get-fda-approval-on-epipen-competitor-by-2018/\">for its generic EpiPen\u003c/a> in late 2016, but expects approval by 2018. Meanwhile, CVS Pharmacy has just released a $109.99 generic \u003ca href=\"http://www.pharmacytimes.com/sap-news/cvs-offers-2pack-adrenaclick-for-fraction-of-epipen-price\">two-pack EpiPen called Adrenaclick\u003c/a>. At $55 a pen, it’s close to Laufer’s DIY price -- and provides consumers with a safe, FDA-approved product.\u003c/p>\n\u003cp>That’s exactly what Laufer hoped might happen. As he sees it, his EpiPencil hack was a classic example of The Emperor Has No Clothes: It revealed the actual cost of the plastic auto injector – and showed others how they could make such a device cheaply.\u003c/p>\n\u003cp>It’s a mixed victory, though. The media spotlight gained supporters for Laufer's collective, but also opened him up to criticism. “I get a lot more fan mail then hate mail,” he says, including from parents. But others sharply condemn his actions, and his hacking group’s broader mission: making medicine at home.\u003c/p>\n\u003cp>\u003cstrong>Home Pharma Hacks Raise Safety Questions\u003c/strong>\u003c/p>\n\u003cp>Shortly after Laufer’s hack, the FDA issued a strongly worded warning against its use: “Using unapproved prescription drugs for personal use is a potentially dangerous practice,” an FDA spokesperson \u003ca href=\"http://www.in-pharmatechnologist.com/Regulatory-Safety/US-FDA-warns-against-30-alternative-to-Mylan-s-EpiPen\">told\u003c/a> the website in-PharmaTechnologist. “Unapproved drugs may be contaminated, sub-potent, super-potent or counterfeit.”\u003c/p>\n\u003cp>Critics agree. Yvette d’Entremont, known as SciBabe, is a former chemist-cum-blogger who quickly labeled the EpiPen hack a potential major fail if misused. “It seems like such a bad idea,” she told the Daily Beast. “It’s all fun and games until your product gets contaminated and you get a giant abscess in your muscle.”\u003c/p>\n\u003caside class=\"pullquote alignright\">'I believe in empowering people, in sharing information. We need to talk about alternatives to expensive medication regimens.’\u003ccite>Michael Laufer\u003c/cite>\u003c/aside>\n\u003cp>Contamination and improper dosing can happen with approved drugs too. Epinephrine is a serious drug, used to shock the heart. Laufer defends his device as safe. “In most ways it is equivalent” to Mylan’s EpiPen, he argues, pointing out that it features a safety cap like approved EpiPens, and only carries a single dose.\u003c/p>\n\u003cp>But it’s still untested. And as the father of toxicology himself, Paracelsus, famously warned: all medicine is poison at a certain dose.\u003c/p>\n\u003cp>Oncologist Ezekiel Emanuel, a bioethicist and senior fellow at the Center for American Progress, adds to the chorus of concern, cautioning strongly against using the device.\u003c/p>\n\u003cp>“We have the FDA for a reason. We want to protect the American public from dangerous drugs, which they have no ability to evaluate independently,” he says. “So now we’re going to have some guy who’s going to make a drug and a drug delivery device, put it out there -- no testing, no evaluation of whether it’s safe or effective -- and who the hell knows how many people are going to be hurt -- or not.”\u003c/p>\n\u003cfigure id=\"attachment_323239\" class=\"wp-caption aligncenter\" style=\"max-width: 678px\">\u003cimg class=\"size-full wp-image-323239\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown.jpg\" alt=\"Michael Laufer demonstrates how to lead the Epi-Pencil in a DIY video posted to YouTube.\" width=\"678\" height=\"487\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown.jpg 678w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown-160x115.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown-240x172.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown-375x269.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/RESEND-capture-of-screenshot-of-Daraprim-chemical-breakdown-520x374.jpg 520w\" sizes=\"(max-width: 678px) 100vw, 678px\">\u003cfigcaption class=\"wp-caption-text\">Michael Laufer demonstrates the EpiPencil in a DIY video posted to YouTube. \u003ccite>(Anne-christine d'Adesky/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Adds Emanuel: “In this case he may turn out to be lucky and no one’s hurt. But we don’t want that regime.”\u003c/p>\n\u003cp>He said the solution to high pharmaceutical prices was \"not this cockamamie 'let people throw drugs out there untested,'\" but to reduce the market power that drug companies rely on to set prices.\u003c/p>\n\u003cp>\"We give drug companies monopolies through the patent law, and marketing exclusivity,\" he said. \"No other country gives a monopoly and then expects good behavior on pricing.\u003c/p>\n\u003cp>\"So what we’ve done is say, 'Oh we’re giving drug companies monopoly pricing power and then we’re like shocked, shocked they're raising prices.\"\u003c/p>\n\u003cp>Margaret McLean, director of bioethics at the\u003ca href=\"https://www.scu.edu/ethics/focus-areas/bioethics/\"> Markkula Center for Applied Ethics\u003c/a> in Santa Clara, also agrees using Laufer's device could be dangerous. She herself, carries an EpiPen. It carries a higher copay than her other medicines, so she sympathizes with parents who can’t afford even generic versions. But the safety risks remain serious.\u003c/p>\n\u003cp>“There is always user error,” says McLean, citing incorrect dosing as a concern. “That is true with FDA-approved drugs too. But the error is less if I don’t have to draw up the right amount of epinephrine myself. I’m grateful for the standardization and check on the injector itself, and that the dose in there is appropriate for me.” She doesn’t want to worry about bubbles in the syringe, which are very dangerous. “There are a lot of steps here,” she says of Laufer’s DIY epinephrine device, “where sitting at home in your kitchen, never having done this before, it puts you in a higher risk category then buying it from the pharmacy.”\u003c/p>\n\u003cp>Still, she understands the urgent unmet need for affordable EpiPens. “The FDA is not able to move things through in an expeditious way, so people rightly get antsy.”\u003c/p>\n\u003cp>Perhaps surprisingly, Laufer agrees about the warnings on safety. “Chemistry is science. So, yes, it’s a concern. You have to think immediately, ‘What if it’s misused?’ But that’s a first-order reaction,” he says. “Ideologically, I believe that more access to more information is inherently better for everyone.” He supports FDA safety reviews and clinical trial tests for new drugs and devices that are marketed to consumers. But he stresses, he’s not marketing anything.\u003c/p>\n\u003caside class=\"pullquote alignright\">'We have the FDA for a reason. We want to protect the American public from dangerous drugs which they have no ability to evaluate independently.'\u003ccite>Ezekiel Emanuel, Center for American Progress\u003c/cite>\u003c/aside>\n\u003cp>Where Laufer draws a hard line – and marks his battleground -- is the domain of the private individual. “What I’m saying is, here is something you can think about... If you decide you’d like to adopt it, then that’s the whole ethic: Here is an idea, play with it, if you like -- no strings attached.”\u003c/p>\n\u003cp>\u003cstrong>More Drug Hacks On the Horizon\u003c/strong>\u003c/p>\n\u003cp>In his cramped faculty office, Laufer greets visitors with a warm smile, eager to share his mission and rebut critics who, he feels, have misperceptions about the true goals and the impact of his hacking action. Online, he looks like a steampunk rebel hero in a metal-studded leather jacket, rimless glasses shoved high on his forehead. Offline, he’s natty in a dark suit, purple tie and tie pin, and fancy abacus-shaped cuff links befitting a math geek.\u003c/p>\n\u003cp>“I believe in empowering people, in sharing information,” Laufer says, citing his hacker creed. “We need to talk about alternatives to expensive medication regimens.” He compares the need for a cheap drug delivery device like his EpiPencil to IKEA furniture: something that should be easy to make, with simple instructions for the average consumer.\u003c/p>\n\u003cp>What people do with that information is not his business, he declares. “I don’t know if anyone has built it besides me,” he says of the EpiPencil. “I don’t want to know. I believe in giving people information they can use to make important decisions about their self-care. That’s what I can offer.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Anyone who copies a patented device risks running afoul of patent law. It's a form of civil disobedience with life-or-death stakes. That make it easy to justify, according to Laufer's group, whose \u003ca href=\"https://fourthievesvinegar.org/faq\">website asks\u003c/a>, \"If the choices presented to you are to die, because you cannot afford medication, or violate a copyright, which would you choose?\"\u003c/p>\n\u003cp>Four Thieves Vinegar is presently focused on “small batch” chemistry--medicines that are easy to make with at-home equipment. Laufer’s first successful hack was pyrimethamine (brand name Daraprim), a decades-old drug used to treat toxoplasmosis in AIDS, cancer and malaria patients. Turing Pharmaceuticals purchased the patent in August 2015 and, a month later, \u003ca href=\"http://www.cbsnews.com/news/generic-drug-price-increases-5000-percent-overnight/\">hiked the price for a single Daraprim pill overnight\u003c/a> by 5,000 percent, from $13.50 to $750. Turing CEO Martin Shkreli became a Big Pharma pariah. In response, Laufer made a batch of DIY Daraprim for $2 a pill. So did a group of \u003ca href=\"https://qz.com/851416/why-martin-shkreli-and-turings-daraprim-still-costs-750-in-the-us-when-australian-schoolkids-can-make-it-for-2/\">Australian high school students\u003c/a>.\u003c/p>\n\u003cp>Laufer has now set his sights on several drugs he feels urgently merit greater public access, including the\u003ca href=\"http://www.rawstory.com/2016/05/american-women-increasingly-turn-to-diy-abortion-drugs-after-gop-laws-shut-down-health-clinics/\"> abortion drugs RU-486 (Mifepristone) and Misoprostol\u003c/a>; Solvadi, a hepatitis C drug; and Glaxo’s HIV prevention pill, GSK-744. He’s keenly aware his choices remain controversial and politically charged.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Looking ahead, Laufer foresees a future of medicine more like Socrates, less like Big Pharma: “Maybe in not too long, the idea of doing chemistry on a personal and individual level and applying it to medicine will be more commonplace. I like dreaming about that.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Lookup Tool: \u003ca href=\"http://khn.org/news/orphan-drugs-lookup-interactive/\">Orphan Drugs Database\u003c/a>\u003cbr>\nVideo: \u003ca href=\"http://khn.org/news/video-former-u-s-rep-henry-waxman-shares-deep-concerns-about-orphan-drugs/\">Interview With Henry Waxman\u003c/a>\u003cbr>\nTimeline: \u003ca href=\"http://khn.org/news/timeline-the-orphan-drug-act/\">The Orphan Drug Act\u003c/a>\u003c/p>\n\u003cp>More than 30 years ago, Congress overwhelmingly passed \u003ca href=\"https://history.nih.gov/research/downloads/PL97-414.pdf\">a landmark health bill\u003c/a> aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored.\u003c/p>\n\u003cp>By the drugmakers’ calculations, the markets for such diseases weren’t big enough to bother with.\u003c/p>\n\u003cp>But lucrative financial incentives created by the Orphan Drug Act signed into law by President Ronald Reagan in 1983 succeeded far beyond anyone’s expectations. More than 200 companies have brought almost 450 “orphan drugs” to market since the law took effect.\u003c/p>\n\u003cp>Yet a Kaiser Health News investigation shows that the system intended to help desperate patients is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions. The companies aren’t breaking the law but they are using the Orphan Drug Act to their advantage in ways that its architects say they didn’t foresee or intend. Today, many orphan medicines, originally developed to treat diseases affecting fewer than 200,000 people, come with astronomical price tags.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>And many drugs that now have orphan status aren’t entirely new. More than 70 were drugs first approved by the Food and Drug Administration for mass market use. These medicines, some with familiar brand names, were later approved as orphans. In each case, their manufacturers received millions of dollars in government incentives plus seven years of exclusive rights to treat that rare disease, or a monopoly.\u003c/p>\n\u003cp>Drugmakers of popular mass market drugs later sought and received orphan status for the cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin, and rheumatoid arthritis drug Humira, the best-selling medicine in the world.\u003c/p>\n\u003cp>More than 80 other orphans won FDA approval for more than one rare disease, and in some cases, multiple rare diseases. For each additional approval, the drugmaker qualified for a fresh batch of incentives. Botox, stocked in most dermatologists’ offices, started out as a drug to treat painful muscle spasms of the eye and now has three orphan drug approvals. It’s also approved as a mass market drug to treat a variety of ailments, including chronic migraines and wrinkles.\u003c/p>\n\u003cp>Altogether, KHN’s investigation found that about a third of orphan approvals by the FDA since the program began have been either for repurposed mass market drugs or drugs that received multiple orphan approvals.\u003c/p>\n\u003cp>“What we are seeing is a system that was created with good intent being hijacked,” said Bernard Munos, a former corporate strategy advisor at drug giant Eli Lilly and Co. who reviewed the KHN analysis of several FDA drug databases. It’s “quite remarkable that it has gone on for so long.”\u003c/p>\n\u003cp>And the proportion of \u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm534863.htm\">new drugs\u003c/a> approved as orphans has ballooned. In 2015, 21 orphan drugs were approved, accounting for 47 percent of all new medicines, up from just 29 percent in 2010; in 2016, nine more orphans won approval, 40 percent of the total.\u003c/p>\n\u003cp>When a drugmaker wins approval of a medicine for an orphan disease, the company gets seven years of exclusive rights to the marketplace, which means the FDA won’t approve another version to treat that rare disease for seven years, even if the brand name company’s patent has run out. The exclusivity is compensation for developing a drug designed for a small number of patients whose total sales weren’t expected to be that profitable.\u003c/p>\n\u003cp>But the exclusivity is a potent pricing tool. Drugmakers can charge whatever they want by shielding their medicine from competition. The market exclusivity granted by the Orphan Drug Act can be a vital part of the protective shield that companies create. What’s more, manufacturers can return to the FDA with the same drug again and again, each time testing the drug against a new rare disease.\u003c/p>\n\u003cp>Critics have assailed drugmakers in the past for gaming the orphan drug approval process. But the extent to which companies have been winning approval for drugs that aren’t what advocates call “true orphans” hadn’t been documented until the Kaiser Health News investigation.\u003c/p>\n\u003cp>Munos said he was “shocked” by the sheer number of mass market drugs being repurposed as well as those approved multiple times.\u003c/p>\n\u003cp>Even agency officials said they weren’t aware of the scope of the issue. After reviewing KHN’s findings for two weeks, Dr. Gayatri Rao director of the FDA’s Office of Orphan Products Development said she “appreciated the work” and expressed interest in studying how often drug companies are “repurposing” a drug for a new rare disease, or taking “multiple bites of the apple.”\u003c/p>\n\u003cp>“We are going to look into this,” she said, adding that she could consider a regulatory change.\u003c/p>\n\u003cp>Rao pointed out that the “repurposing” of drugs does have scientific and patient benefits. For example, cancer drugs approved for one type of malignancy can be tested and approved for others. Gleevec, a drug that revolutionized the treatment of chronic myeloid leukemia, now has nine orphan approvals.\u003c/p>\n\u003cp>But in a \u003ca href=\"http://www.hopkinsmedicine.org/news/media/releases/orphan_drug_loophole_needs_closing_johns_hopkins_researchers_say\">2015 commentary\u003c/a> published in the American Journal of Clinical Oncology, Dr. Martin Makary at the Johns Hopkins University School of Medicine focused on cancer drugs including Gleevec, arguing that the drug was never meant to serve an orphan population. Instead, Makary and his team wrote, drugmakers purposely identify small patient populations to gain additional approvals — a process he described as “salami slicing.”\u003c/p>\n\u003cp>“By salami slicing the disease into subgroups, it allows them to get the orphan drug approval with all the government benefits and even some of the subsidies,” Makary said. The prices of such medications often rise because they have seven years without competition for a new set of patients, Makary added.\u003c/p>\n\u003cp>The FDA has taken a different view of repurposing.\u003c/p>\n\u003cp>“We always talked about how we permit the second bite of the apple, third bite of the apple, as one small way to incentivize repurposing,” Rao said, noting that industry and patient groups have been pressing the FDA for even stronger incentives. “Now, all of sudden, it seems like, wow, this practice may be driving up prices.”\u003c/p>\n\u003cp>Novartis, which owns Gleevec, said in an email statement that the company is advancing research and following the science to “bring the right treatments to the right patients based on unmet need, not the size of the patient population.”\u003c/p>\n\u003cp>Two KHN reporters spent six months analyzing data and talking to lawmakers, patients, advocates, doctors and companies to understand how the FDA’s orphan drug program has evolved amid a national uproar over soaring drug prices. President-elect Donald Trump vowed on the campaign trail to \u003ca href=\"http://www.reuters.com/article/us-usa-trump-pharmaceuticals-idUSKBN13W21I\">bring down\u003c/a> prescription drug prices and during a Jan. 11 press conference said the drug industry is \u003ca href=\"https://www.nytimes.com/2017/01/11/us/politics/trump-press-conference-transcript.html?_r=0\">“getting away with murder.”\u003c/a>\u003c/p>\n\u003cp>The investigation examined how drugmakers use the law to their advantage — often with the guidance of former FDA officials — and have made the development of medicines that were once thought to be business backwaters into one of the pharmaceutical industry’s hottest sectors.\u003c/p>\n\u003cp>Orphan drugs now account for seven of the 10 top-selling drugs of any kind, ranked by annual sales, according to EvaluatePharma.\u003c/p>\n\u003cp>“Orphans are wicked hot,” said Dr. Tim Coté, a former FDA official who now runs a consulting firm that advises drugmakers on orphan drugs.\u003c/p>\n\u003cp>No one disputes that orphan drugs have helped or saved hundreds of thousands of patients suffering from debilitating or even fatal rare diseases. Exactly how many is difficult to estimate because the FDA doesn’t track such information.\u003c/p>\n\u003cp>And drug industry officials say companies should be rewarded, not punished, for making those treatments possible and for pursuing new drugs that aren’t always an economic success.\u003c/p>\n\u003cp>Research and development is “long, costly, risky,” said Anne Pritchett, vice president, policy and research at industry lobbying group PhRMA. “When you look at cystic fibrosis it was 25 years to the development of an effective therapy … I think we would be concerned about anything that would undermine the current [orphan drug] incentives.”\u003c/p>\n\u003cp>Former U.S. Rep. Henry Waxman, D-Calif., a champion of the 1983 Orphan Drug Act takes a different view.\u003c/p>\n\u003cp>“The Orphan Drug Act has been a great success because many people with diseases that affect very few people now have drugs available to them,” Waxman said. “But it’s been in some ways turned on its head when it becomes the basis of manipulating the system for the drug company to make much more money than they would in an open, competitive market.”\u003c/p>\n\u003cp>Booming Business\u003c/p>\n\u003cp>On a late summer day, Tim Coté sat in a corner office of his Sandy Spring, Md., consulting firm, Coté Orphan. He leaned into his computer microphone to dispense insider knowledge about the orphan drug approval process on a webcast hosted by FDAnews, a trade news organization. Listeners paid about $300 a head, but Coté said he wasn’t paid for doing it.\u003c/p>\n\u003cp>The FDA is more flexible in evaluating drugs for rare diseases, he said, explaining that “about half of them get through with just one pivotal clinical trial. Not so for common diseases.” The FDA, citing \u003ca href=\"http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/UCM294773.pdf\">a report\u003c/a> from the National Organization for Rare Disorders, said about two-thirds of orphan drugs were approved with one adequate and well-controlled trial with supportive evidence. It typically requires two or three such trials to approve a mass market drug.\u003c/p>\n\u003cp>Coté also told the webinar audience that clinical trials for orphan drugs are usually smaller and the approval is a “different scientific and regulatory experience.”\u003c/p>\n\u003cp>Coté knows his stuff. He was Rao’s immediate predecessor as chief of the FDA’s Office of Orphan Products Development. It’s not unusual for government officials to leave FDA and other regulatory agencies and \u003ca href=\"http://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry\">obtain jobs as consultants or industry executives\u003c/a>.\u003c/p>\n\u003cp>Coté’s website, headlined “The Inside Track,” notes that he oversaw applications that led to the approval of at least 150 orphan drugs when he was at the FDA and that his firm is now the largest submitter of orphan drug applications.\u003c/p>\n\u003cp>“We write the entire application,” the website for Coté’s company notes, adding that his staff of 25 includes regulatory scientists with deep knowledge and experience in FDA’s “unwritten rules” regarding orphan drugs.\u003c/p>\n\u003cp>Many of Coté’s more than 300 clients are small biotech companies begun by researchers or even passionate parents who found investment backing. Parents Ilan and Annie Ganot, for example, started Solid Biosciences to find treatments and potentially a cure for their son with Duchenne muscular dystrophy.\u003c/p>\n\u003cp>Coté guides them through the regulatory process since most don’t have the expertise. He can offer his expertise and develop an application that makes it easier for the FDA to designate and approve the drug.\u003c/p>\n\u003cp>“When you make the FDA smile, the value of your asset goes up. And that’s how the game is played,” he said in an interview, adding quickly, “It’s really not a game because people’s lives are what is in balance.”\u003c/p>\n\u003cp>Coté and other ex-FDA officials play a vital role in helping drugmakers choose rare disease targets and get through the FDA approval process.\u003c/p>\n\u003cp>A small cottage industry has grown around the Orphan Drug Act. Dr. Marlene Haffner, who preceded Coté in the FDA’s orphan office, started her own consulting firm, too, to advise small and large companies on orphan drug applications. A third company is Camargo Pharmaceutical Services, led by industry veterans and former FDA officials, which advises companies focused on repurposing drugs for orphan approval. The firm tries “to be in front of the FDA a lot — three to four times a month,” said Jennifer King, Camargo’s director of marketing. Fees for consulting on orphan drugs industry wide range from $5,000 to $100,000, depending upon what services are provided, Coté said.\u003c/p>\n\u003cp>Getting through the orphan approval process involves a series of steps.\u003c/p>\n\u003cp>First, drugs must be designated by the FDA as potential candidates for approval. A company has to demonstrate that its drug is a promising treatment for a disease that affects fewer than 200,000 patients. If the FDA agrees and makes the formal designation, financial incentives kick in, including a 50 percent tax break on research and development (R&D) and access to federal grants.\u003c/p>\n\u003cp>When drugs get orphan designation, companies often reap other financial rewards. Shares in publicly traded companies often rise on the news — sometimes soaring \u003ca href=\"http://www.bizjournals.com/triangle/news/2014/02/25/dara-stock-soars-on-orphan-drug.html\">as high as 30 percent\u003c/a>. That happens, in part, because orphans have a track record of being approved at much higher rates than drugs for common diseases.\u003c/p>\n\u003cp>The 50 percent R&D tax credit pays off, too. In 2012, one of the biggest orphan drug companies, BioMarin, received \u003ca href=\"http://files.shareholder.com/downloads/ABEA-3W276N/2866327224x0x664042/776E8656-30BA-4937-A2A0-3AB6450BCA00/2012_Annual_Report.pdf\">$32.6 million\u003c/a> from a combination of federal and state of California tax credits. BioMarin spokeswoman Debra Charlesworth confirmed that the orphan credit made up the “vast majority” of that deferred tax benefit. She also noted that credit “has successfully fueled an industry that didn’t previously exist” and led to more rare disease research.\u003c/p>\n\u003cp>Industry-wide, orphan drug tax credits cost the federal government $1.76 billion in fiscal 2016 — roughly what President Barack Obama asked Congress to spend to fight \u003ca href=\"https://www.washingtonpost.com/news/post-politics/wp/2016/02/08/obama-to-ask-congress-for-1-8-billion-to-combat-zika-virus/\">the Zika virus\u003c/a> before a $1.1 billion expenditure was approved. And, because so many orphan drugs are under development, the U.S. could grant nearly $50 billion in tax credits from 2016 to 2025, estimates \u003ca href=\"https://www.treasury.gov/resource-center/tax-policy/Documents/Tax-Expenditures-FY2017.pdf\">the Treasury Department\u003c/a>.\u003c/p>\n\u003cp>There’s a lot of creativity behind figuring out how to make a drug an orphan.\u003c/p>\n\u003cp>In Coté’s webinar and in multiple interviews, he described many ways companies can win orphan status. They can test their drugs on children with adult diseases, such as schizophrenia, or find drugs for ailments like malaria that are uncommon in America.\u003c/p>\n\u003cp>“African sleeping sickness: horrible problem in Africa but not here, not in the U.S.,” Coté told his webinar audience. “So a drug development effort that was aimed toward some of these tropical diseases can actually get all the benefits of the Orphan Drug Act.”\u003c/p>\n\u003cp>Another popular strategy is to create “follow-on drugs” that represent incremental steps forward.\u003c/p>\n\u003cp>About 30 percent of Coté’s clients are companies looking to improve upon some other orphan drug “which just made billions and billions,” he said in an interview.\u003c/p>\n\u003cp>Repurposing an already approved drug is another strategy his firm promotes. In a \u003ca href=\"https://www.linkedin.com/pulse/re-purposing-drugs-orphans-timothy-cote?published=t\">video\u003c/a> posted on his website in July, Coté explained the advantages for companies that can move directly into a clinical trial without much preparatory work because the drug’s safety has already been demonstrated.\u003c/p>\n\u003cp>“All you gotta do is establish that the product can work in this new orphan indication,” he said, adding tips on how to do it and still make money.\u003c/p>\n\u003cp>‘That Is Not A True Orphan Drug’\u003c/p>\n\u003cp>Turning mass market drugs into orphans has been a familiar path for some of the most popular drugs ever discovered.\u003c/p>\n\u003cp>AbbVie’s Humira is the best-selling drug in the world, and most of its sales are in the U.S. where revenue reached $7.6 billion through \u003ca href=\"https://news.abbvie.com/news/abbvie-reports-third-quarter-2016-financial-results.htm\">the third quarter\u003c/a> of 2016 and $11.8 billion worldwide, according to the company’s latest financial report.\u003c/p>\n\u003cp>Humira was approved by the FDA in late 2002 to treat millions of people who suffer from rheumatoid arthritis. Three years later, AbbVie asked the FDA to designate it as an orphan to treat juvenile rheumatoid arthritis, which they told the FDA affects between 30,000 and 50,000 Americans. That pediatric use was approved in 2008, and Humira subsequently was approved for four more rare diseases, including Crohn’s and uveitis, an inflammatory disease affecting the eyes.\u003c/p>\n\u003cp>The ophthalmologic approval would extend the market exclusivity for Humira for that disease until 2023. When asked why AbbVie sought multiple orphan designations and approvals for Humira, the company declined to comment.\u003c/p>\n\u003cp>Peter Saltonstall, executive director of the National Organization for Rare Disorders, said that Humira is “not a true orphan drug.” But, he said, the company has “the ability to go out and get orphan designation. That’s the way the law reads right now … they can do whatever they want to do.”\u003c/p>\n\u003cp>It is difficult to say exactly how or if orphan exclusivity affects the price of Humira, which is a complex biologic drug and also has been protected by \u003ca href=\"http://www.nytimes.com/2016/07/16/business/makers-of-humira-and-enbrel-using-new-drug-patents-to-delay-generic-versions.html?_r=3\">numerous patents\u003c/a>. The drug has long been AbbVie’s top seller, accounting for 63 percent of its revenues, according to its most recent financial filing.\u003c/p>\n\u003cp>EvaluatePharma notes \u003ca href=\"http://info.evaluategroup.com/rs/607-YGS-364/images/EPOD15.pdf\">in its recent report\u003c/a> that Humira, as well as a handful of other top drugs, receive less than 25 percent of their sales from orphan uses. Still, if Humira’s orphan uses accounted for just 10 percent of annual sales, the revenue would surpass $1 billion.\u003c/p>\n\u003cp>By stacking up a series of orphan disease approvals, one seven-year exclusivity period leads into another, maximizing the length of a company’s monopoly. Sigma-Tau Pharmaceuticals, for example, had some form of orphan exclusivity over its metabolic disorder drug for more than 20 years. The drug, Carnitor, received a second orphan approval four months before its first exclusivity was set to expire. And it won its third orphan approval, for an IV formulation of the drug, just one day before its second exclusivity period was set to expire in December of 1999.\u003c/p>\n\u003cp>“The sequence and timing of regulatory filings for Carnitor reflect the time required to conduct large controlled clinical trials, as well as evolving medical strategies and regulatory pathways pursued by different sponsors over many years,” said GianFranco Fornasini, senior vice president of scientific affairs at Sigma-Tau.\u003c/p>\n\u003cp>The FDA’s Rao said each new exclusivity period is disease-specific and once any seven-year period runs out, generics can come in. Gleevec, for example, won FDA approval to treat several kinds of rare cancer. All but one of its orphan exclusivity periods had expired by 2015, allowing two generics to enter the marketplace. But Gleevec still has exclusivity until 2020 to treat newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in patients who are also on chemotherapy.\u003c/p>\n\u003cp>It’s also true, Rao explained, that some of the drugs that go through the orphan process may not specifically treat a rare disease. For example, a very toxic cancer drug might may not work well in earlier stages because its risks outweigh the benefits. But the company may propose that it will help a smaller group of later-stage cancer patients and win orphan approval just for that group.\u003c/p>\n\u003cp>Former FDA orphan drug director Haffner said her FDA office worked on rules defining how companies could legitimately pursue approval for a small group of patients with a specific unmet medical need.\u003c/p>\n\u003cp>“People have played games with the Orphan Drug Act since it was passed,” said Haffner, who first took a job with drugmaker Amgen after leaving the FDA and then became an independent consultant. “It’s the American way, I don’t mean that in a nasty way. But we take advantage of what’s in front of us.”\u003c/p>\n\u003cp>In 2013, the \u003ca href=\"https://www.federalregister.gov/documents/2013/06/12/2013-13930/orphan-drug-regulations\">FDA clarified the Orphan Drug Act’s regulations\u003c/a> and said it wanted to avoid the possibility that some companies could “potentially ‘game’ approvals by seeking successive narrow approvals of a drug.”\u003c/p>\n\u003cp>In reality, Rao said, the regulations did not really change “much of what our practice was.” The agency wanted to address what Rao said were “common misconceptions” and frequently asked questions so officials changed wording in the regulations to better define exactly what could be considered an orphan drug.\u003c/p>\n\u003cp>Breaking down larger, broader diseases into smaller groups is still allowed under certain conditions and companies can still win multiple orphan approvals for a single drug — even if the total population served rises above the 200,000 mark.\u003c/p>\n\u003cp>Amgen Inc.’s Repatha won marketing approval and exclusive rights in 2015 for the orphan disease homozygous familial hypercholesterolemia, which affects a population of \u003ca href=\"http://www.lipidjournal.com/article/S1933-2874(13)00309-7/abstract\">about 300 people\u003c/a> in the U.S. On the very same day, the drug was approved as a mass market drug to treat up to 11 million people with uncontrolled levels of LDL cholesterol, said Amgen spokeswoman Kristen Davis.\u003c/p>\n\u003cp>Dr. Steven Nissen of the Cleveland Clinic, who ran a broader trial on Repatha, said, “It’s certainly not considered by any of us to be an orphan drug.”\u003c/p>\n\u003cp>Safeguarding The ‘Prize’\u003c/p>\n\u003cp>Considering the long history of what’s happened, Tim Coté acknowledges that there are “some loopholes” in the Orphan Drug Act. Perhaps 3 percent or less of approved orphans were not in the “spirit” of the law, he said.\u003c/p>\n\u003cp>But Coté, rare disease advocates, patients and people in the drug industry expressed fear that changing the Orphan Drug Act or questioning its success would hurt the development of drugs for rare patients.\u003c/p>\n\u003cp>Former U.S. Rep. Jim Greenwood, R-Pa., now president of the Biotechnology Innovation Organization, an industry trade group, said that concerns about high prices for orphan drugs aren’t justified. The incentives, he said, should not be altered because rare diseases are “tragically killing and brutalizing mostly children.”\u003c/p>\n\u003cp>Greenwood seemed unaware that dozens of orphan approvals stemmed from the repurposing of mass market drugs, like Humira or Enbrel, another drug developed first for rheumatoid arthritis. Still, he said, “I would argue that the risk of losing incentives in the system far outweighs the benefit of trying to save a few pennies on the health care dollar.”\u003c/p>\n\u003cp>It’s a sentiment that Coté and other advocates share. While talking about the $311,000 annual price tag for cystic fibrosis drug Kalydeco, Coté said any parent whose child has the disease would be a big fan of the drug.\u003c/p>\n\u003cp>“The price point is justified because actually it has a dramatic effect on the children. Dead children … people are willing to pay a lot to prevent that,” Coté said. “And that’s a real good thing that we have this drug. OK?”\u003c/p>\n\u003cp>The first drug to specifically target the underlying biochemical defect of cystic fibrosis, Kalydeco is approved to treat a subset of patients who have specific mutations in their genes. Development of the drug was financed by the Cystic Fibrosis Foundation, which sold its rights to sales royalties from Kalydeco and other cystic fibrosis drugs for $3.3 billion in 2014.\u003c/p>\n\u003cp>Others, including Henry Waxman, are far more critical and have tried to do something about it over the years. Waxman proposed multiple bills to rein in corporate profits by amending the orphan drug law that he sponsored, but none succeeded.\u003c/p>\n\u003cp>The FDA has also tried but failed, to keep corporations in check.\u003c/p>\n\u003cp>In 2012, drugmaker Depomed Inc. filed suit against the FDA for refusing to give its drug Gralise seven years of market exclusivity as a treatment for pain related to shingles.\u003c/p>\n\u003cp>Rao said the agency wanted to see proof that Gralise was clinically superior to other drugs, noting there “were a bunch of other generics on the market” with different formulations and dosing requirements. Grasile’s active ingredient, gabapentin, is the same one as in Pfizer’s mass market blockbuster \u003ca href=\"http://www.pfizer.com/products/product-detail/neurontin\">Neurontin\u003c/a>, which is also approved for treatment of shingles pain.\u003c/p>\n\u003cp>The FDA approved Gralise but denied seven years of exclusivity.\u003c/p>\n\u003cp>In response, the drugmaker sued the agency and won its case, arguing that according to the law, they didn’t have to prove their drug was clinically superior to gain the monopoly.\u003c/p>\n\u003cp>Today, the drug is one of Depomed’s top products with sales of $81 million in 2015. And, in a \u003ca href=\"http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTEwODc0NDE5JkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3\">recent proxy statement\u003c/a>, Depomed listed “protecting Gralise exclusivity” as a corporate objective under the category of “enhance and protect future cash flow.” Its orphan exclusivity ends in 2018. Depomed spokesman Christopher Keenan said Gralise wanted patent exclusivity to block competition. But, Keenan said, “Had the patent effort failed on all fronts, the Orphan Drug Designation would have been very important.”\u003c/p>\n\u003cp>After reviewing KHN’s analysis, Rao said she wants to better understand why drugmakers are applying for multiple approvals and has asked for a case-by-case review of all orphan designations granted in 2010 and 2015. She said the agency lacks the resources to run an analysis of the entire orphan drug database.\u003c/p>\n\u003cp>“Our goal is to try to get it right,” she said. “There are over 7,000 rare diseases, likely more, the vast majority of which have nothing … I want to ensure that we continue to keep our eye on that prize.”\u003c/p>\n\u003cp>Contributors: John Hillkirk, Scott Hensley at NPR, Diane Webber, Marilyn Thompson (editors); Elizabeth Lucas (data editing); Joe Neel at NPR (radio editing)\u003c/p>\n\u003cp>Interactives, video and presentation: Lydia Zuraw, Emily Kopp, Meredith Rizzo at NPR (digital presentation); Francis Ying (videos, motion graphic); Heidi de Marco (videos, photos, audio); Alley Interactive (database lookup)\u003c/p>\n\u003cp>KHN’s coverage of prescription drug development, costs and pricing is supported in part by the \u003ca href=\"http://www.arnoldfoundation.org/\">Laura and John Arnold Foundation\u003c/a>.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003ca href=\"http://www.kaiserhealthnews.org/\">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/\">Henry J. Kaiser Family Foundation\u003c/a>.\u003c/p>\n\n",
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"excerpt": "Orphan drugs were meant for patients with rare diseases, but drugmakers are increasingly using the special designation to land lucrative federal incentives and monopoly control for every drug that gets approved.",
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"title": "Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies | KQED",
"description": "Orphan drugs were meant for patients with rare diseases, but drugmakers are increasingly using the special designation to land lucrative federal incentives and monopoly control for every drug that gets approved.",
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"headline": "Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies",
"datePublished": "2017-01-17T13:16:17-08:00",
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"nprByline": "\u003ca href=\"http://khn.org/news/author/sarah-jane-tribble/\">\u003cstrong>Sarah Jane Tribble\u003c/strong>\u003c/a> and \u003ca href=\"http://khn.org/news/author/sydney-lupkin/\">\u003cstrong>Sydney Lupkin\u003c/strong>\u003c/a>\u003c/br>Kaiser Health News",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Lookup Tool: \u003ca href=\"http://khn.org/news/orphan-drugs-lookup-interactive/\">Orphan Drugs Database\u003c/a>\u003cbr>\nVideo: \u003ca href=\"http://khn.org/news/video-former-u-s-rep-henry-waxman-shares-deep-concerns-about-orphan-drugs/\">Interview With Henry Waxman\u003c/a>\u003cbr>\nTimeline: \u003ca href=\"http://khn.org/news/timeline-the-orphan-drug-act/\">The Orphan Drug Act\u003c/a>\u003c/p>\n\u003cp>More than 30 years ago, Congress overwhelmingly passed \u003ca href=\"https://history.nih.gov/research/downloads/PL97-414.pdf\">a landmark health bill\u003c/a> aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored.\u003c/p>\n\u003cp>By the drugmakers’ calculations, the markets for such diseases weren’t big enough to bother with.\u003c/p>\n\u003cp>But lucrative financial incentives created by the Orphan Drug Act signed into law by President Ronald Reagan in 1983 succeeded far beyond anyone’s expectations. More than 200 companies have brought almost 450 “orphan drugs” to market since the law took effect.\u003c/p>\n\u003cp>Yet a Kaiser Health News investigation shows that the system intended to help desperate patients is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions. The companies aren’t breaking the law but they are using the Orphan Drug Act to their advantage in ways that its architects say they didn’t foresee or intend. Today, many orphan medicines, originally developed to treat diseases affecting fewer than 200,000 people, come with astronomical price tags.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>And many drugs that now have orphan status aren’t entirely new. More than 70 were drugs first approved by the Food and Drug Administration for mass market use. These medicines, some with familiar brand names, were later approved as orphans. In each case, their manufacturers received millions of dollars in government incentives plus seven years of exclusive rights to treat that rare disease, or a monopoly.\u003c/p>\n\u003cp>Drugmakers of popular mass market drugs later sought and received orphan status for the cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin, and rheumatoid arthritis drug Humira, the best-selling medicine in the world.\u003c/p>\n\u003cp>More than 80 other orphans won FDA approval for more than one rare disease, and in some cases, multiple rare diseases. For each additional approval, the drugmaker qualified for a fresh batch of incentives. Botox, stocked in most dermatologists’ offices, started out as a drug to treat painful muscle spasms of the eye and now has three orphan drug approvals. It’s also approved as a mass market drug to treat a variety of ailments, including chronic migraines and wrinkles.\u003c/p>\n\u003cp>Altogether, KHN’s investigation found that about a third of orphan approvals by the FDA since the program began have been either for repurposed mass market drugs or drugs that received multiple orphan approvals.\u003c/p>\n\u003cp>“What we are seeing is a system that was created with good intent being hijacked,” said Bernard Munos, a former corporate strategy advisor at drug giant Eli Lilly and Co. who reviewed the KHN analysis of several FDA drug databases. It’s “quite remarkable that it has gone on for so long.”\u003c/p>\n\u003cp>And the proportion of \u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm534863.htm\">new drugs\u003c/a> approved as orphans has ballooned. In 2015, 21 orphan drugs were approved, accounting for 47 percent of all new medicines, up from just 29 percent in 2010; in 2016, nine more orphans won approval, 40 percent of the total.\u003c/p>\n\u003cp>When a drugmaker wins approval of a medicine for an orphan disease, the company gets seven years of exclusive rights to the marketplace, which means the FDA won’t approve another version to treat that rare disease for seven years, even if the brand name company’s patent has run out. The exclusivity is compensation for developing a drug designed for a small number of patients whose total sales weren’t expected to be that profitable.\u003c/p>\n\u003cp>But the exclusivity is a potent pricing tool. Drugmakers can charge whatever they want by shielding their medicine from competition. The market exclusivity granted by the Orphan Drug Act can be a vital part of the protective shield that companies create. What’s more, manufacturers can return to the FDA with the same drug again and again, each time testing the drug against a new rare disease.\u003c/p>\n\u003cp>Critics have assailed drugmakers in the past for gaming the orphan drug approval process. But the extent to which companies have been winning approval for drugs that aren’t what advocates call “true orphans” hadn’t been documented until the Kaiser Health News investigation.\u003c/p>\n\u003cp>Munos said he was “shocked” by the sheer number of mass market drugs being repurposed as well as those approved multiple times.\u003c/p>\n\u003cp>Even agency officials said they weren’t aware of the scope of the issue. After reviewing KHN’s findings for two weeks, Dr. Gayatri Rao director of the FDA’s Office of Orphan Products Development said she “appreciated the work” and expressed interest in studying how often drug companies are “repurposing” a drug for a new rare disease, or taking “multiple bites of the apple.”\u003c/p>\n\u003cp>“We are going to look into this,” she said, adding that she could consider a regulatory change.\u003c/p>\n\u003cp>Rao pointed out that the “repurposing” of drugs does have scientific and patient benefits. For example, cancer drugs approved for one type of malignancy can be tested and approved for others. Gleevec, a drug that revolutionized the treatment of chronic myeloid leukemia, now has nine orphan approvals.\u003c/p>\n\u003cp>But in a \u003ca href=\"http://www.hopkinsmedicine.org/news/media/releases/orphan_drug_loophole_needs_closing_johns_hopkins_researchers_say\">2015 commentary\u003c/a> published in the American Journal of Clinical Oncology, Dr. Martin Makary at the Johns Hopkins University School of Medicine focused on cancer drugs including Gleevec, arguing that the drug was never meant to serve an orphan population. Instead, Makary and his team wrote, drugmakers purposely identify small patient populations to gain additional approvals — a process he described as “salami slicing.”\u003c/p>\n\u003cp>“By salami slicing the disease into subgroups, it allows them to get the orphan drug approval with all the government benefits and even some of the subsidies,” Makary said. The prices of such medications often rise because they have seven years without competition for a new set of patients, Makary added.\u003c/p>\n\u003cp>The FDA has taken a different view of repurposing.\u003c/p>\n\u003cp>“We always talked about how we permit the second bite of the apple, third bite of the apple, as one small way to incentivize repurposing,” Rao said, noting that industry and patient groups have been pressing the FDA for even stronger incentives. “Now, all of sudden, it seems like, wow, this practice may be driving up prices.”\u003c/p>\n\u003cp>Novartis, which owns Gleevec, said in an email statement that the company is advancing research and following the science to “bring the right treatments to the right patients based on unmet need, not the size of the patient population.”\u003c/p>\n\u003cp>Two KHN reporters spent six months analyzing data and talking to lawmakers, patients, advocates, doctors and companies to understand how the FDA’s orphan drug program has evolved amid a national uproar over soaring drug prices. President-elect Donald Trump vowed on the campaign trail to \u003ca href=\"http://www.reuters.com/article/us-usa-trump-pharmaceuticals-idUSKBN13W21I\">bring down\u003c/a> prescription drug prices and during a Jan. 11 press conference said the drug industry is \u003ca href=\"https://www.nytimes.com/2017/01/11/us/politics/trump-press-conference-transcript.html?_r=0\">“getting away with murder.”\u003c/a>\u003c/p>\n\u003cp>The investigation examined how drugmakers use the law to their advantage — often with the guidance of former FDA officials — and have made the development of medicines that were once thought to be business backwaters into one of the pharmaceutical industry’s hottest sectors.\u003c/p>\n\u003cp>Orphan drugs now account for seven of the 10 top-selling drugs of any kind, ranked by annual sales, according to EvaluatePharma.\u003c/p>\n\u003cp>“Orphans are wicked hot,” said Dr. Tim Coté, a former FDA official who now runs a consulting firm that advises drugmakers on orphan drugs.\u003c/p>\n\u003cp>No one disputes that orphan drugs have helped or saved hundreds of thousands of patients suffering from debilitating or even fatal rare diseases. Exactly how many is difficult to estimate because the FDA doesn’t track such information.\u003c/p>\n\u003cp>And drug industry officials say companies should be rewarded, not punished, for making those treatments possible and for pursuing new drugs that aren’t always an economic success.\u003c/p>\n\u003cp>Research and development is “long, costly, risky,” said Anne Pritchett, vice president, policy and research at industry lobbying group PhRMA. “When you look at cystic fibrosis it was 25 years to the development of an effective therapy … I think we would be concerned about anything that would undermine the current [orphan drug] incentives.”\u003c/p>\n\u003cp>Former U.S. Rep. Henry Waxman, D-Calif., a champion of the 1983 Orphan Drug Act takes a different view.\u003c/p>\n\u003cp>“The Orphan Drug Act has been a great success because many people with diseases that affect very few people now have drugs available to them,” Waxman said. “But it’s been in some ways turned on its head when it becomes the basis of manipulating the system for the drug company to make much more money than they would in an open, competitive market.”\u003c/p>\n\u003cp>Booming Business\u003c/p>\n\u003cp>On a late summer day, Tim Coté sat in a corner office of his Sandy Spring, Md., consulting firm, Coté Orphan. He leaned into his computer microphone to dispense insider knowledge about the orphan drug approval process on a webcast hosted by FDAnews, a trade news organization. Listeners paid about $300 a head, but Coté said he wasn’t paid for doing it.\u003c/p>\n\u003cp>The FDA is more flexible in evaluating drugs for rare diseases, he said, explaining that “about half of them get through with just one pivotal clinical trial. Not so for common diseases.” The FDA, citing \u003ca href=\"http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/UCM294773.pdf\">a report\u003c/a> from the National Organization for Rare Disorders, said about two-thirds of orphan drugs were approved with one adequate and well-controlled trial with supportive evidence. It typically requires two or three such trials to approve a mass market drug.\u003c/p>\n\u003cp>Coté also told the webinar audience that clinical trials for orphan drugs are usually smaller and the approval is a “different scientific and regulatory experience.”\u003c/p>\n\u003cp>Coté knows his stuff. He was Rao’s immediate predecessor as chief of the FDA’s Office of Orphan Products Development. It’s not unusual for government officials to leave FDA and other regulatory agencies and \u003ca href=\"http://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry\">obtain jobs as consultants or industry executives\u003c/a>.\u003c/p>\n\u003cp>Coté’s website, headlined “The Inside Track,” notes that he oversaw applications that led to the approval of at least 150 orphan drugs when he was at the FDA and that his firm is now the largest submitter of orphan drug applications.\u003c/p>\n\u003cp>“We write the entire application,” the website for Coté’s company notes, adding that his staff of 25 includes regulatory scientists with deep knowledge and experience in FDA’s “unwritten rules” regarding orphan drugs.\u003c/p>\n\u003cp>Many of Coté’s more than 300 clients are small biotech companies begun by researchers or even passionate parents who found investment backing. Parents Ilan and Annie Ganot, for example, started Solid Biosciences to find treatments and potentially a cure for their son with Duchenne muscular dystrophy.\u003c/p>\n\u003cp>Coté guides them through the regulatory process since most don’t have the expertise. He can offer his expertise and develop an application that makes it easier for the FDA to designate and approve the drug.\u003c/p>\n\u003cp>“When you make the FDA smile, the value of your asset goes up. And that’s how the game is played,” he said in an interview, adding quickly, “It’s really not a game because people’s lives are what is in balance.”\u003c/p>\n\u003cp>Coté and other ex-FDA officials play a vital role in helping drugmakers choose rare disease targets and get through the FDA approval process.\u003c/p>\n\u003cp>A small cottage industry has grown around the Orphan Drug Act. Dr. Marlene Haffner, who preceded Coté in the FDA’s orphan office, started her own consulting firm, too, to advise small and large companies on orphan drug applications. A third company is Camargo Pharmaceutical Services, led by industry veterans and former FDA officials, which advises companies focused on repurposing drugs for orphan approval. The firm tries “to be in front of the FDA a lot — three to four times a month,” said Jennifer King, Camargo’s director of marketing. Fees for consulting on orphan drugs industry wide range from $5,000 to $100,000, depending upon what services are provided, Coté said.\u003c/p>\n\u003cp>Getting through the orphan approval process involves a series of steps.\u003c/p>\n\u003cp>First, drugs must be designated by the FDA as potential candidates for approval. A company has to demonstrate that its drug is a promising treatment for a disease that affects fewer than 200,000 patients. If the FDA agrees and makes the formal designation, financial incentives kick in, including a 50 percent tax break on research and development (R&D) and access to federal grants.\u003c/p>\n\u003cp>When drugs get orphan designation, companies often reap other financial rewards. Shares in publicly traded companies often rise on the news — sometimes soaring \u003ca href=\"http://www.bizjournals.com/triangle/news/2014/02/25/dara-stock-soars-on-orphan-drug.html\">as high as 30 percent\u003c/a>. That happens, in part, because orphans have a track record of being approved at much higher rates than drugs for common diseases.\u003c/p>\n\u003cp>The 50 percent R&D tax credit pays off, too. In 2012, one of the biggest orphan drug companies, BioMarin, received \u003ca href=\"http://files.shareholder.com/downloads/ABEA-3W276N/2866327224x0x664042/776E8656-30BA-4937-A2A0-3AB6450BCA00/2012_Annual_Report.pdf\">$32.6 million\u003c/a> from a combination of federal and state of California tax credits. BioMarin spokeswoman Debra Charlesworth confirmed that the orphan credit made up the “vast majority” of that deferred tax benefit. She also noted that credit “has successfully fueled an industry that didn’t previously exist” and led to more rare disease research.\u003c/p>\n\u003cp>Industry-wide, orphan drug tax credits cost the federal government $1.76 billion in fiscal 2016 — roughly what President Barack Obama asked Congress to spend to fight \u003ca href=\"https://www.washingtonpost.com/news/post-politics/wp/2016/02/08/obama-to-ask-congress-for-1-8-billion-to-combat-zika-virus/\">the Zika virus\u003c/a> before a $1.1 billion expenditure was approved. And, because so many orphan drugs are under development, the U.S. could grant nearly $50 billion in tax credits from 2016 to 2025, estimates \u003ca href=\"https://www.treasury.gov/resource-center/tax-policy/Documents/Tax-Expenditures-FY2017.pdf\">the Treasury Department\u003c/a>.\u003c/p>\n\u003cp>There’s a lot of creativity behind figuring out how to make a drug an orphan.\u003c/p>\n\u003cp>In Coté’s webinar and in multiple interviews, he described many ways companies can win orphan status. They can test their drugs on children with adult diseases, such as schizophrenia, or find drugs for ailments like malaria that are uncommon in America.\u003c/p>\n\u003cp>“African sleeping sickness: horrible problem in Africa but not here, not in the U.S.,” Coté told his webinar audience. “So a drug development effort that was aimed toward some of these tropical diseases can actually get all the benefits of the Orphan Drug Act.”\u003c/p>\n\u003cp>Another popular strategy is to create “follow-on drugs” that represent incremental steps forward.\u003c/p>\n\u003cp>About 30 percent of Coté’s clients are companies looking to improve upon some other orphan drug “which just made billions and billions,” he said in an interview.\u003c/p>\n\u003cp>Repurposing an already approved drug is another strategy his firm promotes. In a \u003ca href=\"https://www.linkedin.com/pulse/re-purposing-drugs-orphans-timothy-cote?published=t\">video\u003c/a> posted on his website in July, Coté explained the advantages for companies that can move directly into a clinical trial without much preparatory work because the drug’s safety has already been demonstrated.\u003c/p>\n\u003cp>“All you gotta do is establish that the product can work in this new orphan indication,” he said, adding tips on how to do it and still make money.\u003c/p>\n\u003cp>‘That Is Not A True Orphan Drug’\u003c/p>\n\u003cp>Turning mass market drugs into orphans has been a familiar path for some of the most popular drugs ever discovered.\u003c/p>\n\u003cp>AbbVie’s Humira is the best-selling drug in the world, and most of its sales are in the U.S. where revenue reached $7.6 billion through \u003ca href=\"https://news.abbvie.com/news/abbvie-reports-third-quarter-2016-financial-results.htm\">the third quarter\u003c/a> of 2016 and $11.8 billion worldwide, according to the company’s latest financial report.\u003c/p>\n\u003cp>Humira was approved by the FDA in late 2002 to treat millions of people who suffer from rheumatoid arthritis. Three years later, AbbVie asked the FDA to designate it as an orphan to treat juvenile rheumatoid arthritis, which they told the FDA affects between 30,000 and 50,000 Americans. That pediatric use was approved in 2008, and Humira subsequently was approved for four more rare diseases, including Crohn’s and uveitis, an inflammatory disease affecting the eyes.\u003c/p>\n\u003cp>The ophthalmologic approval would extend the market exclusivity for Humira for that disease until 2023. When asked why AbbVie sought multiple orphan designations and approvals for Humira, the company declined to comment.\u003c/p>\n\u003cp>Peter Saltonstall, executive director of the National Organization for Rare Disorders, said that Humira is “not a true orphan drug.” But, he said, the company has “the ability to go out and get orphan designation. That’s the way the law reads right now … they can do whatever they want to do.”\u003c/p>\n\u003cp>It is difficult to say exactly how or if orphan exclusivity affects the price of Humira, which is a complex biologic drug and also has been protected by \u003ca href=\"http://www.nytimes.com/2016/07/16/business/makers-of-humira-and-enbrel-using-new-drug-patents-to-delay-generic-versions.html?_r=3\">numerous patents\u003c/a>. The drug has long been AbbVie’s top seller, accounting for 63 percent of its revenues, according to its most recent financial filing.\u003c/p>\n\u003cp>EvaluatePharma notes \u003ca href=\"http://info.evaluategroup.com/rs/607-YGS-364/images/EPOD15.pdf\">in its recent report\u003c/a> that Humira, as well as a handful of other top drugs, receive less than 25 percent of their sales from orphan uses. Still, if Humira’s orphan uses accounted for just 10 percent of annual sales, the revenue would surpass $1 billion.\u003c/p>\n\u003cp>By stacking up a series of orphan disease approvals, one seven-year exclusivity period leads into another, maximizing the length of a company’s monopoly. Sigma-Tau Pharmaceuticals, for example, had some form of orphan exclusivity over its metabolic disorder drug for more than 20 years. The drug, Carnitor, received a second orphan approval four months before its first exclusivity was set to expire. And it won its third orphan approval, for an IV formulation of the drug, just one day before its second exclusivity period was set to expire in December of 1999.\u003c/p>\n\u003cp>“The sequence and timing of regulatory filings for Carnitor reflect the time required to conduct large controlled clinical trials, as well as evolving medical strategies and regulatory pathways pursued by different sponsors over many years,” said GianFranco Fornasini, senior vice president of scientific affairs at Sigma-Tau.\u003c/p>\n\u003cp>The FDA’s Rao said each new exclusivity period is disease-specific and once any seven-year period runs out, generics can come in. Gleevec, for example, won FDA approval to treat several kinds of rare cancer. All but one of its orphan exclusivity periods had expired by 2015, allowing two generics to enter the marketplace. But Gleevec still has exclusivity until 2020 to treat newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in patients who are also on chemotherapy.\u003c/p>\n\u003cp>It’s also true, Rao explained, that some of the drugs that go through the orphan process may not specifically treat a rare disease. For example, a very toxic cancer drug might may not work well in earlier stages because its risks outweigh the benefits. But the company may propose that it will help a smaller group of later-stage cancer patients and win orphan approval just for that group.\u003c/p>\n\u003cp>Former FDA orphan drug director Haffner said her FDA office worked on rules defining how companies could legitimately pursue approval for a small group of patients with a specific unmet medical need.\u003c/p>\n\u003cp>“People have played games with the Orphan Drug Act since it was passed,” said Haffner, who first took a job with drugmaker Amgen after leaving the FDA and then became an independent consultant. “It’s the American way, I don’t mean that in a nasty way. But we take advantage of what’s in front of us.”\u003c/p>\n\u003cp>In 2013, the \u003ca href=\"https://www.federalregister.gov/documents/2013/06/12/2013-13930/orphan-drug-regulations\">FDA clarified the Orphan Drug Act’s regulations\u003c/a> and said it wanted to avoid the possibility that some companies could “potentially ‘game’ approvals by seeking successive narrow approvals of a drug.”\u003c/p>\n\u003cp>In reality, Rao said, the regulations did not really change “much of what our practice was.” The agency wanted to address what Rao said were “common misconceptions” and frequently asked questions so officials changed wording in the regulations to better define exactly what could be considered an orphan drug.\u003c/p>\n\u003cp>Breaking down larger, broader diseases into smaller groups is still allowed under certain conditions and companies can still win multiple orphan approvals for a single drug — even if the total population served rises above the 200,000 mark.\u003c/p>\n\u003cp>Amgen Inc.’s Repatha won marketing approval and exclusive rights in 2015 for the orphan disease homozygous familial hypercholesterolemia, which affects a population of \u003ca href=\"http://www.lipidjournal.com/article/S1933-2874(13)00309-7/abstract\">about 300 people\u003c/a> in the U.S. On the very same day, the drug was approved as a mass market drug to treat up to 11 million people with uncontrolled levels of LDL cholesterol, said Amgen spokeswoman Kristen Davis.\u003c/p>\n\u003cp>Dr. Steven Nissen of the Cleveland Clinic, who ran a broader trial on Repatha, said, “It’s certainly not considered by any of us to be an orphan drug.”\u003c/p>\n\u003cp>Safeguarding The ‘Prize’\u003c/p>\n\u003cp>Considering the long history of what’s happened, Tim Coté acknowledges that there are “some loopholes” in the Orphan Drug Act. Perhaps 3 percent or less of approved orphans were not in the “spirit” of the law, he said.\u003c/p>\n\u003cp>But Coté, rare disease advocates, patients and people in the drug industry expressed fear that changing the Orphan Drug Act or questioning its success would hurt the development of drugs for rare patients.\u003c/p>\n\u003cp>Former U.S. Rep. Jim Greenwood, R-Pa., now president of the Biotechnology Innovation Organization, an industry trade group, said that concerns about high prices for orphan drugs aren’t justified. The incentives, he said, should not be altered because rare diseases are “tragically killing and brutalizing mostly children.”\u003c/p>\n\u003cp>Greenwood seemed unaware that dozens of orphan approvals stemmed from the repurposing of mass market drugs, like Humira or Enbrel, another drug developed first for rheumatoid arthritis. Still, he said, “I would argue that the risk of losing incentives in the system far outweighs the benefit of trying to save a few pennies on the health care dollar.”\u003c/p>\n\u003cp>It’s a sentiment that Coté and other advocates share. While talking about the $311,000 annual price tag for cystic fibrosis drug Kalydeco, Coté said any parent whose child has the disease would be a big fan of the drug.\u003c/p>\n\u003cp>“The price point is justified because actually it has a dramatic effect on the children. Dead children … people are willing to pay a lot to prevent that,” Coté said. “And that’s a real good thing that we have this drug. OK?”\u003c/p>\n\u003cp>The first drug to specifically target the underlying biochemical defect of cystic fibrosis, Kalydeco is approved to treat a subset of patients who have specific mutations in their genes. Development of the drug was financed by the Cystic Fibrosis Foundation, which sold its rights to sales royalties from Kalydeco and other cystic fibrosis drugs for $3.3 billion in 2014.\u003c/p>\n\u003cp>Others, including Henry Waxman, are far more critical and have tried to do something about it over the years. Waxman proposed multiple bills to rein in corporate profits by amending the orphan drug law that he sponsored, but none succeeded.\u003c/p>\n\u003cp>The FDA has also tried but failed, to keep corporations in check.\u003c/p>\n\u003cp>In 2012, drugmaker Depomed Inc. filed suit against the FDA for refusing to give its drug Gralise seven years of market exclusivity as a treatment for pain related to shingles.\u003c/p>\n\u003cp>Rao said the agency wanted to see proof that Gralise was clinically superior to other drugs, noting there “were a bunch of other generics on the market” with different formulations and dosing requirements. Grasile’s active ingredient, gabapentin, is the same one as in Pfizer’s mass market blockbuster \u003ca href=\"http://www.pfizer.com/products/product-detail/neurontin\">Neurontin\u003c/a>, which is also approved for treatment of shingles pain.\u003c/p>\n\u003cp>The FDA approved Gralise but denied seven years of exclusivity.\u003c/p>\n\u003cp>In response, the drugmaker sued the agency and won its case, arguing that according to the law, they didn’t have to prove their drug was clinically superior to gain the monopoly.\u003c/p>\n\u003cp>Today, the drug is one of Depomed’s top products with sales of $81 million in 2015. And, in a \u003ca href=\"http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTEwODc0NDE5JkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3\">recent proxy statement\u003c/a>, Depomed listed “protecting Gralise exclusivity” as a corporate objective under the category of “enhance and protect future cash flow.” Its orphan exclusivity ends in 2018. Depomed spokesman Christopher Keenan said Gralise wanted patent exclusivity to block competition. But, Keenan said, “Had the patent effort failed on all fronts, the Orphan Drug Designation would have been very important.”\u003c/p>\n\u003cp>After reviewing KHN’s analysis, Rao said she wants to better understand why drugmakers are applying for multiple approvals and has asked for a case-by-case review of all orphan designations granted in 2010 and 2015. She said the agency lacks the resources to run an analysis of the entire orphan drug database.\u003c/p>\n\u003cp>“Our goal is to try to get it right,” she said. “There are over 7,000 rare diseases, likely more, the vast majority of which have nothing … I want to ensure that we continue to keep our eye on that prize.”\u003c/p>\n\u003cp>Contributors: John Hillkirk, Scott Hensley at NPR, Diane Webber, Marilyn Thompson (editors); Elizabeth Lucas (data editing); Joe Neel at NPR (radio editing)\u003c/p>\n\u003cp>Interactives, video and presentation: Lydia Zuraw, Emily Kopp, Meredith Rizzo at NPR (digital presentation); Francis Ying (videos, motion graphic); Heidi de Marco (videos, photos, audio); Alley Interactive (database lookup)\u003c/p>\n\u003cp>KHN’s coverage of prescription drug development, costs and pricing is supported in part by the \u003ca href=\"http://www.arnoldfoundation.org/\">Laura and John Arnold Foundation\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003ca href=\"http://www.kaiserhealthnews.org/\">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/\">Henry J. Kaiser Family Foundation\u003c/a>.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>One of the largest educational gifts in U.S. history — $500 million — went to a California university today.\u003c/p>\n\u003cp>When \u003ca href=\"https://www.ucsf.edu/\" target=\"_blank\" rel=\"noopener\">UCSF\u003c/a> chancellor Sam Hawgood heard about the donation, he was grateful, of course — and shocked.\u003c/p>\n\u003cp>“I have to pinch myself every time I think about it,” says Hawgood.\u003c/p>\n\u003caside class=\"pullquote alignright\">The money could help fund some of the university’s current biomedical work including \u003ca href=\"https://ww2.kqed.org/futureofyou/2015/11/30/a-cure-for-aids-scientists-say-its-on-the-horizon/\" target=\"_blank\" rel=\"noopener\">finding a cure for AIDS\u003c/a>.\u003c/aside>\n\u003cp>As large donations to American universities go, the UCSF gift is matched only by \u003ca href=\"https://www.philanthropy.com/factfile/gifts_detail?GiftDonorJoin_a_DonorID=PGDON1706\" target=\"_blank\" rel=\"noopener\">$500 million gifts\u003c/a> to two Oregon universities from Nike co-founder Phil Knight.\u003c/p>\n\u003cp>The UCSF windfall comes from the \u003ca href=\"http://dillerteenfellows.org/en/about/helen-diller-family-foundation\" target=\"_blank\" rel=\"noopener\">Helen Diller Foundation\u003c/a>. Diller, who died in 2015, was a San Francisco native and public education advocate. Her foundation had already given $150 million to UCSF before Wednesday’s announcement.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Diller, whose family fortune rose from real estate development, knew about the planned donation before her death. Her daughter Jackie Safier, who’s president of the foundation, says her mother, “r\u003cspan style=\"font-weight: 400\">eally believed [UCSF] could have an incredible impact on healthcare worldwide if they had the necessary resources.”\u003c/span>\u003c/p>\n\u003cp>UCSF is known for its health care schools, including Medicine, Nursing, Pharmacy and Dentistry and its medical centers, the newest of which, at \u003ca href=\"https://www.ucsfhealth.org/\" target=\"_blank\" rel=\"noopener\">Mission Bay\u003c/a> in San Francisco, opened in 2015.\u003c/p>\n\u003cp>Its \u003ca href=\"https://www.ucsf.edu/about/achievements\" target=\"_blank\" rel=\"noopener\">scientific breakthroughs\u003c/a> include: discovering vitamin E, isolating the gene for insulin, co-discovering the AIDS virus and being the first to link obesity to Type 2 diabetes.\u003c/p>\n\u003cp>What’s unusual about the Diller donation is that it’s “relatively unrestricted.” That means the funds don’t have to be used for a narrow purpose. Those types of university contributions, though desperately sought, are uncommon, according to Hawgood.\u003c/p>\n\u003cp>Last year, less than one percent of UCSF’s financial gifts were “discretionary,” the term used for unrestricted funds.\u003c/p>\n\u003cp>“\u003cspan style=\"font-weight: 400\">So it’s extraordinarily remarkable, rare and frankly, exciting,” says Hawgood.\u003c/span>\u003c/p>\n\u003cp>He says the money will go toward attracting “the best of the best” faculty and will support students who couldn’t otherwise afford higher education.\u003c/p>\n\u003cp>“We are really committed to a very diverse student body,” says Hawgood. “This kind of funding for students allows us to put that on steroids.”\u003c/p>\n\u003cp>Four hundred million will go toward UCSF’s endowment and $100 million will support an innovation fund.\u003c/p>\n\u003cp>Of the $400 million, half will go toward supporting current faculty and attracting new talent. The other $200 million will support students at UCSF’s four professional schools, some of it, in the form of scholarships.\u003c/p>\n\u003cp>That financial aid is definitely needed, says Hawgood. The majority of UCSF’s professional students receive financial aid but less than 10 percent get enough to cover all their costs.\u003c/p>\n\u003cp>The final $100 million is part of an innovation fund to be used at the chancellor’s discretion.\u003c/p>\n\u003cp>It could help fund some of the university’s current biomedical work including \u003ca href=\"https://www.ucsf.edu/news/2016/11/404936/science-focus-how-do-white-blood-cells-move-so-fast\" target=\"_blank\" rel=\"noopener\">advanced microscopy techniques\u003c/a>, \u003ca href=\"http://www.genengnews.com/gen-news-highlights/perturb-seq-combines-crispr-and-single-cell-rna-seq/81253575\" target=\"_blank\" rel=\"noopener\">cell engineering\u003c/a> using gene-splicing tools such as \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/04/29/how-a-new-crisprcas9-technique-may-get-us-closer-to-curing-genetic-diseases/\" target=\"_blank\" rel=\"noopener\">CRISPR,\u003c/a> and \u003ca href=\"https://ww2.kqed.org/futureofyou/2015/11/30/a-cure-for-aids-scientists-say-its-on-the-horizon/\" target=\"_blank\" rel=\"noopener\">finding a cure for AIDS\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>UCSF hasn’t disclosed when the funding will become available. When it does, students will be able to discover scholarship opportunities on the university’s \u003ca href=\"https://www.ucsf.edu/education/admissions\" target=\"_blank\" rel=\"noopener\">admissions website\u003c/a>.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>One of the largest educational gifts in U.S. history — $500 million — went to a California university today.\u003c/p>\n\u003cp>When \u003ca href=\"https://www.ucsf.edu/\" target=\"_blank\" rel=\"noopener\">UCSF\u003c/a> chancellor Sam Hawgood heard about the donation, he was grateful, of course — and shocked.\u003c/p>\n\u003cp>“I have to pinch myself every time I think about it,” says Hawgood.\u003c/p>\n\u003caside class=\"pullquote alignright\">The money could help fund some of the university’s current biomedical work including \u003ca href=\"https://ww2.kqed.org/futureofyou/2015/11/30/a-cure-for-aids-scientists-say-its-on-the-horizon/\" target=\"_blank\" rel=\"noopener\">finding a cure for AIDS\u003c/a>.\u003c/aside>\n\u003cp>As large donations to American universities go, the UCSF gift is matched only by \u003ca href=\"https://www.philanthropy.com/factfile/gifts_detail?GiftDonorJoin_a_DonorID=PGDON1706\" target=\"_blank\" rel=\"noopener\">$500 million gifts\u003c/a> to two Oregon universities from Nike co-founder Phil Knight.\u003c/p>\n\u003cp>The UCSF windfall comes from the \u003ca href=\"http://dillerteenfellows.org/en/about/helen-diller-family-foundation\" target=\"_blank\" rel=\"noopener\">Helen Diller Foundation\u003c/a>. Diller, who died in 2015, was a San Francisco native and public education advocate. Her foundation had already given $150 million to UCSF before Wednesday’s announcement.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Diller, whose family fortune rose from real estate development, knew about the planned donation before her death. Her daughter Jackie Safier, who’s president of the foundation, says her mother, “r\u003cspan style=\"font-weight: 400\">eally believed [UCSF] could have an incredible impact on healthcare worldwide if they had the necessary resources.”\u003c/span>\u003c/p>\n\u003cp>UCSF is known for its health care schools, including Medicine, Nursing, Pharmacy and Dentistry and its medical centers, the newest of which, at \u003ca href=\"https://www.ucsfhealth.org/\" target=\"_blank\" rel=\"noopener\">Mission Bay\u003c/a> in San Francisco, opened in 2015.\u003c/p>\n\u003cp>Its \u003ca href=\"https://www.ucsf.edu/about/achievements\" target=\"_blank\" rel=\"noopener\">scientific breakthroughs\u003c/a> include: discovering vitamin E, isolating the gene for insulin, co-discovering the AIDS virus and being the first to link obesity to Type 2 diabetes.\u003c/p>\n\u003cp>What’s unusual about the Diller donation is that it’s “relatively unrestricted.” That means the funds don’t have to be used for a narrow purpose. Those types of university contributions, though desperately sought, are uncommon, according to Hawgood.\u003c/p>\n\u003cp>Last year, less than one percent of UCSF’s financial gifts were “discretionary,” the term used for unrestricted funds.\u003c/p>\n\u003cp>“\u003cspan style=\"font-weight: 400\">So it’s extraordinarily remarkable, rare and frankly, exciting,” says Hawgood.\u003c/span>\u003c/p>\n\u003cp>He says the money will go toward attracting “the best of the best” faculty and will support students who couldn’t otherwise afford higher education.\u003c/p>\n\u003cp>“We are really committed to a very diverse student body,” says Hawgood. “This kind of funding for students allows us to put that on steroids.”\u003c/p>\n\u003cp>Four hundred million will go toward UCSF’s endowment and $100 million will support an innovation fund.\u003c/p>\n\u003cp>Of the $400 million, half will go toward supporting current faculty and attracting new talent. The other $200 million will support students at UCSF’s four professional schools, some of it, in the form of scholarships.\u003c/p>\n\u003cp>That financial aid is definitely needed, says Hawgood. The majority of UCSF’s professional students receive financial aid but less than 10 percent get enough to cover all their costs.\u003c/p>\n\u003cp>The final $100 million is part of an innovation fund to be used at the chancellor’s discretion.\u003c/p>\n\u003cp>It could help fund some of the university’s current biomedical work including \u003ca href=\"https://www.ucsf.edu/news/2016/11/404936/science-focus-how-do-white-blood-cells-move-so-fast\" target=\"_blank\" rel=\"noopener\">advanced microscopy techniques\u003c/a>, \u003ca href=\"http://www.genengnews.com/gen-news-highlights/perturb-seq-combines-crispr-and-single-cell-rna-seq/81253575\" target=\"_blank\" rel=\"noopener\">cell engineering\u003c/a> using gene-splicing tools such as \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/04/29/how-a-new-crisprcas9-technique-may-get-us-closer-to-curing-genetic-diseases/\" target=\"_blank\" rel=\"noopener\">CRISPR,\u003c/a> and \u003ca href=\"https://ww2.kqed.org/futureofyou/2015/11/30/a-cure-for-aids-scientists-say-its-on-the-horizon/\" target=\"_blank\" rel=\"noopener\">finding a cure for AIDS\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>UCSF hasn’t disclosed when the funding will become available. When it does, students will be able to discover scholarship opportunities on the university’s \u003ca href=\"https://www.ucsf.edu/education/admissions\" target=\"_blank\" rel=\"noopener\">admissions website\u003c/a>.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "California Nail Salons Start To Invest In Worker Safety",
"title": "California Nail Salons Start To Invest In Worker Safety",
"headTitle": "State of Health | KQED News",
"content": "\u003cp>What stands out upon entering Mai Dang's nail salon, located on a busy street in Berkeley, Calif., is what's missing — the stinging smell of polish, remover and other nail products. That wasn't always the case. For a decade, Dang suffered from the effects of the chemicals she used at work every day.\u003c/p>\n\u003cp>\"When you do nails, workers get itchy skin and watery eyes,\" says Dang, 40. She also used to have frequent headaches, and one of her workers developed asthma. So when she heard about an opportunity to improve the safety at her salon, she signed up.\u003c/p>\n\u003cp>\"I work every day. I need the air to be pure, to be better for me. I have to take care of my health this way,\" she says, speaking in Vietnamese through an interpreter.\u003c/p>\n\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe src=\"https://www.npr.org/player/embed/509315426/509444361\" width=\"100%\" height=\"290\" frameborder=\"0\" scrolling=\"no\" title=\"NPR embedded audio player\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>\u003ca href=\"http://www.asianhealthservices.org/\">Asian Health Services\u003c/a>, a community clinic in Oakland, started \u003ca href=\"http://www.cahealthynailsalons.org/\">The California Healthy Nail Salon Collaborative\u003c/a> after the clinic identified a pattern of illness among nail salon workers.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"Practically every worker was experiencing some kind of health issue. And we realized that this was an epidemic,\" says Julia Liou, planning and development director at the clinic and the co-founder of the collaborative.\u003c/p>\n\u003cp>Nail salons are big business in the United States — \u003ca href=\"http://files.nailsmag.com/Feature-Articles-in-PDF/NABB2015-16stats.pdf\">approximately $8.5 billion \u003c/a> in revenue in 2015. Some of the chemicals used in salons \u003ca href=\"https://www.osha.gov/SLTC/nailsalons/chemicalhazards.html\">are known to cause\u003c/a> skin disorders and respiratory problems, and possibly even cancer, miscarriages and birth defects. Formaldehyde and toluene are just two of the risky ingredients in the nail polishes, solvents, glues and hardeners in constant use in salons; the Environmental Protection Agency \u003ca href=\"https://www.epa.gov/sites/production/files/2015-05/documents/nailsalonguide.pdf\">lists\u003c/a> at least 20 such worrisome chemicals.\u003c/p>\n\u003cp>But, so far, there's been little government regulation to protect workers. Liou is trying to get salon owners to make changes voluntarily to improve worker safety.\u003c/p>\n\u003cp>\"We don't want to create a fear where it's like, 'Oh nail salons are so scary that people can't go to them,' \" explains Liou. \"But we want to create a space where both the owner and the customer can feel comfortable, and actually create a model where the return on investment ends up being worker health.\"\u003c/p>\n\u003cp>Salons that participate in the collaborative must make significant changes to their business, including buying less toxic nail polishes, thinners and removers. All workers are required to wear specific types of gloves and masks when using certain products. Owners are also required to purchase a portable mechanical ventilation unit.\u003c/p>\n\u003cp>\"It sucks in the air when I do artificial nails so the workers don't have to breathe in the toxic chemicals anymore,\" explains Dang, as she turns on the machine with a remote control. More than 80 percent of salon workers in California are Vietnamese American, and more than half are of reproductive age, according to the collaborative.\u003c/p>\n\u003cfigure id=\"attachment_283568\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-800x533.jpg\" alt=\"Mai Dang's Fashion Nails has been certified as a healthy salon since 2013. Salons with that designation provide proper ventilation, train employees on best practices, and avoid products containing formaldehyde, toluene and other particularly toxic solvents and glues.\" width=\"800\" height=\"533\" class=\"size-medium wp-image-283568\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-800x533.jpg 800w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-160x107.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-768x511.jpg 768w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-1020x679.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-1180x786.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-960x639.jpg 960w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-375x250.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-520x346.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Mai Dang's Fashion Nails has been certified as a healthy salon since 2013. Salons with that designation provide proper ventilation, train employees on best practices, and avoid products containing formaldehyde, toluene and other particularly toxic solvents and glues. \u003ccite>(Jenny Gold/Kaiser Health News)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Alameda County certified Dang's salon, Fashion Nails, as a healthy salon in 2013, based on her changes. In return, Dang got a certificate that she hangs in her window to let customers know she is part of the collaborative. Fashion Nails is also listed as \u003ca href=\"http://www.co.alameda.ca.us/aceh/healthynail/documents/RECOGNIZED-SALONS.pdf\">a healthier nail salon \u003c/a>on a county website.\u003c/p>\n\u003cp>The process, however, was not cheap. Dang says the products she now uses, while safer, cost about 30 percent more. Overall, she estimates that she spent about $3,000 on the upgrades. To pay for it, she raised her prices by $2 per service.\u003c/p>\n\u003cp>One of Dang's customers, Genell Johnson, says she's more than willing to pay extra for the service.\u003c/p>\n\u003cp>\"You get what you pay for,\" Johnson says. \"That's what they always say, and it's very true.\"\u003c/p>\n\u003cp>A survey of customers by the collaborative found that 90 percent were willing to pay at least a dollar more for services they knew were healthier. Johnson says she's a regular at Fashion Nails but had no idea it was a healthy salon.\u003c/p>\n\u003cp>\"Now I'm going to spread the word,\" says Johnson. \"This will be the perfect place, knowing they're so health conscious.\"\u003c/p>\n\u003cp>For Dang, the investment in a healthier salon seems to be paying off. Visits to her salon have increased, and her business has become more profitable, she says.\u003c/p>\n\u003cp>But getting businesses to make changes voluntarily is a slow process. Out of more than 8,000 nail salons in California, only 120 have joined the collaborative so far.\u003c/p>\n\u003cp>\"I think the ultimate root of the issue is that the chemicals are still in the products,\" says collaborative co-founder Liou. \"If we want to look at really how do we improve worker health, we also need the manufacturers to consider how they can they make safer products as well.\"\u003c/p>\n\u003cp>Still, the Healthy Nail Salon Collaborative is making progress. The EPA recently \u003ca href=\"https://www.epa.gov/newsreleases/us-epa-awards-120000-protect-health-bay-area-nail-salons\">gave the collaborative a grant\u003c/a> to help them offer microloans to salons wanting to upgrade.\u003c/p>\n\u003cp>In September, California \u003ca href=\"http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160AB2125\">passed legislation\u003c/a> to help expand the program across the state, by training cities and counties on how to certify healthy nail salons in their regions.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation. You can follow Jenny Gold on Twitter: \u003c/em>\u003ca href=\"https://twitter.com/JennyAGold\">@JennyAGold\u003c/a>. \u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 Kaiser Health News. 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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>What stands out upon entering Mai Dang's nail salon, located on a busy street in Berkeley, Calif., is what's missing — the stinging smell of polish, remover and other nail products. That wasn't always the case. For a decade, Dang suffered from the effects of the chemicals she used at work every day.\u003c/p>\n\u003cp>\"When you do nails, workers get itchy skin and watery eyes,\" says Dang, 40. She also used to have frequent headaches, and one of her workers developed asthma. So when she heard about an opportunity to improve the safety at her salon, she signed up.\u003c/p>\n\u003cp>\"I work every day. I need the air to be pure, to be better for me. I have to take care of my health this way,\" she says, speaking in Vietnamese through an interpreter.\u003c/p>\n\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe src=\"https://www.npr.org/player/embed/509315426/509444361\" width=\"100%\" height=\"290\" frameborder=\"0\" scrolling=\"no\" title=\"NPR embedded audio player\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>\u003ca href=\"http://www.asianhealthservices.org/\">Asian Health Services\u003c/a>, a community clinic in Oakland, started \u003ca href=\"http://www.cahealthynailsalons.org/\">The California Healthy Nail Salon Collaborative\u003c/a> after the clinic identified a pattern of illness among nail salon workers.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"Practically every worker was experiencing some kind of health issue. And we realized that this was an epidemic,\" says Julia Liou, planning and development director at the clinic and the co-founder of the collaborative.\u003c/p>\n\u003cp>Nail salons are big business in the United States — \u003ca href=\"http://files.nailsmag.com/Feature-Articles-in-PDF/NABB2015-16stats.pdf\">approximately $8.5 billion \u003c/a> in revenue in 2015. Some of the chemicals used in salons \u003ca href=\"https://www.osha.gov/SLTC/nailsalons/chemicalhazards.html\">are known to cause\u003c/a> skin disorders and respiratory problems, and possibly even cancer, miscarriages and birth defects. Formaldehyde and toluene are just two of the risky ingredients in the nail polishes, solvents, glues and hardeners in constant use in salons; the Environmental Protection Agency \u003ca href=\"https://www.epa.gov/sites/production/files/2015-05/documents/nailsalonguide.pdf\">lists\u003c/a> at least 20 such worrisome chemicals.\u003c/p>\n\u003cp>But, so far, there's been little government regulation to protect workers. Liou is trying to get salon owners to make changes voluntarily to improve worker safety.\u003c/p>\n\u003cp>\"We don't want to create a fear where it's like, 'Oh nail salons are so scary that people can't go to them,' \" explains Liou. \"But we want to create a space where both the owner and the customer can feel comfortable, and actually create a model where the return on investment ends up being worker health.\"\u003c/p>\n\u003cp>Salons that participate in the collaborative must make significant changes to their business, including buying less toxic nail polishes, thinners and removers. All workers are required to wear specific types of gloves and masks when using certain products. Owners are also required to purchase a portable mechanical ventilation unit.\u003c/p>\n\u003cp>\"It sucks in the air when I do artificial nails so the workers don't have to breathe in the toxic chemicals anymore,\" explains Dang, as she turns on the machine with a remote control. More than 80 percent of salon workers in California are Vietnamese American, and more than half are of reproductive age, according to the collaborative.\u003c/p>\n\u003cfigure id=\"attachment_283568\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-800x533.jpg\" alt=\"Mai Dang's Fashion Nails has been certified as a healthy salon since 2013. Salons with that designation provide proper ventilation, train employees on best practices, and avoid products containing formaldehyde, toluene and other particularly toxic solvents and glues.\" width=\"800\" height=\"533\" class=\"size-medium wp-image-283568\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-800x533.jpg 800w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-160x107.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-768x511.jpg 768w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-1020x679.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-1180x786.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-960x639.jpg 960w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-375x250.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2017/01/salon-2_enl-216a76948fef4044ad8fe46c41f7a076bc2f2fcf-520x346.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Mai Dang's Fashion Nails has been certified as a healthy salon since 2013. Salons with that designation provide proper ventilation, train employees on best practices, and avoid products containing formaldehyde, toluene and other particularly toxic solvents and glues. \u003ccite>(Jenny Gold/Kaiser Health News)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Alameda County certified Dang's salon, Fashion Nails, as a healthy salon in 2013, based on her changes. In return, Dang got a certificate that she hangs in her window to let customers know she is part of the collaborative. Fashion Nails is also listed as \u003ca href=\"http://www.co.alameda.ca.us/aceh/healthynail/documents/RECOGNIZED-SALONS.pdf\">a healthier nail salon \u003c/a>on a county website.\u003c/p>\n\u003cp>The process, however, was not cheap. Dang says the products she now uses, while safer, cost about 30 percent more. Overall, she estimates that she spent about $3,000 on the upgrades. To pay for it, she raised her prices by $2 per service.\u003c/p>\n\u003cp>One of Dang's customers, Genell Johnson, says she's more than willing to pay extra for the service.\u003c/p>\n\u003cp>\"You get what you pay for,\" Johnson says. \"That's what they always say, and it's very true.\"\u003c/p>\n\u003cp>A survey of customers by the collaborative found that 90 percent were willing to pay at least a dollar more for services they knew were healthier. Johnson says she's a regular at Fashion Nails but had no idea it was a healthy salon.\u003c/p>\n\u003cp>\"Now I'm going to spread the word,\" says Johnson. \"This will be the perfect place, knowing they're so health conscious.\"\u003c/p>\n\u003cp>For Dang, the investment in a healthier salon seems to be paying off. Visits to her salon have increased, and her business has become more profitable, she says.\u003c/p>\n\u003cp>But getting businesses to make changes voluntarily is a slow process. Out of more than 8,000 nail salons in California, only 120 have joined the collaborative so far.\u003c/p>\n\u003cp>\"I think the ultimate root of the issue is that the chemicals are still in the products,\" says collaborative co-founder Liou. \"If we want to look at really how do we improve worker health, we also need the manufacturers to consider how they can they make safer products as well.\"\u003c/p>\n\u003cp>Still, the Healthy Nail Salon Collaborative is making progress. The EPA recently \u003ca href=\"https://www.epa.gov/newsreleases/us-epa-awards-120000-protect-health-bay-area-nail-salons\">gave the collaborative a grant\u003c/a> to help them offer microloans to salons wanting to upgrade.\u003c/p>\n\u003cp>In September, California \u003ca href=\"http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160AB2125\">passed legislation\u003c/a> to help expand the program across the state, by training cities and counties on how to certify healthy nail salons in their regions.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation. You can follow Jenny Gold on Twitter: \u003c/em>\u003ca href=\"https://twitter.com/JennyAGold\">@JennyAGold\u003c/a>. \u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\">Kaiser Health News\u003c/a>.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=California+Nail+Salons+Start+To+Invest+In+Worker+Safety&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Vice President Joe Biden is outlining how he intends to pursue his \"cancer moonshot\" agenda after he leaves office next week.\u003c/p>\n\u003cp>[contextly_sidebar id=\"fXg9Yi3NNbgCtbEglpi4NJfWUuSjRQHo\"]The vice president, speaking at the J.P. Morgan Healthcare Conference in San Francisco, Monday, said cancer is a bipartisan issue, and he offered to help the next administration carry on his mission to end the deadly disease. But he said he will also create an organization called the Biden Cancer Initiative; the primary focus will be collaboration between scientists so that research will be widely shared across specialties.\u003c/p>\n\u003cp>“Virologists, geneticists, chemical and biological engineers -- they weren’t all working in unison, but today we’ve reached an inflection point ... and the promise is enormous,\" Biden said.\u003c/p>\n\u003cp>Biden said the initiative will also concentrate on improving data standards to help researchers, work with community care organizations to improve access, and push pharmaceutical companies, insurance providers and biotech companies to make sure patients can afford treatments.\u003c/p>\n\u003cp>The subject hits home for the vice president, whose son, former Delaware Attorney General Beau Biden, died of brain cancer in May 2015.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n",
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"content": "\u003cp>\u003cem>Last year, California became the fifth state to allow terminally ill patients to take lethal medication to end their lives. The new law — the \u003ca href=\"https://ww2.kqed.org/stateofhealth/2016/03/10/californias-physician-assisted-suicide-law-to-take-effect-in-june/\" target=\"_blank\" rel=\"noopener\">End of Life Option Act\u003c/a> — took effect in June, 2016.\u003c/em>\u003c/p>\n\u003cp>\u003cem>Piedmont resident \u003cstrong>Ray Perman\u003c/strong> always knew this is the way he wanted to go. He’s 64, a retired pilot, like his father, and an entrepreneur. He’s dying of cancer. I interviewed him about his decision. The following words, culled from that interview, are his.\u003c/em>\u003c/p>\n\u003cp>[soundcloud url=”https://api.soundcloud.com/tracks/301315866″ params=”color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false” width=”100%” height=”166″ iframe=”true” /]\u003c/p>\n\u003cp>My pelvis is fully populated by prostate cancer. I have a one-inch tumor in my tailbone. I have seven tumors in my ribs, like little Christmas tree lights. So about two months ago, my physician called me in and said, ‘Well Ray, we’ve done everything we can.’ I said, ‘Well then I want to be on hospice. And I’d like to have you start with End of Life Options.’ He looked at me and said ‘I’ll write the prescription.’\u003c/p>\n\u003cp>So now I have my medical aid-in-dying drugs up in my bedroom, ready to go. You’re not allowed to go to the pharmacy and go pick them up. They won’t have you inadvertently leave them on the seat of the 57 bus. It has to be delivered like a loaded weapon. So the end-of-life options team came here with three people, the pharmacist with the drugs, my case manager and also another witness. They arrived here with these drugs and they went through the instructions on how to use them, and had me sign all the appropriate documents under witness, which is what they should absolutely do.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Remember that I have to take these prescriptions on my own. No one can assist me. No one can cajole or put the straw in my mouth or squeeze the drugs into my mouth. I have to take them, which means I have to have the ability to swallow. So what the hospice team is learning, they give you about a five-day window when you can do this drug and do the deed. And they’re learning, because they’ve missed a couple of times with other patients. They didn’t call it early enough, and the person could no longer do the drug and they feel very badly.\u003c/p>\n\u003cfigure id=\"attachment_281642\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-281642\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-800x1002.jpg\" alt=\"Ray Perman is a percussionist, avid traveler and self-described “manic volunteer.” Here he plays the Cuban bell during a trip to Havana last March, where he played with six bands.\" width=\"800\" height=\"1002\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-160x200.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-768x962.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-240x301.jpg 240w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-375x470.jpg 375w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-520x651.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Ray Perman is a percussionist, avid traveler and self-described “manic volunteer.” Here he plays the Cuban bell during a trip to Havana last March, where he played with six bands. \u003ccite>(Courtesy Ray Perman)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>They’ve giving me markers, clues as you get closer to the end. You look for changes in perception of food taste, general weakness, or the need to take a mid-morning nap, which I’m starting to do now. My stairway is a measuring device. People say, ‘Ray, should you get a hospital bed down here?’ I say, no I don’t want to die in my living room. I have a beautiful bedroom with windows on three sides, I want to look at my view. So if I can’t get up the stairway anymore, it means we’re darn close. And we are kind of close.\u003c/p>\n\u003cp>It will be a hard decision. People who go for the aid-in-dying option, I understand only 65 percent actually do it. Of the people who don’t, some basically die of symptoms prior to using the option, some simply change their mind. You know, I’m not a hero. I may chicken out.\u003c/p>\n\u003cp>I attended my daughter’s wedding in September and afterwards my oncologist said, the whole department, we figured you had 50/50 odds of attending. And I had a 70 percent chance of dying last month in December. I mean, who knows how it’ll go. Some days I wake up and I can feel cancer coming. It feels like I’m not going to make it to January 15. I have meetings on January 15 — I’ve got to make those meetings. And my wonderful in-home care provider, she’s pregnant and she’s going to give birth around February 15.\u003c/p>\n\u003cp>Our goal is for me to hold the baby. It’ll be great. Maybe I’ll get there.\u003c/p>\n\u003cfigure id=\"attachment_281644\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-281644\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2017/01/RayFlying-800x778.jpg\" alt=\"Ray Perman’s first career was as a pilot, similar to his father. He poses here with his daughter, Andrea, before a recreational flight. Andrea is now 24. His son, Eric, is 27.\" width=\"800\" height=\"778\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-160x156.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-768x747.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-240x233.jpg 240w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-375x365.jpg 375w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-520x506.jpg 520w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-32x32.jpg 32w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-50x50.jpg 50w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Ray Perman’s first career was as a pilot, similar to his father. He poses here with his daughter, Andrea, before a recreational flight. Andrea is now 24. His son, Eric, is 27. \u003ccite>(Courtesy Ray Perman)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>I made sure that the newspapers don’t say ‘Ray lost his battle with cancer.’ There’s no battle. If I were to be battling or struggling I would be preempting my ability to soak in all the wonderful things that are happening to me emotionally.\u003c/p>\n\u003cp>For me the epiphany in all of this is that I shifted from wanting to die quickly to wanting to enjoy this last phase. I think it’s the explorer in me. I want to carry the torch into that last phase and say ‘My gosh, look what I’m discovering. It’s beautiful.’ You shouldn’t miss it. Don’t fear death. It’s wrong.\u003c/p>\n\u003cfigure id=\"attachment_281521\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-281521\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2017/01/KP-Racing-Team-2016-05-1-800x450.jpg\" alt=\"Ray Perman says he's maintained his "rollicking" sense of humor after being diagnosed with two types of cancer.\" width=\"800\" height=\"450\">\u003cfigcaption class=\"wp-caption-text\">Ray Perman says he’s maintained his “rollicking” sense of humor after being diagnosed with two types of cancer. \u003ccite>(Courtesy of Ray Perman)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>When the hospice team gives me the five day window, I will announce to my relatives: It’s time. I’m going to make it this day, come.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>I will have my closest loved ones around me when I do that. I’ll have an open house in the morning for my friends to give me a hug goodbye and then we’ll probably do the deed in the afternoon. Then my family can have time with my body in the evening, as long as they’d like. And I have a complete description on where to dispose of my ashes. It’ll be in the departure path of a Boeing aircraft that took off with my father, on an outgoing tide.\u003c/p>\n\n",
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"title": "Bay Area Cancer Patient Confronts and Embraces His Right to Die",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cem>Last year, California became the fifth state to allow terminally ill patients to take lethal medication to end their lives. The new law — the \u003ca href=\"https://ww2.kqed.org/stateofhealth/2016/03/10/californias-physician-assisted-suicide-law-to-take-effect-in-june/\" target=\"_blank\" rel=\"noopener\">End of Life Option Act\u003c/a> — took effect in June, 2016.\u003c/em>\u003c/p>\n\u003cp>\u003cem>Piedmont resident \u003cstrong>Ray Perman\u003c/strong> always knew this is the way he wanted to go. He’s 64, a retired pilot, like his father, and an entrepreneur. He’s dying of cancer. I interviewed him about his decision. The following words, culled from that interview, are his.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003cdiv class='utils-parseShortcode-shortcodes-__shortcodes__shortcodeWrapper'>\n \u003ciframe width='”100%”' height='”166″'\n scrolling='no' frameborder='no'\n src='https://w.soundcloud.com/player/?url=”https://api.soundcloud.com/tracks/301315866″&visual=true&”color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false”'\n title='”https://api.soundcloud.com/tracks/301315866″'>\n \u003c/iframe>\n \u003c/div>\u003c/p>\u003cp>\u003c/p>\n\u003cp>My pelvis is fully populated by prostate cancer. I have a one-inch tumor in my tailbone. I have seven tumors in my ribs, like little Christmas tree lights. So about two months ago, my physician called me in and said, ‘Well Ray, we’ve done everything we can.’ I said, ‘Well then I want to be on hospice. And I’d like to have you start with End of Life Options.’ He looked at me and said ‘I’ll write the prescription.’\u003c/p>\n\u003cp>So now I have my medical aid-in-dying drugs up in my bedroom, ready to go. You’re not allowed to go to the pharmacy and go pick them up. They won’t have you inadvertently leave them on the seat of the 57 bus. It has to be delivered like a loaded weapon. So the end-of-life options team came here with three people, the pharmacist with the drugs, my case manager and also another witness. They arrived here with these drugs and they went through the instructions on how to use them, and had me sign all the appropriate documents under witness, which is what they should absolutely do.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Remember that I have to take these prescriptions on my own. No one can assist me. No one can cajole or put the straw in my mouth or squeeze the drugs into my mouth. I have to take them, which means I have to have the ability to swallow. So what the hospice team is learning, they give you about a five-day window when you can do this drug and do the deed. And they’re learning, because they’ve missed a couple of times with other patients. They didn’t call it early enough, and the person could no longer do the drug and they feel very badly.\u003c/p>\n\u003cfigure id=\"attachment_281642\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-281642\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-800x1002.jpg\" alt=\"Ray Perman is a percussionist, avid traveler and self-described “manic volunteer.” Here he plays the Cuban bell during a trip to Havana last March, where he played with six bands.\" width=\"800\" height=\"1002\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-160x200.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-768x962.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-240x301.jpg 240w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-375x470.jpg 375w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayPermanPercussion-520x651.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Ray Perman is a percussionist, avid traveler and self-described “manic volunteer.” Here he plays the Cuban bell during a trip to Havana last March, where he played with six bands. \u003ccite>(Courtesy Ray Perman)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>They’ve giving me markers, clues as you get closer to the end. You look for changes in perception of food taste, general weakness, or the need to take a mid-morning nap, which I’m starting to do now. My stairway is a measuring device. People say, ‘Ray, should you get a hospital bed down here?’ I say, no I don’t want to die in my living room. I have a beautiful bedroom with windows on three sides, I want to look at my view. So if I can’t get up the stairway anymore, it means we’re darn close. And we are kind of close.\u003c/p>\n\u003cp>It will be a hard decision. People who go for the aid-in-dying option, I understand only 65 percent actually do it. Of the people who don’t, some basically die of symptoms prior to using the option, some simply change their mind. You know, I’m not a hero. I may chicken out.\u003c/p>\n\u003cp>I attended my daughter’s wedding in September and afterwards my oncologist said, the whole department, we figured you had 50/50 odds of attending. And I had a 70 percent chance of dying last month in December. I mean, who knows how it’ll go. Some days I wake up and I can feel cancer coming. It feels like I’m not going to make it to January 15. I have meetings on January 15 — I’ve got to make those meetings. And my wonderful in-home care provider, she’s pregnant and she’s going to give birth around February 15.\u003c/p>\n\u003cp>Our goal is for me to hold the baby. It’ll be great. Maybe I’ll get there.\u003c/p>\n\u003cfigure id=\"attachment_281644\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-281644\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2017/01/RayFlying-800x778.jpg\" alt=\"Ray Perman’s first career was as a pilot, similar to his father. He poses here with his daughter, Andrea, before a recreational flight. Andrea is now 24. His son, Eric, is 27.\" width=\"800\" height=\"778\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-160x156.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-768x747.jpg 768w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-240x233.jpg 240w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-375x365.jpg 375w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-520x506.jpg 520w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-32x32.jpg 32w, https://cdn.kqed.org/wp-content/uploads/sites/27/2017/01/RayFlying-50x50.jpg 50w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Ray Perman’s first career was as a pilot, similar to his father. He poses here with his daughter, Andrea, before a recreational flight. Andrea is now 24. His son, Eric, is 27. \u003ccite>(Courtesy Ray Perman)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>I made sure that the newspapers don’t say ‘Ray lost his battle with cancer.’ There’s no battle. If I were to be battling or struggling I would be preempting my ability to soak in all the wonderful things that are happening to me emotionally.\u003c/p>\n\u003cp>For me the epiphany in all of this is that I shifted from wanting to die quickly to wanting to enjoy this last phase. I think it’s the explorer in me. I want to carry the torch into that last phase and say ‘My gosh, look what I’m discovering. It’s beautiful.’ You shouldn’t miss it. Don’t fear death. It’s wrong.\u003c/p>\n\u003cfigure id=\"attachment_281521\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-281521\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2017/01/KP-Racing-Team-2016-05-1-800x450.jpg\" alt=\"Ray Perman says he's maintained his "rollicking" sense of humor after being diagnosed with two types of cancer.\" width=\"800\" height=\"450\">\u003cfigcaption class=\"wp-caption-text\">Ray Perman says he’s maintained his “rollicking” sense of humor after being diagnosed with two types of cancer. \u003ccite>(Courtesy of Ray Perman)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>When the hospice team gives me the five day window, I will announce to my relatives: It’s time. I’m going to make it this day, come.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>I will have my closest loved ones around me when I do that. I’ll have an open house in the morning for my friends to give me a hug goodbye and then we’ll probably do the deed in the afternoon. Then my family can have time with my body in the evening, as long as they’d like. And I have a complete description on where to dispose of my ashes. It’ll be in the departure path of a Boeing aircraft that took off with my father, on an outgoing tide.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Will California’s New 'Right to Try' Law Empower or Exploit Patients?",
"title": "Will California’s New 'Right to Try' Law Empower or Exploit Patients?",
"headTitle": "State of Health | KQED News",
"content": "\u003cp>With the enactment of a new “Right to Try” law, California joins 31 other states that have already passed legislation to support patients’ efforts to access experimental drugs.\u003c/p>\n\u003cp>As of Jan. 1, state agencies and licensing boards will not penalize California doctors or hospitals that want to help patients directly petition pharmaceutical companies for the investigational drugs.\u003c/p>\n\u003cp>Proponents of the “Right to Try” movement had contended that doctors could be hesitant to help such patients because of the risk of using drugs or devices that haven’t passed FDA tests for safety and effectiveness.\u003c/p>\n\u003cp>[soundcloud url=\"https://api.soundcloud.com/tracks/300768363\" params=\"color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false\" width=\"100%\" height=\"166\" iframe=\"true\" /]\u003c/p>\n\u003cp>The new law makes it clear that California doctors can proceed without fear of censure from the state’s medical board. It also eliminates other possible regulatory obstacles on the state level and creates processes for patient consent and data collection.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"The idea is to kind of get government out of the way in this situation and allow people to just go at it with a doctor to try to get access to these potentially life-saving medications,” said the law’s sponsor \u003ca href=\"http://asmdc.org/members/a57/\" target=\"_blank\">Ian Calderon\u003c/a>, the Democratic majority leader in the California Assembly.\u003c/p>\n\u003cp>Supporters of “Right to Try” laws sometimes frame them as the logical counterpart to “Right to Die” laws, which allow physician-assisted suicide for terminally ill patients. California enacted such a law in 2016.\u003c/p>\n\u003cp>\"The patient community is saying, ‘We are smart, we’re informed, we feel it is our right to try some of these therapies, because we’re going to die anyway,’” said Lina Clark, a patients’ rights \u003ca href=\"http://www.hopenowforals.org\" target=\"_blank\">activist\u003c/a> in San Diego.\u003c/p>\n\u003cp>Clark’s husband, \u003ca href=\"http://sci.sdsu.edu/geology/remembering-dr-david-huntley/\" target=\"_blank\">David Huntley\u003c/a>, had wanted to try an experimental drug before his death in 2015 from \u003ca href=\"https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet\" target=\"_blank\">amyotrophic lateral sclerosis\u003c/a> (ALS).\u003c/p>\n\u003cfigure id=\"attachment_278363\" class=\"wp-caption alignnone\" style=\"max-width: 720px\">\u003cimg class=\"size-full wp-image-278363\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento.jpg\" alt=\"David Huntley testified in favor of California's "Right to Try" bill in April, 2015. He died three months later. \" width=\"720\" height=\"960\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento.jpg 720w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-160x213.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-240x320.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-375x500.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-520x693.jpg 520w\" sizes=\"(max-width: 720px) 100vw, 720px\">\u003cfigcaption class=\"wp-caption-text\">David Huntley testified in favor of California's \"Right to Try\" bill in April 2015. He died three months later. \u003ccite>(Courtesy of Lina Clark)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The FDA already offers a \u003ca href=\"http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm\" target=\"_blank\">process\u003c/a>, called “expanded access” or “compassionate use,” for some patients to obtain experimental drugs. But critics say it’s too slow and cumbersome, even though the FDA approves more than 99 percent of requests that come through that pipeline.\u003c/p>\n\u003cp>“It just takes so long, it’s inefficient, it’s ridiculous,” Calderon said of the FDA process. “I don’t understand.”\u003c/p>\n\u003cp>As the state laws proliferate, clinicians and medical ethicists are growing increasingly concerned about the potential safety and financial risks to patients.\u003c/p>\n\u003cp>“If we take the FDA out of it, how do we protect people from physicians or drug companies that will want to sell them things and will want to prey on their desperation?” asked \u003ca href=\"http://healthpolicy.ucsf.edu/people/r-adams-dudley-md-mba\" target=\"_blank\">Dr. R. Adams Dudley\u003c/a>, director of UCSF’s \u003ca href=\"http://healthvalue.ucsf.edu/\" target=\"_blank\">Center for Healthcare Value\u003c/a>.\u003c/p>\n\u003cp>Dudley says the FDA and the clinical trial process were put in place for a reason.\u003c/p>\n\u003cp>\"Have we somehow gotten better at managing snake oil salesmen now, than we were back when we decided we needed an FDA in the first place?\" Dudley said.\u003c/p>\n\u003cp>Under the new law, all that patients and doctors can really do is \u003cem>ask\u003c/em> for an experimental drug. Drug companies don’t have to give it to them, and insurance companies don’t have to pay for it.\u003c/p>\n\u003cp>Dudley fears that family members of a patient might exhaust their life savings trying a drug that hasn’t been proven to work -- and could even speed up death or increase end-of-life suffering.\u003c/p>\n\u003cp>That’s one reason the \u003ca href=\"http://www.nationalnursesunited.org/site/entry/california-nurses-association\" target=\"_blank\">California Nurses Association\u003c/a>, among other groups, strongly opposed the bill.\u003c/p>\n\u003cp>“It basically turns patients -- terminally-ill patients -- into guinea pigs,” said Don Nielsen, the CNA's director of government relations.\u003c/p>\n\u003cp>“There’s really no demonstrated need for this,” Nielsen said. “This so-called \"Right to Try\" movement is nothing more than boilerplate legislation promoted by the far-right Goldwater Institute.”\u003c/p>\n\u003cp>(While the Arizona-based Goldwater Institute has taken an active role in \u003ca href=\"http://goldwaterinstitute.org/en/work/topics/healthcare/right-to-try/right-try/\" target=\"_blank\">promoting\u003c/a> the laws, in California and other states, Calderon insists he came upon the issue independently, while researching physician-assisted suicide for California.)\u003c/p>\n\u003cp>It’s unclear how effective the state laws have been. There’s no data yet on how many patients have used the state laws, compared to the FDA’s expanded access process.\u003c/p>\n\u003cp>Dudley predicts the state-based Right to Try laws may eventually face a court challenge and be declared unconstitutional. That’s because federal law gives the power to regulate pharmaceuticals to the FDA, not the states.\u003c/p>\n\u003cp>But Clark thinks Congress might be open to amending that authority.\u003c/p>\n\u003cp>“It’s kind of parallel with what’s going on with medical marijuana,” Clark said. “It’s legal at the state level, but we still have a federal Drug Enforcement Agency to whom it is illegal. It’s not an ideal situation. It’s kind of similar to that. We ultimately need a federal law.”\u003c/p>\n\u003cp>A federal version of Right to Try was introduced in the Senate last year. In the meantime, a recently passed federal law addressing medical research, the \u003ca href=\"http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf\" target=\"_blank\">21st Century Cures Act\u003c/a>, contains a \u003ca href=\"https://www.statnews.com/pharmalot/2016/11/28/21st-century-experimental-drugs/\" target=\"_blank\">provision\u003c/a> that requires drug companies to be more transparent about how they decide who gets access to experimental drugs and how long it will take.\u003c/p>\n\u003cfigure id=\"attachment_278364\" class=\"wp-caption alignnone\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-278364\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-800x800.jpg\" alt='Lina Clark and her husband David Huntley on vacation in Croatia in 2014, before he succumbed to ALS. The disease made both of them activists for the \"right to try\" in California. ' width=\"800\" height=\"800\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-800x800.jpg 800w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-160x160.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-768x768.jpg 768w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing.jpg 960w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-240x240.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-375x375.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-520x520.jpg 520w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-50x50.jpg 50w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-150x150.jpg 150w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Lina Clark and her husband David Huntley on vacation in Croatia in 2014, before he succumbed to ALS. The disease made both of them activists for the \"Right to Try\" in California. \u003ccite>(Courtesy of Lina Clark)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Editor's note: The original version of this article incorrectly stated the California \"Right To Try\" law allowed access to an experimental drug at any stage. The law actually only allows a patient to request a drug that has passed through Phase I of the FDA clinical process, when a candidate drug is tested for toxicity on otherwise healthy subjects.\u003cbr>\n\u003c/em>\u003c/p>\n\n",
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"excerpt": "California is the 32nd state to pass a law supporting patients’ efforts to access experimental drugs. But critics say the movement poses potential safety and financial risks to vulnerable patients. ",
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"description": "California is the 32nd state to pass a law supporting patients’ efforts to access experimental drugs. But critics say the movement poses potential safety and financial risks to vulnerable patients. ",
"title": "Will California’s New 'Right to Try' Law Empower or Exploit Patients? | KQED",
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"headline": "Will California’s New 'Right to Try' Law Empower or Exploit Patients?",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>With the enactment of a new “Right to Try” law, California joins 31 other states that have already passed legislation to support patients’ efforts to access experimental drugs.\u003c/p>\n\u003cp>As of Jan. 1, state agencies and licensing boards will not penalize California doctors or hospitals that want to help patients directly petition pharmaceutical companies for the investigational drugs.\u003c/p>\n\u003cp>Proponents of the “Right to Try” movement had contended that doctors could be hesitant to help such patients because of the risk of using drugs or devices that haven’t passed FDA tests for safety and effectiveness.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003cdiv class='utils-parseShortcode-shortcodes-__shortcodes__shortcodeWrapper'>\n \u003ciframe width='100%' height='166'\n scrolling='no' frameborder='no'\n src='https://w.soundcloud.com/player/?url=https://api.soundcloud.com/tracks/300768363&visual=true&color=ff5500&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false'\n title='https://api.soundcloud.com/tracks/300768363'>\n \u003c/iframe>\n \u003c/div>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The new law makes it clear that California doctors can proceed without fear of censure from the state’s medical board. It also eliminates other possible regulatory obstacles on the state level and creates processes for patient consent and data collection.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"The idea is to kind of get government out of the way in this situation and allow people to just go at it with a doctor to try to get access to these potentially life-saving medications,” said the law’s sponsor \u003ca href=\"http://asmdc.org/members/a57/\" target=\"_blank\">Ian Calderon\u003c/a>, the Democratic majority leader in the California Assembly.\u003c/p>\n\u003cp>Supporters of “Right to Try” laws sometimes frame them as the logical counterpart to “Right to Die” laws, which allow physician-assisted suicide for terminally ill patients. California enacted such a law in 2016.\u003c/p>\n\u003cp>\"The patient community is saying, ‘We are smart, we’re informed, we feel it is our right to try some of these therapies, because we’re going to die anyway,’” said Lina Clark, a patients’ rights \u003ca href=\"http://www.hopenowforals.org\" target=\"_blank\">activist\u003c/a> in San Diego.\u003c/p>\n\u003cp>Clark’s husband, \u003ca href=\"http://sci.sdsu.edu/geology/remembering-dr-david-huntley/\" target=\"_blank\">David Huntley\u003c/a>, had wanted to try an experimental drug before his death in 2015 from \u003ca href=\"https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet\" target=\"_blank\">amyotrophic lateral sclerosis\u003c/a> (ALS).\u003c/p>\n\u003cfigure id=\"attachment_278363\" class=\"wp-caption alignnone\" style=\"max-width: 720px\">\u003cimg class=\"size-full wp-image-278363\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento.jpg\" alt=\"David Huntley testified in favor of California's "Right to Try" bill in April, 2015. He died three months later. \" width=\"720\" height=\"960\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento.jpg 720w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-160x213.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-240x320.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-375x500.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Sacramento-520x693.jpg 520w\" sizes=\"(max-width: 720px) 100vw, 720px\">\u003cfigcaption class=\"wp-caption-text\">David Huntley testified in favor of California's \"Right to Try\" bill in April 2015. He died three months later. \u003ccite>(Courtesy of Lina Clark)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The FDA already offers a \u003ca href=\"http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm\" target=\"_blank\">process\u003c/a>, called “expanded access” or “compassionate use,” for some patients to obtain experimental drugs. But critics say it’s too slow and cumbersome, even though the FDA approves more than 99 percent of requests that come through that pipeline.\u003c/p>\n\u003cp>“It just takes so long, it’s inefficient, it’s ridiculous,” Calderon said of the FDA process. “I don’t understand.”\u003c/p>\n\u003cp>As the state laws proliferate, clinicians and medical ethicists are growing increasingly concerned about the potential safety and financial risks to patients.\u003c/p>\n\u003cp>“If we take the FDA out of it, how do we protect people from physicians or drug companies that will want to sell them things and will want to prey on their desperation?” asked \u003ca href=\"http://healthpolicy.ucsf.edu/people/r-adams-dudley-md-mba\" target=\"_blank\">Dr. R. Adams Dudley\u003c/a>, director of UCSF’s \u003ca href=\"http://healthvalue.ucsf.edu/\" target=\"_blank\">Center for Healthcare Value\u003c/a>.\u003c/p>\n\u003cp>Dudley says the FDA and the clinical trial process were put in place for a reason.\u003c/p>\n\u003cp>\"Have we somehow gotten better at managing snake oil salesmen now, than we were back when we decided we needed an FDA in the first place?\" Dudley said.\u003c/p>\n\u003cp>Under the new law, all that patients and doctors can really do is \u003cem>ask\u003c/em> for an experimental drug. Drug companies don’t have to give it to them, and insurance companies don’t have to pay for it.\u003c/p>\n\u003cp>Dudley fears that family members of a patient might exhaust their life savings trying a drug that hasn’t been proven to work -- and could even speed up death or increase end-of-life suffering.\u003c/p>\n\u003cp>That’s one reason the \u003ca href=\"http://www.nationalnursesunited.org/site/entry/california-nurses-association\" target=\"_blank\">California Nurses Association\u003c/a>, among other groups, strongly opposed the bill.\u003c/p>\n\u003cp>“It basically turns patients -- terminally-ill patients -- into guinea pigs,” said Don Nielsen, the CNA's director of government relations.\u003c/p>\n\u003cp>“There’s really no demonstrated need for this,” Nielsen said. “This so-called \"Right to Try\" movement is nothing more than boilerplate legislation promoted by the far-right Goldwater Institute.”\u003c/p>\n\u003cp>(While the Arizona-based Goldwater Institute has taken an active role in \u003ca href=\"http://goldwaterinstitute.org/en/work/topics/healthcare/right-to-try/right-try/\" target=\"_blank\">promoting\u003c/a> the laws, in California and other states, Calderon insists he came upon the issue independently, while researching physician-assisted suicide for California.)\u003c/p>\n\u003cp>It’s unclear how effective the state laws have been. There’s no data yet on how many patients have used the state laws, compared to the FDA’s expanded access process.\u003c/p>\n\u003cp>Dudley predicts the state-based Right to Try laws may eventually face a court challenge and be declared unconstitutional. That’s because federal law gives the power to regulate pharmaceuticals to the FDA, not the states.\u003c/p>\n\u003cp>But Clark thinks Congress might be open to amending that authority.\u003c/p>\n\u003cp>“It’s kind of parallel with what’s going on with medical marijuana,” Clark said. “It’s legal at the state level, but we still have a federal Drug Enforcement Agency to whom it is illegal. It’s not an ideal situation. It’s kind of similar to that. We ultimately need a federal law.”\u003c/p>\n\u003cp>A federal version of Right to Try was introduced in the Senate last year. In the meantime, a recently passed federal law addressing medical research, the \u003ca href=\"http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf\" target=\"_blank\">21st Century Cures Act\u003c/a>, contains a \u003ca href=\"https://www.statnews.com/pharmalot/2016/11/28/21st-century-experimental-drugs/\" target=\"_blank\">provision\u003c/a> that requires drug companies to be more transparent about how they decide who gets access to experimental drugs and how long it will take.\u003c/p>\n\u003cfigure id=\"attachment_278364\" class=\"wp-caption alignnone\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-278364\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-800x800.jpg\" alt='Lina Clark and her husband David Huntley on vacation in Croatia in 2014, before he succumbed to ALS. The disease made both of them activists for the \"right to try\" in California. ' width=\"800\" height=\"800\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-800x800.jpg 800w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-160x160.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-768x768.jpg 768w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing.jpg 960w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-240x240.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-375x375.jpg 375w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-520x520.jpg 520w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-50x50.jpg 50w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Right-to-Try-Huntley-Clark-Sailing-150x150.jpg 150w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Lina Clark and her husband David Huntley on vacation in Croatia in 2014, before he succumbed to ALS. The disease made both of them activists for the \"Right to Try\" in California. \u003ccite>(Courtesy of Lina Clark)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Editor's note: The original version of this article incorrectly stated the California \"Right To Try\" law allowed access to an experimental drug at any stage. The law actually only allows a patient to request a drug that has passed through Phase I of the FDA clinical process, when a candidate drug is tested for toxicity on otherwise healthy subjects.\u003cbr>\n\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "California Hopes $3 Billion Experiment Will Improve Health of Neediest",
"title": "California Hopes $3 Billion Experiment Will Improve Health of Neediest",
"headTitle": "State of Health | KQED News",
"content": "\u003cp>Riverside County plans to connect former inmates with health clinics and social services. Orange County hopes to get homeless residents into housing — and help them stay there. Placer County is opening a respite center where homeless patients can go after they leave the hospital.\u003c/p>\n\u003cp>Those are just some of the pilot projects in a $3 billion experimental effort officials hope will improve the health of California’s most vulnerable populations. The effort is a recognition that improving people’s health will take more than just getting them insured.\u003c/p>\n\u003cp>The state has approved plans in 18 counties intended to reduce unnecessary emergency room visits and hospital stays among these groups. In addition to ex-prisoners and the homeless, they include people who have multiple chronic illnesses, substance abuse problems and mental health disorders. The state is accepting a second round of applications for such projects next year.\u003c/p>\n\u003cp>The effort, known as “whole person care,” is part of an agreement between California and the federal government. It gives the state flexibility to try to improve the efficiency and quality of care in the state’s Medicaid program — known as Medi-Cal — which provides health coverage to low-income people.\u003c/p>\n\u003cp>The projects are designed to blend physical care, mental health care and social services for the participants, who are among the neediest and costliest in the state.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“We have people coming out of jail and they are homeless, they don’t have food and they are diabetic and they are bipolar and they drink too much alcohol and they use heroin,” said Judi Nightingale, director of population health for Riverside University Health System. “They need services from different county departments in 20 different locations … and we don’t talk to each other.”\u003c/p>\n\u003cp>Half the funding for the program comes from the federal government, and the other half will be provided by local entities, including counties and hospital systems.\u003c/p>\n\u003cp>Some county leaders fear President-elect Donald Trump’s plan to dismantle the Affordable Care Act could derail their plans, but they hope nothing will change right away. State officials are urging counties to continue laying the groundwork for their projects, which are expected to start next spring or summer.\u003c/p>\n\u003cp>“We are just moving forward in terms of implementation and not speculating on any changes that might happen,” said Sarah Brooks, a deputy director at the state Department of Health Care Services. “We will see what comes in the next year.”\u003c/p>\n\u003cp>Mark Ghaly, a program director with Los Angeles County’s Department of Health Services, said he believes the program is going to stand for at least a while. “The question is will we have enough time to show what works,” he said.\u003c/p>\n\u003cp>The key to success will be getting various agencies to work together to identify participants and serve them no matter where they are, Brooks said.\u003c/p>\n\u003cp>Part of that depends on being able to share data, which remains a challenge for many counties, Brooks said. Most counties have multiple electronic health records systems that may not interact with other government computer systems. There are also patient privacy concerns.\u003c/p>\n\u003cp>Riverside County’s project aims not only to reduce ER use but also to keep former inmates out of jail. They will be screened upon their release and offered help with housing, health insurance, drug treatment and mental health services.\u003c/p>\n\u003cp>Los Angeles County’s project, which will cost $900 million over five years, is an ambitious effort to improve the health of high-risk populations, including the homeless and recent inmates. The county plans to target about 1,000 soon-to-be released inmates each month and will use community health workers to help them get the care and social services they need. The county also is working to get inmates released with a 30-day supply of medications.\u003c/p>\n\u003cp>Ghaly said he believes the project will “stabilize people upon release so they don’t hit the emergency departments in the volume they are now.”\u003c/p>\n\u003cp>Nadereh Pourat, director of research at the UCLA Center for Health Policy Research, said she expects the projects to improve care and outcomes as well as save money. “There is going to be some reduction in [emergency department] use if you are wrapping these additional services around these populations who are complex and high-need,” she said.\u003c/p>\n\u003cp>More than 14 million Californians are covered by Medi-Cal, including about 5 million who have signed up since the Affordable Care Act took effect in 2014. The health reform law allowed states to expand the number of people who were eligible. Many new Medi-Cal beneficiaries went years without coverage and had untreated chronic conditions and mental health and substance use disorders.\u003c/p>\n\u003cp>Insurance coverage is the first step because it gets them in the door, Pourat said. But that must be followed by getting them the right services to keep them out of the hospital. The pilot programs will allow the state to see what works and doesn’t work, Pourat said. They will be evaluated based their impact on ER visits, inpatient stays and other measures of health and housing.\u003c/p>\n\u003cp>“It’s a great laboratory,” she said. “There is not going to be a cookie cutter approach throughout the state.”\u003c/p>\n\u003cp>The planned projects vary in size, method and goals. Many include housing services, care management and data sharing. For the counties that focus on homeless people, federal money cannot be used to pay rent. But it can be used for other housing services such as move-in costs, financial education and outreach to landlords.\u003c/p>\n\u003cp>In Orange County, officials are linking homeless residents to primary care providers and helping them find places to live.\u003c/p>\n\u003cp>“If we are able to get them stabilized and into stable housing … we can improve their overall health,” said Melissa Tober, manager of strategic projects for the Orange County Health Care Agency.\u003c/p>\n\u003cp>In Placer County, which also will target homeless residents, Health and Human Services Director Jeff Brown said each participant will have an intensive care plan, which may include substance abuse treatment, mental health care or peer support. Brown said the pilot project provides the money and flexibility.\u003c/p>\n\u003cp>But, he said, “There really is no road map for the perfect way to implement this, and without that road map or blueprint, it can be a bit difficult.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"http://kff.org/\" target=\"\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n",
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"nprByline": "\u003cstrong>\u003ca href=\"http://khn.org/news/author/anna-gorman\">Anna Gorman\u003c/a>\u003c/strong> ",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Riverside County plans to connect former inmates with health clinics and social services. Orange County hopes to get homeless residents into housing — and help them stay there. Placer County is opening a respite center where homeless patients can go after they leave the hospital.\u003c/p>\n\u003cp>Those are just some of the pilot projects in a $3 billion experimental effort officials hope will improve the health of California’s most vulnerable populations. The effort is a recognition that improving people’s health will take more than just getting them insured.\u003c/p>\n\u003cp>The state has approved plans in 18 counties intended to reduce unnecessary emergency room visits and hospital stays among these groups. In addition to ex-prisoners and the homeless, they include people who have multiple chronic illnesses, substance abuse problems and mental health disorders. The state is accepting a second round of applications for such projects next year.\u003c/p>\n\u003cp>The effort, known as “whole person care,” is part of an agreement between California and the federal government. It gives the state flexibility to try to improve the efficiency and quality of care in the state’s Medicaid program — known as Medi-Cal — which provides health coverage to low-income people.\u003c/p>\n\u003cp>The projects are designed to blend physical care, mental health care and social services for the participants, who are among the neediest and costliest in the state.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“We have people coming out of jail and they are homeless, they don’t have food and they are diabetic and they are bipolar and they drink too much alcohol and they use heroin,” said Judi Nightingale, director of population health for Riverside University Health System. “They need services from different county departments in 20 different locations … and we don’t talk to each other.”\u003c/p>\n\u003cp>Half the funding for the program comes from the federal government, and the other half will be provided by local entities, including counties and hospital systems.\u003c/p>\n\u003cp>Some county leaders fear President-elect Donald Trump’s plan to dismantle the Affordable Care Act could derail their plans, but they hope nothing will change right away. State officials are urging counties to continue laying the groundwork for their projects, which are expected to start next spring or summer.\u003c/p>\n\u003cp>“We are just moving forward in terms of implementation and not speculating on any changes that might happen,” said Sarah Brooks, a deputy director at the state Department of Health Care Services. “We will see what comes in the next year.”\u003c/p>\n\u003cp>Mark Ghaly, a program director with Los Angeles County’s Department of Health Services, said he believes the program is going to stand for at least a while. “The question is will we have enough time to show what works,” he said.\u003c/p>\n\u003cp>The key to success will be getting various agencies to work together to identify participants and serve them no matter where they are, Brooks said.\u003c/p>\n\u003cp>Part of that depends on being able to share data, which remains a challenge for many counties, Brooks said. Most counties have multiple electronic health records systems that may not interact with other government computer systems. There are also patient privacy concerns.\u003c/p>\n\u003cp>Riverside County’s project aims not only to reduce ER use but also to keep former inmates out of jail. They will be screened upon their release and offered help with housing, health insurance, drug treatment and mental health services.\u003c/p>\n\u003cp>Los Angeles County’s project, which will cost $900 million over five years, is an ambitious effort to improve the health of high-risk populations, including the homeless and recent inmates. The county plans to target about 1,000 soon-to-be released inmates each month and will use community health workers to help them get the care and social services they need. The county also is working to get inmates released with a 30-day supply of medications.\u003c/p>\n\u003cp>Ghaly said he believes the project will “stabilize people upon release so they don’t hit the emergency departments in the volume they are now.”\u003c/p>\n\u003cp>Nadereh Pourat, director of research at the UCLA Center for Health Policy Research, said she expects the projects to improve care and outcomes as well as save money. “There is going to be some reduction in [emergency department] use if you are wrapping these additional services around these populations who are complex and high-need,” she said.\u003c/p>\n\u003cp>More than 14 million Californians are covered by Medi-Cal, including about 5 million who have signed up since the Affordable Care Act took effect in 2014. The health reform law allowed states to expand the number of people who were eligible. Many new Medi-Cal beneficiaries went years without coverage and had untreated chronic conditions and mental health and substance use disorders.\u003c/p>\n\u003cp>Insurance coverage is the first step because it gets them in the door, Pourat said. But that must be followed by getting them the right services to keep them out of the hospital. The pilot programs will allow the state to see what works and doesn’t work, Pourat said. They will be evaluated based their impact on ER visits, inpatient stays and other measures of health and housing.\u003c/p>\n\u003cp>“It’s a great laboratory,” she said. “There is not going to be a cookie cutter approach throughout the state.”\u003c/p>\n\u003cp>The planned projects vary in size, method and goals. Many include housing services, care management and data sharing. For the counties that focus on homeless people, federal money cannot be used to pay rent. But it can be used for other housing services such as move-in costs, financial education and outreach to landlords.\u003c/p>\n\u003cp>In Orange County, officials are linking homeless residents to primary care providers and helping them find places to live.\u003c/p>\n\u003cp>“If we are able to get them stabilized and into stable housing … we can improve their overall health,” said Melissa Tober, manager of strategic projects for the Orange County Health Care Agency.\u003c/p>\n\u003cp>In Placer County, which also will target homeless residents, Health and Human Services Director Jeff Brown said each participant will have an intensive care plan, which may include substance abuse treatment, mental health care or peer support. Brown said the pilot project provides the money and flexibility.\u003c/p>\n\u003cp>But, he said, “There really is no road map for the perfect way to implement this, and without that road map or blueprint, it can be a bit difficult.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"http://kff.org/\" target=\"\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Democrats have traditionally been the ones to champion health care programs for low-income Californians. But this month, Republicans proposed a bill that would put $200 million dollars toward improving Denti-Cal, the state’s free dental care program for the poor.\u003c/p>\n\u003cp>“If you have a program that already exists that isn’t properly funded, and isn’t working properly, you should fix that first before spending money on new programs,” said Chad Mayes, an Assembly Republican leader who represents Yucca Valley.\u003c/p>\n\u003cp>About 13 million Californians are eligible for Denti-Cal, including 5 million children. But the program is widely viewed as “broken,” “bureaucratically rigid,” and “a disaster,” according to \u003ca href=\"http://www.lhc.ca.gov/studies/230/Report230.pdf\">a 2016 report\u003c/a> from the \u003ca href=\"http://www.lhc.ca.gov/index.html\" target=\"_blank\" rel=\"noopener\">Little Hoover Commission\u003c/a>, an independent state oversight agency.\u003c/p>\n\u003cp>Most people who have Denti-Cal never actually see the dentist, because they can’t find one who accepts their coverage. Eleven counties in California have no dentists who accept Denti-Cal or who are accepting new Denti-Cal patients, according to a 2014 \u003ca href=\"https://www.auditor.ca.gov/reports/summary/2013-125\">California State Auditor report\u003c/a>.\u003c/p>\n\u003cp>“And we just think that that’s wrong,” Mayes said.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Many dentists limit the number of Denti-Cal patients they see, or stop seeing them altogether because the pay is too low: California’s reimbursement rates are 35 percent of the national average.\u003c/p>\n\u003cp>The Republican bill, \u003ca href=\"https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201720180AB15\">AB 15\u003c/a>, would put all $200 million into paying dentists a better rate, in the hopes of attracting more dentists to participate in the program.\u003c/p>\n\u003cp>“We need to make it as efficient and effective as possible, so that millions of adults and kids in California that aren’t able to receive dental services are able to get them,” Mayes said.\u003c/p>\n\u003cp>But it’s not clear that giving dentists more money actually results in more patients getting care.\u003c/p>\n\u003cp>The \u003ca href=\"http://www.lhc.ca.gov/studies/230/Report230.pdf\" target=\"_blank\" rel=\"noopener\">report\u003c/a> from the Little Hoover Commission – a report Mayes and other Republicans cite frequently in defending their bill – includes 11 recommendations on how to fix Denti-Cal.\u003c/p>\n\u003cp>Not one of the recommendations involves increasing payments to dentists. In fact, the report calls across-the-board rate hikes a “costly” move that would result in attracting only “a few more Denti-Cal providers.”\u003c/p>\n\u003cp>Instead, the report recommends improving the Denti-Cal program by simplifying paperwork, focusing on less expensive prevention strategies (like having pediatricians teach patients about good oral hygiene), and establishing dental clinics inside schools or community centers in remote areas, so that patients can go to a centrally located place for care, rather than traveling 60 miles to a dentist’s office.\u003c/p>\n\u003cp>Senate Republican Leader Jean Fuller, who represents Kern County, acknowledged that the bill doesn’t address those recommendations.\u003c/p>\n\u003cp>“Yes, there are a lot of things that I would like to fix about the program. But I am not the majority party, unfortunately. I am not likely to get to adjust those,” she said. “There are 120,000 children in my district who are not getting the service. So my job is to fight for my children to get what I can.”\u003c/p>\n\u003cp>Paying dentists more money is really about making dentists happy, says Jessica Levinson, a professor at Loyola Law School in Los Angeles.\u003c/p>\n\u003cp>“It’s certainly a Republican goal to be business friendly,” she said. “This proposal is actually a business-friendly, a professional-friendly proposal to try and say to a dentist, ‘You will get higher reimbursement rates and you will be able to serve poor clients.’”\u003c/p>\n\u003cp>Levinson says there could also be something else at play here: campaign money. The \u003ca href=\"http://www.cda.org/\" target=\"_blank\" rel=\"noopener\">California Dental Association\u003c/a> gives more to Democrats in the state, but compared to other similar interest groups, like the California Medical Association, the dental group gives more generously to Republicans.\u003c/p>\n\u003cp>When it comes to Californian candidates running for federal office, in the most recent election cycle, the Dental Association gave exclusively to the Republican party, according to \u003ca href=\"https://www.opensecrets.org/pacs/lookup2.php?strID=C00005751&cycle=2016\">campaign contribution data\u003c/a> from Open Secrets. That’s a complete turnaround from 25 years ago, when the Association gave only to Democrats running at that level.\u003c/p>\n\u003cp>“It’s obvious to me that state office holders in California would be well aware of the fact that the California Dental Association is spending a lot of money for Republican candidates on the federal level,” Levinson said, “So they may be hoping that that money will soon come their way.”\u003c/p>\n\u003cp>Republicans and Democrats both are always on the lookout for new sources of campaign money. Asked if the Dental Association’s shift in giving influenced the Republican bill, Assemblyman Chad Mayes said he wasn’t aware of the shift.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“Actually, I’m a bit offended by even asking the question, because we really, genuinely care about the people of California,” he said. “This is about fixing a broken governmental program.”\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Democrats have traditionally been the ones to champion health care programs for low-income Californians. But this month, Republicans proposed a bill that would put $200 million dollars toward improving Denti-Cal, the state’s free dental care program for the poor.\u003c/p>\n\u003cp>“If you have a program that already exists that isn’t properly funded, and isn’t working properly, you should fix that first before spending money on new programs,” said Chad Mayes, an Assembly Republican leader who represents Yucca Valley.\u003c/p>\n\u003cp>About 13 million Californians are eligible for Denti-Cal, including 5 million children. But the program is widely viewed as “broken,” “bureaucratically rigid,” and “a disaster,” according to \u003ca href=\"http://www.lhc.ca.gov/studies/230/Report230.pdf\">a 2016 report\u003c/a> from the \u003ca href=\"http://www.lhc.ca.gov/index.html\" target=\"_blank\" rel=\"noopener\">Little Hoover Commission\u003c/a>, an independent state oversight agency.\u003c/p>\n\u003cp>Most people who have Denti-Cal never actually see the dentist, because they can’t find one who accepts their coverage. Eleven counties in California have no dentists who accept Denti-Cal or who are accepting new Denti-Cal patients, according to a 2014 \u003ca href=\"https://www.auditor.ca.gov/reports/summary/2013-125\">California State Auditor report\u003c/a>.\u003c/p>\n\u003cp>“And we just think that that’s wrong,” Mayes said.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Many dentists limit the number of Denti-Cal patients they see, or stop seeing them altogether because the pay is too low: California’s reimbursement rates are 35 percent of the national average.\u003c/p>\n\u003cp>The Republican bill, \u003ca href=\"https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201720180AB15\">AB 15\u003c/a>, would put all $200 million into paying dentists a better rate, in the hopes of attracting more dentists to participate in the program.\u003c/p>\n\u003cp>“We need to make it as efficient and effective as possible, so that millions of adults and kids in California that aren’t able to receive dental services are able to get them,” Mayes said.\u003c/p>\n\u003cp>But it’s not clear that giving dentists more money actually results in more patients getting care.\u003c/p>\n\u003cp>The \u003ca href=\"http://www.lhc.ca.gov/studies/230/Report230.pdf\" target=\"_blank\" rel=\"noopener\">report\u003c/a> from the Little Hoover Commission – a report Mayes and other Republicans cite frequently in defending their bill – includes 11 recommendations on how to fix Denti-Cal.\u003c/p>\n\u003cp>Not one of the recommendations involves increasing payments to dentists. In fact, the report calls across-the-board rate hikes a “costly” move that would result in attracting only “a few more Denti-Cal providers.”\u003c/p>\n\u003cp>Instead, the report recommends improving the Denti-Cal program by simplifying paperwork, focusing on less expensive prevention strategies (like having pediatricians teach patients about good oral hygiene), and establishing dental clinics inside schools or community centers in remote areas, so that patients can go to a centrally located place for care, rather than traveling 60 miles to a dentist’s office.\u003c/p>\n\u003cp>Senate Republican Leader Jean Fuller, who represents Kern County, acknowledged that the bill doesn’t address those recommendations.\u003c/p>\n\u003cp>“Yes, there are a lot of things that I would like to fix about the program. But I am not the majority party, unfortunately. I am not likely to get to adjust those,” she said. “There are 120,000 children in my district who are not getting the service. So my job is to fight for my children to get what I can.”\u003c/p>\n\u003cp>Paying dentists more money is really about making dentists happy, says Jessica Levinson, a professor at Loyola Law School in Los Angeles.\u003c/p>\n\u003cp>“It’s certainly a Republican goal to be business friendly,” she said. “This proposal is actually a business-friendly, a professional-friendly proposal to try and say to a dentist, ‘You will get higher reimbursement rates and you will be able to serve poor clients.’”\u003c/p>\n\u003cp>Levinson says there could also be something else at play here: campaign money. The \u003ca href=\"http://www.cda.org/\" target=\"_blank\" rel=\"noopener\">California Dental Association\u003c/a> gives more to Democrats in the state, but compared to other similar interest groups, like the California Medical Association, the dental group gives more generously to Republicans.\u003c/p>\n\u003cp>When it comes to Californian candidates running for federal office, in the most recent election cycle, the Dental Association gave exclusively to the Republican party, according to \u003ca href=\"https://www.opensecrets.org/pacs/lookup2.php?strID=C00005751&cycle=2016\">campaign contribution data\u003c/a> from Open Secrets. That’s a complete turnaround from 25 years ago, when the Association gave only to Democrats running at that level.\u003c/p>\n\u003cp>“It’s obvious to me that state office holders in California would be well aware of the fact that the California Dental Association is spending a lot of money for Republican candidates on the federal level,” Levinson said, “So they may be hoping that that money will soon come their way.”\u003c/p>\n\u003cp>Republicans and Democrats both are always on the lookout for new sources of campaign money. Asked if the Dental Association’s shift in giving influenced the Republican bill, Assemblyman Chad Mayes said he wasn’t aware of the shift.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“Actually, I’m a bit offended by even asking the question, because we really, genuinely care about the people of California,” he said. “This is about fixing a broken governmental program.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>There's a grim chapter in American history that involves forced sterilization. And for much of this past century, California had one of the most active sterilization programs in the country.\u003c/p>\n\u003cp>A state law from 1909 authorized the surgery for people judged to have \"mental disease, which may have been inherited.\" That law remained on the books until 1979.\u003c/p>\n\u003cp>University of Michigan professor Alexandra Minna Stern has been working to identify people who were forcibly sterilized under California's program. NPR's Ailsa Chang spoke with Stern, who said this idea of eugenics was intended to \"eradicate certain genes from the population.\"\u003c/p>\n\u003cp>The professor describes the program as a historic injustice and called for the state of California to compensate surviving victims of sterilization of relatives of those who are now deceased.\u003c/p>\n\u003cp>\u003cem>The interview highlights contain some extra content that did not air in the broadcast version.\u003c/em>\u003c/p>\n\u003chr>\n\u003ch3>Interview highlights\u003c/h3>\n\u003cp>\u003cstrong>On how she found the names of all the victims \u003c/strong>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The names are located in 19 microfilm reels that I happened upon while doing research in Sacramento about seven years ago.\u003c/p>\n\u003cp>\u003cstrong>On what made her look at the microfilms\u003c/strong>\u003c/p>\n\u003cp>I've written a book on the history of eugenics in California. But at that point, I still knew very little about the sterilizations themselves; who was sterilized, where did all of the sterilizations take place, how is the policy enacted?\u003c/p>\n\u003cp>So I did a bit of sleuthing and went to the actual departments themselves — the department of mental health in this case, in Sacramento — and was fortunate that someone there directed me to some file cabinets that contained microfilm reels with materials that had been microfilmed over the course of the '60s and '70s.\u003c/p>\n\u003cp>And lo and behold, there they were! I was able to begin using them as historical documents and that's how the project started.\u003c/p>\n\u003cp>\u003cstrong>On whether she found any patterns among the 20,000 names she discovered\u003c/strong>\u003c/p>\n\u003cp>Our team (and I should say this is the effort of a research team that includes epidemiologists, historians, digital humanists), we have a found a variety of patterns and we keep discovering more.\u003c/p>\n\u003cp>For example, we have determined that patients with Spanish surnames were much more likely to be sterilized than other patients, demonstrating that there was a racial bias in the sterilization program. We were also able to show the kinds of diagnoses that were given to patients, how that affected times of sterilization. We're able to look at age of sterilization and also patterns related to gender.\u003c/p>\n\u003cp>So there's a whole range of patterns that will help us to understand this pattern of history in California and also how it relates to national dynamics more broadly.\u003c/p>\n\u003cfigure id=\"attachment_273662\" class=\"wp-caption alignnone\" style=\"max-width: 427px\">\u003cimg src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich.jpg\" alt=\"University of Michigan professor Alex Stern has completed a database of thousands recommended for sterilization when California had eugenics laws on the book and she says those alive should be compensated.\" width=\"427\" height=\"320\" class=\"size-full wp-image-273662\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich.jpg 427w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich-160x120.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich-240x180.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich-375x281.jpg 375w\" sizes=\"(max-width: 427px) 100vw, 427px\">\u003cfigcaption class=\"wp-caption-text\">University of Michigan professor Alex Stern has completed a database of thousands recommended for sterilization when California had eugenics laws on the book and she says those alive should be compensated. \u003ccite>(Michigan Photography)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>On what Stern and her team found with regard to age and gender patterns\u003c/strong>\u003c/p>\n\u003cp>Well, we found that people were sterilized at very young ages, that really often the focus was on minors, people as young as 7. The average age of sterilization was the low 20s, so many of these people were 15, 16, 17 and 18. We also found that, as I mentioned before, that the Spanish surname individuals were more likely to be sterilized at younger ages, indicating that there was interest on behalf of the state at targeting them at lower reproductive ages. In terms of gender, that pattern that I just mentioned, pertains to women as well.\u003c/p>\n\u003cp>One of the interesting things that we discovered is that initially, more men were sterilized. It started off as sterilization in general and across the country and in California, focused more on men in the teens and 20s and into the 30s. But by the 1930s, that pattern started to change. So by the '40s and '50s, more women were being sterilized.\u003c/p>\n\u003cp>\u003cstrong>On what kinds of \"mental diseases\" were focused on \u003c/strong>\u003c/p>\n\u003cp>It's very important to take that terminology with many historic grains of salt. If we go back in time and look at what the terms meant, it often meant people who were not conforming to societal norms, people who were poor, people who lacked education, perhaps didn't speak sufficient English to make it through school, and so on.\u003c/p>\n\u003cp>But what it meant for those who were enacting the law were people who were determined to have poor IQs, people with certain psychiatric disorders. But generally, often the way it was used was much more as a catch-all category — so people who just didn't fit, kind of like the misfits of society, so to speak. That's the way they looked at them.\u003c/p>\n\u003cp>Looking back on it, I would say that those who were institutionalized — because many more people where institutionalized than actually sterilized — was because maybe they had a psychiatric condition and they were sent to an institution as was the policy at the time in the mid-20th century. ...\u003c/p>\n\u003cp>But for the most part, this program of eugenics ... the idea of sterilization was to eradicate certain genes from the population.\u003c/p>\n\u003cp>\u003cstrong>On whether anyone among those who were sterilized are still alive\u003c/strong>\u003c/p>\n\u003cp>I haven't found anyone who's still alive. I have been contacted by relatives ... people who contacted me whose aunts or uncles were sterilized at some of these institutions. In the recent paper that my team published, we determined through statistical analysis that it is likely that slightly over 800 people, about 500 women and 300 men, are alive today.\u003c/p>\n\u003cp>Those numbers don't map on to exact people, they don't correspond to a precise person. But what we've done, we've generated the most reliable estimates, and based on that estimate and also looking at the timing, we estimate that the majority of these people were sterilized between 1945 and 1949 and their average age is about 88, so fairly old.\u003c/p>\n\u003cp>So what we could do is we could go and look at the records. And that's where I'd like to work with the state of California, because we've essentially created a eugenics registry. We can look at the records and identify likely individuals and then reach out and contact them.\u003c/p>\n\u003cp>I, however, would like to mention that two states that have enacted policies for monetary reparations for sterilization victims — North Carolina and Virginia — the states have to lead in kind of creating a committee and a registry. And because it was the state seeking to provide some type of redress and acknowledge this history, the state was able to actively set up a program and seek out and try to identify individuals. So they would come to the state and they would confirm through documentation that they had been sterilized and then receive recognition and monetary compensation.\u003c/p>\n\u003cp>\u003cstrong>On if there are indications that California is interested in compensating victims of sterilization\u003c/strong>\u003c/p>\n\u003cp>There's indication that the state is interested in this history and is aware of possibility of sterilization abuse. Just three years ago, news broke that about 150 women in two California women's prisons \u003ca href=\"http://www.npr.org/2013/09/20/219366146/calif-seeks-answers-on-questionable-prison-sterilizations\">had been sterilized\u003c/a> without proper consent and proper procedure. That resulted in a state audit in the interest of the state legislators and eventually, a law that was unanimously passed, banning sterilizations except under extreme medical circumstances in California state prisons. So this issue is on the radar screen.\u003c/p>\n\u003cp>It's easy to forget about these patients who were in these remote institutions in the 1940s and '50s in California. However, I think it behooves the state to not forget this history, and all of us to not forget this history. So hopefully, having this fairly solid number that we've generated of an estimate of likely living survivors could help facilitate that process. ...\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>It would also be a good idea to think about other forms of recognition of this historical injustice. For example, putting up a historical plaque in Sacramento somewhere to recognize those who were sterilized, or at one of the institutions such as the Sonoma State Home or the Patton State Home, making sure this history is included in K-12 curriculum. \u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. \u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=On+A+%27Eugenics+Registry%2C%27+A+Record+Of+California%27s+Thousands+Of+Sterilizations&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>There's a grim chapter in American history that involves forced sterilization. And for much of this past century, California had one of the most active sterilization programs in the country.\u003c/p>\n\u003cp>A state law from 1909 authorized the surgery for people judged to have \"mental disease, which may have been inherited.\" That law remained on the books until 1979.\u003c/p>\n\u003cp>University of Michigan professor Alexandra Minna Stern has been working to identify people who were forcibly sterilized under California's program. NPR's Ailsa Chang spoke with Stern, who said this idea of eugenics was intended to \"eradicate certain genes from the population.\"\u003c/p>\n\u003cp>The professor describes the program as a historic injustice and called for the state of California to compensate surviving victims of sterilization of relatives of those who are now deceased.\u003c/p>\n\u003cp>\u003cem>The interview highlights contain some extra content that did not air in the broadcast version.\u003c/em>\u003c/p>\n\u003chr>\n\u003ch3>Interview highlights\u003c/h3>\n\u003cp>\u003cstrong>On how she found the names of all the victims \u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The names are located in 19 microfilm reels that I happened upon while doing research in Sacramento about seven years ago.\u003c/p>\n\u003cp>\u003cstrong>On what made her look at the microfilms\u003c/strong>\u003c/p>\n\u003cp>I've written a book on the history of eugenics in California. But at that point, I still knew very little about the sterilizations themselves; who was sterilized, where did all of the sterilizations take place, how is the policy enacted?\u003c/p>\n\u003cp>So I did a bit of sleuthing and went to the actual departments themselves — the department of mental health in this case, in Sacramento — and was fortunate that someone there directed me to some file cabinets that contained microfilm reels with materials that had been microfilmed over the course of the '60s and '70s.\u003c/p>\n\u003cp>And lo and behold, there they were! I was able to begin using them as historical documents and that's how the project started.\u003c/p>\n\u003cp>\u003cstrong>On whether she found any patterns among the 20,000 names she discovered\u003c/strong>\u003c/p>\n\u003cp>Our team (and I should say this is the effort of a research team that includes epidemiologists, historians, digital humanists), we have a found a variety of patterns and we keep discovering more.\u003c/p>\n\u003cp>For example, we have determined that patients with Spanish surnames were much more likely to be sterilized than other patients, demonstrating that there was a racial bias in the sterilization program. We were also able to show the kinds of diagnoses that were given to patients, how that affected times of sterilization. We're able to look at age of sterilization and also patterns related to gender.\u003c/p>\n\u003cp>So there's a whole range of patterns that will help us to understand this pattern of history in California and also how it relates to national dynamics more broadly.\u003c/p>\n\u003cfigure id=\"attachment_273662\" class=\"wp-caption alignnone\" style=\"max-width: 427px\">\u003cimg src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich.jpg\" alt=\"University of Michigan professor Alex Stern has completed a database of thousands recommended for sterilization when California had eugenics laws on the book and she says those alive should be compensated.\" width=\"427\" height=\"320\" class=\"size-full wp-image-273662\" srcset=\"https://ww2.kqed.org/app/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich.jpg 427w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich-160x120.jpg 160w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich-240x180.jpg 240w, https://ww2.kqed.org/app/uploads/sites/27/2016/12/Alex-Stern-U.-of-Mich-375x281.jpg 375w\" sizes=\"(max-width: 427px) 100vw, 427px\">\u003cfigcaption class=\"wp-caption-text\">University of Michigan professor Alex Stern has completed a database of thousands recommended for sterilization when California had eugenics laws on the book and she says those alive should be compensated. \u003ccite>(Michigan Photography)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>On what Stern and her team found with regard to age and gender patterns\u003c/strong>\u003c/p>\n\u003cp>Well, we found that people were sterilized at very young ages, that really often the focus was on minors, people as young as 7. The average age of sterilization was the low 20s, so many of these people were 15, 16, 17 and 18. We also found that, as I mentioned before, that the Spanish surname individuals were more likely to be sterilized at younger ages, indicating that there was interest on behalf of the state at targeting them at lower reproductive ages. In terms of gender, that pattern that I just mentioned, pertains to women as well.\u003c/p>\n\u003cp>One of the interesting things that we discovered is that initially, more men were sterilized. It started off as sterilization in general and across the country and in California, focused more on men in the teens and 20s and into the 30s. But by the 1930s, that pattern started to change. So by the '40s and '50s, more women were being sterilized.\u003c/p>\n\u003cp>\u003cstrong>On what kinds of \"mental diseases\" were focused on \u003c/strong>\u003c/p>\n\u003cp>It's very important to take that terminology with many historic grains of salt. If we go back in time and look at what the terms meant, it often meant people who were not conforming to societal norms, people who were poor, people who lacked education, perhaps didn't speak sufficient English to make it through school, and so on.\u003c/p>\n\u003cp>But what it meant for those who were enacting the law were people who were determined to have poor IQs, people with certain psychiatric disorders. But generally, often the way it was used was much more as a catch-all category — so people who just didn't fit, kind of like the misfits of society, so to speak. That's the way they looked at them.\u003c/p>\n\u003cp>Looking back on it, I would say that those who were institutionalized — because many more people where institutionalized than actually sterilized — was because maybe they had a psychiatric condition and they were sent to an institution as was the policy at the time in the mid-20th century. ...\u003c/p>\n\u003cp>But for the most part, this program of eugenics ... the idea of sterilization was to eradicate certain genes from the population.\u003c/p>\n\u003cp>\u003cstrong>On whether anyone among those who were sterilized are still alive\u003c/strong>\u003c/p>\n\u003cp>I haven't found anyone who's still alive. I have been contacted by relatives ... people who contacted me whose aunts or uncles were sterilized at some of these institutions. In the recent paper that my team published, we determined through statistical analysis that it is likely that slightly over 800 people, about 500 women and 300 men, are alive today.\u003c/p>\n\u003cp>Those numbers don't map on to exact people, they don't correspond to a precise person. But what we've done, we've generated the most reliable estimates, and based on that estimate and also looking at the timing, we estimate that the majority of these people were sterilized between 1945 and 1949 and their average age is about 88, so fairly old.\u003c/p>\n\u003cp>So what we could do is we could go and look at the records. And that's where I'd like to work with the state of California, because we've essentially created a eugenics registry. We can look at the records and identify likely individuals and then reach out and contact them.\u003c/p>\n\u003cp>I, however, would like to mention that two states that have enacted policies for monetary reparations for sterilization victims — North Carolina and Virginia — the states have to lead in kind of creating a committee and a registry. And because it was the state seeking to provide some type of redress and acknowledge this history, the state was able to actively set up a program and seek out and try to identify individuals. So they would come to the state and they would confirm through documentation that they had been sterilized and then receive recognition and monetary compensation.\u003c/p>\n\u003cp>\u003cstrong>On if there are indications that California is interested in compensating victims of sterilization\u003c/strong>\u003c/p>\n\u003cp>There's indication that the state is interested in this history and is aware of possibility of sterilization abuse. Just three years ago, news broke that about 150 women in two California women's prisons \u003ca href=\"http://www.npr.org/2013/09/20/219366146/calif-seeks-answers-on-questionable-prison-sterilizations\">had been sterilized\u003c/a> without proper consent and proper procedure. That resulted in a state audit in the interest of the state legislators and eventually, a law that was unanimously passed, banning sterilizations except under extreme medical circumstances in California state prisons. So this issue is on the radar screen.\u003c/p>\n\u003cp>It's easy to forget about these patients who were in these remote institutions in the 1940s and '50s in California. However, I think it behooves the state to not forget this history, and all of us to not forget this history. So hopefully, having this fairly solid number that we've generated of an estimate of likely living survivors could help facilitate that process. ...\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>It would also be a good idea to think about other forms of recognition of this historical injustice. For example, putting up a historical plaque in Sacramento somewhere to recognize those who were sterilized, or at one of the institutions such as the Sonoma State Home or the Patton State Home, making sure this history is included in K-12 curriculum. \u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. \u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=On+A+%27Eugenics+Registry%2C%27+A+Record+Of+California%27s+Thousands+Of+Sterilizations&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Leading the Way? Northern California Cities to Embark on Soda Tax Spending",
"title": "Leading the Way? Northern California Cities to Embark on Soda Tax Spending",
"headTitle": "Kaiser Health News | State of Health | KQED News",
"content": "\u003cp>Asian Health Services, a community health center in Oakland’s buzzing Chinatown, sees about 6,000 dental patients a year. Hundreds of others are on a waiting list.\u003c/p>\n\u003cp>“We simply cannot meet the demand,” said Dr. Huong Le, the center’s dental director.\u003c/p>\n\u003cp>But now that voters have passed soda taxes in Oakland, Albany and San Francisco, Le and other Bay Area health providers are eyeing millions of dollars in revenue that could help more patients prevent obesity and dental decay.\u003c/p>\n\u003cp>The San Francisco Bay Area is trying to lead the way in putting soda tax revenues to good use, and cities around the country are watching closely. Some are considering soda taxes of their own.\u003c/p>\n\u003cp>“Soda taxes are going to be spreading like wildfire,” said Harold Goldstein, executive director of the Davis-based nonprofit Public Health Advocates.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The city of Berkeley, also in Alameda County, passed the \u003ca href=\"http://californiahealthline.org/news/is-berkeleys-new-soda-tax-a-tipping-point-or-an-outlie/\" target=\"_blank\">nation’s first such tax \u003c/a>in 2014.\u003c/p>\n\u003cp>In San Francisco, the tax, which takes effect Jan. 1, 2018, is expected to raise up to $15 million annually. Meanwhile in the smaller city of Albany, the tax took effect immediately and is projected to garner $223,000 each year. In Oakland, the penny-per-ounce tax on the distribution of sugar-sweetened beverages is projected to bring in up to $8 million each year, some of which will be used for health education and prevention programs in schools and the community. It takes effect in July.\u003c/p>\n\u003cp>“We felt this was very important because of the dental needs we see within our patient population,” Le said. “We know there’s a strong link between tooth decay and sugary beverages.”\u003c/p>\n\u003cp>The link between sugary beverages and obesity, diabetes and tooth decay is well-established. People who drink one or two cans of sugary drinks per day have a 26 percent greater risk of developing type 2 diabetes, according to one \u003ca href=\"https://www.hsph.harvard.edu/nutritionsource/sugary-drinks-fact-sheet/\" target=\"_blank\">study\u003c/a> by the Harvard School of Public Health.\u003c/p>\n\u003cp>A separate study found that for every 12-ounce soda consumed by a child each day, their odds of becoming obese increased by \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/11229668\" target=\"_blank\">60 percent\u003c/a>. Soda also has been tied to dental erosion which can lead to cavities, according a \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2676420/\" target=\"_blank\">2009 study\u003c/a>. The most frequent sources of erosive acids are soft drinks like cola, the study found.\u003c/p>\n\u003cp>In a report earlier this this year, an oversight commission criticized the state’s dental program for the poor, finding that California is seeing an “epidemic of tooth disease in which toddlers by the thousands have mouthfuls of cavities, children and adults are plagued with toothaches.” This is made worse when families struggle to get an appointment with a dentist, the report said.\u003c/p>\n\u003cp>In Oakland and the rest of Alameda County, \u003ca href=\"http://www.acgov.org/board/bos_calendar/documents/DocsAgendaReg_7_14_14/HEALTH%20CARE%20SERVICES/Regular%20Calendar/Alameda_County_Report_Exec_Summ_Obesity_Rpt.pdf\" target=\"_blank\">one third\u003c/a> of children consume one or more sugary drinks a day.\u003c/p>\n\u003cp>Oakland’s city council will establish a community advisory board to oversee the distribution of soda tax money, and local health advocates want to make sure they’re well-represented, Le said.\u003c/p>\n\u003cp>\u003ca href=\"http://khn.org/news/soda-taxes-gaining-steam-or-getting-steamrolled/\" target=\"_blank\">Goldstein\u003c/a> said the fact that measures recently passed in all three Bay Area cities by a notable margin — in Oakland the tax was approved with 61 percent of the vote — shows that Californians grasp the harmful effects of sugary drinks.\u003c/p>\n\u003cp>Soda taxes, he said, are significant because they raise money to be used in the fight against obesity and other chronic conditions, and they reduce the consumption of sugary drinks.\u003c/p>\n\u003cp>In Berkeley’s low-income neighborhoods, the consumption of soda and other sweetened beverages decreased by 21 percent in the months after the 2014 tax began, according to a \u003ca href=\"http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2016.303362\" target=\"_blank\">UC Berkeley study\u003c/a>.\u003c/p>\n\u003cp>The study also showed a 63 percent increase in the consumption of bottled or tap water. It is not clear whether these results are due to the higher retail prices of sugary drinks or to the increased awareness on the health effects associated with the beverages, the study notes.\u003c/p>\n\u003cp>Goldstein said similar outcomes can be expected in Oakland, San Francisco and Albany, as well as in Boulder, Colo., where voters also passed a similar tax in November. This drives up the total number of cities with soda taxes to six — Philadelphia passed a 1.5 cents-per-ounce tax in June.\u003c/p>\n\u003cp>The American Beverage Association, which has lobbied heavily against soda taxes nationwide, doesn’t see a movement. Spokeswoman Lauren Kane said that \u003ca href=\"http://www.reuters.com/article/us-beverages-sodatax-bloomberg-idUSKCN0Z3275\" target=\"_blank\">43 soda tax proposals have been rejected \u003c/a>since 2008.\u003c/p>\n\u003cp>The association will continue to focus on reducing calories and sugar in beverages, Kane said. These taxes, Kane said, are only a Band-Aid solution to the larger national obesity problem.\u003c/p>\n\u003cp>But they are a start, said Elizabeth Bautista, a health educator at La Clinica, a health center in Oakland’s Fruitvale neighborhood, home to the city’ largest Latino population.\u003c/p>\n\u003cp>Bautista and 15 volunteer health educators known as promotoras engaged their community in the soda tax discussion by going door-to-door and making hundreds of calls to registered voters.\u003c/p>\n\u003cp>The challenge now, Bautista said, is to continue to motivate people to choose alternatives to sugary drinks.\u003c/p>\n\u003cp>The promotoras often share stories of what they see in the field: toddlers with soda in their bottles, and families walking out of dollar stores with grocery bags full of juices and sports drinks.\u003c/p>\n\u003cp>“It’s a serious problem in our community, and there is so much misinformation floating around,” Bautista said. She often hears from families that fruit-flavored sodas are not as harmful as dark sodas. “That of course is not true; that’s a myth we have to eliminate,” she said.\u003c/p>\n\u003cp>Maria Reyes, one of the promotoras, said the clinic is starting additional nutrition and physical activity classes — a healthy cooking class, for example, is expected to be of great interest. These are the type of activities that could be expanded by funds from the soda tax, Reyes said.\u003c/p>\n\u003cp>Reyes believes soda tax advocates in Oakland learned a lot from battles lost in other California cities, such as Richmond and El Monte, where voters rejected soda taxes in 2012.\u003c/p>\n\u003cp>“We learned that we needed a coalition and that we needed to focus the discussion on diabetes and obesity prevention,” Reyes said.\u003c/p>\n\u003cp>The promotoras say they are now hearing from community groups in Contra Costa cities interested in following in their footsteps.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>“This is a big win,” Reyes said. “Once we start seeing results, I think more cities will join us.”\u003cbr>\n\u003cem>\u003cbr>\nThis story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\">Kaiser Health News\u003c/a>, which publishes \u003ca href=\"http://californiahealthline.org/\" target=\"_blank\">California Healthline\u003c/a>, an editorially independent service of the \u003ca href=\"http://www.chcf.org/\" target=\"_blank\">California Health Care Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Asian Health Services, a community health center in Oakland’s buzzing Chinatown, sees about 6,000 dental patients a year. Hundreds of others are on a waiting list.\u003c/p>\n\u003cp>“We simply cannot meet the demand,” said Dr. Huong Le, the center’s dental director.\u003c/p>\n\u003cp>But now that voters have passed soda taxes in Oakland, Albany and San Francisco, Le and other Bay Area health providers are eyeing millions of dollars in revenue that could help more patients prevent obesity and dental decay.\u003c/p>\n\u003cp>The San Francisco Bay Area is trying to lead the way in putting soda tax revenues to good use, and cities around the country are watching closely. Some are considering soda taxes of their own.\u003c/p>\n\u003cp>“Soda taxes are going to be spreading like wildfire,” said Harold Goldstein, executive director of the Davis-based nonprofit Public Health Advocates.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The city of Berkeley, also in Alameda County, passed the \u003ca href=\"http://californiahealthline.org/news/is-berkeleys-new-soda-tax-a-tipping-point-or-an-outlie/\" target=\"_blank\">nation’s first such tax \u003c/a>in 2014.\u003c/p>\n\u003cp>In San Francisco, the tax, which takes effect Jan. 1, 2018, is expected to raise up to $15 million annually. Meanwhile in the smaller city of Albany, the tax took effect immediately and is projected to garner $223,000 each year. In Oakland, the penny-per-ounce tax on the distribution of sugar-sweetened beverages is projected to bring in up to $8 million each year, some of which will be used for health education and prevention programs in schools and the community. It takes effect in July.\u003c/p>\n\u003cp>“We felt this was very important because of the dental needs we see within our patient population,” Le said. “We know there’s a strong link between tooth decay and sugary beverages.”\u003c/p>\n\u003cp>The link between sugary beverages and obesity, diabetes and tooth decay is well-established. People who drink one or two cans of sugary drinks per day have a 26 percent greater risk of developing type 2 diabetes, according to one \u003ca href=\"https://www.hsph.harvard.edu/nutritionsource/sugary-drinks-fact-sheet/\" target=\"_blank\">study\u003c/a> by the Harvard School of Public Health.\u003c/p>\n\u003cp>A separate study found that for every 12-ounce soda consumed by a child each day, their odds of becoming obese increased by \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/11229668\" target=\"_blank\">60 percent\u003c/a>. Soda also has been tied to dental erosion which can lead to cavities, according a \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2676420/\" target=\"_blank\">2009 study\u003c/a>. The most frequent sources of erosive acids are soft drinks like cola, the study found.\u003c/p>\n\u003cp>In a report earlier this this year, an oversight commission criticized the state’s dental program for the poor, finding that California is seeing an “epidemic of tooth disease in which toddlers by the thousands have mouthfuls of cavities, children and adults are plagued with toothaches.” This is made worse when families struggle to get an appointment with a dentist, the report said.\u003c/p>\n\u003cp>In Oakland and the rest of Alameda County, \u003ca href=\"http://www.acgov.org/board/bos_calendar/documents/DocsAgendaReg_7_14_14/HEALTH%20CARE%20SERVICES/Regular%20Calendar/Alameda_County_Report_Exec_Summ_Obesity_Rpt.pdf\" target=\"_blank\">one third\u003c/a> of children consume one or more sugary drinks a day.\u003c/p>\n\u003cp>Oakland’s city council will establish a community advisory board to oversee the distribution of soda tax money, and local health advocates want to make sure they’re well-represented, Le said.\u003c/p>\n\u003cp>\u003ca href=\"http://khn.org/news/soda-taxes-gaining-steam-or-getting-steamrolled/\" target=\"_blank\">Goldstein\u003c/a> said the fact that measures recently passed in all three Bay Area cities by a notable margin — in Oakland the tax was approved with 61 percent of the vote — shows that Californians grasp the harmful effects of sugary drinks.\u003c/p>\n\u003cp>Soda taxes, he said, are significant because they raise money to be used in the fight against obesity and other chronic conditions, and they reduce the consumption of sugary drinks.\u003c/p>\n\u003cp>In Berkeley’s low-income neighborhoods, the consumption of soda and other sweetened beverages decreased by 21 percent in the months after the 2014 tax began, according to a \u003ca href=\"http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2016.303362\" target=\"_blank\">UC Berkeley study\u003c/a>.\u003c/p>\n\u003cp>The study also showed a 63 percent increase in the consumption of bottled or tap water. It is not clear whether these results are due to the higher retail prices of sugary drinks or to the increased awareness on the health effects associated with the beverages, the study notes.\u003c/p>\n\u003cp>Goldstein said similar outcomes can be expected in Oakland, San Francisco and Albany, as well as in Boulder, Colo., where voters also passed a similar tax in November. This drives up the total number of cities with soda taxes to six — Philadelphia passed a 1.5 cents-per-ounce tax in June.\u003c/p>\n\u003cp>The American Beverage Association, which has lobbied heavily against soda taxes nationwide, doesn’t see a movement. Spokeswoman Lauren Kane said that \u003ca href=\"http://www.reuters.com/article/us-beverages-sodatax-bloomberg-idUSKCN0Z3275\" target=\"_blank\">43 soda tax proposals have been rejected \u003c/a>since 2008.\u003c/p>\n\u003cp>The association will continue to focus on reducing calories and sugar in beverages, Kane said. These taxes, Kane said, are only a Band-Aid solution to the larger national obesity problem.\u003c/p>\n\u003cp>But they are a start, said Elizabeth Bautista, a health educator at La Clinica, a health center in Oakland’s Fruitvale neighborhood, home to the city’ largest Latino population.\u003c/p>\n\u003cp>Bautista and 15 volunteer health educators known as promotoras engaged their community in the soda tax discussion by going door-to-door and making hundreds of calls to registered voters.\u003c/p>\n\u003cp>The challenge now, Bautista said, is to continue to motivate people to choose alternatives to sugary drinks.\u003c/p>\n\u003cp>The promotoras often share stories of what they see in the field: toddlers with soda in their bottles, and families walking out of dollar stores with grocery bags full of juices and sports drinks.\u003c/p>\n\u003cp>“It’s a serious problem in our community, and there is so much misinformation floating around,” Bautista said. She often hears from families that fruit-flavored sodas are not as harmful as dark sodas. “That of course is not true; that’s a myth we have to eliminate,” she said.\u003c/p>\n\u003cp>Maria Reyes, one of the promotoras, said the clinic is starting additional nutrition and physical activity classes — a healthy cooking class, for example, is expected to be of great interest. These are the type of activities that could be expanded by funds from the soda tax, Reyes said.\u003c/p>\n\u003cp>Reyes believes soda tax advocates in Oakland learned a lot from battles lost in other California cities, such as Richmond and El Monte, where voters rejected soda taxes in 2012.\u003c/p>\n\u003cp>“We learned that we needed a coalition and that we needed to focus the discussion on diabetes and obesity prevention,” Reyes said.\u003c/p>\n\u003cp>The promotoras say they are now hearing from community groups in Contra Costa cities interested in following in their footsteps.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“This is a big win,” Reyes said. “Once we start seeing results, I think more cities will join us.”\u003cbr>\n\u003cem>\u003cbr>\nThis story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\">Kaiser Health News\u003c/a>, which publishes \u003ca href=\"http://californiahealthline.org/\" target=\"_blank\">California Healthline\u003c/a>, an editorially independent service of the \u003ca href=\"http://www.chcf.org/\" target=\"_blank\">California Health Care Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "The Future of California's Seniors: More Diverse, But More Disabled Too",
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"content": "\u003cp>The number of seniors in California is expected to more than double by 2060, from roughly 5 million to 12 million. A new report from the \u003ca href=\"http://www.lao.ca.gov/\" target=\"_blank\">Legislative Analyst's Office \u003c/a>says this future senior population will be more racially diverse than seniors in the U.S. as a whole: the state's elderly population is projected to become majority nonwhite as soon as 2030.\u003c/p>\n\u003cp>The proportion of these future seniors who are disabled will also increase. That's because nonwhite populations have higher disability rates. Seniors are also expected to live longer, and seniors over age 85 experience higher disability rates as well.\u003c/p>\n\u003cp>Eventually, this will present new and difficult challenges for California in providing long-term care for these seniors, the report concludes.\u003c/p>\n\u003cp>The report explains that:\u003c/p>\n\u003cul>\n\u003cli>Seniors are now about 13 percent of the state population. By 2060, they will be 24 percent.\u003c/li>\n\u003cli>California's Medicaid program, \u003ca href=\"http://www.coveredca.com/medi-cal/\" target=\"_blank\">Medi-Cal\u003c/a>, already spends $14 billion a year on disability services (for all ages). The federal government picks up about half of this cost.\u003c/li>\n\u003cli>Education matters: More educated seniors experience less disability as they age, and educational levels among California seniors are projected to increase over time, which will somewhat offset the impact of other disabling factors.\u003c/li>\n\u003cli>Unpaid caregivers will be crucial: There will be fewer working-age adults per senior in California in the future, so non-disabled seniors may be tapped to do more to care for their disabled counterparts.\u003c/li>\n\u003c/ul>\n\u003cp>The report merely lays out the problem -- there's no conjecture on what the financial impact will be for Medi-Cal or the state. \"Such projections are not available at this time,\" the report's author, \u003ca href=\"http://www.lao.ca.gov/staff/AssignmentDetail/11\" target=\"_blank\">Mac Taylor\u003c/a>, concludes, although he might look into it someday, \"subject to available data.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>[scribd id=332689844 key=key-6N5mtis3iWAZmjsZ12Le mode=scroll]\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The number of seniors in California is expected to more than double by 2060, from roughly 5 million to 12 million. A new report from the \u003ca href=\"http://www.lao.ca.gov/\" target=\"_blank\">Legislative Analyst's Office \u003c/a>says this future senior population will be more racially diverse than seniors in the U.S. as a whole: the state's elderly population is projected to become majority nonwhite as soon as 2030.\u003c/p>\n\u003cp>The proportion of these future seniors who are disabled will also increase. That's because nonwhite populations have higher disability rates. Seniors are also expected to live longer, and seniors over age 85 experience higher disability rates as well.\u003c/p>\n\u003cp>Eventually, this will present new and difficult challenges for California in providing long-term care for these seniors, the report concludes.\u003c/p>\n\u003cp>The report explains that:\u003c/p>\n\u003cul>\n\u003cli>Seniors are now about 13 percent of the state population. By 2060, they will be 24 percent.\u003c/li>\n\u003cli>California's Medicaid program, \u003ca href=\"http://www.coveredca.com/medi-cal/\" target=\"_blank\">Medi-Cal\u003c/a>, already spends $14 billion a year on disability services (for all ages). The federal government picks up about half of this cost.\u003c/li>\n\u003cli>Education matters: More educated seniors experience less disability as they age, and educational levels among California seniors are projected to increase over time, which will somewhat offset the impact of other disabling factors.\u003c/li>\n\u003cli>Unpaid caregivers will be crucial: There will be fewer working-age adults per senior in California in the future, so non-disabled seniors may be tapped to do more to care for their disabled counterparts.\u003c/li>\n\u003c/ul>\n\u003cp>The report merely lays out the problem -- there's no conjecture on what the financial impact will be for Medi-Cal or the state. \"Such projections are not available at this time,\" the report's author, \u003ca href=\"http://www.lao.ca.gov/staff/AssignmentDetail/11\" target=\"_blank\">Mac Taylor\u003c/a>, concludes, although he might look into it someday, \"subject to available data.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
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"tagline": "Art is where you find it",
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"soldout": {
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"info": "The TED Radio Hour is a journey through fascinating ideas, astonishing inventions, fresh approaches to old problems, and new ways to think and create.",
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