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"content": "\u003cp>Jay Zimmerman got his first BB gun when he was seven, and his first shotgun when he was ten.\u003c/p>\n\u003cp>“Growing up in Appalachia, you look forward to getting your first firearm probably more so than your first car,” he says.\u003c/p>\n\u003cp>His grandfather taught him to hunt squirrel and quail. Zimmerman, who lives in Tennessee, says pretty much everyone he knows has a gun. It’s just part of the culture.\u003c/p>\n\u003cp>“When I went into the military, that culture was reinforced,” he says. “Your weapon is almost another appendage. It’s part of who you are.”\u003c/p>\n\u003cp>[soundcloud url=\"https://api.soundcloud.com/tracks/305633357\" 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>Zimmerman was a medic in the army in the late 1990s and early 2000s. He served in Bosnia, Africa, and the Middle East. Since he came home, he’s struggled with PTSD and depression. It reached a crisis point a few years ago, when his best friend -- the guy who had saved his life in a combat zone -- killed himself. Zimmerman decided his time was up too.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“I decided that I would have one more birthday with my daughter, one more Christmas with my daughter,” he says. “I had devised my own exit strategy for sixteen February, 2013.”\u003c/p>\n\u003cp>But then he bumped into a woman who used to ride the same school bus when they were kids. His exit date came and went. They’re married now.\u003c/p>\n\u003cp>Zimmerman is a peer counselor at the \u003ca href=\"http://Mountain%20Home%20VA%20Medical%20Center\" target=\"_blank\">Mountain Home VA Medical Center\u003c/a> in Johnson City, Tennessee. He also travels to conferences all over the country, sharing his story with therapists and with other vets. He tries to set an example that it’s okay to ask for help. Even today, if he’s not doing well, he disassembles his guns and stores them separately from ammunition, so he can’t make any rash decisions. If things get really bad, Zimmerman has a special arrangement with a few friends.\u003c/p>\n\u003cp>“I call them and say, 'Look, I’m feeling like it’s not safe for me to have firearms in my home. Can you store them for me for a couple days till I feel like I’m OK to have them back?'\"\u003c/p>\n\u003cfigure id=\"attachment_274997\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-274997\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Jay-Zimmerman-in-uniform-and-dad-800x600.jpg\" alt=\"Jay Zimmerman (right) was an army medic. He poses with his dad before he deployed to Bosnia in 1998.\" width=\"800\" height=\"600\">\u003cfigcaption class=\"wp-caption-text\">Jay Zimmerman (right) was an army medic. He poses with his dad before he deployed to Bosnia in 1998. \u003ccite>(Photo Courtesy of Jay Zimmerman)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Suicide is an impulsive act. Nearly half the people who survive an attempt say the time between their first thought of suicide and the attempt itself was less than 10 minutes. But the method can mean the difference between life and death: people who take pills have time to change their minds. Not with guns.\u003c/p>\n\u003cp>About 70 percent of veterans who commit suicide do so with a gun, which prompted President Barack Obama to order the VA to talk to vets about gun safety and storage options like the ones Zimmerman uses.\u003c/p>\n\u003cp>But here’s the trouble: Most therapists aren’t gun people. They don’t know how to talk about guns. And so they don’t.\u003c/p>\n\u003cp>“One obvious reason for that is that no one has taught them how,” explained Megan McCarthy, National Deputy Director in the Office for Suicide Prevention at the Department of Veterans Affairs.\u003c/p>\n\u003cp>McCarthy was invited to speak recently at a suicide-prevention conference in San Francisco for therapists who work with vets.\u003c/p>\n\u003cp>“How many of you would say you feel really comfortable having a conversation with any of the people you work with about limiting access to all lethal means?” she asked the roomful of therapists.\u003c/p>\n\u003cp>Hardly anyone raised their hand.\u003c/p>\n\u003cp>“Okay, so that’s why we’re here today,” she said.\u003c/p>\n\u003cp>Researchers recommend starting with a field trip to a shooting range. There, therapists can learn about different kinds of firearms, as well as gun locks, and get an introduction to gun culture.\u003c/p>\n\u003cp>When counseling vets, therapists have to ask more questions and be less directive, according to McCarthy.\u003c/p>\n\u003cp>“We often conceive of ourselves as experts, as people who impart information to clients,” she said. But with vets, \"it may take time to build trust. Telling them what to do the first time you’ve met them is probably not going to be a very effective approach.”\u003c/p>\n\u003cfigure id=\"attachment_275001\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003cimg class=\"size-full wp-image-275001\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/AFSP.VAConference-Audience-1-e1482453949563.jpg\" alt=\"Therapists learn how to talk to vets about guns at a conference in San Francisco.\" width=\"640\" height=\"480\">\u003cfigcaption class=\"wp-caption-text\">Therapists learn how to talk to vets about guns at a conference in San Francisco.\u003c/figcaption>\u003c/figure>\n\u003cp> \u003c/p>\n\u003cp>McCarthy presented a case study at the conference: A 28-year old army veteran who fought in Iraq told his VA psychiatrist that he had an argument with his girlfriend last week. He drove to an empty parking lot and sat with his loaded handgun in his lap, intending to kill himself.\u003c/p>\n\u003cp>He didn’t do it. A week later, the man told his psychiatrist things were still tense with his girlfriend. But he didn’t want to talk about suicide or storing his gun.\u003c/p>\n\u003cp>McCarthy asked the clinicians in the audience what they would do next, if they were this man’s psychiatrist.\u003c/p>\n\u003cp>“Why did he not do it? That would be my question,” said one therapist.\u003c/p>\n\u003cp>“I’d say, would you be willing to talk more about that?” said another.\u003c/p>\n\u003cp>“I would want to see this individual again, within the same week,” said a third. “I believe in strong intervention.”\u003c/p>\n\u003cp>Jay Zimmerman, the former army medic and peer counselor, stood up. He told them they’re all wrong.\u003c/p>\n\u003cp>“Chances are the reason he’s not talking to you is because he’s afraid he’s going to lose his gun, that he carries pretty much all the time,” he said. “My buddies are the same way, we all carry all the time.”\u003c/p>\n\u003cp>Zimmerman said the vet in the case study would rather talk to someone like him than someone in a white coat.\u003c/p>\n\u003cp>“If he’s got that good relationship with me as a peer, as a buddy, he’s probably already called me and talked to me,” he explained.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>The takeaway for psychologists at the San Francisco conference, McCarthy said, is that sometimes their role is not to intervene, but to be a facilitator, someone who can connect vets with peer counselors like Zimmerman, or suggest they talk with a buddy, not always a professional.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Jay Zimmerman got his first BB gun when he was seven, and his first shotgun when he was ten.\u003c/p>\n\u003cp>“Growing up in Appalachia, you look forward to getting your first firearm probably more so than your first car,” he says.\u003c/p>\n\u003cp>His grandfather taught him to hunt squirrel and quail. Zimmerman, who lives in Tennessee, says pretty much everyone he knows has a gun. It’s just part of the culture.\u003c/p>\n\u003cp>“When I went into the military, that culture was reinforced,” he says. “Your weapon is almost another appendage. It’s part of who you are.”\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/305633357&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/305633357'>\n \u003c/iframe>\n \u003c/div>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Zimmerman was a medic in the army in the late 1990s and early 2000s. He served in Bosnia, Africa, and the Middle East. Since he came home, he’s struggled with PTSD and depression. It reached a crisis point a few years ago, when his best friend -- the guy who had saved his life in a combat zone -- killed himself. Zimmerman decided his time was up too.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“I decided that I would have one more birthday with my daughter, one more Christmas with my daughter,” he says. “I had devised my own exit strategy for sixteen February, 2013.”\u003c/p>\n\u003cp>But then he bumped into a woman who used to ride the same school bus when they were kids. His exit date came and went. They’re married now.\u003c/p>\n\u003cp>Zimmerman is a peer counselor at the \u003ca href=\"http://Mountain%20Home%20VA%20Medical%20Center\" target=\"_blank\">Mountain Home VA Medical Center\u003c/a> in Johnson City, Tennessee. He also travels to conferences all over the country, sharing his story with therapists and with other vets. He tries to set an example that it’s okay to ask for help. Even today, if he’s not doing well, he disassembles his guns and stores them separately from ammunition, so he can’t make any rash decisions. If things get really bad, Zimmerman has a special arrangement with a few friends.\u003c/p>\n\u003cp>“I call them and say, 'Look, I’m feeling like it’s not safe for me to have firearms in my home. Can you store them for me for a couple days till I feel like I’m OK to have them back?'\"\u003c/p>\n\u003cfigure id=\"attachment_274997\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-274997\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/Jay-Zimmerman-in-uniform-and-dad-800x600.jpg\" alt=\"Jay Zimmerman (right) was an army medic. He poses with his dad before he deployed to Bosnia in 1998.\" width=\"800\" height=\"600\">\u003cfigcaption class=\"wp-caption-text\">Jay Zimmerman (right) was an army medic. He poses with his dad before he deployed to Bosnia in 1998. \u003ccite>(Photo Courtesy of Jay Zimmerman)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Suicide is an impulsive act. Nearly half the people who survive an attempt say the time between their first thought of suicide and the attempt itself was less than 10 minutes. But the method can mean the difference between life and death: people who take pills have time to change their minds. Not with guns.\u003c/p>\n\u003cp>About 70 percent of veterans who commit suicide do so with a gun, which prompted President Barack Obama to order the VA to talk to vets about gun safety and storage options like the ones Zimmerman uses.\u003c/p>\n\u003cp>But here’s the trouble: Most therapists aren’t gun people. They don’t know how to talk about guns. And so they don’t.\u003c/p>\n\u003cp>“One obvious reason for that is that no one has taught them how,” explained Megan McCarthy, National Deputy Director in the Office for Suicide Prevention at the Department of Veterans Affairs.\u003c/p>\n\u003cp>McCarthy was invited to speak recently at a suicide-prevention conference in San Francisco for therapists who work with vets.\u003c/p>\n\u003cp>“How many of you would say you feel really comfortable having a conversation with any of the people you work with about limiting access to all lethal means?” she asked the roomful of therapists.\u003c/p>\n\u003cp>Hardly anyone raised their hand.\u003c/p>\n\u003cp>“Okay, so that’s why we’re here today,” she said.\u003c/p>\n\u003cp>Researchers recommend starting with a field trip to a shooting range. There, therapists can learn about different kinds of firearms, as well as gun locks, and get an introduction to gun culture.\u003c/p>\n\u003cp>When counseling vets, therapists have to ask more questions and be less directive, according to McCarthy.\u003c/p>\n\u003cp>“We often conceive of ourselves as experts, as people who impart information to clients,” she said. But with vets, \"it may take time to build trust. Telling them what to do the first time you’ve met them is probably not going to be a very effective approach.”\u003c/p>\n\u003cfigure id=\"attachment_275001\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003cimg class=\"size-full wp-image-275001\" src=\"http://ww2.kqed.org/stateofhealth/wp-content/uploads/sites/27/2016/12/AFSP.VAConference-Audience-1-e1482453949563.jpg\" alt=\"Therapists learn how to talk to vets about guns at a conference in San Francisco.\" width=\"640\" height=\"480\">\u003cfigcaption class=\"wp-caption-text\">Therapists learn how to talk to vets about guns at a conference in San Francisco.\u003c/figcaption>\u003c/figure>\n\u003cp> \u003c/p>\n\u003cp>McCarthy presented a case study at the conference: A 28-year old army veteran who fought in Iraq told his VA psychiatrist that he had an argument with his girlfriend last week. He drove to an empty parking lot and sat with his loaded handgun in his lap, intending to kill himself.\u003c/p>\n\u003cp>He didn’t do it. A week later, the man told his psychiatrist things were still tense with his girlfriend. But he didn’t want to talk about suicide or storing his gun.\u003c/p>\n\u003cp>McCarthy asked the clinicians in the audience what they would do next, if they were this man’s psychiatrist.\u003c/p>\n\u003cp>“Why did he not do it? That would be my question,” said one therapist.\u003c/p>\n\u003cp>“I’d say, would you be willing to talk more about that?” said another.\u003c/p>\n\u003cp>“I would want to see this individual again, within the same week,” said a third. “I believe in strong intervention.”\u003c/p>\n\u003cp>Jay Zimmerman, the former army medic and peer counselor, stood up. He told them they’re all wrong.\u003c/p>\n\u003cp>“Chances are the reason he’s not talking to you is because he’s afraid he’s going to lose his gun, that he carries pretty much all the time,” he said. “My buddies are the same way, we all carry all the time.”\u003c/p>\n\u003cp>Zimmerman said the vet in the case study would rather talk to someone like him than someone in a white coat.\u003c/p>\n\u003cp>“If he’s got that good relationship with me as a peer, as a buddy, he’s probably already called me and talked to me,” he explained.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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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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"slug": "drugmakers-manipulate-orphan-drug-rules-to-create-prized-monopolies",
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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",
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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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"disqusTitle": "Unexpected Risks Found in Procedure for 3-Person Baby",
"title": "Unexpected Risks Found in Procedure for 3-Person Baby",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>In September, reproductive endocrinologist John Zhang and his team at the New Hope Fertility Center in New York City captured the world's attention when they \u003ca href=\"http://www.npr.org/sections/thetwo-way/2016/09/27/495668299/new-york-fertility-doctor-says-he-created-baby-with-3-genetic-parents\">announced \u003c/a>the birth of a child to a mother carrying a fatal genetic defect.\u003c/p>\n\u003cp>Using a technique called \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4005369/\">mitochondrial replacement therapy\u003c/a>, the researchers combined DNA from two women and one man to bypass the defect and produce a healthy baby boy — one with, quite literally, three genetic parents.\u003c/p>\n\u003cp>It was heralded as a stunning technological leap for in vitro fertilization, albeit one that the team was forced to perform in Mexico, because the technique has not been approved in the United States.\u003c/p>\n\u003cp>The technique is spreading quickly, gaining official \u003ca href=\"https://www.theguardian.com/science/2016/dec/15/three-parent-embryos-regulator-gives-green-light-to-uk-clinics\">approval\u003c/a> this month from the Human Fertilization and Embryology Authority in the U.K. The move will allow clinics to apply for permission there to carry out the treatment, with the first patients expected to be seen as early as next year.\u003c/p>\n\u003cp>But for all the accolades, the method also has scientists concerned that the fatally flawed mitochondria can resurface to threaten a child's health.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Earlier this month, a study published in \u003ca href=\"http://www.nature.com/nature/journal/vaop/ncurrent/pdf/nature20592.pdf\">Nature\u003c/a> by \u003ca href=\"http://www.ohsu.edu/xd/research/centers-institutes/onprc/scientific-discovery/scientists/mitalipov.cfm\">Shoukhrat Mitalipov\u003c/a>, head of the Center for Embryonic Cell and Gene Therapy at the Oregon Health and Science University in Portland, suggested that in roughly 15 percent of cases, the mitochondrial replacement could fail and allow fatal defects to return, or even increase a child's vulnerability to new ailments.\u003c/p>\n\u003cp>The findings confirmed the suspicions of many researchers, and the conclusions drawn by Mitalipov and his team were unequivocal: The potential for conflicts between transplanted and original mitochondrial genomes is real, and more sophisticated matching of donor and recipient eggs — pairing mothers whose mitochondria share genetic similarities, for example — is needed to avoid potential tragedies.\u003c/p>\n\u003cp>\"This study shows the potential as well as the risks of gene therapy in the germline,\" Mitalipov says. This is especially true of mitochondria, because its genomes are so different than the genomes in the nucleus of cells. Slight variations between mitochondrial genomes, he adds, \"turn out to matter a great deal.\"\u003c/p>\n\u003cp>Mitochondria are the energy powerhouses inside our cells, and they carry their own DNA, separate from our nuclear genome.\u003c/p>\n\u003cp>The danger lies in the fact that mitochondria are in some ways like aliens inside our cells. Two billion years ago they were free-floating bacteria basking in the primordial soup. Then one such microbe merged with another free-floating bacterium, and over evolutionary time, the two formed a complete cell. The bacteria eventually evolved into mitochondria, migrating most of their genes to the cell nucleus and keeping just a few dozen, largely to help them produce energy.\u003c/p>\n\u003cp>Today, our nuclear genome contains around \u003ca href=\"https://ghr.nlm.nih.gov/primer/basics/gene\">20,000 genes,\u003c/a> while a \u003ca href=\"https://ghr.nlm.nih.gov/mitochondrial-dna\">scant 37 genes\u003c/a> reside in the mitochondria. And yet the two genomes are intensely symbiotic: 99 percent of mitochondrial proteins are incorporated from the nucleus.\u003c/p>\n\u003cp>Mitochondria also still divide and replicate like the bacteria they once were, and that constant replication means that \u003ca href=\"http://www2.le.ac.uk/departments/emfpu/genetics/explained/mitochondrial\">mutations\u003c/a> arise 10 to 30 times \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/15062813\">more often\u003c/a> in mitochondrial genes than in the nucleus. If too many mitochondria become dysfunctional, the entire cell suffers and serious health problems can result. Faulty mitochondria are implicated in genetic diseases, as well as many \u003ca href=\"http://www.mitoaction.org/mito-faq\">chronic conditions\u003c/a> from \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2922635/\">infertility\u003c/a> to cancer, cardiac disease and neurodegenerative diseases. That's because when mitochondria falter, the energy system of the cell itself is compromised.\u003c/p>\n\u003cp>A three-parent baby could solve the problem by overriding faulty mitochondria, but it also raises the stakes, because the procedure does not completely replace the defective mitochondria with healthy ones.\u003c/p>\n\u003cp>When the mother's nucleus is transferred, it's like a plant dug up out of ground — a bit of the original soil (in this case, the mother's mitochondria) is still clinging to the roots. That creates a situation that never happens in nature: Two different mitochondrial genomes from two different women are forced to live inside the same cell. In most cases, a \u003ca href=\"http://www.sciencemag.org/news/2016/09/unanswered-questions-surround-baby-born-three-parents\">tiny percentage\u003c/a> (usually less than 2 percent) of the diseased mitochondria remain — but that tiny percentage can really matter.\u003c/p>\n\u003cp>In his new study, Mitalipov crafted three-parent embryos from the eggs of three mothers carrying mutant mitochondrial DNA and from the eggs of 11 healthy women. The embryos were then tweaked to become embryonic stem cells that could live forever, so they could be multiplied and studied. In three cases, the original maternal mitochondrial DNA returned.\u003c/p>\n\u003cp>\"That original, maternal mitochondrial DNA took over,\" Mitalipov says, \"and it was pretty drastic. There was less than 1 percent of the original maternal mitochondrial DNA present after replacement with donor DNA and before fertilization, and yet it took over the whole cell later.\"\u003c/p>\n\u003cp>Mitalipov warns that this reversal might not only occur in the embryonic stem cells; it could also occur in the womb at some point during the development of a baby. Complicating things further, Mitalipov found that some mitochondrial DNA stimulates cells to divide more rapidly, which would mean that a cells containing the maternal mitochondrial DNA could eventually dominate as the embryo developed.\u003c/p>\n\u003cp>Some mitochondrial genomes replicate much faster than others, says University of California molecular biologist \u003ca href=\"http://cancer.ucsf.edu/people/profiles/ofarrell_patrick.3574\">Patrick O'Farrell\u003c/a>, who called Mitalipov's research both impressive and in keeping with his own thinking on the matter.\u003c/p>\n\u003cp>A diseased mitochondrial genome could behave like a super-replicating bully, O'Farrell says, re-emerging and having a large impact on the three-parent baby at any time. It could also affect that child's future offspring. \"The diseased genome might stage a sneak comeback to afflict subsequent generations,\" O'Farrell says. On the other hand, he says, the super-replicators could act as \"superheroes,\" if they carry healthy, fit DNA that is able to out-compete a mutant genome.\u003c/p>\n\u003cp>The nuclear genes donated by a father could also influence the behavior of the mitochondria in ways we cannot yet predict, O'Farrell says. For example, the father might introduce new genes that favor the replication rate of a defective bully genome. Or the father might introduce genes that help a \"wimpy\" healthy genome survive and thrive.\u003c/p>\n\u003cp>Mitalipov's proposed solution to the problem is to match the mitochondria of the mother and the donor, since not all mitochondria are alike. Human mitochondria all over the earth are in a sense a billion or more clones of their original mother, passed down in endless biblical begats from mother to child. Yet, even as clones, they have diverged over time into lineages with different characteristics. These are called haplotypes.\u003c/p>\n\u003cp>O'Farrell mentions blood types as a comparison. Just as you would not want to transfuse blood type A into someone with blood type B, you might not want to mix different lineages. And while he says he thinks the idea of matching lineages is brilliant, he suggests going a step further. \"I say let's ... try to get a match with the dominating genome so that the defective genome will ultimately be completely displaced.\"\u003c/p>\n\u003cp>In fact, he adds, the ideal would be to look for one superhero genome, the fastest replicator of all – one that could displace any diseased genome.\u003c/p>\n\u003cp>To find out which branches are super replicators, O'Farrell hopes to collaborate with other laboratories and test the competitive strength of different haplotypes. Earlier this year, O'Farrell's laboratory published \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27270106\">work\u003c/a> showing that competition between closely related genomes tends to favor the most beneficial, while matchups between distantly related genomes favor super replicators with negative or even lethal consequences. There are, he says, at least 10 major lineages that would be distinct enough to be highly relevant.\u003c/p>\n\u003cp>Mitalipov says that most of the time, matching haplotypes should ensure successful mitochondrial transfers. However, he cautions that even then, tiny differences in the region of the mitochondrial genome that controls replication speed could cause an unexpected surprise. Even in mitochondria from the same haplotype, there could be a single change in a gene that could cause a conflict, he says.\u003c/p>\n\u003cp>In his study, Mitalipov zeroes in on the region that appears responsible for replication speed. In order to find out a mother's haplotype, he says, full sequencing is necessary, and this region from the donor's egg should also be looked at to be sure it matches the mother's. Today, it costs a few hundred dollars to sequence a woman's mitochondrial genome.\u003c/p>\n\u003cp>But battles between mitochondrial genomes are only one part of the emerging story. Some research suggests that nuclear genes evolve to sync well with a mitochondrial haplotype, and that when the pairing is suddenly switched, health might be compromised.\u003c/p>\n\u003cp>Research in fruit flies and in tiny sea creatures called cephalopods shows that when the \"mitonuclear\" partnership diverges too much, infertility and poor health can result. In some cases, however, the divergent pairs are above average and can actually lead to better health.\u003c/p>\n\u003cp>Swapping as little as 0.2 percent of mitochondrial DNA in laboratory animals \"can have profound effects on the function of cells, organs, and even the whole organism, and these effects manifest late in life,\" according to mitochondrial biologist \u003ca href=\"http://www.mrc-mbu.cam.ac.uk/people/patrick-chinnery\">Patrick Chinnery\u003c/a> of the University of Cambridge, \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMcibr1608715\">writing \u003c/a>in November in \u003cem>The New England Journal of Medicine\u003c/em>.\u003c/p>\n\u003cp>Because of all these unknowns, a \u003ca href=\"https://www.nap.edu/read/21871/chapter/1\">U.S. panel recommended last February\u003c/a> that mitochondrial replacement therapy, if approved, implant only male embryos so that the human-altered mitochondrial germline would not be passed down through the generations.\u003c/p>\n\u003cp>Most scientists approve of this advice, but biologist \u003ca href=\"http://www.damiandowlinglab.com/\">Damian Dowling\u003c/a> of Monash University in Melbourne, Australia, has reservations about even this solution.\u003c/p>\n\u003cp>His own research in fruit flies shows that males may actually be more vulnerable than females to impaired health from mitochondrial replacement. Since females pass on mitochondria, natural selection will help daughters sift out any mutations that might be harmful to them, and keep their nuclear and mitochondrial genes well matched. Males aren't so lucky: If mutations don't harm females but do harm males, the males may have to suffer impaired fertility and go to their graves earlier.\u003c/p>\n\u003cp>This is known as the \"\u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/16701262\">mother's curse\u003c/a>\" — a term coined by geneticist \u003ca href=\"http://gemmell-lab.otago.ac.nz/\">Neil Gemmell\u003c/a> of the University of Otago in New Zealand to describe the biological baggage that mothers unwittingly pass down to their male babies.\u003c/p>\n\u003cp>The bottom line, according to biologist \u003ca href=\"http://www.davidrandlab.org/\">David Rand\u003c/a> of Brown University, who studies mitochondrial genomes, is that when you swap mitochondria, the reaction is \"highly unpredictable.\"\u003c/p>\n\u003cp>And that's why many experts are calling for caution even amid all the excitement following the three-parent Mexico trial — though there is reason to believe they aren't being heard.\u003c/p>\n\u003cp>A three-person baby has now been born in China, and two more may soon be born in Ukraine, according to \u003ca href=\"http://www.nature.com/news/reports-of-three-parent-babies-multiply-1.20849\">Nature News\u003c/a>. Zhang, meanwhile, continues to encourage potential patients in Mexico: \"We have received interest both locally and abroad,\" he says, \"and we invite people to learn more about the treatment.\"\u003c/p>\n\u003cp>Doug Wallace, head of the Center for Mitochondrial and Epigenomic Medicine at the Children's Hospital of Philadelphia, is among those calling for a more methodical approach to the technique, though he says he doesn't think there's any way to put the brakes on now. \"I think what's happened is we're going to see more and more trials and some families are going to be exceedingly fortunate — and perhaps some will be an unfortunate part of the learning set.\"\u003c/p>\n\u003cp>Research on mitochondria has to catch up, Wallace says, and while matching haplotypes is a good idea, it isn't so easy to do in practice. \"Finding women to be egg donors is going to be a major limitation,\" he says — especially when you'd first have to survey a large group to find compatible mitochondrial DNA.\u003c/p>\n\u003cp>Still, for women desperate to conceive a healthy child this may seem reasonable. Wallace adds that mitochondrial replacement therapy might find favor even outside those seeking to avoid passing on fatal genetic mutations — such as older women simply facing reduced fertility. \"There's no proof that's the case,\" he says, but if it came to pass, that could mean a therapy that might change the DNA of tens of thousands, maybe hundreds of thousands, of babies conceived by this method.\u003c/p>\n\u003cp>That would have a real impact on the long-term future of society, Wallace adds, and we don't yet fully understand all of the implications.\u003c/p>\n\u003cp>\"I think it's an exciting possibility,\" he says, \"but also a little disconcerting.\"\u003c/p>\n\u003cp>\u003cem>Jill Neimark is an award-winning science journalist and an author of adult and children's books. Her most recent book is \"\u003ca href=\"https://www.amazon.com/Hugging-Tree-Story-About-Resilience/dp/1433819074/ref=sr_1_2?s=books&ie=UTF8&qid=1482511414&sr=1-2\">The Hugging Tree: A Story About Resilience\u003c/a>.\"\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>A version of this article \u003ca href=\"http://undark.org/article/three-parent-babies-battle-mitochondria/\">originally appeared at Undark\u003c/a>, a digital science magazine published by the Knight Science Journalism Fellowship Program at MIT.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Unexpected+Risks+Found+In+Replacing+DNA+To+Prevent+Inherited+Disorders&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"excerpt": "In 2016, scientists combined the genes of three people in an effort to make a baby free of an inherited disease. But the process doesn't wipe out all faulty mitochondria, and could pose new risks.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>In September, reproductive endocrinologist John Zhang and his team at the New Hope Fertility Center in New York City captured the world's attention when they \u003ca href=\"http://www.npr.org/sections/thetwo-way/2016/09/27/495668299/new-york-fertility-doctor-says-he-created-baby-with-3-genetic-parents\">announced \u003c/a>the birth of a child to a mother carrying a fatal genetic defect.\u003c/p>\n\u003cp>Using a technique called \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4005369/\">mitochondrial replacement therapy\u003c/a>, the researchers combined DNA from two women and one man to bypass the defect and produce a healthy baby boy — one with, quite literally, three genetic parents.\u003c/p>\n\u003cp>It was heralded as a stunning technological leap for in vitro fertilization, albeit one that the team was forced to perform in Mexico, because the technique has not been approved in the United States.\u003c/p>\n\u003cp>The technique is spreading quickly, gaining official \u003ca href=\"https://www.theguardian.com/science/2016/dec/15/three-parent-embryos-regulator-gives-green-light-to-uk-clinics\">approval\u003c/a> this month from the Human Fertilization and Embryology Authority in the U.K. The move will allow clinics to apply for permission there to carry out the treatment, with the first patients expected to be seen as early as next year.\u003c/p>\n\u003cp>But for all the accolades, the method also has scientists concerned that the fatally flawed mitochondria can resurface to threaten a child's health.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Earlier this month, a study published in \u003ca href=\"http://www.nature.com/nature/journal/vaop/ncurrent/pdf/nature20592.pdf\">Nature\u003c/a> by \u003ca href=\"http://www.ohsu.edu/xd/research/centers-institutes/onprc/scientific-discovery/scientists/mitalipov.cfm\">Shoukhrat Mitalipov\u003c/a>, head of the Center for Embryonic Cell and Gene Therapy at the Oregon Health and Science University in Portland, suggested that in roughly 15 percent of cases, the mitochondrial replacement could fail and allow fatal defects to return, or even increase a child's vulnerability to new ailments.\u003c/p>\n\u003cp>The findings confirmed the suspicions of many researchers, and the conclusions drawn by Mitalipov and his team were unequivocal: The potential for conflicts between transplanted and original mitochondrial genomes is real, and more sophisticated matching of donor and recipient eggs — pairing mothers whose mitochondria share genetic similarities, for example — is needed to avoid potential tragedies.\u003c/p>\n\u003cp>\"This study shows the potential as well as the risks of gene therapy in the germline,\" Mitalipov says. This is especially true of mitochondria, because its genomes are so different than the genomes in the nucleus of cells. Slight variations between mitochondrial genomes, he adds, \"turn out to matter a great deal.\"\u003c/p>\n\u003cp>Mitochondria are the energy powerhouses inside our cells, and they carry their own DNA, separate from our nuclear genome.\u003c/p>\n\u003cp>The danger lies in the fact that mitochondria are in some ways like aliens inside our cells. Two billion years ago they were free-floating bacteria basking in the primordial soup. Then one such microbe merged with another free-floating bacterium, and over evolutionary time, the two formed a complete cell. The bacteria eventually evolved into mitochondria, migrating most of their genes to the cell nucleus and keeping just a few dozen, largely to help them produce energy.\u003c/p>\n\u003cp>Today, our nuclear genome contains around \u003ca href=\"https://ghr.nlm.nih.gov/primer/basics/gene\">20,000 genes,\u003c/a> while a \u003ca href=\"https://ghr.nlm.nih.gov/mitochondrial-dna\">scant 37 genes\u003c/a> reside in the mitochondria. And yet the two genomes are intensely symbiotic: 99 percent of mitochondrial proteins are incorporated from the nucleus.\u003c/p>\n\u003cp>Mitochondria also still divide and replicate like the bacteria they once were, and that constant replication means that \u003ca href=\"http://www2.le.ac.uk/departments/emfpu/genetics/explained/mitochondrial\">mutations\u003c/a> arise 10 to 30 times \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/15062813\">more often\u003c/a> in mitochondrial genes than in the nucleus. If too many mitochondria become dysfunctional, the entire cell suffers and serious health problems can result. Faulty mitochondria are implicated in genetic diseases, as well as many \u003ca href=\"http://www.mitoaction.org/mito-faq\">chronic conditions\u003c/a> from \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2922635/\">infertility\u003c/a> to cancer, cardiac disease and neurodegenerative diseases. That's because when mitochondria falter, the energy system of the cell itself is compromised.\u003c/p>\n\u003cp>A three-parent baby could solve the problem by overriding faulty mitochondria, but it also raises the stakes, because the procedure does not completely replace the defective mitochondria with healthy ones.\u003c/p>\n\u003cp>When the mother's nucleus is transferred, it's like a plant dug up out of ground — a bit of the original soil (in this case, the mother's mitochondria) is still clinging to the roots. That creates a situation that never happens in nature: Two different mitochondrial genomes from two different women are forced to live inside the same cell. In most cases, a \u003ca href=\"http://www.sciencemag.org/news/2016/09/unanswered-questions-surround-baby-born-three-parents\">tiny percentage\u003c/a> (usually less than 2 percent) of the diseased mitochondria remain — but that tiny percentage can really matter.\u003c/p>\n\u003cp>In his new study, Mitalipov crafted three-parent embryos from the eggs of three mothers carrying mutant mitochondrial DNA and from the eggs of 11 healthy women. The embryos were then tweaked to become embryonic stem cells that could live forever, so they could be multiplied and studied. In three cases, the original maternal mitochondrial DNA returned.\u003c/p>\n\u003cp>\"That original, maternal mitochondrial DNA took over,\" Mitalipov says, \"and it was pretty drastic. There was less than 1 percent of the original maternal mitochondrial DNA present after replacement with donor DNA and before fertilization, and yet it took over the whole cell later.\"\u003c/p>\n\u003cp>Mitalipov warns that this reversal might not only occur in the embryonic stem cells; it could also occur in the womb at some point during the development of a baby. Complicating things further, Mitalipov found that some mitochondrial DNA stimulates cells to divide more rapidly, which would mean that a cells containing the maternal mitochondrial DNA could eventually dominate as the embryo developed.\u003c/p>\n\u003cp>Some mitochondrial genomes replicate much faster than others, says University of California molecular biologist \u003ca href=\"http://cancer.ucsf.edu/people/profiles/ofarrell_patrick.3574\">Patrick O'Farrell\u003c/a>, who called Mitalipov's research both impressive and in keeping with his own thinking on the matter.\u003c/p>\n\u003cp>A diseased mitochondrial genome could behave like a super-replicating bully, O'Farrell says, re-emerging and having a large impact on the three-parent baby at any time. It could also affect that child's future offspring. \"The diseased genome might stage a sneak comeback to afflict subsequent generations,\" O'Farrell says. On the other hand, he says, the super-replicators could act as \"superheroes,\" if they carry healthy, fit DNA that is able to out-compete a mutant genome.\u003c/p>\n\u003cp>The nuclear genes donated by a father could also influence the behavior of the mitochondria in ways we cannot yet predict, O'Farrell says. For example, the father might introduce new genes that favor the replication rate of a defective bully genome. Or the father might introduce genes that help a \"wimpy\" healthy genome survive and thrive.\u003c/p>\n\u003cp>Mitalipov's proposed solution to the problem is to match the mitochondria of the mother and the donor, since not all mitochondria are alike. Human mitochondria all over the earth are in a sense a billion or more clones of their original mother, passed down in endless biblical begats from mother to child. Yet, even as clones, they have diverged over time into lineages with different characteristics. These are called haplotypes.\u003c/p>\n\u003cp>O'Farrell mentions blood types as a comparison. Just as you would not want to transfuse blood type A into someone with blood type B, you might not want to mix different lineages. And while he says he thinks the idea of matching lineages is brilliant, he suggests going a step further. \"I say let's ... try to get a match with the dominating genome so that the defective genome will ultimately be completely displaced.\"\u003c/p>\n\u003cp>In fact, he adds, the ideal would be to look for one superhero genome, the fastest replicator of all – one that could displace any diseased genome.\u003c/p>\n\u003cp>To find out which branches are super replicators, O'Farrell hopes to collaborate with other laboratories and test the competitive strength of different haplotypes. Earlier this year, O'Farrell's laboratory published \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27270106\">work\u003c/a> showing that competition between closely related genomes tends to favor the most beneficial, while matchups between distantly related genomes favor super replicators with negative or even lethal consequences. There are, he says, at least 10 major lineages that would be distinct enough to be highly relevant.\u003c/p>\n\u003cp>Mitalipov says that most of the time, matching haplotypes should ensure successful mitochondrial transfers. However, he cautions that even then, tiny differences in the region of the mitochondrial genome that controls replication speed could cause an unexpected surprise. Even in mitochondria from the same haplotype, there could be a single change in a gene that could cause a conflict, he says.\u003c/p>\n\u003cp>In his study, Mitalipov zeroes in on the region that appears responsible for replication speed. In order to find out a mother's haplotype, he says, full sequencing is necessary, and this region from the donor's egg should also be looked at to be sure it matches the mother's. Today, it costs a few hundred dollars to sequence a woman's mitochondrial genome.\u003c/p>\n\u003cp>But battles between mitochondrial genomes are only one part of the emerging story. Some research suggests that nuclear genes evolve to sync well with a mitochondrial haplotype, and that when the pairing is suddenly switched, health might be compromised.\u003c/p>\n\u003cp>Research in fruit flies and in tiny sea creatures called cephalopods shows that when the \"mitonuclear\" partnership diverges too much, infertility and poor health can result. In some cases, however, the divergent pairs are above average and can actually lead to better health.\u003c/p>\n\u003cp>Swapping as little as 0.2 percent of mitochondrial DNA in laboratory animals \"can have profound effects on the function of cells, organs, and even the whole organism, and these effects manifest late in life,\" according to mitochondrial biologist \u003ca href=\"http://www.mrc-mbu.cam.ac.uk/people/patrick-chinnery\">Patrick Chinnery\u003c/a> of the University of Cambridge, \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMcibr1608715\">writing \u003c/a>in November in \u003cem>The New England Journal of Medicine\u003c/em>.\u003c/p>\n\u003cp>Because of all these unknowns, a \u003ca href=\"https://www.nap.edu/read/21871/chapter/1\">U.S. panel recommended last February\u003c/a> that mitochondrial replacement therapy, if approved, implant only male embryos so that the human-altered mitochondrial germline would not be passed down through the generations.\u003c/p>\n\u003cp>Most scientists approve of this advice, but biologist \u003ca href=\"http://www.damiandowlinglab.com/\">Damian Dowling\u003c/a> of Monash University in Melbourne, Australia, has reservations about even this solution.\u003c/p>\n\u003cp>His own research in fruit flies shows that males may actually be more vulnerable than females to impaired health from mitochondrial replacement. Since females pass on mitochondria, natural selection will help daughters sift out any mutations that might be harmful to them, and keep their nuclear and mitochondrial genes well matched. Males aren't so lucky: If mutations don't harm females but do harm males, the males may have to suffer impaired fertility and go to their graves earlier.\u003c/p>\n\u003cp>This is known as the \"\u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/16701262\">mother's curse\u003c/a>\" — a term coined by geneticist \u003ca href=\"http://gemmell-lab.otago.ac.nz/\">Neil Gemmell\u003c/a> of the University of Otago in New Zealand to describe the biological baggage that mothers unwittingly pass down to their male babies.\u003c/p>\n\u003cp>The bottom line, according to biologist \u003ca href=\"http://www.davidrandlab.org/\">David Rand\u003c/a> of Brown University, who studies mitochondrial genomes, is that when you swap mitochondria, the reaction is \"highly unpredictable.\"\u003c/p>\n\u003cp>And that's why many experts are calling for caution even amid all the excitement following the three-parent Mexico trial — though there is reason to believe they aren't being heard.\u003c/p>\n\u003cp>A three-person baby has now been born in China, and two more may soon be born in Ukraine, according to \u003ca href=\"http://www.nature.com/news/reports-of-three-parent-babies-multiply-1.20849\">Nature News\u003c/a>. Zhang, meanwhile, continues to encourage potential patients in Mexico: \"We have received interest both locally and abroad,\" he says, \"and we invite people to learn more about the treatment.\"\u003c/p>\n\u003cp>Doug Wallace, head of the Center for Mitochondrial and Epigenomic Medicine at the Children's Hospital of Philadelphia, is among those calling for a more methodical approach to the technique, though he says he doesn't think there's any way to put the brakes on now. \"I think what's happened is we're going to see more and more trials and some families are going to be exceedingly fortunate — and perhaps some will be an unfortunate part of the learning set.\"\u003c/p>\n\u003cp>Research on mitochondria has to catch up, Wallace says, and while matching haplotypes is a good idea, it isn't so easy to do in practice. \"Finding women to be egg donors is going to be a major limitation,\" he says — especially when you'd first have to survey a large group to find compatible mitochondrial DNA.\u003c/p>\n\u003cp>Still, for women desperate to conceive a healthy child this may seem reasonable. Wallace adds that mitochondrial replacement therapy might find favor even outside those seeking to avoid passing on fatal genetic mutations — such as older women simply facing reduced fertility. \"There's no proof that's the case,\" he says, but if it came to pass, that could mean a therapy that might change the DNA of tens of thousands, maybe hundreds of thousands, of babies conceived by this method.\u003c/p>\n\u003cp>That would have a real impact on the long-term future of society, Wallace adds, and we don't yet fully understand all of the implications.\u003c/p>\n\u003cp>\"I think it's an exciting possibility,\" he says, \"but also a little disconcerting.\"\u003c/p>\n\u003cp>\u003cem>Jill Neimark is an award-winning science journalist and an author of adult and children's books. Her most recent book is \"\u003ca href=\"https://www.amazon.com/Hugging-Tree-Story-About-Resilience/dp/1433819074/ref=sr_1_2?s=books&ie=UTF8&qid=1482511414&sr=1-2\">The Hugging Tree: A Story About Resilience\u003c/a>.\"\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>A version of this article \u003ca href=\"http://undark.org/article/three-parent-babies-battle-mitochondria/\">originally appeared at Undark\u003c/a>, a digital science magazine published by the Knight Science Journalism Fellowship Program at MIT.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Unexpected+Risks+Found+In+Replacing+DNA+To+Prevent+Inherited+Disorders&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>LA HABRA, California – Rosemary Navarro was living in Mexico when her brother called from California. Something wasn’t right with their mom, then in her early 40s. She was having trouble paying bills and keeping jobs as a food preparer in convalescent homes.\u003c/p>\n\u003cp>Navarro, then 22, moved back to the U.S. with her two young children. \u003c/p>\n\u003cp>Before long, Navarro was feeding her mom, then changing her diapers. Near the end, her mom, a quiet woman who had immigrated to the U.S. as a teenager and loved telenovelas, could communicate only by laughing or crying. She died at 53 in a nursing home. \u003c/p>\n\u003cp>It has happened again and again in her family — relatives struck by the same terrible disease, most without any clue what it was. An aunt, an uncle, a cousin, a grandfather, a great grandfather. “Too many have died,” Navarro said. All in their early 50s. \u003c/p>\n\u003cp>Now the family knows the reason for their curse: It’s a rare type of early-onset Alzheimer’s disease, caused by what’s come to be known as the “Jalisco” genetic mutation. Doctors today can tell someone they have it but can’t stop its destructive march.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>For Navarro, watching her relatives succumb is like looking into a crystal ball, one she wants to hurl across the room. She, too, has the mutation. In April, she turned 40 — the same age her mother was when she started wandering off and forgetting simple things. \u003c/p>\n\u003cp>“I don’t look forward to birthdays,” she said. “I didn’t want to celebrate 40, much less 41.”\u003c/p>\n\u003cp>\u003cstrong>Sparing The Next Generation\u003c/strong>\u003c/p>\n\u003cp>Navarro, who lives in La Habra, Calif., belongs to an exclusive but unenviable club whose members are genetically programmed for early memory loss and death. \u003c/p>\n\u003cp>Of the more than 5 million people across the U.S. who have Alzheimer’s, about one percent have genetic mutations that are known to cause the disease. Navarro’s gene is known as the Jalisco mutation because it is believed to have surfaced first in that Mexican state. Roughly 50 families are known to have it. \u003c/p>\n\u003cp>Cases like Navarro’s are of great interest to Alzheimer’s researchers. Studying this unique population with genetic mutations, they say, could help unlock some of the biggest mysteries of the more common form of the disease: How does it develop? What can be done to stop it?\u003c/p>\n\u003cp>Ordinarily, it’s difficult — if not impossible — to predict Alzheimer’s. But with these families, researchers know the mutation carriers will get the disease. They also know approximately when symptoms will appear, so they can get a real-time look at how the disease develops and possibly design drugs for it before patients lose their memory. \u003c/p>\n\u003cp>“If you know from age 18 or even from birth whether someone is going to develop the disease or not, you have got a big window to intervene,” Navarro’s doctor, John Ringman, a neurology professor at the Keck School of Medicine of the University of Southern California. “We don’t have a way to repair or bring back lost brain cells.” \u003c/p>\n\u003cp>Hundreds of people whose families are afflicted with a variety of early-onset mutations are subjecting themselves to medical tests, hoping scientists can develop therapies to prevent and treat Alzheimer’s. But their participation often comes with the sad realization it may be too late to help them. \u003c/p>\n\u003cp>More than 450 people are part of an international network of research being led by Washington University School of Medicine in St. Louis. Each has a parent with an early-onset gene mutation.\u003c/p>\n\u003cp>“They are all desperately fearful that they themselves have inherited a mutation,” said John C. Morris, director of the school’s Alzheimer’s Disease Research Center. “But what they are really fearful about is that if they did, that they will pass it along to their children.”\u003c/p>\n\u003cp>Children have a 50 percent chance of inheriting the mutation from a parent who carries it.\u003c/p>\n\u003cp>Navarro, whose children are now young adults, is well aware of the statistics. She has joined the network’s research effort, of which Ringman is a part. Last year, a scan showed her brain had already started to shrink — a sign that the disease was taking hold.\u003c/p>\n\u003cp>\u003cstrong>‘At Least We Know Now’\u003cbr>\n\u003c/strong>\u003cbr>\nIn November 2015, Dr. Ringman drove to Colton, Calif. — 60 miles east of Los Angeles — to meet with the large and close-knit Kitchen family. Jay Kitchen and his younger brother John had been referred to him after each suffered a series of baffling symptoms. \u003c/p>\n\u003cp>It had started about four years earlier. Jay, then a 44-year-old sports writer, began having difficulty speaking. He felt off balance and was forgetting things. Soon afterward, his younger brother, John, a high school history teacher, started becoming easily confused. He would forget what day it was and how to get to the market.\u003c/p>\n\u003cp>Doctors were “scratching their heads trying to figure out what was wrong,” said the brothers’ aunt, Linda Ramos. \u003c/p>\n\u003cp>A neurologist referred the brothers to Ringman, who ordered a blood test. On this November morning, Ringman came to Ramos’ home, where the extended family was gathered, with grim news. Both men had the Jalisco mutation. The brothers sat in near silence, Ramos said. \u003c/p>\n\u003cp>Like many families Ringman encounters, the other relatives also absorbed the news with little emotion or surprise — as though the doctor were confirming nameless fears. \u003c/p>\n\u003cp>“My thought was, ‘At least we know now,” Ramos said. “Finally, we know. Thank God we have a name [for it] and maybe we can do something for their kids.” \u003c/p>\n\u003cp>\u003cstrong>One Family Leads To Another\u003cbr>\n\u003c/strong>\u003cbr>\nRingman was a young neurologist at the University of California, Irvine in 1999 when a 42-year-old woman, Rosa Maria Navarro, came to see him. Her daughter Rosemary brought her, distraught because her mother, like so many other relatives, had signs of early Alzheimer’s.\u003c/p>\n\u003cp>Ringman was aware of recently identified familial Alzheimer’s mutations and immediately suspected Rosa Maria had one. She tested positive for the mutation later named Jalisco. \u003c/p>\n\u003cp>Soon afterward, another patient of Ringman’s, also with forebears from Jalisco, tested positive for the same mutation. \u003c/p>\n\u003cp>Ringman started working with doctors in Mexico, and they identified many similar patients who were all at least distantly related. They concluded the disease likely started with one ancestor. \u003c/p>\n\u003cp>Ringman saw the tragedy but also the scientific opportunity in these discoveries. He later joined the Washington University research network in its quest for knowledge and treatment options. \u003c/p>\n\u003cp>Among the network’s early findings: The brain begins to change before any symptoms occur. The research essentially has presented a timeline of brain changes leading up to cognitive decline and has helped scientists decide when and where to aim drugs. \u003c/p>\n\u003cp>The Kitchen brothers are not participating in the research. Both are declining precipitously. Jay only occasionally recognizes family members. John can still hold a conversation but struggles for the right words.\u003c/p>\n\u003cp>“We get a glimmer of hope,” their aunt Ramos said, “but then we think we are foolish for even hoping.”\u003c/p>\n\u003cp>\u003cstrong>Fear And Faith\u003cbr>\n\u003c/strong>\u003cbr>\nNavarro’s 19-year-old daughter, Lizeth, and her 22-year-old son, Ricardo, live with her in a three-bedroom trailer in La Habra. Both say said their mom has started forgetting little things — the movie they saw last week or what they need from the grocery store. \u003c/p>\n\u003cp>Rosemary Navarro keeps working in customer service and tries to focus on her family, not the disease. “I can’t let it overcome me,” she said. \u003c/p>\n\u003cp>She’s joined a drug trial out of Washington University. Each month, a nurse visits and injects a medication, which she’s pretty sure is not a placebo.\u003c/p>\n\u003cp>“I have to have faith in the drug,” she said. “That’s my only solution for now.”\u003c/p>\n\u003cp>“Otherwise …” \u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>She didn’t finish her thought.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>LA HABRA, California – Rosemary Navarro was living in Mexico when her brother called from California. Something wasn’t right with their mom, then in her early 40s. She was having trouble paying bills and keeping jobs as a food preparer in convalescent homes.\u003c/p>\n\u003cp>Navarro, then 22, moved back to the U.S. with her two young children. \u003c/p>\n\u003cp>Before long, Navarro was feeding her mom, then changing her diapers. Near the end, her mom, a quiet woman who had immigrated to the U.S. as a teenager and loved telenovelas, could communicate only by laughing or crying. She died at 53 in a nursing home. \u003c/p>\n\u003cp>It has happened again and again in her family — relatives struck by the same terrible disease, most without any clue what it was. An aunt, an uncle, a cousin, a grandfather, a great grandfather. “Too many have died,” Navarro said. All in their early 50s. \u003c/p>\n\u003cp>Now the family knows the reason for their curse: It’s a rare type of early-onset Alzheimer’s disease, caused by what’s come to be known as the “Jalisco” genetic mutation. Doctors today can tell someone they have it but can’t stop its destructive march.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>For Navarro, watching her relatives succumb is like looking into a crystal ball, one she wants to hurl across the room. She, too, has the mutation. In April, she turned 40 — the same age her mother was when she started wandering off and forgetting simple things. \u003c/p>\n\u003cp>“I don’t look forward to birthdays,” she said. “I didn’t want to celebrate 40, much less 41.”\u003c/p>\n\u003cp>\u003cstrong>Sparing The Next Generation\u003c/strong>\u003c/p>\n\u003cp>Navarro, who lives in La Habra, Calif., belongs to an exclusive but unenviable club whose members are genetically programmed for early memory loss and death. \u003c/p>\n\u003cp>Of the more than 5 million people across the U.S. who have Alzheimer’s, about one percent have genetic mutations that are known to cause the disease. Navarro’s gene is known as the Jalisco mutation because it is believed to have surfaced first in that Mexican state. Roughly 50 families are known to have it. \u003c/p>\n\u003cp>Cases like Navarro’s are of great interest to Alzheimer’s researchers. Studying this unique population with genetic mutations, they say, could help unlock some of the biggest mysteries of the more common form of the disease: How does it develop? What can be done to stop it?\u003c/p>\n\u003cp>Ordinarily, it’s difficult — if not impossible — to predict Alzheimer’s. But with these families, researchers know the mutation carriers will get the disease. They also know approximately when symptoms will appear, so they can get a real-time look at how the disease develops and possibly design drugs for it before patients lose their memory. \u003c/p>\n\u003cp>“If you know from age 18 or even from birth whether someone is going to develop the disease or not, you have got a big window to intervene,” Navarro’s doctor, John Ringman, a neurology professor at the Keck School of Medicine of the University of Southern California. “We don’t have a way to repair or bring back lost brain cells.” \u003c/p>\n\u003cp>Hundreds of people whose families are afflicted with a variety of early-onset mutations are subjecting themselves to medical tests, hoping scientists can develop therapies to prevent and treat Alzheimer’s. But their participation often comes with the sad realization it may be too late to help them. \u003c/p>\n\u003cp>More than 450 people are part of an international network of research being led by Washington University School of Medicine in St. Louis. Each has a parent with an early-onset gene mutation.\u003c/p>\n\u003cp>“They are all desperately fearful that they themselves have inherited a mutation,” said John C. Morris, director of the school’s Alzheimer’s Disease Research Center. “But what they are really fearful about is that if they did, that they will pass it along to their children.”\u003c/p>\n\u003cp>Children have a 50 percent chance of inheriting the mutation from a parent who carries it.\u003c/p>\n\u003cp>Navarro, whose children are now young adults, is well aware of the statistics. She has joined the network’s research effort, of which Ringman is a part. Last year, a scan showed her brain had already started to shrink — a sign that the disease was taking hold.\u003c/p>\n\u003cp>\u003cstrong>‘At Least We Know Now’\u003cbr>\n\u003c/strong>\u003cbr>\nIn November 2015, Dr. Ringman drove to Colton, Calif. — 60 miles east of Los Angeles — to meet with the large and close-knit Kitchen family. Jay Kitchen and his younger brother John had been referred to him after each suffered a series of baffling symptoms. \u003c/p>\n\u003cp>It had started about four years earlier. Jay, then a 44-year-old sports writer, began having difficulty speaking. He felt off balance and was forgetting things. Soon afterward, his younger brother, John, a high school history teacher, started becoming easily confused. He would forget what day it was and how to get to the market.\u003c/p>\n\u003cp>Doctors were “scratching their heads trying to figure out what was wrong,” said the brothers’ aunt, Linda Ramos. \u003c/p>\n\u003cp>A neurologist referred the brothers to Ringman, who ordered a blood test. On this November morning, Ringman came to Ramos’ home, where the extended family was gathered, with grim news. Both men had the Jalisco mutation. The brothers sat in near silence, Ramos said. \u003c/p>\n\u003cp>Like many families Ringman encounters, the other relatives also absorbed the news with little emotion or surprise — as though the doctor were confirming nameless fears. \u003c/p>\n\u003cp>“My thought was, ‘At least we know now,” Ramos said. “Finally, we know. Thank God we have a name [for it] and maybe we can do something for their kids.” \u003c/p>\n\u003cp>\u003cstrong>One Family Leads To Another\u003cbr>\n\u003c/strong>\u003cbr>\nRingman was a young neurologist at the University of California, Irvine in 1999 when a 42-year-old woman, Rosa Maria Navarro, came to see him. Her daughter Rosemary brought her, distraught because her mother, like so many other relatives, had signs of early Alzheimer’s.\u003c/p>\n\u003cp>Ringman was aware of recently identified familial Alzheimer’s mutations and immediately suspected Rosa Maria had one. She tested positive for the mutation later named Jalisco. \u003c/p>\n\u003cp>Soon afterward, another patient of Ringman’s, also with forebears from Jalisco, tested positive for the same mutation. \u003c/p>\n\u003cp>Ringman started working with doctors in Mexico, and they identified many similar patients who were all at least distantly related. They concluded the disease likely started with one ancestor. \u003c/p>\n\u003cp>Ringman saw the tragedy but also the scientific opportunity in these discoveries. He later joined the Washington University research network in its quest for knowledge and treatment options. \u003c/p>\n\u003cp>Among the network’s early findings: The brain begins to change before any symptoms occur. The research essentially has presented a timeline of brain changes leading up to cognitive decline and has helped scientists decide when and where to aim drugs. \u003c/p>\n\u003cp>The Kitchen brothers are not participating in the research. Both are declining precipitously. Jay only occasionally recognizes family members. John can still hold a conversation but struggles for the right words.\u003c/p>\n\u003cp>“We get a glimmer of hope,” their aunt Ramos said, “but then we think we are foolish for even hoping.”\u003c/p>\n\u003cp>\u003cstrong>Fear And Faith\u003cbr>\n\u003c/strong>\u003cbr>\nNavarro’s 19-year-old daughter, Lizeth, and her 22-year-old son, Ricardo, live with her in a three-bedroom trailer in La Habra. Both say said their mom has started forgetting little things — the movie they saw last week or what they need from the grocery store. \u003c/p>\n\u003cp>Rosemary Navarro keeps working in customer service and tries to focus on her family, not the disease. “I can’t let it overcome me,” she said. \u003c/p>\n\u003cp>She’s joined a drug trial out of Washington University. Each month, a nurse visits and injects a medication, which she’s pretty sure is not a placebo.\u003c/p>\n\u003cp>“I have to have faith in the drug,” she said. “That’s my only solution for now.”\u003c/p>\n\u003cp>“Otherwise …” \u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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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?",
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"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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"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": "Drugmakers Push Unproven Solution to Opioid Epidemic They Helped Create",
"title": "Drugmakers Push Unproven Solution to Opioid Epidemic They Helped Create",
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"content": "\u003cp>Pilloried for their role in the epidemic of prescription painkiller abuse, drugmakers are aggressively pushing their remedy to the problem: a new generation of harder-to-manipulate opioids that have racked up billions in sales, even though there's little proof they reduce rates of overdoses or deaths.\u003c/p>\n\u003caside class=\"pullquote alignright\">Harder-to-manipulate opioids have racked up billions in sales, despite a lack of proof that they reduce overdoses.\u003c/aside>\n\u003cp>More than prescriptions are at stake. Critics worry the drugmakers' nationwide lobbying campaign is distracting from more productive solutions and delaying crucial efforts to steer physicians away from prescription opioids — addictive pain medications involved in the deaths of more than 165,000 Americans since 2000.\u003c/p>\n\u003cp>\"If we've learned one lesson from the last 20 years on opioids it's that these products have very, very high inherent risks,\" said Dr. Caleb Alexander, co-director of Johns Hopkins University's Center for Drug Safety and Effectiveness. \"My concern is that they'll contribute to a perception that there is a safe opioid, and there's no such thing as a fully safe opioid.\"\u003c/p>\n\u003cp>The latest drugs — known as abuse-deterrent formulations, or ADFs — are generally harder to crush or dissolve, which the drugmakers tout as making them difficult to snort or inject. But they still are vulnerable to manipulation and potentially addictive when simply swallowed. National data from an industry-sponsored tracking system also show drug abusers quickly drop the reformulated drugs in favor of older painkillers or heroin.\u003c/p>\n\u003cp>In the last two years, pharmaceutical companies have made a concerted under-the-radar push for bills benefiting the anti-abuse opioids in statehouses and in Congress, where proposed legislation would require the Food and Drug Administration to replace older opioids with the new drugs.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The lobbying push features industry-funded advocacy groups and physicians, along with grieving family members, who rarely disclosed the drugmakers' ties during their testimony in support of the drugs.\u003c/p>\n\u003cp>Besides the tamper-resistant pills, ADF opioids are being rolled out in other forms, including injectable drugs and pills that irritate users when they're snorted or contain substances that counteract highs.\u003c/p>\n\u003cp>\u003cstrong>Sales Opportunity\u003c/strong>\u003c/p>\n\u003cp>Making painkillers harder to abuse is a common-sense step. But it's also a multibillion-dollar sales opportunity, offering drugmakers the potential to wipe out lower-cost generic competitors and lock in sales of their higher-priced versions, which cost many times more than conventional pills. The big companies hold multiple patents on the reformulated drugs, shielding them from competition for years — in some cases decades.\u003c/p>\n\u003cp>Though abuse-deterrent painkillers represented less than 5 percent of all opioids prescribed last year, they generated more than $2.4 billion in sales, or roughly a quarter of the nearly $10 billion U.S. market for the drugs, according to IMS Health. The field is dominated by Purdue Pharma's OxyContin, patent-protected until 2030.\u003c/p>\n\u003cp>\"We at Purdue make certain that prescribers and other stakeholders understand that opioids with abuse-deterrent properties won't stop all prescription drug abuse, but they are an important part of the comprehensive approach needed to address this public health issue,\" Purdue spokesman Robert Josephson said in a statement.\u003c/p>\n\u003cp>Like a spokeswoman for Pfizer Inc., Josephson also noted that some public health officials, including the Food and Drug Administration, have endorsed using ADFs.\u003c/p>\n\u003cp>\"We need every tool that we can have in our toolbox,\" said Kentucky state Rep. Addia Wuchner, a Republican who has worked on several bills to benefit reformulated opioids. \"The extra steps are worth the effort in order to prevent this escalation of more addiction.\"\u003c/p>\n\u003cp>\u003cstrong>Massive Lobbying Effort\u003c/strong>\u003c/p>\n\u003cp>The current industry campaign draws on the same 50-state strategy that painkiller manufacturers successfully deployed to help kill or weaken measures aimed at stemming the tide of prescription opioids, a playbook The Associated Press and Center for Public Integrity exposed in September.\u003c/p>\n\u003cp>The \u003ca href=\"https://ww2.kqed.org/stateofhealth/2016/09/19/how-drugmakers-used-money-and-influence-to-shape-the-national-response-to-opioid-abuse/\" target=\"_blank\">reporting \u003c/a>detailed how opioid drugmakers and the nonprofits they help fund spent more than $880 million on lobbying and political contributions at the state and federal level over the past decade, eight times what the gun lobby reported for the same period. The money represents the drugmakers' spending on all their legislative interests, including opioids.\u003c/p>\n\u003cp>The FDA has approved a handful of the reformulated drugs but has not yet concluded that any reduce rates of addiction, abuse or death, and the evidence gap has led to diverging views among health authorities.\u003c/p>\n\u003cp>\u003cstrong>'No less addictive'\u003c/strong>\u003c/p>\n\u003cp>Whereas FDA regulators emphasize the potential promise of reformulated painkillers, other government officials stress that they contain the same heroin-like ingredients as traditional opioids. An estimated 78 Americans die from heroin and prescription opioid overdoses every day.\u003c/p>\n\u003cp>\"'Abuse-deterrent' sounds to people sometimes like 'Oh, maybe it's not addictive.' But it's no less addictive,\" said Dr. Tom Frieden, head of the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Survey results published this year in the Clinical Journal of Pain showed nearly half of U.S. physicians incorrectly believed that reformulated opioids are less addictive than their predecessors.\u003c/p>\n\u003cp>Many experts see a key role for ADFs in reducing the number of people who first begin abusing opioids, and some say the abuse-deterrent formulations should be the default painkiller for patients with histories of drug use, anxiety or depression. But even they worry that some drugmakers are overselling the technology. They stress that separate measures are needed for the majority of opioid abusers who ingest the pills orally.\u003c/p>\n\u003cp>\"The way they're handling the ADF is that this is the answer. And it's not the answer — it's part of the bigger puzzle,\" said Theodore Cicero, a psychiatry professor at Washington University in St. Louis, who has authored several studies on the drugs.\u003c/p>\n\u003cp>\u003cstrong>'You can't put a price tag on anybody's life'\u003c/strong>\u003c/p>\n\u003cp>Two years after the overdose that killed her 21-year-old son, Terri Bartlett traveled to Illinois' state capital to champion an unlikely cause: revamped painkillers.\u003c/p>\n\u003cp>Bartlett's son Michael became hooked on Vicodin and later graduated to heroin. In emotional testimony last year, she urged lawmakers to support a bill that would prioritize the new harder-to-crush pills, saying she believed her son would still be alive if abuse-deterrent formulations had been on the market then.\u003c/p>\n\u003cp>\"You can't put a price tag on anybody's life,\" she said.\u003c/p>\n\u003cp>Bartlett didn't know then that she had been recruited into a wide-ranging lobbying campaign. A public relations firm hired by OxyContin-maker Purdue had helped recruit her to support the bill, along with local sheriffs and fire chiefs.\u003c/p>\n\u003cp>Her words, and similar testimony from parents of drug abusers elsewhere, reflect a tactic used by the drugmakers across the country. For instance, Purdue paid nearly $95,000 for similar lobbying efforts in New York, state records show.\u003c/p>\n\u003cp>And the industry's fingerprints are easy to spot in other areas. Of more than 100 bills dealing with the drugs introduced in 35 states in 2015 and 2016, at least 49 featured nearly identical language requiring insurers to cover abuse-deterrent drugs, according to an analysis of data from Quorum, a legislative tracking service. Several of the bill sponsors said they received the wording from pharmaceutical lobbyists.\u003c/p>\n\u003cp>Since 2012, at least 21 bills related to the drugs have become law, including five that require insurers to pay for the more expensive drugs in Maine, Maryland, Massachusetts, Florida and West Virginia.\u003c/p>\n\u003cp>Wins in such states will give drugmakers momentum to successfully push for copycat laws elsewhere, noted Paul Kelly, a federal lobbyist who has worked on multistate lobbying campaigns for drugstores and major retailers.\u003c/p>\n\u003cp>\"It's like a foot in the door,\" he said.\u003c/p>\n\u003cp>\u003cstrong>Fierce Opposition\u003c/strong>\u003c/p>\n\u003cp>Drugmakers have found fierce opposition to their ADF legislation from insurers and employers who would be on the hook for the far pricier opioid variations.\u003c/p>\n\u003cp>The Illinois bill — and the 48 strikingly similar measures in other states — would require insurers to cover the drugs in the same way as other opioids, which the insurance companies argue would allow drugmakers to charge whatever they want for them.\u003c/p>\n\u003cp>\"That is not the best use of our medical care resources,\" Vernon Rowen, vice president of state government affairs for the insurance company Aetna, told Illinois lawmakers after Bartlett testified. \"It totally eliminates our ability to negotiate discounts with manufacturers.\"\u003c/p>\n\u003cp>New York Gov. Andrew Cuomo and New Jersey Gov. Chris Christie both vetoed such insurance mandates in the past year, citing the high costs and lack of evidence that the drugs help.\u003c/p>\n\u003cp>Federal health officials also have pushed back against requirements to cover the drugs, citing the \"staggering\" costs. For example, a 30-day supply of Pfizer's abuse-deterrent Embeda, a combination drug containing morphine, costs $268, while a 30-day supply of a generic morphine costs roughly $38, according to data compiled by Truven Health Analytics, a company that tracks drug prices set by manufacturers.\u003c/p>\n\u003cp>The Department of Veterans Affairs' Dr. Bernie Good estimated that converting the 8.8 million patient system exclusively to the new reformulations would increase opioid spending more than tenfold, to over $1.6 billion annually. Good, who co-directs the VA's program for medication safety, said the vast majority of veterans are not at risk for snorting or injecting their medications.\u003c/p>\n\u003cp>\"Would the excess money to pay for abuse-deterrent products — mostly to pay for it in cases where it wouldn't be necessary — be better spent for drug treatment centers?\" he asked at a recent federal meeting on the drugs.\u003c/p>\n\u003cp>Federal estimates say at least 2.2 million Americans are addicted to prescription opioids or heroin, yet only one in five actually receives treatment, according to a Surgeon General's report published last month. That's despite some $35 billion already spent annually on substance abuse programs by private and public health providers.\u003c/p>\n\u003cp>State lawmakers who support the abuse-deterrent bills often defend them as an important piece of solving the opioid puzzle, preventing more costly overdoses and hospitalizations.\u003c/p>\n\u003cp>And Fred Brason, executive director of Project Lazarus, a North Carolina-based group that promotes anti-addiction policies in several states, called the focus on the drugs' cost too narrow.\u003c/p>\n\u003cp>\"You're already spending that money at the back end,\" he said. \"You're spending it at the emergency department.\" He also noted the costs of addiction treatment.\u003c/p>\n\u003cp>\u003cstrong>Industry-Supported Groups and Physicians\u003c/strong>\u003c/p>\n\u003cp>When critics raise alarms about higher costs and limited evidence, drugmakers can rely on groups they support financially to argue their side, including the National Association of Drug Diversion Investigators, the Academy of Integrative Pain Management and the Partnership for Drug-Free Kids. Representatives from those groups have testified in favor of abuse-deterrent legislation in at least seven states.\u003c/p>\n\u003cp>NADDI president Charlie Cichon acknowledged his group receives funds from several ADF-makers, but said it views the drugs as a proven part of the solution to the opioid crisis. \"We're not testifying for Purdue Pharma's product or Endo's product,\" he said.\u003c/p>\n\u003cp>And Bob Twillman, executive director of the Academy, said, \"Increased use of abuse-deterrent opioids makes it more likely that those patients who need opiates to treat their pain will be able to get them.\"\u003c/p>\n\u003cp>The Partnership for Drug-Free Kids did not respond to multiple requests for comment.\u003c/p>\n\u003cp>Physicians with financial ties to drugmakers play similar roles. Dr. Gareth Shemesh, a pain specialist, testified in support of a Colorado bill last year brought to the sponsoring legislator by Pfizer. Shemesh had received more than $13,500 from Pfizer that year in speaking fees, travel and meals, and more than $5,000 from Purdue the year before. He did not respond to repeated calls for comment, but Pfizer said he was not paid to testify and did not speak on behalf of any specific product.\u003c/p>\n\u003cp>\u003cstrong>Political Contributions Ramped Up\u003c/strong>\u003c/p>\n\u003cp>Purdue and Pfizer also have ramped up contributions to the Republican and Democratic attorneys general associations, which raise unlimited funds to help elect AGs across the country. In 2015 and 2016, they gave a total of $950,000 — more than in the previous four years combined.\u003c/p>\n\u003cp>To date, 51 attorneys general from U.S. states and territories have signed at least one of two National Association of Attorneys General letters to the FDA, urging the agency to favor abuse-deterrent drugs.\u003c/p>\n\u003cp>The pro-ADF playbook even includes a bit of political theater. In at least seven states, lawmakers or advocates have pounded the reformulated pills with hammers to demonstrate how difficult they are to smash.\u003c/p>\n\u003cp>In Illinois, it was Democratic Rep. Sara Feigenholtz wielding the hammer on the same committee that heard Terri Bartlett's testimony. The main sponsor of the bill prioritizing ADFs, Feigenholtz ranked second-highest among legislative recipients of money from Pfizer since the start of 2010, according to an analysis of data from the National Institute on Money in State Politics. The $6,200 she received during that period was more than she had received in the 14 previous years combined. Her bill passed the committee but later stalled in the Legislature and remains pending.\u003c/p>\n\u003cp>She did not return multiple requests for comment. Pfizer said its contributions to Feigenholtz go back 20 years and it would be \"inaccurate and misleading\" to suggest a tie to any one piece of legislation.\u003c/p>\n\u003cp>Bartlett said she doesn't mind that Purdue was ultimately responsible for her invitation to testify, even though she didn't know that at the time. She still supports the bill.\u003c/p>\n\u003cp>\"I want to believe that in every pharmaceutical company there still remains some sort of humanity,\" she said. \"Saving life is expensive.\"\u003c/p>\n\u003cp>\u003cstrong>'An addict can find a way'\u003c/strong>\u003c/p>\n\u003cp>The FDA has walked a careful line on the new drugs, promoting them as a promising approach to discouraging abuse while acknowledging their real-world benefits remain largely theoretical.\u003c/p>\n\u003cp>Earlier this year, the agency highlighted the drugs in its \"opioids action plan,\" issued after scathing criticism from some members of Congress that the FDA wasn't doing enough to combat the epidemic.\u003c/p>\n\u003cp>Thus far, the agency has approved seven drugs with labeling suggesting they are \"expected to\" discourage abuse, based on studies conducted by pharmaceutical companies.\u003c/p>\n\u003cp>But the FDA has not yet concluded that any of the products have a \"real-world impact\" on measures like overdose or death, according to Dr. Douglas Throckmorton, an agency deputy director. He and other regulators predict, however, that the reformulations will eventually translate into public health results.\u003c/p>\n\u003cp>\"We stand by those predictions,\" Throckmorton said at a recent public meeting on the drugs. \"We're confident in the science, we're confident in the assessments we conducted.\"\u003c/p>\n\u003cp>Even some former FDA advisers who support expanded use of the drugs say they are only part of the solution. Dr. Lewis Nelson, who previously chaired an FDA panel on drug safety, notes that the drugs don't deter the most common form of abuse: swallowing pills whole.\u003c/p>\n\u003cp>\"Certainly, you might not eat one and get high,\" he said. \"You eat three and get high.\"\u003c/p>\n\u003cp>At least one study found that while OxyContin's reformulation coincided with many abusers switching to other drugs, other users still were able to defeat the pills' technology and snort or inject the contents.\u003c/p>\n\u003cp>David Rook, a 40-year-old Henrico, Virginia, resident who now operates a recovery facility, was among them. Before entering treatment, he said, he would break down abuse-deterrent OxyContins and crush-resistant Opanas using water, lemon juice and a microwave.\u003c/p>\n\u003cp>\"The truth is an addict can find a way to abuse a medication one way or the other,\" he said.\u003c/p>\n\u003cp>\u003cstrong>Unpredictable Effects\u003c/strong>\u003c/p>\n\u003cp>A recent HIV outbreak in rural Indiana illustrates the sometimes unpredictable effect of ADFs on abusers' behavior.\u003c/p>\n\u003cp>Approximately 210 people have tested positive for the virus in Scott County since 2014, a public health crisis linked to needle-sharing among abusers of Opana. Endo Pharmaceuticals received approval for a reformulated version of the drug in 2011, making it harder to crush. As a result, many abusers switched from snorting the drug to injecting it with syringes, leading to the spread of the blood-borne HIV virus, according to the state health commissioner and other officials.\u003c/p>\n\u003cp>Endo spokeswoman Heather Zoumas Lubeski declined to comment on the outbreak, but issued a statement saying, \"Patient safety has always been a top priority for Endo and we are committed to providing patients with approved products that are safe and effective when used as prescribed.\"\u003c/p>\n\u003cp>The FDA declined to approve labeling claims for Opana's anti-abuse features, noting that the drug still can easily be cooked and injected.\u003c/p>\n\u003cp>Pfizer, Purdue, Endo and Teva Pharmaceuticals Industries Ltd. spent more than $20 million between 2012 and 2015 on federal lobbying efforts that included support of a bill that would require the FDA to gradually replace current opioids with harder-to-abuse versions that become available. Teva declined comment.\u003c/p>\n\u003cp>Rep. William Keating, D-Mass., first introduced the bill in 2012 and tried again in 2013 and 2015. Like his colleagues at the state level, he employed the hammer-smashing routine to illustrate the medications' crush-resistant properties.\u003c/p>\n\u003cp>Keating said the industry played no part in spurring the bill, even though the head of a nonprofit association funded by abuse-deterrent drugmakers spoke at the press conference introducing his legislation. He also received $2,500 in political contributions from makers of reformulated opioids in 2011 and 2012, a small fraction of his overall fundraising haul.\u003c/p>\n\u003cp>\"My interest in this stems from when I was a district attorney and I got to see the lives that were lost,\" Keating said in an interview.\u003c/p>\n\u003cp>While Keating's bill has not received a vote in Congress, the FDA already has begun moving in the direction suggested by companies, mapping out a process for removing older opioids from the market when newer versions are shown to be more effective at thwarting abuse.\u003c/p>\n\u003cp>\"You don't have to pass a bill, necessarily, to change policy,\" said Dan Cohen of the Abuse Deterrent Coalition, which represents smaller abuse-deterrent manufacturers.\u003c/p>\n\u003cp>The lack of real-world data on reformulated opioids is the main reason some federal officials haven't embraced them.\u003c/p>\n\u003cp>The CDC did not recommend ADFs in its landmark opioid guidelines this year, the first-ever federal recommendations for doctors prescribing the drugs. Why? Frieden, the agency's director, said his staff could not find any evidence showing the updated opioids actually reduce rates of addiction, overdoses or deaths.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Center for Public Integrity data reporter Ben Wieder contributed to this article.\u003c/em>\u003c/p>\n\n",
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"headline": "Drugmakers Push Unproven Solution to Opioid Epidemic They Helped Create",
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"nprByline": "Matthew Perrone\u003cbr />Geoff Mulvihill\u003cbr />Liz Essley Whyte\u003cbr />Associated Press and Center for Public Integrity",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Pilloried for their role in the epidemic of prescription painkiller abuse, drugmakers are aggressively pushing their remedy to the problem: a new generation of harder-to-manipulate opioids that have racked up billions in sales, even though there's little proof they reduce rates of overdoses or deaths.\u003c/p>\n\u003caside class=\"pullquote alignright\">Harder-to-manipulate opioids have racked up billions in sales, despite a lack of proof that they reduce overdoses.\u003c/aside>\n\u003cp>More than prescriptions are at stake. Critics worry the drugmakers' nationwide lobbying campaign is distracting from more productive solutions and delaying crucial efforts to steer physicians away from prescription opioids — addictive pain medications involved in the deaths of more than 165,000 Americans since 2000.\u003c/p>\n\u003cp>\"If we've learned one lesson from the last 20 years on opioids it's that these products have very, very high inherent risks,\" said Dr. Caleb Alexander, co-director of Johns Hopkins University's Center for Drug Safety and Effectiveness. \"My concern is that they'll contribute to a perception that there is a safe opioid, and there's no such thing as a fully safe opioid.\"\u003c/p>\n\u003cp>The latest drugs — known as abuse-deterrent formulations, or ADFs — are generally harder to crush or dissolve, which the drugmakers tout as making them difficult to snort or inject. But they still are vulnerable to manipulation and potentially addictive when simply swallowed. National data from an industry-sponsored tracking system also show drug abusers quickly drop the reformulated drugs in favor of older painkillers or heroin.\u003c/p>\n\u003cp>In the last two years, pharmaceutical companies have made a concerted under-the-radar push for bills benefiting the anti-abuse opioids in statehouses and in Congress, where proposed legislation would require the Food and Drug Administration to replace older opioids with the new drugs.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The lobbying push features industry-funded advocacy groups and physicians, along with grieving family members, who rarely disclosed the drugmakers' ties during their testimony in support of the drugs.\u003c/p>\n\u003cp>Besides the tamper-resistant pills, ADF opioids are being rolled out in other forms, including injectable drugs and pills that irritate users when they're snorted or contain substances that counteract highs.\u003c/p>\n\u003cp>\u003cstrong>Sales Opportunity\u003c/strong>\u003c/p>\n\u003cp>Making painkillers harder to abuse is a common-sense step. But it's also a multibillion-dollar sales opportunity, offering drugmakers the potential to wipe out lower-cost generic competitors and lock in sales of their higher-priced versions, which cost many times more than conventional pills. The big companies hold multiple patents on the reformulated drugs, shielding them from competition for years — in some cases decades.\u003c/p>\n\u003cp>Though abuse-deterrent painkillers represented less than 5 percent of all opioids prescribed last year, they generated more than $2.4 billion in sales, or roughly a quarter of the nearly $10 billion U.S. market for the drugs, according to IMS Health. The field is dominated by Purdue Pharma's OxyContin, patent-protected until 2030.\u003c/p>\n\u003cp>\"We at Purdue make certain that prescribers and other stakeholders understand that opioids with abuse-deterrent properties won't stop all prescription drug abuse, but they are an important part of the comprehensive approach needed to address this public health issue,\" Purdue spokesman Robert Josephson said in a statement.\u003c/p>\n\u003cp>Like a spokeswoman for Pfizer Inc., Josephson also noted that some public health officials, including the Food and Drug Administration, have endorsed using ADFs.\u003c/p>\n\u003cp>\"We need every tool that we can have in our toolbox,\" said Kentucky state Rep. Addia Wuchner, a Republican who has worked on several bills to benefit reformulated opioids. \"The extra steps are worth the effort in order to prevent this escalation of more addiction.\"\u003c/p>\n\u003cp>\u003cstrong>Massive Lobbying Effort\u003c/strong>\u003c/p>\n\u003cp>The current industry campaign draws on the same 50-state strategy that painkiller manufacturers successfully deployed to help kill or weaken measures aimed at stemming the tide of prescription opioids, a playbook The Associated Press and Center for Public Integrity exposed in September.\u003c/p>\n\u003cp>The \u003ca href=\"https://ww2.kqed.org/stateofhealth/2016/09/19/how-drugmakers-used-money-and-influence-to-shape-the-national-response-to-opioid-abuse/\" target=\"_blank\">reporting \u003c/a>detailed how opioid drugmakers and the nonprofits they help fund spent more than $880 million on lobbying and political contributions at the state and federal level over the past decade, eight times what the gun lobby reported for the same period. The money represents the drugmakers' spending on all their legislative interests, including opioids.\u003c/p>\n\u003cp>The FDA has approved a handful of the reformulated drugs but has not yet concluded that any reduce rates of addiction, abuse or death, and the evidence gap has led to diverging views among health authorities.\u003c/p>\n\u003cp>\u003cstrong>'No less addictive'\u003c/strong>\u003c/p>\n\u003cp>Whereas FDA regulators emphasize the potential promise of reformulated painkillers, other government officials stress that they contain the same heroin-like ingredients as traditional opioids. An estimated 78 Americans die from heroin and prescription opioid overdoses every day.\u003c/p>\n\u003cp>\"'Abuse-deterrent' sounds to people sometimes like 'Oh, maybe it's not addictive.' But it's no less addictive,\" said Dr. Tom Frieden, head of the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Survey results published this year in the Clinical Journal of Pain showed nearly half of U.S. physicians incorrectly believed that reformulated opioids are less addictive than their predecessors.\u003c/p>\n\u003cp>Many experts see a key role for ADFs in reducing the number of people who first begin abusing opioids, and some say the abuse-deterrent formulations should be the default painkiller for patients with histories of drug use, anxiety or depression. But even they worry that some drugmakers are overselling the technology. They stress that separate measures are needed for the majority of opioid abusers who ingest the pills orally.\u003c/p>\n\u003cp>\"The way they're handling the ADF is that this is the answer. And it's not the answer — it's part of the bigger puzzle,\" said Theodore Cicero, a psychiatry professor at Washington University in St. Louis, who has authored several studies on the drugs.\u003c/p>\n\u003cp>\u003cstrong>'You can't put a price tag on anybody's life'\u003c/strong>\u003c/p>\n\u003cp>Two years after the overdose that killed her 21-year-old son, Terri Bartlett traveled to Illinois' state capital to champion an unlikely cause: revamped painkillers.\u003c/p>\n\u003cp>Bartlett's son Michael became hooked on Vicodin and later graduated to heroin. In emotional testimony last year, she urged lawmakers to support a bill that would prioritize the new harder-to-crush pills, saying she believed her son would still be alive if abuse-deterrent formulations had been on the market then.\u003c/p>\n\u003cp>\"You can't put a price tag on anybody's life,\" she said.\u003c/p>\n\u003cp>Bartlett didn't know then that she had been recruited into a wide-ranging lobbying campaign. A public relations firm hired by OxyContin-maker Purdue had helped recruit her to support the bill, along with local sheriffs and fire chiefs.\u003c/p>\n\u003cp>Her words, and similar testimony from parents of drug abusers elsewhere, reflect a tactic used by the drugmakers across the country. For instance, Purdue paid nearly $95,000 for similar lobbying efforts in New York, state records show.\u003c/p>\n\u003cp>And the industry's fingerprints are easy to spot in other areas. Of more than 100 bills dealing with the drugs introduced in 35 states in 2015 and 2016, at least 49 featured nearly identical language requiring insurers to cover abuse-deterrent drugs, according to an analysis of data from Quorum, a legislative tracking service. Several of the bill sponsors said they received the wording from pharmaceutical lobbyists.\u003c/p>\n\u003cp>Since 2012, at least 21 bills related to the drugs have become law, including five that require insurers to pay for the more expensive drugs in Maine, Maryland, Massachusetts, Florida and West Virginia.\u003c/p>\n\u003cp>Wins in such states will give drugmakers momentum to successfully push for copycat laws elsewhere, noted Paul Kelly, a federal lobbyist who has worked on multistate lobbying campaigns for drugstores and major retailers.\u003c/p>\n\u003cp>\"It's like a foot in the door,\" he said.\u003c/p>\n\u003cp>\u003cstrong>Fierce Opposition\u003c/strong>\u003c/p>\n\u003cp>Drugmakers have found fierce opposition to their ADF legislation from insurers and employers who would be on the hook for the far pricier opioid variations.\u003c/p>\n\u003cp>The Illinois bill — and the 48 strikingly similar measures in other states — would require insurers to cover the drugs in the same way as other opioids, which the insurance companies argue would allow drugmakers to charge whatever they want for them.\u003c/p>\n\u003cp>\"That is not the best use of our medical care resources,\" Vernon Rowen, vice president of state government affairs for the insurance company Aetna, told Illinois lawmakers after Bartlett testified. \"It totally eliminates our ability to negotiate discounts with manufacturers.\"\u003c/p>\n\u003cp>New York Gov. Andrew Cuomo and New Jersey Gov. Chris Christie both vetoed such insurance mandates in the past year, citing the high costs and lack of evidence that the drugs help.\u003c/p>\n\u003cp>Federal health officials also have pushed back against requirements to cover the drugs, citing the \"staggering\" costs. For example, a 30-day supply of Pfizer's abuse-deterrent Embeda, a combination drug containing morphine, costs $268, while a 30-day supply of a generic morphine costs roughly $38, according to data compiled by Truven Health Analytics, a company that tracks drug prices set by manufacturers.\u003c/p>\n\u003cp>The Department of Veterans Affairs' Dr. Bernie Good estimated that converting the 8.8 million patient system exclusively to the new reformulations would increase opioid spending more than tenfold, to over $1.6 billion annually. Good, who co-directs the VA's program for medication safety, said the vast majority of veterans are not at risk for snorting or injecting their medications.\u003c/p>\n\u003cp>\"Would the excess money to pay for abuse-deterrent products — mostly to pay for it in cases where it wouldn't be necessary — be better spent for drug treatment centers?\" he asked at a recent federal meeting on the drugs.\u003c/p>\n\u003cp>Federal estimates say at least 2.2 million Americans are addicted to prescription opioids or heroin, yet only one in five actually receives treatment, according to a Surgeon General's report published last month. That's despite some $35 billion already spent annually on substance abuse programs by private and public health providers.\u003c/p>\n\u003cp>State lawmakers who support the abuse-deterrent bills often defend them as an important piece of solving the opioid puzzle, preventing more costly overdoses and hospitalizations.\u003c/p>\n\u003cp>And Fred Brason, executive director of Project Lazarus, a North Carolina-based group that promotes anti-addiction policies in several states, called the focus on the drugs' cost too narrow.\u003c/p>\n\u003cp>\"You're already spending that money at the back end,\" he said. \"You're spending it at the emergency department.\" He also noted the costs of addiction treatment.\u003c/p>\n\u003cp>\u003cstrong>Industry-Supported Groups and Physicians\u003c/strong>\u003c/p>\n\u003cp>When critics raise alarms about higher costs and limited evidence, drugmakers can rely on groups they support financially to argue their side, including the National Association of Drug Diversion Investigators, the Academy of Integrative Pain Management and the Partnership for Drug-Free Kids. Representatives from those groups have testified in favor of abuse-deterrent legislation in at least seven states.\u003c/p>\n\u003cp>NADDI president Charlie Cichon acknowledged his group receives funds from several ADF-makers, but said it views the drugs as a proven part of the solution to the opioid crisis. \"We're not testifying for Purdue Pharma's product or Endo's product,\" he said.\u003c/p>\n\u003cp>And Bob Twillman, executive director of the Academy, said, \"Increased use of abuse-deterrent opioids makes it more likely that those patients who need opiates to treat their pain will be able to get them.\"\u003c/p>\n\u003cp>The Partnership for Drug-Free Kids did not respond to multiple requests for comment.\u003c/p>\n\u003cp>Physicians with financial ties to drugmakers play similar roles. Dr. Gareth Shemesh, a pain specialist, testified in support of a Colorado bill last year brought to the sponsoring legislator by Pfizer. Shemesh had received more than $13,500 from Pfizer that year in speaking fees, travel and meals, and more than $5,000 from Purdue the year before. He did not respond to repeated calls for comment, but Pfizer said he was not paid to testify and did not speak on behalf of any specific product.\u003c/p>\n\u003cp>\u003cstrong>Political Contributions Ramped Up\u003c/strong>\u003c/p>\n\u003cp>Purdue and Pfizer also have ramped up contributions to the Republican and Democratic attorneys general associations, which raise unlimited funds to help elect AGs across the country. In 2015 and 2016, they gave a total of $950,000 — more than in the previous four years combined.\u003c/p>\n\u003cp>To date, 51 attorneys general from U.S. states and territories have signed at least one of two National Association of Attorneys General letters to the FDA, urging the agency to favor abuse-deterrent drugs.\u003c/p>\n\u003cp>The pro-ADF playbook even includes a bit of political theater. In at least seven states, lawmakers or advocates have pounded the reformulated pills with hammers to demonstrate how difficult they are to smash.\u003c/p>\n\u003cp>In Illinois, it was Democratic Rep. Sara Feigenholtz wielding the hammer on the same committee that heard Terri Bartlett's testimony. The main sponsor of the bill prioritizing ADFs, Feigenholtz ranked second-highest among legislative recipients of money from Pfizer since the start of 2010, according to an analysis of data from the National Institute on Money in State Politics. The $6,200 she received during that period was more than she had received in the 14 previous years combined. Her bill passed the committee but later stalled in the Legislature and remains pending.\u003c/p>\n\u003cp>She did not return multiple requests for comment. Pfizer said its contributions to Feigenholtz go back 20 years and it would be \"inaccurate and misleading\" to suggest a tie to any one piece of legislation.\u003c/p>\n\u003cp>Bartlett said she doesn't mind that Purdue was ultimately responsible for her invitation to testify, even though she didn't know that at the time. She still supports the bill.\u003c/p>\n\u003cp>\"I want to believe that in every pharmaceutical company there still remains some sort of humanity,\" she said. \"Saving life is expensive.\"\u003c/p>\n\u003cp>\u003cstrong>'An addict can find a way'\u003c/strong>\u003c/p>\n\u003cp>The FDA has walked a careful line on the new drugs, promoting them as a promising approach to discouraging abuse while acknowledging their real-world benefits remain largely theoretical.\u003c/p>\n\u003cp>Earlier this year, the agency highlighted the drugs in its \"opioids action plan,\" issued after scathing criticism from some members of Congress that the FDA wasn't doing enough to combat the epidemic.\u003c/p>\n\u003cp>Thus far, the agency has approved seven drugs with labeling suggesting they are \"expected to\" discourage abuse, based on studies conducted by pharmaceutical companies.\u003c/p>\n\u003cp>But the FDA has not yet concluded that any of the products have a \"real-world impact\" on measures like overdose or death, according to Dr. Douglas Throckmorton, an agency deputy director. He and other regulators predict, however, that the reformulations will eventually translate into public health results.\u003c/p>\n\u003cp>\"We stand by those predictions,\" Throckmorton said at a recent public meeting on the drugs. \"We're confident in the science, we're confident in the assessments we conducted.\"\u003c/p>\n\u003cp>Even some former FDA advisers who support expanded use of the drugs say they are only part of the solution. Dr. Lewis Nelson, who previously chaired an FDA panel on drug safety, notes that the drugs don't deter the most common form of abuse: swallowing pills whole.\u003c/p>\n\u003cp>\"Certainly, you might not eat one and get high,\" he said. \"You eat three and get high.\"\u003c/p>\n\u003cp>At least one study found that while OxyContin's reformulation coincided with many abusers switching to other drugs, other users still were able to defeat the pills' technology and snort or inject the contents.\u003c/p>\n\u003cp>David Rook, a 40-year-old Henrico, Virginia, resident who now operates a recovery facility, was among them. Before entering treatment, he said, he would break down abuse-deterrent OxyContins and crush-resistant Opanas using water, lemon juice and a microwave.\u003c/p>\n\u003cp>\"The truth is an addict can find a way to abuse a medication one way or the other,\" he said.\u003c/p>\n\u003cp>\u003cstrong>Unpredictable Effects\u003c/strong>\u003c/p>\n\u003cp>A recent HIV outbreak in rural Indiana illustrates the sometimes unpredictable effect of ADFs on abusers' behavior.\u003c/p>\n\u003cp>Approximately 210 people have tested positive for the virus in Scott County since 2014, a public health crisis linked to needle-sharing among abusers of Opana. Endo Pharmaceuticals received approval for a reformulated version of the drug in 2011, making it harder to crush. As a result, many abusers switched from snorting the drug to injecting it with syringes, leading to the spread of the blood-borne HIV virus, according to the state health commissioner and other officials.\u003c/p>\n\u003cp>Endo spokeswoman Heather Zoumas Lubeski declined to comment on the outbreak, but issued a statement saying, \"Patient safety has always been a top priority for Endo and we are committed to providing patients with approved products that are safe and effective when used as prescribed.\"\u003c/p>\n\u003cp>The FDA declined to approve labeling claims for Opana's anti-abuse features, noting that the drug still can easily be cooked and injected.\u003c/p>\n\u003cp>Pfizer, Purdue, Endo and Teva Pharmaceuticals Industries Ltd. spent more than $20 million between 2012 and 2015 on federal lobbying efforts that included support of a bill that would require the FDA to gradually replace current opioids with harder-to-abuse versions that become available. Teva declined comment.\u003c/p>\n\u003cp>Rep. William Keating, D-Mass., first introduced the bill in 2012 and tried again in 2013 and 2015. Like his colleagues at the state level, he employed the hammer-smashing routine to illustrate the medications' crush-resistant properties.\u003c/p>\n\u003cp>Keating said the industry played no part in spurring the bill, even though the head of a nonprofit association funded by abuse-deterrent drugmakers spoke at the press conference introducing his legislation. He also received $2,500 in political contributions from makers of reformulated opioids in 2011 and 2012, a small fraction of his overall fundraising haul.\u003c/p>\n\u003cp>\"My interest in this stems from when I was a district attorney and I got to see the lives that were lost,\" Keating said in an interview.\u003c/p>\n\u003cp>While Keating's bill has not received a vote in Congress, the FDA already has begun moving in the direction suggested by companies, mapping out a process for removing older opioids from the market when newer versions are shown to be more effective at thwarting abuse.\u003c/p>\n\u003cp>\"You don't have to pass a bill, necessarily, to change policy,\" said Dan Cohen of the Abuse Deterrent Coalition, which represents smaller abuse-deterrent manufacturers.\u003c/p>\n\u003cp>The lack of real-world data on reformulated opioids is the main reason some federal officials haven't embraced them.\u003c/p>\n\u003cp>The CDC did not recommend ADFs in its landmark opioid guidelines this year, the first-ever federal recommendations for doctors prescribing the drugs. Why? Frieden, the agency's director, said his staff could not find any evidence showing the updated opioids actually reduce rates of addiction, overdoses or deaths.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>Center for Public Integrity data reporter Ben Wieder contributed to this article.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "STD Infections Rise to New Highs After States Close Health Clinics",
"title": "STD Infections Rise to New Highs After States Close Health Clinics",
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"content": "\u003cp>The number of people infected with three major sexually transmitted diseases is at an all-time high, according to a CDC report released Wednesday. And the increase in reported cases of chlamydia, gonorrhea and syphilis is hitting teenagers and young adults hardest.\u003c/p>\n\u003cp>Over half of gonorrhea and chlamydia cases are in people under the age of 25, says Dr. \u003ca href=\"http://www.cdc.gov/about/leadership/new-leaders/nchhstp.html\">Jonathan Mermin\u003c/a>, director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention for the CDC.\u003c/p>\n\u003cp>These STDs can have serious long term health consequences, including chronic pain and fertility problems. Pregnant women can pass syphilis on to their children, leading to \u003ca href=\"http://www.npr.org/sections/health-shots/2015/11/12/455768422/more-babies-are-dying-because-of-congenital-syphilis\">stillbirth or birth defects\u003c/a>.\u003c/p>\n\u003cp>State and local budget cuts to STD care and prevention programs are major drivers in the surge in STDs, Mermin says.\u003c/p>\n\u003cp>\"Our ability to prevent STDs is only as strong as the public health infrastructure to support it,\" he says. \"More than half of state and local STD programs have experienced budget cuts. In 2012, 20 health departments reported having to close their STD clinics.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Syphilis infections have been increasing at a particularly troubling rate, \u003ca href=\"http://www.cdc.gov/nchhstp/newsroom/2016/2015-std-surveillance-report.html\">according to the report\u003c/a>. In 2015, 23,872 cases were reported, a 19 percent increase since 2014. \u003ca href=\"http://www.cdc.gov/std/syphilis/stdfact-syphilis.htm\">Syphilis\u003c/a> cases have been going up over the past decade, while the spike in cases of chlamydia and gonorrhea is more recent.\u003c/p>\n\u003cp>There were 395,216 cases of \u003ca href=\"http://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea.htm\">gonorrhea\u003c/a> and 1.5 million cases of \u003ca href=\"http://www.cdc.gov/std/chlamydia/stdfact-chlamydia.htm\">chlamydia \u003c/a>reported in the same year, showing a rise of 6 and 13 percent over the past year. All three infections can be treated with antibiotics, though gonorrhea is becoming \u003ca href=\"http://www.npr.org/sections/thetwo-way/2016/08/30/491969011/u-n-health-officials-warn-gonorrhea-is-becoming-untreatable\">increasingly resistant to antibiotics\u003c/a>.\u003c/p>\n\u003cp>\"This basically tells us we have to do a better job of reach out to some of these communities that are disproportionately affected by these infections,\" says \u003ca href=\"https://internalmedicine.osu.edu/infectiousdisease/directory/faculty/josebazan/\">Dr. Jose Bazan\u003c/a>, a medical director for an STD clinic at Columbus Public Health and an assistant professor of internal medicine at Ohio State University who was not involved with the report.\u003c/p>\n\u003cp>Men who have sex with men face a greater risk of being infected with syphilis. Over 80 percent of male syphilis cases were reported among gay and bisexual males, and over 90 percent of all syphilis cases were in men. People in racial and sexual minority groups can have more than the usual trouble finding care for preventing and treating STDs.\u003c/p>\n\u003cp>According to a congressional briefing last April by Dr. Gail Bolan, the director for the CDC Division of STD Prevention, over 40 percent of health departments reduced clinic hours, screening, or tracing people who may have been infected.\u003c/p>\n\u003cp>\"If that infrastructure gets STDeroded, people are more likely to have their STDs for a longer period of time, and that can lead to increased transmission,\" Mermin says.\u003c/p>\n\u003cp>The federal government also helps fund state and local STD programs through the CDC, but federal funds have not helped make up for some of the budget cuts on the local level, according to \u003ca href=\"http://www.ncsddc.org/who-we-are/board\">David Harvey\u003c/a>, the executive director for the National Coalition of STD Directors.\u003c/p>\n\u003cp>\"We believe there's a direct relationship between budget cuts and increases in STDs in the United States. There has been no federal increases for STD programs in this country since 2003,\" he says.\u003c/p>\n\u003cp>If the trend is to be reversed, Mermin says there needs to be a real investment in STD prevention so that clinics can monitor these diseases and quickly diagnose and treat people who are infected.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"We've seen success in the past where investments have paid off,\" he says. \"We know what we need to do. We just need to do it more effectively than we've been able to do with this eroding infrastructure.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=STD+Infections+Rise+To+New+Highs+After+States+Close+Health+Clinics&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The number of people infected with three major sexually transmitted diseases is at an all-time high, according to a CDC report released Wednesday. And the increase in reported cases of chlamydia, gonorrhea and syphilis is hitting teenagers and young adults hardest.\u003c/p>\n\u003cp>Over half of gonorrhea and chlamydia cases are in people under the age of 25, says Dr. \u003ca href=\"http://www.cdc.gov/about/leadership/new-leaders/nchhstp.html\">Jonathan Mermin\u003c/a>, director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention for the CDC.\u003c/p>\n\u003cp>These STDs can have serious long term health consequences, including chronic pain and fertility problems. Pregnant women can pass syphilis on to their children, leading to \u003ca href=\"http://www.npr.org/sections/health-shots/2015/11/12/455768422/more-babies-are-dying-because-of-congenital-syphilis\">stillbirth or birth defects\u003c/a>.\u003c/p>\n\u003cp>State and local budget cuts to STD care and prevention programs are major drivers in the surge in STDs, Mermin says.\u003c/p>\n\u003cp>\"Our ability to prevent STDs is only as strong as the public health infrastructure to support it,\" he says. \"More than half of state and local STD programs have experienced budget cuts. In 2012, 20 health departments reported having to close their STD clinics.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Syphilis infections have been increasing at a particularly troubling rate, \u003ca href=\"http://www.cdc.gov/nchhstp/newsroom/2016/2015-std-surveillance-report.html\">according to the report\u003c/a>. In 2015, 23,872 cases were reported, a 19 percent increase since 2014. \u003ca href=\"http://www.cdc.gov/std/syphilis/stdfact-syphilis.htm\">Syphilis\u003c/a> cases have been going up over the past decade, while the spike in cases of chlamydia and gonorrhea is more recent.\u003c/p>\n\u003cp>There were 395,216 cases of \u003ca href=\"http://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea.htm\">gonorrhea\u003c/a> and 1.5 million cases of \u003ca href=\"http://www.cdc.gov/std/chlamydia/stdfact-chlamydia.htm\">chlamydia \u003c/a>reported in the same year, showing a rise of 6 and 13 percent over the past year. All three infections can be treated with antibiotics, though gonorrhea is becoming \u003ca href=\"http://www.npr.org/sections/thetwo-way/2016/08/30/491969011/u-n-health-officials-warn-gonorrhea-is-becoming-untreatable\">increasingly resistant to antibiotics\u003c/a>.\u003c/p>\n\u003cp>\"This basically tells us we have to do a better job of reach out to some of these communities that are disproportionately affected by these infections,\" says \u003ca href=\"https://internalmedicine.osu.edu/infectiousdisease/directory/faculty/josebazan/\">Dr. Jose Bazan\u003c/a>, a medical director for an STD clinic at Columbus Public Health and an assistant professor of internal medicine at Ohio State University who was not involved with the report.\u003c/p>\n\u003cp>Men who have sex with men face a greater risk of being infected with syphilis. Over 80 percent of male syphilis cases were reported among gay and bisexual males, and over 90 percent of all syphilis cases were in men. People in racial and sexual minority groups can have more than the usual trouble finding care for preventing and treating STDs.\u003c/p>\n\u003cp>According to a congressional briefing last April by Dr. Gail Bolan, the director for the CDC Division of STD Prevention, over 40 percent of health departments reduced clinic hours, screening, or tracing people who may have been infected.\u003c/p>\n\u003cp>\"If that infrastructure gets STDeroded, people are more likely to have their STDs for a longer period of time, and that can lead to increased transmission,\" Mermin says.\u003c/p>\n\u003cp>The federal government also helps fund state and local STD programs through the CDC, but federal funds have not helped make up for some of the budget cuts on the local level, according to \u003ca href=\"http://www.ncsddc.org/who-we-are/board\">David Harvey\u003c/a>, the executive director for the National Coalition of STD Directors.\u003c/p>\n\u003cp>\"We believe there's a direct relationship between budget cuts and increases in STDs in the United States. There has been no federal increases for STD programs in this country since 2003,\" he says.\u003c/p>\n\u003cp>If the trend is to be reversed, Mermin says there needs to be a real investment in STD prevention so that clinics can monitor these diseases and quickly diagnose and treat people who are infected.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"We've seen success in the past where investments have paid off,\" he says. \"We know what we need to do. We just need to do it more effectively than we've been able to do with this eroding infrastructure.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=STD+Infections+Rise+To+New+Highs+After+States+Close+Health+Clinics&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Women are less likely to die of breast cancer than they were a decade ago, but not all women are benefiting from that trend.\u003c/p>\n\u003cp>White women saw more of a drop in death rates than black women — 1.9 percent a year from 2010 to 2014, compared to a 1.5 percent decrease for black women, according to a \u003ca href=\"http://www.cdc.gov/mmwr/volumes/65/wr/mm6540a1.htm?s_cid=mm6540a1_w\">report\u003c/a> published Thursday by the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>And while the death rates for women under 50 declined regardless of race, older black women are more likely to die of breast cancer than are white women.\u003c/p>\n\u003cp>That's especially troubling because 40 years ago, black women were less likely to get breast cancer. That's changed. Black women's breast cancer risk is \u003ca href=\"http://www.npr.org/sections/health-shots/2015/10/29/452650557/black-womens-breast-cancer-risk-rises-to-equal-white-womens\">now the same\u003c/a> as that of white women's, and black women are 41 percent more likely to die of the disease.\u003c/p>\n\u003cp>There can be some good reasons for the rise in the number of black women being diagnosed with breast cancer, like more women getting screening mammograms. But there are bad reasons, too.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The CDC report cites calorie-dense foods, lack of exercise and increasing rates of obesity as potential reasons.\u003c/p>\n\u003cp>And while this report found similar reductions in deaths among younger black and white women, older white women saw their death rates drop by 2 percent a year, compared to 1 percent in black women.\u003c/p>\n\u003cp>Access to care is one big reason why, according to \u003ca href=\"http://www.cancer.org/research/acsresearchers/otis-brawley-md-facp\">Otis Brawley\u003c/a>, chief medical and scientific officer for the American Cancer Society.\u003c/p>\n\u003cp>\"Forty to 50 percent of black women get less than optimal care for breast cancer, whether it's mammography or treatment,\" Brawley says.\u003c/p>\n\u003cp>They're not alone in that; poor white women are also much less likely to get adequate care, and more likely to die as a result.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"We need to focus on getting good care, high-quality care to everybody,\" Brawley adds. \"We need to realize that in the United States of America in 2016 a substantial proportion of Americans with cancer get absolutely atrocious care.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Breast+Cancer+Death+Rates+Are+Down%2C+But+Racial+Disparities+Persist&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Women are less likely to die of breast cancer than they were a decade ago, but not all women are benefiting from that trend.\u003c/p>\n\u003cp>White women saw more of a drop in death rates than black women — 1.9 percent a year from 2010 to 2014, compared to a 1.5 percent decrease for black women, according to a \u003ca href=\"http://www.cdc.gov/mmwr/volumes/65/wr/mm6540a1.htm?s_cid=mm6540a1_w\">report\u003c/a> published Thursday by the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>And while the death rates for women under 50 declined regardless of race, older black women are more likely to die of breast cancer than are white women.\u003c/p>\n\u003cp>That's especially troubling because 40 years ago, black women were less likely to get breast cancer. That's changed. Black women's breast cancer risk is \u003ca href=\"http://www.npr.org/sections/health-shots/2015/10/29/452650557/black-womens-breast-cancer-risk-rises-to-equal-white-womens\">now the same\u003c/a> as that of white women's, and black women are 41 percent more likely to die of the disease.\u003c/p>\n\u003cp>There can be some good reasons for the rise in the number of black women being diagnosed with breast cancer, like more women getting screening mammograms. But there are bad reasons, too.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The CDC report cites calorie-dense foods, lack of exercise and increasing rates of obesity as potential reasons.\u003c/p>\n\u003cp>And while this report found similar reductions in deaths among younger black and white women, older white women saw their death rates drop by 2 percent a year, compared to 1 percent in black women.\u003c/p>\n\u003cp>Access to care is one big reason why, according to \u003ca href=\"http://www.cancer.org/research/acsresearchers/otis-brawley-md-facp\">Otis Brawley\u003c/a>, chief medical and scientific officer for the American Cancer Society.\u003c/p>\n\u003cp>\"Forty to 50 percent of black women get less than optimal care for breast cancer, whether it's mammography or treatment,\" Brawley says.\u003c/p>\n\u003cp>They're not alone in that; poor white women are also much less likely to get adequate care, and more likely to die as a result.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"We need to focus on getting good care, high-quality care to everybody,\" Brawley adds. \"We need to realize that in the United States of America in 2016 a substantial proportion of Americans with cancer get absolutely atrocious care.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Breast+Cancer+Death+Rates+Are+Down%2C+But+Racial+Disparities+Persist&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "FDA has a Backlog of More Than 4,000 Applicants to Create EpiPen Generic Drug",
"title": "FDA has a Backlog of More Than 4,000 Applicants to Create EpiPen Generic Drug",
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"content": "\u003cp>Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threatening allergic reactions, and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration.\u003c/p>\n\u003cp>Even after the agency started levying user fees on drugmakers in 2012 to pay for more people to review the medicines, the backlog of decisions still stretches almost four years.\u003c/p>\n\u003cp>As of July 1, the FDA had 4,036 generic drug applications \u003ca href=\"http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM511473.pdf\">awaiting approval\u003c/a>\u003cstrong>, \u003c/strong>and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, a trade group. The FDA has approved more generics in the past few years, but a flood of applications has added to the problem.\u003c/p>\n\u003cp>[contextly_sidebar id=\"BGNOLWPxZUn1WMw7B7RxLMvMuglmKPhF\"]\u003c/p>\n\u003cp>By comparison, the European Medicines Agency, Europe's version of the FDA, has just 24 generics, including \u003ca href=\"http://www.npr.org/sections/health-shots/2015/03/10/388668910/fda-decision-signals-new-competition-for-some-of-the-costliest-drugs\">biologically based biosimilars\u003c/a> awaiting approval. The FDA's generic count doesn't include biosimilars, which are more complicated medicines to review. The EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand-name drugs in about a year on average, according to the EMA.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long. Other off-patent drugs with rising prices and no generic competition have also drawn scrutiny, including Turing Pharmaceuticals' Daraprim, for toxoplasmosis, and Valeant's cardiovascular drugs Isuprel and Nitropress.\u003c/p>\n\u003cp>\u003cstrong>Congress asks why generic version of EpiPens aren't available\u003c/strong>\u003c/p>\n\u003cp>\"We are concerned that Mylan (maker of the EpiPen) has not faced much competition for its product,\" five U.S. senators \u003ca href=\"http://www.grassley.senate.gov/sites/default/files/constituents/upload/2016-08-24%20CEG%20PJ%20AK%20RB%20RJ%20to%20FDA%20(Mylan%20EpiPen)_Redacted.pdf\">wrote Aug. 24\u003c/a> to FDA Commissioner Dr. Robert Califf, adding that one of EpiPen's nongeneric competitors, Auvi-Q, was recalled in October, granting Mylan a near monopoly. \"News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved.\"\u003c/p>\n\u003cp>On Monday, three members of the House Committee on Energy and Commerce \u003ca href=\"https://energycommerce.house.gov/news-center/press-releases/epipen-costs-soar-ec-leaders-press-fda-answers-agency-s-regulatory\">wrote a similar letter\u003c/a> to the FDA, seeking information about the EpiPen generic applications it has received and how they've been prioritized.\u003c/p>\n\u003cp>When asked whether the FDA bears any responsibility for the lack of EpiPen competition, FDA spokesman Kristofer Baumgartner said he couldn't comment on pending applications or confirm their existence, citing confidentiality rules. But he stressed that the FDA pushes pending applications for drugs with no current generics to the front of the line and approved 580 generics in 2015, a record for the agency and 40 percent more than in 2014.\u003c/p>\n\u003cp>\"The FDA is confident that the overall trend in actions on generic drug applications will be one of continuing improvement,\" Baumgartner said.\u003c/p>\n\u003cp>In March, generics giant Teva Pharmaceuticals \u003ca href=\"http://www.bloomberg.com/news/articles/2016-03-01/mylan-s-epipen-gets-boost-as-fda-spots-holes-in-teva-application?cmpid=yhoo.headline\">told investors \u003c/a>that its generic version of EpiPen was rejected by the FDA, and that it wouldn't be able to launch the generic until at least 2017. Adamis Pharmaceuticals \u003ca href=\"http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2175190\">reported\u003c/a> a similar rejection from the FDA for its EpiPen generic in June.\u003c/p>\n\u003cp>Mylan has \u003ca href=\"http://www.npr.org/sections/health-shots/2016/08/29/491797051/maker-of-epipen-to-sell-generic-version-for-half-the-price\">said it will offer a $300 generic\u003c/a> in the coming weeks. Because Mylan also makes the brand-name product, it won't have to wait in line behind other pending generics.\u003c/p>\n\u003cp>Dr. James Baker, the CEO and chief medical officer of the advocacy group Food Allergy and Research Education, said Mylan's move may deter other generic manufacturers from seeking approval. Adrenaclick is the only other epinephrine auto-injector on the market, but it isn't an exact generic of EpiPen and can't be swapped automatically at the pharmacy if a doctor has written a prescription for EpiPen.\u003c/p>\n\u003cp>Adrenaclick also isn't widely available. \"You call up 100 pharmacies, and maybe 10 have the device, from what we gather,\" Baker said of Adrenaclick.\u003c/p>\n\u003cp>He said several factors have allowed EpiPen's price tag to swell over the years. Many patients were in the dark about EpiPen price increases until insurers started shifting more of the cost onto consumers a few years ago, and getting approval for a generic that's both a drug and a device is more complicated than getting approval for a drug alone, he said.\u003c/p>\n\u003cp>Meanwhile, Mylan has aggressively marketed its product and raised doubts about alternatives.\u003c/p>\n\u003cp>And documents show that Mylan submitted a citizen petition to the FDA arguing that people trained to use EpiPens wouldn't be able to use Teva's pending generic epinephrine auto-injector because of design differences.\u003c/p>\n\u003cp>\"Is Mylan doing anything illegal? No,\" Baker said. \"It's taking advantage of all these things to take the market and basically push it to an extreme.\"\u003c/p>\n\u003cp>\u003cstrong>User fees levied to speed up the approval process\u003c/strong>\u003c/p>\n\u003cp>The FDA's generic backlog isn't a new problem. In 2012, it was so large that it prompted the government to start charging user fees to generic manufacturers to provide the funds for the FDA to speed the process. The fees built on the 20-year-old\u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069943.htm\">Prescription Drug User Fee Act\u003c/a>, which required brand-name drugmakers to pay fees to expand FDA's capacity to review applications for those medicines. In the first three years, the FDA collected $1 billion from generic drug manufacturers.\u003c/p>\n\u003cp>The fees were used to hire an additional 1,000 employees, and put the Office of Generic Drugs on par with the Office of New Drugs by reorganizing it and moving it from four outlying buildings to the FDA's main campus in Silver Spring, Md.\u003c/p>\n\u003cp>The funds were also used to upgrade the office's information technology. The FDA says on its \u003ca href=\"http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm\">website\u003c/a>: \"Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.\"\u003c/p>\n\u003cp>In October 2012, there was a backlog of 2,868 generic drugs awaiting approval, and the FDA said it would take a \"first action\" on 90 percent of these drugs by 2017. This summer, the agency met its goal a year early, but a first action isn't an approval. Instead, it stops the review clock and puts the applications back in industry's court.\u003c/p>\n\u003cp>Only 1,551 generics have been approved since the fees on drugmakers were initiated, and that total includes some extra applications that weren't considered part of the official backlog. So, all told, the agency has only approved about half of the backlogged generics that were awaiting approval in 2012.\u003c/p>\n\u003cp>\"Most applications from the backlog will need to come back to FDA for additional review due to deficiencies in the submissions, before approval is possible,\" the agency said in a statement in responses to questions.\u003c/p>\n\u003cp>David Gaugh, senior vice president for science and regulatory affairs at the Generic Pharmaceuticals Association, \u003ca href=\"http://www.gphaonline.org/gpha-media/press/statement-by-david-gaugh-senior-vice-president-sciences-and-regulatory-affairs-gpha-regarding-the-senate-help-hearing-on-gdufa/\">said\u003c/a> standards used to compile generic applications when they were submitted three or four years ago have changed while the applications were sitting in the backlog. So when the FDA got back to those companies, it said the applications were of \"poor quality.\"\u003c/p>\n\u003cp>The applications for generic drugs have continued to pile up even as the FDA approved a record number of generics in 2015 and again in the first seven months of 2016. The number of generic drug applications tripled from 2002 to 2012, according to January congressional \u003ca href=\"http://www.fda.gov/NewsEvents/Testimony/ucm484304.htm\">testimony \u003c/a>from Janet Woodcock, who directs the FDA's Center for Drug Evaluation and Research.\u003c/p>\n\u003cp>Still, some see signs the agency is on the right track.\u003c/p>\n\u003cp>\"I think that it is an optimistic picture overall ... at the FDA, there's been a lot of progress, and I think there is more to be made,\" said \u003ca href=\"http://www.drugepi.org/faculty-staff-trainees/faculty/aaron-kesselheim/\">Dr. Aaron Kesselheim\u003c/a>, an interdisciplinary drug researcher at Harvard Medical School and Brigham and Women's Hospital. \"This is not something that people should think has been solved at this point. It's totally an ongoing process.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Follow Sydney Lupkin \u003c/em>\u003cem>on Twitter:\u003c/em>\u003ca href=\"https://twitter.com/slupkin\">@slupkin\u003c/a>.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threatening allergic reactions, and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration.\u003c/p>\n\u003cp>Even after the agency started levying user fees on drugmakers in 2012 to pay for more people to review the medicines, the backlog of decisions still stretches almost four years.\u003c/p>\n\u003cp>As of July 1, the FDA had 4,036 generic drug applications \u003ca href=\"http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM511473.pdf\">awaiting approval\u003c/a>\u003cstrong>, \u003c/strong>and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, a trade group. The FDA has approved more generics in the past few years, but a flood of applications has added to the problem.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>By comparison, the European Medicines Agency, Europe's version of the FDA, has just 24 generics, including \u003ca href=\"http://www.npr.org/sections/health-shots/2015/03/10/388668910/fda-decision-signals-new-competition-for-some-of-the-costliest-drugs\">biologically based biosimilars\u003c/a> awaiting approval. The FDA's generic count doesn't include biosimilars, which are more complicated medicines to review. The EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand-name drugs in about a year on average, according to the EMA.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long. Other off-patent drugs with rising prices and no generic competition have also drawn scrutiny, including Turing Pharmaceuticals' Daraprim, for toxoplasmosis, and Valeant's cardiovascular drugs Isuprel and Nitropress.\u003c/p>\n\u003cp>\u003cstrong>Congress asks why generic version of EpiPens aren't available\u003c/strong>\u003c/p>\n\u003cp>\"We are concerned that Mylan (maker of the EpiPen) has not faced much competition for its product,\" five U.S. senators \u003ca href=\"http://www.grassley.senate.gov/sites/default/files/constituents/upload/2016-08-24%20CEG%20PJ%20AK%20RB%20RJ%20to%20FDA%20(Mylan%20EpiPen)_Redacted.pdf\">wrote Aug. 24\u003c/a> to FDA Commissioner Dr. Robert Califf, adding that one of EpiPen's nongeneric competitors, Auvi-Q, was recalled in October, granting Mylan a near monopoly. \"News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved.\"\u003c/p>\n\u003cp>On Monday, three members of the House Committee on Energy and Commerce \u003ca href=\"https://energycommerce.house.gov/news-center/press-releases/epipen-costs-soar-ec-leaders-press-fda-answers-agency-s-regulatory\">wrote a similar letter\u003c/a> to the FDA, seeking information about the EpiPen generic applications it has received and how they've been prioritized.\u003c/p>\n\u003cp>When asked whether the FDA bears any responsibility for the lack of EpiPen competition, FDA spokesman Kristofer Baumgartner said he couldn't comment on pending applications or confirm their existence, citing confidentiality rules. But he stressed that the FDA pushes pending applications for drugs with no current generics to the front of the line and approved 580 generics in 2015, a record for the agency and 40 percent more than in 2014.\u003c/p>\n\u003cp>\"The FDA is confident that the overall trend in actions on generic drug applications will be one of continuing improvement,\" Baumgartner said.\u003c/p>\n\u003cp>In March, generics giant Teva Pharmaceuticals \u003ca href=\"http://www.bloomberg.com/news/articles/2016-03-01/mylan-s-epipen-gets-boost-as-fda-spots-holes-in-teva-application?cmpid=yhoo.headline\">told investors \u003c/a>that its generic version of EpiPen was rejected by the FDA, and that it wouldn't be able to launch the generic until at least 2017. Adamis Pharmaceuticals \u003ca href=\"http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&p=irol-newsArticle&ID=2175190\">reported\u003c/a> a similar rejection from the FDA for its EpiPen generic in June.\u003c/p>\n\u003cp>Mylan has \u003ca href=\"http://www.npr.org/sections/health-shots/2016/08/29/491797051/maker-of-epipen-to-sell-generic-version-for-half-the-price\">said it will offer a $300 generic\u003c/a> in the coming weeks. Because Mylan also makes the brand-name product, it won't have to wait in line behind other pending generics.\u003c/p>\n\u003cp>Dr. James Baker, the CEO and chief medical officer of the advocacy group Food Allergy and Research Education, said Mylan's move may deter other generic manufacturers from seeking approval. Adrenaclick is the only other epinephrine auto-injector on the market, but it isn't an exact generic of EpiPen and can't be swapped automatically at the pharmacy if a doctor has written a prescription for EpiPen.\u003c/p>\n\u003cp>Adrenaclick also isn't widely available. \"You call up 100 pharmacies, and maybe 10 have the device, from what we gather,\" Baker said of Adrenaclick.\u003c/p>\n\u003cp>He said several factors have allowed EpiPen's price tag to swell over the years. Many patients were in the dark about EpiPen price increases until insurers started shifting more of the cost onto consumers a few years ago, and getting approval for a generic that's both a drug and a device is more complicated than getting approval for a drug alone, he said.\u003c/p>\n\u003cp>Meanwhile, Mylan has aggressively marketed its product and raised doubts about alternatives.\u003c/p>\n\u003cp>And documents show that Mylan submitted a citizen petition to the FDA arguing that people trained to use EpiPens wouldn't be able to use Teva's pending generic epinephrine auto-injector because of design differences.\u003c/p>\n\u003cp>\"Is Mylan doing anything illegal? No,\" Baker said. \"It's taking advantage of all these things to take the market and basically push it to an extreme.\"\u003c/p>\n\u003cp>\u003cstrong>User fees levied to speed up the approval process\u003c/strong>\u003c/p>\n\u003cp>The FDA's generic backlog isn't a new problem. In 2012, it was so large that it prompted the government to start charging user fees to generic manufacturers to provide the funds for the FDA to speed the process. The fees built on the 20-year-old\u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069943.htm\">Prescription Drug User Fee Act\u003c/a>, which required brand-name drugmakers to pay fees to expand FDA's capacity to review applications for those medicines. In the first three years, the FDA collected $1 billion from generic drug manufacturers.\u003c/p>\n\u003cp>The fees were used to hire an additional 1,000 employees, and put the Office of Generic Drugs on par with the Office of New Drugs by reorganizing it and moving it from four outlying buildings to the FDA's main campus in Silver Spring, Md.\u003c/p>\n\u003cp>The funds were also used to upgrade the office's information technology. The FDA says on its \u003ca href=\"http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm\">website\u003c/a>: \"Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.\"\u003c/p>\n\u003cp>In October 2012, there was a backlog of 2,868 generic drugs awaiting approval, and the FDA said it would take a \"first action\" on 90 percent of these drugs by 2017. This summer, the agency met its goal a year early, but a first action isn't an approval. Instead, it stops the review clock and puts the applications back in industry's court.\u003c/p>\n\u003cp>Only 1,551 generics have been approved since the fees on drugmakers were initiated, and that total includes some extra applications that weren't considered part of the official backlog. So, all told, the agency has only approved about half of the backlogged generics that were awaiting approval in 2012.\u003c/p>\n\u003cp>\"Most applications from the backlog will need to come back to FDA for additional review due to deficiencies in the submissions, before approval is possible,\" the agency said in a statement in responses to questions.\u003c/p>\n\u003cp>David Gaugh, senior vice president for science and regulatory affairs at the Generic Pharmaceuticals Association, \u003ca href=\"http://www.gphaonline.org/gpha-media/press/statement-by-david-gaugh-senior-vice-president-sciences-and-regulatory-affairs-gpha-regarding-the-senate-help-hearing-on-gdufa/\">said\u003c/a> standards used to compile generic applications when they were submitted three or four years ago have changed while the applications were sitting in the backlog. So when the FDA got back to those companies, it said the applications were of \"poor quality.\"\u003c/p>\n\u003cp>The applications for generic drugs have continued to pile up even as the FDA approved a record number of generics in 2015 and again in the first seven months of 2016. The number of generic drug applications tripled from 2002 to 2012, according to January congressional \u003ca href=\"http://www.fda.gov/NewsEvents/Testimony/ucm484304.htm\">testimony \u003c/a>from Janet Woodcock, who directs the FDA's Center for Drug Evaluation and Research.\u003c/p>\n\u003cp>Still, some see signs the agency is on the right track.\u003c/p>\n\u003cp>\"I think that it is an optimistic picture overall ... at the FDA, there's been a lot of progress, and I think there is more to be made,\" said \u003ca href=\"http://www.drugepi.org/faculty-staff-trainees/faculty/aaron-kesselheim/\">Dr. Aaron Kesselheim\u003c/a>, an interdisciplinary drug researcher at Harvard Medical School and Brigham and Women's Hospital. \"This is not something that people should think has been solved at this point. It's totally an ongoing process.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Follow Sydney Lupkin \u003c/em>\u003cem>on Twitter:\u003c/em>\u003ca href=\"https://twitter.com/slupkin\">@slupkin\u003c/a>.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Test Of Experimental Alzheimer's Drug Finds Progress Against Brain Plaques",
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"content": "\u003cp>An experimental drug dramatically reduced the toxic plaques found in the brains of patients with Alzheimer's disease, a team \u003ca href=\"http://nature.com/articles/doi:10.1038/nature19323\">reports\u003c/a> in the journal \u003cem>Nature\u003c/em>.\u003c/p>\n\u003cp>Results from a small number of patients who received a high dose of the drug, called \u003ca href=\"https://www.biogen.com/en_us/research-pipeline/biogen-pipeline.html\">aducanumab\u003c/a>, hint that it may also be able to slow the loss of memory and thinking.\u003c/p>\n\u003cp>\"If that hint of a clinical benefit is confirmed, it would be a game changer in the fight against Alzheimer's disease,\" says \u003ca href=\"http://banneralz.org/about-us/our-leadership.aspx\">Dr. Eric Reiman\u003c/a>, executive director of the Banner Alzheimer's Institute in Phoenix. Reiman wrote a commentary that accompanies the study in \u003cem>Nature\u003c/em>.\u003c/p>\n\u003cp>But it will take much larger studies to show for sure whether aducanumab really does slow down Alzheimer's disease, Reiman says.\u003c/p>\n\u003cp>Officials of \u003ca href=\"https://www.biogen.com/en_us/research-pipeline/biogen-pipeline.html\">Biogen\u003c/a>, which is developing the drug, were also cautious about interpreting the results of the study, which included 165 patients in the early stages of Alzheimer's disease.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"We think we have something important here,\" says \u003ca href=\"https://www.biogen.com/en_us/about-biogen/leadership/leadership-detail.sandrock_alfred.html\">Dr. Alfred Sandrock\u003c/a>, chief medical officer for Biogen. \"We hope we're right because if it's true it would benefit millions of patients. But we don't know we're right yet.\"\u003c/p>\n\u003cp>The results are encouraging for pharmaceutical companies that have spent billions of dollars on efforts to come up with the first drug to treat the underlying cause of Alzheimer's. Those efforts have \u003ca href=\"http://www.npr.org/sections/health-shots/2012/08/24/159997459/failure-of-lilly-drug-is-latest-alzheimers-setback\">failed to produce a single approved drug\u003c/a> so far.\u003c/p>\n\u003cp>But last summer, Biogen began presenting its results with aducanumab at scientific meetings, including the \u003ca href=\"https://www.alz.org/\">Alzheimer's Association\u003c/a> International Conference in July. These early reports suggested the drug had a remarkable ability to remove plaques in the brain.\u003c/p>\n\u003cp>\"It was surprising, encouraging and thought-provoking to see such a striking reduction of existing plaques,\" Reiman says.\u003c/p>\n\u003cp>The \u003ca href=\"http://dx.doi.org/10.1038/nature19323\">publication\u003c/a> in \u003cem>Nature \u003c/em>Wednesday provides details about those early reports.\u003c/p>\n\u003cp>Biogen has already begun two much larger studies of aducanumab. They will include a total of 2,700 patients, and results are still several years off.\u003c/p>\n\u003cp>But there are reasons to think aducanumab may succeed where other drugs have failed.\u003c/p>\n\u003cp>One is that the drug appears to ignore benign forms of amyloid protein while attacking the toxic forms thought to damage brain cells. Another is that aducanumab seems to enhance the ability of existing immune cells in the brain to devour toxins, including amyloid.\u003c/p>\n\u003cp>But there's a downside. The process of removing plaque sometimes causes fluid to build up in the brain. In rare cases, it can also cause bleeding. These side effects are known as amyloid-related imaging abnormalities, or ARIA.\u003c/p>\n\u003cp>\"We were actually anticipating that we would see it,\" Sandrock says. And the researchers did. Twenty patients dropped out of the trial because of adverse effects.\u003c/p>\n\u003cp>If aducanumab works in larger studies, it could help settle a long-running debate about whether amyloid is really the root cause of Alzheimer's. This idea is known as the \u003ca href=\"https://www.alz.org/documents/national/topicsheet_betaamyloid.pdf\">amyloid hypothesis\u003c/a>.\u003c/p>\n\u003cp>And large studies showing that removing amyloid can preserve memory and thinking \"would go a long way toward validating the amyloid hypothesis,\" Sandrock says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Results like those could also lead to the first approved drug to treat the underlying cause of Alzheimer's rather than just the symptoms.\u003c/p>\n\u003cdiv class=\"fullattribution\">\u003cem>Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Test+Of+Experimental+Alzheimer%27s+Drug+Finds+Progress+Against+Brain+Plaques+++&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/em>\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>An experimental drug dramatically reduced the toxic plaques found in the brains of patients with Alzheimer's disease, a team \u003ca href=\"http://nature.com/articles/doi:10.1038/nature19323\">reports\u003c/a> in the journal \u003cem>Nature\u003c/em>.\u003c/p>\n\u003cp>Results from a small number of patients who received a high dose of the drug, called \u003ca href=\"https://www.biogen.com/en_us/research-pipeline/biogen-pipeline.html\">aducanumab\u003c/a>, hint that it may also be able to slow the loss of memory and thinking.\u003c/p>\n\u003cp>\"If that hint of a clinical benefit is confirmed, it would be a game changer in the fight against Alzheimer's disease,\" says \u003ca href=\"http://banneralz.org/about-us/our-leadership.aspx\">Dr. Eric Reiman\u003c/a>, executive director of the Banner Alzheimer's Institute in Phoenix. Reiman wrote a commentary that accompanies the study in \u003cem>Nature\u003c/em>.\u003c/p>\n\u003cp>But it will take much larger studies to show for sure whether aducanumab really does slow down Alzheimer's disease, Reiman says.\u003c/p>\n\u003cp>Officials of \u003ca href=\"https://www.biogen.com/en_us/research-pipeline/biogen-pipeline.html\">Biogen\u003c/a>, which is developing the drug, were also cautious about interpreting the results of the study, which included 165 patients in the early stages of Alzheimer's disease.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"We think we have something important here,\" says \u003ca href=\"https://www.biogen.com/en_us/about-biogen/leadership/leadership-detail.sandrock_alfred.html\">Dr. Alfred Sandrock\u003c/a>, chief medical officer for Biogen. \"We hope we're right because if it's true it would benefit millions of patients. But we don't know we're right yet.\"\u003c/p>\n\u003cp>The results are encouraging for pharmaceutical companies that have spent billions of dollars on efforts to come up with the first drug to treat the underlying cause of Alzheimer's. Those efforts have \u003ca href=\"http://www.npr.org/sections/health-shots/2012/08/24/159997459/failure-of-lilly-drug-is-latest-alzheimers-setback\">failed to produce a single approved drug\u003c/a> so far.\u003c/p>\n\u003cp>But last summer, Biogen began presenting its results with aducanumab at scientific meetings, including the \u003ca href=\"https://www.alz.org/\">Alzheimer's Association\u003c/a> International Conference in July. These early reports suggested the drug had a remarkable ability to remove plaques in the brain.\u003c/p>\n\u003cp>\"It was surprising, encouraging and thought-provoking to see such a striking reduction of existing plaques,\" Reiman says.\u003c/p>\n\u003cp>The \u003ca href=\"http://dx.doi.org/10.1038/nature19323\">publication\u003c/a> in \u003cem>Nature \u003c/em>Wednesday provides details about those early reports.\u003c/p>\n\u003cp>Biogen has already begun two much larger studies of aducanumab. They will include a total of 2,700 patients, and results are still several years off.\u003c/p>\n\u003cp>But there are reasons to think aducanumab may succeed where other drugs have failed.\u003c/p>\n\u003cp>One is that the drug appears to ignore benign forms of amyloid protein while attacking the toxic forms thought to damage brain cells. Another is that aducanumab seems to enhance the ability of existing immune cells in the brain to devour toxins, including amyloid.\u003c/p>\n\u003cp>But there's a downside. The process of removing plaque sometimes causes fluid to build up in the brain. In rare cases, it can also cause bleeding. These side effects are known as amyloid-related imaging abnormalities, or ARIA.\u003c/p>\n\u003cp>\"We were actually anticipating that we would see it,\" Sandrock says. And the researchers did. Twenty patients dropped out of the trial because of adverse effects.\u003c/p>\n\u003cp>If aducanumab works in larger studies, it could help settle a long-running debate about whether amyloid is really the root cause of Alzheimer's. This idea is known as the \u003ca href=\"https://www.alz.org/documents/national/topicsheet_betaamyloid.pdf\">amyloid hypothesis\u003c/a>.\u003c/p>\n\u003cp>And large studies showing that removing amyloid can preserve memory and thinking \"would go a long way toward validating the amyloid hypothesis,\" Sandrock says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Results like those could also lead to the first approved drug to treat the underlying cause of Alzheimer's rather than just the symptoms.\u003c/p>\n\u003cdiv class=\"fullattribution\">\u003cem>Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Test+Of+Experimental+Alzheimer%27s+Drug+Finds+Progress+Against+Brain+Plaques+++&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/em>\u003c/div>\n\n\u003c/div>\u003c/p>",
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"info": "The Political Mind of Jerry Brown brings listeners the wisdom of the former Governor, Mayor, and presidential candidate. Scott Shafer interviewed Brown for more than 40 hours, covering the former governor's life and half-century in the political game – and Brown has some lessons he'd like to share. ",
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"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>",
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"info": "For decades, the process for how police police themselves has been inconsistent – if not opaque. In some states, like California, these proceedings were completely hidden. After a new police transparency law unsealed scores of internal affairs files, our reporters set out to examine these cases and the shadow world of police discipline. On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. Is it the officers, or the public they've sworn to serve?",
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"info": "Political Breakdown is a new series that explores the political intersection of California and the nation. Each week hosts Scott Shafer and Marisa Lagos are joined with a new special guest to unpack politics -- with personality — and offer an insider’s glimpse at how politics happens.",
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"possible": {
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"title": "Possible",
"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
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"radiolab": {
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},
"rightnowish": {
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"tagline": "Art is where you find it",
"info": "Rightnowish digs into life in the Bay Area right now… ish. Journalist Pendarvis Harshaw takes us to galleries painted on the sides of liquor stores in West Oakland. We'll dance in warehouses in the Bayview, make smoothies with kids in South Berkeley, and listen to classical music in a 1984 Cutlass Supreme in Richmond. Every week, Pen talks to movers and shakers about how the Bay Area shapes what they create, and how they shape the place we call home.",
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"tagline": "Real stories with killer beats",
"info": "The Snap Judgment radio show and podcast mixes real stories with killer beats to produce cinematic, dramatic radio. Snap's musical brand of storytelling dares listeners to see the world through the eyes of another. This is storytelling... with a BEAT!! Snap first aired on public radio stations nationwide in July 2010. Today, Snap Judgment airs on over 450 public radio stations and is brought to the airwaves by KQED & PRX.",
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"soldout": {
"id": "soldout",
"title": "SOLD OUT: Rethinking Housing in America",
"tagline": "A new future for housing",
"info": "Sold Out: Rethinking Housing in America",
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