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It's not in rural America.\"\u003c/p>\n\u003cp>But heroin addiction and abuse are not just a big city problem, as Trenary had thought. While the bulk of fatal overdoses still happen in urban areas, \u003ca href=\"https://www.cdc.gov/mmwr/volumes/66/ss/ss6619a1.htm?s_cid=ss6619a1_w\" target=\"_blank\" rel=\"noopener\">the rural overdose rate has increased \u003c/a>to slightly surpass that of cities.\u003c/p>\n\u003cp>Rural Americans say drug addiction and abuse are the most urgent health problems facing their local community, according to\u003ca href=\"https://www.npr.org/HARVARD-POLL/rural-health-poll-10-15-18-updated.pdf\" target=\"_blank\" rel=\"noopener\"> a new poll\u003c/a> by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health. In the poll, 48 percent of people said opioid addiction has gotten worse in their community in the past five years.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Trenary now agrees. A few years ago, he was elected sheriff of Snohomish County and got a rude awakening. He toured the jail and found it had become a de facto detox center, full of \"very, very sick, very, very sick people,\" he says.\u003c/p>\n\u003cp>\"Detoxing from heroin is like having the worst possible stomach virus you can have. People are proned out, just suffering.\"\u003c/p>\n\u003cp>At any given time, about half the inmates were withdrawing from heroin, making for a \u003ca href=\"https://www.heraldnet.com/news/lawsuit-against-snohomish-county-focuses-on-inmates-death/\" target=\"_blank\" rel=\"noopener\">dangerous\u003c/a> and \u003ca href=\"https://komonews.com/news/local/13m-settlement-in-snohomish-county-jail-death-claim\" target=\"_blank\" rel=\"noopener\">expensive\u003c/a> situation.\u003c/p>\n\u003cp>\"It took becoming the sheriff to see the impacts inside the jail with heroin abuse, to see the impacts in the community across the entire county for me to realize that we had to change a lot about what we were doing,\" Trenary says.\u003c/p>\n\u003cp>\u003cstrong>A Disaster Response Approach\u003c/strong>\u003c/p>\n\u003cp>So they did. Snohomish County in Western Washington is taking a unique approach to tackle the problem.\u003c/p>\n\u003cp>Last year, leaders declared the opioid epidemic a life-threatening emergency. The county is now responding to the drug crisis as if it were a natural disaster, the same way it would mobilize to respond to a landslide or flu pandemic.\u003c/p>\n\u003cfigure id=\"attachment_445267\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-full wp-image-445267\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85.jpg\" alt=\"\" width=\"800\" height=\"532\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-160x106.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-768x511.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-375x249.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-520x346.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Snohomish County Sheriff Ty Trenary. He wasn't aware of the extent of the opioid epidemic in his county until he became sheriff and realized the jail had become a defacto detox center. \u003ccite>(Leah Nash/Finding Fixes podcast)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Snohomish County is the first county in the country to treat it this way.\u003c/p>\n\u003cp>The idea grew out of their experience with another tremendous disaster in the county: the massive 2014 landslide in Oso, Wash., which killed 43 people.\u003c/p>\n\u003cp>Back then, the director of communications for the sheriff's office, Shari Ireton, took reporters to see the landslide, and she ended up learning something, too.\u003c/p>\n\u003cp>\"It was amazing to see Black Hawk helicopters flying with our helicopter and a fixed wing over the top of that,\" she says. \"All in coordination with each other, all with the same objective, which is life safety.\"[contextly_sidebar id=\"EkK9yT8ARJNlHsaGPy5VTEvcCBTT8MS7\"]\u003c/p>\n\u003cp>Ireton thought, what if they used that same coordinated system, of everyone working together across government agencies, to tackle the opioid epidemic?\u003c/p>\n\u003cp>County leaders took the idea and ran with it.\u003c/p>\n\u003cp>Now, the response to the opioid epidemic is run out of a special emergency operations center, a lot like during the Oso landslide, where representatives from across local government meet every two weeks, including people in charge of everything from firetrucks to the dump.\u003c/p>\n\u003cp>The technical name for this group is the Multi-Agency Coordination group, or MAC group. It comes straight out of FEMA's emergency response playbook.\u003c/p>\n\u003cp>They talk through PowerPoint slides and rattle off numbers like 7.5 and 6.1, which refer to items on their to-do list. Seven big, overarching goals, which include reducing opioid misuse and reducing damage to the community, are broken down into manageable steps, like distributing needle cleanup kits and a project to train schoolteachers to recognize trauma and addiction.\u003c/p>\n\u003cp>This to-do list is over 100 items long.\u003c/p>\n\u003cp>\"Some of these goals are really long term,\" Ireton says. \"I mean they're going to take years, decades.\"[contextly_sidebar id=\"4DNOyEVwXKrhJsxImwngLjd8ofHh3LVo\"]\u003c/p>\n\u003cp>The key is to be realistic, says Ireton, who is also the spokesperson for this group. You are never going to be successful if your goal is just \"end the opioid epidemic,\" she says.\u003c/p>\n\u003cp>\"By breaking it down, it's like eating an elephant. You just can eat one piece at a time. Breaking it down into a piece that you can actually digest.\" Ireton says.\u003c/p>\n\u003cp>The county's program includes small steps, like making transportation easier for people in drug treatment. They train family members and others in the community on steps to reverse overdoses with medicine, and they send teams of police officers and social workers to help addicted homeless people.[contextly_sidebar id=\"tgGunyxLm8dgF9b7x7IdKyEh7K66M6ez\"]\u003c/p>\n\u003cp>In Marysville, Wash., the woods are full of homeless encampments surrounded by piles of spent syringes and trash. On a recent visit, rain drips through a cedar forest next to a strip mall. Officer Mike Buell is visiting the camp along with social worker Lauren Rainbow. Buell cracks jokes with some illegal campers and introduces himself using his first name.\u003c/p>\n\u003cp>Buell's job isn't to arrest the campers, but to help them get drug treatment and housing. He crouches next to the opening of one tent and explains that he and his colleagues will help the campers with food, coffee and transportation to and from appointments.\u003c/p>\n\u003cp>\"We're basically your Uber,\" Buell says.\u003c/p>\n\u003cp>The new approach is paying off. The teams have helped hundreds of people find housing and drug treatment.\u003c/p>\n\u003cp>That's just one item in the county's plan, and problems with opioids are far from solved here.\u003c/p>\n\u003cp>Snohomish County will keep working on its large and small goals, one bite at a time.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was reported by \u003c/em>\u003ca href=\"https://www.findingfixes.com/\" target=\"_blank\" rel=\"noopener\">\u003cem>Finding Fixes\u003c/em>\u003c/a>\u003cem>, a podcast about solutions to the opioid epidemic, which is a project of \u003c/em>\u003ca href=\"http://www.invw.org/\" target=\"_blank\" rel=\"noopener\">\u003cem>InvestigateWest\u003c/em>\u003c/a>\u003cem>. \u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+Rural+Community+Decided+To+Treat+Its+Opioid+Problem+Like+A+Natural+Disaster&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"A rural county in Washington declared the opioid epidemic a life-threatening emergency. It uses a multiagency coordination group straight out of FEMA's playbook to respond to the crisis.","status":"publish","parent":0,"modified":1540834398,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":35,"wordCount":1019},"headData":{"title":"A Rural Community Decided To Treat Its Opioid Problem Like A Natural Disaster | KQED","description":"A rural county in Washington declared the opioid epidemic a life-threatening emergency. It uses a multiagency coordination group straight out of FEMA's playbook to respond to the crisis.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"A Rural Community Decided To Treat Its Opioid Problem Like A Natural Disaster","datePublished":"2018-10-29T19:00:00.000Z","dateModified":"2018-10-29T17:33:18.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"445259 https://ww2.kqed.org/futureofyou/?p=445259","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/10/29/a-rural-community-decided-to-treat-its-opioid-problem-like-a-natural-disaster/","disqusTitle":"A Rural Community Decided To Treat Its Opioid Problem Like A Natural Disaster","nprByline":"Anna Boiko-Weyrauch, NPR","nprImageAgency":"Leah Nash for Finding Fixes podcast","nprStoryId":"658476111","nprApiLink":"http://api.npr.org/query?id=658476111&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2018/10/28/658476111/a-rural-community-decided-to-treat-its-opioid-problem-like-a-natural-disaster?ft=nprml&f=658476111","nprRetrievedStory":"1","nprPubDate":"Mon, 29 Oct 2018 12:55:00 -0400","nprStoryDate":"Sun, 28 Oct 2018 08:17:00 -0400","nprLastModifiedDate":"Mon, 29 Oct 2018 12:55:33 -0400","nprAudio":"https://ondemand.npr.org/anon.npr-mp3/npr/wesun/2018/10/20181028_wesun_a_rural_community_decided_to_treat_its_opioid_problem_like_a_natural_disaster.mp3?orgId=1&topicId=1128&aggIds=658276358&d=345&p=10&story=658476111&ft=nprml&f=658476111","nprAudioM3u":"http://api.npr.org/m3u/1661520408-b27296.m3u?orgId=1&topicId=1128&aggIds=658276358&d=345&p=10&story=658476111&ft=nprml&f=658476111","audioTrackLength":346,"path":"/futureofyou/445259/a-rural-community-decided-to-treat-its-opioid-problem-like-a-natural-disaster","audioUrl":"https://ondemand.npr.org/anon.npr-mp3/npr/wesun/2018/10/20181028_wesun_a_rural_community_decided_to_treat_its_opioid_problem_like_a_natural_disaster.mp3?orgId=1&topicId=1128&aggIds=658276358&d=345&p=10&story=658476111&ft=nprml&f=658476111","parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>When he was police chief of Stanwood, Wash., population 7,000, Ty Trenary thought rural communities like his were immune from the opioid crisis.\u003c/p>\n\u003cp>Then, one day, a mother walked through his door and said, \"Chief, you have a heroin problem in your community.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"And I remember thinking, 'Well that's not possible,' \" Trenary recalls. \"This is Stanwood and heroin is in big cities with homeless populations. It's not in rural America.\"\u003c/p>\n\u003cp>But heroin addiction and abuse are not just a big city problem, as Trenary had thought. While the bulk of fatal overdoses still happen in urban areas, \u003ca href=\"https://www.cdc.gov/mmwr/volumes/66/ss/ss6619a1.htm?s_cid=ss6619a1_w\" target=\"_blank\" rel=\"noopener\">the rural overdose rate has increased \u003c/a>to slightly surpass that of cities.\u003c/p>\n\u003cp>Rural Americans say drug addiction and abuse are the most urgent health problems facing their local community, according to\u003ca href=\"https://www.npr.org/HARVARD-POLL/rural-health-poll-10-15-18-updated.pdf\" target=\"_blank\" rel=\"noopener\"> a new poll\u003c/a> by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health. In the poll, 48 percent of people said opioid addiction has gotten worse in their community in the past five years.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Trenary now agrees. A few years ago, he was elected sheriff of Snohomish County and got a rude awakening. He toured the jail and found it had become a de facto detox center, full of \"very, very sick, very, very sick people,\" he says.\u003c/p>\n\u003cp>\"Detoxing from heroin is like having the worst possible stomach virus you can have. People are proned out, just suffering.\"\u003c/p>\n\u003cp>At any given time, about half the inmates were withdrawing from heroin, making for a \u003ca href=\"https://www.heraldnet.com/news/lawsuit-against-snohomish-county-focuses-on-inmates-death/\" target=\"_blank\" rel=\"noopener\">dangerous\u003c/a> and \u003ca href=\"https://komonews.com/news/local/13m-settlement-in-snohomish-county-jail-death-claim\" target=\"_blank\" rel=\"noopener\">expensive\u003c/a> situation.\u003c/p>\n\u003cp>\"It took becoming the sheriff to see the impacts inside the jail with heroin abuse, to see the impacts in the community across the entire county for me to realize that we had to change a lot about what we were doing,\" Trenary says.\u003c/p>\n\u003cp>\u003cstrong>A Disaster Response Approach\u003c/strong>\u003c/p>\n\u003cp>So they did. Snohomish County in Western Washington is taking a unique approach to tackle the problem.\u003c/p>\n\u003cp>Last year, leaders declared the opioid epidemic a life-threatening emergency. The county is now responding to the drug crisis as if it were a natural disaster, the same way it would mobilize to respond to a landslide or flu pandemic.\u003c/p>\n\u003cfigure id=\"attachment_445267\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-full wp-image-445267\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85.jpg\" alt=\"\" width=\"800\" height=\"532\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-160x106.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-768x511.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-375x249.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/10/20180823_ff_105_custom-37d326f563ec4055bd7d38d350065ee12644fc95-s800-c85-520x346.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Snohomish County Sheriff Ty Trenary. He wasn't aware of the extent of the opioid epidemic in his county until he became sheriff and realized the jail had become a defacto detox center. \u003ccite>(Leah Nash/Finding Fixes podcast)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Snohomish County is the first county in the country to treat it this way.\u003c/p>\n\u003cp>The idea grew out of their experience with another tremendous disaster in the county: the massive 2014 landslide in Oso, Wash., which killed 43 people.\u003c/p>\n\u003cp>Back then, the director of communications for the sheriff's office, Shari Ireton, took reporters to see the landslide, and she ended up learning something, too.\u003c/p>\n\u003cp>\"It was amazing to see Black Hawk helicopters flying with our helicopter and a fixed wing over the top of that,\" she says. \"All in coordination with each other, all with the same objective, which is life safety.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Ireton thought, what if they used that same coordinated system, of everyone working together across government agencies, to tackle the opioid epidemic?\u003c/p>\n\u003cp>County leaders took the idea and ran with it.\u003c/p>\n\u003cp>Now, the response to the opioid epidemic is run out of a special emergency operations center, a lot like during the Oso landslide, where representatives from across local government meet every two weeks, including people in charge of everything from firetrucks to the dump.\u003c/p>\n\u003cp>The technical name for this group is the Multi-Agency Coordination group, or MAC group. It comes straight out of FEMA's emergency response playbook.\u003c/p>\n\u003cp>They talk through PowerPoint slides and rattle off numbers like 7.5 and 6.1, which refer to items on their to-do list. Seven big, overarching goals, which include reducing opioid misuse and reducing damage to the community, are broken down into manageable steps, like distributing needle cleanup kits and a project to train schoolteachers to recognize trauma and addiction.\u003c/p>\n\u003cp>This to-do list is over 100 items long.\u003c/p>\n\u003cp>\"Some of these goals are really long term,\" Ireton says. \"I mean they're going to take years, decades.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The key is to be realistic, says Ireton, who is also the spokesperson for this group. You are never going to be successful if your goal is just \"end the opioid epidemic,\" she says.\u003c/p>\n\u003cp>\"By breaking it down, it's like eating an elephant. You just can eat one piece at a time. Breaking it down into a piece that you can actually digest.\" Ireton says.\u003c/p>\n\u003cp>The county's program includes small steps, like making transportation easier for people in drug treatment. They train family members and others in the community on steps to reverse overdoses with medicine, and they send teams of police officers and social workers to help addicted homeless people.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In Marysville, Wash., the woods are full of homeless encampments surrounded by piles of spent syringes and trash. On a recent visit, rain drips through a cedar forest next to a strip mall. Officer Mike Buell is visiting the camp along with social worker Lauren Rainbow. Buell cracks jokes with some illegal campers and introduces himself using his first name.\u003c/p>\n\u003cp>Buell's job isn't to arrest the campers, but to help them get drug treatment and housing. He crouches next to the opening of one tent and explains that he and his colleagues will help the campers with food, coffee and transportation to and from appointments.\u003c/p>\n\u003cp>\"We're basically your Uber,\" Buell says.\u003c/p>\n\u003cp>The new approach is paying off. The teams have helped hundreds of people find housing and drug treatment.\u003c/p>\n\u003cp>That's just one item in the county's plan, and problems with opioids are far from solved here.\u003c/p>\n\u003cp>Snohomish County will keep working on its large and small goals, one bite at a time.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was reported by \u003c/em>\u003ca href=\"https://www.findingfixes.com/\" target=\"_blank\" rel=\"noopener\">\u003cem>Finding Fixes\u003c/em>\u003c/a>\u003cem>, a podcast about solutions to the opioid epidemic, which is a project of \u003c/em>\u003ca href=\"http://www.invw.org/\" target=\"_blank\" rel=\"noopener\">\u003cem>InvestigateWest\u003c/em>\u003c/a>\u003cem>. \u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+Rural+Community+Decided+To+Treat+Its+Opioid+Problem+Like+A+Natural+Disaster&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/445259/a-rural-community-decided-to-treat-its-opioid-problem-like-a-natural-disaster","authors":["byline_futureofyou_445259"],"categories":["futureofyou_1060","futureofyou_1","futureofyou_73"],"tags":["futureofyou_828","futureofyou_952","futureofyou_1499","futureofyou_1634","futureofyou_198"],"featImg":"futureofyou_445260","label":"futureofyou"},"futureofyou_445254":{"type":"posts","id":"futureofyou_445254","meta":{"index":"posts_1591205157","site":"futureofyou","id":"445254","score":null,"sort":[1540833728000]},"guestAuthors":[],"slug":"er-patients-given-ketamine-other-drugs-in-clinical-trials-without-their-consent","title":"ER Patients Given Ketamine, Other Drugs in Clinical Trials Without Their Consent","publishDate":1540833728,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp class=\"danger-zone\">Minneapolis hospital tested powerful antipsychotics and the potent anesthetic \u003ca href=\"https://www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/\">ketamine\u003c/a> on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.\u003c/p>\n\u003cp class=\"danger-zone\">Based on those findings\u003cstrong>,\u003c/strong> a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital. In a \u003ca href=\"https://www.citizen.org/our-work/health-and-safety/second-follow-letter-fda-and-ohrp-regarding-unethical-high-risk-clinical-trials-tested-ketamine-management\" target=\"_blank\" rel=\"noopener\">letter\u003c/a> to the Food and Drug Administration and the Department of Health and Human Services office that protects human research subjects, Public Citizen also called for regulators to immediately launch an investigation into the conduct and oversight of the studies and “impose severe sanctions for the serious ethical and regulatory lapses that have occurred in the ketamine clinical trials and other studies” at Minneapolis’s Hennepin County Medical Center.[contextly_sidebar id=\"VBSQOWNGkwEDBdz8APDok0lptMEsHZ3N\"]\u003c/p>\n\u003cp class=\"danger-zone\">The hospital committee that green-lighted the studies, called an institutional review board (IRB), “appears incapable of doing its job,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, who organized the letter. It acted unethically and placed patients in danger, he said, “including by waiving the requirement for informed consent in situations where that is not allowed.”\u003c/p>\n\u003cp>A hospital spokesperson said the findings by inspectors from the FDA “are neither formal nor conclusory.” Hennepin “has provided formal written responses to each” of the inspectors’ findings, she said, adding that the hospital “has undertaken several reviews by independent experts to evaluate its research and emergency medical practices with the intent to improve our processes. …We understand our mission includes providing the highest standards of medical care, and also conducting studies that help to continuously improve the health and wellness of our patients.”\u003c/p>\n\u003cp>Among other violations identified by FDA inspectors, the IRB ruled that researchers did not need consent to make patients part of a clinical trial in which they were given antipsychotic drugs that they might not receive as part of usual care. The Public Citizen letter said the IRB, which is legally obligated to protect research participants, “appears to lack even a basic understanding of federal regulations for the protection of human subjects and is clearly incapable of fulfilling its obligation” to do so.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>In July, Public Citizen and 64 bioethicists, physicians, and other scholars submitted a complaint about two of Hennepin’s ketamine studies to the FDA and HHS’s Office of Human Research Protections. In August, FDA sent inspectors to the hospital.\u003c/p>\n\u003cp>Their report, obtained by Public Citizen through a public records request and shared with STAT, examined additional clinical trials beyond those initially flagged. It found that in four, the hospital IRB “did not determine that informed consent would be sought from each prospective subject” as required by law, while in another five, the IRB granted fast-track review to studies that didn’t qualify for it.\u003c/p>\n\u003cp>At least three of the studies cited by the FDA inspectors involved people brought to the emergency room with “severe” agitation, as assessed by emergency technicians using criteria developed by the researchers. The study leaders apparently persuaded the IRB that such patients could not provide informed consent, and so could be swept into the trial unknowingly.[contextly_sidebar id=\"OXR63kbgFz9mq4tqZdVi1Hy2Rk2yuUa7\"]\u003c/p>\n\u003cp>In fact, such patients are considered “vulnerable,” said bioethicist Leigh Turner of the University of Minnesota, who signed the Public Citizen letter. According to federal law, they are supposed to receive special safeguards, such as having a family member or other representative give or decline consent. That did not happen.\u003c/p>\n\u003cp>Just as concerning, Turner said, it’s not clear that the patients were in fact too agitated to be asked for their consent, as the scientists argued to the IRB. According to the evaluation form’s scoring, “it’s not like they had acute psychosis,” Turner said. “These investigators were basically drugging up individuals with a degree of agitation many of us could experience, like after being pulled over for speeding.”\u003c/p>\n\u003cp>In the first study cited by the FDA inspectors, researchers injected either ketamine or haloperidol into people taken to the ER, to reduce their “agitation.” Ketamine is not approved by the FDA for that use. The unwitting participants were treated not according to clinicians’ best judgment but according to the study’s protocol: Those arriving during certain months got ketamine and those arriving in other months got haloperidol.\u003c/p>\n\u003cp>Among the trial’s \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27102743\" target=\"_blank\" rel=\"noopener\">results\u003c/a> was that some patients given ketamine suffered breathing problems; 39 percent required intubation, compared to 4 percent given haloperidol. Before the trial began, its leaders had warned in a 2013 \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/23231451\" target=\"_blank\" rel=\"noopener\">paper\u003c/a> that ketamine can impair breathing and so should be reserved for only the most severely agitated patients.\u003c/p>\n\u003cp>The identities of five of the seven studies the FDA report flagged are redacted, but one corresponds to the second ketamine \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03554915\" target=\"_blank\" rel=\"noopener\">clinical trial\u003c/a> questioned in Public Citizen’s letter. It compared ketamine to midazolam, also in “agitated” ER patients given one or the other drug essentially randomly, not according to which — if any — might help them. The study was suspended by the medical center in June, for unclear reasons, but it also failed to obtain informed consent from participants, the FDA inspectors found.[contextly_sidebar id=\"VDuCmh6PY0M6Ga88zjfyN4sUMUCXdtg4\"]\u003c/p>\n\u003cp>A third clinical \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03211897?term=hennepin+AND+agitation&rank=1\" target=\"_blank\" rel=\"noopener\">trial\u003c/a> compared the safety and efficacy of four drugs (the antipsychotics olanzapine, haloperidol, and ziprasidone and the sedative midazolam) in agitated patients. The hospital scientists had initially requested an FDA waiver from the informed consent requirement. FDA denied the request. The scientists then requested IRB approval, calling their study observational (meaning patients would be treated according to their doctors’ best judgment rather than receiving drugs as per the trial protocol) and therefore entitled to “expedited review.” The IRB agreed, including giving the okay to forgo consent.\u003c/p>\n\u003cp>In fact the study was not observational: Patients received one of the four drugs based on when they arrived in the ER. They were not informed of this, and so were unwitting participants, the FDA inspectors found.\u003c/p>\n\u003cp>“When the investigators didn’t get FDA clearance, they did an end-run around the agency,” Turner said. “They claimed it was no longer the randomized controlled trial they’d planned, and then pushed it through the IRB as a waiver-of-consent study,” a strategy he called “dodgy.”\u003c/p>\n\u003cp>The FDA inspectors found that “some or all of the subjects [in four studies] were likely to be vulnerable to coercion or undue influence,” yet the IRB did not require the researchers to do anything to safeguard the participants’ safety.\u003c/p>\n\u003cp>In addition to asking HHS to suspend all clinical trials at Hennepin unless doing so would harm participants, Public Citizen called it “imperative” that the hospital disband its current IRB and train a new one, retrain researchers involved in human research, and inform the unwitting participants in past trials of steps “to redress these violations.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003c/span>\u003c/i>\u003ca href=\"https://www.statnews.com/2018/10/29/er-patients-given-ketamine-powerful-drugs-without-consent/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">story\u003c/span>\u003c/i>\u003c/a>\u003ci>\u003cspan style=\"font-weight: 400\"> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003c/p>\n\n","blocks":[],"excerpt":"A Minneapolis hospital tested powerful antipsychotics on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.\r\n","status":"publish","parent":0,"modified":1540833728,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":18,"wordCount":1216},"headData":{"title":"ER Patients Given Ketamine, Other Drugs in Clinical Trials Without Their Consent | KQED","description":"A Minneapolis hospital tested powerful antipsychotics on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.\r\n","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"ER Patients Given Ketamine, Other Drugs in Clinical Trials Without Their Consent","datePublished":"2018-10-29T17:22:08.000Z","dateModified":"2018-10-29T17:22:08.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"445254 https://ww2.kqed.org/futureofyou/?p=445254","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/10/29/er-patients-given-ketamine-other-drugs-in-clinical-trials-without-their-consent/","disqusTitle":"ER Patients Given Ketamine, Other Drugs in Clinical Trials Without Their Consent","nprByline":"Sharon Begley\u003cbr />STAT","path":"/futureofyou/445254/er-patients-given-ketamine-other-drugs-in-clinical-trials-without-their-consent","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">Minneapolis hospital tested powerful antipsychotics and the potent anesthetic \u003ca href=\"https://www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/\">ketamine\u003c/a> on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.\u003c/p>\n\u003cp class=\"danger-zone\">Based on those findings\u003cstrong>,\u003c/strong> a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital. In a \u003ca href=\"https://www.citizen.org/our-work/health-and-safety/second-follow-letter-fda-and-ohrp-regarding-unethical-high-risk-clinical-trials-tested-ketamine-management\" target=\"_blank\" rel=\"noopener\">letter\u003c/a> to the Food and Drug Administration and the Department of Health and Human Services office that protects human research subjects, Public Citizen also called for regulators to immediately launch an investigation into the conduct and oversight of the studies and “impose severe sanctions for the serious ethical and regulatory lapses that have occurred in the ketamine clinical trials and other studies” at Minneapolis’s Hennepin County Medical Center.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">The hospital committee that green-lighted the studies, called an institutional review board (IRB), “appears incapable of doing its job,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, who organized the letter. It acted unethically and placed patients in danger, he said, “including by waiving the requirement for informed consent in situations where that is not allowed.”\u003c/p>\n\u003cp>A hospital spokesperson said the findings by inspectors from the FDA “are neither formal nor conclusory.” Hennepin “has provided formal written responses to each” of the inspectors’ findings, she said, adding that the hospital “has undertaken several reviews by independent experts to evaluate its research and emergency medical practices with the intent to improve our processes. …We understand our mission includes providing the highest standards of medical care, and also conducting studies that help to continuously improve the health and wellness of our patients.”\u003c/p>\n\u003cp>Among other violations identified by FDA inspectors, the IRB ruled that researchers did not need consent to make patients part of a clinical trial in which they were given antipsychotic drugs that they might not receive as part of usual care. The Public Citizen letter said the IRB, which is legally obligated to protect research participants, “appears to lack even a basic understanding of federal regulations for the protection of human subjects and is clearly incapable of fulfilling its obligation” to do so.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In July, Public Citizen and 64 bioethicists, physicians, and other scholars submitted a complaint about two of Hennepin’s ketamine studies to the FDA and HHS’s Office of Human Research Protections. In August, FDA sent inspectors to the hospital.\u003c/p>\n\u003cp>Their report, obtained by Public Citizen through a public records request and shared with STAT, examined additional clinical trials beyond those initially flagged. It found that in four, the hospital IRB “did not determine that informed consent would be sought from each prospective subject” as required by law, while in another five, the IRB granted fast-track review to studies that didn’t qualify for it.\u003c/p>\n\u003cp>At least three of the studies cited by the FDA inspectors involved people brought to the emergency room with “severe” agitation, as assessed by emergency technicians using criteria developed by the researchers. The study leaders apparently persuaded the IRB that such patients could not provide informed consent, and so could be swept into the trial unknowingly.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In fact, such patients are considered “vulnerable,” said bioethicist Leigh Turner of the University of Minnesota, who signed the Public Citizen letter. According to federal law, they are supposed to receive special safeguards, such as having a family member or other representative give or decline consent. That did not happen.\u003c/p>\n\u003cp>Just as concerning, Turner said, it’s not clear that the patients were in fact too agitated to be asked for their consent, as the scientists argued to the IRB. According to the evaluation form’s scoring, “it’s not like they had acute psychosis,” Turner said. “These investigators were basically drugging up individuals with a degree of agitation many of us could experience, like after being pulled over for speeding.”\u003c/p>\n\u003cp>In the first study cited by the FDA inspectors, researchers injected either ketamine or haloperidol into people taken to the ER, to reduce their “agitation.” Ketamine is not approved by the FDA for that use. The unwitting participants were treated not according to clinicians’ best judgment but according to the study’s protocol: Those arriving during certain months got ketamine and those arriving in other months got haloperidol.\u003c/p>\n\u003cp>Among the trial’s \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27102743\" target=\"_blank\" rel=\"noopener\">results\u003c/a> was that some patients given ketamine suffered breathing problems; 39 percent required intubation, compared to 4 percent given haloperidol. Before the trial began, its leaders had warned in a 2013 \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/23231451\" target=\"_blank\" rel=\"noopener\">paper\u003c/a> that ketamine can impair breathing and so should be reserved for only the most severely agitated patients.\u003c/p>\n\u003cp>The identities of five of the seven studies the FDA report flagged are redacted, but one corresponds to the second ketamine \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03554915\" target=\"_blank\" rel=\"noopener\">clinical trial\u003c/a> questioned in Public Citizen’s letter. It compared ketamine to midazolam, also in “agitated” ER patients given one or the other drug essentially randomly, not according to which — if any — might help them. The study was suspended by the medical center in June, for unclear reasons, but it also failed to obtain informed consent from participants, the FDA inspectors found.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>A third clinical \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03211897?term=hennepin+AND+agitation&rank=1\" target=\"_blank\" rel=\"noopener\">trial\u003c/a> compared the safety and efficacy of four drugs (the antipsychotics olanzapine, haloperidol, and ziprasidone and the sedative midazolam) in agitated patients. The hospital scientists had initially requested an FDA waiver from the informed consent requirement. FDA denied the request. The scientists then requested IRB approval, calling their study observational (meaning patients would be treated according to their doctors’ best judgment rather than receiving drugs as per the trial protocol) and therefore entitled to “expedited review.” The IRB agreed, including giving the okay to forgo consent.\u003c/p>\n\u003cp>In fact the study was not observational: Patients received one of the four drugs based on when they arrived in the ER. They were not informed of this, and so were unwitting participants, the FDA inspectors found.\u003c/p>\n\u003cp>“When the investigators didn’t get FDA clearance, they did an end-run around the agency,” Turner said. “They claimed it was no longer the randomized controlled trial they’d planned, and then pushed it through the IRB as a waiver-of-consent study,” a strategy he called “dodgy.”\u003c/p>\n\u003cp>The FDA inspectors found that “some or all of the subjects [in four studies] were likely to be vulnerable to coercion or undue influence,” yet the IRB did not require the researchers to do anything to safeguard the participants’ safety.\u003c/p>\n\u003cp>In addition to asking HHS to suspend all clinical trials at Hennepin unless doing so would harm participants, Public Citizen called it “imperative” that the hospital disband its current IRB and train a new one, retrain researchers involved in human research, and inform the unwitting participants in past trials of steps “to redress these violations.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003c/span>\u003c/i>\u003ca href=\"https://www.statnews.com/2018/10/29/er-patients-given-ketamine-powerful-drugs-without-consent/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">story\u003c/span>\u003c/i>\u003c/a>\u003ci>\u003cspan style=\"font-weight: 400\"> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/445254/er-patients-given-ketamine-other-drugs-in-clinical-trials-without-their-consent","authors":["byline_futureofyou_445254"],"categories":["futureofyou_73"],"tags":["futureofyou_952","futureofyou_1226","futureofyou_204","futureofyou_1224"],"featImg":"futureofyou_444567","label":"futureofyou"},"futureofyou_444164":{"type":"posts","id":"futureofyou_444164","meta":{"index":"posts_1591205157","site":"futureofyou","id":"444164","score":null,"sort":[1535655075000]},"guestAuthors":[],"slug":"fda-investigating-how-a-potential-carcinogen-found-its-way-in-heart-drugs","title":"FDA Investigating How a Potential Carcinogen Found its Way in Heart Drugs","publishDate":1535655075,"format":"standard","headTitle":"Heart health | KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>After learning an ingredient used to make a widely prescribed heart drug contained a substance linked to cancer, the Food and Drug Administration is now testing all drugs in that class for traces of the toxic material.[contextly_sidebar id=\"M4JEVSEfDDhDw0n3meqWeaJPT6i8AOwO\"]\u003c/p>\n\u003cp class=\"danger-zone\">The probe into angiotensin II receptor blockers is part of a widening investigation into a mystery over an impurity known as NDMA, which was found last month in generic valsartan blood pressure pills made by Zhejiang Huahai Pharmaceutical. NDMA, which is considered a possible carcinogen by the Environmental Protection Agency, is an organic chemical once used to make rocket fuel and is an unintended by-product of certain chemical reactions.\u003c/p>\n\u003cp class=\"danger-zone\">The finding caused widespread concern and product recalls by several manufacturers as the FDA and regulators from other countries scrambled to determine how the substance found its way into the medicine. The FDA issued a statement saying it believes the problem occurred “through a specific sequence of steps in the manufacturing process,” but the agency is “still not 100 percent sure this is the root cause.”\u003c/p>\n\u003cp>Numerous companies either manufacture or repackage these drugs, which are regularly used to combat high blood pressure and heart failure. As of now, they noted that more than half of all valsartan medicines that are on the market are being recalled.[contextly_sidebar id=\"sIS8BD5zF1nXJWO6PonqzMGSpfqDl0Bs\"]\u003c/p>\n\u003cp>The episode underscores ongoing concerns about the quality of the pharmaceutical supply chain emanating from countries such as China and India that are large ingredients manufacturers, but have a history of inconsistent — some say inadequate — government oversight. A 2016 \u003ca href=\"https://www.statnews.com/pharmalot/2017/01/17/fda-drug-safety-inspections/\" target=\"_blank\" rel=\"noopener\">report\u003c/a> by the U.S. Government Accountability Office found the FDA was struggling to assess its overseas inspection efforts.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Mindful of such concerns, the FDA statement took pains to explain the steps taken by the agency to respond to the NDMA problem. These included \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm\" target=\"_blank\" rel=\"noopener\">alerts\u003c/a> issued to patients and health care providers on the agency \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm\" target=\"_blank\" rel=\"noopener\">web site\u003c/a>; analysis by FDA staff at its St. Louis laboratory; communicating with regulators in Canada, Europe, and Japan; and inspecting Zhejiang Huahai facilities in China.\u003c/p>\n\u003cp>At the same time, the FDA reiterated an earlier alert that attempted to put the risk into context.\u003c/p>\n\u003cp>The agency estimated that if 8,000 people took the highest valsartan dose of 320 mg in a pill containing NDMA daily for four years — which is the amount of time the FDA believes the affected pill had been on the U.S. market — there may be one additional case of cancer over their lifetimes beyond the average cancer rate among Americans.[contextly_sidebar id=\"enNQmG13yKJp90szHVrMT1LH85pc4uKY\"]\u003c/p>\n\u003cp>“This estimate represented the highest possible level of NDMA exposure. It was a measure of the risk under the most extreme circumstances. Most patients who were exposed to the impurity through the use of valsartan received less exposure than this worst-case scenario,” Gottlieb and Woodcock wrote in a bid to reassure the public about the likelihood of the risk of developing cancer.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Meanwhile, they added that they plan to use what they learn from this scare to “inform assessments of product applications being submitted and currently reviewed by the FDA. We will disseminate that information to manufacturers of all drugs and to the scientific community and re-evaluate our existing guidance to manufacturers.”\u003c/p>\n\n","blocks":[],"excerpt":"The episode underscores ongoing concerns about the quality of the pharmaceutical supply chain emanating from countries such as China and India.","status":"publish","parent":0,"modified":1535655075,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":10,"wordCount":556},"headData":{"title":"FDA Investigating How a Potential Carcinogen Found its Way in Heart Drugs | KQED","description":"The episode underscores ongoing concerns about the quality of the pharmaceutical supply chain emanating from countries such as China and India.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Investigating How a Potential Carcinogen Found its Way in Heart Drugs","datePublished":"2018-08-30T18:51:15.000Z","dateModified":"2018-08-30T18:51:15.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"444164 https://ww2.kqed.org/futureofyou/?p=444164","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/08/30/fda-investigating-how-a-potential-carcinogen-found-its-way-in-heart-drugs/","disqusTitle":"FDA Investigating How a Potential Carcinogen Found its Way in Heart Drugs","source":"Health","nprByline":"Ed Silverman\u003cbr />STAT","path":"/futureofyou/444164/fda-investigating-how-a-potential-carcinogen-found-its-way-in-heart-drugs","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>After learning an ingredient used to make a widely prescribed heart drug contained a substance linked to cancer, the Food and Drug Administration is now testing all drugs in that class for traces of the toxic material.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">The probe into angiotensin II receptor blockers is part of a widening investigation into a mystery over an impurity known as NDMA, which was found last month in generic valsartan blood pressure pills made by Zhejiang Huahai Pharmaceutical. NDMA, which is considered a possible carcinogen by the Environmental Protection Agency, is an organic chemical once used to make rocket fuel and is an unintended by-product of certain chemical reactions.\u003c/p>\n\u003cp class=\"danger-zone\">The finding caused widespread concern and product recalls by several manufacturers as the FDA and regulators from other countries scrambled to determine how the substance found its way into the medicine. The FDA issued a statement saying it believes the problem occurred “through a specific sequence of steps in the manufacturing process,” but the agency is “still not 100 percent sure this is the root cause.”\u003c/p>\n\u003cp>Numerous companies either manufacture or repackage these drugs, which are regularly used to combat high blood pressure and heart failure. As of now, they noted that more than half of all valsartan medicines that are on the market are being recalled.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The episode underscores ongoing concerns about the quality of the pharmaceutical supply chain emanating from countries such as China and India that are large ingredients manufacturers, but have a history of inconsistent — some say inadequate — government oversight. A 2016 \u003ca href=\"https://www.statnews.com/pharmalot/2017/01/17/fda-drug-safety-inspections/\" target=\"_blank\" rel=\"noopener\">report\u003c/a> by the U.S. Government Accountability Office found the FDA was struggling to assess its overseas inspection efforts.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Mindful of such concerns, the FDA statement took pains to explain the steps taken by the agency to respond to the NDMA problem. These included \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm\" target=\"_blank\" rel=\"noopener\">alerts\u003c/a> issued to patients and health care providers on the agency \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm\" target=\"_blank\" rel=\"noopener\">web site\u003c/a>; analysis by FDA staff at its St. Louis laboratory; communicating with regulators in Canada, Europe, and Japan; and inspecting Zhejiang Huahai facilities in China.\u003c/p>\n\u003cp>At the same time, the FDA reiterated an earlier alert that attempted to put the risk into context.\u003c/p>\n\u003cp>The agency estimated that if 8,000 people took the highest valsartan dose of 320 mg in a pill containing NDMA daily for four years — which is the amount of time the FDA believes the affected pill had been on the U.S. market — there may be one additional case of cancer over their lifetimes beyond the average cancer rate among Americans.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>“This estimate represented the highest possible level of NDMA exposure. It was a measure of the risk under the most extreme circumstances. Most patients who were exposed to the impurity through the use of valsartan received less exposure than this worst-case scenario,” Gottlieb and Woodcock wrote in a bid to reassure the public about the likelihood of the risk of developing cancer.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Meanwhile, they added that they plan to use what they learn from this scare to “inform assessments of product applications being submitted and currently reviewed by the FDA. We will disseminate that information to manufacturers of all drugs and to the scientific community and re-evaluate our existing guidance to manufacturers.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/444164/fda-investigating-how-a-potential-carcinogen-found-its-way-in-heart-drugs","authors":["byline_futureofyou_444164"],"series":["futureofyou_350"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_103","futureofyou_952","futureofyou_38","futureofyou_61","futureofyou_279"],"featImg":"futureofyou_444163","label":"source_futureofyou_444164"},"futureofyou_444047":{"type":"posts","id":"futureofyou_444047","meta":{"index":"posts_1591205157","site":"futureofyou","id":"444047","score":null,"sort":[1535133617000]},"guestAuthors":[],"slug":"microdosing-is-touted-by-shroomers-and-reddit-users-science-is-finding-some-truth-in-their-claims","title":"Science is Finding Some Truth in ‘Microdosing’ Claims Touted by ’Shroomers and Reddit Users","publishDate":1535133617,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Dennis van der Meijden isn’t aiming to see the face of God, feel one with the cosmos, grasp the hidden reality of time and space, or embark on a \u003ca href=\"https://www.amazon.com/Psychedelic-Explorers-Guide-Therapeutic-Journeys/dp/1594774021\" target=\"_blank\" rel=\"noopener\">sacred journey\u003c/a>. What the Dutch graphic designer, producer, and rapper (under the professional name Terilekst) wants — and gets — from his twice-weekly “microdoses” of psilocybin is more modest.[contextly_sidebar id=\"2u046KLqIpjlWqt95jSvMRrGksdXK55L\"]\u003c/p>\n\u003cp>“It sharpens all the senses, as if the frequencies of all of your atoms and energy field are raised a little bit and are being slightly more conscious,” said van der Meijden, 39, who told STAT he first microdosed psilocybin — the active ingredient in “magic mushrooms” — three years ago. It makes him energetic enough to skip coffee, “as if I’m kicked in some sort of orbit for that day.” If he becomes distracted, “I’m very much aware of that, as if seeing myself from a bird’s eye view, so I can correct myself very fast.” But van der Meijden says he’s careful not to exceed about 0.4 grams, because 0.5 made him “a bit too joyful and a bit too philosophical,” which wasn’t always appropriate.\u003c/p>\n\u003cp>Microdosing involves taking roughly one-tenth the “trip” dose of a psychedelic drug, an amount too little to trigger hallucinations but enough, its proponents say, to sharpen the mind. Psilocybin microdosers (including hundreds on Reddit) report that the mushrooms can increase creativity, calm anxiety, decrease the need for caffeine, and reduce depression. There is enough evidence that trip doses might have the latter effect that, on Wednesday, London-based Compass Pathways received Food and Drug Administration \u003ca href=\"https://markets.businessinsider.com/news/stocks/compass-pathways-receives-fda-approval-for-psilocybin-therapy-clinical-trial-for-treatment-resistant-depression-1027477289\" target=\"_blank\" rel=\"noopener\">approval\u003c/a> for a Phase 2B clinical trial of psilocybin (in larger-than-microdoses) for treatment-resistant depression. But research into microdosing is minimal.\u003c/p>\n\u003cp>In the nearly 10 years since psychologist and psychedelics researcher James Fadiman introduced the notion of microdosing and devised a widely followed \u003ca href=\"https://sites.google.com/view/microdosingpsychedelics/home\" target=\"_blank\" rel=\"noopener\">protocol\u003c/a> for it, and three years after microdosing psychedelics became the latest Silicon Valley “\u003ca href=\"https://www.forbes.com/sites/robertglatter/2015/11/27/lsd-microdosing-the-new-job-enhancer-in-silicon-valley-and-beyond/#8ece3fe188a8\" target=\"_blank\" rel=\"noopener\">productivity hack\u003c/a>,” all the evidence about its effects has been anecdotal. Psilocybin is illegal almost everywhere, so it’s been nearly impossible to study scientifically. That is changing, however, as the Netherlands and other countries effectively decriminalize it and scientists in places where it remains illegal obtain government permission to study it.[contextly_sidebar id=\"uhfAqZqMFWRdicHoQZb7cSTv52omgvqK\"]\u003c/p>\n\u003cp>The scientific interest is driven, in part, by numerous reports over the years that psilocybin might have antidepressant or anti-anxiety effects that might guide the development of better psychiatric drugs. But it also reflects an itch to see whether there is any basis for the anecdotal accounts. Now, in the first \u003ca href=\"https://www.biorxiv.org/content/early/2018/08/11/384412\" target=\"_blank\" rel=\"noopener\">study\u003c/a> of its kind, scientists in the Netherlands found that psilocybin microdoses have no noticeable effect on the problem-solving, rational-thinking, and abstract-reasoning ability called fluid intelligence. But they do seem to improve two forms of thinking that underlie creativity.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“Performance was significantly higher” on tests of convergent and divergent thinking, said psychologist Bernhard Hommel of Leiden University in the Netherlands, who led the study. Convergent thinking is the ability to focus on abstract concepts to identify a single solution to a well-defined problem. Divergent thinking requires meandering mental forays and mental flexibility. Psychologists consider both to be ingredients of creativity.\u003c/p>\n\u003cp>Whatever the dose, psilocybin (O-phosphoryl-4-hydroxy-N, N-dimethyltryptamine) binds to receptors for the neurotransmitter serotonin. The cortex is packed with these 5-HT2A receptors, especially in areas that control reflection, imagination, and introspection, but “whether there is a minimum dose [of psilocybin that’s required to activate them] is an empirical question that we try to tackle,” Hommel said.\u003c/p>\n\u003cp>To do so, he and his colleagues zeroed in on the effects that many users report: creativity, problem-solving, and the “cognitive flexibility” deemed crucial to both. Leiden’s Luisa Prochazkova took the lead in inviting members of the Psychedelic Society of the Netherlands to participate in the study; she got 38 takers.\u003c/p>\n\u003cp>Before their microdose, the volunteers took three standard psychological tests, two related to creative problem-solving and one an assessment of fluid intelligence. The scientists ran chemical analyses of the mushroom samples to determine how much psilocybin they contained. Since a trip dose is about 3 grams of dried ’shrooms, a microdose is around 0.33 grams. Participants averaged 0.37 grams of the dried preparation, which can be taken with food or packed into gelcaps for easy swallowing.\u003c/p>\n\u003cp>About 90 minutes after the microdose, the participants took the three tests again.\u003c/p>\n\u003cp>In the Picture Concept Task, they saw three rows of three pictures, and had to choose three — one from each row — that were related. That requires converging on the correct solution, like noticing that a bathtub, a sink, and a hose all have something to do with water. The brain must focus, weigh alternatives, and reject wrong ones.\u003c/p>\n\u003cp>In the Alternate Uses Task, the microdosers had five minutes to think of ways to use a pen (tracheotomy? finger splint?) or towel. That measures divergent thinking, to move thoughts away from writing, for example, in the case of the pen.\u003c/p>\n\u003cp>The microdosers also took a “progressive matrices” test: In blocks of two-by-two or three-by-three patterns, with the bottom right one missing, they had to choose which of six possibilities belonged in the blank square — a task that requires fluid intelligence.\u003c/p>\n\u003cp>The scientists found no post-microdose difference on the fluid intelligence test. But after microdosing, performance on the picture concept test was significantly higher (an average score of 7.6) than before (6.6). That suggested an improvement in the convergent thinking element of creativity.\u003c/p>\n\u003cp>The microdosers also came up with significantly more uses for pens and towels, 16.7 vs. 14.7. That suggests a microdose of psilocybin “allowed participants to create more out-of-the-box alternative solutions for a problem,” the scientists wrote. Taken together, the three findings suggest a specific effect of psilocybin microdoses on creativity but not on fluid intelligence.\u003c/p>\n\u003cp>For van der Meijden, a microdose of psilocybin makes his musical brainstorm sessions yield “more concepts, ideas, and solutions,” he said, partly because it lets him “better understand and visualize other people’s concepts.” In his design and illustration work, it produces a “more natural flow of line drawing” and lets him “see more possibilities in how things can be or look.” In his music, it lets him “analyze all the different instruments better” and know, for instance, whether to turn up or down the reverberation effect.\u003c/p>\n\u003cp>The Dutch study, which was published on a preprint site and has not undergone peer review at a journal, has several caveats. For one thing, having seen a test before might make people better at it. More problematic, the study didn’t have a control group of people who took something other than psilocybin. That leaves open the possibility that it wasn’t the compound that improved some forms of thinking, but the expectation that it would do so. Maybe people who microdose believe in its benefits enough to make those expectations reality.\u003c/p>\n\u003cp>On the other hand, the results fit with another new \u003ca href=\"https://www.biorxiv.org/content/early/2018/07/25/376491\" target=\"_blank\" rel=\"noopener\">study\u003c/a> of psilocybin. In this one, scientists led by computational neuroscientist Joana Cabral of the University of Oxford used fMRI scans to study the brain activity of nine people who volunteered to be injected with 2 milligram (trip-inducing) doses. The chemical changed the functional connectivity of various brain regions, so that activity in one became synced with that in another. In particular, the rational, logical, well-behaved frontoparietal regions became “strongly destabilized,” the scientists reported, melding with activity in emotional and other regions to produce “unconstrained consciousness,” “mind wandering,” and a sense that everything is connected to everything else. Seeing connections that elude other people is almost the definition of creativity.\u003c/p>\n\u003cp>The findings in the microdosing study also fit with many anecdotal reports. One college student who is a member of the Portland, Ore., microdosing community said that although he doesn’t microdose psilocybin with the express purpose of boosting creativity or focus, he has found that “things seem to have quieted down, in terms of racing thoughts.” He can still be distracted, said Alex, 38, who asked not to be further identified because the drug is illegal in the U.S. But “if I want to go about doing something, then I have an easier time with it because I’m not being bogged down by my thoughts,” he added.\u003c/p>\n\u003cp>Jakobien van der Weijden takes one psilocybin microdose every three days, with bimonthly breaks, “to work more focused, more efficiently and be more creative” at his marketing job in the Netherlands, he said. “On the downside, I would often feel that the inspiration was still there at night and I would keep working on projects until late. So it was somewhat more difficult to maintain a healthy biorhythm.”\u003c/p>\n\u003cp>As legal strictures loosen, there will likely be more rigorous studies of microdosing psilocybin. “Scientific studies could legitimize the claimed benefits,” said Will Burns, CEO of Wenham, Mass.-based \u003ca href=\"http://www.ideasicle.com/\" target=\"_blank\" rel=\"noopener\">Ideasicle\u003c/a>, which develops branding and marketing ideas. He does not microdose, Burns said, but has \u003ca href=\"https://www.forbes.com/sites/willburns/2015/11/29/lsd-microdosing-deserves-more-serious-research/#6824b00d656d\" target=\"_blank\" rel=\"noopener\">called for\u003c/a> research into its purported effects, including improving productivity and creativity. “Right now, we’re swimming in a world of anecdotes and almost no one has taken this seriously,” he said. “We need scientific studies.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2018/08/23/science-testing-claimed-benefits-of-psilocybin-microdosing/\" target=\"_blank\" rel=\"noopener\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"Microdosing involves taking roughly one-tenth the “trip” dose of a psychedelic drug, an amount too little to trigger hallucinations but enough, its proponents say, to sharpen the mind.","status":"publish","parent":0,"modified":1535066020,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":24,"wordCount":1660},"headData":{"title":"Science is Finding Some Truth in ‘Microdosing’ Claims Touted by ’Shroomers and Reddit Users | KQED","description":"Microdosing involves taking roughly one-tenth the “trip” dose of a psychedelic drug, an amount too little to trigger hallucinations but enough, its proponents say, to sharpen the mind.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Science is Finding Some Truth in ‘Microdosing’ Claims Touted by ’Shroomers and Reddit Users","datePublished":"2018-08-24T18:00:17.000Z","dateModified":"2018-08-23T23:13:40.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"444047 https://ww2.kqed.org/futureofyou/?p=444047","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/08/24/microdosing-is-touted-by-shroomers-and-reddit-users-science-is-finding-some-truth-in-their-claims/","disqusTitle":"Science is Finding Some Truth in ‘Microdosing’ Claims Touted by ’Shroomers and Reddit Users","source":"Health","nprByline":"Sharon Begley\u003cbr />STAT","path":"/futureofyou/444047/microdosing-is-touted-by-shroomers-and-reddit-users-science-is-finding-some-truth-in-their-claims","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Dennis van der Meijden isn’t aiming to see the face of God, feel one with the cosmos, grasp the hidden reality of time and space, or embark on a \u003ca href=\"https://www.amazon.com/Psychedelic-Explorers-Guide-Therapeutic-Journeys/dp/1594774021\" target=\"_blank\" rel=\"noopener\">sacred journey\u003c/a>. What the Dutch graphic designer, producer, and rapper (under the professional name Terilekst) wants — and gets — from his twice-weekly “microdoses” of psilocybin is more modest.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>“It sharpens all the senses, as if the frequencies of all of your atoms and energy field are raised a little bit and are being slightly more conscious,” said van der Meijden, 39, who told STAT he first microdosed psilocybin — the active ingredient in “magic mushrooms” — three years ago. It makes him energetic enough to skip coffee, “as if I’m kicked in some sort of orbit for that day.” If he becomes distracted, “I’m very much aware of that, as if seeing myself from a bird’s eye view, so I can correct myself very fast.” But van der Meijden says he’s careful not to exceed about 0.4 grams, because 0.5 made him “a bit too joyful and a bit too philosophical,” which wasn’t always appropriate.\u003c/p>\n\u003cp>Microdosing involves taking roughly one-tenth the “trip” dose of a psychedelic drug, an amount too little to trigger hallucinations but enough, its proponents say, to sharpen the mind. Psilocybin microdosers (including hundreds on Reddit) report that the mushrooms can increase creativity, calm anxiety, decrease the need for caffeine, and reduce depression. There is enough evidence that trip doses might have the latter effect that, on Wednesday, London-based Compass Pathways received Food and Drug Administration \u003ca href=\"https://markets.businessinsider.com/news/stocks/compass-pathways-receives-fda-approval-for-psilocybin-therapy-clinical-trial-for-treatment-resistant-depression-1027477289\" target=\"_blank\" rel=\"noopener\">approval\u003c/a> for a Phase 2B clinical trial of psilocybin (in larger-than-microdoses) for treatment-resistant depression. But research into microdosing is minimal.\u003c/p>\n\u003cp>In the nearly 10 years since psychologist and psychedelics researcher James Fadiman introduced the notion of microdosing and devised a widely followed \u003ca href=\"https://sites.google.com/view/microdosingpsychedelics/home\" target=\"_blank\" rel=\"noopener\">protocol\u003c/a> for it, and three years after microdosing psychedelics became the latest Silicon Valley “\u003ca href=\"https://www.forbes.com/sites/robertglatter/2015/11/27/lsd-microdosing-the-new-job-enhancer-in-silicon-valley-and-beyond/#8ece3fe188a8\" target=\"_blank\" rel=\"noopener\">productivity hack\u003c/a>,” all the evidence about its effects has been anecdotal. Psilocybin is illegal almost everywhere, so it’s been nearly impossible to study scientifically. That is changing, however, as the Netherlands and other countries effectively decriminalize it and scientists in places where it remains illegal obtain government permission to study it.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The scientific interest is driven, in part, by numerous reports over the years that psilocybin might have antidepressant or anti-anxiety effects that might guide the development of better psychiatric drugs. But it also reflects an itch to see whether there is any basis for the anecdotal accounts. Now, in the first \u003ca href=\"https://www.biorxiv.org/content/early/2018/08/11/384412\" target=\"_blank\" rel=\"noopener\">study\u003c/a> of its kind, scientists in the Netherlands found that psilocybin microdoses have no noticeable effect on the problem-solving, rational-thinking, and abstract-reasoning ability called fluid intelligence. But they do seem to improve two forms of thinking that underlie creativity.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“Performance was significantly higher” on tests of convergent and divergent thinking, said psychologist Bernhard Hommel of Leiden University in the Netherlands, who led the study. Convergent thinking is the ability to focus on abstract concepts to identify a single solution to a well-defined problem. Divergent thinking requires meandering mental forays and mental flexibility. Psychologists consider both to be ingredients of creativity.\u003c/p>\n\u003cp>Whatever the dose, psilocybin (O-phosphoryl-4-hydroxy-N, N-dimethyltryptamine) binds to receptors for the neurotransmitter serotonin. The cortex is packed with these 5-HT2A receptors, especially in areas that control reflection, imagination, and introspection, but “whether there is a minimum dose [of psilocybin that’s required to activate them] is an empirical question that we try to tackle,” Hommel said.\u003c/p>\n\u003cp>To do so, he and his colleagues zeroed in on the effects that many users report: creativity, problem-solving, and the “cognitive flexibility” deemed crucial to both. Leiden’s Luisa Prochazkova took the lead in inviting members of the Psychedelic Society of the Netherlands to participate in the study; she got 38 takers.\u003c/p>\n\u003cp>Before their microdose, the volunteers took three standard psychological tests, two related to creative problem-solving and one an assessment of fluid intelligence. The scientists ran chemical analyses of the mushroom samples to determine how much psilocybin they contained. Since a trip dose is about 3 grams of dried ’shrooms, a microdose is around 0.33 grams. Participants averaged 0.37 grams of the dried preparation, which can be taken with food or packed into gelcaps for easy swallowing.\u003c/p>\n\u003cp>About 90 minutes after the microdose, the participants took the three tests again.\u003c/p>\n\u003cp>In the Picture Concept Task, they saw three rows of three pictures, and had to choose three — one from each row — that were related. That requires converging on the correct solution, like noticing that a bathtub, a sink, and a hose all have something to do with water. The brain must focus, weigh alternatives, and reject wrong ones.\u003c/p>\n\u003cp>In the Alternate Uses Task, the microdosers had five minutes to think of ways to use a pen (tracheotomy? finger splint?) or towel. That measures divergent thinking, to move thoughts away from writing, for example, in the case of the pen.\u003c/p>\n\u003cp>The microdosers also took a “progressive matrices” test: In blocks of two-by-two or three-by-three patterns, with the bottom right one missing, they had to choose which of six possibilities belonged in the blank square — a task that requires fluid intelligence.\u003c/p>\n\u003cp>The scientists found no post-microdose difference on the fluid intelligence test. But after microdosing, performance on the picture concept test was significantly higher (an average score of 7.6) than before (6.6). That suggested an improvement in the convergent thinking element of creativity.\u003c/p>\n\u003cp>The microdosers also came up with significantly more uses for pens and towels, 16.7 vs. 14.7. That suggests a microdose of psilocybin “allowed participants to create more out-of-the-box alternative solutions for a problem,” the scientists wrote. Taken together, the three findings suggest a specific effect of psilocybin microdoses on creativity but not on fluid intelligence.\u003c/p>\n\u003cp>For van der Meijden, a microdose of psilocybin makes his musical brainstorm sessions yield “more concepts, ideas, and solutions,” he said, partly because it lets him “better understand and visualize other people’s concepts.” In his design and illustration work, it produces a “more natural flow of line drawing” and lets him “see more possibilities in how things can be or look.” In his music, it lets him “analyze all the different instruments better” and know, for instance, whether to turn up or down the reverberation effect.\u003c/p>\n\u003cp>The Dutch study, which was published on a preprint site and has not undergone peer review at a journal, has several caveats. For one thing, having seen a test before might make people better at it. More problematic, the study didn’t have a control group of people who took something other than psilocybin. That leaves open the possibility that it wasn’t the compound that improved some forms of thinking, but the expectation that it would do so. Maybe people who microdose believe in its benefits enough to make those expectations reality.\u003c/p>\n\u003cp>On the other hand, the results fit with another new \u003ca href=\"https://www.biorxiv.org/content/early/2018/07/25/376491\" target=\"_blank\" rel=\"noopener\">study\u003c/a> of psilocybin. In this one, scientists led by computational neuroscientist Joana Cabral of the University of Oxford used fMRI scans to study the brain activity of nine people who volunteered to be injected with 2 milligram (trip-inducing) doses. The chemical changed the functional connectivity of various brain regions, so that activity in one became synced with that in another. In particular, the rational, logical, well-behaved frontoparietal regions became “strongly destabilized,” the scientists reported, melding with activity in emotional and other regions to produce “unconstrained consciousness,” “mind wandering,” and a sense that everything is connected to everything else. Seeing connections that elude other people is almost the definition of creativity.\u003c/p>\n\u003cp>The findings in the microdosing study also fit with many anecdotal reports. One college student who is a member of the Portland, Ore., microdosing community said that although he doesn’t microdose psilocybin with the express purpose of boosting creativity or focus, he has found that “things seem to have quieted down, in terms of racing thoughts.” He can still be distracted, said Alex, 38, who asked not to be further identified because the drug is illegal in the U.S. But “if I want to go about doing something, then I have an easier time with it because I’m not being bogged down by my thoughts,” he added.\u003c/p>\n\u003cp>Jakobien van der Weijden takes one psilocybin microdose every three days, with bimonthly breaks, “to work more focused, more efficiently and be more creative” at his marketing job in the Netherlands, he said. “On the downside, I would often feel that the inspiration was still there at night and I would keep working on projects until late. So it was somewhat more difficult to maintain a healthy biorhythm.”\u003c/p>\n\u003cp>As legal strictures loosen, there will likely be more rigorous studies of microdosing psilocybin. “Scientific studies could legitimize the claimed benefits,” said Will Burns, CEO of Wenham, Mass.-based \u003ca href=\"http://www.ideasicle.com/\" target=\"_blank\" rel=\"noopener\">Ideasicle\u003c/a>, which develops branding and marketing ideas. He does not microdose, Burns said, but has \u003ca href=\"https://www.forbes.com/sites/willburns/2015/11/29/lsd-microdosing-deserves-more-serious-research/#6824b00d656d\" target=\"_blank\" rel=\"noopener\">called for\u003c/a> research into its purported effects, including improving productivity and creativity. “Right now, we’re swimming in a world of anecdotes and almost no one has taken this seriously,” he said. “We need scientific studies.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2018/08/23/science-testing-claimed-benefits-of-psilocybin-microdosing/\" target=\"_blank\" rel=\"noopener\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/444047/microdosing-is-touted-by-shroomers-and-reddit-users-science-is-finding-some-truth-in-their-claims","authors":["byline_futureofyou_444047"],"categories":["futureofyou_1060","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_56","futureofyou_1585","futureofyou_952","futureofyou_1078","futureofyou_61"],"collections":["futureofyou_1093","futureofyou_1097"],"featImg":"futureofyou_444051","label":"source_futureofyou_444047"},"futureofyou_443739":{"type":"posts","id":"futureofyou_443739","meta":{"index":"posts_1591205157","site":"futureofyou","id":"443739","score":null,"sort":[1533322856000]},"guestAuthors":[],"slug":"hundreds-claim-anti-depressant-drug-triggered-compulsive-behavior","title":"Hundreds Claim Anti-Depressant Drug Triggered Compulsive Behavior","publishDate":1533322856,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>The casino didn’t always call out to Denise Miley.\u003c/p>\n\u003cp>At most, she and her husband, Brad, would drive over to the Mystic Lake Casino Hotel, just outside Minneapolis, a few times a year.[contextly_sidebar id=\"9sShWsOplz0H3vVUV8sySSc7G2bI7ViQ\"]\u003c/p>\n\u003cp>Then, in the fall of 2014, she got an itch to go more often. She’d ride her bike the 35 miles down to the casino and ask her husband to pick her up. It was just exercise, she’d tell him. Sometimes she would start driving to the office where she worked as an accountant. But when the freeway split off, she’d peel south and head to the slots.\u003c/p>\n\u003cp>“I didn’t have a word for it back then, but I was starting to feel compulsed,” she said. “I wanted to stay longer, and longer, and longer.”\u003c/p>\n\u003cp>She also had no idea her compulsion might be linked to a drug she began taking for depression and anxiety a few weeks before she began seriously gambling. By the time she stopped taking aripiprazole — an antipsychotic sold under the brand name Abilify — she’d stayed in the casino long enough to lose more than $150,000.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Miley, 41, filed a lawsuit in January 2016 against the drug makers Bristol-Myers Squibb and Otsuka, alleging the drug — one of the best-selling in the world — caused compulsive behavior. The suit contends that the companies knew or should have known it could create such urges, and didn’t adequately warn the thousands of people in the U.S. who use the medication each year.\u003c/p>\n\u003cp>Hundreds more people have since sued the companies, claiming that the drug caused them to gamble, eat, or have sex compulsively. And the Food and Drug Administration signaled its own concern in a 2016 \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm498662.htm\" target=\"_blank\" rel=\"noopener\">safety warning\u003c/a>, saying that uncontrollable urges to gamble, binge eat, shop, and have sex \u003ca href=\"https://www.statnews.com/2016/05/03/abilify-gambling-sex-urges/\">had been reported\u003c/a> with use of the antipsychotic.\u003c/p>\n\u003cp>“We have people who have lost their retirement accounts, spent their children’s college funds, blown through a lifetime of savings,” said Gary Wilson, an attorney with Robins Kaplan, a firm representing some of the plaintiffs, including Miley.[contextly_sidebar id=\"WUrxs3xRbhUp0ARmCKpI7XmIsP1oVJc8\"]\u003c/p>\n\u003cp>Scientists haven’t figured out how, exactly, a drug might trigger compulsive behavior. Psychiatrists say that even if Abilify does have a role, it’s probably just part of the explanation, since millions of people take the drug without experiencing such problems.\u003c/p>\n\u003caside>\u003c/aside>\n\u003cp>Otsuka, which developed the drug, and Bristol-Myers Squibb, which marketed it jointly with Otsuka in the U.S., have denied the allegations. Bristol-Myers Squibb referred questions about Abilify to Otsuka, which said it could not comment on pending litigation.\u003c/p>\n\u003cp>The lawsuits have all been lumped together, and the case is presided over by Judge M. Casey Rodgers in the Northern District Court of Florida. The judge picked three bellwether lawsuits to go to trial in a bid to spur a resolution for the other cases, but those three were settled out of court earlier this year for an undisclosed amount.\u003c/p>\n\u003cp>Now, Rodgers has ordered the thousands of other plaintiffs and the drug makers to work out a framework for a global settlement by Sept. 1. At the same time, the court is working to pick a new group of cases to move to trial if a settlement can’t be reached.\u003c/p>\n\u003cp>\u003cstrong>Blockbuster Drug Spurs Safety Warning\u003c/strong>\u003c/p>\n\u003cp>The lawsuits are the latest chapter in the roller-coaster history of Abilify. It was approved by the FDA for schizophrenia in 2002. It’s since been approved for treating bipolar disorder, irritability associated with autistic disorder, Tourette’s syndrome, and major depressive disorder.\u003c/p>\n\u003cp>In 2007, Bristol-Myers Squibb agreed to pay more than $500 million to settle federal charges that it illegally marketed the drug to pediatric physicians and nursing homes. And in 2016, the company reached a $19.5 million settlement with 42 states and Washington, D.C., which accused the drug maker of illegally promoting Abilify to people with Alzheimer’s disease and other forms of dementia.[contextly_sidebar id=\"LnZfdPbBiZTyzqKBvnLrSW8u5Uoeh4mS\"]\u003c/p>\n\u003cp>But it hasn’t all been bad news. Aripiprazole remains one of the most-prescribed drugs on the market. And though it went generic in the U.S. in 2015, it continues to generate big sales. The brand-name version of the drug has raked in more than $51 billion worldwide since it was approved, according to \u003ca href=\"https://www.fiercepharma.com/pharma/from-old-behemoth-lipitor-to-new-king-humira-u-s-best-selling-drugs-over-25-years\" target=\"_blank\" rel=\"noopener\">IQVIA\u003c/a>, a health care analytics company.\u003c/p>\n\u003cp>And in 2017, the \u003ca href=\"https://www.statnews.com/2017/11/13/pill-sensor-fda-approval/\">FDA approved Abilify MyCite\u003c/a>, a version of the drug embedded with a sensor that can alert a patient’s physician or caregiver when its been ingested. It was the first approval of a so-called smart pill.\u003c/p>\n\u003cp>As the drug grew increasingly popular, reports kept cropping up that a small number of patients taking the drug had started gambling uncontrollably and experiencing other compulsive behaviors. Between November 2002 and May 2016 when the FDA issued its warning, there were 184 case reports linking the drug to impulse control problems in the medical literature and the FDA’s adverse event database, according to the agency.\u003c/p>\n\u003cp>The European Medicines Agency was the first regulator to issue a warning, in 2012, that Abilify had been linked to compulsive behavior. In 2015, Canadian drug regulators followed suit. Both required the drug makers to change the labeling, but “pathological gambling” wasn’t added as a potential adverse event to Abilify’s labeling information until January 2016. The FDA didn’t issue a warning to the public until May 2016.\u003c/p>\n\u003caside>\u003c/aside>\n\u003cp>When asked about the reasons for the delay compared with warnings issued in other countries, an FDA spokesperson said, “Our safety signal folks are always reviewing the research.”[contextly_sidebar id=\"bXGbCmsnub7uybQC8z1CP2S7Wf4LFA0O\"]\u003c/p>\n\u003cp>Otsuka maintains that there weren’t any signs the drug might be linked to pathological gambling in its initial clinical trials. In one large study — testing Abilify paired with the antidepressant bupropion, the exact combination that Miley was prescribed — the drug makers reported there weren’t any unexpected adverse events.\u003c/p>\n\u003cp>But Miley said that wasn’t her experience.\u003c/p>\n\u003cp>\u003cstrong>The Itch to Gamble Grows\u003c/strong>\u003c/p>\n\u003cp>It never occurred to Miley that the drug might be to blame for her growing urge to gamble. She started taking the drug in September 2014, two years before the FDA went public with its warning.\u003c/p>\n\u003cp>Nor did it raise a red flag for her psychiatrist when Miley mentioned offhand at an appointment that fall that she’d been gambling more. She pitched it almost as a good thing.\u003c/p>\n\u003cp>“I remember saying, ‘We’re going to the casino a lot more. We’re doing it for an excursion — we’re getting out of the house,’” Miley said.\u003c/p>\n\u003cp>Miley went back to work, but only part time and with the option to work remotely from her home in Maple Grove, Minn. That meant she could go to the casino without anyone realizing where she’d gone. Some days, she told herself she didn’t have that much work to do. Other days, she just ended up there. Miley’s husband knew she sometimes went to the casino alone — but he had no idea how often. She didn’t always tell him. She hated how she felt: alone and ashamed.\u003c/p>\n\u003cp>“This whole thing snowballed extremely fast,” she said. Looking back, she felt so distant from herself — a dedicated mom to four kids who calls herself her family’s “rock.”\u003c/p>\n\u003cfigure id=\"attachment_356302\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/08/IMG_4991.jpg\">\u003cimg src=\"https://www.statnews.com/wp-content/uploads/2018/08/IMG_4991-640x853.jpg\" alt=\"A photo of Denise Miley and her family.\" width=\"640\" height=\"853\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Denise Miley, her husband, Brad, and her four sons in 2017. Courtesy Denise Miley\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>That fall, if her oldest son’s high school basketball games were anywhere near the casino, she’d dash over during halftime. She told her family she was popping out to do some quick Christmas shopping.\u003c/p>\n\u003cp>“I had the full intention of going back to his games,” she said. “But I’d sit there and keep gambling and gambling.”\u003c/p>\n\u003cp>More than once, she didn’t make it back and had to ask someone else to drive her son home. She was losing money, and growing more and more concerned. She finally told her husband she’d lost $10,000.[contextly_sidebar id=\"sRT777cXIzknFQmC7YTj1Ql8vPHYroHO\"]\u003c/p>\n\u003cp>She grew increasingly desperate to win the money back. “That was the first time I had considered or threatened suicide,” she said.\u003c/p>\n\u003cp>She found herself in the same brutal spiral that many of the other plaintiffs say they’ve found themselves in: They started taking Abilify to grapple with depression and other serious psychiatric conditions, but then started experiencing compulsions that crushed them with guilt and damaged their relationships — feeding their depression.\u003c/p>\n\u003cp>Miley’s husband convinced her to talk to a physician who specialized in gambling addiction and who recommended she enter inpatient treatment. But there weren’t any openings. So her husband took her car away, hoping to cut off her ability to get to the casino. She was supposed to take the bus to work.\u003c/p>\n\u003cp>“That’s what he thought I would do,” she said. She did take the bus to work. Then, she’d wait for the bank to open so she could take money out of their account and hop on the lightrail to the Mall of America, where she caught another bus to the casino. Sometimes she made it back to work, but other times she’d miss the bus. Once, she took a taxi and had it drop her off at the bus station, so it looked like she took the bus home from work.\u003c/p>\n\u003cp>“It wasn’t me. It just wasn’t me at all during those times,” she said.\u003c/p>\n\u003cp>That early interaction with her psychiatrist still haunts her. What if he had known about the possible link to Abilify? What if he had taken her off the drug, right then and there? Before the compulsion had stripped her of her savings. Before it had harmed her relationships with her family and friends. Before it had threatened her career. Before it had made her think about suicide.\u003c/p>\n\u003cp>“I just look back a lot and go, ‘How this could have been different,’” she said. “That’s where I get angry.”\u003c/p>\n\u003cp>\u003cstrong>Scientists stumped by a rare link\u003c/strong>\u003c/p>\n\u003cp>The science on the potential link between Abilify and impulse control problems is far from settled.\u003c/p>\n\u003cp>A quick biology lesson: Abilify is a partial dopamine agonist, which means it acts on dopamine, a neurotransmitter that ferries signals between neurons in the brain. It’s involved in multiple pathways, including one that regulates reward processing, pleasure, and motivation.\u003c/p>\n\u003cp>Both sides battled it out in court over the question of whether Abilify is capable of causing uncontrollable impulses, roping in a slew of experts to testify on either side. In March, Rodgers ruled “there’s a genuine dispute of material fact.” That is, it’s not clear what might be happening, but there isn’t enough evidence to prove it’s impossible.\u003c/p>\n\u003cp>Experts say the more critical question — and the bigger mystery — is why impulse-control problems might show up in just a small slice of the millions of patients who take Abilify each year.\u003c/p>\n\u003cp>“If it were as simple as it causing [the behavior], then the streets would be filled with impulsive people,” said Dr. Jon Grant, a psychiatrist who studies impulsive-compulsive disorders at University of Chicago.\u003c/p>\n\u003cp>Answering that question would take a significant amount of time and money, experts said. It would require a randomized trial and a ton of baseline data from brain scans, blood tests, and detailed patient histories to tease out what factors might be at play.\u003c/p>\n\u003cp>“If we stick to science, we have to say there’s a very interesting signal there that’s worth investigating,” said Dr. Timothy Fong, a psychiatrist who serves as the co-director of the University of California, Los Angeles, gambling studies program. “But to do that investigation will take a massive amount of resources,” he added.\u003c/p>\n\u003cp>There’s also a looming question of how responsible the drug might be for impulse control issues in some patients, if at all, Grant said. If it were shown that the drug causes impulse control problems in people with a certain genetic makeup, or people who were exposed to certain environmental factors, what percent of the blame could be placed on the drug?\u003c/p>\n\u003cp>“The legal system looks at it very differently,” Grant said.\u003c/p>\n\u003cp>One piece of evidence cited by the plaintiffs: When some patients started taking the drug, they experienced compulsive behavior. When they stopped the drug, it stopped. In some cases, when a patient started taking Abilify again, the impulses reportedly picked right back up where they’d left off. In its 2016 warning, the FDA noted that in the majority of case reports, the compulsions happened in people with no prior history of impulse control problems.\u003c/p>\n\u003cp>It’s also not the first drug linked to such problems. Similar issues have been seen with certain Parkinson’s drugs that also work on the dopamine system.\u003c/p>\n\u003cp>“The story [about Abilify] is not a story that’s unusual or surprising,” said Fong.\u003c/p>\n\u003cp>\u003cstrong>A promise to get help\u003c/strong>\u003c/p>\n\u003cp>One night in February 2015, Miley was supposed to be celebrating a close friend’s 60th birthday. It was the kind of neighborhood get-together she ordinarily gets excited about. But that morning, she took a familiar trip — down to work and on to the casino.\u003c/p>\n\u003cp>A week earlier, Miley had tried to take $50,000 out of her retirement account, but was told it was going to take several days to get the money. With the casino clawing at her brain, she instead took out a $50,000 loan. She was winning the day of the party — up so much that she thought she’d be able to pay off the debt.\u003c/p>\n\u003cp>She called her friend and told her she was working late. It was smack in the middle of tax season, so she thought it would be believable.\u003c/p>\n\u003cp>“I knew I shouldn’t be lying to people,” Miley said. “But the power that I felt like I needed to gamble was so much more than any of that.”\u003c/p>\n\u003cp>Her friend knew better. Miley was still ahead when the girlfriend showed up with a second friend at the casino at nearly 1 a.m. By that point, Miley had moved to high-stakes poker. One friend told Miley she looked like “a shell of [herself].”\u003c/p>\n\u003cp>She was embarrassed and distraught. She felt out of control, suicidal. They wanted to drive her to the nearest treatment facility, but Miley wanted to see her kids. So with a promise to return in the morning, they drove her home.\u003c/p>\n\u003cp>Miley’s husband, meanwhile, had realized she was gone and checked their bank accounts. To his shock, he realized she had been withdrawing their savings. He moved most of their money to an account Miley couldn’t access. When she arrived home, she made him the same promise: “In the morning, we’ll go.”\u003c/p>\n\u003cp>The next morning, Miley wrote her husband a note saying she was going to work to get everything in order before they went to the treatment facility. She did go to her office. Then she drained the little bit of money her husband had left in their bank account for making their house payment and paying other bills, and made a beeline for the casino.\u003c/p>\n\u003cp>Her husband was so desperate he considered calling the police, since she’d taken his car. He begged her to come home, and, eventually, Miley agreed. They sped straight toward the treatment facility, more than 100 miles from home.\u003c/p>\n\u003cp>“Shame. That’s all I felt, this whole time,” Miley recalled. “Shame at what I was putting my family through. Shame at what I was doing. Shame that I couldn’t control this.”\u003c/p>\n\u003cp>Shortly after she arrived, a provider pulled her off of Abilify and Xanax, which she had been prescribed in December for her growing anxiety, Miley said. She felt the urge to gamble vanish. It happened so fast, in fact, that she felt out of place in treatment.\u003c/p>\n\u003cp>“I could relate to the [other patients’] feelings of shame and embarrassment,” she said. “But I couldn’t relate to always struggling with wanting to go gambling.”\u003c/p>\n\u003cp>After 30 days in the inpatient facility, Miley went to a few Gamblers Anonymous meetings and saw a psychologist who specialized in treating gambling addiction, but ultimately stopped going. She just wasn’t experiencing the same urges anymore.\u003c/p>\n\u003cp>\u003cstrong>‘I could finally start healing’\u003c/strong>\u003c/p>\n\u003cp>In the 3 1/2 years since she stopped taking Abilify, Miley has settled back into a routine. She and her husband love watching their kids play sports and spending time at the lake with her parents and in-laws.\u003c/p>\n\u003cp>They’re trying to rebuild their lives. While she believes her compulsions were out of her control, that doesn’t change what she went through, or what she put her family through, she said. And it doesn’t return the money she gambled away. She took money out of her retirement account after treatment to pay off the bank loan.\u003c/p>\n\u003cp>She felt a little bit of the shame lift when the FDA warning came out in 2016. It no longer was just her pointing to Abilify, or even a law firm. Now, federal regulators were saying there might be a link.\u003c/p>\n\u003cp>“I could finally start healing,” she said. But it still feels raw. She still gets emotional talking about the toll it took on her family.\u003c/p>\n\u003cp>In late 2016, Miley had to go to the Hard Rock Hotel & Casino in Las Vegas for a work trip. She was absolutely dreading it. It dredged up old feelings that she’d tried to stuff away. She had to walk through the casino floor to get from her hotel room to the meeting rooms.\u003c/p>\n\u003cp>Not once, Miley said, did she feel like gambling.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/08/02/abilify-lawsuits-claim-drug-triggered-compulsive-gambling/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003csection>\u003c/section>\n\n","blocks":[],"excerpt":"Hundreds have sued drug makers, claiming that antipsychotic Ablify caused them to gamble, eat, or have sex compulsively.","status":"publish","parent":0,"modified":1533254308,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":75,"wordCount":3130},"headData":{"title":"Hundreds Claim Anti-Depressant Drug Triggered Compulsive Behavior | KQED","description":"Hundreds have sued drug makers, claiming that antipsychotic Ablify caused them to gamble, eat, or have sex compulsively.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Hundreds Claim Anti-Depressant Drug Triggered Compulsive Behavior","datePublished":"2018-08-03T19:00:56.000Z","dateModified":"2018-08-02T23:58:28.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"443739 https://ww2.kqed.org/futureofyou/?p=443739","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/08/03/hundreds-claim-anti-depressant-drug-triggered-compulsive-behavior/","disqusTitle":"Hundreds Claim Anti-Depressant Drug Triggered Compulsive Behavior","source":"Health","nprByline":"Megan Thielking\u003cbr />STAT","path":"/futureofyou/443739/hundreds-claim-anti-depressant-drug-triggered-compulsive-behavior","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The casino didn’t always call out to Denise Miley.\u003c/p>\n\u003cp>At most, she and her husband, Brad, would drive over to the Mystic Lake Casino Hotel, just outside Minneapolis, a few times a year.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Then, in the fall of 2014, she got an itch to go more often. She’d ride her bike the 35 miles down to the casino and ask her husband to pick her up. It was just exercise, she’d tell him. Sometimes she would start driving to the office where she worked as an accountant. But when the freeway split off, she’d peel south and head to the slots.\u003c/p>\n\u003cp>“I didn’t have a word for it back then, but I was starting to feel compulsed,” she said. “I wanted to stay longer, and longer, and longer.”\u003c/p>\n\u003cp>She also had no idea her compulsion might be linked to a drug she began taking for depression and anxiety a few weeks before she began seriously gambling. By the time she stopped taking aripiprazole — an antipsychotic sold under the brand name Abilify — she’d stayed in the casino long enough to lose more than $150,000.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Miley, 41, filed a lawsuit in January 2016 against the drug makers Bristol-Myers Squibb and Otsuka, alleging the drug — one of the best-selling in the world — caused compulsive behavior. The suit contends that the companies knew or should have known it could create such urges, and didn’t adequately warn the thousands of people in the U.S. who use the medication each year.\u003c/p>\n\u003cp>Hundreds more people have since sued the companies, claiming that the drug caused them to gamble, eat, or have sex compulsively. And the Food and Drug Administration signaled its own concern in a 2016 \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm498662.htm\" target=\"_blank\" rel=\"noopener\">safety warning\u003c/a>, saying that uncontrollable urges to gamble, binge eat, shop, and have sex \u003ca href=\"https://www.statnews.com/2016/05/03/abilify-gambling-sex-urges/\">had been reported\u003c/a> with use of the antipsychotic.\u003c/p>\n\u003cp>“We have people who have lost their retirement accounts, spent their children’s college funds, blown through a lifetime of savings,” said Gary Wilson, an attorney with Robins Kaplan, a firm representing some of the plaintiffs, including Miley.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Scientists haven’t figured out how, exactly, a drug might trigger compulsive behavior. Psychiatrists say that even if Abilify does have a role, it’s probably just part of the explanation, since millions of people take the drug without experiencing such problems.\u003c/p>\n\u003caside>\u003c/aside>\n\u003cp>Otsuka, which developed the drug, and Bristol-Myers Squibb, which marketed it jointly with Otsuka in the U.S., have denied the allegations. Bristol-Myers Squibb referred questions about Abilify to Otsuka, which said it could not comment on pending litigation.\u003c/p>\n\u003cp>The lawsuits have all been lumped together, and the case is presided over by Judge M. Casey Rodgers in the Northern District Court of Florida. The judge picked three bellwether lawsuits to go to trial in a bid to spur a resolution for the other cases, but those three were settled out of court earlier this year for an undisclosed amount.\u003c/p>\n\u003cp>Now, Rodgers has ordered the thousands of other plaintiffs and the drug makers to work out a framework for a global settlement by Sept. 1. At the same time, the court is working to pick a new group of cases to move to trial if a settlement can’t be reached.\u003c/p>\n\u003cp>\u003cstrong>Blockbuster Drug Spurs Safety Warning\u003c/strong>\u003c/p>\n\u003cp>The lawsuits are the latest chapter in the roller-coaster history of Abilify. It was approved by the FDA for schizophrenia in 2002. It’s since been approved for treating bipolar disorder, irritability associated with autistic disorder, Tourette’s syndrome, and major depressive disorder.\u003c/p>\n\u003cp>In 2007, Bristol-Myers Squibb agreed to pay more than $500 million to settle federal charges that it illegally marketed the drug to pediatric physicians and nursing homes. And in 2016, the company reached a $19.5 million settlement with 42 states and Washington, D.C., which accused the drug maker of illegally promoting Abilify to people with Alzheimer’s disease and other forms of dementia.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>But it hasn’t all been bad news. Aripiprazole remains one of the most-prescribed drugs on the market. And though it went generic in the U.S. in 2015, it continues to generate big sales. The brand-name version of the drug has raked in more than $51 billion worldwide since it was approved, according to \u003ca href=\"https://www.fiercepharma.com/pharma/from-old-behemoth-lipitor-to-new-king-humira-u-s-best-selling-drugs-over-25-years\" target=\"_blank\" rel=\"noopener\">IQVIA\u003c/a>, a health care analytics company.\u003c/p>\n\u003cp>And in 2017, the \u003ca href=\"https://www.statnews.com/2017/11/13/pill-sensor-fda-approval/\">FDA approved Abilify MyCite\u003c/a>, a version of the drug embedded with a sensor that can alert a patient’s physician or caregiver when its been ingested. It was the first approval of a so-called smart pill.\u003c/p>\n\u003cp>As the drug grew increasingly popular, reports kept cropping up that a small number of patients taking the drug had started gambling uncontrollably and experiencing other compulsive behaviors. Between November 2002 and May 2016 when the FDA issued its warning, there were 184 case reports linking the drug to impulse control problems in the medical literature and the FDA’s adverse event database, according to the agency.\u003c/p>\n\u003cp>The European Medicines Agency was the first regulator to issue a warning, in 2012, that Abilify had been linked to compulsive behavior. In 2015, Canadian drug regulators followed suit. Both required the drug makers to change the labeling, but “pathological gambling” wasn’t added as a potential adverse event to Abilify’s labeling information until January 2016. The FDA didn’t issue a warning to the public until May 2016.\u003c/p>\n\u003caside>\u003c/aside>\n\u003cp>When asked about the reasons for the delay compared with warnings issued in other countries, an FDA spokesperson said, “Our safety signal folks are always reviewing the research.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Otsuka maintains that there weren’t any signs the drug might be linked to pathological gambling in its initial clinical trials. In one large study — testing Abilify paired with the antidepressant bupropion, the exact combination that Miley was prescribed — the drug makers reported there weren’t any unexpected adverse events.\u003c/p>\n\u003cp>But Miley said that wasn’t her experience.\u003c/p>\n\u003cp>\u003cstrong>The Itch to Gamble Grows\u003c/strong>\u003c/p>\n\u003cp>It never occurred to Miley that the drug might be to blame for her growing urge to gamble. She started taking the drug in September 2014, two years before the FDA went public with its warning.\u003c/p>\n\u003cp>Nor did it raise a red flag for her psychiatrist when Miley mentioned offhand at an appointment that fall that she’d been gambling more. She pitched it almost as a good thing.\u003c/p>\n\u003cp>“I remember saying, ‘We’re going to the casino a lot more. We’re doing it for an excursion — we’re getting out of the house,’” Miley said.\u003c/p>\n\u003cp>Miley went back to work, but only part time and with the option to work remotely from her home in Maple Grove, Minn. That meant she could go to the casino without anyone realizing where she’d gone. Some days, she told herself she didn’t have that much work to do. Other days, she just ended up there. Miley’s husband knew she sometimes went to the casino alone — but he had no idea how often. She didn’t always tell him. She hated how she felt: alone and ashamed.\u003c/p>\n\u003cp>“This whole thing snowballed extremely fast,” she said. Looking back, she felt so distant from herself — a dedicated mom to four kids who calls herself her family’s “rock.”\u003c/p>\n\u003cfigure id=\"attachment_356302\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/08/IMG_4991.jpg\">\u003cimg src=\"https://www.statnews.com/wp-content/uploads/2018/08/IMG_4991-640x853.jpg\" alt=\"A photo of Denise Miley and her family.\" width=\"640\" height=\"853\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Denise Miley, her husband, Brad, and her four sons in 2017. Courtesy Denise Miley\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>That fall, if her oldest son’s high school basketball games were anywhere near the casino, she’d dash over during halftime. She told her family she was popping out to do some quick Christmas shopping.\u003c/p>\n\u003cp>“I had the full intention of going back to his games,” she said. “But I’d sit there and keep gambling and gambling.”\u003c/p>\n\u003cp>More than once, she didn’t make it back and had to ask someone else to drive her son home. She was losing money, and growing more and more concerned. She finally told her husband she’d lost $10,000.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>She grew increasingly desperate to win the money back. “That was the first time I had considered or threatened suicide,” she said.\u003c/p>\n\u003cp>She found herself in the same brutal spiral that many of the other plaintiffs say they’ve found themselves in: They started taking Abilify to grapple with depression and other serious psychiatric conditions, but then started experiencing compulsions that crushed them with guilt and damaged their relationships — feeding their depression.\u003c/p>\n\u003cp>Miley’s husband convinced her to talk to a physician who specialized in gambling addiction and who recommended she enter inpatient treatment. But there weren’t any openings. So her husband took her car away, hoping to cut off her ability to get to the casino. She was supposed to take the bus to work.\u003c/p>\n\u003cp>“That’s what he thought I would do,” she said. She did take the bus to work. Then, she’d wait for the bank to open so she could take money out of their account and hop on the lightrail to the Mall of America, where she caught another bus to the casino. Sometimes she made it back to work, but other times she’d miss the bus. Once, she took a taxi and had it drop her off at the bus station, so it looked like she took the bus home from work.\u003c/p>\n\u003cp>“It wasn’t me. It just wasn’t me at all during those times,” she said.\u003c/p>\n\u003cp>That early interaction with her psychiatrist still haunts her. What if he had known about the possible link to Abilify? What if he had taken her off the drug, right then and there? Before the compulsion had stripped her of her savings. Before it had harmed her relationships with her family and friends. Before it had threatened her career. Before it had made her think about suicide.\u003c/p>\n\u003cp>“I just look back a lot and go, ‘How this could have been different,’” she said. “That’s where I get angry.”\u003c/p>\n\u003cp>\u003cstrong>Scientists stumped by a rare link\u003c/strong>\u003c/p>\n\u003cp>The science on the potential link between Abilify and impulse control problems is far from settled.\u003c/p>\n\u003cp>A quick biology lesson: Abilify is a partial dopamine agonist, which means it acts on dopamine, a neurotransmitter that ferries signals between neurons in the brain. It’s involved in multiple pathways, including one that regulates reward processing, pleasure, and motivation.\u003c/p>\n\u003cp>Both sides battled it out in court over the question of whether Abilify is capable of causing uncontrollable impulses, roping in a slew of experts to testify on either side. In March, Rodgers ruled “there’s a genuine dispute of material fact.” That is, it’s not clear what might be happening, but there isn’t enough evidence to prove it’s impossible.\u003c/p>\n\u003cp>Experts say the more critical question — and the bigger mystery — is why impulse-control problems might show up in just a small slice of the millions of patients who take Abilify each year.\u003c/p>\n\u003cp>“If it were as simple as it causing [the behavior], then the streets would be filled with impulsive people,” said Dr. Jon Grant, a psychiatrist who studies impulsive-compulsive disorders at University of Chicago.\u003c/p>\n\u003cp>Answering that question would take a significant amount of time and money, experts said. It would require a randomized trial and a ton of baseline data from brain scans, blood tests, and detailed patient histories to tease out what factors might be at play.\u003c/p>\n\u003cp>“If we stick to science, we have to say there’s a very interesting signal there that’s worth investigating,” said Dr. Timothy Fong, a psychiatrist who serves as the co-director of the University of California, Los Angeles, gambling studies program. “But to do that investigation will take a massive amount of resources,” he added.\u003c/p>\n\u003cp>There’s also a looming question of how responsible the drug might be for impulse control issues in some patients, if at all, Grant said. If it were shown that the drug causes impulse control problems in people with a certain genetic makeup, or people who were exposed to certain environmental factors, what percent of the blame could be placed on the drug?\u003c/p>\n\u003cp>“The legal system looks at it very differently,” Grant said.\u003c/p>\n\u003cp>One piece of evidence cited by the plaintiffs: When some patients started taking the drug, they experienced compulsive behavior. When they stopped the drug, it stopped. In some cases, when a patient started taking Abilify again, the impulses reportedly picked right back up where they’d left off. In its 2016 warning, the FDA noted that in the majority of case reports, the compulsions happened in people with no prior history of impulse control problems.\u003c/p>\n\u003cp>It’s also not the first drug linked to such problems. Similar issues have been seen with certain Parkinson’s drugs that also work on the dopamine system.\u003c/p>\n\u003cp>“The story [about Abilify] is not a story that’s unusual or surprising,” said Fong.\u003c/p>\n\u003cp>\u003cstrong>A promise to get help\u003c/strong>\u003c/p>\n\u003cp>One night in February 2015, Miley was supposed to be celebrating a close friend’s 60th birthday. It was the kind of neighborhood get-together she ordinarily gets excited about. But that morning, she took a familiar trip — down to work and on to the casino.\u003c/p>\n\u003cp>A week earlier, Miley had tried to take $50,000 out of her retirement account, but was told it was going to take several days to get the money. With the casino clawing at her brain, she instead took out a $50,000 loan. She was winning the day of the party — up so much that she thought she’d be able to pay off the debt.\u003c/p>\n\u003cp>She called her friend and told her she was working late. It was smack in the middle of tax season, so she thought it would be believable.\u003c/p>\n\u003cp>“I knew I shouldn’t be lying to people,” Miley said. “But the power that I felt like I needed to gamble was so much more than any of that.”\u003c/p>\n\u003cp>Her friend knew better. Miley was still ahead when the girlfriend showed up with a second friend at the casino at nearly 1 a.m. By that point, Miley had moved to high-stakes poker. One friend told Miley she looked like “a shell of [herself].”\u003c/p>\n\u003cp>She was embarrassed and distraught. She felt out of control, suicidal. They wanted to drive her to the nearest treatment facility, but Miley wanted to see her kids. So with a promise to return in the morning, they drove her home.\u003c/p>\n\u003cp>Miley’s husband, meanwhile, had realized she was gone and checked their bank accounts. To his shock, he realized she had been withdrawing their savings. He moved most of their money to an account Miley couldn’t access. When she arrived home, she made him the same promise: “In the morning, we’ll go.”\u003c/p>\n\u003cp>The next morning, Miley wrote her husband a note saying she was going to work to get everything in order before they went to the treatment facility. She did go to her office. Then she drained the little bit of money her husband had left in their bank account for making their house payment and paying other bills, and made a beeline for the casino.\u003c/p>\n\u003cp>Her husband was so desperate he considered calling the police, since she’d taken his car. He begged her to come home, and, eventually, Miley agreed. They sped straight toward the treatment facility, more than 100 miles from home.\u003c/p>\n\u003cp>“Shame. That’s all I felt, this whole time,” Miley recalled. “Shame at what I was putting my family through. Shame at what I was doing. Shame that I couldn’t control this.”\u003c/p>\n\u003cp>Shortly after she arrived, a provider pulled her off of Abilify and Xanax, which she had been prescribed in December for her growing anxiety, Miley said. She felt the urge to gamble vanish. It happened so fast, in fact, that she felt out of place in treatment.\u003c/p>\n\u003cp>“I could relate to the [other patients’] feelings of shame and embarrassment,” she said. “But I couldn’t relate to always struggling with wanting to go gambling.”\u003c/p>\n\u003cp>After 30 days in the inpatient facility, Miley went to a few Gamblers Anonymous meetings and saw a psychologist who specialized in treating gambling addiction, but ultimately stopped going. She just wasn’t experiencing the same urges anymore.\u003c/p>\n\u003cp>\u003cstrong>‘I could finally start healing’\u003c/strong>\u003c/p>\n\u003cp>In the 3 1/2 years since she stopped taking Abilify, Miley has settled back into a routine. She and her husband love watching their kids play sports and spending time at the lake with her parents and in-laws.\u003c/p>\n\u003cp>They’re trying to rebuild their lives. While she believes her compulsions were out of her control, that doesn’t change what she went through, or what she put her family through, she said. And it doesn’t return the money she gambled away. She took money out of her retirement account after treatment to pay off the bank loan.\u003c/p>\n\u003cp>She felt a little bit of the shame lift when the FDA warning came out in 2016. It no longer was just her pointing to Abilify, or even a law firm. Now, federal regulators were saying there might be a link.\u003c/p>\n\u003cp>“I could finally start healing,” she said. But it still feels raw. She still gets emotional talking about the toll it took on her family.\u003c/p>\n\u003cp>In late 2016, Miley had to go to the Hard Rock Hotel & Casino in Las Vegas for a work trip. She was absolutely dreading it. It dredged up old feelings that she’d tried to stuff away. She had to walk through the casino floor to get from her hotel room to the meeting rooms.\u003c/p>\n\u003cp>Not once, Miley said, did she feel like gambling.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/08/02/abilify-lawsuits-claim-drug-triggered-compulsive-gambling/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003csection>\u003c/section>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/443739/hundreds-claim-anti-depressant-drug-triggered-compulsive-behavior","authors":["byline_futureofyou_443739"],"categories":["futureofyou_73"],"tags":["futureofyou_1076","futureofyou_673","futureofyou_1591","futureofyou_952","futureofyou_198"],"featImg":"futureofyou_443742","label":"source_futureofyou_443739"},"futureofyou_443575":{"type":"posts","id":"futureofyou_443575","meta":{"index":"posts_1591205157","site":"futureofyou","id":"443575","score":null,"sort":[1532558227000]},"guestAuthors":[],"slug":"most-people-think-pots-totally-safe-but-we-dont-actually-know","title":"Most People Think Pot's Totally Safe. But We Don't Actually Know","publishDate":1532558227,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"term":1097,"site":"futureofyou"},"content":"\u003cp>When it comes to pot, many Americans seem to think it is a magic cure-all despite the lack of scientific data to corroborate that view.[contextly_sidebar id=\"qbIMJ6HAj7B7PdjXyzZ3WGlgtNv4dD58\"]\u003c/p>\n\u003cp>Those are the findings of a new survey, published this week in the journal \u003ca href=\"http://annals.org/aim/article/doi/10.7326/M18-0810\">\u003cem>Annals of Internal Medicine\u003c/em>. \u003c/a>The online survey, conducted by researchers at UC San Francisco, found that many Americans believe marijuana has significant health benefits, despite a lack of scientific data to support that view.\u003c/p>\n\u003cp>That data lack is largely due to marijuana's restricted legal status in the U.S., which makes it difficult for scientists to study the drug's impact on human health, according to Timothy Fong, a professor of addiction psychiatry at UC Los Angeles.\u003c/p>\n\u003cp>[contextly_sidebar id=\"1hOtotjglJ20ftdvAgNx5fpFHerDNbOZ\"]Without actual data to go on, people fall back on personal or anecdotal evidence.\u003c/p>\n\u003cp>\"We want to do more studies, but we can’t do a darn thing if the federal government handcuffs us,” Fong told \u003ca href=\"https://www.reuters.com/article/us-health-marijuana/americans-view-of-marijuana-is-rosy-and-unscientific-idUSKBN1KD2IR\" target=\"_blank\" rel=\"noopener\">Reuters.\u003c/a> “This is the kind of study that I think elevates the discussion. And it shows we have a long way to go.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Researchers surveyed 16,280 people in the U.S. and found that 81 percent of respondents believe that smoking marijuana has at least one health benefit, with pain management being the most commonly cited one.\u003c/p>\n\u003cp>Yet a separate study \u003ca href=\"https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(18)30110-5/fulltext?code=lancet-site\" target=\"_blank\" rel=\"noopener\">spanning four years\u003c/a> found no evidence that marijuana use improves the symptoms of chronic pain.\u003c/p>\n\u003cp>The survey also found that 91 percent of respondents believe that marijuana has at least one risk, but the most commonly cited risk — legal trouble — wasn't health related, a finding researchers found troubling because it indicates that many people are downplaying potential harm, according to \u003ca href=\"http://chime.ucsf.edu/people/salomeh-keyhani-md\" target=\"_blank\" rel=\"noopener\">Dr. Salomeh Keyhani,\u003c/a> a professor of medicine at UC San Francisco.\u003c/p>\n\u003cp>“The American public has a much more favorable point of view than is warranted by the evidence,” Dr. Keyhani told \u003ca href=\"https://www.reuters.com/article/us-health-marijuana/americans-view-of-marijuana-is-rosy-and-unscientific-idUSKBN1KD2IR\" target=\"_blank\" rel=\"noopener\">Reuters.\u003c/a> “Perhaps most concerning is that they think that it prevents health problems.”\u003c/p>\n\u003cp>The survey found that 18 percent of respondents believe that smoking marijuana is somewhat or completely safe for adults.\u003c/p>\n\u003cp>In addition, nearly half of those surveyed believe that marijuana can alleviate insomnia, anxiety and depression, none of which are scientifically established, says Dr. Keyhani.[contextly_sidebar id=\"llwIT8YXMfGYSqJGFFEv4ackgmMz0K5Q\"]\u003c/p>\n\u003cp>\"The bottom line is that there's no evidence for the vast majority of this,\" Dr. Keyhani told \u003ca href=\"https://www.livescience.com/63141-marijuana-assumed-beneficial.html\" target=\"_blank\" rel=\"noopener\">Livescience\u003c/a>. \"There's limited data on harm, and people think that means it's OK.\"\u003c/p>\n\u003cp>Researchers created the survey to examine the impact of marketing on the public's perception of marijuana. From \u003ca href=\"https://www.theguardian.com/society/2018/jul/23/cannabis-health-benefits-american-attitudes-study\" target=\"_blank\" rel=\"noopener\">the Guardian\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>Mixed signals regarding marijuana’s potential dangers and benefits have enabled the commercial marijuana industry to promote a maximalist view of marijuana’s possible benefits. Since direct unproven claims of marijuana’s medical benefits, and assertions such as that a product cures cancer, can lead to unwanted attention from the FDA regulators, cannabis companies have learned to be much more subtle.\u003c/p>\u003c/blockquote>\n\u003cp>Despite the federal ban on marijuana, the Food and Drug Administration \u003ca href=\"https://www.kqed.org/futureofyou/443383/meet-sam-the-berkeley-kid-who-inspired-first-marijuana-based-drug\" target=\"_blank\" rel=\"noopener\">recently approved Epidiolex, an epilepsy drug\u003c/a> derived from marijuana. Medical marijuana is also legal in 31 states, a fact that only contributes to its rosy reputation.\u003c/p>\n\u003cp>Still, Keyhani says more research needs to be done. Until that happens, most of the health claims touted by the industry remain unproven.\u003c/p>\n\u003cp>“We need better data,” Keyhani told the Guardian. “We need any data.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n","blocks":[],"excerpt":"The public's view of marijuana's holistic health benefits is more a product of marketing than science, according to a new survey out this week. ","status":"publish","parent":0,"modified":1532558227,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":19,"wordCount":588},"headData":{"title":"Most People Think Pot's Totally Safe. But We Don't Actually Know | KQED","description":"The public's view of marijuana's holistic health benefits is more a product of marketing than science, according to a new survey out this week. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Most People Think Pot's Totally Safe. But We Don't Actually Know","datePublished":"2018-07-25T22:37:07.000Z","dateModified":"2018-07-25T22:37:07.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"443575 https://ww2.kqed.org/futureofyou/?p=443575","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/07/25/most-people-think-pots-totally-safe-but-we-dont-actually-know/","disqusTitle":"Most People Think Pot's Totally Safe. But We Don't Actually Know","path":"/futureofyou/443575/most-people-think-pots-totally-safe-but-we-dont-actually-know","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>When it comes to pot, many Americans seem to think it is a magic cure-all despite the lack of scientific data to corroborate that view.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Those are the findings of a new survey, published this week in the journal \u003ca href=\"http://annals.org/aim/article/doi/10.7326/M18-0810\">\u003cem>Annals of Internal Medicine\u003c/em>. \u003c/a>The online survey, conducted by researchers at UC San Francisco, found that many Americans believe marijuana has significant health benefits, despite a lack of scientific data to support that view.\u003c/p>\n\u003cp>That data lack is largely due to marijuana's restricted legal status in the U.S., which makes it difficult for scientists to study the drug's impact on human health, according to Timothy Fong, a professor of addiction psychiatry at UC Los Angeles.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>Without actual data to go on, people fall back on personal or anecdotal evidence.\u003c/p>\n\u003cp>\"We want to do more studies, but we can’t do a darn thing if the federal government handcuffs us,” Fong told \u003ca href=\"https://www.reuters.com/article/us-health-marijuana/americans-view-of-marijuana-is-rosy-and-unscientific-idUSKBN1KD2IR\" target=\"_blank\" rel=\"noopener\">Reuters.\u003c/a> “This is the kind of study that I think elevates the discussion. And it shows we have a long way to go.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Researchers surveyed 16,280 people in the U.S. and found that 81 percent of respondents believe that smoking marijuana has at least one health benefit, with pain management being the most commonly cited one.\u003c/p>\n\u003cp>Yet a separate study \u003ca href=\"https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(18)30110-5/fulltext?code=lancet-site\" target=\"_blank\" rel=\"noopener\">spanning four years\u003c/a> found no evidence that marijuana use improves the symptoms of chronic pain.\u003c/p>\n\u003cp>The survey also found that 91 percent of respondents believe that marijuana has at least one risk, but the most commonly cited risk — legal trouble — wasn't health related, a finding researchers found troubling because it indicates that many people are downplaying potential harm, according to \u003ca href=\"http://chime.ucsf.edu/people/salomeh-keyhani-md\" target=\"_blank\" rel=\"noopener\">Dr. Salomeh Keyhani,\u003c/a> a professor of medicine at UC San Francisco.\u003c/p>\n\u003cp>“The American public has a much more favorable point of view than is warranted by the evidence,” Dr. Keyhani told \u003ca href=\"https://www.reuters.com/article/us-health-marijuana/americans-view-of-marijuana-is-rosy-and-unscientific-idUSKBN1KD2IR\" target=\"_blank\" rel=\"noopener\">Reuters.\u003c/a> “Perhaps most concerning is that they think that it prevents health problems.”\u003c/p>\n\u003cp>The survey found that 18 percent of respondents believe that smoking marijuana is somewhat or completely safe for adults.\u003c/p>\n\u003cp>In addition, nearly half of those surveyed believe that marijuana can alleviate insomnia, anxiety and depression, none of which are scientifically established, says Dr. Keyhani.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"The bottom line is that there's no evidence for the vast majority of this,\" Dr. Keyhani told \u003ca href=\"https://www.livescience.com/63141-marijuana-assumed-beneficial.html\" target=\"_blank\" rel=\"noopener\">Livescience\u003c/a>. \"There's limited data on harm, and people think that means it's OK.\"\u003c/p>\n\u003cp>Researchers created the survey to examine the impact of marketing on the public's perception of marijuana. From \u003ca href=\"https://www.theguardian.com/society/2018/jul/23/cannabis-health-benefits-american-attitudes-study\" target=\"_blank\" rel=\"noopener\">the Guardian\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>Mixed signals regarding marijuana’s potential dangers and benefits have enabled the commercial marijuana industry to promote a maximalist view of marijuana’s possible benefits. Since direct unproven claims of marijuana’s medical benefits, and assertions such as that a product cures cancer, can lead to unwanted attention from the FDA regulators, cannabis companies have learned to be much more subtle.\u003c/p>\u003c/blockquote>\n\u003cp>Despite the federal ban on marijuana, the Food and Drug Administration \u003ca href=\"https://www.kqed.org/futureofyou/443383/meet-sam-the-berkeley-kid-who-inspired-first-marijuana-based-drug\" target=\"_blank\" rel=\"noopener\">recently approved Epidiolex, an epilepsy drug\u003c/a> derived from marijuana. Medical marijuana is also legal in 31 states, a fact that only contributes to its rosy reputation.\u003c/p>\n\u003cp>Still, Keyhani says more research needs to be done. Until that happens, most of the health claims touted by the industry remain unproven.\u003c/p>\n\u003cp>“We need better data,” Keyhani told the Guardian. “We need any data.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/443575/most-people-think-pots-totally-safe-but-we-dont-actually-know","authors":["11428"],"categories":["futureofyou_1060","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_952","futureofyou_61","futureofyou_1041","futureofyou_1056","futureofyou_271"],"collections":["futureofyou_1093","futureofyou_1097"],"featImg":"futureofyou_443583","label":"futureofyou_1097"},"futureofyou_443435":{"type":"posts","id":"futureofyou_443435","meta":{"index":"posts_1591205157","site":"futureofyou","id":"443435","score":null,"sort":[1531861237000]},"guestAuthors":[],"slug":"insurers-and-government-are-slow-to-cover-expensive-car-t-cancer-therapy","title":"Insurers And Government Are Slow To Cover Expensive CAR-T Cancer Therapy","publishDate":1531861237,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Patients whose blood cancers have failed to respond to repeated rounds of chemotherapy may be candidates for a new type of gene therapy that could send their cancers into remission for years. But the two approved therapies, with price tags of hundreds of thousands of dollars, have roiled the insurance approval process, leading to delays and, in some cases, denials of coverage, clinicians and analysts say.[contextly_sidebar id=\"ReV9Gv0J6j7ADmv2dqbEuegAVdiLN5dE\"]\u003c/p>\n\u003cp>The therapy involves collecting patients' own T cells, a type of white blood cell, genetically modifying them, and then infusing them back into patients, where they hunt down and kill cancer cells. Known as \u003ca href=\"https://www.cancer.gov/about-cancer/treatment/research/car-t-cells\" target=\"_blank\" rel=\"noopener\">CAR-T cell therapy\u003c/a>, it's been characterized as a \"living drug\" by some researchers.\u003c/p>\n\u003cp>Two different CAR-T drugs — \u003ca href=\"https://www.us.kymriah.com/diffuse-large-b-cell-lymphoma-adults/?site=KYDDAY0DTCBR0040&source=01030&gclid=CNDIg4PMpNwCFRj1swod-MwKyw&gclsrc=ds\" target=\"_blank\" rel=\"noopener\">Kymriah\u003c/a> and \u003ca href=\"https://www.yescarta.com/therapy#how-yescarta-is-different\" target=\"_blank\" rel=\"noopener\">Yescarta\u003c/a> — were approved by the FDA last year to treat patients whose blood cancers haven't responded to at least two other rounds of treatment.\u003c/p>\n\u003cp>Kymriah is \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm574154.htm\">approved\u003c/a> for people up to age 25 with a form of acute lymphoblastic leukemia, the most common cancer in children. Kymriah and Yescarta are \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm606540.htm\" target=\"_blank\" rel=\"noopener\">both\u003c/a> \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm581296.htm\" target=\"_blank\" rel=\"noopener\">approved\u003c/a> for adults with advanced lymphomas.\u003c/p>\n\u003cp>Researchers report that some critically ill patients who received the therapy have remained cancer-free for as long as five years.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"This is what patients need,\" says \u003ca href=\"https://www.mayo.edu/research/faculty/lin-yi-m-d-ph-d/bio-00092684\" target=\"_blank\" rel=\"noopener\">Dr. Yi Lin\u003c/a>, a hematologist who oversees the CAR-T cell practice and research for the Mayo Clinic. \"With the likelihood of getting patients into durable survival, we don't want to deny them the therapy.\" She says she receives no personal financial support from the drugs' makers.[contextly_sidebar id=\"nsB5Luqi8Mrdsb9vLceD3T77zYYY4sKK\"]\u003c/p>\n\u003cp>But the treatment comes at a cost — the drug treatments are hugely expensive. Kymriah and Yescarta cost $373,000 for a one-time infusion to treat adults with advanced lymphomas, while Kymriah costs $475,000 to treat acute lymphoblastic leukemia in children and young adults. That's the cost of the drug itself; in addition, many patients experience serious side effects that can land them in a hospital intensive care unit for weeks, \u003ca href=\"https://khn.org/news/cascade-of-costs-could-push-new-gene-therapy-above-1-million-per-patient/\" target=\"_blank\" rel=\"noopener\">pushing treatment costs to more than $1 million\u003c/a>.\u003c/p>\n\u003cp>All of this gives government and private insurers pause.\u003c/p>\n\u003cp>Most commercial insurers are covering CAR-T cell therapies now, but they do so on an individual basis, writing single-patient agreements each time, say cancer specialists. Large insurers that are already familiar with complicated therapies like stem-cell transplants are getting speedier at handling requests for CAR-T cell treatment, they say. But that's not always the case at smaller or regional plans, where delays can add weeks to the approval process.\u003c/p>\n\u003cp>\"A request for CAR-T may end up with somebody on the payer authorization team who doesn't understand the technology or the urgency of the request, when somebody has only weeks or months to live,\" says \u003ca href=\"https://www.asbmt.org/about/contact-us\" target=\"_blank\" rel=\"noopener\">Stephanie Farnia\u003c/a>, director of health policy and strategic relations at the American Society for Blood and Marrow Transplantation.\u003c/p>\n\u003cp>Farnia is in contact with many of the more than 50 medical centers that are authorized to provide treatment. The process of getting to a treatment center and evaluated for therapy is involved, she says. \"To then be substantially delayed due to paperwork is incredibly frustrating\" for patients.[contextly_sidebar id=\"mCjXSziNW7nkG4M52QmA48lgOAVmv3eg\"]\u003c/p>\n\u003cp>Medicare and Medicaid often pose greater coverage challenges than do private insurers, according to insurance experts.\u003c/p>\n\u003cp>Some Medicaid programs don't cover the treatment, says \u003ca href=\"AndrewsCAR-TandInsuranceDFedit.docx\" target=\"_blank\" rel=\"noopener\">Dr. Michael Bishop\u003c/a>, director of the cellular therapy program in the hematology/oncology section at the University of Chicago. Medicaid, the state-federal health program, covers children in low-income households and some adults.\u003c/p>\n\u003cp>\"Medicaid has been very tough,\" he says. \"Certain states just deny coverage — even states with balanced budgets.\"\u003c/p>\n\u003cp>States \u003ca href=\"https://icer-review.org/wp-content/uploads/2017/07/ICER_CAR_T_Final_Evidence_Report_032318.pdf\" target=\"_blank\" rel=\"noopener\">have to evaluate the cost as well as the drugs' effectiveness\u003c/a>, says \u003ca href=\"http://medicaiddirectors.org/about/staff/\" target=\"_blank\" rel=\"noopener\">Matt Salo\u003c/a>, executive director of the National Association of Medicaid Directors.\u003c/p>\n\u003cp>\"Medicaid is a finite pot of money, and it's stretched threadbare even on a good day,\" he says.\u003c/p>\n\u003cp>People who are on Medicare, the health insurance program for people age 65 and older and some people with disabilities, typically haven't faced coverage denials to date, clinicians say. But the government's reimbursement rates are raising concerns for providers.\u003c/p>\n\u003cp>Last spring, Medicare announced payment rates for providers who administer Yescarta and Kymriah on an outpatient basis. The payments would more than cover the costs of the drugs. Medicare beneficiaries' out-of-pocket costs would be capped at $1,340 plus the beneficiaries' Part B deductible (if that hasn't already been met), the agency says.[contextly_sidebar id=\"zRKGtFwAO4CBGEIycv3lNE5oWVwoZuVf\"]\u003c/p>\n\u003cp>The problem with this plan? Facilities typically provide treatment on an inpatient basis, not outpatient, because of the potential for severe, systemic side effects.\u003c/p>\n\u003cp>\"There's a lot of toxicity and questions about whether it can even be provided in an outpatient setting,\" says Gary Goldstein, the business manager at the blood and marrow transplant program at Stanford Health Care in Stanford, Calif.\u003c/p>\n\u003cp>For inpatient care, \"CAR-T cell therapy ... would be paid at a much lower amount compared to outpatient hospital use,\" according to officials at the Centers for Medicare & Medicaid Services.\u003c/p>\n\u003cp>The agency is considering how to handle payment for inpatient CAR-T care for the fiscal year that starts in October. For now, some medical centers are absorbing whatever Medicare doesn't pay.\u003c/p>\n\u003cp>\"How can you tell a patient who's 66, 'If only you'd gotten lymphoma when you were 64'?\" Goldstein asks.\u003c/p>\n\u003cp>But the current approach can't continue indefinitely, he says.\u003c/p>\n\u003cp>\"Even if there aren't any centers that are making that decision today, if coverage doesn't change for Medicare, it absolutely is going to be a problem tomorrow,\" says Goldstein.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003ca href=\"http://khn.org/\" target=\"_blank\" rel=\"noopener\">\u003cem>Kaiser Health News\u003c/em>\u003c/a>\u003cem>, a nonprofit news service, is an editorially independent program of the Kaiser Family Foundation, and is not affiliated with Kaiser Permanente. Michelle Andrews is on Twitter \u003c/em>\u003ca href=\"https://twitter.com/mandrews110\" target=\"_blank\" rel=\"noopener\">\u003cem>@mandrews110\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Insurers+And+Government+Are+Slow+To+Cover+Expensive+CAR-T+Cancer+Therapy&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"Treatment costs for the immunotherapy can run to more than $1 million. Some state Medicaid programs aren't paying for the treatment, and Medicare's complicated payment rates have hospitals worried.","status":"publish","parent":0,"modified":1531864937,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":28,"wordCount":987},"headData":{"title":"Insurers And Government Are Slow To Cover Expensive CAR-T Cancer Therapy | KQED","description":"Treatment costs for the immunotherapy can run to more than $1 million. Some state Medicaid programs aren't paying for the treatment, and Medicare's complicated payment rates have hospitals worried.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Insurers And Government Are Slow To Cover Expensive CAR-T Cancer Therapy","datePublished":"2018-07-17T21:00:37.000Z","dateModified":"2018-07-17T22:02:17.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"443435 https://ww2.kqed.org/futureofyou/?p=443435","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/07/17/insurers-and-government-are-slow-to-cover-expensive-car-t-cancer-therapy/","disqusTitle":"Insurers And Government Are Slow To Cover Expensive CAR-T Cancer Therapy","source":"Health","nprImageCredit":"Fanatic Studio","nprByline":"Michelle Andrews, NPR","nprImageAgency":"Collection Mix: Subjects RF/Getty Images","nprStoryId":"629543151","nprApiLink":"http://api.npr.org/query?id=629543151&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2018/07/17/629543151/insurers-and-government-are-slow-to-cover-expensive-car-t-cancer-therapy?ft=nprml&f=629543151","nprRetrievedStory":"1","nprPubDate":"Tue, 17 Jul 2018 15:36:00 -0400","nprStoryDate":"Tue, 17 Jul 2018 08:02:49 -0400","nprLastModifiedDate":"Tue, 17 Jul 2018 15:36:53 -0400","path":"/futureofyou/443435/insurers-and-government-are-slow-to-cover-expensive-car-t-cancer-therapy","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Patients whose blood cancers have failed to respond to repeated rounds of chemotherapy may be candidates for a new type of gene therapy that could send their cancers into remission for years. But the two approved therapies, with price tags of hundreds of thousands of dollars, have roiled the insurance approval process, leading to delays and, in some cases, denials of coverage, clinicians and analysts say.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The therapy involves collecting patients' own T cells, a type of white blood cell, genetically modifying them, and then infusing them back into patients, where they hunt down and kill cancer cells. Known as \u003ca href=\"https://www.cancer.gov/about-cancer/treatment/research/car-t-cells\" target=\"_blank\" rel=\"noopener\">CAR-T cell therapy\u003c/a>, it's been characterized as a \"living drug\" by some researchers.\u003c/p>\n\u003cp>Two different CAR-T drugs — \u003ca href=\"https://www.us.kymriah.com/diffuse-large-b-cell-lymphoma-adults/?site=KYDDAY0DTCBR0040&source=01030&gclid=CNDIg4PMpNwCFRj1swod-MwKyw&gclsrc=ds\" target=\"_blank\" rel=\"noopener\">Kymriah\u003c/a> and \u003ca href=\"https://www.yescarta.com/therapy#how-yescarta-is-different\" target=\"_blank\" rel=\"noopener\">Yescarta\u003c/a> — were approved by the FDA last year to treat patients whose blood cancers haven't responded to at least two other rounds of treatment.\u003c/p>\n\u003cp>Kymriah is \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm574154.htm\">approved\u003c/a> for people up to age 25 with a form of acute lymphoblastic leukemia, the most common cancer in children. Kymriah and Yescarta are \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm606540.htm\" target=\"_blank\" rel=\"noopener\">both\u003c/a> \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm581296.htm\" target=\"_blank\" rel=\"noopener\">approved\u003c/a> for adults with advanced lymphomas.\u003c/p>\n\u003cp>Researchers report that some critically ill patients who received the therapy have remained cancer-free for as long as five years.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"This is what patients need,\" says \u003ca href=\"https://www.mayo.edu/research/faculty/lin-yi-m-d-ph-d/bio-00092684\" target=\"_blank\" rel=\"noopener\">Dr. Yi Lin\u003c/a>, a hematologist who oversees the CAR-T cell practice and research for the Mayo Clinic. \"With the likelihood of getting patients into durable survival, we don't want to deny them the therapy.\" She says she receives no personal financial support from the drugs' makers.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>But the treatment comes at a cost — the drug treatments are hugely expensive. Kymriah and Yescarta cost $373,000 for a one-time infusion to treat adults with advanced lymphomas, while Kymriah costs $475,000 to treat acute lymphoblastic leukemia in children and young adults. That's the cost of the drug itself; in addition, many patients experience serious side effects that can land them in a hospital intensive care unit for weeks, \u003ca href=\"https://khn.org/news/cascade-of-costs-could-push-new-gene-therapy-above-1-million-per-patient/\" target=\"_blank\" rel=\"noopener\">pushing treatment costs to more than $1 million\u003c/a>.\u003c/p>\n\u003cp>All of this gives government and private insurers pause.\u003c/p>\n\u003cp>Most commercial insurers are covering CAR-T cell therapies now, but they do so on an individual basis, writing single-patient agreements each time, say cancer specialists. Large insurers that are already familiar with complicated therapies like stem-cell transplants are getting speedier at handling requests for CAR-T cell treatment, they say. But that's not always the case at smaller or regional plans, where delays can add weeks to the approval process.\u003c/p>\n\u003cp>\"A request for CAR-T may end up with somebody on the payer authorization team who doesn't understand the technology or the urgency of the request, when somebody has only weeks or months to live,\" says \u003ca href=\"https://www.asbmt.org/about/contact-us\" target=\"_blank\" rel=\"noopener\">Stephanie Farnia\u003c/a>, director of health policy and strategic relations at the American Society for Blood and Marrow Transplantation.\u003c/p>\n\u003cp>Farnia is in contact with many of the more than 50 medical centers that are authorized to provide treatment. The process of getting to a treatment center and evaluated for therapy is involved, she says. \"To then be substantially delayed due to paperwork is incredibly frustrating\" for patients.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Medicare and Medicaid often pose greater coverage challenges than do private insurers, according to insurance experts.\u003c/p>\n\u003cp>Some Medicaid programs don't cover the treatment, says \u003ca href=\"AndrewsCAR-TandInsuranceDFedit.docx\" target=\"_blank\" rel=\"noopener\">Dr. Michael Bishop\u003c/a>, director of the cellular therapy program in the hematology/oncology section at the University of Chicago. Medicaid, the state-federal health program, covers children in low-income households and some adults.\u003c/p>\n\u003cp>\"Medicaid has been very tough,\" he says. \"Certain states just deny coverage — even states with balanced budgets.\"\u003c/p>\n\u003cp>States \u003ca href=\"https://icer-review.org/wp-content/uploads/2017/07/ICER_CAR_T_Final_Evidence_Report_032318.pdf\" target=\"_blank\" rel=\"noopener\">have to evaluate the cost as well as the drugs' effectiveness\u003c/a>, says \u003ca href=\"http://medicaiddirectors.org/about/staff/\" target=\"_blank\" rel=\"noopener\">Matt Salo\u003c/a>, executive director of the National Association of Medicaid Directors.\u003c/p>\n\u003cp>\"Medicaid is a finite pot of money, and it's stretched threadbare even on a good day,\" he says.\u003c/p>\n\u003cp>People who are on Medicare, the health insurance program for people age 65 and older and some people with disabilities, typically haven't faced coverage denials to date, clinicians say. But the government's reimbursement rates are raising concerns for providers.\u003c/p>\n\u003cp>Last spring, Medicare announced payment rates for providers who administer Yescarta and Kymriah on an outpatient basis. The payments would more than cover the costs of the drugs. Medicare beneficiaries' out-of-pocket costs would be capped at $1,340 plus the beneficiaries' Part B deductible (if that hasn't already been met), the agency says.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The problem with this plan? Facilities typically provide treatment on an inpatient basis, not outpatient, because of the potential for severe, systemic side effects.\u003c/p>\n\u003cp>\"There's a lot of toxicity and questions about whether it can even be provided in an outpatient setting,\" says Gary Goldstein, the business manager at the blood and marrow transplant program at Stanford Health Care in Stanford, Calif.\u003c/p>\n\u003cp>For inpatient care, \"CAR-T cell therapy ... would be paid at a much lower amount compared to outpatient hospital use,\" according to officials at the Centers for Medicare & Medicaid Services.\u003c/p>\n\u003cp>The agency is considering how to handle payment for inpatient CAR-T care for the fiscal year that starts in October. For now, some medical centers are absorbing whatever Medicare doesn't pay.\u003c/p>\n\u003cp>\"How can you tell a patient who's 66, 'If only you'd gotten lymphoma when you were 64'?\" Goldstein asks.\u003c/p>\n\u003cp>But the current approach can't continue indefinitely, he says.\u003c/p>\n\u003cp>\"Even if there aren't any centers that are making that decision today, if coverage doesn't change for Medicare, it absolutely is going to be a problem tomorrow,\" says Goldstein.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003ca href=\"http://khn.org/\" target=\"_blank\" rel=\"noopener\">\u003cem>Kaiser Health News\u003c/em>\u003c/a>\u003cem>, a nonprofit news service, is an editorially independent program of the Kaiser Family Foundation, and is not affiliated with Kaiser Permanente. Michelle Andrews is on Twitter \u003c/em>\u003ca href=\"https://twitter.com/mandrews110\" target=\"_blank\" rel=\"noopener\">\u003cem>@mandrews110\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Insurers+And+Government+Are+Slow+To+Cover+Expensive+CAR-T+Cancer+Therapy&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/443435/insurers-and-government-are-slow-to-cover-expensive-car-t-cancer-therapy","authors":["byline_futureofyou_443435"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_103","futureofyou_1470","futureofyou_952","futureofyou_686","futureofyou_1029","futureofyou_35"],"collections":["futureofyou_1097"],"featImg":"futureofyou_443437","label":"source_futureofyou_443435"},"futureofyou_443119":{"type":"posts","id":"futureofyou_443119","meta":{"index":"posts_1591205157","site":"futureofyou","id":"443119","score":null,"sort":[1530546314000]},"guestAuthors":[],"slug":"pot-businesses-urge-california-to-delay-strict-testing-rules","title":"Pot Businesses Urge California to Delay Strict Testing Rules","publishDate":1530546314,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Nearly 150 marijuana businesses in California warned Friday that they could face crippling financial losses unless the state extends a July 1 deadline imposing strict standards for pot testing and packaging.[contextly_sidebar id=\"0fHd0AejefxNkJsARNFShg1Layhsilve\"]\u003c/p>\n\u003cp>In a letter to Gov. Jerry Brown, the United Cannabis Business Association said the changes would further unsettle the struggling legal marketplace that launched Jan. 1, potentially forcing businesses to close their doors.\u003c/p>\n\u003cp>The trade group that represents cannabis companies said there are too few labs to handle the testing, and retailers would have to destroy vast amounts of unsold cannabis that does not meet the new standards.\u003c/p>\n\u003cp>Association president Jerred Kiloh estimated that businesses could face nearly $400 million in losses if those unsold supplies are destroyed.\u003c/p>\n\u003cp>“Forcing the industry into compliance ... will further cripple the already struggling regulated market,” the letter said.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>In a statement, the state Bureau of Cannabis Control gave no indication it would consider rolling back the deadline.\u003c/p>\n\u003cp>“We issued our emergency regulations back in November, and at that time we were pretty clear about the fact that there would be a six-month transition period for retailers to use up their existing supply. We felt that was a sufficient amount of time to deplete stock on hand and adapt to California’s new rules,” agency spokesman Alex Traverso said in an email.[contextly_sidebar id=\"024mYCqF9Xv8Y0Ohhnf1BPJQ8spoTbMY\"]\u003c/p>\n\u003cp>The regulations are being phased in six months after the state broadly legalized marijuana and required that pot sold after Saturday meets strict quality standards. With the deadline approaching, retailers have been unloading untested inventory at bargain-basement prices.\u003c/p>\n\u003cp>The rollout of the nation’s largest legal pot market has been bumpy at best. The black market is still flourishing, and the industry complains about taxes that can approach 50 percent in some areas.\u003c/p>\n\u003cp>Others fear a shortage of retailers for both adult-use and medicinal marijuana could shut down the supply chain, stranding growers with mountains of unsold pot.\u003c/p>\n\u003cp>California is operating under temporary regulations, while the largest city, Los Angeles, has been slow to issue licenses.\u003c/p>\n\u003cp>The change in rules was part of the state’s decision to allow the industry to get a running start at the beginning of the year. Shops were given six months to burn through supplies of cannabis and edibles produced without strict testing requirements.\u003c/p>\n\u003cp>Any marijuana harvested this year, or for sale July 1, must meet quality and safety standards or be destroyed.\u003c/p>\n\u003cp>The letter depicted an emerging industry that is struggling to find its footing.\u003c/p>\n\u003cp>The group said the 30 licensed labs that would test pot would be unable to handle demand, resulting in a shortage of products on shelves. A system intended to track plants from seed to sale has been delayed. And packaging companies are not ready to meet the new rules.\u003c/p>\n\u003cp>“Customers and patients will turn to illicit market retailers and delivery services who will still have an abundance of products for sale. Licensed retailers will be forced to shut down,” the letter said.\u003c/p>\n\u003cp>The businesses and advocacy groups that signed the letter represent a fraction of the state’s legal marketplace. For example, over 3,300 cultivation licenses have been issued, and there are more than 400 licensed retailers.\u003c/p>\n\u003cp>___\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Associated Press writer Brian Melley contributed to this report.\u003c/p>\n\n","blocks":[],"excerpt":"The trade group that represents cannabis companies said there are too few labs to handle the testing, and retailers would have to destroy vast amounts of unsold cannabis.","status":"publish","parent":0,"modified":1530546445,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":21,"wordCount":559},"headData":{"title":"Pot Businesses Urge California to Delay Strict Testing Rules | KQED","description":"The trade group that represents cannabis companies said there are too few labs to handle the testing, and retailers would have to destroy vast amounts of unsold cannabis.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Pot Businesses Urge California to Delay Strict Testing Rules","datePublished":"2018-07-02T15:45:14.000Z","dateModified":"2018-07-02T15:47:25.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"443119 https://ww2.kqed.org/futureofyou/?p=443119","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/07/02/pot-businesses-urge-california-to-delay-strict-testing-rules/","disqusTitle":"Pot Businesses Urge California to Delay Strict Testing Rules","source":"Health","nprByline":"Michael R. Blood\u003cbr />The Associated Press","path":"/futureofyou/443119/pot-businesses-urge-california-to-delay-strict-testing-rules","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Nearly 150 marijuana businesses in California warned Friday that they could face crippling financial losses unless the state extends a July 1 deadline imposing strict standards for pot testing and packaging.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In a letter to Gov. Jerry Brown, the United Cannabis Business Association said the changes would further unsettle the struggling legal marketplace that launched Jan. 1, potentially forcing businesses to close their doors.\u003c/p>\n\u003cp>The trade group that represents cannabis companies said there are too few labs to handle the testing, and retailers would have to destroy vast amounts of unsold cannabis that does not meet the new standards.\u003c/p>\n\u003cp>Association president Jerred Kiloh estimated that businesses could face nearly $400 million in losses if those unsold supplies are destroyed.\u003c/p>\n\u003cp>“Forcing the industry into compliance ... will further cripple the already struggling regulated market,” the letter said.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In a statement, the state Bureau of Cannabis Control gave no indication it would consider rolling back the deadline.\u003c/p>\n\u003cp>“We issued our emergency regulations back in November, and at that time we were pretty clear about the fact that there would be a six-month transition period for retailers to use up their existing supply. We felt that was a sufficient amount of time to deplete stock on hand and adapt to California’s new rules,” agency spokesman Alex Traverso said in an email.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The regulations are being phased in six months after the state broadly legalized marijuana and required that pot sold after Saturday meets strict quality standards. With the deadline approaching, retailers have been unloading untested inventory at bargain-basement prices.\u003c/p>\n\u003cp>The rollout of the nation’s largest legal pot market has been bumpy at best. The black market is still flourishing, and the industry complains about taxes that can approach 50 percent in some areas.\u003c/p>\n\u003cp>Others fear a shortage of retailers for both adult-use and medicinal marijuana could shut down the supply chain, stranding growers with mountains of unsold pot.\u003c/p>\n\u003cp>California is operating under temporary regulations, while the largest city, Los Angeles, has been slow to issue licenses.\u003c/p>\n\u003cp>The change in rules was part of the state’s decision to allow the industry to get a running start at the beginning of the year. Shops were given six months to burn through supplies of cannabis and edibles produced without strict testing requirements.\u003c/p>\n\u003cp>Any marijuana harvested this year, or for sale July 1, must meet quality and safety standards or be destroyed.\u003c/p>\n\u003cp>The letter depicted an emerging industry that is struggling to find its footing.\u003c/p>\n\u003cp>The group said the 30 licensed labs that would test pot would be unable to handle demand, resulting in a shortage of products on shelves. A system intended to track plants from seed to sale has been delayed. And packaging companies are not ready to meet the new rules.\u003c/p>\n\u003cp>“Customers and patients will turn to illicit market retailers and delivery services who will still have an abundance of products for sale. Licensed retailers will be forced to shut down,” the letter said.\u003c/p>\n\u003cp>The businesses and advocacy groups that signed the letter represent a fraction of the state’s legal marketplace. For example, over 3,300 cultivation licenses have been issued, and there are more than 400 licensed retailers.\u003c/p>\n\u003cp>___\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Associated Press writer Brian Melley contributed to this report.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/443119/pot-businesses-urge-california-to-delay-strict-testing-rules","authors":["byline_futureofyou_443119"],"categories":["futureofyou_1060","futureofyou_73"],"tags":["futureofyou_972","futureofyou_1562","futureofyou_952","futureofyou_61","futureofyou_1041","futureofyou_1568"],"collections":["futureofyou_1093"],"featImg":"futureofyou_443051","label":"source_futureofyou_443119"},"futureofyou_443040":{"type":"posts","id":"futureofyou_443040","meta":{"index":"posts_1591205157","site":"futureofyou","id":"443040","score":null,"sort":[1530045641000]},"guestAuthors":[],"slug":"fda-green-lights-marijuana-based-pharmaceutical-drug","title":"FDA Green Lights Marijuana-Based Pharmaceutical Drug","publishDate":1530045641,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>The U.S. Food and Drug Administration has approved a marijuana-derived drug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.[contextly_sidebar id=\"RsxfUCgh8UsJJJ0ikrZvWqEfpFs55Jwz\"]\u003c/p>\n\u003cp>The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. The drug will be marketed under the brand name Epidiolex.\u003c/p>\n\u003cp>CBD has medicinal effects, but it does not cause the mind-altering high that comes from THC, the primary psychoactive component of marijuana.\u003c/p>\n\u003cp>In 2016, researchers at \u003ca href=\"https://www.ucsf.edu/news/2016/01/401246/cannabis-based-drug-reduces-seizures-children-treatment-resistant-epilepsy\" target=\"_blank\" rel=\"noopener\">UCSF Benioff Children’s Hospital San Francisco \u003c/a>introduced the first study looking at the effects of Epidiolex on children and young adults who suffer from severe forms of epilepsy. They found that patients had fewer seizures when treated with the purified cannabinoid.\u003c/p>\n\u003cp>The FDA says this is the first drug approved in the U.S. that contains a purified substance derived from marijuana. The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,\" said FDA Commissioner Scott Gottlieb during a call with reporters about the approval.[contextly_sidebar id=\"RBUAK4wZ7KHOssmYfHT8dDioQ0U69y4E\"]\u003c/p>\n\u003cp>Several states \u003ca href=\"http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx\" target=\"_blank\" rel=\"noopener\">have legalized CBD oil \u003c/a>specifically for the treatment of intractable epilepsy or seizure disorders. And, as NPR has \u003ca href=\"https://www.npr.org/sections/health-shots/2018/04/23/604307015/anxiety-relief-without-the-high-new-studies-on-cbd-a-cannabis-extract\" target=\"_blank\" rel=\"noopener\">reported\u003c/a>, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures. CBD oil has gained popularity with consumers as a remedy for a variety of other ailments. However, the legal status of these products is uncertain, as is their quality. They're not regulated the way pharmaceutical drugs are, so the consistency and dose can vary widely.\u003c/p>\n\u003cp>Having an FDA-approved, pharmaceutical-grade CBD drug will open up a new treatment option for epilepsy patients by delivering a high-quality, consistent dose of CBD, says \u003ca href=\"https://medschool.vanderbilt.edu/brain-institute/person/robert-carson-md-phd\" target=\"_blank\" rel=\"noopener\">Robert Carson\u003c/a> a pediatric neurologist at Vanderbilt University who treats patients with epilepsy.\u003c/p>\n\u003cp>\"Our biggest concerns with the artisanal [or supplement] versions of CBD were related to the consistency,\" Carson says. \"We can't guarantee the consistency.\"\u003c/p>\n\u003cp>Carson says he will likely prescribe Epidiolex going forward. \"I'm always excited about the potential for a new therapy that has been well-studied and has a great potential for benefit,\" he says.\u003c/p>\n\u003cp>Several researchers are studying the potential of CBD to treat psychiatric conditions. For instance, a \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03248167\" target=\"_blank\" rel=\"noopener\">clinical trial is underway\u003c/a> to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. Another clinical trial will determine whether CBD could help \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01311778\" target=\"_blank\" rel=\"noopener\">prevent relapse\u003c/a> in opioid abusers.[contextly_sidebar id=\"TzTIWOn6t1b75631sBYWcr2CwFcxdgut\"]\u003c/p>\n\u003cp>The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance. Like other drugs in this category, which include heroin and LSD, these drugs are considered to have no medical use and a high potential for abuse.\u003c/p>\n\u003cp>But now, with the approval of a CBD drug, the DEA will change this, according to Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research,\u003c/p>\n\u003cp>\"The DEA will need to make a different scheduling decision for CBD...because it now has an accepted medical use,\" he said during a conference call with reporters.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>He said the reclassification is underway now.\u003cstrong>\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=FDA+Green+Lights+Marijuana-Based+Pharmaceutical+Drug+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"For the first time, the FDA has approved a drug containing CBD, an extract of marijuana. This move could pave the way for more research into medical uses for the marijuana extract.","status":"publish","parent":0,"modified":1530045809,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":17,"wordCount":597},"headData":{"title":"FDA Green Lights Marijuana-Based Pharmaceutical Drug | KQED","description":"For the first time, the FDA has approved a drug containing CBD, an extract of marijuana. This move could pave the way for more research into medical uses for the marijuana extract.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Green Lights Marijuana-Based Pharmaceutical Drug","datePublished":"2018-06-26T20:40:41.000Z","dateModified":"2018-06-26T20:43:29.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"443040 https://ww2.kqed.org/futureofyou/?p=443040","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/06/26/fda-green-lights-marijuana-based-pharmaceutical-drug/","disqusTitle":"FDA Green Lights Marijuana-Based Pharmaceutical Drug","source":"Health","nprImageCredit":"Blaine Harrington III","nprByline":"Allison Aubrey, NPR","nprImageAgency":"Getty Images","nprStoryId":"623236189","nprApiLink":"http://api.npr.org/query?id=623236189&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2018/06/25/623236189/fda-green-lights-marijuana-based-pharmaceutical-drug?ft=nprml&f=623236189","nprRetrievedStory":"1","nprPubDate":"Mon, 25 Jun 2018 23:07:00 -0400","nprStoryDate":"Mon, 25 Jun 2018 17:33:01 -0400","nprLastModifiedDate":"Mon, 25 Jun 2018 23:07:07 -0400","path":"/futureofyou/443040/fda-green-lights-marijuana-based-pharmaceutical-drug","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The U.S. Food and Drug Administration has approved a marijuana-derived drug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. The drug will be marketed under the brand name Epidiolex.\u003c/p>\n\u003cp>CBD has medicinal effects, but it does not cause the mind-altering high that comes from THC, the primary psychoactive component of marijuana.\u003c/p>\n\u003cp>In 2016, researchers at \u003ca href=\"https://www.ucsf.edu/news/2016/01/401246/cannabis-based-drug-reduces-seizures-children-treatment-resistant-epilepsy\" target=\"_blank\" rel=\"noopener\">UCSF Benioff Children’s Hospital San Francisco \u003c/a>introduced the first study looking at the effects of Epidiolex on children and young adults who suffer from severe forms of epilepsy. They found that patients had fewer seizures when treated with the purified cannabinoid.\u003c/p>\n\u003cp>The FDA says this is the first drug approved in the U.S. that contains a purified substance derived from marijuana. The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,\" said FDA Commissioner Scott Gottlieb during a call with reporters about the approval.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Several states \u003ca href=\"http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx\" target=\"_blank\" rel=\"noopener\">have legalized CBD oil \u003c/a>specifically for the treatment of intractable epilepsy or seizure disorders. And, as NPR has \u003ca href=\"https://www.npr.org/sections/health-shots/2018/04/23/604307015/anxiety-relief-without-the-high-new-studies-on-cbd-a-cannabis-extract\" target=\"_blank\" rel=\"noopener\">reported\u003c/a>, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures. CBD oil has gained popularity with consumers as a remedy for a variety of other ailments. However, the legal status of these products is uncertain, as is their quality. They're not regulated the way pharmaceutical drugs are, so the consistency and dose can vary widely.\u003c/p>\n\u003cp>Having an FDA-approved, pharmaceutical-grade CBD drug will open up a new treatment option for epilepsy patients by delivering a high-quality, consistent dose of CBD, says \u003ca href=\"https://medschool.vanderbilt.edu/brain-institute/person/robert-carson-md-phd\" target=\"_blank\" rel=\"noopener\">Robert Carson\u003c/a> a pediatric neurologist at Vanderbilt University who treats patients with epilepsy.\u003c/p>\n\u003cp>\"Our biggest concerns with the artisanal [or supplement] versions of CBD were related to the consistency,\" Carson says. \"We can't guarantee the consistency.\"\u003c/p>\n\u003cp>Carson says he will likely prescribe Epidiolex going forward. \"I'm always excited about the potential for a new therapy that has been well-studied and has a great potential for benefit,\" he says.\u003c/p>\n\u003cp>Several researchers are studying the potential of CBD to treat psychiatric conditions. For instance, a \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03248167\" target=\"_blank\" rel=\"noopener\">clinical trial is underway\u003c/a> to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. Another clinical trial will determine whether CBD could help \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01311778\" target=\"_blank\" rel=\"noopener\">prevent relapse\u003c/a> in opioid abusers.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance. Like other drugs in this category, which include heroin and LSD, these drugs are considered to have no medical use and a high potential for abuse.\u003c/p>\n\u003cp>But now, with the approval of a CBD drug, the DEA will change this, according to Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research,\u003c/p>\n\u003cp>\"The DEA will need to make a different scheduling decision for CBD...because it now has an accepted medical use,\" he said during a conference call with reporters.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>He said the reclassification is underway now.\u003cstrong>\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=FDA+Green+Lights+Marijuana-Based+Pharmaceutical+Drug+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/443040/fda-green-lights-marijuana-based-pharmaceutical-drug","authors":["byline_futureofyou_443040"],"categories":["futureofyou_1060","futureofyou_1"],"tags":["futureofyou_1562","futureofyou_952","futureofyou_1563","futureofyou_38","futureofyou_1041","futureofyou_1056"],"collections":["futureofyou_1093"],"featImg":"futureofyou_443041","label":"source_futureofyou_443040"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.","airtime":"SUN 2pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.possible.fm/","meta":{"site":"news","source":"Possible"},"link":"/radio/program/possible","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/possible/id1677184070","spotify":"https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"}},"1a":{"id":"1a","title":"1A","info":"1A is home to the national conversation. 1A brings on great guests and frames the best debate in ways that make you think, share and engage.","airtime":"MON-THU 11pm-12am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/1a.jpg","officialWebsiteLink":"https://the1a.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/1a","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=1188724250&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/1A-p947376/","rss":"https://feeds.npr.org/510316/podcast.xml"}},"all-things-considered":{"id":"all-things-considered","title":"All Things Considered","info":"Every weekday, \u003cem>All Things Considered\u003c/em> hosts Robert Siegel, Audie Cornish, Ari Shapiro, and Kelly McEvers present the program's trademark mix of news, interviews, commentaries, reviews, and offbeat features. Michel Martin hosts on the weekends.","airtime":"MON-FRI 1pm-2pm, 4:30pm-6:30pm\u003cbr />SAT-SUN 5pm-6pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/All-Things-Considered-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/all-things-considered/","meta":{"site":"news","source":"npr"},"link":"/radio/program/all-things-considered"},"american-suburb-podcast":{"id":"american-suburb-podcast","title":"American Suburb: The Podcast","tagline":"The flip side of gentrification, told through one town","info":"Gentrification is changing cities across America, forcing people from neighborhoods they have long called home. Call them the displaced. Now those priced out of the Bay Area are looking for a better life in an unlikely place. American Suburb follows this migration to one California town along the Delta, 45 miles from San Francisco. But is this once sleepy suburb ready for them?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/American-Suburb-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/news/series/american-suburb-podcast","meta":{"site":"news","source":"kqed","order":"13"},"link":"/news/series/american-suburb-podcast/","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=1287748328","tuneIn":"https://tunein.com/radio/American-Suburb-p1086805/","rss":"https://ww2.kqed.org/news/series/american-suburb-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkMzMDExODgxNjA5"}},"baycurious":{"id":"baycurious","title":"Bay Curious","tagline":"Exploring the Bay Area, one question at a time","info":"KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. This podcast feed is usually updated twice a week and is always un-edited.","airtime":"THU 10pm, FRI 1am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Commonwealth-Club-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.commonwealthclub.org/podcasts","meta":{"site":"news","source":"Commonwealth Club of California"},"link":"/radio/program/commonwealth-club","subscribe":{"apple":"https://itunes.apple.com/us/podcast/commonwealth-club-of-california-podcast/id976334034?mt=2","google":"https://podcasts.google.com/feed/aHR0cDovL3d3dy5jb21tb253ZWFsdGhjbHViLm9yZy9hdWRpby9wb2RjYXN0L3dlZWtseS54bWw","tuneIn":"https://tunein.com/radio/Commonwealth-Club-of-California-p1060/"}},"considerthis":{"id":"considerthis","title":"Consider This","tagline":"Make sense of the day","info":"Make sense of the day. Every weekday afternoon, Consider This helps you consider the major stories of the day in less than 15 minutes, featuring the reporting and storytelling resources of NPR. Plus, KQED’s Bianca Taylor brings you the local KQED news you need to know.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Consider-This-Podcast-Tile-703x703-1.jpg","imageAlt":"Consider This from NPR and KQED","officialWebsiteLink":"/podcasts/considerthis","meta":{"site":"news","source":"kqed","order":"7"},"link":"/podcasts/considerthis","subscribe":{"apple":"https://podcasts.apple.com/podcast/id1503226625?mt=2&at=11l79Y&ct=nprdirectory","npr":"https://rpb3r.app.goo.gl/coronavirusdaily","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5ucHIub3JnLzUxMDM1NS9wb2RjYXN0LnhtbA","spotify":"https://open.spotify.com/show/3Z6JdCS2d0eFEpXHKI6WqH"}},"forum":{"id":"forum","title":"Forum","tagline":"The conversation starts here","info":"KQED’s live call-in program discussing local, state, national and international issues, as well as in-depth interviews.","airtime":"MON-FRI 9am-11am, 10pm-11pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Forum-Podcast-Tile-703x703-1.jpg","imageAlt":"KQED Forum with Mina Kim and Alexis Madrigal","officialWebsiteLink":"/forum","meta":{"site":"news","source":"kqed","order":"8"},"link":"/forum","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/kqeds-forum/id73329719","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM5NTU3MzgxNjMz","npr":"https://www.npr.org/podcasts/432307980/forum","stitcher":"https://www.stitcher.com/podcast/kqedfm-kqeds-forum-podcast","rss":"https://feeds.megaphone.fm/KQINC9557381633"}},"freakonomics-radio":{"id":"freakonomics-radio","title":"Freakonomics Radio","info":"Freakonomics Radio is a one-hour award-winning podcast and public-radio project hosted by Stephen Dubner, with co-author Steve Levitt as a regular guest. 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