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Lives","publishDate":1512156012,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>Eli Wheatley and Christian Guardino are among a growing number of patients whose lives are apparently being saved or radically improved by gene therapy.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I think that the gene therapy is a miracle. I can't imagine what my life would be like without it.'\u003c/aside>\n\u003cp>Wheatley, 3, of Lebanon, Ky., and Guardino, 17, of Patchogue, N.Y., were both diagnosed with what were long thought to be incurable genetic disorders. In the past, Wheatley's condition would have probably killed him before his first birthday. Guardino's would have blinded him early in life.\u003c/p>\n\u003cp>But after receiving experimental gene therapies, both seem to be doing fine.\u003c/p>\n\u003cp>\"It's a very exciting time for the field,\" says \u003ca href=\"https://osp.od.nih.gov/carrie-wolinetz-2/\">Carrie Wolinetz\u003c/a>, the associate director for science policy at the National Institutes of Health.\u003c/p>\n\u003cp>So far, gene therapy has only been tested on a relatively small number of patients who have been followed for relatively short periods of time. Many more patients will have to be studied for longer periods before anyone really knows how well the therapies work, how long the benefits last, and whether the therapies are safe.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But doctors and families of those helped so far are elated at the progress.\u003c/p>\n\u003cp>\"This is really an important time in gene therapy,\" says \u003ca href=\"http://www.dfhcc.harvard.edu/insider/member-detail/member/david-a-williams-md/\">Dr. David Williams\u003c/a>, professor of pediatrics at Harvard Medical School and chief scientific officer at Boston Children's Hospital, who was not involved in these children's treatment, but has recently achieved similar success with another genetic condition.\u003c/p>\n\u003cp>Eli's mother, Natalie Wheatley, had been terrified there was something wrong with Eli even before he was born. He barely moved during her pregnancy, she recalls, and never seemed quite right in the first weeks of his life.\u003c/p>\n\u003cp>Finally, doctors told her that her worst fears were true: Her son had \u003ca href=\"https://ghr.nlm.nih.gov/condition/spinal-muscular-atrophy\">spinal muscular atrophy\u003c/a>, a disease of motor neurons that was destroying his muscles.\u003c/p>\n\u003cp>\"They basically told me he wouldn't make it to his first birthday,\" says Wheatley. Take him home and love him and spend as much time with him as you can, she remembers the health team telling her.\u003c/p>\n\u003cp>\"I was devastated — devastated,\" she says.\u003c/p>\n\u003cp>Guardino was diagnosed with a different condition — \u003ca href=\"https://ghr.nlm.nih.gov/condition/leber-congenital-amaurosis\">Leber's congenital amaurosis\u003c/a>, a disease of the eye's retina — when he was born. The disorder isn't fatal. But it was destroying his vision.\u003c/p>\n\u003cp>\"I wouldn't be able to walk around outside on my own,\" says Guardino. During the day, he says, the world looked \"incredibly dark\" and blurry. \"It was sort of like watching your world fade away.\"\u003c/p>\n\u003cp>Now Guardino can see things he'd only dreamed about.\u003c/p>\n\u003cp>After the gene therapy treatment, he says, \"I was able to see things for the first time — like the moon. I was able to see stars for the first time – fireworks — all these amazing things that I've never been able to see before.\"\u003c/p>\n\u003cp>And Wheatley's son, Eli, seems to be thriving.\u003c/p>\n\u003cp>\"He just started preschool in September,\" his mom says. \"He goes to preschool alone. He eats in the cafeteria with all the other kids. He's doing extremely well. It's been amazing — truly amazing.\"\u003c/p>\n\u003cp>Recent success in these different cases \"really shows us we're able to harness this therapy for some pretty terrible diseases,\" says Williams, who \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1700554\">reported last month\u003c/a> in the \u003cem>New England Journal of Medicine\u003c/em> that gene therapy can also halt the progression of disease in boys suffering from \u003ca href=\"https://ghr.nlm.nih.gov/condition/x-linked-adrenoleukodystrophy\">adrenoleukodystrophy\u003c/a>, a fatal genetic brain disease \u003ca href=\"https://www.npr.org/sections/health-shots/2017/10/04/555091418/parents-lobby-states-to-expand-newborn-screening-test-for-rare-brain-disorder\">made famous\u003c/a> by the movie \u003cem>Lorenzo's Oil\u003c/em>.\u003c/p>\n\u003cp>Scientists thought this sort of success would come decades ago. But their first attempts to save people born with defective genes by giving them new, healthy genes fizzled. Some patients who volunteered for early experiments \u003ca href=\"https://www.npr.org/templates/story/story.php?storyId=5369307\">developed cancer\u003c/a>. At least one person \u003ca href=\"https://www.npr.org/templates/story/story.php?storyId=1069810\">died\u003c/a>.\u003c/p>\n\u003cp>\"And that caused a setback in the field, which caused a lot of concern that maybe gene therapy was not ready for prime time,\" the NIH's Wolinetz says.\u003c/p>\n\u003cp>Some scientists feared gene therapy might never work. Researchers went back to the drawing board to come up with better, safer ways to use viruses to deliver healthy genes into a person's body. It's those decades of research that finally seem to be paying off.\u003c/p>\n\u003cp>\"We have reached a point of maturation in the science and in some of the new approaches to gene therapy that have allowed us to make rapid advancements in a fairly short period of time,\" Wolinetz says.\u003c/p>\n\u003cp>The price tag of such a treatment remains a looming question. The first gene therapy product approved by the Food and Drug Administration (a treatment for a form of leukemia, approved last summer) costs hundreds of thousands of dollars for each infusion. Some drug industry analysts predict the next gene therapy could cost close to $1 million per patient.\u003c/p>\n\u003cp>\u003ca href=\"https://www.mskcc.org/profile/peter-bach\">Dr. Peter Bach\u003c/a>, director of the center for health policy and outcomes at Memorial Sloan Kettering Cancer Center, says he's thrilled with the scientific progress that's been made in the field — but the cost of gene therapy drugs troubles him.\u003c/p>\n\u003cp>\"The model by which every innovation is turned around to extract the maximum amount of profit is ultimately taking away our ability to adequately fund many other things that promote health,\" Bach says.\u003c/p>\n\u003cp>Whatever the questions and costs, people who have been helped by these treatments so far seem delighted.\u003c/p>\n\u003cp>\"I think that the gene therapy is a miracle,\" Guardino says. \"I can't imagine what my life would be like without it.\"\u003c/p>\n\u003cp>Natalie Wheatley, whose son Eli was among those \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1706198\">described in another study\u003c/a>, published early this month in the \u003cem>New England Journal of Medicine\u003c/em>, says her son seems to continue to improve.\u003c/p>\n\u003cp>\"I see progress every day,\" Wheatley says. \"So that, to me, offers hope that gene therapy has saved his life. And I think eventually gene therapy will give the world hope. That's my hope anyways.\"\u003c/p>\n\u003cp>The FDA could soon approve for non-experimental use the \u003ca href=\"../../sections/health-shots/2017/10/12/557183740/fda-panel-endorses-gene-therapy-for-a-form-of-childhood-blindness\">first gene therapy for a genetic disorder\u003c/a> — the treatment Guardino received to save his vision.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Meanwhile, scientists are starting to test other forms of gene therapy for a long list of other diseases, including many that are much more common.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Gene+Therapy+Shows+Promise+For+A+Growing+List+Of+Diseases&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"After decades of hope and disappointment, doctors have now been able to treat several different types of genetic conditions by giving each patient a healthy version of their defective gene.","status":"publish","parent":0,"modified":1512156051,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":33,"wordCount":1056},"headData":{"title":"Gene Therapy Is Now Saving Lives | KQED","description":"After decades of hope and disappointment, doctors have now been able to treat several different types of genetic conditions by giving each patient a healthy version of their defective gene.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Gene Therapy Is Now Saving Lives","datePublished":"2017-12-01T19:20:12.000Z","dateModified":"2017-12-01T19:20:51.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"437400 https://ww2.kqed.org/futureofyou/?p=437400","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/12/01/gene-therapy-is-now-saving-lives/","disqusTitle":"Gene Therapy Is Now Saving Lives","nprImageCredit":"Pasieka","nprByline":"Rob Stein\u003cbr />NPR Shots","nprImageAgency":"Science Photo Library/Getty Images","nprStoryId":"565728869","nprApiLink":"http://api.npr.org/query?id=565728869&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2017/11/29/565728869/gene-therapy-shows-promise-for-a-growing-list-of-diseases?ft=nprml&f=565728869","nprRetrievedStory":"1","nprPubDate":"Wed, 29 Nov 2017 13:09:00 -0500","nprStoryDate":"Wed, 29 Nov 2017 07:40:00 -0500","nprLastModifiedDate":"Wed, 29 Nov 2017 13:09:14 -0500","nprAudio":"https://ondemand.npr.org/anon.npr-mp3/npr/me/2017/11/20171129_me_gene_therapy.mp3?orgId=1&topicId=1128&d=322&p=3&story=565728869&ft=nprml&f=565728869","nprAudioM3u":"http://api.npr.org/m3u/1567155749-eee4df.m3u?orgId=1&topicId=1128&d=322&p=3&story=565728869&ft=nprml&f=565728869","path":"/futureofyou/437400/gene-therapy-is-now-saving-lives","audioUrl":"https://ondemand.npr.org/anon.npr-mp3/npr/me/2017/11/20171129_me_gene_therapy.mp3?orgId=1&topicId=1128&d=322&p=3&story=565728869&ft=nprml&f=565728869","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Eli Wheatley and Christian Guardino are among a growing number of patients whose lives are apparently being saved or radically improved by gene therapy.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I think that the gene therapy is a miracle. I can't imagine what my life would be like without it.'\u003c/aside>\n\u003cp>Wheatley, 3, of Lebanon, Ky., and Guardino, 17, of Patchogue, N.Y., were both diagnosed with what were long thought to be incurable genetic disorders. In the past, Wheatley's condition would have probably killed him before his first birthday. Guardino's would have blinded him early in life.\u003c/p>\n\u003cp>But after receiving experimental gene therapies, both seem to be doing fine.\u003c/p>\n\u003cp>\"It's a very exciting time for the field,\" says \u003ca href=\"https://osp.od.nih.gov/carrie-wolinetz-2/\">Carrie Wolinetz\u003c/a>, the associate director for science policy at the National Institutes of Health.\u003c/p>\n\u003cp>So far, gene therapy has only been tested on a relatively small number of patients who have been followed for relatively short periods of time. Many more patients will have to be studied for longer periods before anyone really knows how well the therapies work, how long the benefits last, and whether the therapies are safe.\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>But doctors and families of those helped so far are elated at the progress.\u003c/p>\n\u003cp>\"This is really an important time in gene therapy,\" says \u003ca href=\"http://www.dfhcc.harvard.edu/insider/member-detail/member/david-a-williams-md/\">Dr. David Williams\u003c/a>, professor of pediatrics at Harvard Medical School and chief scientific officer at Boston Children's Hospital, who was not involved in these children's treatment, but has recently achieved similar success with another genetic condition.\u003c/p>\n\u003cp>Eli's mother, Natalie Wheatley, had been terrified there was something wrong with Eli even before he was born. He barely moved during her pregnancy, she recalls, and never seemed quite right in the first weeks of his life.\u003c/p>\n\u003cp>Finally, doctors told her that her worst fears were true: Her son had \u003ca href=\"https://ghr.nlm.nih.gov/condition/spinal-muscular-atrophy\">spinal muscular atrophy\u003c/a>, a disease of motor neurons that was destroying his muscles.\u003c/p>\n\u003cp>\"They basically told me he wouldn't make it to his first birthday,\" says Wheatley. Take him home and love him and spend as much time with him as you can, she remembers the health team telling her.\u003c/p>\n\u003cp>\"I was devastated — devastated,\" she says.\u003c/p>\n\u003cp>Guardino was diagnosed with a different condition — \u003ca href=\"https://ghr.nlm.nih.gov/condition/leber-congenital-amaurosis\">Leber's congenital amaurosis\u003c/a>, a disease of the eye's retina — when he was born. The disorder isn't fatal. But it was destroying his vision.\u003c/p>\n\u003cp>\"I wouldn't be able to walk around outside on my own,\" says Guardino. During the day, he says, the world looked \"incredibly dark\" and blurry. \"It was sort of like watching your world fade away.\"\u003c/p>\n\u003cp>Now Guardino can see things he'd only dreamed about.\u003c/p>\n\u003cp>After the gene therapy treatment, he says, \"I was able to see things for the first time — like the moon. I was able to see stars for the first time – fireworks — all these amazing things that I've never been able to see before.\"\u003c/p>\n\u003cp>And Wheatley's son, Eli, seems to be thriving.\u003c/p>\n\u003cp>\"He just started preschool in September,\" his mom says. \"He goes to preschool alone. He eats in the cafeteria with all the other kids. He's doing extremely well. It's been amazing — truly amazing.\"\u003c/p>\n\u003cp>Recent success in these different cases \"really shows us we're able to harness this therapy for some pretty terrible diseases,\" says Williams, who \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1700554\">reported last month\u003c/a> in the \u003cem>New England Journal of Medicine\u003c/em> that gene therapy can also halt the progression of disease in boys suffering from \u003ca href=\"https://ghr.nlm.nih.gov/condition/x-linked-adrenoleukodystrophy\">adrenoleukodystrophy\u003c/a>, a fatal genetic brain disease \u003ca href=\"https://www.npr.org/sections/health-shots/2017/10/04/555091418/parents-lobby-states-to-expand-newborn-screening-test-for-rare-brain-disorder\">made famous\u003c/a> by the movie \u003cem>Lorenzo's Oil\u003c/em>.\u003c/p>\n\u003cp>Scientists thought this sort of success would come decades ago. But their first attempts to save people born with defective genes by giving them new, healthy genes fizzled. Some patients who volunteered for early experiments \u003ca href=\"https://www.npr.org/templates/story/story.php?storyId=5369307\">developed cancer\u003c/a>. At least one person \u003ca href=\"https://www.npr.org/templates/story/story.php?storyId=1069810\">died\u003c/a>.\u003c/p>\n\u003cp>\"And that caused a setback in the field, which caused a lot of concern that maybe gene therapy was not ready for prime time,\" the NIH's Wolinetz says.\u003c/p>\n\u003cp>Some scientists feared gene therapy might never work. Researchers went back to the drawing board to come up with better, safer ways to use viruses to deliver healthy genes into a person's body. It's those decades of research that finally seem to be paying off.\u003c/p>\n\u003cp>\"We have reached a point of maturation in the science and in some of the new approaches to gene therapy that have allowed us to make rapid advancements in a fairly short period of time,\" Wolinetz says.\u003c/p>\n\u003cp>The price tag of such a treatment remains a looming question. The first gene therapy product approved by the Food and Drug Administration (a treatment for a form of leukemia, approved last summer) costs hundreds of thousands of dollars for each infusion. Some drug industry analysts predict the next gene therapy could cost close to $1 million per patient.\u003c/p>\n\u003cp>\u003ca href=\"https://www.mskcc.org/profile/peter-bach\">Dr. Peter Bach\u003c/a>, director of the center for health policy and outcomes at Memorial Sloan Kettering Cancer Center, says he's thrilled with the scientific progress that's been made in the field — but the cost of gene therapy drugs troubles him.\u003c/p>\n\u003cp>\"The model by which every innovation is turned around to extract the maximum amount of profit is ultimately taking away our ability to adequately fund many other things that promote health,\" Bach says.\u003c/p>\n\u003cp>Whatever the questions and costs, people who have been helped by these treatments so far seem delighted.\u003c/p>\n\u003cp>\"I think that the gene therapy is a miracle,\" Guardino says. \"I can't imagine what my life would be like without it.\"\u003c/p>\n\u003cp>Natalie Wheatley, whose son Eli was among those \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1706198\">described in another study\u003c/a>, published early this month in the \u003cem>New England Journal of Medicine\u003c/em>, says her son seems to continue to improve.\u003c/p>\n\u003cp>\"I see progress every day,\" Wheatley says. \"So that, to me, offers hope that gene therapy has saved his life. And I think eventually gene therapy will give the world hope. That's my hope anyways.\"\u003c/p>\n\u003cp>The FDA could soon approve for non-experimental use the \u003ca href=\"../../sections/health-shots/2017/10/12/557183740/fda-panel-endorses-gene-therapy-for-a-form-of-childhood-blindness\">first gene therapy for a genetic disorder\u003c/a> — the treatment Guardino received to save his vision.\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>Meanwhile, scientists are starting to test other forms of gene therapy for a long list of other diseases, including many that are much more common.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Gene+Therapy+Shows+Promise+For+A+Growing+List+Of+Diseases&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/437400/gene-therapy-is-now-saving-lives","authors":["byline_futureofyou_437400"],"categories":["futureofyou_1","futureofyou_1064"],"tags":["futureofyou_1275","futureofyou_1209"],"featImg":"futureofyou_437401","label":"futureofyou"},"futureofyou_437054":{"type":"posts","id":"futureofyou_437054","meta":{"index":"posts_1591205157","site":"futureofyou","id":"437054","score":null,"sort":[1510765041000]},"guestAuthors":[],"slug":"first-attempt-to-edit-gene-inside-body-in-hopes-of-curing-mans-disease","title":"In First, Scientists Try to Cure Man's Disease by Editing DNA Inside Body","publishDate":1510765041,"format":"aside","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>https://www.youtube.com/watch?v=W-gUUB0ofVA&ab_channel=AssociatedPress\u003c/p>\n\u003cp>Scientists for the first time have tried editing a gene inside the body in a bold attempt to permanently change a person's DNA to cure a disease.\u003c/p>\n\u003cp>The experiment was done Monday in California on 44-year-old Brian Madeux. Through an IV, he received billions of copies of a corrective gene and a genetic tool to cut his DNA in a precise spot.\u003c/p>\n\u003cp>\"It's kind of humbling\" to be the first to test this, said Madeux, who has a metabolic disease called Hunter syndrome. \"I'm willing to take that risk. Hopefully it will help me and other people.\"\u003c/p>\n\u003cp>Signs of whether it's working may come in a month; tests will show for sure in three months.\u003c/p>\n\u003caside class=\"pullquote alignright\">'You’re really toying with Mother Nature.'\u003ccite>Dr. Eric Topol, Scripps Translational Science Institute\u003c/cite>\u003c/aside>\n\u003cp>If it's successful, it could give a major boost to the fledgling field of gene therapy . Scientists have edited people's genes before, altering cells in the lab that are then returned to patients. There also are gene therapies that don't involve editing DNA.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But these methods can only be used for a few types of diseases. Some give results that may not last. Some others supply a new gene like a spare part, but can't control where it inserts in the DNA, possibly causing a new problem like cancer.\u003c/p>\n\u003cp>This time, the gene tinkering is happening in a precise way inside the body. It's like sending a mini surgeon along to place the new gene in exactly the right location.\u003c/p>\n\u003cp>\"We cut your DNA, open it up, insert a gene, stitch it back up. Invisible mending,\" said Dr. Sandy Macrae, president of Sangamo Therapeutics, the California company testing this for two metabolic diseases and hemophilia. \"It becomes part of your DNA and is there for the rest of your life.\"\u003c/p>\n\u003cp>That also means there's no going back, no way to erase any mistakes the editing might cause.\u003c/p>\n\u003caside class=\"aligncenter\">\u003cem>Also from KQED Future of You:\u003c/em>\n\u003cul>\n\u003cli>\u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/31/the-crippling-ransomware-attack-on-kqed-the-inside-story/\" target=\"_blank\" rel=\"noopener\">The Crippling Ransomware Attack on an NPR Member Station\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"https://ww2.kqed.org/futureofyou/2017/11/13/the-difference-between-a-bully-and-a-true-alpha-male/\" target=\"_blank\" rel=\"noopener\">The Difference Between a Bully and a True Alpha Male\u003c/a>\u003c/li>\n\u003c/ul>\n\u003c/aside>\n\u003cp>\"You're really toying with Mother Nature\" and the risks can't be fully known, but the studies should move forward because these are incurable diseases, said one independent expert, Dr. Eric Topol of the Scripps Translational Science Institute in San Diego.\u003c/p>\n\u003cp>Protections are in place to help ensure safety, and animal tests were very encouraging, said Dr. Howard Kaufman, a Boston scientist on the National Institutes of Health panel that approved the studies.\u003c/p>\n\u003cp>He said gene editing's promise is too great to ignore. \"So far there's been no evidence that this is going to be dangerous,\" he said. \"Now is not the time to get scared.\"\u003c/p>\n\u003cp>\u003cstrong>Woe From Head to Toe\u003c/strong>\u003c/p>\n\u003cp>Fewer than 10,000 people worldwide have these metabolic diseases, partly because many die very young. Those with Madeux's condition, Hunter syndrome, lack a gene that makes an enzyme that breaks down certain carbohydrates. These build up in cells and cause havoc throughout the body.\u003c/p>\n\u003cp>Patients may have frequent colds and ear infections, distorted facial features, hearing loss, heart problems, breathing trouble, skin and eye problems, bone and joint flaws, bowel issues and brain and thinking problems.\u003c/p>\n\u003cp>\"Many are in wheelchairs ... dependent on their parents until they die,\" said Dr. Chester Whitley, a University of Minnesota genetics expert who plans to enroll patients in the studies.\u003c/p>\n\u003cp>Weekly IV doses of the missing enzyme can ease some symptoms, but cost $100,000 to $400,000 a year and don't prevent brain damage.\u003c/p>\n\u003cp>Madeux, who now lives near Phoenix, is engaged to a nurse, Marcie Humphrey. He met her 15 years ago in a study that tested this enzyme therapy at UCSF Benioff Children's Hospital Oakland, where the gene editing experiment took place.\u003c/p>\n\u003cp>He has had 26 operations for hernias, bunions, bones pinching his spinal column, and ear, eye and gall bladder problems.\u003c/p>\n\u003cp>\"It seems like I had a surgery every other year of my life\" and many procedures in between, he said. Last year he nearly died from a bronchitis and pneumonia attack. The disease had warped his airway, and \"I was drowning in my secretions, I couldn't cough it out.\"\u003cbr>\nMadeux has a chef's degree and was part owner of two restaurants in Utah, cooking for U.S. ski teams and celebrities, but now can't work in a kitchen or ride horses as he used to.\u003c/p>\n\u003cp>Gene editing won't fix damage he's already suffered, but he hopes it will stop the need for weekly enzyme treatments.\u003c/p>\n\u003cp>Initial studies will involve up to 30 adults to test safety, but the ultimate goal is to treat children very young, before much damage occurs.\u003c/p>\n\u003cp>\u003cstrong>How It Works\u003c/strong>\u003c/p>\n\u003cp>A gene-editing tool called CRISPR has gotten a lot of recent attention, but this study used a different one called zinc finger nucleases. They're like molecular scissors that seek and cut a specific piece of DNA.\u003c/p>\n\u003cp>The therapy has three parts: The new gene and two zinc finger proteins. DNA instructions for each part are placed in a virus that's been altered to not cause infection but to ferry them into cells. Billions of copies of these are given through a vein.\u003c/p>\n\u003cp>They travel to the liver, where cells use the instructions to make the zinc fingers and prepare the corrective gene. The fingers cut the DNA, allowing the new gene to slip in. The new gene then directs the cell to make the enzyme the patient lacked.\u003c/p>\n\u003cp>Only 1 percent of liver cells would have to be corrected to successfully treat the disease, said Madeux's physician and study leader, Dr. Paul Harmatz at the Oakland hospital.\u003c/p>\n\u003cp>\"How bulletproof is the technology? We're just learning,\" but safety tests have been very good, said Dr. Carl June, a University of Pennsylvania scientist who has done other gene therapy work but was not involved in this study.\u003c/p>\n\u003cp>\u003cstrong>What Could Go Wrong\u003c/strong>\u003c/p>\n\u003cp>Safety issues plagued some earlier gene therapies. One worry is that the virus might provoke an immune system attack. In 1999, 18-year-old Jesse Gelsinger died in a gene therapy study from that problem, but the new studies use a different virus that's proved much safer in other experiments.\u003c/p>\n\u003cp>Another worry is that inserting a new gene might have unforeseen effects on other genes. That happened years ago, when researchers used gene therapy to cure some cases of the immune system disorder called \"bubble boy\" disease. Several patients later developed leukemia because the new gene inserted into a place in the native DNA where it unintentionally activated a cancer gene.\u003c/p>\n\u003cp>\"When you stick a chunk of DNA in randomly, sometimes it works well, sometimes it does nothing and sometimes it causes harm,\" said Hank Greely, a Stanford University bioethicist. \"The advantage with gene editing is you can put the gene in where you want it.\"\u003c/p>\n\u003cp>Finally, some fear that the virus could get into other places like the heart, or eggs and sperm where it could affect future generations. Doctors say built-in genetic safeguards prevent the therapy from working anywhere but the liver, like a seed that only germinates in certain conditions.\u003c/p>\n\u003cp>This experiment is not connected to other, more controversial work being debated to try to edit genes in human embryos to prevent diseases before birth — changes that would be passed down from generation to generation.\u003c/p>\n\u003cp>\u003cstrong>Making History\u003c/strong>\u003c/p>\n\u003cp>Madeux's treatment was to have happened a week earlier, but a small glitch prevented it.\u003c/p>\n\u003cp>He and his fiancee returned to Arizona, but nearly didn't make it back to Oakland in time for the second attempt because their Sunday flight was canceled and no others were available until Monday, after the treatment was to take place.\u003c/p>\n\u003cp>Scrambling, they finally got a flight to Monterey, California, and a car service took them just over 100 miles north to Oakland.\u003c/p>\n\u003cp>On Monday he had the three-hour infusion, surrounded by half a dozen doctors, nurses and others wearing head-to-toe protective garb to lower the risk of giving him any germs. His doctor, Harmatz, spent the night at the hospital to help ensure his patient stayed well.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\"I'm nervous and excited,\" Madeux said as he prepared to leave the hospital. \"I've been waiting for this my whole life, something that can potentially cure me.\"\u003c/p>\n\n","blocks":[],"excerpt":"In Oakland, Monday, 44-year-old Brian Madeux received billions of copies of a corrective gene, plus a genetic tool to cut his DNA in a precise spot.","status":"publish","parent":0,"modified":1510789638,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":42,"wordCount":1419},"headData":{"title":"In First, Scientists Try to Cure Man's Disease by Editing DNA Inside Body | KQED","description":"In Oakland, Monday, 44-year-old Brian Madeux received billions of copies of a corrective gene, plus a genetic tool to cut his DNA in a precise spot.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"In First, Scientists Try to Cure Man's Disease by Editing DNA Inside Body","datePublished":"2017-11-15T16:57:21.000Z","dateModified":"2017-11-15T23:47:18.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"437054 https://ww2.kqed.org/futureofyou/?p=437054","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/11/15/first-attempt-to-edit-gene-inside-body-in-hopes-of-curing-mans-disease/","disqusTitle":"In First, Scientists Try to Cure Man's Disease by Editing DNA Inside Body","source":"KQED Future of You","nprByline":"Marilynn Marchione\u003cbr />Associated Press","path":"/futureofyou/437054/first-attempt-to-edit-gene-inside-body-in-hopes-of-curing-mans-disease","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/W-gUUB0ofVA'\n title='//www.youtube.com/embed/W-gUUB0ofVA'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Scientists for the first time have tried editing a gene inside the body in a bold attempt to permanently change a person's DNA to cure a disease.\u003c/p>\n\u003cp>The experiment was done Monday in California on 44-year-old Brian Madeux. Through an IV, he received billions of copies of a corrective gene and a genetic tool to cut his DNA in a precise spot.\u003c/p>\n\u003cp>\"It's kind of humbling\" to be the first to test this, said Madeux, who has a metabolic disease called Hunter syndrome. \"I'm willing to take that risk. Hopefully it will help me and other people.\"\u003c/p>\n\u003cp>Signs of whether it's working may come in a month; tests will show for sure in three months.\u003c/p>\n\u003caside class=\"pullquote alignright\">'You’re really toying with Mother Nature.'\u003ccite>Dr. Eric Topol, Scripps Translational Science Institute\u003c/cite>\u003c/aside>\n\u003cp>If it's successful, it could give a major boost to the fledgling field of gene therapy . Scientists have edited people's genes before, altering cells in the lab that are then returned to patients. There also are gene therapies that don't involve editing DNA.\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>But these methods can only be used for a few types of diseases. Some give results that may not last. Some others supply a new gene like a spare part, but can't control where it inserts in the DNA, possibly causing a new problem like cancer.\u003c/p>\n\u003cp>This time, the gene tinkering is happening in a precise way inside the body. It's like sending a mini surgeon along to place the new gene in exactly the right location.\u003c/p>\n\u003cp>\"We cut your DNA, open it up, insert a gene, stitch it back up. Invisible mending,\" said Dr. Sandy Macrae, president of Sangamo Therapeutics, the California company testing this for two metabolic diseases and hemophilia. \"It becomes part of your DNA and is there for the rest of your life.\"\u003c/p>\n\u003cp>That also means there's no going back, no way to erase any mistakes the editing might cause.\u003c/p>\n\u003caside class=\"aligncenter\">\u003cem>Also from KQED Future of You:\u003c/em>\n\u003cul>\n\u003cli>\u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/31/the-crippling-ransomware-attack-on-kqed-the-inside-story/\" target=\"_blank\" rel=\"noopener\">The Crippling Ransomware Attack on an NPR Member Station\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"https://ww2.kqed.org/futureofyou/2017/11/13/the-difference-between-a-bully-and-a-true-alpha-male/\" target=\"_blank\" rel=\"noopener\">The Difference Between a Bully and a True Alpha Male\u003c/a>\u003c/li>\n\u003c/ul>\n\u003c/aside>\n\u003cp>\"You're really toying with Mother Nature\" and the risks can't be fully known, but the studies should move forward because these are incurable diseases, said one independent expert, Dr. Eric Topol of the Scripps Translational Science Institute in San Diego.\u003c/p>\n\u003cp>Protections are in place to help ensure safety, and animal tests were very encouraging, said Dr. Howard Kaufman, a Boston scientist on the National Institutes of Health panel that approved the studies.\u003c/p>\n\u003cp>He said gene editing's promise is too great to ignore. \"So far there's been no evidence that this is going to be dangerous,\" he said. \"Now is not the time to get scared.\"\u003c/p>\n\u003cp>\u003cstrong>Woe From Head to Toe\u003c/strong>\u003c/p>\n\u003cp>Fewer than 10,000 people worldwide have these metabolic diseases, partly because many die very young. Those with Madeux's condition, Hunter syndrome, lack a gene that makes an enzyme that breaks down certain carbohydrates. These build up in cells and cause havoc throughout the body.\u003c/p>\n\u003cp>Patients may have frequent colds and ear infections, distorted facial features, hearing loss, heart problems, breathing trouble, skin and eye problems, bone and joint flaws, bowel issues and brain and thinking problems.\u003c/p>\n\u003cp>\"Many are in wheelchairs ... dependent on their parents until they die,\" said Dr. Chester Whitley, a University of Minnesota genetics expert who plans to enroll patients in the studies.\u003c/p>\n\u003cp>Weekly IV doses of the missing enzyme can ease some symptoms, but cost $100,000 to $400,000 a year and don't prevent brain damage.\u003c/p>\n\u003cp>Madeux, who now lives near Phoenix, is engaged to a nurse, Marcie Humphrey. He met her 15 years ago in a study that tested this enzyme therapy at UCSF Benioff Children's Hospital Oakland, where the gene editing experiment took place.\u003c/p>\n\u003cp>He has had 26 operations for hernias, bunions, bones pinching his spinal column, and ear, eye and gall bladder problems.\u003c/p>\n\u003cp>\"It seems like I had a surgery every other year of my life\" and many procedures in between, he said. Last year he nearly died from a bronchitis and pneumonia attack. The disease had warped his airway, and \"I was drowning in my secretions, I couldn't cough it out.\"\u003cbr>\nMadeux has a chef's degree and was part owner of two restaurants in Utah, cooking for U.S. ski teams and celebrities, but now can't work in a kitchen or ride horses as he used to.\u003c/p>\n\u003cp>Gene editing won't fix damage he's already suffered, but he hopes it will stop the need for weekly enzyme treatments.\u003c/p>\n\u003cp>Initial studies will involve up to 30 adults to test safety, but the ultimate goal is to treat children very young, before much damage occurs.\u003c/p>\n\u003cp>\u003cstrong>How It Works\u003c/strong>\u003c/p>\n\u003cp>A gene-editing tool called CRISPR has gotten a lot of recent attention, but this study used a different one called zinc finger nucleases. They're like molecular scissors that seek and cut a specific piece of DNA.\u003c/p>\n\u003cp>The therapy has three parts: The new gene and two zinc finger proteins. DNA instructions for each part are placed in a virus that's been altered to not cause infection but to ferry them into cells. Billions of copies of these are given through a vein.\u003c/p>\n\u003cp>They travel to the liver, where cells use the instructions to make the zinc fingers and prepare the corrective gene. The fingers cut the DNA, allowing the new gene to slip in. The new gene then directs the cell to make the enzyme the patient lacked.\u003c/p>\n\u003cp>Only 1 percent of liver cells would have to be corrected to successfully treat the disease, said Madeux's physician and study leader, Dr. Paul Harmatz at the Oakland hospital.\u003c/p>\n\u003cp>\"How bulletproof is the technology? We're just learning,\" but safety tests have been very good, said Dr. Carl June, a University of Pennsylvania scientist who has done other gene therapy work but was not involved in this study.\u003c/p>\n\u003cp>\u003cstrong>What Could Go Wrong\u003c/strong>\u003c/p>\n\u003cp>Safety issues plagued some earlier gene therapies. One worry is that the virus might provoke an immune system attack. In 1999, 18-year-old Jesse Gelsinger died in a gene therapy study from that problem, but the new studies use a different virus that's proved much safer in other experiments.\u003c/p>\n\u003cp>Another worry is that inserting a new gene might have unforeseen effects on other genes. That happened years ago, when researchers used gene therapy to cure some cases of the immune system disorder called \"bubble boy\" disease. Several patients later developed leukemia because the new gene inserted into a place in the native DNA where it unintentionally activated a cancer gene.\u003c/p>\n\u003cp>\"When you stick a chunk of DNA in randomly, sometimes it works well, sometimes it does nothing and sometimes it causes harm,\" said Hank Greely, a Stanford University bioethicist. \"The advantage with gene editing is you can put the gene in where you want it.\"\u003c/p>\n\u003cp>Finally, some fear that the virus could get into other places like the heart, or eggs and sperm where it could affect future generations. Doctors say built-in genetic safeguards prevent the therapy from working anywhere but the liver, like a seed that only germinates in certain conditions.\u003c/p>\n\u003cp>This experiment is not connected to other, more controversial work being debated to try to edit genes in human embryos to prevent diseases before birth — changes that would be passed down from generation to generation.\u003c/p>\n\u003cp>\u003cstrong>Making History\u003c/strong>\u003c/p>\n\u003cp>Madeux's treatment was to have happened a week earlier, but a small glitch prevented it.\u003c/p>\n\u003cp>He and his fiancee returned to Arizona, but nearly didn't make it back to Oakland in time for the second attempt because their Sunday flight was canceled and no others were available until Monday, after the treatment was to take place.\u003c/p>\n\u003cp>Scrambling, they finally got a flight to Monterey, California, and a car service took them just over 100 miles north to Oakland.\u003c/p>\n\u003cp>On Monday he had the three-hour infusion, surrounded by half a dozen doctors, nurses and others wearing head-to-toe protective garb to lower the risk of giving him any germs. His doctor, Harmatz, spent the night at the hospital to help ensure his patient stayed well.\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>\"I'm nervous and excited,\" Madeux said as he prepared to leave the hospital. \"I've been waiting for this my whole life, something that can potentially cure me.\"\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/437054/first-attempt-to-edit-gene-inside-body-in-hopes-of-curing-mans-disease","authors":["byline_futureofyou_437054"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73","futureofyou_1064"],"tags":["futureofyou_1275","futureofyou_295","futureofyou_1209","futureofyou_80","futureofyou_1396"],"featImg":"futureofyou_437058","label":"source_futureofyou_437054"},"futureofyou_436290":{"type":"posts","id":"futureofyou_436290","meta":{"index":"posts_1591205157","site":"futureofyou","id":"436290","score":null,"sort":[1508776931000]},"guestAuthors":[],"slug":"gene-therapy-is-here-and-its-expensive-who-will-pay","title":"Gene Therapy is Here, and It's Expensive. Who Will Pay for It?","publishDate":1508776931,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Gene therapy has the potential to be a one-shot treatment that could reverse blindness, restore blood-clotting function to hemophiliacs, or even cure rare diseases outright. But what kind of price tag comes with that promise — and who will pay for it?\u003c/p>\n\u003caside class=\"pullquote alignright\">'The fact is, we need to move our 20th-century health care system to meet 21st-century scientific and medical breakthroughs.'\u003ccite>Jeff Marrazzo, Spark Therapeutics\u003c/cite>\u003c/aside>\n\u003cp>The question is no longer academic: Spark Therapeutics has \u003ca href=\"http://www.sciencemag.org/news/2017/10/fda-experts-offer-unanimous-endorsement-pioneering-gene-therapy-blindness\" target=\"_blank\" rel=\"noopener\">won\u003c/a> unanimous support from a Food and Drug Administration advisory panel for its gene therapy drug, Luxturna. It seems likely to win FDA approval in the coming months. But the cost will be hefty: Analysts estimate that Luxturna, which has been shown to restore vision in children with an inherited form of blindness, could cost $1 million per patient.\u003c/p>\n\u003cp>Will private insurers be willing to pay? What about taxpayers, via Medicaid and Medicare? And, importantly: What happens if patients — or insurers — do foot a hefty bill, only to find out the drug simply did not work for them?\u003c/p>\n\u003cp>“These one-shot cases are potentially transformative — but not every patient responds to the same extent with gene therapy,” said Dr. Mark McClellan, a former FDA commissioner who now leads the Duke-Margolis Center for Health Policy. “We’re definitely not all the way there yet.”\u003c/p>\n\u003cp>So McClellan has formed a consortium at Duke to brainstorm better ways to cover the costs. He’s bringing gene therapy companies like Spark, Bluebird Bio, and Pfizer to the table — along with insurers like Harvard Pilgrim and Anthem.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“The fact is, we need to move our 20th-century health care system to meet 21st-century scientific and medical breakthroughs,” said Jeff Marrazzo, CEO of Spark Therapeutics.\u003c/p>\n\u003cp>Gene therapies work by infusing a patient with engineered viruses armed with DNA that helps correct the molecular processes that go awry in an inherited disease. It’s costly, in part, because these viruses are more difficult and time-consuming to manufacture than a standard pharmaceutical drug.\u003c/p>\n\u003cp>On top of that, companies typically spend years in costly research and development before finding an approach that works and can win FDA approval. And in most of these diseases, there’s just a relatively small patient pool.\u003c/p>\n\u003cp>What’s more, when they work, the therapies can save patients and insurers big money down the road. Current hemophilia drugs, for instance, cost hundreds of thousands of dollars each year. If a patient could be cured with a one-time infusion — even one that costs $1 million — that might actually be quite cost-effective.\u003c/p>\n\u003cp>Given all that, companies do have good reason to charge a premium for their gene therapy products, McClellan said.\u003c/p>\n\u003cp>On the other hand, scientific breakthroughs mean nothing if they’re not accessible to patients.\u003c/p>\n\u003cp>“The concern is that if you get enough of these types of expensive therapies to hit the market, they’ll perhaps make the premiums unaffordable,” said Dr. Michael Sherman, chief medical officer of Boston-based insurer Harvard Pilgrim Health Care. “So we have to be creative to find the right balance of access and affordability.”\u003c/p>\n\u003cp>The main concept the consortium is kicking around: value-based payments. They’re a form of money-back guarantee, in that patients or their insurers pay for the therapy only if it actually proves effective in reversing or managing their disease.\u003c/p>\n\u003cp>And to make the cost burden lighter, one idea gaining steam is to break these costs into incremental payments over several years — and make those contingent on a patient’s sustained response. That way, if the treatment stops working for a given patient, he or she might not have to pay the full amount.\u003c/p>\n\u003cp>Novartis is taking a baby step in this direction with its newly approved CAR-T cancer drug, Kymriah. It’s priced at $475,000, but Novartis struck a deal with the Centers for Medicare and Medicaid Services: It gets paid only if Kymriah appears to be sending a patient’s cancer into remission a month after treatment.\u003c/p>\n\u003cp>“Paying for a gene therapy for as long as it’s working makes a tremendous amount of sense — but it comes with some challenges,” said Nick Leschly, CEO of Bluebird Bio, which is working on gene therapies for several rare diseases.\u003c/p>\n\u003cp>Among those challenges: What if the patient changes insurance companies a couple years after her gene therapy? Who foots the bill for the remaining payments? Would she even be able to get a new insurance plan with that kind of bill following her around?\u003c/p>\n\u003cp>Also: What if a patient fails to show up for checkups to determine if the drug is still working? That could be a way for him to evade the installment payments.\u003c/p>\n\u003cp>“If a patient decides not to come in, who shoulders that payment?” Leschly said. “Is it on the insurer to make sure the patient shows up?”\u003c/p>\n\u003cp>Still another challenge: What if a drug like Kymriah seems to be working after a month, triggering the insurer to pay the full amount — but then the next week, the patient’s cancer again gains the upper hand? Is there any mechanism for the insurer to claw back some of its payment?\u003c/p>\n\u003cp>The overarching problem is systemic, experts said: There’s simply no mechanism now for a company to spool out a million-dollar bill over several years while assessing the patient’s health and response to therapy at regular intervals.\u003c/p>\n\u003cp>“If we were to propose a model like this to a single commercial insurer, the financial penalties would be significant,” said Marrazzo, the Spark CEO. “The government’s existing price reporting mechanisms are too rigid — so we can’t financially make sense of doing it.”\u003c/p>\n\u003cp>Marrazzo wouldn’t tip his hand as to the price Spark will set for Luxturna. Typically, that comes only after FDA approval. He also declined to give specifics on potential payment models. But some analysts are predicting a fairly old-school approach: a one-time charge in the high six or seven figures for a one-time treatment.\u003c/p>\n\u003cp>As more gene therapies come on the market, experts say it will take a new level of cooperation between policy makers, drug companies, and insurers to come up with rational payment models.\u003c/p>\n\u003cp>“But we’re confident we can figure it out,” Leschly said. “Because if someone has a very serious disease, and we can cure it, the system will find a way to reward that.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2017/10/13/gene-therapy-pricing/\" 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":"As the first gene therapies approach the market, drug makers, insurers, and patients are debating complex questions about cost, value, and payment plans.","status":"publish","parent":0,"modified":1508857535,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":28,"wordCount":1154},"headData":{"title":"Gene Therapy is Here, and It's Expensive. Who Will Pay for It? | KQED","description":"As the first gene therapies approach the market, drug makers, insurers, and patients are debating complex questions about cost, value, and payment plans.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Gene Therapy is Here, and It's Expensive. Who Will Pay for It?","datePublished":"2017-10-23T16:42:11.000Z","dateModified":"2017-10-24T15:05:35.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"436290 https://ww2.kqed.org/futureofyou/?p=436290","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/10/23/gene-therapy-is-here-and-its-expensive-who-will-pay/","disqusTitle":"Gene Therapy is Here, and It's Expensive. Who Will Pay for It?","source":"Future of You","nprByline":"Meghana Keshavan\u003c/br>\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/436290/gene-therapy-is-here-and-its-expensive-who-will-pay","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Gene therapy has the potential to be a one-shot treatment that could reverse blindness, restore blood-clotting function to hemophiliacs, or even cure rare diseases outright. But what kind of price tag comes with that promise — and who will pay for it?\u003c/p>\n\u003caside class=\"pullquote alignright\">'The fact is, we need to move our 20th-century health care system to meet 21st-century scientific and medical breakthroughs.'\u003ccite>Jeff Marrazzo, Spark Therapeutics\u003c/cite>\u003c/aside>\n\u003cp>The question is no longer academic: Spark Therapeutics has \u003ca href=\"http://www.sciencemag.org/news/2017/10/fda-experts-offer-unanimous-endorsement-pioneering-gene-therapy-blindness\" target=\"_blank\" rel=\"noopener\">won\u003c/a> unanimous support from a Food and Drug Administration advisory panel for its gene therapy drug, Luxturna. It seems likely to win FDA approval in the coming months. But the cost will be hefty: Analysts estimate that Luxturna, which has been shown to restore vision in children with an inherited form of blindness, could cost $1 million per patient.\u003c/p>\n\u003cp>Will private insurers be willing to pay? What about taxpayers, via Medicaid and Medicare? And, importantly: What happens if patients — or insurers — do foot a hefty bill, only to find out the drug simply did not work for them?\u003c/p>\n\u003cp>“These one-shot cases are potentially transformative — but not every patient responds to the same extent with gene therapy,” said Dr. Mark McClellan, a former FDA commissioner who now leads the Duke-Margolis Center for Health Policy. “We’re definitely not all the way there yet.”\u003c/p>\n\u003cp>So McClellan has formed a consortium at Duke to brainstorm better ways to cover the costs. He’s bringing gene therapy companies like Spark, Bluebird Bio, and Pfizer to the table — along with insurers like Harvard Pilgrim and Anthem.\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>“The fact is, we need to move our 20th-century health care system to meet 21st-century scientific and medical breakthroughs,” said Jeff Marrazzo, CEO of Spark Therapeutics.\u003c/p>\n\u003cp>Gene therapies work by infusing a patient with engineered viruses armed with DNA that helps correct the molecular processes that go awry in an inherited disease. It’s costly, in part, because these viruses are more difficult and time-consuming to manufacture than a standard pharmaceutical drug.\u003c/p>\n\u003cp>On top of that, companies typically spend years in costly research and development before finding an approach that works and can win FDA approval. And in most of these diseases, there’s just a relatively small patient pool.\u003c/p>\n\u003cp>What’s more, when they work, the therapies can save patients and insurers big money down the road. Current hemophilia drugs, for instance, cost hundreds of thousands of dollars each year. If a patient could be cured with a one-time infusion — even one that costs $1 million — that might actually be quite cost-effective.\u003c/p>\n\u003cp>Given all that, companies do have good reason to charge a premium for their gene therapy products, McClellan said.\u003c/p>\n\u003cp>On the other hand, scientific breakthroughs mean nothing if they’re not accessible to patients.\u003c/p>\n\u003cp>“The concern is that if you get enough of these types of expensive therapies to hit the market, they’ll perhaps make the premiums unaffordable,” said Dr. Michael Sherman, chief medical officer of Boston-based insurer Harvard Pilgrim Health Care. “So we have to be creative to find the right balance of access and affordability.”\u003c/p>\n\u003cp>The main concept the consortium is kicking around: value-based payments. They’re a form of money-back guarantee, in that patients or their insurers pay for the therapy only if it actually proves effective in reversing or managing their disease.\u003c/p>\n\u003cp>And to make the cost burden lighter, one idea gaining steam is to break these costs into incremental payments over several years — and make those contingent on a patient’s sustained response. That way, if the treatment stops working for a given patient, he or she might not have to pay the full amount.\u003c/p>\n\u003cp>Novartis is taking a baby step in this direction with its newly approved CAR-T cancer drug, Kymriah. It’s priced at $475,000, but Novartis struck a deal with the Centers for Medicare and Medicaid Services: It gets paid only if Kymriah appears to be sending a patient’s cancer into remission a month after treatment.\u003c/p>\n\u003cp>“Paying for a gene therapy for as long as it’s working makes a tremendous amount of sense — but it comes with some challenges,” said Nick Leschly, CEO of Bluebird Bio, which is working on gene therapies for several rare diseases.\u003c/p>\n\u003cp>Among those challenges: What if the patient changes insurance companies a couple years after her gene therapy? Who foots the bill for the remaining payments? Would she even be able to get a new insurance plan with that kind of bill following her around?\u003c/p>\n\u003cp>Also: What if a patient fails to show up for checkups to determine if the drug is still working? That could be a way for him to evade the installment payments.\u003c/p>\n\u003cp>“If a patient decides not to come in, who shoulders that payment?” Leschly said. “Is it on the insurer to make sure the patient shows up?”\u003c/p>\n\u003cp>Still another challenge: What if a drug like Kymriah seems to be working after a month, triggering the insurer to pay the full amount — but then the next week, the patient’s cancer again gains the upper hand? Is there any mechanism for the insurer to claw back some of its payment?\u003c/p>\n\u003cp>The overarching problem is systemic, experts said: There’s simply no mechanism now for a company to spool out a million-dollar bill over several years while assessing the patient’s health and response to therapy at regular intervals.\u003c/p>\n\u003cp>“If we were to propose a model like this to a single commercial insurer, the financial penalties would be significant,” said Marrazzo, the Spark CEO. “The government’s existing price reporting mechanisms are too rigid — so we can’t financially make sense of doing it.”\u003c/p>\n\u003cp>Marrazzo wouldn’t tip his hand as to the price Spark will set for Luxturna. Typically, that comes only after FDA approval. He also declined to give specifics on potential payment models. But some analysts are predicting a fairly old-school approach: a one-time charge in the high six or seven figures for a one-time treatment.\u003c/p>\n\u003cp>As more gene therapies come on the market, experts say it will take a new level of cooperation between policy makers, drug companies, and insurers to come up with rational payment models.\u003c/p>\n\u003cp>“But we’re confident we can figure it out,” Leschly said. “Because if someone has a very serious disease, and we can cure it, the system will find a way to reward that.”\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/2017/10/13/gene-therapy-pricing/\" 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/436290/gene-therapy-is-here-and-its-expensive-who-will-pay","authors":["byline_futureofyou_436290"],"categories":["futureofyou_452","futureofyou_1","futureofyou_1064"],"tags":["futureofyou_1275","futureofyou_1209","futureofyou_1381"],"collections":["futureofyou_1097"],"featImg":"futureofyou_244544","label":"source_futureofyou_436290"},"futureofyou_435119":{"type":"posts","id":"futureofyou_435119","meta":{"index":"posts_1591205157","site":"futureofyou","id":"435119","score":null,"sort":[1504162872000]},"guestAuthors":[],"slug":"pioneering-cancer-drug-just-approved-to-cost-475000-and-analysts-say-its-a-bargain","title":"Pioneering Cancer Drug to Cost $475,000 — and Analysts Say It's a Bargain","publishDate":1504162872,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>The Food and Drug Administration on Wednesday approved a futuristic new approach to treating cancer, clearing a Novartis therapy that has produced unprecedented results in patients with a rare and deadly cancer. The price tag: $475,000 for a course of treatment.\u003c/p>\n\u003cp>That sounds staggering to many patients — but it’s far less than analysts expected.\u003c/p>\n\u003cp>The therapy, called a CAR-T, is made by harvesting patients’ white blood cells and rewiring them to home in on tumors. Novartis’s product is the first CAR-T therapy to come before the FDA, leading a pack of novel treatments that promise to change the standard of care for certain aggressive blood cancers.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I think this is most exciting thing I’ve seen in my lifetime.’\u003ccite>Tim Cripe, oncologist with Nationwide Children’s Hospital at an FDA meeting on Kymriah in July\u003c/cite>\u003c/aside>\n\u003cp>Novartis’s therapy is approved to treat children and young adults with relapsed acute lymphoblastic leukemia. It will be marketed as Kymriah.\u003c/p>\n\u003cp>The treatment’s approval has looked a foregone conclusion for months, but its potential price has been the subject of speculation and debate. Novartis picked the $475,000 price tag in an effort to balance patient access to Kymriah while giving the company a return on its investment, said Bruno Strigini, Novartis’s head of oncology, in a conference call Wednesday. The cost is below Wall Street analyst expectations, which reached as high as $750,000 for a dose. And it’s considerably cheaper than the roughly $700,000 price tag that U.K. regulators said would be fair considering Kymriah’s potential benefits.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>[contextly_sidebar id=\"QG4PnjDFa7wR6mRKag9nuRtDY12MT3jG\"]Novartis also said it is working with Medicare on a system in which the government would only pay for CAR-T treatment if patients respond within a month.\u003c/p>\n\u003cp>In a clinical trial, a single dose of Kymriah left 83 percent of participants cancer-free after three months, \u003ca href=\"https://www.statnews.com/2017/07/12/novartis-car-t-fda-approval/\">results oncologists have hailed as a major advance\u003c/a> for patients with few other options. The most frequent side effect was an inflammatory storm called cytokine release syndrome, a reaction to CAR-T that can prove fatal in some patients but is commonly controlled with immunosuppressant drugs.\u003c/p>\n\u003cp>“I think this is most exciting thing I’ve seen in my lifetime,” said Dr. Tim Cripe, an oncologist with Nationwide Children’s Hospital, at an FDA meeting on Kymriah in July.\u003c/p>\n\u003cp>Unlike well-understood pills and commonly injected biotech drugs, CAR-T presents a radical new paradigm for doctors, regulators, and payers. Each dose is custom-tailored for an individual patient, requiring a complex process in which human cells must be safely ferried across the country, reliably re-engineered, and soundly returned.\u003c/p>\n\u003cp>That creates logistical issues unseen with previous drugs. To get Kymriah, patients will have to travel to one of just 32 sites around the country. From there, doctors harvest patients’ white blood cells and ship them off to a Novartis facility in New Jersey where they can be edited and mailed back. The entire process takes about 22 days, the company said. And the $450,000 price tag covers only Novartis’s role, not the costs of travel, hospitalization, or any drugs needed to tamp down Kymriah’s side effects.\u003c/p>\n\u003cp>And it remains unclear just how lucrative a business opportunity Kymriah presents. There are about 3,100 new cases of ALL each year, but roughly 70 percent can be pushed into remission by standard therapy. That could leave just a few hundred patients who might be eligible for Novartis’s therapy, casting doubt on whether the company can get an outsize return on what will be a substantial manufacturing investment.\u003c/p>\n\u003cp>But CAR-T’s potential goes far beyond Wednesday’s approval.\u003c/p>\n\u003cp>Novartis is developing Kymriah for use in lymphoma, and its pipeline includes other CAR-T therapies targeting an array of blood cancers. Kite Pharma, soon to be \u003ca href=\"https://www.statnews.com/2017/08/28/gilead-kite-car-t-cancer/\">acquired by Gilead Sciences\u003c/a>, is awaiting FDA approval for a lymphoma therapy and is, like Novartis, developing a bevy of cell therapies it hopes can treat tumors liquid and solid. Juno Therapeutics, which slipped into a third place after its \u003ca href=\"https://www.statnews.com/2017/03/01/juno-cancer-treatment/\">lead CAR-T ran into safety problems\u003c/a>, has a similar focus.\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/30/novartis-car-t-cancer-approved/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n","blocks":[],"excerpt":"The FDA on Wednesday approved a futuristic new cancer treatment, and Novartis said it would charge $475,000 for it. Analysts had expected a higher price.","status":"publish","parent":0,"modified":1504194097,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":16,"wordCount":750},"headData":{"title":"Pioneering Cancer Drug to Cost $475,000 — and Analysts Say It's a Bargain | KQED","description":"The FDA on Wednesday approved a futuristic new cancer treatment, and Novartis said it would charge $475,000 for it. Analysts had expected a higher price.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Pioneering Cancer Drug to Cost $475,000 — and Analysts Say It's a Bargain","datePublished":"2017-08-31T07:01:12.000Z","dateModified":"2017-08-31T15:41:37.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"435119 https://ww2.kqed.org/futureofyou/?p=435119","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/08/31/pioneering-cancer-drug-just-approved-to-cost-475000-and-analysts-say-its-a-bargain/","disqusTitle":"Pioneering Cancer Drug to Cost $475,000 — and Analysts Say It's a Bargain","nprByline":"Damian Garde\u003c/br>\u003ca href=\"https://www.statnews.com/2017/08/30/novartis-car-t-cancer-approved/\">STAT\u003c/a>","path":"/futureofyou/435119/pioneering-cancer-drug-just-approved-to-cost-475000-and-analysts-say-its-a-bargain","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration on Wednesday approved a futuristic new approach to treating cancer, clearing a Novartis therapy that has produced unprecedented results in patients with a rare and deadly cancer. The price tag: $475,000 for a course of treatment.\u003c/p>\n\u003cp>That sounds staggering to many patients — but it’s far less than analysts expected.\u003c/p>\n\u003cp>The therapy, called a CAR-T, is made by harvesting patients’ white blood cells and rewiring them to home in on tumors. Novartis’s product is the first CAR-T therapy to come before the FDA, leading a pack of novel treatments that promise to change the standard of care for certain aggressive blood cancers.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I think this is most exciting thing I’ve seen in my lifetime.’\u003ccite>Tim Cripe, oncologist with Nationwide Children’s Hospital at an FDA meeting on Kymriah in July\u003c/cite>\u003c/aside>\n\u003cp>Novartis’s therapy is approved to treat children and young adults with relapsed acute lymphoblastic leukemia. It will be marketed as Kymriah.\u003c/p>\n\u003cp>The treatment’s approval has looked a foregone conclusion for months, but its potential price has been the subject of speculation and debate. Novartis picked the $475,000 price tag in an effort to balance patient access to Kymriah while giving the company a return on its investment, said Bruno Strigini, Novartis’s head of oncology, in a conference call Wednesday. The cost is below Wall Street analyst expectations, which reached as high as $750,000 for a dose. And it’s considerably cheaper than the roughly $700,000 price tag that U.K. regulators said would be fair considering Kymriah’s potential benefits.\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>\u003c/p>\u003cp>\u003c/p>\u003cp>Novartis also said it is working with Medicare on a system in which the government would only pay for CAR-T treatment if patients respond within a month.\u003c/p>\n\u003cp>In a clinical trial, a single dose of Kymriah left 83 percent of participants cancer-free after three months, \u003ca href=\"https://www.statnews.com/2017/07/12/novartis-car-t-fda-approval/\">results oncologists have hailed as a major advance\u003c/a> for patients with few other options. The most frequent side effect was an inflammatory storm called cytokine release syndrome, a reaction to CAR-T that can prove fatal in some patients but is commonly controlled with immunosuppressant drugs.\u003c/p>\n\u003cp>“I think this is most exciting thing I’ve seen in my lifetime,” said Dr. Tim Cripe, an oncologist with Nationwide Children’s Hospital, at an FDA meeting on Kymriah in July.\u003c/p>\n\u003cp>Unlike well-understood pills and commonly injected biotech drugs, CAR-T presents a radical new paradigm for doctors, regulators, and payers. Each dose is custom-tailored for an individual patient, requiring a complex process in which human cells must be safely ferried across the country, reliably re-engineered, and soundly returned.\u003c/p>\n\u003cp>That creates logistical issues unseen with previous drugs. To get Kymriah, patients will have to travel to one of just 32 sites around the country. From there, doctors harvest patients’ white blood cells and ship them off to a Novartis facility in New Jersey where they can be edited and mailed back. The entire process takes about 22 days, the company said. And the $450,000 price tag covers only Novartis’s role, not the costs of travel, hospitalization, or any drugs needed to tamp down Kymriah’s side effects.\u003c/p>\n\u003cp>And it remains unclear just how lucrative a business opportunity Kymriah presents. There are about 3,100 new cases of ALL each year, but roughly 70 percent can be pushed into remission by standard therapy. That could leave just a few hundred patients who might be eligible for Novartis’s therapy, casting doubt on whether the company can get an outsize return on what will be a substantial manufacturing investment.\u003c/p>\n\u003cp>But CAR-T’s potential goes far beyond Wednesday’s approval.\u003c/p>\n\u003cp>Novartis is developing Kymriah for use in lymphoma, and its pipeline includes other CAR-T therapies targeting an array of blood cancers. Kite Pharma, soon to be \u003ca href=\"https://www.statnews.com/2017/08/28/gilead-kite-car-t-cancer/\">acquired by Gilead Sciences\u003c/a>, is awaiting FDA approval for a lymphoma therapy and is, like Novartis, developing a bevy of cell therapies it hopes can treat tumors liquid and solid. Juno Therapeutics, which slipped into a third place after its \u003ca href=\"https://www.statnews.com/2017/03/01/juno-cancer-treatment/\">lead CAR-T ran into safety problems\u003c/a>, has a similar focus.\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/30/novartis-car-t-cancer-approved/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/435119/pioneering-cancer-drug-just-approved-to-cost-475000-and-analysts-say-its-a-bargain","authors":["byline_futureofyou_435119"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_1064"],"tags":["futureofyou_103","futureofyou_1275","futureofyou_1209","futureofyou_112"],"featImg":"futureofyou_435120","label":"futureofyou"},"futureofyou_354044":{"type":"posts","id":"futureofyou_354044","meta":{"index":"posts_1591205157","site":"futureofyou","id":"354044","score":null,"sort":[1491244365000]},"guestAuthors":[],"slug":"gene-therapy-may-finally-be-coming-of-age","title":"Gene Therapy May Finally Be Coming of Age","publishDate":1491244365,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Sickle cell anemia is a genetic blood disorder characterized by episodes of severe pain, anemia and other complications. In more affluent countries, life expectancy for those who suffer from the disorder is 40-60 years.\u003c/p>\n\u003cp>Now, in a \u003ca href=\"http://www.nejm.org/doi/pdf/10.1056/NEJMoa1609677\" target=\"_blank\">new study\u003c/a> out this month in \u003cem>The New England Journal of Medicine,\u003c/em> scientists report that a teenage boy with the disorder remained symptom-free for 15 months after undergoing gene therapy.\u003c/p>\n\u003cp>\"We may be on the threshold of finally being able to cure people of genetic diseases safely using gene therapy,\" said Stanford University's Mark Kay, a researcher in the field, in response to the study. Kay cited recent successful gene therapy treatments for \u003ca href=\"https://www.technologyreview.com/s/601651/gene-therapy-is-curing-hemophilia/\" target=\"_blank\">hemophilia\u003c/a>, \u003ca href=\"http://www.bbc.com/news/science-environment-36101786\" target=\"_blank\">hereditary blindness\u003c/a> and even \u003ca href=\"http://www.upi.com/Health_News/2017/01/25/Gene-therapy-helps-2-babies-fight-type-of-leukemia/6931485378663/\" target=\"_blank\">leukemia\u003c/a>.\u003c/p>\n\u003cp>Gene therapy is a simple concept — basically scientists add a working gene to a cell with only broken ones. The working gene then makes up for the broken copies of that gene and cures the genetic disease.\u003c/p>\n\u003caside class=\"pullquote alignright\">'We may be on the threshold of finally being able to cure people of genetic diseases safely using gene therapy.'\u003c/aside>\n\u003cp>But getting the right gene safely to the right spot, in enough cells for a long enough time, turns out to be a tall order. Such a tall order that gene therapy is only now coming into its own as a somewhat reliable way to treat genetic disease.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>This turnaround is not due to some leap of understanding, but because of slow, incremental improvements in every aspect of the process. Scientists are better at getting more cells to take up the therapeutic gene in a much safer way.\u003c/p>\n\u003cp>\u003cstrong>Safer Delivery\u003c/strong>\u003c/p>\n\u003cp>One of the biggest changes in gene therapy occurred in the 2000s, when scientists discovered how to better deliver to the patient functioning genes.\u003c/p>\n\u003cp>Most gene therapies take advantage of viruses, which are very skilled at inserting themselves into a cell’s DNA, where they would usually wreak havoc.\u003c/p>\n\u003cfigure id=\"attachment_357653\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-357653 size-medium\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-800x602.jpg\" width=\"800\" height=\"602\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-800x602.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-160x120.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-768x578.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-1020x768.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-1180x888.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-960x722.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-240x181.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-375x282.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-520x391.jpg 520w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia.jpg 1600w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">The sickled red blood cells cause the symptoms of sickle cell anemia. Adding an engineered beta globin gene to bone marrow cells results in many fewer of the sickled cells. (Wikimedia)\u003c/figcaption>\u003c/figure>\n\u003cp>But with gene therapy, scientists strip out the parts of the virus that make it dangerous. It's this engineered virus they use to deliver the working genes.\u003c/p>\n\u003cp>In early gene therapy research, scientists used retroviruses \u003cb>,\u003c/b> which are easy to\u003cb> \u003c/b>work with and are very good at getting genes into a cell’s DNA.\u003c/p>\n\u003cp>Unfortunately, many of them tend to insert themselves into places in our DNA that switch on genes that can cause cancer; that \u003ca href=\"http://angt.austrianova.com/angt/Brevia.pdf\">happened in a study\u003c/a> back in 2002. Since then, scientists have worked hard to find retroviruses that wouldn’t cause this problem.\u003c/p>\n\u003cp>\u003cstrong>Other Important Tweaks\u003c/strong>\u003c/p>\n\u003cp>But a good delivery vehicle isn’t enough to treat sickle cell anemia. Scientists also need to replace the mutated genetic material that’s causing the illness with a working gene powerful enough to keep the disease at bay. In a 2004 study, scientists \u003ca href=\"http://www.jbc.org/content/279/26/27518.full\" target=\"_blank\">engineered a gene\u003c/a> that seems to do the job for sickle cell anemia.\u003c/p>\n\u003cp>In the case of the boy reported earlier this month, researchers removed his bone marrow cells, used a virus to insert a working gene into them, then returned the engineered bone marrow cells back to the patient. Bone marrow cells are where all new blood cells are made.\u003c/p>\n\u003cp>Another key improvement was to treat the patient with a drug, busulfan. This allowed for more of the engineered cells to take root in the patient’s bone marrow, meaning more of his red blood cells returned to normal.\u003c/p>\n\u003cp>“All of these changes and more have led to a successful outcome,” says Stanford genetic researcher Dr. Michele Calos, speaking of the new study. “This successful study is the culmination of more than 30 years of work by many people.”\u003c/p>\n\u003cp>We may be on the threshold of finally being able to cure people of genetic diseases safely using gene therapy. Or then again, we might not.\u003c/p>\n\u003cp>Over the years, scientists have been heralding the coming gene therapy age again and again. Each time there was a setback that held the field back.\u003c/p>\n\u003cp>Gene therapy is still a very expensive and time-consuming procedure, but if it can be streamlined, it holds promise for the millions of people worldwide struggling with sickle cell anemia, cystic fibrosis and other genetic diseases.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">Dr. Barry Starr is a scientist in the\u003c/span>\u003ca href=\"https://med.stanford.edu/genetics.html\"> \u003cspan style=\"font-weight: 400\">Department of Genetics\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\"> at Stanford University. He runs the\u003c/span>\u003ca href=\"https://med.stanford.edu/genetics/tech.html\"> \u003cspan style=\"font-weight: 400\">Stanford at The Tech\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\"> program and the\u003c/span>\u003ca href=\"http://genetics.thetech.org/\"> \u003cspan style=\"font-weight: 400\">Understanding Genetics\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\"> website with\u003c/span>\u003ca href=\"https://www.thetech.org/\"> \u003cspan style=\"font-weight: 400\">The Tech Museum of Innovation\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\"> in San Jose, California. \u003c/span>\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"Slow, incremental advances in medical technologies have made gene therapy more effective and less dangerous.","status":"publish","parent":0,"modified":1491244268,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":23,"wordCount":784},"headData":{"title":"Gene Therapy May Finally Be Coming of Age | KQED","description":"Slow, incremental advances in medical technologies have made gene therapy more effective and less dangerous.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Gene Therapy May Finally Be Coming of Age","datePublished":"2017-04-03T18:32:45.000Z","dateModified":"2017-04-03T18:31:08.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"354044 https://ww2.kqed.org/futureofyou/?p=354044","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/04/03/gene-therapy-may-finally-be-coming-of-age/","disqusTitle":"Gene Therapy May Finally Be Coming of Age","source":"Your Genes","customPermalink":"2017/03/20/gene-therapy-may-finally-be-coming-of-age/","nprByline":"Barry Starr","path":"/futureofyou/354044/gene-therapy-may-finally-be-coming-of-age","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Sickle cell anemia is a genetic blood disorder characterized by episodes of severe pain, anemia and other complications. In more affluent countries, life expectancy for those who suffer from the disorder is 40-60 years.\u003c/p>\n\u003cp>Now, in a \u003ca href=\"http://www.nejm.org/doi/pdf/10.1056/NEJMoa1609677\" target=\"_blank\">new study\u003c/a> out this month in \u003cem>The New England Journal of Medicine,\u003c/em> scientists report that a teenage boy with the disorder remained symptom-free for 15 months after undergoing gene therapy.\u003c/p>\n\u003cp>\"We may be on the threshold of finally being able to cure people of genetic diseases safely using gene therapy,\" said Stanford University's Mark Kay, a researcher in the field, in response to the study. Kay cited recent successful gene therapy treatments for \u003ca href=\"https://www.technologyreview.com/s/601651/gene-therapy-is-curing-hemophilia/\" target=\"_blank\">hemophilia\u003c/a>, \u003ca href=\"http://www.bbc.com/news/science-environment-36101786\" target=\"_blank\">hereditary blindness\u003c/a> and even \u003ca href=\"http://www.upi.com/Health_News/2017/01/25/Gene-therapy-helps-2-babies-fight-type-of-leukemia/6931485378663/\" target=\"_blank\">leukemia\u003c/a>.\u003c/p>\n\u003cp>Gene therapy is a simple concept — basically scientists add a working gene to a cell with only broken ones. The working gene then makes up for the broken copies of that gene and cures the genetic disease.\u003c/p>\n\u003caside class=\"pullquote alignright\">'We may be on the threshold of finally being able to cure people of genetic diseases safely using gene therapy.'\u003c/aside>\n\u003cp>But getting the right gene safely to the right spot, in enough cells for a long enough time, turns out to be a tall order. Such a tall order that gene therapy is only now coming into its own as a somewhat reliable way to treat genetic disease.\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 turnaround is not due to some leap of understanding, but because of slow, incremental improvements in every aspect of the process. Scientists are better at getting more cells to take up the therapeutic gene in a much safer way.\u003c/p>\n\u003cp>\u003cstrong>Safer Delivery\u003c/strong>\u003c/p>\n\u003cp>One of the biggest changes in gene therapy occurred in the 2000s, when scientists discovered how to better deliver to the patient functioning genes.\u003c/p>\n\u003cp>Most gene therapies take advantage of viruses, which are very skilled at inserting themselves into a cell’s DNA, where they would usually wreak havoc.\u003c/p>\n\u003cfigure id=\"attachment_357653\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-357653 size-medium\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-800x602.jpg\" width=\"800\" height=\"602\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-800x602.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-160x120.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-768x578.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-1020x768.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-1180x888.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-960x722.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-240x181.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-375x282.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia-520x391.jpg 520w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/Risk-Factors-for-Sickle-Cell-Anemia.jpg 1600w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">The sickled red blood cells cause the symptoms of sickle cell anemia. Adding an engineered beta globin gene to bone marrow cells results in many fewer of the sickled cells. (Wikimedia)\u003c/figcaption>\u003c/figure>\n\u003cp>But with gene therapy, scientists strip out the parts of the virus that make it dangerous. It's this engineered virus they use to deliver the working genes.\u003c/p>\n\u003cp>In early gene therapy research, scientists used retroviruses \u003cb>,\u003c/b> which are easy to\u003cb> \u003c/b>work with and are very good at getting genes into a cell’s DNA.\u003c/p>\n\u003cp>Unfortunately, many of them tend to insert themselves into places in our DNA that switch on genes that can cause cancer; that \u003ca href=\"http://angt.austrianova.com/angt/Brevia.pdf\">happened in a study\u003c/a> back in 2002. Since then, scientists have worked hard to find retroviruses that wouldn’t cause this problem.\u003c/p>\n\u003cp>\u003cstrong>Other Important Tweaks\u003c/strong>\u003c/p>\n\u003cp>But a good delivery vehicle isn’t enough to treat sickle cell anemia. Scientists also need to replace the mutated genetic material that’s causing the illness with a working gene powerful enough to keep the disease at bay. In a 2004 study, scientists \u003ca href=\"http://www.jbc.org/content/279/26/27518.full\" target=\"_blank\">engineered a gene\u003c/a> that seems to do the job for sickle cell anemia.\u003c/p>\n\u003cp>In the case of the boy reported earlier this month, researchers removed his bone marrow cells, used a virus to insert a working gene into them, then returned the engineered bone marrow cells back to the patient. Bone marrow cells are where all new blood cells are made.\u003c/p>\n\u003cp>Another key improvement was to treat the patient with a drug, busulfan. This allowed for more of the engineered cells to take root in the patient’s bone marrow, meaning more of his red blood cells returned to normal.\u003c/p>\n\u003cp>“All of these changes and more have led to a successful outcome,” says Stanford genetic researcher Dr. Michele Calos, speaking of the new study. “This successful study is the culmination of more than 30 years of work by many people.”\u003c/p>\n\u003cp>We may be on the threshold of finally being able to cure people of genetic diseases safely using gene therapy. Or then again, we might not.\u003c/p>\n\u003cp>Over the years, scientists have been heralding the coming gene therapy age again and again. Each time there was a setback that held the field back.\u003c/p>\n\u003cp>Gene therapy is still a very expensive and time-consuming procedure, but if it can be streamlined, it holds promise for the millions of people worldwide struggling with sickle cell anemia, cystic fibrosis and other genetic diseases.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">Dr. Barry Starr is a scientist in the\u003c/span>\u003ca href=\"https://med.stanford.edu/genetics.html\"> \u003cspan style=\"font-weight: 400\">Department of Genetics\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\"> at Stanford University. He runs the\u003c/span>\u003ca href=\"https://med.stanford.edu/genetics/tech.html\"> \u003cspan style=\"font-weight: 400\">Stanford at The Tech\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\"> program and the\u003c/span>\u003ca href=\"http://genetics.thetech.org/\"> \u003cspan style=\"font-weight: 400\">Understanding Genetics\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\"> website with\u003c/span>\u003ca href=\"https://www.thetech.org/\"> \u003cspan style=\"font-weight: 400\">The Tech Museum of Innovation\u003c/span>\u003c/a>\u003cspan style=\"font-weight: 400\"> in San Jose, California. \u003c/span>\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/354044/gene-therapy-may-finally-be-coming-of-age","authors":["byline_futureofyou_354044"],"categories":["futureofyou_1064"],"tags":["futureofyou_1209","futureofyou_1210","futureofyou_1211"],"featImg":"futureofyou_357651","label":"source_futureofyou_354044"}},"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? 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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. 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You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg","imageAlt":"KQED MindShift: How We Will Learn","officialWebsiteLink":"/mindshift/","meta":{"site":"news","source":"kqed","order":"2"},"link":"/podcasts/mindshift","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/mindshift-podcast/id1078765985","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5","npr":"https://www.npr.org/podcasts/464615685/mind-shift-podcast","stitcher":"https://www.stitcher.com/podcast/kqed/stories-teachers-share","spotify":"https://open.spotify.com/show/0MxSpNYZKNprFLCl7eEtyx"}},"morning-edition":{"id":"morning-edition","title":"Morning Edition","info":"\u003cem>Morning Edition\u003c/em> takes listeners around the country and the world with multi-faceted stories and commentaries every weekday. 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