As Human Gene-Editing Advances, Doudna Says Ethical Discussions Can't Wait
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A science degree is not required, but a sense of urgency is.\u003c/p>\n\u003cp>This was the primary takeaway from Jennifer Doudna's recent public remarks at\u003ca href=\"http://crisprcon.org/\" target=\"_blank\" rel=\"noopener noreferrer\"> CRISPRcon\u003c/a>, a two day event at UC Berkeley, intended to get nonspecialists talking about the promise and potential peril of the fast-moving biotech landscape.\u003c/p>\n\u003cp>\"Decisions about gene editing have an impact on all of us,\" said Michael Krasney, host of KQED's \"Forum\" radio program and the CRISPRcon emcee. \"That's why there are no outsiders in discussing this topic.\" (For a primer on how CRISPR gene editing works, check out our story \"\u003ca href=\"https://ww2.kqed.org/futureofyou/2015/12/30/a-crispr-solution-to-bubble-boy-disease/\" target=\"_blank\" rel=\"noopener noreferrer\">CRISPR: What You Need to Know About the Medical Science ‘Breakthrough of the Year\u003c/a>.\")\u003c/p>\n\u003caside class=\"pullquote alignright\">\"We can no longer say, well there's a lot of technology development to be done before we have to worry about that application, it's now a question of 'We know this can work, are we willing to go there or not?'\" \u003ccite>Jennifer Doudna, one of the inventors of CRISPR/Cas9 gene-editing technology\u003c/cite>\u003c/aside>\n\u003cp>The National Academies of Sciences, Engineering and Medicine wants public input, as well. The rationale is, if it affects the public, the public should have a say.\u003c/p>\n\u003cp>\u003cstrong>What's at Stake\u003c/strong>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>In her new book, \"\u003ca href=\"http://www.acrackincreation.com/\" target=\"_blank\" rel=\"noopener noreferrer\">A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution\u003c/a>,\" Doudna (who co-authored the book with former student Samuel Sternberg) writes humans are \"on the cusp of a new age in genetic engineering and biological mastery.\"\u003c/p>\n\u003cp>\"It won’t be long before CRISPR allows us to bend nature to our will.”\u003c/p>\n\u003cp>CRISPR applications could bring us \u003ca href=\"https://www.sciencedaily.com/releases/2017/05/170518140335.htm\" target=\"_blank\" rel=\"noopener noreferrer\">higher tomato yields\u003c/a> or cattle \u003ca href=\"https://geneticliteracyproject.org/2016/05/11/gene-edited-hornless-cow-improve-animal-welfare-regulatory-fate-unclear/\" target=\"_blank\" rel=\"noopener noreferrer\">born without horns\u003c/a> (allowing livestock to avoid the potentially painful procedure of having them removed). Ongoing medical research using CRISPR includes \u003ca href=\"https://www.nature.com/news/first-crispr-clinical-trial-gets-green-light-from-us-panel-1.20137\" target=\"_blank\" rel=\"noopener noreferrer\">gene editing to target immune response\u003c/a> in cancer patients and to \u003ca href=\"https://www.nature.com/news/crispr-deployed-to-combat-sickle-cell-anaemia-1.20782\" target=\"_blank\" rel=\"noopener noreferrer\">correct sickle-cell anemia\u003c/a>, a painful blood disorder.\u003c/p>\n\u003cp>But the $10 million question at CRISPRcon loomed large:\u003c/p>\n\u003cp>\"How do you decide which genes are appropriate for germline editing?\" asked a woman in the audience, during a question and answer session with Doudna. Germline editing means that the changes made affect sperm or egg cells, and therefore can be inherited.\u003c/p>\n\u003cp>[contextly_sidebar id=\"HfCYio1aAJwJdg2Ip7LwMBF1sWeN5NFY\"]\"That's a question that could be debated and discussed for the entire time of the conference,\" said Doudna. But her short answer, referencing a \u003ca href=\"http://www.nationalacademies.org/gene-editing/consensus-study/index.htm\" target=\"_blank\" rel=\"noopener noreferrer\">recent report with recommendations\u003c/a> from the National Academies, was, \"We look for situations where there would be no other reasonable way to deal with a genetic disease other than gene editing. And when you think about it that way, those situations are rather rare.\"\u003c/p>\n\u003cp>Preimplantation genetic diagnosis (for parents using in vitro fertilization) and genetic counseling can offer routes to avoid serious genetic mutations without gene editing. This latter technique would, however, require parents to decide if they are willing to terminate a pregnancy.\u003c/p>\n\u003cp>Doudna believes that in most cases genetic counseling and preimplantation genetic diagnosis are sufficient to deal with disorders caused by a single gene. But some couples might not have any other option to conceive a healthy embryo outside of editing their genes. For example, if both parents both have the same disease-causing gene, \"That's an issue where gene editing could be relevant in the future.\"\u003c/p>\n\u003cp>For any parents who want to select for green-eyed, athletic geniuses, their best bet is still a random roll of the dice, not gene-editing, if the National Academies has anything to do with it. \"Do not proceed at this time with human genome editing for purposes other than treatment or prevention of disease and disability,\" the study recommends.\u003c/p>\n\u003cp>But the question of whether embryos should be edited to avoid disease and disability has reached new urgency, says Doudna, with the publication several weeks ago of the first \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/07/27/scientists-in-us-edit-human-embryos-with-crispr-for-first-time-reports-suggest/\" target=\"_blank\" rel=\"noopener noreferrer\">paper\u003c/a> that lays out a good protocol (a written procedure) for targeting a gene linked to disease. It has the potential of being useful in clinical applications.\u003c/p>\n\u003cp>\"What they showed, importantly,\" said Doudna, \"was that there was very few off-target effects [unintended changes] and also they could avoid something called 'mosaicism'. \" That arises when the desired edit occurs in only some of the cells in the developing embryo. Both edited and non-editing cells replicate, resulting in an organism with a genetic patchwork, which may or may not be harmful.\u003c/p>\n\u003cp>\"We now understand that, when applied in certain ways this technology can be very robust, in viable human embryos. We can no longer say, 'Well, there's a lot of technology development to be done before we have to worry about that application.' It's now a question of, 'We know this can work, are we willing to go there or not?' \"\u003c/p>\n\u003cp>Since CRISPRcon, the paper in question has come in for some \u003ca href=\"https://ipscell.com/2017/08/doubts-raised-on-key-points-of-nature-paper-on-crispr-gene-editing-of-human-embryos/\" target=\"_blank\" rel=\"noopener noreferrer\">recent criticism from scientists\u003c/a> not involved in the research. They call into question the main conclusions of the paper and say more definitive studies are needed. That said, most scientists believe precise editing in embryos will be possible someday, and likely someday soon.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>For members of the public eager to be part of the debate, events like CRISPRcon provide a rare forum with scientists like Doudna who have \u003ca href=\"https://ipscell.com/2015/06/doudnacongress/\" target=\"_blank\" rel=\"noopener noreferrer\">testified before Congress\u003c/a> regarding the science and ethics of gene editing. But for the average person on the street, the most direct route to voicing opinions and concerns may be \u003ca href=\"http://www.nationalacademies.org/gene-editing/consensus-study/index.htm\" target=\"_blank\" rel=\"noopener noreferrer\">submitting comments\u003c/a> on the homepage of the National Academies' Human Gene-Editing Initiative. Of course, there is also the tried and true method of \u003ca href=\"https://callyourrep.co/\" target=\"_blank\" rel=\"noopener noreferrer\">calling your representatives\u003c/a>.\u003c/p>\n\n","blocks":[],"excerpt":"Will debating the ethics of gene editing lead to more agreement? Some scientists and policy makers are hoping so. \r\n","status":"publish","parent":0,"modified":1504203620,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":21,"wordCount":959},"headData":{"title":"As Human Gene-Editing Advances, Doudna Says Ethical Discussions Can't Wait | KQED","description":"Will debating the ethics of gene editing lead to more agreement? Some scientists and policy makers are hoping so. \r\n","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"As Human Gene-Editing Advances, Doudna Says Ethical Discussions Can't Wait","datePublished":"2017-08-31T16:30:17.000Z","dateModified":"2017-08-31T18:20:20.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"435096 https://ww2.kqed.org/futureofyou/?p=435096","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/08/31/as-human-gene-editing-advances-doudna-says-ethical-discussions-cant-wait/","disqusTitle":"As Human Gene-Editing Advances, Doudna Says Ethical Discussions Can't Wait","source":"Future of You","path":"/futureofyou/435096/as-human-gene-editing-advances-doudna-says-ethical-discussions-cant-wait","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>If you want to have a role in shaping the near and coming future of biotechnology, the time is now. A science degree is not required, but a sense of urgency is.\u003c/p>\n\u003cp>This was the primary takeaway from Jennifer Doudna's recent public remarks at\u003ca href=\"http://crisprcon.org/\" target=\"_blank\" rel=\"noopener noreferrer\"> CRISPRcon\u003c/a>, a two day event at UC Berkeley, intended to get nonspecialists talking about the promise and potential peril of the fast-moving biotech landscape.\u003c/p>\n\u003cp>\"Decisions about gene editing have an impact on all of us,\" said Michael Krasney, host of KQED's \"Forum\" radio program and the CRISPRcon emcee. \"That's why there are no outsiders in discussing this topic.\" (For a primer on how CRISPR gene editing works, check out our story \"\u003ca href=\"https://ww2.kqed.org/futureofyou/2015/12/30/a-crispr-solution-to-bubble-boy-disease/\" target=\"_blank\" rel=\"noopener noreferrer\">CRISPR: What You Need to Know About the Medical Science ‘Breakthrough of the Year\u003c/a>.\")\u003c/p>\n\u003caside class=\"pullquote alignright\">\"We can no longer say, well there's a lot of technology development to be done before we have to worry about that application, it's now a question of 'We know this can work, are we willing to go there or not?'\" \u003ccite>Jennifer Doudna, one of the inventors of CRISPR/Cas9 gene-editing technology\u003c/cite>\u003c/aside>\n\u003cp>The National Academies of Sciences, Engineering and Medicine wants public input, as well. The rationale is, if it affects the public, the public should have a say.\u003c/p>\n\u003cp>\u003cstrong>What's at Stake\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In her new book, \"\u003ca href=\"http://www.acrackincreation.com/\" target=\"_blank\" rel=\"noopener noreferrer\">A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution\u003c/a>,\" Doudna (who co-authored the book with former student Samuel Sternberg) writes humans are \"on the cusp of a new age in genetic engineering and biological mastery.\"\u003c/p>\n\u003cp>\"It won’t be long before CRISPR allows us to bend nature to our will.”\u003c/p>\n\u003cp>CRISPR applications could bring us \u003ca href=\"https://www.sciencedaily.com/releases/2017/05/170518140335.htm\" target=\"_blank\" rel=\"noopener noreferrer\">higher tomato yields\u003c/a> or cattle \u003ca href=\"https://geneticliteracyproject.org/2016/05/11/gene-edited-hornless-cow-improve-animal-welfare-regulatory-fate-unclear/\" target=\"_blank\" rel=\"noopener noreferrer\">born without horns\u003c/a> (allowing livestock to avoid the potentially painful procedure of having them removed). Ongoing medical research using CRISPR includes \u003ca href=\"https://www.nature.com/news/first-crispr-clinical-trial-gets-green-light-from-us-panel-1.20137\" target=\"_blank\" rel=\"noopener noreferrer\">gene editing to target immune response\u003c/a> in cancer patients and to \u003ca href=\"https://www.nature.com/news/crispr-deployed-to-combat-sickle-cell-anaemia-1.20782\" target=\"_blank\" rel=\"noopener noreferrer\">correct sickle-cell anemia\u003c/a>, a painful blood disorder.\u003c/p>\n\u003cp>But the $10 million question at CRISPRcon loomed large:\u003c/p>\n\u003cp>\"How do you decide which genes are appropriate for germline editing?\" asked a woman in the audience, during a question and answer session with Doudna. Germline editing means that the changes made affect sperm or egg cells, and therefore can be inherited.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>\"That's a question that could be debated and discussed for the entire time of the conference,\" said Doudna. But her short answer, referencing a \u003ca href=\"http://www.nationalacademies.org/gene-editing/consensus-study/index.htm\" target=\"_blank\" rel=\"noopener noreferrer\">recent report with recommendations\u003c/a> from the National Academies, was, \"We look for situations where there would be no other reasonable way to deal with a genetic disease other than gene editing. And when you think about it that way, those situations are rather rare.\"\u003c/p>\n\u003cp>Preimplantation genetic diagnosis (for parents using in vitro fertilization) and genetic counseling can offer routes to avoid serious genetic mutations without gene editing. This latter technique would, however, require parents to decide if they are willing to terminate a pregnancy.\u003c/p>\n\u003cp>Doudna believes that in most cases genetic counseling and preimplantation genetic diagnosis are sufficient to deal with disorders caused by a single gene. But some couples might not have any other option to conceive a healthy embryo outside of editing their genes. For example, if both parents both have the same disease-causing gene, \"That's an issue where gene editing could be relevant in the future.\"\u003c/p>\n\u003cp>For any parents who want to select for green-eyed, athletic geniuses, their best bet is still a random roll of the dice, not gene-editing, if the National Academies has anything to do with it. \"Do not proceed at this time with human genome editing for purposes other than treatment or prevention of disease and disability,\" the study recommends.\u003c/p>\n\u003cp>But the question of whether embryos should be edited to avoid disease and disability has reached new urgency, says Doudna, with the publication several weeks ago of the first \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/07/27/scientists-in-us-edit-human-embryos-with-crispr-for-first-time-reports-suggest/\" target=\"_blank\" rel=\"noopener noreferrer\">paper\u003c/a> that lays out a good protocol (a written procedure) for targeting a gene linked to disease. It has the potential of being useful in clinical applications.\u003c/p>\n\u003cp>\"What they showed, importantly,\" said Doudna, \"was that there was very few off-target effects [unintended changes] and also they could avoid something called 'mosaicism'. \" That arises when the desired edit occurs in only some of the cells in the developing embryo. Both edited and non-editing cells replicate, resulting in an organism with a genetic patchwork, which may or may not be harmful.\u003c/p>\n\u003cp>\"We now understand that, when applied in certain ways this technology can be very robust, in viable human embryos. We can no longer say, 'Well, there's a lot of technology development to be done before we have to worry about that application.' It's now a question of, 'We know this can work, are we willing to go there or not?' \"\u003c/p>\n\u003cp>Since CRISPRcon, the paper in question has come in for some \u003ca href=\"https://ipscell.com/2017/08/doubts-raised-on-key-points-of-nature-paper-on-crispr-gene-editing-of-human-embryos/\" target=\"_blank\" rel=\"noopener noreferrer\">recent criticism from scientists\u003c/a> not involved in the research. They call into question the main conclusions of the paper and say more definitive studies are needed. That said, most scientists believe precise editing in embryos will be possible someday, and likely someday soon.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>For members of the public eager to be part of the debate, events like CRISPRcon provide a rare forum with scientists like Doudna who have \u003ca href=\"https://ipscell.com/2015/06/doudnacongress/\" target=\"_blank\" rel=\"noopener noreferrer\">testified before Congress\u003c/a> regarding the science and ethics of gene editing. But for the average person on the street, the most direct route to voicing opinions and concerns may be \u003ca href=\"http://www.nationalacademies.org/gene-editing/consensus-study/index.htm\" target=\"_blank\" rel=\"noopener noreferrer\">submitting comments\u003c/a> on the homepage of the National Academies' Human Gene-Editing Initiative. Of course, there is also the tried and true method of \u003ca href=\"https://callyourrep.co/\" target=\"_blank\" rel=\"noopener noreferrer\">calling your representatives\u003c/a>.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/435096/as-human-gene-editing-advances-doudna-says-ethical-discussions-cant-wait","authors":["11088"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1308","futureofyou_94","futureofyou_1275","futureofyou_295","futureofyou_953"],"featImg":"futureofyou_435099","label":"source_futureofyou_435096"},"futureofyou_180495":{"type":"posts","id":"futureofyou_180495","meta":{"index":"posts_1591205157","site":"futureofyou","id":"180495","score":null,"sort":[1480435233000]},"guestAuthors":[],"slug":"clinical-trials-on-trial-the-ethics-of-withholding-life-saving-treatment","title":"The Ethics of Withholding Life-Saving Treatment","publishDate":1480435233,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>\u003cem>From the authors of \"\u003ca href=\"http://us.macmillan.com/algorithmstoliveby/brianchristian\" target=\"_blank\">ALGORITHMS TO LIVE BY: The Computer Science of Human Decisions\u003c/a>,\" published by Henry Hold and Co.\u003c/em>\u003c/p>\n\u003cp>Every day we make a series of choices that are all really the same choice underneath: between our \u003cem>favorite\u003c/em> things and \u003cem>new\u003c/em> ones. Do we go to the restaurant we adore, or the place down the road that just opened up? Get our “usual,” or try the special? Invite our best friend, or reach out to a new acquaintance we’d like to get to know better? We intuitively understand that life is a balance between novelty and familiarity, between the latest and the greatest, between taking chances and savoring what we know and love. But the unanswered question is: What is that balance?\u003c/p>\n\u003caside class=\"pullquote alignright\">The cost of knowledge: Twenty-four more infants died in a group receiving conventional treatment than in a group receiving the treatment being tested.\u003c/aside>\n\u003cp>It’s a question with higher stakes than we might realize. And it has a more explicit answer, from a field we don’t often turn to in moments of human indecision, though perhaps we should: computer science. Indeed, computer scientists have been working on finding this balance for more than 50 years. They even have a name for it: the “explore/exploit” tradeoff.\u003c/p>\n\u003cp>Today, algorithms derived from studying the explore/exploit tradeoff power a sizable fraction of the Internet economy, including the advertising business responsible for almost all of Google’s revenue -- they determine when to display the ad that has performed the best so far and when to experiment with potentially superior alternatives. Algorithms have also become essential to political campaigning, an indispensable part of honing messaging and donation appeals.\u003c/p>\n\u003cp>The single most important application of explore/exploit algorithms, however, is a domain where human lives are directly on the line. That domain is clinical trials, and a growing community of doctors, statisticians, and computer scientists think we’re doing them wrong.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>In English, the words “explore” and “exploit” come loaded with opposite connotations. But to a computer scientist, these words have much more specific and neutral meanings. Simply put, exploration is \u003cem>gathering\u003c/em> information, and exploitation is \u003cem>using\u003c/em> the information you have to get a known good result. It’s fairly intuitive that never exploring is no way to live. But computer science shows that failing to exploit can be every bit as bad.\u003c/p>\n\u003cfigure id=\"attachment_180526\" class=\"wp-caption aligncenter\" style=\"max-width: 2592px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program.jpg\">\u003cimg class=\"size-full wp-image-180526\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program.jpg\" alt=\"Respiratory therapist Michelle Sirra takes a blood sample from 3-day-old Stuart Parker in preparation for transfer to an Extracorporeal Membrane Oxygenation unit on Friday, July 21, in San Juan, Puerto Rico. An ECMO team comprised Air Force and Army medical specialists from the Wilford Hall Medical Center at Lackland Air Force Base, Texas, flew to Puerto Rico to transport Stuart to San Antonio for more advanced care. \" width=\"2592\" height=\"1944\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program.jpg 2592w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-960x720.jpg 960w\" sizes=\"(max-width: 2592px) 100vw, 2592px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Respiratory therapist Michelle Sirra takes a blood sample from 3-day-old Stuart Parker in preparation for transfer to an Extracorporeal Membrane Oxygenation unit on Friday, July 21, in San Juan, Puerto Rico. An ECMO team comprised Air Force and Army medical specialists from the Wilford Hall Medical Center at Lackland Air Force Base, Texas, flew to Puerto Rico to transport Stuart to San Antonio for more advanced care. \u003ccite>(Staff Sgt. Matthew Rosine)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>One of the fundamental maxims in medical ethics is the oath to “first, do no harm.” But this is not always as straightforward as it sounds. In clinical trials, doctors and scientists encounter directly the tension between acting on one’s best knowledge and gathering more. Do you give someone the best known conventional treatment, even if it’s not very good? Or do you give them an experimental treatment that \u003cem>might \u003c/em>be significantly better—but might also be worse? Computer science is no substitute for ethics, but perhaps it can offer a degree of precision that ethics alone cannot.\u003c/p>\n\u003cp>The question that has arisen over the last several decades is whether the standard approach to conducting clinical trials really does minimize risk to patients. In a conventional clinical trial, patients are split into equal groups, and each group is assigned to receive a different treatment for the duration of the study. (Only in exceptional cases does a trial get stopped early.) This procedure focuses on decisively resolving the question of which treatment is better, rather than on providing the best treatment to each patient in the trial itself. Maybe this is a false choice. Doctors are gaining some information about which option is better \u003cem>while\u003c/em> the trial proceeds—information that could be used to improve outcomes not only for future patients beyond the trial, but also for the patients currently in it.\u003c/p>\n\u003cp>\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/iStock_17372419_LARGE.jpg\">\u003cimg class=\"aligncenter size-full wp-image-180561\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/iStock_17372419_LARGE.jpg\" alt=\"Juggling balls\" width=\"2715\" height=\"1810\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE.jpg 2715w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-400x267.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-800x533.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-768x512.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-1180x787.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-1920x1280.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-960x640.jpg 960w\" sizes=\"(max-width: 2715px) 100vw, 2715px\">\u003c/a>In 1969, Marvin Zelen, a biostatistician who spent most of his career at Harvard, proposed conducting “adaptive” trials, in which the chance of using a given treatment increases with each success and decreases with each failure. In his proposal, you start with a hat that contains one ball for each of the two treatment options being studied. The treatment for the first patient is selected by drawing a ball at random from the hat. (The ball is put back afterward.) If the chosen treatment is a success, you put another ball of the same kind into the hat—now you have three balls, two of which are for the successful treatment. If it fails, however, then you instead put another ball for the \u003cem>other\u003c/em> treatment into the hat, making it more likely you’ll choose the alternative.\u003c/p>\n\u003cp>Zelen’s algorithm was first used in a clinical trial 16 years later, for a study of extracorporeal membrane oxygenation, or “ECMO”—an audacious approach to treating respiratory failure in infants. Developed in the 1970s by Robert Bartlett of the University of Michigan, ECMO takes blood that’s heading for the lungs and routes it instead out of the body, where it is oxygenated by a machine and returned to the heart. It is a drastic measure, with risks of its own (including the possibility of embolism), but it offered a possible approach in situations where no other options remained. In 1975 ECMO saved the life of a newborn girl in Orange County, California, for whom even a ventilator was not providing enough oxygen. But in its early days the ECMO technology and procedure were considered highly experimental, and early studies in adults showed no benefit compared to conventional treatments.\u003c/p>\n\u003cp>From 1982 to 1984, Bartlett and his colleagues at the University of Michigan performed a study on newborns with respiratory failure. The team was clear that they wanted to address, as they put it, “the ethical issue of withholding an unproven but potentially lifesaving treatment,” and were “reluctant to withhold a lifesaving treatment from alternate patients simply to meet conventional random assignment technique.” Hence they turned to Zelen’s algorithm. The strategy resulted in one infant being assigned the “conventional” treatment and dying, and 11 infants in a row being assigned the experimental ECMO treatment, all of them surviving. Between April and November of 1984, after the end of the official study, 10 additional infants met the criteria for ECMO treatment. Eight were treated with ECMO, and all eight survived. Two were treated conventionally, and both died.\u003c/p>\n\u003cp>These are eye-catching numbers, yet shortly after the University of Michigan study on ECMO was completed, it became mired in controversy. Having so few patients in a trial receive the conventional treatment deviated significantly from standard methodology, and the procedure itself was highly invasive and potentially risky. After the publication of the paper, Jim Ware, professor of biostatistics at the Harvard School of Public Health, and his medical colleagues examined the data carefully and concluded that they “did not justify routine use of ECMO without further study.” So Ware and his colleagues designed a second clinical trial, still trying to balance the acquisition of knowledge with the effective treatment of patients but using a less radical design. They would randomly assign patients to either ECMO or the conventional treatment until a pre-specified number of deaths was observed in one of the groups. Then they would switch all the patients in the study to the more effective treatment of the two.\u003c/p>\n\u003cp>In the first phase of Ware’s study, four of 10 infants receiving conventional treatment died, and all of the nine infants receiving ECMO survived. The four deaths were enough to trigger a transition to the second phase, where all 20 patients were treated with ECMO and 19 survived. Ware and colleagues were convinced, concluding that “it is difficult to defend further randomization ethically.”\u003c/p>\n\u003cp>[contextly_sidebar id=\"4oUXD2ItgXLntfzkJ3EfFLruRYG726oT\"]But some had already concluded this \u003cem>before\u003c/em> the Ware study, and were vocal about it. The critics included Don Berry, one of the world’s leading experts on the explore/exploit tradeoff. In a comment that was published alongside the Ware study, Berry wrote that “randomizing patients to non-ECMO therapy as in the Ware study was unethical. . . . In my view, the Ware study should not have been conducted.”\u003c/p>\n\u003cp>And yet even the Ware study was not conclusive for all in the medical community. In the 1990s yet another study on ECMO was conducted, enrolling nearly 200 infants in the United Kingdom. Instead of using adaptive algorithms, this study followed the traditional methods, splitting the infants randomly into two equal groups. The researchers justified the experiment by saying that ECMO’s usefulness “is controversial because of varying interpretation of the available evidence.” As it turned out, the difference between the treatments wasn’t as pronounced in the United Kingdom as it had been in the two American studies, but the results were nonetheless declared “in accord with the earlier preliminary findings that a policy of ECMO support reduces the risk of death.” The cost of that knowledge? Twenty-four more infants died in the “conventional” group than in the group receiving ECMO treatment.\u003c/p>\n\u003cp>Zelen’s algorithm offers one simple way to navigate the explore/exploit tradeoff, and in the decades since it was first proposed, computer scientists have developed a host of even more refined strategies for how best to gain new information while leveraging what’s been gained so far. These approaches are finally beginning to gain acceptance within the medical mainstream\u003cstrong>.\u003c/strong> Don Berry, for example, has joined the MD Anderson Cancer Center in Houston, where he uses methods developed by studying the explore/exploit tradeoff to design clinical trials for a variety of cancer treatments. And in 2010 and 2015, the FDA released a pair of draft “guidance” documents on “Adaptive Design Clinical Trials” for drugs and medical devices, which suggests that—despite a long history of sticking to an option they trust—they might at last be willing to explore alternatives.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>We don’t think of a doctor choosing which treatment to give a patient as being in the same position as Google’s servers deciding which ad to show next. And we don’t think of Google’s ad servers when we waver over whether to get our favorite dish yet again or branch out. But computer science shows us that these are, in a fundamental and real way, the same problem. In so doing, it offers a profound glimpse into the structure of human decision-making. And a guide for us, in the times when it matters most.\u003c/p>\n\n","blocks":[],"excerpt":"The authors of 'Algorithms to Live By' say the conventional way clinical trials are conducted do not always live up to the medical maxim 'First, do no harm.'","status":"publish","parent":0,"modified":1514569063,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":19,"wordCount":1888},"headData":{"title":"The Ethics of Withholding Life-Saving Treatment | KQED","description":"The authors of 'Algorithms to Live By' say the conventional way clinical trials are conducted do not always live up to the medical maxim 'First, do no harm.'","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"The Ethics of Withholding Life-Saving Treatment","datePublished":"2016-11-29T16:00:33.000Z","dateModified":"2017-12-29T17:37:43.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"180495 http://ww2.kqed.org/futureofyou/?p=180495","disqusUrl":"https://ww2.kqed.org/futureofyou/2016/11/29/clinical-trials-on-trial-the-ethics-of-withholding-life-saving-treatment/","disqusTitle":"The Ethics of Withholding Life-Saving Treatment","source":"Big Ideas","customPermalink":"2016/06/10/clinical-trials-on-trial-the-ethics-of-withholding-life-saving-treatment/","nprByline":"Brian Christian and Tom Griffiths","path":"/futureofyou/180495/clinical-trials-on-trial-the-ethics-of-withholding-life-saving-treatment","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cem>From the authors of \"\u003ca href=\"http://us.macmillan.com/algorithmstoliveby/brianchristian\" target=\"_blank\">ALGORITHMS TO LIVE BY: The Computer Science of Human Decisions\u003c/a>,\" published by Henry Hold and Co.\u003c/em>\u003c/p>\n\u003cp>Every day we make a series of choices that are all really the same choice underneath: between our \u003cem>favorite\u003c/em> things and \u003cem>new\u003c/em> ones. Do we go to the restaurant we adore, or the place down the road that just opened up? Get our “usual,” or try the special? Invite our best friend, or reach out to a new acquaintance we’d like to get to know better? We intuitively understand that life is a balance between novelty and familiarity, between the latest and the greatest, between taking chances and savoring what we know and love. But the unanswered question is: What is that balance?\u003c/p>\n\u003caside class=\"pullquote alignright\">The cost of knowledge: Twenty-four more infants died in a group receiving conventional treatment than in a group receiving the treatment being tested.\u003c/aside>\n\u003cp>It’s a question with higher stakes than we might realize. And it has a more explicit answer, from a field we don’t often turn to in moments of human indecision, though perhaps we should: computer science. Indeed, computer scientists have been working on finding this balance for more than 50 years. They even have a name for it: the “explore/exploit” tradeoff.\u003c/p>\n\u003cp>Today, algorithms derived from studying the explore/exploit tradeoff power a sizable fraction of the Internet economy, including the advertising business responsible for almost all of Google’s revenue -- they determine when to display the ad that has performed the best so far and when to experiment with potentially superior alternatives. Algorithms have also become essential to political campaigning, an indispensable part of honing messaging and donation appeals.\u003c/p>\n\u003cp>The single most important application of explore/exploit algorithms, however, is a domain where human lives are directly on the line. That domain is clinical trials, and a growing community of doctors, statisticians, and computer scientists think we’re doing them wrong.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In English, the words “explore” and “exploit” come loaded with opposite connotations. But to a computer scientist, these words have much more specific and neutral meanings. Simply put, exploration is \u003cem>gathering\u003c/em> information, and exploitation is \u003cem>using\u003c/em> the information you have to get a known good result. It’s fairly intuitive that never exploring is no way to live. But computer science shows that failing to exploit can be every bit as bad.\u003c/p>\n\u003cfigure id=\"attachment_180526\" class=\"wp-caption aligncenter\" style=\"max-width: 2592px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program.jpg\">\u003cimg class=\"size-full wp-image-180526\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program.jpg\" alt=\"Respiratory therapist Michelle Sirra takes a blood sample from 3-day-old Stuart Parker in preparation for transfer to an Extracorporeal Membrane Oxygenation unit on Friday, July 21, in San Juan, Puerto Rico. An ECMO team comprised Air Force and Army medical specialists from the Wilford Hall Medical Center at Lackland Air Force Base, Texas, flew to Puerto Rico to transport Stuart to San Antonio for more advanced care. \" width=\"2592\" height=\"1944\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program.jpg 2592w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/A_Resperatory_Therapist_treating_a_newborn_child_Pulaski_County_Technical_College_Respiratory_Therapist_Program-960x720.jpg 960w\" sizes=\"(max-width: 2592px) 100vw, 2592px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Respiratory therapist Michelle Sirra takes a blood sample from 3-day-old Stuart Parker in preparation for transfer to an Extracorporeal Membrane Oxygenation unit on Friday, July 21, in San Juan, Puerto Rico. An ECMO team comprised Air Force and Army medical specialists from the Wilford Hall Medical Center at Lackland Air Force Base, Texas, flew to Puerto Rico to transport Stuart to San Antonio for more advanced care. \u003ccite>(Staff Sgt. Matthew Rosine)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>One of the fundamental maxims in medical ethics is the oath to “first, do no harm.” But this is not always as straightforward as it sounds. In clinical trials, doctors and scientists encounter directly the tension between acting on one’s best knowledge and gathering more. Do you give someone the best known conventional treatment, even if it’s not very good? Or do you give them an experimental treatment that \u003cem>might \u003c/em>be significantly better—but might also be worse? Computer science is no substitute for ethics, but perhaps it can offer a degree of precision that ethics alone cannot.\u003c/p>\n\u003cp>The question that has arisen over the last several decades is whether the standard approach to conducting clinical trials really does minimize risk to patients. In a conventional clinical trial, patients are split into equal groups, and each group is assigned to receive a different treatment for the duration of the study. (Only in exceptional cases does a trial get stopped early.) This procedure focuses on decisively resolving the question of which treatment is better, rather than on providing the best treatment to each patient in the trial itself. Maybe this is a false choice. Doctors are gaining some information about which option is better \u003cem>while\u003c/em> the trial proceeds—information that could be used to improve outcomes not only for future patients beyond the trial, but also for the patients currently in it.\u003c/p>\n\u003cp>\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/iStock_17372419_LARGE.jpg\">\u003cimg class=\"aligncenter size-full wp-image-180561\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/iStock_17372419_LARGE.jpg\" alt=\"Juggling balls\" width=\"2715\" height=\"1810\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE.jpg 2715w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-400x267.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-800x533.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-768x512.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-1180x787.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-1920x1280.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/06/iStock_17372419_LARGE-960x640.jpg 960w\" sizes=\"(max-width: 2715px) 100vw, 2715px\">\u003c/a>In 1969, Marvin Zelen, a biostatistician who spent most of his career at Harvard, proposed conducting “adaptive” trials, in which the chance of using a given treatment increases with each success and decreases with each failure. In his proposal, you start with a hat that contains one ball for each of the two treatment options being studied. The treatment for the first patient is selected by drawing a ball at random from the hat. (The ball is put back afterward.) If the chosen treatment is a success, you put another ball of the same kind into the hat—now you have three balls, two of which are for the successful treatment. If it fails, however, then you instead put another ball for the \u003cem>other\u003c/em> treatment into the hat, making it more likely you’ll choose the alternative.\u003c/p>\n\u003cp>Zelen’s algorithm was first used in a clinical trial 16 years later, for a study of extracorporeal membrane oxygenation, or “ECMO”—an audacious approach to treating respiratory failure in infants. Developed in the 1970s by Robert Bartlett of the University of Michigan, ECMO takes blood that’s heading for the lungs and routes it instead out of the body, where it is oxygenated by a machine and returned to the heart. It is a drastic measure, with risks of its own (including the possibility of embolism), but it offered a possible approach in situations where no other options remained. In 1975 ECMO saved the life of a newborn girl in Orange County, California, for whom even a ventilator was not providing enough oxygen. But in its early days the ECMO technology and procedure were considered highly experimental, and early studies in adults showed no benefit compared to conventional treatments.\u003c/p>\n\u003cp>From 1982 to 1984, Bartlett and his colleagues at the University of Michigan performed a study on newborns with respiratory failure. The team was clear that they wanted to address, as they put it, “the ethical issue of withholding an unproven but potentially lifesaving treatment,” and were “reluctant to withhold a lifesaving treatment from alternate patients simply to meet conventional random assignment technique.” Hence they turned to Zelen’s algorithm. The strategy resulted in one infant being assigned the “conventional” treatment and dying, and 11 infants in a row being assigned the experimental ECMO treatment, all of them surviving. Between April and November of 1984, after the end of the official study, 10 additional infants met the criteria for ECMO treatment. Eight were treated with ECMO, and all eight survived. Two were treated conventionally, and both died.\u003c/p>\n\u003cp>These are eye-catching numbers, yet shortly after the University of Michigan study on ECMO was completed, it became mired in controversy. Having so few patients in a trial receive the conventional treatment deviated significantly from standard methodology, and the procedure itself was highly invasive and potentially risky. After the publication of the paper, Jim Ware, professor of biostatistics at the Harvard School of Public Health, and his medical colleagues examined the data carefully and concluded that they “did not justify routine use of ECMO without further study.” So Ware and his colleagues designed a second clinical trial, still trying to balance the acquisition of knowledge with the effective treatment of patients but using a less radical design. They would randomly assign patients to either ECMO or the conventional treatment until a pre-specified number of deaths was observed in one of the groups. Then they would switch all the patients in the study to the more effective treatment of the two.\u003c/p>\n\u003cp>In the first phase of Ware’s study, four of 10 infants receiving conventional treatment died, and all of the nine infants receiving ECMO survived. The four deaths were enough to trigger a transition to the second phase, where all 20 patients were treated with ECMO and 19 survived. Ware and colleagues were convinced, concluding that “it is difficult to defend further randomization ethically.”\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>But some had already concluded this \u003cem>before\u003c/em> the Ware study, and were vocal about it. The critics included Don Berry, one of the world’s leading experts on the explore/exploit tradeoff. In a comment that was published alongside the Ware study, Berry wrote that “randomizing patients to non-ECMO therapy as in the Ware study was unethical. . . . In my view, the Ware study should not have been conducted.”\u003c/p>\n\u003cp>And yet even the Ware study was not conclusive for all in the medical community. In the 1990s yet another study on ECMO was conducted, enrolling nearly 200 infants in the United Kingdom. Instead of using adaptive algorithms, this study followed the traditional methods, splitting the infants randomly into two equal groups. The researchers justified the experiment by saying that ECMO’s usefulness “is controversial because of varying interpretation of the available evidence.” As it turned out, the difference between the treatments wasn’t as pronounced in the United Kingdom as it had been in the two American studies, but the results were nonetheless declared “in accord with the earlier preliminary findings that a policy of ECMO support reduces the risk of death.” The cost of that knowledge? Twenty-four more infants died in the “conventional” group than in the group receiving ECMO treatment.\u003c/p>\n\u003cp>Zelen’s algorithm offers one simple way to navigate the explore/exploit tradeoff, and in the decades since it was first proposed, computer scientists have developed a host of even more refined strategies for how best to gain new information while leveraging what’s been gained so far. These approaches are finally beginning to gain acceptance within the medical mainstream\u003cstrong>.\u003c/strong> Don Berry, for example, has joined the MD Anderson Cancer Center in Houston, where he uses methods developed by studying the explore/exploit tradeoff to design clinical trials for a variety of cancer treatments. And in 2010 and 2015, the FDA released a pair of draft “guidance” documents on “Adaptive Design Clinical Trials” for drugs and medical devices, which suggests that—despite a long history of sticking to an option they trust—they might at last be willing to explore alternatives.\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>We don’t think of a doctor choosing which treatment to give a patient as being in the same position as Google’s servers deciding which ad to show next. And we don’t think of Google’s ad servers when we waver over whether to get our favorite dish yet again or branch out. But computer science shows us that these are, in a fundamental and real way, the same problem. In so doing, it offers a profound glimpse into the structure of human decision-making. And a guide for us, in the times when it matters most.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/180495/clinical-trials-on-trial-the-ethics-of-withholding-life-saving-treatment","authors":["byline_futureofyou_180495"],"categories":["futureofyou_452","futureofyou_1"],"tags":["futureofyou_1439","futureofyou_717","futureofyou_954","futureofyou_953"],"featImg":"futureofyou_180523","label":"source_futureofyou_180495"},"futureofyou_258577":{"type":"posts","id":"futureofyou_258577","meta":{"index":"posts_1591205157","site":"futureofyou","id":"258577","score":null,"sort":[1477117824000]},"guestAuthors":[],"slug":"what-stem-cell-researchers-talk-about-when-they-talk-about-ethics","title":"What Stem Cell Researchers Talk About When They Talk About Ethics","publishDate":1477117824,"format":"standard","headTitle":"Future of You | KQED Future of You | KQED Science","labelTerm":{"term":54,"site":"futureofyou"},"content":"\u003cp class=\"p1\">This year marks an anniversary that in all probability flew under your radar: The iPSC is 10-years-old.\u003c/p>\n\u003cp class=\"p1\">Great! you say. What's that, some sort of mobile fantasy sports league?\u003c/p>\n\u003cp class=\"p1\">Nooo. Would you guess \u003cem>induced pluripotent stem cells? \u003c/em>They're the product of a revolution in stem cell research that helped stem the controversy that was roiling the entire field.\u003c/p>\n\u003caside class=\"pullquote alignright\">'You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’'\u003ccite>Hank Greely, Stanford University\u003c/cite>\u003c/aside>\n\u003cp>Prior to the development of iPSCs, stem cells were derived primarily from eggs fertilized in clinics \u003ci>in vitro\u003c/i> that were donated for research purposes. To some, such as President George W. Bush, this was tantamount to abortion. In 2001 he \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744932/\" target=\"_blank\">banned federal funding\u003c/a> for research on newly created human embryonic stem cell lines. (President Barack Obama \u003ca href=\"http://www.nytimes.com/2009/03/10/us/politics/10stem.html?_r=0\" target=\"_blank\">lifted that ban\u003c/a> in 2009.)\u003c/p>\n\u003cp class=\"p1\">But iPSCs are normal cells, such as skin or blood cells, which have been tinkered with and reprogrammed to revert to an embryonic-like state. They are then capable of reproducing as stem cells or developing into \u003ci>other\u003c/i> types of human cells (pluripotent), such as liver, heart, pancreatic or nerve cells.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"p1\">So the ability to derive a stem cell without using human embryonic tissue changed the debate about stem cell research ethics.\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>Plenty of Issues\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">But there are still plenty of hot-button topics in the field.\u003c/p>\n\u003cp class=\"p1\">At a recent gathering in Berkeley to celebrate “\u003ca href=\"http://www.cell-symposia-ipscs.com/conference-program/\" target=\"_blank\">10 Years of iPSCs\u003c/a>,” a panel of researchers and leaders kicked off the ethics discussion with comments on how to make sure researchers get proper permissions from human subjects who sign up for clinical trials. Some members of the public might be surprised what a controversial topic “informed consent” can be.\u003c/p>\n\u003cp class=\"p1\">“Everyone wants to avoid a HeLa situation,” said \u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">Christine Mummery,\u003c/a> of the Leiden University Medical Centr\u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">e\u003c/a> in the Netherlands, referring to the oldest and most commonly used cell line in research.\u003c/p>\n\u003cfigure id=\"attachment_262544\" class=\"wp-caption aligncenter\" style=\"max-width: 2400px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\">\u003cimg class=\"size-full wp-image-262544\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\" alt=\"Cultured HeLa cells.\" width=\"2400\" height=\"1999\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1.jpg 2400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-400x333.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-720x600.jpg 720w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-768x640.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1180x983.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1920x1599.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-960x800.jpg 960w\" sizes=\"(max-width: 2400px) 100vw, 2400px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Cultured HeLa cells. \u003ccite>(National Center for Microscopy and Imaging Research)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>HeLa cells were taken, without permission, from Henrietta Lacks, a patient who died of cervical cancer in 1951\u003cstrong>.\u003c/strong> For reasons no one knows, her cells were the first that could grow “immortally” in a lab, without dying after a few days. Her cells helped test Jonas Salk’s polio vaccine, have been used to research AIDS, cancer, toxic substances, gene mapping, stem cells and much more.\u003c/p>\n\u003cp class=\"p1\">Yet the absence of any consent whatsoever caused immense distress to the Lacks family, once they learned of the appropriation of Henrietta's cells.\u003c/p>\n\u003cp class=\"p1\">“The family has been through a lot with HeLa: they didn’t learn of the cells until 20 years after Lacks’s death, when scientists began using her children in research without their knowledge,” \u003ca href=\"http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html\" target=\"_blank\">wrote Rebecca Skloot\u003c/a>, author of \"The Immortal Life of Henrietta Lacks,\" in the New York Times.\u003ci> \"\u003c/i>Later their medical records were released to the press and published without consent.\" (Skloot makes an appearance in a \u003ca href=\"https://www.youtube.com/watch?v=ej0b7GHGYjs\" target=\"_blank\">rap ballad\u003c/a> about the HeLa cells and the Lacks family, written and performed by Oakland 7th and 8th graders on YouTube this month.)\u003c/p>\n\u003cp class=\"p1\">[contextly_sidebar id=\"QHgtAgdTB2KPycAd1HHOyHGUjvFlbxS7\"]Adding insult to injury, researchers in 2013 published the HeLa genome without family consent. (This was not illegal but, in the views of modern medical ethics, extremely dicey.)\u003c/p>\n\u003cp class=\"p1\">Panelist \u003ca href=\"https://law.stanford.edu/directory/henry-t-greely/\" target=\"_blank\">Hank Greely, \u003c/a>a bioethicist at Stanford University, advised the gathered researchers, “You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’\u003c/p>\n\u003cp class=\"p1\">“Not so much for the legal reasons, though those can be significant,\" he said. \"More because of the political fallout that can come to you and your institution. It could also do damage to the whole stem cell enterprise.”\u003c/p>\n\u003cp class=\"p1\">\u003ca href=\"https://daley.med.harvard.edu/\" target=\"_blank\">George Daley\u003c/a>, of the Children’s Hospital Boston and Harvard Medical School, pointed the audience toward recently revised guidelines from the International Society for Stem Cell Research, which offers \u003ca href=\"http://www.isscr.org/home/publications/guide-clintrans/sample-consent-documents\" target=\"_blank\">templates for informed consent forms\u003c/a>. These include language like this:\u003c/p>\n\u003cp class=\"p1\">\u003cem>Donating your _____ cells for this research project is completely voluntary. You have the right to agree or to refuse to provide your _____ cells for this project. The quality of your current or future medical care and your relationship with [name(s) of institution(s)] will NOT change in any way whether you agree or refuse to provide any cells for this research project.\u003c/em>\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>The Issue of Money\u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">Is it ethical to charge patients to participate in a study? No, was the consensus.\u003c/aside>\n\u003cp>“What happens if someone has a drug based on their genes or cells?” the moderator asked.\u003c/p>\n\u003cp class=\"p1\">“That doesn't happen very often,” said Greely. “Most of the time discoveries are the results of work with tens of thousands or more people.”\u003c/p>\n\u003cp class=\"p1\">But, he conceded, every once in a while a patient comes along with unusual cells or genes that can be the basis for a drug. In that case, he said, a researcher must first and foremost follow whatever they said they’d do in the consent forms.\u003c/p>\n\u003cp class=\"p1\">“But even if you didn't promise them anything in the consent process,” he said, “if someone is making lots of money,\u003cspan class=\"Apple-converted-space\"> \u003c/span>I think frankly it’s a good idea to try to return something.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_262548\" class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\">\u003cimg class=\"size-full wp-image-262548\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\" alt=\"These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \" width=\"1024\" height=\"765\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-400x299.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-800x598.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-768x574.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-960x717.jpg 960w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \u003ccite>(Kathrin Plath lab/UCLA via CIRM, NIH)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">He added that this probably doesn't mean offering royalties, which could foster overblown hopes for study participants. Greely likened it to hyping lottery tickets with very bad odds. Instead, he recommends thinking about a person's community, perhaps donating to causes dear to them. Even simple recognition, he says, is important.\u003c/p>\n\u003cp class=\"p1\">“I was involved in the\u003ca href=\"http://www.nature.com/news/deal-done-over-hela-cell-line-1.13511\" target=\"_blank\"> HeLa resolution\u003c/a> a few years ago,” he said,\u003cspan class=\"Apple-converted-space\"> \u003c/span>“and the Lacks descendants are really quite proud and pleased that their mother, grandmother and great grandmother is being remembered ... and that they are consulted on various things.”\u003c/p>\n\u003cp class=\"p1\">Continuing on the topic of money, the moderator asked what panelists thought about the ethics of paying tissue donors?\u003c/p>\n\u003cp class=\"p1\">On this, the panel seemed united, “As long as it’s a reasonable reimbursement for the pain and suffering, I think it’s hard to make a case against it,” offered \u003ca href=\"https://www.mskcc.org/research-areas/labs/members/lorenz-studer\" target=\"_blank\">Lorenz Studer\u003c/a>, of the Memorial Sloan Kettering Cancer Center. If the amount offered is so high that it becomes an “undue inducement,” said Greely, then it’s a problem.\u003c/p>\n\u003cp class=\"p1\">“Many patients are willing to pay for a treatment that’s unproven. What do you think about the ethics of patients paying to be in a trial?” asked the moderator, acknowledging that many people with serious diseases are desperate to be involved in the latest research and that clinical research is extraordinarily expensive to fund.\u003c/p>\n\u003cp class=\"p1\">No, was the general consensus.\u003c/p>\n\u003cp class=\"p1\">That means people in a control group would be paying for a placebo, Greely noted, and someone desperate to be in a trial might not be making a level-headed decision.\u003c/p>\n\u003cp class=\"p1\">“The simple fact that they’re willing to pay corrupts the informed consent process,\" he said. \"And there is a social justice aspect -- if someone can pay for a trial that’s not an equal distribution of good.”\u003c/p>\n\u003cp class=\"p1\">Someone from the audience chimed in with a question that once would have been relegated to the realm of science fiction: “What are the ethics of designing organs?”\u003c/p>\n\u003cp class=\"p2\">“Think about this with a heart,” said \u003ca href=\"http://profiles.ucsf.edu/deepak.srivastava\" target=\"_blank\">Deepak Srivastava\u003c/a> of the Gladstone Institutes and University of California, San Francisco. “It’s just a pump. I think going forward that we should remove the constraints of the design. What we have may or may not be the best thing in evolution.”\u003c/p>\n\u003cp class=\"p2\">But, said Greely, “Many people would be viscerally upset about the idea of changing ourselves, changing our species.\" So scientists should temper their desire to move quickly.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp class=\"p2\">“If there is one thing I've learned from being around biology for 25 years, it’s that biology is not the same as design,\" Greely said. \"Biology is really complicated! Engineers who design something expect it to work. But if you put something [designed] into an organism, the chances that something odd will happen are extremely high. You have to be extremely careful to avoid making things worse.”\u003c/p>\n\n","blocks":[],"excerpt":"At a celebration of the 10-year anniversary of induced pluripotent stem cells, scientists engaged in a discussion on hot-button issues.","status":"publish","parent":0,"modified":1477516088,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":5,"wordCount":1505},"headData":{"title":"What Stem Cell Researchers Talk About When They Talk About Ethics | KQED","description":"At a celebration of the 10-year anniversary of induced pluripotent stem cells, scientists engaged in a discussion on hot-button issues.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"What Stem Cell Researchers Talk About When They Talk About Ethics","datePublished":"2016-10-22T06:30:24.000Z","dateModified":"2016-10-26T21:08:08.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"258577 http://ww2.kqed.org/futureofyou/?p=258577","disqusUrl":"https://ww2.kqed.org/futureofyou/2016/10/21/what-stem-cell-researchers-talk-about-when-they-talk-about-ethics/","disqusTitle":"What Stem Cell Researchers Talk About When They Talk About Ethics","customPermalink":"2016/10/18/what-stem-cell-researchers-talk-about-when-they-talk-about-ethics/","path":"/futureofyou/258577/what-stem-cell-researchers-talk-about-when-they-talk-about-ethics","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"p1\">This year marks an anniversary that in all probability flew under your radar: The iPSC is 10-years-old.\u003c/p>\n\u003cp class=\"p1\">Great! you say. What's that, some sort of mobile fantasy sports league?\u003c/p>\n\u003cp class=\"p1\">Nooo. Would you guess \u003cem>induced pluripotent stem cells? \u003c/em>They're the product of a revolution in stem cell research that helped stem the controversy that was roiling the entire field.\u003c/p>\n\u003caside class=\"pullquote alignright\">'You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’'\u003ccite>Hank Greely, Stanford University\u003c/cite>\u003c/aside>\n\u003cp>Prior to the development of iPSCs, stem cells were derived primarily from eggs fertilized in clinics \u003ci>in vitro\u003c/i> that were donated for research purposes. To some, such as President George W. Bush, this was tantamount to abortion. In 2001 he \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744932/\" target=\"_blank\">banned federal funding\u003c/a> for research on newly created human embryonic stem cell lines. (President Barack Obama \u003ca href=\"http://www.nytimes.com/2009/03/10/us/politics/10stem.html?_r=0\" target=\"_blank\">lifted that ban\u003c/a> in 2009.)\u003c/p>\n\u003cp class=\"p1\">But iPSCs are normal cells, such as skin or blood cells, which have been tinkered with and reprogrammed to revert to an embryonic-like state. They are then capable of reproducing as stem cells or developing into \u003ci>other\u003c/i> types of human cells (pluripotent), such as liver, heart, pancreatic or nerve cells.\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 class=\"p1\">So the ability to derive a stem cell without using human embryonic tissue changed the debate about stem cell research ethics.\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>Plenty of Issues\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">But there are still plenty of hot-button topics in the field.\u003c/p>\n\u003cp class=\"p1\">At a recent gathering in Berkeley to celebrate “\u003ca href=\"http://www.cell-symposia-ipscs.com/conference-program/\" target=\"_blank\">10 Years of iPSCs\u003c/a>,” a panel of researchers and leaders kicked off the ethics discussion with comments on how to make sure researchers get proper permissions from human subjects who sign up for clinical trials. Some members of the public might be surprised what a controversial topic “informed consent” can be.\u003c/p>\n\u003cp class=\"p1\">“Everyone wants to avoid a HeLa situation,” said \u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">Christine Mummery,\u003c/a> of the Leiden University Medical Centr\u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">e\u003c/a> in the Netherlands, referring to the oldest and most commonly used cell line in research.\u003c/p>\n\u003cfigure id=\"attachment_262544\" class=\"wp-caption aligncenter\" style=\"max-width: 2400px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\">\u003cimg class=\"size-full wp-image-262544\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\" alt=\"Cultured HeLa cells.\" width=\"2400\" height=\"1999\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1.jpg 2400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-400x333.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-720x600.jpg 720w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-768x640.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1180x983.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1920x1599.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-960x800.jpg 960w\" sizes=\"(max-width: 2400px) 100vw, 2400px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Cultured HeLa cells. \u003ccite>(National Center for Microscopy and Imaging Research)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>HeLa cells were taken, without permission, from Henrietta Lacks, a patient who died of cervical cancer in 1951\u003cstrong>.\u003c/strong> For reasons no one knows, her cells were the first that could grow “immortally” in a lab, without dying after a few days. Her cells helped test Jonas Salk’s polio vaccine, have been used to research AIDS, cancer, toxic substances, gene mapping, stem cells and much more.\u003c/p>\n\u003cp class=\"p1\">Yet the absence of any consent whatsoever caused immense distress to the Lacks family, once they learned of the appropriation of Henrietta's cells.\u003c/p>\n\u003cp class=\"p1\">“The family has been through a lot with HeLa: they didn’t learn of the cells until 20 years after Lacks’s death, when scientists began using her children in research without their knowledge,” \u003ca href=\"http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html\" target=\"_blank\">wrote Rebecca Skloot\u003c/a>, author of \"The Immortal Life of Henrietta Lacks,\" in the New York Times.\u003ci> \"\u003c/i>Later their medical records were released to the press and published without consent.\" (Skloot makes an appearance in a \u003ca href=\"https://www.youtube.com/watch?v=ej0b7GHGYjs\" target=\"_blank\">rap ballad\u003c/a> about the HeLa cells and the Lacks family, written and performed by Oakland 7th and 8th graders on YouTube this month.)\u003c/p>\n\u003cp class=\"p1\">\u003c/p>\u003cp>\u003c/p>\u003cp>Adding insult to injury, researchers in 2013 published the HeLa genome without family consent. (This was not illegal but, in the views of modern medical ethics, extremely dicey.)\u003c/p>\n\u003cp class=\"p1\">Panelist \u003ca href=\"https://law.stanford.edu/directory/henry-t-greely/\" target=\"_blank\">Hank Greely, \u003c/a>a bioethicist at Stanford University, advised the gathered researchers, “You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’\u003c/p>\n\u003cp class=\"p1\">“Not so much for the legal reasons, though those can be significant,\" he said. \"More because of the political fallout that can come to you and your institution. It could also do damage to the whole stem cell enterprise.”\u003c/p>\n\u003cp class=\"p1\">\u003ca href=\"https://daley.med.harvard.edu/\" target=\"_blank\">George Daley\u003c/a>, of the Children’s Hospital Boston and Harvard Medical School, pointed the audience toward recently revised guidelines from the International Society for Stem Cell Research, which offers \u003ca href=\"http://www.isscr.org/home/publications/guide-clintrans/sample-consent-documents\" target=\"_blank\">templates for informed consent forms\u003c/a>. These include language like this:\u003c/p>\n\u003cp class=\"p1\">\u003cem>Donating your _____ cells for this research project is completely voluntary. You have the right to agree or to refuse to provide your _____ cells for this project. The quality of your current or future medical care and your relationship with [name(s) of institution(s)] will NOT change in any way whether you agree or refuse to provide any cells for this research project.\u003c/em>\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>The Issue of Money\u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">Is it ethical to charge patients to participate in a study? No, was the consensus.\u003c/aside>\n\u003cp>“What happens if someone has a drug based on their genes or cells?” the moderator asked.\u003c/p>\n\u003cp class=\"p1\">“That doesn't happen very often,” said Greely. “Most of the time discoveries are the results of work with tens of thousands or more people.”\u003c/p>\n\u003cp class=\"p1\">But, he conceded, every once in a while a patient comes along with unusual cells or genes that can be the basis for a drug. In that case, he said, a researcher must first and foremost follow whatever they said they’d do in the consent forms.\u003c/p>\n\u003cp class=\"p1\">“But even if you didn't promise them anything in the consent process,” he said, “if someone is making lots of money,\u003cspan class=\"Apple-converted-space\"> \u003c/span>I think frankly it’s a good idea to try to return something.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_262548\" class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\">\u003cimg class=\"size-full wp-image-262548\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\" alt=\"These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \" width=\"1024\" height=\"765\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-400x299.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-800x598.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-768x574.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-960x717.jpg 960w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \u003ccite>(Kathrin Plath lab/UCLA via CIRM, NIH)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">He added that this probably doesn't mean offering royalties, which could foster overblown hopes for study participants. Greely likened it to hyping lottery tickets with very bad odds. Instead, he recommends thinking about a person's community, perhaps donating to causes dear to them. Even simple recognition, he says, is important.\u003c/p>\n\u003cp class=\"p1\">“I was involved in the\u003ca href=\"http://www.nature.com/news/deal-done-over-hela-cell-line-1.13511\" target=\"_blank\"> HeLa resolution\u003c/a> a few years ago,” he said,\u003cspan class=\"Apple-converted-space\"> \u003c/span>“and the Lacks descendants are really quite proud and pleased that their mother, grandmother and great grandmother is being remembered ... and that they are consulted on various things.”\u003c/p>\n\u003cp class=\"p1\">Continuing on the topic of money, the moderator asked what panelists thought about the ethics of paying tissue donors?\u003c/p>\n\u003cp class=\"p1\">On this, the panel seemed united, “As long as it’s a reasonable reimbursement for the pain and suffering, I think it’s hard to make a case against it,” offered \u003ca href=\"https://www.mskcc.org/research-areas/labs/members/lorenz-studer\" target=\"_blank\">Lorenz Studer\u003c/a>, of the Memorial Sloan Kettering Cancer Center. If the amount offered is so high that it becomes an “undue inducement,” said Greely, then it’s a problem.\u003c/p>\n\u003cp class=\"p1\">“Many patients are willing to pay for a treatment that’s unproven. What do you think about the ethics of patients paying to be in a trial?” asked the moderator, acknowledging that many people with serious diseases are desperate to be involved in the latest research and that clinical research is extraordinarily expensive to fund.\u003c/p>\n\u003cp class=\"p1\">No, was the general consensus.\u003c/p>\n\u003cp class=\"p1\">That means people in a control group would be paying for a placebo, Greely noted, and someone desperate to be in a trial might not be making a level-headed decision.\u003c/p>\n\u003cp class=\"p1\">“The simple fact that they’re willing to pay corrupts the informed consent process,\" he said. \"And there is a social justice aspect -- if someone can pay for a trial that’s not an equal distribution of good.”\u003c/p>\n\u003cp class=\"p1\">Someone from the audience chimed in with a question that once would have been relegated to the realm of science fiction: “What are the ethics of designing organs?”\u003c/p>\n\u003cp class=\"p2\">“Think about this with a heart,” said \u003ca href=\"http://profiles.ucsf.edu/deepak.srivastava\" target=\"_blank\">Deepak Srivastava\u003c/a> of the Gladstone Institutes and University of California, San Francisco. “It’s just a pump. I think going forward that we should remove the constraints of the design. What we have may or may not be the best thing in evolution.”\u003c/p>\n\u003cp class=\"p2\">But, said Greely, “Many people would be viscerally upset about the idea of changing ourselves, changing our species.\" So scientists should temper their desire to move quickly.\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 class=\"p2\">“If there is one thing I've learned from being around biology for 25 years, it’s that biology is not the same as design,\" Greely said. \"Biology is really complicated! Engineers who design something expect it to work. But if you put something [designed] into an organism, the chances that something odd will happen are extremely high. You have to be extremely careful to avoid making things worse.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/258577/what-stem-cell-researchers-talk-about-when-they-talk-about-ethics","authors":["11088"],"programs":["futureofyou_54"],"categories":["futureofyou_452","futureofyou_1","futureofyou_73"],"tags":["futureofyou_396","futureofyou_953","futureofyou_680"],"featImg":"futureofyou_262541","label":"futureofyou_54"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.","airtime":"SUN 2pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.possible.fm/","meta":{"site":"news","source":"Possible"},"link":"/radio/program/possible","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/possible/id1677184070","spotify":"https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"}},"1a":{"id":"1a","title":"1A","info":"1A is home to the national conversation. 1A brings on great guests and frames the best debate in ways that make you think, share and engage.","airtime":"MON-THU 11pm-12am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/1a.jpg","officialWebsiteLink":"https://the1a.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/1a","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=1188724250&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/1A-p947376/","rss":"https://feeds.npr.org/510316/podcast.xml"}},"all-things-considered":{"id":"all-things-considered","title":"All Things Considered","info":"Every weekday, \u003cem>All Things Considered\u003c/em> hosts Robert Siegel, Audie Cornish, Ari Shapiro, and Kelly McEvers present the program's trademark mix of news, interviews, commentaries, reviews, and offbeat features. 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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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On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. Is it the officers, or the public they've sworn to serve?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/On-Our-Watch-Podcast-Tile-703x703-1.jpg","imageAlt":"On Our Watch from NPR and KQED","officialWebsiteLink":"/podcasts/onourwatch","meta":{"site":"news","source":"kqed","order":"1"},"link":"/podcasts/onourwatch","subscribe":{"apple":"https://podcasts.apple.com/podcast/id1567098962","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5ucHIub3JnLzUxMDM2MC9wb2RjYXN0LnhtbD9zYz1nb29nbGVwb2RjYXN0cw","npr":"https://rpb3r.app.goo.gl/onourwatch","spotify":"https://open.spotify.com/show/0OLWoyizopu6tY1XiuX70x","tuneIn":"https://tunein.com/radio/On-Our-Watch-p1436229/","stitcher":"https://www.stitcher.com/show/on-our-watch","rss":"https://feeds.npr.org/510360/podcast.xml"}},"on-the-media":{"id":"on-the-media","title":"On The Media","info":"Our weekly podcast explores how the media 'sausage' is made, casts an incisive eye on fluctuations in the marketplace of ideas, and examines threats to the freedom of information and expression in America and abroad. 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