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"disqusTitle": "The FDA's Controversial Approval of Muscular Dystrophy Drug",
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"content": "\u003cp>When 15-year-old Billy Ellsworth stepped up to the microphone at a Food and Drug Administration public meeting in April, he had no way to know he was part of a historic shift in how the government considers the desires of patients and their advocates in evaluating new drugs.\u003c/p>\n\u003cp>Ellsworth has Duchenne muscular dystrophy, a muscle-wasting disease, that mainly affects boys. And he was taking an experimental drug that the FDA was trying to decide whether to approve.\u003c/p>\n\u003cp>\"I'm going to beat this bloody disease but I need your help,\" Billy told the scientists weighing the evidence about the drug. \"So please help me and my friends and do the right thing. FDA, please don't let me die early.\"\u003c/p>\n\u003cp>Applause swelled from the overflow crowd.\u003c/p>\n\u003cp>His testimony and other pleas like it during the 10-hour hearing clearly affected some of the scientists sitting in judgment of the experimental drug called eteplirsen. But when the scientists turned their attention to the slim evidence before them, they ultimately voted that drugmaker \u003ca href=\"https://www.sarepta.com/\">Sarepta\u003c/a> had not shown that the experimental drug was effective.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Just 12 boys had been involved in the key study, and just about everybody agreed that the research was deeply flawed. But parents of some of those boys were convinced that the drug was in fact helping delay the progression of a disease that ultimately proves fatal.\u003c/p>\n\u003cp>\"We came away really heartbroken in many ways,\" said Pat Furlong, a longtime advocate who founded \u003ca href=\"http://www.parentprojectmd.org/\">Parent Project Muscular Dystrophy\u003c/a> and who had lost two sons to the disease.\u003c/p>\n\u003cp>One similar drug had previously been rejected by the FDA, and two others were turned away before they could even get through the door. There was no approved drug to stop the progression of this disease.\u003c/p>\n\u003cp>But that wasn't the end of the story.\u003c/p>\n\u003cp>Times are changing at the FDA and other federal agencies. In recent years, legislation and regulation has pushed for a greater patient voice in decisions. The FDA's job wasn't simply to look at the science, as it has done for many years. They have \"to look to what is meaningful benefit on the part of the patients,\" Furlong said. \"What do the patients value?\"\u003c/p>\n\u003cp>In this case, the parents saw real promise in this drug, despite the results from the flawed study. They also noted that the drug appears to be safe, so there wasn't much risk. And the research did show that boys on the drug were producing a small amount of a potentially helpful protein called dystrophin, which could be a sign that the drug provides some benefit.\u003c/p>\n\u003cp>That was all part of the FDA's thinking when on Monday \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm521263.htm\">it approved\u003c/a> eteplirsen, brand name Exondys 51, on a provisional basis. A \u003ca href=\"http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_summary%20review_Redacted.pdf\">letter\u003c/a> written by FDA Commissioner Robert Califf laid out in remarkably frank terms the heated internal debate at the agency, which \u003ca href=\"https://www.statnews.com/pharmalot/2016/09/14/fda-sarepta-farkas-duchenne/\">may have led to the departure\u003c/a> of one key scientist who was opposed to approving the drug.\u003c/p>\n\u003cp>\"It is inevitable that in some of these situations, highly qualified experts will disagree,\" Califf wrote, and he praised Dr. Janet Woodcock, the head of the FDA division that reviews new drugs, who made the call \"in the face of profound changes in science and social interactions related to drugs.\"\u003c/p>\n\u003cp>Califf said Woodcock ultimately made a scientific judgment call, anchored on the observation that the drug does prompt patients to produce at least a small amount of dystrophin.\u003c/p>\n\u003cp>Yet the role of advocacy here was inescapable. It is, after all, the patients who face the risks and the benefits.\u003c/p>\n\u003cp>\"You can look at this as being a potentially damaging precedent, and on the other hand you can look of this as being an innovative precedent, that could bring good things and earlier access to medicines,\" Eric Hoffman told NPR.\u003c/p>\n\u003cp>Hoffman and Louis Kunkel \u003ca href=\"http://www.cell.com/cell/abstract/0092-8674(87)90579-4?_returnURL=http%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2F0092867487905794%3Fshowall%3Dtrue\">discovered the dystrophin gene in 1987\u003c/a>. Hoffman is now CEO of ReveraGen, a company working on a drug for the disease, as well as associate dean of research at the University of Binghamton's pharmacy school in New York.\u003c/p>\n\u003cp>The FDA decision approves the drug on an accelerated basis, but that approval is contingent on follow-up studies and it can be withdrawn. In other diseases, provisional approvals have been reversed after follow-up studies failed to show the drugs were effective. (Avastin for advanced breast cancer is \u003ca href=\"http://www.npr.org/sections/health-shots/2011/11/18/142503630/fda-pulls-approval-of-avastin-for-advanced-breast-cancer\">a notable example\u003c/a>, despite pleas from patient groups to keep the approval intact).\u003c/p>\n\u003cp>The Sarepta drug addresses just one genetic mutation in muscular dystrophy, and that particular flaw only affects about 1,500 boys in the entire United States. Drugmaker Sarepta plans to use the same approach now to target other mutations related to the disease, and to use those study results to comply with the FDA's requirement for more and better studies.\u003c/p>\n\u003cp>In the meantime, Sarepta can start charging $300,000 per patient per year for treatment with eteplirsen.\u003c/p>\n\u003cp>\"Yes, there was a lot of pressure,\" Dr. Edward Kaye, CEO of Sarepta said, \"but I think the FDA demonstrated the flexibility they are allowed under the law. It took a lot of courage for them to do this. It's always easy to take the safe path and say, just give us more data.\"\u003c/p>\n\u003cp>Advocate Pat Furlong agreed. \"I think the important aspect of this is maybe a new social contract,\" she said. Since the drug is apparently safe and possibly useful, parents wanted to make the drug available while the questions about usefulness and value are fully answered. \"And at the end of five years we can reevaluate whether this really hits its mark in terms of the healthcare cost and the benefit to patients,\" she said.\u003c/p>\n\u003cp>More than a dozen potential drugs for this disease are in the pipeline now, and at the very least they now have a standard against which they can be judged.\u003c/p>\n\u003cp>The decision about eteplirsen would have been considerably easier, for patients and scientists alike, if the company had conducted its trials carefully and rigorously.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\"Considering that a substantially flawed development program contributed to the difficulty of coming to resolution in this case, we must redouble our efforts to ... use methods that will produce high-quality evidence from the outset,\" Califf wrote.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Controversy+Continues+Over+Muscular+Dystrophy+Drug%2C+Despite+FDA+Approval&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>When 15-year-old Billy Ellsworth stepped up to the microphone at a Food and Drug Administration public meeting in April, he had no way to know he was part of a historic shift in how the government considers the desires of patients and their advocates in evaluating new drugs.\u003c/p>\n\u003cp>Ellsworth has Duchenne muscular dystrophy, a muscle-wasting disease, that mainly affects boys. And he was taking an experimental drug that the FDA was trying to decide whether to approve.\u003c/p>\n\u003cp>\"I'm going to beat this bloody disease but I need your help,\" Billy told the scientists weighing the evidence about the drug. \"So please help me and my friends and do the right thing. FDA, please don't let me die early.\"\u003c/p>\n\u003cp>Applause swelled from the overflow crowd.\u003c/p>\n\u003cp>His testimony and other pleas like it during the 10-hour hearing clearly affected some of the scientists sitting in judgment of the experimental drug called eteplirsen. But when the scientists turned their attention to the slim evidence before them, they ultimately voted that drugmaker \u003ca href=\"https://www.sarepta.com/\">Sarepta\u003c/a> had not shown that the experimental drug was effective.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Just 12 boys had been involved in the key study, and just about everybody agreed that the research was deeply flawed. But parents of some of those boys were convinced that the drug was in fact helping delay the progression of a disease that ultimately proves fatal.\u003c/p>\n\u003cp>\"We came away really heartbroken in many ways,\" said Pat Furlong, a longtime advocate who founded \u003ca href=\"http://www.parentprojectmd.org/\">Parent Project Muscular Dystrophy\u003c/a> and who had lost two sons to the disease.\u003c/p>\n\u003cp>One similar drug had previously been rejected by the FDA, and two others were turned away before they could even get through the door. There was no approved drug to stop the progression of this disease.\u003c/p>\n\u003cp>But that wasn't the end of the story.\u003c/p>\n\u003cp>Times are changing at the FDA and other federal agencies. In recent years, legislation and regulation has pushed for a greater patient voice in decisions. The FDA's job wasn't simply to look at the science, as it has done for many years. They have \"to look to what is meaningful benefit on the part of the patients,\" Furlong said. \"What do the patients value?\"\u003c/p>\n\u003cp>In this case, the parents saw real promise in this drug, despite the results from the flawed study. They also noted that the drug appears to be safe, so there wasn't much risk. And the research did show that boys on the drug were producing a small amount of a potentially helpful protein called dystrophin, which could be a sign that the drug provides some benefit.\u003c/p>\n\u003cp>That was all part of the FDA's thinking when on Monday \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm521263.htm\">it approved\u003c/a> eteplirsen, brand name Exondys 51, on a provisional basis. A \u003ca href=\"http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_summary%20review_Redacted.pdf\">letter\u003c/a> written by FDA Commissioner Robert Califf laid out in remarkably frank terms the heated internal debate at the agency, which \u003ca href=\"https://www.statnews.com/pharmalot/2016/09/14/fda-sarepta-farkas-duchenne/\">may have led to the departure\u003c/a> of one key scientist who was opposed to approving the drug.\u003c/p>\n\u003cp>\"It is inevitable that in some of these situations, highly qualified experts will disagree,\" Califf wrote, and he praised Dr. Janet Woodcock, the head of the FDA division that reviews new drugs, who made the call \"in the face of profound changes in science and social interactions related to drugs.\"\u003c/p>\n\u003cp>Califf said Woodcock ultimately made a scientific judgment call, anchored on the observation that the drug does prompt patients to produce at least a small amount of dystrophin.\u003c/p>\n\u003cp>Yet the role of advocacy here was inescapable. It is, after all, the patients who face the risks and the benefits.\u003c/p>\n\u003cp>\"You can look at this as being a potentially damaging precedent, and on the other hand you can look of this as being an innovative precedent, that could bring good things and earlier access to medicines,\" Eric Hoffman told NPR.\u003c/p>\n\u003cp>Hoffman and Louis Kunkel \u003ca href=\"http://www.cell.com/cell/abstract/0092-8674(87)90579-4?_returnURL=http%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2F0092867487905794%3Fshowall%3Dtrue\">discovered the dystrophin gene in 1987\u003c/a>. Hoffman is now CEO of ReveraGen, a company working on a drug for the disease, as well as associate dean of research at the University of Binghamton's pharmacy school in New York.\u003c/p>\n\u003cp>The FDA decision approves the drug on an accelerated basis, but that approval is contingent on follow-up studies and it can be withdrawn. In other diseases, provisional approvals have been reversed after follow-up studies failed to show the drugs were effective. (Avastin for advanced breast cancer is \u003ca href=\"http://www.npr.org/sections/health-shots/2011/11/18/142503630/fda-pulls-approval-of-avastin-for-advanced-breast-cancer\">a notable example\u003c/a>, despite pleas from patient groups to keep the approval intact).\u003c/p>\n\u003cp>The Sarepta drug addresses just one genetic mutation in muscular dystrophy, and that particular flaw only affects about 1,500 boys in the entire United States. Drugmaker Sarepta plans to use the same approach now to target other mutations related to the disease, and to use those study results to comply with the FDA's requirement for more and better studies.\u003c/p>\n\u003cp>In the meantime, Sarepta can start charging $300,000 per patient per year for treatment with eteplirsen.\u003c/p>\n\u003cp>\"Yes, there was a lot of pressure,\" Dr. Edward Kaye, CEO of Sarepta said, \"but I think the FDA demonstrated the flexibility they are allowed under the law. It took a lot of courage for them to do this. It's always easy to take the safe path and say, just give us more data.\"\u003c/p>\n\u003cp>Advocate Pat Furlong agreed. \"I think the important aspect of this is maybe a new social contract,\" she said. Since the drug is apparently safe and possibly useful, parents wanted to make the drug available while the questions about usefulness and value are fully answered. \"And at the end of five years we can reevaluate whether this really hits its mark in terms of the healthcare cost and the benefit to patients,\" she said.\u003c/p>\n\u003cp>More than a dozen potential drugs for this disease are in the pipeline now, and at the very least they now have a standard against which they can be judged.\u003c/p>\n\u003cp>The decision about eteplirsen would have been considerably easier, for patients and scientists alike, if the company had conducted its trials carefully and rigorously.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"Considering that a substantially flawed development program contributed to the difficulty of coming to resolution in this case, we must redouble our efforts to ... use methods that will produce high-quality evidence from the outset,\" Califf wrote.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Controversy+Continues+Over+Muscular+Dystrophy+Drug%2C+Despite+FDA+Approval&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>",
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"info": "Political Breakdown is a new series that explores the political intersection of California and the nation. Each week hosts Scott Shafer and Marisa Lagos are joined with a new special guest to unpack politics -- with personality — and offer an insider’s glimpse at how politics happens.",
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"possible": {
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"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
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"radiolab": {
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"reveal": {
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"info": "Created by The Center for Investigative Reporting and PRX, Reveal is public radios first one-hour weekly radio show and podcast dedicated to investigative reporting. Credible, fact based and without a partisan agenda, Reveal combines the power and artistry of driveway moment storytelling with data-rich reporting on critically important issues. The result is stories that inform and inspire, arming our listeners with information to right injustices, hold the powerful accountable and improve lives.Reveal is hosted by Al Letson and showcases the award-winning work of CIR and newsrooms large and small across the nation. In a radio and podcast market crowded with choices, Reveal focuses on important and often surprising stories that illuminate the world for our listeners.",
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},
"rightnowish": {
"id": "rightnowish",
"title": "Rightnowish",
"tagline": "Art is where you find it",
"info": "Rightnowish digs into life in the Bay Area right now… ish. Journalist Pendarvis Harshaw takes us to galleries painted on the sides of liquor stores in West Oakland. We'll dance in warehouses in the Bayview, make smoothies with kids in South Berkeley, and listen to classical music in a 1984 Cutlass Supreme in Richmond. Every week, Pen talks to movers and shakers about how the Bay Area shapes what they create, and how they shape the place we call home.",
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