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Yet.","publishDate":1517252159,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>In 1995, in order to educate its clients on what technology to adopt, the IT consulting firm Gartner \u003ca href=\"https://www.gartner.com/technology/research/methodologies/hype-cycle.jsp\" target=\"_blank\" rel=\"noopener\">released a graph\u003c/a> illustrating the “hype cycle.”\u003c/p>\n\u003cp>The model posits that when a new technology is developed, it creates a frenzy of anticipation, leading to a Peak of Inflated Expectations. \u003ca href=\"https://theconversation.com/fitbits-decline-is-a-reflection-of-the-end-of-the-over-hyped-promise-of-wearables-73823\" target=\"_blank\" rel=\"noopener\">Failing\u003c/a> to live up to its pie-in-the-sky promise, the technology then becomes the butt of \u003ca href=\"https://www.youtube.com/watch?v=9507aK_nBHo&ab_channel=cgmcreative\">jokes and derision\u003c/a> — a Trough of Disillusionment.\u003c/p>\n\u003cfigure id=\"attachment_438726\" class=\"wp-caption aligncenter\" style=\"max-width: 506px\">\u003cimg class=\"wp-image-438726 \" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/gartner-for-marketers-hype-cycle.png\" alt=\"A graph showing the rise, fall, and subsequent rise of new forms of technology\" width=\"506\" height=\"259\">\u003cfigcaption class=\"wp-caption-text\">The Hype Cycle.\u003c/figcaption>\u003c/figure>\n\u003cp>But as it improves, it reaccumulates credibility -- the Slope of Enlightenment. The technology then matures into the mainstream, where the rollercoaster lifecycle finally smooths out along the Plateau of Productivity.\u003c/p>\n\u003cp>And this, says Dr. Robert Wachter, author of \"\u003ca href=\"https://ww2.kqed.org/futureofyou/tag/the-digital-doctor/\">The Digital Doctor\u003c/a>\" and chair of the Department of Medicine at UCSF, “turns out to be a perfect map for digital medicine.”\u003c/p>\n\u003cp>\u003cstrong>Does This Stuff Work? \u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">'We’re trying to emphasize this is not the end of wearables. [But] we don’t want to overpromise what these can achieve.'\u003ccite>Dr. Brennan Spiegel, Cedars-Sinai Health Services Research\u003c/cite>\u003c/aside>\n\u003cp>A \u003ca href=\"https://www.nature.com/articles/s41746-017-0002-4\" target=\"_blank\" rel=\"noopener\">meta-analysis\u003c/a> published this month in the journal \u003cem>Digital Medicine\u003c/em> would seem to buttress Wachter’s view. The study, conducted mostly by researchers at Cedars-Sinai Medical Center in Los Angeles, takes a broad look at the effectiveness of wearable sensors. The study looked at 16 randomized controlled trials, published from 2000 to 2016, which researchers assessed to be high quality. To be included in the study, devices had to be non-invasive, wearable, and capable of automatically transmitting data to a web portal or mobile app for review by patients or health providers. Among the devices tested were internet-connected weight scales, blood pressure monitors and activity trackers with text-message reminders.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The primary question researchers wanted to answer: Do these wearable biosensors make patients healthier?\u003c/p>\n\u003cp>Not very much, was the conclusion. The analysis found no significant difference in health outcomes like weight or blood pressure between patients who used the devices and those who didn't.\u003c/p>\n\u003cp>The researchers say they were not surprised, and they hope the work will pave the way for better development and use of remote health monitoring.\u003c/p>\n\u003cp>“We’re trying to emphasize this is not the end of wearables,” says co-author Dr. Brennan Spiegel, director of Cedars-Sinai Health Services Research in Los Angeles. “[But] we don’t want to overpromise what these can achieve.”\u003c/p>\n\u003cp>The authors did note some positive effect in certain cases. For instance, \u003ca href=\"http://www.mdpi.com/1424-8220/14/4/6229/htm\">a study\u003c/a> looking at Parkinson’s patients found a positive effect when physical therapy included devices that gave feedback about gaits; and in some trials patients did lose weight.\u003c/p>\n\u003cfigure id=\"attachment_438738\" class=\"wp-caption alignleft\" style=\"max-width: 640px\">\u003cimg class=\"wp-image-438738 size-large\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/6905654506_5ac041bada_k-1020x752.jpg\" alt=\"Three joggers near a body of water.\" width=\"640\" height=\"472\">\u003cfigcaption class=\"wp-caption-text\">Wearing an activity tracker does not necessarily lead to more activity.\u003c/figcaption>\u003c/figure>\n\u003cp>“The most successful studies tend to be coupled with some behavioral intervention,” Spiegel says. This added component sometimes took the form of a health coach or cognitive behavioral therapy, in addition to use of the device.\u003c/p>\n\u003cp>That means the greatest hurdles to efficacy in the digital health revolution may not be technical, but human.\u003c/p>\n\u003cp>“What we conclude in the study is that digital health is not a computer science or an engineering science; it’s a social and behavioral science.\"\u003c/p>\n\u003caside class=\"pullquote alignright\">'Medicine is probably the last field to be touched by technology.'\u003ccite>Dr. Bob Wachter, author of 'The Digital Doctor'\u003c/cite>\u003c/aside>\n\u003cp>Other recently published research, a \u003ca href=\"http://mhealth.jmir.org/2018/1/e23/\" target=\"_blank\" rel=\"noopener\">systematic review\u003c/a> of systematic reviews, focused on mobile health interventions, most frequently involving text messaging. The analysis, published in the\u003cem> Journal of Medical Internet Research mHealth and uHealth\u003c/em>, looked at 371 studies published between 2009 and 2016, comprised of nearly 80,000 patients. The studied interventions included apps to manage chronic disease, increase treatment adherence and modify behavior. The analysis found evidence that mobile health apps helped with a variety of conditions, including symptom improvement in chronic pulmonary disease and heart failure; glycemic control in diabetes patients; and blood pressure in those with hypertension. There was also evidence that text reminders improved adherence to tuberculosis and HIV therapies.\u003c/p>\n\u003cp>[contextly_sidebar id=\"cJJOGi35mjmKyVRrfPXWGXPW5fc4Gdks\"]However, the quality of the evidence for many studies was rated as generally low. Among the more rigorous studies were those that found good evidence for improvement in asthma symptoms, appointment attendance and smoking cessation rates.\u003c/p>\n\u003cp>\u003cstrong>Medicine Needs to do Better. Will Technology Help?\u003c/strong>\u003c/p>\n\u003cp>Wachter ticked off the ways medicine is \"coming up short in what we want from it.\"\u003c/p>\n\u003cp>\"Safety is not very good,\" he says. \"We harm and kill a lot of people because of medical mistakes. People are not very satisfied ... . Access is often quite bad. And the costs are bankrupting local governments, national governments, and businesses and individuals.”\u003c/p>\n\u003caside class=\"pullquote alignright\">'[Investors] wanted a quick win, but now they realize there aren’t a lot of quick wins in health care.'\u003ccite>Melissa Buckley, California Health Care Foundation\u003c/cite>\u003c/aside>\n\u003cp>And yet, “Medicine is probably the last field to be touched by technology,\" he says. \"Think about how manufacturing, retail, financial services, travel, journalism, pretty much every field has been overtaken by technology.”\u003c/p>\n\u003cp>These manifold inefficiencies present a natural target for technologists, Wachter says.\u003c/p>\n\u003cp>“You have the technology trigger, a massive uptick in expectation. Then, of course, studies like [the one in \u003cem>Digital Medicine\u003c/em>] come out and it leads to a rapid downslope, that Trough of Disillusionment.\"\u003c/p>\n\u003cp>Still, Wachter, as well as many other experts, believe remote sensors, mobile health and tech-enhanced medical services will play an important role in the future of medicine, because there are so many people who need help monitoring chronic disease and guidance on diet and exercise. It’s just too time-consuming and costly to always get these directly from medical professionals, Wachter says.\u003c/p>\n\u003cp>“Right now many people take a half-day off work to go to a 15- minute visit to see the doctor. That’s crazy. How can that be the model over time?”\u003c/p>\n\u003cp>Wachter predicts digital health devices will eventually become as indispensable as smartphones and personal assistants.\u003c/p>\n\u003cp>“That has not happened yet in remote patient monitoring. My suspicion is that over time it probably will, but we have to learn a lot.”\u003c/p>\n\u003cp>Melissa Buckley is director of the Health Innovation Fund for the California Health Care Foundation, which is dedicated to improving health care for low-income state residents. The fund invests in technology and service companies it hopes will help in that mission.\u003c/p>\n\u003cp>Buckley says she’s seen companies only in the last two years try to shorten the hype cycle, which they're doing by becoming more realistic and intentional in the design and deployment of technology. She points out that some of the studies cited in the \u003cem>Digital Health \u003c/em>analysis date back to 2000, when devices were relatively primitive.\u003c/p>\n\u003cp>During the initial phase of excitement over using technology to solve health problems, she says, many investors put money into simple concepts. “They wanted a quick win, but now they realize there aren’t a lot of quick wins in health care.”\u003c/p>\n\u003cp>The field is learning, she believes, to be more attuned to what patients really need.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>“But just because [some tool] is digital, we shouldn’t think it will be magically effective.”\u003c/p>\n\n","blocks":[],"excerpt":"Studies of wearable biosensors for patients found they made patients healthier very occasionally, with most interventions showing no benefit over conventional treatment.\r\n","status":"publish","parent":0,"modified":1517528450,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":33,"wordCount":1223},"headData":{"title":"If Digital Health is the Future, the Future is Not Here. Yet. | KQED","description":"Studies of wearable biosensors for patients found they made patients healthier very occasionally, with most interventions showing no benefit over conventional treatment.\r\n","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"If Digital Health is the Future, the Future is Not Here. Yet.","datePublished":"2018-01-29T18:55:59.000Z","dateModified":"2018-02-01T23:40:50.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"438782 https://ww2.kqed.org/futureofyou/?p=438782","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/01/29/digital-medicine-may-have-just-hit-the-trough-of-disillusionment/","disqusTitle":"If Digital Health is the Future, the Future is Not Here. Yet.","source":"KQED Future of You","path":"/futureofyou/438782/digital-medicine-may-have-just-hit-the-trough-of-disillusionment","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>In 1995, in order to educate its clients on what technology to adopt, the IT consulting firm Gartner \u003ca href=\"https://www.gartner.com/technology/research/methodologies/hype-cycle.jsp\" target=\"_blank\" rel=\"noopener\">released a graph\u003c/a> illustrating the “hype cycle.”\u003c/p>\n\u003cp>The model posits that when a new technology is developed, it creates a frenzy of anticipation, leading to a Peak of Inflated Expectations. \u003ca href=\"https://theconversation.com/fitbits-decline-is-a-reflection-of-the-end-of-the-over-hyped-promise-of-wearables-73823\" target=\"_blank\" rel=\"noopener\">Failing\u003c/a> to live up to its pie-in-the-sky promise, the technology then becomes the butt of \u003ca href=\"https://www.youtube.com/watch?v=9507aK_nBHo&ab_channel=cgmcreative\">jokes and derision\u003c/a> — a Trough of Disillusionment.\u003c/p>\n\u003cfigure id=\"attachment_438726\" class=\"wp-caption aligncenter\" style=\"max-width: 506px\">\u003cimg class=\"wp-image-438726 \" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/gartner-for-marketers-hype-cycle.png\" alt=\"A graph showing the rise, fall, and subsequent rise of new forms of technology\" width=\"506\" height=\"259\">\u003cfigcaption class=\"wp-caption-text\">The Hype Cycle.\u003c/figcaption>\u003c/figure>\n\u003cp>But as it improves, it reaccumulates credibility -- the Slope of Enlightenment. The technology then matures into the mainstream, where the rollercoaster lifecycle finally smooths out along the Plateau of Productivity.\u003c/p>\n\u003cp>And this, says Dr. Robert Wachter, author of \"\u003ca href=\"https://ww2.kqed.org/futureofyou/tag/the-digital-doctor/\">The Digital Doctor\u003c/a>\" and chair of the Department of Medicine at UCSF, “turns out to be a perfect map for digital medicine.”\u003c/p>\n\u003cp>\u003cstrong>Does This Stuff Work? \u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">'We’re trying to emphasize this is not the end of wearables. [But] we don’t want to overpromise what these can achieve.'\u003ccite>Dr. Brennan Spiegel, Cedars-Sinai Health Services Research\u003c/cite>\u003c/aside>\n\u003cp>A \u003ca href=\"https://www.nature.com/articles/s41746-017-0002-4\" target=\"_blank\" rel=\"noopener\">meta-analysis\u003c/a> published this month in the journal \u003cem>Digital Medicine\u003c/em> would seem to buttress Wachter’s view. The study, conducted mostly by researchers at Cedars-Sinai Medical Center in Los Angeles, takes a broad look at the effectiveness of wearable sensors. The study looked at 16 randomized controlled trials, published from 2000 to 2016, which researchers assessed to be high quality. To be included in the study, devices had to be non-invasive, wearable, and capable of automatically transmitting data to a web portal or mobile app for review by patients or health providers. Among the devices tested were internet-connected weight scales, blood pressure monitors and activity trackers with text-message reminders.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The primary question researchers wanted to answer: Do these wearable biosensors make patients healthier?\u003c/p>\n\u003cp>Not very much, was the conclusion. The analysis found no significant difference in health outcomes like weight or blood pressure between patients who used the devices and those who didn't.\u003c/p>\n\u003cp>The researchers say they were not surprised, and they hope the work will pave the way for better development and use of remote health monitoring.\u003c/p>\n\u003cp>“We’re trying to emphasize this is not the end of wearables,” says co-author Dr. Brennan Spiegel, director of Cedars-Sinai Health Services Research in Los Angeles. “[But] we don’t want to overpromise what these can achieve.”\u003c/p>\n\u003cp>The authors did note some positive effect in certain cases. For instance, \u003ca href=\"http://www.mdpi.com/1424-8220/14/4/6229/htm\">a study\u003c/a> looking at Parkinson’s patients found a positive effect when physical therapy included devices that gave feedback about gaits; and in some trials patients did lose weight.\u003c/p>\n\u003cfigure id=\"attachment_438738\" class=\"wp-caption alignleft\" style=\"max-width: 640px\">\u003cimg class=\"wp-image-438738 size-large\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/6905654506_5ac041bada_k-1020x752.jpg\" alt=\"Three joggers near a body of water.\" width=\"640\" height=\"472\">\u003cfigcaption class=\"wp-caption-text\">Wearing an activity tracker does not necessarily lead to more activity.\u003c/figcaption>\u003c/figure>\n\u003cp>“The most successful studies tend to be coupled with some behavioral intervention,” Spiegel says. This added component sometimes took the form of a health coach or cognitive behavioral therapy, in addition to use of the device.\u003c/p>\n\u003cp>That means the greatest hurdles to efficacy in the digital health revolution may not be technical, but human.\u003c/p>\n\u003cp>“What we conclude in the study is that digital health is not a computer science or an engineering science; it’s a social and behavioral science.\"\u003c/p>\n\u003caside class=\"pullquote alignright\">'Medicine is probably the last field to be touched by technology.'\u003ccite>Dr. Bob Wachter, author of 'The Digital Doctor'\u003c/cite>\u003c/aside>\n\u003cp>Other recently published research, a \u003ca href=\"http://mhealth.jmir.org/2018/1/e23/\" target=\"_blank\" rel=\"noopener\">systematic review\u003c/a> of systematic reviews, focused on mobile health interventions, most frequently involving text messaging. The analysis, published in the\u003cem> Journal of Medical Internet Research mHealth and uHealth\u003c/em>, looked at 371 studies published between 2009 and 2016, comprised of nearly 80,000 patients. The studied interventions included apps to manage chronic disease, increase treatment adherence and modify behavior. The analysis found evidence that mobile health apps helped with a variety of conditions, including symptom improvement in chronic pulmonary disease and heart failure; glycemic control in diabetes patients; and blood pressure in those with hypertension. There was also evidence that text reminders improved adherence to tuberculosis and HIV therapies.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>However, the quality of the evidence for many studies was rated as generally low. Among the more rigorous studies were those that found good evidence for improvement in asthma symptoms, appointment attendance and smoking cessation rates.\u003c/p>\n\u003cp>\u003cstrong>Medicine Needs to do Better. Will Technology Help?\u003c/strong>\u003c/p>\n\u003cp>Wachter ticked off the ways medicine is \"coming up short in what we want from it.\"\u003c/p>\n\u003cp>\"Safety is not very good,\" he says. \"We harm and kill a lot of people because of medical mistakes. People are not very satisfied ... . Access is often quite bad. And the costs are bankrupting local governments, national governments, and businesses and individuals.”\u003c/p>\n\u003caside class=\"pullquote alignright\">'[Investors] wanted a quick win, but now they realize there aren’t a lot of quick wins in health care.'\u003ccite>Melissa Buckley, California Health Care Foundation\u003c/cite>\u003c/aside>\n\u003cp>And yet, “Medicine is probably the last field to be touched by technology,\" he says. \"Think about how manufacturing, retail, financial services, travel, journalism, pretty much every field has been overtaken by technology.”\u003c/p>\n\u003cp>These manifold inefficiencies present a natural target for technologists, Wachter says.\u003c/p>\n\u003cp>“You have the technology trigger, a massive uptick in expectation. Then, of course, studies like [the one in \u003cem>Digital Medicine\u003c/em>] come out and it leads to a rapid downslope, that Trough of Disillusionment.\"\u003c/p>\n\u003cp>Still, Wachter, as well as many other experts, believe remote sensors, mobile health and tech-enhanced medical services will play an important role in the future of medicine, because there are so many people who need help monitoring chronic disease and guidance on diet and exercise. It’s just too time-consuming and costly to always get these directly from medical professionals, Wachter says.\u003c/p>\n\u003cp>“Right now many people take a half-day off work to go to a 15- minute visit to see the doctor. That’s crazy. How can that be the model over time?”\u003c/p>\n\u003cp>Wachter predicts digital health devices will eventually become as indispensable as smartphones and personal assistants.\u003c/p>\n\u003cp>“That has not happened yet in remote patient monitoring. My suspicion is that over time it probably will, but we have to learn a lot.”\u003c/p>\n\u003cp>Melissa Buckley is director of the Health Innovation Fund for the California Health Care Foundation, which is dedicated to improving health care for low-income state residents. The fund invests in technology and service companies it hopes will help in that mission.\u003c/p>\n\u003cp>Buckley says she’s seen companies only in the last two years try to shorten the hype cycle, which they're doing by becoming more realistic and intentional in the design and deployment of technology. She points out that some of the studies cited in the \u003cem>Digital Health \u003c/em>analysis date back to 2000, when devices were relatively primitive.\u003c/p>\n\u003cp>During the initial phase of excitement over using technology to solve health problems, she says, many investors put money into simple concepts. “They wanted a quick win, but now they realize there aren’t a lot of quick wins in health care.”\u003c/p>\n\u003cp>The field is learning, she believes, to be more attuned to what patients really need.\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>“But just because [some tool] is digital, we shouldn’t think it will be magically effective.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/438782/digital-medicine-may-have-just-hit-the-trough-of-disillusionment","authors":["11088"],"categories":["futureofyou_1060","futureofyou_452","futureofyou_1062","futureofyou_73"],"tags":["futureofyou_717","futureofyou_26","futureofyou_1275","futureofyou_80","futureofyou_145","futureofyou_25"],"featImg":"futureofyou_274615","label":"source_futureofyou_438782"},"futureofyou_437552":{"type":"posts","id":"futureofyou_437552","meta":{"index":"posts_1591205157","site":"futureofyou","id":"437552","score":null,"sort":[1513090813000]},"guestAuthors":[],"slug":"just-because-you-have-a-mild-concussion-doesnt-mean-youre-ok","title":"Just Because You Have a 'Mild' Concussion Doesn't Mean You're OK","publishDate":1513090813,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Last February Baxter Bailey injured himself trying to break into his own home when he couldn’t find his key. Crawling through a window leading to the utility room, he slipped and fell, hitting his head on the concrete floor.\u003c/p>\n\u003cp>He was unconscious for about an hour.\u003c/p>\n\u003cp>“My skull, my forehead was bloody, bruised and banged,” says the 77-year-old architect from Richmond, Virginia. “And I had blood all over my shirt, my pants and underwear.”\u003c/p>\n\u003cp>At the hospital, “Doctors told me that my brain moved inside the skull,” Baxter says. But a small hemorrhage in the brain visible through scans wasn’t bad enough to keep him as an inpatient for more than a day. Baxter was diagnosed with a concussion, or what medical professionals call a mild traumatic brain injury, and released.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Unlike other neurological diseases, one cannot pinpoint the area of injury in concussion.'\u003ccite>Teena Shetty, neurologist\u003c/cite>\u003c/aside>\n\u003cp>“Within two weeks, the abrasion on my head got healed, and you couldn’t tell that anything ever happened to me if you looked at me,” says Baxter.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But his troubles were just starting. Two months later, Baxter was in the emergency room again. He had started losing control of his left side. He found lifting his leg to get into a car difficult. Walking caused him trouble. This time the scans showed a chronic hematoma — swelling and bruising — on the right side of his skull.\u003c/p>\n\u003cp>“It was like 3 inches long and an inch thick and I could see that my brain literally was off center and my cerebellum was misaligned,” says Baxter. Doctors told him he needed immediate surgery. The plan was to drill a little hole in his head the size of a dime.\u003c/p>\n\u003cp>“I thought, ‘My lord, is this the end of me?’ ”\u003c/p>\n\u003cp>\u003cstrong>A Lot of Brain Injuries\u003c/strong>\u003c/p>\n\u003cp>Each year, about \u003ca href=\"https://www.cdc.gov/mmwr/volumes/66/ss/ss6609a1.htm\" target=\"_blank\" rel=\"noopener\">2.5 million people in the United States\u003c/a> are admitted to emergency rooms with traumatic brain injuries, according to the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>The difficulties of studying concussions, with their vague symptoms and hidden physical damage, have turned brain injury into a “silent epidemic,” in the words of \u003ca href=\"http://profiles.ucsf.edu/pratik.mukherjee\" target=\"_blank\" rel=\"noopener\">Pratik Mukherjee\u003c/a>, a neuroradiologist at UCSF.\u003c/p>\n\u003cp>\u003ca href=\"https://www.hss.edu/physicians_shetty-teena.asp\" target=\"_blank\" rel=\"noopener\">Teena Shetty\u003c/a>, a neurologist at New York City's Hospital for Special Surgery, agrees. “Unlike other neurological diseases, one cannot pinpoint the area of injury in concussion,” she says.\u003c/p>\n\u003cp>Doctors are not even in agreement about how to treat concussions. Some advise resuming daily activities as soon as possible, others suggest avoiding demanding work and staying away from bright lights and loud sounds.\u003c/p>\n\u003cp>Existing guidelines are not backed by evidence, according to \u003ca href=\"https://www.urmc.rochester.edu/people/20187378-jeffrey-j-bazarian\" target=\"_blank\" rel=\"noopener\">Jeff Bazarian\u003c/a>, professor of emergency medicine at the University of Rochester Medical Center, in New York.\u003c/p>\n\u003cfigure id=\"attachment_437557\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003cimg class=\"size-large wp-image-437557\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-1020x765.jpg\" alt=\"\" width=\"640\" height=\"480\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-1020x765.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-160x120.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-960x720.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-240x180.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-375x281.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-520x390.jpg 520w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o.jpg 1024w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003cfigcaption class=\"wp-caption-text\">Tom Gal, 37-year old entrepreneur from San Francisco, recovering from a car accident at Zuckerberg San Francisco General Hospital and Trauma Center. \u003ccite>(Courtesy Tom Gal)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>A New Approach Tracks Patients in Detail\u003c/strong>\u003c/p>\n\u003cp>Predicting which concussion patients will fully recover and which will be permanently debilitated is more or less a guessing game.\u003c/p>\n\u003cp>Tom Gal, a 37-year old entrepreneur from San Francisco, spent almost two days in a coma after being hit by a car last August. He woke up with no memory of what happened and had to learn the details from his medical report. But eight months after the injury, he says he is doing just fine. In contrast, 29-year-old bread baker Ana Diaz, from Richmond, Virginia, complains about short-term memory lapses and increased anxiety six months after a biking accident that left her with no signs of head trauma on a CT scan.\u003c/p>\n\u003cp>In light of such counter-intuitive outcomes, many researchers feel it is now time to make the diagnosis and prognosis of concussions more precise and evidence-based.\u003c/p>\n\u003cp>According to Mukherjee, \u003ca href=\"https://link.springer.com/article/10.1186/s12245-014-0031-6\" target=\"_blank\" rel=\"noopener\">15 to 30 percent of concussion patients\u003c/a> will experience \u003ca href=\"http://www.neurosymptoms.org/post-concussion-syndrome/4582101276\" target=\"_blank\" rel=\"noopener\">worsening brain function\u003c/a> later on, including problems with thinking, memory, attention and decision-making. Patients can also experience sleep disorders and headaches that persist for weeks, months or years. In the severest cases, people can develop epilepsy and seizures, with increased risk of Alzheimer’s disease.\u003c/p>\n\u003cp>As a result, about 3 to 5 million people live with the long-term physical, cognitive and psychological health disabilities of traumatic brain injury. Estimated annual direct and indirect costs are over $75 billion, \u003ca href=\"https://www.cdc.gov/traumaticbraininjury/severe.html\" target=\"_blank\" rel=\"noopener\">according to\u003c/a> the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>What’s needed, some researchers believe, is a large study focused on improving how doctors measure concussions and predict the long-term effects on patients.\u003c/p>\n\u003cp>Baxter, Gal and Diaz may have found one. While recovering from their injuries, they signed up for a study called \u003ca href=\"https://tracktbi.ucsf.edu/\" target=\"_blank\" rel=\"noopener\">TRACK TBI, \u003c/a>for Transforming Research in Clinical Knowledge in Traumatic Brain Injury.\u003c/p>\n\u003cp>TRACK TBI, spearheaded at UCSF, started in 2014 with just 75 enrolled patients. The cohort has now expanded to include over 2,000, with the goal of enrolling 1,000 more. The study spans 19 research centers across the country, and major funding comes from the National Institutes of Health and the Department of Defense. TRACK TBI is also partnering with CENTER TBI, a European sister-trial, monitoring 10,000 concussion patients.\u003c/p>\n\u003cp>Study researchers want to analyze the results of blood analysis, MRI scans and cognitive tests to find which patients are at higher risk of developing long-term cognitive problems after suffering concussions.\u003c/p>\n\u003cfigure id=\"attachment_437556\" class=\"wp-caption alignnone\" style=\"max-width: 640px\">\u003cimg class=\"wp-image-437556 size-large\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/12/Pratik-with-brain-image-1020x574.jpg\" alt=\"\" width=\"640\" height=\"360\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-1020x574.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-160x90.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-800x450.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-768x432.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-1180x664.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-960x540.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-240x135.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-375x211.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-520x293.jpg 520w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003cfigcaption class=\"wp-caption-text\">Pratik Mukherjee, neuroradiologist at UCSF, looking at a brain image. \u003ccite>(Julia Vassey/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>Getting a Closer Look\u003c/strong>\u003c/p>\n\u003cp>The problem with diagnosing concussions starts in the emergency room. The majority of patients with mild, non-life-threatening traumatic brain injuries get released from ER without any follow-up evaluation.\u003c/p>\n\u003cp>“And that is a mistake,” says Mukherjee, who is also one of TRACK TBI’s principal investigators.\u003c/p>\n\u003cp>CT scans in the ERs across the country can miss subtle brain damage, as occurred in Baxter’s first CT scan. These diagnostics can only detect structural changes or internal bleeding in the brain, like the hemorrhage Baxter eventually developed.\u003c/p>\n\u003cp>Even following severe traumatic brain injuries, as Gal suffered, neither CT nor standard MRI can detect microstructural changes and alterations in brain functioning.\u003c/p>\n\u003cp>But it is these subtle changes that may predict the likelihood of lasting problems, including impaired focus, attention, memory and decision-making.\u003c/p>\n\u003cp>TRACK TBI researchers are looking for biochemical signals that could ensure reliable, speedy diagnoses and good predictions of whether patients will suffer long-term effects.\u003c/p>\n\u003cp>Mapping is another focus of TRACK TBI. Powerful MRI scanners with software that allows precise reconstruction of high resolution MRI images could help scientists create brain maps.\u003c/p>\n\u003cp>The study is using the latest MRI scanners, at least twice as powerful as the ones installed in many of the country’s hospitals and imaging centers, to peer deeper into the brain and search for abnormalities in the fine-grain structure of the brain’s “white matter.” If this is damaged, it can disrupt brain functions like imprinting memories, maintaining focus and making decisions.\u003c/p>\n\u003cp>Patients enrolled in the TRACK TBI study get scanned two weeks after their head injury and then again six months later to reveal the presence of any chronic effects.\u003c/p>\n\u003cp>Researchers are also scanning for the presence of specific types of proteins in the blood that can be detected in brain-injury patients. TRACK TBI is particularly focusing on GFAP (glial fibrillary acidic protein) and Tau protein.\u003c/p>\n\u003cdiv>\u003c/div>\n\u003cp>“This is similar to how they diagnose heart attacks,” says Mukherjee. “If you are having a heart attack, the heart will spill particular proteins that can be detected, and provide a good objective test.”\u003c/p>\n\u003cp>In the 1950s and 1960s an electrocardiogram was the only way to measure a patient’s heart for signs of heart disease. But a patient could show a normal-looking EKG even while suffering a heart attack. With time, blood tests measuring proteins have proven to be more reliable. Using a similar approach could transform concussion diagnoses as well.\u003c/p>\n\u003cp>Shetty, who is not involved in the study, believes it has “a tremendous potential to understand relationships between biomarkers, neuroimaging and cognitive data.”\u003c/p>\n\u003cp>\u003ca href=\"https://www2.eecs.berkeley.edu/Faculty/Homepages/chunleiliu.html\" target=\"_blank\" rel=\"noopener\">Chunlei Liu\u003c/a>, an associate professor of the Helen Wills Neuroscience Institute at UC Berkeley, who also has no relationship to the study, is glad to see TRACK TBI’s multipronged approach.\u003c/p>\n\u003cp>Because brain trauma involves systemic changes in different parts of the brain, Liu says, “A single biomarker won't make a definitive answer.”\u003c/p>\n\u003cp>[contextly_sidebar id=\"fpfN1gUvcMM6xziiLMO3LOmy1Q3hTGxh\"]This approach is part of a trend. The \u003ca href=\"http://www.careconsortium.net/\" target=\"_blank\" rel=\"noopener\">CARE Consortium\u003c/a>, funded by the NCAA and the U.S. Department of Defense, is similar in many ways to TRACK TBI, but focuses on student-athletes and military service members. At the University of Pittsburgh. the \u003ca href=\"http://www.adapttrial.org/\" target=\"_blank\" rel=\"noopener\">ADAPT Trial\u003c/a> is focusing on children with severe traumatic brain injury, hoping to determine the best care procedures.\u003c/p>\n\u003cp>If prognostic biomarkers can be identified by TRACK and other studies, it could help scientists resurrect once-promising treatments that were abandoned after failed clinical trials. One of the most disappointing failures was the PROTECT trial, which in 2015 experimented with treating acute traumatic brain injury with progesterone, a steroid found to sometimes have powerful neuroprotective properties.The study showed promising results on lab animals, but it collapsed after moving to phase III human trials.\u003c/p>\n\u003cp>“Currently with the clinical trials, it has been one-size-fits-all for every patient,” says Mukherjee. He says researchers often enroll participants without knowing if they are prone to developing complications. “But this is a mistake, because patients are affected in many different ways, and types of pathologies are different.”\u003c/p>\n\u003cp>If biomarkers can be discovered, researchers can determine exactly which patients will or will not benefit from treatment.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>And patients recovering from brain injuries may be able to face their future with a clearer idea of the path ahead.\u003c/p>\n\n","blocks":[],"excerpt":"The difficulties of studying concussions, with their vague symptoms and hidden physical damage, have turned diagnosing brain injuries into a guessing game. Researchers are now looking into making it more precise.","status":"publish","parent":0,"modified":1513354898,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":47,"wordCount":1679},"headData":{"title":"Just Because You Have a 'Mild' Concussion Doesn't Mean You're OK | KQED","description":"The difficulties of studying concussions, with their vague symptoms and hidden physical damage, have turned diagnosing brain injuries into a guessing game. Researchers are now looking into making it more precise.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Just Because You Have a 'Mild' Concussion Doesn't Mean You're OK","datePublished":"2017-12-12T15:00:13.000Z","dateModified":"2017-12-15T16:21:38.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"437552 https://ww2.kqed.org/futureofyou/?p=437552","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/12/12/just-because-you-have-a-mild-concussion-doesnt-mean-youre-ok/","disqusTitle":"Just Because You Have a 'Mild' Concussion Doesn't Mean You're OK","source":"KQED Future of You","nprByline":"Julia Vassey\u003cbr />KQED Future of You","path":"/futureofyou/437552/just-because-you-have-a-mild-concussion-doesnt-mean-youre-ok","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Last February Baxter Bailey injured himself trying to break into his own home when he couldn’t find his key. Crawling through a window leading to the utility room, he slipped and fell, hitting his head on the concrete floor.\u003c/p>\n\u003cp>He was unconscious for about an hour.\u003c/p>\n\u003cp>“My skull, my forehead was bloody, bruised and banged,” says the 77-year-old architect from Richmond, Virginia. “And I had blood all over my shirt, my pants and underwear.”\u003c/p>\n\u003cp>At the hospital, “Doctors told me that my brain moved inside the skull,” Baxter says. But a small hemorrhage in the brain visible through scans wasn’t bad enough to keep him as an inpatient for more than a day. Baxter was diagnosed with a concussion, or what medical professionals call a mild traumatic brain injury, and released.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Unlike other neurological diseases, one cannot pinpoint the area of injury in concussion.'\u003ccite>Teena Shetty, neurologist\u003c/cite>\u003c/aside>\n\u003cp>“Within two weeks, the abrasion on my head got healed, and you couldn’t tell that anything ever happened to me if you looked at me,” says Baxter.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But his troubles were just starting. Two months later, Baxter was in the emergency room again. He had started losing control of his left side. He found lifting his leg to get into a car difficult. Walking caused him trouble. This time the scans showed a chronic hematoma — swelling and bruising — on the right side of his skull.\u003c/p>\n\u003cp>“It was like 3 inches long and an inch thick and I could see that my brain literally was off center and my cerebellum was misaligned,” says Baxter. Doctors told him he needed immediate surgery. The plan was to drill a little hole in his head the size of a dime.\u003c/p>\n\u003cp>“I thought, ‘My lord, is this the end of me?’ ”\u003c/p>\n\u003cp>\u003cstrong>A Lot of Brain Injuries\u003c/strong>\u003c/p>\n\u003cp>Each year, about \u003ca href=\"https://www.cdc.gov/mmwr/volumes/66/ss/ss6609a1.htm\" target=\"_blank\" rel=\"noopener\">2.5 million people in the United States\u003c/a> are admitted to emergency rooms with traumatic brain injuries, according to the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>The difficulties of studying concussions, with their vague symptoms and hidden physical damage, have turned brain injury into a “silent epidemic,” in the words of \u003ca href=\"http://profiles.ucsf.edu/pratik.mukherjee\" target=\"_blank\" rel=\"noopener\">Pratik Mukherjee\u003c/a>, a neuroradiologist at UCSF.\u003c/p>\n\u003cp>\u003ca href=\"https://www.hss.edu/physicians_shetty-teena.asp\" target=\"_blank\" rel=\"noopener\">Teena Shetty\u003c/a>, a neurologist at New York City's Hospital for Special Surgery, agrees. “Unlike other neurological diseases, one cannot pinpoint the area of injury in concussion,” she says.\u003c/p>\n\u003cp>Doctors are not even in agreement about how to treat concussions. Some advise resuming daily activities as soon as possible, others suggest avoiding demanding work and staying away from bright lights and loud sounds.\u003c/p>\n\u003cp>Existing guidelines are not backed by evidence, according to \u003ca href=\"https://www.urmc.rochester.edu/people/20187378-jeffrey-j-bazarian\" target=\"_blank\" rel=\"noopener\">Jeff Bazarian\u003c/a>, professor of emergency medicine at the University of Rochester Medical Center, in New York.\u003c/p>\n\u003cfigure id=\"attachment_437557\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003cimg class=\"size-large wp-image-437557\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-1020x765.jpg\" alt=\"\" width=\"640\" height=\"480\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-1020x765.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-160x120.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-960x720.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-240x180.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-375x281.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o-520x390.jpg 520w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/16463775_10154204797011497_6888461288485270646_o.jpg 1024w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003cfigcaption class=\"wp-caption-text\">Tom Gal, 37-year old entrepreneur from San Francisco, recovering from a car accident at Zuckerberg San Francisco General Hospital and Trauma Center. \u003ccite>(Courtesy Tom Gal)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>A New Approach Tracks Patients in Detail\u003c/strong>\u003c/p>\n\u003cp>Predicting which concussion patients will fully recover and which will be permanently debilitated is more or less a guessing game.\u003c/p>\n\u003cp>Tom Gal, a 37-year old entrepreneur from San Francisco, spent almost two days in a coma after being hit by a car last August. He woke up with no memory of what happened and had to learn the details from his medical report. But eight months after the injury, he says he is doing just fine. In contrast, 29-year-old bread baker Ana Diaz, from Richmond, Virginia, complains about short-term memory lapses and increased anxiety six months after a biking accident that left her with no signs of head trauma on a CT scan.\u003c/p>\n\u003cp>In light of such counter-intuitive outcomes, many researchers feel it is now time to make the diagnosis and prognosis of concussions more precise and evidence-based.\u003c/p>\n\u003cp>According to Mukherjee, \u003ca href=\"https://link.springer.com/article/10.1186/s12245-014-0031-6\" target=\"_blank\" rel=\"noopener\">15 to 30 percent of concussion patients\u003c/a> will experience \u003ca href=\"http://www.neurosymptoms.org/post-concussion-syndrome/4582101276\" target=\"_blank\" rel=\"noopener\">worsening brain function\u003c/a> later on, including problems with thinking, memory, attention and decision-making. Patients can also experience sleep disorders and headaches that persist for weeks, months or years. In the severest cases, people can develop epilepsy and seizures, with increased risk of Alzheimer’s disease.\u003c/p>\n\u003cp>As a result, about 3 to 5 million people live with the long-term physical, cognitive and psychological health disabilities of traumatic brain injury. Estimated annual direct and indirect costs are over $75 billion, \u003ca href=\"https://www.cdc.gov/traumaticbraininjury/severe.html\" target=\"_blank\" rel=\"noopener\">according to\u003c/a> the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>What’s needed, some researchers believe, is a large study focused on improving how doctors measure concussions and predict the long-term effects on patients.\u003c/p>\n\u003cp>Baxter, Gal and Diaz may have found one. While recovering from their injuries, they signed up for a study called \u003ca href=\"https://tracktbi.ucsf.edu/\" target=\"_blank\" rel=\"noopener\">TRACK TBI, \u003c/a>for Transforming Research in Clinical Knowledge in Traumatic Brain Injury.\u003c/p>\n\u003cp>TRACK TBI, spearheaded at UCSF, started in 2014 with just 75 enrolled patients. The cohort has now expanded to include over 2,000, with the goal of enrolling 1,000 more. The study spans 19 research centers across the country, and major funding comes from the National Institutes of Health and the Department of Defense. TRACK TBI is also partnering with CENTER TBI, a European sister-trial, monitoring 10,000 concussion patients.\u003c/p>\n\u003cp>Study researchers want to analyze the results of blood analysis, MRI scans and cognitive tests to find which patients are at higher risk of developing long-term cognitive problems after suffering concussions.\u003c/p>\n\u003cfigure id=\"attachment_437556\" class=\"wp-caption alignnone\" style=\"max-width: 640px\">\u003cimg class=\"wp-image-437556 size-large\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/12/Pratik-with-brain-image-1020x574.jpg\" alt=\"\" width=\"640\" height=\"360\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-1020x574.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-160x90.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-800x450.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-768x432.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-1180x664.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-960x540.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-240x135.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-375x211.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/12/Pratik-with-brain-image-520x293.jpg 520w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003cfigcaption class=\"wp-caption-text\">Pratik Mukherjee, neuroradiologist at UCSF, looking at a brain image. \u003ccite>(Julia Vassey/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>Getting a Closer Look\u003c/strong>\u003c/p>\n\u003cp>The problem with diagnosing concussions starts in the emergency room. The majority of patients with mild, non-life-threatening traumatic brain injuries get released from ER without any follow-up evaluation.\u003c/p>\n\u003cp>“And that is a mistake,” says Mukherjee, who is also one of TRACK TBI’s principal investigators.\u003c/p>\n\u003cp>CT scans in the ERs across the country can miss subtle brain damage, as occurred in Baxter’s first CT scan. These diagnostics can only detect structural changes or internal bleeding in the brain, like the hemorrhage Baxter eventually developed.\u003c/p>\n\u003cp>Even following severe traumatic brain injuries, as Gal suffered, neither CT nor standard MRI can detect microstructural changes and alterations in brain functioning.\u003c/p>\n\u003cp>But it is these subtle changes that may predict the likelihood of lasting problems, including impaired focus, attention, memory and decision-making.\u003c/p>\n\u003cp>TRACK TBI researchers are looking for biochemical signals that could ensure reliable, speedy diagnoses and good predictions of whether patients will suffer long-term effects.\u003c/p>\n\u003cp>Mapping is another focus of TRACK TBI. Powerful MRI scanners with software that allows precise reconstruction of high resolution MRI images could help scientists create brain maps.\u003c/p>\n\u003cp>The study is using the latest MRI scanners, at least twice as powerful as the ones installed in many of the country’s hospitals and imaging centers, to peer deeper into the brain and search for abnormalities in the fine-grain structure of the brain’s “white matter.” If this is damaged, it can disrupt brain functions like imprinting memories, maintaining focus and making decisions.\u003c/p>\n\u003cp>Patients enrolled in the TRACK TBI study get scanned two weeks after their head injury and then again six months later to reveal the presence of any chronic effects.\u003c/p>\n\u003cp>Researchers are also scanning for the presence of specific types of proteins in the blood that can be detected in brain-injury patients. TRACK TBI is particularly focusing on GFAP (glial fibrillary acidic protein) and Tau protein.\u003c/p>\n\u003cdiv>\u003c/div>\n\u003cp>“This is similar to how they diagnose heart attacks,” says Mukherjee. “If you are having a heart attack, the heart will spill particular proteins that can be detected, and provide a good objective test.”\u003c/p>\n\u003cp>In the 1950s and 1960s an electrocardiogram was the only way to measure a patient’s heart for signs of heart disease. But a patient could show a normal-looking EKG even while suffering a heart attack. With time, blood tests measuring proteins have proven to be more reliable. Using a similar approach could transform concussion diagnoses as well.\u003c/p>\n\u003cp>Shetty, who is not involved in the study, believes it has “a tremendous potential to understand relationships between biomarkers, neuroimaging and cognitive data.”\u003c/p>\n\u003cp>\u003ca href=\"https://www2.eecs.berkeley.edu/Faculty/Homepages/chunleiliu.html\" target=\"_blank\" rel=\"noopener\">Chunlei Liu\u003c/a>, an associate professor of the Helen Wills Neuroscience Institute at UC Berkeley, who also has no relationship to the study, is glad to see TRACK TBI’s multipronged approach.\u003c/p>\n\u003cp>Because brain trauma involves systemic changes in different parts of the brain, Liu says, “A single biomarker won't make a definitive answer.”\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>This approach is part of a trend. The \u003ca href=\"http://www.careconsortium.net/\" target=\"_blank\" rel=\"noopener\">CARE Consortium\u003c/a>, funded by the NCAA and the U.S. Department of Defense, is similar in many ways to TRACK TBI, but focuses on student-athletes and military service members. At the University of Pittsburgh. the \u003ca href=\"http://www.adapttrial.org/\" target=\"_blank\" rel=\"noopener\">ADAPT Trial\u003c/a> is focusing on children with severe traumatic brain injury, hoping to determine the best care procedures.\u003c/p>\n\u003cp>If prognostic biomarkers can be identified by TRACK and other studies, it could help scientists resurrect once-promising treatments that were abandoned after failed clinical trials. One of the most disappointing failures was the PROTECT trial, which in 2015 experimented with treating acute traumatic brain injury with progesterone, a steroid found to sometimes have powerful neuroprotective properties.The study showed promising results on lab animals, but it collapsed after moving to phase III human trials.\u003c/p>\n\u003cp>“Currently with the clinical trials, it has been one-size-fits-all for every patient,” says Mukherjee. He says researchers often enroll participants without knowing if they are prone to developing complications. “But this is a mistake, because patients are affected in many different ways, and types of pathologies are different.”\u003c/p>\n\u003cp>If biomarkers can be discovered, researchers can determine exactly which patients will or will not benefit from treatment.\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>And patients recovering from brain injuries may be able to face their future with a clearer idea of the path ahead.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/437552/just-because-you-have-a-mild-concussion-doesnt-mean-youre-ok","authors":["byline_futureofyou_437552"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1413","futureofyou_717","futureofyou_1414","futureofyou_1275","futureofyou_80"],"featImg":"futureofyou_437555","label":"source_futureofyou_437552"},"futureofyou_436409":{"type":"posts","id":"futureofyou_436409","meta":{"index":"posts_1591205157","site":"futureofyou","id":"436409","score":null,"sort":[1510591614000]},"guestAuthors":[],"slug":"new-trials-aim-to-stop-alzheimers-before-it-starts","title":"Amyloid Approach to Alzheimer’s Has Repeatedly Failed. Early Intervention May Be Its Last Shot","publishDate":1510591614,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Neuroscientist Paul Aisen has seen a lot of brains in patients afflicted with Alzheimer’s disease. In the tie-dye pattern characteristic of brain-imaging PET scans, researchers like Aisen are able to spot one of Alzheimer’s hallmarks: clumps of a certain type of protein that can be detected years before memory loss sets in.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The amyloid story needs to be finished, and either it works or it doesn’t in the current trials.'\u003ccite>Dr. David Knopman, Mayo Clinic\u003c/cite>\u003c/aside>\n\u003cp>Long-term studies indicate this protein — known as amyloid beta — starts building up excessively in the brain 15 or 20 years \u003ca href=\"https://www.mayoclinic.org/medical-professionals/clinical-updates/neurosciences/preclinical-alzheimers-disease\" target=\"_blank\" rel=\"noopener\">before any signs \u003c/a>of memory loss or cognitive difficulties. Healthy brains are \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/24493463\" target=\"_blank\" rel=\"noopener\">generally free \u003c/a>from these fibers of accumulated amyloid that have been linked to brain cell damage seen in Alzheimer's patients.\u003c/p>\n\u003cp>About\u003ca href=\"https://www.alz.org/facts/\" target=\"_blank\" rel=\"noopener\"> 5.5 million Americans\u003c/a> currently have the disease, according to the Alzheimer's Association.\u003c/p>\n\u003cp>Researchers like Aisen, who teaches at the University of Southern California's Keck School of Medicine, are betting that the early targeting and destruction of amyloid proteins will stop the disease before it can wreak havoc on a patient’s mind, and even long before overt symptoms appear. It's a novel idea for tackling Alzheimer's, based on tools like brain-imaging PET scans and long-term studies that have tracked amyloid buildup along with declines in memory.\u003c/p>\n\u003cp>A group of clinical trials just underway or currently recruiting subjects will test this approach. If they fail, it could prove to be the nail in the coffin for treatment based on the \u003ca href=\"https://www.google.com/search?q=amyloid+hypothesis\" target=\"_blank\" rel=\"noopener\">amyloid hypothesis\u003c/a> -- the idea that eradicating amyloid plaque will prevent or cure the disease. Multiple trials targeting the protein after symptoms have already begun have shown \u003ca href=\"https://www.theatlantic.com/health/archive/2017/02/alzheimers-amyloid-hypothesis/517185/\" target=\"_blank\" rel=\"noopener\">disappointing results\u003c/a>, including Eli Lilly’s high-profile \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/01/11/failure-of-experimental-alzheimers-drug-the-latest-blow-to-amyloid-hypothesis/\" target=\"_blank\" rel=\"noopener\">flop\u003c/a> last year with the drug solanezumab.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Dr. David Knopman, a clinician and researcher in cognitive disorders at the Mayo Clinic, thinks looking for drugs outside of amyloid targets “is critically important for the field.\" He mentions targeting the\u003ca href=\"http://blogs.sciencemag.org/pipeline/archives/2017/05/26/a-movement-towards-tau-in-alzheimers\" target=\"_blank\" rel=\"noopener\"> tau protein \u003c/a>as an approach researchers are excited about.\u003c/p>\n\u003cp>\"Even if an anti-amyloid agent did work,\" he says, \"there must be other processes downstream that could be more easily targeted or effective than amyloid.”\u003c/p>\n\u003cp>\u003cstrong>Amyloid, But Early\u003c/strong>\u003cbr>\n[contextly_sidebar id=\"cahpe4dxxqEqzeVeXObMxbAPDdMuyzx3\"]But according to Aisen, solanezumab is not dead yet. The problem with past trials, he believes, is they did not get to patients early enough.\u003c/p>\n\u003cp>“We strongly believe the effect will be greater in prevention trials that are underway, probably about 15 years earlier in the course of Alzheimer’s than the studies that were completed,\" he says.\u003c/p>\n\u003cp>This new crop of trials — five in total — have either recently begun or will soon get underway. Each trial is aiming to treat and prevent Alzheimer’s by targeting amyloid before cognitive symptoms ever develop.\u003c/p>\n\u003cp>Aisen is one of the lead scientists for the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (or A4) trial. As part of the trial, solanezumab will be given to seniors ages 65 to 85 who have elevated levels of amyloid plaque but no outward symptoms. Some of the 1,150 participants will receive the drug, an antibody that cleans up free-floating amyloid, over the course of four-and-a-half years, while others will get a placebo.\u003c/p>\n\u003cp>The participants will be monitored throughout for changes in memory and cognition, along with lab tests and brain imaging to detect physiological changes.\u003c/p>\n\u003cp>Another study known as the EARLY trial is still recruiting participants, ages 60 to 85, also healthy but at risk for Alzheimer's due to an elevated amyloid level or other factors. The treatment period lasts for four-and-a-half years with a drug that hampers the production of the protein. Both the A4 and the EARLY trials are coordinated by the \u003ca href=\"http://keck.usc.edu/atri/research/studies/\" target=\"_blank\" rel=\"noopener\">Alzheimer’s Therapeutic Research Institute\u003c/a>, which Aisen directs.\u003c/p>\n\u003cp>The \u003ca href=\"http://banneralz.org/research-clinical-trials/studies-currently-enrolling.aspx\" target=\"_blank\" rel=\"noopener\">Banner Alzheimer’s Institute\u003c/a> is conducting a trial on a different drug that also blocks the production of amyloid. Its Alzheimer’s Prevention Initiative program is still recruiting 1,300 participants worldwide for the trial, which will last 5 to 8 years. Known as the API Generation study, individuals ages 60 to 75 who are healthy but have a genetic profile that increases their risk for Alzheimer’s will be treated with one of two drugs. One targets amyloid in the brain for removal, and the other acts in a unique way that’s analogous to “the body being able to create its own vaccine,” says principal scientist Jessica Langbaum at Banner Alzheimer’s Institute.\u003c/p>\n\u003cp>Participants are selected based on a genetic risk factor known as APOE4, though they will not be made aware of this if they choose not to, says Langbaum. The study will also provide genetic counseling so that risk profiles aren’t misunderstood as prophecies of disease.\u003c/p>\n\u003cp>The Banner institute has created a registry called \u003ca href=\"http://banneralz.org/research-clinical-trials/genematch.aspx\" target=\"_blank\" rel=\"noopener\">GeneMatch\u003c/a> for Alzheimer's \u003ca href=\"http://banneralz.org/research-clinical-trials/studies-currently-enrolling.aspx\" target=\"_blank\" rel=\"noopener\">studies\u003c/a> currently enrolling people. These studies call for subjects as young as 40.\u003c/p>\n\u003cp>\u003cstrong>'Either It Works or It Doesn't'\u003c/strong>\u003c/p>\n\u003cp>In these three trials, even though the subjects have biochemical markers linked to the disease, the participants will not necessarily wind up with Alzheimer's.\u003c/p>\n\u003cp>Not so with two other two trials that are looking at a form of \u003ca href=\"https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/in-depth/alzheimers/art-20048356\" target=\"_blank\" rel=\"noopener\">early onset Alzheimer’s. \u003c/a>These individuals all have one of a few rare genes in which the disease manifests before age 65, usually when people are in their 40s or 50s. About 5 percent of people with Alzheimer's fall into this category.\u003c/p>\n\u003cp>Will targeting amyloid in the asymptomatic stage keep dementia at bay? That’s the billion-dollar question. But it's going to take several years for the results to trickle in.\u003c/p>\n\u003cp>Says Knopman: \"The amyloid story needs to be finished, and either it works or it doesn't in the current trials.\"\u003c/p>\n\u003cp>\u003cem>Dr. Paul Aisen discusses early targeting of amyloid in 2014.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=99ysY7LOajQ\u003c/p>\n\n","blocks":[],"excerpt":"If the trials are unsuccessful, it could mean the end of the line for the idea that amyloid plaque is the real cause of the disease.","status":"publish","parent":0,"modified":1513096756,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":24,"wordCount":1026},"headData":{"title":"Amyloid Approach to Alzheimer’s Has Repeatedly Failed. Early Intervention May Be Its Last Shot | KQED","description":"If the trials are unsuccessful, it could mean the end of the line for the idea that amyloid plaque is the real cause of the disease.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Amyloid Approach to Alzheimer’s Has Repeatedly Failed. Early Intervention May Be Its Last Shot","datePublished":"2017-11-13T16:46:54.000Z","dateModified":"2017-12-12T16:39:16.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"436409 https://ww2.kqed.org/futureofyou/?p=436409","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/11/13/new-trials-aim-to-stop-alzheimers-before-it-starts/","disqusTitle":"Amyloid Approach to Alzheimer’s Has Repeatedly Failed. Early Intervention May Be Its Last Shot","source":"KQED Future of You","nprByline":"Li Miao Lovett","path":"/futureofyou/436409/new-trials-aim-to-stop-alzheimers-before-it-starts","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Neuroscientist Paul Aisen has seen a lot of brains in patients afflicted with Alzheimer’s disease. In the tie-dye pattern characteristic of brain-imaging PET scans, researchers like Aisen are able to spot one of Alzheimer’s hallmarks: clumps of a certain type of protein that can be detected years before memory loss sets in.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The amyloid story needs to be finished, and either it works or it doesn’t in the current trials.'\u003ccite>Dr. David Knopman, Mayo Clinic\u003c/cite>\u003c/aside>\n\u003cp>Long-term studies indicate this protein — known as amyloid beta — starts building up excessively in the brain 15 or 20 years \u003ca href=\"https://www.mayoclinic.org/medical-professionals/clinical-updates/neurosciences/preclinical-alzheimers-disease\" target=\"_blank\" rel=\"noopener\">before any signs \u003c/a>of memory loss or cognitive difficulties. Healthy brains are \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/24493463\" target=\"_blank\" rel=\"noopener\">generally free \u003c/a>from these fibers of accumulated amyloid that have been linked to brain cell damage seen in Alzheimer's patients.\u003c/p>\n\u003cp>About\u003ca href=\"https://www.alz.org/facts/\" target=\"_blank\" rel=\"noopener\"> 5.5 million Americans\u003c/a> currently have the disease, according to the Alzheimer's Association.\u003c/p>\n\u003cp>Researchers like Aisen, who teaches at the University of Southern California's Keck School of Medicine, are betting that the early targeting and destruction of amyloid proteins will stop the disease before it can wreak havoc on a patient’s mind, and even long before overt symptoms appear. It's a novel idea for tackling Alzheimer's, based on tools like brain-imaging PET scans and long-term studies that have tracked amyloid buildup along with declines in memory.\u003c/p>\n\u003cp>A group of clinical trials just underway or currently recruiting subjects will test this approach. If they fail, it could prove to be the nail in the coffin for treatment based on the \u003ca href=\"https://www.google.com/search?q=amyloid+hypothesis\" target=\"_blank\" rel=\"noopener\">amyloid hypothesis\u003c/a> -- the idea that eradicating amyloid plaque will prevent or cure the disease. Multiple trials targeting the protein after symptoms have already begun have shown \u003ca href=\"https://www.theatlantic.com/health/archive/2017/02/alzheimers-amyloid-hypothesis/517185/\" target=\"_blank\" rel=\"noopener\">disappointing results\u003c/a>, including Eli Lilly’s high-profile \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/01/11/failure-of-experimental-alzheimers-drug-the-latest-blow-to-amyloid-hypothesis/\" target=\"_blank\" rel=\"noopener\">flop\u003c/a> last year with the drug solanezumab.\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>Dr. David Knopman, a clinician and researcher in cognitive disorders at the Mayo Clinic, thinks looking for drugs outside of amyloid targets “is critically important for the field.\" He mentions targeting the\u003ca href=\"http://blogs.sciencemag.org/pipeline/archives/2017/05/26/a-movement-towards-tau-in-alzheimers\" target=\"_blank\" rel=\"noopener\"> tau protein \u003c/a>as an approach researchers are excited about.\u003c/p>\n\u003cp>\"Even if an anti-amyloid agent did work,\" he says, \"there must be other processes downstream that could be more easily targeted or effective than amyloid.”\u003c/p>\n\u003cp>\u003cstrong>Amyloid, But Early\u003c/strong>\u003cbr>\n\u003c/p>\u003cp>\u003c/p>\u003cp>But according to Aisen, solanezumab is not dead yet. The problem with past trials, he believes, is they did not get to patients early enough.\u003c/p>\n\u003cp>“We strongly believe the effect will be greater in prevention trials that are underway, probably about 15 years earlier in the course of Alzheimer’s than the studies that were completed,\" he says.\u003c/p>\n\u003cp>This new crop of trials — five in total — have either recently begun or will soon get underway. Each trial is aiming to treat and prevent Alzheimer’s by targeting amyloid before cognitive symptoms ever develop.\u003c/p>\n\u003cp>Aisen is one of the lead scientists for the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (or A4) trial. As part of the trial, solanezumab will be given to seniors ages 65 to 85 who have elevated levels of amyloid plaque but no outward symptoms. Some of the 1,150 participants will receive the drug, an antibody that cleans up free-floating amyloid, over the course of four-and-a-half years, while others will get a placebo.\u003c/p>\n\u003cp>The participants will be monitored throughout for changes in memory and cognition, along with lab tests and brain imaging to detect physiological changes.\u003c/p>\n\u003cp>Another study known as the EARLY trial is still recruiting participants, ages 60 to 85, also healthy but at risk for Alzheimer's due to an elevated amyloid level or other factors. The treatment period lasts for four-and-a-half years with a drug that hampers the production of the protein. Both the A4 and the EARLY trials are coordinated by the \u003ca href=\"http://keck.usc.edu/atri/research/studies/\" target=\"_blank\" rel=\"noopener\">Alzheimer’s Therapeutic Research Institute\u003c/a>, which Aisen directs.\u003c/p>\n\u003cp>The \u003ca href=\"http://banneralz.org/research-clinical-trials/studies-currently-enrolling.aspx\" target=\"_blank\" rel=\"noopener\">Banner Alzheimer’s Institute\u003c/a> is conducting a trial on a different drug that also blocks the production of amyloid. Its Alzheimer’s Prevention Initiative program is still recruiting 1,300 participants worldwide for the trial, which will last 5 to 8 years. Known as the API Generation study, individuals ages 60 to 75 who are healthy but have a genetic profile that increases their risk for Alzheimer’s will be treated with one of two drugs. One targets amyloid in the brain for removal, and the other acts in a unique way that’s analogous to “the body being able to create its own vaccine,” says principal scientist Jessica Langbaum at Banner Alzheimer’s Institute.\u003c/p>\n\u003cp>Participants are selected based on a genetic risk factor known as APOE4, though they will not be made aware of this if they choose not to, says Langbaum. The study will also provide genetic counseling so that risk profiles aren’t misunderstood as prophecies of disease.\u003c/p>\n\u003cp>The Banner institute has created a registry called \u003ca href=\"http://banneralz.org/research-clinical-trials/genematch.aspx\" target=\"_blank\" rel=\"noopener\">GeneMatch\u003c/a> for Alzheimer's \u003ca href=\"http://banneralz.org/research-clinical-trials/studies-currently-enrolling.aspx\" target=\"_blank\" rel=\"noopener\">studies\u003c/a> currently enrolling people. These studies call for subjects as young as 40.\u003c/p>\n\u003cp>\u003cstrong>'Either It Works or It Doesn't'\u003c/strong>\u003c/p>\n\u003cp>In these three trials, even though the subjects have biochemical markers linked to the disease, the participants will not necessarily wind up with Alzheimer's.\u003c/p>\n\u003cp>Not so with two other two trials that are looking at a form of \u003ca href=\"https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/in-depth/alzheimers/art-20048356\" target=\"_blank\" rel=\"noopener\">early onset Alzheimer’s. \u003c/a>These individuals all have one of a few rare genes in which the disease manifests before age 65, usually when people are in their 40s or 50s. About 5 percent of people with Alzheimer's fall into this category.\u003c/p>\n\u003cp>Will targeting amyloid in the asymptomatic stage keep dementia at bay? That’s the billion-dollar question. But it's going to take several years for the results to trickle in.\u003c/p>\n\u003cp>Says Knopman: \"The amyloid story needs to be finished, and either it works or it doesn't in the current trials.\"\u003c/p>\n\u003cp>\u003cem>Dr. Paul Aisen discusses early targeting of amyloid in 2014.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/99ysY7LOajQ'\n title='//www.youtube.com/embed/99ysY7LOajQ'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/436409/new-trials-aim-to-stop-alzheimers-before-it-starts","authors":["byline_futureofyou_436409"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_999","futureofyou_717","futureofyou_1275"],"collections":["futureofyou_1097"],"featImg":"futureofyou_436907","label":"source_futureofyou_436409"},"futureofyou_434812":{"type":"posts","id":"futureofyou_434812","meta":{"index":"posts_1591205157","site":"futureofyou","id":"434812","score":null,"sort":[1502735444000]},"guestAuthors":[],"slug":"why-do-old-people-want-your-young-blood-video","title":"Why Do Old People Want Your Young Blood? (Video)","publishDate":1502735444,"format":"aside","headTitle":"KQED Future of You | KQED Science","labelTerm":{"term":1097,"site":"futureofyou"},"content":"\u003cp>https://www.youtube.com/watch?v=N88pPUWrc5k\u003c/p>\n\u003cp>The newest anti-aging trend sounds straight out of a vampire movie: injecting young blood into old people.\u003c/p>\n\u003cp>As alarming as that may sound, human trials have started to test whether blood from young people improves the health of older folks.\u003c/p>\n\u003cp>One \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02803554?term=ambrosia+LLC&rank=1\" target=\"_blank\" rel=\"noopener noreferrer\">ongoing trial\u003c/a>, based in California, is infusing \"older\" people (ages 35 and above) with the blood of younger people (ages 16-25). The older group is then tested a month later for improvements in blood-borne indicators associated with aging and disease, such as insulin and hemoglobin levels.\u003c/p>\n\u003cp>While the science is still out on young blood's benefit to humans, a \u003ca href=\"https://www.nature.com/news/ageing-research-blood-to-blood-1.16762\" target=\"_blank\" rel=\"noopener noreferrer\">body of research\u003c/a> does indicate, in animal studies at least, that young blood can improve organ and tissue function and prolong the life of older animals.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>To learn more about the hope and hype surrounding young blood, watch the video above, from \"\u003ca href=\"https://www.youtube.com/channel/UC4K10PNjqgGLKA3lo5V8KdQ\" target=\"_blank\" rel=\"noopener noreferrer\">Above the Noise\u003c/a>,\" KQED's YouTube series for teens.\u003c/p>\n\n","blocks":[],"excerpt":"Human trials have started to test whether blood from young people improves the health of older folks.","status":"publish","parent":0,"modified":1502821445,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":7,"wordCount":164},"headData":{"title":"Why Do Old People Want Your Young Blood? (Video) | KQED","description":"Human trials have started to test whether blood from young people improves the health of older folks.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Why Do Old People Want Your Young Blood? (Video)","datePublished":"2017-08-14T18:30:44.000Z","dateModified":"2017-08-15T18:24:05.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"434812 https://ww2.kqed.org/futureofyou/?p=434812","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/08/14/why-do-old-people-want-your-young-blood-video/","disqusTitle":"Why Do Old People Want Your Young Blood? (Video)","nprByline":"Above the Noise","path":"/futureofyou/434812/why-do-old-people-want-your-young-blood-video","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/N88pPUWrc5k'\n title='//www.youtube.com/embed/N88pPUWrc5k'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>The newest anti-aging trend sounds straight out of a vampire movie: injecting young blood into old people.\u003c/p>\n\u003cp>As alarming as that may sound, human trials have started to test whether blood from young people improves the health of older folks.\u003c/p>\n\u003cp>One \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT02803554?term=ambrosia+LLC&rank=1\" target=\"_blank\" rel=\"noopener noreferrer\">ongoing trial\u003c/a>, based in California, is infusing \"older\" people (ages 35 and above) with the blood of younger people (ages 16-25). The older group is then tested a month later for improvements in blood-borne indicators associated with aging and disease, such as insulin and hemoglobin levels.\u003c/p>\n\u003cp>While the science is still out on young blood's benefit to humans, a \u003ca href=\"https://www.nature.com/news/ageing-research-blood-to-blood-1.16762\" target=\"_blank\" rel=\"noopener noreferrer\">body of research\u003c/a> does indicate, in animal studies at least, that young blood can improve organ and tissue function and prolong the life of older animals.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>To learn more about the hope and hype surrounding young blood, watch the video above, from \"\u003ca href=\"https://www.youtube.com/channel/UC4K10PNjqgGLKA3lo5V8KdQ\" target=\"_blank\" rel=\"noopener noreferrer\">Above the Noise\u003c/a>,\" KQED's YouTube series for teens.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/434812/why-do-old-people-want-your-young-blood-video","authors":["byline_futureofyou_434812"],"categories":["futureofyou_1062","futureofyou_1"],"tags":["futureofyou_532","futureofyou_1241","futureofyou_717","futureofyou_1337"],"collections":["futureofyou_1097"],"featImg":"futureofyou_434828","label":"futureofyou_1097"},"futureofyou_343296":{"type":"posts","id":"futureofyou_343296","meta":{"index":"posts_1591205157","site":"futureofyou","id":"343296","score":null,"sort":[1489174884000]},"guestAuthors":[],"slug":"cancer-study-recruits-patients-at-record-pace-heres-why","title":"Cancer Study Recruits Patients at Record Pace. Here's Why","publishDate":1489174884,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>Many studies designed to try out new drugs simply languish. They don't attract enough patients, and they aren't completed. That slows medical progress.\u003c/p>\n\u003cp>But here's a story of one study that has bucked that trend — in fact, it is so popular, scientists had to put the brakes on it for a while.\u003c/p>\n\u003cp>The study is called the \u003ca href=\"https://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match#1\">NCI-MATCH\u003c/a> trial. It upends the normal way of classifying cancers for treatment: Instead of categorizing malignancies by the organ where they first appear, this method of sorting focuses on particular mutations in the genes of cancer cells.\u003c/p>\n\u003cp>\"Instead of thinking of a breast cancer treatment or a lung cancer treatment or colon, it looks at the different mutations that occur in the tumors,\" explains oncologist Robert Comis, who leads the study.\u003c/p>\n\u003cp>NCI-MATCH recruits people who have tried and failed the traditional cancer treatments. People like 74-year-old Nancy Nahmias.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"It all started when I was diagnosed with cancer of the liver,\" Nahmias says. \"I was put on chemo, which I reacted very poorly to.\" In fact, she developed a severe reaction called \u003ca href=\"https://www.cdc.gov/sepsis/basic/qa.html\">sepsis\u003c/a>, which put her in the hospital for six weeks.\u003c/p>\n\u003cp>Standard chemotherapy was out of the question, her doctors told her.\u003c/p>\n\u003cp>[contextly_sidebar id=\"8HvFsm2US3VJYjZMBum0MAzyztdlyh8W\"]Nahmias' daughter, a physician, learned about the NCI-MATCH trial and encouraged her mother to give it a try. Scientists screened the genetic pattern of her tumor and found a mutation that might be amenable to a treatment not usually given to patients who have liver cancer. Nahmias signed up about two months ago, at Thomas Jefferson University, one of many sites running the study.\u003c/p>\n\u003cp>The study has been recruiting patients at a record pace. In its first three months it enrolled 800 patients, far more than the 150 the researchers expected, Comis says.\u003c/p>\n\u003cp>The organizers had to pause the study briefly, to reconfigure their labs to keep up with the flood of patients.\u003c/p>\n\u003cp>That rapid clip is no doubt because the study is aimed at patients who are running out of traditional treatment options.\u003c/p>\n\u003cp>But it's also because the researchers who designed the study stopped to ask what would appeal to potential participants. \u003ca href=\"http://fightcolorectalcancer.org/about/our-team/nancy-roach/\">Nancy Roach\u003c/a>, a longtime patient's advocate who lives in rural Oregon, got involved early on, and helped advise the scientists planning this study.\u003c/p>\n\u003cp>\u003cstrong>Know Your Audience\u003c/strong>\u003c/p>\n\u003cp>\"This is going to sound goofy, but my dad was in advertising,\" she tells Shots. \"Remember the scrubbing bubbles — Dow scrubbing bubbles? That was my dad. So I grew up watching commercials and thinking about what consumers wanted.\"\u003c/p>\n\u003cp>Roach brought that sensibility to the conferences where the NCI-MATCH trial was being designed. The original plan would have split the study participants who seem to be doing well on the test treatment into two groups. One group would continue the treatment; the other would take a break, called a drug holiday.\u003c/p>\n\u003cp>Roach remembers her immediate reaction to that design: \"Taking a patient who's responding to treatment and taking them off treatment? That is not going to fly.\"\u003c/p>\n\u003cp>She correctly anticipated how patients like Nancy Nahmias would have reacted, as they deliberated whether to sign up for the trial.\u003c/p>\n\u003cp>\"I would not have liked that,\" Nahmias says. \"If it seems to be working, let's face it, I don't want to do anything to sabotage myself.\"\u003c/p>\n\u003cp>\u003ca href=\"https://www.med.upenn.edu/apps/faculty/index.php/g348/p17520\">Dr. Peter O'Dwyer,\u003c/a> a University of Pennsylvania oncologist who was involved in the study design, readily admits that \"the design had certain attractions, but it clearly had certain flaws.\"\u003c/p>\n\u003cp>On the one hand, incorporating a drug holiday would have helped doctors tell whether a tumor was just growing slowly, or actually responding to treatment, O'Dwyer says.\u003c/p>\n\u003cp>On the other hand, the researchers could see the point that Nancy Roach and others in the patient advisory group were making.\u003c/p>\n\u003cp>\u003cstrong>Want Patients in Your study? Listen to Their Concerns\u003c/strong>\u003c/p>\n\u003cp>\"We all agreed, and changed the design of the study accordingly,\" O'Dwyer says. That meant the scientists wouldn't be able to distinguish as easily the slow-growing tumors from ones responding to treatment — that insight would have to come from a follow-up study.\u003c/p>\n\u003cp>Comis says researchers used to design studies without any patient input, back in the day when patients tended not to question their physicians. But just as patients have gotten more involved in their own care, their advocates have become more involved in the technical discussions of study design.\u003c/p>\n\u003cp>\"That has increasingly become the norm in the development of clinical trials,\" Comis says.\u003c/p>\n\u003cp>He and O'Dwyer work together in Philadelphia at a research organization known by its acronym, \u003ca href=\"http://ecog-acrin.org/\">ECOG-ACRIN\u003c/a>.\u003c/p>\n\u003cp>Years ago, Comis was involved in a landmark study that put cooperation with patients to the test.\u003c/p>\n\u003cp>Back in the 1990s, doctors were increasingly encouraging breast cancer patients to undergo very aggressive treatment that involved having a bone-marrow transplant. The treatment, which can have serious side effects, was based on poor evidence, Comis says, so he wanted to run a rigorous trial to see if it really worked for this group of patients.\u003c/p>\n\u003cp>\u003cstrong>Patients Can Have biases, Too\u003c/strong>\u003c/p>\n\u003cp>\"We struggled throughout the '90s to put enough patients on clinical trials, which ultimately showed that it didn't work,\" Comis says.\u003c/p>\n\u003cp>Patients and their advocates, as well as doctors, really didn't want to question the prevailing wisdom about bone marrow transplants, he says. \"And I think one of the reasons some of those early trials took so long was that the whole external environment was against participation in these particular trials.\"\u003c/p>\n\u003cp>That experience validated Comis' view that patient advocates are central to doing good research.\u003c/p>\n\u003cp>From Nancy Roach's perspective, it takes a bit of nerve to speak up in a room of doctors and scientists and ask, \"Will the results of this study actually help anybody?\"\u003c/p>\n\u003cp>But it's Roach's responsibility to ask those basic questions. \"I'm not a scientist,\" she says. \"I'm not a clinician. I'm there on behalf of patients.\"\u003c/p>\n\u003cp>Her own journey started when her mother-in-law developed colorectal cancer. Roach went from being an advocate for one patient to an advocate for many; she co-founded the Colon Cancer Alliance in 1999, advocating for those with cancer and their families. And while she's gratified to see more and more people stepping in to become patient's advocates in research design, she notes that most are white and economically advantaged.\u003c/p>\n\u003cp>\"Honestly,\" she says, \"most of them look like me. And that's a problem.\"\u003c/p>\n\u003cp>African-Americans are under-represented in clinical trials, she notes. That may be in part because their doctors aren't recommending experimental treatments as often. But it may also be that the clinical trials haven't made a big enough effort to listen to the needs of various communities of patients.\u003c/p>\n\u003cp>Roach hopes this will be the next frontier for patient involvement.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>You can contact Richard Harris at \u003ca href=\"mailto:rharris@npr.org\">rharris@npr.org\u003c/a>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Advice+From+Patients+On+A+Study%27s+Design+Makes+For+Better+Science+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"Increasingly, advocates for patients are in the room when big medical studies are designed, demanding answers to questions: like: ;Will the results of this study actually help anybody?'","status":"publish","parent":0,"modified":1489174918,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":41,"wordCount":1177},"headData":{"title":"Cancer Study Recruits Patients at Record Pace. Here's Why | KQED","description":"Increasingly, advocates for patients are in the room when big medical studies are designed, demanding answers to questions: like: ;Will the results of this study actually help anybody?'","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Cancer Study Recruits Patients at Record Pace. Here's Why","datePublished":"2017-03-10T19:41:24.000Z","dateModified":"2017-03-10T19:41:58.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"343296 https://ww2.kqed.org/futureofyou/?p=343296","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/03/10/cancer-study-recruits-patients-at-record-pace-heres-why/","disqusTitle":"Cancer Study Recruits Patients at Record Pace. Here's Why","nprByline":"Richard Harris\u003cbr />NPR Shots","nprImageAgency":"Andrew Wortmann/Courtesy of Fight Colorectal Cancer","nprStoryId":"515226648","nprApiLink":"http://api.npr.org/query?id=515226648&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"http://www.npr.org/sections/health-shots/2017/02/24/515226648/advice-from-patients-on-a-studys-design-makes-for-better-science?ft=nprml&f=515226648","nprRetrievedStory":"1","nprPubDate":"Fri, 24 Feb 2017 11:42:00 -0500","nprStoryDate":"Fri, 24 Feb 2017 11:42:36 -0500","nprLastModifiedDate":"Fri, 24 Feb 2017 11:42:36 -0500","path":"/futureofyou/343296/cancer-study-recruits-patients-at-record-pace-heres-why","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Many studies designed to try out new drugs simply languish. They don't attract enough patients, and they aren't completed. That slows medical progress.\u003c/p>\n\u003cp>But here's a story of one study that has bucked that trend — in fact, it is so popular, scientists had to put the brakes on it for a while.\u003c/p>\n\u003cp>The study is called the \u003ca href=\"https://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match#1\">NCI-MATCH\u003c/a> trial. It upends the normal way of classifying cancers for treatment: Instead of categorizing malignancies by the organ where they first appear, this method of sorting focuses on particular mutations in the genes of cancer cells.\u003c/p>\n\u003cp>\"Instead of thinking of a breast cancer treatment or a lung cancer treatment or colon, it looks at the different mutations that occur in the tumors,\" explains oncologist Robert Comis, who leads the study.\u003c/p>\n\u003cp>NCI-MATCH recruits people who have tried and failed the traditional cancer treatments. People like 74-year-old Nancy Nahmias.\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>\"It all started when I was diagnosed with cancer of the liver,\" Nahmias says. \"I was put on chemo, which I reacted very poorly to.\" In fact, she developed a severe reaction called \u003ca href=\"https://www.cdc.gov/sepsis/basic/qa.html\">sepsis\u003c/a>, which put her in the hospital for six weeks.\u003c/p>\n\u003cp>Standard chemotherapy was out of the question, her doctors told her.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>Nahmias' daughter, a physician, learned about the NCI-MATCH trial and encouraged her mother to give it a try. Scientists screened the genetic pattern of her tumor and found a mutation that might be amenable to a treatment not usually given to patients who have liver cancer. Nahmias signed up about two months ago, at Thomas Jefferson University, one of many sites running the study.\u003c/p>\n\u003cp>The study has been recruiting patients at a record pace. In its first three months it enrolled 800 patients, far more than the 150 the researchers expected, Comis says.\u003c/p>\n\u003cp>The organizers had to pause the study briefly, to reconfigure their labs to keep up with the flood of patients.\u003c/p>\n\u003cp>That rapid clip is no doubt because the study is aimed at patients who are running out of traditional treatment options.\u003c/p>\n\u003cp>But it's also because the researchers who designed the study stopped to ask what would appeal to potential participants. \u003ca href=\"http://fightcolorectalcancer.org/about/our-team/nancy-roach/\">Nancy Roach\u003c/a>, a longtime patient's advocate who lives in rural Oregon, got involved early on, and helped advise the scientists planning this study.\u003c/p>\n\u003cp>\u003cstrong>Know Your Audience\u003c/strong>\u003c/p>\n\u003cp>\"This is going to sound goofy, but my dad was in advertising,\" she tells Shots. \"Remember the scrubbing bubbles — Dow scrubbing bubbles? That was my dad. So I grew up watching commercials and thinking about what consumers wanted.\"\u003c/p>\n\u003cp>Roach brought that sensibility to the conferences where the NCI-MATCH trial was being designed. The original plan would have split the study participants who seem to be doing well on the test treatment into two groups. One group would continue the treatment; the other would take a break, called a drug holiday.\u003c/p>\n\u003cp>Roach remembers her immediate reaction to that design: \"Taking a patient who's responding to treatment and taking them off treatment? That is not going to fly.\"\u003c/p>\n\u003cp>She correctly anticipated how patients like Nancy Nahmias would have reacted, as they deliberated whether to sign up for the trial.\u003c/p>\n\u003cp>\"I would not have liked that,\" Nahmias says. \"If it seems to be working, let's face it, I don't want to do anything to sabotage myself.\"\u003c/p>\n\u003cp>\u003ca href=\"https://www.med.upenn.edu/apps/faculty/index.php/g348/p17520\">Dr. Peter O'Dwyer,\u003c/a> a University of Pennsylvania oncologist who was involved in the study design, readily admits that \"the design had certain attractions, but it clearly had certain flaws.\"\u003c/p>\n\u003cp>On the one hand, incorporating a drug holiday would have helped doctors tell whether a tumor was just growing slowly, or actually responding to treatment, O'Dwyer says.\u003c/p>\n\u003cp>On the other hand, the researchers could see the point that Nancy Roach and others in the patient advisory group were making.\u003c/p>\n\u003cp>\u003cstrong>Want Patients in Your study? Listen to Their Concerns\u003c/strong>\u003c/p>\n\u003cp>\"We all agreed, and changed the design of the study accordingly,\" O'Dwyer says. That meant the scientists wouldn't be able to distinguish as easily the slow-growing tumors from ones responding to treatment — that insight would have to come from a follow-up study.\u003c/p>\n\u003cp>Comis says researchers used to design studies without any patient input, back in the day when patients tended not to question their physicians. But just as patients have gotten more involved in their own care, their advocates have become more involved in the technical discussions of study design.\u003c/p>\n\u003cp>\"That has increasingly become the norm in the development of clinical trials,\" Comis says.\u003c/p>\n\u003cp>He and O'Dwyer work together in Philadelphia at a research organization known by its acronym, \u003ca href=\"http://ecog-acrin.org/\">ECOG-ACRIN\u003c/a>.\u003c/p>\n\u003cp>Years ago, Comis was involved in a landmark study that put cooperation with patients to the test.\u003c/p>\n\u003cp>Back in the 1990s, doctors were increasingly encouraging breast cancer patients to undergo very aggressive treatment that involved having a bone-marrow transplant. The treatment, which can have serious side effects, was based on poor evidence, Comis says, so he wanted to run a rigorous trial to see if it really worked for this group of patients.\u003c/p>\n\u003cp>\u003cstrong>Patients Can Have biases, Too\u003c/strong>\u003c/p>\n\u003cp>\"We struggled throughout the '90s to put enough patients on clinical trials, which ultimately showed that it didn't work,\" Comis says.\u003c/p>\n\u003cp>Patients and their advocates, as well as doctors, really didn't want to question the prevailing wisdom about bone marrow transplants, he says. \"And I think one of the reasons some of those early trials took so long was that the whole external environment was against participation in these particular trials.\"\u003c/p>\n\u003cp>That experience validated Comis' view that patient advocates are central to doing good research.\u003c/p>\n\u003cp>From Nancy Roach's perspective, it takes a bit of nerve to speak up in a room of doctors and scientists and ask, \"Will the results of this study actually help anybody?\"\u003c/p>\n\u003cp>But it's Roach's responsibility to ask those basic questions. \"I'm not a scientist,\" she says. \"I'm not a clinician. I'm there on behalf of patients.\"\u003c/p>\n\u003cp>Her own journey started when her mother-in-law developed colorectal cancer. Roach went from being an advocate for one patient to an advocate for many; she co-founded the Colon Cancer Alliance in 1999, advocating for those with cancer and their families. And while she's gratified to see more and more people stepping in to become patient's advocates in research design, she notes that most are white and economically advantaged.\u003c/p>\n\u003cp>\"Honestly,\" she says, \"most of them look like me. And that's a problem.\"\u003c/p>\n\u003cp>African-Americans are under-represented in clinical trials, she notes. That may be in part because their doctors aren't recommending experimental treatments as often. But it may also be that the clinical trials haven't made a big enough effort to listen to the needs of various communities of patients.\u003c/p>\n\u003cp>Roach hopes this will be the next frontier for patient involvement.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>You can contact Richard Harris at \u003ca href=\"mailto:rharris@npr.org\">rharris@npr.org\u003c/a>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Advice+From+Patients+On+A+Study%27s+Design+Makes+For+Better+Science+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/343296/cancer-study-recruits-patients-at-record-pace-heres-why","authors":["byline_futureofyou_343296"],"categories":["futureofyou_1062","futureofyou_1"],"tags":["futureofyou_103","futureofyou_717","futureofyou_120","futureofyou_80","futureofyou_1206"],"featImg":"futureofyou_343297","label":"futureofyou"},"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_212117":{"type":"posts","id":"futureofyou_212117","meta":{"index":"posts_1591205157","site":"futureofyou","id":"212117","score":null,"sort":[1469728571000]},"guestAuthors":[],"slug":"14000-to-get-into-a-clinical-trial-pay-to-play-listings-creep-into-governments-website","title":"$14,000 to Get Into a Clinical Trial? Pay-to-Play Listings Creep Into Government's Website","publishDate":1469728571,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>Last summer, Linda Smith learned she was losing significant cartilage in her knees, a consequence of her lifelong love of skiing, running and ultimate frisbee.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"It’s unethical that these companies are saying, ‘Sure, come take part in our study and by the way, we’re going to charge you for the privilege.’ ”\u003c/aside>\n\u003cp>Diagnosed with osteoarthritis, she wanted to avoid surgery and was eager to consider alternatives.\u003c/p>\n\u003cp>So the 56-year-old Morgan Hill, Calif., resident embarked on a search for clinical trials, which test potential treatments on human subjects. She scoured the government-run website ClinicalTrials.gov, focusing on a form of stem cell therapy — a promising but unproven approach for her condition.\u003c/p>\n\u003cp>She thought she’d scored with StemGenex, a clinic in La Jolla, and called to inquire. The screener asked a long list of questions, then dropped a bomb: If Smith wanted in, she’d have to pay “associated” costs.\u003c/p>\n\u003cp>Total charge: $14,000.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“I was outraged,” Smith said. Her anger only grew when the screener suggested she could raise the money, as other callers had, through family and friends in an online GoFundMe campaign, she said.\u003c/p>\n\u003cp>Smith, a retired hospital administrator, knew enough about clinical studies to understand that the $14,000 price tag was unusual. Most trials are free and some even pay people to participate, in recognition of the possible risks and inconvenience involved.\u003c/p>\n\u003cp>The ClinicialTrials.gov website, run by the National Institutes of Health (NIH) through its National Library of Medicine, is the most comprehensive such database available to the public in the United States, with listings for more than 210,000 clinical studies both here and abroad. But Smith’s experience exposes one of its little-known limitations: It does not require trial sponsors to disclose charges to patients — and does not even independently vet the listings.\u003c/p>\n\u003cp>“I went back to the website and looked at the study again. It doesn’t say that patients are the funding source,” said Smith, who refused the $14,000 proposal. “I was disappointed in the NIH. I thought, ‘Why are you letting this occur?'”\u003c/p>\n\u003cp>\u003cstrong>Misleading Consumers\u003c/strong>\u003c/p>\n\u003cp>StemGenex denies that it charges for participation in its clinical study. It says it only charges for the treatment that is being studied and that participation in the study is separate and voluntary.\u003c/p>\n\u003cp>Some ethicists and other experts who shared Smith’s concern said that’s a false distinction. If trial sponsors require participants to pay, they said, the government website ought to let people know.\u003c/p>\n\u003cp>They argued that ClinicalTrials.gov’s failure to disclose charges by trial sponsors misleads consumers and allows the site to become a marketing tool for pay-to-play research.\u003c/p>\n\u003cfigure id=\"attachment_212124\" class=\"wp-caption aligncenter\" style=\"max-width: 770px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/linda-smith-4.jpg\">\u003cimg class=\"wp-image-212124 size-full\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/linda-smith-4.jpg\" alt=\"Linda Smith lost significant cartilage in both of her knees due to years of skiing, running and ultimate frisbee. The 56-year-old Morgan Hill, Calif., resident researched stem cell therapy for osteoarthritis to avoid surgery. \" width=\"770\" height=\"513\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/linda-smith-4.jpg 770w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/linda-smith-4-400x266.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/linda-smith-4-768x512.jpg 768w\" sizes=\"(max-width: 770px) 100vw, 770px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Linda Smith lost significant cartilage in both of her knees due to years of skiing, running and ultimate frisbee. The 56-year-old Morgan Hill, Calif., resident researched stem cell therapy for osteoarthritis to avoid surgery. \u003ccite>(Heidi de Marco/KHN)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“It’s unethical that these companies are saying, ‘Sure, come take part in our study and by the way, we’re going to charge you for the privilege’,” said Alison Bateman-House, a postdoctoral fellow in medical ethics at the New York University School of Medicine. “If you’re going to be charging patients for the opportunity to be involved in the study, they should not be allowed to be listed on ClinicalTrials.gov, or at least the cost should be listed on the site.”\u003c/p>\n\u003cp>She and others worry that many patients seeking to participate in clinical trials might be desperately sick or in pain, and vulnerable to requests for money they don’t have. These patients see the website’s “.gov” domain and the NIH imprimatur as stamps of approval that mean the research is legitimate, these critics say.\u003c/p>\n\u003cp>“The average patient and even people in health care … kind of let their guard down when they’re in that database. It’s like, ‘If a trial is listed here, it must be OK’,” said Paul Knoepfler, an associate professor at the University of California, Davis, School of Medicine who writes a blog about stem cell research. “Most people don’t realize that creeping into that database are some trials whose main goal is to generate profit.”\u003c/p>\n\u003cp>Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics, said it’s not clear if this phenomenon is only occurring with stem cell studies, but the surge in stem cell research — and in clinics offering high-priced, unproven treatments — has intensified the problem.\u003c/p>\n\u003cp>“It’s not just a handful of patients who are encountering these kind of so-called studies on ClinicalTrials.gov and not just a handful of studies,” he said. “It is a bigger problem than that.”\u003c/p>\n\u003cp>Asked whether costs should be disclosed on ClinicalTrials.gov, Dr. Rebecca Williams, assistant director of the website, said “that’s a valid question.”\u003c/p>\n\u003cp>As a practical matter, she said, “that has been information we don’t collect in a systematic way and nor is it available. We have no way to know whether they’re for-profit or not, and don’t have a policy that would exclude them.”\u003c/p>\n\u003cp>\u003cstrong>Not an Endorsement\u003c/strong>\u003c/p>\n\u003cp>Williams pointed to the website’s disclaimer that the government is not liable for and does not “make any warranties” about information in the database. She also noted that the site suggests questions for consumers to ask, including, “Who will pay for my participation?”\u003c/p>\n\u003cp>Williams stressed that the website is intended primarily as a “clearinghouse” of listings, and that just because a study is there “does not necessarily mean an endorsement by the federal government.”\u003c/p>\n\u003cp>It means that the study sponsors have attested that the information they’re submitting is complete and that their research complies with “all of the applicable regulations that may apply,” she said.\u003c/p>\n\u003cp>The website is not legally required to independently verify the information provided by study sponsors. ClinicalTrials.gov relies heavily on the honor system, Williams said.\u003c/p>\n\u003cp>Study sponsors who wish to list their studies on the website register online and must provide a variety of details, including, in most cases, information about the committees that oversee the welfare and treatment of human subjects.\u003c/p>\n\u003cp>Thanks to a 2007 law, changes will be made to the website’s listings and requirements, possibly by the end of this year. But Williams said it’s “unlikely” they will include disclosures of costs to patients.\u003c/p>\n\u003cp>Generally speaking, the U.S. Food and Drug Administration regulates clinical trials of medications and medical devices, and sets guidelines that determine when patients can be charged. But stem cell research, which often uses a patients’ own cells for treatment, can fall into a gray area, and what requires FDA approval is sometimes unclear or in dispute.\u003c/p>\n\u003cp>\u003cstrong>Pay to Play\u003c/strong>\u003c/p>\n\u003cp>StemGenex says it does not charge anyone for the osteoporosis study listed in ClinicalTrials.gov.\u003c/p>\n\u003cp>“StemGenex’s study is intended to be an observational study comparing two sets of data — before and after stem cell treatment,” Candace Henderson, the clinic’s vice president of operations, said in a prepared statement.\u003c/p>\n\u003cp>The way she explained it, patients who first pay for the company’s stem cell treatment can then “volunteer” to participate in the long-term observational study of how well the treatment works.\u003c/p>\n\u003cp>“The actual treatment is not part of the study protocol,” Henderson said. She declined to share a copy of the protocol, saying it “is proprietary to StemGenex.”\u003c/p>\n\u003cp>But the reality is that patients who want to participate in research like this must first shell out thousands for the stem cell treatment, University of Minnesota’s Turner said. In effect, he said, they pay to play.\u003c/p>\n\u003cp>StemGenex says it invests revenue from its clinical trials “in innovation and research to further the development and advancement” of therapies. It has four other studies listed on the NIH website: for Parkinson’s disease, multiple sclerosis, rheumatoid arthritis and chronic obstructive pulmonary disease. In those cases, too, participants “are recruited from among patients who are having stem cell treatment,” Henderson said in the company statement.\u003c/p>\n\u003cp>\u003ca href=\"https://stemgenex.com/frequently-asked-questions/#tab-14\" target=\"_blank\">On its website\u003c/a>, the company explains that it harvests dormant stem cells from a patient’s fat through “a mini-liposuction” and isolates the cells from the fat. The cells are then “activated with the patient’s growth factors,” and infused back into the patient. The stem cells then “follow inflammatory signals from damaged tissues and have multiple ways of repairing these damaged areas.”\u003c/p>\n\u003cp>The company, which describes itself as “\u003ca href=\"https://stemgenex.com/about-us/\" target=\"_blank\">the premiere leader in the United States for regenerative medicine\u003c/a>,” says it offers a “\u003ca href=\"https://stemgenex.com/treatment-center/traveling-stemgenex/make-getting-easy/\" target=\"_blank\">a concierge approach to treatment\u003c/a>,” which includes covering the cost of its patients’ hotel accommodations and a car service that “\u003ca href=\"https://stemgenex.com/frequently-asked-questions/\" target=\"_blank\">will be waiting for you at the airport baggage claim when you arrive\u003c/a>.”\u003c/p>\n\u003cp>\u003ca href=\"https://stemgenex.com/frequently-asked-questions/#tab-14\" target=\"_blank\">The company acknowledges\u003c/a> that its procedures — like most stem cell treatments — are not FDA-approved. \u003ca href=\"https://stemgenex.com/press/stemgenex-new-clinical-study-aims-provide-relief-osteoarthritis-patients-latest-stem-cell-therapy/\" target=\"_blank\">On its website\u003c/a>, however, StemGenex underscores that its studies are “registered through The National Institutes of Health which can be found at\u003ca href=\"http://www.clinicaltrials.gov.xn--ivg/\" rel=\"nofollow\">http://www.clinicaltrials.gov.”\u003c/a>\u003c/p>\n\u003cp>“By providing patients access to stem cell studies registered through The National Institutes of Health, patients now have the ability to choose treatment for osteoarthritis that focuses on both safety and efficacy,” it says.\u003c/p>\n\u003cp>\u003ca href=\"https://stemgenex.com/frequently-asked-questions/#tab-14\" target=\"_blank\">Also on its website\u003c/a>, the clinic says that having studies registered on ClinicalTrials.gov gives it a “significant advantage compared with treatment centers offering unregistered studies.”\u003c/p>\n\u003cp>Turner called the messages misleading, because they suggest the NIH has vetted the clinic’s osteoarthritis and other studies. “In fact, nobody at the NIH or in our government has necessarily, or even likely, looked at this study,” he said.\u003c/p>\n\u003cp>He pointed to other stem cell clinics posting on ClinicalTrials.gov that ask patients to pay, including one in Rancho Mirage that is conducting a study on stem cell treatment for conditions such as emphysema, osteoarthritis and erectile dysfunction.\u003c/p>\n\u003cp>Knoepfler said he used to direct patients to ClinicalTrials.gov, but then, “I started realizing, ‘wait a minute … there are listings on that website that are not what I thought would be on ClinicalTrials.gov.'”\u003c/p>\n\u003cp>He and other critics would like to see ClinicalTrials.gov reevaluate its position on allowing for-profit trials to post on the website.\u003c/p>\n\u003cp>“It’s one of the best sources we have, but there’s still room for misleading and incomplete information, and I would imagine in some cases, there are people preying on desperate patients, even on the ClinicalTrials.gov registry,” said \u003ca href=\"http://csdd.tufts.edu/about/staff_profile/ken_getz\" target=\"_blank\">Ken Getz\u003c/a>, an associate professor at Tufts University School of Medicine, and founder of the Center for Information and Study on Clinical Research Participation.\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\">Kaiser Health News\u003c/a>, which publishes \u003ca href=\"http://www.californiahealthline.org/\" target=\"_blank\">California Healthline\u003c/a>, a service of the \u003ca href=\"http://www.chcf.org/\" target=\"_blank\">California Health Care Foundation\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp> \u003c/p>\n\n","blocks":[],"excerpt":"The ClinicialTrials.gov website, run by the NIH, lists more than 210,000 clinical studies. But the site does not require trial sponsors to disclose when patients will be charged to participate.","status":"publish","parent":0,"modified":1475119407,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":48,"wordCount":1913},"headData":{"title":"$14,000 to Get Into a Clinical Trial? Pay-to-Play Listings Creep Into Government's Website | KQED","description":"The ClinicialTrials.gov website, run by the NIH, lists more than 210,000 clinical studies. But the site does not require trial sponsors to disclose when patients will be charged to participate.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"$14,000 to Get Into a Clinical Trial? Pay-to-Play Listings Creep Into Government's Website","datePublished":"2016-07-28T17:56:11.000Z","dateModified":"2016-09-29T03:23:27.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"212117 http://ww2.kqed.org/futureofyou/?p=212117","disqusUrl":"https://ww2.kqed.org/futureofyou/2016/07/28/14000-to-get-into-a-clinical-trial-pay-to-play-listings-creep-into-governments-website/","disqusTitle":"$14,000 to Get Into a Clinical Trial? Pay-to-Play Listings Creep Into Government's Website","nprByline":"Emily Bazar\u003cbr />\u003ca href=\"http://khn.org/\">Kaiser Health News\u003c/a>","path":"/futureofyou/212117/14000-to-get-into-a-clinical-trial-pay-to-play-listings-creep-into-governments-website","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Last summer, Linda Smith learned she was losing significant cartilage in her knees, a consequence of her lifelong love of skiing, running and ultimate frisbee.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"It’s unethical that these companies are saying, ‘Sure, come take part in our study and by the way, we’re going to charge you for the privilege.’ ”\u003c/aside>\n\u003cp>Diagnosed with osteoarthritis, she wanted to avoid surgery and was eager to consider alternatives.\u003c/p>\n\u003cp>So the 56-year-old Morgan Hill, Calif., resident embarked on a search for clinical trials, which test potential treatments on human subjects. She scoured the government-run website ClinicalTrials.gov, focusing on a form of stem cell therapy — a promising but unproven approach for her condition.\u003c/p>\n\u003cp>She thought she’d scored with StemGenex, a clinic in La Jolla, and called to inquire. The screener asked a long list of questions, then dropped a bomb: If Smith wanted in, she’d have to pay “associated” costs.\u003c/p>\n\u003cp>Total charge: $14,000.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“I was outraged,” Smith said. Her anger only grew when the screener suggested she could raise the money, as other callers had, through family and friends in an online GoFundMe campaign, she said.\u003c/p>\n\u003cp>Smith, a retired hospital administrator, knew enough about clinical studies to understand that the $14,000 price tag was unusual. Most trials are free and some even pay people to participate, in recognition of the possible risks and inconvenience involved.\u003c/p>\n\u003cp>The ClinicialTrials.gov website, run by the National Institutes of Health (NIH) through its National Library of Medicine, is the most comprehensive such database available to the public in the United States, with listings for more than 210,000 clinical studies both here and abroad. But Smith’s experience exposes one of its little-known limitations: It does not require trial sponsors to disclose charges to patients — and does not even independently vet the listings.\u003c/p>\n\u003cp>“I went back to the website and looked at the study again. It doesn’t say that patients are the funding source,” said Smith, who refused the $14,000 proposal. “I was disappointed in the NIH. I thought, ‘Why are you letting this occur?'”\u003c/p>\n\u003cp>\u003cstrong>Misleading Consumers\u003c/strong>\u003c/p>\n\u003cp>StemGenex denies that it charges for participation in its clinical study. It says it only charges for the treatment that is being studied and that participation in the study is separate and voluntary.\u003c/p>\n\u003cp>Some ethicists and other experts who shared Smith’s concern said that’s a false distinction. If trial sponsors require participants to pay, they said, the government website ought to let people know.\u003c/p>\n\u003cp>They argued that ClinicalTrials.gov’s failure to disclose charges by trial sponsors misleads consumers and allows the site to become a marketing tool for pay-to-play research.\u003c/p>\n\u003cfigure id=\"attachment_212124\" class=\"wp-caption aligncenter\" style=\"max-width: 770px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/linda-smith-4.jpg\">\u003cimg class=\"wp-image-212124 size-full\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/linda-smith-4.jpg\" alt=\"Linda Smith lost significant cartilage in both of her knees due to years of skiing, running and ultimate frisbee. The 56-year-old Morgan Hill, Calif., resident researched stem cell therapy for osteoarthritis to avoid surgery. \" width=\"770\" height=\"513\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/linda-smith-4.jpg 770w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/linda-smith-4-400x266.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/linda-smith-4-768x512.jpg 768w\" sizes=\"(max-width: 770px) 100vw, 770px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Linda Smith lost significant cartilage in both of her knees due to years of skiing, running and ultimate frisbee. The 56-year-old Morgan Hill, Calif., resident researched stem cell therapy for osteoarthritis to avoid surgery. \u003ccite>(Heidi de Marco/KHN)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“It’s unethical that these companies are saying, ‘Sure, come take part in our study and by the way, we’re going to charge you for the privilege’,” said Alison Bateman-House, a postdoctoral fellow in medical ethics at the New York University School of Medicine. “If you’re going to be charging patients for the opportunity to be involved in the study, they should not be allowed to be listed on ClinicalTrials.gov, or at least the cost should be listed on the site.”\u003c/p>\n\u003cp>She and others worry that many patients seeking to participate in clinical trials might be desperately sick or in pain, and vulnerable to requests for money they don’t have. These patients see the website’s “.gov” domain and the NIH imprimatur as stamps of approval that mean the research is legitimate, these critics say.\u003c/p>\n\u003cp>“The average patient and even people in health care … kind of let their guard down when they’re in that database. It’s like, ‘If a trial is listed here, it must be OK’,” said Paul Knoepfler, an associate professor at the University of California, Davis, School of Medicine who writes a blog about stem cell research. “Most people don’t realize that creeping into that database are some trials whose main goal is to generate profit.”\u003c/p>\n\u003cp>Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics, said it’s not clear if this phenomenon is only occurring with stem cell studies, but the surge in stem cell research — and in clinics offering high-priced, unproven treatments — has intensified the problem.\u003c/p>\n\u003cp>“It’s not just a handful of patients who are encountering these kind of so-called studies on ClinicalTrials.gov and not just a handful of studies,” he said. “It is a bigger problem than that.”\u003c/p>\n\u003cp>Asked whether costs should be disclosed on ClinicalTrials.gov, Dr. Rebecca Williams, assistant director of the website, said “that’s a valid question.”\u003c/p>\n\u003cp>As a practical matter, she said, “that has been information we don’t collect in a systematic way and nor is it available. We have no way to know whether they’re for-profit or not, and don’t have a policy that would exclude them.”\u003c/p>\n\u003cp>\u003cstrong>Not an Endorsement\u003c/strong>\u003c/p>\n\u003cp>Williams pointed to the website’s disclaimer that the government is not liable for and does not “make any warranties” about information in the database. She also noted that the site suggests questions for consumers to ask, including, “Who will pay for my participation?”\u003c/p>\n\u003cp>Williams stressed that the website is intended primarily as a “clearinghouse” of listings, and that just because a study is there “does not necessarily mean an endorsement by the federal government.”\u003c/p>\n\u003cp>It means that the study sponsors have attested that the information they’re submitting is complete and that their research complies with “all of the applicable regulations that may apply,” she said.\u003c/p>\n\u003cp>The website is not legally required to independently verify the information provided by study sponsors. ClinicalTrials.gov relies heavily on the honor system, Williams said.\u003c/p>\n\u003cp>Study sponsors who wish to list their studies on the website register online and must provide a variety of details, including, in most cases, information about the committees that oversee the welfare and treatment of human subjects.\u003c/p>\n\u003cp>Thanks to a 2007 law, changes will be made to the website’s listings and requirements, possibly by the end of this year. But Williams said it’s “unlikely” they will include disclosures of costs to patients.\u003c/p>\n\u003cp>Generally speaking, the U.S. Food and Drug Administration regulates clinical trials of medications and medical devices, and sets guidelines that determine when patients can be charged. But stem cell research, which often uses a patients’ own cells for treatment, can fall into a gray area, and what requires FDA approval is sometimes unclear or in dispute.\u003c/p>\n\u003cp>\u003cstrong>Pay to Play\u003c/strong>\u003c/p>\n\u003cp>StemGenex says it does not charge anyone for the osteoporosis study listed in ClinicalTrials.gov.\u003c/p>\n\u003cp>“StemGenex’s study is intended to be an observational study comparing two sets of data — before and after stem cell treatment,” Candace Henderson, the clinic’s vice president of operations, said in a prepared statement.\u003c/p>\n\u003cp>The way she explained it, patients who first pay for the company’s stem cell treatment can then “volunteer” to participate in the long-term observational study of how well the treatment works.\u003c/p>\n\u003cp>“The actual treatment is not part of the study protocol,” Henderson said. She declined to share a copy of the protocol, saying it “is proprietary to StemGenex.”\u003c/p>\n\u003cp>But the reality is that patients who want to participate in research like this must first shell out thousands for the stem cell treatment, University of Minnesota’s Turner said. In effect, he said, they pay to play.\u003c/p>\n\u003cp>StemGenex says it invests revenue from its clinical trials “in innovation and research to further the development and advancement” of therapies. It has four other studies listed on the NIH website: for Parkinson’s disease, multiple sclerosis, rheumatoid arthritis and chronic obstructive pulmonary disease. In those cases, too, participants “are recruited from among patients who are having stem cell treatment,” Henderson said in the company statement.\u003c/p>\n\u003cp>\u003ca href=\"https://stemgenex.com/frequently-asked-questions/#tab-14\" target=\"_blank\">On its website\u003c/a>, the company explains that it harvests dormant stem cells from a patient’s fat through “a mini-liposuction” and isolates the cells from the fat. The cells are then “activated with the patient’s growth factors,” and infused back into the patient. The stem cells then “follow inflammatory signals from damaged tissues and have multiple ways of repairing these damaged areas.”\u003c/p>\n\u003cp>The company, which describes itself as “\u003ca href=\"https://stemgenex.com/about-us/\" target=\"_blank\">the premiere leader in the United States for regenerative medicine\u003c/a>,” says it offers a “\u003ca href=\"https://stemgenex.com/treatment-center/traveling-stemgenex/make-getting-easy/\" target=\"_blank\">a concierge approach to treatment\u003c/a>,” which includes covering the cost of its patients’ hotel accommodations and a car service that “\u003ca href=\"https://stemgenex.com/frequently-asked-questions/\" target=\"_blank\">will be waiting for you at the airport baggage claim when you arrive\u003c/a>.”\u003c/p>\n\u003cp>\u003ca href=\"https://stemgenex.com/frequently-asked-questions/#tab-14\" target=\"_blank\">The company acknowledges\u003c/a> that its procedures — like most stem cell treatments — are not FDA-approved. \u003ca href=\"https://stemgenex.com/press/stemgenex-new-clinical-study-aims-provide-relief-osteoarthritis-patients-latest-stem-cell-therapy/\" target=\"_blank\">On its website\u003c/a>, however, StemGenex underscores that its studies are “registered through The National Institutes of Health which can be found at\u003ca href=\"http://www.clinicaltrials.gov.xn--ivg/\" rel=\"nofollow\">http://www.clinicaltrials.gov.”\u003c/a>\u003c/p>\n\u003cp>“By providing patients access to stem cell studies registered through The National Institutes of Health, patients now have the ability to choose treatment for osteoarthritis that focuses on both safety and efficacy,” it says.\u003c/p>\n\u003cp>\u003ca href=\"https://stemgenex.com/frequently-asked-questions/#tab-14\" target=\"_blank\">Also on its website\u003c/a>, the clinic says that having studies registered on ClinicalTrials.gov gives it a “significant advantage compared with treatment centers offering unregistered studies.”\u003c/p>\n\u003cp>Turner called the messages misleading, because they suggest the NIH has vetted the clinic’s osteoarthritis and other studies. “In fact, nobody at the NIH or in our government has necessarily, or even likely, looked at this study,” he said.\u003c/p>\n\u003cp>He pointed to other stem cell clinics posting on ClinicalTrials.gov that ask patients to pay, including one in Rancho Mirage that is conducting a study on stem cell treatment for conditions such as emphysema, osteoarthritis and erectile dysfunction.\u003c/p>\n\u003cp>Knoepfler said he used to direct patients to ClinicalTrials.gov, but then, “I started realizing, ‘wait a minute … there are listings on that website that are not what I thought would be on ClinicalTrials.gov.'”\u003c/p>\n\u003cp>He and other critics would like to see ClinicalTrials.gov reevaluate its position on allowing for-profit trials to post on the website.\u003c/p>\n\u003cp>“It’s one of the best sources we have, but there’s still room for misleading and incomplete information, and I would imagine in some cases, there are people preying on desperate patients, even on the ClinicalTrials.gov registry,” said \u003ca href=\"http://csdd.tufts.edu/about/staff_profile/ken_getz\" target=\"_blank\">Ken Getz\u003c/a>, an associate professor at Tufts University School of Medicine, and founder of the Center for Information and Study on Clinical Research Participation.\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\">Kaiser Health News\u003c/a>, which publishes \u003ca href=\"http://www.californiahealthline.org/\" target=\"_blank\">California Healthline\u003c/a>, a service of the \u003ca href=\"http://www.chcf.org/\" target=\"_blank\">California Health Care Foundation\u003c/a>.\u003c/em>\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> \u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/212117/14000-to-get-into-a-clinical-trial-pay-to-play-listings-creep-into-governments-website","authors":["byline_futureofyou_212117"],"categories":["futureofyou_1062"],"tags":["futureofyou_717","futureofyou_680","futureofyou_1001"],"featImg":"futureofyou_212122","label":"futureofyou"},"futureofyou_100492":{"type":"posts","id":"futureofyou_100492","meta":{"index":"posts_1591205157","site":"futureofyou","id":"100492","score":null,"sort":[1453321812000]},"guestAuthors":[],"slug":"how-to-find-clinical-trials-of-experimental-drugs","title":"How to Find Clinical Trials of Experimental Drugs","publishDate":1453321812,"format":"standard","headTitle":"Future of You | KQED Future of You | KQED Science","labelTerm":{"term":54,"site":"futureofyou"},"content":"\u003cp>Perhaps nothing triggers frustration and hope in patients like prescription drugs.\u003c/p>\n\u003cp>Consider the hepatitis C drug \u003ca href=\"http://www.nytimes.com/2015/05/20/business/high-cost-of-hepatitis-c-drug-prompts-a-call-to-void-its-patents.html?_r=0\" target=\"_blank\">Sovaldi\u003c/a>, infamous for its $84,000 retail price tag for a 12-week course.\u003c/p>\n\u003cp>Despite the price, the drug embodies significant hope. Sovaldi and other \u003ca href=\"http://www.nytimes.com/2015/09/02/opinion/costly-hepatitis-c-drugs-for-everyone.html\" target=\"_blank\">recently approved hepatitis C medications\u003c/a> have vastly improved treatment of the disease.\u003c/p>\n\u003cp>\u003ca href=\"http://www.sovaldi.com/about-sovaldi/study-results\" target=\"_blank\">Sovaldi’s\u003c/a> potential was confirmed during clinical trials when it was tested on humans as part of the drug \u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/\" target=\"_blank\">approval process\u003c/a>. Many hepatitis B patients probably wish they could have participated.\u003c/p>\n\u003cp>Today, I’ll explain how you can find \u003ca href=\"https://clinicaltrials.gov/ct2/about-studies/learn\" target=\"_blank\">clinical trials\u003c/a> of drugs that could treat your condition – but access isn’t a sure thing. The trial could take a year or more of your time. And more often than not, the experimental drug doesn’t work.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003ca href=\"http://catalyst.phrma.org/5-things-you-didn-t-know-about-researching-and-developing-a-new-medicine\">Less than 12 percent\u003c/a> of the medicines that enter clinical trials are approved by the U.S. Food and Drug Administration, according to the Pharmaceutical Research and Manufacturers of America, known as \u003ca href=\"http://www.phrma.org/\" target=\"_blank\">PhRMA\u003c/a>.\u003c/p>\n\u003cp>“There is hope,” says \u003ca href=\"http://www.pacific.edu/Academics/Schools-and-Colleges/Thomas-J-Long-School-of-Pharmacy-and-Health-Sciences/Faculty-and-Departments/Pharmacy-Practice/Sachin-Shah.html\" target=\"_blank\">Sachin Shah\u003c/a>, a pharmacy professor at University of the Pacific who conducts clinical trials himself. “But there is no guarantee.”\u003c/p>\n\u003cp>\u003cstrong>Q: I have a rare muscle disorder and have been looking for clinical trials for five years, but most of the stuff I find is in St. Louis or Atlanta or elsewhere. Do you have any tips on finding one I can participate in?\u003c/strong>\u003c/p>\n\u003cp>A: This question comes from Michael Urbach, 59, who has \u003ca href=\"http://www.ninds.nih.gov/disorders/inclusion_body_myositis/inclusion_body_myositis.htm\" target=\"_blank\">inclusion body myositis\u003c/a>, which has progressively weakened muscles in his arms, legs and throat. There is neither a cure nor a standard treatment for the disease.\u003c/p>\n\u003cp>Urbach, a resident of Oakley in Contra Costa County, tries to remain positive, but is “anxious to try \u003cem>something,\u003c/em>” he says.\u003c/p>\n\u003cp>So he did what experts suggest you do first: He asked his doctor about clinical trials.\u003c/p>\n\u003cp>“He told me, ‘You have to go online and find something’,” Urbach says.\u003c/p>\n\u003cp>Like Urbach, you’ll probably end up doing a lot of your own research to find a clinical trial if your doctor can’t help. But beware — the volume of information available online can be daunting, and the quality questionable.\u003c/p>\n\u003cp>So rely primarily on sites that end in .org, .edu and .gov, says Danielle Lavieri, a spokeswoman for the \u003ca href=\"https://www.ciscrp.org/\" target=\"_blank\">Center for Information and Study on Clinical Research Participation\u003c/a>(CISCRP). Those domains tend to be less commercial.\u003c/p>\n\u003cp>The most comprehensive online compilation of clinical trials is at \u003ca href=\"https://clinicaltrials.gov/\" target=\"_blank\">ClinicalTrials.gov\u003c/a>, a government-run website that allows you to search by disease and location.\u003c/p>\n\u003cp>But the language on the site can be technical and the site difficult to navigate.\u003c/p>\n\u003cp>“You’re asking people to search a non-user-friendly site and then to understand what they’re reading,” says Danielle Hicks of the \u003ca href=\"http://www.lungcancerfoundation.org/\" target=\"_blank\">Bonnie J. Addario Lung Cancer Foundation\u003c/a>, based in California.\u003c/p>\n\u003cp>Hicks suggests contacting a patient advocacy group specific to your disease. Many offer personalized searches for clinical trials, usually for free, she says.\u003c/p>\n\u003cp>CISCRP, too, performs custom searches and suggests trials that meet your criteria. Visit \u003ca href=\"https://www.ciscrp.org/programs-events/search-clinical-trials/\" target=\"_blank\">CISCRP.org\u003c/a> or call 877-MED-HERO.\u003c/p>\n\u003cp>\u003ca href=\"https://www.researchmatch.org/\" target=\"_blank\">ResearchMatch.org\u003c/a> allows researchers to contact you directly after you’ve registered if they think you’re a good match for their study.\u003c/p>\n\u003cp>You can also get in touch with a drug company directly if you know it is developing a medication that may help your condition, Shah says.\u003c/p>\n\u003cp>And don’t discount your own network. \u003ca href=\"http://www.mydetourdeforce.com/\" target=\"_blank\">Julie Soderlund\u003c/a>, who was diagnosed with stage IV melanoma in August, found leads on a Facebook support group.\u003c/p>\n\u003cp>“I’ve learned a lot from that group of people,” says the 37-year-old Santa Cruz resident.\u003c/p>\n\u003cp>She participated in one clinical trial and is now searching for another.\u003c/p>\n\u003cp>If you’ve found a trial that you think is a good fit, reach out to the researchers. The CISCRP website (CISCRP.org) offers a list of important questions to ask in its online “\u003ca href=\"https://www.ciscrp.org/education-center/\" target=\"_blank\">Education Center\u003c/a>.”\u003c/p>\n\u003cp>You can also find a “\u003ca href=\"https://www.ciscrp.org/wp-content/uploads/2014/01/Participant-Bill-of-Rights.pdf\" target=\"_blank\">Participant Bill of Rights\u003c/a>” there. Read it.\u003c/p>\n\u003cp>For instance, did you know that you can leave a trial before it’s over? Let’s say you’re having unpleasant side effects, Lavieri says. “A lot of people may think they’re stuck,” she says. “You have the right to drop out at any time.”\u003c/p>\n\u003cp>Even if you find a trial that may work for you, you still may face obstacles:\u003c/p>\n\u003cp>\u003cstrong>LOCATION:\u003c/strong> Finding a trial may be especially hard if you live in a rural area, have a rare condition, or both.\u003c/p>\n\u003cp>“Of all the clinical trials I have found, none of them are here,” Urbach says. “Everything is out of state or in a different country.”\u003c/p>\n\u003cp>If you find a trial that requires travel, ask if you will be reimbursed for travel costs, Lavieri suggests.\u003c/p>\n\u003cp>There are groups that help cover costs associated with clinical trials, such as \u003ca href=\"http://www.lazarex.org/\" target=\"_blank\">Lazarex Cancer Foundation\u003c/a> (lazarex.org).\u003c/p>\n\u003cp>Beyond travel costs, consider the support system of family and friends you’ll need nearby, Soderlund advises.\u003c/p>\n\u003cp>“You have to think about, ‘Who do I know in the city where I’m going to get treatment?’” she says. “What kind of support am I going to be able to get if I get sick after treatment?”\u003c/p>\n\u003cp>\u003cstrong>PLACEBO\u003c/strong>: In rare cases, all participants in a trial receive the experimental drug, says Jocelyn Ulrich of PhRMA.\u003c/p>\n\u003cp>More commonly, some participants receive the trial drug and others get a placebo – a substance or treatment that looks like the experimental treatment but has no therapeutic effect.\u003c/p>\n\u003cp>If a disease is life-threatening or dangerous, however, participants will never simply receive a placebo, Shah says. “You cannot \u003cem>not\u003c/em> treat someone,” he says.\u003c/p>\n\u003cp>Instead, all participants will receive at least the “standard of care,” the best treatment for a specific condition that’s already approved and available, Ulrich says.\u003c/p>\n\u003cp>In these trials, you may receive only the standard of care, or you may receive the standard of care plus the investigative drug, she says.\u003c/p>\n\u003cp>“You’re not guaranteed to be on the study drug,” Hicks says.\u003c/p>\n\u003cp>\u003cstrong>PREVIOUS TREATMENT\u003c/strong>: Your previous medical treatments, even routine chemotherapy, may disqualify you from participation.\u003c/p>\n\u003cp>“Most adults don’t look at clinical trials until they’re in desperate mode,” Hicks says. “By that time, they may have had treatment that will disqualify them.”\u003c/p>\n\u003cp>\u003cstrong>EFFECTIVENESS\u003c/strong>: Remember, the trial drug might not work, it might not work for you, or it might cause unintended side-effects that require the trial to be shut down.\u003c/p>\n\u003cp>“It may work. It may not work,” Shah says, “but you have a chance you didn’t have before.”\u003c/p>\n\u003cp>\u003cem> \u003ca href=\"http://www.khn.org/\">Kaiser Health News \u003c/a>is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp> \u003c/p>\n\n","blocks":[],"excerpt":"Tips for finding trials of drugs that may treat your condition but have not yet been approved by the FDA.","status":"publish","parent":0,"modified":1477272136,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":47,"wordCount":1192},"headData":{"title":"How to Find Clinical Trials of Experimental Drugs | KQED","description":"Tips for finding trials of drugs that may treat your condition but have not yet been approved by the FDA.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"How to Find Clinical Trials of Experimental Drugs","datePublished":"2016-01-20T20:30:12.000Z","dateModified":"2016-10-24T01:22:16.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"100492 http://ww2.kqed.org/futureofyou/?p=100492","disqusUrl":"https://ww2.kqed.org/futureofyou/2016/01/20/how-to-find-clinical-trials-of-experimental-drugs/","disqusTitle":"How to Find Clinical Trials of Experimental Drugs","nprByline":"Emily Bazar\u003cbr />Kaiser Health News","path":"/futureofyou/100492/how-to-find-clinical-trials-of-experimental-drugs","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Perhaps nothing triggers frustration and hope in patients like prescription drugs.\u003c/p>\n\u003cp>Consider the hepatitis C drug \u003ca href=\"http://www.nytimes.com/2015/05/20/business/high-cost-of-hepatitis-c-drug-prompts-a-call-to-void-its-patents.html?_r=0\" target=\"_blank\">Sovaldi\u003c/a>, infamous for its $84,000 retail price tag for a 12-week course.\u003c/p>\n\u003cp>Despite the price, the drug embodies significant hope. Sovaldi and other \u003ca href=\"http://www.nytimes.com/2015/09/02/opinion/costly-hepatitis-c-drugs-for-everyone.html\" target=\"_blank\">recently approved hepatitis C medications\u003c/a> have vastly improved treatment of the disease.\u003c/p>\n\u003cp>\u003ca href=\"http://www.sovaldi.com/about-sovaldi/study-results\" target=\"_blank\">Sovaldi’s\u003c/a> potential was confirmed during clinical trials when it was tested on humans as part of the drug \u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/\" target=\"_blank\">approval process\u003c/a>. Many hepatitis B patients probably wish they could have participated.\u003c/p>\n\u003cp>Today, I’ll explain how you can find \u003ca href=\"https://clinicaltrials.gov/ct2/about-studies/learn\" target=\"_blank\">clinical trials\u003c/a> of drugs that could treat your condition – but access isn’t a sure thing. The trial could take a year or more of your time. And more often than not, the experimental drug doesn’t work.\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>\u003ca href=\"http://catalyst.phrma.org/5-things-you-didn-t-know-about-researching-and-developing-a-new-medicine\">Less than 12 percent\u003c/a> of the medicines that enter clinical trials are approved by the U.S. Food and Drug Administration, according to the Pharmaceutical Research and Manufacturers of America, known as \u003ca href=\"http://www.phrma.org/\" target=\"_blank\">PhRMA\u003c/a>.\u003c/p>\n\u003cp>“There is hope,” says \u003ca href=\"http://www.pacific.edu/Academics/Schools-and-Colleges/Thomas-J-Long-School-of-Pharmacy-and-Health-Sciences/Faculty-and-Departments/Pharmacy-Practice/Sachin-Shah.html\" target=\"_blank\">Sachin Shah\u003c/a>, a pharmacy professor at University of the Pacific who conducts clinical trials himself. “But there is no guarantee.”\u003c/p>\n\u003cp>\u003cstrong>Q: I have a rare muscle disorder and have been looking for clinical trials for five years, but most of the stuff I find is in St. Louis or Atlanta or elsewhere. Do you have any tips on finding one I can participate in?\u003c/strong>\u003c/p>\n\u003cp>A: This question comes from Michael Urbach, 59, who has \u003ca href=\"http://www.ninds.nih.gov/disorders/inclusion_body_myositis/inclusion_body_myositis.htm\" target=\"_blank\">inclusion body myositis\u003c/a>, which has progressively weakened muscles in his arms, legs and throat. There is neither a cure nor a standard treatment for the disease.\u003c/p>\n\u003cp>Urbach, a resident of Oakley in Contra Costa County, tries to remain positive, but is “anxious to try \u003cem>something,\u003c/em>” he says.\u003c/p>\n\u003cp>So he did what experts suggest you do first: He asked his doctor about clinical trials.\u003c/p>\n\u003cp>“He told me, ‘You have to go online and find something’,” Urbach says.\u003c/p>\n\u003cp>Like Urbach, you’ll probably end up doing a lot of your own research to find a clinical trial if your doctor can’t help. But beware — the volume of information available online can be daunting, and the quality questionable.\u003c/p>\n\u003cp>So rely primarily on sites that end in .org, .edu and .gov, says Danielle Lavieri, a spokeswoman for the \u003ca href=\"https://www.ciscrp.org/\" target=\"_blank\">Center for Information and Study on Clinical Research Participation\u003c/a>(CISCRP). Those domains tend to be less commercial.\u003c/p>\n\u003cp>The most comprehensive online compilation of clinical trials is at \u003ca href=\"https://clinicaltrials.gov/\" target=\"_blank\">ClinicalTrials.gov\u003c/a>, a government-run website that allows you to search by disease and location.\u003c/p>\n\u003cp>But the language on the site can be technical and the site difficult to navigate.\u003c/p>\n\u003cp>“You’re asking people to search a non-user-friendly site and then to understand what they’re reading,” says Danielle Hicks of the \u003ca href=\"http://www.lungcancerfoundation.org/\" target=\"_blank\">Bonnie J. Addario Lung Cancer Foundation\u003c/a>, based in California.\u003c/p>\n\u003cp>Hicks suggests contacting a patient advocacy group specific to your disease. Many offer personalized searches for clinical trials, usually for free, she says.\u003c/p>\n\u003cp>CISCRP, too, performs custom searches and suggests trials that meet your criteria. Visit \u003ca href=\"https://www.ciscrp.org/programs-events/search-clinical-trials/\" target=\"_blank\">CISCRP.org\u003c/a> or call 877-MED-HERO.\u003c/p>\n\u003cp>\u003ca href=\"https://www.researchmatch.org/\" target=\"_blank\">ResearchMatch.org\u003c/a> allows researchers to contact you directly after you’ve registered if they think you’re a good match for their study.\u003c/p>\n\u003cp>You can also get in touch with a drug company directly if you know it is developing a medication that may help your condition, Shah says.\u003c/p>\n\u003cp>And don’t discount your own network. \u003ca href=\"http://www.mydetourdeforce.com/\" target=\"_blank\">Julie Soderlund\u003c/a>, who was diagnosed with stage IV melanoma in August, found leads on a Facebook support group.\u003c/p>\n\u003cp>“I’ve learned a lot from that group of people,” says the 37-year-old Santa Cruz resident.\u003c/p>\n\u003cp>She participated in one clinical trial and is now searching for another.\u003c/p>\n\u003cp>If you’ve found a trial that you think is a good fit, reach out to the researchers. The CISCRP website (CISCRP.org) offers a list of important questions to ask in its online “\u003ca href=\"https://www.ciscrp.org/education-center/\" target=\"_blank\">Education Center\u003c/a>.”\u003c/p>\n\u003cp>You can also find a “\u003ca href=\"https://www.ciscrp.org/wp-content/uploads/2014/01/Participant-Bill-of-Rights.pdf\" target=\"_blank\">Participant Bill of Rights\u003c/a>” there. Read it.\u003c/p>\n\u003cp>For instance, did you know that you can leave a trial before it’s over? Let’s say you’re having unpleasant side effects, Lavieri says. “A lot of people may think they’re stuck,” she says. “You have the right to drop out at any time.”\u003c/p>\n\u003cp>Even if you find a trial that may work for you, you still may face obstacles:\u003c/p>\n\u003cp>\u003cstrong>LOCATION:\u003c/strong> Finding a trial may be especially hard if you live in a rural area, have a rare condition, or both.\u003c/p>\n\u003cp>“Of all the clinical trials I have found, none of them are here,” Urbach says. “Everything is out of state or in a different country.”\u003c/p>\n\u003cp>If you find a trial that requires travel, ask if you will be reimbursed for travel costs, Lavieri suggests.\u003c/p>\n\u003cp>There are groups that help cover costs associated with clinical trials, such as \u003ca href=\"http://www.lazarex.org/\" target=\"_blank\">Lazarex Cancer Foundation\u003c/a> (lazarex.org).\u003c/p>\n\u003cp>Beyond travel costs, consider the support system of family and friends you’ll need nearby, Soderlund advises.\u003c/p>\n\u003cp>“You have to think about, ‘Who do I know in the city where I’m going to get treatment?’” she says. “What kind of support am I going to be able to get if I get sick after treatment?”\u003c/p>\n\u003cp>\u003cstrong>PLACEBO\u003c/strong>: In rare cases, all participants in a trial receive the experimental drug, says Jocelyn Ulrich of PhRMA.\u003c/p>\n\u003cp>More commonly, some participants receive the trial drug and others get a placebo – a substance or treatment that looks like the experimental treatment but has no therapeutic effect.\u003c/p>\n\u003cp>If a disease is life-threatening or dangerous, however, participants will never simply receive a placebo, Shah says. “You cannot \u003cem>not\u003c/em> treat someone,” he says.\u003c/p>\n\u003cp>Instead, all participants will receive at least the “standard of care,” the best treatment for a specific condition that’s already approved and available, Ulrich says.\u003c/p>\n\u003cp>In these trials, you may receive only the standard of care, or you may receive the standard of care plus the investigative drug, she says.\u003c/p>\n\u003cp>“You’re not guaranteed to be on the study drug,” Hicks says.\u003c/p>\n\u003cp>\u003cstrong>PREVIOUS TREATMENT\u003c/strong>: Your previous medical treatments, even routine chemotherapy, may disqualify you from participation.\u003c/p>\n\u003cp>“Most adults don’t look at clinical trials until they’re in desperate mode,” Hicks says. “By that time, they may have had treatment that will disqualify them.”\u003c/p>\n\u003cp>\u003cstrong>EFFECTIVENESS\u003c/strong>: Remember, the trial drug might not work, it might not work for you, or it might cause unintended side-effects that require the trial to be shut down.\u003c/p>\n\u003cp>“It may work. It may not work,” Shah says, “but you have a chance you didn’t have before.”\u003c/p>\n\u003cp>\u003cem> \u003ca href=\"http://www.khn.org/\">Kaiser Health News \u003c/a>is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.\u003c/em>\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> \u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/100492/how-to-find-clinical-trials-of-experimental-drugs","authors":["byline_futureofyou_100492"],"programs":["futureofyou_54"],"categories":["futureofyou_1060"],"tags":["futureofyou_717","futureofyou_38","futureofyou_80","futureofyou_718"],"featImg":"futureofyou_100513","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. 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Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.","airtime":"SUN 2pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.possible.fm/","meta":{"site":"news","source":"Possible"},"link":"/radio/program/possible","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/possible/id1677184070","spotify":"https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"}},"1a":{"id":"1a","title":"1A","info":"1A is home to the national conversation. 1A brings on great guests and frames the best debate in ways that make you think, share and engage.","airtime":"MON-THU 11pm-12am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/1a.jpg","officialWebsiteLink":"https://the1a.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/1a","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=1188724250&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/1A-p947376/","rss":"https://feeds.npr.org/510316/podcast.xml"}},"all-things-considered":{"id":"all-things-considered","title":"All Things Considered","info":"Every weekday, \u003cem>All Things Considered\u003c/em> hosts Robert Siegel, Audie Cornish, Ari Shapiro, and Kelly McEvers present the program's trademark mix of news, interviews, commentaries, reviews, and offbeat features. Michel Martin hosts on the weekends.","airtime":"MON-FRI 1pm-2pm, 4:30pm-6:30pm\u003cbr />SAT-SUN 5pm-6pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/All-Things-Considered-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/all-things-considered/","meta":{"site":"news","source":"npr"},"link":"/radio/program/all-things-considered"},"american-suburb-podcast":{"id":"american-suburb-podcast","title":"American Suburb: The Podcast","tagline":"The flip side of gentrification, told through one town","info":"Gentrification is changing cities across America, forcing people from neighborhoods they have long called home. Call them the displaced. Now those priced out of the Bay Area are looking for a better life in an unlikely place. American Suburb follows this migration to one California town along the Delta, 45 miles from San Francisco. But is this once sleepy suburb ready for them?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/American-Suburb-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/news/series/american-suburb-podcast","meta":{"site":"news","source":"kqed","order":"13"},"link":"/news/series/american-suburb-podcast/","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=1287748328","tuneIn":"https://tunein.com/radio/American-Suburb-p1086805/","rss":"https://ww2.kqed.org/news/series/american-suburb-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkMzMDExODgxNjA5"}},"baycurious":{"id":"baycurious","title":"Bay Curious","tagline":"Exploring the Bay Area, one question at a time","info":"KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. This podcast feed is usually updated twice a week and is always un-edited.","airtime":"THU 10pm, FRI 1am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Commonwealth-Club-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.commonwealthclub.org/podcasts","meta":{"site":"news","source":"Commonwealth Club of California"},"link":"/radio/program/commonwealth-club","subscribe":{"apple":"https://itunes.apple.com/us/podcast/commonwealth-club-of-california-podcast/id976334034?mt=2","google":"https://podcasts.google.com/feed/aHR0cDovL3d3dy5jb21tb253ZWFsdGhjbHViLm9yZy9hdWRpby9wb2RjYXN0L3dlZWtseS54bWw","tuneIn":"https://tunein.com/radio/Commonwealth-Club-of-California-p1060/"}},"considerthis":{"id":"considerthis","title":"Consider This","tagline":"Make sense of the day","info":"Make sense of the day. Every weekday afternoon, Consider This helps you consider the major stories of the day in less than 15 minutes, featuring the reporting and storytelling resources of NPR. Plus, KQED’s Bianca Taylor brings you the local KQED news you need to know.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Consider-This-Podcast-Tile-703x703-1.jpg","imageAlt":"Consider This from NPR and KQED","officialWebsiteLink":"/podcasts/considerthis","meta":{"site":"news","source":"kqed","order":"7"},"link":"/podcasts/considerthis","subscribe":{"apple":"https://podcasts.apple.com/podcast/id1503226625?mt=2&at=11l79Y&ct=nprdirectory","npr":"https://rpb3r.app.goo.gl/coronavirusdaily","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5ucHIub3JnLzUxMDM1NS9wb2RjYXN0LnhtbA","spotify":"https://open.spotify.com/show/3Z6JdCS2d0eFEpXHKI6WqH"}},"forum":{"id":"forum","title":"Forum","tagline":"The conversation starts here","info":"KQED’s live call-in program discussing local, state, national and international issues, as well as in-depth interviews.","airtime":"MON-FRI 9am-11am, 10pm-11pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Forum-Podcast-Tile-703x703-1.jpg","imageAlt":"KQED Forum with Mina Kim and Alexis Madrigal","officialWebsiteLink":"/forum","meta":{"site":"news","source":"kqed","order":"8"},"link":"/forum","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/kqeds-forum/id73329719","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM5NTU3MzgxNjMz","npr":"https://www.npr.org/podcasts/432307980/forum","stitcher":"https://www.stitcher.com/podcast/kqedfm-kqeds-forum-podcast","rss":"https://feeds.megaphone.fm/KQINC9557381633"}},"freakonomics-radio":{"id":"freakonomics-radio","title":"Freakonomics Radio","info":"Freakonomics Radio is a one-hour award-winning podcast and public-radio project hosted by Stephen Dubner, with co-author Steve Levitt as a regular guest. 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