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Given that both groups were also getting choline from regular feeding, the dose ensured that those supplemented received well over the Institute of Medicine's guideline that infants receive at least 125 milligrams a day.\u003c/p>\n\u003cp>At 5 weeks old, the children were exposed to a series of clicking sounds in the lab while their brain activity was monitored by \u003ca href=\"https://medlineplus.gov/ency/article/003931.htm\">electroencephalogram\u003c/a>, or EEG, a method for recording electrical brain activity via electrodes placed on the scalp. Normally, when exposed to the same sound successively, both infant and adult brains will exhibit \"inhibition,\" or a far weaker pulse of activity in response to the second sound. We realize that the now familiar tone is insignificant; our brains are unmoved.\u003c/p>\n\u003cp>However, in some kids this inhibition doesn't occur — a finding linked with an increased risk for attention problems, social withdrawal and, later in life, schizophrenia.\u003c/p>\n\u003cp>The \u003ca href=\"http://ajp.psychiatryonline.org/doi/abs/10.1176/appi.ajp.2012.12070940\">results published in 2013\u003c/a> in the \u003cem>American Journal of Psychiatry\u003c/em> by Freedman's group show that 76 percent of newborns whose mothers received choline supplements had normal inhibition to the sound stimuli. The proportion fell to 43 percent in those born to mothers who didn't get them. It appeared that choline might steer the infant brain away from a developmental course that predicted mental health problems.\u003c/p>\n\u003cp>A follow-up study at 40 months found that the children who had received choline supplements \u003cem>in utero\u003c/em> and after birth had fewer attention problems and less social withdrawal.\u003c/p>\n\u003cp>Excessive choline consumption — or that over 7,500 milligrams a day — has been associated with drops in blood pressure, sweating, gastrointestinal side effects and a \"fishy\" body odor. But most diets contain adequate choline, and supplementation to optimal levels poses no known side effects or risk to fetal development, Freedman says.\u003c/p>\n\u003cp>\u003cstrong>A genetic theory \u003c/strong>\u003c/p>\n\u003cp>One of the first genes to be linked to schizophrenia goes by the catchy name \"\u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/26376812\">CHRNA7\u003c/a>.\" Normally it encodes for a receptor on neurons in the brain that respond to the neurotransmitter acetylcholine as well as nicotine, a transmission essential to normal brain function and cognition. Genetic mutations in the CHRNA7 gene cause decreased levels of the neuronal receptor to be produced in people with schizophrenia.\u003c/p>\n\u003cp>A light bulb glowed for Freedman.\u003c/p>\n\u003cp>And the idea, he admits, is rather simple when you think about it: Choline is known to be essential to brain development and function and is also frequently deficient in pregnant women.\u003c/p>\n\u003cp>Couple these facts with animal and human research by Freedman and his colleagues showing that choline in the amniotic fluid also activates the CHRNA7 receptor in the developing fetal brain.\u003c/p>\n\u003cp>\"It occurred to us that just as folic acid can help overcome defects in brain and spinal cord development, perhaps supplementing mothers with choline could help prevent mental illness,\" Freedman recalls. \"And now that the children in our study are over 4 years old, we can see that those given the supplement appear to be on a different developmental track, one with fewer mental problems.\"\u003c/p>\n\u003cp>Moreover, though experimental psychosis treatments targeting the CHRNA7 gene and the receptor it codes for are being explored by other researchers, Freedman explains that levels of the receptor peak in the fetal brain and diminish after birth. \"We realized the optimal time to try this intervention is during pregnancy,\" he says.\u003c/p>\n\u003cp>Though choline is available in a number of foods — eggs, seafood and liver are particularly rich in the nutrient — Freedman's work suggests that for many women, dietary sources may be inadequate during pregnancy. Also, prenatal supplements tend not to include it.\u003c/p>\n\u003cp>Two past observational studies — conducted with diet questionnaires rather than the more rigorous placebo-controlled supplementation Freedman's group tried — also found beneficial effects associated with higher maternal choline intake during pregnancy. At 7 years of age, children of moms consuming over 400 milligrams of choline a day performed better on memory and intelligence tests. At 18 months, infants whose mothers had higher blood levels of choline had significantly higher cognitive test scores.\u003c/p>\n\u003cp>Dr. Steve Zeisel of the University of North Carolina was one of the first doctors to strongly advocate for choline supplementation in pregnancy. In 2012, Zeisel \u003ca href=\"http://ajcn.nutrition.org/content/96/6/1465.long\">published the only other\u003c/a> placebo-controlled trial of the vitamin in pregnant moms. While he did not assess for future mental health risks, the findings suggested that choline supplementation did not enhance infant cognitive function at 1 year of age. However, Freedman point outs that all of the women included in the trial were highly educated and were found to have blood metabolites reflecting diets high in healthful, choline-containing foods.\u003c/p>\n\u003cp>The prospects of choline supplementation in pregnancy have piqued medical interest, but also notes of caution. \"I think the choline research is really intriguing, and we're starting to investigate maternal choline levels as well,\" says \u003ca href=\"http://profiles.columbiapsychiatry.org/profile/cmonk\">Catherine Monk\u003c/a>, an associate professor in psychiatry and obstetrics and gynecology at Columbia University Medical Center. \"Some prenatal vitamins do contain it and foods rich in choline are readily available. But we have a lot more research to do before we start recommending it widely.\"\u003c/p>\n\u003cp>In general, evidence-based interventions during pregnancy and early childhood to prevent mental illness are scant. Yet there are some modifiable risk factors that might make a difference, many of which focus on improving maternal wellbeing.\u003c/p>\n\u003cp>Monk's own research explores on the impact of an expecting mother's emotional state on the developing fetus. She and others have shown that stress, depression and anxiety during pregnancy increase a child's risk for ADHD, conduct disorders and depression later in life. At Columbia, Monk and her colleagues employ a program Practical Resources for Effective Postpartum Parenting, or PREPP, in which pregnant women who are distressed and at high-risk for postpartum depression are counseled and taught coping skills to make pregnancy and parenting more manageable emotionally.\u003c/p>\n\u003cp>Optimal nutrition, including choline and adequate amounts of zinc and omega-3 fatty acids, may also have developmental and mental health benefits as might avoiding smoking.\u003c/p>\n\u003cp>\u003cstrong>The future of funding\u003c/strong>\u003c/p>\n\u003cp>Despite incomplete data on choline supplementation, Freedman's research colleague \u003ca href=\"http://www.ucdenver.edu/academics/colleges/medicalschool/programs/winnlab/AboutUs/Pages/CamilleHoffman.aspx\">Dr. Camille Hoffman-Shuler\u003c/a>, an obstetrician, sees it as a promising intervention that should continue to be explored.\u003c/p>\n\u003cp>\"Obstetricians and midwives are not widely aware of choline supplementation,\" she says. \"But I do recommend it to pregnant women, especially if they have other mental health vulnerabilities. And I'd personally want it with a future pregnancy based on existing data.\"\u003c/p>\n\u003cp>Both Freedman and Hoffman-Shuler hope to continue choline research, yet decry the obstacles to securing the money to do it.\u003c/p>\n\u003cp>\"The NIH is currently funding no trials of any intervention in humans during pregnancy to prevent mental illness,\" says Freedman, \"yet ideally we'd follow these children for another 20 to 25 years to see if they develop mental illness. This is beyond the scope of most imaginable — and fundable — experiments.\"\u003c/p>\n\u003cp>Hoffman-Shuler is prepared to do what it takes. \"The hardest part is getting this across to the funding agencies and the public,\" she says. But this is a serious public health issue in which prevention during pregnancy is far more preferable to the loss of health and consequences that come with mental illness!\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Bret Stetka is a writer based in New York and an editorial director at\u003c/em> \u003ca href=\"http://www.medscape.com/public/bios/bio-bretstetka\" target=\"_blank\">Medscape\u003c/a>. \u003cem>His work has appeared in\u003c/em> Wired\u003cem>,\u003c/em> Scientific American \u003cem>and on The Atlantic.com. He graduated from University of Virginia School of Medicine in 2005. You can follow him on Twitter: \u003c/em>\u003ca href=\"https://twitter.com/BretStetka\" target=\"_blank\">@BretStetka\u003c/a>.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Can+Mental+Illness+Be+Prevented+In+The+Womb%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"excerpt": "Researchers are exploring changes in prenatal nutrition to lower risks for future mental disorders. The work is preliminary, but there is ample precedent for maternal diet affecting children's health.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Every day in the United States, millions of expectant mothers take a prenatal vitamin on the advice of their doctor.\u003c/p>\n\u003cp>The counsel typically comes with physical health in mind: folic acid to help avoid fetal spinal cord problems; iodine to spur healthy brain development; calcium to be bound like molecular Legos into diminutive baby bones.\u003c/p>\n\u003cp>But what about a child's future mental health? Questions about whether ADHD might arise a few years down the road or whether schizophrenia could crop up in young adulthood tend to be overshadowed by more immediate parental anxieties. As a friend with a newborn daughter recently fretted over lunch, \"I'm just trying not to drop her!\"\u003c/p>\n\u003cp>Yet much as pediatricians administer childhood vaccines to guard against future infections, some psychiatrists now are thinking about how to shift their treatment-centric discipline toward one that also deals in early prevention.\u003c/p>\n\u003cp>In 2013, University of Colorado psychiatrist \u003ca href=\"http://www.ucdenver.edu/academics/colleges/medicalschool/departments/psychiatry/Faculty/Pages/Freedman,%20Robert.aspx\">Robert Freedman\u003c/a> and colleagues recruited 100 healthy, pregnant women from greater Denver to study whether giving the \u003ca href=\"//www.ncbi.nlm.nih.gov/books/NBK114308/\">B vitamin choline\u003c/a> during pregnancy would enhance brain growth in the developing fetus.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The moms-to-be were randomly given either a placebo or a form of choline called phosphatidylcholine. Choline itself is broken down by bacteria in the gut; by giving it in this related form the supplement can more effectively be absorbed into the bloodstream.\u003c/p>\n\u003cp>Those in the treatment group received 3,600 milligrams of phosphatidylcholine in the morning and 2,700 milligrams at night. Since phosphatidylcholine is roughly 13-15 percent choline, the amount the women received was about 900 milligrams of choline a day, twice that recommended by the Health and Medicine Division of the National Academies (and about the same amount contained in three large eggs).\u003c/p>\n\u003cp>After birth, infants were given either 100 milligrams of liquid phosphatidylcholine or placebo once a day for approximately three months. Given that both groups were also getting choline from regular feeding, the dose ensured that those supplemented received well over the Institute of Medicine's guideline that infants receive at least 125 milligrams a day.\u003c/p>\n\u003cp>At 5 weeks old, the children were exposed to a series of clicking sounds in the lab while their brain activity was monitored by \u003ca href=\"https://medlineplus.gov/ency/article/003931.htm\">electroencephalogram\u003c/a>, or EEG, a method for recording electrical brain activity via electrodes placed on the scalp. Normally, when exposed to the same sound successively, both infant and adult brains will exhibit \"inhibition,\" or a far weaker pulse of activity in response to the second sound. We realize that the now familiar tone is insignificant; our brains are unmoved.\u003c/p>\n\u003cp>However, in some kids this inhibition doesn't occur — a finding linked with an increased risk for attention problems, social withdrawal and, later in life, schizophrenia.\u003c/p>\n\u003cp>The \u003ca href=\"http://ajp.psychiatryonline.org/doi/abs/10.1176/appi.ajp.2012.12070940\">results published in 2013\u003c/a> in the \u003cem>American Journal of Psychiatry\u003c/em> by Freedman's group show that 76 percent of newborns whose mothers received choline supplements had normal inhibition to the sound stimuli. The proportion fell to 43 percent in those born to mothers who didn't get them. It appeared that choline might steer the infant brain away from a developmental course that predicted mental health problems.\u003c/p>\n\u003cp>A follow-up study at 40 months found that the children who had received choline supplements \u003cem>in utero\u003c/em> and after birth had fewer attention problems and less social withdrawal.\u003c/p>\n\u003cp>Excessive choline consumption — or that over 7,500 milligrams a day — has been associated with drops in blood pressure, sweating, gastrointestinal side effects and a \"fishy\" body odor. But most diets contain adequate choline, and supplementation to optimal levels poses no known side effects or risk to fetal development, Freedman says.\u003c/p>\n\u003cp>\u003cstrong>A genetic theory \u003c/strong>\u003c/p>\n\u003cp>One of the first genes to be linked to schizophrenia goes by the catchy name \"\u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/26376812\">CHRNA7\u003c/a>.\" Normally it encodes for a receptor on neurons in the brain that respond to the neurotransmitter acetylcholine as well as nicotine, a transmission essential to normal brain function and cognition. Genetic mutations in the CHRNA7 gene cause decreased levels of the neuronal receptor to be produced in people with schizophrenia.\u003c/p>\n\u003cp>A light bulb glowed for Freedman.\u003c/p>\n\u003cp>And the idea, he admits, is rather simple when you think about it: Choline is known to be essential to brain development and function and is also frequently deficient in pregnant women.\u003c/p>\n\u003cp>Couple these facts with animal and human research by Freedman and his colleagues showing that choline in the amniotic fluid also activates the CHRNA7 receptor in the developing fetal brain.\u003c/p>\n\u003cp>\"It occurred to us that just as folic acid can help overcome defects in brain and spinal cord development, perhaps supplementing mothers with choline could help prevent mental illness,\" Freedman recalls. \"And now that the children in our study are over 4 years old, we can see that those given the supplement appear to be on a different developmental track, one with fewer mental problems.\"\u003c/p>\n\u003cp>Moreover, though experimental psychosis treatments targeting the CHRNA7 gene and the receptor it codes for are being explored by other researchers, Freedman explains that levels of the receptor peak in the fetal brain and diminish after birth. \"We realized the optimal time to try this intervention is during pregnancy,\" he says.\u003c/p>\n\u003cp>Though choline is available in a number of foods — eggs, seafood and liver are particularly rich in the nutrient — Freedman's work suggests that for many women, dietary sources may be inadequate during pregnancy. Also, prenatal supplements tend not to include it.\u003c/p>\n\u003cp>Two past observational studies — conducted with diet questionnaires rather than the more rigorous placebo-controlled supplementation Freedman's group tried — also found beneficial effects associated with higher maternal choline intake during pregnancy. At 7 years of age, children of moms consuming over 400 milligrams of choline a day performed better on memory and intelligence tests. At 18 months, infants whose mothers had higher blood levels of choline had significantly higher cognitive test scores.\u003c/p>\n\u003cp>Dr. Steve Zeisel of the University of North Carolina was one of the first doctors to strongly advocate for choline supplementation in pregnancy. In 2012, Zeisel \u003ca href=\"http://ajcn.nutrition.org/content/96/6/1465.long\">published the only other\u003c/a> placebo-controlled trial of the vitamin in pregnant moms. While he did not assess for future mental health risks, the findings suggested that choline supplementation did not enhance infant cognitive function at 1 year of age. However, Freedman point outs that all of the women included in the trial were highly educated and were found to have blood metabolites reflecting diets high in healthful, choline-containing foods.\u003c/p>\n\u003cp>The prospects of choline supplementation in pregnancy have piqued medical interest, but also notes of caution. \"I think the choline research is really intriguing, and we're starting to investigate maternal choline levels as well,\" says \u003ca href=\"http://profiles.columbiapsychiatry.org/profile/cmonk\">Catherine Monk\u003c/a>, an associate professor in psychiatry and obstetrics and gynecology at Columbia University Medical Center. \"Some prenatal vitamins do contain it and foods rich in choline are readily available. But we have a lot more research to do before we start recommending it widely.\"\u003c/p>\n\u003cp>In general, evidence-based interventions during pregnancy and early childhood to prevent mental illness are scant. Yet there are some modifiable risk factors that might make a difference, many of which focus on improving maternal wellbeing.\u003c/p>\n\u003cp>Monk's own research explores on the impact of an expecting mother's emotional state on the developing fetus. She and others have shown that stress, depression and anxiety during pregnancy increase a child's risk for ADHD, conduct disorders and depression later in life. At Columbia, Monk and her colleagues employ a program Practical Resources for Effective Postpartum Parenting, or PREPP, in which pregnant women who are distressed and at high-risk for postpartum depression are counseled and taught coping skills to make pregnancy and parenting more manageable emotionally.\u003c/p>\n\u003cp>Optimal nutrition, including choline and adequate amounts of zinc and omega-3 fatty acids, may also have developmental and mental health benefits as might avoiding smoking.\u003c/p>\n\u003cp>\u003cstrong>The future of funding\u003c/strong>\u003c/p>\n\u003cp>Despite incomplete data on choline supplementation, Freedman's research colleague \u003ca href=\"http://www.ucdenver.edu/academics/colleges/medicalschool/programs/winnlab/AboutUs/Pages/CamilleHoffman.aspx\">Dr. Camille Hoffman-Shuler\u003c/a>, an obstetrician, sees it as a promising intervention that should continue to be explored.\u003c/p>\n\u003cp>\"Obstetricians and midwives are not widely aware of choline supplementation,\" she says. \"But I do recommend it to pregnant women, especially if they have other mental health vulnerabilities. And I'd personally want it with a future pregnancy based on existing data.\"\u003c/p>\n\u003cp>Both Freedman and Hoffman-Shuler hope to continue choline research, yet decry the obstacles to securing the money to do it.\u003c/p>\n\u003cp>\"The NIH is currently funding no trials of any intervention in humans during pregnancy to prevent mental illness,\" says Freedman, \"yet ideally we'd follow these children for another 20 to 25 years to see if they develop mental illness. This is beyond the scope of most imaginable — and fundable — experiments.\"\u003c/p>\n\u003cp>Hoffman-Shuler is prepared to do what it takes. \"The hardest part is getting this across to the funding agencies and the public,\" she says. But this is a serious public health issue in which prevention during pregnancy is far more preferable to the loss of health and consequences that come with mental illness!\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>Bret Stetka is a writer based in New York and an editorial director at\u003c/em> \u003ca href=\"http://www.medscape.com/public/bios/bio-bretstetka\" target=\"_blank\">Medscape\u003c/a>. \u003cem>His work has appeared in\u003c/em> Wired\u003cem>,\u003c/em> Scientific American \u003cem>and on The Atlantic.com. He graduated from University of Virginia School of Medicine in 2005. You can follow him on Twitter: \u003c/em>\u003ca href=\"https://twitter.com/BretStetka\" target=\"_blank\">@BretStetka\u003c/a>.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Can+Mental+Illness+Be+Prevented+In+The+Womb%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Can Ecstasy Help Relieve Social Anxiety Epidemic Among Autistic People?",
"title": "Can Ecstasy Help Relieve Social Anxiety Epidemic Among Autistic People?",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>For a long time, Daniel Au Valencia got the message that she was wrong, wrong, wrong. She stood wrong. She talked wrong. She looked at people wrong.\u003c/p>\n\u003cp>“There’s a lot of shame around autism,” she says. “There’s a lot of being told you look weird.”\u003c/p>\n\u003cp>\u003ca href=\"http://actingnt.blogspot.com/\">Valencia\u003c/a>, 22, often taps her feet when talking to someone. Or she’ll flap her hands. She says those movements help her communicate emotions and stay calm.\u003c/p>\n\u003caside class=\"alignright\">\u003ca href=\"#note\">A note on pronouns\u003c/a>\u003c/aside>\n\u003cp>“A common question is, ‘Why are you doing that?' in a very accusatory tone,” she says.\u003c/p>\n\u003cp>Don't even get her started on eye contact. A social skills teacher once tried to show her how to make eye contact without making people uncomfortable.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Don’t avoid it, but don’t stare.\u003c/p>\n\u003cp>“What I would have to do is, \"Okay, eye contact. One, two, three, glance away, glance back. One, two, three, glance away,’” Valencia explains. “And at that point, I’m no longer listening, I am pretending to listen.”\u003c/p>\n\u003cp>A lot of people just walk away.\u003c/p>\n\u003cp>“It can be anxiety-provoking,” she says. “That anxiety comes from being excluded, being rejected, being ridiculed for things that are just part of naturally being me.”\u003c/p>\n\u003cp>Valencia likes hanging out with people. She’s into salsa dancing, acting, improv and Pokemon Go. But sometimes social situations can be so stressful that Valencia hangs back on the sidelines, or avoids them altogether. She never answers the phone.\u003c/p>\n\u003cp>“It creates a cycle of self-judgment,” she says, “and makes the anxiety worse.”\u003c/p>\n\u003cfigure id=\"attachment_266972\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/MDMA_image-e1477009038956.jpg\">\u003cimg class=\"wp-image-266972 size-large\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/MDMA_image-1020x791.jpg\" alt=\"MDMA_image\" width=\"640\" height=\"496\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Daniel Au Valencia participated in a pilot study examining the potential of MDMA as a treatment for social anxiety in autistic adults. \u003ccite>(April Dembosky/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>Experimental Study\u003c/strong>\u003c/p>\n\u003cp>Then last year Valencia heard about an unusual experimental study. Unlike a lot of other studies, this one didn’t say anything about trying to “cure autism.” This one was exploring a treatment specifically for social anxiety in autistic adults.\u003c/p>\n\u003cp>“Anxiety, unlike autism, is actually a problem that you might want to get rid of,” Valencia says.\u003c/p>\n\u003cp>Many traditional therapies don’t work for autistic people, says Nick Walker, an autistic advocate and consultant on the new study, because they reinforce stigma around autism and are “designed to coerce autistic people into acting like they’re not autistic.”\u003c/p>\n\u003cp>He sees this new research as a uniquely “culturally appropriate” approach to addressing the “epidemic” of social anxiety in autistic adults – anxiety caused by a lifetime of repeated, traumatic social interactions.\u003c/p>\n\u003cp>The treatment is MDMA, known more commonly as Ecstacy or Molly. On the street, it is often cut with speed or other drugs, and is popular among ravers for lowering inhibitions, heightening physical sensations, and making people feel all lovey.\u003c/p>\n\u003cp>But researchers are finding that pure MDMA has potential to be a true medicine. Early studies backed by MAPS, the Multidisciplinary Association of Psychedelic Studies based in Santa Cruz, show it can ease or erase symptoms of post-traumatic stress disorder. In \u003ca href=\"http://www.maps.org/research-archive/publications/Oehen_2012_MDMA_PTSD_Swisstudy.pdf\">one study\u003c/a>, 83 percent of study participants treated with MDMA and psychotherapy were cured of their PTSD, compared to 25 percent who were cured from talk therapy alone.\u003c/p>\n\u003cp>“MDMA creates a sensation of feeling safe,” says psychologist \u003ca href=\"http://www.icpr2016.nl/speakers/alicia-danforth-phd/\">Alicia Danforth\u003c/a>, one of the researchers conducting the social anxiety study at UCLA’s Los Angeles Biomedical Research Institute, along with psychiatrist \u003ca href=\"http://www.harboruclapsych.com/charles-s-grob-m-d/\">Charles Grob\u003c/a>.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I felt the changes in my body. My bodily needs were radically altered.'\u003ccite>Daniel Au Valencia, Study participant\u003c/cite>\u003c/aside>\n\u003cp>MDMA floods the brain with serotonin and dopamine, they say, and quiets the fear response from the amygdala, allowing people to confront past traumatic experiences without becoming overwhelmed. Or they can try new things without fear or inhibition getting in the way.\u003c/p>\n\u003cp>“It creates a practice environment to try different social skills out,” Danforth says. “MDMA can be a bit like training wheels for the psyche.”\u003c/p>\n\u003cp>Valencia is one of just 12 autistic adults participating in the pilot study. Given the small size, researchers won’t get statistically meaningful data on the efficacy of MDMA in treating social anxiety. Their focus is proving that this research can be done safely in this population, with the hopes that others will conduct larger-scale studies.\u003c/p>\n\u003cp>The treatment consists of two MDMA sessions, 10 a.m. to 6 p.m., six weeks apart. Danforth and Grob meet with each study participant several times before and after each session for psychotherapy and to measure their social anxiety levels.\u003c/p>\n\u003cp>Before the first MDMA session, they ask participants to set an intention. Danforth says they want them to think about how they hope to grow or change from the treatment.\u003c/p>\n\u003cp>“It can be something simple: ‘I want to be better at small talk, or I want to learn the skill of asking someone out on a date,’” Danforth says. “It can also be very large, ‘I’m working on forgiveness or unresolved grief or loss.’”\u003c/p>\n\u003cp>Valencia’s goal was to be more assertive.\u003c/p>\n\u003cp>“One of the things that makes anxiety go away is to be in control of the situation rather than waiting for things to happen,” she says.\u003c/p>\n\u003cp>\u003cstrong>The First Session\u003c/strong>\u003c/p>\n\u003cp>Valencia arrived at 10 a.m. for her first MDMA session at a bland office building on the UCLA campus. Researchers transformed the room to a kind of den that Danforth describes as “autism friendly” -- soft lighting, soothing colors, and a luxury leather recliner facing a wall-sized poster of a forest canopy with light streaming through the trees.\u003c/p>\n\u003cp>New-age flute music played over the computer speakers as Valencia swallowed the MDMA capsule. Within a half hour, she knew it was not a placebo.\u003c/p>\n\u003cp>“I felt the changes in my body,” Valencia describes. “My bodily needs were radically altered.”\u003c/p>\n\u003cp>She describes one moment that was particularly powerful, when researchers brought in a plate of grapes.\u003c/p>\n\u003cp>“I bit into half a grape,” Valencia says. “I felt the flavors, the texture, the nuance.”\u003c/p>\n\u003cp>This sparked a classic psychedelic epiphany.\u003c/p>\n\u003cp>“Wow, I can really enjoy every bit of life more, if I can do it mindfully,” she says.\u003c/p>\n\u003cp>Later in the session, she felt a rush of energy in her body and said, “I feel like dancing.”\u003c/p>\n\u003cp>Then Valencia did something that would normally take her eons to build up the courage to do.\u003c/p>\n\u003cp>She asked Danforth if she would care to salsa.\u003c/p>\n\u003cp>“I was thinking, my intention is to be more assertive,” Valencia says. “Well, one part of being assertive is ask for what you want.”\u003c/p>\n\u003cp>Danforth says in the context of the therapy and Valencia’s intention, this was completely appropriate. It was in keeping with Danforth’s previous research, where she collected qualitative reports from autistic adults who had taken MDMA recreationally.\u003c/p>\n\u003cp>“We call them the Five C’s,” she says. “People reported changes in their level of courage or confidence, communication, feeling connected, a sense of communion or belonging, and mental clarity.”\u003c/p>\n\u003cfigure id=\"attachment_266943\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/MDMA_1-e1477009669302.jpg\">\u003cimg class=\"size-large wp-image-266943\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/MDMA_1-1020x765.jpg\" alt='Valencia uses emotion cards to help her understand and articulate her feelings. There are about 60 in the deck, including a few \"make your own\" cards.' width=\"640\" height=\"480\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Valencia uses emotion cards to help her understand and articulate her feelings. There are about 60 in the deck, including a few \"make your own\" cards. \u003ccite>(April Dembosky/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>Follow-Up\u003c/strong>\u003c/p>\n\u003cp>The day after the MDMA session, the researchers meet with each participant to talk about what happened. Then they call them every day for a week after that to check in.\u003c/p>\n\u003cp>“The treatment is just a day,” Danforth says. “It’s what you do with those insights and how you integrate it into your everyday life.”\u003c/p>\n\u003cp>After her first session, Valencia started using a deck of “emotion cards” each day to help her understand what she was feeling. Each card has a word – “peaceful,” “loving,” “uncomfortable,” “frustrated,” “receptive” -- with a corresponding illustration.\u003c/p>\n\u003cp>“I’ve learned about the importance of connecting with your emotions,” she says. “I have learned that you can experience a whole lot of different emotions at once.”\u003c/p>\n\u003cp>While that may seem innate for a lot of typically developing individuals, it’s novel for a lot of autistic people, Danforth says. MDMA is known for helping people get clarity about their feeling states, to find words to express them, she says. That, in turn, helps people articulate their needs so they can “shape the world to be more to their liking.”\u003c/p>\n\u003cp>That was one of Valencia’s big takeaways: “Knowing that I have a choice,” she says. “Anytime something is bothering me, I can do something about it.”\u003c/p>\n\u003cp>\u003cstrong>The Second Session\u003c/strong>\u003c/p>\n\u003cp>When it was time for Valencia’s second MDMA session, she felt her original goal of being more assertive was now not quite right. It felt like a concession to societal pressure to fit in. She needed to let go of that, she says, and release the pressure she was putting on herself to always be involved, to be better all the time, to be different.\u003c/p>\n\u003cp>“In session number two, there was a moment I was just sitting in a big comfy chair,” Valencia says. “Letting my hands do whatever my hands wanted to do, kind of floating around. It looks like nothing is happening.”\u003c/p>\n\u003cp>But in fact, Valencia says, her mind was racing with thoughts, one idea popping up after another.\u003c/p>\n\u003cp>“And I thought, ‘Oh, these are some good ideas. I should write them down,” she says. “And then I stopped myself. ‘Do I have to do this? I can just sit here. And enjoy them.’”\u003c/p>\n\u003cp>When she flipped through the emotion cards, she picked one where the illustration was a swirl of blackness. The word was “depressed,” but Valencia says she saw something else.\u003c/p>\n\u003cp>“Not having to do something in every moment, not having to \u003cem>feel \u003c/em>anything for just a couple hours,” she says. “That was such a relief.”\u003c/p>\n\u003cp>\u003cstrong>Reflections \u003c/strong>\u003c/p>\n\u003cp>Valencia completed the treatment last year. It’s impossible to draw a direct line between the treatment and how Valencia is doing right now, but she says she’s doing great. She’s got a steady full-time job, her own apartment, and she just got married. The study is still ongoing, so Valencia won’t know if her scores on the social anxiety tests improved until all participants finish the treatment and the researchers analyze the data.\u003c/p>\n\u003cp>But she says her biggest takeaway from the experiment is more about emotions than social anxiety.\u003c/p>\n\u003cp>She says she’s learned that there’s no such thing as good emotions or bad emotions.\u003c/p>\n\u003cp>“All emotions deserve to exist,” she says.\u003c/p>\n\u003cp>This underscores a process of transformation Valencia started a couple years before the MDMA treatment around her autistic identity. She started reading essays by Nick Walker, the autism advocate based in Berkeley. He rejects the notion that autism is a disease, the same way the gay community rejects the notion that homosexuality is a disease.\u003c/p>\n\u003cp>Walker says autistic brains are simply different. They’re part of the patchwork of neurodiversity in the human population.\u003c/p>\n\u003cp>“There’s the dominant belief in society that there's good brains and bad brains,” Valencia says. “And from a neurodiversity perspective, all those concepts are no longer valid.”\u003c/p>\n\u003cp>After the MDMA treatment, Valencia started to see emotions in the same way, along the same continuum of self-acceptance.\u003c/p>\n\u003cp>“Once you do away with that most basic of dichotomies, good versus bad, and just make it all sort of a jumbled mess of the same thing, then you can either hate yourself as a whole or you can accept and love yourself as a whole,” she says. “And I think, it’s not always as easy as making a decision, but it’s pretty obvious which one is preferable.”\u003ca id=\"note\">\u003c/a>\u003c/p>\n\u003cp>\u003cem>Editor's Note:\u003c/em>\u003c/p>\n\u003cp>\u003cem>After completing the full course of MDMA treatment and working on assertiveness, Valencia began asking friends and acquaintances to use the pronouns “they, them, their.” Valencia identifies as gender-vague.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Using “they” or “them” to refer to an individual presents certain grammatical and syntactical challenges, and in light of this, Valencia asked KQED to use female pronouns instead.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>For a long time, Daniel Au Valencia got the message that she was wrong, wrong, wrong. She stood wrong. She talked wrong. She looked at people wrong.\u003c/p>\n\u003cp>“There’s a lot of shame around autism,” she says. “There’s a lot of being told you look weird.”\u003c/p>\n\u003cp>\u003ca href=\"http://actingnt.blogspot.com/\">Valencia\u003c/a>, 22, often taps her feet when talking to someone. Or she’ll flap her hands. She says those movements help her communicate emotions and stay calm.\u003c/p>\n\u003caside class=\"alignright\">\u003ca href=\"#note\">A note on pronouns\u003c/a>\u003c/aside>\n\u003cp>“A common question is, ‘Why are you doing that?' in a very accusatory tone,” she says.\u003c/p>\n\u003cp>Don't even get her started on eye contact. A social skills teacher once tried to show her how to make eye contact without making people uncomfortable.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Don’t avoid it, but don’t stare.\u003c/p>\n\u003cp>“What I would have to do is, \"Okay, eye contact. One, two, three, glance away, glance back. One, two, three, glance away,’” Valencia explains. “And at that point, I’m no longer listening, I am pretending to listen.”\u003c/p>\n\u003cp>A lot of people just walk away.\u003c/p>\n\u003cp>“It can be anxiety-provoking,” she says. “That anxiety comes from being excluded, being rejected, being ridiculed for things that are just part of naturally being me.”\u003c/p>\n\u003cp>Valencia likes hanging out with people. She’s into salsa dancing, acting, improv and Pokemon Go. But sometimes social situations can be so stressful that Valencia hangs back on the sidelines, or avoids them altogether. She never answers the phone.\u003c/p>\n\u003cp>“It creates a cycle of self-judgment,” she says, “and makes the anxiety worse.”\u003c/p>\n\u003cfigure id=\"attachment_266972\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/MDMA_image-e1477009038956.jpg\">\u003cimg class=\"wp-image-266972 size-large\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/MDMA_image-1020x791.jpg\" alt=\"MDMA_image\" width=\"640\" height=\"496\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Daniel Au Valencia participated in a pilot study examining the potential of MDMA as a treatment for social anxiety in autistic adults. \u003ccite>(April Dembosky/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>Experimental Study\u003c/strong>\u003c/p>\n\u003cp>Then last year Valencia heard about an unusual experimental study. Unlike a lot of other studies, this one didn’t say anything about trying to “cure autism.” This one was exploring a treatment specifically for social anxiety in autistic adults.\u003c/p>\n\u003cp>“Anxiety, unlike autism, is actually a problem that you might want to get rid of,” Valencia says.\u003c/p>\n\u003cp>Many traditional therapies don’t work for autistic people, says Nick Walker, an autistic advocate and consultant on the new study, because they reinforce stigma around autism and are “designed to coerce autistic people into acting like they’re not autistic.”\u003c/p>\n\u003cp>He sees this new research as a uniquely “culturally appropriate” approach to addressing the “epidemic” of social anxiety in autistic adults – anxiety caused by a lifetime of repeated, traumatic social interactions.\u003c/p>\n\u003cp>The treatment is MDMA, known more commonly as Ecstacy or Molly. On the street, it is often cut with speed or other drugs, and is popular among ravers for lowering inhibitions, heightening physical sensations, and making people feel all lovey.\u003c/p>\n\u003cp>But researchers are finding that pure MDMA has potential to be a true medicine. Early studies backed by MAPS, the Multidisciplinary Association of Psychedelic Studies based in Santa Cruz, show it can ease or erase symptoms of post-traumatic stress disorder. In \u003ca href=\"http://www.maps.org/research-archive/publications/Oehen_2012_MDMA_PTSD_Swisstudy.pdf\">one study\u003c/a>, 83 percent of study participants treated with MDMA and psychotherapy were cured of their PTSD, compared to 25 percent who were cured from talk therapy alone.\u003c/p>\n\u003cp>“MDMA creates a sensation of feeling safe,” says psychologist \u003ca href=\"http://www.icpr2016.nl/speakers/alicia-danforth-phd/\">Alicia Danforth\u003c/a>, one of the researchers conducting the social anxiety study at UCLA’s Los Angeles Biomedical Research Institute, along with psychiatrist \u003ca href=\"http://www.harboruclapsych.com/charles-s-grob-m-d/\">Charles Grob\u003c/a>.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I felt the changes in my body. My bodily needs were radically altered.'\u003ccite>Daniel Au Valencia, Study participant\u003c/cite>\u003c/aside>\n\u003cp>MDMA floods the brain with serotonin and dopamine, they say, and quiets the fear response from the amygdala, allowing people to confront past traumatic experiences without becoming overwhelmed. Or they can try new things without fear or inhibition getting in the way.\u003c/p>\n\u003cp>“It creates a practice environment to try different social skills out,” Danforth says. “MDMA can be a bit like training wheels for the psyche.”\u003c/p>\n\u003cp>Valencia is one of just 12 autistic adults participating in the pilot study. Given the small size, researchers won’t get statistically meaningful data on the efficacy of MDMA in treating social anxiety. Their focus is proving that this research can be done safely in this population, with the hopes that others will conduct larger-scale studies.\u003c/p>\n\u003cp>The treatment consists of two MDMA sessions, 10 a.m. to 6 p.m., six weeks apart. Danforth and Grob meet with each study participant several times before and after each session for psychotherapy and to measure their social anxiety levels.\u003c/p>\n\u003cp>Before the first MDMA session, they ask participants to set an intention. Danforth says they want them to think about how they hope to grow or change from the treatment.\u003c/p>\n\u003cp>“It can be something simple: ‘I want to be better at small talk, or I want to learn the skill of asking someone out on a date,’” Danforth says. “It can also be very large, ‘I’m working on forgiveness or unresolved grief or loss.’”\u003c/p>\n\u003cp>Valencia’s goal was to be more assertive.\u003c/p>\n\u003cp>“One of the things that makes anxiety go away is to be in control of the situation rather than waiting for things to happen,” she says.\u003c/p>\n\u003cp>\u003cstrong>The First Session\u003c/strong>\u003c/p>\n\u003cp>Valencia arrived at 10 a.m. for her first MDMA session at a bland office building on the UCLA campus. Researchers transformed the room to a kind of den that Danforth describes as “autism friendly” -- soft lighting, soothing colors, and a luxury leather recliner facing a wall-sized poster of a forest canopy with light streaming through the trees.\u003c/p>\n\u003cp>New-age flute music played over the computer speakers as Valencia swallowed the MDMA capsule. Within a half hour, she knew it was not a placebo.\u003c/p>\n\u003cp>“I felt the changes in my body,” Valencia describes. “My bodily needs were radically altered.”\u003c/p>\n\u003cp>She describes one moment that was particularly powerful, when researchers brought in a plate of grapes.\u003c/p>\n\u003cp>“I bit into half a grape,” Valencia says. “I felt the flavors, the texture, the nuance.”\u003c/p>\n\u003cp>This sparked a classic psychedelic epiphany.\u003c/p>\n\u003cp>“Wow, I can really enjoy every bit of life more, if I can do it mindfully,” she says.\u003c/p>\n\u003cp>Later in the session, she felt a rush of energy in her body and said, “I feel like dancing.”\u003c/p>\n\u003cp>Then Valencia did something that would normally take her eons to build up the courage to do.\u003c/p>\n\u003cp>She asked Danforth if she would care to salsa.\u003c/p>\n\u003cp>“I was thinking, my intention is to be more assertive,” Valencia says. “Well, one part of being assertive is ask for what you want.”\u003c/p>\n\u003cp>Danforth says in the context of the therapy and Valencia’s intention, this was completely appropriate. It was in keeping with Danforth’s previous research, where she collected qualitative reports from autistic adults who had taken MDMA recreationally.\u003c/p>\n\u003cp>“We call them the Five C’s,” she says. “People reported changes in their level of courage or confidence, communication, feeling connected, a sense of communion or belonging, and mental clarity.”\u003c/p>\n\u003cfigure id=\"attachment_266943\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/MDMA_1-e1477009669302.jpg\">\u003cimg class=\"size-large wp-image-266943\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/MDMA_1-1020x765.jpg\" alt='Valencia uses emotion cards to help her understand and articulate her feelings. There are about 60 in the deck, including a few \"make your own\" cards.' width=\"640\" height=\"480\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Valencia uses emotion cards to help her understand and articulate her feelings. There are about 60 in the deck, including a few \"make your own\" cards. \u003ccite>(April Dembosky/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>Follow-Up\u003c/strong>\u003c/p>\n\u003cp>The day after the MDMA session, the researchers meet with each participant to talk about what happened. Then they call them every day for a week after that to check in.\u003c/p>\n\u003cp>“The treatment is just a day,” Danforth says. “It’s what you do with those insights and how you integrate it into your everyday life.”\u003c/p>\n\u003cp>After her first session, Valencia started using a deck of “emotion cards” each day to help her understand what she was feeling. Each card has a word – “peaceful,” “loving,” “uncomfortable,” “frustrated,” “receptive” -- with a corresponding illustration.\u003c/p>\n\u003cp>“I’ve learned about the importance of connecting with your emotions,” she says. “I have learned that you can experience a whole lot of different emotions at once.”\u003c/p>\n\u003cp>While that may seem innate for a lot of typically developing individuals, it’s novel for a lot of autistic people, Danforth says. MDMA is known for helping people get clarity about their feeling states, to find words to express them, she says. That, in turn, helps people articulate their needs so they can “shape the world to be more to their liking.”\u003c/p>\n\u003cp>That was one of Valencia’s big takeaways: “Knowing that I have a choice,” she says. “Anytime something is bothering me, I can do something about it.”\u003c/p>\n\u003cp>\u003cstrong>The Second Session\u003c/strong>\u003c/p>\n\u003cp>When it was time for Valencia’s second MDMA session, she felt her original goal of being more assertive was now not quite right. It felt like a concession to societal pressure to fit in. She needed to let go of that, she says, and release the pressure she was putting on herself to always be involved, to be better all the time, to be different.\u003c/p>\n\u003cp>“In session number two, there was a moment I was just sitting in a big comfy chair,” Valencia says. “Letting my hands do whatever my hands wanted to do, kind of floating around. It looks like nothing is happening.”\u003c/p>\n\u003cp>But in fact, Valencia says, her mind was racing with thoughts, one idea popping up after another.\u003c/p>\n\u003cp>“And I thought, ‘Oh, these are some good ideas. I should write them down,” she says. “And then I stopped myself. ‘Do I have to do this? I can just sit here. And enjoy them.’”\u003c/p>\n\u003cp>When she flipped through the emotion cards, she picked one where the illustration was a swirl of blackness. The word was “depressed,” but Valencia says she saw something else.\u003c/p>\n\u003cp>“Not having to do something in every moment, not having to \u003cem>feel \u003c/em>anything for just a couple hours,” she says. “That was such a relief.”\u003c/p>\n\u003cp>\u003cstrong>Reflections \u003c/strong>\u003c/p>\n\u003cp>Valencia completed the treatment last year. It’s impossible to draw a direct line between the treatment and how Valencia is doing right now, but she says she’s doing great. She’s got a steady full-time job, her own apartment, and she just got married. The study is still ongoing, so Valencia won’t know if her scores on the social anxiety tests improved until all participants finish the treatment and the researchers analyze the data.\u003c/p>\n\u003cp>But she says her biggest takeaway from the experiment is more about emotions than social anxiety.\u003c/p>\n\u003cp>She says she’s learned that there’s no such thing as good emotions or bad emotions.\u003c/p>\n\u003cp>“All emotions deserve to exist,” she says.\u003c/p>\n\u003cp>This underscores a process of transformation Valencia started a couple years before the MDMA treatment around her autistic identity. She started reading essays by Nick Walker, the autism advocate based in Berkeley. He rejects the notion that autism is a disease, the same way the gay community rejects the notion that homosexuality is a disease.\u003c/p>\n\u003cp>Walker says autistic brains are simply different. They’re part of the patchwork of neurodiversity in the human population.\u003c/p>\n\u003cp>“There’s the dominant belief in society that there's good brains and bad brains,” Valencia says. “And from a neurodiversity perspective, all those concepts are no longer valid.”\u003c/p>\n\u003cp>After the MDMA treatment, Valencia started to see emotions in the same way, along the same continuum of self-acceptance.\u003c/p>\n\u003cp>“Once you do away with that most basic of dichotomies, good versus bad, and just make it all sort of a jumbled mess of the same thing, then you can either hate yourself as a whole or you can accept and love yourself as a whole,” she says. “And I think, it’s not always as easy as making a decision, but it’s pretty obvious which one is preferable.”\u003ca id=\"note\">\u003c/a>\u003c/p>\n\u003cp>\u003cem>Editor's Note:\u003c/em>\u003c/p>\n\u003cp>\u003cem>After completing the full course of MDMA treatment and working on assertiveness, Valencia began asking friends and acquaintances to use the pronouns “they, them, their.” Valencia identifies as gender-vague.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>Researchers have discovered a piece in the puzzle of how the Zika virus spreads in human cells and neutralizes the body’s defenses.\u003c/p>\n\u003cp>A study by scientists at the University of California, San Diego School of Medicine answered a fundamental question posed by biologists: What happens when the virus enters a human cell?\u003c/p>\n\u003cp>Zika infections lead to modifications in the genetic material of both the virus itself and humans’ immune systems, influencing the virus’ spread and the body’s immune response, according to the researchers. Their study was published last week in \u003cem>Cell Host & Microbe\u003c/em>.\u003c/p>\n\u003cp>While humans’ genetic material is made up of DNA and RNA, some viruses’ genomes — including Zika and HIV — are comprised only of RNA. In humans, RNA carries genetic information from DNA to create new cells.\u003c/p>\n\u003cp>Researchers found that when the Zika virus infected a human cell, the cell modified viral RNA to get rid of the infection. But that adaptation triggered human enzymes that may have impacted the cell’s protective shield. The Zika infection also induced modifications on human RNA, according to the study.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Changing viral RNA let the virus “hide in plain sight,” said Tariq Rana, the lead author of the study and a professor of pediatrics at UC San Diego.\u003c/p>\n\u003cp>That discovery probably won’t help find a vaccine for Zika, but it could contribute to the discovery of drugs to prevent birth defects in some babies born to women who contracted the virus while pregnant, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. He was not involved in the study.\u003c/p>\n\u003cp>It might also help scientists develop drugs in the future that can specifically target and stop Zika from changing RNA, Rana said.\u003c/p>\n\u003cp>And understanding how Zika changes RNA opens the door to studying when fetuses are harmed during pregnancies and what potential risk factors may be, said Amesh Adalja, a senior associate at the Center for Health Security, part of the University of Pittsburgh Medical Center.\u003c/p>\n\u003cp>The research may be a key to understanding how Zika causes so much damage to a developing fetus, said Adalja, who was also not part of the study.\u003c/p>\n\u003cp>“What you’re seeing with Zika is science progressing at breakneck speed to discover mysteries about this virus that no one paid attention to for decades and decades,” Adalja said.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Changing viral RNA let the virus “hide in plain sight,” said Tariq Rana, the lead author of the study and a professor of pediatrics at UC San Diego.\u003c/p>\n\u003cp>That discovery probably won’t help find a vaccine for Zika, but it could contribute to the discovery of drugs to prevent birth defects in some babies born to women who contracted the virus while pregnant, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. He was not involved in the study.\u003c/p>\n\u003cp>It might also help scientists develop drugs in the future that can specifically target and stop Zika from changing RNA, Rana said.\u003c/p>\n\u003cp>And understanding how Zika changes RNA opens the door to studying when fetuses are harmed during pregnancies and what potential risk factors may be, said Amesh Adalja, a senior associate at the Center for Health Security, part of the University of Pittsburgh Medical Center.\u003c/p>\n\u003cp>The research may be a key to understanding how Zika causes so much damage to a developing fetus, said Adalja, who was also not part of the study.\u003c/p>\n\u003cp>“What you’re seeing with Zika is science progressing at breakneck speed to discover mysteries about this virus that no one paid attention to for decades and decades,” Adalja said.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Mind-Controlled, Robotic Arm Restores Some Sense of Touch to Paralyzed Man",
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"content": "\u003cp>Twelve years ago, a car wreck took away Nathan Copeland's ability to control his hands or sense what his fingers were touching.\u003c/p>\n\u003cp>A few months ago, researchers at the University of Pittsburgh and the University of Pittsburgh Medical Center gave Copeland a new way to reach out and feel the world around him. It's a mind-controlled robotic arm that has pressure sensors in each fingertip that send signals directly to Copeland's brain.\u003c/p>\n\u003cp>The scientists \u003ca href=\"http://stm.sciencemag.org/content/early/2016/10/12/scitranslmed.aaf8083\">published\u003c/a> details of their work online Thursday in the journal \u003cem>Science Translational Medicine.\u003c/em>\u003c/p>\n\u003cp>\"It's a really weird sensation,\" Copeland, now 30, says in a video made shortly after he first tried the system. \"Sometimes it feels, kind of, like electrical and sometimes it's more of a pressure.\" But he also describes many of the sensations coming from his robotic hand as \"natural.\"\u003c/p>\n\u003cp>When Copeland touches an object with the robotic hand, he can tell which finger the sensation is coming from and whether an object feels hard or soft, says \u003ca href=\"http://www.rehabmedicine.pitt.edu/people/bios/gaunt_2016.html\">Robert Gaunt\u003c/a>, a bioengineer and assistant professor in the Department of Physical Medicine & Rehabilitation at the University of Pittsburgh.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"But we're really not at the point where we could, say, get him to feel the difference between silk and burlap,\" Gaunt says.\u003c/p>\n\u003cp>The success represents an advance that is \"absolutely critical in terms of making prosthetics useful,\" says \u003ca href=\"http://jhmvhi.jhu.edu/people/michael-p-mcloughlin/\">Mike McLoughlin\u003c/a>, an engineer at the Johns Hopkins University Applied Physics Laboratory.\u003c/p>\n\u003cp>McLoughlin is part of a team at Hopkins that developed the \u003ca href=\"http://www.jhuapl.edu/prosthetics/scientists/mpl.asp\">Modular Prosthetic Limb\u003c/a> that Copeland is using. The research at both Hopkins and in Pittsburgh is supported by the government's Defense Advanced Research Projects Agency.\u003c/p>\n\u003cp>For several years now, people have been able to control robotic arms using thoughts alone. But they have relied entirely on vision to know whether the arm is going in the right direction or grasping an object with the proper amount of force.\u003c/p>\n\u003cp>That makes it very challenging to perform simple tasks like grasping a foam coffee cup without crushing it, McLoughlin says.\u003c/p>\n\u003cp>\"Without sensory feedback, somebody would have to actually have to look at the prosthetic, look at the cup, start to close the hand, (and) visually see the cup is starting to deform,\" he says.\u003c/p>\n\u003cp>Restoring Copeland's sense of touch was a painstaking process, but the Pittsburgh team knew it was possible.\u003c/p>\n\u003cp>\"His hand has been disconnected from his brain because of his spinal cord injury,\" Gaunt says. \"But the brain hasn't lost its ability to feel.\"\u003c/p>\n\u003cp>So the team began looking for a way to send touch sensations directly to Copeland's brain. The first step was to monitor his brain activity using a technique called \u003ca href=\"http://megcommunity.org/what-is-meg\">magnetoencephalography\u003c/a>.\u003c/p>\n\u003cp>\"We were able to see the parts of his brain that became active when he was watching videos of a hand being touched,\" Gaunt says.\u003c/p>\n\u003cp>Next, the researchers placed tiny electrodes in Copeland's brain that could stimulate the areas corresponding to each finger. Then they waited for the brain to heal, as it adjusted to the presence of the electrodes.\u003c/p>\n\u003cp>It was several weeks before the team was able to send the first tiny pulse of electricity to Copeland's brain. \"When it finally happened, he just very calmly said, 'Yep, I felt it on my index finger,' \" Gaunt recalls. \"But in the background I was breathing a sigh of relief and other people were cheering.\"\u003c/p>\n\u003cp>Of course, mind-controlled robots are still years away from consumer applications, McLoughlin says. At the moment, they are still too expensive, too bulky and too finicky to be used outside a laboratory setting. And there's no good way to control them without implanting electrodes in the brain.\u003c/p>\n\u003cp>Still, the ability to receive touch sensation from a robotic arm has the potential to help not only thousands of people who are paralyzed, but also people with a wide range of physical disabilities, McLoughlin says. For example, robots that provide sensory feedback could eventually help a disabled person cook a meal or clean up things at home.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"We're on the verge of something here that's going to transform lives,\" he says.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Brain+Implant+Restores+Sense+Of+Touch+To+Paralyzed+Man&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Twelve years ago, a car wreck took away Nathan Copeland's ability to control his hands or sense what his fingers were touching.\u003c/p>\n\u003cp>A few months ago, researchers at the University of Pittsburgh and the University of Pittsburgh Medical Center gave Copeland a new way to reach out and feel the world around him. It's a mind-controlled robotic arm that has pressure sensors in each fingertip that send signals directly to Copeland's brain.\u003c/p>\n\u003cp>The scientists \u003ca href=\"http://stm.sciencemag.org/content/early/2016/10/12/scitranslmed.aaf8083\">published\u003c/a> details of their work online Thursday in the journal \u003cem>Science Translational Medicine.\u003c/em>\u003c/p>\n\u003cp>\"It's a really weird sensation,\" Copeland, now 30, says in a video made shortly after he first tried the system. \"Sometimes it feels, kind of, like electrical and sometimes it's more of a pressure.\" But he also describes many of the sensations coming from his robotic hand as \"natural.\"\u003c/p>\n\u003cp>When Copeland touches an object with the robotic hand, he can tell which finger the sensation is coming from and whether an object feels hard or soft, says \u003ca href=\"http://www.rehabmedicine.pitt.edu/people/bios/gaunt_2016.html\">Robert Gaunt\u003c/a>, a bioengineer and assistant professor in the Department of Physical Medicine & Rehabilitation at the University of Pittsburgh.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"But we're really not at the point where we could, say, get him to feel the difference between silk and burlap,\" Gaunt says.\u003c/p>\n\u003cp>The success represents an advance that is \"absolutely critical in terms of making prosthetics useful,\" says \u003ca href=\"http://jhmvhi.jhu.edu/people/michael-p-mcloughlin/\">Mike McLoughlin\u003c/a>, an engineer at the Johns Hopkins University Applied Physics Laboratory.\u003c/p>\n\u003cp>McLoughlin is part of a team at Hopkins that developed the \u003ca href=\"http://www.jhuapl.edu/prosthetics/scientists/mpl.asp\">Modular Prosthetic Limb\u003c/a> that Copeland is using. The research at both Hopkins and in Pittsburgh is supported by the government's Defense Advanced Research Projects Agency.\u003c/p>\n\u003cp>For several years now, people have been able to control robotic arms using thoughts alone. But they have relied entirely on vision to know whether the arm is going in the right direction or grasping an object with the proper amount of force.\u003c/p>\n\u003cp>That makes it very challenging to perform simple tasks like grasping a foam coffee cup without crushing it, McLoughlin says.\u003c/p>\n\u003cp>\"Without sensory feedback, somebody would have to actually have to look at the prosthetic, look at the cup, start to close the hand, (and) visually see the cup is starting to deform,\" he says.\u003c/p>\n\u003cp>Restoring Copeland's sense of touch was a painstaking process, but the Pittsburgh team knew it was possible.\u003c/p>\n\u003cp>\"His hand has been disconnected from his brain because of his spinal cord injury,\" Gaunt says. \"But the brain hasn't lost its ability to feel.\"\u003c/p>\n\u003cp>So the team began looking for a way to send touch sensations directly to Copeland's brain. The first step was to monitor his brain activity using a technique called \u003ca href=\"http://megcommunity.org/what-is-meg\">magnetoencephalography\u003c/a>.\u003c/p>\n\u003cp>\"We were able to see the parts of his brain that became active when he was watching videos of a hand being touched,\" Gaunt says.\u003c/p>\n\u003cp>Next, the researchers placed tiny electrodes in Copeland's brain that could stimulate the areas corresponding to each finger. Then they waited for the brain to heal, as it adjusted to the presence of the electrodes.\u003c/p>\n\u003cp>It was several weeks before the team was able to send the first tiny pulse of electricity to Copeland's brain. \"When it finally happened, he just very calmly said, 'Yep, I felt it on my index finger,' \" Gaunt recalls. \"But in the background I was breathing a sigh of relief and other people were cheering.\"\u003c/p>\n\u003cp>Of course, mind-controlled robots are still years away from consumer applications, McLoughlin says. At the moment, they are still too expensive, too bulky and too finicky to be used outside a laboratory setting. And there's no good way to control them without implanting electrodes in the brain.\u003c/p>\n\u003cp>Still, the ability to receive touch sensation from a robotic arm has the potential to help not only thousands of people who are paralyzed, but also people with a wide range of physical disabilities, McLoughlin says. For example, robots that provide sensory feedback could eventually help a disabled person cook a meal or clean up things at home.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"We're on the verge of something here that's going to transform lives,\" he says.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Brain+Implant+Restores+Sense+Of+Touch+To+Paralyzed+Man&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>If your heart is going to stop, right outside a hospital is not a bad place for it.\u003c/p>\n\u003cp>And if 41 people within a 330-yard radius have a \u003ca href=\"http://www.pulsepoint.org/\" target=\"_blank\">cellphone app\u003c/a> alerting them to your distress, so much the better.\u003c/p>\n\u003cp>That's what happened in Seattle last week when Stephen DeMont collapsed at a bus stop in front of University of Washington Medical Center.\u003c/p>\n\u003cp>While a medical student rushed over and began chest compressions, a cardiac nurse just getting off her shift was alerted by her phone, sprinted outside and assisted until paramedics arrived.\u003c/p>\n\u003cp>Five days later, DeMont, 60, is walking, smiling and talking about how the PulsePoint app helped save his life.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Seattle officials say the rescue shows the potential a free download has for connecting CPR-trained citizens with patients who urgently need their help. It's being used in 2,000 U.S. cities in 28 states.\u003c/p>\n\u003cp>\"I put it on my phone yesterday,\" said DeMont's wife, Debi Quirk, a former registered nurse. \"He would not be here as we see him today.\"\u003c/p>\n\u003cp>Seattle officials hope DeMont's story will help persuade thousands more people to sign up for notifications; so far, about 4,000 people in Seattle have downloaded PulsePoint since the city adopted it earlier this year with financial support from an employee charitable fund at Boeing. The goal is to have 15,000 using it.\u003c/p>\n\u003cp>The app, which works through a city's 911 system, was developed by Richard Price, the former chief of the San Ramon Valley Fire Protection District in Northern California. When a call comes in, operators alert people within a certain radius that CPR assistance is needed, along with the location of the nearest portable defibrillator.\u003c/p>\n\u003cp>About 900,000 people around the country have downloaded and carry the app, and 34,000 people have been activated to respond, Price said, adding that alerts have been issued in 13,000 cardiac events.\u003c/p>\n\u003cp>He came up with the idea in 2009. Price told KQED in a 2011 \u003ca href=\"http://ww2.kqed.org/news/wp-content/uploads/sites/10/2011/01/cardiaciphoneapp.mp3\" target=\"_blank\">interview\u003c/a> that he'd been eating lunch in a deli with three colleagues, when \"we heard a siren, and we were wondering where the guys were going. They parked right in front of the deli we were eating at.\"\u003c/p>\n\u003cp>As it turned out, an unconscious patient close by was in need of help.\u003c/p>\n\u003cp>\"Here's the fire chief in uniform, a defibrillator in my car. One of my [lunch companions] is a paramedic, and right next door to us, someone was in great need and we were completely unaware of it.\u003c/p>\n\u003cp>\"We sat the the rest of the afternoon and diagrammed on deli napkins how we could make sure that never happened again.\"\u003c/p>\n\u003cp>In that 2011 interview, Price said survival rates for those in cardiac arrest are very high when CPR is used within the first 2-3 minutes after cardiac arrest.\u003c/p>\n\u003cp>It's not clear how many lives have been saved thanks to the app. Patient confidentiality laws often prevent hospitals from disclosing a patient's outcome.\u003c/p>\n\u003cp>Madeline Dahl, a 23-year-old cardiac nurse at the University of Washington Medical Center, said she downloaded the app about a month ago after reading a news story that mentioned it. Last Friday morning was the first time she'd ever received an alert. She bolted down a couple flights of stairs and ran outside into the rain, where she found 27-year-old medical student Zach Forcade performing chest compressions.\u003c/p>\n\u003cp>Forcade had been on his way into the hospital for a lecture when he saw DeMont, who was just getting off his bicycle, slump over.\u003c/p>\n\u003cp>\"I hadn't responded to a cardiac arrest before,\" Forcade said. \"I thought, 'Did he just fall?' ... Even being in the medical field, I thought, 'Oh, man, who's going to step up?'\"\u003c/p>\n\u003cp>He told another passerby to call 911, which triggered an alert sent out to 41 responders nearby. It was reassuring when Dahl arrived to provide any needed backup, help check for a pulse and otherwise make sure Forcade was responding correctly, he said.\u003c/p>\n\u003cp>For DeMont, it was about more than just being lucky. A contract technical writer at Expedia, he said he has a love-hate relationship with technology — \"You see all these things about people falling off cliffs texting, people are so disconnected\" — but the response from Forcade, Dahl and the use of PulsePoint reaffirmed his belief in its power to make a positive difference.\u003c/p>\n\u003cp>\"There's hope,\" DeMont said.\u003c/p>\n\u003cp>He's due to have a defibrillator implanted on Thursday. Now he just has to figure out how to pay the $100,000 tab without insurance.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>For that, his family has turned to a program with a different app: GoFundMe.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>If your heart is going to stop, right outside a hospital is not a bad place for it.\u003c/p>\n\u003cp>And if 41 people within a 330-yard radius have a \u003ca href=\"http://www.pulsepoint.org/\" target=\"_blank\">cellphone app\u003c/a> alerting them to your distress, so much the better.\u003c/p>\n\u003cp>That's what happened in Seattle last week when Stephen DeMont collapsed at a bus stop in front of University of Washington Medical Center.\u003c/p>\n\u003cp>While a medical student rushed over and began chest compressions, a cardiac nurse just getting off her shift was alerted by her phone, sprinted outside and assisted until paramedics arrived.\u003c/p>\n\u003cp>Five days later, DeMont, 60, is walking, smiling and talking about how the PulsePoint app helped save his life.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Seattle officials say the rescue shows the potential a free download has for connecting CPR-trained citizens with patients who urgently need their help. It's being used in 2,000 U.S. cities in 28 states.\u003c/p>\n\u003cp>\"I put it on my phone yesterday,\" said DeMont's wife, Debi Quirk, a former registered nurse. \"He would not be here as we see him today.\"\u003c/p>\n\u003cp>Seattle officials hope DeMont's story will help persuade thousands more people to sign up for notifications; so far, about 4,000 people in Seattle have downloaded PulsePoint since the city adopted it earlier this year with financial support from an employee charitable fund at Boeing. The goal is to have 15,000 using it.\u003c/p>\n\u003cp>The app, which works through a city's 911 system, was developed by Richard Price, the former chief of the San Ramon Valley Fire Protection District in Northern California. When a call comes in, operators alert people within a certain radius that CPR assistance is needed, along with the location of the nearest portable defibrillator.\u003c/p>\n\u003cp>About 900,000 people around the country have downloaded and carry the app, and 34,000 people have been activated to respond, Price said, adding that alerts have been issued in 13,000 cardiac events.\u003c/p>\n\u003cp>He came up with the idea in 2009. Price told KQED in a 2011 \u003ca href=\"http://ww2.kqed.org/news/wp-content/uploads/sites/10/2011/01/cardiaciphoneapp.mp3\" target=\"_blank\">interview\u003c/a> that he'd been eating lunch in a deli with three colleagues, when \"we heard a siren, and we were wondering where the guys were going. They parked right in front of the deli we were eating at.\"\u003c/p>\n\u003cp>As it turned out, an unconscious patient close by was in need of help.\u003c/p>\n\u003cp>\"Here's the fire chief in uniform, a defibrillator in my car. One of my [lunch companions] is a paramedic, and right next door to us, someone was in great need and we were completely unaware of it.\u003c/p>\n\u003cp>\"We sat the the rest of the afternoon and diagrammed on deli napkins how we could make sure that never happened again.\"\u003c/p>\n\u003cp>In that 2011 interview, Price said survival rates for those in cardiac arrest are very high when CPR is used within the first 2-3 minutes after cardiac arrest.\u003c/p>\n\u003cp>It's not clear how many lives have been saved thanks to the app. Patient confidentiality laws often prevent hospitals from disclosing a patient's outcome.\u003c/p>\n\u003cp>Madeline Dahl, a 23-year-old cardiac nurse at the University of Washington Medical Center, said she downloaded the app about a month ago after reading a news story that mentioned it. Last Friday morning was the first time she'd ever received an alert. She bolted down a couple flights of stairs and ran outside into the rain, where she found 27-year-old medical student Zach Forcade performing chest compressions.\u003c/p>\n\u003cp>Forcade had been on his way into the hospital for a lecture when he saw DeMont, who was just getting off his bicycle, slump over.\u003c/p>\n\u003cp>\"I hadn't responded to a cardiac arrest before,\" Forcade said. \"I thought, 'Did he just fall?' ... Even being in the medical field, I thought, 'Oh, man, who's going to step up?'\"\u003c/p>\n\u003cp>He told another passerby to call 911, which triggered an alert sent out to 41 responders nearby. It was reassuring when Dahl arrived to provide any needed backup, help check for a pulse and otherwise make sure Forcade was responding correctly, he said.\u003c/p>\n\u003cp>For DeMont, it was about more than just being lucky. A contract technical writer at Expedia, he said he has a love-hate relationship with technology — \"You see all these things about people falling off cliffs texting, people are so disconnected\" — but the response from Forcade, Dahl and the use of PulsePoint reaffirmed his belief in its power to make a positive difference.\u003c/p>\n\u003cp>\"There's hope,\" DeMont said.\u003c/p>\n\u003cp>He's due to have a defibrillator implanted on Thursday. Now he just has to figure out how to pay the $100,000 tab without insurance.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>For that, his family has turned to a program with a different app: GoFundMe.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Segway Inventor Says He'll Make Improvements to Advanced Wheelchair",
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"content": "\u003cp>Thirteen years ago, just as the United States began what was to become its longest war, a futuristic wheelchair hit the market.\u003c/p>\n\u003cp>The \u003ca href=\"http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm082381.htm\">iBOT allowed\u003c/a> paralyzed people, including many veterans of Iraq and Afghanistan, to stand up by rising to eye level. It also did something no wheelchair ever had: climb stairs.\u003c/p>\n\u003cp>But even though users loved it, the iBOT \u003ca href=\"http://hereandnow.legacy.wbur.org/2011/12/26/ibot-johnson-phase\">went out of production in 2009\u003c/a> when Johnson & Johnson discontinued it.\u003c/p>\n\u003cp>\"I was very disappointed,\" says disabled veteran Gary Linfoot, a former Army helicopter pilot. \"I knew my tent was up, I had one, but I knew there were other people out there who could use this device, this technology and it would not be available to them.\"\u003c/p>\n\u003cp>Now, however, the iBOT could be coming back.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Toyota announced this year that it's bankrolling a reboot of the iBOT, which the machine's inventor, Dean Kamen, says will allow him to make some improvements.\u003c/p>\n\u003cp>\"With advances in computers, the advances in solid-state gyros and electronics ... we can take a hundred pounds out of it. We can take a lot of cost out of it. We can improve it,\" he told NPR.\u003c/p>\n\u003cp>Kamen is widely known as the inventor of the Segway, which was actually a byproduct from development of the iBOT. The first iteration of the wheelchair had a $25,000 price tag — too high even for the department of Veterans Affairs in most cases. Most veterans who had iBOTs got them from veterans charities, and all but a few are now sitting in the garage, with nowhere to service them.\u003c/p>\n\u003cp>Today, Toyota is interested in some of the machine's balancing technology, possibly to be used in the company's \u003ca href=\"http://newsroom.toyota.co.jp/en/detail/10171645/\">robotic helpers for the aging\u003c/a>. And that could mean new parts and new life for existing iBOTs as well as a new version of the chair.\u003c/p>\n\u003cp>It also helps that the Food and Drug Administration reclassified the iBOT from its \u003ca href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/\">strictest regulatory category\u003c/a> for medical devices Class 3, alongside replacement heart valves, to Class 2, alongside condoms. That will also lower the expense of the machine, and Kamen says testimony by veterans using the machine was one key to persuading the FDA to make that switch.\u003c/p>\n\u003cp>For people like Linfoot, it was a game changer.\u003c/p>\n\u003cp>He lost the use of his legs after a 2008 helicopter crash south of Baghdad. \"I wasn't shot down or anything,\" he says. \"It was just a mechanical malfunction. Probably a $25 part failed and we lost all power to the rotor system.\"\u003c/p>\n\u003cp>Linfoot and his co-pilot survived, but the impact left Linfoot paralyzed below the chest. The iBOT allows him to navigate street curbs and the hills around his home north of Nashville, Tenn.\u003c/p>\n\u003cp>\"It goes beyond just reaching in the cabinet to get the cookies that my wife might hide up there, or the good booze,\" he says, sitting on top of what looks like an easy chair balanced on a pair of unicycles.\u003c/p>\n\u003cp>Plus the ability to stand up is huge.\u003c/p>\n\u003cp>\"When you go out to a social setting, back up at 6 feet, talking to somebody eye to eye, you get this sense of dignity,\" he says. \"The disability just kind of fades into the background.\"\u003c/p>\n\u003cp>Kamen said he hopes stories like Linfoot's will help persuade his new backers to return the iBOT to production and make it available to a wider group of people.\u003c/p>\n\u003cp>\"The reason some of these veterans need these things is they've literally given up pieces of their body for this country,\" he says. \"The least we can do is give them back the best technology that is currently available.\"\u003c/p>\n\u003cp>Several other companies have designed chairs that can get people with spinal injuries \u003ca href=\"http://levousa.com/\">up to eye level\u003c/a> and \u003ca href=\"http://www.tracfab.com\">even off-road\u003c/a>. But doctors at the department of Veterans Affairs are more excited about inventions that can actually get veterans walking again. The health effects of immobility for paralyzed people are just like the effects of sitting down all the time for able-bodied people, they say.\u003c/p>\n\u003cp>\"Sitting is the new smoking,\" says Dr. Will Bauman, director of the \u003ca href=\"http://www.rehab.research.va.gov/cent/bronx.html\">Center of Excellence on the Medical Consequences of Spinal Cord Injury\u003c/a> at the James J. Peters VA Medical Center in the Bronx. He and Dr. Ann Spungen, associate director of the center, have studied the secondary health effects of paralysis.\u003c/p>\n\u003cp>\"Just like you and I, if we sat around all day, we already know that's the worst thing can do to ourselves,\" says Spungen.\u003c/p>\n\u003cp>Immobilized people are prone to weakened bones, higher blood pressure, urinary tract infections and constipation that can be debilitating. At the Bronx VA, veterans have been using an exoskeleton called a ReWalk to get them moving again. It's like a backpack with robotic leg braces that allows patients to walk using crutches.\u003c/p>\n\u003cp>So far, devices \u003ca href=\"http://eksobionics.com/\">like these\u003c/a> aren't that useful outside a safe, flat surface. Regular therapy with these machines can help reduce pain and promote better sleep, Spungen says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>With as little as four to six hours of walking a week, about half of patients lost more than a kilogram of body fat, says Spungen. For many problems, she says, \"the best cure is to take a walk.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+Reboot+For+Wheelchair+That+Can+Stand+Up+And+Climb+Stairs&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Thirteen years ago, just as the United States began what was to become its longest war, a futuristic wheelchair hit the market.\u003c/p>\n\u003cp>The \u003ca href=\"http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm082381.htm\">iBOT allowed\u003c/a> paralyzed people, including many veterans of Iraq and Afghanistan, to stand up by rising to eye level. It also did something no wheelchair ever had: climb stairs.\u003c/p>\n\u003cp>But even though users loved it, the iBOT \u003ca href=\"http://hereandnow.legacy.wbur.org/2011/12/26/ibot-johnson-phase\">went out of production in 2009\u003c/a> when Johnson & Johnson discontinued it.\u003c/p>\n\u003cp>\"I was very disappointed,\" says disabled veteran Gary Linfoot, a former Army helicopter pilot. \"I knew my tent was up, I had one, but I knew there were other people out there who could use this device, this technology and it would not be available to them.\"\u003c/p>\n\u003cp>Now, however, the iBOT could be coming back.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Toyota announced this year that it's bankrolling a reboot of the iBOT, which the machine's inventor, Dean Kamen, says will allow him to make some improvements.\u003c/p>\n\u003cp>\"With advances in computers, the advances in solid-state gyros and electronics ... we can take a hundred pounds out of it. We can take a lot of cost out of it. We can improve it,\" he told NPR.\u003c/p>\n\u003cp>Kamen is widely known as the inventor of the Segway, which was actually a byproduct from development of the iBOT. The first iteration of the wheelchair had a $25,000 price tag — too high even for the department of Veterans Affairs in most cases. Most veterans who had iBOTs got them from veterans charities, and all but a few are now sitting in the garage, with nowhere to service them.\u003c/p>\n\u003cp>Today, Toyota is interested in some of the machine's balancing technology, possibly to be used in the company's \u003ca href=\"http://newsroom.toyota.co.jp/en/detail/10171645/\">robotic helpers for the aging\u003c/a>. And that could mean new parts and new life for existing iBOTs as well as a new version of the chair.\u003c/p>\n\u003cp>It also helps that the Food and Drug Administration reclassified the iBOT from its \u003ca href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/\">strictest regulatory category\u003c/a> for medical devices Class 3, alongside replacement heart valves, to Class 2, alongside condoms. That will also lower the expense of the machine, and Kamen says testimony by veterans using the machine was one key to persuading the FDA to make that switch.\u003c/p>\n\u003cp>For people like Linfoot, it was a game changer.\u003c/p>\n\u003cp>He lost the use of his legs after a 2008 helicopter crash south of Baghdad. \"I wasn't shot down or anything,\" he says. \"It was just a mechanical malfunction. Probably a $25 part failed and we lost all power to the rotor system.\"\u003c/p>\n\u003cp>Linfoot and his co-pilot survived, but the impact left Linfoot paralyzed below the chest. The iBOT allows him to navigate street curbs and the hills around his home north of Nashville, Tenn.\u003c/p>\n\u003cp>\"It goes beyond just reaching in the cabinet to get the cookies that my wife might hide up there, or the good booze,\" he says, sitting on top of what looks like an easy chair balanced on a pair of unicycles.\u003c/p>\n\u003cp>Plus the ability to stand up is huge.\u003c/p>\n\u003cp>\"When you go out to a social setting, back up at 6 feet, talking to somebody eye to eye, you get this sense of dignity,\" he says. \"The disability just kind of fades into the background.\"\u003c/p>\n\u003cp>Kamen said he hopes stories like Linfoot's will help persuade his new backers to return the iBOT to production and make it available to a wider group of people.\u003c/p>\n\u003cp>\"The reason some of these veterans need these things is they've literally given up pieces of their body for this country,\" he says. \"The least we can do is give them back the best technology that is currently available.\"\u003c/p>\n\u003cp>Several other companies have designed chairs that can get people with spinal injuries \u003ca href=\"http://levousa.com/\">up to eye level\u003c/a> and \u003ca href=\"http://www.tracfab.com\">even off-road\u003c/a>. But doctors at the department of Veterans Affairs are more excited about inventions that can actually get veterans walking again. The health effects of immobility for paralyzed people are just like the effects of sitting down all the time for able-bodied people, they say.\u003c/p>\n\u003cp>\"Sitting is the new smoking,\" says Dr. Will Bauman, director of the \u003ca href=\"http://www.rehab.research.va.gov/cent/bronx.html\">Center of Excellence on the Medical Consequences of Spinal Cord Injury\u003c/a> at the James J. Peters VA Medical Center in the Bronx. He and Dr. Ann Spungen, associate director of the center, have studied the secondary health effects of paralysis.\u003c/p>\n\u003cp>\"Just like you and I, if we sat around all day, we already know that's the worst thing can do to ourselves,\" says Spungen.\u003c/p>\n\u003cp>Immobilized people are prone to weakened bones, higher blood pressure, urinary tract infections and constipation that can be debilitating. At the Bronx VA, veterans have been using an exoskeleton called a ReWalk to get them moving again. It's like a backpack with robotic leg braces that allows patients to walk using crutches.\u003c/p>\n\u003cp>So far, devices \u003ca href=\"http://eksobionics.com/\">like these\u003c/a> aren't that useful outside a safe, flat surface. Regular therapy with these machines can help reduce pain and promote better sleep, Spungen says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>With as little as four to six hours of walking a week, about half of patients lost more than a kilogram of body fat, says Spungen. For many problems, she says, \"the best cure is to take a walk.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+Reboot+For+Wheelchair+That+Can+Stand+Up+And+Climb+Stairs&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "'Nothing Like It In the Textbooks': When Unproven Stem Cell Treatments Go Awry",
"title": "'Nothing Like It In the Textbooks': When Unproven Stem Cell Treatments Go Awry",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>https://www.youtube.com/watch?v=8VmqVHBALM4&ab_channel=KPBSNews\u003c/p>\n\u003cp>Jim Gass made sure to record the moment in an iPhone video because he’d paid tens of thousands of dollars and traveled a great distance to get there.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.youtube.com/watch?v=r4k7ibKDkDg\">the video\u003c/a>, Gass can be seen sitting in his wheelchair in a beige hospital room. He smiles while a doctor injects something into his arm. In case there’s any question about what’s going into Gass’s vein, the doctor points to the syringe and says, “Stem cells.”\u003c/p>\n\u003cp>Translating into Spanish a moment later, he says, “Células madre.”\u003c/p>\n\u003cp>Gass traveled to Hospital Angeles in Tijuana, Mexico with the hope of recovering from a debilitating stroke. He received stem cells from Dr. Cesar Amescua based on a referral from \u003ca href=\"http://www.stemedica.com/\">Stemedica Cell Technologies, Inc.\u003c/a>, a San Diego company known for reportedly helping famous former athletes like hockey legend Gordie Howe make “\u003ca href=\"http://www.mlive.com/redwings/index.ssf/2014/12/red_wings_great_gordie_howe_un.html\">miraculous\u003c/a>” recoveries from strokes.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But Gass didn’t get better.\u003c/p>\n\u003caside class=\"pullquote alignright\">'We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.'\u003c/aside>\n\u003cp>\"What he didn’t know, smiling in that iPhone video, was that his paralysis would get worse. Nor did he realize that his doctors back home would later find what they call a bizarre tumor in his spine, where Gass says he received injections of fetal stem cells procured by a different company, \u003ca href=\"http://www.globalstemcellhealth.com/\">Global Stem Cell Health, Inc.\u003c/a>\u003c/p>\n\u003cp>Gass had found himself caught up in the world of “\u003ca href=\"http://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stem-cell-tourism.html?_r=0\">stem cell tourism\u003c/a>.” The stem cell treatment industry is flourishing in the U.S. without much oversight. Southern California is \u003ca href=\"http://www.sandiegouniontribune.com/business/biotech/sdut-stem-cell-treatments-unauthorized-report-knoepfler-2016jun30-htmlstory.html\">a hotspot\u003c/a> for clinics advertising stem cell treatments for everything from stroke to autism. And experts say San Diego is an attractive location for any company hoping to usher patients across the border for expensive treatments that have not been proven to be safe or effective in humans.\u003c/p>\n\u003cp>The U.S. Food and Drug Administration held \u003ca href=\"http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm\">a meeting\u003c/a> on stem cells this month, \u003ca href=\"http://www.kpbs.org/news/2016/sep/05/researchers-question-safety-value-of-untested/\">possibly signaling moves toward increased regulation\u003c/a>. Some scientists think regulators are not doing enough to oversee a growing industry they believe preys on desperate patients. UC San Diego stem cell researcher \u003ca href=\"http://cmm.ucsd.edu/goldstein/\">Larry Goldstein\u003c/a> said his field would welcome regulation to protect consumers from what he called “snake oil treatments.”\u003c/p>\n\u003cp>“Thoughtful FDA regulation of the growing stem cell industry is essential to help consumers distinguish fraudulent claims from legitimate clinical trials, research and therapy development,” Goldstein wrote in an email.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=U7b8ncmePJI&ab_channel=KPBSNews\u003c/p>\n\u003cp>Stemedica spokesman \u003ca href=\"http://www.stemedica.com/company/management/david_mcguigan.asp\">Dave McGuigan\u003c/a> defends the company’s practices in the U.S. and beyond, saying, “Through our clinical trials in the United States and outside the United States, well over 500 patients have been treated since 2009. And we haven’t had a serious adverse event.”\u003c/p>\n\u003cp>When asked for comment on Jim Gass’ treatment in Tijuana, McGuigan initially said that Gass had never been treated with Stemedica cells. McGuigan also insisted that Stemedica never referred Gass to Dr. Amescua. Shortly after KPBS showed him \u003ca href=\"http://www.kpbs.org/documents/2016/sep/20/jim-gasss-email-correspondence-stemedica/\">emails\u003c/a> and \u003ca href=\"https://www.youtube.com/watch?v=r4k7ibKDkDg\">footage\u003c/a> contradicting his assertion, McGuigan — still on camera and wearing a KPBS microphone — told a fellow Stemedica employee, “Clearly what we’ve been saying as a statement of fact has been incorrect.”\u003c/p>\n\u003cp>The day after the interview, Stemedica officials confirmed that their company did refer Gass to Dr. Amescua, and that Gass was in fact treated intravenously with Stemedica’s adult stem cells. Those were distinct from the fetal stem cells Gass says were injected into his spine.\u003c/p>\n\u003cp>McGuigan said Stemedica works hard to advance stem cell research in a scientifically sound and legally compliant way. But Stemedica has faced criticism over the work it’s associated with outside the U.S.\u003c/p>\n\u003cp>A former member of Stemedica’s scientific advisory board is among those questioning some of the company’s practices. \u003ca href=\"https://www.nyscf.org/news/nyscf-press-releases/item/1636-dr-mahendra-rao-joins-nyscf-as-vp-for-regenerative-medicine\">Mahendra Rao\u003c/a>, currently the vice president for regenerative medicine at the New York Stem Cell Foundation, wrote in an email to KPBS, “Their work with athletes, their interaction with poorly monitored clinics and their business strategy leave me uncomfortable.”\u003c/p>\n\u003cp>\u003cstrong>'He was my hero'\u003c/strong>\u003c/p>\n\u003cp>Gass spent most of his life in Boston, but for the moment he lives in San Diego County. On most weekday mornings he can be found exercising at \u003ca href=\"http://www.projectwalk.com/\">Project Walk\u003c/a> in Carlsbad. Project Walk is sort of like a gym, but for people dealing with varying degrees of paralysis. Here, a personal trainer helps Jim get out of his wheelchair and put his languishing muscles to work.\u003c/p>\n\u003caside class=\"pullquote alignright\">A patient warns: 'Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.'\u003c/aside>\n\u003cp>“My goal is to transfer from this chair to a bed without using a lift,” Gass said. “And right now I can’t do that.”\u003c/p>\n\u003cp>Gass had a stroke in 2009 at the age of 60. He lost the use of his left arm and leg. Walking was still possible with the help of a cane and a leg brace. But his career as an attorney, his active lifestyle, his love of traveling the world — all of that came to a halt.\u003c/p>\n\u003cp>Gass said his doctors told him there was no cure for his paralysis, and he should focus on physical therapy. He couldn’t accept that there wasn’t anything else he could do.\u003c/p>\n\u003cp>“I got interested in treatment,” he said. “It turned out that stem cells appeared to be what everybody was focused on as the treatment of the future for stroke.”\u003c/p>\n\u003cp>Scientists in the field of regenerative medicine say stem cell treatments are on the horizon for a number of conditions, but they’re still in early stages and it’ll be years before they’re approved.\u003c/p>\n\u003cp>Nevertheless, online searches yield plenty of inspiring stories about stroke patients who’ve gone abroad for stem cell treatments. Gass knew these treatments hadn’t been proven to work, but he decided he was willing to pay expensive fees and travel across the globe on the chance they might help him regain some control of his body.\u003c/p>\n\u003cp>Gass traveled to China and Argentina for a series of stem cell treatments in 2011. He said those treatments didn’t seem to help, but they didn’t seem to hurt. So he decided to give stem cells another shot, based partly on what he’d been hearing about retired NFL star John Brodie.\u003c/p>\n\u003cp>“He used to be the quarterback for the San Francisco 49ers,” Gass said. “When I was growing up, he was my hero.”\u003c/p>\n\u003cp>Brodie, another stroke victim, was said to be making a dramatic recovery thanks to stem cells. In late 2013, Gass emailed the company linked with Brodie’s treatments. That company was Stemedica. In an \u003ca href=\"https://www.youtube.com/watch?v=f7oknI4zimY\">interview with MoneyTV from 2010\u003c/a>, Stemedica chief executive officer Maynard Howe discussed Brodie’s treatment.\u003c/p>\n\u003cfigure id=\"attachment_262605\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Gass_1_t800.png\">\u003cimg class=\"size-full wp-image-262605\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Gass_1_t800.png\" alt=\"Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016.\" width=\"800\" height=\"478\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800.png 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800-400x239.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800-768x459.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016. \u003ccite>(Kris Arciaga)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“John was part of a clinical study that was conducted outside of the United States,” Howe said. “John had a miraculous recovery. He’s back playing golf now. He’s got his speech back. And John travels all over the world by himself.”\u003c/p>\n\u003cp>A few years after Brodie’s treatment, another former athlete and stroke victim was reportedly \u003ca href=\"http://www.huffingtonpost.ca/2014/12/19/gordie-howe-stem-cell-recovery_n_6358012.html\">walking again\u003c/a> following treatment in Tijuana with Stemedica’s cells. This time it was hockey legend Gordie Howe (no relation to Stemedica executives Maynard and Roger Howe). Howe, who died earlier this year, \u003ca href=\"http://www.cbs8.com/story/29079426/inside-the-tijuana-stem-cell-clinic-that-treated-gordie-howe?clienttype=generic&mobilecgbypass\">reportedly\u003c/a> received Stemedica’s cells free of charge in Tijuana \u003ca href=\"https://www.thestar.com/news/canada/2015/04/18/a-closer-look-at-the-startling-recovery-of-gordie-howe.html\">from Dr. Amescua\u003c/a>, the same doctor who would treat Gass.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.youtube.com/watch?v=qn8Vd-SSgNQ\">a San Diego TV news story\u003c/a> about Howe’s recovery, Dr. Amescua is shown saying, “We cannot claim that we will cure the patient with stem cells. OK? But we can definitely say that patients will have an improvement.”\u003c/p>\n\u003cp>Stemedica continues to make news with another former NFL athlete’s story of recovery. In \u003ca href=\"http://www.usatoday.com/story/sports/nfl/packers/2016/09/05/bart-starr-returns-tijuana-stem-cells/89881768/\">a USA Today article\u003c/a> published earlier this month, former Green Bay Packers quarterback Bart Starr discussed his repeated trips to Tijuana for treatments with Stemedica cells.\u003c/p>\n\u003cp>Stem cell scientists don’t discount the possibility that these men saw their condition improve. But they say beyond anecdotal evidence, no proof has been offered that stem cells were responsible for anyone’s “miraculous” recovery.\u003c/p>\n\u003cp>Stemedica has used variations on the word “miracle” in connection with stem cells on a number of occasions. Stemedica executives have even co-written \u003ca href=\"http://www.stemedica.com/info/education/the-miracle-of-stem-cells.asp\">a book\u003c/a> titled “The Miracle of Stem Cells.” The company’s website includes a link to purchase the book for $39.95.\u003c/p>\n\u003cp>Spokesman Dave McGuigan said patients are clearly informed that Stemedica cells come with no promises. “We absolutely do not promise to cure patients,” he said.\u003c/p>\n\u003cp>\u003cstrong>\"We have had NO cases of infection or adverse events\"\u003c/strong>\u003c/p>\n\u003cp>Gass, however, was sold.\u003c/p>\n\u003cp>He emailed Stemedica to ask where he could go for treatment. A company representative referred Gass to Dr. Amescua, a man Stemedica \u003ca href=\"http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/062410-Stemedica-Cesar-Amescua-Garcia-Medical-Regulatory-Affairs-Director%E2%80%93Latin-America.asp\">has described in the past\u003c/a> as its “Medical and Regulatory Affairs Director for Latin America” (the company said it has no relationship with Dr. Amescua today).\u003c/p>\n\u003cp>The Stemedica representative wrote to Gass in an email, “Hospital Angeles in Tijuana, Mexico is approved by the Mexican FDA equivalent (COFEPRIS) to conduct a stroke trial with Stemedica's stem cells.”\u003c/p>\n\u003cp>Gass said he followed Stemedica’s referral and got in touch with Dr. Amescua. He said further down the line, he was told that for $30,000, he could receive a round of treatment involving two different types of stem cells.\u003c/p>\n\u003cp>The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from \u003ca href=\"http://www.stemedica.com/technology/productlines.asp\">adult bone marrow\u003c/a>.\u003c/p>\n\u003cp>Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).\u003c/p>\n\u003cp>Also based in San Diego County, GSCH is run by Dr. Michael Bayer, \u003ca href=\"http://www.stemedica.com/info/013009-stemedica-announces-appointment-of-dr-michael-bayer-as-director-medical-services.asp\">a former Stemedica executive\u003c/a>. Stemedica spokesman Dave McGuigan said there’s now “a clear separation of church and state between what Michael does and what Stemedica does.”\u003c/p>\n\u003cp>A GSCH representative explained the distinction to Gass in an email, writing, “Stemedica cannot treat patients because of FDA regulations, and this is how GSCH was started — to treat ‘no option’ patients seeking alternative therapies.”\u003c/p>\n\u003cp>Gass said he went to Tijuana twice for two separate rounds of treatment in 2014, and his bank statements show that he wired $30,000 to GSCH on two separate occasions that year.\u003c/p>\n\u003cp>Stem cell experts say that mesenchymal cells such as those produced by Stemedica cannot replace destroyed neurons, the very cells killed during a stroke. \u003ca href=\"http://stroke.ahajournals.org/content/early/2016/06/02/STROKEAHA.116.012995.abstract?sid=6d720047-0b70-4b9d-b589-a01ebc09e000\">Limited evidence\u003c/a> has shown possible benefit from injecting modified mesenchymal stem cells directly into the brains of stroke patients, but Gass received Stemedica’s mesenchymal cells intravenously.\u003c/p>\n\u003cp>The use of fetal stem cells in Gass’ case was also highly suspect, according to scientists in the field. They say patients receiving fetal stem cell treatments in other countries can’t always know for sure where these cells come from or how they’ve been prepared for injection. No definitive evidence has been published showing that fetal stem cells can help people recover from a stroke.\u003c/p>\n\u003cp>Stem cell scientists also warn that tumor formation is a distinct possibility when introducing fetal stem cells into humans without proper precautions. A GSCH representative wrote in an email to Gass, “We have had NO cases of infection or adverse events.”\u003c/p>\n\u003cp>Gass said after each of his treatments in Tijuana, he was told to wait three to six months for signs of improvement. He said after the second treatment, something happened.\u003c/p>\n\u003cp>\"I started to feel changes,” Gass said. “But they were not good changes. I started to feel pain in my back.\"\u003c/p>\n\u003cp>\u003cstrong>\"There’s really nothing like it in the textbooks\"\u003c/strong>\u003c/p>\n\u003cp>At this point, Gass said he was also starting to lose even more feeling and movement below his waist. When his doctors in Boston discovered what was causing his back pain and worsening his paralysis, they were shocked.\u003c/p>\n\u003cp>“None of us had ever seen anything like it,” said \u003ca href=\"http://physiciandirectory.brighamandwomens.org/details/12438/aaron-berkowitz-neurology-boston\">Dr. Aaron Berkowitz\u003c/a> of Brigham and Women’s Hospital.\u003c/p>\n\u003cp>Berkowitz and his colleagues found a growth developing in the lower part of Gass’ spine, where Gass said he received injections of GSCH’s fetal stem cells in Tijuana. Genetic analysis revealed that the growth was partly made up of cells from another human being.\u003c/p>\n\u003cp>Berkowitz said even putting a name to this growth was challenging. It was growing like a cancer, but it didn’t have the genetic signatures of cancer.\u003c/p>\n\u003cp>He said, “There’s really nothing like it in the textbooks.” But, he said, “Literally, it’s a tumor, in the sense that it’s an abnormal swelling.”\u003c/p>\n\u003cp>Earlier this year, Berkowtiz co-authored \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMc1600188#t=article\">a paper in the \u003cem>New England Journal of Medicine\u003c/em>\u003c/a> about Gass’ situation.\u003c/p>\n\u003cp>“We could point very tangibly to a very important risk that patients should be aware of before pursuing something like this,” Berkowitz said.\u003c/p>\n\u003cp>Gass gave his doctors the go-ahead to fight the tumor with radiation, and that seemed to halt the swelling. But Gass is concerned it may be growing again. He doesn’t rule out the possibility that he could one day sue those connected with his treatments.\u003c/p>\n\u003cp>Gass isn’t the only patient who has experienced complications after receiving stem cell treatments. Medical journals have documented two similar cases. One patient was found to have \u003ca href=\"http://jasn.asnjournals.org/content/21/7/1218.full\">masses in one of her kidneys\u003c/a> following a stem cell treatment. In another case, a brain tumor \u003ca href=\"http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000029\">was discovered\u003c/a> after a boy suffering from a rare neurodegenerative disease received injections of fetal stem cells. Both journal articles kept the patients anonymous.\u003c/p>\n\u003cp>Gass received stem cell treatments in other countries years before going to Tijuana. Berkowitz said without a sample of the cells used in each case, he can’t be certain which treatment is directly linked with the tumor. But Berkowitz said Gass only reported feeling pain in his back after the second round of treatment in Tijuana, which Gass said included injections of GSCH’s fetal stem cells into his spine.\u003c/p>\n\u003cp>\u003cstrong>'We have no current plans to publish our results'\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"http://www.scripps.edu/research/faculty/loring\">Jeanne Loring\u003c/a>, a scientist at the Scripps Research Institute in La Jolla developing \u003ca href=\"https://www.scripps.edu/news/press/2016/20160721loring.html\">a stem cell therapy for Parkinson’s disease\u003c/a>, spoke with KPBS about the stem cell treatment industry broadly, not about any company in particular, because some firms have a reputation for being litigious.\u003c/p>\n\u003cp>“It’s unfortunate that what I work on and what they work on are both called stem cells, because they’re not at all the same,” Loring said. “It’s not a terrific idea to be putting stuff that you don’t know very much about into people and expecting it to work.”\u003c/p>\n\u003cp>Companies promoting stem cell treatments often say they’re only facilitating research. They say they don’t promise to cure patients, only to connect them with clinical trials.\u003c/p>\n\u003cp>Stemedica is sponsoring a number of clinical trials overseen by scientists at reputable institutions within the U.S. These trials \u003ca href=\"https://clinicaltrials.gov/ct2/results?term=stemedica&Search=Search\">are listed on ClinicalTrials.gov\u003c/a>, an online database of human medical studies maintained by the National Institutes of Health.\u003c/p>\n\u003cp>\u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01297413?term=stemedica&rank=2\">One ongoing Stemedica-sponsored trial\u003c/a> approved by UC San Diego’s Institutional Review Board is primarily aiming to test whether or not it’s safe to give Stemedica’s mesenchymal stem cells intravenously to stroke patients. Stemedica \u003ca href=\"http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/2011-0217-Stemedica-Approval-From-UCSD-Ischemic-Stroke-Study.asp\">says it has received the FDA’s approval\u003c/a> to move forward with this trial.\u003c/p>\n\u003cp>The trial started over five years ago, and has not yet reported results. Principal investigator and UCSD School of Medicine professor \u003ca href=\"http://neurosurgery.ucsd.edu/mike-levy-md-phd/\">Michael Levy\u003c/a> said the study is proceeding with appropriate caution.\u003c/p>\n\u003cp>“This is work that needs to be done,” he said. “Because people are paying huge amounts of money to get something that they’re not sure what they’re getting, and to pursue a hope that may not be there. We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.”\u003c/p>\n\u003cp>Loring said if a stem cell company truly is helping patients make remarkable recoveries, they should prove it by publishing their results.\u003c/p>\n\u003cp>“If they had really good results, they would publish them,” she said. “Because that would be like the best marketing strategy.”\u003c/p>\n\u003cp>Stemedica could not provide published data from any of its human trials.\u003c/p>\n\u003cp>Gass’ sister-in-law, concerned about the treatment Jim was about to receive, asked Global Stem Cell Health if they’d ever published evidence that their treatments work. A representative replied to her via email, “We have no current plans to publish our results.”\u003c/p>\n\u003cp>Ethical concerns have been raised about the fees patients are charged to participate in certain stem cell trials outside the country. Loring said patients are not typically charged large sums of money to participate in clinical trials. She thinks patients should be wary of any trial, or any company, that does charge tens of thousands of dollars for participation in a medical study.\u003c/p>\n\u003cp>When Stemedica spokesman Dave McGuigan was asked about patients who pay large sums of money to receive Stemedica cells as part of a trial outside the U.S., he said Stemedica and their foreign clinical trial partners put up “significant dollars” to carry out these studies, and patients are “asked to participate in those costs.”\u003c/p>\n\u003cp>“We’re talking about people that have a medical condition for which there is often no cure,” McGuigan said. “And so they have searched the world to find out what their options are.”\u003c/p>\n\u003cp>Dr. Amescua has confirmed that after KPBS approached him for comment on Gass’ treatment, he was able to find hospital records pertaining to Gass. Global Stem Cell Health did not respond to KPBS’ interview request.\u003c/p>\n\u003cp>\u003cstrong>A call for regulation\u003c/strong>\u003c/p>\n\u003cp>Gass went through a process often referred to as “stem cell tourism” to receive his treatments. In years past, patients often had to leave the country to seek unproven stem cell treatments. But UC Davis stem cell scientist \u003ca href=\"http://www.ucdmc.ucdavis.edu/cellbio/faculty/knoepfler/\">Paul Knoepfler\u003c/a> says that’s no longer the case.\u003c/p>\n\u003cp>Knoepfler recently co-authored \u003ca href=\"http://www.sciencedirect.com/science/article/pii/S1934590916301576\">a study\u003c/a> identifying 351 stem cell companies advertising unapproved treatments at 570 unique clinic locations right here in the U.S. for everything from autism to Alzheimer’s, stroke to diabetes.\u003c/p>\n\u003cp>“This kind of turns the idea of stem cell tourism on its head,” Knoepfler said. Now, he said, “Most Americans really don’t have to travel, say, to Mexico or Asia or somewhere in the Caribbean to get an unapproved stem cell treatment.”\u003c/p>\n\u003cp>Some scientists wonder why the FDA hasn’t taken more action against companies promoting unproven stem cell treatments. Scripps Research Institute scientist Jeanne Loring believes regulators may simply be outmatched.\u003c/p>\n\u003cp>“The clinics are popping up faster than the FDA can close them,” she said.\u003c/p>\n\u003cp>An FDA spokeswoman did not comment on Jim Gass’ situation or the specific companies involved with his treatment. The FDA has \u003ca href=\"http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm\">approved the use of blood forming stem cells\u003c/a> in patients with certain blood disorders, but the FDA spokeswoman wrote in an email to KPBS, “At this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits.”\u003c/p>\n\u003cp>Loring attended the FDA’s meeting on stem cells earlier this month and spoke about why she thinks better regulation is needed. She believes there could be more patients out there who aren’t coming forward to discuss the harms they’ve suffered in connection with unproven stem cell treatments.\u003c/p>\n\u003cp>Patients sometimes raise money for these treatments through web sites like GoFundMe.com. Some say they’re willing to take a chance on unproven stem cell therapies because they have nothing to lose.\u003c/p>\n\u003cp>Gass now knows he did have a lot to lose. He said all told, he lost hundreds of thousands of dollars pursuing stem cell treatments around the world, and now he’s left with a painful tumor and significantly decreased mobility.\u003c/p>\n\u003cp>Gass hopes other patients considering reaching out to companies promoting unproven stem cell treatments will be more educated about the risks than he was.\u003c/p>\n\u003cp>He said, “Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>inewsource reporter Leo Castaneda contributed to this report.\u003c/em>\u003c/p>\n\n",
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"excerpt": "Once, American 'stem cell tourism' patients had to seek out unproven treatments in foreign countries. But now the industry is flourishing in the U.S., without much oversight. ",
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"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/8VmqVHBALM4'\n title='//www.youtube.com/embed/8VmqVHBALM4'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Jim Gass made sure to record the moment in an iPhone video because he’d paid tens of thousands of dollars and traveled a great distance to get there.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.youtube.com/watch?v=r4k7ibKDkDg\">the video\u003c/a>, Gass can be seen sitting in his wheelchair in a beige hospital room. He smiles while a doctor injects something into his arm. In case there’s any question about what’s going into Gass’s vein, the doctor points to the syringe and says, “Stem cells.”\u003c/p>\n\u003cp>Translating into Spanish a moment later, he says, “Células madre.”\u003c/p>\n\u003cp>Gass traveled to Hospital Angeles in Tijuana, Mexico with the hope of recovering from a debilitating stroke. He received stem cells from Dr. Cesar Amescua based on a referral from \u003ca href=\"http://www.stemedica.com/\">Stemedica Cell Technologies, Inc.\u003c/a>, a San Diego company known for reportedly helping famous former athletes like hockey legend Gordie Howe make “\u003ca href=\"http://www.mlive.com/redwings/index.ssf/2014/12/red_wings_great_gordie_howe_un.html\">miraculous\u003c/a>” recoveries from strokes.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But Gass didn’t get better.\u003c/p>\n\u003caside class=\"pullquote alignright\">'We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.'\u003c/aside>\n\u003cp>\"What he didn’t know, smiling in that iPhone video, was that his paralysis would get worse. Nor did he realize that his doctors back home would later find what they call a bizarre tumor in his spine, where Gass says he received injections of fetal stem cells procured by a different company, \u003ca href=\"http://www.globalstemcellhealth.com/\">Global Stem Cell Health, Inc.\u003c/a>\u003c/p>\n\u003cp>Gass had found himself caught up in the world of “\u003ca href=\"http://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stem-cell-tourism.html?_r=0\">stem cell tourism\u003c/a>.” The stem cell treatment industry is flourishing in the U.S. without much oversight. Southern California is \u003ca href=\"http://www.sandiegouniontribune.com/business/biotech/sdut-stem-cell-treatments-unauthorized-report-knoepfler-2016jun30-htmlstory.html\">a hotspot\u003c/a> for clinics advertising stem cell treatments for everything from stroke to autism. And experts say San Diego is an attractive location for any company hoping to usher patients across the border for expensive treatments that have not been proven to be safe or effective in humans.\u003c/p>\n\u003cp>The U.S. Food and Drug Administration held \u003ca href=\"http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm\">a meeting\u003c/a> on stem cells this month, \u003ca href=\"http://www.kpbs.org/news/2016/sep/05/researchers-question-safety-value-of-untested/\">possibly signaling moves toward increased regulation\u003c/a>. Some scientists think regulators are not doing enough to oversee a growing industry they believe preys on desperate patients. UC San Diego stem cell researcher \u003ca href=\"http://cmm.ucsd.edu/goldstein/\">Larry Goldstein\u003c/a> said his field would welcome regulation to protect consumers from what he called “snake oil treatments.”\u003c/p>\n\u003cp>“Thoughtful FDA regulation of the growing stem cell industry is essential to help consumers distinguish fraudulent claims from legitimate clinical trials, research and therapy development,” Goldstein wrote in an email.\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/U7b8ncmePJI'\n title='//www.youtube.com/embed/U7b8ncmePJI'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Stemedica spokesman \u003ca href=\"http://www.stemedica.com/company/management/david_mcguigan.asp\">Dave McGuigan\u003c/a> defends the company’s practices in the U.S. and beyond, saying, “Through our clinical trials in the United States and outside the United States, well over 500 patients have been treated since 2009. And we haven’t had a serious adverse event.”\u003c/p>\n\u003cp>When asked for comment on Jim Gass’ treatment in Tijuana, McGuigan initially said that Gass had never been treated with Stemedica cells. McGuigan also insisted that Stemedica never referred Gass to Dr. Amescua. Shortly after KPBS showed him \u003ca href=\"http://www.kpbs.org/documents/2016/sep/20/jim-gasss-email-correspondence-stemedica/\">emails\u003c/a> and \u003ca href=\"https://www.youtube.com/watch?v=r4k7ibKDkDg\">footage\u003c/a> contradicting his assertion, McGuigan — still on camera and wearing a KPBS microphone — told a fellow Stemedica employee, “Clearly what we’ve been saying as a statement of fact has been incorrect.”\u003c/p>\n\u003cp>The day after the interview, Stemedica officials confirmed that their company did refer Gass to Dr. Amescua, and that Gass was in fact treated intravenously with Stemedica’s adult stem cells. Those were distinct from the fetal stem cells Gass says were injected into his spine.\u003c/p>\n\u003cp>McGuigan said Stemedica works hard to advance stem cell research in a scientifically sound and legally compliant way. But Stemedica has faced criticism over the work it’s associated with outside the U.S.\u003c/p>\n\u003cp>A former member of Stemedica’s scientific advisory board is among those questioning some of the company’s practices. \u003ca href=\"https://www.nyscf.org/news/nyscf-press-releases/item/1636-dr-mahendra-rao-joins-nyscf-as-vp-for-regenerative-medicine\">Mahendra Rao\u003c/a>, currently the vice president for regenerative medicine at the New York Stem Cell Foundation, wrote in an email to KPBS, “Their work with athletes, their interaction with poorly monitored clinics and their business strategy leave me uncomfortable.”\u003c/p>\n\u003cp>\u003cstrong>'He was my hero'\u003c/strong>\u003c/p>\n\u003cp>Gass spent most of his life in Boston, but for the moment he lives in San Diego County. On most weekday mornings he can be found exercising at \u003ca href=\"http://www.projectwalk.com/\">Project Walk\u003c/a> in Carlsbad. Project Walk is sort of like a gym, but for people dealing with varying degrees of paralysis. Here, a personal trainer helps Jim get out of his wheelchair and put his languishing muscles to work.\u003c/p>\n\u003caside class=\"pullquote alignright\">A patient warns: 'Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.'\u003c/aside>\n\u003cp>“My goal is to transfer from this chair to a bed without using a lift,” Gass said. “And right now I can’t do that.”\u003c/p>\n\u003cp>Gass had a stroke in 2009 at the age of 60. He lost the use of his left arm and leg. Walking was still possible with the help of a cane and a leg brace. But his career as an attorney, his active lifestyle, his love of traveling the world — all of that came to a halt.\u003c/p>\n\u003cp>Gass said his doctors told him there was no cure for his paralysis, and he should focus on physical therapy. He couldn’t accept that there wasn’t anything else he could do.\u003c/p>\n\u003cp>“I got interested in treatment,” he said. “It turned out that stem cells appeared to be what everybody was focused on as the treatment of the future for stroke.”\u003c/p>\n\u003cp>Scientists in the field of regenerative medicine say stem cell treatments are on the horizon for a number of conditions, but they’re still in early stages and it’ll be years before they’re approved.\u003c/p>\n\u003cp>Nevertheless, online searches yield plenty of inspiring stories about stroke patients who’ve gone abroad for stem cell treatments. Gass knew these treatments hadn’t been proven to work, but he decided he was willing to pay expensive fees and travel across the globe on the chance they might help him regain some control of his body.\u003c/p>\n\u003cp>Gass traveled to China and Argentina for a series of stem cell treatments in 2011. He said those treatments didn’t seem to help, but they didn’t seem to hurt. So he decided to give stem cells another shot, based partly on what he’d been hearing about retired NFL star John Brodie.\u003c/p>\n\u003cp>“He used to be the quarterback for the San Francisco 49ers,” Gass said. “When I was growing up, he was my hero.”\u003c/p>\n\u003cp>Brodie, another stroke victim, was said to be making a dramatic recovery thanks to stem cells. In late 2013, Gass emailed the company linked with Brodie’s treatments. That company was Stemedica. In an \u003ca href=\"https://www.youtube.com/watch?v=f7oknI4zimY\">interview with MoneyTV from 2010\u003c/a>, Stemedica chief executive officer Maynard Howe discussed Brodie’s treatment.\u003c/p>\n\u003cfigure id=\"attachment_262605\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Gass_1_t800.png\">\u003cimg class=\"size-full wp-image-262605\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Gass_1_t800.png\" alt=\"Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016.\" width=\"800\" height=\"478\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800.png 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800-400x239.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800-768x459.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016. \u003ccite>(Kris Arciaga)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“John was part of a clinical study that was conducted outside of the United States,” Howe said. “John had a miraculous recovery. He’s back playing golf now. He’s got his speech back. And John travels all over the world by himself.”\u003c/p>\n\u003cp>A few years after Brodie’s treatment, another former athlete and stroke victim was reportedly \u003ca href=\"http://www.huffingtonpost.ca/2014/12/19/gordie-howe-stem-cell-recovery_n_6358012.html\">walking again\u003c/a> following treatment in Tijuana with Stemedica’s cells. This time it was hockey legend Gordie Howe (no relation to Stemedica executives Maynard and Roger Howe). Howe, who died earlier this year, \u003ca href=\"http://www.cbs8.com/story/29079426/inside-the-tijuana-stem-cell-clinic-that-treated-gordie-howe?clienttype=generic&mobilecgbypass\">reportedly\u003c/a> received Stemedica’s cells free of charge in Tijuana \u003ca href=\"https://www.thestar.com/news/canada/2015/04/18/a-closer-look-at-the-startling-recovery-of-gordie-howe.html\">from Dr. Amescua\u003c/a>, the same doctor who would treat Gass.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.youtube.com/watch?v=qn8Vd-SSgNQ\">a San Diego TV news story\u003c/a> about Howe’s recovery, Dr. Amescua is shown saying, “We cannot claim that we will cure the patient with stem cells. OK? But we can definitely say that patients will have an improvement.”\u003c/p>\n\u003cp>Stemedica continues to make news with another former NFL athlete’s story of recovery. In \u003ca href=\"http://www.usatoday.com/story/sports/nfl/packers/2016/09/05/bart-starr-returns-tijuana-stem-cells/89881768/\">a USA Today article\u003c/a> published earlier this month, former Green Bay Packers quarterback Bart Starr discussed his repeated trips to Tijuana for treatments with Stemedica cells.\u003c/p>\n\u003cp>Stem cell scientists don’t discount the possibility that these men saw their condition improve. But they say beyond anecdotal evidence, no proof has been offered that stem cells were responsible for anyone’s “miraculous” recovery.\u003c/p>\n\u003cp>Stemedica has used variations on the word “miracle” in connection with stem cells on a number of occasions. Stemedica executives have even co-written \u003ca href=\"http://www.stemedica.com/info/education/the-miracle-of-stem-cells.asp\">a book\u003c/a> titled “The Miracle of Stem Cells.” The company’s website includes a link to purchase the book for $39.95.\u003c/p>\n\u003cp>Spokesman Dave McGuigan said patients are clearly informed that Stemedica cells come with no promises. “We absolutely do not promise to cure patients,” he said.\u003c/p>\n\u003cp>\u003cstrong>\"We have had NO cases of infection or adverse events\"\u003c/strong>\u003c/p>\n\u003cp>Gass, however, was sold.\u003c/p>\n\u003cp>He emailed Stemedica to ask where he could go for treatment. A company representative referred Gass to Dr. Amescua, a man Stemedica \u003ca href=\"http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/062410-Stemedica-Cesar-Amescua-Garcia-Medical-Regulatory-Affairs-Director%E2%80%93Latin-America.asp\">has described in the past\u003c/a> as its “Medical and Regulatory Affairs Director for Latin America” (the company said it has no relationship with Dr. Amescua today).\u003c/p>\n\u003cp>The Stemedica representative wrote to Gass in an email, “Hospital Angeles in Tijuana, Mexico is approved by the Mexican FDA equivalent (COFEPRIS) to conduct a stroke trial with Stemedica's stem cells.”\u003c/p>\n\u003cp>Gass said he followed Stemedica’s referral and got in touch with Dr. Amescua. He said further down the line, he was told that for $30,000, he could receive a round of treatment involving two different types of stem cells.\u003c/p>\n\u003cp>The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from \u003ca href=\"http://www.stemedica.com/technology/productlines.asp\">adult bone marrow\u003c/a>.\u003c/p>\n\u003cp>Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).\u003c/p>\n\u003cp>Also based in San Diego County, GSCH is run by Dr. Michael Bayer, \u003ca href=\"http://www.stemedica.com/info/013009-stemedica-announces-appointment-of-dr-michael-bayer-as-director-medical-services.asp\">a former Stemedica executive\u003c/a>. Stemedica spokesman Dave McGuigan said there’s now “a clear separation of church and state between what Michael does and what Stemedica does.”\u003c/p>\n\u003cp>A GSCH representative explained the distinction to Gass in an email, writing, “Stemedica cannot treat patients because of FDA regulations, and this is how GSCH was started — to treat ‘no option’ patients seeking alternative therapies.”\u003c/p>\n\u003cp>Gass said he went to Tijuana twice for two separate rounds of treatment in 2014, and his bank statements show that he wired $30,000 to GSCH on two separate occasions that year.\u003c/p>\n\u003cp>Stem cell experts say that mesenchymal cells such as those produced by Stemedica cannot replace destroyed neurons, the very cells killed during a stroke. \u003ca href=\"http://stroke.ahajournals.org/content/early/2016/06/02/STROKEAHA.116.012995.abstract?sid=6d720047-0b70-4b9d-b589-a01ebc09e000\">Limited evidence\u003c/a> has shown possible benefit from injecting modified mesenchymal stem cells directly into the brains of stroke patients, but Gass received Stemedica’s mesenchymal cells intravenously.\u003c/p>\n\u003cp>The use of fetal stem cells in Gass’ case was also highly suspect, according to scientists in the field. They say patients receiving fetal stem cell treatments in other countries can’t always know for sure where these cells come from or how they’ve been prepared for injection. No definitive evidence has been published showing that fetal stem cells can help people recover from a stroke.\u003c/p>\n\u003cp>Stem cell scientists also warn that tumor formation is a distinct possibility when introducing fetal stem cells into humans without proper precautions. A GSCH representative wrote in an email to Gass, “We have had NO cases of infection or adverse events.”\u003c/p>\n\u003cp>Gass said after each of his treatments in Tijuana, he was told to wait three to six months for signs of improvement. He said after the second treatment, something happened.\u003c/p>\n\u003cp>\"I started to feel changes,” Gass said. “But they were not good changes. I started to feel pain in my back.\"\u003c/p>\n\u003cp>\u003cstrong>\"There’s really nothing like it in the textbooks\"\u003c/strong>\u003c/p>\n\u003cp>At this point, Gass said he was also starting to lose even more feeling and movement below his waist. When his doctors in Boston discovered what was causing his back pain and worsening his paralysis, they were shocked.\u003c/p>\n\u003cp>“None of us had ever seen anything like it,” said \u003ca href=\"http://physiciandirectory.brighamandwomens.org/details/12438/aaron-berkowitz-neurology-boston\">Dr. Aaron Berkowitz\u003c/a> of Brigham and Women’s Hospital.\u003c/p>\n\u003cp>Berkowitz and his colleagues found a growth developing in the lower part of Gass’ spine, where Gass said he received injections of GSCH’s fetal stem cells in Tijuana. Genetic analysis revealed that the growth was partly made up of cells from another human being.\u003c/p>\n\u003cp>Berkowitz said even putting a name to this growth was challenging. It was growing like a cancer, but it didn’t have the genetic signatures of cancer.\u003c/p>\n\u003cp>He said, “There’s really nothing like it in the textbooks.” But, he said, “Literally, it’s a tumor, in the sense that it’s an abnormal swelling.”\u003c/p>\n\u003cp>Earlier this year, Berkowtiz co-authored \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMc1600188#t=article\">a paper in the \u003cem>New England Journal of Medicine\u003c/em>\u003c/a> about Gass’ situation.\u003c/p>\n\u003cp>“We could point very tangibly to a very important risk that patients should be aware of before pursuing something like this,” Berkowitz said.\u003c/p>\n\u003cp>Gass gave his doctors the go-ahead to fight the tumor with radiation, and that seemed to halt the swelling. But Gass is concerned it may be growing again. He doesn’t rule out the possibility that he could one day sue those connected with his treatments.\u003c/p>\n\u003cp>Gass isn’t the only patient who has experienced complications after receiving stem cell treatments. Medical journals have documented two similar cases. One patient was found to have \u003ca href=\"http://jasn.asnjournals.org/content/21/7/1218.full\">masses in one of her kidneys\u003c/a> following a stem cell treatment. In another case, a brain tumor \u003ca href=\"http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000029\">was discovered\u003c/a> after a boy suffering from a rare neurodegenerative disease received injections of fetal stem cells. Both journal articles kept the patients anonymous.\u003c/p>\n\u003cp>Gass received stem cell treatments in other countries years before going to Tijuana. Berkowitz said without a sample of the cells used in each case, he can’t be certain which treatment is directly linked with the tumor. But Berkowitz said Gass only reported feeling pain in his back after the second round of treatment in Tijuana, which Gass said included injections of GSCH’s fetal stem cells into his spine.\u003c/p>\n\u003cp>\u003cstrong>'We have no current plans to publish our results'\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"http://www.scripps.edu/research/faculty/loring\">Jeanne Loring\u003c/a>, a scientist at the Scripps Research Institute in La Jolla developing \u003ca href=\"https://www.scripps.edu/news/press/2016/20160721loring.html\">a stem cell therapy for Parkinson’s disease\u003c/a>, spoke with KPBS about the stem cell treatment industry broadly, not about any company in particular, because some firms have a reputation for being litigious.\u003c/p>\n\u003cp>“It’s unfortunate that what I work on and what they work on are both called stem cells, because they’re not at all the same,” Loring said. “It’s not a terrific idea to be putting stuff that you don’t know very much about into people and expecting it to work.”\u003c/p>\n\u003cp>Companies promoting stem cell treatments often say they’re only facilitating research. They say they don’t promise to cure patients, only to connect them with clinical trials.\u003c/p>\n\u003cp>Stemedica is sponsoring a number of clinical trials overseen by scientists at reputable institutions within the U.S. These trials \u003ca href=\"https://clinicaltrials.gov/ct2/results?term=stemedica&Search=Search\">are listed on ClinicalTrials.gov\u003c/a>, an online database of human medical studies maintained by the National Institutes of Health.\u003c/p>\n\u003cp>\u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01297413?term=stemedica&rank=2\">One ongoing Stemedica-sponsored trial\u003c/a> approved by UC San Diego’s Institutional Review Board is primarily aiming to test whether or not it’s safe to give Stemedica’s mesenchymal stem cells intravenously to stroke patients. Stemedica \u003ca href=\"http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/2011-0217-Stemedica-Approval-From-UCSD-Ischemic-Stroke-Study.asp\">says it has received the FDA’s approval\u003c/a> to move forward with this trial.\u003c/p>\n\u003cp>The trial started over five years ago, and has not yet reported results. Principal investigator and UCSD School of Medicine professor \u003ca href=\"http://neurosurgery.ucsd.edu/mike-levy-md-phd/\">Michael Levy\u003c/a> said the study is proceeding with appropriate caution.\u003c/p>\n\u003cp>“This is work that needs to be done,” he said. “Because people are paying huge amounts of money to get something that they’re not sure what they’re getting, and to pursue a hope that may not be there. We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.”\u003c/p>\n\u003cp>Loring said if a stem cell company truly is helping patients make remarkable recoveries, they should prove it by publishing their results.\u003c/p>\n\u003cp>“If they had really good results, they would publish them,” she said. “Because that would be like the best marketing strategy.”\u003c/p>\n\u003cp>Stemedica could not provide published data from any of its human trials.\u003c/p>\n\u003cp>Gass’ sister-in-law, concerned about the treatment Jim was about to receive, asked Global Stem Cell Health if they’d ever published evidence that their treatments work. A representative replied to her via email, “We have no current plans to publish our results.”\u003c/p>\n\u003cp>Ethical concerns have been raised about the fees patients are charged to participate in certain stem cell trials outside the country. Loring said patients are not typically charged large sums of money to participate in clinical trials. She thinks patients should be wary of any trial, or any company, that does charge tens of thousands of dollars for participation in a medical study.\u003c/p>\n\u003cp>When Stemedica spokesman Dave McGuigan was asked about patients who pay large sums of money to receive Stemedica cells as part of a trial outside the U.S., he said Stemedica and their foreign clinical trial partners put up “significant dollars” to carry out these studies, and patients are “asked to participate in those costs.”\u003c/p>\n\u003cp>“We’re talking about people that have a medical condition for which there is often no cure,” McGuigan said. “And so they have searched the world to find out what their options are.”\u003c/p>\n\u003cp>Dr. Amescua has confirmed that after KPBS approached him for comment on Gass’ treatment, he was able to find hospital records pertaining to Gass. Global Stem Cell Health did not respond to KPBS’ interview request.\u003c/p>\n\u003cp>\u003cstrong>A call for regulation\u003c/strong>\u003c/p>\n\u003cp>Gass went through a process often referred to as “stem cell tourism” to receive his treatments. In years past, patients often had to leave the country to seek unproven stem cell treatments. But UC Davis stem cell scientist \u003ca href=\"http://www.ucdmc.ucdavis.edu/cellbio/faculty/knoepfler/\">Paul Knoepfler\u003c/a> says that’s no longer the case.\u003c/p>\n\u003cp>Knoepfler recently co-authored \u003ca href=\"http://www.sciencedirect.com/science/article/pii/S1934590916301576\">a study\u003c/a> identifying 351 stem cell companies advertising unapproved treatments at 570 unique clinic locations right here in the U.S. for everything from autism to Alzheimer’s, stroke to diabetes.\u003c/p>\n\u003cp>“This kind of turns the idea of stem cell tourism on its head,” Knoepfler said. Now, he said, “Most Americans really don’t have to travel, say, to Mexico or Asia or somewhere in the Caribbean to get an unapproved stem cell treatment.”\u003c/p>\n\u003cp>Some scientists wonder why the FDA hasn’t taken more action against companies promoting unproven stem cell treatments. Scripps Research Institute scientist Jeanne Loring believes regulators may simply be outmatched.\u003c/p>\n\u003cp>“The clinics are popping up faster than the FDA can close them,” she said.\u003c/p>\n\u003cp>An FDA spokeswoman did not comment on Jim Gass’ situation or the specific companies involved with his treatment. The FDA has \u003ca href=\"http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm\">approved the use of blood forming stem cells\u003c/a> in patients with certain blood disorders, but the FDA spokeswoman wrote in an email to KPBS, “At this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits.”\u003c/p>\n\u003cp>Loring attended the FDA’s meeting on stem cells earlier this month and spoke about why she thinks better regulation is needed. She believes there could be more patients out there who aren’t coming forward to discuss the harms they’ve suffered in connection with unproven stem cell treatments.\u003c/p>\n\u003cp>Patients sometimes raise money for these treatments through web sites like GoFundMe.com. Some say they’re willing to take a chance on unproven stem cell therapies because they have nothing to lose.\u003c/p>\n\u003cp>Gass now knows he did have a lot to lose. He said all told, he lost hundreds of thousands of dollars pursuing stem cell treatments around the world, and now he’s left with a painful tumor and significantly decreased mobility.\u003c/p>\n\u003cp>Gass hopes other patients considering reaching out to companies promoting unproven stem cell treatments will be more educated about the risks than he was.\u003c/p>\n\u003cp>He said, “Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>inewsource reporter Leo Castaneda contributed to this report.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "'Holy Grail' Device Would Make Kidney Dialysis Much Easier",
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"content": "\u003cp>There’s new hope of a better and longer life for many patients with failing kidneys.\u003c/p>\n\u003cp>When someone’s kidneys stop working effectively to cleanse wastes from the blood, patients must have it done mechanically, using a dialysis machine to remove the blood, clean it, and send it back into the body. That process is hard on the veins because it requires such a large opening to do it.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It transitions over the period of a few months into something that’s indistinguishable from your own tissue.'\u003ccite>Jeff Lawson, Humacyte\u003c/cite>\u003c/aside>\n\u003cp>Currently, patients get a plastic tube, or shunt, surgically inserted in a vein to hold it open for dialysis. But those shunts can get infected over time, or rejected by a patient’s immune system, and in any case, they need to be replaced about every year.\u003c/p>\n\u003cp>Now researchers are testing a new kind of shunt—one made out of human tissue. It combines with a patient’s stem cells to make the device part of the patient’s body; theoretically, it could last a lifetime.\u003c/p>\n\u003cp>\u003cstrong>‘I Just Accept It’\u003c/strong>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The first patient in California to participate in the Phase III clinical trial for the new shunt is dialysis patient Raymond Ramirez. (A Phase III clinical trial is the stage of research required before submitting a treatment for FDA approval.)\u003c/p>\n\u003cp>The 67-year-old resident of Whittier, Calif., just east of Los Angeles, says he’s a bit of a train wreck. He’s in a wheelchair because of an above-the-knee amputation on his right leg, and he stops rolling around his TV room for a minute to list some of his maladies.\u003c/p>\n\u003cfigure id=\"attachment_260201\" class=\"wp-caption aligncenter\" style=\"max-width: 3264px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/stemcells2.jpg\">\u003cimg class=\"size-full wp-image-260201\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/stemcells2.jpg\" alt=\"The most challenging of Ray Ramirez's health problems right now is his kidney disease, because his veins are failing, making dialysis difficult.\" width=\"3264\" height=\"2448\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2.jpg 3264w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-960x720.jpg 960w\" sizes=\"(max-width: 3264px) 100vw, 3264px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">The most challenging of Ray Ramirez's health problems right now is his kidney disease, because his veins are failing, making dialysis difficult. \u003ccite>(David Gorn/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“Omigod, it’s never-ending,” he says with a laugh. “In Vietnam, when I got wounded, they took out my ribs. So, on my left side, my ribs they’re just gone.” He has to think a minute for more.\u003c/p>\n\u003cp>“I’ve had intestinal problems, I’ve had bladder cancer, a tumor in my bladder,” he says, “I have a blind eye in my right eye. Blood clot in my retina.\"\u003c/p>\n\u003cp>Ramirez says he’s not one of those guys who likes to dwell on his problems.\u003c/p>\n\u003cp>“I’ve always been a happy guy,” he says. “I don’t like it, no, hell no, it hurts. I’ve hurt like crazy since I was a youngster. I just accept it.”\u003c/p>\n\u003cp>Right now, the big challenge for Ramirez is dialysis, because his veins are failing. And that's how he ended up in the Veterans Affairs Hospital in Long Beach on a recent day for an appointment with vascular surgeon Ian Gordon. Since the Phase III study is randomized, Ramirez has a 50-50 of getting the experimental human tissue shunt or the traditional plastic one.\u003c/p>\n\u003cp>\u003cstrong>How Does the Shunt Work?\u003c/strong>\u003c/p>\n\u003cp>Imagine one of those long foam noodles kids play with in the pool—hollow and kind of like cellulose—only it’s the diameter of your little finger. That’s what the shunts look like. But it’s an intricate process to get them to that stage.\u003c/p>\n\u003caside class=\"pullquote alignright\">'One of the holy grails, if you can use that phrase, in vascular surgery is to come up with a prosthetic artificial graft that has the same properties as the patient’s own blood vessels.'\u003ccite>Dr. Ian Gordon,\u003cbr>\nVA Hospital, Long Beach\u003c/cite>\u003c/aside>\n\u003cp>First, you take human muscle cells from organ donors, and grow them into a tubular shape, says Jeff Lawson, chief medical officer at Humacyte, the North Carolina company that makes these things. As they grow, the cells secrete a sticky form of cellulose that holds them in the shape.\u003c/p>\n\u003cp>“So what’s left then is a scaffold of human tissue,” Lawson says. “We call it human extracellular matrix.”\u003c/p>\n\u003cp>Then you use a chemical wash to slough off the original donor cells, leaving the sticky cellulose structure behind—the foam noodle the diameter of your pinky finger.\u003c/p>\n\u003cp>The stem cell part of the equation, Lawson says, happens inside the patient.\u003c/p>\n\u003cp>“This scaffold, once implanted, uniquely becomes repopulated with their own stem cells,\" he says. \"That then turns back into something that looks like a vascular cell. And it now transitions over the period of a few months into something that’s indistinguishable from your own tissue.”\u003c/p>\n\u003cp>If it works, applications of this technology are endless, says Dr. Gordon, from vein replacement to heart surgery.\u003c/p>\n\u003cp>“One of the holy grails, if you can use that phrase, in vascular surgery is to come up with a prosthetic artificial graft,” he says, “that has the same properties as the patient’s own blood vessels.”\u003c/p>\n\u003cp>So far, this one seems to do that.\u003c/p>\n\u003cp>\u003cstrong>A Voter Mandate to Get Results\u003c/strong>\u003c/p>\n\u003cp>This is the kind of success the state stem cell agency was aiming for, when California voters created it in 2004 by approving Proposition 71. The California Institute for Regenerative Medicine (CIRM), based in Oakland, now has just four years of funding left, and is putting more money into mature clinical trials.\u003c/p>\n\u003cp>While many people think of stem cell therapy as an a treatment that injects the cells into a patient’s body, there are other types of treatments that rely on stem cells.\u003c/p>\n\u003cp>“At CIRM we’re interested in anything that involves or uses stem cells in the correction of a disease process,” says CIRM CEO Randall Mills. “About a quarter of our portfolio product itself isn’t a stem cell.”\u003c/p>\n\u003cp>There are a couple of important reasons for CIRM’s move to fund more clinical studies, says UC-San Diego’s director of stem cell research, Larry Goldstein\u003c/p>\n\u003cp>“Ten years ago I don’t think there were that many projects that were really ready for clinical trials,” Goldstein said. “The field itself has developed projects that are at clinical stage.”\u003c/p>\n\u003cp>And, Goldstein says, the voters who created the agency wanted it to produce results.\u003c/p>\n\u003cp>“The voter mandate was more than just basic research,\" he says, \"it was basic plus clinical.”\u003c/p>\n\u003cp>If the agency keeps pumping out these types of clinical results, Goldstein says, California voters may soon see another ballot measure to keep it going.\u003c/p>\n\u003cp>Humacyte officials say 118 patients around the world have received the new type of human tissue shunt – in both Phase II and Phase III of the clinical trial. About that many have participated in the trials and received the plastic shunt—neither the patient nor the doctor knows which shunt is to be installed until the moment in the surgery when a computer tells the doctor which one to use.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>In the case of Ray Ramirez, he found out after he woke up from surgery, he got the plastic one.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>There’s new hope of a better and longer life for many patients with failing kidneys.\u003c/p>\n\u003cp>When someone’s kidneys stop working effectively to cleanse wastes from the blood, patients must have it done mechanically, using a dialysis machine to remove the blood, clean it, and send it back into the body. That process is hard on the veins because it requires such a large opening to do it.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It transitions over the period of a few months into something that’s indistinguishable from your own tissue.'\u003ccite>Jeff Lawson, Humacyte\u003c/cite>\u003c/aside>\n\u003cp>Currently, patients get a plastic tube, or shunt, surgically inserted in a vein to hold it open for dialysis. But those shunts can get infected over time, or rejected by a patient’s immune system, and in any case, they need to be replaced about every year.\u003c/p>\n\u003cp>Now researchers are testing a new kind of shunt—one made out of human tissue. It combines with a patient’s stem cells to make the device part of the patient’s body; theoretically, it could last a lifetime.\u003c/p>\n\u003cp>\u003cstrong>‘I Just Accept It’\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The first patient in California to participate in the Phase III clinical trial for the new shunt is dialysis patient Raymond Ramirez. (A Phase III clinical trial is the stage of research required before submitting a treatment for FDA approval.)\u003c/p>\n\u003cp>The 67-year-old resident of Whittier, Calif., just east of Los Angeles, says he’s a bit of a train wreck. He’s in a wheelchair because of an above-the-knee amputation on his right leg, and he stops rolling around his TV room for a minute to list some of his maladies.\u003c/p>\n\u003cfigure id=\"attachment_260201\" class=\"wp-caption aligncenter\" style=\"max-width: 3264px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/stemcells2.jpg\">\u003cimg class=\"size-full wp-image-260201\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/stemcells2.jpg\" alt=\"The most challenging of Ray Ramirez's health problems right now is his kidney disease, because his veins are failing, making dialysis difficult.\" width=\"3264\" height=\"2448\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2.jpg 3264w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-960x720.jpg 960w\" sizes=\"(max-width: 3264px) 100vw, 3264px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">The most challenging of Ray Ramirez's health problems right now is his kidney disease, because his veins are failing, making dialysis difficult. \u003ccite>(David Gorn/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“Omigod, it’s never-ending,” he says with a laugh. “In Vietnam, when I got wounded, they took out my ribs. So, on my left side, my ribs they’re just gone.” He has to think a minute for more.\u003c/p>\n\u003cp>“I’ve had intestinal problems, I’ve had bladder cancer, a tumor in my bladder,” he says, “I have a blind eye in my right eye. Blood clot in my retina.\"\u003c/p>\n\u003cp>Ramirez says he’s not one of those guys who likes to dwell on his problems.\u003c/p>\n\u003cp>“I’ve always been a happy guy,” he says. “I don’t like it, no, hell no, it hurts. I’ve hurt like crazy since I was a youngster. I just accept it.”\u003c/p>\n\u003cp>Right now, the big challenge for Ramirez is dialysis, because his veins are failing. And that's how he ended up in the Veterans Affairs Hospital in Long Beach on a recent day for an appointment with vascular surgeon Ian Gordon. Since the Phase III study is randomized, Ramirez has a 50-50 of getting the experimental human tissue shunt or the traditional plastic one.\u003c/p>\n\u003cp>\u003cstrong>How Does the Shunt Work?\u003c/strong>\u003c/p>\n\u003cp>Imagine one of those long foam noodles kids play with in the pool—hollow and kind of like cellulose—only it’s the diameter of your little finger. That’s what the shunts look like. But it’s an intricate process to get them to that stage.\u003c/p>\n\u003caside class=\"pullquote alignright\">'One of the holy grails, if you can use that phrase, in vascular surgery is to come up with a prosthetic artificial graft that has the same properties as the patient’s own blood vessels.'\u003ccite>Dr. Ian Gordon,\u003cbr>\nVA Hospital, Long Beach\u003c/cite>\u003c/aside>\n\u003cp>First, you take human muscle cells from organ donors, and grow them into a tubular shape, says Jeff Lawson, chief medical officer at Humacyte, the North Carolina company that makes these things. As they grow, the cells secrete a sticky form of cellulose that holds them in the shape.\u003c/p>\n\u003cp>“So what’s left then is a scaffold of human tissue,” Lawson says. “We call it human extracellular matrix.”\u003c/p>\n\u003cp>Then you use a chemical wash to slough off the original donor cells, leaving the sticky cellulose structure behind—the foam noodle the diameter of your pinky finger.\u003c/p>\n\u003cp>The stem cell part of the equation, Lawson says, happens inside the patient.\u003c/p>\n\u003cp>“This scaffold, once implanted, uniquely becomes repopulated with their own stem cells,\" he says. \"That then turns back into something that looks like a vascular cell. And it now transitions over the period of a few months into something that’s indistinguishable from your own tissue.”\u003c/p>\n\u003cp>If it works, applications of this technology are endless, says Dr. Gordon, from vein replacement to heart surgery.\u003c/p>\n\u003cp>“One of the holy grails, if you can use that phrase, in vascular surgery is to come up with a prosthetic artificial graft,” he says, “that has the same properties as the patient’s own blood vessels.”\u003c/p>\n\u003cp>So far, this one seems to do that.\u003c/p>\n\u003cp>\u003cstrong>A Voter Mandate to Get Results\u003c/strong>\u003c/p>\n\u003cp>This is the kind of success the state stem cell agency was aiming for, when California voters created it in 2004 by approving Proposition 71. The California Institute for Regenerative Medicine (CIRM), based in Oakland, now has just four years of funding left, and is putting more money into mature clinical trials.\u003c/p>\n\u003cp>While many people think of stem cell therapy as an a treatment that injects the cells into a patient’s body, there are other types of treatments that rely on stem cells.\u003c/p>\n\u003cp>“At CIRM we’re interested in anything that involves or uses stem cells in the correction of a disease process,” says CIRM CEO Randall Mills. “About a quarter of our portfolio product itself isn’t a stem cell.”\u003c/p>\n\u003cp>There are a couple of important reasons for CIRM’s move to fund more clinical studies, says UC-San Diego’s director of stem cell research, Larry Goldstein\u003c/p>\n\u003cp>“Ten years ago I don’t think there were that many projects that were really ready for clinical trials,” Goldstein said. “The field itself has developed projects that are at clinical stage.”\u003c/p>\n\u003cp>And, Goldstein says, the voters who created the agency wanted it to produce results.\u003c/p>\n\u003cp>“The voter mandate was more than just basic research,\" he says, \"it was basic plus clinical.”\u003c/p>\n\u003cp>If the agency keeps pumping out these types of clinical results, Goldstein says, California voters may soon see another ballot measure to keep it going.\u003c/p>\n\u003cp>Humacyte officials say 118 patients around the world have received the new type of human tissue shunt – in both Phase II and Phase III of the clinical trial. About that many have participated in the trials and received the plastic shunt—neither the patient nor the doctor knows which shunt is to be installed until the moment in the surgery when a computer tells the doctor which one to use.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In the case of Ray Ramirez, he found out after he woke up from surgery, he got the plastic one.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>A couple of weeks ago, it was a \u003ca href=\"http://jama.jamanetwork.com/article.aspx?articleid=2553448\" target=\"_blank\">study\u003c/a> published in JAMA, the Journal of the American Medical Association, that found an activity tracker \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/09/20/weight-loss-study-finds-fitness-tracker-is-no-help/\" target=\"_blank\">failed to help users lose weight\u003c/a>.\u003c/p>\n\u003cp>Next came headlines like \"\u003ca class=\"_sQb\" href=\"http://www.cosmopolitan.com/health-fitness/a3617025/fitness-trackers-dont-help-you-lose-weight-after-all/\" target=\"_blank\">Fitness Trackers Don't Help You Lose Weight, After All\u003c/a>\" (in Cosmo, no less).\u003c/p>\n\u003caside class=\"pullquote alignright\">Study finds no improvement in health of Fitbit Zip users. But are the results translatable to real life?\u003c/aside>\n\u003cp>Now The Lancet Diabetes & Endocrinology has published a \u003ca href=\"http://www.thelancet.com/journals/landia/article/PIIS2213-8587(16)30284-4/fulltext\" target=\"_blank\">study\u003c/a> that found individuals who got cash or charity donation incentives to wear a Fitbit Zip activity tracker showed, after one year, no improvement in weight, blood pressure and other fitness measures\u003ca href=\"https://www.google.com/search?q=maximum+oxygen+consumption\" target=\"_blank\">.\u003c/a>\u003c/p>\n\u003cp>The study recruited 800 employees, aged 21-65, from 13 different companies in Singapore. It was designed to measure the Fitbits' impacts on health outcomes and how financial incentives affected peoples' use of the device.\u003c/p>\n\u003cp>Participants were randomly placed in four different groups, two of which were given the Fitbits plus weekly financial incentives, with a high of $30 awarded for logging 70,000 or more steps. Participants in one of the cash-incentive groups could keep the money; people in the other had to donate it to a charity of their choice. A third group got the Fitbit Zip and access to Fitbit's website but no incentives; and the fourth, a control group, was given no trackers, just some information about exercise.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The people who got to pocket the cash or donate it to charity logged more daily steps each week than the people in the non-incentivized groups. The cash group also saw a significantly smaller attrition rate -- after six months, just 12 percent of that group had stopped wearing the devices.\u003c/p>\n\u003cp>\u003cstrong>No Cash, No Fitbit\u003c/strong>\u003c/p>\n\u003cp>But the incentives stopped at the six-month mark. Over the six months after that, by the end of a full year from the study's start, 90 percent of participants in all groups had stopped wearing the devices.\u003c/p>\n\u003cp>And ... no one had a significant improvement in any health measure.\u003c/p>\n\u003cp>The researchers attributed the lack of improved health to the reality that an increase in steps does not necessarily translate to much of a boost in moderate-intensity and vigorous-intensity physical activity.\u003c/p>\n\u003cp>So what is the conclusion here?\u003c/p>\n\u003cp>\"Although other incentive strategies might generate greater increases in step activity and improvements in health outcomes,\" the researchers wrote, \"incentives would probably need to be in place long term to avoid any potential decrease in physical activity resulting from discontinuation.\"\u003c/p>\n\u003cp>The lack of any observable health benefits from use of the trackers, they wrote, called into question \"the value of these devices for health promotion.\"\u003c/p>\n\u003cp>\u003cstrong>Not So Fast ...\u003c/strong>\u003c/p>\n\u003cp>A different \u003ca href=\"http://preview.thenewsmarket.com/Previews/JOUR/DocumentAssets/448807.pdf\" target=\"_blank\">study\u003c/a> we mentioned earlier, published in \u003cem>JAMA \u003c/em>last month, found that those who were put on a weight-loss plan encompassing diet, exercise and counseling actually \u003cem>lost more weight\u003c/em> than those who were given the same plus a fitness tracker. That didn't look too good for Team Digital Health.\u003c/p>\n\u003cp>But not everyone thought the study was relevant. Aaron Coleman, founder and CEO of Fitabase, a company that makes data tools \"which make Fitbits awesome in research,\" published a \u003ca href=\"https://medium.com/@aaroncoleman/its-not-time-to-throw-away-your-fitbit-but-it-is-time-to-rethink-how-to-do-research-94dc498eb63f#.iy10v11qg\">piece\u003c/a> on Medium criticizing news reports that failed to note that the device the users gave participants is now obsolete.\u003c/p>\n\u003cblockquote>\u003cp>The problem? The device used in the intervention bears no resemblance to a “wearable” as we’d call it today. It was ... a discontinued, very clunky, very clinical looking arm strap and sensor brick called the Bodymedia FIT Core.\u003c/p>\n\u003cp id=\"7802\" class=\"graf graf--p graf-after--figure\">Even the amount of data collected in the study suggests that the term “wearable” may be a bit of a stretch, as on the days that participants wore the device, the median wear time was 4 hours (241.1 min/d to be exact).\u003c/p>\n\u003cp>To equate the user experience of today’s modern wearables, as many have done with this, got me a little sarcastic…\u003c/p>\u003c/blockquote>\n\u003cblockquote class=\"twitter-tweet\">\n\u003cp dir=\"ltr\" lang=\"en\">And in other news, online social networks don't work according to a new study of 300 people given MySpace accounts. \u003ca href=\"https://t.co/1J8GvdIP37\">https://t.co/1J8GvdIP37\u003c/a>\u003c/p>\n\u003cp>— Aaron Coleman (@aaronc) \u003ca href=\"https://twitter.com/aaronc/status/778594171036676096\">September 21, 2016\u003c/a>\u003c/p>\u003c/blockquote>\n\u003cp>But the study in \u003cem>The Lancet Diabetes & Endocrinology\u003c/em> does, indeed, use a newer if not the most advanced tracker, from the \u003ca href=\"http://www.idc.com/getdoc.jsp?containerId=prUS41284516\" target=\"_blank\">leading brand\u003c/a> in mobile health. This would seem to address Coleman's main quarrel with the earlier research. So we gave him a call to ask him what he thought.\u003c/p>\n\u003cp>\"They used an actual Fitbit in the intervention, which is an improvement over the last study in terms of trying to make it applicable to modern wearables,\" he says. But he didn't think the results could be \"generalized into day-to-day Fibit wearing.\"\u003c/p>\n\u003cp>In the case of Fitbits, Coleman contends, \"There's so many other components -- a social network component and having friends involved -- that make the experience.\"\u003c/p>\n\u003cp>He says taking more steps, which is what the study incentivized, is not necessarily the right goal. (He personally uses other measures such as heart rate in his fitness regimen.) And he thought the study's design did not equate to use of the devices in the real-world.\u003c/p>\n\u003cp>\"I don't know if incentivizing and handing them a device generalizes to daily life,\" he says.\u003c/p>\n\u003cp>As for Fitbit itself, the company issued a statement last week in response to the study. \"We are confident in the positive results our millions of users have seen from using Fitbit products,\" it read. The statement went on to say the company was in the process of improving its trackers.\u003c/p>\n\u003cp>The study's lead author, Eric Finkelstein, acknowledged that some of the newer fitness wearables have more advanced features, like exercise prompts and social media functions, but he still thinks it is unlikely people will radically change their exercise regimes without a more comprehensive approach.\u003c/p>\n\u003cp>“These trackers can encourage people to take more steps, but it still seems like these random extra steps aren’t enough to really improve your health,” he says.\u003c/p>\n\u003cp>Emmanuel Stamatakis, a physical activity expert at the University of Sydney, who was not part of the study, agreed. \"We should not be so naive to believe that simply by giving a sleek-looking gadget to someone, they will change deeply rooted lifestyle habits,\" he says.\u003c/p>\n\u003cp>In the meantime, Fitbit last week released a \u003ca href=\"https://www.springbuk.com/wearable-study/#top\" target=\"_blank\">case study \u003c/a>that it says shows employers can save money in health care costs if employees use the company's devices. The Verge critiques that study \u003ca href=\"http://www.theverge.com/2016/10/5/13176236/fitbit-study-corporate-wellness-health-care-savings\" target=\"_blank\">here\u003c/a>.\u003c/p>\n\u003cp>Fitabase also last week made public a \"\u003ca href=\"https://www.fitabase.com/research-library/\" target=\"_blank\">Fitbit Research Library\u003c/a>\" with 167 studies assessing or using the devices.\u003c/p>\n\u003cp>\u003cem>Associated Press contributed to this report.\u003c/em>\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp> \u003c/p>\n\n",
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"excerpt": "A study published last week found individuals incentivized to wear a Fitbit Zip tracker showed, after one year, no improvement in weight, blood pressure and cardiorespiratory fitness measures.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>A couple of weeks ago, it was a \u003ca href=\"http://jama.jamanetwork.com/article.aspx?articleid=2553448\" target=\"_blank\">study\u003c/a> published in JAMA, the Journal of the American Medical Association, that found an activity tracker \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/09/20/weight-loss-study-finds-fitness-tracker-is-no-help/\" target=\"_blank\">failed to help users lose weight\u003c/a>.\u003c/p>\n\u003cp>Next came headlines like \"\u003ca class=\"_sQb\" href=\"http://www.cosmopolitan.com/health-fitness/a3617025/fitness-trackers-dont-help-you-lose-weight-after-all/\" target=\"_blank\">Fitness Trackers Don't Help You Lose Weight, After All\u003c/a>\" (in Cosmo, no less).\u003c/p>\n\u003caside class=\"pullquote alignright\">Study finds no improvement in health of Fitbit Zip users. But are the results translatable to real life?\u003c/aside>\n\u003cp>Now The Lancet Diabetes & Endocrinology has published a \u003ca href=\"http://www.thelancet.com/journals/landia/article/PIIS2213-8587(16)30284-4/fulltext\" target=\"_blank\">study\u003c/a> that found individuals who got cash or charity donation incentives to wear a Fitbit Zip activity tracker showed, after one year, no improvement in weight, blood pressure and other fitness measures\u003ca href=\"https://www.google.com/search?q=maximum+oxygen+consumption\" target=\"_blank\">.\u003c/a>\u003c/p>\n\u003cp>The study recruited 800 employees, aged 21-65, from 13 different companies in Singapore. It was designed to measure the Fitbits' impacts on health outcomes and how financial incentives affected peoples' use of the device.\u003c/p>\n\u003cp>Participants were randomly placed in four different groups, two of which were given the Fitbits plus weekly financial incentives, with a high of $30 awarded for logging 70,000 or more steps. Participants in one of the cash-incentive groups could keep the money; people in the other had to donate it to a charity of their choice. A third group got the Fitbit Zip and access to Fitbit's website but no incentives; and the fourth, a control group, was given no trackers, just some information about exercise.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The people who got to pocket the cash or donate it to charity logged more daily steps each week than the people in the non-incentivized groups. The cash group also saw a significantly smaller attrition rate -- after six months, just 12 percent of that group had stopped wearing the devices.\u003c/p>\n\u003cp>\u003cstrong>No Cash, No Fitbit\u003c/strong>\u003c/p>\n\u003cp>But the incentives stopped at the six-month mark. Over the six months after that, by the end of a full year from the study's start, 90 percent of participants in all groups had stopped wearing the devices.\u003c/p>\n\u003cp>And ... no one had a significant improvement in any health measure.\u003c/p>\n\u003cp>The researchers attributed the lack of improved health to the reality that an increase in steps does not necessarily translate to much of a boost in moderate-intensity and vigorous-intensity physical activity.\u003c/p>\n\u003cp>So what is the conclusion here?\u003c/p>\n\u003cp>\"Although other incentive strategies might generate greater increases in step activity and improvements in health outcomes,\" the researchers wrote, \"incentives would probably need to be in place long term to avoid any potential decrease in physical activity resulting from discontinuation.\"\u003c/p>\n\u003cp>The lack of any observable health benefits from use of the trackers, they wrote, called into question \"the value of these devices for health promotion.\"\u003c/p>\n\u003cp>\u003cstrong>Not So Fast ...\u003c/strong>\u003c/p>\n\u003cp>A different \u003ca href=\"http://preview.thenewsmarket.com/Previews/JOUR/DocumentAssets/448807.pdf\" target=\"_blank\">study\u003c/a> we mentioned earlier, published in \u003cem>JAMA \u003c/em>last month, found that those who were put on a weight-loss plan encompassing diet, exercise and counseling actually \u003cem>lost more weight\u003c/em> than those who were given the same plus a fitness tracker. That didn't look too good for Team Digital Health.\u003c/p>\n\u003cp>But not everyone thought the study was relevant. Aaron Coleman, founder and CEO of Fitabase, a company that makes data tools \"which make Fitbits awesome in research,\" published a \u003ca href=\"https://medium.com/@aaroncoleman/its-not-time-to-throw-away-your-fitbit-but-it-is-time-to-rethink-how-to-do-research-94dc498eb63f#.iy10v11qg\">piece\u003c/a> on Medium criticizing news reports that failed to note that the device the users gave participants is now obsolete.\u003c/p>\n\u003cblockquote>\u003cp>The problem? The device used in the intervention bears no resemblance to a “wearable” as we’d call it today. It was ... a discontinued, very clunky, very clinical looking arm strap and sensor brick called the Bodymedia FIT Core.\u003c/p>\n\u003cp id=\"7802\" class=\"graf graf--p graf-after--figure\">Even the amount of data collected in the study suggests that the term “wearable” may be a bit of a stretch, as on the days that participants wore the device, the median wear time was 4 hours (241.1 min/d to be exact).\u003c/p>\n\u003cp>To equate the user experience of today’s modern wearables, as many have done with this, got me a little sarcastic…\u003c/p>\u003c/blockquote>\n\u003cblockquote class=\"twitter-tweet\">\n\u003cp dir=\"ltr\" lang=\"en\">And in other news, online social networks don't work according to a new study of 300 people given MySpace accounts. \u003ca href=\"https://t.co/1J8GvdIP37\">https://t.co/1J8GvdIP37\u003c/a>\u003c/p>\n\u003cp>— Aaron Coleman (@aaronc) \u003ca href=\"https://twitter.com/aaronc/status/778594171036676096\">September 21, 2016\u003c/a>\u003c/p>\u003c/blockquote>\n\u003cp>But the study in \u003cem>The Lancet Diabetes & Endocrinology\u003c/em> does, indeed, use a newer if not the most advanced tracker, from the \u003ca href=\"http://www.idc.com/getdoc.jsp?containerId=prUS41284516\" target=\"_blank\">leading brand\u003c/a> in mobile health. This would seem to address Coleman's main quarrel with the earlier research. So we gave him a call to ask him what he thought.\u003c/p>\n\u003cp>\"They used an actual Fitbit in the intervention, which is an improvement over the last study in terms of trying to make it applicable to modern wearables,\" he says. But he didn't think the results could be \"generalized into day-to-day Fibit wearing.\"\u003c/p>\n\u003cp>In the case of Fitbits, Coleman contends, \"There's so many other components -- a social network component and having friends involved -- that make the experience.\"\u003c/p>\n\u003cp>He says taking more steps, which is what the study incentivized, is not necessarily the right goal. (He personally uses other measures such as heart rate in his fitness regimen.) And he thought the study's design did not equate to use of the devices in the real-world.\u003c/p>\n\u003cp>\"I don't know if incentivizing and handing them a device generalizes to daily life,\" he says.\u003c/p>\n\u003cp>As for Fitbit itself, the company issued a statement last week in response to the study. \"We are confident in the positive results our millions of users have seen from using Fitbit products,\" it read. The statement went on to say the company was in the process of improving its trackers.\u003c/p>\n\u003cp>The study's lead author, Eric Finkelstein, acknowledged that some of the newer fitness wearables have more advanced features, like exercise prompts and social media functions, but he still thinks it is unlikely people will radically change their exercise regimes without a more comprehensive approach.\u003c/p>\n\u003cp>“These trackers can encourage people to take more steps, but it still seems like these random extra steps aren’t enough to really improve your health,” he says.\u003c/p>\n\u003cp>Emmanuel Stamatakis, a physical activity expert at the University of Sydney, who was not part of the study, agreed. \"We should not be so naive to believe that simply by giving a sleek-looking gadget to someone, they will change deeply rooted lifestyle habits,\" he says.\u003c/p>\n\u003cp>In the meantime, Fitbit last week released a \u003ca href=\"https://www.springbuk.com/wearable-study/#top\" target=\"_blank\">case study \u003c/a>that it says shows employers can save money in health care costs if employees use the company's devices. The Verge critiques that study \u003ca href=\"http://www.theverge.com/2016/10/5/13176236/fitbit-study-corporate-wellness-health-care-savings\" target=\"_blank\">here\u003c/a>.\u003c/p>\n\u003cp>Fitabase also last week made public a \"\u003ca href=\"https://www.fitabase.com/research-library/\" target=\"_blank\">Fitbit Research Library\u003c/a>\" with 167 studies assessing or using the devices.\u003c/p>\n\u003cp>\u003cem>Associated Press contributed to this report.\u003c/em>\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>The noose is drawing ever-tighter around Theranos. The Wall Street Journal is reporting the San Francisco hedge fund \u003ca href=\"http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=24258473\" target=\"_blank\">Partner Fund Management\u003c/a> is suing the company and its founder, Elizabeth Holmes, for \"engaging in securities fraud and other violations,\" according to a document reviewed by the Journal. The fund has invested nearly $100 million in Theranos, the paper says.\u003c/p>\n\u003cp>The company is already being sued by patients seeking class-action status in complaints related to inaccurate blood tests.\u003c/p>\n\u003cp>Last week, Theranos said it was \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/05/theranos-labs/\" target=\"_blank\">getting out of the consumer blood-testing business\u003c/a>, shutting down a handful of remaining blood-testing centers and shuttering its labs.\u003c/p>\n\u003cp>Read the Journal story below ...\u003c/p>\n\u003cp>http://www.wsj.com/articles/major-investor-sues-theranos-1476139613\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The noose is drawing ever-tighter around Theranos. The Wall Street Journal is reporting the San Francisco hedge fund \u003ca href=\"http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=24258473\" target=\"_blank\">Partner Fund Management\u003c/a> is suing the company and its founder, Elizabeth Holmes, for \"engaging in securities fraud and other violations,\" according to a document reviewed by the Journal. The fund has invested nearly $100 million in Theranos, the paper says.\u003c/p>\n\u003cp>The company is already being sued by patients seeking class-action status in complaints related to inaccurate blood tests.\u003c/p>\n\u003cp>Last week, Theranos said it was \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/05/theranos-labs/\" target=\"_blank\">getting out of the consumer blood-testing business\u003c/a>, shutting down a handful of remaining blood-testing centers and shuttering its labs.\u003c/p>\n\u003cp>Read the Journal story below ...\u003c/p>\n\u003cp>http://www.wsj.com/articles/major-investor-sues-theranos-1476139613\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>No news is good news when it comes to the fortunes of blood-testing company Theranos.\u003c/p>\n\u003cp>And yesterday, there was news.\u003c/p>\n\u003cp>Company CEO Elizabeth Holmes posted an \u003ca href=\"https://news.theranos.com/2016/10/05/an-open-letter-elizabeth-holmes/\" target=\"_blank\">open letter\u003c/a> Wednesday announcing that Theranos will shut down its two clinical labs and its handful of remaining blood-testing centers. That will result in layoffs for about 340 employees -- approximately 40 percent of the company's workforce -- in Arizona, California and Pennsylvania.\u003c/p>\n\u003cp>Holmes said in her letter, addressed to \"stakeholders,\" that the company will now focus on the development of a portable blood-testing device, which Holmes unveiled at a scientific conference in August.\u003c/p>\n\u003cp>Theranos calls that product a miniLab, and at least some lab experts who we and other media outlets spoke to \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/07/29/theranos-elizabeth-holmes-will-face-1000-scientists-monday-can-she-say-anything-to-gain-their-trust/\" target=\"_blank\">did not think\u003c/a> it represented a significant advance in the field.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Holmes' announcement yesterday comes in the midst of the company's appeal of severe sanctions imposed by the Centers for Medicare & Medicaid Services, which among other penalties banned Holmes from owning or running any clinical laboratory for two years. The sanctions stem from deficiencies at Theranos' Newark, California lab, including problems with a blood-clotting test that CMS judged to be life-threatening. That lab has been closed since July, when regulators revoked the company's license to operate it.\u003c/p>\n\u003cp>Theranos has another lab in Scottsdale, Arizona, so now that will be shuttered as well. But because the government's sanctions preclude Holmes from owning or operating any lab, it's unclear how Holmes could have stayed with the company should Theranos have wished to keep its Arizona lab open. And Holmes, apparently, isn't going anywhere. At least, that seemed to be the case in mid-July, when Theranos issued a sort of \u003ca href=\"https://news.theranos.com/2016/07/19/theranos-statement-on-cms-findings/\" target=\"_blank\">FAQ\u003c/a> about what the government's sanctions meant for its operations.\u003c/p>\n\u003cp>\"The clinical lab is just one of Theranos’ many opportunities to provide access to high-integrity, affordable and actionable health care information, and the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes,\" the company said.\u003c/p>\n\u003cp>In her open letter yesterday, Holmes said Theranos had installed a new executive team \"leading our work toward obtaining FDA clearances, building commercial partnerships, and pursuing publications in scientific journals. We are fortunate to have supporters and investors who believe deeply in our mission of affordable, less invasive lab testing, and to have the runway to realize our vision.\"\u003c/p>\n\u003cp>We sent Theranos and Hill+Knowlton Strategies, which Theranos uses for media relations, a query as to how the shuttering of its consumer blood-testing business might affect its appeal of the sanctions. Hill+Knowlton said Theranos would have no comment beyond Holmes' open letter \"at this time.\"\u003c/p>\n\u003cp>CMS has said it routinely negotiates with companies that it penalizes, but the circumstances for which it lifts sanctions did not seem to apply to Theranos. CMS also said at one point that closing down its labs would not be enough to prevent the penalties from being implemented.\u003c/p>\n\u003cp>If Theranos has no further comment right now, here's someone who does: Wall Street Journal reporter John Carreyrou, whose \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">investigative reporting\u003c/a> heralded the beginning of the end for Theranos' status as a golden child of Silicon Valley \"disruption.\" Carreyrou yesterday indulged in a victory tweet:\u003c/p>\n\u003cp>https://twitter.com/JohnCarreyrou/status/783844650213715968\u003c/p>\n\u003cp>\u003cstrong>Litany of Woes\u003c/strong>\u003c/p>\n\u003cp>We won't go into the specifics of the many developments that have led to Theranos in just a year's time becoming -- it's probably fair to say -- a corporate pariah. (See our \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/07/14/the-rise-and-fall-of-theranos-a-cartoon-history/\" target=\"_blank\">cartoon history of the company here\u003c/a> for more.) Theranos made its name by touting what it said was a revolutionary diagnostic technology, which allowed for dozens of blood tests from just a few drops of blood, and for extremely low prices.\u003c/p>\n\u003cp>A high-profile partnership with Walgreens, opening dozens of Theranos blood-testing centers within the pharmacy chain’s stores, gave its technology the imprimatur of a major health care provider.\u003c/p>\n\u003cp>Investors piled on, bestowing the company with a $9 billion valuation, according to Forbes, $4.5 billion of which would accrue to Holmes.\u003c/p>\n\u003cp>But it all came tumbling down -- rapidly. The lab testing community had already been grumbling that Theranos had never published in a a single word of proof in a peer-reviewed journal that its methods worked. Then came \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/01/26/for-theranos-the-bad-news-keeps-coming/\">Wall Street Journal articles alleging\u003c/a>, among other improprieties, that Theranos failed to report tests showing its vaunted tech may not be accurate. CMS soon threatened its sanctions, which were based on an unrelated lab inspection. Scientific studies emerged that showed Theranos' test results deviated from norms; \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/06/12/walgreens-shutting-down-theranos-centers-immediately-as-it-ends-partnership/\">Walgreens bailed\u003c/a>; the company invalidated tens of thousands of patient blood tests; lawsuits proliferated; the SEC and U.S. Attorney's Office for Northern California opened investigations; and an attempted comeback at the annual meeting of the American Association for Clinical Chemistry was a bust: attendees had fully expected, at long last, some hard validating data, but instead got what some characterized as a marketing presentation for a not overly exciting new product.\u003c/p>\n\u003cp>Plus there's the whole \u003ca href=\"http://www.vanityfair.com/hollywood/2016/06/jennifer-lawrence-theranos-elizabeth-holmes\" target=\"_blank\">Jennifer Lawrence thing\u003c/a>. ...\u003c/p>\n\u003cp>More to come, we're sure.\u003c/p>\n\u003cp>Here's yesterday's full \u003ca href=\"https://news.theranos.com/2016/10/05/an-open-letter-elizabeth-holmes/\" target=\"_blank\">open letter \u003c/a>from Holmes on Theranos' website:\u003c/p>\n\u003cblockquote>\u003cp>For our stakeholders,\u003c/p>\n\u003cp>After many months spent assessing our strengths and addressing our weaknesses, we have moved to structure our company around the model best aligned with our core values and mission.\u003c/p>\n\u003cp>We have decided to close our clinical labs and Theranos Wellness Centers, which will impact approximately 340 employees in Arizona, California, and Pennsylvania. We are profoundly grateful to these team members, many of whom have devoted years to Theranos and our mission, for their commitment to our company and our guests.\u003c/p>\n\u003cp>We will return our undivided attention to our miniLab platform. Our ultimate goal is to commercialize miniaturized, automated laboratories capable of small-volume sample testing, with an emphasis on vulnerable patient populations, including oncology, pediatrics, and intensive care.\u003c/p>\n\u003cp>We have a new executive team leading our work toward obtaining FDA clearances, building commercial partnerships, and pursuing publications in scientific journals.\u003c/p>\n\u003cp>We are fortunate to have supporters and investors who believe deeply in our mission of affordable, less invasive lab testing, and to have the runway to realize our vision.\u003c/p>\n\u003cp>I look forward to sharing more with you as we progress along the way.\u003c/p>\n\u003cp>Sincerely,\u003c/p>\n\u003cp>Elizabeth Holmes\u003c/p>\u003c/blockquote>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This posted has been edited. It originally said that Theranos does not have an in-house spokesperson, which it does. \u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>No news is good news when it comes to the fortunes of blood-testing company Theranos.\u003c/p>\n\u003cp>And yesterday, there was news.\u003c/p>\n\u003cp>Company CEO Elizabeth Holmes posted an \u003ca href=\"https://news.theranos.com/2016/10/05/an-open-letter-elizabeth-holmes/\" target=\"_blank\">open letter\u003c/a> Wednesday announcing that Theranos will shut down its two clinical labs and its handful of remaining blood-testing centers. That will result in layoffs for about 340 employees -- approximately 40 percent of the company's workforce -- in Arizona, California and Pennsylvania.\u003c/p>\n\u003cp>Holmes said in her letter, addressed to \"stakeholders,\" that the company will now focus on the development of a portable blood-testing device, which Holmes unveiled at a scientific conference in August.\u003c/p>\n\u003cp>Theranos calls that product a miniLab, and at least some lab experts who we and other media outlets spoke to \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/07/29/theranos-elizabeth-holmes-will-face-1000-scientists-monday-can-she-say-anything-to-gain-their-trust/\" target=\"_blank\">did not think\u003c/a> it represented a significant advance in the field.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Holmes' announcement yesterday comes in the midst of the company's appeal of severe sanctions imposed by the Centers for Medicare & Medicaid Services, which among other penalties banned Holmes from owning or running any clinical laboratory for two years. The sanctions stem from deficiencies at Theranos' Newark, California lab, including problems with a blood-clotting test that CMS judged to be life-threatening. That lab has been closed since July, when regulators revoked the company's license to operate it.\u003c/p>\n\u003cp>Theranos has another lab in Scottsdale, Arizona, so now that will be shuttered as well. But because the government's sanctions preclude Holmes from owning or operating any lab, it's unclear how Holmes could have stayed with the company should Theranos have wished to keep its Arizona lab open. And Holmes, apparently, isn't going anywhere. At least, that seemed to be the case in mid-July, when Theranos issued a sort of \u003ca href=\"https://news.theranos.com/2016/07/19/theranos-statement-on-cms-findings/\" target=\"_blank\">FAQ\u003c/a> about what the government's sanctions meant for its operations.\u003c/p>\n\u003cp>\"The clinical lab is just one of Theranos’ many opportunities to provide access to high-integrity, affordable and actionable health care information, and the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes,\" the company said.\u003c/p>\n\u003cp>In her open letter yesterday, Holmes said Theranos had installed a new executive team \"leading our work toward obtaining FDA clearances, building commercial partnerships, and pursuing publications in scientific journals. We are fortunate to have supporters and investors who believe deeply in our mission of affordable, less invasive lab testing, and to have the runway to realize our vision.\"\u003c/p>\n\u003cp>We sent Theranos and Hill+Knowlton Strategies, which Theranos uses for media relations, a query as to how the shuttering of its consumer blood-testing business might affect its appeal of the sanctions. Hill+Knowlton said Theranos would have no comment beyond Holmes' open letter \"at this time.\"\u003c/p>\n\u003cp>CMS has said it routinely negotiates with companies that it penalizes, but the circumstances for which it lifts sanctions did not seem to apply to Theranos. CMS also said at one point that closing down its labs would not be enough to prevent the penalties from being implemented.\u003c/p>\n\u003cp>If Theranos has no further comment right now, here's someone who does: Wall Street Journal reporter John Carreyrou, whose \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">investigative reporting\u003c/a> heralded the beginning of the end for Theranos' status as a golden child of Silicon Valley \"disruption.\" Carreyrou yesterday indulged in a victory tweet:\u003c/p>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\n\u003cp>\u003cstrong>Litany of Woes\u003c/strong>\u003c/p>\n\u003cp>We won't go into the specifics of the many developments that have led to Theranos in just a year's time becoming -- it's probably fair to say -- a corporate pariah. (See our \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/07/14/the-rise-and-fall-of-theranos-a-cartoon-history/\" target=\"_blank\">cartoon history of the company here\u003c/a> for more.) Theranos made its name by touting what it said was a revolutionary diagnostic technology, which allowed for dozens of blood tests from just a few drops of blood, and for extremely low prices.\u003c/p>\n\u003cp>A high-profile partnership with Walgreens, opening dozens of Theranos blood-testing centers within the pharmacy chain’s stores, gave its technology the imprimatur of a major health care provider.\u003c/p>\n\u003cp>Investors piled on, bestowing the company with a $9 billion valuation, according to Forbes, $4.5 billion of which would accrue to Holmes.\u003c/p>\n\u003cp>But it all came tumbling down -- rapidly. The lab testing community had already been grumbling that Theranos had never published in a a single word of proof in a peer-reviewed journal that its methods worked. Then came \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/01/26/for-theranos-the-bad-news-keeps-coming/\">Wall Street Journal articles alleging\u003c/a>, among other improprieties, that Theranos failed to report tests showing its vaunted tech may not be accurate. CMS soon threatened its sanctions, which were based on an unrelated lab inspection. Scientific studies emerged that showed Theranos' test results deviated from norms; \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/06/12/walgreens-shutting-down-theranos-centers-immediately-as-it-ends-partnership/\">Walgreens bailed\u003c/a>; the company invalidated tens of thousands of patient blood tests; lawsuits proliferated; the SEC and U.S. Attorney's Office for Northern California opened investigations; and an attempted comeback at the annual meeting of the American Association for Clinical Chemistry was a bust: attendees had fully expected, at long last, some hard validating data, but instead got what some characterized as a marketing presentation for a not overly exciting new product.\u003c/p>\n\u003cp>Plus there's the whole \u003ca href=\"http://www.vanityfair.com/hollywood/2016/06/jennifer-lawrence-theranos-elizabeth-holmes\" target=\"_blank\">Jennifer Lawrence thing\u003c/a>. ...\u003c/p>\n\u003cp>More to come, we're sure.\u003c/p>\n\u003cp>Here's yesterday's full \u003ca href=\"https://news.theranos.com/2016/10/05/an-open-letter-elizabeth-holmes/\" target=\"_blank\">open letter \u003c/a>from Holmes on Theranos' website:\u003c/p>\n\u003cblockquote>\u003cp>For our stakeholders,\u003c/p>\n\u003cp>After many months spent assessing our strengths and addressing our weaknesses, we have moved to structure our company around the model best aligned with our core values and mission.\u003c/p>\n\u003cp>We have decided to close our clinical labs and Theranos Wellness Centers, which will impact approximately 340 employees in Arizona, California, and Pennsylvania. We are profoundly grateful to these team members, many of whom have devoted years to Theranos and our mission, for their commitment to our company and our guests.\u003c/p>\n\u003cp>We will return our undivided attention to our miniLab platform. Our ultimate goal is to commercialize miniaturized, automated laboratories capable of small-volume sample testing, with an emphasis on vulnerable patient populations, including oncology, pediatrics, and intensive care.\u003c/p>\n\u003cp>We have a new executive team leading our work toward obtaining FDA clearances, building commercial partnerships, and pursuing publications in scientific journals.\u003c/p>\n\u003cp>We are fortunate to have supporters and investors who believe deeply in our mission of affordable, less invasive lab testing, and to have the runway to realize our vision.\u003c/p>\n\u003cp>I look forward to sharing more with you as we progress along the way.\u003c/p>\n\u003cp>Sincerely,\u003c/p>\n\u003cp>Elizabeth Holmes\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This posted has been edited. It originally said that Theranos does not have an in-house spokesperson, which it does. \u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Controversial Doll Therapy Catches On For Treating People With Dementia",
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"content": "\u003cp>Sitting beside a neatly made crib, 88-year-old Vivian Guzofsky holds up a baby doll dressed in puppy dog pajamas.\u003c/p>\n\u003cp>\"Hello gorgeous,\" she says, laughing. \"You're so cute.\"\u003c/p>\n\u003caside class=\"pullquote alignright\">Supporters of doll therapy for dementia patients say it can lessen distress, improve communication and reduce the need for psychotropic medication. Critics say the dolls are demeaning and infantilize seniors.\u003c/aside>\n\u003cp>Guzofsky, who has Alzheimer's disease, lives on a secure memory floor at a home for seniors in Beverly Hills, Calif. She visits the dolls in the home's pretend nursery nearly every day. Sometimes Guzofsky changes their clothes or lays them down for a nap. One morning in August, she sings to them: \"You are my sunshine, my only sunshine. You make me happy when skies are gray.\"\u003c/p>\n\u003cp>No one knows whether she believes she is holding a doll or a real baby. What the staff at Sunrise Senior Living do know is that Guzofsky, who can get agitated and aggressive, is always calm when caring for the dolls.\u003c/p>\n\u003cp>Doll therapy is catching on at nursing homes and other senior facilities across the country. It's used to help ease anxiety among residents with \u003ca href=\"http://www.ninds.nih.gov/disorders/dementias/dementia.htm\">dementia,\u003c/a> who can experience personality changes, agitation and aggression. But the therapy is controversial.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Supporters say the dolls can lessen distress, improve communication and reduce the need for psychotropic medication. Critics say the dolls are demeaning and infantilize seniors.\u003c/p>\n\u003cp>Typically, caregivers will give residents the option of holding, changing or dressing the dolls, without saying whether the dolls are babies or toys. Caregivers may also use the dolls to start conversations about the residents' own children or grandchildren.\u003c/p>\n\u003cp>Care providers who use the technique say the dolls help engage elderly people who are no longer able to participate in many activities.\u003c/p>\n\u003cp>\"A lot of people with Alzheimer's are bored and may become depressed or agitated or unhappy because they aren't engaged,\" says Ruth Drew, director of family & information services at the \u003ca href=\"http://www.alz.org/\">Alzheimer's Association\u003c/a>.\u003c/p>\n\u003cp>Caregivers aren't trying to make their charges believe the dolls are real infants, Drew says. They are just \"trying to meet them where they are and communicate with them in a way that makes sense to them,\" she says.\u003c/p>\n\u003cp>But some care providers do not like the technique.\u003c/p>\n\u003cp>\"They are adults and we want to treat them like adults,\" says Stephanie Zeverino, who works in community relations at a Belmont Village center in Los Angeles. \"These are very well-educated residents.\"\u003c/p>\n\u003cp>Staff members there work with residents to play brain games that promote critical thinking, she says. And they use other types of therapy including art and music.\u003c/p>\n\u003cp>\"We want to provide a sense of dignity,\" Zeverino says.\u003c/p>\n\u003cfigure id=\"attachment_256787\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/dolls2.jpg\">\u003cimg class=\"size-full wp-image-256787\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/dolls2.jpg\" alt=\"Marilou Roos, 87, rarely speaks and sleeps much of the day. But caregiver Jessica Butler says Roos brightens up when caring for dolls.\" width=\"800\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/dolls2.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/dolls2-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/dolls2-768x576.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Marilou Roos, 87, rarely speaks and sleeps much of the day. But caregiver Jessica Butler says Roos brightens up when caring for dolls. \u003ccite>(eidi de Marco/Kaiser Health News)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"http://journal.frontiersin.org/article/10.3389/fpsyg.2014.00342/full\">Studies\u003c/a> on doll therapy are limited, but some \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/25160532\">research\u003c/a> has shown it can reduce the need for medications and lessen agitation, aggression and wandering.\u003c/p>\n\u003cp>\"Having the doll ... offers them an anchor or a sense of attachment in a time of uncertainty,\" says Gary Mitchell, a nurse specialist at Four Seasons Health Care facilities in Northern Ireland, and author of a new book: \u003cem>Doll Therapy in Dementia Care: Evidence and Practice.\u003c/em>\u003c/p>\n\u003cp>\"A lot of people associate the doll with their younger days and having people to care for,\" Mitchell says.\u003c/p>\n\u003cp>However, he acknowledges that doll therapy can perpetuate the stigma associated with dementia that caregivers are trying to get away from.\u003c/p>\n\u003cp>Some families worry about their relatives being laughed at when they engage in doll therapy, Mitchell says. He had the same concerns when he worked at a senior residential center. But when one resident requested that he allow her to continue caring for a doll, he saw the positive impact of the therapy. Mitchell says doll therapy should be used cautiously and more studies are needed.\u003c/p>\n\u003cp>At Sunrise Beverly Hills, the nursery is set up like a baby's room. A stuffed bear rests inside the wooden crib. On a shelf above are framed photos of Guzofsky and a few other women who regularly interact with the dolls. A few bottles, a Dr. Seuss book and diapers sit on a nearby changing table.\u003c/p>\n\u003cp>The nursery is just one of several areas designed to engage residents, says Rita Altman, senior vice president of memory care for Sunrise, which has facilities in the U.S., Canada and the United Kingdom. There are also art centers, offices, gardens and kitchens where residents may find familiar objects from their past.\u003c/p>\n\u003cp>Altman says the nurseries tend to attract residents who have an instinct to care for babies. Some people may not be able to talk anymore, but still find a sense of security with a doll, she says. \"You can read it in their body language when they pick up the doll.\"\u003c/p>\n\u003cp>Sunrise caregivers also use the dolls to spark conversations by asking questions: How many children do you have? Was your first baby a boy or a girl? What are the best things about being a mom?\u003c/p>\n\u003cp>The executive director of the Beverly Hills facility, \u003ca href=\"http://www.sunriseseniorliving.com/blog/october-2015/sunrises-jason-malone-wins-calas-outstanding-executive-director-award.aspx\">Jason Malone\u003c/a>, says he was skeptical about the use of dolls when he first heard about them.\u003c/p>\n\u003cp>\"I almost felt like we were being deceitful,\" he says. \"It didn't feel like it was real.\"\u003c/p>\n\u003cp>But he quickly changed his mind when he realized that staff could use the dolls respectfully.\u003c/p>\n\u003cp>\"We don't want to confuse treating our seniors as children,\" Malone says. \"That's not what this activity is truly about.\"\u003c/p>\n\u003cp>Guzofsky began caring for the dolls soon after moving into the facility. When asked what she likes about them, she says, \"I love babies. I have some very nice ones back where I live now.\"\u003c/p>\n\u003cp>Guzofsky's daughter, Carol Mizel, says her mom raised three children and volunteered extensively in Colorado and Mexico before being diagnosed with Alzheimer's about five years ago. Mizel doesn't see any downside to her mother caring for the dolls.\u003c/p>\n\u003cp>It is a \"creative way of dealing with her where she is now,\" she says.\u003c/p>\n\u003cp>For some residents, including 87-year-old Marilou Roos, holding the dolls is one of the only times they interact with the staff. Roos uses a wheelchair and rarely speaks. She sleeps much of the day.\u003c/p>\n\u003cp>\"There is not much [Marilou] can participate in,\" says Vladimir Kaplun, former coordinator of the secure memory floor. \"When she spends some time with the babies, she wakes up and she brightens up.\"\u003c/p>\n\u003cp>On a recent day, caregiver Jessica Butler sits next to Roos, who holds a doll against her chest and pats her on the back. She kisses the doll twice.\u003c/p>\n\u003cp>\"The baby's beautiful like you,\" Butler says.\u003c/p>\n\u003cp>\"It's a boy,\" Roos says. \"Five months.\"\u003c/p>\n\u003cp>Caring for the dolls is second nature to Roos, who made a career of being a mom to five children, according to her daughter, Ellen Swarts.\u003c/p>\n\u003cp>It's been difficult for Swarts to watch the decline of her mother, who hasn't called her by name in over a year. Watching her with the dolls helps, Swarts says.\u003c/p>\n\u003cp>\"To see the light in her eyes when she has a baby in her arms, I don't care if it's real or if it's pretending,\" she said. \"If that gives her comfort, I am a-OK with it.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003ca href=\"http://www.kaiserhealthnews.org/\">\u003cem>Kaiser Health News\u003c/em>\u003c/a>\u003cem> is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\">Kaiser Health News\u003c/a>.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Doll+Therapy+May+Help+Calm+People+With+Dementia%2C+But+It+Has+Critics&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Sitting beside a neatly made crib, 88-year-old Vivian Guzofsky holds up a baby doll dressed in puppy dog pajamas.\u003c/p>\n\u003cp>\"Hello gorgeous,\" she says, laughing. \"You're so cute.\"\u003c/p>\n\u003caside class=\"pullquote alignright\">Supporters of doll therapy for dementia patients say it can lessen distress, improve communication and reduce the need for psychotropic medication. Critics say the dolls are demeaning and infantilize seniors.\u003c/aside>\n\u003cp>Guzofsky, who has Alzheimer's disease, lives on a secure memory floor at a home for seniors in Beverly Hills, Calif. She visits the dolls in the home's pretend nursery nearly every day. Sometimes Guzofsky changes their clothes or lays them down for a nap. One morning in August, she sings to them: \"You are my sunshine, my only sunshine. You make me happy when skies are gray.\"\u003c/p>\n\u003cp>No one knows whether she believes she is holding a doll or a real baby. What the staff at Sunrise Senior Living do know is that Guzofsky, who can get agitated and aggressive, is always calm when caring for the dolls.\u003c/p>\n\u003cp>Doll therapy is catching on at nursing homes and other senior facilities across the country. It's used to help ease anxiety among residents with \u003ca href=\"http://www.ninds.nih.gov/disorders/dementias/dementia.htm\">dementia,\u003c/a> who can experience personality changes, agitation and aggression. But the therapy is controversial.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Supporters say the dolls can lessen distress, improve communication and reduce the need for psychotropic medication. Critics say the dolls are demeaning and infantilize seniors.\u003c/p>\n\u003cp>Typically, caregivers will give residents the option of holding, changing or dressing the dolls, without saying whether the dolls are babies or toys. Caregivers may also use the dolls to start conversations about the residents' own children or grandchildren.\u003c/p>\n\u003cp>Care providers who use the technique say the dolls help engage elderly people who are no longer able to participate in many activities.\u003c/p>\n\u003cp>\"A lot of people with Alzheimer's are bored and may become depressed or agitated or unhappy because they aren't engaged,\" says Ruth Drew, director of family & information services at the \u003ca href=\"http://www.alz.org/\">Alzheimer's Association\u003c/a>.\u003c/p>\n\u003cp>Caregivers aren't trying to make their charges believe the dolls are real infants, Drew says. They are just \"trying to meet them where they are and communicate with them in a way that makes sense to them,\" she says.\u003c/p>\n\u003cp>But some care providers do not like the technique.\u003c/p>\n\u003cp>\"They are adults and we want to treat them like adults,\" says Stephanie Zeverino, who works in community relations at a Belmont Village center in Los Angeles. \"These are very well-educated residents.\"\u003c/p>\n\u003cp>Staff members there work with residents to play brain games that promote critical thinking, she says. And they use other types of therapy including art and music.\u003c/p>\n\u003cp>\"We want to provide a sense of dignity,\" Zeverino says.\u003c/p>\n\u003cfigure id=\"attachment_256787\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/dolls2.jpg\">\u003cimg class=\"size-full wp-image-256787\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/dolls2.jpg\" alt=\"Marilou Roos, 87, rarely speaks and sleeps much of the day. But caregiver Jessica Butler says Roos brightens up when caring for dolls.\" width=\"800\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/dolls2.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/dolls2-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/dolls2-768x576.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Marilou Roos, 87, rarely speaks and sleeps much of the day. But caregiver Jessica Butler says Roos brightens up when caring for dolls. \u003ccite>(eidi de Marco/Kaiser Health News)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003ca href=\"http://journal.frontiersin.org/article/10.3389/fpsyg.2014.00342/full\">Studies\u003c/a> on doll therapy are limited, but some \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/25160532\">research\u003c/a> has shown it can reduce the need for medications and lessen agitation, aggression and wandering.\u003c/p>\n\u003cp>\"Having the doll ... offers them an anchor or a sense of attachment in a time of uncertainty,\" says Gary Mitchell, a nurse specialist at Four Seasons Health Care facilities in Northern Ireland, and author of a new book: \u003cem>Doll Therapy in Dementia Care: Evidence and Practice.\u003c/em>\u003c/p>\n\u003cp>\"A lot of people associate the doll with their younger days and having people to care for,\" Mitchell says.\u003c/p>\n\u003cp>However, he acknowledges that doll therapy can perpetuate the stigma associated with dementia that caregivers are trying to get away from.\u003c/p>\n\u003cp>Some families worry about their relatives being laughed at when they engage in doll therapy, Mitchell says. He had the same concerns when he worked at a senior residential center. But when one resident requested that he allow her to continue caring for a doll, he saw the positive impact of the therapy. Mitchell says doll therapy should be used cautiously and more studies are needed.\u003c/p>\n\u003cp>At Sunrise Beverly Hills, the nursery is set up like a baby's room. A stuffed bear rests inside the wooden crib. On a shelf above are framed photos of Guzofsky and a few other women who regularly interact with the dolls. A few bottles, a Dr. Seuss book and diapers sit on a nearby changing table.\u003c/p>\n\u003cp>The nursery is just one of several areas designed to engage residents, says Rita Altman, senior vice president of memory care for Sunrise, which has facilities in the U.S., Canada and the United Kingdom. There are also art centers, offices, gardens and kitchens where residents may find familiar objects from their past.\u003c/p>\n\u003cp>Altman says the nurseries tend to attract residents who have an instinct to care for babies. Some people may not be able to talk anymore, but still find a sense of security with a doll, she says. \"You can read it in their body language when they pick up the doll.\"\u003c/p>\n\u003cp>Sunrise caregivers also use the dolls to spark conversations by asking questions: How many children do you have? Was your first baby a boy or a girl? What are the best things about being a mom?\u003c/p>\n\u003cp>The executive director of the Beverly Hills facility, \u003ca href=\"http://www.sunriseseniorliving.com/blog/october-2015/sunrises-jason-malone-wins-calas-outstanding-executive-director-award.aspx\">Jason Malone\u003c/a>, says he was skeptical about the use of dolls when he first heard about them.\u003c/p>\n\u003cp>\"I almost felt like we were being deceitful,\" he says. \"It didn't feel like it was real.\"\u003c/p>\n\u003cp>But he quickly changed his mind when he realized that staff could use the dolls respectfully.\u003c/p>\n\u003cp>\"We don't want to confuse treating our seniors as children,\" Malone says. \"That's not what this activity is truly about.\"\u003c/p>\n\u003cp>Guzofsky began caring for the dolls soon after moving into the facility. When asked what she likes about them, she says, \"I love babies. I have some very nice ones back where I live now.\"\u003c/p>\n\u003cp>Guzofsky's daughter, Carol Mizel, says her mom raised three children and volunteered extensively in Colorado and Mexico before being diagnosed with Alzheimer's about five years ago. Mizel doesn't see any downside to her mother caring for the dolls.\u003c/p>\n\u003cp>It is a \"creative way of dealing with her where she is now,\" she says.\u003c/p>\n\u003cp>For some residents, including 87-year-old Marilou Roos, holding the dolls is one of the only times they interact with the staff. Roos uses a wheelchair and rarely speaks. She sleeps much of the day.\u003c/p>\n\u003cp>\"There is not much [Marilou] can participate in,\" says Vladimir Kaplun, former coordinator of the secure memory floor. \"When she spends some time with the babies, she wakes up and she brightens up.\"\u003c/p>\n\u003cp>On a recent day, caregiver Jessica Butler sits next to Roos, who holds a doll against her chest and pats her on the back. She kisses the doll twice.\u003c/p>\n\u003cp>\"The baby's beautiful like you,\" Butler says.\u003c/p>\n\u003cp>\"It's a boy,\" Roos says. \"Five months.\"\u003c/p>\n\u003cp>Caring for the dolls is second nature to Roos, who made a career of being a mom to five children, according to her daughter, Ellen Swarts.\u003c/p>\n\u003cp>It's been difficult for Swarts to watch the decline of her mother, who hasn't called her by name in over a year. Watching her with the dolls helps, Swarts says.\u003c/p>\n\u003cp>\"To see the light in her eyes when she has a baby in her arms, I don't care if it's real or if it's pretending,\" she said. \"If that gives her comfort, I am a-OK with it.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"info": "What kind of no sabo word is Hyphenación? For us, it’s about living within a hyphenation. Like being a third-gen Mexican-American from the Texas border now living that Bay Area Chicano life. Like Xorje! Each week we bring together a couple of hyphenated Latinos to talk all about personal life choices: family, careers, relationships, belonging … everything is on the table. ",
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"info": "The Political Mind of Jerry Brown brings listeners the wisdom of the former Governor, Mayor, and presidential candidate. Scott Shafer interviewed Brown for more than 40 hours, covering the former governor's life and half-century in the political game – and Brown has some lessons he'd like to share. ",
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"marketplace": {
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"info": "Our flagship program, helmed by Kai Ryssdal, examines what the day in money delivered, through stories, conversations, newsworthy numbers and more. Updated Monday through Friday at about 3:30 p.m. PT.",
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"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>",
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"info": "For decades, the process for how police police themselves has been inconsistent – if not opaque. In some states, like California, these proceedings were completely hidden. After a new police transparency law unsealed scores of internal affairs files, our reporters set out to examine these cases and the shadow world of police discipline. On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. Is it the officers, or the public they've sworn to serve?",
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"info": "Our weekly podcast explores how the media 'sausage' is made, casts an incisive eye on fluctuations in the marketplace of ideas, and examines threats to the freedom of information and expression in America and abroad. For one hour a week, the show tries to lift the veil from the process of \"making media,\" especially news media, because it's through that lens that we see the world and the world sees us",
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"politicalbreakdown": {
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"title": "Political Breakdown",
"tagline": "Politics from a personal perspective",
"info": "Political Breakdown is a new series that explores the political intersection of California and the nation. Each week hosts Scott Shafer and Marisa Lagos are joined with a new special guest to unpack politics -- with personality — and offer an insider’s glimpse at how politics happens.",
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"possible": {
"id": "possible",
"title": "Possible",
"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
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"pri-the-world": {
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"title": "PRI's The World: Latest Edition",
"info": "Each weekday, host Marco Werman and his team of producers bring you the world's most interesting stories in an hour of radio that reminds us just how small our planet really is.",
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"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/The-World-Podcast-Tile-360x360-1.jpg",
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"radiolab": {
"id": "radiolab",
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"info": "A two-time Peabody Award-winner, Radiolab is an investigation told through sounds and stories, and centered around one big idea. In the Radiolab world, information sounds like music and science and culture collide. Hosted by Jad Abumrad and Robert Krulwich, the show is designed for listeners who demand skepticism, but appreciate wonder. WNYC Studios is the producer of other leading podcasts including Freakonomics Radio, Death, Sex & Money, On the Media and many more.",
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"reveal": {
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"info": "Created by The Center for Investigative Reporting and PRX, Reveal is public radios first one-hour weekly radio show and podcast dedicated to investigative reporting. Credible, fact based and without a partisan agenda, Reveal combines the power and artistry of driveway moment storytelling with data-rich reporting on critically important issues. The result is stories that inform and inspire, arming our listeners with information to right injustices, hold the powerful accountable and improve lives.Reveal is hosted by Al Letson and showcases the award-winning work of CIR and newsrooms large and small across the nation. In a radio and podcast market crowded with choices, Reveal focuses on important and often surprising stories that illuminate the world for our listeners.",
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},
"rightnowish": {
"id": "rightnowish",
"title": "Rightnowish",
"tagline": "Art is where you find it",
"info": "Rightnowish digs into life in the Bay Area right now… ish. Journalist Pendarvis Harshaw takes us to galleries painted on the sides of liquor stores in West Oakland. We'll dance in warehouses in the Bayview, make smoothies with kids in South Berkeley, and listen to classical music in a 1984 Cutlass Supreme in Richmond. Every week, Pen talks to movers and shakers about how the Bay Area shapes what they create, and how they shape the place we call home.",
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"order": 16
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},
"science-friday": {
"id": "science-friday",
"title": "Science Friday",
"info": "Science Friday is a weekly science talk show, broadcast live over public radio stations nationwide. Each week, the show focuses on science topics that are in the news and tries to bring an educated, balanced discussion to bear on the scientific issues at hand. Panels of expert guests join host Ira Flatow, a veteran science journalist, to discuss science and to take questions from listeners during the call-in portion of the program.",
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"snap-judgment": {
"id": "snap-judgment",
"title": "Snap Judgment",
"tagline": "Real stories with killer beats",
"info": "The Snap Judgment radio show and podcast mixes real stories with killer beats to produce cinematic, dramatic radio. Snap's musical brand of storytelling dares listeners to see the world through the eyes of another. This is storytelling... with a BEAT!! Snap first aired on public radio stations nationwide in July 2010. Today, Snap Judgment airs on over 450 public radio stations and is brought to the airwaves by KQED & PRX.",
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