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"content": "\u003cp>Patients with hepatitis C have yet another advanced treatment option, as the Food and Drug Administration on Thursday approved a new once-a-day pill developed by drugmaker Merck.\u003c/p>\n\u003cp>The FDA said Merck can begin marketing Zepatier for patients with two of the subtypes the liver-destroying virus, types 1 and 4. The combination pill includes the medications elbasvir and grazoprevir, which attack the virus in two different ways.\u003c/p>\n\u003cp>Merck & Co. said the price will be $54,600 for a 12-week treatment regimen. Insurers will likely still demand some discounts on that price.\u003c/p>\n\u003cp>The approval is good news for patients, because the growing competition should crimp the sky-high prices for hepatitis C drugs, and the additional option means there's one that will work for nearly every subgroup of people with hepatitis C.\u003c/p>\n\u003cp>[contextly_sidebar id=\"SdBBGkqABQOruS25weRmHsTLEh9KZIaJ\"]Roughly 3 million Americans and millions more in other countries have the blood-borne virus, which doesn't produce symptoms — jaundice, fluid accumulation in the abdomen, bleeding and infections — until significant damage has been done. Many develop liver cancer or cirrhosis and require a liver transplant, but die before a match is available.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>There are six genetic subtypes of the hepatitis C virus, and the five drugs now approved in the U.S. generally only treat some of those. Patients with both hepatitis C and HIV or another serious condition are particularly difficult to treat, as are those who already have severe liver or kidney damage. Some of the drugs target those patient groups; Merck's is approved for patients with cirrhosis, for example.\u003c/p>\n\u003cp>The five hepatitis C treatments all can cure 90 percent of patients or better in three months or less. By comparison, the prior generation of treatments took a year, barely cured half of patients and required both daily pills and frequent shots of immune-system stimulator interferon. That caused awful flu-like side effects many patients could not tolerate.\u003c/p>\n\u003cp>Merck's Zepatier was approved for treating patients with hepatitis C genotype 1, the most common type in the U.S., and gentopye 4, one of the least common. It was tested in a total of 1,373 patients, with or without liver cirrhosis.\u003c/p>\n\u003cp>Twelve weeks after treatment ended, 94 percent to 97 percent of those with genotype 1, and 97 percent to 100 percent of those with genotype 4, had no virus detectable in their blood, suggesting they'd been cured, according to the FDA.\u003c/p>\n\u003cp>The drug's side effects include fatigue, headache, nausea and problems with liver function.\u003c/p>\n\u003cp>The increasing competition will help insurers and other payers win bigger discounts from all the makers of hepatitis C drugs. That includes market leader Gilead Sciences Inc., which makes Harvoni and Sovaldi; AbbVie Inc., which makes Viekira Pak; Bristol-Myers Squibb Co., which makes Daklinza, and Merck.\u003c/p>\n\u003cp>Harvoni carries a list price of $94,000 for one course of treatment, but insurers have been getting discounts of about 45 percent off that to include the drug on their formulary of covered medicines. It's far and away the market leader.\u003c/p>\n\u003cp>Merck said the list price for Zepatier is in the range of what it believes are the net prices competitors are getting from payers.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Also on Thursday, Bristol-Myers said the European Union approved sales there for Daklinza, which won U.S. approval in 2004.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>There are six genetic subtypes of the hepatitis C virus, and the five drugs now approved in the U.S. generally only treat some of those. Patients with both hepatitis C and HIV or another serious condition are particularly difficult to treat, as are those who already have severe liver or kidney damage. Some of the drugs target those patient groups; Merck's is approved for patients with cirrhosis, for example.\u003c/p>\n\u003cp>The five hepatitis C treatments all can cure 90 percent of patients or better in three months or less. By comparison, the prior generation of treatments took a year, barely cured half of patients and required both daily pills and frequent shots of immune-system stimulator interferon. That caused awful flu-like side effects many patients could not tolerate.\u003c/p>\n\u003cp>Merck's Zepatier was approved for treating patients with hepatitis C genotype 1, the most common type in the U.S., and gentopye 4, one of the least common. It was tested in a total of 1,373 patients, with or without liver cirrhosis.\u003c/p>\n\u003cp>Twelve weeks after treatment ended, 94 percent to 97 percent of those with genotype 1, and 97 percent to 100 percent of those with genotype 4, had no virus detectable in their blood, suggesting they'd been cured, according to the FDA.\u003c/p>\n\u003cp>The drug's side effects include fatigue, headache, nausea and problems with liver function.\u003c/p>\n\u003cp>The increasing competition will help insurers and other payers win bigger discounts from all the makers of hepatitis C drugs. That includes market leader Gilead Sciences Inc., which makes Harvoni and Sovaldi; AbbVie Inc., which makes Viekira Pak; Bristol-Myers Squibb Co., which makes Daklinza, and Merck.\u003c/p>\n\u003cp>Harvoni carries a list price of $94,000 for one course of treatment, but insurers have been getting discounts of about 45 percent off that to include the drug on their formulary of covered medicines. It's far and away the market leader.\u003c/p>\n\u003cp>Merck said the list price for Zepatier is in the range of what it believes are the net prices competitors are getting from payers.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Also on Thursday, Bristol-Myers said the European Union approved sales there for Daklinza, which won U.S. approval in 2004.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>\u003cstrong>Update Friday, Jan. 29\u003c/strong>: On Thursday, health insurer Capital BlueCross said beleaguered blood-testing company Theranos would stop drawing blood at the insurer's retail store in Enola, Pa., according to \u003ca href=\"http://www.wsj.com/articles/theranos-stops-drawing-blood-from-patients-at-capital-bluecross-pennsylvania-store-1454093470\" target=\"_blank\">The Wall Street Journal\u003c/a> and \u003ca href=\"http://www.pennlive.com/news/2016/01/capital_blue_steps_back_from_e.html\" target=\"_blank\">local reports\u003c/a>.\u003c/p>\n\u003cp>That move came on the same day that Walgreens suspended Theranos services at its Palo Alto, Calif., store and told Theranos to stop sending blood samples taken at any Walgreens to Theranos' Newark lab for testing. That lab was found to be deficient in a way that put patients in \"immediate jeopardy,\" according to the Centers for Medicare & Medicaid Services, which conducted an inspection last fall.\u003c/p>\n\u003cp>\u003cem>Original post\u003c/em>\u003cbr>\nWalgreens is suspending Theranos Lab services at the drugstore chain's outlet in Palo Alto, Calif. (also known as Theranos' hometown). Early Theranos-adopter Walgreens also told the company to \"\u003ca href=\"http://news.walgreens.com/press-releases/general-news/walgreens-informs-theranos-to-cease-use-of-its-newark-calif-lab-for-blood-test-analysis.htm\" target=\"_blank\">immediately cease\u003c/a>\" sending blood samples collected at Walgreens stores to Theranos' Newark, Calif. lab, which the government found out-of-compliance with standards.\u003c/p>\n\u003cp>The Centers for Medicare & Medicaid Services, the agency that conducted the inspection of the Newark lab last fall, said the facility was deficient in a way that puts patients in \"immediate jeopardy.\"\u003c/p>\n\u003cp>According to the agency, that term is defined as “a situation in which immediate corrective action is necessary because the laboratory’s non-compliance … has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Walgreens had offered Theranos' FDA-approved blood test for herpes at the Palo Alto drugstore. An employee there says, with the suspension, the Palo Alto outlet is currently not offering any blood testing.\u003c/p>\n\u003cp>The drugstore chain also says it will require blood samples collected at other stores to be sent to Theranos' certified Arizona lab, or to an accredited outside lab. Theranos has several dozen facilities located in Walgreens outlets in Arizona.\u003c/p>\n\u003cp>Theranos responded to news of the CMS findings by stating that the agency's inspection took place last year, and that the report doesn't reflect current practices. The Silicon Valley company also said it is taking corrective steps. Theranos Vice President of Communications Brooke Buchanan said in an email statement today that, \"We look forward to continuing to work with Walgreens to provide access to reliable, high quality, and low-cost lab testing services.\"\u003c/p>\n\u003cp>She also said the company would fix \"quickly and completely\" the one issue -- related to hematology -- that resulted in the \"immediate jeopardy\" characterization.\u003c/p>\n\u003cp>We asked Buchanan how Theranos planned to address the CMS mandate that it identify and take \"corrective action\" for patients who have been potentially affected by the problems at the lab.\u003c/p>\n\u003cp>\"We are developing our corrective action plan and that is part of the plan,\" she said.\u003c/p>\n\u003cp>Founded by CEO Elizabeth Holmes, Theranos has raised millions by pitching its technology as a cheaper, faster way to run dozens of blood tests.\u003c/p>\n\u003cp>Deerfield, Illinois-based Walgreens said no patient samples will be sent to the Newark lab until the issues raised by CMS have been resolved.\u003c/p>\n\u003cp>Any pulling back by Walgreens could be a serious blow to Theranos, once a Silicon Valley darling that seemed poise to disrupt the blood-testing industry. Over the past several months, however, the company has suffered the slings and arrows of The Wall Street Journal, which has published a string of negative stories casting doubts on Theranos' proprietary blood-testing technology.\u003c/p>\n\u003cp>\u003ca href=\"http://www.bloomberg.com/news/articles/2016-01-28/walgreens-halts-use-of-theranos-california-lab-after-u-s-report?cmpid=twtr1\" target=\"_blank\">Bloomberg\u003c/a> characterized the partnership between Walgreens and the secretive Theranos as \"the most public evidence of Theranos's promise of providing quicker and cheaper lab testing.\"\u003c/p>\n\u003cp>Bloomberg is also reporting that the Cleveland Clinic and Intermountain Healthcare, both of which Theranos hoped would evaluate its technology, are balking:\u003c/p>\n\u003cblockquote>\u003cp>Theranos had asked the Cleveland Clinic, a prominent research hospital, to run a study comparing Theranos’s technology to traditional blood draw, Holmes has said.\u003c/p>\n\u003cp>The Cleveland Clinic, however, said Wednesday that it had started no such program.\u003c/p>\n\u003cp>“The Cleveland Clinic has not begun any work related to the study at this time,” spokeswoman Eileen Sheil said Wednesday. “We are not consultants, nor do we have any financial investments in the company. ..”\u003c/p>\n\u003cp>Intermountain Healthcare, a 22-hospital system based in Utah, said in October that it was planning to run a pilot program with Theranos technology, to be used alongside traditional blood testing for comparison.\u003c/p>\n\u003cp>Intermountain hasn’t used Theranos’s technology yet, according to spokesman Daron Cowley. “We have not yet scheduled a possible pilot” study, Cowley said Wednesday in an e-mail. “We’ll certainly evaluate this and all information before beginning a pilot.”\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Associated Press contributed to this report.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cstrong>Update Friday, Jan. 29\u003c/strong>: On Thursday, health insurer Capital BlueCross said beleaguered blood-testing company Theranos would stop drawing blood at the insurer's retail store in Enola, Pa., according to \u003ca href=\"http://www.wsj.com/articles/theranos-stops-drawing-blood-from-patients-at-capital-bluecross-pennsylvania-store-1454093470\" target=\"_blank\">The Wall Street Journal\u003c/a> and \u003ca href=\"http://www.pennlive.com/news/2016/01/capital_blue_steps_back_from_e.html\" target=\"_blank\">local reports\u003c/a>.\u003c/p>\n\u003cp>That move came on the same day that Walgreens suspended Theranos services at its Palo Alto, Calif., store and told Theranos to stop sending blood samples taken at any Walgreens to Theranos' Newark lab for testing. That lab was found to be deficient in a way that put patients in \"immediate jeopardy,\" according to the Centers for Medicare & Medicaid Services, which conducted an inspection last fall.\u003c/p>\n\u003cp>\u003cem>Original post\u003c/em>\u003cbr>\nWalgreens is suspending Theranos Lab services at the drugstore chain's outlet in Palo Alto, Calif. (also known as Theranos' hometown). Early Theranos-adopter Walgreens also told the company to \"\u003ca href=\"http://news.walgreens.com/press-releases/general-news/walgreens-informs-theranos-to-cease-use-of-its-newark-calif-lab-for-blood-test-analysis.htm\" target=\"_blank\">immediately cease\u003c/a>\" sending blood samples collected at Walgreens stores to Theranos' Newark, Calif. lab, which the government found out-of-compliance with standards.\u003c/p>\n\u003cp>The Centers for Medicare & Medicaid Services, the agency that conducted the inspection of the Newark lab last fall, said the facility was deficient in a way that puts patients in \"immediate jeopardy.\"\u003c/p>\n\u003cp>According to the agency, that term is defined as “a situation in which immediate corrective action is necessary because the laboratory’s non-compliance … has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Walgreens had offered Theranos' FDA-approved blood test for herpes at the Palo Alto drugstore. An employee there says, with the suspension, the Palo Alto outlet is currently not offering any blood testing.\u003c/p>\n\u003cp>The drugstore chain also says it will require blood samples collected at other stores to be sent to Theranos' certified Arizona lab, or to an accredited outside lab. Theranos has several dozen facilities located in Walgreens outlets in Arizona.\u003c/p>\n\u003cp>Theranos responded to news of the CMS findings by stating that the agency's inspection took place last year, and that the report doesn't reflect current practices. The Silicon Valley company also said it is taking corrective steps. Theranos Vice President of Communications Brooke Buchanan said in an email statement today that, \"We look forward to continuing to work with Walgreens to provide access to reliable, high quality, and low-cost lab testing services.\"\u003c/p>\n\u003cp>She also said the company would fix \"quickly and completely\" the one issue -- related to hematology -- that resulted in the \"immediate jeopardy\" characterization.\u003c/p>\n\u003cp>We asked Buchanan how Theranos planned to address the CMS mandate that it identify and take \"corrective action\" for patients who have been potentially affected by the problems at the lab.\u003c/p>\n\u003cp>\"We are developing our corrective action plan and that is part of the plan,\" she said.\u003c/p>\n\u003cp>Founded by CEO Elizabeth Holmes, Theranos has raised millions by pitching its technology as a cheaper, faster way to run dozens of blood tests.\u003c/p>\n\u003cp>Deerfield, Illinois-based Walgreens said no patient samples will be sent to the Newark lab until the issues raised by CMS have been resolved.\u003c/p>\n\u003cp>Any pulling back by Walgreens could be a serious blow to Theranos, once a Silicon Valley darling that seemed poise to disrupt the blood-testing industry. Over the past several months, however, the company has suffered the slings and arrows of The Wall Street Journal, which has published a string of negative stories casting doubts on Theranos' proprietary blood-testing technology.\u003c/p>\n\u003cp>\u003ca href=\"http://www.bloomberg.com/news/articles/2016-01-28/walgreens-halts-use-of-theranos-california-lab-after-u-s-report?cmpid=twtr1\" target=\"_blank\">Bloomberg\u003c/a> characterized the partnership between Walgreens and the secretive Theranos as \"the most public evidence of Theranos's promise of providing quicker and cheaper lab testing.\"\u003c/p>\n\u003cp>Bloomberg is also reporting that the Cleveland Clinic and Intermountain Healthcare, both of which Theranos hoped would evaluate its technology, are balking:\u003c/p>\n\u003cblockquote>\u003cp>Theranos had asked the Cleveland Clinic, a prominent research hospital, to run a study comparing Theranos’s technology to traditional blood draw, Holmes has said.\u003c/p>\n\u003cp>The Cleveland Clinic, however, said Wednesday that it had started no such program.\u003c/p>\n\u003cp>“The Cleveland Clinic has not begun any work related to the study at this time,” spokeswoman Eileen Sheil said Wednesday. “We are not consultants, nor do we have any financial investments in the company. ..”\u003c/p>\n\u003cp>Intermountain Healthcare, a 22-hospital system based in Utah, said in October that it was planning to run a pilot program with Theranos technology, to be used alongside traditional blood testing for comparison.\u003c/p>\n\u003cp>Intermountain hasn’t used Theranos’s technology yet, according to spokesman Daron Cowley. “We have not yet scheduled a possible pilot” study, Cowley said Wednesday in an e-mail. “We’ll certainly evaluate this and all information before beginning a pilot.”\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Associated Press contributed to this report.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "A Schizophrenic's Poignant Journey -- All Told on YouTube",
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"content": "\u003cp>When she was 22, Rachel Star Withers uploaded a video to YouTube called \"Normal: Living With Schizophrenia.\" It starts with her striding across her family's property in Fort Mill, S.C. She looks across the rolling grounds, unsmiling. Her eyes are narrow and grim.\u003c/p>\n\u003cp>She sits down in front of a deserted white cottage and starts sharing. \"I see monsters. I see myself chopped up and bloody a lot. Sometimes I'll be walking, and the whole room will just tilt. Like this,\" she grasps the camera and jerks the frame crooked. She surfaces a fleeting grin. \"Try and imagine walking.\"\u003c/p>\n\u003cp>She becomes serious again. \"I'm making this because I don't want you to feel alone, whether you're struggling with any kind of mental illness or just struggling.\"\u003c/p>\n\u003cp>At the time, 2008, there were very few people who had done anything like this online. \"As I got diagnosed [with schizophrenia], I started researching everything. The only stuff I could find was like every horror movie,\" she says. \"I felt so alone for years.\"\u003c/p>\n\u003cp>She decided that schizophrenia was really not that scary. \"I want people to find me and see a real person.\" Over the past eight years, she has made 53 videos documenting her journey with schizophrenia and depression, and her therapy. And she is not the only one. There are hundreds of videos online of people publicly sharing their experiences with mental illness.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>In her early videos, Withers glowers. She tried to give off an aura of toughness befitting the daughter of a Hell's Angel biker. But there's also a sense that terror is a deep undercurrent in her life. \"All right, let's go,\" she says in the video \"Watch If You Forget,\" where she documents getting electroconvulsive therapy for depression. Then, in the next few seconds, \"I'm about to start the electroshock therapy and, yeah, I'm pretty nervous.\"\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=Q47ZtLI4Huc\u003c/p>\n\u003cp>Things have changed a lot since then. Now, almost all her videos open with Withers flicking her black curls, arms raised with swagger: \"Hey, what's up! I'm Rachel Star!\"\u003c/p>\n\u003cp>\u003cstrong>Millenials More Comfortable Sharing Mental Health Issues\u003c/strong>\u003c/p>\n\u003cp>That public sharing of mental illness might be making a huge impact on the way our society views these disorders, especially for those of us who are digital natives. Millennials tend to be more comfortable talking about mental health issues, according to a \u003ca href=\"http://www.adaa.org/college-aged-adults-face-less-mental-health-stigma\">poll\u003c/a> released Jan. 14 by the Anxiety and Depression Association of America, along with two national suicide prevention foundations.\u003c/p>\n\u003cp>When it came to seeing a mental health professional, for instance, 48 percent of survey respondents between the ages of 18 and 34 said that it was a sign of strength. About 35 percent of all prior generations felt the same way.\u003c/p>\n\u003cp>\"Our young people are accepting that mental health problems exist, and they want help for it, and they are not looking at these things as something to be ashamed of,\" says \u003ca href=\"http://asp.cumc.columbia.edu/facdb/profile_list.asp?uni=aa2289&DepAffil=NYSPI\">Anne Marie Albano\u003c/a>, a clinical psychologist at Columbia University who is on the board for the ADAA.\u003c/p>\n\u003cp>She thinks that social media and videos like Withers' have helped lower stigma around mental illnesses. \"Young people take advantage of this,\" Albano says. \"It gives the opportunity for people to tell their stories and post images. This allows them to feel more hope than prior generations.\"\u003c/p>\n\u003cp>\u003cimg class=\"alignnone size-medium wp-image-104496\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/poll-800x368.jpg\" alt=\"poll\" width=\"800\" height=\"368\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/poll-800x368.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/poll-400x184.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/poll-768x353.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/poll.jpg 824w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/p>\n\u003cp>There might be other reasons young people are less concerned about stigma surrounding mental illness. Perhaps as you age, your outlook becomes more pessimistic, says \u003ca href=\"http://tdi.dartmouth.edu/faculty/staff-directory/staff-bios/john-naslund\">John Naslund\u003c/a>, a Ph.D. candidate at the Dartmouth Institute for Health Policy and Clinical Practice who studies social media and mental health. He notes that the ADAA poll found that a higher percentage of older adults than young people didn't believe that something like suicide could be prevented. \"Maybe they've been through this before and have had people close to them take their own lives.\"\u003c/p>\n\u003cp>He hopes things really are getting better. \"It's very possible. That would be a very exciting change in the way society views mental illness,\" Naslund says. But the problem has not been solved. Even if information moves quickly, change is slow. \"It's really important to acknowledge that people who have a serious mental disorder still face a lot of stigma,\" he says.\u003c/p>\n\u003cp>\u003cstrong>\"I Felt Like a Freak\"\u003c/strong>\u003c/p>\n\u003cp>When she was younger, Withers struggled with a lot of shame and humiliation over her disorders. \"For so many years, I felt like a freak,\" she says. Part of that was the religious community she had joined. \"Think militant Christian. Like a militaristic type,\" she says. When she was 17, she graduated from high school early to attend the former Teen Mania Ministries Honor Academy in Dallas. \"I honestly thought that's what God wanted me to do.\"\u003c/p>\n\u003cp>At the same time, her mental condition was deteriorating. She says her schizophrenia was starting to emerge and transform into something unmanageable. The counselor at Honor Academy diagnosed her with depression and prescribed pills. They didn't help. Eventually she told them about her hallucinations. \"This being a Christian place, they decided I was possessed by demons.\"\u003c/p>\n\u003cp>For three days, Withers fasted. Each morning, she met three of the school's spiritual advisers, and they spent the day performing an exorcism in a closed room. They read Bible verses, and Withers confessed to everything she could think of that might be construed as a sin — even watching demon-related TV shows like \u003cem>Buffy The Vampire Slayer.\u003c/em>\u003c/p>\n\u003cp>At the end of the crucible, Withers was on the floor, exhausted. \"I was young and here are these people who, you know, I'm told are close to God. I was like ... OK. It must be right,\" she says. \"Surprise! It didn't work. I spent six more months there as an outcast.\"\u003c/p>\n\u003cp>Reducing this kind of stigma is a fundamental reason Withers continues making videos. She wants others to see those struggling with mental disorders with more compassion, and she wants people with a mental diagnosis to see themselves more positively.\u003c/p>\n\u003cp>\u003cimg class=\"alignnone size-full wp-image-104494\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/blacksnaky.jpg\" alt=\"blacksnaky\" width=\"618\" height=\"347\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/blacksnaky.jpg 618w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/blacksnaky-400x225.jpg 400w\" sizes=\"(max-width: 618px) 100vw, 618px\">\u003c/p>\n\u003cp>\u003cstrong>An Online Community\u003c/strong>\u003c/p>\n\u003cp>After she posted her first video, Withers says, \"People just come out of the woodwork emailing me, messaging me. The friends I've had the longest time, even people I've never met in real life with schizophrenia and like disorders. We just started talking.\" She got invited to mental health forums and to mental health support groups on Facebook.\u003c/p>\n\u003cp>\"Thank you for these videos. They really help me to better understand my sister,\" YouTube user Kathryn Hatzenbuhler posted under one video.\u003c/p>\n\u003cp>These online communities are an important part of Withers' life now. \"Whenever I'm posting on Twitter, I'll put #schizophrenia and #schizophrenic. I'm hoping to find other people who are having problems,\" she says.\u003c/p>\n\u003cp>Withers ended up making a coloring book for kids with schizophrenia, and she shares ways she has figured out to deal with her visions and voices.\u003c/p>\n\u003cp>Via webcam, she showed me two askew mirrors in her room that can be angled away from the viewer. \"People with mental disorders don't do well with mirrors. I just start hallucinating,\" she says. \"It's real hard putting on makeup, you have to imagine. Having the mirrors at an angle helps.\"\u003c/p>\n\u003cp>In one video, she talks about walking up to one of her hallucinations to touch it, and that alone took away some of the fear. \"It's kind of something to help you get used to your hallucinations, so you know how to respond, because the voices are always horrible. The voices are never like, 'Oh my God, you look so good today.' \"\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=v13xt0NvzBA\u003c/p>\n\u003cp>There's no hiding her disorder from anybody on Facebook, so people she knew in real life started finding out. It caused her pain at some jobs (\"This one girl was like, 'Oh she's crazy. I'm not working with her.' \"), but it also led some people to talk about their own or their family's experiences with mental disorder. \"They'll be like, 'So ... I saw your post, Rachel. I had a question.' \"\u003c/p>\n\u003cp>Researchers think there's a potential gold mine of mental health benefits in exchanging messages and encouragement online like this. \"Social support is always the No. 1 variable that predicts a better prognosis and better care management of anyone's illness,\" Albano says.\u003c/p>\n\u003cp>\u003cstrong>Effect of Social Media \u003c/strong>\u003c/p>\n\u003cp>It's a small leap from there to think that participating in mental health-focused communities on YouTube and Facebook might actually be making people healthier and preventing suicides. \"That's probably absolutely correct,\" says \u003ca href=\"https://humansciences.iit.edu/faculty/patrick-corrigan\">Patrick Corrigan\u003c/a>, a professor of psychology at the Illinois Institute of Technology. But scientists are only just now beginning to measure the effect social media might have on clinical outcomes. \"It's quite a new area of thinking, online peer-to-peer support for mental illness,\" Naslund says.\u003c/p>\n\u003cp>But there's an obvious downside to being public on social media about mental health problems. \"Say I have a network of friends and I have a breakdown one day. It will spread through social media, maybe in negative ways,\" says \u003ca href=\"http://socialwork.nyu.edu/our-faculty/full-time/michael-lindsey.html\">Michael Lindsey\u003c/a>, a professor of social work at New York University. That could be through someone's real social groups, like at work or school, or it could be anonymous, via Internet trolls. For those already depressed, anxious or paranoid, cruel comments and messages could have a terrible impact.\u003c/p>\n\u003cp>But in Naslund's research, he says that problems with online attacks have been extraordinarily rare. \"If someone did post a derogatory comment, seemed a little harmful, other people would come to the defense and say, 'Don't listen to that,' \" he says. \"[Social media are] way more supportive than we imagined.\"\u003c/p>\n\u003cp>According to Naslund, the benefits seem to vastly outweigh the harms. \"That's clear in the literature,\" he says.\u003c/p>\n\u003cp>And Withers agrees. She doesn't think that people with mental health problems usually go on social media and spiral out of control even more. \"I'm sure it happens somewhere on some area of the Internet,\" she says. \"But I think usually when I'm feeling depressed and stuff, but then I see someone else thinking of hurting themselves, the opposite kicks in. It's like, no. You have so much to live for. You're able to pull yourself out in a way to help someone else.\"\u003c/p>\n\u003cp>When Withers does get trolls, she blocks them. \"Anything remotely violent towards me gets blocked,\" she says. \"Like — I'm not going to respond to that. Don't call me that word.\"\u003c/p>\n\u003cp>\u003cstrong>A Note of Caution\u003c/strong>\u003c/p>\n\u003cp>Still, she cautions others to think carefully before coming out to the world about their mental illness. It can be dangerous, she admits. She says she gets phone stalkers and death threats. But she is still glad that she did it. It's uncomfortable for her to think what might have happened if she never went online about her depression and schizophrenia. \"I see myself being a lot more closed off,\" she says. \"I hope I would have found other people's videos.\"\u003c/p>\n\u003cp>Withers attributes a lot of her transformation to \u003ca href=\"https://www.nlm.nih.gov/medlineplus/ency/article/007474.htm\">electroconvulsive therapy\u003c/a>. She says it knocked out a lot of her deep depression. And Withers thinks sharing on the Internet has also helped. \"It helps me to vocalize it and put it all out there,\" she says, and it makes her feel like she is less \"broken and sick\" when other users empathize with her online.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=HbnEBfW0UDs\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Recently, she posted a video to YouTube called \"There Will Be Beautiful Days.\" It's short, reaching just past a minute long. Withers smiles and says she knows things are hard now. Maybe harder than they've ever been. But it's going to be OK. And at some point, you'll have some good days. Maybe even just one great day, but it'll be enough. It will make life worth fighting for.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>When she was 22, Rachel Star Withers uploaded a video to YouTube called \"Normal: Living With Schizophrenia.\" It starts with her striding across her family's property in Fort Mill, S.C. She looks across the rolling grounds, unsmiling. Her eyes are narrow and grim.\u003c/p>\n\u003cp>She sits down in front of a deserted white cottage and starts sharing. \"I see monsters. I see myself chopped up and bloody a lot. Sometimes I'll be walking, and the whole room will just tilt. Like this,\" she grasps the camera and jerks the frame crooked. She surfaces a fleeting grin. \"Try and imagine walking.\"\u003c/p>\n\u003cp>She becomes serious again. \"I'm making this because I don't want you to feel alone, whether you're struggling with any kind of mental illness or just struggling.\"\u003c/p>\n\u003cp>At the time, 2008, there were very few people who had done anything like this online. \"As I got diagnosed [with schizophrenia], I started researching everything. The only stuff I could find was like every horror movie,\" she says. \"I felt so alone for years.\"\u003c/p>\n\u003cp>She decided that schizophrenia was really not that scary. \"I want people to find me and see a real person.\" Over the past eight years, she has made 53 videos documenting her journey with schizophrenia and depression, and her therapy. And she is not the only one. There are hundreds of videos online of people publicly sharing their experiences 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>In her early videos, Withers glowers. She tried to give off an aura of toughness befitting the daughter of a Hell's Angel biker. But there's also a sense that terror is a deep undercurrent in her life. \"All right, let's go,\" she says in the video \"Watch If You Forget,\" where she documents getting electroconvulsive therapy for depression. Then, in the next few seconds, \"I'm about to start the electroshock therapy and, yeah, I'm pretty nervous.\"\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/Q47ZtLI4Huc'\n title='//www.youtube.com/embed/Q47ZtLI4Huc'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Things have changed a lot since then. Now, almost all her videos open with Withers flicking her black curls, arms raised with swagger: \"Hey, what's up! I'm Rachel Star!\"\u003c/p>\n\u003cp>\u003cstrong>Millenials More Comfortable Sharing Mental Health Issues\u003c/strong>\u003c/p>\n\u003cp>That public sharing of mental illness might be making a huge impact on the way our society views these disorders, especially for those of us who are digital natives. Millennials tend to be more comfortable talking about mental health issues, according to a \u003ca href=\"http://www.adaa.org/college-aged-adults-face-less-mental-health-stigma\">poll\u003c/a> released Jan. 14 by the Anxiety and Depression Association of America, along with two national suicide prevention foundations.\u003c/p>\n\u003cp>When it came to seeing a mental health professional, for instance, 48 percent of survey respondents between the ages of 18 and 34 said that it was a sign of strength. About 35 percent of all prior generations felt the same way.\u003c/p>\n\u003cp>\"Our young people are accepting that mental health problems exist, and they want help for it, and they are not looking at these things as something to be ashamed of,\" says \u003ca href=\"http://asp.cumc.columbia.edu/facdb/profile_list.asp?uni=aa2289&DepAffil=NYSPI\">Anne Marie Albano\u003c/a>, a clinical psychologist at Columbia University who is on the board for the ADAA.\u003c/p>\n\u003cp>She thinks that social media and videos like Withers' have helped lower stigma around mental illnesses. \"Young people take advantage of this,\" Albano says. \"It gives the opportunity for people to tell their stories and post images. This allows them to feel more hope than prior generations.\"\u003c/p>\n\u003cp>\u003cimg class=\"alignnone size-medium wp-image-104496\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/poll-800x368.jpg\" alt=\"poll\" width=\"800\" height=\"368\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/poll-800x368.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/poll-400x184.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/poll-768x353.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/poll.jpg 824w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/p>\n\u003cp>There might be other reasons young people are less concerned about stigma surrounding mental illness. Perhaps as you age, your outlook becomes more pessimistic, says \u003ca href=\"http://tdi.dartmouth.edu/faculty/staff-directory/staff-bios/john-naslund\">John Naslund\u003c/a>, a Ph.D. candidate at the Dartmouth Institute for Health Policy and Clinical Practice who studies social media and mental health. He notes that the ADAA poll found that a higher percentage of older adults than young people didn't believe that something like suicide could be prevented. \"Maybe they've been through this before and have had people close to them take their own lives.\"\u003c/p>\n\u003cp>He hopes things really are getting better. \"It's very possible. That would be a very exciting change in the way society views mental illness,\" Naslund says. But the problem has not been solved. Even if information moves quickly, change is slow. \"It's really important to acknowledge that people who have a serious mental disorder still face a lot of stigma,\" he says.\u003c/p>\n\u003cp>\u003cstrong>\"I Felt Like a Freak\"\u003c/strong>\u003c/p>\n\u003cp>When she was younger, Withers struggled with a lot of shame and humiliation over her disorders. \"For so many years, I felt like a freak,\" she says. Part of that was the religious community she had joined. \"Think militant Christian. Like a militaristic type,\" she says. When she was 17, she graduated from high school early to attend the former Teen Mania Ministries Honor Academy in Dallas. \"I honestly thought that's what God wanted me to do.\"\u003c/p>\n\u003cp>At the same time, her mental condition was deteriorating. She says her schizophrenia was starting to emerge and transform into something unmanageable. The counselor at Honor Academy diagnosed her with depression and prescribed pills. They didn't help. Eventually she told them about her hallucinations. \"This being a Christian place, they decided I was possessed by demons.\"\u003c/p>\n\u003cp>For three days, Withers fasted. Each morning, she met three of the school's spiritual advisers, and they spent the day performing an exorcism in a closed room. They read Bible verses, and Withers confessed to everything she could think of that might be construed as a sin — even watching demon-related TV shows like \u003cem>Buffy The Vampire Slayer.\u003c/em>\u003c/p>\n\u003cp>At the end of the crucible, Withers was on the floor, exhausted. \"I was young and here are these people who, you know, I'm told are close to God. I was like ... OK. It must be right,\" she says. \"Surprise! It didn't work. I spent six more months there as an outcast.\"\u003c/p>\n\u003cp>Reducing this kind of stigma is a fundamental reason Withers continues making videos. She wants others to see those struggling with mental disorders with more compassion, and she wants people with a mental diagnosis to see themselves more positively.\u003c/p>\n\u003cp>\u003cimg class=\"alignnone size-full wp-image-104494\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/blacksnaky.jpg\" alt=\"blacksnaky\" width=\"618\" height=\"347\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/blacksnaky.jpg 618w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/blacksnaky-400x225.jpg 400w\" sizes=\"(max-width: 618px) 100vw, 618px\">\u003c/p>\n\u003cp>\u003cstrong>An Online Community\u003c/strong>\u003c/p>\n\u003cp>After she posted her first video, Withers says, \"People just come out of the woodwork emailing me, messaging me. The friends I've had the longest time, even people I've never met in real life with schizophrenia and like disorders. We just started talking.\" She got invited to mental health forums and to mental health support groups on Facebook.\u003c/p>\n\u003cp>\"Thank you for these videos. They really help me to better understand my sister,\" YouTube user Kathryn Hatzenbuhler posted under one video.\u003c/p>\n\u003cp>These online communities are an important part of Withers' life now. \"Whenever I'm posting on Twitter, I'll put #schizophrenia and #schizophrenic. I'm hoping to find other people who are having problems,\" she says.\u003c/p>\n\u003cp>Withers ended up making a coloring book for kids with schizophrenia, and she shares ways she has figured out to deal with her visions and voices.\u003c/p>\n\u003cp>Via webcam, she showed me two askew mirrors in her room that can be angled away from the viewer. \"People with mental disorders don't do well with mirrors. I just start hallucinating,\" she says. \"It's real hard putting on makeup, you have to imagine. Having the mirrors at an angle helps.\"\u003c/p>\n\u003cp>In one video, she talks about walking up to one of her hallucinations to touch it, and that alone took away some of the fear. \"It's kind of something to help you get used to your hallucinations, so you know how to respond, because the voices are always horrible. The voices are never like, 'Oh my God, you look so good today.' \"\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/v13xt0NvzBA'\n title='//www.youtube.com/embed/v13xt0NvzBA'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>There's no hiding her disorder from anybody on Facebook, so people she knew in real life started finding out. It caused her pain at some jobs (\"This one girl was like, 'Oh she's crazy. I'm not working with her.' \"), but it also led some people to talk about their own or their family's experiences with mental disorder. \"They'll be like, 'So ... I saw your post, Rachel. I had a question.' \"\u003c/p>\n\u003cp>Researchers think there's a potential gold mine of mental health benefits in exchanging messages and encouragement online like this. \"Social support is always the No. 1 variable that predicts a better prognosis and better care management of anyone's illness,\" Albano says.\u003c/p>\n\u003cp>\u003cstrong>Effect of Social Media \u003c/strong>\u003c/p>\n\u003cp>It's a small leap from there to think that participating in mental health-focused communities on YouTube and Facebook might actually be making people healthier and preventing suicides. \"That's probably absolutely correct,\" says \u003ca href=\"https://humansciences.iit.edu/faculty/patrick-corrigan\">Patrick Corrigan\u003c/a>, a professor of psychology at the Illinois Institute of Technology. But scientists are only just now beginning to measure the effect social media might have on clinical outcomes. \"It's quite a new area of thinking, online peer-to-peer support for mental illness,\" Naslund says.\u003c/p>\n\u003cp>But there's an obvious downside to being public on social media about mental health problems. \"Say I have a network of friends and I have a breakdown one day. It will spread through social media, maybe in negative ways,\" says \u003ca href=\"http://socialwork.nyu.edu/our-faculty/full-time/michael-lindsey.html\">Michael Lindsey\u003c/a>, a professor of social work at New York University. That could be through someone's real social groups, like at work or school, or it could be anonymous, via Internet trolls. For those already depressed, anxious or paranoid, cruel comments and messages could have a terrible impact.\u003c/p>\n\u003cp>But in Naslund's research, he says that problems with online attacks have been extraordinarily rare. \"If someone did post a derogatory comment, seemed a little harmful, other people would come to the defense and say, 'Don't listen to that,' \" he says. \"[Social media are] way more supportive than we imagined.\"\u003c/p>\n\u003cp>According to Naslund, the benefits seem to vastly outweigh the harms. \"That's clear in the literature,\" he says.\u003c/p>\n\u003cp>And Withers agrees. She doesn't think that people with mental health problems usually go on social media and spiral out of control even more. \"I'm sure it happens somewhere on some area of the Internet,\" she says. \"But I think usually when I'm feeling depressed and stuff, but then I see someone else thinking of hurting themselves, the opposite kicks in. It's like, no. You have so much to live for. You're able to pull yourself out in a way to help someone else.\"\u003c/p>\n\u003cp>When Withers does get trolls, she blocks them. \"Anything remotely violent towards me gets blocked,\" she says. \"Like — I'm not going to respond to that. Don't call me that word.\"\u003c/p>\n\u003cp>\u003cstrong>A Note of Caution\u003c/strong>\u003c/p>\n\u003cp>Still, she cautions others to think carefully before coming out to the world about their mental illness. It can be dangerous, she admits. She says she gets phone stalkers and death threats. But she is still glad that she did it. It's uncomfortable for her to think what might have happened if she never went online about her depression and schizophrenia. \"I see myself being a lot more closed off,\" she says. \"I hope I would have found other people's videos.\"\u003c/p>\n\u003cp>Withers attributes a lot of her transformation to \u003ca href=\"https://www.nlm.nih.gov/medlineplus/ency/article/007474.htm\">electroconvulsive therapy\u003c/a>. She says it knocked out a lot of her deep depression. And Withers thinks sharing on the Internet has also helped. \"It helps me to vocalize it and put it all out there,\" she says, and it makes her feel like she is less \"broken and sick\" when other users empathize with her online.\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/HbnEBfW0UDs'\n title='//www.youtube.com/embed/HbnEBfW0UDs'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Recently, she posted a video to YouTube called \"There Will Be Beautiful Days.\" It's short, reaching just past a minute long. Withers smiles and says she knows things are hard now. Maybe harder than they've ever been. But it's going to be OK. And at some point, you'll have some good days. Maybe even just one great day, but it'll be enough. It will make life worth fighting for.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>A government inspection of blood-testing company Theranos' lab has found deficiencies that \"pose immediate jeopardy to patient health and safety.\"\u003c/p>\n\u003cp>Immediate jeopardy, as defined by CMS, means \"a situation in which immediate corrective action is necessary because the laboratory's non-compliance ... has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.\"\u003c/p>\n\u003cp>The \u003ca href=\"https://www.scribd.com/doc/296874497/Letter-from-CMS-to-Theranos\" target=\"_blank\">letter\u003c/a> informing Theranos of the inspection results was sent to the company on Monday by the Centers for Medicare & Medicaid Services, which oversees lab inspections. It cites five different conditions for certification, specified under the \u003ca href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm\" target=\"_blank\">Clinical Laboratory Improvement Amendments\u003c/a> of 1988 (CLIA), that have not been met by the lab.\u003c/p>\n\u003cp>CMS has given Theranos 10 days to correct the deficiencies. In addition, the company must show evidence of \"corrective action\" for patients who have been found to have been affected by problems at the lab.\u003c/p>\n\u003cp>After the letter's release, the company defended itself in a statement from vice president Brooke Buchanan. Buchanan said the inspection, conducted in November, didn't reflect the current condition of the lab, and that it had already fixed some of the problems cited by inspectors.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"A full plan of correction will be submitted to CMS within days,\" Buchanan said. (For the full statement, scroll to the bottom.)\u003c/p>\n\u003cp>Read the entire CMS letter here -- more after the jump.\u003c/p>\n\u003cp>[scribd id=296874497 key=key-hOWLaaDMsFe6OQCno57r mode=scroll]\u003c/p>\n\u003cp>The government action underscores negative publicity resulting from a string of articles by The Wall Street Journal alleging \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/26/for-theranos-the-bad-news-keeps-coming/\" target=\"_blank\">serious problems\u003c/a> with the company's patented blood-testing process, which is supposed to require blood that can be collected with just the prick of a finger in order to test for a \u003ca href=\"https://www.theranos.com/test-menu\" target=\"_blank\">host of substances and medical conditions\u003c/a>. But currently, it uses the technology for just one test, to detect herpes.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Full statement from Theranos\u003c/em>:\u003c/p>\n\u003cblockquote>\u003cp>We received a report from CMS documenting their findings from a scheduled survey in our Newark, CA lab that took place last fall. In line with our commitment to leading the lab industry in transparency, we wanted you to hear directly from us regarding this survey and report:\u003c/p>\n\u003cp>This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems. We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action. A full plan of correction will be submitted to CMS within days.\u003c/p>\n\u003cp>CMS’s findings included standard and condition-level deficiencies, and one finding at the “immediate jeopardy” level, based on a condition-level deficiency in one specific area – hematology. To be clear, that finding does not apply to the whole lab, and none of these findings relate to our Arizona lab, where we currently process over 90 percent of our tests.\u003c/p>\n\u003cp>Three of the condition-level deficiencies are related to personnel, such as documentation and oversight; one is related to analytic systems; and the one referenced above to hematology. CMS found that within hematology, certain policies, procedures, and associated events did not meet the relevant standards.\u003c/p>\n\u003cp>We were grateful to have our regulators directly review our alternative proficiency testing processes for our proprietary technologies and related operations. (See more on that at the end of this note below.)\u003c/p>\n\u003cp>As part of our review, we have made policy and personnel changes in our Newark, CA lab, including adding a new CLIA lab director with the conclusion of our lab director search. Our new lab director, Dr. Kingshuk Das, is a board-certified pathologist and M.D. and, among other accomplishments, an Associate Medical Director of UCLA’s Clinical Laboratories. We have also brought on a new clinical consultant, Dr. Waldo Concepcion, the Chief of Clinical Transplantation and Professor of Surgery at Stanford University Medical Center.\u003c/p>\n\u003cp>We value engagement with our regulators, which helps us build best-in-class systems, and are committed to ensuring that all our labs operate at the highest standards.\u003c/p>\n\u003cp>Theranos remains the sole company to call for - and voluntarily submit itself to - stronger regulatory oversight. Theranos has voluntarily committed to FDA review of its laboratory-developed tests and publishing its prices, lab proficiency testing pass rate, customer satisfaction scores, guest visit times, and more, to realize a system in which individuals become more engaged with their health, and early detection and prevention of disease become realities.\u003c/p>\n\u003cp>***\u003c/p>\n\u003cp>CMS issued no findings on the following allegations mentioned in recent media coverage:\u003cbr>\n• An allegation of proficiency testing “cheating”\u003cbr>\n• An allegation that management “instructed lab employees to keep testing patients” despite indications of purported problems\u003cbr>\n• An alleged complaint to CMS in which an R&D employee allegedly “deleted” QC data\u003cbr>\n• An allegation that Theranos improperly hid the existence of its lab holding its proprietary technologies\u003cbr>\n• An allegation that Theranos manipulated data to make its proprietary machines seem more accurate\u003cbr>\n• An allegation of a “dilution” protocol causing inaccurate results\u003cbr>\n• An allegation regarding the handling of a purported “proficiency-testing sample” in February 2014\u003c/p>\u003c/blockquote>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>A government inspection of blood-testing company Theranos' lab has found deficiencies that \"pose immediate jeopardy to patient health and safety.\"\u003c/p>\n\u003cp>Immediate jeopardy, as defined by CMS, means \"a situation in which immediate corrective action is necessary because the laboratory's non-compliance ... has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.\"\u003c/p>\n\u003cp>The \u003ca href=\"https://www.scribd.com/doc/296874497/Letter-from-CMS-to-Theranos\" target=\"_blank\">letter\u003c/a> informing Theranos of the inspection results was sent to the company on Monday by the Centers for Medicare & Medicaid Services, which oversees lab inspections. It cites five different conditions for certification, specified under the \u003ca href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm\" target=\"_blank\">Clinical Laboratory Improvement Amendments\u003c/a> of 1988 (CLIA), that have not been met by the lab.\u003c/p>\n\u003cp>CMS has given Theranos 10 days to correct the deficiencies. In addition, the company must show evidence of \"corrective action\" for patients who have been found to have been affected by problems at the lab.\u003c/p>\n\u003cp>After the letter's release, the company defended itself in a statement from vice president Brooke Buchanan. Buchanan said the inspection, conducted in November, didn't reflect the current condition of the lab, and that it had already fixed some of the problems cited by inspectors.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"A full plan of correction will be submitted to CMS within days,\" Buchanan said. (For the full statement, scroll to the bottom.)\u003c/p>\n\u003cp>Read the entire CMS letter here -- more after the jump.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003ciframe\n class=\"scribd_iframe_embed\"\n src=\"//www.scribd.com/embeds/296874497/content?start_page=1&view_mode=&access_key=key-hOWLaaDMsFe6OQCno57r\"\n title=\"http://www.scribd.com/doc/296874497\"\n data-auto-height=\"true\" scrolling=\"no\" id=\"scribd_296874497\"\n width=\"100%\" height=\"500\" frameborder=\"0\">\u003c/iframe>\n \u003ca class=\"utils-parseShortcode-shortcodes-__scribdShortcode__scribd_footer\"\n href=\"http://www.scribd.com/doc/296874497\"\n target=\"_blank\" rel=\"noopener noreferrer\">View this document on Scribd\u003c/a>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The government action underscores negative publicity resulting from a string of articles by The Wall Street Journal alleging \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/26/for-theranos-the-bad-news-keeps-coming/\" target=\"_blank\">serious problems\u003c/a> with the company's patented blood-testing process, which is supposed to require blood that can be collected with just the prick of a finger in order to test for a \u003ca href=\"https://www.theranos.com/test-menu\" target=\"_blank\">host of substances and medical conditions\u003c/a>. But currently, it uses the technology for just one test, to detect herpes.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Full statement from Theranos\u003c/em>:\u003c/p>\n\u003cblockquote>\u003cp>We received a report from CMS documenting their findings from a scheduled survey in our Newark, CA lab that took place last fall. In line with our commitment to leading the lab industry in transparency, we wanted you to hear directly from us regarding this survey and report:\u003c/p>\n\u003cp>This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems. We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action. A full plan of correction will be submitted to CMS within days.\u003c/p>\n\u003cp>CMS’s findings included standard and condition-level deficiencies, and one finding at the “immediate jeopardy” level, based on a condition-level deficiency in one specific area – hematology. To be clear, that finding does not apply to the whole lab, and none of these findings relate to our Arizona lab, where we currently process over 90 percent of our tests.\u003c/p>\n\u003cp>Three of the condition-level deficiencies are related to personnel, such as documentation and oversight; one is related to analytic systems; and the one referenced above to hematology. CMS found that within hematology, certain policies, procedures, and associated events did not meet the relevant standards.\u003c/p>\n\u003cp>We were grateful to have our regulators directly review our alternative proficiency testing processes for our proprietary technologies and related operations. (See more on that at the end of this note below.)\u003c/p>\n\u003cp>As part of our review, we have made policy and personnel changes in our Newark, CA lab, including adding a new CLIA lab director with the conclusion of our lab director search. Our new lab director, Dr. Kingshuk Das, is a board-certified pathologist and M.D. and, among other accomplishments, an Associate Medical Director of UCLA’s Clinical Laboratories. We have also brought on a new clinical consultant, Dr. Waldo Concepcion, the Chief of Clinical Transplantation and Professor of Surgery at Stanford University Medical Center.\u003c/p>\n\u003cp>We value engagement with our regulators, which helps us build best-in-class systems, and are committed to ensuring that all our labs operate at the highest standards.\u003c/p>\n\u003cp>Theranos remains the sole company to call for - and voluntarily submit itself to - stronger regulatory oversight. 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"content": "\u003cp>Scientists pursuing the biological roots of schizophrenia have zeroed in on a potential factor — a normal brain process that gets kicked into overdrive. The finding could someday lead to ways to treat the disease or even prevent it.\u003c/p>\n\u003cp>The result — accomplished by analysis of genetics, autopsy brain tissue and laboratory mice — is \"going to be a game-changer\" in terms of understanding schizophrenia and offering routes for treatment and potential for prevention, said Bruce Cuthbert, acting deputy director of the National Institute of Mental Health, which helped fund the research.\u003c/p>\n\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe width=\"100%\" height=\"124\" scrolling=\"no\" frameborder=\"no\" src=\"//embed.wbur.org/player/hereandnow/2016/01/27/schizophrenia-gene\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>An expert unconnected to the research said the study's conclusion was not yet proven, but plausible.\u003c/p>\n\u003cp>Almost 1 percent of the general population will have schizophrenia at some point in their lives. They may hear voices or hallucinate, talk about strange ideas, and believe others are reading their minds or plotting against them.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Nobody knows what causes the disorder, so the new result offers a possible peek into a black box. The work is reported in a \u003ca href=\"http://www.nature.com/nature/journal/vaop/ncurrent/full/nature16549.html\" target=\"_blank\">paper\u003c/a> released Wednesday by the journal Nature.\u003c/p>\n\u003cp>The finding might pertain to \"a very substantial fraction of cases, maybe most cases, even,\" said senior author Steven McCarroll, of Harvard Medical School and the Broad Institute in Cambridge, Massachusetts.\u003c/p>\n\u003cp>https://vimeo.com/106122585\u003c/p>\n\u003cp>The result links schizophrenia risk to a problem with a normal process that happens in adolescence and early adulthood, when disease symptoms often appear. That age range is when the brain trims back the number of specialized places on brain cells where the cells signal each other, called synapses. The new work suggests a connection to schizophrenia when this process gets out of hand, deleting too many synapses.\u003c/p>\n\u003cp>\"It's like you have a gardener who was supposed to prune the bushes and just got overactive,\" Cuthbert observed. \"You end up with bushes that are pruned way too much.\"\u003c/p>\n\u003cp>The result doesn't mean over-pruning causes schizophrenia on its own. It could promote the disease in combination with other factors in the brain, McCarroll said.\u003c/p>\n\u003cp>[contextly_sidebar id=\"uuZTjFjJXl20JTX7E1Sm3O0Vq2hq0aGz\"]The work began with a genetic investigation. Previous analysis of the human DNA indicates over 100 places that influence the risk of getting schizophrenia, but detailed biological explanations for those influences are very rare. The new work identified a risk gene and found evidence for the over-pruning idea.\u003c/p>\n\u003cp>Drawing on DNA data from 28,799 people with schizophrenia and 35,986 people without it, the researchers found that a gene called C4 can raise a person's risk by about 30 percent over that of the general population.\u003c/p>\n\u003cp>The gene comes in several forms, and researchers examining brain tissue found evidence that the forms that pose the most risk of schizophrenia were also the most active in the brain. In lab mice, they found that the gene plays a key role in pruning synapses.\u003c/p>\n\u003cp>The study doesn't directly demonstrate that excessive pruning of synapses plays a role in schizophrenia, but the idea makes sense, McCarroll said. It ties together previous observations, among them that schizophrenia most often develops during youth and that patients' brains show unusually few synapses, he said.\u003c/p>\n\u003cp>[contextly_sidebar id=\"602z5KFzIF50tC5NzfumWiNV260SBmeO\"]Dr. Kenneth Kendler, a schizophrenia genetics expert at Virginia Commonwealth University in Richmond who didn't participate in the project, said the work presents an impressive array of results. The evidence that C4 can raise schizophrenia risk is strong, he said. The proposal that it does so through excessive pruning of synapses is \"plausible and interesting, but not yet fully convincing,\" he said.\u003c/p>\n\u003cp>\"We don't yet know (whether) their hypothesis is completely true,\" Kendler said, but the work is still \"a pretty big deal.\"\u003c/p>\n\u003cp>If it's true, scientists can think about finding drugs that would intervene, McCarroll said. They might be useful to give when young people show symptoms that suggest they may be on the road to developing schizophrenia, he said. And even after the diagnosis, such drugs might keep the disease from getting worse, he said.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>But any such treatments are years away, he cautioned.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Scientists pursuing the biological roots of schizophrenia have zeroed in on a potential factor — a normal brain process that gets kicked into overdrive. The finding could someday lead to ways to treat the disease or even prevent it.\u003c/p>\n\u003cp>The result — accomplished by analysis of genetics, autopsy brain tissue and laboratory mice — is \"going to be a game-changer\" in terms of understanding schizophrenia and offering routes for treatment and potential for prevention, said Bruce Cuthbert, acting deputy director of the National Institute of Mental Health, which helped fund the research.\u003c/p>\n\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe width=\"100%\" height=\"124\" scrolling=\"no\" frameborder=\"no\" src=\"//embed.wbur.org/player/hereandnow/2016/01/27/schizophrenia-gene\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>An expert unconnected to the research said the study's conclusion was not yet proven, but plausible.\u003c/p>\n\u003cp>Almost 1 percent of the general population will have schizophrenia at some point in their lives. They may hear voices or hallucinate, talk about strange ideas, and believe others are reading their minds or plotting against them.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Nobody knows what causes the disorder, so the new result offers a possible peek into a black box. The work is reported in a \u003ca href=\"http://www.nature.com/nature/journal/vaop/ncurrent/full/nature16549.html\" target=\"_blank\">paper\u003c/a> released Wednesday by the journal Nature.\u003c/p>\n\u003cp>The finding might pertain to \"a very substantial fraction of cases, maybe most cases, even,\" said senior author Steven McCarroll, of Harvard Medical School and the Broad Institute in Cambridge, Massachusetts.\u003c/p>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The result links schizophrenia risk to a problem with a normal process that happens in adolescence and early adulthood, when disease symptoms often appear. That age range is when the brain trims back the number of specialized places on brain cells where the cells signal each other, called synapses. The new work suggests a connection to schizophrenia when this process gets out of hand, deleting too many synapses.\u003c/p>\n\u003cp>\"It's like you have a gardener who was supposed to prune the bushes and just got overactive,\" Cuthbert observed. \"You end up with bushes that are pruned way too much.\"\u003c/p>\n\u003cp>The result doesn't mean over-pruning causes schizophrenia on its own. It could promote the disease in combination with other factors in the brain, McCarroll said.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>The work began with a genetic investigation. Previous analysis of the human DNA indicates over 100 places that influence the risk of getting schizophrenia, but detailed biological explanations for those influences are very rare. The new work identified a risk gene and found evidence for the over-pruning idea.\u003c/p>\n\u003cp>Drawing on DNA data from 28,799 people with schizophrenia and 35,986 people without it, the researchers found that a gene called C4 can raise a person's risk by about 30 percent over that of the general population.\u003c/p>\n\u003cp>The gene comes in several forms, and researchers examining brain tissue found evidence that the forms that pose the most risk of schizophrenia were also the most active in the brain. In lab mice, they found that the gene plays a key role in pruning synapses.\u003c/p>\n\u003cp>The study doesn't directly demonstrate that excessive pruning of synapses plays a role in schizophrenia, but the idea makes sense, McCarroll said. It ties together previous observations, among them that schizophrenia most often develops during youth and that patients' brains show unusually few synapses, he said.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>Dr. Kenneth Kendler, a schizophrenia genetics expert at Virginia Commonwealth University in Richmond who didn't participate in the project, said the work presents an impressive array of results. The evidence that C4 can raise schizophrenia risk is strong, he said. The proposal that it does so through excessive pruning of synapses is \"plausible and interesting, but not yet fully convincing,\" he said.\u003c/p>\n\u003cp>\"We don't yet know (whether) their hypothesis is completely true,\" Kendler said, but the work is still \"a pretty big deal.\"\u003c/p>\n\u003cp>If it's true, scientists can think about finding drugs that would intervene, McCarroll said. They might be useful to give when young people show symptoms that suggest they may be on the road to developing schizophrenia, he said. And even after the diagnosis, such drugs might keep the disease from getting worse, he said.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>But any such treatments are years away, he cautioned.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>\u003cstrong>Update Jan. 28\u003c/strong> And yet \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/28/walgreens-suspends-theranos-service-at-palo-alto/\" target=\"_blank\">more bad news\u003c/a> for Theranos -- from its biggest public supporter, Walgreens.\u003c/p>\n\u003cp>\u003cstrong>Update Jan. 27\u003c/strong> The Centers for Medicare & Medicaid Services has given Theranos 10 days to correct deficiences at its Newark lab. A government inspection of the lab found problems that “pose immediate jeopardy to patient health and safety,” CMS said. \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/27/government-says-theranos-lab-problems-pose-immediate-jeopardy-to-patients/\" target=\"_blank\">See the story here\u003c/a>.\u003c/p>\n\u003cp>\u003cem>Original post\u003c/em>\u003c/p>\n\u003cp>So how much do Theranos employees \u003cem>not\u003c/em> look forward to the morning delivery of The Wall Street Journal?\u003c/p>\n\u003cp>On Sunday, the paper \u003ca href=\"http://www.wsj.com/articles/problems-found-at-theranos-lab-1453684743?utm_content=buffer2ea86&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer\" target=\"_blank\">published another damaging report\u003c/a> documenting the blood-testing company's swift fall from grace. Citing \"people familiar with the matter,\" the Journal said an inspection of Theranos' lab in Newark, Calif. by the Centers for Medicare and Medicaid Services turned up \"serious deficiencies.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>If Theranos is found to be out of compliance with CMS standards, then it could potentially be decertified and barred from Medicare and Medicaid. Decertifications are rare, and providers are usually given the right to correct deficiencies.The paper said the inspection findings were \"about to be made public.\" A spokesperson for CMS told KQED in an email the agency could not say when the report will be released. Theranos did not respond to a request for comment but told the Journal it had not yet seen the report.\u003c/p>\n\u003cp>The Journal story is reporter John Carreyrou's latest bubble-deflating piece on Palo Alto-based Theranos. The company, founded in 2003 by 19-year-old Elizabeth Holmes, was once the epitome of a \"disruptive\" high-flying health care startup, introducing diagnostic tests that required only a pinprick's worth of blood.\u003c/p>\n\u003cp>Last year, the private firm was valued at $9 billion, and \u003ca href=\"http://www.forbes.com/sites/matthewherper/2015/07/15/giving-theranos-a-few-tests/#5e2e7b1c1721\" target=\"_blank\">Fortune called\u003c/a> Holmes the \"world's youngest female billionaire\" (she'll be 32 next week).\u003c/p>\n\u003cp>But over the past several months, the story of Theranos has taken an unpleasant turn. Last October, the FDA said Theranos vials (\"nanotainers\"), which collect the blood from patients' fingers, had been improperly listed by the company as exempt from FDA review and approval. The FDA also said Theranos had inadequate procedures for reviewing complaints — including those suggesting the devices may be faulty.\u003c/p>\n\u003cp>Meanwhile, The Wall Street Journal reported Theranos was having \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\"> a lot of problems\u003c/a> with its breakthrough technology:\u003c/p>\n\u003cblockquote>\u003cp>One former senior employee says Theranos was routinely using the device, named Edison after the prolific inventor, for only 15 tests in December 2014. Some employees were leery about the machine’s accuracy, according to the former employees and emails reviewed by The Wall Street Journal.\u003c/p>\n\u003cp>In a complaint to regulators, one Theranos employee accused the company of failing to report test results that raised questions about the precision of the Edison system. Such a failure could be a violation of federal rules for laboratories, the former employee said.\u003c/p>\n\u003cp>Theranos also hasn’t disclosed publicly that it does the vast majority of its tests with traditional machines bought from companies like Siemens AG.\u003c/p>\u003c/blockquote>\n\u003cp>Theranos stopped using Edison for \u003ca href=\"http://www.bloomberg.com/news/articles/2015-10-16/theranos-limits-new-blood-technology-to-one-in-200-tests\" target=\"_blank\">all but one\u003c/a> of the 200 tests it \u003ca href=\"https://www.theranos.com/test-menu\" target=\"_blank\">lists\u003c/a>. In late December, the Journal published another \u003ca href=\"http://www.wsj.com/articles/at-theranos-many-strategies-and-snags-1451259629\" target=\"_blank\">article\u003c/a> with more revelations, including an alleged incident in which managers at the company deleted data from a quality control test to make Edison's results appear more accurate than they really were, sending the faulty results to the patient.\u003c/p>\n\u003cp>A spokesperson for Theranos told the Journal the company did not believe the incident occurred.\u003c/p>\n\u003cp>Walgreens, meanwhile, has \u003ca href=\"http://www.usatoday.com/story/tech/2015/10/24/walgreens-halts-expansion-its-theranos-centers/74537868/\" target=\"_blank\">put on hold plans to expand\u003c/a> the Theranos stations it hosts in dozens of stores in three states.\u003c/p>\n\u003cp>As the Journal has published its reports, Theranos has issued a \u003ca href=\"https://www.theranos.com/news/press-releases\" target=\"_blank\">string of responses \u003c/a>denouncing the accuracy of the stories. The latest statement is from Dec. 21, in the form of a \u003ca href=\"https://www.theranos.com/news/posts/wall-street-journal-letter-to-the-editor\" target=\"_blank\">letter to the Journal's editor\u003c/a>.\u003c/p>\n\u003cblockquote>\u003cp>The Journal has relied almost entirely on anonymous sources – without disclosing those sources’ qualifications, biases, affiliations, motives, or even how recently they were employed. Theranos has not only made its top scientists and engineers available to the Journal, but has provided exhaustive information and on-the-record statements to address every allegation raised by the Journal. ...\u003c/p>\n\u003cp>By continually relying on mostly anonymous sources, while dismissing concrete facts, documents, and expert scientists and engineers in the field provided by Theranos, the Journal denies its readers the ability to scrutinize and weigh the sources’ identities, motives, and the veracity of their statements.\u003c/p>\u003c/blockquote>\n\u003cp>But last October, Christina Farr, reporting for Future of You,\u003ca href=\"http://ww2.kqed.org/futureofyou/2015/10/15/critics-demand-theranos-lift-veil-of-secrecy-on-blood-test/\" target=\"_blank\"> wrote frankly\u003c/a> about the skepticism surrounding Theranos beyond that of The Wall Street Journal's:\u003c/p>\n\u003cblockquote>\u003cp>(S)ome scientists and health writers saw past the hype months ago. They took to their personal blogs and social media to ask some pertinent questions about the science behind Theranos’ test, which largely went unanswered. Some requested that Theranos publish peer-reviewed studies to prove the validity of its test.\u003c/p>\n\u003cp>At health conferences and gatherings, I’ve heard similar skepticism about Theranos’ science and its multi-billion dollar valuation, as well as increasing calls for proof to back up its claims. Theranos has sought FDA approval for its tests, but it \u003ca href=\"http://www.businessinsider.com/science-of-elizabeth-holmes-theranos-2015-4\" target=\"_blank\">has evaded questions about its technology. \u003c/a>\u003c/p>\n\u003cp>As Dr. David Koch, president of the American Association for Clinical Chemistry and a professor at Emory University \u003ca href=\"http://www.businessinsider.com/science-of-elizabeth-holmes-theranos-2015-4\" target=\"_blank\">told Business Insider in April\u003c/a>: “It’s impossible to comment on how good this is going to be — it may be wonderful and it may bomb, but I really can’t be more definitive because there’s nothing to really look at, to read, to react to.”\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\n\u003cp>More, we're quite sure, to come...\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cstrong>Update Jan. 28\u003c/strong> And yet \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/28/walgreens-suspends-theranos-service-at-palo-alto/\" target=\"_blank\">more bad news\u003c/a> for Theranos -- from its biggest public supporter, Walgreens.\u003c/p>\n\u003cp>\u003cstrong>Update Jan. 27\u003c/strong> The Centers for Medicare & Medicaid Services has given Theranos 10 days to correct deficiences at its Newark lab. A government inspection of the lab found problems that “pose immediate jeopardy to patient health and safety,” CMS said. \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/27/government-says-theranos-lab-problems-pose-immediate-jeopardy-to-patients/\" target=\"_blank\">See the story here\u003c/a>.\u003c/p>\n\u003cp>\u003cem>Original post\u003c/em>\u003c/p>\n\u003cp>So how much do Theranos employees \u003cem>not\u003c/em> look forward to the morning delivery of The Wall Street Journal?\u003c/p>\n\u003cp>On Sunday, the paper \u003ca href=\"http://www.wsj.com/articles/problems-found-at-theranos-lab-1453684743?utm_content=buffer2ea86&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer\" target=\"_blank\">published another damaging report\u003c/a> documenting the blood-testing company's swift fall from grace. Citing \"people familiar with the matter,\" the Journal said an inspection of Theranos' lab in Newark, Calif. by the Centers for Medicare and Medicaid Services turned up \"serious deficiencies.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>If Theranos is found to be out of compliance with CMS standards, then it could potentially be decertified and barred from Medicare and Medicaid. Decertifications are rare, and providers are usually given the right to correct deficiencies.The paper said the inspection findings were \"about to be made public.\" A spokesperson for CMS told KQED in an email the agency could not say when the report will be released. Theranos did not respond to a request for comment but told the Journal it had not yet seen the report.\u003c/p>\n\u003cp>The Journal story is reporter John Carreyrou's latest bubble-deflating piece on Palo Alto-based Theranos. The company, founded in 2003 by 19-year-old Elizabeth Holmes, was once the epitome of a \"disruptive\" high-flying health care startup, introducing diagnostic tests that required only a pinprick's worth of blood.\u003c/p>\n\u003cp>Last year, the private firm was valued at $9 billion, and \u003ca href=\"http://www.forbes.com/sites/matthewherper/2015/07/15/giving-theranos-a-few-tests/#5e2e7b1c1721\" target=\"_blank\">Fortune called\u003c/a> Holmes the \"world's youngest female billionaire\" (she'll be 32 next week).\u003c/p>\n\u003cp>But over the past several months, the story of Theranos has taken an unpleasant turn. Last October, the FDA said Theranos vials (\"nanotainers\"), which collect the blood from patients' fingers, had been improperly listed by the company as exempt from FDA review and approval. The FDA also said Theranos had inadequate procedures for reviewing complaints — including those suggesting the devices may be faulty.\u003c/p>\n\u003cp>Meanwhile, The Wall Street Journal reported Theranos was having \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\"> a lot of problems\u003c/a> with its breakthrough technology:\u003c/p>\n\u003cblockquote>\u003cp>One former senior employee says Theranos was routinely using the device, named Edison after the prolific inventor, for only 15 tests in December 2014. Some employees were leery about the machine’s accuracy, according to the former employees and emails reviewed by The Wall Street Journal.\u003c/p>\n\u003cp>In a complaint to regulators, one Theranos employee accused the company of failing to report test results that raised questions about the precision of the Edison system. Such a failure could be a violation of federal rules for laboratories, the former employee said.\u003c/p>\n\u003cp>Theranos also hasn’t disclosed publicly that it does the vast majority of its tests with traditional machines bought from companies like Siemens AG.\u003c/p>\u003c/blockquote>\n\u003cp>Theranos stopped using Edison for \u003ca href=\"http://www.bloomberg.com/news/articles/2015-10-16/theranos-limits-new-blood-technology-to-one-in-200-tests\" target=\"_blank\">all but one\u003c/a> of the 200 tests it \u003ca href=\"https://www.theranos.com/test-menu\" target=\"_blank\">lists\u003c/a>. In late December, the Journal published another \u003ca href=\"http://www.wsj.com/articles/at-theranos-many-strategies-and-snags-1451259629\" target=\"_blank\">article\u003c/a> with more revelations, including an alleged incident in which managers at the company deleted data from a quality control test to make Edison's results appear more accurate than they really were, sending the faulty results to the patient.\u003c/p>\n\u003cp>A spokesperson for Theranos told the Journal the company did not believe the incident occurred.\u003c/p>\n\u003cp>Walgreens, meanwhile, has \u003ca href=\"http://www.usatoday.com/story/tech/2015/10/24/walgreens-halts-expansion-its-theranos-centers/74537868/\" target=\"_blank\">put on hold plans to expand\u003c/a> the Theranos stations it hosts in dozens of stores in three states.\u003c/p>\n\u003cp>As the Journal has published its reports, Theranos has issued a \u003ca href=\"https://www.theranos.com/news/press-releases\" target=\"_blank\">string of responses \u003c/a>denouncing the accuracy of the stories. The latest statement is from Dec. 21, in the form of a \u003ca href=\"https://www.theranos.com/news/posts/wall-street-journal-letter-to-the-editor\" target=\"_blank\">letter to the Journal's editor\u003c/a>.\u003c/p>\n\u003cblockquote>\u003cp>The Journal has relied almost entirely on anonymous sources – without disclosing those sources’ qualifications, biases, affiliations, motives, or even how recently they were employed. Theranos has not only made its top scientists and engineers available to the Journal, but has provided exhaustive information and on-the-record statements to address every allegation raised by the Journal. ...\u003c/p>\n\u003cp>By continually relying on mostly anonymous sources, while dismissing concrete facts, documents, and expert scientists and engineers in the field provided by Theranos, the Journal denies its readers the ability to scrutinize and weigh the sources’ identities, motives, and the veracity of their statements.\u003c/p>\u003c/blockquote>\n\u003cp>But last October, Christina Farr, reporting for Future of You,\u003ca href=\"http://ww2.kqed.org/futureofyou/2015/10/15/critics-demand-theranos-lift-veil-of-secrecy-on-blood-test/\" target=\"_blank\"> wrote frankly\u003c/a> about the skepticism surrounding Theranos beyond that of The Wall Street Journal's:\u003c/p>\n\u003cblockquote>\u003cp>(S)ome scientists and health writers saw past the hype months ago. They took to their personal blogs and social media to ask some pertinent questions about the science behind Theranos’ test, which largely went unanswered. Some requested that Theranos publish peer-reviewed studies to prove the validity of its test.\u003c/p>\n\u003cp>At health conferences and gatherings, I’ve heard similar skepticism about Theranos’ science and its multi-billion dollar valuation, as well as increasing calls for proof to back up its claims. Theranos has sought FDA approval for its tests, but it \u003ca href=\"http://www.businessinsider.com/science-of-elizabeth-holmes-theranos-2015-4\" target=\"_blank\">has evaded questions about its technology. \u003c/a>\u003c/p>\n\u003cp>As Dr. David Koch, president of the American Association for Clinical Chemistry and a professor at Emory University \u003ca href=\"http://www.businessinsider.com/science-of-elizabeth-holmes-theranos-2015-4\" target=\"_blank\">told Business Insider in April\u003c/a>: “It’s impossible to comment on how good this is going to be — it may be wonderful and it may bomb, but I really can’t be more definitive because there’s nothing to really look at, to read, to react to.”\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\n\u003cp>More, we're quite sure, to come...\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>If you’re one of those people who likes drinking more than everyone else, you might have an excuse: You have lazy genes.\u003c/p>\n\u003cp>Well, at least one lazy gene.\u003c/p>\n\u003cp>A \u003ca href=\"https://translate.google.com/translate?hl=en&sl=es&u=http://www.uv.es/gicf/4A2_Andres_GICF_17.pdf&prev=search\">new study\u003c/a> out of the University of Valencia in Spain confirms something about Spaniards that scientists have known about Asians for a long time: People with a “lazy” version of the \u003ca href=\"http://www.omim.org/entry/103720\">ADH1B \u003c/a>gene find alcohol more enjoyable than people with a more efficient one.\u003c/p>\n\u003caside class=\"pullquote alignright\">How much you drink and how it affects you has something to do with your genetics.\u003c/aside>\n\u003cp>People of Asian descent who enjoy alcohol more because of their genes \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/17718397\">are also more likely to suffer from alcoholism\u003c/a>. A recent \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/24735490\">study \u003c/a>confirmed this in British and Irish people, as well.\u003c/p>\n\u003cp>The finding could help counselors tailor treatments for people with alcoholism.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Why It's Lazy\u003c/strong>\u003c/p>\n\u003cfigure id=\"attachment_102957\" class=\"wp-caption aligncenter\" style=\"max-width: 700px\">\u003cimg class=\"size-full wp-image-102957\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/Breathalyzer.jpg\" alt=\"A lazy gene means alcohol stays in your blood longer. (Wikimedia Commons)\" width=\"700\" height=\"401\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/Breathalyzer.jpg 700w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/Breathalyzer-400x229.jpg 400w\" sizes=\"(max-width: 700px) 100vw, 700px\">\u003cfigcaption class=\"wp-caption-text\">A lazy gene means alcohol stays in your blood longer. (\u003ca href=\"https://commons.wikimedia.org/wiki/File:Breathalyzer.jpg\">Wikimedia Commons\u003c/a>)\u003c/figcaption>\u003c/figure>\n\u003cp>There are a couple of different classes of genes that get rid of the alcohol once it gets into your bloodstream. The first set, which includes the ADH1B gene turns alcohol into something called acetaldehyde.\u003c/p>\n\u003cp>This is a nasty chemical that can turn your face red, make you sick to your stomach or cause your head to hurt. Our bodies get rid of this chemical using a second gene called ALDH2.\u003c/p>\n\u003cp>If you have the lazy version of ADH1B, alcohol gets turned into acetaldehyde at a leisurely pace. So leisurely that the second gene, ALDH2, has no trouble getting rid of it. There is no time for it to build up and so you only get the pleasurable effects of alcohol.\u003c/p>\n\u003cp>It is a different story if your ADH1B gene is a hard worker. In this case it can be so zealous that it converts alcohol into acetaldehyde too quickly for ALDH2 to handle. Now alcohol can be much less pleasurable because all that aldehyde is making you sick.\u003c/p>\n\u003cp>This is why people with the hard working version are less likely to suffer from alcoholism. And of course why people with the lazy version are more likely to keep drinking. They only have a positive physical reaction to drinking.\u003c/p>\n\u003cp>\u003cstrong>How to Tell if ADH1B Is Lazy\u003c/strong>\u003c/p>\n\u003cp>If you drink, you probably already know if you have a hardworking ADH1B gene. But if you want to see it in your DNA results, here’s how to do it with a personal genetics test like 23andMe.\u003c/p>\n\u003cp>First search for rs1229984 in the search box. Then click on the link with the same name and up will come the following:\u003c/p>\n\u003cp>\u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/26/alcoholism-may-be-rooted-in-your-dna/starr-graphic/\" rel=\"attachment wp-att-101611\">\u003cimg class=\"aligncenter size-full wp-image-101611\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/starr-graphic.png\" alt=\"starr graphic\" width=\"775\" height=\"289\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/starr-graphic.png 775w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/starr-graphic-400x149.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/starr-graphic-768x286.png 768w\" sizes=\"(max-width: 775px) 100vw, 775px\">\u003c/a>\u003c/p>\n\u003cp>The C versions are the lazy ones. So if you are CC (like in the image above), both copies of your ADH1B gene are lazy. This gene does nothing to affect your enjoyment of alcohol.\u003c/p>\n\u003cp>If you have one T, you have one hardworking gene; if you have two Ts, both of your copies are hardworking. You will probably not find alcohol as enjoyable as someone with two C's. But at least you are at a lower risk for alcoholism!\u003c/p>\n\u003cp>It is important to mention that not everyone with a lazy ADH1B gene will suffer from alcoholism. If this were true then most people of European descent would struggle with alcohol as most of them have this version of the gene.\u003c/p>\n\u003cp>No, having this version just makes you more likely to have trouble.\u003c/p>\n\u003cp>\u003cstrong>More Than One Gene\u003c/strong>\u003c/p>\n\u003cp>Of course ADH1B isn't the only gene involved in dealing with alcohol. Other genes, including the ALDH2 are important players too.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>And some of these genes can come in lazy and hardworking copies too. Click \u003ca href=\"http://ww2.kqed.org/quest/2010/12/20/a-dangerous-blush/\">here \u003c/a>to learn more about the lazy version of ALDH2 and what having that does to your enjoyment of alcohol.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>If you’re one of those people who likes drinking more than everyone else, you might have an excuse: You have lazy genes.\u003c/p>\n\u003cp>Well, at least one lazy gene.\u003c/p>\n\u003cp>A \u003ca href=\"https://translate.google.com/translate?hl=en&sl=es&u=http://www.uv.es/gicf/4A2_Andres_GICF_17.pdf&prev=search\">new study\u003c/a> out of the University of Valencia in Spain confirms something about Spaniards that scientists have known about Asians for a long time: People with a “lazy” version of the \u003ca href=\"http://www.omim.org/entry/103720\">ADH1B \u003c/a>gene find alcohol more enjoyable than people with a more efficient one.\u003c/p>\n\u003caside class=\"pullquote alignright\">How much you drink and how it affects you has something to do with your genetics.\u003c/aside>\n\u003cp>People of Asian descent who enjoy alcohol more because of their genes \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/17718397\">are also more likely to suffer from alcoholism\u003c/a>. A recent \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/24735490\">study \u003c/a>confirmed this in British and Irish people, as well.\u003c/p>\n\u003cp>The finding could help counselors tailor treatments for people with alcoholism.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Why It's Lazy\u003c/strong>\u003c/p>\n\u003cfigure id=\"attachment_102957\" class=\"wp-caption aligncenter\" style=\"max-width: 700px\">\u003cimg class=\"size-full wp-image-102957\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/Breathalyzer.jpg\" alt=\"A lazy gene means alcohol stays in your blood longer. (Wikimedia Commons)\" width=\"700\" height=\"401\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/Breathalyzer.jpg 700w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/Breathalyzer-400x229.jpg 400w\" sizes=\"(max-width: 700px) 100vw, 700px\">\u003cfigcaption class=\"wp-caption-text\">A lazy gene means alcohol stays in your blood longer. (\u003ca href=\"https://commons.wikimedia.org/wiki/File:Breathalyzer.jpg\">Wikimedia Commons\u003c/a>)\u003c/figcaption>\u003c/figure>\n\u003cp>There are a couple of different classes of genes that get rid of the alcohol once it gets into your bloodstream. The first set, which includes the ADH1B gene turns alcohol into something called acetaldehyde.\u003c/p>\n\u003cp>This is a nasty chemical that can turn your face red, make you sick to your stomach or cause your head to hurt. Our bodies get rid of this chemical using a second gene called ALDH2.\u003c/p>\n\u003cp>If you have the lazy version of ADH1B, alcohol gets turned into acetaldehyde at a leisurely pace. So leisurely that the second gene, ALDH2, has no trouble getting rid of it. There is no time for it to build up and so you only get the pleasurable effects of alcohol.\u003c/p>\n\u003cp>It is a different story if your ADH1B gene is a hard worker. In this case it can be so zealous that it converts alcohol into acetaldehyde too quickly for ALDH2 to handle. Now alcohol can be much less pleasurable because all that aldehyde is making you sick.\u003c/p>\n\u003cp>This is why people with the hard working version are less likely to suffer from alcoholism. And of course why people with the lazy version are more likely to keep drinking. They only have a positive physical reaction to drinking.\u003c/p>\n\u003cp>\u003cstrong>How to Tell if ADH1B Is Lazy\u003c/strong>\u003c/p>\n\u003cp>If you drink, you probably already know if you have a hardworking ADH1B gene. But if you want to see it in your DNA results, here’s how to do it with a personal genetics test like 23andMe.\u003c/p>\n\u003cp>First search for rs1229984 in the search box. Then click on the link with the same name and up will come the following:\u003c/p>\n\u003cp>\u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/26/alcoholism-may-be-rooted-in-your-dna/starr-graphic/\" rel=\"attachment wp-att-101611\">\u003cimg class=\"aligncenter size-full wp-image-101611\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/starr-graphic.png\" alt=\"starr graphic\" width=\"775\" height=\"289\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/starr-graphic.png 775w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/starr-graphic-400x149.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/starr-graphic-768x286.png 768w\" sizes=\"(max-width: 775px) 100vw, 775px\">\u003c/a>\u003c/p>\n\u003cp>The C versions are the lazy ones. So if you are CC (like in the image above), both copies of your ADH1B gene are lazy. This gene does nothing to affect your enjoyment of alcohol.\u003c/p>\n\u003cp>If you have one T, you have one hardworking gene; if you have two Ts, both of your copies are hardworking. You will probably not find alcohol as enjoyable as someone with two C's. But at least you are at a lower risk for alcoholism!\u003c/p>\n\u003cp>It is important to mention that not everyone with a lazy ADH1B gene will suffer from alcoholism. If this were true then most people of European descent would struggle with alcohol as most of them have this version of the gene.\u003c/p>\n\u003cp>No, having this version just makes you more likely to have trouble.\u003c/p>\n\u003cp>\u003cstrong>More Than One Gene\u003c/strong>\u003c/p>\n\u003cp>Of course ADH1B isn't the only gene involved in dealing with alcohol. Other genes, including the ALDH2 are important players too.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>And some of these genes can come in lazy and hardworking copies too. Click \u003ca href=\"http://ww2.kqed.org/quest/2010/12/20/a-dangerous-blush/\">here \u003c/a>to learn more about the lazy version of ALDH2 and what having that does to your enjoyment of alcohol.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Commentary: Medical Journals' Proposal 'Could Change Medical Science Forever'",
"title": "Commentary: Medical Journals' Proposal 'Could Change Medical Science Forever'",
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"content": "\u003cp>Medical editors don't usually attract much attention. They perform their daily duties evaluating submissions and producing articles that, on good days, influence practice and policy.\u003c/p>\n\u003cp>But last Wednesday, the editors of the leading medical journals around the world made \u003ca href=\"http://www.icmje.org/news-and-editorials/M15-2928-PAP.pdf\">a proposal\u003c/a> that could change medical science forever. They said that researchers would have to publicly share the data gathered in their clinical studies as a condition of publishing the results in the journals. This idea is now out for public comment.\u003c/p>\n\u003cp>As it stands now, medical scientists can publish their findings without ever making available the data upon which their conclusions were based.\u003c/p>\n\u003caside class=\"alignright\">Leading medical journals are proposing as a condition of publication of research a commitment to share data on individual patients within six months.\u003c/aside>\n\u003cp>Only some of the top journals, such as \u003cem>The BMJ,\u003c/em> have tried to make data sharing a condition of publication. But authors who didn't want to comply could just go elsewhere.\u003c/p>\n\u003cp>Think about it. The scientists who generate the data, with the participation of the people being studied and often with public funding, control it and most often don't share. By holding the data tight, researchers who ran a study are the only ones who can conduct additional analysis and studies.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>If the proposed change is adopted, as I hope it will be, it would make sharing more compelling.\u003c/p>\n\u003cp>Inaccessible data is a problem rife throughout medical science. Industry traditionally held its data close — but so did academics.\u003c/p>\n\u003cp>These researchers have felt that they deserved the right to future papers for all their hard work gathering the original data. And maybe they didn't want others examining their work.\u003c/p>\n\u003cp>But this practice shields data from scrutiny. It forgoes an opportunity to crowdsource knowledge from scientists who weren't associated with the original study. It also violates the sensible practice of showing your work, not just the presumed answer.\u003c/p>\n\u003cp>Some skeptics contend that those who pore over data generated elsewhere are nothing more than \"\u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMe1516564\">research parasites\u003c/a>.\" But that disparaging term neglects the key role that independent scientists can play in bringing new insights and also in validating the quality of the data that were collected. Access is also central to the scientific method and the idea of replication to establish the truth.\u003c/p>\n\u003cp>The editors who made the proposal sought to be sensitive to the rights of researchers, funders and participants. But their intent is clear: It's time to share.\u003c/p>\n\u003cp>The past culture has impeded science. For example, many times in my career as a heart disease researcher, I respectfully requested access to clinical trial data held by others. The response was no — regardless of the merit of the request — and most often from other academics. It is a behavior that would be hard to imagine in other fields, like physics or astronomy.\u003c/p>\n\u003cp>The data from clinical trials have the potential to provide additional knowledge that often goes untapped.\u003c/p>\n\u003cp>There were times my research group was able to gain access to data through the National Heart, Lung and Blood Institute, which promotes sharing of trials it funds, or through litigation. We uncovered insights that weren't in the original articles. Our work produced papers that found their way into the \u003cem>New England Journal of Medicine\u003c/em> and \u003cem>JAMA,\u003c/em> the Journal of the American Medical Association. The findings have since been cited by thousands of other papers, incorporated in treatment guidelines for doctors and patients. In several cases our results upended the original conclusions.\u003c/p>\n\u003cp>Others have also used trial data to replicate and extend findings from the initial studies and made critically important contributions.\u003c/p>\n\u003cp>In recent years the momentum for open science has grown rapidly. This action by the editors follows directly from \u003ca href=\"http://iom.nationalacademies.org/Activities/Research/SharingClinicalTrialData/2015-JAN-14.aspx\">guidance\u003c/a> in 2015 from the National Academy of Medicine (formerly the Institute of Medicine), a body of the nation's top medical experts, that said clearly it is time for the culture of medical research to change.\u003c/p>\n\u003cp>Companies such as GlaxoSmithKline, Johnson & Johnson and Medtronic have led the way in sharing their trial data. Our group at the Yale Center for Outcomes Research and Evaluation started the \u003ca href=\"http://yoda.yale.edu/\">Yale Open Data Access Project\u003c/a> to promote data sharing and was an early advocate for open science. We are showing the feasibility of establishing partnerships with industry and acting as a trusted intermediary. Visit the site, and you can see a variety of trials from Johnson & Johnson that are available to scientists around the world.\u003c/p>\n\u003cp>With sharing, the sky hasn't fallen and worthwhile independent projects that could not have been done otherwise are proceeding. Many academics and companies are lagging, however. As a result, the data from a large number of trials remain off-limits.\u003c/p>\n\u003cp>Amid the progress, there has been a lack of consequences for not sharing. Even as the benefits from sharing are manifold, to be honest, it's easier not to share. Why expose your data to others? Why compromise your ability to publish more at your own pace? Why risk the possibility that someone could find an error? Why let others benefit from your hard work? Why spend the money to do it?\u003c/p>\n\u003cp>The absence of an incentive to share seems about to change. The proposal by the medical editors outlines an approach that would require: a data-sharing policy when the study is started; a commitment to share within six months of publication; and that those who use the data acknowledge those who produced it. The data should be down to the level of the individual patient (identifying information will be removed) rather than just summary data, an important detail that will allow rigorous science to proceed.\u003c/p>\n\u003cp>Among the first things we learn in school are to share and to show our work. This lesson has been lost on medicine for many years. The medical editors are reminding us that we scientists have a principal responsibility to society and to those who agreed to participate in our studies.\u003c/p>\n\u003cp>There are many details to resolve. How will sharing work? Who will pay for it? How will the researchers who produced the work get credit in the subsequent analyses? All good and difficult questions, but it is high time to find solutions.\u003c/p>\n\u003cp>For now, this proposal is out for public comment. It is likely that mostly scientists will weigh in on how the change would affect their work. It would be great, in my view, if the general public participated too. Do people want to see scientific data exposed to the light, available to advance knowledge for generations? The public stands to benefit the most. I hope that voices other than those of my colleagues will be heard.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Harlan Krumholz is a cardiologist and the Harold H. Hines Jr. Professor of Medicine at Yale School of Medicine. He directs the Yale-New Haven Hospital Center for Outcomes Research and Evaluation and is a co-director of the Robert Wood Johnson Foundation Clinical Scholars Program. To comment on the proposal described above, you can go to\u003c/em> \u003ca href=\"http://www.icmje.org/\">www.icmje.org\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Medical editors don't usually attract much attention. They perform their daily duties evaluating submissions and producing articles that, on good days, influence practice and policy.\u003c/p>\n\u003cp>But last Wednesday, the editors of the leading medical journals around the world made \u003ca href=\"http://www.icmje.org/news-and-editorials/M15-2928-PAP.pdf\">a proposal\u003c/a> that could change medical science forever. They said that researchers would have to publicly share the data gathered in their clinical studies as a condition of publishing the results in the journals. This idea is now out for public comment.\u003c/p>\n\u003cp>As it stands now, medical scientists can publish their findings without ever making available the data upon which their conclusions were based.\u003c/p>\n\u003caside class=\"alignright\">Leading medical journals are proposing as a condition of publication of research a commitment to share data on individual patients within six months.\u003c/aside>\n\u003cp>Only some of the top journals, such as \u003cem>The BMJ,\u003c/em> have tried to make data sharing a condition of publication. But authors who didn't want to comply could just go elsewhere.\u003c/p>\n\u003cp>Think about it. The scientists who generate the data, with the participation of the people being studied and often with public funding, control it and most often don't share. By holding the data tight, researchers who ran a study are the only ones who can conduct additional analysis and studies.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>If the proposed change is adopted, as I hope it will be, it would make sharing more compelling.\u003c/p>\n\u003cp>Inaccessible data is a problem rife throughout medical science. Industry traditionally held its data close — but so did academics.\u003c/p>\n\u003cp>These researchers have felt that they deserved the right to future papers for all their hard work gathering the original data. And maybe they didn't want others examining their work.\u003c/p>\n\u003cp>But this practice shields data from scrutiny. It forgoes an opportunity to crowdsource knowledge from scientists who weren't associated with the original study. It also violates the sensible practice of showing your work, not just the presumed answer.\u003c/p>\n\u003cp>Some skeptics contend that those who pore over data generated elsewhere are nothing more than \"\u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMe1516564\">research parasites\u003c/a>.\" But that disparaging term neglects the key role that independent scientists can play in bringing new insights and also in validating the quality of the data that were collected. Access is also central to the scientific method and the idea of replication to establish the truth.\u003c/p>\n\u003cp>The editors who made the proposal sought to be sensitive to the rights of researchers, funders and participants. But their intent is clear: It's time to share.\u003c/p>\n\u003cp>The past culture has impeded science. For example, many times in my career as a heart disease researcher, I respectfully requested access to clinical trial data held by others. The response was no — regardless of the merit of the request — and most often from other academics. It is a behavior that would be hard to imagine in other fields, like physics or astronomy.\u003c/p>\n\u003cp>The data from clinical trials have the potential to provide additional knowledge that often goes untapped.\u003c/p>\n\u003cp>There were times my research group was able to gain access to data through the National Heart, Lung and Blood Institute, which promotes sharing of trials it funds, or through litigation. We uncovered insights that weren't in the original articles. Our work produced papers that found their way into the \u003cem>New England Journal of Medicine\u003c/em> and \u003cem>JAMA,\u003c/em> the Journal of the American Medical Association. The findings have since been cited by thousands of other papers, incorporated in treatment guidelines for doctors and patients. In several cases our results upended the original conclusions.\u003c/p>\n\u003cp>Others have also used trial data to replicate and extend findings from the initial studies and made critically important contributions.\u003c/p>\n\u003cp>In recent years the momentum for open science has grown rapidly. This action by the editors follows directly from \u003ca href=\"http://iom.nationalacademies.org/Activities/Research/SharingClinicalTrialData/2015-JAN-14.aspx\">guidance\u003c/a> in 2015 from the National Academy of Medicine (formerly the Institute of Medicine), a body of the nation's top medical experts, that said clearly it is time for the culture of medical research to change.\u003c/p>\n\u003cp>Companies such as GlaxoSmithKline, Johnson & Johnson and Medtronic have led the way in sharing their trial data. Our group at the Yale Center for Outcomes Research and Evaluation started the \u003ca href=\"http://yoda.yale.edu/\">Yale Open Data Access Project\u003c/a> to promote data sharing and was an early advocate for open science. We are showing the feasibility of establishing partnerships with industry and acting as a trusted intermediary. Visit the site, and you can see a variety of trials from Johnson & Johnson that are available to scientists around the world.\u003c/p>\n\u003cp>With sharing, the sky hasn't fallen and worthwhile independent projects that could not have been done otherwise are proceeding. Many academics and companies are lagging, however. As a result, the data from a large number of trials remain off-limits.\u003c/p>\n\u003cp>Amid the progress, there has been a lack of consequences for not sharing. Even as the benefits from sharing are manifold, to be honest, it's easier not to share. Why expose your data to others? Why compromise your ability to publish more at your own pace? Why risk the possibility that someone could find an error? Why let others benefit from your hard work? Why spend the money to do it?\u003c/p>\n\u003cp>The absence of an incentive to share seems about to change. The proposal by the medical editors outlines an approach that would require: a data-sharing policy when the study is started; a commitment to share within six months of publication; and that those who use the data acknowledge those who produced it. The data should be down to the level of the individual patient (identifying information will be removed) rather than just summary data, an important detail that will allow rigorous science to proceed.\u003c/p>\n\u003cp>Among the first things we learn in school are to share and to show our work. This lesson has been lost on medicine for many years. The medical editors are reminding us that we scientists have a principal responsibility to society and to those who agreed to participate in our studies.\u003c/p>\n\u003cp>There are many details to resolve. How will sharing work? Who will pay for it? How will the researchers who produced the work get credit in the subsequent analyses? All good and difficult questions, but it is high time to find solutions.\u003c/p>\n\u003cp>For now, this proposal is out for public comment. It is likely that mostly scientists will weigh in on how the change would affect their work. It would be great, in my view, if the general public participated too. Do people want to see scientific data exposed to the light, available to advance knowledge for generations? The public stands to benefit the most. I hope that voices other than those of my colleagues will be heard.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"disqusTitle": "Hacked Medical Devices Still a Big Threat in 2016",
"title": "Hacked Medical Devices Still a Big Threat in 2016",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>Hackers aren’t just breaking into email accounts and online banking systems anymore. They’re also exploiting healthcare—going after \u003ca href=\"http://www.latimes.com/business/la-fi-anthem-hack-fallout-20150206-story.html\">electronic medical records\u003c/a>, wifi enabled medical devices and even remotely controlled surgical robots.\u003c/p>\n\u003cp>Medical devices and records have emerged as big cyber security risks. That’s why the \u003ca href=\"http://www.fda.gov/\">Food and Drug Administration\u003c/a> recently proposed \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481968.htm\">new guidelines\u003c/a> for how medical device manufacturers should secure their products.\u003c/p>\n\u003cp>Among the FDA's recommendations, manufacturers are being asked to:\u003c/p>\n\u003cul>\n\u003cli>Develop a risk management program that includes a plan for when a vulnerability is discovered.\u003c/li>\n\u003cli>Write disclosure policies, so hospitals and patients understand which aspects of a device may be less secure.\u003c/li>\n\u003cli>Release regular software and hardware updates for medical devices after they’re on the market.\u003c/li>\n\u003c/ul>\n\u003cp>\u003cstrong>\u003cem>[Scroll down to see three real life cyber security attacks] \u003c/em>\u003c/strong>\u003c/p>\n\u003cp>But security experts, like \u003ca href=\"https://www.schneier.com/\">Bruce Schneier\u003c/a>, say non-legally binding guidelines are just not enough.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"It's basically industry best practice,\" says Schneier. \"But without enforcement, it's just pleading.\"\u003c/p>\n\u003cp>Critics are concerned that the responsibility is still primarily left up to manufacturers to disclose when a device has been hacked.\u003c/p>\n\u003cp>Consumer Watchdog president Jamie Court says recommendations are not enough and we won't see new laws until public officials are affected. \"All its gonna take is one congressman’s defibrillator being hacked and we’ll have some new laws really quickly,\" according to Court.\u003c/p>\n\u003cp>The FDA is \u003ca href=\"https://www.federalregister.gov/articles/2016/01/22/2016-01172/postmarket-management-of-cybersecurity-in-medical-devices-draft-guidance-for-industry-and-food-and\">taking public comments\u003c/a> on its \u003ca href=\"http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM482022.pdf\">guidelines\u003c/a> until April 21.\u003c/p>\n\u003cp>Read on to see three real life situations the FDA guidance is designed to prevent.\u003c/p>\n\u003cp>\u003cstrong>Security Experts Hack a Surgical Robot\u003c/strong>\u003c/p>\n\u003cp>\u003cimg class=\"alignleft size-full wp-image-103162\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot.jpg\" alt=\"FDA_Icon_SurgicalRobot\" width=\"142\" height=\"142\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot.jpg 142w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-75x75.jpg 75w\" sizes=\"(max-width: 142px) 100vw, 142px\">Remote surgery—where a surgeon in one location controls a medical robot in another—is extremely useful in places that don't have trained medical experts.\u003c/p>\n\u003cp>For these long distance operations, doctors often use a low-quality connection to the internet, or even wifi. But \u003ca href=\"http://www.washington.edu/news/2015/05/07/uw-researchers-hack-a-teleoperated-surgical-robot-to-reveal-security-flaws/\">researchers at the University of Washington\u003c/a> proved they could hack into these public communication systems that control teleoperated robots.\u003c/p>\n\u003cp>They accessed the network that controlled the robot and disrupted the signals, making the robot’s movement jerky and difficult to control. And by moving the robotic arms too quickly or beyond a predetermined point they could get the robot to shut down completely.\u003c/p>\n\u003cp>If this had occurred during an actual life-saving procedure the outcome could have been fatal. Fortunately the researchers also figured out ways to encrypt the device—the exact type of precaution the FDA encourages in its new draft guidance.\u003c/p>\n\u003cp>\u003cstrong>Hacker Proves He Can Kill a Patient Through a Drug Pump\u003c/strong>\u003c/p>\n\u003cp>\u003cimg class=\"alignleft size-full wp-image-103164\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125.jpg\" alt=\"FDA_Icon_InfusionPump_160125\" width=\"142\" height=\"142\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125.jpg 142w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-75x75.jpg 75w\" sizes=\"(max-width: 142px) 100vw, 142px\">In 2013 cybersecurity expert \u003ca href=\"https://www.linkedin.com/in/billyrios\">Billy Rios\u003c/a> remotely \u003ca href=\"http://ww2.kqed.org/futureofyou/2015/08/03/millions-of-americans-use-medical-devices-that-are-vulnerable-to-hacking/\">hacked into a Hospira infusion pump\u003c/a>. The pump releases controlled amounts of a substance and can be used to administer insulin to a diabetic or chemotherapy drugs to a cancer patient.\u003c/p>\n\u003cp>They're found in almost every hospital and usually sit next to a patient's bed. Hundreds of them can be monitored and controlled from a central station in the hospital.\u003c/p>\n\u003cp>Rios ordered the pump off of eBay for $100 and was able to figure out the device's pre-programmed password by reading its technical manuals. This information, in conjunction with knowledge about the device's software and what network it was operating on was enough to give him access.\u003c/p>\n\u003cp>He then proved he could remotely administer a lethal dose of drugs through the Hospira pump. Luckily Rios is a benign or \"white hat hacker\" and turned over his findings to the Department of Homeland security. His report galvanized the FDA to \u003ca href=\"http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm456815.htm\">issue its first warning\u003c/a> about a medical device.\u003c/p>\n\u003cp>\u003cstrong>Hackers Demand Ransom for Medical Records\u003c/strong>\u003c/p>\n\u003cp>\u003cimg class=\"alignleft size-full wp-image-103165\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/FDA_Icon_MediaRecords.jpg\" alt=\"FDA_Icon_MediaRecords\" width=\"142\" height=\"142\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords.jpg 142w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-75x75.jpg 75w\" sizes=\"(max-width: 142px) 100vw, 142px\">When \u003ca href=\"http://www.latimes.com/business/la-fi-ucla-medical-data-20150717-story.html\">4.5 million UCLA medical records\u003c/a> and \u003ca href=\"http://www.wsj.com/articles/anthem-hacked-database-included-78-8-million-people-1424807364\">78.8 million Anthem medical records \u003c/a>were hacked it made major headlines.\u003c/p>\n\u003cp>But smaller healthcare organizations aren't immune and one incident, north of Chicago, resembled a bank heist.\u003c/p>\n\u003cp>In 2012, \u003ca href=\"http://www.healthgrades.com/group-directory/il-illinois/libertyville/surgeons-of-lake-county-llc-ooo8pmb\">Surgeons of Lake County\u003c/a>, a small medical practice in Illinois, \u003ca href=\"https://www.send2press.com/newswire/2012-07-0720-001.shtml\">fell victim to a digital data breach\u003c/a>.\u003c/p>\n\u003cp>Hackers accessed the practice's server where e-mails and more than 7,000 electronic medical records were stored. The hackers then encrypted the files and demanded a ransom.\u003c/p>\n\u003cp>The doctors refused to comply and alerted local authorities. They also offered free credit monitoring services to patients following the attack.\u003c/p>\n\u003cp>The medical practice would not discuss the investigation. But the practice issued a press release to alert the public and the Department of Health and Human Services included the hack on its website, which lists \u003ca href=\"https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf\">breaches affecting 500 or more individuals\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The good news—the FDA says it hasn't received any reports of fatal cybersecurity breaches, which hospitals and device makers are required to report.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Hackers aren’t just breaking into email accounts and online banking systems anymore. They’re also exploiting healthcare—going after \u003ca href=\"http://www.latimes.com/business/la-fi-anthem-hack-fallout-20150206-story.html\">electronic medical records\u003c/a>, wifi enabled medical devices and even remotely controlled surgical robots.\u003c/p>\n\u003cp>Medical devices and records have emerged as big cyber security risks. That’s why the \u003ca href=\"http://www.fda.gov/\">Food and Drug Administration\u003c/a> recently proposed \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481968.htm\">new guidelines\u003c/a> for how medical device manufacturers should secure their products.\u003c/p>\n\u003cp>Among the FDA's recommendations, manufacturers are being asked to:\u003c/p>\n\u003cul>\n\u003cli>Develop a risk management program that includes a plan for when a vulnerability is discovered.\u003c/li>\n\u003cli>Write disclosure policies, so hospitals and patients understand which aspects of a device may be less secure.\u003c/li>\n\u003cli>Release regular software and hardware updates for medical devices after they’re on the market.\u003c/li>\n\u003c/ul>\n\u003cp>\u003cstrong>\u003cem>[Scroll down to see three real life cyber security attacks] \u003c/em>\u003c/strong>\u003c/p>\n\u003cp>But security experts, like \u003ca href=\"https://www.schneier.com/\">Bruce Schneier\u003c/a>, say non-legally binding guidelines are just not enough.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"It's basically industry best practice,\" says Schneier. \"But without enforcement, it's just pleading.\"\u003c/p>\n\u003cp>Critics are concerned that the responsibility is still primarily left up to manufacturers to disclose when a device has been hacked.\u003c/p>\n\u003cp>Consumer Watchdog president Jamie Court says recommendations are not enough and we won't see new laws until public officials are affected. \"All its gonna take is one congressman’s defibrillator being hacked and we’ll have some new laws really quickly,\" according to Court.\u003c/p>\n\u003cp>The FDA is \u003ca href=\"https://www.federalregister.gov/articles/2016/01/22/2016-01172/postmarket-management-of-cybersecurity-in-medical-devices-draft-guidance-for-industry-and-food-and\">taking public comments\u003c/a> on its \u003ca href=\"http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM482022.pdf\">guidelines\u003c/a> until April 21.\u003c/p>\n\u003cp>Read on to see three real life situations the FDA guidance is designed to prevent.\u003c/p>\n\u003cp>\u003cstrong>Security Experts Hack a Surgical Robot\u003c/strong>\u003c/p>\n\u003cp>\u003cimg class=\"alignleft size-full wp-image-103162\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot.jpg\" alt=\"FDA_Icon_SurgicalRobot\" width=\"142\" height=\"142\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot.jpg 142w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_SurgicalRobot-75x75.jpg 75w\" sizes=\"(max-width: 142px) 100vw, 142px\">Remote surgery—where a surgeon in one location controls a medical robot in another—is extremely useful in places that don't have trained medical experts.\u003c/p>\n\u003cp>For these long distance operations, doctors often use a low-quality connection to the internet, or even wifi. But \u003ca href=\"http://www.washington.edu/news/2015/05/07/uw-researchers-hack-a-teleoperated-surgical-robot-to-reveal-security-flaws/\">researchers at the University of Washington\u003c/a> proved they could hack into these public communication systems that control teleoperated robots.\u003c/p>\n\u003cp>They accessed the network that controlled the robot and disrupted the signals, making the robot’s movement jerky and difficult to control. And by moving the robotic arms too quickly or beyond a predetermined point they could get the robot to shut down completely.\u003c/p>\n\u003cp>If this had occurred during an actual life-saving procedure the outcome could have been fatal. Fortunately the researchers also figured out ways to encrypt the device—the exact type of precaution the FDA encourages in its new draft guidance.\u003c/p>\n\u003cp>\u003cstrong>Hacker Proves He Can Kill a Patient Through a Drug Pump\u003c/strong>\u003c/p>\n\u003cp>\u003cimg class=\"alignleft size-full wp-image-103164\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125.jpg\" alt=\"FDA_Icon_InfusionPump_160125\" width=\"142\" height=\"142\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125.jpg 142w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_InfusionPump_160125-75x75.jpg 75w\" sizes=\"(max-width: 142px) 100vw, 142px\">In 2013 cybersecurity expert \u003ca href=\"https://www.linkedin.com/in/billyrios\">Billy Rios\u003c/a> remotely \u003ca href=\"http://ww2.kqed.org/futureofyou/2015/08/03/millions-of-americans-use-medical-devices-that-are-vulnerable-to-hacking/\">hacked into a Hospira infusion pump\u003c/a>. The pump releases controlled amounts of a substance and can be used to administer insulin to a diabetic or chemotherapy drugs to a cancer patient.\u003c/p>\n\u003cp>They're found in almost every hospital and usually sit next to a patient's bed. Hundreds of them can be monitored and controlled from a central station in the hospital.\u003c/p>\n\u003cp>Rios ordered the pump off of eBay for $100 and was able to figure out the device's pre-programmed password by reading its technical manuals. This information, in conjunction with knowledge about the device's software and what network it was operating on was enough to give him access.\u003c/p>\n\u003cp>He then proved he could remotely administer a lethal dose of drugs through the Hospira pump. Luckily Rios is a benign or \"white hat hacker\" and turned over his findings to the Department of Homeland security. His report galvanized the FDA to \u003ca href=\"http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm456815.htm\">issue its first warning\u003c/a> about a medical device.\u003c/p>\n\u003cp>\u003cstrong>Hackers Demand Ransom for Medical Records\u003c/strong>\u003c/p>\n\u003cp>\u003cimg class=\"alignleft size-full wp-image-103165\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/01/FDA_Icon_MediaRecords.jpg\" alt=\"FDA_Icon_MediaRecords\" width=\"142\" height=\"142\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords.jpg 142w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/13/2016/01/FDA_Icon_MediaRecords-75x75.jpg 75w\" sizes=\"(max-width: 142px) 100vw, 142px\">When \u003ca href=\"http://www.latimes.com/business/la-fi-ucla-medical-data-20150717-story.html\">4.5 million UCLA medical records\u003c/a> and \u003ca href=\"http://www.wsj.com/articles/anthem-hacked-database-included-78-8-million-people-1424807364\">78.8 million Anthem medical records \u003c/a>were hacked it made major headlines.\u003c/p>\n\u003cp>But smaller healthcare organizations aren't immune and one incident, north of Chicago, resembled a bank heist.\u003c/p>\n\u003cp>In 2012, \u003ca href=\"http://www.healthgrades.com/group-directory/il-illinois/libertyville/surgeons-of-lake-county-llc-ooo8pmb\">Surgeons of Lake County\u003c/a>, a small medical practice in Illinois, \u003ca href=\"https://www.send2press.com/newswire/2012-07-0720-001.shtml\">fell victim to a digital data breach\u003c/a>.\u003c/p>\n\u003cp>Hackers accessed the practice's server where e-mails and more than 7,000 electronic medical records were stored. The hackers then encrypted the files and demanded a ransom.\u003c/p>\n\u003cp>The doctors refused to comply and alerted local authorities. They also offered free credit monitoring services to patients following the attack.\u003c/p>\n\u003cp>The medical practice would not discuss the investigation. But the practice issued a press release to alert the public and the Department of Health and Human Services included the hack on its website, which lists \u003ca href=\"https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf\">breaches affecting 500 or more individuals\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The good news—the FDA says it hasn't received any reports of fatal cybersecurity breaches, which hospitals and device makers are required to report.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Watch How Scientists Grow Mini-Brains",
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"content": "\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe src=\"//players.brightcove.net/245991542/344c319b-6d23-4cbc-975e-c8530534af8a_default/index.html?videoId=4714066937001\" frameborder=\"0\" width=\"100%\" height=\"500\" scrolling=\"yes\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>Time for another \"science-is-awesome-yet-freaks-me-out\" moment.\u003c/p>\n\u003cp>While this may not surprise anyone who has recently been following politics, apparently we are now in the era of the mini-brain.\u003c/p>\n\u003cp>Courtesy of the Boston Globe's Stat, check out this \u003ca href=\"http://www.statnews.com/2016/01/21/mini-brains-science-happens/\" target=\"_blank\">video\u003c/a> about Tufts University researchers who have concocted a way to create a tiny brain using mice neurons.\u003c/p>\n\u003cp>Scientists \"have perfected a recipe for growing millions of neurons inside a scaffolding of pure silk,\" Stat says. \"The neurons, drawn from mice, join together and send signals to each other, like real brains do. And they can survive in these brain-like webs for months.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The brains are about a centimeter long, and the webs that hold them are shaped into a doughnut-shaped cocoon made of silk.\u003c/p>\n\u003cp>It must be cool when someone asks, \"So what do you do?\" you can answer, \"I grow brains.\" But the real reason behind the project: a better understanding of how the human brain works. Currently, researchers are studying how the mini-brains respond to drugs and concussion-like injuries.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Let's just hope the famous \u003ca href=\"http://ww2.kqed.org/science/2015/07/21/can-a-thousand-tiny-swarming-robots-outsmart-nature/\" target=\"_blank\">tiny swarming robots\u003c/a> do not get a hold of these, lest we give up our role as the pre-eminent species on planet earth.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe src=\"//players.brightcove.net/245991542/344c319b-6d23-4cbc-975e-c8530534af8a_default/index.html?videoId=4714066937001\" frameborder=\"0\" width=\"100%\" height=\"500\" scrolling=\"yes\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>Time for another \"science-is-awesome-yet-freaks-me-out\" moment.\u003c/p>\n\u003cp>While this may not surprise anyone who has recently been following politics, apparently we are now in the era of the mini-brain.\u003c/p>\n\u003cp>Courtesy of the Boston Globe's Stat, check out this \u003ca href=\"http://www.statnews.com/2016/01/21/mini-brains-science-happens/\" target=\"_blank\">video\u003c/a> about Tufts University researchers who have concocted a way to create a tiny brain using mice neurons.\u003c/p>\n\u003cp>Scientists \"have perfected a recipe for growing millions of neurons inside a scaffolding of pure silk,\" Stat says. \"The neurons, drawn from mice, join together and send signals to each other, like real brains do. And they can survive in these brain-like webs for months.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The brains are about a centimeter long, and the webs that hold them are shaped into a doughnut-shaped cocoon made of silk.\u003c/p>\n\u003cp>It must be cool when someone asks, \"So what do you do?\" you can answer, \"I grow brains.\" But the real reason behind the project: a better understanding of how the human brain works. Currently, researchers are studying how the mini-brains respond to drugs and concussion-like injuries.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Let's just hope the famous \u003ca href=\"http://ww2.kqed.org/science/2015/07/21/can-a-thousand-tiny-swarming-robots-outsmart-nature/\" target=\"_blank\">tiny swarming robots\u003c/a> do not get a hold of these, lest we give up our role as the pre-eminent species on planet earth.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Lumosity CEO Admits Brain-Training Games May Not Ward Off Mental Decline",
"title": "Lumosity CEO Admits Brain-Training Games May Not Ward Off Mental Decline",
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"content": "\u003cp>Lumos Labs CEO Steve Berkowitz says his company is no longer making claims that its suite of cognitive training games can make your brain healthier. In fact, he admits \"the jury is still out\" on the efficacy of so-called brain-training.\u003c/p>\n\u003cp>\"We're not out there saying that there are direct benefits to it. We're not out there saying anything other than, 'Hey you know, this is something, give it a try.' \"\u003c/p>\n\u003caside class=\"pullquote alignright\">\"We're not out there saying anything other than, 'Hey you know, this is something, give it a try.' \"\u003c/aside>\n\u003cp>Lumos, based in San Francisco, was recently slammed by the Federal Trade Commission for deceptive advertising. \"Lumosity preyed on consumers’ fears about age-related cognitive decline, suggesting their games could stave off memory loss, dementia, and even Alzheimer’s disease,” the FTC said. “But Lumosity simply did not have the science to back up its ads.”\u003c/p>\n\u003cp>[contextly_sidebar id=\"pkXcCDOpysj05BqIY91OSL0YKzMO6UeP\"]Berkowitz's comments came in an interview with KQED Wednesday, a couple of weeks after the FTC announced Lumos would pay a $2 million penalty that would go to partial refunds to Lumosity customers. These users pay $14.95 per month or $299.95 per year to play games intended to improve memory, attention and other cognitive abilities, as well as potentially ward off maladies of aging like dementia.\u003c/p>\n\u003cp>The CEO said the company had \"pivoted\" to becoming a research platform for the study of cognitive training and that it wanted to put together a coalition of stakeholders in industry and academia to create guidelines and standards for future studies in the field.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"The foundation of all of this stuff is that it's new,\" he said. \"Any new industry is divisive and creates debate. And I think that's the good news about innovation.\"\u003c/p>\n\u003cp>\u003cstrong>Lumosity: Rapid Growth ... and Controversial\u003c/strong>\u003c/p>\n\u003cp>A little history:\u003c/p>\n\u003cp>Lumos Labs was founded in 2005 by \u003ca href=\"http://techcrunch.com/2013/04/03/founder-stories-lumositys-mike-scanlon-on-exercising-the-brain/\" target=\"_blank\">Michael Scanlon\u003c/a>, a Stanford Ph.D. student in neuroscience, David Drescher and Kunal Sarkar.\u003c/p>\n\u003cp>The idea was to create an online training program for your brain, leveraging research in \u003ca href=\"https://www.google.com/search?q=neuroplasticity\" target=\"_blank\">neuroplasticity \u003c/a>-- the mutable quality of the brain -- that showed the possibility of enhanced cognition through changing environment. In 2007, the company launched Lumosity, a website where you could exercise your brain by playing games and -- so its advertising went -- improve your memory, attention and other mental abilities.\u003c/p>\n\u003cp>By 2013, the company had \u003ca href=\"http://www.forbes.com/companies/lumosity/\" target=\"_blank\">made it onto Forbes’ list\u003c/a> of America’s Most Promising Companies, capitalizing on a brain-training \u003ca href=\"http://usatoday30.usatoday.com/tech/products/story/2011-08-24/Brain-training-games-are-new-exercise-craze/50125152/1\" target=\"_blank\">craze \u003c/a>and earning rave reviews in the \u003ca href=\"http://www.inc.com/magazine/201312/robin-schatz/from-research-lab-to-market-leader-in-no-time.html\" target=\"_blank\">business press\u003c/a>. In 2014, CNN Health \u003ca href=\"http://www.cnn.com/2014/09/09/health/brain-training-apps/\" target=\"_blank\">published a report\u003c/a> that rated Lumosity the best app to train your brain. More than 70 million people in 182 countries have played its games, Lumosity says.\u003c/p>\n\u003cp>As it grew, the company marketed itself on TV, radio and online. (In fact, the public radio audience has been one of its target audiences, as listeners can attest.) The general thrust of the ads was that Lumosity could “improve key skills and affect quality of life\" and that “healthy people have (used) brain training to sharpen their daily lives and ward off cognitive decline.” It published “success stories” on its website, including wide-eyed testimonials like this:\u003c/p>\n\u003cp>“In 2007, we learned that my mother had early onset Alzheimer’s. I joined Lumosity at first for my mother. I now use this site not only for her, but for my brain as well.”\u003c/p>\n\u003cp>Not everyone was on board. \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/22708717\" target=\"_blank\">Researchers \u003c/a>studying the topic found \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/22708717\" target=\"_blank\">little to no evidence\u003c/a> of sustained cognitive benefits from such exercises. Some studies determined they did \u003ca href=\"http://www.sciencedirect.com/science/article/pii/S0160289612000839\" target=\"_blank\">little more\u003c/a> than improve an ability to perform the narrow task a player was accessing in each game. In 2014, the Stanford Center on Longevity issued “\u003ca href=\"http://longevity3.stanford.edu/blog/2014/10/15/the-consensus-on-the-brain-training-industry-from-the-scientific-community-2/\" target=\"_blank\">A Consensus on the Brain Training Industry From the Scientific Community\u003c/a>,” signed by dozens of scientists in the field.\u003c/p>\n\u003cp>“To date, there is little evidence that playing brain games improves underlying broad cognitive abilities,” the analysis said, “or that it enables one to better navigate a complex realm of everyday life.\"\u003c/p>\n\u003cp>Currently, many researchers believe that although brain-training companies have greatly exaggerated the benefits of their products, \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/15/lumosity-cant-prove-claims-say-scientists-but-brain-training-worth-researching/\" target=\"_blank\">further study in the field is warranted\u003c/a>.\u003c/p>\n\u003cp>But the government did not feel the need to wait for the final verdict. It wanted Lumos to pay $50 million in redress, but \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/05/federal-court-orders-lumosity-to-stop-claiming-games-prevent-dementia/\" target=\"_blank\">settled for $2 million\u003c/a> after reviewing the company's finances. It also required Lumosity to notify customers it had settled “a deceptive advertising lawsuit” and provide a link to turn off auto-renewal of subscriptions.\u003c/p>\n\u003cp>\u003cstrong>'Passionate About the Product'\u003c/strong>\u003c/p>\n\u003cp>In the interview Wednesday, Berkowitz, who has only been on the job since November, seemed eager to distance the company from the controversial claims it has made in the past, and also renounce any notion that a product like Lumosity could be a panacea for the brain's inevitable decline.\u003c/p>\n\u003cp>\"It's never been a driver of this company, to be some health-related solution,” Berkowitz said. “As we go back and look at the kind of reasons why we're building the product, it really is to bring the idea of science back out to people.”\u003c/p>\n\u003cp>He said the type of hyperbolic language the FTC cited had been removed in 2014, before the FTC was involved, and was in any event \"a very small piece\" of the company's marketing. He likened the customer testimonials to which the FTC objected (you can \u003ca href=\"https://web.archive.org/web/20130112214959/http://www.lumosity.com/why-lumosity/success-stories\" target=\"_blank\">still see some of those here\u003c/a>, on the Internet Archive's WayBack Machine) to the user-generated reviews on Apple's App Store or Google Play.\u003c/p>\n\u003cp>\"These are things run by those companies and are independent,\" he said.\u003c/p>\n\u003cp>But didn't Lumosity choose to publish those particular testimonials?\u003c/p>\n\u003cp>\"It was on the website. So if you call it choosing to run it, yeah. Today, they're not up there.\"\u003c/p>\n\u003cp>The FTC also slammed Lumosity for soliciting users' success stories by offering prizes, without disclosing this fact on its site. Berkowitz attributed such problematic marketing decisions to growing pains.\u003c/p>\n\u003cp>\"As a young company, what you're doing, people are very passionate about the product,\" he said. Now \"we're focusing on making sure that the things that we're doing have a basis in fact.\"\u003c/p>\n\u003cp>As to the question of how many of his customers had availed themselves of the FTC-mandated option to cancel their auto-renewal, he said, \"We've had some, but I think nothing's been outside of our expectation.\"\u003c/p>\n\u003cp>Last August, market research firm MarketsandMarkets \u003ca href=\"http://www.marketsandmarkets.com/Market-Reports/cognitive-assessment-market-1039.html\" target=\"_blank\">predicted\u003c/a> that the cognitive assessment and training market will grow from $2.4 billion in 2015 to $7.5 billion by 2020.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Whether that number will have to be reassessed due to consumer doubt is anyone's guess.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Lumos Labs CEO Steve Berkowitz says his company is no longer making claims that its suite of cognitive training games can make your brain healthier. In fact, he admits \"the jury is still out\" on the efficacy of so-called brain-training.\u003c/p>\n\u003cp>\"We're not out there saying that there are direct benefits to it. We're not out there saying anything other than, 'Hey you know, this is something, give it a try.' \"\u003c/p>\n\u003caside class=\"pullquote alignright\">\"We're not out there saying anything other than, 'Hey you know, this is something, give it a try.' \"\u003c/aside>\n\u003cp>Lumos, based in San Francisco, was recently slammed by the Federal Trade Commission for deceptive advertising. \"Lumosity preyed on consumers’ fears about age-related cognitive decline, suggesting their games could stave off memory loss, dementia, and even Alzheimer’s disease,” the FTC said. “But Lumosity simply did not have the science to back up its ads.”\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>Berkowitz's comments came in an interview with KQED Wednesday, a couple of weeks after the FTC announced Lumos would pay a $2 million penalty that would go to partial refunds to Lumosity customers. These users pay $14.95 per month or $299.95 per year to play games intended to improve memory, attention and other cognitive abilities, as well as potentially ward off maladies of aging like dementia.\u003c/p>\n\u003cp>The CEO said the company had \"pivoted\" to becoming a research platform for the study of cognitive training and that it wanted to put together a coalition of stakeholders in industry and academia to create guidelines and standards for future studies 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>\"The foundation of all of this stuff is that it's new,\" he said. \"Any new industry is divisive and creates debate. And I think that's the good news about innovation.\"\u003c/p>\n\u003cp>\u003cstrong>Lumosity: Rapid Growth ... and Controversial\u003c/strong>\u003c/p>\n\u003cp>A little history:\u003c/p>\n\u003cp>Lumos Labs was founded in 2005 by \u003ca href=\"http://techcrunch.com/2013/04/03/founder-stories-lumositys-mike-scanlon-on-exercising-the-brain/\" target=\"_blank\">Michael Scanlon\u003c/a>, a Stanford Ph.D. student in neuroscience, David Drescher and Kunal Sarkar.\u003c/p>\n\u003cp>The idea was to create an online training program for your brain, leveraging research in \u003ca href=\"https://www.google.com/search?q=neuroplasticity\" target=\"_blank\">neuroplasticity \u003c/a>-- the mutable quality of the brain -- that showed the possibility of enhanced cognition through changing environment. In 2007, the company launched Lumosity, a website where you could exercise your brain by playing games and -- so its advertising went -- improve your memory, attention and other mental abilities.\u003c/p>\n\u003cp>By 2013, the company had \u003ca href=\"http://www.forbes.com/companies/lumosity/\" target=\"_blank\">made it onto Forbes’ list\u003c/a> of America’s Most Promising Companies, capitalizing on a brain-training \u003ca href=\"http://usatoday30.usatoday.com/tech/products/story/2011-08-24/Brain-training-games-are-new-exercise-craze/50125152/1\" target=\"_blank\">craze \u003c/a>and earning rave reviews in the \u003ca href=\"http://www.inc.com/magazine/201312/robin-schatz/from-research-lab-to-market-leader-in-no-time.html\" target=\"_blank\">business press\u003c/a>. In 2014, CNN Health \u003ca href=\"http://www.cnn.com/2014/09/09/health/brain-training-apps/\" target=\"_blank\">published a report\u003c/a> that rated Lumosity the best app to train your brain. More than 70 million people in 182 countries have played its games, Lumosity says.\u003c/p>\n\u003cp>As it grew, the company marketed itself on TV, radio and online. (In fact, the public radio audience has been one of its target audiences, as listeners can attest.) The general thrust of the ads was that Lumosity could “improve key skills and affect quality of life\" and that “healthy people have (used) brain training to sharpen their daily lives and ward off cognitive decline.” It published “success stories” on its website, including wide-eyed testimonials like this:\u003c/p>\n\u003cp>“In 2007, we learned that my mother had early onset Alzheimer’s. I joined Lumosity at first for my mother. I now use this site not only for her, but for my brain as well.”\u003c/p>\n\u003cp>Not everyone was on board. \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/22708717\" target=\"_blank\">Researchers \u003c/a>studying the topic found \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/22708717\" target=\"_blank\">little to no evidence\u003c/a> of sustained cognitive benefits from such exercises. Some studies determined they did \u003ca href=\"http://www.sciencedirect.com/science/article/pii/S0160289612000839\" target=\"_blank\">little more\u003c/a> than improve an ability to perform the narrow task a player was accessing in each game. In 2014, the Stanford Center on Longevity issued “\u003ca href=\"http://longevity3.stanford.edu/blog/2014/10/15/the-consensus-on-the-brain-training-industry-from-the-scientific-community-2/\" target=\"_blank\">A Consensus on the Brain Training Industry From the Scientific Community\u003c/a>,” signed by dozens of scientists in the field.\u003c/p>\n\u003cp>“To date, there is little evidence that playing brain games improves underlying broad cognitive abilities,” the analysis said, “or that it enables one to better navigate a complex realm of everyday life.\"\u003c/p>\n\u003cp>Currently, many researchers believe that although brain-training companies have greatly exaggerated the benefits of their products, \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/15/lumosity-cant-prove-claims-say-scientists-but-brain-training-worth-researching/\" target=\"_blank\">further study in the field is warranted\u003c/a>.\u003c/p>\n\u003cp>But the government did not feel the need to wait for the final verdict. It wanted Lumos to pay $50 million in redress, but \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/01/05/federal-court-orders-lumosity-to-stop-claiming-games-prevent-dementia/\" target=\"_blank\">settled for $2 million\u003c/a> after reviewing the company's finances. It also required Lumosity to notify customers it had settled “a deceptive advertising lawsuit” and provide a link to turn off auto-renewal of subscriptions.\u003c/p>\n\u003cp>\u003cstrong>'Passionate About the Product'\u003c/strong>\u003c/p>\n\u003cp>In the interview Wednesday, Berkowitz, who has only been on the job since November, seemed eager to distance the company from the controversial claims it has made in the past, and also renounce any notion that a product like Lumosity could be a panacea for the brain's inevitable decline.\u003c/p>\n\u003cp>\"It's never been a driver of this company, to be some health-related solution,” Berkowitz said. “As we go back and look at the kind of reasons why we're building the product, it really is to bring the idea of science back out to people.”\u003c/p>\n\u003cp>He said the type of hyperbolic language the FTC cited had been removed in 2014, before the FTC was involved, and was in any event \"a very small piece\" of the company's marketing. He likened the customer testimonials to which the FTC objected (you can \u003ca href=\"https://web.archive.org/web/20130112214959/http://www.lumosity.com/why-lumosity/success-stories\" target=\"_blank\">still see some of those here\u003c/a>, on the Internet Archive's WayBack Machine) to the user-generated reviews on Apple's App Store or Google Play.\u003c/p>\n\u003cp>\"These are things run by those companies and are independent,\" he said.\u003c/p>\n\u003cp>But didn't Lumosity choose to publish those particular testimonials?\u003c/p>\n\u003cp>\"It was on the website. So if you call it choosing to run it, yeah. Today, they're not up there.\"\u003c/p>\n\u003cp>The FTC also slammed Lumosity for soliciting users' success stories by offering prizes, without disclosing this fact on its site. Berkowitz attributed such problematic marketing decisions to growing pains.\u003c/p>\n\u003cp>\"As a young company, what you're doing, people are very passionate about the product,\" he said. Now \"we're focusing on making sure that the things that we're doing have a basis in fact.\"\u003c/p>\n\u003cp>As to the question of how many of his customers had availed themselves of the FTC-mandated option to cancel their auto-renewal, he said, \"We've had some, but I think nothing's been outside of our expectation.\"\u003c/p>\n\u003cp>Last August, market research firm MarketsandMarkets \u003ca href=\"http://www.marketsandmarkets.com/Market-Reports/cognitive-assessment-market-1039.html\" target=\"_blank\">predicted\u003c/a> that the cognitive assessment and training market will grow from $2.4 billion in 2015 to $7.5 billion by 2020.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>Dozens of makers of medicines and diagnostic tests have joined together in an unprecedented effort to tackle \"superbugs\" — infections that increasingly don't respond to drugs and threaten millions of people in countries rich and poor.\u003c/p>\n\u003cp>Altogether, 74 drugmakers, 11 makers of diagnostic tests and nine industry groups have signed a groundbreaking agreement to work with governments and each other to prevent and improve treatment of drug-resistant infections. They plan to announce the new agreement Thursday at the World Economic Forum in Davos, Switzerland.\u003c/p>\n\u003caside class=\"pullquote alignright\">By 2050, superbugs are expected to kill about 10 million people annually without major intervention.\u003c/aside>\n\u003cp>The effort is sorely needed. Many common infections no longer respond to conventional drugs, mainly due to overuse of antibiotics, few new drugs to fight bacteria, viruses, parasites and fungi, and declining industry research in the field. A key factor driving those problems is the relatively low prices infection-fighting medicines bring, compared to many drugs patients take for years for chronic conditions.\u003c/p>\n\u003cp>Bacteria and other microbes can naturally develop resistance to drugs, particularly when patients don't take all of their prescriptions and the stronger microbes survive and multiply. Taking antibiotics for viruses and other nonbacterial infections also contributes to resistance. And widespread use of antibiotics to spur faster growth of livestock raised for food exacerbates the problem. Meanwhile, in poor countries, many people can't afford these medications and die unnecessarily.\u003c/p>\n\u003cp>With more and more bugs evolving to overcome infection-fighting drugs, by 2050 superbugs are expected to kill about 10 million people annually without major intervention. That's according to a recent analysis, called \"The Review on Antimicrobial Resistance,\" commissioned in 2014 by the UK government. The analysis also forecasts global economic output will be reduced by a total of $100 trillion by 2050.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Against that backdrop, drug and device makers and industry groups from 16 countries have signed the \"Declaration on Combating Antimicrobial Resistance.\" It's the first statement on how government and industry should work together to prevent more antimicrobial drugs from becoming ineffective, encourage development of new drugs and provide access to them for all those needing the medicines, regardless of their income or location.\u003c/p>\n\u003cp>\"Antimicrobials are the backbone of modern medicine, and have played a key role in increasing life expectancy globally,\" Dr. Paul Stoffels, Johnson & Johnson's chief scientific officer, said in a statement. \"For the world to continue to have new antibiotics, we need investments in basic science and novel incentive models for industry R&D, and to protect our existing treatments, we need new frameworks for appropriate use.\"\u003c/p>\n\u003cp>Other companies participating in the effort include companies making antimicrobial drugs and vaccines, such as GlaxoSmithKline PLC, Novartis AG and Pfizer Inc. They're joined by companies such as the Roche Group and Alere Inc. that make tests used to diagnose the specific type of infection a patient has. Those are crucial to ensure the patient gets the best treatment, rather than an antibiotic for an infection caused by a virus or other organism.\u003c/p>\n\u003cp>The declaration calls for steps including:\u003c/p>\n\u003cp>—governments committing funding to implement the World Health Organization's Global Action Plan to create programs ensuring that health systems use antibiotics appropriately, along with increasing use of fast diagnostic tests and boosting reimbursements for them to ensure patients get the correct treatment.\u003c/p>\n\u003cp>—better education of doctors and nurses on appropriate antibiotic use.\u003c/p>\n\u003cp>—improved infection control through better hygiene, vaccination and preventive treatments.\u003c/p>\n\u003cp>—reduced used of antibiotics in livestock.\u003c/p>\n\u003cp>—higher reimbursements for antibiotics and diagnostic tests in developed markets.\u003c/p>\n\u003cp>—more collaboration between researchers at drugmakers and those at universities and government.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>—more access to antibiotics in countries around the world.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Dozens of makers of medicines and diagnostic tests have joined together in an unprecedented effort to tackle \"superbugs\" — infections that increasingly don't respond to drugs and threaten millions of people in countries rich and poor.\u003c/p>\n\u003cp>Altogether, 74 drugmakers, 11 makers of diagnostic tests and nine industry groups have signed a groundbreaking agreement to work with governments and each other to prevent and improve treatment of drug-resistant infections. They plan to announce the new agreement Thursday at the World Economic Forum in Davos, Switzerland.\u003c/p>\n\u003caside class=\"pullquote alignright\">By 2050, superbugs are expected to kill about 10 million people annually without major intervention.\u003c/aside>\n\u003cp>The effort is sorely needed. Many common infections no longer respond to conventional drugs, mainly due to overuse of antibiotics, few new drugs to fight bacteria, viruses, parasites and fungi, and declining industry research in the field. A key factor driving those problems is the relatively low prices infection-fighting medicines bring, compared to many drugs patients take for years for chronic conditions.\u003c/p>\n\u003cp>Bacteria and other microbes can naturally develop resistance to drugs, particularly when patients don't take all of their prescriptions and the stronger microbes survive and multiply. Taking antibiotics for viruses and other nonbacterial infections also contributes to resistance. And widespread use of antibiotics to spur faster growth of livestock raised for food exacerbates the problem. Meanwhile, in poor countries, many people can't afford these medications and die unnecessarily.\u003c/p>\n\u003cp>With more and more bugs evolving to overcome infection-fighting drugs, by 2050 superbugs are expected to kill about 10 million people annually without major intervention. That's according to a recent analysis, called \"The Review on Antimicrobial Resistance,\" commissioned in 2014 by the UK government. The analysis also forecasts global economic output will be reduced by a total of $100 trillion by 2050.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"info": "Gentrification is changing cities across America, forcing people from neighborhoods they have long called home. Call them the displaced. Now those priced out of the Bay Area are looking for a better life in an unlikely place. American Suburb follows this migration to one California town along the Delta, 45 miles from San Francisco. But is this once sleepy suburb ready for them?",
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},
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"id": "baycurious",
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"tagline": "Exploring the Bay Area, one question at a time",
"info": "KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.",
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},
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},
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"info": "KQED’s statewide radio news program providing daily coverage of issues, trends and public policy decisions.",
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"order": 8
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"tagline": "Your state, your stories",
"info": "Every week, The California Report Magazine takes you on a road trip for the ears: to visit the places and meet the people who make California unique. The in-depth storytelling podcast from the California Report.",
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"airtime": "SUN 1pm-2pm, TUE 10pm, WED 1am",
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"source": "City Arts & Lectures"
},
"link": "https://www.cityarts.net",
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"order": 1
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"title": "Code Switch / Life Kit",
"info": "\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />",
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"id": "commonwealth-club",
"title": "Commonwealth Club of California Podcast",
"info": "The Commonwealth Club of California is the nation's oldest and largest public affairs forum. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. This podcast feed is usually updated twice a week and is always un-edited.",
"airtime": "THU 10pm, FRI 1am",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Commonwealth-Club-Podcast-Tile-360x360-1.jpg",
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"source": "Commonwealth Club of California"
},
"link": "/radio/program/commonwealth-club",
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"title": "Forum",
"tagline": "The conversation starts here",
"info": "KQED’s live call-in program discussing local, state, national and international issues, as well as in-depth interviews.",
"airtime": "MON-FRI 9am-11am, 10pm-11pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Forum-Podcast-Tile-703x703-1.jpg",
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"order": 9
},
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"meta": {
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"source": "WNYC"
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"info": "A live production of NPR and WBUR Boston, in collaboration with stations across the country, Here & Now reflects the fluid world of news as it's happening in the middle of the day, with timely, in-depth news, interviews and conversation. Hosted by Robin Young, Jeremy Hobson and Tonya Mosley.",
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"hidden-brain": {
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"info": "Shankar Vedantam uses science and storytelling to reveal the unconscious patterns that drive human behavior, shape our choices and direct our relationships.",
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"airtime": "SUN 7pm-8pm",
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"source": "NPR"
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"how-i-built-this": {
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"title": "How I Built This with Guy Raz",
"info": "Guy Raz dives into the stories behind some of the world's best known companies. How I Built This weaves a narrative journey about innovators, entrepreneurs and idealists—and the movements they built.",
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"airtime": "SUN 7:30pm-8pm",
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"hyphenacion": {
"id": "hyphenacion",
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"tagline": "Where conversation and cultura meet",
"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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"jerrybrown": {
"id": "jerrybrown",
"title": "The Political Mind of Jerry Brown",
"tagline": "Lessons from a lifetime in politics",
"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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"order": 18
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},
"latino-usa": {
"id": "latino-usa",
"title": "Latino USA",
"airtime": "MON 1am-2am, SUN 6pm-7pm",
"info": "Latino USA, the radio journal of news and culture, is the only national, English-language radio program produced from a Latino perspective.",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/latinoUsa.jpg",
"officialWebsiteLink": "http://latinousa.org/",
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},
"link": "/radio/program/latino-usa",
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"apple": "https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=79681317&at=11l79Y&ct=nprdirectory",
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"rss": "https://feeds.npr.org/510016/podcast.xml"
}
},
"marketplace": {
"id": "marketplace",
"title": "Marketplace",
"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.",
"airtime": "MON-FRI 4pm-4:30pm, MON-WED 6:30pm-7pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Marketplace-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.marketplace.org/",
"meta": {
"site": "news",
"source": "American Public Media"
},
"link": "/radio/program/marketplace",
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"rss": "https://feeds.publicradio.org/public_feeds/marketplace-pm/rss/rss"
}
},
"masters-of-scale": {
"id": "masters-of-scale",
"title": "Masters of Scale",
"info": "Masters of Scale is an original podcast in which LinkedIn co-founder and Greylock Partner Reid Hoffman sets out to describe and prove theories that explain how great entrepreneurs take their companies from zero to a gazillion in ingenious fashion.",
"airtime": "Every other Wednesday June 12 through October 16 at 8pm (repeats Thursdays at 2am)",
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"officialWebsiteLink": "https://mastersofscale.com/",
"meta": {
"site": "radio",
"source": "WaitWhat"
},
"link": "/radio/program/masters-of-scale",
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"rss": "https://rss.art19.com/masters-of-scale"
}
},
"mindshift": {
"id": "mindshift",
"title": "MindShift",
"tagline": "A podcast about the future of learning and how we raise our kids",
"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>",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg",
"imageAlt": "KQED MindShift: How We Will Learn",
"officialWebsiteLink": "/mindshift/",
"meta": {
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"source": "kqed",
"order": 12
},
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