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"content": "\u003cp>Stanford Medicine is holding its fourth Big Data in Biomedicine Conference today and Thursday. From the website: \"Now in its fourth year, the event provides a forum for experts to discuss ways to use large-scale data analysis and technology to improve human health. This year’s event will include a focus on Stanford Medicine’s work in precision health\"\u003c/p>\n\u003cp>Here's the \u003ca href=\"http://scopeblog.stanford.edu/2016/05/25/stanfords-big-data-in-biomedicine-conference-begins-today/\" target=\"_blank\">schedule of speakers\u003c/a>. Dr. Robert Califf, head of the FDA, will speak at 4:15 p.m. today. Tomorrow's schedule includes a panel discussion on digital health and technology featuring a partner with Google Ventures, among others.\u003c/p>\n\u003cp>Click on the photo and scroll down to watch live.\u003c/p>\n\u003cp>\u003ca href=\"http://bigdata.stanford.edu/\">\u003cimg class=\"aligncenter size-full wp-image-170418\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/Screen-shot-2016-05-25-at-11.06.17-AM.png\" alt=\"Screen shot 2016-05-25 at 11.06.17 AM\" width=\"780\" height=\"574\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/Screen-shot-2016-05-25-at-11.06.17-AM.png 780w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Screen-shot-2016-05-25-at-11.06.17-AM-400x294.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Screen-shot-2016-05-25-at-11.06.17-AM-768x565.png 768w\" sizes=\"(max-width: 780px) 100vw, 780px\">\u003c/a>\u003c/p>\n\u003cp>You can also follow on Twitter:\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>[twitter-timeline id=735537076590936064 username=jbrooksfoy]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>[twitter-timeline id=735537076590936064 username=jbrooksfoy]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003c/p>\n[twitter-timeline id=735537076590936064]\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Stanford Medicine is holding its fourth Big Data in Biomedicine Conference today and Thursday. From the website: \"Now in its fourth year, the event provides a forum for experts to discuss ways to use large-scale data analysis and technology to improve human health. This year’s event will include a focus on Stanford Medicine’s work in precision health\"\u003c/p>\n\u003cp>Here's the \u003ca href=\"http://scopeblog.stanford.edu/2016/05/25/stanfords-big-data-in-biomedicine-conference-begins-today/\" target=\"_blank\">schedule of speakers\u003c/a>. Dr. Robert Califf, head of the FDA, will speak at 4:15 p.m. today. Tomorrow's schedule includes a panel discussion on digital health and technology featuring a partner with Google Ventures, among others.\u003c/p>\n\u003cp>Click on the photo and scroll down to watch live.\u003c/p>\n\u003cp>\u003ca href=\"http://bigdata.stanford.edu/\">\u003cimg class=\"aligncenter size-full wp-image-170418\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/Screen-shot-2016-05-25-at-11.06.17-AM.png\" alt=\"Screen shot 2016-05-25 at 11.06.17 AM\" width=\"780\" height=\"574\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/Screen-shot-2016-05-25-at-11.06.17-AM.png 780w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Screen-shot-2016-05-25-at-11.06.17-AM-400x294.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/Screen-shot-2016-05-25-at-11.06.17-AM-768x565.png 768w\" sizes=\"(max-width: 780px) 100vw, 780px\">\u003c/a>\u003c/p>\n\u003cp>You can also follow on Twitter:\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"disqusTitle": "Will MinuteClinics In Northern California Cut Wait Times for Veterans?",
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"content": "\u003cp>Struggling with long wait times, the Veterans Affairs Health Care System is trying something new: a partnership with the CVS Pharmacy chain \u003ca href=\"http://cvshealth.com/newsroom/press-releases/minuteclinic-announces-first-its-kind-initiative-veterans-affairs-palo-alto\">to offer urgent care\u003c/a> services to more than 65,000 veterans.\u003c/p>\n\u003cp>The experiment begins today at the VA's operations in Palo Alto, Calif.\u003c/p>\n\u003cp>Veterans can visit 14 \u003ca href=\"http://www.cvs.com/minuteclinic/visit/about-us\">CVS MinuteClinics\u003c/a> in the San Francisco Bay Area and Sacramento, where staff will treat them for conditions such as respiratory infections, order lab tests and prescribe medications which can be filled at CVS pharmacies.\u003c/p>\n\u003cp>The care will be free for veterans, and the VA will reimburse CVS for the treatment and medications. Whether the partnership will spread to other VA locales isn't yet clear.\u003c/p>\n\u003cp>The collaboration comes amid renewed scrutiny of the nation's troubled VA health system, which has tried without much success to improve long wait times for veterans needing health care.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Despite a $10 billion program called Veterans Choice that allows veterans to receive care outside the closed VA system, vets nationwide wait for an appointment even longer than they did before the program started in 2014, according to a \u003ca href=\"http://www.gao.gov/assets/680/675867.pdf\">federal audit\u003c/a>.\u003c/p>\n\u003cp>The MinuteClinic partnership isn't part of the Veterans Choice program.\u003c/p>\n\u003cp>\"The concern has always been, how do we make sure veterans get the care they need in a timely way and in a way that works for the veteran?\" said \u003ca href=\"http://www.ptsd.va.gov/professional/continuing_ed/presenters/ezeji-okoye-md.asp\">Dr. Stephen Ezeji-Okoye\u003c/a>, the Palo Alto VA's deputy chief of staff. The deal indicates that the VA is willing to try outside partnerships to meet veterans' needs, he said. \"We want to have not just timely access but geographic access to care.\"\u003c/p>\n\u003cp>Sarah Russell, the Palo Alto VA's chief medical informatics officer, came up with the idea, said Ezeji-Okoye.\u003c/p>\n\u003cp>The VA will integrate MinuteClinics' patient records with its own electronic health records to provide consistency of care, Ezeji-Okoye said.\u003c/p>\n\u003cp>The Palo Alto VA fares better than some other facilities nationwide in providing timely care to veterans, \u003ca href=\"http://www.va.gov/HEALTH/docs/DR45_052016_Pending_and_EWL_Biweekly_Desired_Date_Division.pdf\">according to VA data\u003c/a>, and Ezeji-Okoye said most patients with urgent care needs are seen quickly.\u003c/p>\n\u003cp>But the system was so busy in the past year that \u003ca href=\"http://www.va.gov/HEALTH/docs/DR45_052016_Pending_and_EWL_Biweekly_Desired_Date_Division.pdf\">about 11 percent\u003c/a> of appointments at its network of hospitals and clinics – which stretch south from Sonora to Monterey – couldn't be scheduled within 30 or fewer days, which is considered an acceptable time frame, \u003ca href=\"http://www.va.gov/HEALTH/docs/DR45_052016_Pending_and_EWL_Biweekly_Desired_Date_Division.pdf\">VA data show\u003c/a>. That includes appointments that would require urgent care.\u003c/p>\n\u003cp>More than 5,000 appointments systemwide were scheduled more than 30 days out, but each hospital and clinic's performance varied widely. At a Fremont clinic, less than 2 percent of appointment requests couldn't be scheduled within 30 days. At the VA's rural Modesto clinic, by contrast, more than 17 percent of requests weren't scheduled within 30 days.\u003c/p>\n\u003cp>Once the MinuteClinic operation is well underway, Ezeji-Okoye anticipates that between 10 and 15 veterans – from among the estimated 150 who call the Palo Alto VA's advice nurse hotline daily – will be treated at the retail clinics on any given day.\u003c/p>\n\u003cp>About 95,000 veterans are eligible to use the Palo Alto system, one of the VA's largest in the Western United States. About 65,000 use it every year.\u003c/p>\n\u003cp>The $330,000 pilot project will be evaluated after one year. CVS' MinuteClinic president, Dr. Andrew Sussman, hopes it can be rolled out nationally if it succeeds. CVS is by far the biggest player in retail pharmacy clinics, operating 1,135 of them in 35 states.\u003c/p>\n\u003cp>\"We'd love to have that opportunity to expand after we go through this phase,\" Sussman said. \"We're well-suited to help because of our large footprint and ability to see people on a quick basis.\"\u003c/p>\n\u003cp>It is unclear, however, what the VA's nationwide plans are. The Veterans Health Administration office didn't respond to Kaiser Health News' request for comment.\u003c/p>\n\u003cp>Blake Schindler, a retired Army major who lives in Santa Clara near one of the participating MinuteClinics, was intrigued, but cautious about the idea. He counts himself lucky, because unlike some other veterans, he has access to the U.S. military's TRICARE health insurance program for active and some retired service members.\u003c/p>\n\u003cp>\"It could make a big difference, but how much access are the veterans going to have? That was the big problem with the Veterans Choice program; it didn't end up the way it was supposed to,\" said Schindler, 58.\u003c/p>\n\u003cp>\"I'm always hopeful when I hear about these things; I keep an open mind until I have experience with it,\" he added.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\">Kaiser Health News\u003c/a>, which publishes California Healthline, a service of the California Health Care Foundation. You can follow Barbara Feder Ostrov on Twitter:\u003c/em> \u003ca href=\"https://twitter.com/barbfederostrov\">@barbfederostrov\u003c/a>.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 Kaiser Health News. 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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Despite a $10 billion program called Veterans Choice that allows veterans to receive care outside the closed VA system, vets nationwide wait for an appointment even longer than they did before the program started in 2014, according to a \u003ca href=\"http://www.gao.gov/assets/680/675867.pdf\">federal audit\u003c/a>.\u003c/p>\n\u003cp>The MinuteClinic partnership isn't part of the Veterans Choice program.\u003c/p>\n\u003cp>\"The concern has always been, how do we make sure veterans get the care they need in a timely way and in a way that works for the veteran?\" said \u003ca href=\"http://www.ptsd.va.gov/professional/continuing_ed/presenters/ezeji-okoye-md.asp\">Dr. Stephen Ezeji-Okoye\u003c/a>, the Palo Alto VA's deputy chief of staff. The deal indicates that the VA is willing to try outside partnerships to meet veterans' needs, he said. \"We want to have not just timely access but geographic access to care.\"\u003c/p>\n\u003cp>Sarah Russell, the Palo Alto VA's chief medical informatics officer, came up with the idea, said Ezeji-Okoye.\u003c/p>\n\u003cp>The VA will integrate MinuteClinics' patient records with its own electronic health records to provide consistency of care, Ezeji-Okoye said.\u003c/p>\n\u003cp>The Palo Alto VA fares better than some other facilities nationwide in providing timely care to veterans, \u003ca href=\"http://www.va.gov/HEALTH/docs/DR45_052016_Pending_and_EWL_Biweekly_Desired_Date_Division.pdf\">according to VA data\u003c/a>, and Ezeji-Okoye said most patients with urgent care needs are seen quickly.\u003c/p>\n\u003cp>But the system was so busy in the past year that \u003ca href=\"http://www.va.gov/HEALTH/docs/DR45_052016_Pending_and_EWL_Biweekly_Desired_Date_Division.pdf\">about 11 percent\u003c/a> of appointments at its network of hospitals and clinics – which stretch south from Sonora to Monterey – couldn't be scheduled within 30 or fewer days, which is considered an acceptable time frame, \u003ca href=\"http://www.va.gov/HEALTH/docs/DR45_052016_Pending_and_EWL_Biweekly_Desired_Date_Division.pdf\">VA data show\u003c/a>. That includes appointments that would require urgent care.\u003c/p>\n\u003cp>More than 5,000 appointments systemwide were scheduled more than 30 days out, but each hospital and clinic's performance varied widely. At a Fremont clinic, less than 2 percent of appointment requests couldn't be scheduled within 30 days. At the VA's rural Modesto clinic, by contrast, more than 17 percent of requests weren't scheduled within 30 days.\u003c/p>\n\u003cp>Once the MinuteClinic operation is well underway, Ezeji-Okoye anticipates that between 10 and 15 veterans – from among the estimated 150 who call the Palo Alto VA's advice nurse hotline daily – will be treated at the retail clinics on any given day.\u003c/p>\n\u003cp>About 95,000 veterans are eligible to use the Palo Alto system, one of the VA's largest in the Western United States. About 65,000 use it every year.\u003c/p>\n\u003cp>The $330,000 pilot project will be evaluated after one year. CVS' MinuteClinic president, Dr. Andrew Sussman, hopes it can be rolled out nationally if it succeeds. CVS is by far the biggest player in retail pharmacy clinics, operating 1,135 of them in 35 states.\u003c/p>\n\u003cp>\"We'd love to have that opportunity to expand after we go through this phase,\" Sussman said. \"We're well-suited to help because of our large footprint and ability to see people on a quick basis.\"\u003c/p>\n\u003cp>It is unclear, however, what the VA's nationwide plans are. The Veterans Health Administration office didn't respond to Kaiser Health News' request for comment.\u003c/p>\n\u003cp>Blake Schindler, a retired Army major who lives in Santa Clara near one of the participating MinuteClinics, was intrigued, but cautious about the idea. He counts himself lucky, because unlike some other veterans, he has access to the U.S. military's TRICARE health insurance program for active and some retired service members.\u003c/p>\n\u003cp>\"It could make a big difference, but how much access are the veterans going to have? That was the big problem with the Veterans Choice program; it didn't end up the way it was supposed to,\" said Schindler, 58.\u003c/p>\n\u003cp>\"I'm always hopeful when I hear about these things; I keep an open mind until I have experience with it,\" he added.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\">Kaiser Health News\u003c/a>, which publishes California Healthline, a service of the California Health Care Foundation. You can follow Barbara Feder Ostrov on Twitter:\u003c/em> \u003ca href=\"https://twitter.com/barbfederostrov\">@barbfederostrov\u003c/a>.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\">Kaiser Health News\u003c/a>.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=To+Cut+Wait+Times%2C+VA+Tries+MinuteClinics+In+Northern+California&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>In a lab at the Massachusetts Institute of Technology, all the work that happens in a vast pharmaceutical manufacturing plant happens in a device the size of your kitchen refrigerator.\u003c/p>\n\u003cp>And it's fast. This prototype machine produces 1,000 pills in 24 hours, faster than it can take to produce some batches in a factory. \u003ca href=\"http://web.mit.edu/cheme/people/profile.html?id=49\">Allan Myerson\u003c/a>, a professor of chemical engineering at MIT and a leader of the effort, says it could become eventually an option for anyone who makes medications, which typically require a lengthy and complex process of crystallization.\u003c/p>\n\u003cp>\"We're giving them an alternative to traditional plants and we're reducing the time it takes to manufacturer a drug,\" he says.\u003c/p>\n\u003cp>The Defense Department is funding this project because the devices could go to field hospitals for troops, hard-to-reach areas to help combat a disease outbreak, or be dropped at strategic spots across the U.S.\u003c/p>\n\u003cp>\"If there was an emergency you could have these little plants located all over. You just turn them on and you start turning out different pharmaceuticals that are needed,\" Myerson says.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Sounds simple? It's not. This mini drug plant represents a sea change in how medications have been made for a long time.\u003c/p>\n\u003cp>\"For roughly two centuries, to be honest,\" says \u003ca href=\"http://web.mit.edu/chemistry/jamison/Group/TFJ/TFJ.html\">Tim Jamison\u003c/a>, a professor of chemistry at MIT and one of Myerson's partners, along with \u003ca href=\"http://web.mit.edu/jensenlab/\">Klavs Jensen\u003c/a>, a professor of chemical engineering at MIT. \"The way that we tend to do chemistry is in flasks and beakers and that sort of thing, and we call that batch chemistry — one batch at a time,\" he says.\u003c/p>\n\u003cp>That's the way virtually all pharmaceuticals are made. Big batches of chemicals are synthesized, then they have to cool down, then are synthesized again to create new compounds. Then those compounds have to crystallize, filter and dry. Powders are added to make a tablet or capsule. These steps that can take months. This new device, says Jamison, produces medicine in one fast continuous process.\u003c/p>\n\u003cp>\"We had to figure out new ways to make molecules, new ways to think about making molecules but from my perspective that has also provided us with a lot of opportunities that are very powerful,\" says Jamison. His lab and Myerson's also are collaborating with the \u003ca href=\"https://novartis-mit.mit.edu/\">Novartis- MIT Center for Continuous Manufacturing\u003c/a>, which is funded by the pharmaceutical company Novartis.\u003c/p>\n\u003cp>The prototype raises the possibility that hospitals and pharmacies could make their own pills as needed, says James McQuivey, an analyst at Forrester Research.\u003c/p>\n\u003cp>\"If it can done at lower cost, here's one way at least that we could reduce the exorbitant cost of medications and that could a social good as well as an economic good,\" McQuivey says.\u003c/p>\n\u003cp>Most of the cost of an expensive drug is not the materials or manufacturing or transportation says McQuivey; it's in the drug makers' monopoly control. So, he says, \"If we can distribute the manufacturing of anything, pharmaceuticals included, so that more people have the opportunity to manufacture it, now there will be competition among those manufacturers.\"\u003c/p>\n\u003cp>Drug makers have at least two big concerns about the widespread use of this device, says \u003ca href=\"https://www.brandeis.edu/facultyguide/person.html?emplid=26e88d31e32aad89974f01e99c5c4f56618a695f\">Dr. Paul Beninger\u003c/a>, who oversees pharmaceutical safety at manufacturer Genzyme Sanofi. He said first and foremost, the drug industry worries about intellectual property rights.\u003c/p>\n\u003cp>Drug manufacturers own \u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm#How%20long%20is%20exclusivity%20granted%20for?\">exclusive rights\u003c/a> to produce the drugs they develop for a period of time, typically three to five years depending on how much is new in the drug. His other worry is safety, including monitoring of machines to ensure quality and safety.\u003c/p>\n\u003cp>\"There are some really significant issues that this MIT project has to deal with if they're going to try and make this a successful venture,\" he says.\u003c/p>\n\u003cp>MIT researchers say continuous monitoring would be built into the continuous production process. The Food and Drug Administration is \u003ca href=\"http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM341197.pdf\">working on\u003c/a> how to oversee this type of process.\u003c/p>\n\u003cp>On the patent concern, MIT developers say the device is being tested to make generic drugs for now, but that pharmacies or hospitals might someday license the right to produce drugs that have just been approved, not existing ones.\u003c/p>\n\u003cp>For now, their focus is on making an even smaller more portable unit, producing more and more complex drugs and seeking FDA approval for the device.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This story is part of a reporting partnership with NPR, WBUR and\u003c/em> \u003ca href=\"http://www.kaiserhealthnews.org\">Kaiser Health News\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 WBUR. 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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>In a lab at the Massachusetts Institute of Technology, all the work that happens in a vast pharmaceutical manufacturing plant happens in a device the size of your kitchen refrigerator.\u003c/p>\n\u003cp>And it's fast. This prototype machine produces 1,000 pills in 24 hours, faster than it can take to produce some batches in a factory. \u003ca href=\"http://web.mit.edu/cheme/people/profile.html?id=49\">Allan Myerson\u003c/a>, a professor of chemical engineering at MIT and a leader of the effort, says it could become eventually an option for anyone who makes medications, which typically require a lengthy and complex process of crystallization.\u003c/p>\n\u003cp>\"We're giving them an alternative to traditional plants and we're reducing the time it takes to manufacturer a drug,\" he says.\u003c/p>\n\u003cp>The Defense Department is funding this project because the devices could go to field hospitals for troops, hard-to-reach areas to help combat a disease outbreak, or be dropped at strategic spots across the U.S.\u003c/p>\n\u003cp>\"If there was an emergency you could have these little plants located all over. You just turn them on and you start turning out different pharmaceuticals that are needed,\" Myerson says.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Sounds simple? It's not. This mini drug plant represents a sea change in how medications have been made for a long time.\u003c/p>\n\u003cp>\"For roughly two centuries, to be honest,\" says \u003ca href=\"http://web.mit.edu/chemistry/jamison/Group/TFJ/TFJ.html\">Tim Jamison\u003c/a>, a professor of chemistry at MIT and one of Myerson's partners, along with \u003ca href=\"http://web.mit.edu/jensenlab/\">Klavs Jensen\u003c/a>, a professor of chemical engineering at MIT. \"The way that we tend to do chemistry is in flasks and beakers and that sort of thing, and we call that batch chemistry — one batch at a time,\" he says.\u003c/p>\n\u003cp>That's the way virtually all pharmaceuticals are made. Big batches of chemicals are synthesized, then they have to cool down, then are synthesized again to create new compounds. Then those compounds have to crystallize, filter and dry. Powders are added to make a tablet or capsule. These steps that can take months. This new device, says Jamison, produces medicine in one fast continuous process.\u003c/p>\n\u003cp>\"We had to figure out new ways to make molecules, new ways to think about making molecules but from my perspective that has also provided us with a lot of opportunities that are very powerful,\" says Jamison. His lab and Myerson's also are collaborating with the \u003ca href=\"https://novartis-mit.mit.edu/\">Novartis- MIT Center for Continuous Manufacturing\u003c/a>, which is funded by the pharmaceutical company Novartis.\u003c/p>\n\u003cp>The prototype raises the possibility that hospitals and pharmacies could make their own pills as needed, says James McQuivey, an analyst at Forrester Research.\u003c/p>\n\u003cp>\"If it can done at lower cost, here's one way at least that we could reduce the exorbitant cost of medications and that could a social good as well as an economic good,\" McQuivey says.\u003c/p>\n\u003cp>Most of the cost of an expensive drug is not the materials or manufacturing or transportation says McQuivey; it's in the drug makers' monopoly control. So, he says, \"If we can distribute the manufacturing of anything, pharmaceuticals included, so that more people have the opportunity to manufacture it, now there will be competition among those manufacturers.\"\u003c/p>\n\u003cp>Drug makers have at least two big concerns about the widespread use of this device, says \u003ca href=\"https://www.brandeis.edu/facultyguide/person.html?emplid=26e88d31e32aad89974f01e99c5c4f56618a695f\">Dr. Paul Beninger\u003c/a>, who oversees pharmaceutical safety at manufacturer Genzyme Sanofi. He said first and foremost, the drug industry worries about intellectual property rights.\u003c/p>\n\u003cp>Drug manufacturers own \u003ca href=\"http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm#How%20long%20is%20exclusivity%20granted%20for?\">exclusive rights\u003c/a> to produce the drugs they develop for a period of time, typically three to five years depending on how much is new in the drug. His other worry is safety, including monitoring of machines to ensure quality and safety.\u003c/p>\n\u003cp>\"There are some really significant issues that this MIT project has to deal with if they're going to try and make this a successful venture,\" he says.\u003c/p>\n\u003cp>MIT researchers say continuous monitoring would be built into the continuous production process. The Food and Drug Administration is \u003ca href=\"http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM341197.pdf\">working on\u003c/a> how to oversee this type of process.\u003c/p>\n\u003cp>On the patent concern, MIT developers say the device is being tested to make generic drugs for now, but that pharmacies or hospitals might someday license the right to produce drugs that have just been approved, not existing ones.\u003c/p>\n\u003cp>For now, their focus is on making an even smaller more portable unit, producing more and more complex drugs and seeking FDA approval for the device.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>This story is part of a reporting partnership with NPR, WBUR and\u003c/em> \u003ca href=\"http://www.kaiserhealthnews.org\">Kaiser Health News\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 WBUR. To see more, visit \u003ca href=\"http://www.wbur.org\">WBUR\u003c/a>.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Inventing+A+Machine+That+Spits+Out+Drugs+In+A+Whole+New+Way&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Theranos Corrects Tens of Thousands of Blood Tests",
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"content": "\u003cp>The Wall Street Journal reported last night that the company has told its regulator, the Centers for Medicare & Medicaid Services, that it has \u003ca href=\"http://www.wsj.com/articles/theranos-voids-two-years-of-edison-blood-test-results-1463616976\" target=\"_blank\">voided tens of thousands\u003c/a> -- two years worth -- of patient blood test results. The tests were run on both the company's proprietary Edison machines and conventional testing equipment, the paper said. Some results were thrown out and some revised.\u003c/p>\n\u003cp>The Journal, which owns this story in a big way, cited its usual source: \"a person familiar with the matter.\" Forcing Theranos to issue its usual confirmation, plus this statement:\u003c/p>\n\u003caside class=\"pullquote alignright\">One physician received a corrected report for a patient who was unnecessarily sent to the ER based on erroneous test results, The Wall Street Journal said.\u003c/aside>\n\u003cp>\"Excellence in quality and patient safety is our top priority and we’ve taken comprehensive corrective measures to address the issues CMS raised in their observations,\" Theranos spokesperson Brooke Buchanan said in an email to KQED. \"As these matters are currently under review, we have no further comment at this time.\"\u003c/p>\n\u003cp>If you've been following this story -- which has unfolded like some sort of Silicon Valley morality tale -- you know that Theranos made a splash with investors and the media by claiming it was going to remake the diagnostic testing industry with more efficient and cheaper blood tests. The company said it could sample just a finger-prick's worth of blood, collected in a device it called a \"nanotainer;\" that small amount of blood, the company claimed, was enough to run a host of tests. The FDA, however, approved the process for just one of those tests, and the company collects samples for all others the traditional way -- from a patient's vein.\u003c/p>\n\u003cp>In March, The Wall Street Journal reported Theranos had run tests measuring blood-clotting time on 81 patients despite erratic results from quality-control checks. Around the time the story came out, Theranos released a statement saying it had contacted any patients potentially affected by inaccurate tests.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients’ health,\" said Theranos’ Newark, California lab director, Dr. Kingshuk Das, in a \u003ca href=\"https://www.theranos.com/news/posts/statement-regarding-newark-california-lab-survey\">statement\u003c/a>.\u003c/p>\n\u003cp>Apparently, Theranos has expanded that group of patients. From the Journal:\u003c/p>\n\u003cblockquote>\u003cp>[The corrections mean] some patients received erroneous results that might have thrown off health decisions made with their doctors. ...\u003c/p>\n\u003cp>Several physician practices in the Phoenix area confirmed receiving corrected test reports from Theranos in recent weeks. ...\u003c/p>\n\u003cp>There have been massive recalls of single tests in the past, but I’m not aware of one where a company recalled the entirety of the results from its testing platform,” said Geoffrey Baird, associate professor in the department of laboratory medicine at the University of Washington in Seattle. “I believe that’s unprecedented.”\u003c/p>\u003c/blockquote>\n\u003cp>One Phoenix-area physician received a corrected report for a patient who was unnecessarily sent to the ER based on the original test results, the paper said.\u003c/p>\n\u003cp>These revised or voided tests may or may not satisfy CMS, which has been weighing whether to drop the hammer on Theranos since March, when the agency informed the company it had not submitted credible evidence of correcting serious deficiencies at its Newark, California lab. Those deficiencies, which CMS had uncovered during an inspection, were potentially life-threatening to patients, CMS said.\u003c/p>\n\u003cp>Among the penalties CMS threatened: revoking the lab's federal license to operate and suspending Theranos founder and CEO Elizabeth Holmes from involvement in the blood-testing industry for two years. CMS also named president and COO Sunny Balwani as subject to suspension, but Balwani last week announced his departure from the company.\u003c/p>\n\u003cp>At the same time it informed Theranos of potential penalties, CMS gave the company one last chance to submit additional proof of its compliance with regulations. Theranos responsed to CMS with additional information, and there's been no word from CMS since that story broke in April.\u003c/p>\n\u003cp>If CMS declines to accept Theranos' filing as valid proof of compliance, the company will still have options for administrative appeal. So it's possible the final resolution of the case may not come for months.\u003c/p>\n\u003cp>But even if Theranos manages to avoid sanctions from CMS, it still faces investigations by both the SEC and the U.S. Attorney’s Office for the Northern District of California. It also faces what many assume will be the end of its \u003ca href=\"http://www.nytimes.com/2016/04/22/business/a-once-avid-ally-walgreens-is-struggling-to-shake-off-theranos.html?_r=0\">high-profile deal\u003c/a> with the Walgreens Boots Alliance, which put dozens of Theranos \"Wellness Centers\" in Walgreens stores in Arizona, giving the secretive company and its unproven technology a needed dose of credibility.\u003c/p>\n\u003cp>That has now been wiped out by the one-two punch of the Journal's investigative reports and the failed federal inspection. Last October, the Journal reported allegations by Theranos employees that the company may have violated reporting rules related to proficiency tests run on Edison.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Theranos' Buchanan says federal regulators have issued no findings related to allegations of cheating on proficiency testing or manipulating data. The struggling company recently added a group of doctors and medical scientists to its advisory board to comb through data and help Theranos publish its results publicly.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Wall Street Journal reported last night that the company has told its regulator, the Centers for Medicare & Medicaid Services, that it has \u003ca href=\"http://www.wsj.com/articles/theranos-voids-two-years-of-edison-blood-test-results-1463616976\" target=\"_blank\">voided tens of thousands\u003c/a> -- two years worth -- of patient blood test results. The tests were run on both the company's proprietary Edison machines and conventional testing equipment, the paper said. Some results were thrown out and some revised.\u003c/p>\n\u003cp>The Journal, which owns this story in a big way, cited its usual source: \"a person familiar with the matter.\" Forcing Theranos to issue its usual confirmation, plus this statement:\u003c/p>\n\u003caside class=\"pullquote alignright\">One physician received a corrected report for a patient who was unnecessarily sent to the ER based on erroneous test results, The Wall Street Journal said.\u003c/aside>\n\u003cp>\"Excellence in quality and patient safety is our top priority and we’ve taken comprehensive corrective measures to address the issues CMS raised in their observations,\" Theranos spokesperson Brooke Buchanan said in an email to KQED. \"As these matters are currently under review, we have no further comment at this time.\"\u003c/p>\n\u003cp>If you've been following this story -- which has unfolded like some sort of Silicon Valley morality tale -- you know that Theranos made a splash with investors and the media by claiming it was going to remake the diagnostic testing industry with more efficient and cheaper blood tests. The company said it could sample just a finger-prick's worth of blood, collected in a device it called a \"nanotainer;\" that small amount of blood, the company claimed, was enough to run a host of tests. The FDA, however, approved the process for just one of those tests, and the company collects samples for all others the traditional way -- from a patient's vein.\u003c/p>\n\u003cp>In March, The Wall Street Journal reported Theranos had run tests measuring blood-clotting time on 81 patients despite erratic results from quality-control checks. Around the time the story came out, Theranos released a statement saying it had contacted any patients potentially affected by inaccurate tests.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients’ health,\" said Theranos’ Newark, California lab director, Dr. Kingshuk Das, in a \u003ca href=\"https://www.theranos.com/news/posts/statement-regarding-newark-california-lab-survey\">statement\u003c/a>.\u003c/p>\n\u003cp>Apparently, Theranos has expanded that group of patients. From the Journal:\u003c/p>\n\u003cblockquote>\u003cp>[The corrections mean] some patients received erroneous results that might have thrown off health decisions made with their doctors. ...\u003c/p>\n\u003cp>Several physician practices in the Phoenix area confirmed receiving corrected test reports from Theranos in recent weeks. ...\u003c/p>\n\u003cp>There have been massive recalls of single tests in the past, but I’m not aware of one where a company recalled the entirety of the results from its testing platform,” said Geoffrey Baird, associate professor in the department of laboratory medicine at the University of Washington in Seattle. “I believe that’s unprecedented.”\u003c/p>\u003c/blockquote>\n\u003cp>One Phoenix-area physician received a corrected report for a patient who was unnecessarily sent to the ER based on the original test results, the paper said.\u003c/p>\n\u003cp>These revised or voided tests may or may not satisfy CMS, which has been weighing whether to drop the hammer on Theranos since March, when the agency informed the company it had not submitted credible evidence of correcting serious deficiencies at its Newark, California lab. Those deficiencies, which CMS had uncovered during an inspection, were potentially life-threatening to patients, CMS said.\u003c/p>\n\u003cp>Among the penalties CMS threatened: revoking the lab's federal license to operate and suspending Theranos founder and CEO Elizabeth Holmes from involvement in the blood-testing industry for two years. CMS also named president and COO Sunny Balwani as subject to suspension, but Balwani last week announced his departure from the company.\u003c/p>\n\u003cp>At the same time it informed Theranos of potential penalties, CMS gave the company one last chance to submit additional proof of its compliance with regulations. Theranos responsed to CMS with additional information, and there's been no word from CMS since that story broke in April.\u003c/p>\n\u003cp>If CMS declines to accept Theranos' filing as valid proof of compliance, the company will still have options for administrative appeal. So it's possible the final resolution of the case may not come for months.\u003c/p>\n\u003cp>But even if Theranos manages to avoid sanctions from CMS, it still faces investigations by both the SEC and the U.S. Attorney’s Office for the Northern District of California. It also faces what many assume will be the end of its \u003ca href=\"http://www.nytimes.com/2016/04/22/business/a-once-avid-ally-walgreens-is-struggling-to-shake-off-theranos.html?_r=0\">high-profile deal\u003c/a> with the Walgreens Boots Alliance, which put dozens of Theranos \"Wellness Centers\" in Walgreens stores in Arizona, giving the secretive company and its unproven technology a needed dose of credibility.\u003c/p>\n\u003cp>That has now been wiped out by the one-two punch of the Journal's investigative reports and the failed federal inspection. Last October, the Journal reported allegations by Theranos employees that the company may have violated reporting rules related to proficiency tests run on Edison.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Theranos' Buchanan says federal regulators have issued no findings related to allegations of cheating on proficiency testing or manipulating data. The struggling company recently added a group of doctors and medical scientists to its advisory board to comb through data and help Theranos publish its results publicly.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Scientists Create Part-Human, Part-Animal Embryos",
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"content": "\u003cp>A handful of scientists around the United States are trying to do something that some people find disturbing: make embryos that are part human, part animal.\u003c/p>\n\u003cp>The researchers hope these embryos, known as chimeras, could eventually help save the lives of people with a wide range of diseases.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"You're getting into unsettling ground that I think is damaging to our sense of humanity.\"\u003ccite>Stuart Newman, a professor of cell biology and anatomy at the New York Medical College.\u003c/cite>\u003c/aside>\n\u003cp>One way would be to use chimera embryos to create better animal models to study how human diseases happen and how they progress.\u003c/p>\n\u003cp>Perhaps the boldest hope is to create farm animals that have human organs that could be transplanted into terminally ill patients.\u003c/p>\n\u003cp>But some scientists and bioethicists worry the creation of these interspecies embryos crosses the line. \"You're getting into unsettling ground that I think is damaging to our sense of humanity,\" says \u003ca href=\"http://www.nymc.edu/faculty/directory/by-name/newman-stuart/\">Stuart Newman\u003c/a>, a professor of cell biology and anatomy at the New York Medical College.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The experiments are so sensitive that the National Institutes of Health has imposed a \u003ca href=\"http://www.npr.org/sections/health-shots/2015/11/06/454693391/should-human-stem-cells-be-used-to-make-partly-human-chimeras\">moratorium\u003c/a> on funding them while officials explore the ethical issues they raise.\u003c/p>\n\u003cp>Nevertheless, a small number of researchers are pursuing the work with private funding. They hope the results will convince the NIH to lift the moratorium.\u003c/p>\n\u003cp>\"We're not trying to make a chimera just because we want to see some kind of monstrous creature,\" says \u003ca href=\"http://animalscience.ucdavis.edu/faculty/ross/\">Pablo Ross\u003c/a>, a reproductive biologist at the University of California, Davis. \"We're doing this for a biomedical purpose.\"\u003c/p>\n\u003cp>The NIH is expected to announce soon how it plans to handle requests for funding.\u003c/p>\n\u003cp>Recently, Ross agreed to let me visit his lab for an unusual look at his research. During the visit, Ross demonstrated how he's trying to create a pancreas that theoretically could be transplanted into a patient with diabetes.\u003c/p>\n\u003cp>The first step involves using new \u003ca href=\"http://www.npr.org/sections/health-shots/2015/12/28/460705645/gene-editing-tool-hailed-as-a-breakthrough-and-it-really-is-one\">gene-editing\u003c/a> techniques to remove the gene pig embryos need to make a pancreas.\u003c/p>\n\u003cp>Working under an elaborate microscope, Ross makes a small hole in the embryo's outer membrane with a laser. Next, he injects a molecule synthesized in the laboratory to home in and delete the pancreas gene inside. (In separate experiments, he's done this to sheep embryos, too.)\u003c/p>\n\u003cp>After the embryos have had their DNA edited this way, Ross creates another hole in the membrane so he can inject \u003ca href=\"http://stemcells.nih.gov/info/basics/pages/basics10.aspx\">human induced pluripotent stem cells\u003c/a>, or \u003ca href=\"http://stemcells.nih.gov/info/basics/pages/basics10.aspx\">iPS\u003c/a> for short, into the pig embryos.\u003c/p>\n\u003cp>Like human embryonic stem cells, iPS cells can turn into any kind of cell or tissue in the body. The researchers' hope is that the human stem cells will take advantage of the void in the embryo to start forming a human pancreas.\u003c/p>\n\u003cp>Because iPS cells can be made from any adult's skin cells, any organs they form would match the patient who needs the transplant, vastly reducing the risk that the body would reject the new organ.\u003c/p>\n\u003cp>But for the embryo to develop and produce an organ, Ross has to put the chimera embryos into the wombs of adult pigs. That involves a surgical procedure, which is performed in a large operating room across the street from Ross's lab.\u003c/p>\n\u003cfigure id=\"attachment_166039\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-800x600.jpg\" alt=\"Pablo Ross of UC Davis inserts human stem cells into a pig embryo as part of experiments to create chimeric embryos.\" width=\"800\" height=\"600\" class=\"size-medium wp-image-166039\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-960x720.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Pablo Ross of UC Davis inserts human stem cells into a pig embryo as part of experiments to create chimeric embryos. \u003ccite>(Rob Stein/NPR)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The day Ross opened his lab to me, a surgical team was anesthetizing an adult female pig so surgeons could make an incision to get access to its uterus.\u003c/p>\n\u003cp>Ross then rushed over with a special syringe filled with chimera embryos. He injected 25 embryos into each side of the animal's uterus. The procedure took about an hour. He repeated the process on a second pig.\u003c/p>\n\u003cp>Every time Ross does this, he then waits a few weeks to allow the embryos to develop to their 28th day — a time when primitive structures such as organs start to form.\u003c/p>\n\u003cp>Ross then retrieves the chimeric embryos to dissect them so he can see what the human stem cells are doing inside. He examines whether the human stem cells have started to form a pancreas, and whether they have begun making any other types of tissues.\u003c/p>\n\u003cp>The uncertainty is part of what makes the work so controversial. Ross and other scientists conducting these experiments can't know exactly where the human stem cells will go. Ross hopes they'll only grow a human pancreas. But they could go elsewhere, such as to the brain.\u003c/p>\n\u003cp>\"If you have pigs with partly human brains you would have animals that might actually have consciousness like a human,\" Newman says. \"It might have human-type needs. We don't really know.\"\u003c/p>\n\u003cp>That possibility raises new questions about the morality of using the animals for experimentation. Another concern is that the stem cells could form human sperm and human eggs in the chimeras.\u003c/p>\n\u003cp>\"If a male chimeric pig mated with a female chimeric pig, the result could be a human fetus developing in the uterus of that female chimera,\" Newman says. Another possibility is the animals could give birth to some kind of part-human, part-pig creature.\u003c/p>\n\u003cp>\"One of the concerns that a lot of people have is that there's something sacrosanct about what it means to be human expressed in our DNA,\" says \u003ca href=\"https://sols.asu.edu/people/jason-robert\">Jason Robert\u003c/a>, a bioethicist at Arizona State University. \"And that by inserting that into other animals and giving those other animals potentially some of the capacities of humans that this could be a kind of violation — a kind of, maybe, even a playing God.\"\u003c/p>\n\u003cp>Ross defends what his work. \"I don't consider that we're playing God or even close to that,\" Ross says. \"We're just trying to use the technologies that we have developed to improve peoples' life.\"\u003c/p>\n\u003cp>Still, Ross acknowledges the concerns. So he's moving very carefully, he says. For example, he's only letting the chimera embryos develop for 28 days. At that point, he removes the embryos and dissects them.\u003c/p>\n\u003cp>If he discovers the stem cells are going to the wrong places in the embryos, he says he can take steps to stop that from happening. In addition, he'd make sure adult chimeras are never allowed to mate, he says.\u003c/p>\n\u003cp>\"We're very aware and sensitive to the ethical concerns,\" he says. \"One of the reasons we're doing this research the way we're doing it is because we want to provide scientific information to inform those concerns.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Ross is working with \u003ca href=\"http://www.salk.edu/scientist/juan-carlos-izpisua-belmonte/\">Juan Carlos Izpisua Belmonte\u003c/a> from the Salk Intitute for Biological Studies in La Jolla, Calif., and \u003ca href=\"https://med.stanford.edu/profiles/hiromitsu-nakauchi\">Hiromitsu Nakauchi \u003c/a>at Stanford University. \u003ca href=\"http://www.stemcell.umn.edu/bio/stem-cell-ins-faculty-staff/daniel-garry\">Daniel Garry\u003c/a> of the University of Minnesota and colleagues are conducting similar work.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=In+Search+For+Cures%2C+Scientists+Create+Embryos+That+Are+Both+Animal+And+Human&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>A handful of scientists around the United States are trying to do something that some people find disturbing: make embryos that are part human, part animal.\u003c/p>\n\u003cp>The researchers hope these embryos, known as chimeras, could eventually help save the lives of people with a wide range of diseases.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"You're getting into unsettling ground that I think is damaging to our sense of humanity.\"\u003ccite>Stuart Newman, a professor of cell biology and anatomy at the New York Medical College.\u003c/cite>\u003c/aside>\n\u003cp>One way would be to use chimera embryos to create better animal models to study how human diseases happen and how they progress.\u003c/p>\n\u003cp>Perhaps the boldest hope is to create farm animals that have human organs that could be transplanted into terminally ill patients.\u003c/p>\n\u003cp>But some scientists and bioethicists worry the creation of these interspecies embryos crosses the line. \"You're getting into unsettling ground that I think is damaging to our sense of humanity,\" says \u003ca href=\"http://www.nymc.edu/faculty/directory/by-name/newman-stuart/\">Stuart Newman\u003c/a>, a professor of cell biology and anatomy at the New York Medical College.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The experiments are so sensitive that the National Institutes of Health has imposed a \u003ca href=\"http://www.npr.org/sections/health-shots/2015/11/06/454693391/should-human-stem-cells-be-used-to-make-partly-human-chimeras\">moratorium\u003c/a> on funding them while officials explore the ethical issues they raise.\u003c/p>\n\u003cp>Nevertheless, a small number of researchers are pursuing the work with private funding. They hope the results will convince the NIH to lift the moratorium.\u003c/p>\n\u003cp>\"We're not trying to make a chimera just because we want to see some kind of monstrous creature,\" says \u003ca href=\"http://animalscience.ucdavis.edu/faculty/ross/\">Pablo Ross\u003c/a>, a reproductive biologist at the University of California, Davis. \"We're doing this for a biomedical purpose.\"\u003c/p>\n\u003cp>The NIH is expected to announce soon how it plans to handle requests for funding.\u003c/p>\n\u003cp>Recently, Ross agreed to let me visit his lab for an unusual look at his research. During the visit, Ross demonstrated how he's trying to create a pancreas that theoretically could be transplanted into a patient with diabetes.\u003c/p>\n\u003cp>The first step involves using new \u003ca href=\"http://www.npr.org/sections/health-shots/2015/12/28/460705645/gene-editing-tool-hailed-as-a-breakthrough-and-it-really-is-one\">gene-editing\u003c/a> techniques to remove the gene pig embryos need to make a pancreas.\u003c/p>\n\u003cp>Working under an elaborate microscope, Ross makes a small hole in the embryo's outer membrane with a laser. Next, he injects a molecule synthesized in the laboratory to home in and delete the pancreas gene inside. (In separate experiments, he's done this to sheep embryos, too.)\u003c/p>\n\u003cp>After the embryos have had their DNA edited this way, Ross creates another hole in the membrane so he can inject \u003ca href=\"http://stemcells.nih.gov/info/basics/pages/basics10.aspx\">human induced pluripotent stem cells\u003c/a>, or \u003ca href=\"http://stemcells.nih.gov/info/basics/pages/basics10.aspx\">iPS\u003c/a> for short, into the pig embryos.\u003c/p>\n\u003cp>Like human embryonic stem cells, iPS cells can turn into any kind of cell or tissue in the body. The researchers' hope is that the human stem cells will take advantage of the void in the embryo to start forming a human pancreas.\u003c/p>\n\u003cp>Because iPS cells can be made from any adult's skin cells, any organs they form would match the patient who needs the transplant, vastly reducing the risk that the body would reject the new organ.\u003c/p>\n\u003cp>But for the embryo to develop and produce an organ, Ross has to put the chimera embryos into the wombs of adult pigs. That involves a surgical procedure, which is performed in a large operating room across the street from Ross's lab.\u003c/p>\n\u003cfigure id=\"attachment_166039\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-800x600.jpg\" alt=\"Pablo Ross of UC Davis inserts human stem cells into a pig embryo as part of experiments to create chimeric embryos.\" width=\"800\" height=\"600\" class=\"size-medium wp-image-166039\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/05/chimeras-1a-7ce31e2e2827205b2edcbe1cbc21e0c171e77a46-960x720.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Pablo Ross of UC Davis inserts human stem cells into a pig embryo as part of experiments to create chimeric embryos. \u003ccite>(Rob Stein/NPR)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The day Ross opened his lab to me, a surgical team was anesthetizing an adult female pig so surgeons could make an incision to get access to its uterus.\u003c/p>\n\u003cp>Ross then rushed over with a special syringe filled with chimera embryos. He injected 25 embryos into each side of the animal's uterus. The procedure took about an hour. He repeated the process on a second pig.\u003c/p>\n\u003cp>Every time Ross does this, he then waits a few weeks to allow the embryos to develop to their 28th day — a time when primitive structures such as organs start to form.\u003c/p>\n\u003cp>Ross then retrieves the chimeric embryos to dissect them so he can see what the human stem cells are doing inside. He examines whether the human stem cells have started to form a pancreas, and whether they have begun making any other types of tissues.\u003c/p>\n\u003cp>The uncertainty is part of what makes the work so controversial. Ross and other scientists conducting these experiments can't know exactly where the human stem cells will go. Ross hopes they'll only grow a human pancreas. But they could go elsewhere, such as to the brain.\u003c/p>\n\u003cp>\"If you have pigs with partly human brains you would have animals that might actually have consciousness like a human,\" Newman says. \"It might have human-type needs. We don't really know.\"\u003c/p>\n\u003cp>That possibility raises new questions about the morality of using the animals for experimentation. Another concern is that the stem cells could form human sperm and human eggs in the chimeras.\u003c/p>\n\u003cp>\"If a male chimeric pig mated with a female chimeric pig, the result could be a human fetus developing in the uterus of that female chimera,\" Newman says. Another possibility is the animals could give birth to some kind of part-human, part-pig creature.\u003c/p>\n\u003cp>\"One of the concerns that a lot of people have is that there's something sacrosanct about what it means to be human expressed in our DNA,\" says \u003ca href=\"https://sols.asu.edu/people/jason-robert\">Jason Robert\u003c/a>, a bioethicist at Arizona State University. \"And that by inserting that into other animals and giving those other animals potentially some of the capacities of humans that this could be a kind of violation — a kind of, maybe, even a playing God.\"\u003c/p>\n\u003cp>Ross defends what his work. \"I don't consider that we're playing God or even close to that,\" Ross says. \"We're just trying to use the technologies that we have developed to improve peoples' life.\"\u003c/p>\n\u003cp>Still, Ross acknowledges the concerns. So he's moving very carefully, he says. For example, he's only letting the chimera embryos develop for 28 days. At that point, he removes the embryos and dissects them.\u003c/p>\n\u003cp>If he discovers the stem cells are going to the wrong places in the embryos, he says he can take steps to stop that from happening. In addition, he'd make sure adult chimeras are never allowed to mate, he says.\u003c/p>\n\u003cp>\"We're very aware and sensitive to the ethical concerns,\" he says. \"One of the reasons we're doing this research the way we're doing it is because we want to provide scientific information to inform those concerns.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Ross is working with \u003ca href=\"http://www.salk.edu/scientist/juan-carlos-izpisua-belmonte/\">Juan Carlos Izpisua Belmonte\u003c/a> from the Salk Intitute for Biological Studies in La Jolla, Calif., and \u003ca href=\"https://med.stanford.edu/profiles/hiromitsu-nakauchi\">Hiromitsu Nakauchi \u003c/a>at Stanford University. \u003ca href=\"http://www.stemcell.umn.edu/bio/stem-cell-ins-faculty-staff/daniel-garry\">Daniel Garry\u003c/a> of the University of Minnesota and colleagues are conducting similar work.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=In+Search+For+Cures%2C+Scientists+Create+Embryos+That+Are+Both+Animal+And+Human&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Monitoring a person's every move may sound like something out of Dave Eggers' dystopian novel, \"\u003ca href=\"https://en.wikipedia.org/wiki/The_Circle_(Eggers_novel)\">The Circle\u003c/a>.\"\u003c/p>\n\u003cp>But, in fact, wireless RFID (\u003ca href=\"http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htm\">radio frequency identification\u003c/a>) technology, which uses radio waves to transmit information to nearby devices, is already being used to track everything from \u003ca href=\"http://www.wsj.com/articles/SB10001424052748704421304575383213061198090\">jeans\u003c/a> to \u003ca href=\"http://www.theverge.com/2013/5/10/4316658/internet-of-cows-technology-offers-ways-to-track-livestock-but\">cattle\u003c/a> to \u003ca href=\"http://www.wired.com/2015/03/disney-magicband/\">Disney World visitors\u003c/a>.\u003c/p>\n\u003cp>And now, hospital patients. More than 10 health care providers, including \u003ca href=\"http://www.rfidjournal.com/articles/view?9513\">Johns Hokpins University School of Medicine\u003c/a> and \u003ca href=\"http://www.rfidjournal.com/articles/view?5324\">Massachusetts General Hospital \u003c/a>are using the technology to track patients.\u003c/p>\n\u003cp>[contextly_sidebar id=\"8he4PoVz4CgNMY6a0Dj8Bclqm3rFzurU\"]One of the most recent adopters is \u003ca href=\"http://www.mayoclinic.org/\" target=\"_blank\">Mayo Clinic\u003c/a> in Rochester, Minnesota.\u003c/p>\n\u003cp>From his office in Rochester, Dr. \u003ca href=\"http://www.mayoclinic.org/biographies/hellmich-thomas-r-m-d/bio-20055663\">Tom Hellmich\u003c/a>, knows exactly what's going on in Mayo Clinic's Emergency Department, half a mile away.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"There is a medical emergency that came in by ambulance, and I can tell you that a physician has been in that room for 38 minutes and there are 11 people in there right now,\" he tells me over the phone.\u003c/p>\n\u003cp>Hellmich is looking at a digital dashboard on his computer screen, called the \u003ca href=\"http://www.mayo.edu/center-for-innovation/projects/yes-board\">YES Board\u003c/a>. It displays—in real time—the location of every staff member and patient, as well as what the patient's chief complaint is.\u003c/p>\n\u003cp>The system relies on 750 sensors installed in the emergency department's walls and ceilings. The sensors receive location data from RFID tags embedded in patients' wristbands and staff members' badges.\u003c/p>\n\u003cp>The information is displayed on Hellmich's dashboard and multiple screens throughout the emergency department. It's also accessible from any intranet-enabled device after user-authentication. The system tracks how much time a patient has spent alone, when he or she came in and whether the patient leaves his or her room—say, to go get an X-ray.\u003c/p>\n\u003cp>By recording the movements of every person in the emergency department, Mayo hopes to reduce wait-time for patients, and improve care by helping staff, patients and families find each other more easily.\u003c/p>\n\u003caside class=\"pullquote alignright\">'What I’ve seen in health data is the government will say they need the information in the name of public health, and that will always override privacy or civil liberties concerns.’\u003ccite>Michelle de Mooy,Center for Democracy & Technology\u003c/cite>\u003c/aside>\n\u003cp>\"We are already living in this age of big data where clinical information is being used for a patient’s journey as they go through the system,\" says Kalyan Pasupathy, scientific director of Mayo Clinic's Clinical Engineering Learning Laboratory.\u003c/p>\n\u003cp>Pasupathy and Hellmich led a team of multi-disciplinary professionals to develop the system.\u003c/p>\n\u003cp>\"One thing we were missing in that picture is physical location information.\"\u003c/p>\n\u003cp>When Mayo rolled out the system last year, patients barely noticed, Hellmich says. Many assumed the clinic already had something like it in place.\u003c/p>\n\u003cp>But Mayo Clinic staff were less enthusiastic at first.\u003c/p>\n\u003cp>\"Physicians, nurses, lab techs were all worried about this being Big Brother,\" says Hellmech. \"So that was our biggest concern and our biggest hurdle.\"\u003c/p>\n\u003cp>The team that developed the system says they assuaged fears by establishing an ethics committee to review how the technology would be used. No individual Mayo employee would have his or her location information analyzed without prior consent, the committee decided. This means, for example, the hospital wouldn't evaluate the duration of someone's lunch break or track whether two staff members spent time together.\u003c/p>\n\u003cp>When staff are on a break, outside the ED, or in the restroom, they are listed as \"out of department.\" The committee also agreed that the information wouldn't be used in performance reviews.\u003c/p>\n\u003cp>But Michelle de Mooy from the \u003ca href=\"https://cdt.org/\">Center for Democracy & Technology\u003c/a>, which works on Internet privacy issues, points to concerns about who might be able to see the data.\u003c/p>\n\u003cp>\"I would really want to be sure that there were restrictions on who could access the information, how much they could access. And that doesn't just include performance evaluations, but also insurance companies,\" she says. \"The government is another really big question. There's a lot of people who get their health care through the government, so there are questions about how much they can see.\"\u003c/p>\n\u003cp>The information in patients' RFID wristbands doesn't contain personal medical data or names. Rather, a string of numbers is assigned to each patient and only shows up as a person's name once a staff member is logged in and looking at the YES Board.\u003c/p>\n\u003cp>If accessed in isolation, information on the wristband has no personal identifying details. So if a hacker got a hold of a patient's RFID wristband, they'd see just a string of numbers. The numbers only becoming meaningful in the YES Board where they are matched up with patient names.\u003c/p>\n\u003cp>By the end of this year, Mayo Clinic plans to report quality control metrics to the government—things like average patient wait-time and the duration of stay. Eventually this reporting could be automated, says Hellmich.\u003c/p>\n\u003cp>De Mooy says hospitals need to thoughtful about data sharing with the government.\u003c/p>\n\u003cp>“What I’ve seen in health data is the government will say they need the information in the name of public health, and that will always override privacy or civil liberties concerns.”\u003c/p>\n\u003cp>While this may be true, the hospital isn't scaling back; in fact, it's adding new tracking locations. Previously, patients weren't monitored while they were in bathrooms, but that changed when staff decided patients might fall or otherwise need help while there.\u003c/p>\n\u003cp>Eventually, the hospital aims to use the technology to track the spread of infectious disease. If someone leaves the emergency room and is later diagnosed with tuberculosis, for example, RFID would enable staff to see whom that person came into contact with in the ER, and when.\u003c/p>\n\u003cp>The clinic is now considering whether the entire hospital network, not just the emergency department, should be wired for RFID.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"We really need to think about what the unintended consequences could be,\" De Mooy says. \"Thinking about it now, not just if or when the data gets into the wrong hands or there's a data breach.\"\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Monitoring a person's every move may sound like something out of Dave Eggers' dystopian novel, \"\u003ca href=\"https://en.wikipedia.org/wiki/The_Circle_(Eggers_novel)\">The Circle\u003c/a>.\"\u003c/p>\n\u003cp>But, in fact, wireless RFID (\u003ca href=\"http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htm\">radio frequency identification\u003c/a>) technology, which uses radio waves to transmit information to nearby devices, is already being used to track everything from \u003ca href=\"http://www.wsj.com/articles/SB10001424052748704421304575383213061198090\">jeans\u003c/a> to \u003ca href=\"http://www.theverge.com/2013/5/10/4316658/internet-of-cows-technology-offers-ways-to-track-livestock-but\">cattle\u003c/a> to \u003ca href=\"http://www.wired.com/2015/03/disney-magicband/\">Disney World visitors\u003c/a>.\u003c/p>\n\u003cp>And now, hospital patients. More than 10 health care providers, including \u003ca href=\"http://www.rfidjournal.com/articles/view?9513\">Johns Hokpins University School of Medicine\u003c/a> and \u003ca href=\"http://www.rfidjournal.com/articles/view?5324\">Massachusetts General Hospital \u003c/a>are using the technology to track patients.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>One of the most recent adopters is \u003ca href=\"http://www.mayoclinic.org/\" target=\"_blank\">Mayo Clinic\u003c/a> in Rochester, Minnesota.\u003c/p>\n\u003cp>From his office in Rochester, Dr. \u003ca href=\"http://www.mayoclinic.org/biographies/hellmich-thomas-r-m-d/bio-20055663\">Tom Hellmich\u003c/a>, knows exactly what's going on in Mayo Clinic's Emergency Department, half a mile away.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"There is a medical emergency that came in by ambulance, and I can tell you that a physician has been in that room for 38 minutes and there are 11 people in there right now,\" he tells me over the phone.\u003c/p>\n\u003cp>Hellmich is looking at a digital dashboard on his computer screen, called the \u003ca href=\"http://www.mayo.edu/center-for-innovation/projects/yes-board\">YES Board\u003c/a>. It displays—in real time—the location of every staff member and patient, as well as what the patient's chief complaint is.\u003c/p>\n\u003cp>The system relies on 750 sensors installed in the emergency department's walls and ceilings. The sensors receive location data from RFID tags embedded in patients' wristbands and staff members' badges.\u003c/p>\n\u003cp>The information is displayed on Hellmich's dashboard and multiple screens throughout the emergency department. It's also accessible from any intranet-enabled device after user-authentication. The system tracks how much time a patient has spent alone, when he or she came in and whether the patient leaves his or her room—say, to go get an X-ray.\u003c/p>\n\u003cp>By recording the movements of every person in the emergency department, Mayo hopes to reduce wait-time for patients, and improve care by helping staff, patients and families find each other more easily.\u003c/p>\n\u003caside class=\"pullquote alignright\">'What I’ve seen in health data is the government will say they need the information in the name of public health, and that will always override privacy or civil liberties concerns.’\u003ccite>Michelle de Mooy,Center for Democracy & Technology\u003c/cite>\u003c/aside>\n\u003cp>\"We are already living in this age of big data where clinical information is being used for a patient’s journey as they go through the system,\" says Kalyan Pasupathy, scientific director of Mayo Clinic's Clinical Engineering Learning Laboratory.\u003c/p>\n\u003cp>Pasupathy and Hellmich led a team of multi-disciplinary professionals to develop the system.\u003c/p>\n\u003cp>\"One thing we were missing in that picture is physical location information.\"\u003c/p>\n\u003cp>When Mayo rolled out the system last year, patients barely noticed, Hellmich says. Many assumed the clinic already had something like it in place.\u003c/p>\n\u003cp>But Mayo Clinic staff were less enthusiastic at first.\u003c/p>\n\u003cp>\"Physicians, nurses, lab techs were all worried about this being Big Brother,\" says Hellmech. \"So that was our biggest concern and our biggest hurdle.\"\u003c/p>\n\u003cp>The team that developed the system says they assuaged fears by establishing an ethics committee to review how the technology would be used. No individual Mayo employee would have his or her location information analyzed without prior consent, the committee decided. This means, for example, the hospital wouldn't evaluate the duration of someone's lunch break or track whether two staff members spent time together.\u003c/p>\n\u003cp>When staff are on a break, outside the ED, or in the restroom, they are listed as \"out of department.\" The committee also agreed that the information wouldn't be used in performance reviews.\u003c/p>\n\u003cp>But Michelle de Mooy from the \u003ca href=\"https://cdt.org/\">Center for Democracy & Technology\u003c/a>, which works on Internet privacy issues, points to concerns about who might be able to see the data.\u003c/p>\n\u003cp>\"I would really want to be sure that there were restrictions on who could access the information, how much they could access. And that doesn't just include performance evaluations, but also insurance companies,\" she says. \"The government is another really big question. There's a lot of people who get their health care through the government, so there are questions about how much they can see.\"\u003c/p>\n\u003cp>The information in patients' RFID wristbands doesn't contain personal medical data or names. Rather, a string of numbers is assigned to each patient and only shows up as a person's name once a staff member is logged in and looking at the YES Board.\u003c/p>\n\u003cp>If accessed in isolation, information on the wristband has no personal identifying details. So if a hacker got a hold of a patient's RFID wristband, they'd see just a string of numbers. The numbers only becoming meaningful in the YES Board where they are matched up with patient names.\u003c/p>\n\u003cp>By the end of this year, Mayo Clinic plans to report quality control metrics to the government—things like average patient wait-time and the duration of stay. Eventually this reporting could be automated, says Hellmich.\u003c/p>\n\u003cp>De Mooy says hospitals need to thoughtful about data sharing with the government.\u003c/p>\n\u003cp>“What I’ve seen in health data is the government will say they need the information in the name of public health, and that will always override privacy or civil liberties concerns.”\u003c/p>\n\u003cp>While this may be true, the hospital isn't scaling back; in fact, it's adding new tracking locations. Previously, patients weren't monitored while they were in bathrooms, but that changed when staff decided patients might fall or otherwise need help while there.\u003c/p>\n\u003cp>Eventually, the hospital aims to use the technology to track the spread of infectious disease. If someone leaves the emergency room and is later diagnosed with tuberculosis, for example, RFID would enable staff to see whom that person came into contact with in the ER, and when.\u003c/p>\n\u003cp>The clinic is now considering whether the entire hospital network, not just the emergency department, should be wired for RFID.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"We really need to think about what the unintended consequences could be,\" De Mooy says. \"Thinking about it now, not just if or when the data gets into the wrong hands or there's a data breach.\"\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>A 64-year-old cancer patient has received the nation's first penis transplant, a groundbreaking operation that may also help some of the U.S. veterans maimed by roadside bombs.\u003c/p>\n\u003cp>In a case that represents the latest frontier in the growing field of reconstructive transplants, Thomas Manning of Halifax, Massachusetts, is faring well after the 15-hour operation last week, Massachusetts General Hospital said Monday.\u003c/p>\n\u003cp>His doctors said they are cautiously optimistic that Manning eventually will be able to urinate normally and function sexually again for the first time since aggressive penile cancer led to the amputation of his genitals in 2012. They said his psychological state will play a big role in his recovery.\u003c/p>\n\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=4895992613001\" frameborder=\"0\" width=\"100%\" height=\"500\" scrolling=\"yes\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>\"Emotionally he's doing amazing. I'm really impressed with how he's handling things. He's just a positive person,\" Dr. Curtis Cetrulo, who was among the lead surgeons on a team of more than 50, said at a news conference. \"He wants to be whole again. He does not want to be in the shadows.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Manning, who is single, did not appear at the news conference but said in a statement: \"Today I begin a new chapter filled with personal hope and hope for others who have suffered genital injuries. In sharing this success with all of you, it is my hope we can usher in a bright future for this type of transplantation.\"\u003c/p>\n\u003cp>The identity of the deceased donor was not released.\u003c/p>\n\u003cp>The operation is highly experimental — only one other patient, in South Africa, has a transplanted penis. But four additional hospitals around the country have permission from the United Network for Organ Sharing, which oversees the nation's transplant system, to attempt the delicate surgery.\u003c/p>\n\u003cp>The loss of a penis, whether from cancer, accident or war injury, is emotionally traumatic, affecting urination, sexual intimacy and the ability to conceive a child. Many patients suffer in silence because of the stigma their injuries sometimes carry; Cetrulo said many become isolated and despondent.\u003c/p>\n\u003cp>Unlike traditional life-saving transplants of hearts, kidneys or livers, reconstructive transplants are done to improve quality of life. And while a penis transplant may sound radical, it follows transplants of faces, hands and even the uterus.\u003c/p>\n\u003cp>\"This is a logical next step,\" said Dr. W. P. Andrew Lee, chairman of plastic and reconstructive surgery at Johns Hopkins University School of Medicine.\u003c/p>\n\u003cp>His hospital is preparing for a penis transplant in a wounded veteran soon, and Lee said this new field is important for \"people who want to feel whole again after the loss of important body parts.\"\u003c/p>\n\u003cp>Still, candidates face some serious risks: rejection of the tissue, and side effects from the anti-rejection drugs that must be taken for life. Doctors are working to reduce the medication needed.\u003c/p>\n\u003cp>Penis transplants have generated intense interest among veterans from Iraq and Afghanistan, but they will require more extensive surgery since their injuries, often from roadside bombs, tend to be more extensive, with damage to blood vessels, nerves and pelvic tissue that also will need repair, Lee noted.\u003c/p>\n\u003cp>The Department of Defense Trauma Registry has recorded 1,367 male service members who survived with genitourinary injuries between 2001 and 2013. It's not clear how many victims lost all or part of the penis.\u003c/p>\n\u003cp>A man in China received a penis transplant in 2005. But doctors said he asked them to remove his new organ two weeks later because he and his wife were having psychological problems.\u003c/p>\n\u003cp>In December 2014, a 21-year-old man in South Africa whose penis had been amputated following complications from circumcision in his late teens received a transplant.\u003c/p>\n\u003cp>Dr. Andre van der Merwe of the University of Stellenbosch told The Associated Press that the man is healthy, has normal sexual function and was able to conceive, although the baby was stillborn. But his recovery was difficult, with blood clots and infections, the doctor said.\u003c/p>\n\u003cp>For congenital abnormalities or transgender surgery, doctors can fashion the form of a penis from a patient's own skin, using implants to achieve erection. But transplanting a functional penis requires connecting tiny blood vessels and nerves.\u003c/p>\n\u003cp>A bigger challenge than the surgery itself is finding donor organs.\u003c/p>\n\u003cp>\"People are still reluctant to donate,\" van der Merwe said. \"There are huge psychological issues about donating your relative's penis.\"\u003c/p>\n\u003cp>In the U.S., people or their families who agree to donate organs such as the heart or lung must be asked separately about also donating a penis, hand or other body part, said Dr. Scott Levin, a hand transplant surgeon at the University of Pennsylvania and vice chairman of UNOS' committee on reconstructive transplants.\u003c/p>\n\u003cp>In Boston, Cetrulo said the transplanted penis has good blood flow and so far shows no signs of rejection. He said that Manning should be released from the hospital soon, and that the surgery had three aims: ensuring the transplanted penis looks natural, is capable of normal urination — which he hopes will resume in a few weeks — and eventually normal sexual function.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Reproduction won't be possible, he said, since Manning did not receive new testes.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>A 64-year-old cancer patient has received the nation's first penis transplant, a groundbreaking operation that may also help some of the U.S. veterans maimed by roadside bombs.\u003c/p>\n\u003cp>In a case that represents the latest frontier in the growing field of reconstructive transplants, Thomas Manning of Halifax, Massachusetts, is faring well after the 15-hour operation last week, Massachusetts General Hospital said Monday.\u003c/p>\n\u003cp>His doctors said they are cautiously optimistic that Manning eventually will be able to urinate normally and function sexually again for the first time since aggressive penile cancer led to the amputation of his genitals in 2012. They said his psychological state will play a big role in his recovery.\u003c/p>\n\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=4895992613001\" frameborder=\"0\" width=\"100%\" height=\"500\" scrolling=\"yes\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>\"Emotionally he's doing amazing. I'm really impressed with how he's handling things. He's just a positive person,\" Dr. Curtis Cetrulo, who was among the lead surgeons on a team of more than 50, said at a news conference. \"He wants to be whole again. He does not want to be in the shadows.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Manning, who is single, did not appear at the news conference but said in a statement: \"Today I begin a new chapter filled with personal hope and hope for others who have suffered genital injuries. In sharing this success with all of you, it is my hope we can usher in a bright future for this type of transplantation.\"\u003c/p>\n\u003cp>The identity of the deceased donor was not released.\u003c/p>\n\u003cp>The operation is highly experimental — only one other patient, in South Africa, has a transplanted penis. But four additional hospitals around the country have permission from the United Network for Organ Sharing, which oversees the nation's transplant system, to attempt the delicate surgery.\u003c/p>\n\u003cp>The loss of a penis, whether from cancer, accident or war injury, is emotionally traumatic, affecting urination, sexual intimacy and the ability to conceive a child. Many patients suffer in silence because of the stigma their injuries sometimes carry; Cetrulo said many become isolated and despondent.\u003c/p>\n\u003cp>Unlike traditional life-saving transplants of hearts, kidneys or livers, reconstructive transplants are done to improve quality of life. And while a penis transplant may sound radical, it follows transplants of faces, hands and even the uterus.\u003c/p>\n\u003cp>\"This is a logical next step,\" said Dr. W. P. Andrew Lee, chairman of plastic and reconstructive surgery at Johns Hopkins University School of Medicine.\u003c/p>\n\u003cp>His hospital is preparing for a penis transplant in a wounded veteran soon, and Lee said this new field is important for \"people who want to feel whole again after the loss of important body parts.\"\u003c/p>\n\u003cp>Still, candidates face some serious risks: rejection of the tissue, and side effects from the anti-rejection drugs that must be taken for life. Doctors are working to reduce the medication needed.\u003c/p>\n\u003cp>Penis transplants have generated intense interest among veterans from Iraq and Afghanistan, but they will require more extensive surgery since their injuries, often from roadside bombs, tend to be more extensive, with damage to blood vessels, nerves and pelvic tissue that also will need repair, Lee noted.\u003c/p>\n\u003cp>The Department of Defense Trauma Registry has recorded 1,367 male service members who survived with genitourinary injuries between 2001 and 2013. It's not clear how many victims lost all or part of the penis.\u003c/p>\n\u003cp>A man in China received a penis transplant in 2005. But doctors said he asked them to remove his new organ two weeks later because he and his wife were having psychological problems.\u003c/p>\n\u003cp>In December 2014, a 21-year-old man in South Africa whose penis had been amputated following complications from circumcision in his late teens received a transplant.\u003c/p>\n\u003cp>Dr. Andre van der Merwe of the University of Stellenbosch told The Associated Press that the man is healthy, has normal sexual function and was able to conceive, although the baby was stillborn. But his recovery was difficult, with blood clots and infections, the doctor said.\u003c/p>\n\u003cp>For congenital abnormalities or transgender surgery, doctors can fashion the form of a penis from a patient's own skin, using implants to achieve erection. But transplanting a functional penis requires connecting tiny blood vessels and nerves.\u003c/p>\n\u003cp>A bigger challenge than the surgery itself is finding donor organs.\u003c/p>\n\u003cp>\"People are still reluctant to donate,\" van der Merwe said. \"There are huge psychological issues about donating your relative's penis.\"\u003c/p>\n\u003cp>In the U.S., people or their families who agree to donate organs such as the heart or lung must be asked separately about also donating a penis, hand or other body part, said Dr. Scott Levin, a hand transplant surgeon at the University of Pennsylvania and vice chairman of UNOS' committee on reconstructive transplants.\u003c/p>\n\u003cp>In Boston, Cetrulo said the transplanted penis has good blood flow and so far shows no signs of rejection. He said that Manning should be released from the hospital soon, and that the surgery had three aims: ensuring the transplanted penis looks natural, is capable of normal urination — which he hopes will resume in a few weeks — and eventually normal sexual function.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Reproduction won't be possible, he said, since Manning did not receive new testes.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "For Some With Troubled Past, Becoming Human Guinea Pig is Best Way to Make a Living",
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"content": "\u003cp>There are lots of ways to make a buck, but becoming a human guinea pig for drug research has to be one of the oddest.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"The vast majority of participants are under-represented minorities.\"\u003ccite>Jill Fisher, sociologist, University of North Carolina's Center for Bioethics\u003c/cite>\u003c/aside>\n\u003cp>\"We are selling our bodies, most definitely,\" says Paul Clough, who has taken part in more than 80 drug tests in the past 11 years. \"Well, renting,\" might be more accurate, he concedes. Clough, who's 37, also runs a \u003ca href=\"http://www.jalr.org/\">website\u003c/a> that helps people find trials to sign up for.\u003c/p>\n\u003cp>Some are like the one he's doing right now, which stretches over three months and involves multiple stints living in a clinic with other volunteers, eating cafeteria food and showing up on time to get his vitals checked or to pop another pill.\u003c/p>\n\u003cp>\"It's like summer camp,\" he says, then reconsiders, since in this trial he can't leave. \"It's kind of like being in jail, except you don't get shanked in the shower.\"\u003c/p>\n\u003cp>Clough first heard about this line of work from a homeless man in Kansas City. Since then, he moved to Austin, Texas, to be closer to some of the big clinics that pay well. He says he can make thousands of dollars in just a few weeks. \"Generally, the more procedures, the more perceived risk in a study, the more it's going to pay,\" he says.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The early tests, though usually safe, can carry unexpected hazards. In January, the test of an experimental pain drug in France \u003ca href=\"http://www.npr.org/sections/health-shots/2016/05/03/475867184/botched-french-drug-trial-followed-rules-but-lacked-common-sense\">was halted\u003c/a> after several participants developed serious neurological problems. One man died.\u003c/p>\n\u003cp>\"Every time you see a TV commercial for a drug and they rattle off all the reasons why you shouldn't take the drug — that's all information that they got from people like me,\" says Clough.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"It's kind of like being in jail, except you don't get shanked in the shower.\"\u003ccite>Professional human test-subject Paul Clough\u003c/cite>\u003c/aside>\n\u003cp>He may be overstating the case a bit. Larger trials of the potential new medicines in people with illnesses the drugs aim to treat are more likely to uncover a wide range of side effects, but there's no question that these early tests in humans help reveal the potential hazards of experimental medicines.\u003c/p>\n\u003cp>Those so-called \u003ca href=\"https://www.nlm.nih.gov/services/ctphases.html\">phase 1 studies\u003c/a> involve a small group of healthy people to determine the right dosage and to get a first look at what the side effects in humans might be. A drug that passes the first test will then move on to larger human studies where it is typically compared with a placebo or other treatment in patients suffering from the condition it's meant to help.\u003c/p>\n\u003cp>Clough says he'll do about eight or nine trials a year. It's enough to fund day-to-day life, plus travel. He's planning a trip to Alaska to photograph bears.\u003c/p>\n\u003cp>Like other serial participants in clinical trials, Clough knows that what he's doing could potentially help others down the line. But that's not the main drive for volunteers. \"We need money,\" says Clough.\u003c/p>\n\u003cp>\u003cstrong>For Some, a Rare Opportunity\u003c/strong>\u003c/p>\n\u003cp>And for some people, especially those with a history of incarceration, clinical trials are a rare opportunity. \"I can't get a regular job because I have a couple of legal problems in my background,\" he says. But when he signs up for a clinical trial, he says, \"They're only looking at what your body does, not what you did.\"\u003c/p>\n\u003cp>Sociologist \u003ca href=\"https://www.med.unc.edu/socialmed/people/jill-fisher\">Jill Fisher\u003c/a>, at the Center for Bioethics at University of North Carolina in Chapel Hill, says that's a perspective she's come across frequently in her research. She \u003ca href=\"http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4408988/\">studies\u003c/a> people who participate repeatedly in phase 1 clinical trials, including self-proclaimed professionals like Clough. \"I think that says a lot about our system overall and what kind of opportunities we have for people in a period of post-incarceration,\" she says.\u003c/p>\n\u003cp>Until the 1970s, experimental medications were often tested in prisoners. Now, clinics rely on healthy volunteers, who get paid for taking the risk, typically around $200 a night spent in a facility.\u003c/p>\n\u003cp>For a lot of people, it's good money. But Fisher says there are a few things about phase 1 clinical research that are concerning.\u003c/p>\n\u003cp>For one, medical research trials in the later stages of drug development — usually involving patients who could gain something more than money from taking the experimental medication — \u003ca href=\"http://www.npr.org/sections/health-shots/2015/12/16/459666750/clinical-trials-still-dont-reflect-the-diversity-of-america\">tend not\u003c/a> to involve enough minority participants. By contrast, in phase 1 research, she says, \"The vast majority of participants are under-represented minorities.\" In the Northeast they're typically black men, and in the Southwest they're typically Hispanic men.\u003c/p>\n\u003cp>The drugs they're testing may go on to make billions of dollars for pharmaceutical companies, though the vast majority that manage pass phase 1 never make it to market.\u003c/p>\n\u003cp>\"I am very concerned about the fact that we're using a segment of our population who might not ever be able to afford the drugs that they're part of testing, and not compensating them perhaps to the degree that we really should,\" she says.\u003c/p>\n\u003cp>Robert Biafore doesn't see it that way. He's a former car salesman who lost his job when the economy went sour in 2008. Biafore says he's participated in at least 50 trials in the last six years.\u003c/p>\n\u003cp>\"My time will come to an end ... and I will go back to selling cars. But in the meantime, this is easy. And I'm getting full medical checks,\" says Biafore, who's uninsured. \"Where else am I going to go and get labs done, physicals done, ECGs done, MRIs looked at and people are going to look at my body and tell me what is wrong with me before something's even wrong?\"\u003c/p>\n\u003cp>He acknowledges that his line of work has risks. But Biafore says the worst that's happened to him was that he got a rash and vomited.\u003c/p>\n\u003cp>\"It's all part of the game,\" he says. \"You're letting scientists use your body to get data for clinical results, so they can get it approved by the [Food and Drug Administration]. It is what it is. You can't be afraid of it.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Every time someone picks up medicine from a pharmacy, or gets a prescription, they owe a debt to the human guinea pigs. \"If it wasn't for people like us you wouldn't get that medication,\" Biafore says.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Professional+%27Guinea+Pigs%27+Can+Make+A+Living+Testing+Drugs+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The early tests, though usually safe, can carry unexpected hazards. In January, the test of an experimental pain drug in France \u003ca href=\"http://www.npr.org/sections/health-shots/2016/05/03/475867184/botched-french-drug-trial-followed-rules-but-lacked-common-sense\">was halted\u003c/a> after several participants developed serious neurological problems. One man died.\u003c/p>\n\u003cp>\"Every time you see a TV commercial for a drug and they rattle off all the reasons why you shouldn't take the drug — that's all information that they got from people like me,\" says Clough.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"It's kind of like being in jail, except you don't get shanked in the shower.\"\u003ccite>Professional human test-subject Paul Clough\u003c/cite>\u003c/aside>\n\u003cp>He may be overstating the case a bit. Larger trials of the potential new medicines in people with illnesses the drugs aim to treat are more likely to uncover a wide range of side effects, but there's no question that these early tests in humans help reveal the potential hazards of experimental medicines.\u003c/p>\n\u003cp>Those so-called \u003ca href=\"https://www.nlm.nih.gov/services/ctphases.html\">phase 1 studies\u003c/a> involve a small group of healthy people to determine the right dosage and to get a first look at what the side effects in humans might be. A drug that passes the first test will then move on to larger human studies where it is typically compared with a placebo or other treatment in patients suffering from the condition it's meant to help.\u003c/p>\n\u003cp>Clough says he'll do about eight or nine trials a year. It's enough to fund day-to-day life, plus travel. He's planning a trip to Alaska to photograph bears.\u003c/p>\n\u003cp>Like other serial participants in clinical trials, Clough knows that what he's doing could potentially help others down the line. But that's not the main drive for volunteers. \"We need money,\" says Clough.\u003c/p>\n\u003cp>\u003cstrong>For Some, a Rare Opportunity\u003c/strong>\u003c/p>\n\u003cp>And for some people, especially those with a history of incarceration, clinical trials are a rare opportunity. \"I can't get a regular job because I have a couple of legal problems in my background,\" he says. But when he signs up for a clinical trial, he says, \"They're only looking at what your body does, not what you did.\"\u003c/p>\n\u003cp>Sociologist \u003ca href=\"https://www.med.unc.edu/socialmed/people/jill-fisher\">Jill Fisher\u003c/a>, at the Center for Bioethics at University of North Carolina in Chapel Hill, says that's a perspective she's come across frequently in her research. She \u003ca href=\"http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4408988/\">studies\u003c/a> people who participate repeatedly in phase 1 clinical trials, including self-proclaimed professionals like Clough. \"I think that says a lot about our system overall and what kind of opportunities we have for people in a period of post-incarceration,\" she says.\u003c/p>\n\u003cp>Until the 1970s, experimental medications were often tested in prisoners. Now, clinics rely on healthy volunteers, who get paid for taking the risk, typically around $200 a night spent in a facility.\u003c/p>\n\u003cp>For a lot of people, it's good money. But Fisher says there are a few things about phase 1 clinical research that are concerning.\u003c/p>\n\u003cp>For one, medical research trials in the later stages of drug development — usually involving patients who could gain something more than money from taking the experimental medication — \u003ca href=\"http://www.npr.org/sections/health-shots/2015/12/16/459666750/clinical-trials-still-dont-reflect-the-diversity-of-america\">tend not\u003c/a> to involve enough minority participants. By contrast, in phase 1 research, she says, \"The vast majority of participants are under-represented minorities.\" In the Northeast they're typically black men, and in the Southwest they're typically Hispanic men.\u003c/p>\n\u003cp>The drugs they're testing may go on to make billions of dollars for pharmaceutical companies, though the vast majority that manage pass phase 1 never make it to market.\u003c/p>\n\u003cp>\"I am very concerned about the fact that we're using a segment of our population who might not ever be able to afford the drugs that they're part of testing, and not compensating them perhaps to the degree that we really should,\" she says.\u003c/p>\n\u003cp>Robert Biafore doesn't see it that way. He's a former car salesman who lost his job when the economy went sour in 2008. Biafore says he's participated in at least 50 trials in the last six years.\u003c/p>\n\u003cp>\"My time will come to an end ... and I will go back to selling cars. But in the meantime, this is easy. And I'm getting full medical checks,\" says Biafore, who's uninsured. \"Where else am I going to go and get labs done, physicals done, ECGs done, MRIs looked at and people are going to look at my body and tell me what is wrong with me before something's even wrong?\"\u003c/p>\n\u003cp>He acknowledges that his line of work has risks. But Biafore says the worst that's happened to him was that he got a rash and vomited.\u003c/p>\n\u003cp>\"It's all part of the game,\" he says. \"You're letting scientists use your body to get data for clinical results, so they can get it approved by the [Food and Drug Administration]. It is what it is. You can't be afraid of it.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Every time someone picks up medicine from a pharmacy, or gets a prescription, they owe a debt to the human guinea pigs. \"If it wasn't for people like us you wouldn't get that medication,\" Biafore says.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Professional+%27Guinea+Pigs%27+Can+Make+A+Living+Testing+Drugs+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>It's 2:00 p.m. and you have a few more hours until the end of your workday.\u003c/p>\n\u003caside class=\"pullquote alignright\">The evidence doesn’t suggest symptoms are permanent. They can be alleviated by changing workplace habits.\u003c/aside>\n\u003cp>Your eyes sting, your vision is getting blurry and your head hurts. The computer screen that you've been staring at for the past six hours seems so bright that you want to shut your eyes.\u003c/p>\n\u003cp>Sound familiar? We'd bet yes.\u003c/p>\n\u003cp>Piotr Le, a Georgetown University grad student, thinks so, too. He used to work in consulting — and that meant staring at a computer screen for 12 or more hours every workday.\u003c/p>\n\u003cp>\"Partially I left because of the physical deterioration of my body,\" Le says. \"A lot of eye rubbing. That's why my prescription got worse. I would wake up with neck pain and back pain.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Depending on whether you consult an optometrist or an ophthalmologist, you might get different answers on what ails you. Is it computer vision syndrome? Is it digital eyestrain? Is it just dry eyes and some eyestrain?\u003c/p>\n\u003cp>[contextly_sidebar id=\"QNoGq8UBrCbujTBCY73WRgfrXV78zHln\"]The most common definition is given by the American Optometric Association, which coined \u003ca href=\"http://www.aoa.org/patients-and-public/caring-for-your-vision/protecting-your-vision/computer-vision-syndrome?sso=y\">computer vision syndrome\u003c/a> and digital eyestrain as a group of vision-related problems from viewing digital screens for a long time.\u003c/p>\n\u003cp>The American Academy of Ophthalmology labels it \u003ca href=\"http://www.aao.org/eye-health/tips-prevention/computer-usage\">digital-related eyestrain\u003c/a>. The group emphasizes that extended reading and writing can also strain the eyes.\u003c/p>\n\u003cp>Neither computer vision syndrome nor digital eyestrain is an official medical condition. They are more of a collection of symptoms that sometimes include headache, neck and shoulder pain.\u003c/p>\n\u003cp>\"Classification schemes do take time to develop, and so it may not have crept into medical coding,\" says Dr. Michael X. Repka, a Johns Hopkins ophthalmologist and clinical spokesman for the American Academy of Ophthalmology.\u003c/p>\n\u003cp>Repka says in the past these symptoms would be lumped under \u003ca href=\"http://eyewiki.aao.org/Asthenopia\">asthenopia\u003c/a>, a condition that encompasses eye fatigue, ache around the eyes, blurred vision and headache. Computer vision syndrome, he says, is considered to be under asthenopia in the \u003ca href=\"http://icdlist.com/icd-10/H53.149\">ICD-10 medical coding system\u003c/a>.\u003c/p>\n\u003cp>\"Computer vision syndrome ... is not a recognized medical entity,\" says James Sheedy, a professor of optometry at Pacific University and head of the Vision Ergonomics Research Laboratory. \"A medical diagnosis is a condition where the anatomy or physiology isn't functioning properly. There are several different medical diagnoses that could be the cause of what is commonly called computer vision syndrome. There are different names put on it. Those are really names to create a black box where you put everything into ... but it's really the same thing.\"\u003c/p>\n\u003caside class=\"pullquote alignright\">Follow the 20-20-20 rule: Every 20 minutes, look at something at least 20 feet away for 20 seconds.\u003c/aside>\n\u003cp>The fact that these symptoms are common is self-evident. Optometrists and ophthalmologists agree that many patients walk into their offices with these complaints. But is there enough evidence to upgrade their diagnostic status?\u003c/p>\n\u003cp>\"I think research is coming out now that this really is a different condition,\" says Mark Rosenfield, a professor at SUNY College of Optometry. \"There is something about these screens that is different from paper and so we're trying to figure out what aspects of screens is it that is causing problems. People didn't look at paper for that length of time [that] people are looking at screens, so I think that could be a factor too — the fact that people are looking at these things for such long periods of time.\"\u003c/p>\n\u003cp>So why do our digital screens cause us so much trouble?\u003c/p>\n\u003cp>\"We're not really designed to do full-time near work; we're designed to do part-time near work, and so to the extent that we have to do so much near work our eyes are in tension virtually all the time,\" says Steve Loomis, president of the American Optometric Association. \"The average worker spends seven hours a day on some digital device. ... I'm among them and so what we know is that that means that the muscles in the eye are in a state of tension.\"\u003c/p>\n\u003cp>In a \u003ca href=\"http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=64714113&site=ehost-live\">review of studies\u003c/a> for the journal \u003cem>Ophthalmic & Physiological Optics,\u003c/em> Rosenfield found that we have more incomplete blinks during computer operations, which reduces the volume of tears in our eyes. Too few tears causes irritation and a burning sensation in the eyes.\u003c/p>\n\u003cp>A \u003ca href=\"http://content.iospress.com/articles/work/wor2162\">more recent review\u003c/a> of the syndrome in \u003cem>IOS Press\u003c/em> lists other factors: glare from windows, overhead lights and the computer. Also, the particulars of how your computer or digital devices are arranged, including the height and viewing distance of the device from our eyes. We also tend to hold hand-held devices closer to our eyes than we should.\u003c/p>\n\u003cp>\"The eyes work best we know by looking down about 15 degrees in most desktop computer situations. This means that the top of the computer screen displays should be level with the eyes,\" Sheedy says. \"If it's higher or lower than that the person tends to tilt the head back or forward and now they have an imbalance and this creates muscular tension and it can give them a neck ache.\"\u003c/p>\n\u003cp>The evidence doesn't suggest these symptoms are permanent. They can be alleviated by changing our workplace habits. Anti-glare screen filters and eyedrops may help some. Optometrists say that some people who use reading glasses may benefit from trying glasses with a different focal length for computer work.\u003c/p>\n\u003cp>One of the most commonly cited — and cheapest — things to do is just to give your eyes a rest. Follow the 20-20-20 rule: Every 20 minutes, look at something at least 20 feet away for 20 seconds.\u003c/p>\n\u003cp>Grad student Le now stares at his computer only four to six hours a day. He says he still gets occasional neck pain from looking down at his laptop. And the white backgrounds of PDFs and Word documents still bother his eyes some. He's also trying software to make the tone of his screen warmer.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>But his go-to move is taking a break. \"I close my eyes and look at the skyline,\" he says, \"or something that is not bright.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=After+A+Long+Day+At+The+Computer+Do+You+Have+A+Medical+Problem%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>It's 2:00 p.m. and you have a few more hours until the end of your workday.\u003c/p>\n\u003caside class=\"pullquote alignright\">The evidence doesn’t suggest symptoms are permanent. They can be alleviated by changing workplace habits.\u003c/aside>\n\u003cp>Your eyes sting, your vision is getting blurry and your head hurts. The computer screen that you've been staring at for the past six hours seems so bright that you want to shut your eyes.\u003c/p>\n\u003cp>Sound familiar? We'd bet yes.\u003c/p>\n\u003cp>Piotr Le, a Georgetown University grad student, thinks so, too. He used to work in consulting — and that meant staring at a computer screen for 12 or more hours every workday.\u003c/p>\n\u003cp>\"Partially I left because of the physical deterioration of my body,\" Le says. \"A lot of eye rubbing. That's why my prescription got worse. I would wake up with neck pain and back pain.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Depending on whether you consult an optometrist or an ophthalmologist, you might get different answers on what ails you. Is it computer vision syndrome? Is it digital eyestrain? Is it just dry eyes and some eyestrain?\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>The most common definition is given by the American Optometric Association, which coined \u003ca href=\"http://www.aoa.org/patients-and-public/caring-for-your-vision/protecting-your-vision/computer-vision-syndrome?sso=y\">computer vision syndrome\u003c/a> and digital eyestrain as a group of vision-related problems from viewing digital screens for a long time.\u003c/p>\n\u003cp>The American Academy of Ophthalmology labels it \u003ca href=\"http://www.aao.org/eye-health/tips-prevention/computer-usage\">digital-related eyestrain\u003c/a>. The group emphasizes that extended reading and writing can also strain the eyes.\u003c/p>\n\u003cp>Neither computer vision syndrome nor digital eyestrain is an official medical condition. They are more of a collection of symptoms that sometimes include headache, neck and shoulder pain.\u003c/p>\n\u003cp>\"Classification schemes do take time to develop, and so it may not have crept into medical coding,\" says Dr. Michael X. Repka, a Johns Hopkins ophthalmologist and clinical spokesman for the American Academy of Ophthalmology.\u003c/p>\n\u003cp>Repka says in the past these symptoms would be lumped under \u003ca href=\"http://eyewiki.aao.org/Asthenopia\">asthenopia\u003c/a>, a condition that encompasses eye fatigue, ache around the eyes, blurred vision and headache. Computer vision syndrome, he says, is considered to be under asthenopia in the \u003ca href=\"http://icdlist.com/icd-10/H53.149\">ICD-10 medical coding system\u003c/a>.\u003c/p>\n\u003cp>\"Computer vision syndrome ... is not a recognized medical entity,\" says James Sheedy, a professor of optometry at Pacific University and head of the Vision Ergonomics Research Laboratory. \"A medical diagnosis is a condition where the anatomy or physiology isn't functioning properly. There are several different medical diagnoses that could be the cause of what is commonly called computer vision syndrome. There are different names put on it. Those are really names to create a black box where you put everything into ... but it's really the same thing.\"\u003c/p>\n\u003caside class=\"pullquote alignright\">Follow the 20-20-20 rule: Every 20 minutes, look at something at least 20 feet away for 20 seconds.\u003c/aside>\n\u003cp>The fact that these symptoms are common is self-evident. Optometrists and ophthalmologists agree that many patients walk into their offices with these complaints. But is there enough evidence to upgrade their diagnostic status?\u003c/p>\n\u003cp>\"I think research is coming out now that this really is a different condition,\" says Mark Rosenfield, a professor at SUNY College of Optometry. \"There is something about these screens that is different from paper and so we're trying to figure out what aspects of screens is it that is causing problems. People didn't look at paper for that length of time [that] people are looking at screens, so I think that could be a factor too — the fact that people are looking at these things for such long periods of time.\"\u003c/p>\n\u003cp>So why do our digital screens cause us so much trouble?\u003c/p>\n\u003cp>\"We're not really designed to do full-time near work; we're designed to do part-time near work, and so to the extent that we have to do so much near work our eyes are in tension virtually all the time,\" says Steve Loomis, president of the American Optometric Association. \"The average worker spends seven hours a day on some digital device. ... I'm among them and so what we know is that that means that the muscles in the eye are in a state of tension.\"\u003c/p>\n\u003cp>In a \u003ca href=\"http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=64714113&site=ehost-live\">review of studies\u003c/a> for the journal \u003cem>Ophthalmic & Physiological Optics,\u003c/em> Rosenfield found that we have more incomplete blinks during computer operations, which reduces the volume of tears in our eyes. Too few tears causes irritation and a burning sensation in the eyes.\u003c/p>\n\u003cp>A \u003ca href=\"http://content.iospress.com/articles/work/wor2162\">more recent review\u003c/a> of the syndrome in \u003cem>IOS Press\u003c/em> lists other factors: glare from windows, overhead lights and the computer. Also, the particulars of how your computer or digital devices are arranged, including the height and viewing distance of the device from our eyes. We also tend to hold hand-held devices closer to our eyes than we should.\u003c/p>\n\u003cp>\"The eyes work best we know by looking down about 15 degrees in most desktop computer situations. This means that the top of the computer screen displays should be level with the eyes,\" Sheedy says. \"If it's higher or lower than that the person tends to tilt the head back or forward and now they have an imbalance and this creates muscular tension and it can give them a neck ache.\"\u003c/p>\n\u003cp>The evidence doesn't suggest these symptoms are permanent. They can be alleviated by changing our workplace habits. Anti-glare screen filters and eyedrops may help some. Optometrists say that some people who use reading glasses may benefit from trying glasses with a different focal length for computer work.\u003c/p>\n\u003cp>One of the most commonly cited — and cheapest — things to do is just to give your eyes a rest. Follow the 20-20-20 rule: Every 20 minutes, look at something at least 20 feet away for 20 seconds.\u003c/p>\n\u003cp>Grad student Le now stares at his computer only four to six hours a day. He says he still gets occasional neck pain from looking down at his laptop. And the white backgrounds of PDFs and Word documents still bother his eyes some. He's also trying software to make the tone of his screen warmer.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But his go-to move is taking a break. \"I close my eyes and look at the skyline,\" he says, \"or something that is not bright.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=After+A+Long+Day+At+The+Computer+Do+You+Have+A+Medical+Problem%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>On Jan. 10, a healthy 49-year-old man came down with headaches and blurry vision. He was participating in the test of an experimental drug that might help dull nerve pain, and it was the fifth day in a row that he'd taken the medicine.\u003c/p>\n\u003cp>The symptoms were serious enough to land the man in the hospital. Despite the fact that he was experiencing stroke-like symptoms, five other healthy volunteers received a sixth dose of the experimental medicine at the highest dose used in the study the next morning.\u003c/p>\n\u003cp>Two hours later, the hospital called Biotrial, the company running the study, to say that an MRI scan showed the hospitalized man had had a massive stroke in the brain stem. Later that day, he was declared brain dead. He died Jan. 17, a week after checking into the hospital. According to French \u003ca href=\"http://www.ouest-france.fr/leditiondusoir/data/665/reader/reader.html?t=1453223878036#!preferred/1/package/665/pub/666/page/8\">newspapers\u003c/a>, he was Guillaume Molinet, an artist and father of four.\u003c/p>\n\u003cp>The five other volunteers who got the highest dose of the drug were then hospitalized. One was free of symptoms. But four had headaches, were fading in and out of consciousness and had short-term memory problems. Brain scans showed that they had identical, symmetrical brain injuries in two parts of the brain.\u003c/p>\n\u003cp>The study was the first one to try the drug in humans. Healthy volunteers were recruited to test preliminary doses for the drug and its safety in a so-called \u003ca href=\"http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm\">phase 1 study\u003c/a>.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Independent Investigation Finds Missteps\u003c/strong>\u003c/p>\n\u003cp>The situation was totally unexpected, said \u003ca href=\"http://www.pharmacologie.u-bordeaux2.fr/en/presentation/biographies/Bernard-Begaud.htm\">Bernard Begaud\u003c/a>, a pharmacologist at the University of Bordeaux in France. \"The brain imaging was very strange, unlike anything we know in medicine,\" he says.\u003c/p>\n\u003cp>He led the independent scientific investigation of what went wrong. Their \u003ca href=\"http://ansm.sante.fr/var/ansm_site/storage/original/application/744c7c6daf96b141bc9509e2f85c227e.pdf\">report\u003c/a>, released in April, outlined hypotheses on what happened and called for some changes in how clinical trials are conducted. The group concluded that the trial followed the rules and was perfectly legal but suffered from missteps.\u003c/p>\n\u003cp>None of the other 90 volunteers exposed to the drug at lower doses experienced any problems. \"It was like a threshold,\" said Begaud. There were no problems for people who had taken 20 milligrams of the drug for 10 days straight. But for those taking doses of 50 milligrams, the fifth day \"was a disaster, suddenly,\" he says. \"It's absolutely catastrophic, for medical research and of course for the volunteers.\"\u003c/p>\n\u003cp>In a presentation to outside investigators, Biotrial called the reaction an \"explosive and delayed toxicity not simply related to exposure levels.\"\u003c/p>\n\u003cp>There were mistakes that came from ignoring common sense, Begaud said.\u003c/p>\n\u003cp>First, the people running the trial gave extremely high doses of the drug — about 40 times the amount that they expected was needed to quell pain. Their goal in the study was to completely block a certain enzyme. They'd increased the dose given to different subject groups in an odd pattern, too. Second, they ignored the fact that one participant was hospitalized and proceeded to give another high dose to five more people. Third, Begaud said, the trial was a \"fishing expedition.\" The drug hadn't shown much promise for treating pain, but the company decided to test it in humans anyway.\u003c/p>\n\u003cp>Biotrial conducted the study in Rennes, France, for a Portuguese firm called Bial, developer of the experimental medicine.\u003c/p>\n\u003cp>The drugmaker defended its approach. \"The dosage estimation over the trial was fully in accordance with the Protocol approved by the French authorities,\" Bial representative Susana Vasconcelos told Shots in an email.\u003c/p>\n\u003cp>According to a Bial press release, the experimental drug, BIA 10-2474, was primarily \u003ca href=\"https://www.bial.com/en/pressroom.138/news.140/phase_i_clinical_trial_rennes.a558.html\">meant\u003c/a> to act \"in the area of pain,\" specifically to treat nerve pain, but also potentially chronic pain, anxiety and the tremors related to Parkinson's disease.\u003c/p>\n\u003cp>\u003cstrong>A Search For New Way To Relieve Pain\u003c/strong>\u003c/p>\n\u003cp>The drug appears to work on the endocannabinoid system in the brain. That's a collection of receptors in the brain and nervous system involved in pain and stress response (and also in getting high from smoking weed).\u003c/p>\n\u003cp>But in this case, the compound likely also acted on parts of the brain that didn't have anything to do with endocannabinoid system, according to \u003ca href=\"http://www.anatomy.uci.edu/piomelli.html\">Daniele Piomelli\u003c/a>, a pharmacologist at the University of California, Irvine. (He wasn't on the scientific committee that investigated the trial).\u003c/p>\n\u003cp>Piomelli's research group in California was involved \u003ca href=\"http://www.nature.com/nature/journal/v394/n6690/full/394277a0.html\">early on\u003c/a> in identifying this family of drugs, which has since gotten a lot of attention in the pharmaceutical world. He said the compounds were particularly attractive because they had the potential to do the beneficial things that smoking weed can do, like reduce anxiety and relieve pain, without serious side effects, such as memory loss.\u003c/p>\n\u003cp>Specifically, the compound prevents an enzyme called \u003ca href=\"http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146581/\">fatty acid amide hydrolase\u003c/a>, or FAAH, from breaking down a molecule in the brain that's involved in the body's response to pain and anxiety. \"The January tragedy was a surprise and a shock to everybody,\" said Piomelli. \"All the other FAAH inhibitors that had been tested in the past had been shown to be totally safe.\" He says even mild side effects were rare. \"What happened in Rennes didn't match with anything we knew.\"\u003c/p>\n\u003cp>The scientific committee investigating the trial hypothesizes that the bad effects likely resulted from the repeated high doses. They say the drug may have accumulated in the volunteers' bodies enough to trigger an unexpected side effect.\u003c/p>\n\u003cp>Other drug companies had ditched similar molecules \u003ca href=\"http://journals.lww.com/pain/pages/articleviewer.aspx?year=2012&issue=09000&article=00013&type=abstract\">because\u003c/a> they weren't very effective. And BIA 10-2474 hadn't shown much promise for pain relief.\u003c/p>\n\u003cp>\"I still don't understand why they would bother,\" said \u003ca href=\"https://www.nottingham.ac.uk/life-sciences/people/steve.alexander\">Steve Alexander\u003c/a>, a molecular pharmacologist at the University of Nottingham Medical School. \"Most drug companies ... would move on and go and look for something with a higher potency and a better selectivity.\"\u003c/p>\n\u003cp>\"As it is usual, at this early stage of evaluation in healthy volunteers no specific therapeutic target had been selected,\" an email from Bial's Vasconcelos said. \"However, as described in the clinical trial protocol, it aimed to evaluate the potential effects of the compound on the endocannabinoid system, namely in pain sensitivity.\"\u003c/p>\n\u003cp>Furthermore, the email said, \"preclinical tests on animals performed with higher doses to the ones administered on the phase 1 clinical trial, did not show any evidence that could have prevented conducting the trial in man.\"\u003c/p>\n\u003cp>Begaud and his colleagues recommend that clinical tests of a drug shouldn't be started until there is a clear understanding of the benefits the work might give. \"We feel that we have to change this paradigm — to first prove the potential and after we go to toxicology and if it's safe we jump to humans,\" Begaud said.\u003c/p>\n\u003cp>Of the four surviving volunteers who were hospitalized, two continue to have memory problems and other issues from their brain injuries, like vertigo and seeing double, he says. Many of the 90 volunteers exposed to the drug at lower doses are being monitored with brain imaging and neurological exams, and none have shown any problems.\u003c/p>\n\u003cp>Alexander says there may have been a hint from animal studies about potential problems. Two mice and a rat that died in toxicology studies showed brain damage, especially to the hippocampus, much like that of the affected volunteers. Such injuries happen a lot in drug studies on animals but not, Alexander said, with FAAH inhibitors.\u003c/p>\n\u003cp>\"The fact that what they observed was an inflammatory response in the brain, which is entirely contrary to what one would expect from an FAAH inhibitor — that to me would have been, not a red light, but an amber light,\" said Alexander.\u003c/p>\n\u003cp>Stephane Schubhan, one of the men who was hospitalized and continues to have symptoms, \u003ca href=\"http://www.irishtimes.com/news/world/europe/survivor-of-lethal-french-drug-trial-speaks-out-1.2554593\">told\u003c/a> \u003cem>The Irish Times\u003c/em> that he hadn't heard about the animals dying in pre-clinical trials.\u003c/p>\n\u003cp>\u003cstrong>Other Studies Put On Hold\u003c/strong>\u003c/p>\n\u003cp>Properly informing volunteers about their risks is a challenge across the world, said \u003ca href=\"http://law.wustl.edu/faculty/pages.aspx?id=226\">Rebecca Dresser\u003c/a>, a medical ethicist with Washington University in St. Louis. The first time a drug is tried in humans is the most dangerous period in drug development, but she says subjects often don't understand the risks of participating.\u003c/p>\n\u003cp>\"That requires conversation, back and forth. It's like teaching, not just reciting a bunch of information to people,\" said Dresser.\u003c/p>\n\u003cp>\"Their trials were not badly designed,\" says Piomelli, aside from the unusual dosing. \"But at the end of day it's not just following the rules. You need to have common sense.\"\u003c/p>\n\u003cp>\"If you have a patient in the hospital hospitalized with what looks like a stroke and you go ahead and do another set of administrations, quite frankly, I find this criminal, because this is an act of total lack of conscience,\" says Piomelli.\u003c/p>\n\u003cp>He says the consequences from the failed trial could be huge for his field of research and for phase 1 trials.\u003c/p>\n\u003cp>After the news from France, Janssen Pharmaceuticals, a unit of Johnson & Johnson, \u003ca href=\"http://www.forbes.com/sites/davidkroll/2016/01/20/janssen-voluntarily-suspends-faah-inhibitor-phase-2-trials-in-wake-of-bial-tragedy/#7cc530a568bb\">halted\u003c/a> research on similar compounds. And three Yale University trials using FAAH inhibitors were \u003ca href=\"https://clinicaltrials.gov/ct2/results?term=faah+inhibitor+yale&Search=Search\">suspended\u003c/a> until further notice. The Food and Drug Administration said it couldn't comment on clinical holds unless they're first disclosed by the company or institution sponsoring the research.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\"The only silver lining, if there is one in this story, is that possibly in the future guidelines will be put in place to prevent this from happening again,\" said Pomelli. But, he said, it's a meager silver lining.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Botched+French+Drug+Trial+Followed+Rules+But+Lacked+%27Common+Sense%27&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>On Jan. 10, a healthy 49-year-old man came down with headaches and blurry vision. He was participating in the test of an experimental drug that might help dull nerve pain, and it was the fifth day in a row that he'd taken the medicine.\u003c/p>\n\u003cp>The symptoms were serious enough to land the man in the hospital. Despite the fact that he was experiencing stroke-like symptoms, five other healthy volunteers received a sixth dose of the experimental medicine at the highest dose used in the study the next morning.\u003c/p>\n\u003cp>Two hours later, the hospital called Biotrial, the company running the study, to say that an MRI scan showed the hospitalized man had had a massive stroke in the brain stem. Later that day, he was declared brain dead. He died Jan. 17, a week after checking into the hospital. According to French \u003ca href=\"http://www.ouest-france.fr/leditiondusoir/data/665/reader/reader.html?t=1453223878036#!preferred/1/package/665/pub/666/page/8\">newspapers\u003c/a>, he was Guillaume Molinet, an artist and father of four.\u003c/p>\n\u003cp>The five other volunteers who got the highest dose of the drug were then hospitalized. One was free of symptoms. But four had headaches, were fading in and out of consciousness and had short-term memory problems. Brain scans showed that they had identical, symmetrical brain injuries in two parts of the brain.\u003c/p>\n\u003cp>The study was the first one to try the drug in humans. Healthy volunteers were recruited to test preliminary doses for the drug and its safety in a so-called \u003ca href=\"http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm\">phase 1 study\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Independent Investigation Finds Missteps\u003c/strong>\u003c/p>\n\u003cp>The situation was totally unexpected, said \u003ca href=\"http://www.pharmacologie.u-bordeaux2.fr/en/presentation/biographies/Bernard-Begaud.htm\">Bernard Begaud\u003c/a>, a pharmacologist at the University of Bordeaux in France. \"The brain imaging was very strange, unlike anything we know in medicine,\" he says.\u003c/p>\n\u003cp>He led the independent scientific investigation of what went wrong. Their \u003ca href=\"http://ansm.sante.fr/var/ansm_site/storage/original/application/744c7c6daf96b141bc9509e2f85c227e.pdf\">report\u003c/a>, released in April, outlined hypotheses on what happened and called for some changes in how clinical trials are conducted. The group concluded that the trial followed the rules and was perfectly legal but suffered from missteps.\u003c/p>\n\u003cp>None of the other 90 volunteers exposed to the drug at lower doses experienced any problems. \"It was like a threshold,\" said Begaud. There were no problems for people who had taken 20 milligrams of the drug for 10 days straight. But for those taking doses of 50 milligrams, the fifth day \"was a disaster, suddenly,\" he says. \"It's absolutely catastrophic, for medical research and of course for the volunteers.\"\u003c/p>\n\u003cp>In a presentation to outside investigators, Biotrial called the reaction an \"explosive and delayed toxicity not simply related to exposure levels.\"\u003c/p>\n\u003cp>There were mistakes that came from ignoring common sense, Begaud said.\u003c/p>\n\u003cp>First, the people running the trial gave extremely high doses of the drug — about 40 times the amount that they expected was needed to quell pain. Their goal in the study was to completely block a certain enzyme. They'd increased the dose given to different subject groups in an odd pattern, too. Second, they ignored the fact that one participant was hospitalized and proceeded to give another high dose to five more people. Third, Begaud said, the trial was a \"fishing expedition.\" The drug hadn't shown much promise for treating pain, but the company decided to test it in humans anyway.\u003c/p>\n\u003cp>Biotrial conducted the study in Rennes, France, for a Portuguese firm called Bial, developer of the experimental medicine.\u003c/p>\n\u003cp>The drugmaker defended its approach. \"The dosage estimation over the trial was fully in accordance with the Protocol approved by the French authorities,\" Bial representative Susana Vasconcelos told Shots in an email.\u003c/p>\n\u003cp>According to a Bial press release, the experimental drug, BIA 10-2474, was primarily \u003ca href=\"https://www.bial.com/en/pressroom.138/news.140/phase_i_clinical_trial_rennes.a558.html\">meant\u003c/a> to act \"in the area of pain,\" specifically to treat nerve pain, but also potentially chronic pain, anxiety and the tremors related to Parkinson's disease.\u003c/p>\n\u003cp>\u003cstrong>A Search For New Way To Relieve Pain\u003c/strong>\u003c/p>\n\u003cp>The drug appears to work on the endocannabinoid system in the brain. That's a collection of receptors in the brain and nervous system involved in pain and stress response (and also in getting high from smoking weed).\u003c/p>\n\u003cp>But in this case, the compound likely also acted on parts of the brain that didn't have anything to do with endocannabinoid system, according to \u003ca href=\"http://www.anatomy.uci.edu/piomelli.html\">Daniele Piomelli\u003c/a>, a pharmacologist at the University of California, Irvine. (He wasn't on the scientific committee that investigated the trial).\u003c/p>\n\u003cp>Piomelli's research group in California was involved \u003ca href=\"http://www.nature.com/nature/journal/v394/n6690/full/394277a0.html\">early on\u003c/a> in identifying this family of drugs, which has since gotten a lot of attention in the pharmaceutical world. He said the compounds were particularly attractive because they had the potential to do the beneficial things that smoking weed can do, like reduce anxiety and relieve pain, without serious side effects, such as memory loss.\u003c/p>\n\u003cp>Specifically, the compound prevents an enzyme called \u003ca href=\"http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146581/\">fatty acid amide hydrolase\u003c/a>, or FAAH, from breaking down a molecule in the brain that's involved in the body's response to pain and anxiety. \"The January tragedy was a surprise and a shock to everybody,\" said Piomelli. \"All the other FAAH inhibitors that had been tested in the past had been shown to be totally safe.\" He says even mild side effects were rare. \"What happened in Rennes didn't match with anything we knew.\"\u003c/p>\n\u003cp>The scientific committee investigating the trial hypothesizes that the bad effects likely resulted from the repeated high doses. They say the drug may have accumulated in the volunteers' bodies enough to trigger an unexpected side effect.\u003c/p>\n\u003cp>Other drug companies had ditched similar molecules \u003ca href=\"http://journals.lww.com/pain/pages/articleviewer.aspx?year=2012&issue=09000&article=00013&type=abstract\">because\u003c/a> they weren't very effective. And BIA 10-2474 hadn't shown much promise for pain relief.\u003c/p>\n\u003cp>\"I still don't understand why they would bother,\" said \u003ca href=\"https://www.nottingham.ac.uk/life-sciences/people/steve.alexander\">Steve Alexander\u003c/a>, a molecular pharmacologist at the University of Nottingham Medical School. \"Most drug companies ... would move on and go and look for something with a higher potency and a better selectivity.\"\u003c/p>\n\u003cp>\"As it is usual, at this early stage of evaluation in healthy volunteers no specific therapeutic target had been selected,\" an email from Bial's Vasconcelos said. \"However, as described in the clinical trial protocol, it aimed to evaluate the potential effects of the compound on the endocannabinoid system, namely in pain sensitivity.\"\u003c/p>\n\u003cp>Furthermore, the email said, \"preclinical tests on animals performed with higher doses to the ones administered on the phase 1 clinical trial, did not show any evidence that could have prevented conducting the trial in man.\"\u003c/p>\n\u003cp>Begaud and his colleagues recommend that clinical tests of a drug shouldn't be started until there is a clear understanding of the benefits the work might give. \"We feel that we have to change this paradigm — to first prove the potential and after we go to toxicology and if it's safe we jump to humans,\" Begaud said.\u003c/p>\n\u003cp>Of the four surviving volunteers who were hospitalized, two continue to have memory problems and other issues from their brain injuries, like vertigo and seeing double, he says. Many of the 90 volunteers exposed to the drug at lower doses are being monitored with brain imaging and neurological exams, and none have shown any problems.\u003c/p>\n\u003cp>Alexander says there may have been a hint from animal studies about potential problems. Two mice and a rat that died in toxicology studies showed brain damage, especially to the hippocampus, much like that of the affected volunteers. Such injuries happen a lot in drug studies on animals but not, Alexander said, with FAAH inhibitors.\u003c/p>\n\u003cp>\"The fact that what they observed was an inflammatory response in the brain, which is entirely contrary to what one would expect from an FAAH inhibitor — that to me would have been, not a red light, but an amber light,\" said Alexander.\u003c/p>\n\u003cp>Stephane Schubhan, one of the men who was hospitalized and continues to have symptoms, \u003ca href=\"http://www.irishtimes.com/news/world/europe/survivor-of-lethal-french-drug-trial-speaks-out-1.2554593\">told\u003c/a> \u003cem>The Irish Times\u003c/em> that he hadn't heard about the animals dying in pre-clinical trials.\u003c/p>\n\u003cp>\u003cstrong>Other Studies Put On Hold\u003c/strong>\u003c/p>\n\u003cp>Properly informing volunteers about their risks is a challenge across the world, said \u003ca href=\"http://law.wustl.edu/faculty/pages.aspx?id=226\">Rebecca Dresser\u003c/a>, a medical ethicist with Washington University in St. Louis. The first time a drug is tried in humans is the most dangerous period in drug development, but she says subjects often don't understand the risks of participating.\u003c/p>\n\u003cp>\"That requires conversation, back and forth. It's like teaching, not just reciting a bunch of information to people,\" said Dresser.\u003c/p>\n\u003cp>\"Their trials were not badly designed,\" says Piomelli, aside from the unusual dosing. \"But at the end of day it's not just following the rules. You need to have common sense.\"\u003c/p>\n\u003cp>\"If you have a patient in the hospital hospitalized with what looks like a stroke and you go ahead and do another set of administrations, quite frankly, I find this criminal, because this is an act of total lack of conscience,\" says Piomelli.\u003c/p>\n\u003cp>He says the consequences from the failed trial could be huge for his field of research and for phase 1 trials.\u003c/p>\n\u003cp>After the news from France, Janssen Pharmaceuticals, a unit of Johnson & Johnson, \u003ca href=\"http://www.forbes.com/sites/davidkroll/2016/01/20/janssen-voluntarily-suspends-faah-inhibitor-phase-2-trials-in-wake-of-bial-tragedy/#7cc530a568bb\">halted\u003c/a> research on similar compounds. And three Yale University trials using FAAH inhibitors were \u003ca href=\"https://clinicaltrials.gov/ct2/results?term=faah+inhibitor+yale&Search=Search\">suspended\u003c/a> until further notice. The Food and Drug Administration said it couldn't comment on clinical holds unless they're first disclosed by the company or institution sponsoring the research.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"The only silver lining, if there is one in this story, is that possibly in the future guidelines will be put in place to prevent this from happening again,\" said Pomelli. But, he said, it's a meager silver lining.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Botched+French+Drug+Trial+Followed+Rules+But+Lacked+%27Common+Sense%27&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Elizabeth Holmes fit into the Silicon Valley success mold. A young Stanford dropout who left school to pursue her entrepreneurial vision, she founded Theranos and said she would disrupt the world of medicine with easy and inexpensive blood tests.\u003c/p>\n\u003caside class=\"pullquote alignright\">In Silicon Valley, secrecy and raising big money before achieving results are par for the course. Not so in the world of biomed.\u003c/aside>\n\u003cp>But now her company is \u003ca href=\"http://www.npr.org/2016/04/19/474868428/innovative-blood-testing-company-theranos-under-criminal-investigation\">under federal investigation\u003c/a> and extra scrutiny \u003ca href=\"http://www.latimes.com/business/la-fi-theranos-investigations-20160419-story.html\">by federal regulators\u003c/a>. And questions are being raised about whether applying hardware and software business culture to biotechnology is dangerous.\u003c/p>\n\u003cp>Holmes was an alluring figure; young and intense in the kind of way Apple founder Steve Jobs was. Like Jobs, she wore \u003ca href=\"http://www.glamour.com/story/theranos-founder-elizabeth-holmes-career-advice\">only black turtlenecks\u003c/a> because she didn't have time to think about her wardrobe.\u003c/p>\n\u003cp>And of course, there was \u003ca href=\"http://www.tedmed.com/talks/show?id=309114\">the TED talk\u003c/a> in which Holmes painted a picture of a world in which too many people avoided blood tests because of the cost, inconvenience and discomfort of giving so much blood. Sometimes they learned too late about a serious health condition. But, her company — \u003ca href=\"https://www.theranos.com/\">Theranos\u003c/a> — had the solution.\u003c/p>\n\u003cp>\"We've made it possible to run comprehensive laboratory tests from a tiny sample or a few drops of blood that could be taken from a finger,\" she told the audience.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Holmes had a beautiful vision, backed by hundreds of millions of dollars in investment, and \u003ca href=\"https://www.theranos.com/leadership\">a board of big names\u003c/a> like Henry Kissinger and George P. Schulz. The media had a love fest. \u003cem>Time\u003c/em> magazine called Holmes \u003ca href=\"http://time.com/3822734/elizabeth-holmes-2015-time-100/\">one of the 100 most influential people\u003c/a> in the world. She was profiled in \u003ca href=\"http://fortune.com/2014/06/12/theranos-blood-holmes/\">Fortune\u003c/a> and \u003ca href=\"http://www.newyorker.com/magazine/2014/12/15/blood-simpler\">The New Yorker\u003c/a>. Even medical professionals like \u003ca href=\"http://www.businessinsider.com/scientist-skeptical-thranos-blood-test-elizabeth-holmes-2015-6\">Dr. John Ioannidis\u003c/a>, a professor at Stanford University Medical School were intrigued.\u003c/p>\n\u003caside class=\"pullquote alignright\">“This is equivalent to me, being a biomedical researcher, trying to become an architect and build a skyscraper. Would you give me a few billion dollars please?”\u003ccite> Dr. John Ioannidis, Stanford Medical School professor\u003c/cite>\u003c/aside>\n\u003cp>\"My first reaction was, it sounds really brilliant,\" Ioannides says. \"I would like to collaborate with these people and maybe even use their technology in my own studies.\" Studies — that's what medicine and science is built upon.\u003c/p>\n\u003cp>\"So the first thing that I did as a researcher, as a scientist is check the scientific literature,\" says Ioannidis. \"How much do we know about what they do? And I couldn't find even a single paper.\"\u003c/p>\n\u003cp>Then there was the advisory board: big names in politics, not science. And Holmes had no background in medicine. \"This is equivalent to me, being a biomedical researcher, trying to become an architect and build a skyscraper. Would you give me a few billion dollars please?\"\u003c/p>\n\u003cp>Of course, no one would give him a few billion dollars.\u003c/p>\n\u003cp>But in the tech world, maybe they would. Jo-Ellen Pozner, a professor at the University of California, Berkeley Haas School of Business, says some of the greatest companies were built on hype and a big idea.\u003c/p>\n\u003cp>\"Often the product comes after the money, and so the first job is to get the investors to give you the money and that requires that you really sell them on this big idea before it's actually in hand,\" Pozner says.\u003c/p>\n\u003cp>Pozner points to \u003ca href=\"http://www.npr.org/sections/theprotojournalist/2014/01/08/260457752/can-jeff-bezos-save-planet-earth\">Jeff Bezos\u003c/a> and his company Amazon, which started as an online bookseller. \"He called the company Amazon because he wanted it to be the biggest retailer in the world, so he named it after the biggest river in the world,\" she says. \"That projects a certain kind of optimism about where we're going and what we have in mind and what we're able to accomplish.\"\u003c/p>\n\u003cp>Despite many years when Amazon made no profit, Bezos drew investors and in turn he expanded and got more customers.\u003c/p>\n\u003cp>Secrecy is also part of the tech world playbook — no studies needed. Google keeps its search algorithms secret — as a way to keep them out of the hands of competitors.\u003c/p>\n\u003cp>\"So there are so many things going on in our firm and we're not telling you about them and that's part of the allure and the mystique of the organization,\" says Pozner. \"That keeps people excited about what's coming next.\"\u003c/p>\n\u003cp>This is totally contrary to how the medical and biotech fields work — studies are published in journals and reviewed by peers and products require government approval. This may gum up the works of Silicon Valley's fast-paced innovation economy, but it's for a good reason, says Stanford's Ioannidis.\u003c/p>\n\u003cp>\"It's not such a horrible thing if your mobile phone battery dies an hour earlier than it's supposed to,\" he says. \"But if a patient gets given the wrong results and then going down the path of making wrong decisions, that's serious. People can lose their lives.\"\u003c/p>\n\u003cp>As for Theranos and Elizabeth Holmes — the company is \u003ca href=\"http://www.bloomberg.com/news/articles/2016-04-18/theranos-is-under-investigation-by-sec-u-s-attorney-s-office\">facing scrutiny\u003c/a> from the Securities and Exchange Commission and the U.S. Attorney's Office for the Northern District of California. Some Theranos supporters believe in the end Holmes will turn out to be right.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Meanwhile, venture capital dollars going into biotech rose nearly 20 percent between 2014 and 2015. Perhaps this round of funding will come with less hype and more scrutiny.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Biotech%27s+Theranos+Offers+A+Cautionary+Tale+For+Silicon+Valley&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Elizabeth Holmes fit into the Silicon Valley success mold. A young Stanford dropout who left school to pursue her entrepreneurial vision, she founded Theranos and said she would disrupt the world of medicine with easy and inexpensive blood tests.\u003c/p>\n\u003caside class=\"pullquote alignright\">In Silicon Valley, secrecy and raising big money before achieving results are par for the course. Not so in the world of biomed.\u003c/aside>\n\u003cp>But now her company is \u003ca href=\"http://www.npr.org/2016/04/19/474868428/innovative-blood-testing-company-theranos-under-criminal-investigation\">under federal investigation\u003c/a> and extra scrutiny \u003ca href=\"http://www.latimes.com/business/la-fi-theranos-investigations-20160419-story.html\">by federal regulators\u003c/a>. And questions are being raised about whether applying hardware and software business culture to biotechnology is dangerous.\u003c/p>\n\u003cp>Holmes was an alluring figure; young and intense in the kind of way Apple founder Steve Jobs was. Like Jobs, she wore \u003ca href=\"http://www.glamour.com/story/theranos-founder-elizabeth-holmes-career-advice\">only black turtlenecks\u003c/a> because she didn't have time to think about her wardrobe.\u003c/p>\n\u003cp>And of course, there was \u003ca href=\"http://www.tedmed.com/talks/show?id=309114\">the TED talk\u003c/a> in which Holmes painted a picture of a world in which too many people avoided blood tests because of the cost, inconvenience and discomfort of giving so much blood. Sometimes they learned too late about a serious health condition. But, her company — \u003ca href=\"https://www.theranos.com/\">Theranos\u003c/a> — had the solution.\u003c/p>\n\u003cp>\"We've made it possible to run comprehensive laboratory tests from a tiny sample or a few drops of blood that could be taken from a finger,\" she told the audience.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Holmes had a beautiful vision, backed by hundreds of millions of dollars in investment, and \u003ca href=\"https://www.theranos.com/leadership\">a board of big names\u003c/a> like Henry Kissinger and George P. Schulz. The media had a love fest. \u003cem>Time\u003c/em> magazine called Holmes \u003ca href=\"http://time.com/3822734/elizabeth-holmes-2015-time-100/\">one of the 100 most influential people\u003c/a> in the world. She was profiled in \u003ca href=\"http://fortune.com/2014/06/12/theranos-blood-holmes/\">Fortune\u003c/a> and \u003ca href=\"http://www.newyorker.com/magazine/2014/12/15/blood-simpler\">The New Yorker\u003c/a>. Even medical professionals like \u003ca href=\"http://www.businessinsider.com/scientist-skeptical-thranos-blood-test-elizabeth-holmes-2015-6\">Dr. John Ioannidis\u003c/a>, a professor at Stanford University Medical School were intrigued.\u003c/p>\n\u003caside class=\"pullquote alignright\">“This is equivalent to me, being a biomedical researcher, trying to become an architect and build a skyscraper. Would you give me a few billion dollars please?”\u003ccite> Dr. John Ioannidis, Stanford Medical School professor\u003c/cite>\u003c/aside>\n\u003cp>\"My first reaction was, it sounds really brilliant,\" Ioannides says. \"I would like to collaborate with these people and maybe even use their technology in my own studies.\" Studies — that's what medicine and science is built upon.\u003c/p>\n\u003cp>\"So the first thing that I did as a researcher, as a scientist is check the scientific literature,\" says Ioannidis. \"How much do we know about what they do? And I couldn't find even a single paper.\"\u003c/p>\n\u003cp>Then there was the advisory board: big names in politics, not science. And Holmes had no background in medicine. \"This is equivalent to me, being a biomedical researcher, trying to become an architect and build a skyscraper. Would you give me a few billion dollars please?\"\u003c/p>\n\u003cp>Of course, no one would give him a few billion dollars.\u003c/p>\n\u003cp>But in the tech world, maybe they would. Jo-Ellen Pozner, a professor at the University of California, Berkeley Haas School of Business, says some of the greatest companies were built on hype and a big idea.\u003c/p>\n\u003cp>\"Often the product comes after the money, and so the first job is to get the investors to give you the money and that requires that you really sell them on this big idea before it's actually in hand,\" Pozner says.\u003c/p>\n\u003cp>Pozner points to \u003ca href=\"http://www.npr.org/sections/theprotojournalist/2014/01/08/260457752/can-jeff-bezos-save-planet-earth\">Jeff Bezos\u003c/a> and his company Amazon, which started as an online bookseller. \"He called the company Amazon because he wanted it to be the biggest retailer in the world, so he named it after the biggest river in the world,\" she says. \"That projects a certain kind of optimism about where we're going and what we have in mind and what we're able to accomplish.\"\u003c/p>\n\u003cp>Despite many years when Amazon made no profit, Bezos drew investors and in turn he expanded and got more customers.\u003c/p>\n\u003cp>Secrecy is also part of the tech world playbook — no studies needed. Google keeps its search algorithms secret — as a way to keep them out of the hands of competitors.\u003c/p>\n\u003cp>\"So there are so many things going on in our firm and we're not telling you about them and that's part of the allure and the mystique of the organization,\" says Pozner. \"That keeps people excited about what's coming next.\"\u003c/p>\n\u003cp>This is totally contrary to how the medical and biotech fields work — studies are published in journals and reviewed by peers and products require government approval. This may gum up the works of Silicon Valley's fast-paced innovation economy, but it's for a good reason, says Stanford's Ioannidis.\u003c/p>\n\u003cp>\"It's not such a horrible thing if your mobile phone battery dies an hour earlier than it's supposed to,\" he says. \"But if a patient gets given the wrong results and then going down the path of making wrong decisions, that's serious. People can lose their lives.\"\u003c/p>\n\u003cp>As for Theranos and Elizabeth Holmes — the company is \u003ca href=\"http://www.bloomberg.com/news/articles/2016-04-18/theranos-is-under-investigation-by-sec-u-s-attorney-s-office\">facing scrutiny\u003c/a> from the Securities and Exchange Commission and the U.S. Attorney's Office for the Northern District of California. Some Theranos supporters believe in the end Holmes will turn out to be right.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Meanwhile, venture capital dollars going into biotech rose nearly 20 percent between 2014 and 2015. Perhaps this round of funding will come with less hype and more scrutiny.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Biotech%27s+Theranos+Offers+A+Cautionary+Tale+For+Silicon+Valley&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Robots Are Now Handling Pills. Will Pharmacists Be Liberated or Out of Work?",
"title": "Robots Are Now Handling Pills. Will Pharmacists Be Liberated or Out of Work?",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>One of the most important things a pharmacist does after five or six years of training is make sure you get the correct number of pills in the correct dosage.\u003c/p>\n\u003cp>Now, it seems, robots are better at doing that than people. Even trained pharmacist people. Actually, it's a perfect job for a robot: a repetitive and mundane task.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Automation has led to the ability for us to reinvent ourselves as a profession, and we need to take the challenge.'\u003ccite>Dr. Marilyn Stebbins, UCSF\u003c/cite>\u003c/aside>\n\u003cp>And artificial intelligence has finally matured to the point where doctors trust robots (with human supervision) to do it. For five years now, the UCSF Medical Center has relied on an automated “robot pharmacy” to fill prescriptions, and a fleet of thousands of autonomous bots to deliver them.\u003c/p>\n\u003cp>Rita Jew, director of the UCSF program, says the robots have worked for five years with 100% accuracy.\u003c/p>\n\u003cp>Humans are involved only to stock the medications in the canisters that the robots pluck off a rack, and to grab the packaged and labeled medications the robot spits out and send it on its way.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>And if the meds are going to a patient in the hospital, a human might hand them off to a \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/03/01/hospital-uses-robots-instead-of-people-to-cart-things-around/\" target=\"_blank\">Tug robot\u003c/a> that rolls around the hospital from floor to floor, dropping off prescriptions at each nurse’s station.\u003c/p>\n\u003cp>The job of finding medications and dispensing the right amount for the right patient, is called “pulling” drugs. There used to be seven pharmacy technicians pulling drugs, with three to four pharmacists supervising them. Now, Jew says she needs at most two technicians to interface with the bots, and the other techs were reassigned to work such as collecting medication history\u003c/p>\n\u003cfigure id=\"attachment_121044\" class=\"wp-caption aligncenter\" style=\"max-width: 770px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/03/tug.jpg\">\u003cimg class=\"size-full wp-image-121044\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/03/tug.jpg\" alt=\"A tug enters the kitchen of the UCSF Benioff Children’s Hospital in San Francisco. \" width=\"770\" height=\"514\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/03/tug.jpg 770w, https://ww2.kqed.org/app/uploads/sites/13/2016/03/tug-400x267.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/03/tug-768x513.jpg 768w\" sizes=\"(max-width: 770px) 100vw, 770px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">A tug enters the kitchen of the UCSF Benioff Children’s Hospital in San Francisco. \u003ccite>(Heidi de Marco/KHN)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Robots are faster and more accurate than people—a recent \u003ca href=\"http://www.ajhp.org/content/72/17/1471.abstract\">study\u003c/a> from a medical center in Houston found that in one year their pharmacists made an average of almost five medication errors for every 100,000 prescriptions. That’s not a lot, but it’s a lot more than zero.\u003c/p>\n\u003cp>\u003cstrong>Will Robots Replace Pharmacists?\u003c/strong>\u003c/p>\n\u003cp>This bionic competition has some pharmacists worried about whether humans have a role in the future of their profession. A paper published in the American Journal of Pharmacy Education last year warned of a potential glut of more than 40,000 pharmacy school grads by 2022.\u003c/p>\n\u003cp>“Technology and automation are going to do a whole lot of things that the traditional pharmacist has done,” says Dr. Marilyn Stebbins, a pharmacy professor and vice-chair of clinical innovation at UCSF. “If the pharmacists don’t prove their value outside of their existing roles, automation will win because ultimately it will be cheaper.”\u003c/p>\n\u003cp>That means pharmacists need to carve out new niches robots can’t fill.\u003c/p>\n\u003cp>California lawmakers recently \u003ca href=\"http://www.leginfo.ca.gov/pub/13-14/bill/sen/sb_0451-0500/sb_493_bill_20131001_chaptered.html\" target=\"_blank\">authorized pharmacists\u003c/a> who have certain levels of training and experience to prescribe medications, including nicotine replacements and hormonal birth control, and take a more active role in primary care.\u003c/p>\n\u003cp>[contextly_sidebar id=\"bM52RWQkoiFSagHpIhxBjL4WpsA39bOf\"]This means the person behind the counter at Walgreens would be able to help patients quit smoking, or review their full medical record to make sure they’re getting the best medication for their condition.\u003c/p>\n\u003cp>“It’s kind of a pivot in the role of the pharmacist but it’s up to us to take this opportunity,” says Dr. Lisa Kroon, a clinical pharmacy professor at UCSF.\u003c/p>\n\u003cp>But so far this new role doesn’t come with any extra pay for extra services. The new law doesn’t include regulations to allow pharmacists to be paid for their services. Pharmacists are still reimbursed just for the products they provide. So Stebbins says pharmacists' potential to fill gaps in the healthcare system may remain untapped until there's some way to pay them for it.\u003c/p>\n\u003cp>\u003cstrong>Facing a New Future\u003c/strong>\u003c/p>\n\u003cp>Kroon has been practicing for 20 years, and she says pharmacists have been talking about the “threat” of automation for as long as she can remember. But she says this is the wrong way to think about technology.\u003c/p>\n\u003cp>“Our stand here at our school is if [dispensing medication] is all you want to do, don’t come to this school,” Kroon says.\u003c/p>\n\u003cp>One innovation Stebbins is working on is an app that allows patients to track their blood pressure and other vital signs.\u003c/p>\n\u003cp>The data are then shared with both their doctor and pharmacist—but it’s the pharmacist who would be responsible for checking in with patients, tracking their data, making sure they’re taking their medication and monitoring whether the medication is working.\u003c/p>\n\u003cfigure id=\"attachment_153717\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/04/robotic-pharmacy-main_0.jpg\">\u003cimg class=\"size-medium wp-image-153717\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/04/robotic-pharmacy-main_0-800x533.jpg\" alt=\"Pharmacy resident Oliver Hsu photographs medication expiration dates.\" width=\"800\" height=\"533\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-800x533.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-400x267.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-768x512.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-1180x787.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-1920x1280.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-960x640.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Pharmacy resident Oliver Hsu photographs medication expiration dates. \u003ccite>(Susan Merrell/UCSF)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“The pharmacist is the ultimate medication manager,” Stebbins says. “That’s what our training is all about.”\u003c/p>\n\u003cp>Stebbins has also helped develop a new automated call service, in which patients get a phone call within the first two days after they leave the hospital, asking if they have questions about their medication. If they do, Stebbins gets a text or email and she or one of her team of pharmacy students can respond to the patient’s concerns.\u003c/p>\n\u003cp>Getting the pharmacist involved sooner through services like this call service, frees up more time for the physician to focus on other aspects of the patient’s recovery.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“People have to embrace technology, and not fear it,” she says. “The ultimate thing is that automation has led to the ability for us to reinvent ourselves as a profession, and we need to take the challenge.”\u003c/p>\n\n",
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"excerpt": "Robots can fill prescriptions with more accuracy than humans, leaving pharmacists to reimagine their role.\r\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>One of the most important things a pharmacist does after five or six years of training is make sure you get the correct number of pills in the correct dosage.\u003c/p>\n\u003cp>Now, it seems, robots are better at doing that than people. Even trained pharmacist people. Actually, it's a perfect job for a robot: a repetitive and mundane task.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Automation has led to the ability for us to reinvent ourselves as a profession, and we need to take the challenge.'\u003ccite>Dr. Marilyn Stebbins, UCSF\u003c/cite>\u003c/aside>\n\u003cp>And artificial intelligence has finally matured to the point where doctors trust robots (with human supervision) to do it. For five years now, the UCSF Medical Center has relied on an automated “robot pharmacy” to fill prescriptions, and a fleet of thousands of autonomous bots to deliver them.\u003c/p>\n\u003cp>Rita Jew, director of the UCSF program, says the robots have worked for five years with 100% accuracy.\u003c/p>\n\u003cp>Humans are involved only to stock the medications in the canisters that the robots pluck off a rack, and to grab the packaged and labeled medications the robot spits out and send it on its way.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>And if the meds are going to a patient in the hospital, a human might hand them off to a \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/03/01/hospital-uses-robots-instead-of-people-to-cart-things-around/\" target=\"_blank\">Tug robot\u003c/a> that rolls around the hospital from floor to floor, dropping off prescriptions at each nurse’s station.\u003c/p>\n\u003cp>The job of finding medications and dispensing the right amount for the right patient, is called “pulling” drugs. There used to be seven pharmacy technicians pulling drugs, with three to four pharmacists supervising them. Now, Jew says she needs at most two technicians to interface with the bots, and the other techs were reassigned to work such as collecting medication history\u003c/p>\n\u003cfigure id=\"attachment_121044\" class=\"wp-caption aligncenter\" style=\"max-width: 770px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/03/tug.jpg\">\u003cimg class=\"size-full wp-image-121044\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/03/tug.jpg\" alt=\"A tug enters the kitchen of the UCSF Benioff Children’s Hospital in San Francisco. \" width=\"770\" height=\"514\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/03/tug.jpg 770w, https://ww2.kqed.org/app/uploads/sites/13/2016/03/tug-400x267.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/03/tug-768x513.jpg 768w\" sizes=\"(max-width: 770px) 100vw, 770px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">A tug enters the kitchen of the UCSF Benioff Children’s Hospital in San Francisco. \u003ccite>(Heidi de Marco/KHN)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Robots are faster and more accurate than people—a recent \u003ca href=\"http://www.ajhp.org/content/72/17/1471.abstract\">study\u003c/a> from a medical center in Houston found that in one year their pharmacists made an average of almost five medication errors for every 100,000 prescriptions. That’s not a lot, but it’s a lot more than zero.\u003c/p>\n\u003cp>\u003cstrong>Will Robots Replace Pharmacists?\u003c/strong>\u003c/p>\n\u003cp>This bionic competition has some pharmacists worried about whether humans have a role in the future of their profession. A paper published in the American Journal of Pharmacy Education last year warned of a potential glut of more than 40,000 pharmacy school grads by 2022.\u003c/p>\n\u003cp>“Technology and automation are going to do a whole lot of things that the traditional pharmacist has done,” says Dr. Marilyn Stebbins, a pharmacy professor and vice-chair of clinical innovation at UCSF. “If the pharmacists don’t prove their value outside of their existing roles, automation will win because ultimately it will be cheaper.”\u003c/p>\n\u003cp>That means pharmacists need to carve out new niches robots can’t fill.\u003c/p>\n\u003cp>California lawmakers recently \u003ca href=\"http://www.leginfo.ca.gov/pub/13-14/bill/sen/sb_0451-0500/sb_493_bill_20131001_chaptered.html\" target=\"_blank\">authorized pharmacists\u003c/a> who have certain levels of training and experience to prescribe medications, including nicotine replacements and hormonal birth control, and take a more active role in primary care.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>This means the person behind the counter at Walgreens would be able to help patients quit smoking, or review their full medical record to make sure they’re getting the best medication for their condition.\u003c/p>\n\u003cp>“It’s kind of a pivot in the role of the pharmacist but it’s up to us to take this opportunity,” says Dr. Lisa Kroon, a clinical pharmacy professor at UCSF.\u003c/p>\n\u003cp>But so far this new role doesn’t come with any extra pay for extra services. The new law doesn’t include regulations to allow pharmacists to be paid for their services. Pharmacists are still reimbursed just for the products they provide. So Stebbins says pharmacists' potential to fill gaps in the healthcare system may remain untapped until there's some way to pay them for it.\u003c/p>\n\u003cp>\u003cstrong>Facing a New Future\u003c/strong>\u003c/p>\n\u003cp>Kroon has been practicing for 20 years, and she says pharmacists have been talking about the “threat” of automation for as long as she can remember. But she says this is the wrong way to think about technology.\u003c/p>\n\u003cp>“Our stand here at our school is if [dispensing medication] is all you want to do, don’t come to this school,” Kroon says.\u003c/p>\n\u003cp>One innovation Stebbins is working on is an app that allows patients to track their blood pressure and other vital signs.\u003c/p>\n\u003cp>The data are then shared with both their doctor and pharmacist—but it’s the pharmacist who would be responsible for checking in with patients, tracking their data, making sure they’re taking their medication and monitoring whether the medication is working.\u003c/p>\n\u003cfigure id=\"attachment_153717\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/04/robotic-pharmacy-main_0.jpg\">\u003cimg class=\"size-medium wp-image-153717\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/04/robotic-pharmacy-main_0-800x533.jpg\" alt=\"Pharmacy resident Oliver Hsu photographs medication expiration dates.\" width=\"800\" height=\"533\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-800x533.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-400x267.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-768x512.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-1180x787.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-1920x1280.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/04/robotic-pharmacy-main_0-960x640.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Pharmacy resident Oliver Hsu photographs medication expiration dates. \u003ccite>(Susan Merrell/UCSF)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“The pharmacist is the ultimate medication manager,” Stebbins says. “That’s what our training is all about.”\u003c/p>\n\u003cp>Stebbins has also helped develop a new automated call service, in which patients get a phone call within the first two days after they leave the hospital, asking if they have questions about their medication. If they do, Stebbins gets a text or email and she or one of her team of pharmacy students can respond to the patient’s concerns.\u003c/p>\n\u003cp>Getting the pharmacist involved sooner through services like this call service, frees up more time for the physician to focus on other aspects of the patient’s recovery.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“People have to embrace technology, and not fear it,” she says. “The ultimate thing is that automation has led to the ability for us to reinvent ourselves as a profession, and we need to take the challenge.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"info": "What kind of no sabo word is Hyphenación? For us, it’s about living within a hyphenation. Like being a third-gen Mexican-American from the Texas border now living that Bay Area Chicano life. Like Xorje! Each week we bring together a couple of hyphenated Latinos to talk all about personal life choices: family, careers, relationships, belonging … everything is on the table. ",
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"info": "Our flagship program, helmed by Kai Ryssdal, examines what the day in money delivered, through stories, conversations, newsworthy numbers and more. Updated Monday through Friday at about 3:30 p.m. PT.",
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"mindshift": {
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"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>",
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"order": 12
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"info": "\u003cem>Morning Edition\u003c/em> takes listeners around the country and the world with multi-faceted stories and commentaries every weekday. Hosts Steve Inskeep, David Greene and Rachel Martin bring you the latest breaking news and features to prepare you for the day.",
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"tagline": "Deeply-reported investigative journalism",
"info": "For decades, the process for how police police themselves has been inconsistent – if not opaque. In some states, like California, these proceedings were completely hidden. After a new police transparency law unsealed scores of internal affairs files, our reporters set out to examine these cases and the shadow world of police discipline. On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. Is it the officers, or the public they've sworn to serve?",
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"info": "Our weekly podcast explores how the media 'sausage' is made, casts an incisive eye on fluctuations in the marketplace of ideas, and examines threats to the freedom of information and expression in America and abroad. For one hour a week, the show tries to lift the veil from the process of \"making media,\" especially news media, because it's through that lens that we see the world and the world sees us",
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"perspectives": {
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"info": "The economy explained. Imagine you could call up a friend and say, Meet me at the bar and tell me what's going on with the economy. Now imagine that's actually a fun evening.",
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"tagline": "Politics from a personal perspective",
"info": "Political Breakdown is a new series that explores the political intersection of California and the nation. Each week hosts Scott Shafer and Marisa Lagos are joined with a new special guest to unpack politics -- with personality — and offer an insider’s glimpse at how politics happens.",
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"possible": {
"id": "possible",
"title": "Possible",
"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
"airtime": "SUN 2pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.possible.fm/",
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"source": "Possible"
},
"link": "/radio/program/possible",
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},
"pri-the-world": {
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"title": "PRI's The World: Latest Edition",
"info": "Each weekday, host Marco Werman and his team of producers bring you the world's most interesting stories in an hour of radio that reminds us just how small our planet really is.",
"airtime": "MON-FRI 2pm-3pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/The-World-Podcast-Tile-360x360-1.jpg",
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},
"radiolab": {
"id": "radiolab",
"title": "Radiolab",
"info": "A two-time Peabody Award-winner, Radiolab is an investigation told through sounds and stories, and centered around one big idea. In the Radiolab world, information sounds like music and science and culture collide. Hosted by Jad Abumrad and Robert Krulwich, the show is designed for listeners who demand skepticism, but appreciate wonder. WNYC Studios is the producer of other leading podcasts including Freakonomics Radio, Death, Sex & Money, On the Media and many more.",
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},
"reveal": {
"id": "reveal",
"title": "Reveal",
"info": "Created by The Center for Investigative Reporting and PRX, Reveal is public radios first one-hour weekly radio show and podcast dedicated to investigative reporting. Credible, fact based and without a partisan agenda, Reveal combines the power and artistry of driveway moment storytelling with data-rich reporting on critically important issues. The result is stories that inform and inspire, arming our listeners with information to right injustices, hold the powerful accountable and improve lives.Reveal is hosted by Al Letson and showcases the award-winning work of CIR and newsrooms large and small across the nation. In a radio and podcast market crowded with choices, Reveal focuses on important and often surprising stories that illuminate the world for our listeners.",
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