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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The \u003ca href=\"https://www.scribd.com/document/317817195/CMS-Notification-of-Imposition-of-Sanctions-for-Theranos\" target=\"_blank\">penalties\u003c/a> CMS imposed on Theranos include revoking the blood-testing company’s license to operate the Newark, California lab and barring founder and CEO Elizabeth Holmes from owning, operating or directing a lab for at least two years. CMS also canceled the Newark lab’s approval to receive payments from Medicare and Medicaid.\u003c/p>\n\u003cp>When the penalties were announced in July, laboratory medicine experts called them unusually harsh.\u003c/p>\n\u003cp>Dr. Norman Paradis, a professor of medicine at Dartmouth, who has consulted for both diagnostic startups and biomed investors, said the magnitude of the penalties could be one-of-a-kind.\u003c/p>\n\u003cp>“I’ve never heard of a penalty this severe,” he said. “I’m surprised that they could not have avoided this in light of the new involvement of experienced people and renowned attorneys.”\u003c/p>\n\u003cp>In April, Theranos hired a number of experts for its medical advisory board. High-powered lawyer David Boies represents the company and \u003ca href=\"http://www.nytimes.com/2016/02/03/business/dealbook/david-boiess-dual-roles-at-theranos-set-up-conflict.html\" target=\"_blank\">also serves\u003c/a> on its board.\u003c/p>\n\u003cp>Earlier this month, Holmes attempted a fresh start by giving a much-anticipated presentation at the annual meeting of the American Association for Clinical Chemistry. That was a gathering of the very sort of experts who had expressed skepticism about the company's central claim -- that it could perform dozens of tests by collecting just a few drops of the patient's blood from a finger prick. The FDA has approved only one of those assays, for the herpes simplex virus.\u003c/p>\n\u003cp>But rather than using the presentation to produce data verifying its technology, Holmes unveiled a new portable testing device called a miniLab, which was \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/07/29/theranos-elizabeth-holmes-will-face-1000-scientists-monday-can-she-say-anything-to-gain-their-trust/\" target=\"_blank\">underwhelming\u003c/a> to those present.\u003c/p>\n\u003cp>The Wall Street Journal has reported the company is facing at least eight lawsuits related to that original, controversial and mysterious technology, called \"Edison,\" which Theranos\u003cstrong> \u003c/strong>says is now obsolete. In May, the company \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/05/19/theranos-corrects-tens-of-thousands-of-blood-tests/\" target=\"_blank\">voided or corrected\u003c/a> tens of thousands of blood tests from 2014-15.\u003c/p>\n\u003cp>Per \u003ca href=\"https://www.law.cornell.edu/cfr/text/42/493.1844\" target=\"_blank\">federal regulations\u003c/a>, if Theranos loses its appeal, which will go to an administrative law judge, it can file a request for review by an appeals board. If it loses that one, it will have 60 days to request judicial review with the U.S. Court of Appeals.\u003c/p>\n\u003cp>Experts who have commented on the case have said if no settlement can be reached, companies almost never win these things.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>In the meantime, Theranos is still operating its remaining lab, in Arizona. But how brisk can business be? Walgreens withdrew from its partnership with the company, shutting down dozens of Theranos blood-draw centers in the pharmacy chain's Arizona stores. That leaves just a handful of collection sites for customers to patronize.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Some early-stage, post-operative breast cancer patients meeting a certain genetic profile can avoid potentially dangerous and expensive chemotherapy with only a slightly lower survival rate, and without the cancer spreading, a \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1602253\">major study\u003c/a> published in The New England Journal of Medicine Wednesday has found.\u003c/p>\n\u003cp>The study said that 46 percent of subjects who were classified as high-risk by traditional clinical criteria but low-risk according to their genetics could skip chemo and expose themselves to just a slightly greater risk – 1.5 percent -- of the cancer \u003ca href=\"http://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=46283\" target=\"_blank\">metastasizing\u003c/a> after five years.\u003c/p>\n\u003cp>Those who received chemo had a 95.9 percent rate of success after five years, compared to 94.4 percent of those who did not get the treatment.\u003c/p>\n\u003cfigure id=\"attachment_230055\" class=\"wp-caption aligncenter\" style=\"max-width: 460px\">\u003cimg class=\"size-medium wp-image-230055\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-460x600.jpg\" alt=\"A mammogram image.\" width=\"460\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-460x600.jpg 460w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-400x521.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-768x1001.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-906x1180.jpg 906w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-1180x1538.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-960x1251.jpg 960w\" sizes=\"(max-width: 460px) 100vw, 460px\">\u003cfigcaption class=\"wp-caption-text\">A mammogram image. \u003ccite>(Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>In other words, the difference between opting for chemo or not is so small that \"You would have to treat 100 of those [patients] with chemotherapy for the benefit of one,\" said Dr. Laura van't Veer, one of the leaders of the breast oncology program at the University of California, San Francisco, who helped develop the test that the researchers used to determine the genetic risk level of recurrence for each patient.\u003c/p>\n\u003cp>That still may be enough of a difference for some patients and their doctors to choose chemo. In an \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMe1607947?query=featured_genetics\" target=\"_blank\">editorial\u003c/a> that accompanied the study in the NEJM, Dr. Clifford A. Hudis, chief executive officer of the American Society of Clinical Oncology, and Dr. Maura Dickler, a researcher who also treats breast cancer patients at Memorial Sloan Kettering Cancer Center in New York City, said the decision whether to undergo chemo or not won't be a slam dunk, even with the new information provided by the test.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It's such a low benefit that many breast cancer patients will decide not to take chemotherapy.'\u003ccite>Prof. Laura van't Veer, UCSF\u003c/cite>\u003c/aside>\n\u003cp>\"(A) difference of 1.5 percentage points, if real, might mean more to one patient than to another,\" they wrote. \"Thus, the stated difference does not precisely exclude a benefit that clinicians and patients might find meaningful.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Dr. van't Veer said, nevertheless, many whose risk is low according to the test would opt out: \"It doesn't mean you should not acknowledge [the risk], but it's such a low benefit that many breast cancer patients will decide not to take chemotherapy.\"\u003c/p>\n\u003cp>Dr. Fatima Cardoso, the study's lead author and a breast cancer specialist at the Champalimaud Clinical Center in Lisbon, Portugal, said that women at her clinic shown to be at low genetic risk through MammaPrint usually choose to forego chemo.\u003c/p>\n\u003cp>\"But there always [are] some patients for whom 1 percent benefit is enough — and you need to respect the wishes of each individual patient.\"\u003c/p>\n\u003cp>Side effects from chemotherapy can include hair loss, mouth sores, diarrhea, early menopause, dental issues and in rare cases leukemia and other diseases.\u003c/p>\n\u003cp>MammaPrint is priced at $4,200 and is covered by some insurance in the U.S.\u003c/p>\n\u003cp>\u003cstrong>European Study\u003c/strong>\u003c/p>\n\u003cp>The phase 3 study, called MINDACT, enrolled 6,693 breast cancer patients, recruited from 2007 to 2011 from 112 hospitals in nine European countries. Patients were between 18 and 70.\u003c/p>\n\u003cp>The point of the study was to compare a 70-gene risk-assessment test called \u003ca href=\"http://www.agendia.com/healthcare-professionals/breast-cancer/mammaprint/\" target=\"_blank\">MammaPrint\u003c/a> to a risk classification system that ignores genetics but takes into account clinical characteristics like a patient's age, tumor diameter, and whether the cancer has spread to the lymph nodes. The researchers wanted to know whether patients who were classified as high-risk according to the clinical criteria but low-risk according to MammaPrint had better or worse outcomes if they did not receive chemo.\u003c/p>\n\u003cp>Dr. van’t Veer and other researchers in the study are part of a company, \u003ca href=\"http://www.agendia.com/about/executive-management/\">Agendia\u003c/a>, that has sold MammaPrint commercially in the U.S. since 2008.\u003c/p>\n\u003cp>A total of 1,550 patients fell under a group with either high clinical and low genetic risk profiles or low clinical and high genetic risk profiles. Those patients were then randomized into either receiving chemo or not. After five years, those who had not received the treatment were 1.5 percent more likely to avoid seeing the cancer spread into distant areas than those who had received the treatment. [contextly_sidebar id=\"ZGXIiKTBs6PgwGIe3Te78GFDOl9QSCmS\"]\u003c/p>\n\u003cp>The study focused on women with stage 1, stage 2 and operable stage 3 breast cancer, with up to three affected lymph nodes.\u003c/p>\n\u003cp>About 246,660 patients will receive an invasive breast cancer diagnosis in 2016, according to the \u003ca href=\"http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics\" target=\"_blank\">American Cancer Society\u003c/a>. Of that group, van't Veer estimated that MammaPrint could flag 35,000 to 40,000 breast cancer patients as being in a position not to pursue chemotherapy and still experience a statistically small chance of recurrence.\u003c/p>\n\u003cp>Karuna Jaggar, the executive director of Breast Cancer Action, a breast cancer advocacy organization, thought the study was significant, and a win for what's known as precision medicine -- tailoring treatments according to the individual characteristics of patients.\u003c/p>\n\u003cp>\"We know that there are harms that come with any treatment, whether it's surgery, radiation or chemotherapy. And it's very important for patients to be able to weigh the risks and benefits when making their own treatment decisions.\"\u003c/p>\n\u003cp>Jaggar said the financial fallout from receiving chemotherapy can be significant. Besides the cost of treatment, which she said can reach well over $100,000, \"There's a lot of data that shows even several years after treatment, women who have undergone chemotherapy are more likely to be un- and underemployed.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003ca href=\"http://www.npr.org/sections/health-shots/2016/08/24/491213713/study-of-breast-cancer-treatment-reveals-paradox-of-precision-medicine\" target=\"_blank\">NPR\u003c/a> contributed to this report.\u003c/em>\u003c/p>\n\n",
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"excerpt": "Up to 46 percent of breast cancer patients who receive chemotherapy may find it no more effective than if they had skipped it altogether, and a genetic test can spare them the unnecessary treatment, a new study says.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Some early-stage, post-operative breast cancer patients meeting a certain genetic profile can avoid potentially dangerous and expensive chemotherapy with only a slightly lower survival rate, and without the cancer spreading, a \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1602253\">major study\u003c/a> published in The New England Journal of Medicine Wednesday has found.\u003c/p>\n\u003cp>The study said that 46 percent of subjects who were classified as high-risk by traditional clinical criteria but low-risk according to their genetics could skip chemo and expose themselves to just a slightly greater risk – 1.5 percent -- of the cancer \u003ca href=\"http://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=46283\" target=\"_blank\">metastasizing\u003c/a> after five years.\u003c/p>\n\u003cp>Those who received chemo had a 95.9 percent rate of success after five years, compared to 94.4 percent of those who did not get the treatment.\u003c/p>\n\u003cfigure id=\"attachment_230055\" class=\"wp-caption aligncenter\" style=\"max-width: 460px\">\u003cimg class=\"size-medium wp-image-230055\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-460x600.jpg\" alt=\"A mammogram image.\" width=\"460\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-460x600.jpg 460w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-400x521.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-768x1001.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-906x1180.jpg 906w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-1180x1538.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/iStock_000067189851_Large-1920x2502-960x1251.jpg 960w\" sizes=\"(max-width: 460px) 100vw, 460px\">\u003cfigcaption class=\"wp-caption-text\">A mammogram image. \u003ccite>(Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>In other words, the difference between opting for chemo or not is so small that \"You would have to treat 100 of those [patients] with chemotherapy for the benefit of one,\" said Dr. Laura van't Veer, one of the leaders of the breast oncology program at the University of California, San Francisco, who helped develop the test that the researchers used to determine the genetic risk level of recurrence for each patient.\u003c/p>\n\u003cp>That still may be enough of a difference for some patients and their doctors to choose chemo. In an \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMe1607947?query=featured_genetics\" target=\"_blank\">editorial\u003c/a> that accompanied the study in the NEJM, Dr. Clifford A. Hudis, chief executive officer of the American Society of Clinical Oncology, and Dr. Maura Dickler, a researcher who also treats breast cancer patients at Memorial Sloan Kettering Cancer Center in New York City, said the decision whether to undergo chemo or not won't be a slam dunk, even with the new information provided by the test.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It's such a low benefit that many breast cancer patients will decide not to take chemotherapy.'\u003ccite>Prof. Laura van't Veer, UCSF\u003c/cite>\u003c/aside>\n\u003cp>\"(A) difference of 1.5 percentage points, if real, might mean more to one patient than to another,\" they wrote. \"Thus, the stated difference does not precisely exclude a benefit that clinicians and patients might find meaningful.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Dr. van't Veer said, nevertheless, many whose risk is low according to the test would opt out: \"It doesn't mean you should not acknowledge [the risk], but it's such a low benefit that many breast cancer patients will decide not to take chemotherapy.\"\u003c/p>\n\u003cp>Dr. Fatima Cardoso, the study's lead author and a breast cancer specialist at the Champalimaud Clinical Center in Lisbon, Portugal, said that women at her clinic shown to be at low genetic risk through MammaPrint usually choose to forego chemo.\u003c/p>\n\u003cp>\"But there always [are] some patients for whom 1 percent benefit is enough — and you need to respect the wishes of each individual patient.\"\u003c/p>\n\u003cp>Side effects from chemotherapy can include hair loss, mouth sores, diarrhea, early menopause, dental issues and in rare cases leukemia and other diseases.\u003c/p>\n\u003cp>MammaPrint is priced at $4,200 and is covered by some insurance in the U.S.\u003c/p>\n\u003cp>\u003cstrong>European Study\u003c/strong>\u003c/p>\n\u003cp>The phase 3 study, called MINDACT, enrolled 6,693 breast cancer patients, recruited from 2007 to 2011 from 112 hospitals in nine European countries. Patients were between 18 and 70.\u003c/p>\n\u003cp>The point of the study was to compare a 70-gene risk-assessment test called \u003ca href=\"http://www.agendia.com/healthcare-professionals/breast-cancer/mammaprint/\" target=\"_blank\">MammaPrint\u003c/a> to a risk classification system that ignores genetics but takes into account clinical characteristics like a patient's age, tumor diameter, and whether the cancer has spread to the lymph nodes. The researchers wanted to know whether patients who were classified as high-risk according to the clinical criteria but low-risk according to MammaPrint had better or worse outcomes if they did not receive chemo.\u003c/p>\n\u003cp>Dr. van’t Veer and other researchers in the study are part of a company, \u003ca href=\"http://www.agendia.com/about/executive-management/\">Agendia\u003c/a>, that has sold MammaPrint commercially in the U.S. since 2008.\u003c/p>\n\u003cp>A total of 1,550 patients fell under a group with either high clinical and low genetic risk profiles or low clinical and high genetic risk profiles. Those patients were then randomized into either receiving chemo or not. After five years, those who had not received the treatment were 1.5 percent more likely to avoid seeing the cancer spread into distant areas than those who had received the treatment. \u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The study focused on women with stage 1, stage 2 and operable stage 3 breast cancer, with up to three affected lymph nodes.\u003c/p>\n\u003cp>About 246,660 patients will receive an invasive breast cancer diagnosis in 2016, according to the \u003ca href=\"http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics\" target=\"_blank\">American Cancer Society\u003c/a>. Of that group, van't Veer estimated that MammaPrint could flag 35,000 to 40,000 breast cancer patients as being in a position not to pursue chemotherapy and still experience a statistically small chance of recurrence.\u003c/p>\n\u003cp>Karuna Jaggar, the executive director of Breast Cancer Action, a breast cancer advocacy organization, thought the study was significant, and a win for what's known as precision medicine -- tailoring treatments according to the individual characteristics of patients.\u003c/p>\n\u003cp>\"We know that there are harms that come with any treatment, whether it's surgery, radiation or chemotherapy. And it's very important for patients to be able to weigh the risks and benefits when making their own treatment decisions.\"\u003c/p>\n\u003cp>Jaggar said the financial fallout from receiving chemotherapy can be significant. Besides the cost of treatment, which she said can reach well over $100,000, \"There's a lot of data that shows even several years after treatment, women who have undergone chemotherapy are more likely to be un- and underemployed.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003ca href=\"http://www.npr.org/sections/health-shots/2016/08/24/491213713/study-of-breast-cancer-treatment-reveals-paradox-of-precision-medicine\" target=\"_blank\">NPR\u003c/a> contributed to this report.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "After IVF, Some Struggle With What To Do With Leftover Embryos",
"title": "After IVF, Some Struggle With What To Do With Leftover Embryos",
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"content": "\u003cp>When Scott Gatz and his husband decided to become fathers several years ago, pursuing parenthood meant finding both an egg donor and a surrogate to help them conceive a baby. Their first round of in vitro fertilization produced seven healthy embryos. One of those embryos was successfully transferred to their surrogate's womb, resulting in their son Matthew, who is now 6-years-old.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"Every time we read the 'destroy' option on the form, my stomach does a somersault. It feels as if our future children are showing up once a year to confront us.\"\u003c/aside>\n\u003cp>While the San Francisco couple feels their family is now complete, they are still in a quandary over what to do with their six remaining embryos — what they call their \"maybe babies.\"\u003c/p>\n\u003cp>Every year they're forced to weigh their options again, Gatz tells Shots, when a letter arrives from the fertility clinic. It asks whether they want to destroy the embryos, donate them for medical research, give them to another infertile couple or continue paying $800 annually to keep the embryos frozen.\u003c/p>\n\u003cp>\"Every time we read the 'destroy' option on the form, my stomach does a somersault,\" Gatz says. \"It feels as if our future children are showing up once a year to confront us.\"\u003c/p>\n\u003cp>The men are not alone in their ambivalence. It's estimated that, in the United States, there are almost \u003ca href=\"http://www.hhs.gov/opa/about-opa-and-initiatives/embryo-adoption/\">one million\u003c/a> frozen embryos now in storage, a number that includes embryos reserved for research, as well as those reserved to expand families.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Indecision Reigns\u003c/strong>\u003c/p>\n\u003cp>In a 2005 \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/16084886\">study\u003c/a> that interviewed 58 couples who conceived through IVF and had at least one frozen embryo in storage, more than 70 percent had not yet decided — even several years after the procedure — how they would dispose of a surplus embryo. Some said they considered the embryos to be biologic tissue or a genetic or psychological \"insurance policy.\" Others told the researchers they thought of the embryos as living entities — \"virtual children\" that have interests that needed to be considered and protected.\u003c/p>\n\u003cp>\"With the astonishing advancements in reproductive science, IVF now produces far more embryos than it did in the past,\" says Dr. Anna Glezer, a psychiatrist at the University of California, San Francisco. The choices that abundance poses are very difficult for some couples, she says, \"which raises the need for psychological resources, such as peer support groups for these families.'\u003c/p>\n\u003cp>After conceiving their daughter via IVF, Megan and Jay Khmelev had eight remaining embryos. For two years, says Megan, she was overcome by guilt, anxiety, and sadness as she struggled with what to do with them. At the beginning of her fertility journey, she had imagined one day donating the embryos to science or to another infertile couple.\u003c/p>\n\u003cp>But after her daughter arrived, she says, she couldn't imagine parting with the surplus embryos in this way. The Khmelevs didn't want eight more children, but discarding the embryos didn't feel like the right choice, either.\u003c/p>\n\u003cp>\"I wish someone had told me that I'd be haunted by the grief of my infertility struggle all over again as I wrestled with my decision,\" Megan says.\u003c/p>\n\u003cp>\u003ca href=\"http://eggwhisperer.com/\">Dr. Aimee Eyvazzadeh\u003c/a>, a reproductive endocrinologist in the San Francisco Bay area, says many families she counsels struggle with these choices.\u003c/p>\n\u003cp>\"It's a complicated process,\" Eyvazzadeh says. \"At the beginning of IVF, patients hope for many embryos, because they long to have a baby. They don't realize how their feelings might change once their children are born.\"\u003c/p>\n\u003cp>In the 1980s, when fertility clinics began freezing embryos, there wasn't any available research about how patients would feel regarding their frozen embryos after they became parents. More than 30 years later, though the number of IVF babies has \u003ca href=\"http://www.npr.org/sections/health-shots/2014/02/18/279035110/ivf-baby-boom-births-from-fertility-procedure-hit-new-high\">steadily climbed\u003c/a>, many fertility doctors are still unsure how to handle some patients' ambivalence.\u003c/p>\n\u003cp>\"Our clinic told us that we could freeze our embryos and explained the cost associated with yearly storage fees,\" Gatz says, \"but they didn't mention the feelings that might arise as we faced these choices.\"\u003c/p>\n\u003cp>A study \u003ca href=\"http://www.fertstert.org/article/S0015-0282(15)02109-3/abstract\">published\u003c/a> in the March issue of the journal \u003cem>Fertility and Sterility\u003c/em> found that that after successful IVF treatment, most of the 131 couples responding to a survey were dissatisfied with the education they obtained from their health care providers about disposal decisions. And less than 50 percent were satisfied with the emotional guidance they got.\u003c/p>\n\u003cp>Yet other research suggests that \u003ca href=\"http://www.sciencedirect.com/science/article/pii/S0015028215022232\">peer support\u003c/a> \u003cem>can \u003c/em>help people make these complicated choices, by giving them a place to disclose their struggles in the company of others who have been through the process.\u003c/p>\n\u003cp>\u003ca href=\"http://latalktherapy.com/dr-lederer/\">Francine Lederer,\u003c/a> a clinical psychologist in private practice in Los Angeles, offers a \"disposition support group,\" specifically aimed at couples and individuals who are deciding what to do with their embryos.\u003c/p>\n\u003cp>\"After successful IVF treatments, many couples come to view their embryos as human life, which makes it even harder for them to find closure,\" Lederer says. Some even have funeral ceremonies for the embryos.\u003c/p>\n\u003cp>For other couples, making these decisions ignites emotional conflict between the spouses, or even beyond — to include the extended family, Lederer finds, because religious beliefs and personal preferences play a role in how each person views the stored embryos. One couple she counseled who had decided to destroy the embryos mentioned that to their parents and discovered the in-laws were aghast.\u003c/p>\n\u003cp>\"Too often, these families have never shared their stories aloud,\" says Lederer. \"Support groups can make a difference by allowing them to talk about their personal experiences with others who understand, which can help them to feel less isolated.\"\u003c/p>\n\u003cp>Megan and Jay Khmelev finally decided to do additional rounds of IVF, and use the remaining embryos themselves, but none resulted in a viable pregnancy.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"I'm glad I did the transfers anyway,\" Megan says. \"It gave me and my husband closure, knowing that we had given them a chance to become life.\"\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+IVF%2C+Some+Struggle+With+What+To+Do+With+Leftover+Embryos&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>When Scott Gatz and his husband decided to become fathers several years ago, pursuing parenthood meant finding both an egg donor and a surrogate to help them conceive a baby. Their first round of in vitro fertilization produced seven healthy embryos. One of those embryos was successfully transferred to their surrogate's womb, resulting in their son Matthew, who is now 6-years-old.\u003c/p>\n\u003caside class=\"pullquote alignright\">\"Every time we read the 'destroy' option on the form, my stomach does a somersault. It feels as if our future children are showing up once a year to confront us.\"\u003c/aside>\n\u003cp>While the San Francisco couple feels their family is now complete, they are still in a quandary over what to do with their six remaining embryos — what they call their \"maybe babies.\"\u003c/p>\n\u003cp>Every year they're forced to weigh their options again, Gatz tells Shots, when a letter arrives from the fertility clinic. It asks whether they want to destroy the embryos, donate them for medical research, give them to another infertile couple or continue paying $800 annually to keep the embryos frozen.\u003c/p>\n\u003cp>\"Every time we read the 'destroy' option on the form, my stomach does a somersault,\" Gatz says. \"It feels as if our future children are showing up once a year to confront us.\"\u003c/p>\n\u003cp>The men are not alone in their ambivalence. It's estimated that, in the United States, there are almost \u003ca href=\"http://www.hhs.gov/opa/about-opa-and-initiatives/embryo-adoption/\">one million\u003c/a> frozen embryos now in storage, a number that includes embryos reserved for research, as well as those reserved to expand families.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Indecision Reigns\u003c/strong>\u003c/p>\n\u003cp>In a 2005 \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/16084886\">study\u003c/a> that interviewed 58 couples who conceived through IVF and had at least one frozen embryo in storage, more than 70 percent had not yet decided — even several years after the procedure — how they would dispose of a surplus embryo. Some said they considered the embryos to be biologic tissue or a genetic or psychological \"insurance policy.\" Others told the researchers they thought of the embryos as living entities — \"virtual children\" that have interests that needed to be considered and protected.\u003c/p>\n\u003cp>\"With the astonishing advancements in reproductive science, IVF now produces far more embryos than it did in the past,\" says Dr. Anna Glezer, a psychiatrist at the University of California, San Francisco. The choices that abundance poses are very difficult for some couples, she says, \"which raises the need for psychological resources, such as peer support groups for these families.'\u003c/p>\n\u003cp>After conceiving their daughter via IVF, Megan and Jay Khmelev had eight remaining embryos. For two years, says Megan, she was overcome by guilt, anxiety, and sadness as she struggled with what to do with them. At the beginning of her fertility journey, she had imagined one day donating the embryos to science or to another infertile couple.\u003c/p>\n\u003cp>But after her daughter arrived, she says, she couldn't imagine parting with the surplus embryos in this way. The Khmelevs didn't want eight more children, but discarding the embryos didn't feel like the right choice, either.\u003c/p>\n\u003cp>\"I wish someone had told me that I'd be haunted by the grief of my infertility struggle all over again as I wrestled with my decision,\" Megan says.\u003c/p>\n\u003cp>\u003ca href=\"http://eggwhisperer.com/\">Dr. Aimee Eyvazzadeh\u003c/a>, a reproductive endocrinologist in the San Francisco Bay area, says many families she counsels struggle with these choices.\u003c/p>\n\u003cp>\"It's a complicated process,\" Eyvazzadeh says. \"At the beginning of IVF, patients hope for many embryos, because they long to have a baby. They don't realize how their feelings might change once their children are born.\"\u003c/p>\n\u003cp>In the 1980s, when fertility clinics began freezing embryos, there wasn't any available research about how patients would feel regarding their frozen embryos after they became parents. More than 30 years later, though the number of IVF babies has \u003ca href=\"http://www.npr.org/sections/health-shots/2014/02/18/279035110/ivf-baby-boom-births-from-fertility-procedure-hit-new-high\">steadily climbed\u003c/a>, many fertility doctors are still unsure how to handle some patients' ambivalence.\u003c/p>\n\u003cp>\"Our clinic told us that we could freeze our embryos and explained the cost associated with yearly storage fees,\" Gatz says, \"but they didn't mention the feelings that might arise as we faced these choices.\"\u003c/p>\n\u003cp>A study \u003ca href=\"http://www.fertstert.org/article/S0015-0282(15)02109-3/abstract\">published\u003c/a> in the March issue of the journal \u003cem>Fertility and Sterility\u003c/em> found that that after successful IVF treatment, most of the 131 couples responding to a survey were dissatisfied with the education they obtained from their health care providers about disposal decisions. And less than 50 percent were satisfied with the emotional guidance they got.\u003c/p>\n\u003cp>Yet other research suggests that \u003ca href=\"http://www.sciencedirect.com/science/article/pii/S0015028215022232\">peer support\u003c/a> \u003cem>can \u003c/em>help people make these complicated choices, by giving them a place to disclose their struggles in the company of others who have been through the process.\u003c/p>\n\u003cp>\u003ca href=\"http://latalktherapy.com/dr-lederer/\">Francine Lederer,\u003c/a> a clinical psychologist in private practice in Los Angeles, offers a \"disposition support group,\" specifically aimed at couples and individuals who are deciding what to do with their embryos.\u003c/p>\n\u003cp>\"After successful IVF treatments, many couples come to view their embryos as human life, which makes it even harder for them to find closure,\" Lederer says. Some even have funeral ceremonies for the embryos.\u003c/p>\n\u003cp>For other couples, making these decisions ignites emotional conflict between the spouses, or even beyond — to include the extended family, Lederer finds, because religious beliefs and personal preferences play a role in how each person views the stored embryos. One couple she counseled who had decided to destroy the embryos mentioned that to their parents and discovered the in-laws were aghast.\u003c/p>\n\u003cp>\"Too often, these families have never shared their stories aloud,\" says Lederer. \"Support groups can make a difference by allowing them to talk about their personal experiences with others who understand, which can help them to feel less isolated.\"\u003c/p>\n\u003cp>Megan and Jay Khmelev finally decided to do additional rounds of IVF, and use the remaining embryos themselves, but none resulted in a viable pregnancy.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"I'm glad I did the transfers anyway,\" Megan says. \"It gave me and my husband closure, knowing that we had given them a chance to become life.\"\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+IVF%2C+Some+Struggle+With+What+To+Do+With+Leftover+Embryos&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Puberty is no picnic, even in the best of circumstances. Once the sex hormones estrogen or testosterone kick in, there’s no turning back: Here come breasts and periods, Adam’s apples and acne. It’s a tough passage for many kids, but for some — transgender youth whose bodies don’t match their gender identity — puberty can be unbearable.\u003c/p>\n\u003caside class=\"pullquote alignright\">Full-blown puberty is irreversible, but for transgender children, it’s no longer inevitable.\u003c/aside>\n\u003cp>For one Oakland family, their daughter’s path was clear from the time she was three. Her birth certificate said “male,” but the child would always say she wanted to be a girl, and that soon became, “I AM a girl,” said the mother, who asked that her family’s name not be used to protect her daughter’s privacy. She recalled a day when the girl wept in frustration trying to fashion a skirt out of some t-shirts.\u003c/p>\n\u003cp>“Finally I just said, ‘Honey, do you want a dress?’’ and they went to a store and bought one. “I literally thought she was going to faint or hyperventilate,” said the mother. “She couldn’t sit still, she was so excited and so happy. It was a moment of pure joy for her, and also a turning point,” she said.\u003c/p>\n\u003cp>She was happy growing up and attended a progressive school in the San Francisco Bay Area as a girl. But when she was approaching puberty, she became very nervous, “worried about getting facial hair or watching her shoulders get broader. It was all very painful for her,” her mother said.\u003c/p>\n\u003cp>The child was experiencing what’s known as \u003ca href=\"http://www.dsm5.org/documents/gender%20dysphoria%20fact%20sheet.pdf\" target=\"_blank\">gender dysphoria\u003c/a>, a DSM-5 diagnosis of significant ongoing distress, with the feeling of being assigned the wrong gender at birth. Researchers at Harvard \u003ca href=\"http://www.jahonline.org/article/S1054-139X%2814%2900693-4/abstract\" target=\"_blank\">recently found\u003c/a> that transgender youth are at a much higher risk for mental disorders, including depression, anxiety, suicidal thoughts and self-harm. They are more than twice as likely as non-trans youth to be diagnosed with depression (50.6 percent vs. 20.6 percent) or suffer from anxiety (26.7 percent vs. 10 percent).\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“These kids are saying to the world, ‘I was born in the wrong body, and there’s something just not right about living this way,’” said Scott Leibowitz, head child and adolescent psychiatrist at the Ann & Robert H. Lurie Children’s Hospital of Chicago.\u003c/p>\n\u003cp>\u003cstrong>Blockers ‘Safe and Effective’\u003c/strong>\u003c/p>\n\u003cp>Full-blown puberty is irreversible, but for transgender children, it’s no longer inevitable. By taking a gonadotropin-releasing hormone (GnRH) agonist, secretion of the sex hormones can be stopped and the onset of puberty suppressed, so that the body does not develop secondary sex characteristics. This has been done safely for decades to suppress sex hormones in children who develop too early, a condition known as precocious puberty. Suppressors have also been used to treat endometriosis, uterine fibroids and prostate cancer.\u003c/p>\n\u003cp>It was only in 2008 that \u003ca href=\"https://endocrine.org/\" target=\"_blank\">the Endocrine Society\u003c/a> approved puberty suppressors as a treatment for transgender adolescents as young as 12 years old. The Society, with members in more than 100 countries, has \u003ca href=\"https://www.endocrine.org/news-room/press-release-archives/2013/medical-intervention-in-transgender-adolescents-appears-to-be-safe-and-effective\" target=\"_blank\">since declared\u003c/a> that the intervention appears to be safe and effective. In 2011 the \u003ca href=\"http://www.wpath.org/site_page.cfm?pk_association_webpage_menu=1347&pk_association_webpage=4233\" target=\"_blank\">World Professional Association for Transgender Health\u003c/a> (WPATH), also issued Standards of Care for the treatment of patients with gender dysphoria, which include puberty suppression.\u003c/p>\n\u003caside class=\"pullquote alignright\">'As soon as he got breast buds, it was like the panic button was hit. He was quickly and very intensely uncomfortable and afraid.'\u003c/aside>\n\u003cp>There are few reported side effects to this off-label use of sex hormone suppressors. Despite early concerns that blocking sex hormones might harm bone development, a \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/25427144\" target=\"_blank\">recent study\u003c/a> from the Netherlands found no evidence of long-term effects on bone mineral density. If the suppressors are halted, puberty resumes as if there had been no treatment.\u003c/p>\n\u003cp>Data on the use of puberty blockers is scarce, but in the past decade or so, it’s believed thousands of transgender youth and their families have chosen to suppress puberty to give adolescents a time-out while they figure out the next step in their development.\u003c/p>\n\u003cp>A St. Louis, Mo., child was classified as female at birth, one of a set of twin girls. But the parents had been discussing puberty blockers with him since he was seven years old, after he had begun dressing as a boy and showing more masculine traits.\u003c/p>\n\u003cp>“I remember watching a documentary where he learned what blockers were and we talked about it and he was sure that’s what he wanted when the time came,” said his mother, who also asked that the family’s names not be used to protect her child’s privacy.\u003c/p>\n\u003cp>“As soon as he got breast buds, it was like the panic button was hit,” the mother said. “He was quickly and very intensely uncomfortable and afraid. He would cry, knowing that this was the beginning of something that he didn’t want, that he knew wasn’t right for him,” she said.\u003c/p>\n\u003cp>In March, after the boy turned 11, a pediatric endocrinologist prescribed the sex hormone suppressor Eligard, an injection that he receives every four months. According to his mother, because they intervened early, the unwanted breast buds receded quickly, along with her son’s depression and anxiety. “I don’t know what we would have done if we were not able to stop puberty so he doesn’t have to feel in constant conflict with his own body,” she said.\u003c/p>\n\u003cp>So far, according to the mother, the biggest problem their family has faced has been trying to get insurance coverage for her son’s treatment. She said they have been lucky to obtain the injections at cost — $500 per shot — rather than the $1,500 to $2,000 per shot that the therapy typically costs. Her husband’s employer, which self-funds its medical insurance plan, chose a clause that excludes transgender care.\u003c/p>\n\u003cp>That kind of exclusion could change, especially since the Obama Administration recently issued \u003ca href=\"https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-11458.pdf\" target=\"_blank\">final regulations on Section 1557 of the Affordable Care Act\u003c/a> that ban the denial of health care on the basis of gender identity in programs that receive federal funding. The rule could help people who feel they have been discriminated against to bring complaints or lawsuits, according to the \u003ca href=\"http://transgenderlawcenter.org/archives/12908\" target=\"_blank\">Transgender Law Center\u003c/a> in Oakland, Calif.\u003c/p>\n\u003cp>In 2014, Oregon became the first state to provide Medicaid coverage for adolescents receiving puberty blockers. Medicaid programs in other states, including New York and California, have also expanded transgender healthcare coverage, although that does not mean that puberty blockers always are covered.\u003c/p>\n\u003cp>\u003cstrong>How Early is Too Early?\u003c/strong>\u003c/p>\n\u003cp>Treatment with puberty blockers gives transgender children a breather so they can continue to mature and decide whether they will pursue treatment with cross-sex hormones or gender reassignment surgery. For many families, the question is not whether to intervene with blockers, but how early to start.\u003c/p>\n\u003cp>Because the onset of puberty varies so widely — as early as age 9 for some — suppression can begin at different ages. And that’s prompted some disagreement within the field — the “age versus stage” debate — about when to begin, according to Leibowitz. Most often blockers are initiated at the first visible signs of development as measured by the \u003ca href=\"http://www.childgrowthfoundation.org/CMS/FILES/Puberty_and_the_Tanner_Stages.pdf\" target=\"_blank\">Tanner Stages\u003c/a>, a scale of sexual maturation developed by pediatrician James Tanner. The trigger for suppression is usually Tanner stage 2, when pubic hair and breast buds appear.\u003c/p>\n\u003cp>“If you are able to suspend puberty as soon as it happens you’re optimizing the benefits that it can bring physically,” said Leibowitz. Starting early may alleviate the need for surgical breast removal or voice modification therapy later on. It also makes it far easier for transgender teens to fit in. “That ability to blend in and be perceived as the gender that they identify with is associated with long-term psychological benefits,” said Leibowitz.\u003c/p>\n\u003cp>But does that mean that 9- or 10-year-old transgender kids should be started on puberty blockers? Even though the treatment is reversible and is considered safe, Leibowitz said some clinicians argue the age issue is important because less is known about very early interventions. How long can puberty be safely suppressed? And if the next step is transitioning with cross-sex hormones, at what age should that begin?\u003c/p>\n\u003cp>Of course, there is no treatment at all unless the parents of transgender children agree. “For most of my clients [who are minors], the issue revolves around whether they can start hormones or puberty blockers without parental consent, and the short answer is ‘No,”’ said Danielle Castro, a psychotherapist and project director at the Center of Excellence for Transgender Health at the University of California, San Francisco.\u003c/p>\n\u003cp>Castro said families of some transgender youth refuse the intervention because they believe their children are “just going through a phase.” A \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/18981931\" target=\"_blank\">study\u003c/a> in 2008 found that 43 percent of very young children who experienced gender dysphoria no longer felt that way after adolescence. The 27 percent who remained dysphoric were the ones who had felt that way most strongly when they were young.\u003c/p>\n\u003cp>Young children may indeed change their minds, but gender identity seems to be fixed by the time kids have reached puberty. The Endocrine Society finds that transgender adolescents grow up to be transgender adults “100 percent of the time.” Dr. Stephen Rosenthal, director of the Child and Adolescent Gender Center at UCSF, \u003ca href=\"http://press.endocrine.org/doi/pdf/10.1210/jc.2014-1919\" target=\"_blank\">agrees\u003c/a>: “Children who meet the mental health criteria for gender dysphoria in adolescence are likely to be transgender for life.”\u003c/p>\n\u003cp>In a \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/20646177\" target=\"_blank\">recent study\u003c/a> of 70 participants all the adolescents who had been given puberty blockers went through with sex reassignment.\u003c/p>\n\u003cp>\u003cstrong>The Standard of Care\u003c/strong>\u003c/p>\n\u003cp>Even though the Oakland family had agreed in advance that their daughter would start on blockers at the right time, “we had to reassure her constantly that we wouldn’t let it go too far,” she said.\u003c/p>\n\u003cp>When she turned 13, the girl started receiving monthly injections of Lupron, a widely prescribed sex hormone suppressor. “As soon as she started, you could just see the relief in her,” said the mother. “You could see it in her demeanor, in her mood; it was just a huge weight off her shoulders,” she said.\u003c/p>\n\u003cp>The family’s insurer, Kaiser Permanente, covered the treatment. Puberty blockers are considered “standard of care in the appropriate clinical circumstances,” said Erica Metz, medical director for Transgender Health at Kaiser Permanente Northern California. According to Metz, the treatment “gives patients and their families time to work with their mental health and medical providers to determine if it is appropriate to start transitioning.”\u003c/p>\n\u003cp>When the girl was 14, she started taking estrogen — the next step in her male-to-female transition. Instead of growing facial hair and a male physique, she developed breasts and some curves. Her voice didn’t deepen, and she doesn’t have an Adam’s apple.\u003c/p>\n\u003cp>The mother described her daughter as a social, outgoing and well-adjusted teenager. She knows the \u003ca href=\"http://williamsinstitute.law.ucla.edu/research/suicide-attempts-among-transgender-and-gender-non-conforming-adults/\" target=\"_blank\">grim mental health statistics\u003c/a> for transgender people — 41 percent have attempted suicide, nearly nine times the national average — and she doesn’t want to imagine a world where her daughter would be without puberty blockers, a medical intervention that she called a “lifesaver.”\u003c/p>\n\u003cp>“The thought of her having had to go through male puberty, I think it would have destroyed her mental health and well-being,” the mother said.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Puberty is no picnic, even in the best of circumstances. Once the sex hormones estrogen or testosterone kick in, there’s no turning back: Here come breasts and periods, Adam’s apples and acne. It’s a tough passage for many kids, but for some — transgender youth whose bodies don’t match their gender identity — puberty can be unbearable.\u003c/p>\n\u003caside class=\"pullquote alignright\">Full-blown puberty is irreversible, but for transgender children, it’s no longer inevitable.\u003c/aside>\n\u003cp>For one Oakland family, their daughter’s path was clear from the time she was three. Her birth certificate said “male,” but the child would always say she wanted to be a girl, and that soon became, “I AM a girl,” said the mother, who asked that her family’s name not be used to protect her daughter’s privacy. She recalled a day when the girl wept in frustration trying to fashion a skirt out of some t-shirts.\u003c/p>\n\u003cp>“Finally I just said, ‘Honey, do you want a dress?’’ and they went to a store and bought one. “I literally thought she was going to faint or hyperventilate,” said the mother. “She couldn’t sit still, she was so excited and so happy. It was a moment of pure joy for her, and also a turning point,” she said.\u003c/p>\n\u003cp>She was happy growing up and attended a progressive school in the San Francisco Bay Area as a girl. But when she was approaching puberty, she became very nervous, “worried about getting facial hair or watching her shoulders get broader. It was all very painful for her,” her mother said.\u003c/p>\n\u003cp>The child was experiencing what’s known as \u003ca href=\"http://www.dsm5.org/documents/gender%20dysphoria%20fact%20sheet.pdf\" target=\"_blank\">gender dysphoria\u003c/a>, a DSM-5 diagnosis of significant ongoing distress, with the feeling of being assigned the wrong gender at birth. Researchers at Harvard \u003ca href=\"http://www.jahonline.org/article/S1054-139X%2814%2900693-4/abstract\" target=\"_blank\">recently found\u003c/a> that transgender youth are at a much higher risk for mental disorders, including depression, anxiety, suicidal thoughts and self-harm. They are more than twice as likely as non-trans youth to be diagnosed with depression (50.6 percent vs. 20.6 percent) or suffer from anxiety (26.7 percent vs. 10 percent).\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“These kids are saying to the world, ‘I was born in the wrong body, and there’s something just not right about living this way,’” said Scott Leibowitz, head child and adolescent psychiatrist at the Ann & Robert H. Lurie Children’s Hospital of Chicago.\u003c/p>\n\u003cp>\u003cstrong>Blockers ‘Safe and Effective’\u003c/strong>\u003c/p>\n\u003cp>Full-blown puberty is irreversible, but for transgender children, it’s no longer inevitable. By taking a gonadotropin-releasing hormone (GnRH) agonist, secretion of the sex hormones can be stopped and the onset of puberty suppressed, so that the body does not develop secondary sex characteristics. This has been done safely for decades to suppress sex hormones in children who develop too early, a condition known as precocious puberty. Suppressors have also been used to treat endometriosis, uterine fibroids and prostate cancer.\u003c/p>\n\u003cp>It was only in 2008 that \u003ca href=\"https://endocrine.org/\" target=\"_blank\">the Endocrine Society\u003c/a> approved puberty suppressors as a treatment for transgender adolescents as young as 12 years old. The Society, with members in more than 100 countries, has \u003ca href=\"https://www.endocrine.org/news-room/press-release-archives/2013/medical-intervention-in-transgender-adolescents-appears-to-be-safe-and-effective\" target=\"_blank\">since declared\u003c/a> that the intervention appears to be safe and effective. In 2011 the \u003ca href=\"http://www.wpath.org/site_page.cfm?pk_association_webpage_menu=1347&pk_association_webpage=4233\" target=\"_blank\">World Professional Association for Transgender Health\u003c/a> (WPATH), also issued Standards of Care for the treatment of patients with gender dysphoria, which include puberty suppression.\u003c/p>\n\u003caside class=\"pullquote alignright\">'As soon as he got breast buds, it was like the panic button was hit. He was quickly and very intensely uncomfortable and afraid.'\u003c/aside>\n\u003cp>There are few reported side effects to this off-label use of sex hormone suppressors. Despite early concerns that blocking sex hormones might harm bone development, a \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/25427144\" target=\"_blank\">recent study\u003c/a> from the Netherlands found no evidence of long-term effects on bone mineral density. If the suppressors are halted, puberty resumes as if there had been no treatment.\u003c/p>\n\u003cp>Data on the use of puberty blockers is scarce, but in the past decade or so, it’s believed thousands of transgender youth and their families have chosen to suppress puberty to give adolescents a time-out while they figure out the next step in their development.\u003c/p>\n\u003cp>A St. Louis, Mo., child was classified as female at birth, one of a set of twin girls. But the parents had been discussing puberty blockers with him since he was seven years old, after he had begun dressing as a boy and showing more masculine traits.\u003c/p>\n\u003cp>“I remember watching a documentary where he learned what blockers were and we talked about it and he was sure that’s what he wanted when the time came,” said his mother, who also asked that the family’s names not be used to protect her child’s privacy.\u003c/p>\n\u003cp>“As soon as he got breast buds, it was like the panic button was hit,” the mother said. “He was quickly and very intensely uncomfortable and afraid. He would cry, knowing that this was the beginning of something that he didn’t want, that he knew wasn’t right for him,” she said.\u003c/p>\n\u003cp>In March, after the boy turned 11, a pediatric endocrinologist prescribed the sex hormone suppressor Eligard, an injection that he receives every four months. According to his mother, because they intervened early, the unwanted breast buds receded quickly, along with her son’s depression and anxiety. “I don’t know what we would have done if we were not able to stop puberty so he doesn’t have to feel in constant conflict with his own body,” she said.\u003c/p>\n\u003cp>So far, according to the mother, the biggest problem their family has faced has been trying to get insurance coverage for her son’s treatment. She said they have been lucky to obtain the injections at cost — $500 per shot — rather than the $1,500 to $2,000 per shot that the therapy typically costs. Her husband’s employer, which self-funds its medical insurance plan, chose a clause that excludes transgender care.\u003c/p>\n\u003cp>That kind of exclusion could change, especially since the Obama Administration recently issued \u003ca href=\"https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-11458.pdf\" target=\"_blank\">final regulations on Section 1557 of the Affordable Care Act\u003c/a> that ban the denial of health care on the basis of gender identity in programs that receive federal funding. The rule could help people who feel they have been discriminated against to bring complaints or lawsuits, according to the \u003ca href=\"http://transgenderlawcenter.org/archives/12908\" target=\"_blank\">Transgender Law Center\u003c/a> in Oakland, Calif.\u003c/p>\n\u003cp>In 2014, Oregon became the first state to provide Medicaid coverage for adolescents receiving puberty blockers. Medicaid programs in other states, including New York and California, have also expanded transgender healthcare coverage, although that does not mean that puberty blockers always are covered.\u003c/p>\n\u003cp>\u003cstrong>How Early is Too Early?\u003c/strong>\u003c/p>\n\u003cp>Treatment with puberty blockers gives transgender children a breather so they can continue to mature and decide whether they will pursue treatment with cross-sex hormones or gender reassignment surgery. For many families, the question is not whether to intervene with blockers, but how early to start.\u003c/p>\n\u003cp>Because the onset of puberty varies so widely — as early as age 9 for some — suppression can begin at different ages. And that’s prompted some disagreement within the field — the “age versus stage” debate — about when to begin, according to Leibowitz. Most often blockers are initiated at the first visible signs of development as measured by the \u003ca href=\"http://www.childgrowthfoundation.org/CMS/FILES/Puberty_and_the_Tanner_Stages.pdf\" target=\"_blank\">Tanner Stages\u003c/a>, a scale of sexual maturation developed by pediatrician James Tanner. The trigger for suppression is usually Tanner stage 2, when pubic hair and breast buds appear.\u003c/p>\n\u003cp>“If you are able to suspend puberty as soon as it happens you’re optimizing the benefits that it can bring physically,” said Leibowitz. Starting early may alleviate the need for surgical breast removal or voice modification therapy later on. It also makes it far easier for transgender teens to fit in. “That ability to blend in and be perceived as the gender that they identify with is associated with long-term psychological benefits,” said Leibowitz.\u003c/p>\n\u003cp>But does that mean that 9- or 10-year-old transgender kids should be started on puberty blockers? Even though the treatment is reversible and is considered safe, Leibowitz said some clinicians argue the age issue is important because less is known about very early interventions. How long can puberty be safely suppressed? And if the next step is transitioning with cross-sex hormones, at what age should that begin?\u003c/p>\n\u003cp>Of course, there is no treatment at all unless the parents of transgender children agree. “For most of my clients [who are minors], the issue revolves around whether they can start hormones or puberty blockers without parental consent, and the short answer is ‘No,”’ said Danielle Castro, a psychotherapist and project director at the Center of Excellence for Transgender Health at the University of California, San Francisco.\u003c/p>\n\u003cp>Castro said families of some transgender youth refuse the intervention because they believe their children are “just going through a phase.” A \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/18981931\" target=\"_blank\">study\u003c/a> in 2008 found that 43 percent of very young children who experienced gender dysphoria no longer felt that way after adolescence. The 27 percent who remained dysphoric were the ones who had felt that way most strongly when they were young.\u003c/p>\n\u003cp>Young children may indeed change their minds, but gender identity seems to be fixed by the time kids have reached puberty. The Endocrine Society finds that transgender adolescents grow up to be transgender adults “100 percent of the time.” Dr. Stephen Rosenthal, director of the Child and Adolescent Gender Center at UCSF, \u003ca href=\"http://press.endocrine.org/doi/pdf/10.1210/jc.2014-1919\" target=\"_blank\">agrees\u003c/a>: “Children who meet the mental health criteria for gender dysphoria in adolescence are likely to be transgender for life.”\u003c/p>\n\u003cp>In a \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/20646177\" target=\"_blank\">recent study\u003c/a> of 70 participants all the adolescents who had been given puberty blockers went through with sex reassignment.\u003c/p>\n\u003cp>\u003cstrong>The Standard of Care\u003c/strong>\u003c/p>\n\u003cp>Even though the Oakland family had agreed in advance that their daughter would start on blockers at the right time, “we had to reassure her constantly that we wouldn’t let it go too far,” she said.\u003c/p>\n\u003cp>When she turned 13, the girl started receiving monthly injections of Lupron, a widely prescribed sex hormone suppressor. “As soon as she started, you could just see the relief in her,” said the mother. “You could see it in her demeanor, in her mood; it was just a huge weight off her shoulders,” she said.\u003c/p>\n\u003cp>The family’s insurer, Kaiser Permanente, covered the treatment. Puberty blockers are considered “standard of care in the appropriate clinical circumstances,” said Erica Metz, medical director for Transgender Health at Kaiser Permanente Northern California. According to Metz, the treatment “gives patients and their families time to work with their mental health and medical providers to determine if it is appropriate to start transitioning.”\u003c/p>\n\u003cp>When the girl was 14, she started taking estrogen — the next step in her male-to-female transition. Instead of growing facial hair and a male physique, she developed breasts and some curves. Her voice didn’t deepen, and she doesn’t have an Adam’s apple.\u003c/p>\n\u003cp>The mother described her daughter as a social, outgoing and well-adjusted teenager. She knows the \u003ca href=\"http://williamsinstitute.law.ucla.edu/research/suicide-attempts-among-transgender-and-gender-non-conforming-adults/\" target=\"_blank\">grim mental health statistics\u003c/a> for transgender people — 41 percent have attempted suicide, nearly nine times the national average — and she doesn’t want to imagine a world where her daughter would be without puberty blockers, a medical intervention that she called a “lifesaver.”\u003c/p>\n\u003cp>“The thought of her having had to go through male puberty, I think it would have destroyed her mental health and well-being,” the mother said.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Hospitals Create Separate Units to Accommodate Elderly",
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"content": "\u003cp>Janet Prochazka was active and outspoken, living by herself and working as a special education tutor. Then, in March, a bad fall landed her in the hospital.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The older you are, the worse the hospital is for you.'\u003c/aside>\n\u003cp>Doctors cared for her wounds and treated her pneumonia. But Prochazka, 75, didn’t sleep or eat well at Zuckerberg San Francisco General Hospital and Trauma Center. She became confused and agitated and ultimately contracted a serious stomach infection. After more than three weeks in the hospital and three more in a rehabilitation facility, she emerged far weaker than before, shaky and unable to think clearly.\u003c/p>\n\u003cp>She had to stop working and wasn’t able to drive for months. And now, she’s considering a move to Maine to be closer to relatives for support.\u003c/p>\n\u003cp>“It’s a big, big change,” said her stepdaughter, Kitty Gilbert, soon after Prochazka returned home. “I am hopeful that she will regain a lot of what she lost, but I am not sure.”\u003c/p>\n\u003cp>Many elderly patients like Prochazka deteriorate mentally or physically in the hospital, even if they recover from the original illness or injury that brought them there. About one-third of patients over 70 years old and more than half of patients over 85 leave the hospital more disabled than when they arrived, research shows.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>As a result, many seniors are unable to care for themselves after discharge and need assistance with daily activities such as bathing, dressing or even walking.\u003c/p>\n\u003cp>“The older you are, the worse the hospital is for you,” said Ken Covinsky, a physician and researcher at the University of California, San Francisco division of geriatrics. “A lot of the stuff we do in medicine does more harm than good. And sometimes with the care of older people, less is more.”\u003c/p>\n\u003cp>Hospital staff often fail to feed older patients properly, get them out of bed enough or control their pain adequately. Providers frequently restrict their movements by tethering them to beds with oxygen tanks and IV poles. Doctors subject them to unnecessary procedures and prescribe redundant or potentially harmful medications. And caregivers deprive them of sleep by placing them in noisy wards or checking vital signs at all hours of the night.\u003c/p>\n\u003cp>Interrupted sleep, unappetizing food and days in bed may be merely annoying for younger patients, but they can cause lasting damage to older ones. Elderly patients are far different than their younger counterparts — so much so that some hospitals are treating some of them in separate medical units.\u003c/p>\n\u003cp>San Francisco General is one of them. Its Acute Care for Elders (ACE) ward, which opened in 2007, has special accommodations and a team of providers to address the unique needs of older patients. They focus less on the original diagnosis and more on how to get patients back home, living as independently as possible.\u003c/p>\n\u003cp>Early on, the staff tests patients’ memories and assesses how well they can walk and care for themselves at home. Then they give patients practice doing things for themselves as much as possible throughout their stay. They remove catheters and IVs, and encourage patients to get out of bed and eat in a communal dining area.\u003c/p>\n\u003cp>“Bed rest is really, really bad,” said the medical director of the ACE unit, Edgar Pierluissi. “It sets off an explosive chain of events that are very detrimental to people’s health.”\u003c/p>\n\u003cp>Such units are still rare — there are only about 200 around the country. And even where they exist, not every senior is admitted, in part because space is limited.\u003c/p>\n\u003cp>Prochazka went to the emergency room first, then intensive care. She was transferred to ACE about a week later. The staff weaned her off some of her medications and got her up and walking. They also limited the disorienting nighttime checks. Prochazka said she got “the first good night of sleep I have had.”\u003c/p>\n\u003cp>But for her, the move might have been too late.\u003c/p>\n\u003cp>“She will not leave here where she started,” Pierluissi said several days before Prochazka was discharged. “She is going to be weaker and unable to do the things you really need to do to live independently.”\u003c/p>\n\u003cp>\u003cstrong>Not a Priority\u003c/strong>\u003c/p>\n\u003cp>How hospitals handle the old — and very old — is a pressing problem. Elderly patients are a growing clientele for hospitals, a trend that will only accelerate as baby boomers age. Patients over 65 already make up more than one-third of all discharges, according to the federal government, and nearly 13 million seniors are hospitalized each year. And they stay longer than younger patients.\u003c/p>\n\u003cp>Many seniors are already suspended precariously between independent living and reliance on others. They are weakened by multiple chronic diseases and medications.\u003c/p>\n\u003cp>One bad hospitalization can tip them over the edge, and they may never recover, said Melissa Mattison, chief of the hospital medicine unit at Massachusetts General Hospital.\u003c/p>\n\u003cp>“It is like putting Humpty Dumpty back together again,” said Mattison, who wrote a 2013 report detailing the risks elderly patients face in the hospital.\u003c/p>\n\u003cp>Yet the unique needs of older patients are not a priority for most hospitals, Covinsky said. Doctors and other hospital staff focus so intensely on treating injuries or acute illnesses — like pneumonia or an exacerbation of heart disease — that they can overlook nearly all other aspects of caring for the patients, he noted.\u003c/p>\n\u003cp>In addition, hospitals face few consequences if elderly patients become more impaired or less functional during their stays. The federal government penalizes hospitals when patients fall, get preventable infections or return to the hospital within 30 days of their discharge. But hospitals aren’t held accountable if patients lose their memories or their ability to walk. As a result, most don’t measure those things.\u003c/p>\n\u003cp>“If you don’t measure it, you can’t fix it,” Covinsky said.\u003c/p>\n\u003cp>Improving care for older patients requires an investment that hospital administrators are not always willing to make, experts said. Some argue, however, that the investment pays off — not just for older people but for hospitals themselves as well as for a country intent on controlling health care spending.\u003c/p>\n\u003cp>Though research on the financial impact of problematic hospital care for the elderly has been limited, a 2010 report by the Department of Health and Human Services’ Office of Inspector General found that more than a quarter of hospitalized Medicare beneficiaries had suffered an “adverse event,” or harm as a result of medical care.\u003c/p>\n\u003cp>Those events, such as bed sores or oxygen deficiency, cost Medicare about $4.4 billion annually, according to the report. Physicians who reviewed the incidents determined that 44 percent could have been prevented.\u003c/p>\n\u003cp>In addition to outright mistakes, poor or inadequate treatment in hospitals leads to needless medical spending on extended hospital visits, readmissions, in-home caregivers and nursing home care. Nursing home stays cost about $85,000 a year. And the average hospital stay for an elderly person is $12,000, according to the Agency for Healthcare Research and Quality.\u003c/p>\n\u003cp>“If you don’t feed a patient, if you don’t mobilize a patient, you have just made it far more likely they will go to a skilled nursing [facility], and that’s expensive,” said Robert Palmer, director of the geriatrics and gerontology center at Eastern Virginia Medical School and one of the brains behind the idea of ACE units.\u003c/p>\n\u003cp>ACE units have been shown to reduce hospital-inflicted disabilities in older patients, decrease lengths of stay and reduce the number of patients discharged to nursing homes. In one 2012 Health Affairs study, Palmer and other researchers found that hospital units for the elderly saved about $1,000 per patient visit.\u003c/p>\n\u003cp>\u003cstrong>A Different Life\u003c/strong>\u003c/p>\n\u003cp>After coming home, Prochazka said she felt weak. It took weeks of walking her labradoodle, Gino, to regain strength.\u003c/p>\n\u003cp>Her stepdaughter, Gilbert, said Prochazka has started to improve. “We knew she was getting better when she was getting ornery,” she said.\u003c/p>\n\u003cp>But Prochazka, who is highly educated, still has some short-term memory loss, Gilbert said.\u003c/p>\n\u003cp>Prochazka knows that her life after hospitalization is different than before — she will have to depend more on others. It’s not an easy adjustment, she said.\u003c/p>\n\u003cp>“I have been somebody who has always been both mentally and physically active,” she said. “Before I fell … I was respected for what I have and what I did and all of a sudden, I’m not.”\u003c/p>\n\u003cp>She said her time at San Francisco General was frustrating. Getting the infection just as she was starting to recover was especially hard, she said. “I felt like I had been dealt a blow I really didn’t need.”\u003c/p>\n\u003cp>For other patients, being admitted proactively to the special geriatric unit can stave off such precipitous declines.\u003c/p>\n\u003cp>Rosenda Esquivel, 80, spent 18 days at San Francisco General, much of it in the unit, this spring. She suffered no noticeable setbacks, physical or mental, during her time in the hospital, according to Annelie Nilsson, a clinical nurse specialist in the unit.\u003c/p>\n\u003cp>Esquivel, an animated woman who used to work as a home caregiver, was admitted with intense arthritic pain and, while hospitalized, underwent a procedure to address an abnormal heartbeat.\u003c/p>\n\u003cp>Soon after her arrival, Pierluissi, the ACE unit medical director, speaking to Esquivel in her native Spanish, sought to determine how independent she was at home. He learned that a friend helped take care of her but that she took pride in cooking and cleaning for herself.\u003c/p>\n\u003cp>The doctor noticed that Esquivel needed help to get up from a chair but that she could get around with a walker. Her memory, though, wasn’t too strong. A few minutes after hearing three words — “honesty,” “baseball” and “flower” — she could only recall one of them.\u003c/p>\n\u003cp>Pierluissi came up with a plan for her time in the hospital: Get Esquivel’s pain under control. Make sure she walks three or four times a day. Arrange for her to have a caregiver at home to remind her to take her diabetes and blood pressure medications.\u003c/p>\n\u003cp>Then, release her as fast as possible.\u003c/p>\n\u003cp>“The less time she spends here, the better,” Pierluissi said.\u003c/p>\n\u003cp>This story was reported while its author, Anna Gorman, participated in a fellowship supported by New America Media, the Gerontological Society of America and The Commonwealth Fund.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>KHN’s coverage of aging and long-term care issues is supported by a grant from The SCAN Foundation, and its coverage of late life and geriatric care is supported by The John A. Hartford Foundation.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Janet Prochazka was active and outspoken, living by herself and working as a special education tutor. Then, in March, a bad fall landed her in the hospital.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The older you are, the worse the hospital is for you.'\u003c/aside>\n\u003cp>Doctors cared for her wounds and treated her pneumonia. But Prochazka, 75, didn’t sleep or eat well at Zuckerberg San Francisco General Hospital and Trauma Center. She became confused and agitated and ultimately contracted a serious stomach infection. After more than three weeks in the hospital and three more in a rehabilitation facility, she emerged far weaker than before, shaky and unable to think clearly.\u003c/p>\n\u003cp>She had to stop working and wasn’t able to drive for months. And now, she’s considering a move to Maine to be closer to relatives for support.\u003c/p>\n\u003cp>“It’s a big, big change,” said her stepdaughter, Kitty Gilbert, soon after Prochazka returned home. “I am hopeful that she will regain a lot of what she lost, but I am not sure.”\u003c/p>\n\u003cp>Many elderly patients like Prochazka deteriorate mentally or physically in the hospital, even if they recover from the original illness or injury that brought them there. About one-third of patients over 70 years old and more than half of patients over 85 leave the hospital more disabled than when they arrived, research shows.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>As a result, many seniors are unable to care for themselves after discharge and need assistance with daily activities such as bathing, dressing or even walking.\u003c/p>\n\u003cp>“The older you are, the worse the hospital is for you,” said Ken Covinsky, a physician and researcher at the University of California, San Francisco division of geriatrics. “A lot of the stuff we do in medicine does more harm than good. And sometimes with the care of older people, less is more.”\u003c/p>\n\u003cp>Hospital staff often fail to feed older patients properly, get them out of bed enough or control their pain adequately. Providers frequently restrict their movements by tethering them to beds with oxygen tanks and IV poles. Doctors subject them to unnecessary procedures and prescribe redundant or potentially harmful medications. And caregivers deprive them of sleep by placing them in noisy wards or checking vital signs at all hours of the night.\u003c/p>\n\u003cp>Interrupted sleep, unappetizing food and days in bed may be merely annoying for younger patients, but they can cause lasting damage to older ones. Elderly patients are far different than their younger counterparts — so much so that some hospitals are treating some of them in separate medical units.\u003c/p>\n\u003cp>San Francisco General is one of them. Its Acute Care for Elders (ACE) ward, which opened in 2007, has special accommodations and a team of providers to address the unique needs of older patients. They focus less on the original diagnosis and more on how to get patients back home, living as independently as possible.\u003c/p>\n\u003cp>Early on, the staff tests patients’ memories and assesses how well they can walk and care for themselves at home. Then they give patients practice doing things for themselves as much as possible throughout their stay. They remove catheters and IVs, and encourage patients to get out of bed and eat in a communal dining area.\u003c/p>\n\u003cp>“Bed rest is really, really bad,” said the medical director of the ACE unit, Edgar Pierluissi. “It sets off an explosive chain of events that are very detrimental to people’s health.”\u003c/p>\n\u003cp>Such units are still rare — there are only about 200 around the country. And even where they exist, not every senior is admitted, in part because space is limited.\u003c/p>\n\u003cp>Prochazka went to the emergency room first, then intensive care. She was transferred to ACE about a week later. The staff weaned her off some of her medications and got her up and walking. They also limited the disorienting nighttime checks. Prochazka said she got “the first good night of sleep I have had.”\u003c/p>\n\u003cp>But for her, the move might have been too late.\u003c/p>\n\u003cp>“She will not leave here where she started,” Pierluissi said several days before Prochazka was discharged. “She is going to be weaker and unable to do the things you really need to do to live independently.”\u003c/p>\n\u003cp>\u003cstrong>Not a Priority\u003c/strong>\u003c/p>\n\u003cp>How hospitals handle the old — and very old — is a pressing problem. Elderly patients are a growing clientele for hospitals, a trend that will only accelerate as baby boomers age. Patients over 65 already make up more than one-third of all discharges, according to the federal government, and nearly 13 million seniors are hospitalized each year. And they stay longer than younger patients.\u003c/p>\n\u003cp>Many seniors are already suspended precariously between independent living and reliance on others. They are weakened by multiple chronic diseases and medications.\u003c/p>\n\u003cp>One bad hospitalization can tip them over the edge, and they may never recover, said Melissa Mattison, chief of the hospital medicine unit at Massachusetts General Hospital.\u003c/p>\n\u003cp>“It is like putting Humpty Dumpty back together again,” said Mattison, who wrote a 2013 report detailing the risks elderly patients face in the hospital.\u003c/p>\n\u003cp>Yet the unique needs of older patients are not a priority for most hospitals, Covinsky said. Doctors and other hospital staff focus so intensely on treating injuries or acute illnesses — like pneumonia or an exacerbation of heart disease — that they can overlook nearly all other aspects of caring for the patients, he noted.\u003c/p>\n\u003cp>In addition, hospitals face few consequences if elderly patients become more impaired or less functional during their stays. The federal government penalizes hospitals when patients fall, get preventable infections or return to the hospital within 30 days of their discharge. But hospitals aren’t held accountable if patients lose their memories or their ability to walk. As a result, most don’t measure those things.\u003c/p>\n\u003cp>“If you don’t measure it, you can’t fix it,” Covinsky said.\u003c/p>\n\u003cp>Improving care for older patients requires an investment that hospital administrators are not always willing to make, experts said. Some argue, however, that the investment pays off — not just for older people but for hospitals themselves as well as for a country intent on controlling health care spending.\u003c/p>\n\u003cp>Though research on the financial impact of problematic hospital care for the elderly has been limited, a 2010 report by the Department of Health and Human Services’ Office of Inspector General found that more than a quarter of hospitalized Medicare beneficiaries had suffered an “adverse event,” or harm as a result of medical care.\u003c/p>\n\u003cp>Those events, such as bed sores or oxygen deficiency, cost Medicare about $4.4 billion annually, according to the report. Physicians who reviewed the incidents determined that 44 percent could have been prevented.\u003c/p>\n\u003cp>In addition to outright mistakes, poor or inadequate treatment in hospitals leads to needless medical spending on extended hospital visits, readmissions, in-home caregivers and nursing home care. Nursing home stays cost about $85,000 a year. And the average hospital stay for an elderly person is $12,000, according to the Agency for Healthcare Research and Quality.\u003c/p>\n\u003cp>“If you don’t feed a patient, if you don’t mobilize a patient, you have just made it far more likely they will go to a skilled nursing [facility], and that’s expensive,” said Robert Palmer, director of the geriatrics and gerontology center at Eastern Virginia Medical School and one of the brains behind the idea of ACE units.\u003c/p>\n\u003cp>ACE units have been shown to reduce hospital-inflicted disabilities in older patients, decrease lengths of stay and reduce the number of patients discharged to nursing homes. In one 2012 Health Affairs study, Palmer and other researchers found that hospital units for the elderly saved about $1,000 per patient visit.\u003c/p>\n\u003cp>\u003cstrong>A Different Life\u003c/strong>\u003c/p>\n\u003cp>After coming home, Prochazka said she felt weak. It took weeks of walking her labradoodle, Gino, to regain strength.\u003c/p>\n\u003cp>Her stepdaughter, Gilbert, said Prochazka has started to improve. “We knew she was getting better when she was getting ornery,” she said.\u003c/p>\n\u003cp>But Prochazka, who is highly educated, still has some short-term memory loss, Gilbert said.\u003c/p>\n\u003cp>Prochazka knows that her life after hospitalization is different than before — she will have to depend more on others. It’s not an easy adjustment, she said.\u003c/p>\n\u003cp>“I have been somebody who has always been both mentally and physically active,” she said. “Before I fell … I was respected for what I have and what I did and all of a sudden, I’m not.”\u003c/p>\n\u003cp>She said her time at San Francisco General was frustrating. Getting the infection just as she was starting to recover was especially hard, she said. “I felt like I had been dealt a blow I really didn’t need.”\u003c/p>\n\u003cp>For other patients, being admitted proactively to the special geriatric unit can stave off such precipitous declines.\u003c/p>\n\u003cp>Rosenda Esquivel, 80, spent 18 days at San Francisco General, much of it in the unit, this spring. She suffered no noticeable setbacks, physical or mental, during her time in the hospital, according to Annelie Nilsson, a clinical nurse specialist in the unit.\u003c/p>\n\u003cp>Esquivel, an animated woman who used to work as a home caregiver, was admitted with intense arthritic pain and, while hospitalized, underwent a procedure to address an abnormal heartbeat.\u003c/p>\n\u003cp>Soon after her arrival, Pierluissi, the ACE unit medical director, speaking to Esquivel in her native Spanish, sought to determine how independent she was at home. He learned that a friend helped take care of her but that she took pride in cooking and cleaning for herself.\u003c/p>\n\u003cp>The doctor noticed that Esquivel needed help to get up from a chair but that she could get around with a walker. Her memory, though, wasn’t too strong. A few minutes after hearing three words — “honesty,” “baseball” and “flower” — she could only recall one of them.\u003c/p>\n\u003cp>Pierluissi came up with a plan for her time in the hospital: Get Esquivel’s pain under control. Make sure she walks three or four times a day. Arrange for her to have a caregiver at home to remind her to take her diabetes and blood pressure medications.\u003c/p>\n\u003cp>Then, release her as fast as possible.\u003c/p>\n\u003cp>“The less time she spends here, the better,” Pierluissi said.\u003c/p>\n\u003cp>This story was reported while its author, Anna Gorman, participated in a fellowship supported by New America Media, the Gerontological Society of America and The Commonwealth Fund.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>https://www.youtube.com/watch?v=n6JRG733ReQ&ab_channel=AACC\u003c/p>\n\u003cp>Speaking Monday before an estimated 2,650 people -- most of them laboratory scientists -- at the annual meeting of the American Association for Clinical Chemistry, Theranos CEO Elizabeth Holmes \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/07/29/theranos-elizabeth-holmes-will-face-1000-scientists-monday-can-she-say-anything-to-gain-their-trust/\" target=\"_blank\">introduced a new device\u003c/a> that can fit on a desktop. Holmes said the machine, called a miniLab, integrates several blood-testing methodologies and, using robots and its proprietary “nanotainer” collection tube, will be able to process small volumes of blood remotely and send data back to a centralized location.\u003c/p>\n\u003cp>Holmes did not present data concerning the problematic consumer blood tests the company ran over the past few years -- tests that have led to a suspension of Holmes by the Centers for Medicare & Medicaid Services as well as severe penalties for Theranos, multiple lawsuits, and the loss of the company's key parternship with Walgreens.\u003c/p>\n\u003cp>You can watch Holmes' entire presentation, plus the question and answer period, above.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/n6JRG733ReQ'\n title='//www.youtube.com/embed/n6JRG733ReQ'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Speaking Monday before an estimated 2,650 people -- most of them laboratory scientists -- at the annual meeting of the American Association for Clinical Chemistry, Theranos CEO Elizabeth Holmes \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/07/29/theranos-elizabeth-holmes-will-face-1000-scientists-monday-can-she-say-anything-to-gain-their-trust/\" target=\"_blank\">introduced a new device\u003c/a> that can fit on a desktop. Holmes said the machine, called a miniLab, integrates several blood-testing methodologies and, using robots and its proprietary “nanotainer” collection tube, will be able to process small volumes of blood remotely and send data back to a centralized location.\u003c/p>\n\u003cp>Holmes did not present data concerning the problematic consumer blood tests the company ran over the past few years -- tests that have led to a suspension of Holmes by the Centers for Medicare & Medicaid Services as well as severe penalties for Theranos, multiple lawsuits, and the loss of the company's key parternship with Walgreens.\u003c/p>\n\u003cp>You can watch Holmes' entire presentation, plus the question and answer period, above.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>Forget \"Edison.\" Let's talk \"miniLab.\"\u003c/p>\n\u003cp>That was the message Elizabeth Holmes sent at her highly anticipated presentation Monday at the American Association for Clinical Chemistry's annual meeting in Philadelphia.\u003c/p>\n\u003caside class=\"pullquote alignright\">'In retrospect it was no different from going to a typical talk by a sponsored vendor.'\u003ccite>Dr. Jerry Yeo, University of Chicago\u003c/cite>\u003c/aside>\n\u003cp>Speaking for roughly 55 minutes in front of an estimated 2,650 people -- most of them laboratory scientists -- Holmes introduced a new device that can fit on a desktop. The machine, called a miniLab, integrates several blood-testing methodologies and, using robots and the company's proprietary \"\u003ca href=\"https://www.google.com/search?q=nanotainer\" target=\"_blank\">nanotainer\u003c/a>\" collection tube, will be able to process small volumes of blood remotely and send data back to a centralized location.\u003c/p>\n\u003cp>Holmes presented internal company data that showed the system worked for a range of tests, including a new assay for Zika.\u003c/p>\n\u003cp>Dr. Jerry Yeo, however, director of clinical chemistry laboratories at the University of Chicago, seemed to speak for a number of scientists when he summed up his response this way:\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>[contextly_sidebar id=\"1op21qHuw941CUAVPi6ZWhtkUjJaSEaz\"]\"There was nothing revolutionary or disruptive behind the technology of the miniLab,\" Yeo said.\u003c/p>\n\u003cp>Yeo said the miniLab uses spectrophotometry and other measurement principles that are \"well known in the field and are existing, current technologies employed by many diagnostic vendors.\"\u003c/p>\n\u003cp>While the internal performance data Holmes showed \"looked impressive,\" he said, \"ultimately the proof will require that these units be tested in independent clinical labs, so for now the jury is out, until we see some peer-reviewed publications from those sources.\"\u003c/p>\n\u003cp>Yeo also said the data Holmes provided were incomplete in terms of fully assessing the machine.\u003c/p>\n\u003cp>\"In retrospect it was no different from going to a typical talk by a sponsored vendor,\" Yeo said.\u003c/p>\n\u003cp>Dr. Stephen R. Master, one of the event's moderators, said the presentation might have gone better had Theranos not previously made so many grandiose claims, most notably that it could perform dozens of tests from just a few drops of blood.\u003c/p>\n\u003cp>\"When push came to shove, what they actually showed was far, far less,\" Master said. \"It wasn’t 'Give me a couple of drops of blood and I’ll do everything. It was 'I'll do a panel of four tests here, or six or eight. Can they do more? They didn't show it.\"\u003c/p>\n\u003cp>Master said that while many of his colleagues thought including different pieces of lab equipment in a box was an interesting feat of engineering, \"It's not as if there's something here we haven't fundamentally seen before.\"\u003c/p>\n\u003cp>He contrasted Theranos' presentation with one he saw the night before, at a plenary session. The presenter \"also had a box with a bunch of different modules, but he had over 200 peer-reviewed papers.\"\u003c/p>\n\u003cp>In response to the criticism, Theranos Scientific and Medical Advisory Board member Susan Evans said Holmes demonstrated that the architecture of Theranos' technologies, as well as the associated science and technology, are sound.\u003c/p>\n\u003cp>\"Innovations like this are very exciting,\" Evans said. \"The Theranos miniLab has the potential to increase access and bring laboratory testing to the patient, whether close to home or in remote locations that are currently underserved.\"\u003c/p>\n\u003cp>(This response, by the way, was sent through public relations colossus Hill+Knowlton Strategies -- now, apparently, working with Theranos.)\u003c/p>\n\u003caside class=\"pullquote alignright\">‘I was not that impressed with the technology, but at least she shared the technology they have.’\u003ccite>Dr. David Koch, former president AACC\u003c/cite>\u003c/aside>\n\u003cp>Many if not most of the audience were expecting Holmes to present data concerning the technology, known as \"Edison,\" behind the problematic consumer blood tests the company ran over the past few years. As part of an attempt to correct problems flagged by the Centers for Medicare and Medicaid Services, Theranos was forced to invalidate tens of thousands of these tests, some of which are now the subject of lawsuits, including one that claims incorrect test results led to a heart attack.\u003c/p>\n\u003cp>But nowhere in her presentation did Holmes present validating data for Edison. Nor did she address problems at the company's California lab that have led to her two-year suspension from owning or operating a lab, and to severe penalties for Theranos.\u003c/p>\n\u003cp>\"We know there’s a lot of questions about the past,” Holmes said, \"and in the appropriate forum, we’ll address those.\"\u003c/p>\n\u003cp>She said the technology known as \"Edison,\" the subject of so much controversy over the past year, is obsolete.\u003c/p>\n\u003cp>After the presentation, Holmes answered questions from the audience for about 35 minutes.\u003c/p>\n\u003cp>Also in the audience was Dr. David Koch, director of clinical chemistry at Grady Memorial Hospital in Atlanta and a past president of the AACC. About the miniLab, he said, \"I was not that impressed with the technology. I think it’s apparently still coming along, but at least she shared the technology they have.”\u003c/p>\n\u003cp>Koch said colleagues noted the absence of any data concerning Theranos' famous claim to be able to perform multiple tests from just a few drops of blood from a fingerprick.\u003c/p>\n\u003cp>But, he said, \"I'm glad she came. It's a start.\"\u003c/p>\n\u003cp>Dr. Greg Miller, professor of pathology at Virginia Commonwealth University, said he thought Holmes did a \"credible job.\"\u003c/p>\n\u003cp>\"She explained the technology they’ve developed. She made it clear it’s the newest version of the technology and that it’s gone through several generations.”\u003c/p>\n\u003cp>While Miller wouldn't call the data presented \"a full validation, of the method or the technology,\" he said \"it showed credibility for the example she showed, and it shows potential for it being a useful piece of technology.\"\u003c/p>\n\u003cp>\u003cstrong>Consensus in the Media: A Failure\u003c/strong>\u003c/p>\n\u003cp>No on has taken a poll of the couple of thousand lab experts in the audience, but the reaction that has made its way through to media covering Theranos, as well as the media's characterization of the presentation itself, mostly ranges from tepid to extremely negative.\u003c/p>\n\u003cp>Nick Stockton of \u003ca href=\"http://www.wired.com/2016/08/theranos-chance-clear-name-instead-tried-pivot/\" target=\"_blank\">Wired\u003c/a> expressed a common theme:\u003c/p>\n\u003cblockquote>\u003cp>The miniLab itself still has to get validated by an independent lab. And even that wouldn’t give Theranos the clean slate it desires. Not from this crowd. Remember, this company got famous claiming faster, cheaper, painless, and above all revolutionary tests. Now it wants that same level of attention to pitch a mini lab that features no radically new technology.\u003c/p>\u003c/blockquote>\n\u003cp>From Jen Christensen, at \u003ca href=\"http://www.cnn.com/2016/08/02/health/theranos-holmes-presentation/index.html\" target=\"_blank\">CNN\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>(T)he broader feeling seemed to be that there was not enough there. Some of the crowd lingered after the session to discuss the ideas with their peers.\u003c/p>\n\u003cp>\"There's just not enough data here,\" said Bobby Reddy, who runs a lab-related tech startup in Urbana, Illinois.\u003c/p>\n\u003cp>\"The failing here is to show up without enough data to show that the technology works. It might be enough for a poster session, but not this,\" said Joshua Hayden at Weill Cornell Medicine, who works with one of the moderators at the conference session. \"This industry is hungry for new ideas, we want disruptive technology in this field. But this doesn't seem to be it so far, and most of us don't like all the smoke and mirrors they've used over the years.\"\u003c/p>\u003c/blockquote>\n\u003cp>And Matthew Herper of \u003ca href=\"http://www.forbes.com/sites/matthewherper/2016/08/01/theranos-presents-data-on-new-blood-test-machine-remains-mum-on-previous-technology/#7d5bf7974159\" target=\"_blank\">Forbes\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>\"Everything we’re interested in, they’re not talking about,” says Daniel Holmes (no relation), head of clinical chemistry at St. Paul’s Hospital in British Columbia, who reviewed the presentation for FORBES. “This is essentially a prototype instrument. They’re doing initial studies of a prototype.”\u003c/p>\n\u003cp>Geoffrey Baird, an associate professor of medicine at the University of Washington who has been critical of Theranos, went further, calling the presentation “a bait and switch.” He says: “We’re not seeing Theranos technology. We’re seeing an early-stage technology, an idea.”\u003c/p>\n\u003cp>As far as it goes, the data do seem to show a promising prototype. The data do show some agreement between the miniLab and existing devices used by Siemens. The question will be how convincing outside experts find these results.\u003c/p>\u003c/blockquote>\n\u003cp>And Christina Farr at \u003ca href=\"http://www.fastcompany.com/3062433/scientists-wanted-transparency-from-theranos-but-got-a-product-launch-instead\" target=\"_blank\">Fast Company\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>\"Clearly, the scientific and medical community was hoping for a data-driven discussion today, and instead got a new product announcement,\" says John Torous, a psychiatrist and clinical informatics fellow at Harvard Medical School. ...\u003c/p>\n\u003cp>(S)cientists are questioning whether the MiniLab technology is a breakthrough. The current market is already fairly saturated: Abbott's iStat system, for instance, is a handheld device for clinicians to test patients for a plethora of common tests. Roche just received FDA clearance for its Cobas device, which can test for ailments like the flu and some strep infections in under 20 minutes. And Theranos competitors Quest and Labcorp already operate versions of this type of equipment in their own labs.\u003c/p>\n\u003cp>\"I can't imagine why they're wasting their time,\" says MIT-trained material scientist and biotech entrepreneur Kaveh Milaninia by phone. \"It's a tough market.\"\u003c/p>\u003c/blockquote>\n\u003cp>And (Theranos' Public Enemy No. 1) \u003ca href=\"http://www.wsj.com/articles/theranos-founder-elizabeth-holmes-introduces-new-blood-testing-device-1470089582\" target=\"_blank\">John Carreyrou of \u003c/a>\u003ca href=\"http://www.wsj.com/articles/theranos-founder-elizabeth-holmes-introduces-new-blood-testing-device-1470089582\" target=\"_blank\">The Wall Street Journal\u003c/a>\u003ca href=\"http://www.wsj.com/articles/theranos-founder-elizabeth-holmes-introduces-new-blood-testing-device-1470089582\" target=\"_blank\">:\u003c/a>\u003c/p>\n\u003cblockquote>\u003cp>The data covered 11 blood tests, but the miniLab can’t perform all of those tests on a single 160-microliter blood sample, according to a person familiar with the matter. At most, the miniLab can perform only three or four tests on a sample of that size, so a patient ordering all 11 tests would need to have his finger pricked three to four times, the person said….\u003c/p>\n\u003cp>Some lab experts at the conference said the underlying lab techniques relied on by Theranos’s new device, such as spectrophotometry, have been in use for years. The length of time needed to process samples and produce results, ranging from 20 minutes to two hours, also doesn’t improve on what is commercially available, some lab experts said.\u003c/p>\u003c/blockquote>\n\u003cp>And Beth Mole of \u003ca href=\"http://arstechnica.com/science/2016/08/with-chance-to-soothe-theranos-critics-with-data-holmes-gives-sales-pitch/\" target=\"_blank\">Ars Technica\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>Yesterday’s presentation could have been the data-driven turning point Holmes has been promising. And the conference attendees—experts in clinical testing—gathered anxiously to hear the results.\u003c/p>\n\u003cp>But instead of validation studies of its existing technology, they got, essentially, a sales pitch for future technology.\u003c/p>\n\u003cp>Holmes spent her entire 45-minute time slot talking about a new blood testing device called the miniLab. Any questions about the company's old, disastrous blood testing device (the Edison) were flatly refused—even including questions about the differences between the Edison and miniLab.\u003c/p>\u003c/blockquote>\n\u003cp>Some in the audience, or those who were following online, expressed their dissatisfaction with the presentation on Twitter:\u003c/p>\n\u003cp>https://twitter.com/AAdamsonMD/status/760243720981716992\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>https://twitter.com/CherylRofer/status/760235711106654210\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>https://twitter.com/rvaughanw/status/760233452574765056\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>https://twitter.com/NVTolan/status/760231507512463360\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>https://twitter.com/clayew/status/760231816796200960\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>https://twitter.com/Rachakonda_V/status/760231187772153856\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>https://twitter.com/JohnTorousMD/status/760220182740697090\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>https://twitter.com/fishbyte/status/760229430484733952\u003c/p>\n\u003cp>\u003cstrong>Previous post\u003c/strong>\u003c/p>\n\u003cp>Hey, try this archetypal nightmare out for size ...\u003c/p>\n\u003cp>\u003cem>Youʼre in a room. Speaking. There are people there -- hundreds and hundreds of people. They are not particularly friendly. Actually, they are hostile. You have displeased them. You had made certain unsubstantiated claims about something they know a great deal about. Yes, they are experts. They know exactly how to determine what is truth. And what is ... \u003c/em>\u003c/p>\n\u003cp>Then you wake up. Covered in sweat ...\u003c/p>\n\u003cp>This is pretty much the scenario Theranos CEO and founder Elizabeth Holmes is going to face on Monday in Philadelphia, at the American Association for Clinical Chemistry's 68th Annual Scientific Meeting & Clinical Lab Expo.\u003c/p>\n\u003cp>Holmes will \u003ca href=\"https://www.aacc.org/meetings-and-events/2016-annual-meeting-and-expo/conference-program/theranos-science-and-technology\" target=\"_blank\">present\u003c/a>, for the first time and in front of hundreds of lab experts, “reproducibility and correlation data” for the blood-testing technology her company claims to have developed but has never proven to the satisfaction of the scientific community. Holmes will also “share data to demonstrate the precision and accuracy” of its tests.\u003c/p>\n\u003caside class=\"pullquote alignright\">'If she presents us with scientific data ... she could feasibly convince people in the room that she has what she has been saying she has, all along.'\u003ccite>Dr. Patti Jones,\u003cbr>\nAmerican Association for Clinical Chemists\u003c/cite>\u003c/aside>\n\u003cp>Those tests can ostensibly be performed using only a small amount of capillary blood from a patient's finger, instead of the traditional tubes-full taken from a vein.\u003c/p>\n\u003cp>But a \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">Wall Street Journal investigation\u003c/a> characterized those claims as dubious. Later, a Theranos lab in California was found by its regulator to be so deficient as to represent a threat to patients' lives. And this month, regulators suspended the lab’s license and banned Holmes from owning, operating or directing a blood-testing lab for two years. (The company has until early September to appeal the government’s decision, and the suspensions don’t take place for the appeal period.)\u003c/p>\n\u003cp>Both the U.S. Attorneyʼs Office for the Northern District of California and the SEC are \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/04/18/elizabeth-holmes-says-theranos-will-absolutely-survive-video/\" target=\"_blank\">investigating\u003c/a>, and \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/07/19/lawsuit-faulty-theranos-test-results-contributed-to-heart-attack/\" target=\"_blank\">lawsuits aplenty\u003c/a> have been filed.\u003c/p>\n\u003cp>[contextly_sidebar id=\"Oo2Y0iji0udKw2zJpUVJaUL2HOf28w6T\"]Now Theranos is typically described with adjectives ranging from “troubled” to “beleaguered” to “disgraced.” And the company, once valued at $9 billion, is in serious danger of becoming permanent \u003ca href=\"https://www.youtube.com/watch?v=CU94GPs-LQw&ab_channel=texasjoehotdoggy\" target=\"_blank\">shorthand\u003c/a> for greed-driven Silicon Valley hubris.\u003c/p>\n\u003cp>If Holmes has any chance of rebuilding her shattered reputation, and if Theranos is to have any chance of clawing its way back to respectability, it will start in Philadelphia, on Monday. The company has appointed a \u003ca href=\"https://www.theranos.com/news/posts/theranos-announces-leading-medical-and-laboratory-experts-join-scientific-and-medical-advisory-board\" target=\"_blank\">scientific and medical advisory board\u003c/a>, in part to help with \"publication and presentation in scientific journals and at scientific meetings.\" The board includes several former AACC officials, so one would assume Holmes will, as they say, come correct.\u003c/p>\n\u003cp>\u003cstrong>90 Minutes\u003c/strong>\u003c/p>\n\u003cp>Still, whatever she presents may or may not be enough to convert hardcore skeptics. The presentation will last 45 minutes, followed by a 45-minute question-and-answer period, according to AACC members helping with the session. Anywhere from 800 to 1,500 people are expected to be in attendance, and the presentation is open to anyone who registers for the conference, including the media, though no questions from reporters will be taken.\u003c/p>\n\u003cp>Three moderators will ask their own questions as well as questions from the audience, which will be forwarded to the moderators after three other experts come to a consensus as what is most scientifically relevant to the discussion.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The reason why a lot of us are skeptical, and perhaps even disgusted with the whole thing, is that they had a very cavalier attitude about the data that they were producing.' \u003ccite>Dr. David Koch, Grady Memorial Hospital\u003c/cite>\u003c/aside>\n\u003cp>The AACC had extended an invitation to Holmes for several years before she agreed to come speak. The announcement of this year's talk came soon after the Centers for Medicare & Medicaid Services threatened unprecedented sanctions against Theranos, as well as news of the U.S. Attorneyʼs and SEC's investigations.I asked Dr. Patti Jones, who made the decision to invite Holmes this year, if she had any reservations after all that news shook out.\u003c/p>\n\u003cp>“Of course,” said Jones, who is the clinical director of the chemistry and metabolic disease labs at Children’s Medical Center in Dallas. “I reconsidered every step along the way. But the bottom line is, I really think there is an opportunity to really see data here, to see the science. AACCʼs members have the expertise to interpret what she tells us. To be able to look at that data and say, 'Okay,' or 'Not okay.' \"\u003c/p>\n\u003cp>Jones said she had heard from members both opposed and in support of the invitation, and that the opposition was “much more\u003cbr>\nvocal.” She said no one from the AACC leadership will see Holmesʼ presentation in advance.\u003c/p>\n\u003cp>\"Weʼre not endorsing her in any way,\" Jones said. \"Weʼre just providing a room to show us what she has.”\u003c/p>\n\u003cp>I asked her if Holmes had any chance, given recent history, of convincing her colleagues she's legit.\u003c/p>\n\u003cp>“I think she can,” Jones said. “I think if she presents us with scientific data that shows not only that her system -- both the collection and the analysis work -- but how well they work in comparison to other methods, then she could feasibly convince people in the room that she has what she has been saying she has all along.”\u003c/p>\n\u003cfigure id=\"attachment_156559\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/ap_458918420528_wide-7b077d6d2c055cd84422729660306a155c7c88a8-e1469754321977.jpg\">\u003cimg class=\"wp-image-156559 size-large\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/ap_458918420528_wide-7b077d6d2c055cd84422729660306a155c7c88a8-1180x664.jpg\" alt=\"Elizabeth Holmes, founder and CEO of Theranos, speaks at the Fortune Global Forum in San Francisco, Nov. 2, 2015.\" width=\"640\" height=\"360\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Elizabeth Holmes speaks at the Fortune Global Forum in San Francisco, Nov. 2, 2015.\u003c/figcaption>\u003c/figure>\n\u003cp>I asked five other experts in laboratory medicine, most of whom will be in attendance Monday, what Holmes has to do to turn things around. Here are edited excerpts from those conversations:\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. David Koch, director of clinical chemistry, Grady Memorial Hospital, Atlanta; former president AACC\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>\"She really needs to talk about how she and Theranos didn't understand clinical laboratories and how best to practice laboratory medicine. She needs to acknowledge that they've made mistakes and that she has, in fact, made a turn from past practices and behaviors. She needs to say one of those mistakes was not sharing data, not having it vetted by professionals in the field, and not coming to meetings such as the AACC Annual Meeting.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Their technology is still a black box, which nobody knows what the details are. Anything that she presents would not be peer-reviewed.\u003ccite>Dr. Eleftherios Diamandis,\u003cbr>\nMount Sinai Hospital, Toronto\u003c/cite>\u003c/aside>\n\u003cp>The reason why a lot of us are skeptical, and perhaps even disgusted with the whole thing, is that they had a very cavalier attitude about the data they were producing, much of which turns out to apparently not be correct.\u003c/p>\n\u003cp>The laboratory has advanced year by year for the whole history of our profession, and if this is one more advancement, fine. But we want to see the data and even evaluate the instrument or device in our laboratories. Or in physicians offices, drugstores, or even in patients' homes.\u003c/p>\n\u003cp>I expect some hard questions, especially if her presentation is a little lacking, weak on substance.\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. Eleftherios Diamandis, division head of clinical biochemistry, Mount Sinai Hospital, Toronto; \u003ca href=\"https://www.ghdonline.org/uploads/Diamandis_-_2015_-%20_Theranos_phenomenon_promises_and_fallacies.pdf\" target=\"_blank\">\"Theranos phenomenon: Promises and fallacies\"\u003c/a>\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>I think the AACC is in a very odd situation, to have a lecture by somebody who was caught manipulating quality assurance, delivering results that some people believe have endangered patients.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Their situation is so unique that they really just need to turn this machine over to a completely independent person.'\u003ccite>Dr. Norman Paradis, Dartmouth College\u003c/cite>\u003c/aside>\n\u003cp>I think her reputation is in big question here. Irrespective of the opinion of people like me, that she shouldn't be invited in the first place, apparently she's going to show up and give the lecture, although I will wait until I see her before I believe that.\u003c/p>\n\u003cp>Their technology is still a black box, which nobody knows what the details are. They still haven't published a single word. Anything that she presents would not be peer-reviewed. It will be something that experts in the field have not seen or had a chance to really criticize.\u003c/p>\n\u003cp>That will be a major hurdle, because she can come and tell us anything she wants. She's got the magic black box. You put in one little drop of blood and you get 1,000 analyses with impossible accuracy,\u003c/p>\n\u003cp>But how am I going to be able to verify that the claims are actually correct? I will only believe it if experts evaluate this technology and find it to be robust.\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. Fred Apple, medical director of clinical laboratories, Hennepin County Medical Center, Minnesota\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>Iʼm hoping we're going to see, ʻHereʼs my technology, hereʼs my process, how we generate data, and here is the R&D weʼve done that proves our technology works.'\u003c/p>\n\u003cp>We want to look at clinical sensitivity, limits of detection, reproducibility, analytical correlation against another assay, turnaround time, stability of samples, as well as how it compares to whatʼs already out there in the literature.\u003c/p>\n\u003cp>Show me some data and a statistically relevant number of patients, so we can do some comparisons.\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. Jerry Yeo, director, clinical chemistry laboratories, Department of Pathology, University of Chicago\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>At this point, Holmes has a very high bar to clear to gain\u003cbr>\ncredibility, given her history of secrecy, lack of peer-reviewed publications and most damaging, the abject failures with compliance with basic requirements of the CLIA (Clinical Labroatory Improvement Amendments) guidelines leading to CMS banning her for 2 years.\u003c/p>\n\u003cp>Even if she suddenly revealed “revolutionary performance data” of her mysterious Edison invention, she still has to explain how that system managed to put out two years of bad data that had to be\u003ca href=\"http://ww2.kqed.org/futureofyou/2016/05/19/theranos-corrects-tens-of-thousands-of-blood-tests/\" target=\"_blank\"> voided, corrected\u003c/a>. Or how the system failed to comply with CLIA\u003cbr>\nregulations.\u003c/p>\n\u003cp>I seriously doubt she can do all that at this AACC venue. If it turns out to be a highly staged presentation with sanitized, prescreened questions, it might produce an opposite effect of loss of credibility to\u003cbr>\nboth Holmes and AACC leadership.\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. Norman Paradis, professor of medicine, Dartmouth; \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/04/25/analysis-why-medical-lab-experts-were-always-skeptical-of-theranos/\" target=\"_blank\">\"Why Medical Lab Experts Were Always Skeptical of Theranos\"\u003c/a>\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>If she puts up real data, there's got to be some credibility associated with that. But this has never really happened before.\u003c/p>\n\u003cp>Big pharma gets in trouble every so often in big ways, but this just doesn't tend to happen in diagnostics: People know how to validate assays. That's not a new thing. You could take your tech and just go to a completely independent university-based group to validate it. You can do it internally, by bringing in what's called a clinical research organization.\u003c/p>\n\u003cp>The FDA has published a voluminous document on good clinical practices. Why it's taken so long is just not clear.\u003c/p>\n\u003cp>So I do think if they show real data, that will be something. If she's managed to get data in a stealth manner, get data that is independent, then that obviously would be a much more reassuring thing.\u003c/p>\n\u003cp>But they still need to get FDA approval. And this won't move them along at all on that front.\u003c/p>\n\u003cp>Their situation is so unique that they really just need to turn this machine over to a completely independent person.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>This is absolutely an amazing story. I've never seen anything like it.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Forget \"Edison.\" Let's talk \"miniLab.\"\u003c/p>\n\u003cp>That was the message Elizabeth Holmes sent at her highly anticipated presentation Monday at the American Association for Clinical Chemistry's annual meeting in Philadelphia.\u003c/p>\n\u003caside class=\"pullquote alignright\">'In retrospect it was no different from going to a typical talk by a sponsored vendor.'\u003ccite>Dr. Jerry Yeo, University of Chicago\u003c/cite>\u003c/aside>\n\u003cp>Speaking for roughly 55 minutes in front of an estimated 2,650 people -- most of them laboratory scientists -- Holmes introduced a new device that can fit on a desktop. The machine, called a miniLab, integrates several blood-testing methodologies and, using robots and the company's proprietary \"\u003ca href=\"https://www.google.com/search?q=nanotainer\" target=\"_blank\">nanotainer\u003c/a>\" collection tube, will be able to process small volumes of blood remotely and send data back to a centralized location.\u003c/p>\n\u003cp>Holmes presented internal company data that showed the system worked for a range of tests, including a new assay for Zika.\u003c/p>\n\u003cp>Dr. Jerry Yeo, however, director of clinical chemistry laboratories at the University of Chicago, seemed to speak for a number of scientists when he summed up his response this way:\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>\"There was nothing revolutionary or disruptive behind the technology of the miniLab,\" Yeo said.\u003c/p>\n\u003cp>Yeo said the miniLab uses spectrophotometry and other measurement principles that are \"well known in the field and are existing, current technologies employed by many diagnostic vendors.\"\u003c/p>\n\u003cp>While the internal performance data Holmes showed \"looked impressive,\" he said, \"ultimately the proof will require that these units be tested in independent clinical labs, so for now the jury is out, until we see some peer-reviewed publications from those sources.\"\u003c/p>\n\u003cp>Yeo also said the data Holmes provided were incomplete in terms of fully assessing the machine.\u003c/p>\n\u003cp>\"In retrospect it was no different from going to a typical talk by a sponsored vendor,\" Yeo said.\u003c/p>\n\u003cp>Dr. Stephen R. Master, one of the event's moderators, said the presentation might have gone better had Theranos not previously made so many grandiose claims, most notably that it could perform dozens of tests from just a few drops of blood.\u003c/p>\n\u003cp>\"When push came to shove, what they actually showed was far, far less,\" Master said. \"It wasn’t 'Give me a couple of drops of blood and I’ll do everything. It was 'I'll do a panel of four tests here, or six or eight. Can they do more? They didn't show it.\"\u003c/p>\n\u003cp>Master said that while many of his colleagues thought including different pieces of lab equipment in a box was an interesting feat of engineering, \"It's not as if there's something here we haven't fundamentally seen before.\"\u003c/p>\n\u003cp>He contrasted Theranos' presentation with one he saw the night before, at a plenary session. The presenter \"also had a box with a bunch of different modules, but he had over 200 peer-reviewed papers.\"\u003c/p>\n\u003cp>In response to the criticism, Theranos Scientific and Medical Advisory Board member Susan Evans said Holmes demonstrated that the architecture of Theranos' technologies, as well as the associated science and technology, are sound.\u003c/p>\n\u003cp>\"Innovations like this are very exciting,\" Evans said. \"The Theranos miniLab has the potential to increase access and bring laboratory testing to the patient, whether close to home or in remote locations that are currently underserved.\"\u003c/p>\n\u003cp>(This response, by the way, was sent through public relations colossus Hill+Knowlton Strategies -- now, apparently, working with Theranos.)\u003c/p>\n\u003caside class=\"pullquote alignright\">‘I was not that impressed with the technology, but at least she shared the technology they have.’\u003ccite>Dr. David Koch, former president AACC\u003c/cite>\u003c/aside>\n\u003cp>Many if not most of the audience were expecting Holmes to present data concerning the technology, known as \"Edison,\" behind the problematic consumer blood tests the company ran over the past few years. As part of an attempt to correct problems flagged by the Centers for Medicare and Medicaid Services, Theranos was forced to invalidate tens of thousands of these tests, some of which are now the subject of lawsuits, including one that claims incorrect test results led to a heart attack.\u003c/p>\n\u003cp>But nowhere in her presentation did Holmes present validating data for Edison. Nor did she address problems at the company's California lab that have led to her two-year suspension from owning or operating a lab, and to severe penalties for Theranos.\u003c/p>\n\u003cp>\"We know there’s a lot of questions about the past,” Holmes said, \"and in the appropriate forum, we’ll address those.\"\u003c/p>\n\u003cp>She said the technology known as \"Edison,\" the subject of so much controversy over the past year, is obsolete.\u003c/p>\n\u003cp>After the presentation, Holmes answered questions from the audience for about 35 minutes.\u003c/p>\n\u003cp>Also in the audience was Dr. David Koch, director of clinical chemistry at Grady Memorial Hospital in Atlanta and a past president of the AACC. About the miniLab, he said, \"I was not that impressed with the technology. I think it’s apparently still coming along, but at least she shared the technology they have.”\u003c/p>\n\u003cp>Koch said colleagues noted the absence of any data concerning Theranos' famous claim to be able to perform multiple tests from just a few drops of blood from a fingerprick.\u003c/p>\n\u003cp>But, he said, \"I'm glad she came. It's a start.\"\u003c/p>\n\u003cp>Dr. Greg Miller, professor of pathology at Virginia Commonwealth University, said he thought Holmes did a \"credible job.\"\u003c/p>\n\u003cp>\"She explained the technology they’ve developed. She made it clear it’s the newest version of the technology and that it’s gone through several generations.”\u003c/p>\n\u003cp>While Miller wouldn't call the data presented \"a full validation, of the method or the technology,\" he said \"it showed credibility for the example she showed, and it shows potential for it being a useful piece of technology.\"\u003c/p>\n\u003cp>\u003cstrong>Consensus in the Media: A Failure\u003c/strong>\u003c/p>\n\u003cp>No on has taken a poll of the couple of thousand lab experts in the audience, but the reaction that has made its way through to media covering Theranos, as well as the media's characterization of the presentation itself, mostly ranges from tepid to extremely negative.\u003c/p>\n\u003cp>Nick Stockton of \u003ca href=\"http://www.wired.com/2016/08/theranos-chance-clear-name-instead-tried-pivot/\" target=\"_blank\">Wired\u003c/a> expressed a common theme:\u003c/p>\n\u003cblockquote>\u003cp>The miniLab itself still has to get validated by an independent lab. And even that wouldn’t give Theranos the clean slate it desires. Not from this crowd. Remember, this company got famous claiming faster, cheaper, painless, and above all revolutionary tests. Now it wants that same level of attention to pitch a mini lab that features no radically new technology.\u003c/p>\u003c/blockquote>\n\u003cp>From Jen Christensen, at \u003ca href=\"http://www.cnn.com/2016/08/02/health/theranos-holmes-presentation/index.html\" target=\"_blank\">CNN\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>(T)he broader feeling seemed to be that there was not enough there. Some of the crowd lingered after the session to discuss the ideas with their peers.\u003c/p>\n\u003cp>\"There's just not enough data here,\" said Bobby Reddy, who runs a lab-related tech startup in Urbana, Illinois.\u003c/p>\n\u003cp>\"The failing here is to show up without enough data to show that the technology works. It might be enough for a poster session, but not this,\" said Joshua Hayden at Weill Cornell Medicine, who works with one of the moderators at the conference session. \"This industry is hungry for new ideas, we want disruptive technology in this field. But this doesn't seem to be it so far, and most of us don't like all the smoke and mirrors they've used over the years.\"\u003c/p>\u003c/blockquote>\n\u003cp>And Matthew Herper of \u003ca href=\"http://www.forbes.com/sites/matthewherper/2016/08/01/theranos-presents-data-on-new-blood-test-machine-remains-mum-on-previous-technology/#7d5bf7974159\" target=\"_blank\">Forbes\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>\"Everything we’re interested in, they’re not talking about,” says Daniel Holmes (no relation), head of clinical chemistry at St. Paul’s Hospital in British Columbia, who reviewed the presentation for FORBES. “This is essentially a prototype instrument. They’re doing initial studies of a prototype.”\u003c/p>\n\u003cp>Geoffrey Baird, an associate professor of medicine at the University of Washington who has been critical of Theranos, went further, calling the presentation “a bait and switch.” He says: “We’re not seeing Theranos technology. We’re seeing an early-stage technology, an idea.”\u003c/p>\n\u003cp>As far as it goes, the data do seem to show a promising prototype. The data do show some agreement between the miniLab and existing devices used by Siemens. The question will be how convincing outside experts find these results.\u003c/p>\u003c/blockquote>\n\u003cp>And Christina Farr at \u003ca href=\"http://www.fastcompany.com/3062433/scientists-wanted-transparency-from-theranos-but-got-a-product-launch-instead\" target=\"_blank\">Fast Company\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>\"Clearly, the scientific and medical community was hoping for a data-driven discussion today, and instead got a new product announcement,\" says John Torous, a psychiatrist and clinical informatics fellow at Harvard Medical School. ...\u003c/p>\n\u003cp>(S)cientists are questioning whether the MiniLab technology is a breakthrough. The current market is already fairly saturated: Abbott's iStat system, for instance, is a handheld device for clinicians to test patients for a plethora of common tests. Roche just received FDA clearance for its Cobas device, which can test for ailments like the flu and some strep infections in under 20 minutes. And Theranos competitors Quest and Labcorp already operate versions of this type of equipment in their own labs.\u003c/p>\n\u003cp>\"I can't imagine why they're wasting their time,\" says MIT-trained material scientist and biotech entrepreneur Kaveh Milaninia by phone. \"It's a tough market.\"\u003c/p>\u003c/blockquote>\n\u003cp>And (Theranos' Public Enemy No. 1) \u003ca href=\"http://www.wsj.com/articles/theranos-founder-elizabeth-holmes-introduces-new-blood-testing-device-1470089582\" target=\"_blank\">John Carreyrou of \u003c/a>\u003ca href=\"http://www.wsj.com/articles/theranos-founder-elizabeth-holmes-introduces-new-blood-testing-device-1470089582\" target=\"_blank\">The Wall Street Journal\u003c/a>\u003ca href=\"http://www.wsj.com/articles/theranos-founder-elizabeth-holmes-introduces-new-blood-testing-device-1470089582\" target=\"_blank\">:\u003c/a>\u003c/p>\n\u003cblockquote>\u003cp>The data covered 11 blood tests, but the miniLab can’t perform all of those tests on a single 160-microliter blood sample, according to a person familiar with the matter. At most, the miniLab can perform only three or four tests on a sample of that size, so a patient ordering all 11 tests would need to have his finger pricked three to four times, the person said….\u003c/p>\n\u003cp>Some lab experts at the conference said the underlying lab techniques relied on by Theranos’s new device, such as spectrophotometry, have been in use for years. The length of time needed to process samples and produce results, ranging from 20 minutes to two hours, also doesn’t improve on what is commercially available, some lab experts said.\u003c/p>\u003c/blockquote>\n\u003cp>And Beth Mole of \u003ca href=\"http://arstechnica.com/science/2016/08/with-chance-to-soothe-theranos-critics-with-data-holmes-gives-sales-pitch/\" target=\"_blank\">Ars Technica\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>Yesterday’s presentation could have been the data-driven turning point Holmes has been promising. And the conference attendees—experts in clinical testing—gathered anxiously to hear the results.\u003c/p>\n\u003cp>But instead of validation studies of its existing technology, they got, essentially, a sales pitch for future technology.\u003c/p>\n\u003cp>Holmes spent her entire 45-minute time slot talking about a new blood testing device called the miniLab. Any questions about the company's old, disastrous blood testing device (the Edison) were flatly refused—even including questions about the differences between the Edison and miniLab.\u003c/p>\u003c/blockquote>\n\u003cp>Some in the audience, or those who were following online, expressed their dissatisfaction with the presentation on Twitter:\u003c/p>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\n\u003cp>\u003cstrong>Previous post\u003c/strong>\u003c/p>\n\u003cp>Hey, try this archetypal nightmare out for size ...\u003c/p>\n\u003cp>\u003cem>Youʼre in a room. Speaking. There are people there -- hundreds and hundreds of people. They are not particularly friendly. Actually, they are hostile. You have displeased them. You had made certain unsubstantiated claims about something they know a great deal about. Yes, they are experts. They know exactly how to determine what is truth. And what is ... \u003c/em>\u003c/p>\n\u003cp>Then you wake up. Covered in sweat ...\u003c/p>\n\u003cp>This is pretty much the scenario Theranos CEO and founder Elizabeth Holmes is going to face on Monday in Philadelphia, at the American Association for Clinical Chemistry's 68th Annual Scientific Meeting & Clinical Lab Expo.\u003c/p>\n\u003cp>Holmes will \u003ca href=\"https://www.aacc.org/meetings-and-events/2016-annual-meeting-and-expo/conference-program/theranos-science-and-technology\" target=\"_blank\">present\u003c/a>, for the first time and in front of hundreds of lab experts, “reproducibility and correlation data” for the blood-testing technology her company claims to have developed but has never proven to the satisfaction of the scientific community. Holmes will also “share data to demonstrate the precision and accuracy” of its tests.\u003c/p>\n\u003caside class=\"pullquote alignright\">'If she presents us with scientific data ... she could feasibly convince people in the room that she has what she has been saying she has, all along.'\u003ccite>Dr. Patti Jones,\u003cbr>\nAmerican Association for Clinical Chemists\u003c/cite>\u003c/aside>\n\u003cp>Those tests can ostensibly be performed using only a small amount of capillary blood from a patient's finger, instead of the traditional tubes-full taken from a vein.\u003c/p>\n\u003cp>But a \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">Wall Street Journal investigation\u003c/a> characterized those claims as dubious. Later, a Theranos lab in California was found by its regulator to be so deficient as to represent a threat to patients' lives. And this month, regulators suspended the lab’s license and banned Holmes from owning, operating or directing a blood-testing lab for two years. (The company has until early September to appeal the government’s decision, and the suspensions don’t take place for the appeal period.)\u003c/p>\n\u003cp>Both the U.S. Attorneyʼs Office for the Northern District of California and the SEC are \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/04/18/elizabeth-holmes-says-theranos-will-absolutely-survive-video/\" target=\"_blank\">investigating\u003c/a>, and \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/07/19/lawsuit-faulty-theranos-test-results-contributed-to-heart-attack/\" target=\"_blank\">lawsuits aplenty\u003c/a> have been filed.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>Now Theranos is typically described with adjectives ranging from “troubled” to “beleaguered” to “disgraced.” And the company, once valued at $9 billion, is in serious danger of becoming permanent \u003ca href=\"https://www.youtube.com/watch?v=CU94GPs-LQw&ab_channel=texasjoehotdoggy\" target=\"_blank\">shorthand\u003c/a> for greed-driven Silicon Valley hubris.\u003c/p>\n\u003cp>If Holmes has any chance of rebuilding her shattered reputation, and if Theranos is to have any chance of clawing its way back to respectability, it will start in Philadelphia, on Monday. The company has appointed a \u003ca href=\"https://www.theranos.com/news/posts/theranos-announces-leading-medical-and-laboratory-experts-join-scientific-and-medical-advisory-board\" target=\"_blank\">scientific and medical advisory board\u003c/a>, in part to help with \"publication and presentation in scientific journals and at scientific meetings.\" The board includes several former AACC officials, so one would assume Holmes will, as they say, come correct.\u003c/p>\n\u003cp>\u003cstrong>90 Minutes\u003c/strong>\u003c/p>\n\u003cp>Still, whatever she presents may or may not be enough to convert hardcore skeptics. The presentation will last 45 minutes, followed by a 45-minute question-and-answer period, according to AACC members helping with the session. Anywhere from 800 to 1,500 people are expected to be in attendance, and the presentation is open to anyone who registers for the conference, including the media, though no questions from reporters will be taken.\u003c/p>\n\u003cp>Three moderators will ask their own questions as well as questions from the audience, which will be forwarded to the moderators after three other experts come to a consensus as what is most scientifically relevant to the discussion.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The reason why a lot of us are skeptical, and perhaps even disgusted with the whole thing, is that they had a very cavalier attitude about the data that they were producing.' \u003ccite>Dr. David Koch, Grady Memorial Hospital\u003c/cite>\u003c/aside>\n\u003cp>The AACC had extended an invitation to Holmes for several years before she agreed to come speak. The announcement of this year's talk came soon after the Centers for Medicare & Medicaid Services threatened unprecedented sanctions against Theranos, as well as news of the U.S. Attorneyʼs and SEC's investigations.I asked Dr. Patti Jones, who made the decision to invite Holmes this year, if she had any reservations after all that news shook out.\u003c/p>\n\u003cp>“Of course,” said Jones, who is the clinical director of the chemistry and metabolic disease labs at Children’s Medical Center in Dallas. “I reconsidered every step along the way. But the bottom line is, I really think there is an opportunity to really see data here, to see the science. AACCʼs members have the expertise to interpret what she tells us. To be able to look at that data and say, 'Okay,' or 'Not okay.' \"\u003c/p>\n\u003cp>Jones said she had heard from members both opposed and in support of the invitation, and that the opposition was “much more\u003cbr>\nvocal.” She said no one from the AACC leadership will see Holmesʼ presentation in advance.\u003c/p>\n\u003cp>\"Weʼre not endorsing her in any way,\" Jones said. \"Weʼre just providing a room to show us what she has.”\u003c/p>\n\u003cp>I asked her if Holmes had any chance, given recent history, of convincing her colleagues she's legit.\u003c/p>\n\u003cp>“I think she can,” Jones said. “I think if she presents us with scientific data that shows not only that her system -- both the collection and the analysis work -- but how well they work in comparison to other methods, then she could feasibly convince people in the room that she has what she has been saying she has all along.”\u003c/p>\n\u003cfigure id=\"attachment_156559\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/ap_458918420528_wide-7b077d6d2c055cd84422729660306a155c7c88a8-e1469754321977.jpg\">\u003cimg class=\"wp-image-156559 size-large\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/05/ap_458918420528_wide-7b077d6d2c055cd84422729660306a155c7c88a8-1180x664.jpg\" alt=\"Elizabeth Holmes, founder and CEO of Theranos, speaks at the Fortune Global Forum in San Francisco, Nov. 2, 2015.\" width=\"640\" height=\"360\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Elizabeth Holmes speaks at the Fortune Global Forum in San Francisco, Nov. 2, 2015.\u003c/figcaption>\u003c/figure>\n\u003cp>I asked five other experts in laboratory medicine, most of whom will be in attendance Monday, what Holmes has to do to turn things around. Here are edited excerpts from those conversations:\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. David Koch, director of clinical chemistry, Grady Memorial Hospital, Atlanta; former president AACC\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>\"She really needs to talk about how she and Theranos didn't understand clinical laboratories and how best to practice laboratory medicine. She needs to acknowledge that they've made mistakes and that she has, in fact, made a turn from past practices and behaviors. She needs to say one of those mistakes was not sharing data, not having it vetted by professionals in the field, and not coming to meetings such as the AACC Annual Meeting.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Their technology is still a black box, which nobody knows what the details are. Anything that she presents would not be peer-reviewed.\u003ccite>Dr. Eleftherios Diamandis,\u003cbr>\nMount Sinai Hospital, Toronto\u003c/cite>\u003c/aside>\n\u003cp>The reason why a lot of us are skeptical, and perhaps even disgusted with the whole thing, is that they had a very cavalier attitude about the data they were producing, much of which turns out to apparently not be correct.\u003c/p>\n\u003cp>The laboratory has advanced year by year for the whole history of our profession, and if this is one more advancement, fine. But we want to see the data and even evaluate the instrument or device in our laboratories. Or in physicians offices, drugstores, or even in patients' homes.\u003c/p>\n\u003cp>I expect some hard questions, especially if her presentation is a little lacking, weak on substance.\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. Eleftherios Diamandis, division head of clinical biochemistry, Mount Sinai Hospital, Toronto; \u003ca href=\"https://www.ghdonline.org/uploads/Diamandis_-_2015_-%20_Theranos_phenomenon_promises_and_fallacies.pdf\" target=\"_blank\">\"Theranos phenomenon: Promises and fallacies\"\u003c/a>\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>I think the AACC is in a very odd situation, to have a lecture by somebody who was caught manipulating quality assurance, delivering results that some people believe have endangered patients.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Their situation is so unique that they really just need to turn this machine over to a completely independent person.'\u003ccite>Dr. Norman Paradis, Dartmouth College\u003c/cite>\u003c/aside>\n\u003cp>I think her reputation is in big question here. Irrespective of the opinion of people like me, that she shouldn't be invited in the first place, apparently she's going to show up and give the lecture, although I will wait until I see her before I believe that.\u003c/p>\n\u003cp>Their technology is still a black box, which nobody knows what the details are. They still haven't published a single word. Anything that she presents would not be peer-reviewed. It will be something that experts in the field have not seen or had a chance to really criticize.\u003c/p>\n\u003cp>That will be a major hurdle, because she can come and tell us anything she wants. She's got the magic black box. You put in one little drop of blood and you get 1,000 analyses with impossible accuracy,\u003c/p>\n\u003cp>But how am I going to be able to verify that the claims are actually correct? I will only believe it if experts evaluate this technology and find it to be robust.\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. Fred Apple, medical director of clinical laboratories, Hennepin County Medical Center, Minnesota\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>Iʼm hoping we're going to see, ʻHereʼs my technology, hereʼs my process, how we generate data, and here is the R&D weʼve done that proves our technology works.'\u003c/p>\n\u003cp>We want to look at clinical sensitivity, limits of detection, reproducibility, analytical correlation against another assay, turnaround time, stability of samples, as well as how it compares to whatʼs already out there in the literature.\u003c/p>\n\u003cp>Show me some data and a statistically relevant number of patients, so we can do some comparisons.\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. Jerry Yeo, director, clinical chemistry laboratories, Department of Pathology, University of Chicago\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>At this point, Holmes has a very high bar to clear to gain\u003cbr>\ncredibility, given her history of secrecy, lack of peer-reviewed publications and most damaging, the abject failures with compliance with basic requirements of the CLIA (Clinical Labroatory Improvement Amendments) guidelines leading to CMS banning her for 2 years.\u003c/p>\n\u003cp>Even if she suddenly revealed “revolutionary performance data” of her mysterious Edison invention, she still has to explain how that system managed to put out two years of bad data that had to be\u003ca href=\"http://ww2.kqed.org/futureofyou/2016/05/19/theranos-corrects-tens-of-thousands-of-blood-tests/\" target=\"_blank\"> voided, corrected\u003c/a>. Or how the system failed to comply with CLIA\u003cbr>\nregulations.\u003c/p>\n\u003cp>I seriously doubt she can do all that at this AACC venue. If it turns out to be a highly staged presentation with sanitized, prescreened questions, it might produce an opposite effect of loss of credibility to\u003cbr>\nboth Holmes and AACC leadership.\u003c/p>\n\u003cp>\u003cstrong>\u003cem>Dr. Norman Paradis, professor of medicine, Dartmouth; \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/04/25/analysis-why-medical-lab-experts-were-always-skeptical-of-theranos/\" target=\"_blank\">\"Why Medical Lab Experts Were Always Skeptical of Theranos\"\u003c/a>\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>If she puts up real data, there's got to be some credibility associated with that. But this has never really happened before.\u003c/p>\n\u003cp>Big pharma gets in trouble every so often in big ways, but this just doesn't tend to happen in diagnostics: People know how to validate assays. That's not a new thing. You could take your tech and just go to a completely independent university-based group to validate it. You can do it internally, by bringing in what's called a clinical research organization.\u003c/p>\n\u003cp>The FDA has published a voluminous document on good clinical practices. Why it's taken so long is just not clear.\u003c/p>\n\u003cp>So I do think if they show real data, that will be something. If she's managed to get data in a stealth manner, get data that is independent, then that obviously would be a much more reassuring thing.\u003c/p>\n\u003cp>But they still need to get FDA approval. And this won't move them along at all on that front.\u003c/p>\n\u003cp>Their situation is so unique that they really just need to turn this machine over to a completely independent person.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"title": "New York Bans Sex Offenders From Playing Pokémon Go",
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"content": "\u003cp>\u003cstrong>Update Aug. 1, 2016:\u003c/strong> Last week we reported that a children's advocacy group called on Pokémon Go developer Niantic to update the game so it's less dangerous to children who play it. That came in the wake of lots of reports about accidents, injuries, and even death. But other mishaps represent a different sort of danger: players being led to a home for sex offenders, and to a halfway house for drug addicts.\u003c/p>\n\u003caside class=\"alignright\">\n\u003cul>\n\u003cli>\u003ca href=\"http://www.inquisitr.com/3341656/pokemon-go-accident-man-accidentally-urinates-on-kid-while-hunting-pokemons/\">Man accidentally urinates on kid while hunting Pokemons\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.japantimes.co.jp/news/2016/07/25/national/pokemon-go-craze-leads-spate-accidents-traffic-offenses-across-japan/#.V5Y4UCMrLJw\">Pokemon Go’ craze leads to spate of accidents, traffic offenses across Japan\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.deccanchronicle.com/technology/in-other-news/270716/mumbai-records-indias-first-road-accident-driven-by-pokemon-go.html\">Mumbai records India's firs road accident driven by Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.news.com.au/national/victoria/crime/woman-dies-in-hit-and-run-in-west-melbourne/news-story/9020de64d0e500d087b522d08e5d3e29\">Woman out playing Pokemon Go died in hit and run in W. Melbourne\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.huffingtonpost.com.au/2016/07/28/driver-crashes-car-into-school-because-of-pokemon-go/\">Driver Crashes Car Into School Because of Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.ynetnews.com/articles/0,7340,L-4834386,00.html\">Two Israelis injured in Pokemon Go accidents\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.clickondetroit.com/news/man-arrested-after-pokemon-hit-and-go-accident\">Mar arrested after Pokemon hit and GO accident\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.universityherald.com/articles/35660/20160729/pokemon-go-accident-player-crashes-car-school.htm\">Pokemon Go Accident: Player Crashes Car in School\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.cityofrehoboth.com/news/general/pokemon-go-causes-collision-marked-patrol-car\">Pokemon Go causes collision with marked patrol car\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.cartelpress.com/pokemon-go-major-highway-accident-man-stops-middle-highway-catch-pikachu/\" target=\"_blank\">Major Highway Accident After Man Stops In Middle Of Highway To Catch Pikachu!\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.syracuse.com/us-news/index.ssf/2016/07/pokemon_go_shooting_robbery_las_vegas.html\">Pokemon Go player shoots attempted armed robber in Las Vegas\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.foxnews.com/us/2016/07/25/police-drunken-driver-was-playing-pokemon-go-during-crash.html\">Drunken driver was playing Pokemon Go during crash\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://time.com/4420930/pokemon-go-teens-us-border-canada/\">Canadian Teens Cause an International Incident Playing Pokémon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.sacbee.com/news/local/crime/article91273662.html\">‘Pokémon Go’ players robbed at gunpoint in Elk Grove park\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"https://uk.finance.yahoo.com/video/pokemon-accident-insurance-134800372.html\">Pokémon Go accident insurance\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.thesmokinggun.com/documents/stupid/pokemon-go-car-crash-362895\" target=\"_blank\">\"Pokémon Go\" Nearly Claims First Victim\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.stltoday.com/news/local/crime-and-courts/robbers-use-popular-pok-mon-go-game-to-lure-in/article_ca161f27-37b7-57bb-bfa6-a30b0563e3f0.html\">Robbers target players of popular Pokemon Go smartphone game\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.independent.co.uk/life-style/gadgets-and-tech/news/pokemon-go-death-guatemala-shot-danger-safety-dead-a7145836.html\" target=\"_blank\">Teenager shot dead while searching for creatures in Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.philly.com/philly/blogs/real-time/NJ-Pokemon-player-gets-stuck-up-a-tree.html\" target=\"_blank\">Pokemon Go Player Gets Stuck Up a Tree\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.seattletimes.com/seattle-news/crime/seattle-logs-first-pokemon-go-accident/\" target=\"_blank\">Washington State Patrol reports its first 'Pokemon Go' car crash\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.enterprisenews.com/news/20160720/west-bridgewater-accident-caused-by-driver-playing-pokemon-go\" target=\"_blank\">West Bridgewater accident caused by driver playing Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.wtae.com/news/teenager-hit-by-car-blames-pokemon-go/40694020\" target=\"_blank\">Teenager hit by car blames Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.baltimoresun.com/news/maryland/baltimore-county/towson/ph-tt-pokemon-player-robbed-20160721-story.html\">Man assaulted, robbed in Towson while playing Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.timesjournal.com/news/article_36de3989-8fb6-5b68-8327-3113deaf0425.html\">Young Pokemon Go trainer involved in accident\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.baynews9.com/content/news/baynews9/news/article.html/content/news/articles/bn9/2016/7/22/one_arrested_after_1.html\">Man arrested after 150 trespass at Tampa park to play Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.wdaz.com/news/minnesota/4076620-possible-pok%C3%A9mon-go-accident-sends-14-year-old-hospital\" target=\"_blank\">Possible Pokémon Go accident sends 14-year-old to hospital\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://globalnews.ca/news/2833844/pregnant-pokemon-go-player-hit-by-car-given-emergency-c-section-to-save-baby/\" target=\"_blank\">Pregnant Pokemon Go player hit by car\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.wpxi.com/news/mom-says-teenage-daughter-hit-by-car-in-tarentum-after-playing-pokemon-go/399354824\" target=\"_blank\">Mom says teenage daughter hit by car in Tarentum after playing Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.kbtx.com/content/news/AM-police-Pokemon-Go-player-leaves-vehicle-causes-wreck-386558831.html\" target=\"_blank\">A&M police: Pokemon Go player leaves vehicle, causes wreck\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"https://www.youtube.com/watch?v=pFbFk3wuA7w\" target=\"_blank\">Woman stuck in graveyard while playing Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.cbc.ca/news/canada/montreal/pokemon-go-quebec-city-collision-1.3677891\" target=\"_blank\">Playing Pokemon Go while driving, 2 players crash into Quebec City cops\u003c/a>\u003c/li>\n\u003c/ul>\n\u003c/aside>\n\u003cp>The group acted in the wake of many reported accidents and other mishaps, such as the game leading players into a home for sex offenders and a halfway house for drug addicts. (See the original post, below.)\u003c/p>\n\u003cp>Today, New York Gov. Andrew Cuomo brought more attention to the issue by \u003ca href=\"https://www.governor.ny.gov/news/governor-cuomo-directs-department-corrections-and-community-supervision-restrict-sex-offenders\" target=\"_blank\">directing state authorities\u003c/a> to prevent nearly 3,000 registered sex offenders now on parole from playing the game.\u003c/p>\n\u003cp>Cuomo also sent a \u003ca href=\"https://www.governor.ny.gov/sites/governor.ny.gov/files/atoms/files/PokemonLetter.pdf\" target=\"_blank\">lette\u003c/a>r to Niantic asking for help in keeping sexual predators away. In the letter, Cuomo called out a feature \"where, for a small fee, a 'lure' can be purchased to intentionally encourage traffic to a particular location\" as having potential to be abused by predators.\u003c/p>\n\u003cp>Last week, Niantic's consumer marketing director\u003ca href=\"http://hosted.ap.org/dynamic/stories/U/US_POKEMON_GO_WHATS_NEXT?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT\" target=\"_blank\"> told Associated Press\u003c/a> that the company was working on a way to ensure \"everyone is playing safely and doing things in a respectful manner.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Pokémon Go, as surely you know by now, involves using your smartphone to apprehend \u003ca href=\"http://www.vox.com/2016/7/21/12200702/pokemon-go-151-ranked\" target=\"_blank\">animated creatures\u003c/a> superimposed over real surroundings.\u003c/p>\n\u003cp>It's been a smash hit. But as you can see in our updated list of all the accidents and other misfortunes related to the game, safety is a real concern. Whether the totality of the incidents represents a statistically significant level of danger, we can't say. But it should at least serve as a warning to use common sense while playing or when letting your kids go out hunting for Voltorb and friends.\u003c/p>\n\u003cp>\u003cstrong>Original post, July 22, 2016\u003c/strong>\u003c/p>\n\u003cp>Last weekend, I took to the streets to play Pokémon Go with my daughter.\u003c/p>\n\u003cp>She loved it!\u003c/p>\n\u003cp>She's seven.\u003c/p>\n\u003cp>Not that it matters. We can safely say that \u003ca href=\"http://www.vox.com/culture/2016/7/14/12190170/pokemon-go-ios-android-adult-age\" target=\"_blank\">lots of \u003c/a>people no longer in grade school are also Pokémon Going. Last week, around the office, I spied a 20-something meandering her way to the elevator, eyes locked on her phone in a way appropriate for someone tracking an earthbound asteroid, but that's it. I thought -- and I swear this is true: This woman could walk right off a cliff.\u003c/p>\n\u003cp>Later I \u003ca href=\"http://www.cnn.com/2016/07/15/health/pokemon-go-players-fall-down-cliff/\" target=\"_blank\">saw\u003c/a> two people walked right off a cliff.\u003c/p>\n\u003cblockquote>\u003cp>Two men in their early 20s fell an estimated 50 to 90 feet down a cliff in Encinitas, California, on Wednesday afternoon while playing \"Pokémon Go\" ... The men sustained injuries, although the extent is not clear.\u003c/p>\u003c/blockquote>\n\u003cp>Okay, check this out: In Baltimore, Monday, a driver playing Pokémon Go (not a good idea) \u003ca href=\"http://www.abcactionnews.com/news/national/police-body-cam-catches-distracted-pokemon-go-driver-crashing-into-baltimore-police-car\" target=\"_blank\">crashed \u003c/a>into a parked police car (also not a good idea). The event was caught on a police body camera ...\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=KvA9ZgC73vc\u003c/p>\n\u003cp>\"That's what I get for playing this dumbass game,\" the driver, accurately, told the officers.\u003c/p>\n\u003cp>Here's a \u003ca href=\"https://www.reddit.com/r/pokemongo/comments/4rq9bs/pokemon_go_put_me_in_the_er_last_night/?st=iqwtwv61&sh=4384e9f4\" target=\"_blank\">Reddit post\u003c/a> from someone who \"slipped and fell down a ditch\" while playing the game -- which, in case you've been reading a book these past couple of weeks, involves apprehending \u003ca href=\"http://www.vox.com/2016/7/21/12200702/pokemon-go-151-ranked\" target=\"_blank\">animated creatures\u003c/a> superimposed over real surroundings, as seen through the camera of your smartphone.\u003c/p>\n\u003cp>\"Fractured the fifth metatarsal bone in my foot, 6-8 weeks for recovery,\" the Reddit poster almost cheerfully explained. \"I told all the doctors I was walking my dog lol... Watch where you're going, folks!\"\u003c/p>\n\u003cp>That is certainly sound advice, though not the kind you'd think would be necessary on an \u003ca href=\"http://www.usatoday.com/story/tech/gaming/2016/07/12/watch-where-you-pokmon-go-police-warn/86987972/\" target=\"_blank\">official basis\u003c/a>. In fact, police departments around the country are \u003ca href=\"http://www.cnet.com/news/dont-play-pokemon-go-while-driving-a-car-state-says/\" target=\"_blank\">issuing safety warnings\u003c/a> related to the game.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Developers did not consider the game’s physical danger for children and others.'\u003ccite>Children's advocacy group Common Sense Media, in letter to game developer Niantic\u003c/cite>\u003c/aside>\n\u003cp>On Tuesday, a San Francisco children’s advocacy group told KQED's Peter Jon Shuler that playing the game while walking around is the equivalent of distracted driving. (Lots of people are playing while driving, too, as \u003ca href=\"https://www.google.com/search?q=driving+while+playing+pokemon+go+warning\" target=\"_blank\">DMVs around the country have noted\u003c/a>.)\u003c/p>\n\u003cp>Ariel Fox Johnson of Common Sense Media said that aside from all the accidents, mapping errors have led people into potentially harmful or inappropriate locations -- such as a home for sex offenders and a halfway house for drug addicts.\u003c/p>\n\u003cp>Johnson took game developer Niantic to task.\u003c/p>\n\u003cp>\"We think that they need to do more to protect children’s physical safety,\" she said, \"and make sure that parents know and that kids know how they can stay safe and be aware of their surroundings while playing this game.\"\u003c/p>\n\u003cp>Johnson’s group sent a \u003ca href=\"https://www.commonsensemedia.org/sites/default/files/uploads/kids_action/niantic_letter.7.19.16.pdf\" target=\"_blank\">five-page letter\u003c/a> to Niantic outlining its concerns.\u003c/p>\n\u003cp>\"Children, in particular, are more likely to have difficulty identifying when game play may pose a real life threat to their safety,\" the letter said. \"Developers did not consider the game’s physical danger for children and others.\" Among the group's entreaties, it urges Niantic to \"Provide clearer and more conspicuous warnings about the dangers of gameplay in an augmented reality environment, including warnings to parents who consent to gameplay on behalf of their children.\"\u003c/p>\n\u003cp>Niantic did not respond to Shuler's request for comment.\u003c/p>\n\u003cp>Irina Raicu, director of the Internet Ethics program at the Markulla Center for Applied Ethics at Santa Clara University, in California, told Shuler the game raises new issues, as players are going wherever it leads them.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=-sIhx61okqI\u003c/p>\n\u003cp>\"On one hand, people are going out and they’re walking, and in some situations they’re actually interacting with other players,\" she said. \"But then I’m also hearing people just describing what looks like hundreds of zombies walking around just looking down at their screens.\"\u003c/p>\n\u003cp>Raicu, too, believes Niantic needs to do more to proactively protect the safety of children and teens.\u003c/p>\n\u003cp>\"Distracted walking\" \u003ca href=\"http://www.nsc.org/Connect/NSCNewsReleases/Lists/Posts/Post.aspx?List=1f2e4535-5dc3-45d6-b190-9b49c7229931&ID=15&Web=36d1832e-7bc3-4029-98a1-317c5cd5c625\" target=\"_blank\">accident\u003c/a>s have been surging for years, due to mass smartphone adoption. Pokémon Go adds a new vulnerability. The National Safety Council 10 days ago urged \"gamers to consider safety over their scores before a life is lost. No race to \"capture\" a cartoon monster is worth a life.\"\u003c/p>\n\u003cp>So, yeah. For crying out loud, use your head: Be safe.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\"He died pursuing \u003ca href=\"http://bulbapedia.bulbagarden.net/wiki/Voltorb_(Pok%C3%A9mon)\" target=\"_blank\"> Voltorb\u003c/a>\" will not look good on a tombstone.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cstrong>Update Aug. 1, 2016:\u003c/strong> Last week we reported that a children's advocacy group called on Pokémon Go developer Niantic to update the game so it's less dangerous to children who play it. That came in the wake of lots of reports about accidents, injuries, and even death. But other mishaps represent a different sort of danger: players being led to a home for sex offenders, and to a halfway house for drug addicts.\u003c/p>\n\u003caside class=\"alignright\">\n\u003cul>\n\u003cli>\u003ca href=\"http://www.inquisitr.com/3341656/pokemon-go-accident-man-accidentally-urinates-on-kid-while-hunting-pokemons/\">Man accidentally urinates on kid while hunting Pokemons\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.japantimes.co.jp/news/2016/07/25/national/pokemon-go-craze-leads-spate-accidents-traffic-offenses-across-japan/#.V5Y4UCMrLJw\">Pokemon Go’ craze leads to spate of accidents, traffic offenses across Japan\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.deccanchronicle.com/technology/in-other-news/270716/mumbai-records-indias-first-road-accident-driven-by-pokemon-go.html\">Mumbai records India's firs road accident driven by Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.news.com.au/national/victoria/crime/woman-dies-in-hit-and-run-in-west-melbourne/news-story/9020de64d0e500d087b522d08e5d3e29\">Woman out playing Pokemon Go died in hit and run in W. Melbourne\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.huffingtonpost.com.au/2016/07/28/driver-crashes-car-into-school-because-of-pokemon-go/\">Driver Crashes Car Into School Because of Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.ynetnews.com/articles/0,7340,L-4834386,00.html\">Two Israelis injured in Pokemon Go accidents\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.clickondetroit.com/news/man-arrested-after-pokemon-hit-and-go-accident\">Mar arrested after Pokemon hit and GO accident\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.universityherald.com/articles/35660/20160729/pokemon-go-accident-player-crashes-car-school.htm\">Pokemon Go Accident: Player Crashes Car in School\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.cityofrehoboth.com/news/general/pokemon-go-causes-collision-marked-patrol-car\">Pokemon Go causes collision with marked patrol car\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.cartelpress.com/pokemon-go-major-highway-accident-man-stops-middle-highway-catch-pikachu/\" target=\"_blank\">Major Highway Accident After Man Stops In Middle Of Highway To Catch Pikachu!\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.syracuse.com/us-news/index.ssf/2016/07/pokemon_go_shooting_robbery_las_vegas.html\">Pokemon Go player shoots attempted armed robber in Las Vegas\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.foxnews.com/us/2016/07/25/police-drunken-driver-was-playing-pokemon-go-during-crash.html\">Drunken driver was playing Pokemon Go during crash\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://time.com/4420930/pokemon-go-teens-us-border-canada/\">Canadian Teens Cause an International Incident Playing Pokémon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.sacbee.com/news/local/crime/article91273662.html\">‘Pokémon Go’ players robbed at gunpoint in Elk Grove park\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"https://uk.finance.yahoo.com/video/pokemon-accident-insurance-134800372.html\">Pokémon Go accident insurance\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.thesmokinggun.com/documents/stupid/pokemon-go-car-crash-362895\" target=\"_blank\">\"Pokémon Go\" Nearly Claims First Victim\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.stltoday.com/news/local/crime-and-courts/robbers-use-popular-pok-mon-go-game-to-lure-in/article_ca161f27-37b7-57bb-bfa6-a30b0563e3f0.html\">Robbers target players of popular Pokemon Go smartphone game\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.independent.co.uk/life-style/gadgets-and-tech/news/pokemon-go-death-guatemala-shot-danger-safety-dead-a7145836.html\" target=\"_blank\">Teenager shot dead while searching for creatures in Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.philly.com/philly/blogs/real-time/NJ-Pokemon-player-gets-stuck-up-a-tree.html\" target=\"_blank\">Pokemon Go Player Gets Stuck Up a Tree\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.seattletimes.com/seattle-news/crime/seattle-logs-first-pokemon-go-accident/\" target=\"_blank\">Washington State Patrol reports its first 'Pokemon Go' car crash\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.enterprisenews.com/news/20160720/west-bridgewater-accident-caused-by-driver-playing-pokemon-go\" target=\"_blank\">West Bridgewater accident caused by driver playing Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.wtae.com/news/teenager-hit-by-car-blames-pokemon-go/40694020\" target=\"_blank\">Teenager hit by car blames Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.baltimoresun.com/news/maryland/baltimore-county/towson/ph-tt-pokemon-player-robbed-20160721-story.html\">Man assaulted, robbed in Towson while playing Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.timesjournal.com/news/article_36de3989-8fb6-5b68-8327-3113deaf0425.html\">Young Pokemon Go trainer involved in accident\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.baynews9.com/content/news/baynews9/news/article.html/content/news/articles/bn9/2016/7/22/one_arrested_after_1.html\">Man arrested after 150 trespass at Tampa park to play Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.wdaz.com/news/minnesota/4076620-possible-pok%C3%A9mon-go-accident-sends-14-year-old-hospital\" target=\"_blank\">Possible Pokémon Go accident sends 14-year-old to hospital\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://globalnews.ca/news/2833844/pregnant-pokemon-go-player-hit-by-car-given-emergency-c-section-to-save-baby/\" target=\"_blank\">Pregnant Pokemon Go player hit by car\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.wpxi.com/news/mom-says-teenage-daughter-hit-by-car-in-tarentum-after-playing-pokemon-go/399354824\" target=\"_blank\">Mom says teenage daughter hit by car in Tarentum after playing Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.kbtx.com/content/news/AM-police-Pokemon-Go-player-leaves-vehicle-causes-wreck-386558831.html\" target=\"_blank\">A&M police: Pokemon Go player leaves vehicle, causes wreck\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"https://www.youtube.com/watch?v=pFbFk3wuA7w\" target=\"_blank\">Woman stuck in graveyard while playing Pokemon Go\u003c/a>\u003c/li>\n\u003cli>\u003ca href=\"http://www.cbc.ca/news/canada/montreal/pokemon-go-quebec-city-collision-1.3677891\" target=\"_blank\">Playing Pokemon Go while driving, 2 players crash into Quebec City cops\u003c/a>\u003c/li>\n\u003c/ul>\n\u003c/aside>\n\u003cp>The group acted in the wake of many reported accidents and other mishaps, such as the game leading players into a home for sex offenders and a halfway house for drug addicts. (See the original post, below.)\u003c/p>\n\u003cp>Today, New York Gov. Andrew Cuomo brought more attention to the issue by \u003ca href=\"https://www.governor.ny.gov/news/governor-cuomo-directs-department-corrections-and-community-supervision-restrict-sex-offenders\" target=\"_blank\">directing state authorities\u003c/a> to prevent nearly 3,000 registered sex offenders now on parole from playing the game.\u003c/p>\n\u003cp>Cuomo also sent a \u003ca href=\"https://www.governor.ny.gov/sites/governor.ny.gov/files/atoms/files/PokemonLetter.pdf\" target=\"_blank\">lette\u003c/a>r to Niantic asking for help in keeping sexual predators away. In the letter, Cuomo called out a feature \"where, for a small fee, a 'lure' can be purchased to intentionally encourage traffic to a particular location\" as having potential to be abused by predators.\u003c/p>\n\u003cp>Last week, Niantic's consumer marketing director\u003ca href=\"http://hosted.ap.org/dynamic/stories/U/US_POKEMON_GO_WHATS_NEXT?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT\" target=\"_blank\"> told Associated Press\u003c/a> that the company was working on a way to ensure \"everyone is playing safely and doing things in a respectful manner.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Pokémon Go, as surely you know by now, involves using your smartphone to apprehend \u003ca href=\"http://www.vox.com/2016/7/21/12200702/pokemon-go-151-ranked\" target=\"_blank\">animated creatures\u003c/a> superimposed over real surroundings.\u003c/p>\n\u003cp>It's been a smash hit. But as you can see in our updated list of all the accidents and other misfortunes related to the game, safety is a real concern. Whether the totality of the incidents represents a statistically significant level of danger, we can't say. But it should at least serve as a warning to use common sense while playing or when letting your kids go out hunting for Voltorb and friends.\u003c/p>\n\u003cp>\u003cstrong>Original post, July 22, 2016\u003c/strong>\u003c/p>\n\u003cp>Last weekend, I took to the streets to play Pokémon Go with my daughter.\u003c/p>\n\u003cp>She loved it!\u003c/p>\n\u003cp>She's seven.\u003c/p>\n\u003cp>Not that it matters. We can safely say that \u003ca href=\"http://www.vox.com/culture/2016/7/14/12190170/pokemon-go-ios-android-adult-age\" target=\"_blank\">lots of \u003c/a>people no longer in grade school are also Pokémon Going. Last week, around the office, I spied a 20-something meandering her way to the elevator, eyes locked on her phone in a way appropriate for someone tracking an earthbound asteroid, but that's it. I thought -- and I swear this is true: This woman could walk right off a cliff.\u003c/p>\n\u003cp>Later I \u003ca href=\"http://www.cnn.com/2016/07/15/health/pokemon-go-players-fall-down-cliff/\" target=\"_blank\">saw\u003c/a> two people walked right off a cliff.\u003c/p>\n\u003cblockquote>\u003cp>Two men in their early 20s fell an estimated 50 to 90 feet down a cliff in Encinitas, California, on Wednesday afternoon while playing \"Pokémon Go\" ... The men sustained injuries, although the extent is not clear.\u003c/p>\u003c/blockquote>\n\u003cp>Okay, check this out: In Baltimore, Monday, a driver playing Pokémon Go (not a good idea) \u003ca href=\"http://www.abcactionnews.com/news/national/police-body-cam-catches-distracted-pokemon-go-driver-crashing-into-baltimore-police-car\" target=\"_blank\">crashed \u003c/a>into a parked police car (also not a good idea). The event was caught on a police body camera ...\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/KvA9ZgC73vc'\n title='//www.youtube.com/embed/KvA9ZgC73vc'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>\"That's what I get for playing this dumbass game,\" the driver, accurately, told the officers.\u003c/p>\n\u003cp>Here's a \u003ca href=\"https://www.reddit.com/r/pokemongo/comments/4rq9bs/pokemon_go_put_me_in_the_er_last_night/?st=iqwtwv61&sh=4384e9f4\" target=\"_blank\">Reddit post\u003c/a> from someone who \"slipped and fell down a ditch\" while playing the game -- which, in case you've been reading a book these past couple of weeks, involves apprehending \u003ca href=\"http://www.vox.com/2016/7/21/12200702/pokemon-go-151-ranked\" target=\"_blank\">animated creatures\u003c/a> superimposed over real surroundings, as seen through the camera of your smartphone.\u003c/p>\n\u003cp>\"Fractured the fifth metatarsal bone in my foot, 6-8 weeks for recovery,\" the Reddit poster almost cheerfully explained. \"I told all the doctors I was walking my dog lol... Watch where you're going, folks!\"\u003c/p>\n\u003cp>That is certainly sound advice, though not the kind you'd think would be necessary on an \u003ca href=\"http://www.usatoday.com/story/tech/gaming/2016/07/12/watch-where-you-pokmon-go-police-warn/86987972/\" target=\"_blank\">official basis\u003c/a>. In fact, police departments around the country are \u003ca href=\"http://www.cnet.com/news/dont-play-pokemon-go-while-driving-a-car-state-says/\" target=\"_blank\">issuing safety warnings\u003c/a> related to the game.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Developers did not consider the game’s physical danger for children and others.'\u003ccite>Children's advocacy group Common Sense Media, in letter to game developer Niantic\u003c/cite>\u003c/aside>\n\u003cp>On Tuesday, a San Francisco children’s advocacy group told KQED's Peter Jon Shuler that playing the game while walking around is the equivalent of distracted driving. (Lots of people are playing while driving, too, as \u003ca href=\"https://www.google.com/search?q=driving+while+playing+pokemon+go+warning\" target=\"_blank\">DMVs around the country have noted\u003c/a>.)\u003c/p>\n\u003cp>Ariel Fox Johnson of Common Sense Media said that aside from all the accidents, mapping errors have led people into potentially harmful or inappropriate locations -- such as a home for sex offenders and a halfway house for drug addicts.\u003c/p>\n\u003cp>Johnson took game developer Niantic to task.\u003c/p>\n\u003cp>\"We think that they need to do more to protect children’s physical safety,\" she said, \"and make sure that parents know and that kids know how they can stay safe and be aware of their surroundings while playing this game.\"\u003c/p>\n\u003cp>Johnson’s group sent a \u003ca href=\"https://www.commonsensemedia.org/sites/default/files/uploads/kids_action/niantic_letter.7.19.16.pdf\" target=\"_blank\">five-page letter\u003c/a> to Niantic outlining its concerns.\u003c/p>\n\u003cp>\"Children, in particular, are more likely to have difficulty identifying when game play may pose a real life threat to their safety,\" the letter said. \"Developers did not consider the game’s physical danger for children and others.\" Among the group's entreaties, it urges Niantic to \"Provide clearer and more conspicuous warnings about the dangers of gameplay in an augmented reality environment, including warnings to parents who consent to gameplay on behalf of their children.\"\u003c/p>\n\u003cp>Niantic did not respond to Shuler's request for comment.\u003c/p>\n\u003cp>Irina Raicu, director of the Internet Ethics program at the Markulla Center for Applied Ethics at Santa Clara University, in California, told Shuler the game raises new issues, as players are going wherever it leads them.\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/-sIhx61okqI'\n title='//www.youtube.com/embed/-sIhx61okqI'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>\"On one hand, people are going out and they’re walking, and in some situations they’re actually interacting with other players,\" she said. \"But then I’m also hearing people just describing what looks like hundreds of zombies walking around just looking down at their screens.\"\u003c/p>\n\u003cp>Raicu, too, believes Niantic needs to do more to proactively protect the safety of children and teens.\u003c/p>\n\u003cp>\"Distracted walking\" \u003ca href=\"http://www.nsc.org/Connect/NSCNewsReleases/Lists/Posts/Post.aspx?List=1f2e4535-5dc3-45d6-b190-9b49c7229931&ID=15&Web=36d1832e-7bc3-4029-98a1-317c5cd5c625\" target=\"_blank\">accident\u003c/a>s have been surging for years, due to mass smartphone adoption. Pokémon Go adds a new vulnerability. The National Safety Council 10 days ago urged \"gamers to consider safety over their scores before a life is lost. No race to \"capture\" a cartoon monster is worth a life.\"\u003c/p>\n\u003cp>So, yeah. For crying out loud, use your head: Be safe.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"He died pursuing \u003ca href=\"http://bulbapedia.bulbagarden.net/wiki/Voltorb_(Pok%C3%A9mon)\" target=\"_blank\"> Voltorb\u003c/a>\" will not look good on a tombstone.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Do Alternative Treatments for Autism Work?",
"title": "Do Alternative Treatments for Autism Work?",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>A huge majority of parents who have a child with autism have tried some sort of unorthodox treatment to alleviate core symptoms and improve skills like communication or social behavior. A 2015 \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/26366192\" target=\"_blank\">study\u003c/a> found 88 percent of parents (1,084 respondents) had tried some form of complementary or alternative medicine for their child.\u003c/p>\n\u003cp>The treatments range from special diets and supplements — two of the most frequently tried interventions — to music or animal therapy. But parents have little guidance from medical science, because the evidence for alternatives is thin, if it exists at all.\u003c/p>\n\u003cp>That said, there is some evidence suggesting children may benefit from simple treatments like vitamin B12, omega-3 fatty acids, and vitamin D, says UCSF psychiatrist \u003ca href=\"http://profiles.ucsf.edu/robert.hendren\" target=\"_blank\">Dr. Robert Hendren\u003c/a>, who specializes in autism. Hendren's studies of small patient populations have found these supplements produced some positive results in improving social behavior and reducing hyperactivity.\u003c/p>\n\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe id=\"datawrapper-chart-WAKDD\" src=\"//datawrapper.dwcdn.net/WAKDD/3/\" frameborder=\"0\" allowtransparency=\"true\" allowfullscreen=\"allowfullscreen\" webkitallowfullscreen=\"webkitallowfullscreen\" mozallowfullscreen=\"mozallowfullscreen\" oallowfullscreen=\"oallowfullscreen\" msallowfullscreen=\"msallowfullscreen\" width=\"100%\" height=\"680\" scrolling=\"yes\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>“It’s not quite like they’re cured, that they no longer have any evidence of ever having had autism,\" says Dr. Hendren. \"But certainly people do a lot better.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Autism can lead to chronic issues like intestinal inflammation and anxiety. Hendren says supplements can improve a child's overall health. When the immune system is stronger, a child has more resources to handle stress; this, in turn, may reduce tantrums or self-injuries.\u003c/p>\n\u003cp>\u003cstrong>Alternatives Don't Work for Everyone\u003c/strong>\u003c/p>\n\u003cp>I didn’t have to look far to find a family who had experimented with alternative therapies. In fact, a colleague of mine at KQED has a 15-year-old son with autism, named Leo Rosa.\u003c/p>\n\u003cp>When Leo was diagnosed as a toddler, his mother, Shannon Des Roches Rosa, was heartbroken, but after reading fervently about the disorder she learned a cure might be possible through a nontraditional approach.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I would caution people about saying, 'Well, if a little bit is good, then why don't you take a walloping dose and maybe that would be better.' '\u003ccite>Dr. Robert Hendren, UCSF\u003c/cite>\u003c/aside>\n\u003cp>Shannon saw a doctor who specializes in integrative medicine, and says he told her that treating Leo’s disorder was a matter of boosting his immune system and cleansing his body.\u003c/p>\n\u003cp>The doctor tested his blood, allergies, urine, hair and saliva.\u003c/p>\n\u003cp>\"The tests came back and said that he was allergic to everything,\" Shannon exclaims, \"from, like, chocolate to milk to dairy to asparagus — all these really weird things!\"\u003c/p>\n\u003cp>A yeast overgrowth was also identified. So the doctor prescribed numerous supplements and restricted sugar, dairy, gluten and soy in Leo's diet.\u003c/p>\n\u003cp>Shannon created a color-coded Excel chart to keep track of the pills, shots and creams.\u003c/p>\n\u003cp>Then the doctor added \u003ca href=\"http://cornerstoneintegrativecare.com/bioset/bioset-and-autism/\" target=\"_blank\">Bioset\u003c/a> to the mix — a combination of acupressure, plus muscle testing for the immune system. In muscle testing, practitioners often ask patients to extend their arm and resist downward pressure. The practitioner uses the level of resistance to check energy blockages, test the function of organs or uncover nutritional deficiencies.\u003c/p>\n\u003cp>Shannon was not convinced.\u003c/p>\n\u003cp>\"It’s like laying hands on you,\" says Shannon. \"What rational person could ever think that could be useful? It’s like getting your aura read.\"\u003c/p>\n\u003cfigure id=\"attachment_199268\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-199268 size-medium\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/IMG_0532-800x600.jpg\" alt=\"Leo Rosa uses an electronic talker to help him communicate that he wants a snack to his mom, Shannon De Roche Rosa. \" width=\"800\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-960x720.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Leo Rosa uses and electronic talker to communicate that he wants a snack to his mom, Shannon Des Roches Rosa. \u003ccite>(Lesley McClurg/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Shannon says she wasn't seeing any improvement in Leo's condition, but the doctor told her not to worry because the treatments were preparation for the final step, chelation, a detox therapy intended to remove heavy metals from the body.\u003c/p>\n\u003cp>But the Rosas were skeptical about the idea, after digging around on the internet and learning about potential dangers from the process. So they decided to draw the line on alternative treatments.\u003c/p>\n\u003cp>\u003cstrong>What Does Research Say?\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cp>The Food and Drug Administration now \u003ca href=\"http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm229313.htm\" target=\"_blank\">warns\u003c/a> that chelation products sold over the counter can lead to serious mineral deficiencies by stripping the body of crucial elements, which can \"cause serious harm, including dehydration, kidney failure, and death.\"\u003c/p>\n\u003cp>As for dietary changes and nutritional supplements, it's difficult to study them. Trials are often too short to track dietary changes adequately; blind studies are often challenging to conduct; and the research doesn’t offer the reward of a patent.\u003c/p>\n\u003cp>Dr. Hendren has led a handful of studies on popular options, including methyl B12, omega-3 fatty acids, and vitamin D, all of which he may prescribe based on slightly positive data and witnessing patient improvement in his practice. He's also reviewed the \u003ca href=\"http://www.hindawi.com/journals/aurt/2012/870391/\" target=\"_blank\">science\u003c/a> on more than 90 alternative therapies.\u003c/p>\n\u003cp>\"But I would caution people about saying, 'Well, if a little bit is good, then why don't you take a walloping dose and maybe that would be better,'\" Dr. Hendren says.\u003c/p>\n\u003cp>He's continuing to look at alternative treatments, including three current studies on pancreatic digestive enzymes; vasopressin (a neurohormone similar to oxytocin); and sulforaphane (concentrated broccoli extract).\u003c/p>\n\u003cp>The supplement with the most \u003ca href=\"http://link.springer.com/article/10.1007%2Fs10803-011-1418-3\" target=\"_blank\">evidence\u003c/a> to support its use is the natural hormone melatonin.\u003c/p>\n\u003cp>People with autism often struggle with insomnia and melatonin helps patients sleep better, which seems to improve their social interactions, says Dr. Hendren.\u003c/p>\n\u003cp>“Their eyes seemed clearer, their face or interactions seemed brighter,\" he says. \"They looked at me or at others as though they were just fully realizing that those people were there.”\u003c/p>\n\u003cp>\u003cstrong>What About Dietary Changes?\u003c/strong>\u003c/p>\n\u003cp>One of the most popular things parents try is eliminating gluten or casein from their child's diet. Gluten is found in wheat, barley and rye; casein is in dairy products.\u003c/p>\n\u003cp>Dr. Hendren says he doesn’t generally suggest special diets because there is insufficient evidence to demonstrate a clear benefit.\u003c/p>\n\u003cp>\"I would try and encourage people to stay within the range of things that have been studied and are within the range of things that are known and effective,\" says Hendren.\u003cb> \u003ci>\u003cbr>\n\u003c/i>\u003c/b>\u003c/p>\n\u003cp>If parents are interested in going gluten or dairy free, he suggests they work with a nutrition expert.\u003c/p>\n\u003cfigure id=\"attachment_199270\" class=\"wp-caption aligncenter\" style=\"max-width: 735px\">\u003cimg class=\"wp-image-199270 size-full\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/Leo-and-Shannon-e1467927955144.jpg\" alt=\"Leo and Shannon Rosa riding BART together. \" width=\"735\" height=\"575\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/Leo-and-Shannon-e1467927955144.jpg 735w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/Leo-and-Shannon-e1467927955144-400x313.jpg 400w\" sizes=\"(max-width: 735px) 100vw, 735px\">\u003cfigcaption class=\"wp-caption-text\">Leo and Shannon Rosa riding Muni together in San Francisco. \u003ccite>(Susan Etlinger/ KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Restricting Leo Rosa's diet was a costly experiment that turned into a nightmare, says his mother, Shannon.\u003c/p>\n\u003cp>\"He still ate, but he wasn’t happy about it,\" she says. \"He was such a little sad, hollowed-eyed Oliver Twist-looking dude at this time. It was so sad.\"\u003c/p>\n\u003cp>Shannon Des Roches Rosa is no longer experimenting with Leo’s diet. In fact, she says she'd like to go back to the moment Leo was diagnosed and give herself advice.\u003cstrong>\u003cem>\u003cbr>\n\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>“Your son is a great kid,\" she says. \"He’s going to be okay. Don't think about trying to turn him into someone he isn’t.”\u003c/p>\n\u003cp>Shannon says the \u003cem>real\u003c/em> miracle cure is acceptance and love.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Editor's Note: This post has been updated to reflect that autism is a disorder, not a disease.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>A huge majority of parents who have a child with autism have tried some sort of unorthodox treatment to alleviate core symptoms and improve skills like communication or social behavior. A 2015 \u003ca href=\"http://www.ncbi.nlm.nih.gov/pubmed/26366192\" target=\"_blank\">study\u003c/a> found 88 percent of parents (1,084 respondents) had tried some form of complementary or alternative medicine for their child.\u003c/p>\n\u003cp>The treatments range from special diets and supplements — two of the most frequently tried interventions — to music or animal therapy. But parents have little guidance from medical science, because the evidence for alternatives is thin, if it exists at all.\u003c/p>\n\u003cp>That said, there is some evidence suggesting children may benefit from simple treatments like vitamin B12, omega-3 fatty acids, and vitamin D, says UCSF psychiatrist \u003ca href=\"http://profiles.ucsf.edu/robert.hendren\" target=\"_blank\">Dr. Robert Hendren\u003c/a>, who specializes in autism. Hendren's studies of small patient populations have found these supplements produced some positive results in improving social behavior and reducing hyperactivity.\u003c/p>\n\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe id=\"datawrapper-chart-WAKDD\" src=\"//datawrapper.dwcdn.net/WAKDD/3/\" frameborder=\"0\" allowtransparency=\"true\" allowfullscreen=\"allowfullscreen\" webkitallowfullscreen=\"webkitallowfullscreen\" mozallowfullscreen=\"mozallowfullscreen\" oallowfullscreen=\"oallowfullscreen\" msallowfullscreen=\"msallowfullscreen\" width=\"100%\" height=\"680\" scrolling=\"yes\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>“It’s not quite like they’re cured, that they no longer have any evidence of ever having had autism,\" says Dr. Hendren. \"But certainly people do a lot better.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Autism can lead to chronic issues like intestinal inflammation and anxiety. Hendren says supplements can improve a child's overall health. When the immune system is stronger, a child has more resources to handle stress; this, in turn, may reduce tantrums or self-injuries.\u003c/p>\n\u003cp>\u003cstrong>Alternatives Don't Work for Everyone\u003c/strong>\u003c/p>\n\u003cp>I didn’t have to look far to find a family who had experimented with alternative therapies. In fact, a colleague of mine at KQED has a 15-year-old son with autism, named Leo Rosa.\u003c/p>\n\u003cp>When Leo was diagnosed as a toddler, his mother, Shannon Des Roches Rosa, was heartbroken, but after reading fervently about the disorder she learned a cure might be possible through a nontraditional approach.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I would caution people about saying, 'Well, if a little bit is good, then why don't you take a walloping dose and maybe that would be better.' '\u003ccite>Dr. Robert Hendren, UCSF\u003c/cite>\u003c/aside>\n\u003cp>Shannon saw a doctor who specializes in integrative medicine, and says he told her that treating Leo’s disorder was a matter of boosting his immune system and cleansing his body.\u003c/p>\n\u003cp>The doctor tested his blood, allergies, urine, hair and saliva.\u003c/p>\n\u003cp>\"The tests came back and said that he was allergic to everything,\" Shannon exclaims, \"from, like, chocolate to milk to dairy to asparagus — all these really weird things!\"\u003c/p>\n\u003cp>A yeast overgrowth was also identified. So the doctor prescribed numerous supplements and restricted sugar, dairy, gluten and soy in Leo's diet.\u003c/p>\n\u003cp>Shannon created a color-coded Excel chart to keep track of the pills, shots and creams.\u003c/p>\n\u003cp>Then the doctor added \u003ca href=\"http://cornerstoneintegrativecare.com/bioset/bioset-and-autism/\" target=\"_blank\">Bioset\u003c/a> to the mix — a combination of acupressure, plus muscle testing for the immune system. In muscle testing, practitioners often ask patients to extend their arm and resist downward pressure. The practitioner uses the level of resistance to check energy blockages, test the function of organs or uncover nutritional deficiencies.\u003c/p>\n\u003cp>Shannon was not convinced.\u003c/p>\n\u003cp>\"It’s like laying hands on you,\" says Shannon. \"What rational person could ever think that could be useful? It’s like getting your aura read.\"\u003c/p>\n\u003cfigure id=\"attachment_199268\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-199268 size-medium\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/IMG_0532-800x600.jpg\" alt=\"Leo Rosa uses an electronic talker to help him communicate that he wants a snack to his mom, Shannon De Roche Rosa. \" width=\"800\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/IMG_0532-960x720.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Leo Rosa uses and electronic talker to communicate that he wants a snack to his mom, Shannon Des Roches Rosa. \u003ccite>(Lesley McClurg/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Shannon says she wasn't seeing any improvement in Leo's condition, but the doctor told her not to worry because the treatments were preparation for the final step, chelation, a detox therapy intended to remove heavy metals from the body.\u003c/p>\n\u003cp>But the Rosas were skeptical about the idea, after digging around on the internet and learning about potential dangers from the process. So they decided to draw the line on alternative treatments.\u003c/p>\n\u003cp>\u003cstrong>What Does Research Say?\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cp>The Food and Drug Administration now \u003ca href=\"http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm229313.htm\" target=\"_blank\">warns\u003c/a> that chelation products sold over the counter can lead to serious mineral deficiencies by stripping the body of crucial elements, which can \"cause serious harm, including dehydration, kidney failure, and death.\"\u003c/p>\n\u003cp>As for dietary changes and nutritional supplements, it's difficult to study them. Trials are often too short to track dietary changes adequately; blind studies are often challenging to conduct; and the research doesn’t offer the reward of a patent.\u003c/p>\n\u003cp>Dr. Hendren has led a handful of studies on popular options, including methyl B12, omega-3 fatty acids, and vitamin D, all of which he may prescribe based on slightly positive data and witnessing patient improvement in his practice. He's also reviewed the \u003ca href=\"http://www.hindawi.com/journals/aurt/2012/870391/\" target=\"_blank\">science\u003c/a> on more than 90 alternative therapies.\u003c/p>\n\u003cp>\"But I would caution people about saying, 'Well, if a little bit is good, then why don't you take a walloping dose and maybe that would be better,'\" Dr. Hendren says.\u003c/p>\n\u003cp>He's continuing to look at alternative treatments, including three current studies on pancreatic digestive enzymes; vasopressin (a neurohormone similar to oxytocin); and sulforaphane (concentrated broccoli extract).\u003c/p>\n\u003cp>The supplement with the most \u003ca href=\"http://link.springer.com/article/10.1007%2Fs10803-011-1418-3\" target=\"_blank\">evidence\u003c/a> to support its use is the natural hormone melatonin.\u003c/p>\n\u003cp>People with autism often struggle with insomnia and melatonin helps patients sleep better, which seems to improve their social interactions, says Dr. Hendren.\u003c/p>\n\u003cp>“Their eyes seemed clearer, their face or interactions seemed brighter,\" he says. \"They looked at me or at others as though they were just fully realizing that those people were there.”\u003c/p>\n\u003cp>\u003cstrong>What About Dietary Changes?\u003c/strong>\u003c/p>\n\u003cp>One of the most popular things parents try is eliminating gluten or casein from their child's diet. Gluten is found in wheat, barley and rye; casein is in dairy products.\u003c/p>\n\u003cp>Dr. Hendren says he doesn’t generally suggest special diets because there is insufficient evidence to demonstrate a clear benefit.\u003c/p>\n\u003cp>\"I would try and encourage people to stay within the range of things that have been studied and are within the range of things that are known and effective,\" says Hendren.\u003cb> \u003ci>\u003cbr>\n\u003c/i>\u003c/b>\u003c/p>\n\u003cp>If parents are interested in going gluten or dairy free, he suggests they work with a nutrition expert.\u003c/p>\n\u003cfigure id=\"attachment_199270\" class=\"wp-caption aligncenter\" style=\"max-width: 735px\">\u003cimg class=\"wp-image-199270 size-full\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/Leo-and-Shannon-e1467927955144.jpg\" alt=\"Leo and Shannon Rosa riding BART together. \" width=\"735\" height=\"575\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/Leo-and-Shannon-e1467927955144.jpg 735w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/Leo-and-Shannon-e1467927955144-400x313.jpg 400w\" sizes=\"(max-width: 735px) 100vw, 735px\">\u003cfigcaption class=\"wp-caption-text\">Leo and Shannon Rosa riding Muni together in San Francisco. \u003ccite>(Susan Etlinger/ KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Restricting Leo Rosa's diet was a costly experiment that turned into a nightmare, says his mother, Shannon.\u003c/p>\n\u003cp>\"He still ate, but he wasn’t happy about it,\" she says. \"He was such a little sad, hollowed-eyed Oliver Twist-looking dude at this time. It was so sad.\"\u003c/p>\n\u003cp>Shannon Des Roches Rosa is no longer experimenting with Leo’s diet. In fact, she says she'd like to go back to the moment Leo was diagnosed and give herself advice.\u003cstrong>\u003cem>\u003cbr>\n\u003c/em>\u003c/strong>\u003c/p>\n\u003cp>“Your son is a great kid,\" she says. \"He’s going to be okay. Don't think about trying to turn him into someone he isn’t.”\u003c/p>\n\u003cp>Shannon says the \u003cem>real\u003c/em> miracle cure is acceptance and love.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"disqusTitle": "Theranos Lab License Yanked, Elizabeth Holmes Suspended",
"title": "Theranos Lab License Yanked, Elizabeth Holmes Suspended",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>The feds finally lowered the boom on Theranos.\u003c/p>\n\u003cp>The Centers for Medicare & Medicaid Services \u003ca href=\"https://www.scribd.com/document/317817195/CMS-Notification-of-Imposition-of-Sanctions-for-Theranos\" target=\"_blank\">has revoked\u003c/a> the blood-testing company's license to operate its Newark, California lab and barred founder and CEO Elizabeth Holmes from owning, operating or directing a lab for at least two years. CMS also cancelled the Newark lab's approval to receive payments from Medicare and Medicaid. (The news first broke when Theranos released a statement last night \u003ca href=\"https://www.theranos.com/news/posts/theranos-receives-notice-of-sanctions-from-the-centers-for-medicare-medicaid-services\" target=\"_blank\">announcing\u003c/a> the sanctions.)\u003c/p>\n\u003cp>The harsh, even crippling federal sanctions resulted from an inspection of the lab last November. That inspection found numerous deficiencies in the lab's operations, including problems with a blood-clotting test that were potentially life-threatening.\u003c/p>\n\u003cp>CMS had threatened the penalties in April but gave Theranos a chance to respond. In the interim, Theranos voided or corrected \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/05/19/theranos-corrects-tens-of-thousands-of-blood-tests/\" target=\"_blank\">tens of thousands of blood tests\u003c/a>, sending notices to doctors and patients in May.\u003c/p>\n\u003cp>“We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions,\" said Holmes in a statement. \"Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"While we are disappointed by CMS’ decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance.”\u003c/p>\n\u003cp>The tone of \u003ca href=\"https://www.scribd.com/document/317817195/CMS-Notification-of-Imposition-of-Sanctions-for-Theranos\">CMS' 33-page missive\u003c/a> detailing Theranos' failure to mitigate the inadequacies of its lab reads like a school administrator's report to the parents of a kid about to get kicked out of school. Despite five separate submissions containing what Theranos said were proof of corrections, CMS asserted that response was \"not credible.\" Among the problems CMS found with Theranos' filings was a lack of proof of the company's claims that patients were unaffected by tests not meeting quality control standards. CMS also dinged the firm for not finding the cause of quality control failures and for making \"contradictory statements in the submissions (that) call into question the reliability of the information contained in the submission.\"\u003c/p>\n\u003cp>CMS spokesman Aaron Albright said in an email that Theranos could \"begin negotiations\" with the agency. Any agreement would be based on the ability of Theranos to \"remove immediate jeopardy,\" he said, as well as other factors like the severity of the stipulated deficiencies and \"the overall compliance history of the laboratory.\"\u003c/p>\n\u003cp>That does not sound particularly hopeful for Theranos, but it does have two rounds of administrative appeals available to it, which could delay some of the penalties, including the revocation of the Newark lab's license. The company has 60 days before the revocation takes effect, to decide whether to appeal.\u003c/p>\n\u003cp>Theranos has ceased operations at the problematic Newark lab but still operates a testing facility in Arizona. However, that may also be in jeopardy, according to the Journal, which reported Theranos could potentially be barred from operating \u003cem>any\u003c/em> labs. If and when sanctions are imposed, the Journal said, \"Holmes could no longer own shares of any private company operating laboratories. ... . If she remains with the company, Theranos could be forced to shut down the Arizona lab, lawyers say. \"\u003c/p>\n\u003cp>Speaking to the paper, Geoffrey Baird, associate professor in the University of Washington's department of laboratory medicine, said CMS' action is especially harsh.\u003c/p>\n\u003cp>\"I can't think of anything this severe ever happening to a clinical laboratory of this size and scale,\" Baird said. \"I think the company will have to show [Holmes] the door somehow, which might not be possible under the current governance. This is so rare, and essentially unprecedented in a company of this size, that it is hard to know exactly how they will proceed. Personally, I believe she is obligated to step down immediately.”\u003c/p>\n\u003cp>Dr. Norman Paradis, a professor of medicine at Dartmouth, who has consulted for both diagnostic startups and biomed investors, agreed that the magnitude of the penalty could be one-of-a-kind.\u003c/p>\n\u003cp>\"I've never heard of a penalty this severe,\" he said in an email. \"I'm surprised that they could not have avoided this in light of the new involvement of experienced people and renowned attorneys.\"\u003c/p>\n\u003cp>In April, Theranos hired a number of experts for its medical advisory board. High-powered lawyer David Boies represents the company and \u003ca href=\"http://www.nytimes.com/2016/02/03/business/dealbook/david-boiess-dual-roles-at-theranos-set-up-conflict.html\" target=\"_blank\">also serves\u003c/a> on its board.\u003c/p>\n\u003cp>\u003cstrong>Rapid Fall\u003c/strong>\u003c/p>\n\u003cp>It's hard to believe that, at this time last year, Theranos was riding high, having \u003ca href=\"http://fortune.com/2015/10/28/theranos-is-seeking-to-raise-200-million-in-new-funding/\">raised as much as $750 million\u003c/a>, with its latest round of funding valuing the company at around $9 billion. Holmes herself was estimated to be worth $4.5 billion, putting her at the very top of Forbes' \u003ca href=\"http://www.forbes.com/self-made-women/#3ad19b014177\">list\u003c/a> of \"richest self-made women.\" (Besting even Oprah.)\u003c/p>\n\u003cp>Holmes and the company she founded in 2003 had risen to prominence on its claim of having devised groundbreaking technology that required only a finger-prick's worth of blood to test for an array of diseases and conditions, all at an extremely low cost. Holmes frequently used the language of patient self-empowerment to portray her company as a disruptor of the highly profitable diagnostic-testing industry.\u003c/p>\n\u003cp>But in late October, The Wall Street Journal published a pair of \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">investigative articles\u003c/a> citing anonymous former employees who claimed Theranos' technology, which the company dubbed \"Edison,\" did not work as advertised, and that Theranos may have cheated on required proficiency testing. That was followed in January by the partial release of the CMS report, which stated the situation at the Newark lab could cause \"serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”\u003c/p>\n\u003cp>That assessment seemed to buttress the opinion of some scientists who had complained about Theranos' failure to publish evidence that its technology actually worked, which is the \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/05/02/theranos-debacle-shows-differences-between-silicon-valley-and-biomed/\" target=\"_blank\">usual route\u003c/a> to acceptance by the scientific community. And the bad news just kept coming:\u003c/p>\n\u003cul>\n\u003cli>Negative reaction caused Hillary Clinton to \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/03/16/elizabeth-holmes-fundraiser-for-hillary-clinton-at-theranos-raises-eyebrows/\" target=\"_blank\">move a scheduled fundraiser\u003c/a> hosted by Holmes at Theranos headquarters.\u003c/li>\n\u003cli>A published \u003ca href=\"http://www.forbes.com/sites/matthewherper/2016/03/28/theranos-tests-have-flaws-but-may-be-fixable-independent-researchers-say/#4a83e2a9560b\" target=\"_blank\">study said\u003c/a> some of Theranos' test results were significantly off.\u003c/li>\n\u003cli>Federal prosecutors and the SEC launched \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/04/18/elizabeth-holmes-says-theranos-will-absolutely-survive-video/\" target=\"_blank\">investigations\u003c/a> into the company.\u003c/li>\n\u003cli>A flurry of consumer \u003ca href=\"http://arstechnica.com/science/2016/05/walgreens-failed-to-vet-theranos-tests-that-patients-are-now-suing-over/\" target=\"_blank\">lawsuits\u003c/a> were filed.\u003c/li>\n\u003cli>Spokeswoman Brooke Buchanan, who had helmed press relations for John McCain's 2008 presidential campaign, \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/06/24/report-theranos-spokesperson-brooke-buchanan-leaving-company/\" target=\"_blank\">left the firm\u003c/a>.\u003c/li>\n\u003cli>Walgreens \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/06/12/walgreens-shutting-down-theranos-centers-immediately-as-it-ends-partnership/\" target=\"_blank\">shut down\u003c/a> all Theranos centers within its stores.\u003c/li>\n\u003cli>Forbes said Holmes' net worth had \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/06/01/theranos-from-all-angles/\" target=\"_blank\">dropped to zero\u003c/a>.\u003c/li>\n\u003c/ul>\n\u003cp>Coming up next: a scheduled appearance by Holmes at the American Association for Clinical Chemistry's annual meeting, Aug. 1 in Philadelphia. There, Holmes is slated to present \"Reproducibility and correlation data for various tests comparing Theranos’ capillary collection and storage device with traditional venipuncture methods.\" In attendance will be hundreds of laboratory medicine experts and academics, well-qualified to endorse or debunk whatever Holmes presents. From Kimberly Weiseul of \u003ca href=\"http://www.inc.com/kimberly-weisul/theranos-promises-to-share-research-in-august.html\" target=\"_blank\">Inc.\u003c/a> last month:\u003c/p>\n\u003cblockquote>\u003cp>[Holmes] may actually face a somewhat sympathetic audience, says Dr. Patricia Jones, the president of the AACC and the clinical director of chemistry for the Children's Medical Center in Dallas.\u003c/p>\n\u003cp>\"I've talked to all sorts of members of our organization since we announced that she's speaking,\" says Jones. \"There's some real excitement that we're going to get to see what she's doing, and there are some who say it's all smoke and mirrors, and she's not going to show us anything.\"\u003c/p>\n\u003cp>While \"everyone is concerned,\" Jones also says, \"I think for the most part people are willing to give her the benefit of the doubt, even at this point.\"\u003c/p>\u003c/blockquote>\n\u003cp>Well that was last month's \"this point.\" Next month's \"this point\" may be a whole other story.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>[scribd id=317817195 key=key-189WxKQFu0HGaDjm0Ze2 mode=scroll]\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The feds finally lowered the boom on Theranos.\u003c/p>\n\u003cp>The Centers for Medicare & Medicaid Services \u003ca href=\"https://www.scribd.com/document/317817195/CMS-Notification-of-Imposition-of-Sanctions-for-Theranos\" target=\"_blank\">has revoked\u003c/a> the blood-testing company's license to operate its Newark, California lab and barred founder and CEO Elizabeth Holmes from owning, operating or directing a lab for at least two years. CMS also cancelled the Newark lab's approval to receive payments from Medicare and Medicaid. (The news first broke when Theranos released a statement last night \u003ca href=\"https://www.theranos.com/news/posts/theranos-receives-notice-of-sanctions-from-the-centers-for-medicare-medicaid-services\" target=\"_blank\">announcing\u003c/a> the sanctions.)\u003c/p>\n\u003cp>The harsh, even crippling federal sanctions resulted from an inspection of the lab last November. That inspection found numerous deficiencies in the lab's operations, including problems with a blood-clotting test that were potentially life-threatening.\u003c/p>\n\u003cp>CMS had threatened the penalties in April but gave Theranos a chance to respond. In the interim, Theranos voided or corrected \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/05/19/theranos-corrects-tens-of-thousands-of-blood-tests/\" target=\"_blank\">tens of thousands of blood tests\u003c/a>, sending notices to doctors and patients in May.\u003c/p>\n\u003cp>“We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions,\" said Holmes in a statement. \"Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"While we are disappointed by CMS’ decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance.”\u003c/p>\n\u003cp>The tone of \u003ca href=\"https://www.scribd.com/document/317817195/CMS-Notification-of-Imposition-of-Sanctions-for-Theranos\">CMS' 33-page missive\u003c/a> detailing Theranos' failure to mitigate the inadequacies of its lab reads like a school administrator's report to the parents of a kid about to get kicked out of school. Despite five separate submissions containing what Theranos said were proof of corrections, CMS asserted that response was \"not credible.\" Among the problems CMS found with Theranos' filings was a lack of proof of the company's claims that patients were unaffected by tests not meeting quality control standards. CMS also dinged the firm for not finding the cause of quality control failures and for making \"contradictory statements in the submissions (that) call into question the reliability of the information contained in the submission.\"\u003c/p>\n\u003cp>CMS spokesman Aaron Albright said in an email that Theranos could \"begin negotiations\" with the agency. Any agreement would be based on the ability of Theranos to \"remove immediate jeopardy,\" he said, as well as other factors like the severity of the stipulated deficiencies and \"the overall compliance history of the laboratory.\"\u003c/p>\n\u003cp>That does not sound particularly hopeful for Theranos, but it does have two rounds of administrative appeals available to it, which could delay some of the penalties, including the revocation of the Newark lab's license. The company has 60 days before the revocation takes effect, to decide whether to appeal.\u003c/p>\n\u003cp>Theranos has ceased operations at the problematic Newark lab but still operates a testing facility in Arizona. However, that may also be in jeopardy, according to the Journal, which reported Theranos could potentially be barred from operating \u003cem>any\u003c/em> labs. If and when sanctions are imposed, the Journal said, \"Holmes could no longer own shares of any private company operating laboratories. ... . If she remains with the company, Theranos could be forced to shut down the Arizona lab, lawyers say. \"\u003c/p>\n\u003cp>Speaking to the paper, Geoffrey Baird, associate professor in the University of Washington's department of laboratory medicine, said CMS' action is especially harsh.\u003c/p>\n\u003cp>\"I can't think of anything this severe ever happening to a clinical laboratory of this size and scale,\" Baird said. \"I think the company will have to show [Holmes] the door somehow, which might not be possible under the current governance. This is so rare, and essentially unprecedented in a company of this size, that it is hard to know exactly how they will proceed. Personally, I believe she is obligated to step down immediately.”\u003c/p>\n\u003cp>Dr. Norman Paradis, a professor of medicine at Dartmouth, who has consulted for both diagnostic startups and biomed investors, agreed that the magnitude of the penalty could be one-of-a-kind.\u003c/p>\n\u003cp>\"I've never heard of a penalty this severe,\" he said in an email. \"I'm surprised that they could not have avoided this in light of the new involvement of experienced people and renowned attorneys.\"\u003c/p>\n\u003cp>In April, Theranos hired a number of experts for its medical advisory board. High-powered lawyer David Boies represents the company and \u003ca href=\"http://www.nytimes.com/2016/02/03/business/dealbook/david-boiess-dual-roles-at-theranos-set-up-conflict.html\" target=\"_blank\">also serves\u003c/a> on its board.\u003c/p>\n\u003cp>\u003cstrong>Rapid Fall\u003c/strong>\u003c/p>\n\u003cp>It's hard to believe that, at this time last year, Theranos was riding high, having \u003ca href=\"http://fortune.com/2015/10/28/theranos-is-seeking-to-raise-200-million-in-new-funding/\">raised as much as $750 million\u003c/a>, with its latest round of funding valuing the company at around $9 billion. Holmes herself was estimated to be worth $4.5 billion, putting her at the very top of Forbes' \u003ca href=\"http://www.forbes.com/self-made-women/#3ad19b014177\">list\u003c/a> of \"richest self-made women.\" (Besting even Oprah.)\u003c/p>\n\u003cp>Holmes and the company she founded in 2003 had risen to prominence on its claim of having devised groundbreaking technology that required only a finger-prick's worth of blood to test for an array of diseases and conditions, all at an extremely low cost. Holmes frequently used the language of patient self-empowerment to portray her company as a disruptor of the highly profitable diagnostic-testing industry.\u003c/p>\n\u003cp>But in late October, The Wall Street Journal published a pair of \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">investigative articles\u003c/a> citing anonymous former employees who claimed Theranos' technology, which the company dubbed \"Edison,\" did not work as advertised, and that Theranos may have cheated on required proficiency testing. That was followed in January by the partial release of the CMS report, which stated the situation at the Newark lab could cause \"serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”\u003c/p>\n\u003cp>That assessment seemed to buttress the opinion of some scientists who had complained about Theranos' failure to publish evidence that its technology actually worked, which is the \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/05/02/theranos-debacle-shows-differences-between-silicon-valley-and-biomed/\" target=\"_blank\">usual route\u003c/a> to acceptance by the scientific community. And the bad news just kept coming:\u003c/p>\n\u003cul>\n\u003cli>Negative reaction caused Hillary Clinton to \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/03/16/elizabeth-holmes-fundraiser-for-hillary-clinton-at-theranos-raises-eyebrows/\" target=\"_blank\">move a scheduled fundraiser\u003c/a> hosted by Holmes at Theranos headquarters.\u003c/li>\n\u003cli>A published \u003ca href=\"http://www.forbes.com/sites/matthewherper/2016/03/28/theranos-tests-have-flaws-but-may-be-fixable-independent-researchers-say/#4a83e2a9560b\" target=\"_blank\">study said\u003c/a> some of Theranos' test results were significantly off.\u003c/li>\n\u003cli>Federal prosecutors and the SEC launched \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/04/18/elizabeth-holmes-says-theranos-will-absolutely-survive-video/\" target=\"_blank\">investigations\u003c/a> into the company.\u003c/li>\n\u003cli>A flurry of consumer \u003ca href=\"http://arstechnica.com/science/2016/05/walgreens-failed-to-vet-theranos-tests-that-patients-are-now-suing-over/\" target=\"_blank\">lawsuits\u003c/a> were filed.\u003c/li>\n\u003cli>Spokeswoman Brooke Buchanan, who had helmed press relations for John McCain's 2008 presidential campaign, \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/06/24/report-theranos-spokesperson-brooke-buchanan-leaving-company/\" target=\"_blank\">left the firm\u003c/a>.\u003c/li>\n\u003cli>Walgreens \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/06/12/walgreens-shutting-down-theranos-centers-immediately-as-it-ends-partnership/\" target=\"_blank\">shut down\u003c/a> all Theranos centers within its stores.\u003c/li>\n\u003cli>Forbes said Holmes' net worth had \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/06/01/theranos-from-all-angles/\" target=\"_blank\">dropped to zero\u003c/a>.\u003c/li>\n\u003c/ul>\n\u003cp>Coming up next: a scheduled appearance by Holmes at the American Association for Clinical Chemistry's annual meeting, Aug. 1 in Philadelphia. There, Holmes is slated to present \"Reproducibility and correlation data for various tests comparing Theranos’ capillary collection and storage device with traditional venipuncture methods.\" In attendance will be hundreds of laboratory medicine experts and academics, well-qualified to endorse or debunk whatever Holmes presents. From Kimberly Weiseul of \u003ca href=\"http://www.inc.com/kimberly-weisul/theranos-promises-to-share-research-in-august.html\" target=\"_blank\">Inc.\u003c/a> last month:\u003c/p>\n\u003cblockquote>\u003cp>[Holmes] may actually face a somewhat sympathetic audience, says Dr. Patricia Jones, the president of the AACC and the clinical director of chemistry for the Children's Medical Center in Dallas.\u003c/p>\n\u003cp>\"I've talked to all sorts of members of our organization since we announced that she's speaking,\" says Jones. \"There's some real excitement that we're going to get to see what she's doing, and there are some who say it's all smoke and mirrors, and she's not going to show us anything.\"\u003c/p>\n\u003cp>While \"everyone is concerned,\" Jones also says, \"I think for the most part people are willing to give her the benefit of the doubt, even at this point.\"\u003c/p>\u003c/blockquote>\n\u003cp>Well that was last month's \"this point.\" Next month's \"this point\" may be a whole other story.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>San Francisco Chronicle tech columnist Thomas Lee says Theranos's top spokesperson, Brooke Buchanan, is \u003ca href=\"http://www.sfchronicle.com/business/article/Theranos-spokeswoman-Brooke-Buchanan-to-exit-8323546.php\" target=\"_blank\">leaving the company\u003c/a>.\u003c/p>\n\u003cp>Buchanan did not return a call and text to her cellphone, but the Chronicle says she confirmed her departure, without offering further comment.\u003c/p>\n\u003cp>Lee writes ...\u003c/p>\n\u003cblockquote>\u003cp>(I)t was not clear whether [Theranos founder Elizabeth] Holmes was listening to [Buchanan's] advice. For example, Theranos \u003ca href=\"http://www.sfchronicle.com/business/article/Theranos-CEO-Elizabeth-Holmes-takes-big-gamble-at-8003887.php\">recently agreed to present the company’s blood-testing technology at a major medical conference Aug. 1\u003c/a>. Holmes also plans to hold a major press conference after the event with 200 members of the national media, a \u003ca href=\"http://www.sfchronicle.com/business/article/Theranos-CEO-Elizabeth-Holmes-takes-big-gamble-at-8003887.php\">decision that public-relations experts\u003c/a> I spoke to earlier this \u003ca href=\"https://ly.linkedin.com/in/brooke-buchanan-56218021?trk=pub-pbmap\">month\u003c/a> strongly questioned. Why would Holmes agree to speak to reporters when Theranos is facing a criminal investigation from federal prosecutors and inquiries from regulatory agencies?\u003c/p>\u003c/blockquote>\n\u003cp>Buchanan, whose title is vice president of communications, joined Theranos last November, not long after The Wall Street Journal had published two devastating \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">investigative reports\u003c/a> about the company. It was all downhill from there. One of Buchananan's skills listed on \u003ca href=\"https://ly.linkedin.com/in/brooke-buchanan-56218021?trk=pub-pbmap\">Linkedin\u003c/a> is \"crisis communications,\" something that must have come in handy as she was forced to \u003ca href=\"https://www.theranos.com/news/press-releases\">respond\u003c/a> to a drumbeat of bad news about the company, including a failed government inspection, the resulting threat of crippling sanctions, and the severing of its partnership with Walgreens, which unceremoniously announced it would immediately stop offering Theranos services in its stores. We could go into more detail, but suffice it to say the whole saga is dramatic enough to inspire a \u003ca href=\"http://www.vanityfair.com/hollywood/2016/06/jennifer-lawrence-theranos-elizabeth-holmes\" target=\"_blank\">coming movie\u003c/a> with Jennifer Lawrence.\u003c/p>\n\u003cp>Buchanan came to Theranos after \u003ca href=\"https://www.linkedin.com/in/brooke-buchanan-56218021\" target=\"_blank\">stints\u003c/a> at Williams-Sonoma and Walmart. But she is best known as the press secretary for GOP presidential candidate John McCain during his 2008 election campaign against Barack Obama. (\u003ca href=\"https://www.youtube.com/watch?v=J-z6Of25r8k\" target=\"_blank\">Here she i\u003c/a>s in 2007, saying she \"will quit smoking when we win the nomination.\")\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Buchananan's departure would be yet another blow for Theranos, and will open up another job at the company. Among the\u003ca href=\"https://www.theranos.com/careers/corporate\" target=\"_blank\"> positions\u003c/a> listed on the Theranos website: both an executive assistant and a personal assistant for founder and CEO Elizabeth Holmes.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>San Francisco Chronicle tech columnist Thomas Lee says Theranos's top spokesperson, Brooke Buchanan, is \u003ca href=\"http://www.sfchronicle.com/business/article/Theranos-spokeswoman-Brooke-Buchanan-to-exit-8323546.php\" target=\"_blank\">leaving the company\u003c/a>.\u003c/p>\n\u003cp>Buchanan did not return a call and text to her cellphone, but the Chronicle says she confirmed her departure, without offering further comment.\u003c/p>\n\u003cp>Lee writes ...\u003c/p>\n\u003cblockquote>\u003cp>(I)t was not clear whether [Theranos founder Elizabeth] Holmes was listening to [Buchanan's] advice. For example, Theranos \u003ca href=\"http://www.sfchronicle.com/business/article/Theranos-CEO-Elizabeth-Holmes-takes-big-gamble-at-8003887.php\">recently agreed to present the company’s blood-testing technology at a major medical conference Aug. 1\u003c/a>. Holmes also plans to hold a major press conference after the event with 200 members of the national media, a \u003ca href=\"http://www.sfchronicle.com/business/article/Theranos-CEO-Elizabeth-Holmes-takes-big-gamble-at-8003887.php\">decision that public-relations experts\u003c/a> I spoke to earlier this \u003ca href=\"https://ly.linkedin.com/in/brooke-buchanan-56218021?trk=pub-pbmap\">month\u003c/a> strongly questioned. Why would Holmes agree to speak to reporters when Theranos is facing a criminal investigation from federal prosecutors and inquiries from regulatory agencies?\u003c/p>\u003c/blockquote>\n\u003cp>Buchanan, whose title is vice president of communications, joined Theranos last November, not long after The Wall Street Journal had published two devastating \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">investigative reports\u003c/a> about the company. It was all downhill from there. One of Buchananan's skills listed on \u003ca href=\"https://ly.linkedin.com/in/brooke-buchanan-56218021?trk=pub-pbmap\">Linkedin\u003c/a> is \"crisis communications,\" something that must have come in handy as she was forced to \u003ca href=\"https://www.theranos.com/news/press-releases\">respond\u003c/a> to a drumbeat of bad news about the company, including a failed government inspection, the resulting threat of crippling sanctions, and the severing of its partnership with Walgreens, which unceremoniously announced it would immediately stop offering Theranos services in its stores. We could go into more detail, but suffice it to say the whole saga is dramatic enough to inspire a \u003ca href=\"http://www.vanityfair.com/hollywood/2016/06/jennifer-lawrence-theranos-elizabeth-holmes\" target=\"_blank\">coming movie\u003c/a> with Jennifer Lawrence.\u003c/p>\n\u003cp>Buchanan came to Theranos after \u003ca href=\"https://www.linkedin.com/in/brooke-buchanan-56218021\" target=\"_blank\">stints\u003c/a> at Williams-Sonoma and Walmart. But she is best known as the press secretary for GOP presidential candidate John McCain during his 2008 election campaign against Barack Obama. (\u003ca href=\"https://www.youtube.com/watch?v=J-z6Of25r8k\" target=\"_blank\">Here she i\u003c/a>s in 2007, saying she \"will quit smoking when we win the nomination.\")\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Buchananan's departure would be yet another blow for Theranos, and will open up another job at the company. Among the\u003ca href=\"https://www.theranos.com/careers/corporate\" target=\"_blank\"> positions\u003c/a> listed on the Theranos website: both an executive assistant and a personal assistant for founder and CEO Elizabeth Holmes.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Walgreens has had enough of Theranos, the beleaguered blood-testing company.\u003c/p>\n\u003cp>In a \u003ca href=\"http://news.walgreens.com/press-releases/general-news/walgreens-terminates-relationship-with-theranos-will-be-closing-operations-at-all-40-theranos-wellness-centers-in-arizona.htm\" target=\"_blank\">press release\u003c/a> Sunday, the drugstore chain announced \"it will be terminating its relationship and closing operations at all 40 Theranos Wellness Centers at its stores in Arizona, effective immediately.\"\u003c/p>\n\u003cp>“In light of the voiding of a number of test results,\" said Walgreens Senior Vice President Brad Fluegel, in the statement, \"and as the Centers for Medicare and Medicaid Services (CMS) has rejected Theranos’ plan of correction and considers sanctions, we have carefully considered our relationship with Theranos and believe it is in our customers’ best interests to terminate our partnership.”\u003c/p>\n\u003cp>The announcement ends a relationship that began in 2013, with the \u003ca href=\"http://www.businesswire.com/news/home/20131113005513/en/Theranos-Walgreens-Expand-Diagnostic-Lab-Testing-Phoenix\">opening\u003c/a> of Theranos centers at Walgreens in Phoenix and Scottsdale, putting a previously furtive Theranos on the map.\u003c/p>\n\u003cp>Brooke Buchanan, Theranos' vice president of communications (one can think of cushier jobs at this point), issued \u003ca href=\"https://www.theranos.com/news/posts/statement-from-theranos-7\">this statement\u003c/a> in response to Walgreens' announcement:\u003c/p>\n\u003cblockquote>\u003cp>Quality and safety are our top priorities and we are working closely with government officials to ensure that we not only comply with all federal regulations but exceed them. We are disappointed that Walgreens has chosen to terminate our relationship and remain fully committed to our mission to provide patients access to affordable health information and look forward to continuing to serve customers in Arizona and California through our independent retail locations.\u003c/p>\u003c/blockquote>\n\u003cp>The \u003ca href=\"http://www.wsj.com/articles/walgreen-terminates-partnership-with-blood-testing-firm-theranos-1465777062\">Wall Street Journal\u003c/a> is reporting that Walgreens executives decided to sever the relationship with Theranos in January, after the Centers for Medicare & Medicaid Services, which regulates the nation's blood labs, found serious, even life-threatening, deficiencies at Theranos' facility in Newark, Calif. The federal agency later rejected Theranos' submission of proof that it had corrected those problems, threatening to pull the lab's license and ban founder and CEO Elizabeth Holmes from operating a lab for two years.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Theranos has since submitted a further plan of correction and is awaiting a final decision from CMS. Theranos also voided or corrected tens of thousands of blood tests, sending notices to doctors and patients in May.\u003c/p>\n\u003cp>The Journal, citing \"people familiar with the matter,\" said Walgreens waited until now to terminate the Theranos deal out of fear it would be sued.\u003c/p>\n\u003cp>Theranos helped \u003ca href=\"http://www.usatoday.com/story/tech/2015/07/02/new-arizona-law-and-fda-approval-gives-theranos-something-to-celebrate/29634373/\">push through an Arizona law\u003c/a> in 2015 that gave consumers the right to order their own blood tests.\u003c/p>\n\u003cp>Theranos still lists five locations where consumers can get their blood tested, four in Arizona and one in California. The Walgreens web page that used to list the locations of Theranos centers now redirects to the drugstore chain's home page.\u003c/p>\n\u003cp>So what effect will this have on Theranos' business? From \u003ca href=\"http://www.nytimes.com/2016/06/13/business/walgreens-cuts-ties-to-blood-testing-company-theranos.html\">The New York Times\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>While Theranos might struggle along with its own retail units, clearly most of its customers came from the testing centers in Walgreens. Having easily accessible locations in corner drugstores was part of Theranos’s grand plan to upend the laboratory testing business, and it had at one time said it eventually envisioned being in Walgreens drugstores nationwide.\u003c/p>\u003c/blockquote>\n\u003cp>And from \u003ca href=\"http://www.wsj.com/articles/walgreen-terminates-partnership-with-blood-testing-firm-theranos-1465777062\">The Wall Street Journal\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>Without Walgreens, Theranos would no longer be competing with major labs. To regain its access to consumers, it would have to forge a new retail partnership, offer its blood-testing services directly to more doctors’ offices or open its own blood-draw sites, among other options. It already has moved to open a blood-testing center in Arizona. Recently, the company has been exploring a tie-up with another pharmacy or supermarket, according to a person familiar with the matter.\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\n\u003cp>And don't forget, \u003ca href=\"http://www.beckershospitalreview.com/legal-regulatory-issues/third-theranos-lawsuit-brings-walgreens-into-the-mix.html\" target=\"_blank\">several lawsuits\u003c/a> are pending, as well.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Walgreens has had enough of Theranos, the beleaguered blood-testing company.\u003c/p>\n\u003cp>In a \u003ca href=\"http://news.walgreens.com/press-releases/general-news/walgreens-terminates-relationship-with-theranos-will-be-closing-operations-at-all-40-theranos-wellness-centers-in-arizona.htm\" target=\"_blank\">press release\u003c/a> Sunday, the drugstore chain announced \"it will be terminating its relationship and closing operations at all 40 Theranos Wellness Centers at its stores in Arizona, effective immediately.\"\u003c/p>\n\u003cp>“In light of the voiding of a number of test results,\" said Walgreens Senior Vice President Brad Fluegel, in the statement, \"and as the Centers for Medicare and Medicaid Services (CMS) has rejected Theranos’ plan of correction and considers sanctions, we have carefully considered our relationship with Theranos and believe it is in our customers’ best interests to terminate our partnership.”\u003c/p>\n\u003cp>The announcement ends a relationship that began in 2013, with the \u003ca href=\"http://www.businesswire.com/news/home/20131113005513/en/Theranos-Walgreens-Expand-Diagnostic-Lab-Testing-Phoenix\">opening\u003c/a> of Theranos centers at Walgreens in Phoenix and Scottsdale, putting a previously furtive Theranos on the map.\u003c/p>\n\u003cp>Brooke Buchanan, Theranos' vice president of communications (one can think of cushier jobs at this point), issued \u003ca href=\"https://www.theranos.com/news/posts/statement-from-theranos-7\">this statement\u003c/a> in response to Walgreens' announcement:\u003c/p>\n\u003cblockquote>\u003cp>Quality and safety are our top priorities and we are working closely with government officials to ensure that we not only comply with all federal regulations but exceed them. We are disappointed that Walgreens has chosen to terminate our relationship and remain fully committed to our mission to provide patients access to affordable health information and look forward to continuing to serve customers in Arizona and California through our independent retail locations.\u003c/p>\u003c/blockquote>\n\u003cp>The \u003ca href=\"http://www.wsj.com/articles/walgreen-terminates-partnership-with-blood-testing-firm-theranos-1465777062\">Wall Street Journal\u003c/a> is reporting that Walgreens executives decided to sever the relationship with Theranos in January, after the Centers for Medicare & Medicaid Services, which regulates the nation's blood labs, found serious, even life-threatening, deficiencies at Theranos' facility in Newark, Calif. The federal agency later rejected Theranos' submission of proof that it had corrected those problems, threatening to pull the lab's license and ban founder and CEO Elizabeth Holmes from operating a lab for two years.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Theranos has since submitted a further plan of correction and is awaiting a final decision from CMS. Theranos also voided or corrected tens of thousands of blood tests, sending notices to doctors and patients in May.\u003c/p>\n\u003cp>The Journal, citing \"people familiar with the matter,\" said Walgreens waited until now to terminate the Theranos deal out of fear it would be sued.\u003c/p>\n\u003cp>Theranos helped \u003ca href=\"http://www.usatoday.com/story/tech/2015/07/02/new-arizona-law-and-fda-approval-gives-theranos-something-to-celebrate/29634373/\">push through an Arizona law\u003c/a> in 2015 that gave consumers the right to order their own blood tests.\u003c/p>\n\u003cp>Theranos still lists five locations where consumers can get their blood tested, four in Arizona and one in California. The Walgreens web page that used to list the locations of Theranos centers now redirects to the drugstore chain's home page.\u003c/p>\n\u003cp>So what effect will this have on Theranos' business? From \u003ca href=\"http://www.nytimes.com/2016/06/13/business/walgreens-cuts-ties-to-blood-testing-company-theranos.html\">The New York Times\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>While Theranos might struggle along with its own retail units, clearly most of its customers came from the testing centers in Walgreens. Having easily accessible locations in corner drugstores was part of Theranos’s grand plan to upend the laboratory testing business, and it had at one time said it eventually envisioned being in Walgreens drugstores nationwide.\u003c/p>\u003c/blockquote>\n\u003cp>And from \u003ca href=\"http://www.wsj.com/articles/walgreen-terminates-partnership-with-blood-testing-firm-theranos-1465777062\">The Wall Street Journal\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>Without Walgreens, Theranos would no longer be competing with major labs. To regain its access to consumers, it would have to forge a new retail partnership, offer its blood-testing services directly to more doctors’ offices or open its own blood-draw sites, among other options. It already has moved to open a blood-testing center in Arizona. Recently, the company has been exploring a tie-up with another pharmacy or supermarket, according to a person familiar with the matter.\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\n\u003cp>And don't forget, \u003ca href=\"http://www.beckershospitalreview.com/legal-regulatory-issues/third-theranos-lawsuit-brings-walgreens-into-the-mix.html\" target=\"_blank\">several lawsuits\u003c/a> are pending, as well.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"link": "https://www.cityarts.net",
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},
"closealltabs": {
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"order": 1
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"info": "\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />",
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"id": "commonwealth-club",
"title": "Commonwealth Club of California Podcast",
"info": "The Commonwealth Club of California is the nation's oldest and largest public affairs forum. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. This podcast feed is usually updated twice a week and is always un-edited.",
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"source": "Commonwealth Club of California"
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"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Forum-Podcast-Tile-703x703-1.jpg",
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"order": 9
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"meta": {
"site": "radio",
"source": "WNYC"
},
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"id": "fresh-air",
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"apple": "https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=214089682&at=11l79Y&ct=nprdirectory",
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"hidden-brain": {
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"airtime": "SUN 7pm-8pm",
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"source": "NPR"
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"airtime": "SUN 7:30pm-8pm",
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"link": "/radio/program/how-i-built-this",
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"hyphenacion": {
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"tagline": "Where conversation and cultura meet",
"info": "What kind of no sabo word is Hyphenación? For us, it’s about living within a hyphenation. Like being a third-gen Mexican-American from the Texas border now living that Bay Area Chicano life. Like Xorje! Each week we bring together a couple of hyphenated Latinos to talk all about personal life choices: family, careers, relationships, belonging … everything is on the table. ",
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"order": 15
},
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"jerrybrown": {
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"title": "The Political Mind of Jerry Brown",
"tagline": "Lessons from a lifetime in politics",
"info": "The Political Mind of Jerry Brown brings listeners the wisdom of the former Governor, Mayor, and presidential candidate. Scott Shafer interviewed Brown for more than 40 hours, covering the former governor's life and half-century in the political game and Brown has some lessons he'd like to share. ",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/The-Political-Mind-of-Jerry-Brown-Podcast-Tile-703x703-1.jpg",
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"order": 18
},
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},
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"id": "latino-usa",
"title": "Latino USA",
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"info": "Latino USA, the radio journal of news and culture, is the only national, English-language radio program produced from a Latino perspective.",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/latinoUsa.jpg",
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"link": "/radio/program/latino-usa",
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"apple": "https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=79681317&at=11l79Y&ct=nprdirectory",
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"rss": "https://feeds.npr.org/510016/podcast.xml"
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},
"marketplace": {
"id": "marketplace",
"title": "Marketplace",
"info": "Our flagship program, helmed by Kai Ryssdal, examines what the day in money delivered, through stories, conversations, newsworthy numbers and more. Updated Monday through Friday at about 3:30 p.m. PT.",
"airtime": "MON-FRI 4pm-4:30pm, MON-WED 6:30pm-7pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Marketplace-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.marketplace.org/",
"meta": {
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"source": "American Public Media"
},
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},
"masters-of-scale": {
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"title": "Masters of Scale",
"info": "Masters of Scale is an original podcast in which LinkedIn co-founder and Greylock Partner Reid Hoffman sets out to describe and prove theories that explain how great entrepreneurs take their companies from zero to a gazillion in ingenious fashion.",
"airtime": "Every other Wednesday June 12 through October 16 at 8pm (repeats Thursdays at 2am)",
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"rss": "https://rss.art19.com/masters-of-scale"
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},
"mindshift": {
"id": "mindshift",
"title": "MindShift",
"tagline": "A podcast about the future of learning and how we raise our kids",
"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg",
"imageAlt": "KQED MindShift: How We Will Learn",
"officialWebsiteLink": "/mindshift/",
"meta": {
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"order": 12
},
"link": "/podcasts/mindshift",
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"google": "https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5",
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},
"morning-edition": {
"id": "morning-edition",
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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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"onourwatch": {
"id": "onourwatch",
"title": "On Our Watch",
"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?",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/On-Our-Watch-Podcast-Tile-703x703-1.jpg",
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"officialWebsiteLink": "/podcasts/onourwatch",
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"source": "kqed",
"order": 11
},
"link": "/podcasts/onourwatch",
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"google": "https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5ucHIub3JnLzUxMDM2MC9wb2RjYXN0LnhtbD9zYz1nb29nbGVwb2RjYXN0cw",
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},
"on-the-media": {
"id": "on-the-media",
"title": "On The Media",
"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",
"airtime": "SUN 2pm-3pm, MON 12am-1am",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/onTheMedia.png",
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},
"link": "/radio/program/on-the-media",
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"tuneIn": "https://tunein.com/radio/On-the-Media-p69/",
"rss": "http://feeds.wnyc.org/onthemedia"
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},
"pbs-newshour": {
"id": "pbs-newshour",
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"info": "Analysis, background reports and updates from the PBS NewsHour putting today's news in context.",
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"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/PBS-News-Hour-Podcast-Tile-360x360-1.jpg",
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},
"link": "/radio/program/pbs-newshour",
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"apple": "https://itunes.apple.com/us/podcast/pbs-newshour-full-show/id394432287?mt=2",
"tuneIn": "https://tunein.com/radio/PBS-NewsHour---Full-Show-p425698/",
"rss": "https://www.pbs.org/newshour/feeds/rss/podcasts/show"
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},
"perspectives": {
"id": "perspectives",
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"tagline": "KQED's series of daily listener commentaries since 1991",
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"order": 14
},
"link": "/perspectives",
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"planet-money": {
"id": "planet-money",
"title": "Planet Money",
"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.",
"airtime": "SUN 3pm-4pm",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/planetmoney.jpg",
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"source": "npr"
},
"link": "/radio/program/planet-money",
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