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"content": "\u003cp class=\"p1\">This year marks an anniversary that in all probability flew under your radar: The iPSC is 10-years-old.\u003c/p>\n\u003cp class=\"p1\">Great! you say. What's that, some sort of mobile fantasy sports league?\u003c/p>\n\u003cp class=\"p1\">Nooo. Would you guess \u003cem>induced pluripotent stem cells? \u003c/em>They're the product of a revolution in stem cell research that helped stem the controversy that was roiling the entire field.\u003c/p>\n\u003caside class=\"pullquote alignright\">'You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’'\u003ccite>Hank Greely, Stanford University\u003c/cite>\u003c/aside>\n\u003cp>Prior to the development of iPSCs, stem cells were derived primarily from eggs fertilized in clinics \u003ci>in vitro\u003c/i> that were donated for research purposes. To some, such as President George W. Bush, this was tantamount to abortion. In 2001 he \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744932/\" target=\"_blank\">banned federal funding\u003c/a> for research on newly created human embryonic stem cell lines. (President Barack Obama \u003ca href=\"http://www.nytimes.com/2009/03/10/us/politics/10stem.html?_r=0\" target=\"_blank\">lifted that ban\u003c/a> in 2009.)\u003c/p>\n\u003cp class=\"p1\">But iPSCs are normal cells, such as skin or blood cells, which have been tinkered with and reprogrammed to revert to an embryonic-like state. They are then capable of reproducing as stem cells or developing into \u003ci>other\u003c/i> types of human cells (pluripotent), such as liver, heart, pancreatic or nerve cells.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"p1\">So the ability to derive a stem cell without using human embryonic tissue changed the debate about stem cell research ethics.\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>Plenty of Issues\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">But there are still plenty of hot-button topics in the field.\u003c/p>\n\u003cp class=\"p1\">At a recent gathering in Berkeley to celebrate “\u003ca href=\"http://www.cell-symposia-ipscs.com/conference-program/\" target=\"_blank\">10 Years of iPSCs\u003c/a>,” a panel of researchers and leaders kicked off the ethics discussion with comments on how to make sure researchers get proper permissions from human subjects who sign up for clinical trials. Some members of the public might be surprised what a controversial topic “informed consent” can be.\u003c/p>\n\u003cp class=\"p1\">“Everyone wants to avoid a HeLa situation,” said \u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">Christine Mummery,\u003c/a> of the Leiden University Medical Centr\u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">e\u003c/a> in the Netherlands, referring to the oldest and most commonly used cell line in research.\u003c/p>\n\u003cfigure id=\"attachment_262544\" class=\"wp-caption aligncenter\" style=\"max-width: 2400px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\">\u003cimg class=\"size-full wp-image-262544\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\" alt=\"Cultured HeLa cells.\" width=\"2400\" height=\"1999\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1.jpg 2400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-400x333.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-720x600.jpg 720w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-768x640.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1180x983.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1920x1599.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-960x800.jpg 960w\" sizes=\"(max-width: 2400px) 100vw, 2400px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Cultured HeLa cells. \u003ccite>(National Center for Microscopy and Imaging Research)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>HeLa cells were taken, without permission, from Henrietta Lacks, a patient who died of cervical cancer in 1951\u003cstrong>.\u003c/strong> For reasons no one knows, her cells were the first that could grow “immortally” in a lab, without dying after a few days. Her cells helped test Jonas Salk’s polio vaccine, have been used to research AIDS, cancer, toxic substances, gene mapping, stem cells and much more.\u003c/p>\n\u003cp class=\"p1\">Yet the absence of any consent whatsoever caused immense distress to the Lacks family, once they learned of the appropriation of Henrietta's cells.\u003c/p>\n\u003cp class=\"p1\">“The family has been through a lot with HeLa: they didn’t learn of the cells until 20 years after Lacks’s death, when scientists began using her children in research without their knowledge,” \u003ca href=\"http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html\" target=\"_blank\">wrote Rebecca Skloot\u003c/a>, author of \"The Immortal Life of Henrietta Lacks,\" in the New York Times.\u003ci> \"\u003c/i>Later their medical records were released to the press and published without consent.\" (Skloot makes an appearance in a \u003ca href=\"https://www.youtube.com/watch?v=ej0b7GHGYjs\" target=\"_blank\">rap ballad\u003c/a> about the HeLa cells and the Lacks family, written and performed by Oakland 7th and 8th graders on YouTube this month.)\u003c/p>\n\u003cp class=\"p1\">[contextly_sidebar id=\"QHgtAgdTB2KPycAd1HHOyHGUjvFlbxS7\"]Adding insult to injury, researchers in 2013 published the HeLa genome without family consent. (This was not illegal but, in the views of modern medical ethics, extremely dicey.)\u003c/p>\n\u003cp class=\"p1\">Panelist \u003ca href=\"https://law.stanford.edu/directory/henry-t-greely/\" target=\"_blank\">Hank Greely, \u003c/a>a bioethicist at Stanford University, advised the gathered researchers, “You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’\u003c/p>\n\u003cp class=\"p1\">“Not so much for the legal reasons, though those can be significant,\" he said. \"More because of the political fallout that can come to you and your institution. It could also do damage to the whole stem cell enterprise.”\u003c/p>\n\u003cp class=\"p1\">\u003ca href=\"https://daley.med.harvard.edu/\" target=\"_blank\">George Daley\u003c/a>, of the Children’s Hospital Boston and Harvard Medical School, pointed the audience toward recently revised guidelines from the International Society for Stem Cell Research, which offers \u003ca href=\"http://www.isscr.org/home/publications/guide-clintrans/sample-consent-documents\" target=\"_blank\">templates for informed consent forms\u003c/a>. These include language like this:\u003c/p>\n\u003cp class=\"p1\">\u003cem>Donating your _____ cells for this research project is completely voluntary. You have the right to agree or to refuse to provide your _____ cells for this project. The quality of your current or future medical care and your relationship with [name(s) of institution(s)] will NOT change in any way whether you agree or refuse to provide any cells for this research project.\u003c/em>\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>The Issue of Money\u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">Is it ethical to charge patients to participate in a study? No, was the consensus.\u003c/aside>\n\u003cp>“What happens if someone has a drug based on their genes or cells?” the moderator asked.\u003c/p>\n\u003cp class=\"p1\">“That doesn't happen very often,” said Greely. “Most of the time discoveries are the results of work with tens of thousands or more people.”\u003c/p>\n\u003cp class=\"p1\">But, he conceded, every once in a while a patient comes along with unusual cells or genes that can be the basis for a drug. In that case, he said, a researcher must first and foremost follow whatever they said they’d do in the consent forms.\u003c/p>\n\u003cp class=\"p1\">“But even if you didn't promise them anything in the consent process,” he said, “if someone is making lots of money,\u003cspan class=\"Apple-converted-space\"> \u003c/span>I think frankly it’s a good idea to try to return something.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_262548\" class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\">\u003cimg class=\"size-full wp-image-262548\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\" alt=\"These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \" width=\"1024\" height=\"765\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-400x299.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-800x598.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-768x574.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-960x717.jpg 960w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \u003ccite>(Kathrin Plath lab/UCLA via CIRM, NIH)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">He added that this probably doesn't mean offering royalties, which could foster overblown hopes for study participants. Greely likened it to hyping lottery tickets with very bad odds. Instead, he recommends thinking about a person's community, perhaps donating to causes dear to them. Even simple recognition, he says, is important.\u003c/p>\n\u003cp class=\"p1\">“I was involved in the\u003ca href=\"http://www.nature.com/news/deal-done-over-hela-cell-line-1.13511\" target=\"_blank\"> HeLa resolution\u003c/a> a few years ago,” he said,\u003cspan class=\"Apple-converted-space\"> \u003c/span>“and the Lacks descendants are really quite proud and pleased that their mother, grandmother and great grandmother is being remembered ... and that they are consulted on various things.”\u003c/p>\n\u003cp class=\"p1\">Continuing on the topic of money, the moderator asked what panelists thought about the ethics of paying tissue donors?\u003c/p>\n\u003cp class=\"p1\">On this, the panel seemed united, “As long as it’s a reasonable reimbursement for the pain and suffering, I think it’s hard to make a case against it,” offered \u003ca href=\"https://www.mskcc.org/research-areas/labs/members/lorenz-studer\" target=\"_blank\">Lorenz Studer\u003c/a>, of the Memorial Sloan Kettering Cancer Center. If the amount offered is so high that it becomes an “undue inducement,” said Greely, then it’s a problem.\u003c/p>\n\u003cp class=\"p1\">“Many patients are willing to pay for a treatment that’s unproven. What do you think about the ethics of patients paying to be in a trial?” asked the moderator, acknowledging that many people with serious diseases are desperate to be involved in the latest research and that clinical research is extraordinarily expensive to fund.\u003c/p>\n\u003cp class=\"p1\">No, was the general consensus.\u003c/p>\n\u003cp class=\"p1\">That means people in a control group would be paying for a placebo, Greely noted, and someone desperate to be in a trial might not be making a level-headed decision.\u003c/p>\n\u003cp class=\"p1\">“The simple fact that they’re willing to pay corrupts the informed consent process,\" he said. \"And there is a social justice aspect -- if someone can pay for a trial that’s not an equal distribution of good.”\u003c/p>\n\u003cp class=\"p1\">Someone from the audience chimed in with a question that once would have been relegated to the realm of science fiction: “What are the ethics of designing organs?”\u003c/p>\n\u003cp class=\"p2\">“Think about this with a heart,” said \u003ca href=\"http://profiles.ucsf.edu/deepak.srivastava\" target=\"_blank\">Deepak Srivastava\u003c/a> of the Gladstone Institutes and University of California, San Francisco. “It’s just a pump. I think going forward that we should remove the constraints of the design. What we have may or may not be the best thing in evolution.”\u003c/p>\n\u003cp class=\"p2\">But, said Greely, “Many people would be viscerally upset about the idea of changing ourselves, changing our species.\" So scientists should temper their desire to move quickly.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp class=\"p2\">“If there is one thing I've learned from being around biology for 25 years, it’s that biology is not the same as design,\" Greely said. \"Biology is really complicated! Engineers who design something expect it to work. But if you put something [designed] into an organism, the chances that something odd will happen are extremely high. You have to be extremely careful to avoid making things worse.”\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"p1\">This year marks an anniversary that in all probability flew under your radar: The iPSC is 10-years-old.\u003c/p>\n\u003cp class=\"p1\">Great! you say. What's that, some sort of mobile fantasy sports league?\u003c/p>\n\u003cp class=\"p1\">Nooo. Would you guess \u003cem>induced pluripotent stem cells? \u003c/em>They're the product of a revolution in stem cell research that helped stem the controversy that was roiling the entire field.\u003c/p>\n\u003caside class=\"pullquote alignright\">'You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’'\u003ccite>Hank Greely, Stanford University\u003c/cite>\u003c/aside>\n\u003cp>Prior to the development of iPSCs, stem cells were derived primarily from eggs fertilized in clinics \u003ci>in vitro\u003c/i> that were donated for research purposes. To some, such as President George W. Bush, this was tantamount to abortion. In 2001 he \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744932/\" target=\"_blank\">banned federal funding\u003c/a> for research on newly created human embryonic stem cell lines. (President Barack Obama \u003ca href=\"http://www.nytimes.com/2009/03/10/us/politics/10stem.html?_r=0\" target=\"_blank\">lifted that ban\u003c/a> in 2009.)\u003c/p>\n\u003cp class=\"p1\">But iPSCs are normal cells, such as skin or blood cells, which have been tinkered with and reprogrammed to revert to an embryonic-like state. They are then capable of reproducing as stem cells or developing into \u003ci>other\u003c/i> types of human cells (pluripotent), such as liver, heart, pancreatic or nerve cells.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp class=\"p1\">So the ability to derive a stem cell without using human embryonic tissue changed the debate about stem cell research ethics.\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>Plenty of Issues\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">But there are still plenty of hot-button topics in the field.\u003c/p>\n\u003cp class=\"p1\">At a recent gathering in Berkeley to celebrate “\u003ca href=\"http://www.cell-symposia-ipscs.com/conference-program/\" target=\"_blank\">10 Years of iPSCs\u003c/a>,” a panel of researchers and leaders kicked off the ethics discussion with comments on how to make sure researchers get proper permissions from human subjects who sign up for clinical trials. Some members of the public might be surprised what a controversial topic “informed consent” can be.\u003c/p>\n\u003cp class=\"p1\">“Everyone wants to avoid a HeLa situation,” said \u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">Christine Mummery,\u003c/a> of the Leiden University Medical Centr\u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">e\u003c/a> in the Netherlands, referring to the oldest and most commonly used cell line in research.\u003c/p>\n\u003cfigure id=\"attachment_262544\" class=\"wp-caption aligncenter\" style=\"max-width: 2400px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\">\u003cimg class=\"size-full wp-image-262544\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\" alt=\"Cultured HeLa cells.\" width=\"2400\" height=\"1999\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1.jpg 2400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-400x333.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-720x600.jpg 720w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-768x640.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1180x983.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1920x1599.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-960x800.jpg 960w\" sizes=\"(max-width: 2400px) 100vw, 2400px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Cultured HeLa cells. \u003ccite>(National Center for Microscopy and Imaging Research)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>HeLa cells were taken, without permission, from Henrietta Lacks, a patient who died of cervical cancer in 1951\u003cstrong>.\u003c/strong> For reasons no one knows, her cells were the first that could grow “immortally” in a lab, without dying after a few days. Her cells helped test Jonas Salk’s polio vaccine, have been used to research AIDS, cancer, toxic substances, gene mapping, stem cells and much more.\u003c/p>\n\u003cp class=\"p1\">Yet the absence of any consent whatsoever caused immense distress to the Lacks family, once they learned of the appropriation of Henrietta's cells.\u003c/p>\n\u003cp class=\"p1\">“The family has been through a lot with HeLa: they didn’t learn of the cells until 20 years after Lacks’s death, when scientists began using her children in research without their knowledge,” \u003ca href=\"http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html\" target=\"_blank\">wrote Rebecca Skloot\u003c/a>, author of \"The Immortal Life of Henrietta Lacks,\" in the New York Times.\u003ci> \"\u003c/i>Later their medical records were released to the press and published without consent.\" (Skloot makes an appearance in a \u003ca href=\"https://www.youtube.com/watch?v=ej0b7GHGYjs\" target=\"_blank\">rap ballad\u003c/a> about the HeLa cells and the Lacks family, written and performed by Oakland 7th and 8th graders on YouTube this month.)\u003c/p>\n\u003cp class=\"p1\">\u003c/p>\u003cp>\u003c/p>\u003cp>Adding insult to injury, researchers in 2013 published the HeLa genome without family consent. (This was not illegal but, in the views of modern medical ethics, extremely dicey.)\u003c/p>\n\u003cp class=\"p1\">Panelist \u003ca href=\"https://law.stanford.edu/directory/henry-t-greely/\" target=\"_blank\">Hank Greely, \u003c/a>a bioethicist at Stanford University, advised the gathered researchers, “You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’\u003c/p>\n\u003cp class=\"p1\">“Not so much for the legal reasons, though those can be significant,\" he said. \"More because of the political fallout that can come to you and your institution. It could also do damage to the whole stem cell enterprise.”\u003c/p>\n\u003cp class=\"p1\">\u003ca href=\"https://daley.med.harvard.edu/\" target=\"_blank\">George Daley\u003c/a>, of the Children’s Hospital Boston and Harvard Medical School, pointed the audience toward recently revised guidelines from the International Society for Stem Cell Research, which offers \u003ca href=\"http://www.isscr.org/home/publications/guide-clintrans/sample-consent-documents\" target=\"_blank\">templates for informed consent forms\u003c/a>. These include language like this:\u003c/p>\n\u003cp class=\"p1\">\u003cem>Donating your _____ cells for this research project is completely voluntary. You have the right to agree or to refuse to provide your _____ cells for this project. The quality of your current or future medical care and your relationship with [name(s) of institution(s)] will NOT change in any way whether you agree or refuse to provide any cells for this research project.\u003c/em>\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>The Issue of Money\u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">Is it ethical to charge patients to participate in a study? No, was the consensus.\u003c/aside>\n\u003cp>“What happens if someone has a drug based on their genes or cells?” the moderator asked.\u003c/p>\n\u003cp class=\"p1\">“That doesn't happen very often,” said Greely. “Most of the time discoveries are the results of work with tens of thousands or more people.”\u003c/p>\n\u003cp class=\"p1\">But, he conceded, every once in a while a patient comes along with unusual cells or genes that can be the basis for a drug. In that case, he said, a researcher must first and foremost follow whatever they said they’d do in the consent forms.\u003c/p>\n\u003cp class=\"p1\">“But even if you didn't promise them anything in the consent process,” he said, “if someone is making lots of money,\u003cspan class=\"Apple-converted-space\"> \u003c/span>I think frankly it’s a good idea to try to return something.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_262548\" class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\">\u003cimg class=\"size-full wp-image-262548\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\" alt=\"These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \" width=\"1024\" height=\"765\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-400x299.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-800x598.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-768x574.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-960x717.jpg 960w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \u003ccite>(Kathrin Plath lab/UCLA via CIRM, NIH)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">He added that this probably doesn't mean offering royalties, which could foster overblown hopes for study participants. Greely likened it to hyping lottery tickets with very bad odds. Instead, he recommends thinking about a person's community, perhaps donating to causes dear to them. Even simple recognition, he says, is important.\u003c/p>\n\u003cp class=\"p1\">“I was involved in the\u003ca href=\"http://www.nature.com/news/deal-done-over-hela-cell-line-1.13511\" target=\"_blank\"> HeLa resolution\u003c/a> a few years ago,” he said,\u003cspan class=\"Apple-converted-space\"> \u003c/span>“and the Lacks descendants are really quite proud and pleased that their mother, grandmother and great grandmother is being remembered ... and that they are consulted on various things.”\u003c/p>\n\u003cp class=\"p1\">Continuing on the topic of money, the moderator asked what panelists thought about the ethics of paying tissue donors?\u003c/p>\n\u003cp class=\"p1\">On this, the panel seemed united, “As long as it’s a reasonable reimbursement for the pain and suffering, I think it’s hard to make a case against it,” offered \u003ca href=\"https://www.mskcc.org/research-areas/labs/members/lorenz-studer\" target=\"_blank\">Lorenz Studer\u003c/a>, of the Memorial Sloan Kettering Cancer Center. If the amount offered is so high that it becomes an “undue inducement,” said Greely, then it’s a problem.\u003c/p>\n\u003cp class=\"p1\">“Many patients are willing to pay for a treatment that’s unproven. What do you think about the ethics of patients paying to be in a trial?” asked the moderator, acknowledging that many people with serious diseases are desperate to be involved in the latest research and that clinical research is extraordinarily expensive to fund.\u003c/p>\n\u003cp class=\"p1\">No, was the general consensus.\u003c/p>\n\u003cp class=\"p1\">That means people in a control group would be paying for a placebo, Greely noted, and someone desperate to be in a trial might not be making a level-headed decision.\u003c/p>\n\u003cp class=\"p1\">“The simple fact that they’re willing to pay corrupts the informed consent process,\" he said. \"And there is a social justice aspect -- if someone can pay for a trial that’s not an equal distribution of good.”\u003c/p>\n\u003cp class=\"p1\">Someone from the audience chimed in with a question that once would have been relegated to the realm of science fiction: “What are the ethics of designing organs?”\u003c/p>\n\u003cp class=\"p2\">“Think about this with a heart,” said \u003ca href=\"http://profiles.ucsf.edu/deepak.srivastava\" target=\"_blank\">Deepak Srivastava\u003c/a> of the Gladstone Institutes and University of California, San Francisco. “It’s just a pump. I think going forward that we should remove the constraints of the design. What we have may or may not be the best thing in evolution.”\u003c/p>\n\u003cp class=\"p2\">But, said Greely, “Many people would be viscerally upset about the idea of changing ourselves, changing our species.\" So scientists should temper their desire to move quickly.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp class=\"p2\">“If there is one thing I've learned from being around biology for 25 years, it’s that biology is not the same as design,\" Greely said. \"Biology is really complicated! Engineers who design something expect it to work. But if you put something [designed] into an organism, the chances that something odd will happen are extremely high. You have to be extremely careful to avoid making things worse.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Cardiac Patient Aided by Bystanders Who Were Alerted by App",
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"content": "\u003cp>If your heart is going to stop, right outside a hospital is not a bad place for it.\u003c/p>\n\u003cp>And if 41 people within a 330-yard radius have a \u003ca href=\"http://www.pulsepoint.org/\" target=\"_blank\">cellphone app\u003c/a> alerting them to your distress, so much the better.\u003c/p>\n\u003cp>That's what happened in Seattle last week when Stephen DeMont collapsed at a bus stop in front of University of Washington Medical Center.\u003c/p>\n\u003cp>While a medical student rushed over and began chest compressions, a cardiac nurse just getting off her shift was alerted by her phone, sprinted outside and assisted until paramedics arrived.\u003c/p>\n\u003cp>Five days later, DeMont, 60, is walking, smiling and talking about how the PulsePoint app helped save his life.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Seattle officials say the rescue shows the potential a free download has for connecting CPR-trained citizens with patients who urgently need their help. It's being used in 2,000 U.S. cities in 28 states.\u003c/p>\n\u003cp>\"I put it on my phone yesterday,\" said DeMont's wife, Debi Quirk, a former registered nurse. \"He would not be here as we see him today.\"\u003c/p>\n\u003cp>Seattle officials hope DeMont's story will help persuade thousands more people to sign up for notifications; so far, about 4,000 people in Seattle have downloaded PulsePoint since the city adopted it earlier this year with financial support from an employee charitable fund at Boeing. The goal is to have 15,000 using it.\u003c/p>\n\u003cp>The app, which works through a city's 911 system, was developed by Richard Price, the former chief of the San Ramon Valley Fire Protection District in Northern California. When a call comes in, operators alert people within a certain radius that CPR assistance is needed, along with the location of the nearest portable defibrillator.\u003c/p>\n\u003cp>About 900,000 people around the country have downloaded and carry the app, and 34,000 people have been activated to respond, Price said, adding that alerts have been issued in 13,000 cardiac events.\u003c/p>\n\u003cp>He came up with the idea in 2009. Price told KQED in a 2011 \u003ca href=\"http://ww2.kqed.org/news/wp-content/uploads/sites/10/2011/01/cardiaciphoneapp.mp3\" target=\"_blank\">interview\u003c/a> that he'd been eating lunch in a deli with three colleagues, when \"we heard a siren, and we were wondering where the guys were going. They parked right in front of the deli we were eating at.\"\u003c/p>\n\u003cp>As it turned out, an unconscious patient close by was in need of help.\u003c/p>\n\u003cp>\"Here's the fire chief in uniform, a defibrillator in my car. One of my [lunch companions] is a paramedic, and right next door to us, someone was in great need and we were completely unaware of it.\u003c/p>\n\u003cp>\"We sat the the rest of the afternoon and diagrammed on deli napkins how we could make sure that never happened again.\"\u003c/p>\n\u003cp>In that 2011 interview, Price said survival rates for those in cardiac arrest are very high when CPR is used within the first 2-3 minutes after cardiac arrest.\u003c/p>\n\u003cp>It's not clear how many lives have been saved thanks to the app. Patient confidentiality laws often prevent hospitals from disclosing a patient's outcome.\u003c/p>\n\u003cp>Madeline Dahl, a 23-year-old cardiac nurse at the University of Washington Medical Center, said she downloaded the app about a month ago after reading a news story that mentioned it. Last Friday morning was the first time she'd ever received an alert. She bolted down a couple flights of stairs and ran outside into the rain, where she found 27-year-old medical student Zach Forcade performing chest compressions.\u003c/p>\n\u003cp>Forcade had been on his way into the hospital for a lecture when he saw DeMont, who was just getting off his bicycle, slump over.\u003c/p>\n\u003cp>\"I hadn't responded to a cardiac arrest before,\" Forcade said. \"I thought, 'Did he just fall?' ... Even being in the medical field, I thought, 'Oh, man, who's going to step up?'\"\u003c/p>\n\u003cp>He told another passerby to call 911, which triggered an alert sent out to 41 responders nearby. It was reassuring when Dahl arrived to provide any needed backup, help check for a pulse and otherwise make sure Forcade was responding correctly, he said.\u003c/p>\n\u003cp>For DeMont, it was about more than just being lucky. A contract technical writer at Expedia, he said he has a love-hate relationship with technology — \"You see all these things about people falling off cliffs texting, people are so disconnected\" — but the response from Forcade, Dahl and the use of PulsePoint reaffirmed his belief in its power to make a positive difference.\u003c/p>\n\u003cp>\"There's hope,\" DeMont said.\u003c/p>\n\u003cp>He's due to have a defibrillator implanted on Thursday. Now he just has to figure out how to pay the $100,000 tab without insurance.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>For that, his family has turned to a program with a different app: GoFundMe.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>If your heart is going to stop, right outside a hospital is not a bad place for it.\u003c/p>\n\u003cp>And if 41 people within a 330-yard radius have a \u003ca href=\"http://www.pulsepoint.org/\" target=\"_blank\">cellphone app\u003c/a> alerting them to your distress, so much the better.\u003c/p>\n\u003cp>That's what happened in Seattle last week when Stephen DeMont collapsed at a bus stop in front of University of Washington Medical Center.\u003c/p>\n\u003cp>While a medical student rushed over and began chest compressions, a cardiac nurse just getting off her shift was alerted by her phone, sprinted outside and assisted until paramedics arrived.\u003c/p>\n\u003cp>Five days later, DeMont, 60, is walking, smiling and talking about how the PulsePoint app helped save his life.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Seattle officials say the rescue shows the potential a free download has for connecting CPR-trained citizens with patients who urgently need their help. It's being used in 2,000 U.S. cities in 28 states.\u003c/p>\n\u003cp>\"I put it on my phone yesterday,\" said DeMont's wife, Debi Quirk, a former registered nurse. \"He would not be here as we see him today.\"\u003c/p>\n\u003cp>Seattle officials hope DeMont's story will help persuade thousands more people to sign up for notifications; so far, about 4,000 people in Seattle have downloaded PulsePoint since the city adopted it earlier this year with financial support from an employee charitable fund at Boeing. The goal is to have 15,000 using it.\u003c/p>\n\u003cp>The app, which works through a city's 911 system, was developed by Richard Price, the former chief of the San Ramon Valley Fire Protection District in Northern California. When a call comes in, operators alert people within a certain radius that CPR assistance is needed, along with the location of the nearest portable defibrillator.\u003c/p>\n\u003cp>About 900,000 people around the country have downloaded and carry the app, and 34,000 people have been activated to respond, Price said, adding that alerts have been issued in 13,000 cardiac events.\u003c/p>\n\u003cp>He came up with the idea in 2009. Price told KQED in a 2011 \u003ca href=\"http://ww2.kqed.org/news/wp-content/uploads/sites/10/2011/01/cardiaciphoneapp.mp3\" target=\"_blank\">interview\u003c/a> that he'd been eating lunch in a deli with three colleagues, when \"we heard a siren, and we were wondering where the guys were going. They parked right in front of the deli we were eating at.\"\u003c/p>\n\u003cp>As it turned out, an unconscious patient close by was in need of help.\u003c/p>\n\u003cp>\"Here's the fire chief in uniform, a defibrillator in my car. One of my [lunch companions] is a paramedic, and right next door to us, someone was in great need and we were completely unaware of it.\u003c/p>\n\u003cp>\"We sat the the rest of the afternoon and diagrammed on deli napkins how we could make sure that never happened again.\"\u003c/p>\n\u003cp>In that 2011 interview, Price said survival rates for those in cardiac arrest are very high when CPR is used within the first 2-3 minutes after cardiac arrest.\u003c/p>\n\u003cp>It's not clear how many lives have been saved thanks to the app. Patient confidentiality laws often prevent hospitals from disclosing a patient's outcome.\u003c/p>\n\u003cp>Madeline Dahl, a 23-year-old cardiac nurse at the University of Washington Medical Center, said she downloaded the app about a month ago after reading a news story that mentioned it. Last Friday morning was the first time she'd ever received an alert. She bolted down a couple flights of stairs and ran outside into the rain, where she found 27-year-old medical student Zach Forcade performing chest compressions.\u003c/p>\n\u003cp>Forcade had been on his way into the hospital for a lecture when he saw DeMont, who was just getting off his bicycle, slump over.\u003c/p>\n\u003cp>\"I hadn't responded to a cardiac arrest before,\" Forcade said. \"I thought, 'Did he just fall?' ... Even being in the medical field, I thought, 'Oh, man, who's going to step up?'\"\u003c/p>\n\u003cp>He told another passerby to call 911, which triggered an alert sent out to 41 responders nearby. It was reassuring when Dahl arrived to provide any needed backup, help check for a pulse and otherwise make sure Forcade was responding correctly, he said.\u003c/p>\n\u003cp>For DeMont, it was about more than just being lucky. A contract technical writer at Expedia, he said he has a love-hate relationship with technology — \"You see all these things about people falling off cliffs texting, people are so disconnected\" — but the response from Forcade, Dahl and the use of PulsePoint reaffirmed his belief in its power to make a positive difference.\u003c/p>\n\u003cp>\"There's hope,\" DeMont said.\u003c/p>\n\u003cp>He's due to have a defibrillator implanted on Thursday. Now he just has to figure out how to pay the $100,000 tab without insurance.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>For that, his family has turned to a program with a different app: GoFundMe.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Segway Inventor Says He'll Make Improvements to Advanced Wheelchair",
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"content": "\u003cp>Thirteen years ago, just as the United States began what was to become its longest war, a futuristic wheelchair hit the market.\u003c/p>\n\u003cp>The \u003ca href=\"http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm082381.htm\">iBOT allowed\u003c/a> paralyzed people, including many veterans of Iraq and Afghanistan, to stand up by rising to eye level. It also did something no wheelchair ever had: climb stairs.\u003c/p>\n\u003cp>But even though users loved it, the iBOT \u003ca href=\"http://hereandnow.legacy.wbur.org/2011/12/26/ibot-johnson-phase\">went out of production in 2009\u003c/a> when Johnson & Johnson discontinued it.\u003c/p>\n\u003cp>\"I was very disappointed,\" says disabled veteran Gary Linfoot, a former Army helicopter pilot. \"I knew my tent was up, I had one, but I knew there were other people out there who could use this device, this technology and it would not be available to them.\"\u003c/p>\n\u003cp>Now, however, the iBOT could be coming back.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Toyota announced this year that it's bankrolling a reboot of the iBOT, which the machine's inventor, Dean Kamen, says will allow him to make some improvements.\u003c/p>\n\u003cp>\"With advances in computers, the advances in solid-state gyros and electronics ... we can take a hundred pounds out of it. We can take a lot of cost out of it. We can improve it,\" he told NPR.\u003c/p>\n\u003cp>Kamen is widely known as the inventor of the Segway, which was actually a byproduct from development of the iBOT. The first iteration of the wheelchair had a $25,000 price tag — too high even for the department of Veterans Affairs in most cases. Most veterans who had iBOTs got them from veterans charities, and all but a few are now sitting in the garage, with nowhere to service them.\u003c/p>\n\u003cp>Today, Toyota is interested in some of the machine's balancing technology, possibly to be used in the company's \u003ca href=\"http://newsroom.toyota.co.jp/en/detail/10171645/\">robotic helpers for the aging\u003c/a>. And that could mean new parts and new life for existing iBOTs as well as a new version of the chair.\u003c/p>\n\u003cp>It also helps that the Food and Drug Administration reclassified the iBOT from its \u003ca href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/\">strictest regulatory category\u003c/a> for medical devices Class 3, alongside replacement heart valves, to Class 2, alongside condoms. That will also lower the expense of the machine, and Kamen says testimony by veterans using the machine was one key to persuading the FDA to make that switch.\u003c/p>\n\u003cp>For people like Linfoot, it was a game changer.\u003c/p>\n\u003cp>He lost the use of his legs after a 2008 helicopter crash south of Baghdad. \"I wasn't shot down or anything,\" he says. \"It was just a mechanical malfunction. Probably a $25 part failed and we lost all power to the rotor system.\"\u003c/p>\n\u003cp>Linfoot and his co-pilot survived, but the impact left Linfoot paralyzed below the chest. The iBOT allows him to navigate street curbs and the hills around his home north of Nashville, Tenn.\u003c/p>\n\u003cp>\"It goes beyond just reaching in the cabinet to get the cookies that my wife might hide up there, or the good booze,\" he says, sitting on top of what looks like an easy chair balanced on a pair of unicycles.\u003c/p>\n\u003cp>Plus the ability to stand up is huge.\u003c/p>\n\u003cp>\"When you go out to a social setting, back up at 6 feet, talking to somebody eye to eye, you get this sense of dignity,\" he says. \"The disability just kind of fades into the background.\"\u003c/p>\n\u003cp>Kamen said he hopes stories like Linfoot's will help persuade his new backers to return the iBOT to production and make it available to a wider group of people.\u003c/p>\n\u003cp>\"The reason some of these veterans need these things is they've literally given up pieces of their body for this country,\" he says. \"The least we can do is give them back the best technology that is currently available.\"\u003c/p>\n\u003cp>Several other companies have designed chairs that can get people with spinal injuries \u003ca href=\"http://levousa.com/\">up to eye level\u003c/a> and \u003ca href=\"http://www.tracfab.com\">even off-road\u003c/a>. But doctors at the department of Veterans Affairs are more excited about inventions that can actually get veterans walking again. The health effects of immobility for paralyzed people are just like the effects of sitting down all the time for able-bodied people, they say.\u003c/p>\n\u003cp>\"Sitting is the new smoking,\" says Dr. Will Bauman, director of the \u003ca href=\"http://www.rehab.research.va.gov/cent/bronx.html\">Center of Excellence on the Medical Consequences of Spinal Cord Injury\u003c/a> at the James J. Peters VA Medical Center in the Bronx. He and Dr. Ann Spungen, associate director of the center, have studied the secondary health effects of paralysis.\u003c/p>\n\u003cp>\"Just like you and I, if we sat around all day, we already know that's the worst thing can do to ourselves,\" says Spungen.\u003c/p>\n\u003cp>Immobilized people are prone to weakened bones, higher blood pressure, urinary tract infections and constipation that can be debilitating. At the Bronx VA, veterans have been using an exoskeleton called a ReWalk to get them moving again. It's like a backpack with robotic leg braces that allows patients to walk using crutches.\u003c/p>\n\u003cp>So far, devices \u003ca href=\"http://eksobionics.com/\">like these\u003c/a> aren't that useful outside a safe, flat surface. Regular therapy with these machines can help reduce pain and promote better sleep, Spungen says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>With as little as four to six hours of walking a week, about half of patients lost more than a kilogram of body fat, says Spungen. For many problems, she says, \"the best cure is to take a walk.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+Reboot+For+Wheelchair+That+Can+Stand+Up+And+Climb+Stairs&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Thirteen years ago, just as the United States began what was to become its longest war, a futuristic wheelchair hit the market.\u003c/p>\n\u003cp>The \u003ca href=\"http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm082381.htm\">iBOT allowed\u003c/a> paralyzed people, including many veterans of Iraq and Afghanistan, to stand up by rising to eye level. It also did something no wheelchair ever had: climb stairs.\u003c/p>\n\u003cp>But even though users loved it, the iBOT \u003ca href=\"http://hereandnow.legacy.wbur.org/2011/12/26/ibot-johnson-phase\">went out of production in 2009\u003c/a> when Johnson & Johnson discontinued it.\u003c/p>\n\u003cp>\"I was very disappointed,\" says disabled veteran Gary Linfoot, a former Army helicopter pilot. \"I knew my tent was up, I had one, but I knew there were other people out there who could use this device, this technology and it would not be available to them.\"\u003c/p>\n\u003cp>Now, however, the iBOT could be coming back.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Toyota announced this year that it's bankrolling a reboot of the iBOT, which the machine's inventor, Dean Kamen, says will allow him to make some improvements.\u003c/p>\n\u003cp>\"With advances in computers, the advances in solid-state gyros and electronics ... we can take a hundred pounds out of it. We can take a lot of cost out of it. We can improve it,\" he told NPR.\u003c/p>\n\u003cp>Kamen is widely known as the inventor of the Segway, which was actually a byproduct from development of the iBOT. The first iteration of the wheelchair had a $25,000 price tag — too high even for the department of Veterans Affairs in most cases. Most veterans who had iBOTs got them from veterans charities, and all but a few are now sitting in the garage, with nowhere to service them.\u003c/p>\n\u003cp>Today, Toyota is interested in some of the machine's balancing technology, possibly to be used in the company's \u003ca href=\"http://newsroom.toyota.co.jp/en/detail/10171645/\">robotic helpers for the aging\u003c/a>. And that could mean new parts and new life for existing iBOTs as well as a new version of the chair.\u003c/p>\n\u003cp>It also helps that the Food and Drug Administration reclassified the iBOT from its \u003ca href=\"http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/\">strictest regulatory category\u003c/a> for medical devices Class 3, alongside replacement heart valves, to Class 2, alongside condoms. That will also lower the expense of the machine, and Kamen says testimony by veterans using the machine was one key to persuading the FDA to make that switch.\u003c/p>\n\u003cp>For people like Linfoot, it was a game changer.\u003c/p>\n\u003cp>He lost the use of his legs after a 2008 helicopter crash south of Baghdad. \"I wasn't shot down or anything,\" he says. \"It was just a mechanical malfunction. Probably a $25 part failed and we lost all power to the rotor system.\"\u003c/p>\n\u003cp>Linfoot and his co-pilot survived, but the impact left Linfoot paralyzed below the chest. The iBOT allows him to navigate street curbs and the hills around his home north of Nashville, Tenn.\u003c/p>\n\u003cp>\"It goes beyond just reaching in the cabinet to get the cookies that my wife might hide up there, or the good booze,\" he says, sitting on top of what looks like an easy chair balanced on a pair of unicycles.\u003c/p>\n\u003cp>Plus the ability to stand up is huge.\u003c/p>\n\u003cp>\"When you go out to a social setting, back up at 6 feet, talking to somebody eye to eye, you get this sense of dignity,\" he says. \"The disability just kind of fades into the background.\"\u003c/p>\n\u003cp>Kamen said he hopes stories like Linfoot's will help persuade his new backers to return the iBOT to production and make it available to a wider group of people.\u003c/p>\n\u003cp>\"The reason some of these veterans need these things is they've literally given up pieces of their body for this country,\" he says. \"The least we can do is give them back the best technology that is currently available.\"\u003c/p>\n\u003cp>Several other companies have designed chairs that can get people with spinal injuries \u003ca href=\"http://levousa.com/\">up to eye level\u003c/a> and \u003ca href=\"http://www.tracfab.com\">even off-road\u003c/a>. But doctors at the department of Veterans Affairs are more excited about inventions that can actually get veterans walking again. The health effects of immobility for paralyzed people are just like the effects of sitting down all the time for able-bodied people, they say.\u003c/p>\n\u003cp>\"Sitting is the new smoking,\" says Dr. Will Bauman, director of the \u003ca href=\"http://www.rehab.research.va.gov/cent/bronx.html\">Center of Excellence on the Medical Consequences of Spinal Cord Injury\u003c/a> at the James J. Peters VA Medical Center in the Bronx. He and Dr. Ann Spungen, associate director of the center, have studied the secondary health effects of paralysis.\u003c/p>\n\u003cp>\"Just like you and I, if we sat around all day, we already know that's the worst thing can do to ourselves,\" says Spungen.\u003c/p>\n\u003cp>Immobilized people are prone to weakened bones, higher blood pressure, urinary tract infections and constipation that can be debilitating. At the Bronx VA, veterans have been using an exoskeleton called a ReWalk to get them moving again. It's like a backpack with robotic leg braces that allows patients to walk using crutches.\u003c/p>\n\u003cp>So far, devices \u003ca href=\"http://eksobionics.com/\">like these\u003c/a> aren't that useful outside a safe, flat surface. Regular therapy with these machines can help reduce pain and promote better sleep, Spungen says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>With as little as four to six hours of walking a week, about half of patients lost more than a kilogram of body fat, says Spungen. For many problems, she says, \"the best cure is to take a walk.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+Reboot+For+Wheelchair+That+Can+Stand+Up+And+Climb+Stairs&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "'Nothing Like It In the Textbooks': When Unproven Stem Cell Treatments Go Awry",
"title": "'Nothing Like It In the Textbooks': When Unproven Stem Cell Treatments Go Awry",
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"content": "\u003cp>https://www.youtube.com/watch?v=8VmqVHBALM4&ab_channel=KPBSNews\u003c/p>\n\u003cp>Jim Gass made sure to record the moment in an iPhone video because he’d paid tens of thousands of dollars and traveled a great distance to get there.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.youtube.com/watch?v=r4k7ibKDkDg\">the video\u003c/a>, Gass can be seen sitting in his wheelchair in a beige hospital room. He smiles while a doctor injects something into his arm. In case there’s any question about what’s going into Gass’s vein, the doctor points to the syringe and says, “Stem cells.”\u003c/p>\n\u003cp>Translating into Spanish a moment later, he says, “Células madre.”\u003c/p>\n\u003cp>Gass traveled to Hospital Angeles in Tijuana, Mexico with the hope of recovering from a debilitating stroke. He received stem cells from Dr. Cesar Amescua based on a referral from \u003ca href=\"http://www.stemedica.com/\">Stemedica Cell Technologies, Inc.\u003c/a>, a San Diego company known for reportedly helping famous former athletes like hockey legend Gordie Howe make “\u003ca href=\"http://www.mlive.com/redwings/index.ssf/2014/12/red_wings_great_gordie_howe_un.html\">miraculous\u003c/a>” recoveries from strokes.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But Gass didn’t get better.\u003c/p>\n\u003caside class=\"pullquote alignright\">'We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.'\u003c/aside>\n\u003cp>\"What he didn’t know, smiling in that iPhone video, was that his paralysis would get worse. Nor did he realize that his doctors back home would later find what they call a bizarre tumor in his spine, where Gass says he received injections of fetal stem cells procured by a different company, \u003ca href=\"http://www.globalstemcellhealth.com/\">Global Stem Cell Health, Inc.\u003c/a>\u003c/p>\n\u003cp>Gass had found himself caught up in the world of “\u003ca href=\"http://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stem-cell-tourism.html?_r=0\">stem cell tourism\u003c/a>.” The stem cell treatment industry is flourishing in the U.S. without much oversight. Southern California is \u003ca href=\"http://www.sandiegouniontribune.com/business/biotech/sdut-stem-cell-treatments-unauthorized-report-knoepfler-2016jun30-htmlstory.html\">a hotspot\u003c/a> for clinics advertising stem cell treatments for everything from stroke to autism. And experts say San Diego is an attractive location for any company hoping to usher patients across the border for expensive treatments that have not been proven to be safe or effective in humans.\u003c/p>\n\u003cp>The U.S. Food and Drug Administration held \u003ca href=\"http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm\">a meeting\u003c/a> on stem cells this month, \u003ca href=\"http://www.kpbs.org/news/2016/sep/05/researchers-question-safety-value-of-untested/\">possibly signaling moves toward increased regulation\u003c/a>. Some scientists think regulators are not doing enough to oversee a growing industry they believe preys on desperate patients. UC San Diego stem cell researcher \u003ca href=\"http://cmm.ucsd.edu/goldstein/\">Larry Goldstein\u003c/a> said his field would welcome regulation to protect consumers from what he called “snake oil treatments.”\u003c/p>\n\u003cp>“Thoughtful FDA regulation of the growing stem cell industry is essential to help consumers distinguish fraudulent claims from legitimate clinical trials, research and therapy development,” Goldstein wrote in an email.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=U7b8ncmePJI&ab_channel=KPBSNews\u003c/p>\n\u003cp>Stemedica spokesman \u003ca href=\"http://www.stemedica.com/company/management/david_mcguigan.asp\">Dave McGuigan\u003c/a> defends the company’s practices in the U.S. and beyond, saying, “Through our clinical trials in the United States and outside the United States, well over 500 patients have been treated since 2009. And we haven’t had a serious adverse event.”\u003c/p>\n\u003cp>When asked for comment on Jim Gass’ treatment in Tijuana, McGuigan initially said that Gass had never been treated with Stemedica cells. McGuigan also insisted that Stemedica never referred Gass to Dr. Amescua. Shortly after KPBS showed him \u003ca href=\"http://www.kpbs.org/documents/2016/sep/20/jim-gasss-email-correspondence-stemedica/\">emails\u003c/a> and \u003ca href=\"https://www.youtube.com/watch?v=r4k7ibKDkDg\">footage\u003c/a> contradicting his assertion, McGuigan — still on camera and wearing a KPBS microphone — told a fellow Stemedica employee, “Clearly what we’ve been saying as a statement of fact has been incorrect.”\u003c/p>\n\u003cp>The day after the interview, Stemedica officials confirmed that their company did refer Gass to Dr. Amescua, and that Gass was in fact treated intravenously with Stemedica’s adult stem cells. Those were distinct from the fetal stem cells Gass says were injected into his spine.\u003c/p>\n\u003cp>McGuigan said Stemedica works hard to advance stem cell research in a scientifically sound and legally compliant way. But Stemedica has faced criticism over the work it’s associated with outside the U.S.\u003c/p>\n\u003cp>A former member of Stemedica’s scientific advisory board is among those questioning some of the company’s practices. \u003ca href=\"https://www.nyscf.org/news/nyscf-press-releases/item/1636-dr-mahendra-rao-joins-nyscf-as-vp-for-regenerative-medicine\">Mahendra Rao\u003c/a>, currently the vice president for regenerative medicine at the New York Stem Cell Foundation, wrote in an email to KPBS, “Their work with athletes, their interaction with poorly monitored clinics and their business strategy leave me uncomfortable.”\u003c/p>\n\u003cp>\u003cstrong>'He was my hero'\u003c/strong>\u003c/p>\n\u003cp>Gass spent most of his life in Boston, but for the moment he lives in San Diego County. On most weekday mornings he can be found exercising at \u003ca href=\"http://www.projectwalk.com/\">Project Walk\u003c/a> in Carlsbad. Project Walk is sort of like a gym, but for people dealing with varying degrees of paralysis. Here, a personal trainer helps Jim get out of his wheelchair and put his languishing muscles to work.\u003c/p>\n\u003caside class=\"pullquote alignright\">A patient warns: 'Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.'\u003c/aside>\n\u003cp>“My goal is to transfer from this chair to a bed without using a lift,” Gass said. “And right now I can’t do that.”\u003c/p>\n\u003cp>Gass had a stroke in 2009 at the age of 60. He lost the use of his left arm and leg. Walking was still possible with the help of a cane and a leg brace. But his career as an attorney, his active lifestyle, his love of traveling the world — all of that came to a halt.\u003c/p>\n\u003cp>Gass said his doctors told him there was no cure for his paralysis, and he should focus on physical therapy. He couldn’t accept that there wasn’t anything else he could do.\u003c/p>\n\u003cp>“I got interested in treatment,” he said. “It turned out that stem cells appeared to be what everybody was focused on as the treatment of the future for stroke.”\u003c/p>\n\u003cp>Scientists in the field of regenerative medicine say stem cell treatments are on the horizon for a number of conditions, but they’re still in early stages and it’ll be years before they’re approved.\u003c/p>\n\u003cp>Nevertheless, online searches yield plenty of inspiring stories about stroke patients who’ve gone abroad for stem cell treatments. Gass knew these treatments hadn’t been proven to work, but he decided he was willing to pay expensive fees and travel across the globe on the chance they might help him regain some control of his body.\u003c/p>\n\u003cp>Gass traveled to China and Argentina for a series of stem cell treatments in 2011. He said those treatments didn’t seem to help, but they didn’t seem to hurt. So he decided to give stem cells another shot, based partly on what he’d been hearing about retired NFL star John Brodie.\u003c/p>\n\u003cp>“He used to be the quarterback for the San Francisco 49ers,” Gass said. “When I was growing up, he was my hero.”\u003c/p>\n\u003cp>Brodie, another stroke victim, was said to be making a dramatic recovery thanks to stem cells. In late 2013, Gass emailed the company linked with Brodie’s treatments. That company was Stemedica. In an \u003ca href=\"https://www.youtube.com/watch?v=f7oknI4zimY\">interview with MoneyTV from 2010\u003c/a>, Stemedica chief executive officer Maynard Howe discussed Brodie’s treatment.\u003c/p>\n\u003cfigure id=\"attachment_262605\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Gass_1_t800.png\">\u003cimg class=\"size-full wp-image-262605\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Gass_1_t800.png\" alt=\"Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016.\" width=\"800\" height=\"478\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800.png 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800-400x239.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800-768x459.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016. \u003ccite>(Kris Arciaga)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“John was part of a clinical study that was conducted outside of the United States,” Howe said. “John had a miraculous recovery. He’s back playing golf now. He’s got his speech back. And John travels all over the world by himself.”\u003c/p>\n\u003cp>A few years after Brodie’s treatment, another former athlete and stroke victim was reportedly \u003ca href=\"http://www.huffingtonpost.ca/2014/12/19/gordie-howe-stem-cell-recovery_n_6358012.html\">walking again\u003c/a> following treatment in Tijuana with Stemedica’s cells. This time it was hockey legend Gordie Howe (no relation to Stemedica executives Maynard and Roger Howe). Howe, who died earlier this year, \u003ca href=\"http://www.cbs8.com/story/29079426/inside-the-tijuana-stem-cell-clinic-that-treated-gordie-howe?clienttype=generic&mobilecgbypass\">reportedly\u003c/a> received Stemedica’s cells free of charge in Tijuana \u003ca href=\"https://www.thestar.com/news/canada/2015/04/18/a-closer-look-at-the-startling-recovery-of-gordie-howe.html\">from Dr. Amescua\u003c/a>, the same doctor who would treat Gass.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.youtube.com/watch?v=qn8Vd-SSgNQ\">a San Diego TV news story\u003c/a> about Howe’s recovery, Dr. Amescua is shown saying, “We cannot claim that we will cure the patient with stem cells. OK? But we can definitely say that patients will have an improvement.”\u003c/p>\n\u003cp>Stemedica continues to make news with another former NFL athlete’s story of recovery. In \u003ca href=\"http://www.usatoday.com/story/sports/nfl/packers/2016/09/05/bart-starr-returns-tijuana-stem-cells/89881768/\">a USA Today article\u003c/a> published earlier this month, former Green Bay Packers quarterback Bart Starr discussed his repeated trips to Tijuana for treatments with Stemedica cells.\u003c/p>\n\u003cp>Stem cell scientists don’t discount the possibility that these men saw their condition improve. But they say beyond anecdotal evidence, no proof has been offered that stem cells were responsible for anyone’s “miraculous” recovery.\u003c/p>\n\u003cp>Stemedica has used variations on the word “miracle” in connection with stem cells on a number of occasions. Stemedica executives have even co-written \u003ca href=\"http://www.stemedica.com/info/education/the-miracle-of-stem-cells.asp\">a book\u003c/a> titled “The Miracle of Stem Cells.” The company’s website includes a link to purchase the book for $39.95.\u003c/p>\n\u003cp>Spokesman Dave McGuigan said patients are clearly informed that Stemedica cells come with no promises. “We absolutely do not promise to cure patients,” he said.\u003c/p>\n\u003cp>\u003cstrong>\"We have had NO cases of infection or adverse events\"\u003c/strong>\u003c/p>\n\u003cp>Gass, however, was sold.\u003c/p>\n\u003cp>He emailed Stemedica to ask where he could go for treatment. A company representative referred Gass to Dr. Amescua, a man Stemedica \u003ca href=\"http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/062410-Stemedica-Cesar-Amescua-Garcia-Medical-Regulatory-Affairs-Director%E2%80%93Latin-America.asp\">has described in the past\u003c/a> as its “Medical and Regulatory Affairs Director for Latin America” (the company said it has no relationship with Dr. Amescua today).\u003c/p>\n\u003cp>The Stemedica representative wrote to Gass in an email, “Hospital Angeles in Tijuana, Mexico is approved by the Mexican FDA equivalent (COFEPRIS) to conduct a stroke trial with Stemedica's stem cells.”\u003c/p>\n\u003cp>Gass said he followed Stemedica’s referral and got in touch with Dr. Amescua. He said further down the line, he was told that for $30,000, he could receive a round of treatment involving two different types of stem cells.\u003c/p>\n\u003cp>The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from \u003ca href=\"http://www.stemedica.com/technology/productlines.asp\">adult bone marrow\u003c/a>.\u003c/p>\n\u003cp>Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).\u003c/p>\n\u003cp>Also based in San Diego County, GSCH is run by Dr. Michael Bayer, \u003ca href=\"http://www.stemedica.com/info/013009-stemedica-announces-appointment-of-dr-michael-bayer-as-director-medical-services.asp\">a former Stemedica executive\u003c/a>. Stemedica spokesman Dave McGuigan said there’s now “a clear separation of church and state between what Michael does and what Stemedica does.”\u003c/p>\n\u003cp>A GSCH representative explained the distinction to Gass in an email, writing, “Stemedica cannot treat patients because of FDA regulations, and this is how GSCH was started — to treat ‘no option’ patients seeking alternative therapies.”\u003c/p>\n\u003cp>Gass said he went to Tijuana twice for two separate rounds of treatment in 2014, and his bank statements show that he wired $30,000 to GSCH on two separate occasions that year.\u003c/p>\n\u003cp>Stem cell experts say that mesenchymal cells such as those produced by Stemedica cannot replace destroyed neurons, the very cells killed during a stroke. \u003ca href=\"http://stroke.ahajournals.org/content/early/2016/06/02/STROKEAHA.116.012995.abstract?sid=6d720047-0b70-4b9d-b589-a01ebc09e000\">Limited evidence\u003c/a> has shown possible benefit from injecting modified mesenchymal stem cells directly into the brains of stroke patients, but Gass received Stemedica’s mesenchymal cells intravenously.\u003c/p>\n\u003cp>The use of fetal stem cells in Gass’ case was also highly suspect, according to scientists in the field. They say patients receiving fetal stem cell treatments in other countries can’t always know for sure where these cells come from or how they’ve been prepared for injection. No definitive evidence has been published showing that fetal stem cells can help people recover from a stroke.\u003c/p>\n\u003cp>Stem cell scientists also warn that tumor formation is a distinct possibility when introducing fetal stem cells into humans without proper precautions. A GSCH representative wrote in an email to Gass, “We have had NO cases of infection or adverse events.”\u003c/p>\n\u003cp>Gass said after each of his treatments in Tijuana, he was told to wait three to six months for signs of improvement. He said after the second treatment, something happened.\u003c/p>\n\u003cp>\"I started to feel changes,” Gass said. “But they were not good changes. I started to feel pain in my back.\"\u003c/p>\n\u003cp>\u003cstrong>\"There’s really nothing like it in the textbooks\"\u003c/strong>\u003c/p>\n\u003cp>At this point, Gass said he was also starting to lose even more feeling and movement below his waist. When his doctors in Boston discovered what was causing his back pain and worsening his paralysis, they were shocked.\u003c/p>\n\u003cp>“None of us had ever seen anything like it,” said \u003ca href=\"http://physiciandirectory.brighamandwomens.org/details/12438/aaron-berkowitz-neurology-boston\">Dr. Aaron Berkowitz\u003c/a> of Brigham and Women’s Hospital.\u003c/p>\n\u003cp>Berkowitz and his colleagues found a growth developing in the lower part of Gass’ spine, where Gass said he received injections of GSCH’s fetal stem cells in Tijuana. Genetic analysis revealed that the growth was partly made up of cells from another human being.\u003c/p>\n\u003cp>Berkowitz said even putting a name to this growth was challenging. It was growing like a cancer, but it didn’t have the genetic signatures of cancer.\u003c/p>\n\u003cp>He said, “There’s really nothing like it in the textbooks.” But, he said, “Literally, it’s a tumor, in the sense that it’s an abnormal swelling.”\u003c/p>\n\u003cp>Earlier this year, Berkowtiz co-authored \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMc1600188#t=article\">a paper in the \u003cem>New England Journal of Medicine\u003c/em>\u003c/a> about Gass’ situation.\u003c/p>\n\u003cp>“We could point very tangibly to a very important risk that patients should be aware of before pursuing something like this,” Berkowitz said.\u003c/p>\n\u003cp>Gass gave his doctors the go-ahead to fight the tumor with radiation, and that seemed to halt the swelling. But Gass is concerned it may be growing again. He doesn’t rule out the possibility that he could one day sue those connected with his treatments.\u003c/p>\n\u003cp>Gass isn’t the only patient who has experienced complications after receiving stem cell treatments. Medical journals have documented two similar cases. One patient was found to have \u003ca href=\"http://jasn.asnjournals.org/content/21/7/1218.full\">masses in one of her kidneys\u003c/a> following a stem cell treatment. In another case, a brain tumor \u003ca href=\"http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000029\">was discovered\u003c/a> after a boy suffering from a rare neurodegenerative disease received injections of fetal stem cells. Both journal articles kept the patients anonymous.\u003c/p>\n\u003cp>Gass received stem cell treatments in other countries years before going to Tijuana. Berkowitz said without a sample of the cells used in each case, he can’t be certain which treatment is directly linked with the tumor. But Berkowitz said Gass only reported feeling pain in his back after the second round of treatment in Tijuana, which Gass said included injections of GSCH’s fetal stem cells into his spine.\u003c/p>\n\u003cp>\u003cstrong>'We have no current plans to publish our results'\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"http://www.scripps.edu/research/faculty/loring\">Jeanne Loring\u003c/a>, a scientist at the Scripps Research Institute in La Jolla developing \u003ca href=\"https://www.scripps.edu/news/press/2016/20160721loring.html\">a stem cell therapy for Parkinson’s disease\u003c/a>, spoke with KPBS about the stem cell treatment industry broadly, not about any company in particular, because some firms have a reputation for being litigious.\u003c/p>\n\u003cp>“It’s unfortunate that what I work on and what they work on are both called stem cells, because they’re not at all the same,” Loring said. “It’s not a terrific idea to be putting stuff that you don’t know very much about into people and expecting it to work.”\u003c/p>\n\u003cp>Companies promoting stem cell treatments often say they’re only facilitating research. They say they don’t promise to cure patients, only to connect them with clinical trials.\u003c/p>\n\u003cp>Stemedica is sponsoring a number of clinical trials overseen by scientists at reputable institutions within the U.S. These trials \u003ca href=\"https://clinicaltrials.gov/ct2/results?term=stemedica&Search=Search\">are listed on ClinicalTrials.gov\u003c/a>, an online database of human medical studies maintained by the National Institutes of Health.\u003c/p>\n\u003cp>\u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01297413?term=stemedica&rank=2\">One ongoing Stemedica-sponsored trial\u003c/a> approved by UC San Diego’s Institutional Review Board is primarily aiming to test whether or not it’s safe to give Stemedica’s mesenchymal stem cells intravenously to stroke patients. Stemedica \u003ca href=\"http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/2011-0217-Stemedica-Approval-From-UCSD-Ischemic-Stroke-Study.asp\">says it has received the FDA’s approval\u003c/a> to move forward with this trial.\u003c/p>\n\u003cp>The trial started over five years ago, and has not yet reported results. Principal investigator and UCSD School of Medicine professor \u003ca href=\"http://neurosurgery.ucsd.edu/mike-levy-md-phd/\">Michael Levy\u003c/a> said the study is proceeding with appropriate caution.\u003c/p>\n\u003cp>“This is work that needs to be done,” he said. “Because people are paying huge amounts of money to get something that they’re not sure what they’re getting, and to pursue a hope that may not be there. We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.”\u003c/p>\n\u003cp>Loring said if a stem cell company truly is helping patients make remarkable recoveries, they should prove it by publishing their results.\u003c/p>\n\u003cp>“If they had really good results, they would publish them,” she said. “Because that would be like the best marketing strategy.”\u003c/p>\n\u003cp>Stemedica could not provide published data from any of its human trials.\u003c/p>\n\u003cp>Gass’ sister-in-law, concerned about the treatment Jim was about to receive, asked Global Stem Cell Health if they’d ever published evidence that their treatments work. A representative replied to her via email, “We have no current plans to publish our results.”\u003c/p>\n\u003cp>Ethical concerns have been raised about the fees patients are charged to participate in certain stem cell trials outside the country. Loring said patients are not typically charged large sums of money to participate in clinical trials. She thinks patients should be wary of any trial, or any company, that does charge tens of thousands of dollars for participation in a medical study.\u003c/p>\n\u003cp>When Stemedica spokesman Dave McGuigan was asked about patients who pay large sums of money to receive Stemedica cells as part of a trial outside the U.S., he said Stemedica and their foreign clinical trial partners put up “significant dollars” to carry out these studies, and patients are “asked to participate in those costs.”\u003c/p>\n\u003cp>“We’re talking about people that have a medical condition for which there is often no cure,” McGuigan said. “And so they have searched the world to find out what their options are.”\u003c/p>\n\u003cp>Dr. Amescua has confirmed that after KPBS approached him for comment on Gass’ treatment, he was able to find hospital records pertaining to Gass. Global Stem Cell Health did not respond to KPBS’ interview request.\u003c/p>\n\u003cp>\u003cstrong>A call for regulation\u003c/strong>\u003c/p>\n\u003cp>Gass went through a process often referred to as “stem cell tourism” to receive his treatments. In years past, patients often had to leave the country to seek unproven stem cell treatments. But UC Davis stem cell scientist \u003ca href=\"http://www.ucdmc.ucdavis.edu/cellbio/faculty/knoepfler/\">Paul Knoepfler\u003c/a> says that’s no longer the case.\u003c/p>\n\u003cp>Knoepfler recently co-authored \u003ca href=\"http://www.sciencedirect.com/science/article/pii/S1934590916301576\">a study\u003c/a> identifying 351 stem cell companies advertising unapproved treatments at 570 unique clinic locations right here in the U.S. for everything from autism to Alzheimer’s, stroke to diabetes.\u003c/p>\n\u003cp>“This kind of turns the idea of stem cell tourism on its head,” Knoepfler said. Now, he said, “Most Americans really don’t have to travel, say, to Mexico or Asia or somewhere in the Caribbean to get an unapproved stem cell treatment.”\u003c/p>\n\u003cp>Some scientists wonder why the FDA hasn’t taken more action against companies promoting unproven stem cell treatments. Scripps Research Institute scientist Jeanne Loring believes regulators may simply be outmatched.\u003c/p>\n\u003cp>“The clinics are popping up faster than the FDA can close them,” she said.\u003c/p>\n\u003cp>An FDA spokeswoman did not comment on Jim Gass’ situation or the specific companies involved with his treatment. The FDA has \u003ca href=\"http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm\">approved the use of blood forming stem cells\u003c/a> in patients with certain blood disorders, but the FDA spokeswoman wrote in an email to KPBS, “At this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits.”\u003c/p>\n\u003cp>Loring attended the FDA’s meeting on stem cells earlier this month and spoke about why she thinks better regulation is needed. She believes there could be more patients out there who aren’t coming forward to discuss the harms they’ve suffered in connection with unproven stem cell treatments.\u003c/p>\n\u003cp>Patients sometimes raise money for these treatments through web sites like GoFundMe.com. Some say they’re willing to take a chance on unproven stem cell therapies because they have nothing to lose.\u003c/p>\n\u003cp>Gass now knows he did have a lot to lose. He said all told, he lost hundreds of thousands of dollars pursuing stem cell treatments around the world, and now he’s left with a painful tumor and significantly decreased mobility.\u003c/p>\n\u003cp>Gass hopes other patients considering reaching out to companies promoting unproven stem cell treatments will be more educated about the risks than he was.\u003c/p>\n\u003cp>He said, “Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>inewsource reporter Leo Castaneda contributed to this report.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/8VmqVHBALM4'\n title='//www.youtube.com/embed/8VmqVHBALM4'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Jim Gass made sure to record the moment in an iPhone video because he’d paid tens of thousands of dollars and traveled a great distance to get there.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.youtube.com/watch?v=r4k7ibKDkDg\">the video\u003c/a>, Gass can be seen sitting in his wheelchair in a beige hospital room. He smiles while a doctor injects something into his arm. In case there’s any question about what’s going into Gass’s vein, the doctor points to the syringe and says, “Stem cells.”\u003c/p>\n\u003cp>Translating into Spanish a moment later, he says, “Células madre.”\u003c/p>\n\u003cp>Gass traveled to Hospital Angeles in Tijuana, Mexico with the hope of recovering from a debilitating stroke. He received stem cells from Dr. Cesar Amescua based on a referral from \u003ca href=\"http://www.stemedica.com/\">Stemedica Cell Technologies, Inc.\u003c/a>, a San Diego company known for reportedly helping famous former athletes like hockey legend Gordie Howe make “\u003ca href=\"http://www.mlive.com/redwings/index.ssf/2014/12/red_wings_great_gordie_howe_un.html\">miraculous\u003c/a>” recoveries from strokes.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But Gass didn’t get better.\u003c/p>\n\u003caside class=\"pullquote alignright\">'We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.'\u003c/aside>\n\u003cp>\"What he didn’t know, smiling in that iPhone video, was that his paralysis would get worse. Nor did he realize that his doctors back home would later find what they call a bizarre tumor in his spine, where Gass says he received injections of fetal stem cells procured by a different company, \u003ca href=\"http://www.globalstemcellhealth.com/\">Global Stem Cell Health, Inc.\u003c/a>\u003c/p>\n\u003cp>Gass had found himself caught up in the world of “\u003ca href=\"http://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stem-cell-tourism.html?_r=0\">stem cell tourism\u003c/a>.” The stem cell treatment industry is flourishing in the U.S. without much oversight. Southern California is \u003ca href=\"http://www.sandiegouniontribune.com/business/biotech/sdut-stem-cell-treatments-unauthorized-report-knoepfler-2016jun30-htmlstory.html\">a hotspot\u003c/a> for clinics advertising stem cell treatments for everything from stroke to autism. And experts say San Diego is an attractive location for any company hoping to usher patients across the border for expensive treatments that have not been proven to be safe or effective in humans.\u003c/p>\n\u003cp>The U.S. Food and Drug Administration held \u003ca href=\"http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm\">a meeting\u003c/a> on stem cells this month, \u003ca href=\"http://www.kpbs.org/news/2016/sep/05/researchers-question-safety-value-of-untested/\">possibly signaling moves toward increased regulation\u003c/a>. Some scientists think regulators are not doing enough to oversee a growing industry they believe preys on desperate patients. UC San Diego stem cell researcher \u003ca href=\"http://cmm.ucsd.edu/goldstein/\">Larry Goldstein\u003c/a> said his field would welcome regulation to protect consumers from what he called “snake oil treatments.”\u003c/p>\n\u003cp>“Thoughtful FDA regulation of the growing stem cell industry is essential to help consumers distinguish fraudulent claims from legitimate clinical trials, research and therapy development,” Goldstein wrote in an email.\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/U7b8ncmePJI'\n title='//www.youtube.com/embed/U7b8ncmePJI'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Stemedica spokesman \u003ca href=\"http://www.stemedica.com/company/management/david_mcguigan.asp\">Dave McGuigan\u003c/a> defends the company’s practices in the U.S. and beyond, saying, “Through our clinical trials in the United States and outside the United States, well over 500 patients have been treated since 2009. And we haven’t had a serious adverse event.”\u003c/p>\n\u003cp>When asked for comment on Jim Gass’ treatment in Tijuana, McGuigan initially said that Gass had never been treated with Stemedica cells. McGuigan also insisted that Stemedica never referred Gass to Dr. Amescua. Shortly after KPBS showed him \u003ca href=\"http://www.kpbs.org/documents/2016/sep/20/jim-gasss-email-correspondence-stemedica/\">emails\u003c/a> and \u003ca href=\"https://www.youtube.com/watch?v=r4k7ibKDkDg\">footage\u003c/a> contradicting his assertion, McGuigan — still on camera and wearing a KPBS microphone — told a fellow Stemedica employee, “Clearly what we’ve been saying as a statement of fact has been incorrect.”\u003c/p>\n\u003cp>The day after the interview, Stemedica officials confirmed that their company did refer Gass to Dr. Amescua, and that Gass was in fact treated intravenously with Stemedica’s adult stem cells. Those were distinct from the fetal stem cells Gass says were injected into his spine.\u003c/p>\n\u003cp>McGuigan said Stemedica works hard to advance stem cell research in a scientifically sound and legally compliant way. But Stemedica has faced criticism over the work it’s associated with outside the U.S.\u003c/p>\n\u003cp>A former member of Stemedica’s scientific advisory board is among those questioning some of the company’s practices. \u003ca href=\"https://www.nyscf.org/news/nyscf-press-releases/item/1636-dr-mahendra-rao-joins-nyscf-as-vp-for-regenerative-medicine\">Mahendra Rao\u003c/a>, currently the vice president for regenerative medicine at the New York Stem Cell Foundation, wrote in an email to KPBS, “Their work with athletes, their interaction with poorly monitored clinics and their business strategy leave me uncomfortable.”\u003c/p>\n\u003cp>\u003cstrong>'He was my hero'\u003c/strong>\u003c/p>\n\u003cp>Gass spent most of his life in Boston, but for the moment he lives in San Diego County. On most weekday mornings he can be found exercising at \u003ca href=\"http://www.projectwalk.com/\">Project Walk\u003c/a> in Carlsbad. Project Walk is sort of like a gym, but for people dealing with varying degrees of paralysis. Here, a personal trainer helps Jim get out of his wheelchair and put his languishing muscles to work.\u003c/p>\n\u003caside class=\"pullquote alignright\">A patient warns: 'Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.'\u003c/aside>\n\u003cp>“My goal is to transfer from this chair to a bed without using a lift,” Gass said. “And right now I can’t do that.”\u003c/p>\n\u003cp>Gass had a stroke in 2009 at the age of 60. He lost the use of his left arm and leg. Walking was still possible with the help of a cane and a leg brace. But his career as an attorney, his active lifestyle, his love of traveling the world — all of that came to a halt.\u003c/p>\n\u003cp>Gass said his doctors told him there was no cure for his paralysis, and he should focus on physical therapy. He couldn’t accept that there wasn’t anything else he could do.\u003c/p>\n\u003cp>“I got interested in treatment,” he said. “It turned out that stem cells appeared to be what everybody was focused on as the treatment of the future for stroke.”\u003c/p>\n\u003cp>Scientists in the field of regenerative medicine say stem cell treatments are on the horizon for a number of conditions, but they’re still in early stages and it’ll be years before they’re approved.\u003c/p>\n\u003cp>Nevertheless, online searches yield plenty of inspiring stories about stroke patients who’ve gone abroad for stem cell treatments. Gass knew these treatments hadn’t been proven to work, but he decided he was willing to pay expensive fees and travel across the globe on the chance they might help him regain some control of his body.\u003c/p>\n\u003cp>Gass traveled to China and Argentina for a series of stem cell treatments in 2011. He said those treatments didn’t seem to help, but they didn’t seem to hurt. So he decided to give stem cells another shot, based partly on what he’d been hearing about retired NFL star John Brodie.\u003c/p>\n\u003cp>“He used to be the quarterback for the San Francisco 49ers,” Gass said. “When I was growing up, he was my hero.”\u003c/p>\n\u003cp>Brodie, another stroke victim, was said to be making a dramatic recovery thanks to stem cells. In late 2013, Gass emailed the company linked with Brodie’s treatments. That company was Stemedica. In an \u003ca href=\"https://www.youtube.com/watch?v=f7oknI4zimY\">interview with MoneyTV from 2010\u003c/a>, Stemedica chief executive officer Maynard Howe discussed Brodie’s treatment.\u003c/p>\n\u003cfigure id=\"attachment_262605\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Gass_1_t800.png\">\u003cimg class=\"size-full wp-image-262605\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Gass_1_t800.png\" alt=\"Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016.\" width=\"800\" height=\"478\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800.png 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800-400x239.png 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Gass_1_t800-768x459.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Jim Gass is pictured at a Project Walk's paralysis recovery center in Carlsbad, July 20, 2016. \u003ccite>(Kris Arciaga)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“John was part of a clinical study that was conducted outside of the United States,” Howe said. “John had a miraculous recovery. He’s back playing golf now. He’s got his speech back. And John travels all over the world by himself.”\u003c/p>\n\u003cp>A few years after Brodie’s treatment, another former athlete and stroke victim was reportedly \u003ca href=\"http://www.huffingtonpost.ca/2014/12/19/gordie-howe-stem-cell-recovery_n_6358012.html\">walking again\u003c/a> following treatment in Tijuana with Stemedica’s cells. This time it was hockey legend Gordie Howe (no relation to Stemedica executives Maynard and Roger Howe). Howe, who died earlier this year, \u003ca href=\"http://www.cbs8.com/story/29079426/inside-the-tijuana-stem-cell-clinic-that-treated-gordie-howe?clienttype=generic&mobilecgbypass\">reportedly\u003c/a> received Stemedica’s cells free of charge in Tijuana \u003ca href=\"https://www.thestar.com/news/canada/2015/04/18/a-closer-look-at-the-startling-recovery-of-gordie-howe.html\">from Dr. Amescua\u003c/a>, the same doctor who would treat Gass.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.youtube.com/watch?v=qn8Vd-SSgNQ\">a San Diego TV news story\u003c/a> about Howe’s recovery, Dr. Amescua is shown saying, “We cannot claim that we will cure the patient with stem cells. OK? But we can definitely say that patients will have an improvement.”\u003c/p>\n\u003cp>Stemedica continues to make news with another former NFL athlete’s story of recovery. In \u003ca href=\"http://www.usatoday.com/story/sports/nfl/packers/2016/09/05/bart-starr-returns-tijuana-stem-cells/89881768/\">a USA Today article\u003c/a> published earlier this month, former Green Bay Packers quarterback Bart Starr discussed his repeated trips to Tijuana for treatments with Stemedica cells.\u003c/p>\n\u003cp>Stem cell scientists don’t discount the possibility that these men saw their condition improve. But they say beyond anecdotal evidence, no proof has been offered that stem cells were responsible for anyone’s “miraculous” recovery.\u003c/p>\n\u003cp>Stemedica has used variations on the word “miracle” in connection with stem cells on a number of occasions. Stemedica executives have even co-written \u003ca href=\"http://www.stemedica.com/info/education/the-miracle-of-stem-cells.asp\">a book\u003c/a> titled “The Miracle of Stem Cells.” The company’s website includes a link to purchase the book for $39.95.\u003c/p>\n\u003cp>Spokesman Dave McGuigan said patients are clearly informed that Stemedica cells come with no promises. “We absolutely do not promise to cure patients,” he said.\u003c/p>\n\u003cp>\u003cstrong>\"We have had NO cases of infection or adverse events\"\u003c/strong>\u003c/p>\n\u003cp>Gass, however, was sold.\u003c/p>\n\u003cp>He emailed Stemedica to ask where he could go for treatment. A company representative referred Gass to Dr. Amescua, a man Stemedica \u003ca href=\"http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/062410-Stemedica-Cesar-Amescua-Garcia-Medical-Regulatory-Affairs-Director%E2%80%93Latin-America.asp\">has described in the past\u003c/a> as its “Medical and Regulatory Affairs Director for Latin America” (the company said it has no relationship with Dr. Amescua today).\u003c/p>\n\u003cp>The Stemedica representative wrote to Gass in an email, “Hospital Angeles in Tijuana, Mexico is approved by the Mexican FDA equivalent (COFEPRIS) to conduct a stroke trial with Stemedica's stem cells.”\u003c/p>\n\u003cp>Gass said he followed Stemedica’s referral and got in touch with Dr. Amescua. He said further down the line, he was told that for $30,000, he could receive a round of treatment involving two different types of stem cells.\u003c/p>\n\u003cp>The first type, Gass said he was told, would be mesenchymal stem cells. He said he was informed that they would be manufactured by Stemedica, and would be injected into a vein in his arm. Stemedica said its mesenchymal stem cells are derived from \u003ca href=\"http://www.stemedica.com/technology/productlines.asp\">adult bone marrow\u003c/a>.\u003c/p>\n\u003cp>Gass said he was told that the other type of stem cell would be fetal in origin, and would be injected directly into his cerebrospinal fluid. These fetal neural stem cells, Gass recalled being told, would be procured from Russia not by Stemedica, but by a different company, Global Stem Cell Health (GSCH).\u003c/p>\n\u003cp>Also based in San Diego County, GSCH is run by Dr. Michael Bayer, \u003ca href=\"http://www.stemedica.com/info/013009-stemedica-announces-appointment-of-dr-michael-bayer-as-director-medical-services.asp\">a former Stemedica executive\u003c/a>. Stemedica spokesman Dave McGuigan said there’s now “a clear separation of church and state between what Michael does and what Stemedica does.”\u003c/p>\n\u003cp>A GSCH representative explained the distinction to Gass in an email, writing, “Stemedica cannot treat patients because of FDA regulations, and this is how GSCH was started — to treat ‘no option’ patients seeking alternative therapies.”\u003c/p>\n\u003cp>Gass said he went to Tijuana twice for two separate rounds of treatment in 2014, and his bank statements show that he wired $30,000 to GSCH on two separate occasions that year.\u003c/p>\n\u003cp>Stem cell experts say that mesenchymal cells such as those produced by Stemedica cannot replace destroyed neurons, the very cells killed during a stroke. \u003ca href=\"http://stroke.ahajournals.org/content/early/2016/06/02/STROKEAHA.116.012995.abstract?sid=6d720047-0b70-4b9d-b589-a01ebc09e000\">Limited evidence\u003c/a> has shown possible benefit from injecting modified mesenchymal stem cells directly into the brains of stroke patients, but Gass received Stemedica’s mesenchymal cells intravenously.\u003c/p>\n\u003cp>The use of fetal stem cells in Gass’ case was also highly suspect, according to scientists in the field. They say patients receiving fetal stem cell treatments in other countries can’t always know for sure where these cells come from or how they’ve been prepared for injection. No definitive evidence has been published showing that fetal stem cells can help people recover from a stroke.\u003c/p>\n\u003cp>Stem cell scientists also warn that tumor formation is a distinct possibility when introducing fetal stem cells into humans without proper precautions. A GSCH representative wrote in an email to Gass, “We have had NO cases of infection or adverse events.”\u003c/p>\n\u003cp>Gass said after each of his treatments in Tijuana, he was told to wait three to six months for signs of improvement. He said after the second treatment, something happened.\u003c/p>\n\u003cp>\"I started to feel changes,” Gass said. “But they were not good changes. I started to feel pain in my back.\"\u003c/p>\n\u003cp>\u003cstrong>\"There’s really nothing like it in the textbooks\"\u003c/strong>\u003c/p>\n\u003cp>At this point, Gass said he was also starting to lose even more feeling and movement below his waist. When his doctors in Boston discovered what was causing his back pain and worsening his paralysis, they were shocked.\u003c/p>\n\u003cp>“None of us had ever seen anything like it,” said \u003ca href=\"http://physiciandirectory.brighamandwomens.org/details/12438/aaron-berkowitz-neurology-boston\">Dr. Aaron Berkowitz\u003c/a> of Brigham and Women’s Hospital.\u003c/p>\n\u003cp>Berkowitz and his colleagues found a growth developing in the lower part of Gass’ spine, where Gass said he received injections of GSCH’s fetal stem cells in Tijuana. Genetic analysis revealed that the growth was partly made up of cells from another human being.\u003c/p>\n\u003cp>Berkowitz said even putting a name to this growth was challenging. It was growing like a cancer, but it didn’t have the genetic signatures of cancer.\u003c/p>\n\u003cp>He said, “There’s really nothing like it in the textbooks.” But, he said, “Literally, it’s a tumor, in the sense that it’s an abnormal swelling.”\u003c/p>\n\u003cp>Earlier this year, Berkowtiz co-authored \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMc1600188#t=article\">a paper in the \u003cem>New England Journal of Medicine\u003c/em>\u003c/a> about Gass’ situation.\u003c/p>\n\u003cp>“We could point very tangibly to a very important risk that patients should be aware of before pursuing something like this,” Berkowitz said.\u003c/p>\n\u003cp>Gass gave his doctors the go-ahead to fight the tumor with radiation, and that seemed to halt the swelling. But Gass is concerned it may be growing again. He doesn’t rule out the possibility that he could one day sue those connected with his treatments.\u003c/p>\n\u003cp>Gass isn’t the only patient who has experienced complications after receiving stem cell treatments. Medical journals have documented two similar cases. One patient was found to have \u003ca href=\"http://jasn.asnjournals.org/content/21/7/1218.full\">masses in one of her kidneys\u003c/a> following a stem cell treatment. In another case, a brain tumor \u003ca href=\"http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000029\">was discovered\u003c/a> after a boy suffering from a rare neurodegenerative disease received injections of fetal stem cells. Both journal articles kept the patients anonymous.\u003c/p>\n\u003cp>Gass received stem cell treatments in other countries years before going to Tijuana. Berkowitz said without a sample of the cells used in each case, he can’t be certain which treatment is directly linked with the tumor. But Berkowitz said Gass only reported feeling pain in his back after the second round of treatment in Tijuana, which Gass said included injections of GSCH’s fetal stem cells into his spine.\u003c/p>\n\u003cp>\u003cstrong>'We have no current plans to publish our results'\u003c/strong>\u003c/p>\n\u003cp>\u003ca href=\"http://www.scripps.edu/research/faculty/loring\">Jeanne Loring\u003c/a>, a scientist at the Scripps Research Institute in La Jolla developing \u003ca href=\"https://www.scripps.edu/news/press/2016/20160721loring.html\">a stem cell therapy for Parkinson’s disease\u003c/a>, spoke with KPBS about the stem cell treatment industry broadly, not about any company in particular, because some firms have a reputation for being litigious.\u003c/p>\n\u003cp>“It’s unfortunate that what I work on and what they work on are both called stem cells, because they’re not at all the same,” Loring said. “It’s not a terrific idea to be putting stuff that you don’t know very much about into people and expecting it to work.”\u003c/p>\n\u003cp>Companies promoting stem cell treatments often say they’re only facilitating research. They say they don’t promise to cure patients, only to connect them with clinical trials.\u003c/p>\n\u003cp>Stemedica is sponsoring a number of clinical trials overseen by scientists at reputable institutions within the U.S. These trials \u003ca href=\"https://clinicaltrials.gov/ct2/results?term=stemedica&Search=Search\">are listed on ClinicalTrials.gov\u003c/a>, an online database of human medical studies maintained by the National Institutes of Health.\u003c/p>\n\u003cp>\u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT01297413?term=stemedica&rank=2\">One ongoing Stemedica-sponsored trial\u003c/a> approved by UC San Diego’s Institutional Review Board is primarily aiming to test whether or not it’s safe to give Stemedica’s mesenchymal stem cells intravenously to stroke patients. Stemedica \u003ca href=\"http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/2011-0217-Stemedica-Approval-From-UCSD-Ischemic-Stroke-Study.asp\">says it has received the FDA’s approval\u003c/a> to move forward with this trial.\u003c/p>\n\u003cp>The trial started over five years ago, and has not yet reported results. Principal investigator and UCSD School of Medicine professor \u003ca href=\"http://neurosurgery.ucsd.edu/mike-levy-md-phd/\">Michael Levy\u003c/a> said the study is proceeding with appropriate caution.\u003c/p>\n\u003cp>“This is work that needs to be done,” he said. “Because people are paying huge amounts of money to get something that they’re not sure what they’re getting, and to pursue a hope that may not be there. We need to go back to square one where you do the appropriate research and find out if there’s anything factual to support any of this stuff.”\u003c/p>\n\u003cp>Loring said if a stem cell company truly is helping patients make remarkable recoveries, they should prove it by publishing their results.\u003c/p>\n\u003cp>“If they had really good results, they would publish them,” she said. “Because that would be like the best marketing strategy.”\u003c/p>\n\u003cp>Stemedica could not provide published data from any of its human trials.\u003c/p>\n\u003cp>Gass’ sister-in-law, concerned about the treatment Jim was about to receive, asked Global Stem Cell Health if they’d ever published evidence that their treatments work. A representative replied to her via email, “We have no current plans to publish our results.”\u003c/p>\n\u003cp>Ethical concerns have been raised about the fees patients are charged to participate in certain stem cell trials outside the country. Loring said patients are not typically charged large sums of money to participate in clinical trials. She thinks patients should be wary of any trial, or any company, that does charge tens of thousands of dollars for participation in a medical study.\u003c/p>\n\u003cp>When Stemedica spokesman Dave McGuigan was asked about patients who pay large sums of money to receive Stemedica cells as part of a trial outside the U.S., he said Stemedica and their foreign clinical trial partners put up “significant dollars” to carry out these studies, and patients are “asked to participate in those costs.”\u003c/p>\n\u003cp>“We’re talking about people that have a medical condition for which there is often no cure,” McGuigan said. “And so they have searched the world to find out what their options are.”\u003c/p>\n\u003cp>Dr. Amescua has confirmed that after KPBS approached him for comment on Gass’ treatment, he was able to find hospital records pertaining to Gass. Global Stem Cell Health did not respond to KPBS’ interview request.\u003c/p>\n\u003cp>\u003cstrong>A call for regulation\u003c/strong>\u003c/p>\n\u003cp>Gass went through a process often referred to as “stem cell tourism” to receive his treatments. In years past, patients often had to leave the country to seek unproven stem cell treatments. But UC Davis stem cell scientist \u003ca href=\"http://www.ucdmc.ucdavis.edu/cellbio/faculty/knoepfler/\">Paul Knoepfler\u003c/a> says that’s no longer the case.\u003c/p>\n\u003cp>Knoepfler recently co-authored \u003ca href=\"http://www.sciencedirect.com/science/article/pii/S1934590916301576\">a study\u003c/a> identifying 351 stem cell companies advertising unapproved treatments at 570 unique clinic locations right here in the U.S. for everything from autism to Alzheimer’s, stroke to diabetes.\u003c/p>\n\u003cp>“This kind of turns the idea of stem cell tourism on its head,” Knoepfler said. Now, he said, “Most Americans really don’t have to travel, say, to Mexico or Asia or somewhere in the Caribbean to get an unapproved stem cell treatment.”\u003c/p>\n\u003cp>Some scientists wonder why the FDA hasn’t taken more action against companies promoting unproven stem cell treatments. Scripps Research Institute scientist Jeanne Loring believes regulators may simply be outmatched.\u003c/p>\n\u003cp>“The clinics are popping up faster than the FDA can close them,” she said.\u003c/p>\n\u003cp>An FDA spokeswoman did not comment on Jim Gass’ situation or the specific companies involved with his treatment. The FDA has \u003ca href=\"http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm\">approved the use of blood forming stem cells\u003c/a> in patients with certain blood disorders, but the FDA spokeswoman wrote in an email to KPBS, “At this time, the value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits.”\u003c/p>\n\u003cp>Loring attended the FDA’s meeting on stem cells earlier this month and spoke about why she thinks better regulation is needed. She believes there could be more patients out there who aren’t coming forward to discuss the harms they’ve suffered in connection with unproven stem cell treatments.\u003c/p>\n\u003cp>Patients sometimes raise money for these treatments through web sites like GoFundMe.com. Some say they’re willing to take a chance on unproven stem cell therapies because they have nothing to lose.\u003c/p>\n\u003cp>Gass now knows he did have a lot to lose. He said all told, he lost hundreds of thousands of dollars pursuing stem cell treatments around the world, and now he’s left with a painful tumor and significantly decreased mobility.\u003c/p>\n\u003cp>Gass hopes other patients considering reaching out to companies promoting unproven stem cell treatments will be more educated about the risks than he was.\u003c/p>\n\u003cp>He said, “Don’t do it. Look at me. You don’t want to spend the rest of your life in a wheelchair. I don’t either.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"disqusTitle": "The Rise and Fall of Theranos: A Cartoon History",
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"content": "\u003cp>\u003cimg class=\"aligncenter size-full wp-image-203045\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/KQED_Theranos_01.jpg\" alt=\"KQED_Theranos_01\" width=\"1920\" height=\"2295\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_01.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_01-400x478.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_01-502x600.jpg 502w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_01-768x918.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_01-987x1180.jpg 987w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_01-1180x1410.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_01-960x1148.jpg 960w\" sizes=\"(max-width: 1920px) 100vw, 1920px\"> \u003cimg class=\"aligncenter size-full wp-image-203046\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/KQED_Theranos_02.jpg\" alt=\"KQED_Theranos_02\" width=\"1920\" height=\"2824\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_02.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_02-400x588.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_02-408x600.jpg 408w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_02-768x1130.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_02-802x1180.jpg 802w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_02-1180x1736.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_02-960x1412.jpg 960w\" sizes=\"(max-width: 1920px) 100vw, 1920px\"> \u003cimg class=\"aligncenter size-full wp-image-203047\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/KQED_Theranos_03.jpg\" alt=\"KQED_Theranos_03\" width=\"1920\" height=\"2711\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_03.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_03-400x565.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_03-425x600.jpg 425w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_03-768x1084.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_03-836x1180.jpg 836w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_03-1180x1666.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_03-960x1356.jpg 960w\" sizes=\"(max-width: 1920px) 100vw, 1920px\"> \u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/KQED_Theranos_04r.jpg\">\u003cimg class=\"aligncenter size-large wp-image-203679\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/KQED_Theranos_04r-872x1180.jpg\" alt=\"KQED_Theranos_04r\" width=\"640\" height=\"866\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_04r-872x1180.jpg 872w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_04r-400x541.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_04r-443x600.jpg 443w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_04r-768x1039.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_04r.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_04r-1180x1597.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_04r-960x1299.jpg 960w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003c/a>\u003cimg class=\"aligncenter size-full wp-image-203049\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/KQED_Theranos_05.jpg\" alt=\"KQED_Theranos_05\" width=\"1920\" height=\"2443\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_05.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_05-400x509.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_05-472x600.jpg 472w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_05-768x977.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_05-927x1180.jpg 927w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_05-1180x1501.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_05-960x1222.jpg 960w\" sizes=\"(max-width: 1920px) 100vw, 1920px\">\u003c/p>\n\u003cp>\u003cimg class=\"aligncenter size-full wp-image-203593\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/KQED_Theranos_06r.jpg\" alt=\"KQED_Theranos_06r\" width=\"1920\" height=\"2711\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_06r.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_06r-400x565.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_06r-425x600.jpg 425w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_06r-768x1084.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_06r-836x1180.jpg 836w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_06r-1180x1666.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_06r-960x1356.jpg 960w\" sizes=\"(max-width: 1920px) 100vw, 1920px\"> \u003ca href=\"https://www.theranos.com/news/posts/theranos-statement-on-cms-findings\" target=\"_blank\" rel=\"noopener\">\u003cimg class=\"aligncenter wp-image-203051\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/07/KQED_Theranos_07.jpg\" alt=\"KQED_Theranos_07\" usemap=\"#theranos\" width=\"1920\" height=\"2125\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_07.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/07/KQED_Theranos_07-400x443.jpg 400w, 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400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/KQED_Theranos_08r2-458x600.jpg 458w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/KQED_Theranos_08r2-768x1007.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/KQED_Theranos_08r2-900x1180.jpg 900w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/KQED_Theranos_08r2-1180x1547.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/KQED_Theranos_08r2-960x1259.jpg 960w\" sizes=\"(max-width: 1920px) 100vw, 1920px\">\u003c/a>\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/KQED_Theranos_09r.jpg\">\u003cimg class=\"aligncenter size-full wp-image-262504\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/KQED_Theranos_09r.jpg\" alt=\"KQED_Theranos_09r\" width=\"1920\" height=\"3142\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/KQED_Theranos_09r.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/KQED_Theranos_09r-400x655.jpg 400w, 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"excerpt": "Once the golden child of Silicon Valley innovation, now the poster child for Silicon Valley hype--in our cartoon history, a couple of new events to reflect the continued unraveling of Theranos ...",
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"disqusTitle": "'Holy Grail' Device Would Make Kidney Dialysis Much Easier",
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"content": "\u003cp>There’s new hope of a better and longer life for many patients with failing kidneys.\u003c/p>\n\u003cp>When someone’s kidneys stop working effectively to cleanse wastes from the blood, patients must have it done mechanically, using a dialysis machine to remove the blood, clean it, and send it back into the body. That process is hard on the veins because it requires such a large opening to do it.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It transitions over the period of a few months into something that’s indistinguishable from your own tissue.'\u003ccite>Jeff Lawson, Humacyte\u003c/cite>\u003c/aside>\n\u003cp>Currently, patients get a plastic tube, or shunt, surgically inserted in a vein to hold it open for dialysis. But those shunts can get infected over time, or rejected by a patient’s immune system, and in any case, they need to be replaced about every year.\u003c/p>\n\u003cp>Now researchers are testing a new kind of shunt—one made out of human tissue. It combines with a patient’s stem cells to make the device part of the patient’s body; theoretically, it could last a lifetime.\u003c/p>\n\u003cp>\u003cstrong>‘I Just Accept It’\u003c/strong>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The first patient in California to participate in the Phase III clinical trial for the new shunt is dialysis patient Raymond Ramirez. (A Phase III clinical trial is the stage of research required before submitting a treatment for FDA approval.)\u003c/p>\n\u003cp>The 67-year-old resident of Whittier, Calif., just east of Los Angeles, says he’s a bit of a train wreck. He’s in a wheelchair because of an above-the-knee amputation on his right leg, and he stops rolling around his TV room for a minute to list some of his maladies.\u003c/p>\n\u003cfigure id=\"attachment_260201\" class=\"wp-caption aligncenter\" style=\"max-width: 3264px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/stemcells2.jpg\">\u003cimg class=\"size-full wp-image-260201\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/stemcells2.jpg\" alt=\"The most challenging of Ray Ramirez's health problems right now is his kidney disease, because his veins are failing, making dialysis difficult.\" width=\"3264\" height=\"2448\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2.jpg 3264w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-960x720.jpg 960w\" sizes=\"(max-width: 3264px) 100vw, 3264px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">The most challenging of Ray Ramirez's health problems right now is his kidney disease, because his veins are failing, making dialysis difficult. \u003ccite>(David Gorn/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“Omigod, it’s never-ending,” he says with a laugh. “In Vietnam, when I got wounded, they took out my ribs. So, on my left side, my ribs they’re just gone.” He has to think a minute for more.\u003c/p>\n\u003cp>“I’ve had intestinal problems, I’ve had bladder cancer, a tumor in my bladder,” he says, “I have a blind eye in my right eye. Blood clot in my retina.\"\u003c/p>\n\u003cp>Ramirez says he’s not one of those guys who likes to dwell on his problems.\u003c/p>\n\u003cp>“I’ve always been a happy guy,” he says. “I don’t like it, no, hell no, it hurts. I’ve hurt like crazy since I was a youngster. I just accept it.”\u003c/p>\n\u003cp>Right now, the big challenge for Ramirez is dialysis, because his veins are failing. And that's how he ended up in the Veterans Affairs Hospital in Long Beach on a recent day for an appointment with vascular surgeon Ian Gordon. Since the Phase III study is randomized, Ramirez has a 50-50 of getting the experimental human tissue shunt or the traditional plastic one.\u003c/p>\n\u003cp>\u003cstrong>How Does the Shunt Work?\u003c/strong>\u003c/p>\n\u003cp>Imagine one of those long foam noodles kids play with in the pool—hollow and kind of like cellulose—only it’s the diameter of your little finger. That’s what the shunts look like. But it’s an intricate process to get them to that stage.\u003c/p>\n\u003caside class=\"pullquote alignright\">'One of the holy grails, if you can use that phrase, in vascular surgery is to come up with a prosthetic artificial graft that has the same properties as the patient’s own blood vessels.'\u003ccite>Dr. Ian Gordon,\u003cbr>\nVA Hospital, Long Beach\u003c/cite>\u003c/aside>\n\u003cp>First, you take human muscle cells from organ donors, and grow them into a tubular shape, says Jeff Lawson, chief medical officer at Humacyte, the North Carolina company that makes these things. As they grow, the cells secrete a sticky form of cellulose that holds them in the shape.\u003c/p>\n\u003cp>“So what’s left then is a scaffold of human tissue,” Lawson says. “We call it human extracellular matrix.”\u003c/p>\n\u003cp>Then you use a chemical wash to slough off the original donor cells, leaving the sticky cellulose structure behind—the foam noodle the diameter of your pinky finger.\u003c/p>\n\u003cp>The stem cell part of the equation, Lawson says, happens inside the patient.\u003c/p>\n\u003cp>“This scaffold, once implanted, uniquely becomes repopulated with their own stem cells,\" he says. \"That then turns back into something that looks like a vascular cell. And it now transitions over the period of a few months into something that’s indistinguishable from your own tissue.”\u003c/p>\n\u003cp>If it works, applications of this technology are endless, says Dr. Gordon, from vein replacement to heart surgery.\u003c/p>\n\u003cp>“One of the holy grails, if you can use that phrase, in vascular surgery is to come up with a prosthetic artificial graft,” he says, “that has the same properties as the patient’s own blood vessels.”\u003c/p>\n\u003cp>So far, this one seems to do that.\u003c/p>\n\u003cp>\u003cstrong>A Voter Mandate to Get Results\u003c/strong>\u003c/p>\n\u003cp>This is the kind of success the state stem cell agency was aiming for, when California voters created it in 2004 by approving Proposition 71. The California Institute for Regenerative Medicine (CIRM), based in Oakland, now has just four years of funding left, and is putting more money into mature clinical trials.\u003c/p>\n\u003cp>While many people think of stem cell therapy as an a treatment that injects the cells into a patient’s body, there are other types of treatments that rely on stem cells.\u003c/p>\n\u003cp>“At CIRM we’re interested in anything that involves or uses stem cells in the correction of a disease process,” says CIRM CEO Randall Mills. “About a quarter of our portfolio product itself isn’t a stem cell.”\u003c/p>\n\u003cp>There are a couple of important reasons for CIRM’s move to fund more clinical studies, says UC-San Diego’s director of stem cell research, Larry Goldstein\u003c/p>\n\u003cp>“Ten years ago I don’t think there were that many projects that were really ready for clinical trials,” Goldstein said. “The field itself has developed projects that are at clinical stage.”\u003c/p>\n\u003cp>And, Goldstein says, the voters who created the agency wanted it to produce results.\u003c/p>\n\u003cp>“The voter mandate was more than just basic research,\" he says, \"it was basic plus clinical.”\u003c/p>\n\u003cp>If the agency keeps pumping out these types of clinical results, Goldstein says, California voters may soon see another ballot measure to keep it going.\u003c/p>\n\u003cp>Humacyte officials say 118 patients around the world have received the new type of human tissue shunt – in both Phase II and Phase III of the clinical trial. About that many have participated in the trials and received the plastic shunt—neither the patient nor the doctor knows which shunt is to be installed until the moment in the surgery when a computer tells the doctor which one to use.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>In the case of Ray Ramirez, he found out after he woke up from surgery, he got the plastic one.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>There’s new hope of a better and longer life for many patients with failing kidneys.\u003c/p>\n\u003cp>When someone’s kidneys stop working effectively to cleanse wastes from the blood, patients must have it done mechanically, using a dialysis machine to remove the blood, clean it, and send it back into the body. That process is hard on the veins because it requires such a large opening to do it.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It transitions over the period of a few months into something that’s indistinguishable from your own tissue.'\u003ccite>Jeff Lawson, Humacyte\u003c/cite>\u003c/aside>\n\u003cp>Currently, patients get a plastic tube, or shunt, surgically inserted in a vein to hold it open for dialysis. But those shunts can get infected over time, or rejected by a patient’s immune system, and in any case, they need to be replaced about every year.\u003c/p>\n\u003cp>Now researchers are testing a new kind of shunt—one made out of human tissue. It combines with a patient’s stem cells to make the device part of the patient’s body; theoretically, it could last a lifetime.\u003c/p>\n\u003cp>\u003cstrong>‘I Just Accept It’\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The first patient in California to participate in the Phase III clinical trial for the new shunt is dialysis patient Raymond Ramirez. (A Phase III clinical trial is the stage of research required before submitting a treatment for FDA approval.)\u003c/p>\n\u003cp>The 67-year-old resident of Whittier, Calif., just east of Los Angeles, says he’s a bit of a train wreck. He’s in a wheelchair because of an above-the-knee amputation on his right leg, and he stops rolling around his TV room for a minute to list some of his maladies.\u003c/p>\n\u003cfigure id=\"attachment_260201\" class=\"wp-caption aligncenter\" style=\"max-width: 3264px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/stemcells2.jpg\">\u003cimg class=\"size-full wp-image-260201\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/stemcells2.jpg\" alt=\"The most challenging of Ray Ramirez's health problems right now is his kidney disease, because his veins are failing, making dialysis difficult.\" width=\"3264\" height=\"2448\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2.jpg 3264w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-800x600.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-768x576.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-1180x885.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-1920x1440.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/stemcells2-960x720.jpg 960w\" sizes=\"(max-width: 3264px) 100vw, 3264px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">The most challenging of Ray Ramirez's health problems right now is his kidney disease, because his veins are failing, making dialysis difficult. \u003ccite>(David Gorn/KQED)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“Omigod, it’s never-ending,” he says with a laugh. “In Vietnam, when I got wounded, they took out my ribs. So, on my left side, my ribs they’re just gone.” He has to think a minute for more.\u003c/p>\n\u003cp>“I’ve had intestinal problems, I’ve had bladder cancer, a tumor in my bladder,” he says, “I have a blind eye in my right eye. Blood clot in my retina.\"\u003c/p>\n\u003cp>Ramirez says he’s not one of those guys who likes to dwell on his problems.\u003c/p>\n\u003cp>“I’ve always been a happy guy,” he says. “I don’t like it, no, hell no, it hurts. I’ve hurt like crazy since I was a youngster. I just accept it.”\u003c/p>\n\u003cp>Right now, the big challenge for Ramirez is dialysis, because his veins are failing. And that's how he ended up in the Veterans Affairs Hospital in Long Beach on a recent day for an appointment with vascular surgeon Ian Gordon. Since the Phase III study is randomized, Ramirez has a 50-50 of getting the experimental human tissue shunt or the traditional plastic one.\u003c/p>\n\u003cp>\u003cstrong>How Does the Shunt Work?\u003c/strong>\u003c/p>\n\u003cp>Imagine one of those long foam noodles kids play with in the pool—hollow and kind of like cellulose—only it’s the diameter of your little finger. That’s what the shunts look like. But it’s an intricate process to get them to that stage.\u003c/p>\n\u003caside class=\"pullquote alignright\">'One of the holy grails, if you can use that phrase, in vascular surgery is to come up with a prosthetic artificial graft that has the same properties as the patient’s own blood vessels.'\u003ccite>Dr. Ian Gordon,\u003cbr>\nVA Hospital, Long Beach\u003c/cite>\u003c/aside>\n\u003cp>First, you take human muscle cells from organ donors, and grow them into a tubular shape, says Jeff Lawson, chief medical officer at Humacyte, the North Carolina company that makes these things. As they grow, the cells secrete a sticky form of cellulose that holds them in the shape.\u003c/p>\n\u003cp>“So what’s left then is a scaffold of human tissue,” Lawson says. “We call it human extracellular matrix.”\u003c/p>\n\u003cp>Then you use a chemical wash to slough off the original donor cells, leaving the sticky cellulose structure behind—the foam noodle the diameter of your pinky finger.\u003c/p>\n\u003cp>The stem cell part of the equation, Lawson says, happens inside the patient.\u003c/p>\n\u003cp>“This scaffold, once implanted, uniquely becomes repopulated with their own stem cells,\" he says. \"That then turns back into something that looks like a vascular cell. And it now transitions over the period of a few months into something that’s indistinguishable from your own tissue.”\u003c/p>\n\u003cp>If it works, applications of this technology are endless, says Dr. Gordon, from vein replacement to heart surgery.\u003c/p>\n\u003cp>“One of the holy grails, if you can use that phrase, in vascular surgery is to come up with a prosthetic artificial graft,” he says, “that has the same properties as the patient’s own blood vessels.”\u003c/p>\n\u003cp>So far, this one seems to do that.\u003c/p>\n\u003cp>\u003cstrong>A Voter Mandate to Get Results\u003c/strong>\u003c/p>\n\u003cp>This is the kind of success the state stem cell agency was aiming for, when California voters created it in 2004 by approving Proposition 71. The California Institute for Regenerative Medicine (CIRM), based in Oakland, now has just four years of funding left, and is putting more money into mature clinical trials.\u003c/p>\n\u003cp>While many people think of stem cell therapy as an a treatment that injects the cells into a patient’s body, there are other types of treatments that rely on stem cells.\u003c/p>\n\u003cp>“At CIRM we’re interested in anything that involves or uses stem cells in the correction of a disease process,” says CIRM CEO Randall Mills. “About a quarter of our portfolio product itself isn’t a stem cell.”\u003c/p>\n\u003cp>There are a couple of important reasons for CIRM’s move to fund more clinical studies, says UC-San Diego’s director of stem cell research, Larry Goldstein\u003c/p>\n\u003cp>“Ten years ago I don’t think there were that many projects that were really ready for clinical trials,” Goldstein said. “The field itself has developed projects that are at clinical stage.”\u003c/p>\n\u003cp>And, Goldstein says, the voters who created the agency wanted it to produce results.\u003c/p>\n\u003cp>“The voter mandate was more than just basic research,\" he says, \"it was basic plus clinical.”\u003c/p>\n\u003cp>If the agency keeps pumping out these types of clinical results, Goldstein says, California voters may soon see another ballot measure to keep it going.\u003c/p>\n\u003cp>Humacyte officials say 118 patients around the world have received the new type of human tissue shunt – in both Phase II and Phase III of the clinical trial. About that many have participated in the trials and received the plastic shunt—neither the patient nor the doctor knows which shunt is to be installed until the moment in the surgery when a computer tells the doctor which one to use.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In the case of Ray Ramirez, he found out after he woke up from surgery, he got the plastic one.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>A couple of weeks ago, it was a \u003ca href=\"http://jama.jamanetwork.com/article.aspx?articleid=2553448\" target=\"_blank\">study\u003c/a> published in JAMA, the Journal of the American Medical Association, that found an activity tracker \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/09/20/weight-loss-study-finds-fitness-tracker-is-no-help/\" target=\"_blank\">failed to help users lose weight\u003c/a>.\u003c/p>\n\u003cp>Next came headlines like \"\u003ca class=\"_sQb\" href=\"http://www.cosmopolitan.com/health-fitness/a3617025/fitness-trackers-dont-help-you-lose-weight-after-all/\" target=\"_blank\">Fitness Trackers Don't Help You Lose Weight, After All\u003c/a>\" (in Cosmo, no less).\u003c/p>\n\u003caside class=\"pullquote alignright\">Study finds no improvement in health of Fitbit Zip users. But are the results translatable to real life?\u003c/aside>\n\u003cp>Now The Lancet Diabetes & Endocrinology has published a \u003ca href=\"http://www.thelancet.com/journals/landia/article/PIIS2213-8587(16)30284-4/fulltext\" target=\"_blank\">study\u003c/a> that found individuals who got cash or charity donation incentives to wear a Fitbit Zip activity tracker showed, after one year, no improvement in weight, blood pressure and other fitness measures\u003ca href=\"https://www.google.com/search?q=maximum+oxygen+consumption\" target=\"_blank\">.\u003c/a>\u003c/p>\n\u003cp>The study recruited 800 employees, aged 21-65, from 13 different companies in Singapore. It was designed to measure the Fitbits' impacts on health outcomes and how financial incentives affected peoples' use of the device.\u003c/p>\n\u003cp>Participants were randomly placed in four different groups, two of which were given the Fitbits plus weekly financial incentives, with a high of $30 awarded for logging 70,000 or more steps. Participants in one of the cash-incentive groups could keep the money; people in the other had to donate it to a charity of their choice. A third group got the Fitbit Zip and access to Fitbit's website but no incentives; and the fourth, a control group, was given no trackers, just some information about exercise.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The people who got to pocket the cash or donate it to charity logged more daily steps each week than the people in the non-incentivized groups. The cash group also saw a significantly smaller attrition rate -- after six months, just 12 percent of that group had stopped wearing the devices.\u003c/p>\n\u003cp>\u003cstrong>No Cash, No Fitbit\u003c/strong>\u003c/p>\n\u003cp>But the incentives stopped at the six-month mark. Over the six months after that, by the end of a full year from the study's start, 90 percent of participants in all groups had stopped wearing the devices.\u003c/p>\n\u003cp>And ... no one had a significant improvement in any health measure.\u003c/p>\n\u003cp>The researchers attributed the lack of improved health to the reality that an increase in steps does not necessarily translate to much of a boost in moderate-intensity and vigorous-intensity physical activity.\u003c/p>\n\u003cp>So what is the conclusion here?\u003c/p>\n\u003cp>\"Although other incentive strategies might generate greater increases in step activity and improvements in health outcomes,\" the researchers wrote, \"incentives would probably need to be in place long term to avoid any potential decrease in physical activity resulting from discontinuation.\"\u003c/p>\n\u003cp>The lack of any observable health benefits from use of the trackers, they wrote, called into question \"the value of these devices for health promotion.\"\u003c/p>\n\u003cp>\u003cstrong>Not So Fast ...\u003c/strong>\u003c/p>\n\u003cp>A different \u003ca href=\"http://preview.thenewsmarket.com/Previews/JOUR/DocumentAssets/448807.pdf\" target=\"_blank\">study\u003c/a> we mentioned earlier, published in \u003cem>JAMA \u003c/em>last month, found that those who were put on a weight-loss plan encompassing diet, exercise and counseling actually \u003cem>lost more weight\u003c/em> than those who were given the same plus a fitness tracker. That didn't look too good for Team Digital Health.\u003c/p>\n\u003cp>But not everyone thought the study was relevant. Aaron Coleman, founder and CEO of Fitabase, a company that makes data tools \"which make Fitbits awesome in research,\" published a \u003ca href=\"https://medium.com/@aaroncoleman/its-not-time-to-throw-away-your-fitbit-but-it-is-time-to-rethink-how-to-do-research-94dc498eb63f#.iy10v11qg\">piece\u003c/a> on Medium criticizing news reports that failed to note that the device the users gave participants is now obsolete.\u003c/p>\n\u003cblockquote>\u003cp>The problem? The device used in the intervention bears no resemblance to a “wearable” as we’d call it today. It was ... a discontinued, very clunky, very clinical looking arm strap and sensor brick called the Bodymedia FIT Core.\u003c/p>\n\u003cp id=\"7802\" class=\"graf graf--p graf-after--figure\">Even the amount of data collected in the study suggests that the term “wearable” may be a bit of a stretch, as on the days that participants wore the device, the median wear time was 4 hours (241.1 min/d to be exact).\u003c/p>\n\u003cp>To equate the user experience of today’s modern wearables, as many have done with this, got me a little sarcastic…\u003c/p>\u003c/blockquote>\n\u003cblockquote class=\"twitter-tweet\">\n\u003cp dir=\"ltr\" lang=\"en\">And in other news, online social networks don't work according to a new study of 300 people given MySpace accounts. \u003ca href=\"https://t.co/1J8GvdIP37\">https://t.co/1J8GvdIP37\u003c/a>\u003c/p>\n\u003cp>— Aaron Coleman (@aaronc) \u003ca href=\"https://twitter.com/aaronc/status/778594171036676096\">September 21, 2016\u003c/a>\u003c/p>\u003c/blockquote>\n\u003cp>But the study in \u003cem>The Lancet Diabetes & Endocrinology\u003c/em> does, indeed, use a newer if not the most advanced tracker, from the \u003ca href=\"http://www.idc.com/getdoc.jsp?containerId=prUS41284516\" target=\"_blank\">leading brand\u003c/a> in mobile health. This would seem to address Coleman's main quarrel with the earlier research. So we gave him a call to ask him what he thought.\u003c/p>\n\u003cp>\"They used an actual Fitbit in the intervention, which is an improvement over the last study in terms of trying to make it applicable to modern wearables,\" he says. But he didn't think the results could be \"generalized into day-to-day Fibit wearing.\"\u003c/p>\n\u003cp>In the case of Fitbits, Coleman contends, \"There's so many other components -- a social network component and having friends involved -- that make the experience.\"\u003c/p>\n\u003cp>He says taking more steps, which is what the study incentivized, is not necessarily the right goal. (He personally uses other measures such as heart rate in his fitness regimen.) And he thought the study's design did not equate to use of the devices in the real-world.\u003c/p>\n\u003cp>\"I don't know if incentivizing and handing them a device generalizes to daily life,\" he says.\u003c/p>\n\u003cp>As for Fitbit itself, the company issued a statement last week in response to the study. \"We are confident in the positive results our millions of users have seen from using Fitbit products,\" it read. The statement went on to say the company was in the process of improving its trackers.\u003c/p>\n\u003cp>The study's lead author, Eric Finkelstein, acknowledged that some of the newer fitness wearables have more advanced features, like exercise prompts and social media functions, but he still thinks it is unlikely people will radically change their exercise regimes without a more comprehensive approach.\u003c/p>\n\u003cp>“These trackers can encourage people to take more steps, but it still seems like these random extra steps aren’t enough to really improve your health,” he says.\u003c/p>\n\u003cp>Emmanuel Stamatakis, a physical activity expert at the University of Sydney, who was not part of the study, agreed. \"We should not be so naive to believe that simply by giving a sleek-looking gadget to someone, they will change deeply rooted lifestyle habits,\" he says.\u003c/p>\n\u003cp>In the meantime, Fitbit last week released a \u003ca href=\"https://www.springbuk.com/wearable-study/#top\" target=\"_blank\">case study \u003c/a>that it says shows employers can save money in health care costs if employees use the company's devices. The Verge critiques that study \u003ca href=\"http://www.theverge.com/2016/10/5/13176236/fitbit-study-corporate-wellness-health-care-savings\" target=\"_blank\">here\u003c/a>.\u003c/p>\n\u003cp>Fitabase also last week made public a \"\u003ca href=\"https://www.fitabase.com/research-library/\" target=\"_blank\">Fitbit Research Library\u003c/a>\" with 167 studies assessing or using the devices.\u003c/p>\n\u003cp>\u003cem>Associated Press contributed to this report.\u003c/em>\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp> \u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>A couple of weeks ago, it was a \u003ca href=\"http://jama.jamanetwork.com/article.aspx?articleid=2553448\" target=\"_blank\">study\u003c/a> published in JAMA, the Journal of the American Medical Association, that found an activity tracker \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/09/20/weight-loss-study-finds-fitness-tracker-is-no-help/\" target=\"_blank\">failed to help users lose weight\u003c/a>.\u003c/p>\n\u003cp>Next came headlines like \"\u003ca class=\"_sQb\" href=\"http://www.cosmopolitan.com/health-fitness/a3617025/fitness-trackers-dont-help-you-lose-weight-after-all/\" target=\"_blank\">Fitness Trackers Don't Help You Lose Weight, After All\u003c/a>\" (in Cosmo, no less).\u003c/p>\n\u003caside class=\"pullquote alignright\">Study finds no improvement in health of Fitbit Zip users. But are the results translatable to real life?\u003c/aside>\n\u003cp>Now The Lancet Diabetes & Endocrinology has published a \u003ca href=\"http://www.thelancet.com/journals/landia/article/PIIS2213-8587(16)30284-4/fulltext\" target=\"_blank\">study\u003c/a> that found individuals who got cash or charity donation incentives to wear a Fitbit Zip activity tracker showed, after one year, no improvement in weight, blood pressure and other fitness measures\u003ca href=\"https://www.google.com/search?q=maximum+oxygen+consumption\" target=\"_blank\">.\u003c/a>\u003c/p>\n\u003cp>The study recruited 800 employees, aged 21-65, from 13 different companies in Singapore. It was designed to measure the Fitbits' impacts on health outcomes and how financial incentives affected peoples' use of the device.\u003c/p>\n\u003cp>Participants were randomly placed in four different groups, two of which were given the Fitbits plus weekly financial incentives, with a high of $30 awarded for logging 70,000 or more steps. Participants in one of the cash-incentive groups could keep the money; people in the other had to donate it to a charity of their choice. A third group got the Fitbit Zip and access to Fitbit's website but no incentives; and the fourth, a control group, was given no trackers, just some information about exercise.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The people who got to pocket the cash or donate it to charity logged more daily steps each week than the people in the non-incentivized groups. The cash group also saw a significantly smaller attrition rate -- after six months, just 12 percent of that group had stopped wearing the devices.\u003c/p>\n\u003cp>\u003cstrong>No Cash, No Fitbit\u003c/strong>\u003c/p>\n\u003cp>But the incentives stopped at the six-month mark. Over the six months after that, by the end of a full year from the study's start, 90 percent of participants in all groups had stopped wearing the devices.\u003c/p>\n\u003cp>And ... no one had a significant improvement in any health measure.\u003c/p>\n\u003cp>The researchers attributed the lack of improved health to the reality that an increase in steps does not necessarily translate to much of a boost in moderate-intensity and vigorous-intensity physical activity.\u003c/p>\n\u003cp>So what is the conclusion here?\u003c/p>\n\u003cp>\"Although other incentive strategies might generate greater increases in step activity and improvements in health outcomes,\" the researchers wrote, \"incentives would probably need to be in place long term to avoid any potential decrease in physical activity resulting from discontinuation.\"\u003c/p>\n\u003cp>The lack of any observable health benefits from use of the trackers, they wrote, called into question \"the value of these devices for health promotion.\"\u003c/p>\n\u003cp>\u003cstrong>Not So Fast ...\u003c/strong>\u003c/p>\n\u003cp>A different \u003ca href=\"http://preview.thenewsmarket.com/Previews/JOUR/DocumentAssets/448807.pdf\" target=\"_blank\">study\u003c/a> we mentioned earlier, published in \u003cem>JAMA \u003c/em>last month, found that those who were put on a weight-loss plan encompassing diet, exercise and counseling actually \u003cem>lost more weight\u003c/em> than those who were given the same plus a fitness tracker. That didn't look too good for Team Digital Health.\u003c/p>\n\u003cp>But not everyone thought the study was relevant. Aaron Coleman, founder and CEO of Fitabase, a company that makes data tools \"which make Fitbits awesome in research,\" published a \u003ca href=\"https://medium.com/@aaroncoleman/its-not-time-to-throw-away-your-fitbit-but-it-is-time-to-rethink-how-to-do-research-94dc498eb63f#.iy10v11qg\">piece\u003c/a> on Medium criticizing news reports that failed to note that the device the users gave participants is now obsolete.\u003c/p>\n\u003cblockquote>\u003cp>The problem? The device used in the intervention bears no resemblance to a “wearable” as we’d call it today. It was ... a discontinued, very clunky, very clinical looking arm strap and sensor brick called the Bodymedia FIT Core.\u003c/p>\n\u003cp id=\"7802\" class=\"graf graf--p graf-after--figure\">Even the amount of data collected in the study suggests that the term “wearable” may be a bit of a stretch, as on the days that participants wore the device, the median wear time was 4 hours (241.1 min/d to be exact).\u003c/p>\n\u003cp>To equate the user experience of today’s modern wearables, as many have done with this, got me a little sarcastic…\u003c/p>\u003c/blockquote>\n\u003cblockquote class=\"twitter-tweet\">\n\u003cp dir=\"ltr\" lang=\"en\">And in other news, online social networks don't work according to a new study of 300 people given MySpace accounts. \u003ca href=\"https://t.co/1J8GvdIP37\">https://t.co/1J8GvdIP37\u003c/a>\u003c/p>\n\u003cp>— Aaron Coleman (@aaronc) \u003ca href=\"https://twitter.com/aaronc/status/778594171036676096\">September 21, 2016\u003c/a>\u003c/p>\u003c/blockquote>\n\u003cp>But the study in \u003cem>The Lancet Diabetes & Endocrinology\u003c/em> does, indeed, use a newer if not the most advanced tracker, from the \u003ca href=\"http://www.idc.com/getdoc.jsp?containerId=prUS41284516\" target=\"_blank\">leading brand\u003c/a> in mobile health. This would seem to address Coleman's main quarrel with the earlier research. So we gave him a call to ask him what he thought.\u003c/p>\n\u003cp>\"They used an actual Fitbit in the intervention, which is an improvement over the last study in terms of trying to make it applicable to modern wearables,\" he says. But he didn't think the results could be \"generalized into day-to-day Fibit wearing.\"\u003c/p>\n\u003cp>In the case of Fitbits, Coleman contends, \"There's so many other components -- a social network component and having friends involved -- that make the experience.\"\u003c/p>\n\u003cp>He says taking more steps, which is what the study incentivized, is not necessarily the right goal. (He personally uses other measures such as heart rate in his fitness regimen.) And he thought the study's design did not equate to use of the devices in the real-world.\u003c/p>\n\u003cp>\"I don't know if incentivizing and handing them a device generalizes to daily life,\" he says.\u003c/p>\n\u003cp>As for Fitbit itself, the company issued a statement last week in response to the study. \"We are confident in the positive results our millions of users have seen from using Fitbit products,\" it read. The statement went on to say the company was in the process of improving its trackers.\u003c/p>\n\u003cp>The study's lead author, Eric Finkelstein, acknowledged that some of the newer fitness wearables have more advanced features, like exercise prompts and social media functions, but he still thinks it is unlikely people will radically change their exercise regimes without a more comprehensive approach.\u003c/p>\n\u003cp>“These trackers can encourage people to take more steps, but it still seems like these random extra steps aren’t enough to really improve your health,” he says.\u003c/p>\n\u003cp>Emmanuel Stamatakis, a physical activity expert at the University of Sydney, who was not part of the study, agreed. \"We should not be so naive to believe that simply by giving a sleek-looking gadget to someone, they will change deeply rooted lifestyle habits,\" he says.\u003c/p>\n\u003cp>In the meantime, Fitbit last week released a \u003ca href=\"https://www.springbuk.com/wearable-study/#top\" target=\"_blank\">case study \u003c/a>that it says shows employers can save money in health care costs if employees use the company's devices. The Verge critiques that study \u003ca href=\"http://www.theverge.com/2016/10/5/13176236/fitbit-study-corporate-wellness-health-care-savings\" target=\"_blank\">here\u003c/a>.\u003c/p>\n\u003cp>Fitabase also last week made public a \"\u003ca href=\"https://www.fitabase.com/research-library/\" target=\"_blank\">Fitbit Research Library\u003c/a>\" with 167 studies assessing or using the devices.\u003c/p>\n\u003cp>\u003cem>Associated Press contributed to this report.\u003c/em>\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>The noose is drawing ever-tighter around Theranos. The Wall Street Journal is reporting the San Francisco hedge fund \u003ca href=\"http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=24258473\" target=\"_blank\">Partner Fund Management\u003c/a> is suing the company and its founder, Elizabeth Holmes, for \"engaging in securities fraud and other violations,\" according to a document reviewed by the Journal. The fund has invested nearly $100 million in Theranos, the paper says.\u003c/p>\n\u003cp>The company is already being sued by patients seeking class-action status in complaints related to inaccurate blood tests.\u003c/p>\n\u003cp>Last week, Theranos said it was \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/05/theranos-labs/\" target=\"_blank\">getting out of the consumer blood-testing business\u003c/a>, shutting down a handful of remaining blood-testing centers and shuttering its labs.\u003c/p>\n\u003cp>Read the Journal story below ...\u003c/p>\n\u003cp>http://www.wsj.com/articles/major-investor-sues-theranos-1476139613\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The noose is drawing ever-tighter around Theranos. The Wall Street Journal is reporting the San Francisco hedge fund \u003ca href=\"http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=24258473\" target=\"_blank\">Partner Fund Management\u003c/a> is suing the company and its founder, Elizabeth Holmes, for \"engaging in securities fraud and other violations,\" according to a document reviewed by the Journal. The fund has invested nearly $100 million in Theranos, the paper says.\u003c/p>\n\u003cp>The company is already being sued by patients seeking class-action status in complaints related to inaccurate blood tests.\u003c/p>\n\u003cp>Last week, Theranos said it was \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/05/theranos-labs/\" target=\"_blank\">getting out of the consumer blood-testing business\u003c/a>, shutting down a handful of remaining blood-testing centers and shuttering its labs.\u003c/p>\n\u003cp>Read the Journal story below ...\u003c/p>\n\u003cp>http://www.wsj.com/articles/major-investor-sues-theranos-1476139613\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp>Rini Kramer-Carter has tried everything to pull herself out of her dark emotional hole: individual therapy, support groups, tai chi and numerous antidepressants.\u003c/p>\n\u003cp>The 73-year-old Los Angeles musician rattles off the list: Prozac, Cymbalta, Lexapro.\u003c/p>\n\u003cp>“I’ve been on a bunch,” she said. “I still cry all the time.”\u003c/p>\n\u003cp>She has what’s known as “treatment-resistant depression.” It’s commonly defined as depression that doesn’t respond to two different medications when taken one after the other, at the right dose and for the right amount of time.\u003c/p>\n\u003cp>\u003cimg class=\"aligncenter size-medium wp-image-224252\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/08/DepressedMan-800x453.jpg\" alt=\"DepressedMan\" width=\"800\" height=\"453\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-800x453.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-400x227.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-768x435.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-1180x669.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-960x544.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Nearly 16 million adults have major depression, and up to \u003ca href=\"http://www.ajgponline.org/article/S1064-7481%2816%2930126-9/fulltext?rss=yes\">a third\u003c/a> do not respond to treatment. The disease afflicts people of all ages, but experts say that as many as half of older adults don’t get better with standard treatment.\u003c/p>\n\u003cp>Mental health experts expect treatment-resistant depression to become more widespread as baby boomers age. Boomers already have been identified as having \u003ca href=\"http://www.gallup.com/poll/181364/reports-depression-treatment-highest-among-baby-boomers.aspx\">higher rates\u003c/a> of depression than previous generations, and over time their depression may no longer respond to medication.\u003c/p>\n\u003cp>“We are seeing treatment-resistant depression more, and we are recognizing it more,” said Helen Lavretsky, a geriatric psychiatrist at UCLA. “And in older adults, the answer to understanding what it is and what to do about it is more complicated than in younger adults.”\u003c/p>\n\u003cp>The consequences among older adults can be devastating. Persistent depression can raise the risk of early death and suicide, expedite memory decline and lead to a loss of independence.\u003c/p>\n\u003cp>\u003cstrong>Why Antidepressants Aren't Enough\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cp>The phenomenon isn’t well studied, but psychiatrists believe there are several reasons why depression in older adults may not respond to treatment. For one thing, if a person has been depressed and taken different medications for a long time, it can diminish their effectiveness. Patients also may neglect to take their medication as prescribed, because they have memory problems or they believe they no longer need it.\u003c/p>\n\u003cp>“Sometimes people say, ‘I’m better. I don’t need this,’ and stop the medicine,” said Anthony P. Weiner, who directs outpatient geriatric psychiatry at Massachusetts General Hospital. “Then the symptoms recur … and if the person goes back on the medicine, it may not be fully effective.”\u003c/p>\n\u003cp>Seniors are also more likely to have chronic medical illnesses, which raises the risk of depression. Their illnesses may make it more difficult for them to recover from depression. And it can mask whether antidepressants are working, because symptoms of chronic illness can be mistaken for depression — and vice versa.\u003c/p>\n\u003cp>Poverty, isolation, pain, grief over the loss of a spouse, or being a caregiver can also lead to or intensify a senior’s depression. And no matter what medication the patients take, Lavretsky noted, those external factors don’t go away.\u003c/p>\n\u003cp>“Either they change their perspective or they change their circumstances, or the depression just persists,” she said.\u003c/p>\n\u003cp>\u003cimg class=\"aligncenter size-medium wp-image-225685\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/08/depressedwomanrain-800x473.jpg\" alt=\"depressedwomanrain\" width=\"800\" height=\"473\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-800x473.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-400x236.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-768x454.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-1180x698.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-960x568.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/p>\n\u003cp>Antidepressants can help seniors gain some perspective. But Lavretsky and others agree that even if the medications are effective, they shouldn’t be used in isolation. “It’s an emotional experience,” Weiner said. “The whole answer isn’t just, ‘Oh, here take a pill.’ There is such a central role for psychotherapy.”\u003c/p>\n\u003cp>Kramer-Carter, who speaks slowly and hugs everyone she meets, has felt depressed for as long as she can remember. As a young adult, she worked as a secretary and a proofreader but got fired more than once because she had trouble getting out of bed and making it to work on time. She went to the emergency room many times and in her 30s, she was diagnosed with depression.\u003c/p>\n\u003cp>Now, she spends a few days each week driving her husband, Eugene Carter, to medical appointments. When she feels up to it, she volunteers delivering food to poor families.\u003c/p>\n\u003cp>Kramer-Carter checks all the boxes for being at high-risk of treatment-resistant depression. She is a long-time caregiver, first for her parents and now for her husband, a stroke survivor with short-term memory problems. Her own list of health problems is long: diabetes, high blood pressure, arthritis, fibromyalgia and gout.\u003c/p>\n\u003cp>“Who wants to be aching all the time?” she said.\u003c/p>\n\u003caside class=\"pullquote alignright\">'If I can stay in bed all day, that’s what I do.'\u003ccite>Rini Kramer-Carter\u003c/cite>\u003c/aside>\n\u003cp>Money problems don’t help either. The couple depends financially on Social Security. If she had more money, she said she would go to the theater or see live concerts. She misses both.\u003c/p>\n\u003cp>“We wouldn’t be so stuck,” she said. As it is, they spend everything on food, rent and other bills.\u003c/p>\n\u003cp>“It’s a constant struggle,” she said. “You have to borrow from Peter to pay Paul.”\u003c/p>\n\u003cp>Despite the prevalence of treatment-resistant depression, \u003ca href=\"http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3363299/\" target=\"_blank\">few resources\u003c/a> exist to help psychiatrists make treatment decisions. Clinical trials have been scant, and there are no universally accepted protocols for the condition. The risks and benefits of different medications for older adults are largely unknown.\u003c/p>\n\u003cp>Given a shortage of geriatric psychiatrists, decisions on treatment are often left to primary care providers, who may not have relevant training or might be reluctant to take on such complicated care.\u003c/p>\n\u003cp>Doctors with patients who don’t respond to traditional therapies frequently make ad hoc decisions about whether to change the dosage, add a medication or switch to a new one.\u003c/p>\n\u003cp>“The clinicians use their best experience and trial and error,” said Evelyn Whitlock, chief science officer at the Patient-Centered Outcomes Research Institute. “They try something, and if it doesn’t work, they try something else.”\u003c/p>\n\u003cp>Trial and error is not ideal, she said. Many of these people have been living with depression for so many years, and providers need to be able to provide them with effective treatment.\u003c/p>\n\u003cp>\u003cstrong>New Approaches\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cp>In an effort to produce better medical outcomes for people with treatment-resistant depression, the Patient-Centered Outcomes Research Institute announced in July that it was funding \u003ca href=\"http://www.pcori.org/news-release/pcori-board-approves-40-million-improving-treatment-options-depression\" target=\"_blank\">three major studies\u003c/a> that will test different approaches to the illness. The goal of the research is to produce tangible evidence that can be used immediately to help patients and their doctors make more informed treatment decisions. [contextly_sidebar id=\"QvUjqDKFRFEtGPmtPTeoqpzPvYGJtv45\"]\u003c/p>\n\u003cp>The Washington, D.C. nonprofit, which finances health research, earmarked $40 million for the five-year studies, which it expects to begin this fall. They will include more than 2,500 patients at sites in California, Ohio, New York, Texas, Pennsylvania and elsewhere.\u003c/p>\n\u003cp>One of the studies will examine electroconvulsive therapy — its impact on quality of life and its potential for relieving the symptoms. Another will compare the effectiveness and safety of three strategies — using magnetic fields to stimulate nerve cells in the brain, adding an antipsychotic medication or switching to a specific antidepressant. The research will assess how these approaches affect the patients’ ability to function at home and work.\u003c/p>\n\u003cp>The third and largest study, with about 1,500 patients, will focus specifically on older adults, testing different drugs and studying how aging affects the risk and benefits of antidepressants. UCLA, where Kramer-Carter is being treated, is part of the third study, which will weigh life circumstances and disabilities in addition to depression.\u003c/p>\n\u003cp>The grants represent an “unprecedented opportunity to look at this population,” Lavretsky said.\u003c/p>\n\u003cp>“It will be a comprehensive look at the condition, why it happens and what are the ways of alleviating suffering,” she said. “Are there some similarities among all people with treatment-resistant depression? I suspect we will find some.”\u003c/p>\n\u003cp>On a recent afternoon, Rini Kramer-Carter visited Lavretsky at UCLA. She said the only time she truly escapes her sadness is when she plays percussion along with other musicians. But she hasn’t been playing lately, and she has been sleeping up to 20 hours a day.\u003c/p>\n\u003cp>\u003cimg class=\"size-medium wp-image-257360\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Prozac-428x600.jpg\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/Prozac-428x600.jpg 428w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Prozac-400x560.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Prozac.jpg 731w\" sizes=\"(max-width: 428px) 100vw, 428px\">\u003c/p>\n\u003cp>“If I can stay in bed all day, that’s what I do,” she said.\u003c/p>\n\u003cp>Sometimes she watches TV comedies to try to dissipate her black moods.\u003c/p>\n\u003cp>Kramer-Carter said she learned about Lavretsky after seeing a newspaper ad for another research study, of a drug typically used to treat early-stage dementia. During their appointment, Lavretsky went over a list of questions included in the study. “On a scale of zero to 10, where do you place yourself in terms of depression?” the doctor asked her. Nine, she responded.\u003c/p>\n\u003cp>She told Lavretsky she sometimes felt restless and anxious, but not suicidal.\u003c/p>\n\u003cp>“Do you feel full of energy?” Lavretsky asked.\u003c/p>\n\u003cp>“Do I look like I am full of energy?” she responded with a sigh.\u003c/p>\n\u003cp>Lavretsky told her that no pill will completely fix her problems, but medication might give her more energy and the ability to cope. Kramer-Carter said she knows a drug won’t produce any miracles. She just wants some relief.\u003c/p>\n\u003cp>“I just want to be able to live my life,” she said.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"http://kff.org/\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Rini Kramer-Carter has tried everything to pull herself out of her dark emotional hole: individual therapy, support groups, tai chi and numerous antidepressants.\u003c/p>\n\u003cp>The 73-year-old Los Angeles musician rattles off the list: Prozac, Cymbalta, Lexapro.\u003c/p>\n\u003cp>“I’ve been on a bunch,” she said. “I still cry all the time.”\u003c/p>\n\u003cp>She has what’s known as “treatment-resistant depression.” It’s commonly defined as depression that doesn’t respond to two different medications when taken one after the other, at the right dose and for the right amount of time.\u003c/p>\n\u003cp>\u003cimg class=\"aligncenter size-medium wp-image-224252\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/08/DepressedMan-800x453.jpg\" alt=\"DepressedMan\" width=\"800\" height=\"453\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-800x453.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-400x227.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-768x435.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-1180x669.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/DepressedMan-960x544.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Nearly 16 million adults have major depression, and up to \u003ca href=\"http://www.ajgponline.org/article/S1064-7481%2816%2930126-9/fulltext?rss=yes\">a third\u003c/a> do not respond to treatment. The disease afflicts people of all ages, but experts say that as many as half of older adults don’t get better with standard treatment.\u003c/p>\n\u003cp>Mental health experts expect treatment-resistant depression to become more widespread as baby boomers age. Boomers already have been identified as having \u003ca href=\"http://www.gallup.com/poll/181364/reports-depression-treatment-highest-among-baby-boomers.aspx\">higher rates\u003c/a> of depression than previous generations, and over time their depression may no longer respond to medication.\u003c/p>\n\u003cp>“We are seeing treatment-resistant depression more, and we are recognizing it more,” said Helen Lavretsky, a geriatric psychiatrist at UCLA. “And in older adults, the answer to understanding what it is and what to do about it is more complicated than in younger adults.”\u003c/p>\n\u003cp>The consequences among older adults can be devastating. Persistent depression can raise the risk of early death and suicide, expedite memory decline and lead to a loss of independence.\u003c/p>\n\u003cp>\u003cstrong>Why Antidepressants Aren't Enough\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cp>The phenomenon isn’t well studied, but psychiatrists believe there are several reasons why depression in older adults may not respond to treatment. For one thing, if a person has been depressed and taken different medications for a long time, it can diminish their effectiveness. Patients also may neglect to take their medication as prescribed, because they have memory problems or they believe they no longer need it.\u003c/p>\n\u003cp>“Sometimes people say, ‘I’m better. I don’t need this,’ and stop the medicine,” said Anthony P. Weiner, who directs outpatient geriatric psychiatry at Massachusetts General Hospital. “Then the symptoms recur … and if the person goes back on the medicine, it may not be fully effective.”\u003c/p>\n\u003cp>Seniors are also more likely to have chronic medical illnesses, which raises the risk of depression. Their illnesses may make it more difficult for them to recover from depression. And it can mask whether antidepressants are working, because symptoms of chronic illness can be mistaken for depression — and vice versa.\u003c/p>\n\u003cp>Poverty, isolation, pain, grief over the loss of a spouse, or being a caregiver can also lead to or intensify a senior’s depression. And no matter what medication the patients take, Lavretsky noted, those external factors don’t go away.\u003c/p>\n\u003cp>“Either they change their perspective or they change their circumstances, or the depression just persists,” she said.\u003c/p>\n\u003cp>\u003cimg class=\"aligncenter size-medium wp-image-225685\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/08/depressedwomanrain-800x473.jpg\" alt=\"depressedwomanrain\" width=\"800\" height=\"473\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-800x473.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-400x236.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-768x454.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-1180x698.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/08/depressedwomanrain-960x568.jpg 960w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003c/p>\n\u003cp>Antidepressants can help seniors gain some perspective. But Lavretsky and others agree that even if the medications are effective, they shouldn’t be used in isolation. “It’s an emotional experience,” Weiner said. “The whole answer isn’t just, ‘Oh, here take a pill.’ There is such a central role for psychotherapy.”\u003c/p>\n\u003cp>Kramer-Carter, who speaks slowly and hugs everyone she meets, has felt depressed for as long as she can remember. As a young adult, she worked as a secretary and a proofreader but got fired more than once because she had trouble getting out of bed and making it to work on time. She went to the emergency room many times and in her 30s, she was diagnosed with depression.\u003c/p>\n\u003cp>Now, she spends a few days each week driving her husband, Eugene Carter, to medical appointments. When she feels up to it, she volunteers delivering food to poor families.\u003c/p>\n\u003cp>Kramer-Carter checks all the boxes for being at high-risk of treatment-resistant depression. She is a long-time caregiver, first for her parents and now for her husband, a stroke survivor with short-term memory problems. Her own list of health problems is long: diabetes, high blood pressure, arthritis, fibromyalgia and gout.\u003c/p>\n\u003cp>“Who wants to be aching all the time?” she said.\u003c/p>\n\u003caside class=\"pullquote alignright\">'If I can stay in bed all day, that’s what I do.'\u003ccite>Rini Kramer-Carter\u003c/cite>\u003c/aside>\n\u003cp>Money problems don’t help either. The couple depends financially on Social Security. If she had more money, she said she would go to the theater or see live concerts. She misses both.\u003c/p>\n\u003cp>“We wouldn’t be so stuck,” she said. As it is, they spend everything on food, rent and other bills.\u003c/p>\n\u003cp>“It’s a constant struggle,” she said. “You have to borrow from Peter to pay Paul.”\u003c/p>\n\u003cp>Despite the prevalence of treatment-resistant depression, \u003ca href=\"http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3363299/\" target=\"_blank\">few resources\u003c/a> exist to help psychiatrists make treatment decisions. Clinical trials have been scant, and there are no universally accepted protocols for the condition. The risks and benefits of different medications for older adults are largely unknown.\u003c/p>\n\u003cp>Given a shortage of geriatric psychiatrists, decisions on treatment are often left to primary care providers, who may not have relevant training or might be reluctant to take on such complicated care.\u003c/p>\n\u003cp>Doctors with patients who don’t respond to traditional therapies frequently make ad hoc decisions about whether to change the dosage, add a medication or switch to a new one.\u003c/p>\n\u003cp>“The clinicians use their best experience and trial and error,” said Evelyn Whitlock, chief science officer at the Patient-Centered Outcomes Research Institute. “They try something, and if it doesn’t work, they try something else.”\u003c/p>\n\u003cp>Trial and error is not ideal, she said. Many of these people have been living with depression for so many years, and providers need to be able to provide them with effective treatment.\u003c/p>\n\u003cp>\u003cstrong>New Approaches\u003cbr>\n\u003c/strong>\u003c/p>\n\u003cp>In an effort to produce better medical outcomes for people with treatment-resistant depression, the Patient-Centered Outcomes Research Institute announced in July that it was funding \u003ca href=\"http://www.pcori.org/news-release/pcori-board-approves-40-million-improving-treatment-options-depression\" target=\"_blank\">three major studies\u003c/a> that will test different approaches to the illness. The goal of the research is to produce tangible evidence that can be used immediately to help patients and their doctors make more informed treatment decisions. \u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The Washington, D.C. nonprofit, which finances health research, earmarked $40 million for the five-year studies, which it expects to begin this fall. They will include more than 2,500 patients at sites in California, Ohio, New York, Texas, Pennsylvania and elsewhere.\u003c/p>\n\u003cp>One of the studies will examine electroconvulsive therapy — its impact on quality of life and its potential for relieving the symptoms. Another will compare the effectiveness and safety of three strategies — using magnetic fields to stimulate nerve cells in the brain, adding an antipsychotic medication or switching to a specific antidepressant. The research will assess how these approaches affect the patients’ ability to function at home and work.\u003c/p>\n\u003cp>The third and largest study, with about 1,500 patients, will focus specifically on older adults, testing different drugs and studying how aging affects the risk and benefits of antidepressants. UCLA, where Kramer-Carter is being treated, is part of the third study, which will weigh life circumstances and disabilities in addition to depression.\u003c/p>\n\u003cp>The grants represent an “unprecedented opportunity to look at this population,” Lavretsky said.\u003c/p>\n\u003cp>“It will be a comprehensive look at the condition, why it happens and what are the ways of alleviating suffering,” she said. “Are there some similarities among all people with treatment-resistant depression? I suspect we will find some.”\u003c/p>\n\u003cp>On a recent afternoon, Rini Kramer-Carter visited Lavretsky at UCLA. She said the only time she truly escapes her sadness is when she plays percussion along with other musicians. But she hasn’t been playing lately, and she has been sleeping up to 20 hours a day.\u003c/p>\n\u003cp>\u003cimg class=\"size-medium wp-image-257360\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Prozac-428x600.jpg\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/Prozac-428x600.jpg 428w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Prozac-400x560.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Prozac.jpg 731w\" sizes=\"(max-width: 428px) 100vw, 428px\">\u003c/p>\n\u003cp>“If I can stay in bed all day, that’s what I do,” she said.\u003c/p>\n\u003cp>Sometimes she watches TV comedies to try to dissipate her black moods.\u003c/p>\n\u003cp>Kramer-Carter said she learned about Lavretsky after seeing a newspaper ad for another research study, of a drug typically used to treat early-stage dementia. During their appointment, Lavretsky went over a list of questions included in the study. “On a scale of zero to 10, where do you place yourself in terms of depression?” the doctor asked her. Nine, she responded.\u003c/p>\n\u003cp>She told Lavretsky she sometimes felt restless and anxious, but not suicidal.\u003c/p>\n\u003cp>“Do you feel full of energy?” Lavretsky asked.\u003c/p>\n\u003cp>“Do I look like I am full of energy?” she responded with a sigh.\u003c/p>\n\u003cp>Lavretsky told her that no pill will completely fix her problems, but medication might give her more energy and the ability to cope. Kramer-Carter said she knows a drug won’t produce any miracles. She just wants some relief.\u003c/p>\n\u003cp>“I just want to be able to live my life,” she 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 \u003ca href=\"http://khn.org/\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"http://kff.org/\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>At age 7, Josh Hardy became the poster child for a movement to help desperately ill or dying patients access experimental therapies which, they hope, will save their lives.\u003c/p>\n\u003cp>People around the world rallied 2½ years ago when a small biotech company refused to provide the Fredericksburg, Va., boy, who had battled cancer since infancy, with an experimental drug that doctors believed could save Josh from a life-threatening infection. Within days, a social media campaign called #SaveJosh, sparked by his mother’s anguished Facebook post and propelled by well-connected supporters, spurred thousands of people to contact the company, Chimerix Inc. of North Carolina, prompting it to release the drug.\u003c/p>\n\u003cp>For a time, Josh recovered. But his body remained weakened by disease, and Josh died last month at age 10.\u003c/p>\n\u003cp>Yet the #SaveJosh campaign has had an enduring impact on efforts to expand “compassionate use” of experimental therapies.\u003c/p>\n\u003cp>Josh’s story — and the plight of thousands of others facing life-threatening diseases with no government-approved therapies — has inspired multiple, sometimes conflicting efforts by government, industry and activists to make experimental medications more widely available.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The Food and Drug Administration, whose staff initiated the clinical trial that provided Josh his medication, has reduced the time that doctors spend requesting an unapproved drug to just 45 minutes. The agency says it approves 99 percent of such applications, granting most requests in four days and emergency requests within hours. The agency is even considering hiring “navigators” to walk doctors through the process.\u003c/p>\n\u003cp>Nonetheless, some patient advocates are leading a drive to provide access to experimental drugs without the FDA’s help.\u003c/p>\n\u003cp>Thirty-two states have passed laws designed to give patients the “right to try” an unapproved medication, by protecting doctors who provide such therapies from losing their state medical licenses. Republicans have included the right to try unapproved drugs in their national presidential platform.\u003c/p>\n\u003cfigure id=\"attachment_257510\" class=\"wp-caption aligncenter\" style=\"max-width: 770px\">\u003cimg class=\"size-full wp-image-257510\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/jordanmclinn_righttotry_getty_770.jpg\" alt=\"From left, Laura McLinn, of Indianapolis, her son Jordan, 7, and Sen. Ron Johnson, R-Wis., pose for a picture. \" width=\"770\" height=\"513\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/jordanmclinn_righttotry_getty_770.jpg 770w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/jordanmclinn_righttotry_getty_770-400x266.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/jordanmclinn_righttotry_getty_770-768x512.jpg 768w\" sizes=\"(max-width: 770px) 100vw, 770px\">\u003cfigcaption class=\"wp-caption-text\">From left, Laura McLinn, of Indianapolis, her son Jordan, 7, and Sen. Ron Johnson, R-Wis., pose for a picture. \u003ccite>(Tom Williams/CQ Roll Call)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>California became the 32\u003csup>nd\u003c/sup> state to pass such a law last week when Gov. Jerry Brown signed a bill sponsored by Assemblyman Ian Calderon. Brown vetoed a similar bill last year.\u003c/p>\n\u003cp>The law, \u003ca href=\"https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160AB1668\" target=\"_blank\">Assembly Bill 1668,\u003c/a> allows terminally ill patients who have exhausted their options to access medications that have not yet been approved by the FDA. The “right to try” law also protects physicians from discipline if they treat a terminally patient with a drug that is still in trials.\u003c/p>\n\u003cp>Lina Clark and her husband, David Huntley, started advocating for right-to-try legislation in 2015 because they grew frustrated with the inability to access drugs still in the FDA approval pipeline. Huntley, who testified before legislators in Sacramento as part of their effort to change the law, died of Lou Gehrig’s disease last year.\u003c/p>\n\u003cp>“It is a very swift moving disease,” said Clark, who lives in San Diego. “That is why the right to try laws are so important. If there is a treatment that is showing great promise, you can save lives or extend lives, or at the minimum alleviate suffering.”\u003c/p>\n\u003cp>Clark said she was grateful that California and so many other states have passed the laws. “I think it’s sending a message to the FDA as well as our Congress that this is the will of the people,” she said.\u003c/p>\n\u003cp>Christina Sandefur, executive vice president at the libertarian Goldwater Institute, which has coordinated right-to-try efforts, said terminally ill patients shouldn’t have to ask for a “permission slip” from the FDA. “If you are dying and you’ve exhausted all other options and this medication has passed basic safety testing, you should be able to work directly with the drug companies and your doctor without having to go through the FDA.”\u003c/p>\n\u003caside class=\"pullquote alignright\">'If there is a treatment that is showing great promise, you can save lives or extend lives, or at the minimum alleviate suffering.'\u003ccite>Lina Clark\u003c/cite>\u003c/aside>\n\u003cp>Yet even some supporters of the right to try acknowledge the state laws have helped relatively few patients.\u003c/p>\n\u003cp>Sen. Ron Johnson (R-Wis.) chairman of the Homeland Security and Governmental Affairs Committee, introduced a federal right-to-try bill in May as a way to bolster the state initiatives. At a hearing in September, Johnson said his bill “simply says patients, who have no alternative and are facing death, should have the right to try to save their own lives — and the right to hope.”\u003c/p>\n\u003cp>\u003cstrong>Drug developers get the message\u003c/strong>\u003c/p>\n\u003cp>The renewed interest in compassionate use — which first emerged as a national issue during the AIDS crisis of the 1980s — also has spurred pharmaceutical companies to ramp up “expanded access” programs.\u003c/p>\n\u003cp>Some are concerned that social media campaigns give unfair advantages to families who are well-connected and media-savvy. Minorities, immigrants and people who aren’t fluent in English could be less able to mount effective campaigns, said Alison Bateman-House, a bioethicist at New York University Langone Medical Center. She’s been working with Johnson & Johnson to help ensure its compassionate use system allocates drugs fairly.\u003c/p>\n\u003cp>Marathon Pharmaceuticals, which is developing a steroid to treat a fatal disease called Duchenne muscular dystrophy, has been working with patient advocacy groups to enroll patients in its compassionate use program. The Illinois company anticipates enrolling 800 patients by February in its expanded access program for the steroid, called deflazacort.[contextly_sidebar id=\"iuK8vS5MXWGFCwnvt55mBoVFH47qvbl1\"]\u003c/p>\n\u003cp>While some drug developers were moved by Josh’s plight, others were motivated by a fear of negative publicity, Bateman-House said. Almost overnight, Chimerix became a symbol of corporate indifference. Critics posted the home address of Chimerix executives online, and some received death threats. The company replaced its CEO within a month of the controversy.\u003c/p>\n\u003cp>“The majority of the pharmaceutical industry suddenly got terrified that they were going to be the next Chimerix,” Bateman-House said.\u003c/p>\n\u003cp>And while drug companies tend to look like the bad guys when they deny drug access, Bateman-House said there are legitimate reasons for caution. Experimental medications haven’t been fully tested for safety and could make people with terminal illnesses die faster and in more pain.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Patients who have no alternative and are facing death, should have the right to try to save their own lives — and the right to hope.'\u003ccite>Sen. Ron Johnson (R-Wis.)\u003c/cite>\u003c/aside>\n\u003cp>“Companies worry about the risk,” said Richard Klein, director of the FDA’s patient liaison program. His story was “really public and really in the limelight. If he had not done well, what would have happened to that tiny little company? They would have been at a tremendous disadvantage.”\u003c/p>\n\u003cp>\u003cstrong>Patient advocates disagree on strategy\u003c/strong>\u003c/p>\n\u003cp>Advocates for people with life-threatening illnesses disagree about the best way to expand access to experimental therapies.\u003c/p>\n\u003cp>Laura McLinn, an Indianapolis mother whose 7-year-old suffers from Duchenne muscular dystrophy, supports right-to-try laws. She championed Indiana’s right-to-try legislation, and her son, Jordan, stood next to Gov. Mike Pence when he signed the bill into law.\u003c/p>\n\u003cp>Although Jordan looks perpetually cheerful, dressed for public photographs in a firefighter costume and helmet, he’s already beginning to decline. Jordan gets tired faster than he used to. He cries at night when his body hurts. He falls and can’t keep up with his friends. “He can’t do the things they are dong at recess and he doesn’t understand why,” McLinn told a Senate committee in February.\u003c/p>\n\u003cp>In spite of the McLinn family’s support for the right-to-try movement, Indiana’s law hasn’t helped Jordan access any experimental therapies.\u003c/p>\n\u003cp>Although Jordan is taking an unapproved steroid, McLinn hasn’t accessed it through right-to-try laws. She orders the medication through the mail from an overseas manufacturer. The FDA permits these orders under certain circumstances, such as when patients with serious disease have no alternatives.\u003c/p>\n\u003cp>McLinn said Jordan’s best hope for a medical breakthrough will come from a traditional clinical trial, overseen by the FDA and run by a Massachusetts pharmaceutical company, Sarepta Therapeutics, which \u003ca href=\"http://khn.org/news/fda-approves-first-drug-to-treat-rare-form-of-muscular-dystrophy/\">won approval in September\u003c/a> for another muscular dystrophy drug. McLinn said she hopes her son will begin the trial within months.\u003c/p>\n\u003cp>Some say right-to-try laws have accomplished little in the past two years.\u003c/p>\n\u003cfigure id=\"attachment_257511\" class=\"wp-caption aligncenter\" style=\"max-width: 760px\">\u003cimg class=\"size-full wp-image-257511\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Josh-Hardy.jpg\" alt=\"Josh Hardy takes aim at his brother Jude while playing at home. He died in September 2016.\" width=\"760\" height=\"487\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/Josh-Hardy.jpg 760w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Josh-Hardy-400x256.jpg 400w\" sizes=\"(max-width: 760px) 100vw, 760px\">\u003cfigcaption class=\"wp-caption-text\">Josh Hardy takes aim at his brother Jude while playing at home. He died in September 2016. \u003ccite>(Peter Cihelka/The Free Lance–Star)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“The right-to-try laws are something that a lot of families and patients are interested in, but they don’t really have any teeth in them,” said Dr. Valerie Cwik, executive vice president and chief medical and scientific officer at the Muscular Dystrophy Association.\u003c/p>\n\u003cp>Right-to-try laws wouldn’t have helped Josh Hardy, because the laws don’t require drug developers to actually make their medications available, Bateman-House said. The laws also don’t require that insurance companies pay for the treatments. The movement’s main intent is to undermine the FDA, Bateman-House said.\u003c/p>\n\u003cp>“The cruel reality with the right-to-try legislation is that it will not grant patients the immediate access to treatments they desperately need,” said Andrew McFadyen, executive director of the Isaac Foundation, a nonprofit based in Ontario, Canada, that funds research to fight MPS, the fatal genetic disease that afflicts his 12-year-old son.\u003c/p>\n\u003cp>The first doctor to openly acknowledge using a state right-to-try law, Houston cancer specialist Ebrahim Delpassand, came forward in September at Johnson’s hearing, where he testified via video. Delpassand said that he has given an unapproved drug, LU-177, to 78 patients with advanced neuroendocrine cancers under Texas’s right-to-try law.\u003c/p>\n\u003cp>Those numbers are dwarfed by the number granted expanded access by the FDA, which last year approved 1,262 requests for all drugs. The actual number of patients included in these FDA requests is much larger, because some requests were made on behalf of trials that include hundreds or even thousands of patients.\u003c/p>\n\u003cp>For example, about 35,000 patients received the lung cancer drug Iressa through expanded access before that drug was approved, said Klein.\u003c/p>\n\u003cp>At the Senate hearing, Johnson acknowledged that state right-to-try laws haven’t produced as many big wins as supporters had hoped.\u003c/p>\n\u003cp>Although state right-to-try laws protect doctors from losing their licenses if they prescribe unapproved drugs, physicians may be reluctant to use the laws, for fear of violating federal regulations, Johnson said.\u003c/p>\n\u003cp>Even in a right-to-try state, doctors such as Delpassand “are taking a huge risk” in providing unapproved treatments, Johnson said. “We need the federal law for the state laws to kick in. Until the federal government acts, the state laws are not effective.”\u003c/p>\n\u003cp>\u003cem>Anna Gorman contributed reporting. \u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"http://kff.org/\" target=\"\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n",
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"excerpt": "How a young boy with terminal cancer inspired dying patients and their families to fight for access to experimental therapies they hope will save their lives.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The Food and Drug Administration, whose staff initiated the clinical trial that provided Josh his medication, has reduced the time that doctors spend requesting an unapproved drug to just 45 minutes. The agency says it approves 99 percent of such applications, granting most requests in four days and emergency requests within hours. The agency is even considering hiring “navigators” to walk doctors through the process.\u003c/p>\n\u003cp>Nonetheless, some patient advocates are leading a drive to provide access to experimental drugs without the FDA’s help.\u003c/p>\n\u003cp>Thirty-two states have passed laws designed to give patients the “right to try” an unapproved medication, by protecting doctors who provide such therapies from losing their state medical licenses. Republicans have included the right to try unapproved drugs in their national presidential platform.\u003c/p>\n\u003cfigure id=\"attachment_257510\" class=\"wp-caption aligncenter\" style=\"max-width: 770px\">\u003cimg class=\"size-full wp-image-257510\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/jordanmclinn_righttotry_getty_770.jpg\" alt=\"From left, Laura McLinn, of Indianapolis, her son Jordan, 7, and Sen. Ron Johnson, R-Wis., pose for a picture. \" width=\"770\" height=\"513\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/jordanmclinn_righttotry_getty_770.jpg 770w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/jordanmclinn_righttotry_getty_770-400x266.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/jordanmclinn_righttotry_getty_770-768x512.jpg 768w\" sizes=\"(max-width: 770px) 100vw, 770px\">\u003cfigcaption class=\"wp-caption-text\">From left, Laura McLinn, of Indianapolis, her son Jordan, 7, and Sen. Ron Johnson, R-Wis., pose for a picture. \u003ccite>(Tom Williams/CQ Roll Call)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>California became the 32\u003csup>nd\u003c/sup> state to pass such a law last week when Gov. Jerry Brown signed a bill sponsored by Assemblyman Ian Calderon. Brown vetoed a similar bill last year.\u003c/p>\n\u003cp>The law, \u003ca href=\"https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160AB1668\" target=\"_blank\">Assembly Bill 1668,\u003c/a> allows terminally ill patients who have exhausted their options to access medications that have not yet been approved by the FDA. The “right to try” law also protects physicians from discipline if they treat a terminally patient with a drug that is still in trials.\u003c/p>\n\u003cp>Lina Clark and her husband, David Huntley, started advocating for right-to-try legislation in 2015 because they grew frustrated with the inability to access drugs still in the FDA approval pipeline. Huntley, who testified before legislators in Sacramento as part of their effort to change the law, died of Lou Gehrig’s disease last year.\u003c/p>\n\u003cp>“It is a very swift moving disease,” said Clark, who lives in San Diego. “That is why the right to try laws are so important. If there is a treatment that is showing great promise, you can save lives or extend lives, or at the minimum alleviate suffering.”\u003c/p>\n\u003cp>Clark said she was grateful that California and so many other states have passed the laws. “I think it’s sending a message to the FDA as well as our Congress that this is the will of the people,” she said.\u003c/p>\n\u003cp>Christina Sandefur, executive vice president at the libertarian Goldwater Institute, which has coordinated right-to-try efforts, said terminally ill patients shouldn’t have to ask for a “permission slip” from the FDA. “If you are dying and you’ve exhausted all other options and this medication has passed basic safety testing, you should be able to work directly with the drug companies and your doctor without having to go through the FDA.”\u003c/p>\n\u003caside class=\"pullquote alignright\">'If there is a treatment that is showing great promise, you can save lives or extend lives, or at the minimum alleviate suffering.'\u003ccite>Lina Clark\u003c/cite>\u003c/aside>\n\u003cp>Yet even some supporters of the right to try acknowledge the state laws have helped relatively few patients.\u003c/p>\n\u003cp>Sen. Ron Johnson (R-Wis.) chairman of the Homeland Security and Governmental Affairs Committee, introduced a federal right-to-try bill in May as a way to bolster the state initiatives. At a hearing in September, Johnson said his bill “simply says patients, who have no alternative and are facing death, should have the right to try to save their own lives — and the right to hope.”\u003c/p>\n\u003cp>\u003cstrong>Drug developers get the message\u003c/strong>\u003c/p>\n\u003cp>The renewed interest in compassionate use — which first emerged as a national issue during the AIDS crisis of the 1980s — also has spurred pharmaceutical companies to ramp up “expanded access” programs.\u003c/p>\n\u003cp>Some are concerned that social media campaigns give unfair advantages to families who are well-connected and media-savvy. Minorities, immigrants and people who aren’t fluent in English could be less able to mount effective campaigns, said Alison Bateman-House, a bioethicist at New York University Langone Medical Center. She’s been working with Johnson & Johnson to help ensure its compassionate use system allocates drugs fairly.\u003c/p>\n\u003cp>Marathon Pharmaceuticals, which is developing a steroid to treat a fatal disease called Duchenne muscular dystrophy, has been working with patient advocacy groups to enroll patients in its compassionate use program. The Illinois company anticipates enrolling 800 patients by February in its expanded access program for the steroid, called deflazacort.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>While some drug developers were moved by Josh’s plight, others were motivated by a fear of negative publicity, Bateman-House said. Almost overnight, Chimerix became a symbol of corporate indifference. Critics posted the home address of Chimerix executives online, and some received death threats. The company replaced its CEO within a month of the controversy.\u003c/p>\n\u003cp>“The majority of the pharmaceutical industry suddenly got terrified that they were going to be the next Chimerix,” Bateman-House said.\u003c/p>\n\u003cp>And while drug companies tend to look like the bad guys when they deny drug access, Bateman-House said there are legitimate reasons for caution. Experimental medications haven’t been fully tested for safety and could make people with terminal illnesses die faster and in more pain.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Patients who have no alternative and are facing death, should have the right to try to save their own lives — and the right to hope.'\u003ccite>Sen. Ron Johnson (R-Wis.)\u003c/cite>\u003c/aside>\n\u003cp>“Companies worry about the risk,” said Richard Klein, director of the FDA’s patient liaison program. His story was “really public and really in the limelight. If he had not done well, what would have happened to that tiny little company? They would have been at a tremendous disadvantage.”\u003c/p>\n\u003cp>\u003cstrong>Patient advocates disagree on strategy\u003c/strong>\u003c/p>\n\u003cp>Advocates for people with life-threatening illnesses disagree about the best way to expand access to experimental therapies.\u003c/p>\n\u003cp>Laura McLinn, an Indianapolis mother whose 7-year-old suffers from Duchenne muscular dystrophy, supports right-to-try laws. She championed Indiana’s right-to-try legislation, and her son, Jordan, stood next to Gov. Mike Pence when he signed the bill into law.\u003c/p>\n\u003cp>Although Jordan looks perpetually cheerful, dressed for public photographs in a firefighter costume and helmet, he’s already beginning to decline. Jordan gets tired faster than he used to. He cries at night when his body hurts. He falls and can’t keep up with his friends. “He can’t do the things they are dong at recess and he doesn’t understand why,” McLinn told a Senate committee in February.\u003c/p>\n\u003cp>In spite of the McLinn family’s support for the right-to-try movement, Indiana’s law hasn’t helped Jordan access any experimental therapies.\u003c/p>\n\u003cp>Although Jordan is taking an unapproved steroid, McLinn hasn’t accessed it through right-to-try laws. She orders the medication through the mail from an overseas manufacturer. The FDA permits these orders under certain circumstances, such as when patients with serious disease have no alternatives.\u003c/p>\n\u003cp>McLinn said Jordan’s best hope for a medical breakthrough will come from a traditional clinical trial, overseen by the FDA and run by a Massachusetts pharmaceutical company, Sarepta Therapeutics, which \u003ca href=\"http://khn.org/news/fda-approves-first-drug-to-treat-rare-form-of-muscular-dystrophy/\">won approval in September\u003c/a> for another muscular dystrophy drug. McLinn said she hopes her son will begin the trial within months.\u003c/p>\n\u003cp>Some say right-to-try laws have accomplished little in the past two years.\u003c/p>\n\u003cfigure id=\"attachment_257511\" class=\"wp-caption aligncenter\" style=\"max-width: 760px\">\u003cimg class=\"size-full wp-image-257511\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/Josh-Hardy.jpg\" alt=\"Josh Hardy takes aim at his brother Jude while playing at home. He died in September 2016.\" width=\"760\" height=\"487\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/Josh-Hardy.jpg 760w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/Josh-Hardy-400x256.jpg 400w\" sizes=\"(max-width: 760px) 100vw, 760px\">\u003cfigcaption class=\"wp-caption-text\">Josh Hardy takes aim at his brother Jude while playing at home. He died in September 2016. \u003ccite>(Peter Cihelka/The Free Lance–Star)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>“The right-to-try laws are something that a lot of families and patients are interested in, but they don’t really have any teeth in them,” said Dr. Valerie Cwik, executive vice president and chief medical and scientific officer at the Muscular Dystrophy Association.\u003c/p>\n\u003cp>Right-to-try laws wouldn’t have helped Josh Hardy, because the laws don’t require drug developers to actually make their medications available, Bateman-House said. The laws also don’t require that insurance companies pay for the treatments. The movement’s main intent is to undermine the FDA, Bateman-House said.\u003c/p>\n\u003cp>“The cruel reality with the right-to-try legislation is that it will not grant patients the immediate access to treatments they desperately need,” said Andrew McFadyen, executive director of the Isaac Foundation, a nonprofit based in Ontario, Canada, that funds research to fight MPS, the fatal genetic disease that afflicts his 12-year-old son.\u003c/p>\n\u003cp>The first doctor to openly acknowledge using a state right-to-try law, Houston cancer specialist Ebrahim Delpassand, came forward in September at Johnson’s hearing, where he testified via video. Delpassand said that he has given an unapproved drug, LU-177, to 78 patients with advanced neuroendocrine cancers under Texas’s right-to-try law.\u003c/p>\n\u003cp>Those numbers are dwarfed by the number granted expanded access by the FDA, which last year approved 1,262 requests for all drugs. The actual number of patients included in these FDA requests is much larger, because some requests were made on behalf of trials that include hundreds or even thousands of patients.\u003c/p>\n\u003cp>For example, about 35,000 patients received the lung cancer drug Iressa through expanded access before that drug was approved, said Klein.\u003c/p>\n\u003cp>At the Senate hearing, Johnson acknowledged that state right-to-try laws haven’t produced as many big wins as supporters had hoped.\u003c/p>\n\u003cp>Although state right-to-try laws protect doctors from losing their licenses if they prescribe unapproved drugs, physicians may be reluctant to use the laws, for fear of violating federal regulations, Johnson said.\u003c/p>\n\u003cp>Even in a right-to-try state, doctors such as Delpassand “are taking a huge risk” in providing unapproved treatments, Johnson said. “We need the federal law for the state laws to kick in. Until the federal government acts, the state laws are not effective.”\u003c/p>\n\u003cp>\u003cem>Anna Gorman contributed reporting. \u003c/em>\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 \u003ca href=\"http://khn.org/\" target=\"_blank\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"http://kff.org/\" target=\"\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>No news is good news when it comes to the fortunes of blood-testing company Theranos.\u003c/p>\n\u003cp>And yesterday, there was news.\u003c/p>\n\u003cp>Company CEO Elizabeth Holmes posted an \u003ca href=\"https://news.theranos.com/2016/10/05/an-open-letter-elizabeth-holmes/\" target=\"_blank\">open letter\u003c/a> Wednesday announcing that Theranos will shut down its two clinical labs and its handful of remaining blood-testing centers. That will result in layoffs for about 340 employees -- approximately 40 percent of the company's workforce -- in Arizona, California and Pennsylvania.\u003c/p>\n\u003cp>Holmes said in her letter, addressed to \"stakeholders,\" that the company will now focus on the development of a portable blood-testing device, which Holmes unveiled at a scientific conference in August.\u003c/p>\n\u003cp>Theranos calls that product a miniLab, and at least some lab experts who we and other media outlets spoke to \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/07/29/theranos-elizabeth-holmes-will-face-1000-scientists-monday-can-she-say-anything-to-gain-their-trust/\" target=\"_blank\">did not think\u003c/a> it represented a significant advance in the field.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Holmes' announcement yesterday comes in the midst of the company's appeal of severe sanctions imposed by the Centers for Medicare & Medicaid Services, which among other penalties banned Holmes from owning or running any clinical laboratory for two years. The sanctions stem from deficiencies at Theranos' Newark, California lab, including problems with a blood-clotting test that CMS judged to be life-threatening. That lab has been closed since July, when regulators revoked the company's license to operate it.\u003c/p>\n\u003cp>Theranos has another lab in Scottsdale, Arizona, so now that will be shuttered as well. But because the government's sanctions preclude Holmes from owning or operating any lab, it's unclear how Holmes could have stayed with the company should Theranos have wished to keep its Arizona lab open. And Holmes, apparently, isn't going anywhere. At least, that seemed to be the case in mid-July, when Theranos issued a sort of \u003ca href=\"https://news.theranos.com/2016/07/19/theranos-statement-on-cms-findings/\" target=\"_blank\">FAQ\u003c/a> about what the government's sanctions meant for its operations.\u003c/p>\n\u003cp>\"The clinical lab is just one of Theranos’ many opportunities to provide access to high-integrity, affordable and actionable health care information, and the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes,\" the company said.\u003c/p>\n\u003cp>In her open letter yesterday, Holmes said Theranos had installed a new executive team \"leading our work toward obtaining FDA clearances, building commercial partnerships, and pursuing publications in scientific journals. We are fortunate to have supporters and investors who believe deeply in our mission of affordable, less invasive lab testing, and to have the runway to realize our vision.\"\u003c/p>\n\u003cp>We sent Theranos and Hill+Knowlton Strategies, which Theranos uses for media relations, a query as to how the shuttering of its consumer blood-testing business might affect its appeal of the sanctions. Hill+Knowlton said Theranos would have no comment beyond Holmes' open letter \"at this time.\"\u003c/p>\n\u003cp>CMS has said it routinely negotiates with companies that it penalizes, but the circumstances for which it lifts sanctions did not seem to apply to Theranos. CMS also said at one point that closing down its labs would not be enough to prevent the penalties from being implemented.\u003c/p>\n\u003cp>If Theranos has no further comment right now, here's someone who does: Wall Street Journal reporter John Carreyrou, whose \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">investigative reporting\u003c/a> heralded the beginning of the end for Theranos' status as a golden child of Silicon Valley \"disruption.\" Carreyrou yesterday indulged in a victory tweet:\u003c/p>\n\u003cp>https://twitter.com/JohnCarreyrou/status/783844650213715968\u003c/p>\n\u003cp>\u003cstrong>Litany of Woes\u003c/strong>\u003c/p>\n\u003cp>We won't go into the specifics of the many developments that have led to Theranos in just a year's time becoming -- it's probably fair to say -- a corporate pariah. (See our \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/07/14/the-rise-and-fall-of-theranos-a-cartoon-history/\" target=\"_blank\">cartoon history of the company here\u003c/a> for more.) Theranos made its name by touting what it said was a revolutionary diagnostic technology, which allowed for dozens of blood tests from just a few drops of blood, and for extremely low prices.\u003c/p>\n\u003cp>A high-profile partnership with Walgreens, opening dozens of Theranos blood-testing centers within the pharmacy chain’s stores, gave its technology the imprimatur of a major health care provider.\u003c/p>\n\u003cp>Investors piled on, bestowing the company with a $9 billion valuation, according to Forbes, $4.5 billion of which would accrue to Holmes.\u003c/p>\n\u003cp>But it all came tumbling down -- rapidly. The lab testing community had already been grumbling that Theranos had never published in a a single word of proof in a peer-reviewed journal that its methods worked. Then came \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/01/26/for-theranos-the-bad-news-keeps-coming/\">Wall Street Journal articles alleging\u003c/a>, among other improprieties, that Theranos failed to report tests showing its vaunted tech may not be accurate. CMS soon threatened its sanctions, which were based on an unrelated lab inspection. Scientific studies emerged that showed Theranos' test results deviated from norms; \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/06/12/walgreens-shutting-down-theranos-centers-immediately-as-it-ends-partnership/\">Walgreens bailed\u003c/a>; the company invalidated tens of thousands of patient blood tests; lawsuits proliferated; the SEC and U.S. Attorney's Office for Northern California opened investigations; and an attempted comeback at the annual meeting of the American Association for Clinical Chemistry was a bust: attendees had fully expected, at long last, some hard validating data, but instead got what some characterized as a marketing presentation for a not overly exciting new product.\u003c/p>\n\u003cp>Plus there's the whole \u003ca href=\"http://www.vanityfair.com/hollywood/2016/06/jennifer-lawrence-theranos-elizabeth-holmes\" target=\"_blank\">Jennifer Lawrence thing\u003c/a>. ...\u003c/p>\n\u003cp>More to come, we're sure.\u003c/p>\n\u003cp>Here's yesterday's full \u003ca href=\"https://news.theranos.com/2016/10/05/an-open-letter-elizabeth-holmes/\" target=\"_blank\">open letter \u003c/a>from Holmes on Theranos' website:\u003c/p>\n\u003cblockquote>\u003cp>For our stakeholders,\u003c/p>\n\u003cp>After many months spent assessing our strengths and addressing our weaknesses, we have moved to structure our company around the model best aligned with our core values and mission.\u003c/p>\n\u003cp>We have decided to close our clinical labs and Theranos Wellness Centers, which will impact approximately 340 employees in Arizona, California, and Pennsylvania. We are profoundly grateful to these team members, many of whom have devoted years to Theranos and our mission, for their commitment to our company and our guests.\u003c/p>\n\u003cp>We will return our undivided attention to our miniLab platform. Our ultimate goal is to commercialize miniaturized, automated laboratories capable of small-volume sample testing, with an emphasis on vulnerable patient populations, including oncology, pediatrics, and intensive care.\u003c/p>\n\u003cp>We have a new executive team leading our work toward obtaining FDA clearances, building commercial partnerships, and pursuing publications in scientific journals.\u003c/p>\n\u003cp>We are fortunate to have supporters and investors who believe deeply in our mission of affordable, less invasive lab testing, and to have the runway to realize our vision.\u003c/p>\n\u003cp>I look forward to sharing more with you as we progress along the way.\u003c/p>\n\u003cp>Sincerely,\u003c/p>\n\u003cp>Elizabeth Holmes\u003c/p>\u003c/blockquote>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This posted has been edited. It originally said that Theranos does not have an in-house spokesperson, which it does. \u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>No news is good news when it comes to the fortunes of blood-testing company Theranos.\u003c/p>\n\u003cp>And yesterday, there was news.\u003c/p>\n\u003cp>Company CEO Elizabeth Holmes posted an \u003ca href=\"https://news.theranos.com/2016/10/05/an-open-letter-elizabeth-holmes/\" target=\"_blank\">open letter\u003c/a> Wednesday announcing that Theranos will shut down its two clinical labs and its handful of remaining blood-testing centers. That will result in layoffs for about 340 employees -- approximately 40 percent of the company's workforce -- in Arizona, California and Pennsylvania.\u003c/p>\n\u003cp>Holmes said in her letter, addressed to \"stakeholders,\" that the company will now focus on the development of a portable blood-testing device, which Holmes unveiled at a scientific conference in August.\u003c/p>\n\u003cp>Theranos calls that product a miniLab, and at least some lab experts who we and other media outlets spoke to \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/07/29/theranos-elizabeth-holmes-will-face-1000-scientists-monday-can-she-say-anything-to-gain-their-trust/\" target=\"_blank\">did not think\u003c/a> it represented a significant advance in the field.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Holmes' announcement yesterday comes in the midst of the company's appeal of severe sanctions imposed by the Centers for Medicare & Medicaid Services, which among other penalties banned Holmes from owning or running any clinical laboratory for two years. The sanctions stem from deficiencies at Theranos' Newark, California lab, including problems with a blood-clotting test that CMS judged to be life-threatening. That lab has been closed since July, when regulators revoked the company's license to operate it.\u003c/p>\n\u003cp>Theranos has another lab in Scottsdale, Arizona, so now that will be shuttered as well. But because the government's sanctions preclude Holmes from owning or operating any lab, it's unclear how Holmes could have stayed with the company should Theranos have wished to keep its Arizona lab open. And Holmes, apparently, isn't going anywhere. At least, that seemed to be the case in mid-July, when Theranos issued a sort of \u003ca href=\"https://news.theranos.com/2016/07/19/theranos-statement-on-cms-findings/\" target=\"_blank\">FAQ\u003c/a> about what the government's sanctions meant for its operations.\u003c/p>\n\u003cp>\"The clinical lab is just one of Theranos’ many opportunities to provide access to high-integrity, affordable and actionable health care information, and the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes,\" the company said.\u003c/p>\n\u003cp>In her open letter yesterday, Holmes said Theranos had installed a new executive team \"leading our work toward obtaining FDA clearances, building commercial partnerships, and pursuing publications in scientific journals. We are fortunate to have supporters and investors who believe deeply in our mission of affordable, less invasive lab testing, and to have the runway to realize our vision.\"\u003c/p>\n\u003cp>We sent Theranos and Hill+Knowlton Strategies, which Theranos uses for media relations, a query as to how the shuttering of its consumer blood-testing business might affect its appeal of the sanctions. Hill+Knowlton said Theranos would have no comment beyond Holmes' open letter \"at this time.\"\u003c/p>\n\u003cp>CMS has said it routinely negotiates with companies that it penalizes, but the circumstances for which it lifts sanctions did not seem to apply to Theranos. CMS also said at one point that closing down its labs would not be enough to prevent the penalties from being implemented.\u003c/p>\n\u003cp>If Theranos has no further comment right now, here's someone who does: Wall Street Journal reporter John Carreyrou, whose \u003ca href=\"http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901\" target=\"_blank\">investigative reporting\u003c/a> heralded the beginning of the end for Theranos' status as a golden child of Silicon Valley \"disruption.\" Carreyrou yesterday indulged in a victory tweet:\u003c/p>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\n\u003cp>\u003cstrong>Litany of Woes\u003c/strong>\u003c/p>\n\u003cp>We won't go into the specifics of the many developments that have led to Theranos in just a year's time becoming -- it's probably fair to say -- a corporate pariah. (See our \u003ca href=\"http://ww2.kqed.org/futureofyou/2016/07/14/the-rise-and-fall-of-theranos-a-cartoon-history/\" target=\"_blank\">cartoon history of the company here\u003c/a> for more.) Theranos made its name by touting what it said was a revolutionary diagnostic technology, which allowed for dozens of blood tests from just a few drops of blood, and for extremely low prices.\u003c/p>\n\u003cp>A high-profile partnership with Walgreens, opening dozens of Theranos blood-testing centers within the pharmacy chain’s stores, gave its technology the imprimatur of a major health care provider.\u003c/p>\n\u003cp>Investors piled on, bestowing the company with a $9 billion valuation, according to Forbes, $4.5 billion of which would accrue to Holmes.\u003c/p>\n\u003cp>But it all came tumbling down -- rapidly. The lab testing community had already been grumbling that Theranos had never published in a a single word of proof in a peer-reviewed journal that its methods worked. Then came \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/01/26/for-theranos-the-bad-news-keeps-coming/\">Wall Street Journal articles alleging\u003c/a>, among other improprieties, that Theranos failed to report tests showing its vaunted tech may not be accurate. CMS soon threatened its sanctions, which were based on an unrelated lab inspection. Scientific studies emerged that showed Theranos' test results deviated from norms; \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/06/12/walgreens-shutting-down-theranos-centers-immediately-as-it-ends-partnership/\">Walgreens bailed\u003c/a>; the company invalidated tens of thousands of patient blood tests; lawsuits proliferated; the SEC and U.S. Attorney's Office for Northern California opened investigations; and an attempted comeback at the annual meeting of the American Association for Clinical Chemistry was a bust: attendees had fully expected, at long last, some hard validating data, but instead got what some characterized as a marketing presentation for a not overly exciting new product.\u003c/p>\n\u003cp>Plus there's the whole \u003ca href=\"http://www.vanityfair.com/hollywood/2016/06/jennifer-lawrence-theranos-elizabeth-holmes\" target=\"_blank\">Jennifer Lawrence thing\u003c/a>. ...\u003c/p>\n\u003cp>More to come, we're sure.\u003c/p>\n\u003cp>Here's yesterday's full \u003ca href=\"https://news.theranos.com/2016/10/05/an-open-letter-elizabeth-holmes/\" target=\"_blank\">open letter \u003c/a>from Holmes on Theranos' website:\u003c/p>\n\u003cblockquote>\u003cp>For our stakeholders,\u003c/p>\n\u003cp>After many months spent assessing our strengths and addressing our weaknesses, we have moved to structure our company around the model best aligned with our core values and mission.\u003c/p>\n\u003cp>We have decided to close our clinical labs and Theranos Wellness Centers, which will impact approximately 340 employees in Arizona, California, and Pennsylvania. We are profoundly grateful to these team members, many of whom have devoted years to Theranos and our mission, for their commitment to our company and our guests.\u003c/p>\n\u003cp>We will return our undivided attention to our miniLab platform. Our ultimate goal is to commercialize miniaturized, automated laboratories capable of small-volume sample testing, with an emphasis on vulnerable patient populations, including oncology, pediatrics, and intensive care.\u003c/p>\n\u003cp>We have a new executive team leading our work toward obtaining FDA clearances, building commercial partnerships, and pursuing publications in scientific journals.\u003c/p>\n\u003cp>We are fortunate to have supporters and investors who believe deeply in our mission of affordable, less invasive lab testing, and to have the runway to realize our vision.\u003c/p>\n\u003cp>I look forward to sharing more with you as we progress along the way.\u003c/p>\n\u003cp>Sincerely,\u003c/p>\n\u003cp>Elizabeth Holmes\u003c/p>\u003c/blockquote>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This posted has been edited. It originally said that Theranos does not have an in-house spokesperson, which it does. \u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Researchers Hunt for a Link Between Microbiome and Autism",
"title": "Researchers Hunt for a Link Between Microbiome and Autism",
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"content": "\u003cp>Maude Magali David and Christine Tataru work in a neat and clean office. Sitting on bright pink exercise balls, the research duo analyzes data, occasionally standing to write on a whiteboard.\u003c/p>\n\u003cp>The tidy setting belies the nature of the less-than-sanitary subject of their work.\u003c/p>\n\u003caside class=\"pullquote alignright\">For now, research into a link between the microbiome and autism is 'at a stage where more questions than answers are being generated.'\u003c/aside>\n\u003cp>David and Tataru are interested in poop. Specifically, they’re interested in the microbial life living in the poop of children. If they learn enough about those microbes, they hope, they will find similarities and differences between the gut-life of kids who have autism and those who don’t. And that could change therapeutic approaches to treating autism spectrum disorder.\u003c/p>\n\u003cp>David runs the \u003ca href=\"https://microbiome.stanford.edu/\" target=\"_blank\">Autism Microbiome \u003c/a>project at the Stanford University School of Medicine's \u003ca href=\"http://wall-lab.stanford.edu/\" target=\"_blank\">Wall Lab\u003c/a>, along with the lab's principal investigator, Dennis Wall. In the past several years, interest in the microbiome—bacteria, fungi and \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4500141/\" target=\"_blank\"> other single-celled organisms \u003c/a>living on and within our bodies—has surged. These microbes were once considered either benign or dangerous\u003cstrong>, \u003c/strong>causing illness and disease\u003cstrong>. \u003c/strong>But we now know they also play a huge role in maintaining our health.\u003c/p>\n\u003cp>\u003cstrong>Gut Bugs Are Hot\u003c/strong>\u003c/p>\n\u003cfigure id=\"attachment_256705\" class=\"wp-caption alignright\" style=\"max-width: 450px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/kids.jpg\">\u003cimg class=\"size-medium wp-image-256705\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/kids-450x600.jpg\" alt=\"Kim and her son Jake, who has autism spectrum disorder, in a family photo. The family is participating in a study searching for links between microbiomes and autism spectrum disorder.\" width=\"450\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids-450x600.jpg 450w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids-400x533.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids-768x1024.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids-885x1180.jpg 885w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids.jpg 960w\" sizes=\"(max-width: 450px) 100vw, 450px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Kim and her son Jake, who has autism spectrum disorder, in a family photo. The family is participating in a study searching for links between microbiomes and autism spectrum disorder.\u003c/figcaption>\u003c/figure>\n\u003cp>The shift in perspective has been dramatic. Gut bugs are now \u003ca href=\"http://learn.genetics.utah.edu/content/microbiome/friends/\" target=\"_blank\">credited as being instrumental\u003c/a> in a host of critical processes: extracting food nutrients, developing organ systems, producing vitamins and training the immune system to behave properly. They have even been found to help regulate blood pressure.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>This spring the White House announced a \u003ca href=\"https://www.whitehouse.gov/blog/2016/05/13/announcing-national-microbiome-initiative\" target=\"_blank\">major new initiative \u003c/a>to coordinate the study of these all-important bugs, including \u003ca href=\"https://www.whitehouse.gov/the-press-office/2016/05/12/fact-sheet-announcing-national-microbiome-initiative\" target=\"_blank\">funding \u003c/a>of about a half-billion dollars from the federal government and scores of universities, nonprofits and business.\u003c/p>\n\u003cp>\"The microbiome is the hot thing to study now,\" says Kevin Becker, a researcher at the National Institutes of Health. \"But I think that's exciting; the research is very robust.\"\u003c/p>\n\u003cp>\u003cstrong>Link to Autism\u003c/strong>\u003c/p>\n\u003cp>In 2007, Becker was the first researcher to suggest that the microbiome \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2048743/\" target=\"_blank\">might be connected \u003c/a>to symptoms of autism spectrum disorder. In the decade since, researchers have \u003ca href=\"http://pediatrics.aappublications.org/content/133/5/872.short\" target=\"_blank\">accumulated more evidence\u003c/a> that the gastrointestinal tracts of children with ASD are \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564498/\" target=\"_blank\">often different\u003c/a>. Depending on the survey, 60 to 90 percent have irritable bowel syndrome or have complained of diarrhea, stomachaches or gluten intolerance, which inflames the gut. For example, a \u003ca href=\"http://journals.lww.com/jrnldbp/Abstract/2006/04002/Frequency_of_Gastrointestinal_Symptoms_in_Children.11.aspx\" target=\"_blank\"> study of 150 children\u003c/a> published in 2006 found that 70 percent of kids with ASD suffered from gastrointestinal woes, compared to 42 percent of developmentally disabled children and 28 percent of children with no developmental disorder.\u003c/p>\n\u003cp>A \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897394/\" target=\"_blank\">study published in \u003c/a>\u003cem>Cell \u003c/em>in 2013 studied lab mice with ASD-like symptoms, such as avoiding social interaction and compulsive and repetitive behavior\u003cstrong>.\u003c/strong> Remarkably, after subjecting the mice to the human \u003cem>Bacteroides fragilis, \u003c/em>the researchers noted the mice became less anxious and more social. The findings, wrote the authors, \"support a gut-microbiome-brain connection in ASD and identify a potential probiotic therapy for GI and behavioral symptoms of autism.\"\u003c/p>\n\u003cp>\"I read that and thought, 'OK there is something going on here!'\" says David. \"We just need a study with sufficient power to figure out what's going on in humans.\"\u003c/p>\n\u003cp>A few months later she began working with Wall, an autism and bioinformatics expert, on a project that would answer a key question: What is the connection between bacteria in the gut and autism in children?\u003c/p>\n\u003cp>The researchers reached out through social media for families with at least two children under eight who eat the same things but who differ in that at least one is free of ASD. The families—280 have signed up thus far—send in a two- to three-minute video of their kids, saliva and stool samples, and answers to a questionnaire about behavior and diet. In return, the families will receive the results (which the team cautions should not be used for diagnosis).\u003c/p>\n\u003cp>By sampling kids from the same families, the researchers are able to control for some of the factors that contribute to differences in children's gut flora\u003cstrong>, \u003c/strong>such as diet and home environment. Because the study allows for participation by subjects who never have to leave their homes, it has attracted more participants than is typical of such studies.\u003c/p>\n\u003cp>\u003cstrong>At Home With Autism\u003c/strong>\u003c/p>\n\u003cp>One family in the study lives in Pittsburgh. Kim is a busy mother whose days pass in a whirl. She has three five-year-olds: triplets Allie, Hunter and Jake. The kids love playing hide-and-seek. Allie likes dolls and princesses. If anything happens to upset her brothers, she becomes protective. Hunter likes superheroes, and Jake is into cars and trains.\u003c/p>\n\u003cp>\"Jake is the wild man,\" says Kim. \"He just wants to run and see what trouble he can get into.\"\u003c/p>\n\u003cp>Jake is the only one of the siblings with autism. And practically since birth, his mom says, he's had more stomachaches and gastrointestinal problems.\u003c/p>\n\u003cp>Even before participating in the autism study, Kim took steps to improve Jake's diet and gut health, which she believes have helped his symptoms. With fewer intestinal woes, Jake became calmer, less aggressive and more cheerful, she says.\u003c/p>\n\u003cp>When she came across a notice for the \u003ca href=\"https://microbiome.stanford.edu/\" target=\"_blank\">Autism Microbiome \u003c/a>project on Facebook, she was immediately intrigued. She appreciated the change in focus from most of the research on the disorder.\u003c/p>\n\u003cp>\"I think it's really ahead of the times,\" she says. \"A lot of people look at autism and think of it as a psychological disease, and I think of it as more medical. So anything that supports the medical community looking at autism research in a different way, I want to be part of.\"\u003c/p>\n\u003cp>After she signed up, filled out the questionnaire and sent in the requested videos, a sampling kit arrived at her door a few weeks later.\u003c/p>\n\u003cp>\"My hope is that this is going to be a way to help children in the future,\" she says.\u003c/p>\n\u003cp>\u003cstrong>'A Bit More Complex'\u003c/strong>\u003c/p>\n\u003cp>Now that enough samples have been returned from families like Kim's, researchers at the Wall lab have started looking at the early results.\u003c/p>\n\u003cp>In the first phase of their work, David, Tataru, Wall and a fourth member of the team, clinical coordinator Jena Daniels, are analyzing sequences from the stool samples and looking for similarities and differences in what bacteria are present, how abundant they are and what the community of gut bacteria look like.\u003c/p>\n\u003cp>\"We were hoping to find something clear and simple, such as \u003cem>this\u003c/em> bacteria signals autism\" says Tataru. \"Turns out, it's a bit more complex than we were expecting.\"\u003c/p>\n\u003cp>There are no immediately clear distinctions by type or number between the microbiomes of children with autism and those without. The researchers are, however, detecting some subtle differences. Kids within families are the most similar to each other. But kids with ASD in different families have microbiomes that are more alike than the microbiomes of non-autistic children in different families.\u003c/p>\n\u003cp>It's an interesting finding, even if the researchers are not sure what to make of it yet. As a 2014 review of the emerging data on the subject said, “The field is at a stage where more questions than answers are being generated.” And even some leading scientists involved in microbiome research have \u003ca href=\"http://www.nytimes.com/2015/06/28/magazine/can-the-bacteria-in-your-gut-explain-your-mood.html\" target=\"_blank\">cautioned\u003c/a> patients and their families not to get ahead of the research in looking for easy answers.\u003c/p>\n\u003cp>But for scientists like Kevin Becker at the NIH, who is not involved in the project, the turn toward the microbiome in researching ASD is a positive development. \"Genetics has been the focus for a long time and it often dominates the discussion,\" he says. \"Most autistic cases have no known genetic cause. Looking into these other paths is a welcome change.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>The Autism Microbiome project plans to submit its first research paper for publication next month.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Maude Magali David and Christine Tataru work in a neat and clean office. Sitting on bright pink exercise balls, the research duo analyzes data, occasionally standing to write on a whiteboard.\u003c/p>\n\u003cp>The tidy setting belies the nature of the less-than-sanitary subject of their work.\u003c/p>\n\u003caside class=\"pullquote alignright\">For now, research into a link between the microbiome and autism is 'at a stage where more questions than answers are being generated.'\u003c/aside>\n\u003cp>David and Tataru are interested in poop. Specifically, they’re interested in the microbial life living in the poop of children. If they learn enough about those microbes, they hope, they will find similarities and differences between the gut-life of kids who have autism and those who don’t. And that could change therapeutic approaches to treating autism spectrum disorder.\u003c/p>\n\u003cp>David runs the \u003ca href=\"https://microbiome.stanford.edu/\" target=\"_blank\">Autism Microbiome \u003c/a>project at the Stanford University School of Medicine's \u003ca href=\"http://wall-lab.stanford.edu/\" target=\"_blank\">Wall Lab\u003c/a>, along with the lab's principal investigator, Dennis Wall. In the past several years, interest in the microbiome—bacteria, fungi and \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4500141/\" target=\"_blank\"> other single-celled organisms \u003c/a>living on and within our bodies—has surged. These microbes were once considered either benign or dangerous\u003cstrong>, \u003c/strong>causing illness and disease\u003cstrong>. \u003c/strong>But we now know they also play a huge role in maintaining our health.\u003c/p>\n\u003cp>\u003cstrong>Gut Bugs Are Hot\u003c/strong>\u003c/p>\n\u003cfigure id=\"attachment_256705\" class=\"wp-caption alignright\" style=\"max-width: 450px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/kids.jpg\">\u003cimg class=\"size-medium wp-image-256705\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/kids-450x600.jpg\" alt=\"Kim and her son Jake, who has autism spectrum disorder, in a family photo. The family is participating in a study searching for links between microbiomes and autism spectrum disorder.\" width=\"450\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids-450x600.jpg 450w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids-400x533.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids-768x1024.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids-885x1180.jpg 885w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/kids.jpg 960w\" sizes=\"(max-width: 450px) 100vw, 450px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Kim and her son Jake, who has autism spectrum disorder, in a family photo. The family is participating in a study searching for links between microbiomes and autism spectrum disorder.\u003c/figcaption>\u003c/figure>\n\u003cp>The shift in perspective has been dramatic. Gut bugs are now \u003ca href=\"http://learn.genetics.utah.edu/content/microbiome/friends/\" target=\"_blank\">credited as being instrumental\u003c/a> in a host of critical processes: extracting food nutrients, developing organ systems, producing vitamins and training the immune system to behave properly. They have even been found to help regulate blood pressure.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>This spring the White House announced a \u003ca href=\"https://www.whitehouse.gov/blog/2016/05/13/announcing-national-microbiome-initiative\" target=\"_blank\">major new initiative \u003c/a>to coordinate the study of these all-important bugs, including \u003ca href=\"https://www.whitehouse.gov/the-press-office/2016/05/12/fact-sheet-announcing-national-microbiome-initiative\" target=\"_blank\">funding \u003c/a>of about a half-billion dollars from the federal government and scores of universities, nonprofits and business.\u003c/p>\n\u003cp>\"The microbiome is the hot thing to study now,\" says Kevin Becker, a researcher at the National Institutes of Health. \"But I think that's exciting; the research is very robust.\"\u003c/p>\n\u003cp>\u003cstrong>Link to Autism\u003c/strong>\u003c/p>\n\u003cp>In 2007, Becker was the first researcher to suggest that the microbiome \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2048743/\" target=\"_blank\">might be connected \u003c/a>to symptoms of autism spectrum disorder. In the decade since, researchers have \u003ca href=\"http://pediatrics.aappublications.org/content/133/5/872.short\" target=\"_blank\">accumulated more evidence\u003c/a> that the gastrointestinal tracts of children with ASD are \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564498/\" target=\"_blank\">often different\u003c/a>. Depending on the survey, 60 to 90 percent have irritable bowel syndrome or have complained of diarrhea, stomachaches or gluten intolerance, which inflames the gut. For example, a \u003ca href=\"http://journals.lww.com/jrnldbp/Abstract/2006/04002/Frequency_of_Gastrointestinal_Symptoms_in_Children.11.aspx\" target=\"_blank\"> study of 150 children\u003c/a> published in 2006 found that 70 percent of kids with ASD suffered from gastrointestinal woes, compared to 42 percent of developmentally disabled children and 28 percent of children with no developmental disorder.\u003c/p>\n\u003cp>A \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897394/\" target=\"_blank\">study published in \u003c/a>\u003cem>Cell \u003c/em>in 2013 studied lab mice with ASD-like symptoms, such as avoiding social interaction and compulsive and repetitive behavior\u003cstrong>.\u003c/strong> Remarkably, after subjecting the mice to the human \u003cem>Bacteroides fragilis, \u003c/em>the researchers noted the mice became less anxious and more social. The findings, wrote the authors, \"support a gut-microbiome-brain connection in ASD and identify a potential probiotic therapy for GI and behavioral symptoms of autism.\"\u003c/p>\n\u003cp>\"I read that and thought, 'OK there is something going on here!'\" says David. \"We just need a study with sufficient power to figure out what's going on in humans.\"\u003c/p>\n\u003cp>A few months later she began working with Wall, an autism and bioinformatics expert, on a project that would answer a key question: What is the connection between bacteria in the gut and autism in children?\u003c/p>\n\u003cp>The researchers reached out through social media for families with at least two children under eight who eat the same things but who differ in that at least one is free of ASD. The families—280 have signed up thus far—send in a two- to three-minute video of their kids, saliva and stool samples, and answers to a questionnaire about behavior and diet. In return, the families will receive the results (which the team cautions should not be used for diagnosis).\u003c/p>\n\u003cp>By sampling kids from the same families, the researchers are able to control for some of the factors that contribute to differences in children's gut flora\u003cstrong>, \u003c/strong>such as diet and home environment. Because the study allows for participation by subjects who never have to leave their homes, it has attracted more participants than is typical of such studies.\u003c/p>\n\u003cp>\u003cstrong>At Home With Autism\u003c/strong>\u003c/p>\n\u003cp>One family in the study lives in Pittsburgh. Kim is a busy mother whose days pass in a whirl. She has three five-year-olds: triplets Allie, Hunter and Jake. The kids love playing hide-and-seek. Allie likes dolls and princesses. If anything happens to upset her brothers, she becomes protective. Hunter likes superheroes, and Jake is into cars and trains.\u003c/p>\n\u003cp>\"Jake is the wild man,\" says Kim. \"He just wants to run and see what trouble he can get into.\"\u003c/p>\n\u003cp>Jake is the only one of the siblings with autism. And practically since birth, his mom says, he's had more stomachaches and gastrointestinal problems.\u003c/p>\n\u003cp>Even before participating in the autism study, Kim took steps to improve Jake's diet and gut health, which she believes have helped his symptoms. With fewer intestinal woes, Jake became calmer, less aggressive and more cheerful, she says.\u003c/p>\n\u003cp>When she came across a notice for the \u003ca href=\"https://microbiome.stanford.edu/\" target=\"_blank\">Autism Microbiome \u003c/a>project on Facebook, she was immediately intrigued. She appreciated the change in focus from most of the research on the disorder.\u003c/p>\n\u003cp>\"I think it's really ahead of the times,\" she says. \"A lot of people look at autism and think of it as a psychological disease, and I think of it as more medical. So anything that supports the medical community looking at autism research in a different way, I want to be part of.\"\u003c/p>\n\u003cp>After she signed up, filled out the questionnaire and sent in the requested videos, a sampling kit arrived at her door a few weeks later.\u003c/p>\n\u003cp>\"My hope is that this is going to be a way to help children in the future,\" she says.\u003c/p>\n\u003cp>\u003cstrong>'A Bit More Complex'\u003c/strong>\u003c/p>\n\u003cp>Now that enough samples have been returned from families like Kim's, researchers at the Wall lab have started looking at the early results.\u003c/p>\n\u003cp>In the first phase of their work, David, Tataru, Wall and a fourth member of the team, clinical coordinator Jena Daniels, are analyzing sequences from the stool samples and looking for similarities and differences in what bacteria are present, how abundant they are and what the community of gut bacteria look like.\u003c/p>\n\u003cp>\"We were hoping to find something clear and simple, such as \u003cem>this\u003c/em> bacteria signals autism\" says Tataru. \"Turns out, it's a bit more complex than we were expecting.\"\u003c/p>\n\u003cp>There are no immediately clear distinctions by type or number between the microbiomes of children with autism and those without. The researchers are, however, detecting some subtle differences. Kids within families are the most similar to each other. But kids with ASD in different families have microbiomes that are more alike than the microbiomes of non-autistic children in different families.\u003c/p>\n\u003cp>It's an interesting finding, even if the researchers are not sure what to make of it yet. As a 2014 review of the emerging data on the subject said, “The field is at a stage where more questions than answers are being generated.” And even some leading scientists involved in microbiome research have \u003ca href=\"http://www.nytimes.com/2015/06/28/magazine/can-the-bacteria-in-your-gut-explain-your-mood.html\" target=\"_blank\">cautioned\u003c/a> patients and their families not to get ahead of the research in looking for easy answers.\u003c/p>\n\u003cp>But for scientists like Kevin Becker at the NIH, who is not involved in the project, the turn toward the microbiome in researching ASD is a positive development. \"Genetics has been the focus for a long time and it often dominates the discussion,\" he says. \"Most autistic cases have no known genetic cause. Looking into these other paths is a welcome change.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"info": "What kind of no sabo word is Hyphenación? For us, it’s about living within a hyphenation. Like being a third-gen Mexican-American from the Texas border now living that Bay Area Chicano life. Like Xorje! Each week we bring together a couple of hyphenated Latinos to talk all about personal life choices: family, careers, relationships, belonging … everything is on the table. ",
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"info": "The Political Mind of Jerry Brown brings listeners the wisdom of the former Governor, Mayor, and presidential candidate. Scott Shafer interviewed Brown for more than 40 hours, covering the former governor's life and half-century in the political game – and Brown has some lessons he'd like to share. ",
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"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>",
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"info": "For decades, the process for how police police themselves has been inconsistent – if not opaque. In some states, like California, these proceedings were completely hidden. After a new police transparency law unsealed scores of internal affairs files, our reporters set out to examine these cases and the shadow world of police discipline. On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. Is it the officers, or the public they've sworn to serve?",
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"info": "Political Breakdown is a new series that explores the political intersection of California and the nation. Each week hosts Scott Shafer and Marisa Lagos are joined with a new special guest to unpack politics -- with personality — and offer an insider’s glimpse at how politics happens.",
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"possible": {
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"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
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"radiolab": {
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},
"rightnowish": {
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"title": "Rightnowish",
"tagline": "Art is where you find it",
"info": "Rightnowish digs into life in the Bay Area right now… ish. Journalist Pendarvis Harshaw takes us to galleries painted on the sides of liquor stores in West Oakland. We'll dance in warehouses in the Bayview, make smoothies with kids in South Berkeley, and listen to classical music in a 1984 Cutlass Supreme in Richmond. Every week, Pen talks to movers and shakers about how the Bay Area shapes what they create, and how they shape the place we call home.",
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"info": "The Snap Judgment radio show and podcast mixes real stories with killer beats to produce cinematic, dramatic radio. Snap's musical brand of storytelling dares listeners to see the world through the eyes of another. This is storytelling... with a BEAT!! Snap first aired on public radio stations nationwide in July 2010. Today, Snap Judgment airs on over 450 public radio stations and is brought to the airwaves by KQED & PRX.",
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"soldout": {
"id": "soldout",
"title": "SOLD OUT: Rethinking Housing in America",
"tagline": "A new future for housing",
"info": "Sold Out: Rethinking Housing in America",
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