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"content": "\u003cp>Editing cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn — a potential game-changer for the companies developing CRISPR-based therapies.[contextly_sidebar id=\"Pbm72hAOjQOHNUgNeQaKv0l2d5rX0APO\"]\u003c/p>\n\u003cp>In the studies, published in Nature Medicine, scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient. That could make some CRISPR’d cells ticking time bombs, according to researchers from Sweden’s Karolinska Institute and, separately, Novartis.\u003c/p>\n\u003cp class=\"danger-zone\">\u003ca href=\"https://www.statnews.com/feature/crispr/tracker/\">CRISPR\u003c/a> has already dodged two potentially fatal bullets — a 2017 \u003ca href=\"https://www.nature.com/articles/nmeth.4293.epdf\" target=\"_blank\" rel=\"noopener\">claim\u003c/a> that it causes sky-high numbers of off-target effects was \u003ca href=\"https://www.nature.com/articles/nmeth.4664\" target=\"_blank\" rel=\"noopener\">retracted\u003c/a> in March, and a \u003ca href=\"https://www.biorxiv.org/content/early/2018/01/05/243345\" target=\"_blank\" rel=\"noopener\">report \u003c/a>of human immunity to Cas9 was largely shrugged off as \u003ca href=\"https://www.statnews.com/2018/01/08/immunity-crispr-cas9/\">solvable\u003c/a>. But experts are taking the cancer-risk finding seriously.\u003c/p>\n\u003cp class=\"danger-zone\">The CEO of CRISPR Therapeutics, Sam Kulkarni, told STAT the results are “plausible.” Although they likely apply to one of the main ways that CRISPR edits genomes (replacing disease-causing DNA with healthy versions) more than another (just excising DNA), he said, “it’s something we need to pay attention to, especially as CRISPR expands to more diseases. We need to do the work and make sure edited cells returned to patients don’t become cancerous.”\u003c/p>\n\u003cp class=\"\">Another leading CRISPR scientist, who asked not to be named because of involvement with genome-editing companies, called the new data “pretty striking,” and raised concerns that a potential fatal flaw in some uses of CRISPR had “been missed.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>On the other hand, the Novartis paper has been \u003ca href=\"https://www.biorxiv.org/content/early/2017/07/26/168443\" target=\"_blank\" rel=\"noopener\">available\u003c/a> in preliminary form since last summer, and CRISPR experts “haven’t freaked out,” said Erik Sontheimer of the University of Massachusetts Medical School, whose CRISPR research \u003ca href=\"https://www.statnews.com/2018/03/05/crispr-off-target-editing/\">centers\u003c/a> on novel enzymes and off-target effects. “This is something that bears paying attention to, but I don’t think it’s a deal-breaker” for CRISPR therapies.\u003c/p>\n\u003cp>The Karolinska and Novartis groups tested CRISPR on different kinds of human cells — retinal cells and pluripotent stem cells, respectively. But they found essentially the same phenomenon. Standard CRISPR-Cas9 works by cutting both strands of the DNA double helix. That injury causes a cell to activate a biochemical first-aid kit orchestrated by a gene called \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4235614/\" target=\"_blank\" rel=\"noopener\">p53,\u003c/a> which either mends the DNA break or makes the cell self-destruct.[contextly_sidebar id=\"X1qu0ifjesXey9YHHpOinoS4KNdNuyur\"]\u003c/p>\n\u003cp>Whichever action p53 takes, the consequence is the same: CRISPR doesn’t work, either because the genome edit is stitched up or the cell is dead. (The Novartis team calculated that p53 reduces CRISPR efficiency in pluripotent stem cells seventeenfold.) That might explain something found over and over: CRISPR is woefully inefficient, with only a small minority of cells into which CRISPR is introduced, usually by a virus, actually having their genomes edited as intended.\u003c/p>\n\u003cp>“We found that cutting the genome with CRISPR-Cas9 induced the activation of … p53,” said Emma Haapaniemi, the lead author of the \u003ca href=\"https://www.nature.com/articles/s41591-018-0049-z\" target=\"_blank\" rel=\"noopener\">Karolinska study\u003c/a>. That “makes editing much more difficult.”\u003c/p>\n\u003cp>The flip side of p53 repairing CRISPR edits, or killing cells that accept the edits, is that cells that survive with the edits do so precisely because they have a dysfunctional p53 and therefore lack this fix-it-or-kill-it mechanism.\u003c/p>\n\u003cp>The reason why that could be a problem is that p53 dysfunction can cause cancer. And not just occasionally. P53 mutations are \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827900/figure/A001008F1/\" target=\"_blank\" rel=\"noopener\">responsible for\u003c/a> nearly half of ovarian cancers; 43 percent of colorectal cancers; 38 percent of lung cancers; nearly one-third of pancreatic, stomach, and liver cancers; and one-quarter of breast cancers, among others.\u003c/p>\n\u003cp>The Novartis team was trying to see how it could increase the efficiency of CRISPR editing of pluripotent stem cells. Because this kind of stem cell can morph into virtually any kind of cell, it might be able to treat a variety of diseases. Neuroscientist Ajamete Kaykas of the company’s Institutes for BioMedical Research in Cambridge, Mass., got CRISPR’s efficiency at inserting or deleting chunks of DNA up to 80 percent. Unfortunately, when CRISPR worked, it was because p53 didn’t, which raises cancer concerns.\u003c/p>\n\u003cp>As a result, the Novartis \u003ca href=\"https://www.nature.com/articles/s41591-018-0050-6\" target=\"_blank\" rel=\"noopener\">paper\u003c/a> concludes that “it will be critical to ensure that [genome-edited cells] have a functional p53 before and after [genome] engineering.” The Karolinska team warns that p53 and related genes “should be monitored when developing cell-based therapies utilizing CRISPR-Cas9.”[contextly_sidebar id=\"f80ZxqMXgIrsBguckwJZNJRkL6wI6fMd\"]\u003c/p>\n\u003cp>The p53 finding doesn’t mean CRISPR is toast. For one thing, “the two papers present preliminary results,” biochemist Bernhard Schmierer of the Karolinska, co-leader of its study, told STAT. “It is unclear if the findings translate into cells actually used in current clinical studies.”\u003c/p>\n\u003cp>For another, the p53 problem might be worse with Cas9 than with other DNA-cutting enzymes used in CRISPR. And, crucially, it probably affects only one avenue of genome-editing.\u003c/p>\n\u003cp>CRISPR edits genomes in either of two ways. It slices out a chunk of disease-causing DNA, in a process called non-homologous end joining (NHEJ), or gene disruption. That’s how CRISPR Therapeutics is going after sickle cell disease. Alternatively, CRISPR both cuts out a disease-causing stretch of DNA and replaces it with healthy nucleotides, in homology-directed repair (HDR), or gene correction. Several university labs are investigating HDR to treat Duchenne \u003ca href=\"https://www.nature.com/articles/s41551-017-0137-2\" target=\"_blank\" rel=\"noopener\">muscular dystrophy,\u003c/a> among many other diseases.\u003c/p>\n\u003cp>In the normal, mature cells she and her team studied, Haapaniemi said, gene disruption “can happen even when p53 is activated.”\u003c/p>\n\u003cp>That’s good news for CRISPR Therapeutics’ sickle-cell and thalassemia \u003ca href=\"http://www.crisprtx.com/our-programs/our-pipeline.php\" target=\"_blank\" rel=\"noopener\">programs \u003c/a>as well as for Editas Medicine’s lead product, targeting a form of blindness, and others in its \u003ca href=\"http://www.editasmedicine.com/pipeline\" target=\"_blank\" rel=\"noopener\">pipeline\u003c/a>, all of which use NHEJ gene disruption. It also should not affect the gene-disruption approach that Intellia Therapeutics and Regeneron are \u003ca href=\"https://www.intelliatx.com/pipeline/\" target=\"_blank\" rel=\"noopener\">taking\u003c/a> to \u003ca href=\"https://ghr.nlm.nih.gov/condition/transthyretin-amyloidosis\" target=\"_blank\" rel=\"noopener\">transthyretin amyloidosis\u003c/a>.\u003c/p>\n\u003cp>CRISPR-based editing of T cells to treat cancer, as scientists at the University of Pennsylvania are studying in a \u003ca href=\"https://www.statnews.com/2016/06/21/crispr-human-trials/\">clinical trial,\u003c/a> should also not have a p53 problem. Nor should any therapy developed with CRISPR base editing, which does not make the double-stranded breaks that trigger p53. Developed by Harvard’s David Liu, base editing replaces a wrong DNA “letter” with the right one, without cutting, and is the basis for startup \u003ca href=\"https://www.statnews.com/2018/05/14/crispr-editas-beam-base-editing/\" target=\"_blank\" rel=\"noopener\">Beam Therapeutics\u003c/a>.\u003c/p>\n\u003cp>The p53 problem, however, might affect other products that companies hope to develop via gene correction, including glycogen storage disease, cystic fibrosis, and severe combined immunodeficiency.\u003c/p>\n\u003cp>It’s also a potential problem for stem cells. There, the Novartis team showed, p53 inactivation seems to be necessary for both NHEJ disruption and HDR correction. (Novartis’ Kaykas said he could not speak to a reporter without clearance from the company’s communications office.) That could be an issue for therapies using CRISPR’d stem cells: The same dysfunctional p53 that allows CRISPR to work its magic also makes cells likely to become cancerous.\u003c/p>\n\u003cp>Which raises an obvious question — if successfully CRISPR’d cells can seed cancers, why hasn’t this been seen before, and why haven’t the many CRISPR’d mice developed tumors?\u003c/p>\n\u003cp>Karolinska’s Haapaniemi said the effect shows up in large-scale experiments like hers and Novartis’ “but can be missed in small-scale studies where people only focus on editing one gene in one cell type.” In speaking to other scientists, she said, “it seems that other teams have noticed the effect of p53 on editing,” but have not highlighted it.\u003c/p>\n\u003cp>Jacob Corn of the University of California, Berkeley, said that although his lab has seen evidence of p53 activation in a few cases, they have “looked hard for growth effects after editing in [human stem cells] and found nothing.”\u003c/p>\n\u003cp>As for why no one has reported CRISPR’d mice getting cancer, Haapaniemi said, “This is a good question.” One reason might be that “laboratory mice are killed early,” perhaps leaving too little time for them to develop cancer.\u003c/p>\n\u003cp>But Corn said he and others “have all been looking for the possibility of cancer. So far, no one has seen evidence of [it] based on p53 status or induced by editing.”\u003c/p>\n\u003cp>Nevertheless, he called the two papers “important, since they remind everyone that genome editing isn’t magic.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/06/11/crispr-hurdle-edited-cells-might-cause-cancer/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Editing cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn — a potential game-changer for the companies developing CRISPR-based therapies.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In the studies, published in Nature Medicine, scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient. That could make some CRISPR’d cells ticking time bombs, according to researchers from Sweden’s Karolinska Institute and, separately, Novartis.\u003c/p>\n\u003cp class=\"danger-zone\">\u003ca href=\"https://www.statnews.com/feature/crispr/tracker/\">CRISPR\u003c/a> has already dodged two potentially fatal bullets — a 2017 \u003ca href=\"https://www.nature.com/articles/nmeth.4293.epdf\" target=\"_blank\" rel=\"noopener\">claim\u003c/a> that it causes sky-high numbers of off-target effects was \u003ca href=\"https://www.nature.com/articles/nmeth.4664\" target=\"_blank\" rel=\"noopener\">retracted\u003c/a> in March, and a \u003ca href=\"https://www.biorxiv.org/content/early/2018/01/05/243345\" target=\"_blank\" rel=\"noopener\">report \u003c/a>of human immunity to Cas9 was largely shrugged off as \u003ca href=\"https://www.statnews.com/2018/01/08/immunity-crispr-cas9/\">solvable\u003c/a>. But experts are taking the cancer-risk finding seriously.\u003c/p>\n\u003cp class=\"danger-zone\">The CEO of CRISPR Therapeutics, Sam Kulkarni, told STAT the results are “plausible.” Although they likely apply to one of the main ways that CRISPR edits genomes (replacing disease-causing DNA with healthy versions) more than another (just excising DNA), he said, “it’s something we need to pay attention to, especially as CRISPR expands to more diseases. We need to do the work and make sure edited cells returned to patients don’t become cancerous.”\u003c/p>\n\u003cp class=\"\">Another leading CRISPR scientist, who asked not to be named because of involvement with genome-editing companies, called the new data “pretty striking,” and raised concerns that a potential fatal flaw in some uses of CRISPR had “been missed.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>On the other hand, the Novartis paper has been \u003ca href=\"https://www.biorxiv.org/content/early/2017/07/26/168443\" target=\"_blank\" rel=\"noopener\">available\u003c/a> in preliminary form since last summer, and CRISPR experts “haven’t freaked out,” said Erik Sontheimer of the University of Massachusetts Medical School, whose CRISPR research \u003ca href=\"https://www.statnews.com/2018/03/05/crispr-off-target-editing/\">centers\u003c/a> on novel enzymes and off-target effects. “This is something that bears paying attention to, but I don’t think it’s a deal-breaker” for CRISPR therapies.\u003c/p>\n\u003cp>The Karolinska and Novartis groups tested CRISPR on different kinds of human cells — retinal cells and pluripotent stem cells, respectively. But they found essentially the same phenomenon. Standard CRISPR-Cas9 works by cutting both strands of the DNA double helix. That injury causes a cell to activate a biochemical first-aid kit orchestrated by a gene called \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4235614/\" target=\"_blank\" rel=\"noopener\">p53,\u003c/a> which either mends the DNA break or makes the cell self-destruct.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Whichever action p53 takes, the consequence is the same: CRISPR doesn’t work, either because the genome edit is stitched up or the cell is dead. (The Novartis team calculated that p53 reduces CRISPR efficiency in pluripotent stem cells seventeenfold.) That might explain something found over and over: CRISPR is woefully inefficient, with only a small minority of cells into which CRISPR is introduced, usually by a virus, actually having their genomes edited as intended.\u003c/p>\n\u003cp>“We found that cutting the genome with CRISPR-Cas9 induced the activation of … p53,” said Emma Haapaniemi, the lead author of the \u003ca href=\"https://www.nature.com/articles/s41591-018-0049-z\" target=\"_blank\" rel=\"noopener\">Karolinska study\u003c/a>. That “makes editing much more difficult.”\u003c/p>\n\u003cp>The flip side of p53 repairing CRISPR edits, or killing cells that accept the edits, is that cells that survive with the edits do so precisely because they have a dysfunctional p53 and therefore lack this fix-it-or-kill-it mechanism.\u003c/p>\n\u003cp>The reason why that could be a problem is that p53 dysfunction can cause cancer. And not just occasionally. P53 mutations are \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827900/figure/A001008F1/\" target=\"_blank\" rel=\"noopener\">responsible for\u003c/a> nearly half of ovarian cancers; 43 percent of colorectal cancers; 38 percent of lung cancers; nearly one-third of pancreatic, stomach, and liver cancers; and one-quarter of breast cancers, among others.\u003c/p>\n\u003cp>The Novartis team was trying to see how it could increase the efficiency of CRISPR editing of pluripotent stem cells. Because this kind of stem cell can morph into virtually any kind of cell, it might be able to treat a variety of diseases. Neuroscientist Ajamete Kaykas of the company’s Institutes for BioMedical Research in Cambridge, Mass., got CRISPR’s efficiency at inserting or deleting chunks of DNA up to 80 percent. Unfortunately, when CRISPR worked, it was because p53 didn’t, which raises cancer concerns.\u003c/p>\n\u003cp>As a result, the Novartis \u003ca href=\"https://www.nature.com/articles/s41591-018-0050-6\" target=\"_blank\" rel=\"noopener\">paper\u003c/a> concludes that “it will be critical to ensure that [genome-edited cells] have a functional p53 before and after [genome] engineering.” The Karolinska team warns that p53 and related genes “should be monitored when developing cell-based therapies utilizing CRISPR-Cas9.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The p53 finding doesn’t mean CRISPR is toast. For one thing, “the two papers present preliminary results,” biochemist Bernhard Schmierer of the Karolinska, co-leader of its study, told STAT. “It is unclear if the findings translate into cells actually used in current clinical studies.”\u003c/p>\n\u003cp>For another, the p53 problem might be worse with Cas9 than with other DNA-cutting enzymes used in CRISPR. And, crucially, it probably affects only one avenue of genome-editing.\u003c/p>\n\u003cp>CRISPR edits genomes in either of two ways. It slices out a chunk of disease-causing DNA, in a process called non-homologous end joining (NHEJ), or gene disruption. That’s how CRISPR Therapeutics is going after sickle cell disease. Alternatively, CRISPR both cuts out a disease-causing stretch of DNA and replaces it with healthy nucleotides, in homology-directed repair (HDR), or gene correction. Several university labs are investigating HDR to treat Duchenne \u003ca href=\"https://www.nature.com/articles/s41551-017-0137-2\" target=\"_blank\" rel=\"noopener\">muscular dystrophy,\u003c/a> among many other diseases.\u003c/p>\n\u003cp>In the normal, mature cells she and her team studied, Haapaniemi said, gene disruption “can happen even when p53 is activated.”\u003c/p>\n\u003cp>That’s good news for CRISPR Therapeutics’ sickle-cell and thalassemia \u003ca href=\"http://www.crisprtx.com/our-programs/our-pipeline.php\" target=\"_blank\" rel=\"noopener\">programs \u003c/a>as well as for Editas Medicine’s lead product, targeting a form of blindness, and others in its \u003ca href=\"http://www.editasmedicine.com/pipeline\" target=\"_blank\" rel=\"noopener\">pipeline\u003c/a>, all of which use NHEJ gene disruption. It also should not affect the gene-disruption approach that Intellia Therapeutics and Regeneron are \u003ca href=\"https://www.intelliatx.com/pipeline/\" target=\"_blank\" rel=\"noopener\">taking\u003c/a> to \u003ca href=\"https://ghr.nlm.nih.gov/condition/transthyretin-amyloidosis\" target=\"_blank\" rel=\"noopener\">transthyretin amyloidosis\u003c/a>.\u003c/p>\n\u003cp>CRISPR-based editing of T cells to treat cancer, as scientists at the University of Pennsylvania are studying in a \u003ca href=\"https://www.statnews.com/2016/06/21/crispr-human-trials/\">clinical trial,\u003c/a> should also not have a p53 problem. Nor should any therapy developed with CRISPR base editing, which does not make the double-stranded breaks that trigger p53. Developed by Harvard’s David Liu, base editing replaces a wrong DNA “letter” with the right one, without cutting, and is the basis for startup \u003ca href=\"https://www.statnews.com/2018/05/14/crispr-editas-beam-base-editing/\" target=\"_blank\" rel=\"noopener\">Beam Therapeutics\u003c/a>.\u003c/p>\n\u003cp>The p53 problem, however, might affect other products that companies hope to develop via gene correction, including glycogen storage disease, cystic fibrosis, and severe combined immunodeficiency.\u003c/p>\n\u003cp>It’s also a potential problem for stem cells. There, the Novartis team showed, p53 inactivation seems to be necessary for both NHEJ disruption and HDR correction. (Novartis’ Kaykas said he could not speak to a reporter without clearance from the company’s communications office.) That could be an issue for therapies using CRISPR’d stem cells: The same dysfunctional p53 that allows CRISPR to work its magic also makes cells likely to become cancerous.\u003c/p>\n\u003cp>Which raises an obvious question — if successfully CRISPR’d cells can seed cancers, why hasn’t this been seen before, and why haven’t the many CRISPR’d mice developed tumors?\u003c/p>\n\u003cp>Karolinska’s Haapaniemi said the effect shows up in large-scale experiments like hers and Novartis’ “but can be missed in small-scale studies where people only focus on editing one gene in one cell type.” In speaking to other scientists, she said, “it seems that other teams have noticed the effect of p53 on editing,” but have not highlighted it.\u003c/p>\n\u003cp>Jacob Corn of the University of California, Berkeley, said that although his lab has seen evidence of p53 activation in a few cases, they have “looked hard for growth effects after editing in [human stem cells] and found nothing.”\u003c/p>\n\u003cp>As for why no one has reported CRISPR’d mice getting cancer, Haapaniemi said, “This is a good question.” One reason might be that “laboratory mice are killed early,” perhaps leaving too little time for them to develop cancer.\u003c/p>\n\u003cp>But Corn said he and others “have all been looking for the possibility of cancer. So far, no one has seen evidence of [it] based on p53 status or induced by editing.”\u003c/p>\n\u003cp>Nevertheless, he called the two papers “important, since they remind everyone that genome editing isn’t magic.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/06/11/crispr-hurdle-edited-cells-might-cause-cancer/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>The deaths of celebrity chef Anthony Bourdain and fashion designer Kate Spade highlight a troubling trend — rising suicides among middle-aged Americans.[contextly_sidebar id=”VRyDwaewBsFbQgWstXuEk6sa8awOu2Ef”]\u003c/p>\n\u003cp>Mental health problems, often undiagnosed, are usually involved and experts say knowing warning signs and who is at risk can help stop a crisis from becoming a tragedy.\u003c/p>\n\u003cp>Bourdain, 61, and Spade, 55, died three days and a continent apart this week amid a new U.S. report showing an uptick in suicides rates in nearly every state since 1999. Middle-aged adults — ages 45 to 64 — had the largest rate increase, according to the \u003ca href=\"https://www.cdc.gov/media/releases/2018/p0607-suicide-prevention.html\" target=\"_blank\" rel=\"noopener\">report\u003c/a> from the Centers for Disease Control and Prevention.\u003c/p>\n\u003cdiv id=\"div-gpt-ad-1470255291270-0\" class=\"ad-placeholder\">\n\u003cp>Previous studies have suggested economic downturns and the nation’s opioid crisis contributed to the rise in middle-aged suicides.\u003c/p>\n\u003cp>Dr. Christine Moutier, a psychiatrist and chief medical officer for the American \u003ca href=\"https://afsp.org/\" target=\"_blank\" rel=\"noopener\">Foundation\u003c/a> for Suicide Prevention, said Friday it’s important for everyone to know the warning signs and to intervene when family members, friends or co-workers appear troubled. Asking if they’ve had suicidal thoughts is not harmful and lets them know you care, she said.\u003c/p>\n\u003cp>Behavior that may indicate someone is suicidal includes:\u003c/p>\n\u003cp>—Talking about feeling hopeless, trapped, a burden to others or wanting to die.\u003c/p>\n\u003cp>—Unusual mood swings or withdrawing from family, friends and usual activities.\u003c/p>\n\u003cp>—Giving away important possessions.\u003c/p>\n\u003cp>—Increased use of alcohol or drugs.\u003c/p>\n\u003cp>This week’s report found that many suicides were in people with no known mental illness. But Dr. Joshua Gordon, director of the National Institute of Mental Health, said that contradicts years of data, suggesting many have “gone undiagnosed and untreated. It’s very troubling.”\u003c/p>\n\u003cp>Gordon said doctors need to ask patients at every opportunity about their mental health and evaluate their risk for suicide.[contextly_sidebar id=”5yHVylMSzJGpyUIEUKvOwWpHBWw6aZNt”]\u003c/p>\n\u003cp>“When you ask everybody and not just people you might suspect, you double the number you detect,” he said.\u003c/p>\n\u003cp>Gordon noted that psychotherapy and certain psychiatric drugs have been shown to reduce suicidal tendencies.\u003c/p>\n\u003cp>Moutier of the American Foundation for Suicide Prevention, said that suicides can be “contagious” — hearing about one may make others who are already at risk turn to self-harm. She said celebrity suicides also typically prompt an increase in calls to suicide \u003ca href=\"https://suicidepreventionlifeline.org/\" target=\"_blank\" rel=\"noopener\">help lines.\u003c/a>\u003c/p>\n\u003cp>“People should know that suicide is preventable. Anyone contemplating suicide should know that help is available, and that there is no shame in seeking care for your mental health,” Dr. Altha Stewart of the American Psychiatric \u003ca href=\"https://www.psychiatry.org/patients-families/suicide-prevention\" target=\"_blank\" rel=\"noopener\">Association\u003c/a> said in a statement.\u003c/p>\n\u003c/div>\n\u003cp>[ad fullwidth]\u003c/p>\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The deaths of celebrity chef Anthony Bourdain and fashion designer Kate Spade highlight a troubling trend — rising suicides among middle-aged Americans.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Mental health problems, often undiagnosed, are usually involved and experts say knowing warning signs and who is at risk can help stop a crisis from becoming a tragedy.\u003c/p>\n\u003cp>Bourdain, 61, and Spade, 55, died three days and a continent apart this week amid a new U.S. report showing an uptick in suicides rates in nearly every state since 1999. Middle-aged adults — ages 45 to 64 — had the largest rate increase, according to the \u003ca href=\"https://www.cdc.gov/media/releases/2018/p0607-suicide-prevention.html\" target=\"_blank\" rel=\"noopener\">report\u003c/a> from the Centers for Disease Control and Prevention.\u003c/p>\n\u003cdiv id=\"div-gpt-ad-1470255291270-0\" class=\"ad-placeholder\">\n\u003cp>Previous studies have suggested economic downturns and the nation’s opioid crisis contributed to the rise in middle-aged suicides.\u003c/p>\n\u003cp>Dr. Christine Moutier, a psychiatrist and chief medical officer for the American \u003ca href=\"https://afsp.org/\" target=\"_blank\" rel=\"noopener\">Foundation\u003c/a> for Suicide Prevention, said Friday it’s important for everyone to know the warning signs and to intervene when family members, friends or co-workers appear troubled. Asking if they’ve had suicidal thoughts is not harmful and lets them know you care, she said.\u003c/p>\n\u003cp>Behavior that may indicate someone is suicidal includes:\u003c/p>\n\u003cp>—Talking about feeling hopeless, trapped, a burden to others or wanting to die.\u003c/p>\n\u003cp>—Unusual mood swings or withdrawing from family, friends and usual activities.\u003c/p>\n\u003cp>—Giving away important possessions.\u003c/p>\n\u003cp>—Increased use of alcohol or drugs.\u003c/p>\n\u003cp>This week’s report found that many suicides were in people with no known mental illness. But Dr. Joshua Gordon, director of the National Institute of Mental Health, said that contradicts years of data, suggesting many have “gone undiagnosed and untreated. It’s very troubling.”\u003c/p>\n\u003cp>Gordon said doctors need to ask patients at every opportunity about their mental health and evaluate their risk for suicide.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>“When you ask everybody and not just people you might suspect, you double the number you detect,” he said.\u003c/p>\n\u003cp>Gordon noted that psychotherapy and certain psychiatric drugs have been shown to reduce suicidal tendencies.\u003c/p>\n\u003cp>Moutier of the American Foundation for Suicide Prevention, said that suicides can be “contagious” — hearing about one may make others who are already at risk turn to self-harm. She said celebrity suicides also typically prompt an increase in calls to suicide \u003ca href=\"https://suicidepreventionlifeline.org/\" target=\"_blank\" rel=\"noopener\">help lines.\u003c/a>\u003c/p>\n\u003cp>“People should know that suicide is preventable. Anyone contemplating suicide should know that help is available, and that there is no shame in seeking care for your mental health,” Dr. Altha Stewart of the American Psychiatric \u003ca href=\"https://www.psychiatry.org/patients-families/suicide-prevention\" target=\"_blank\" rel=\"noopener\">Association\u003c/a> said in a statement.\u003c/p>\n\u003c/div>\n\u003cp>\u003c/p>\u003c/div>",
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"disqusTitle": "From Chaos To Calm: A Life Changed By Ketamine",
"title": "From Chaos To Calm: A Life Changed By Ketamine",
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"content": "\u003cp>For six years now, life has been really good for James. He has a great job as the creative director of an advertising firm in New York City. He enjoys spending time with his wife and kids.[contextly_sidebar id=\"s4NBmRFOwEaVfa4ea1pL5Kssair4SGBs\"]\u003c/p>\n\u003cp>And it has all been possible, he says, because for the past six years he has been taking a drug called\u003ca href=\"https://www.npr.org/sections/health-shots/2015/09/28/443203592/club-drug-ketamine-gains-traction-as-a-treatment-for-depression\" target=\"_blank\" rel=\"noopener\"> ketamine\u003c/a>.\u003c/p>\n\u003cp>Before ketamine, James was unable to work or focus his thoughts. His mind was filled with violent images. And his mood could go from ebullient to dark in a matter of minutes.\u003c/p>\n\u003cp>Ketamine \"helped me get my life back,\" says James, who asked that we not use his last name to protect his career.\u003c/p>\n\u003cp>Ketamine was developed as a human and animal anesthetic in the 1960s. And almost from the time it reached the market it has also been used as a mind-bending party drug.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But ketamine's story took a surprising turn in 2006, when researchers at the National Institutes of Health \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/16894061\">showed\u003c/a> that an intravenous dose could relieve severe depression in a matter of hours. Since then, doctors have prescribed ketamine \"off label\" to \u003ca href=\"https://www.npr.org/sections/health-shots/2017/03/20/520169959/ketamine-for-severe-depression-how-do-you-not-offer-this-drug-to-people\" target=\"_blank\" rel=\"noopener\">thousands of depressed patients\u003c/a> who don't respond to other drugs.\u003c/p>\n\u003cp>And pharmaceutical companies are \u003ca href=\"https://www.npr.org/sections/health-shots/2015/05/28/409800015/ketamine-depression-treatments-inspired-by-club-drug-move-ahead-in-tests\" target=\"_blank\" rel=\"noopener\">testing\u003c/a> several new ketamine-related drugs to treat depression. Johnson & Johnson expects to seek approval for its nasal spray \u003ca href=\"https://www.jnj.com/media-center/press-releases/new-phase-3-data-show-esketamine-nasal-spray-demonstrated-rapid-improvements-in-depressive-symptoms-in-patients-with-treatment-resistant-depression\" target=\"_blank\" rel=\"noopener\">esketamine\u003c/a> later this year, though the approval would be limited to use in a clinical setting.[contextly_sidebar id=\"WxNsPZS18b7j3a9u3SqMCjwKimnR3LX8\"]\u003c/p>\n\u003cp>Meanwhile, doctors have begun trying ketamine on patients with a wide range of psychiatric disorders other than depression. And there is now growing evidence it can help people with anxiety, bipolar disorder, post-traumatic stress disorder, and perhaps even obsessive-compulsive disorder.\u003c/p>\n\u003cp>\"I think it's actually one of the biggest advances in psychiatry in a very long time,\" says Dr. \u003ca href=\"https://www.mcleanhospital.org/biography/martin-teicher\" target=\"_blank\" rel=\"noopener\">Martin Teicher\u003c/a>, an associate professor of psychiatry at Harvard Medical School and director of the Developmental Biopsychiatry Research Program at McLean Hospital.\u003c/p>\n\u003cp>Ketamine may also offer new hope for people like James who have symptoms of several different psychiatric disorders.\u003c/p>\n\u003cp>James had a happy childhood, he says. But his thoughts were out of control. \"I always felt like I was crossing a freeway and my thoughts were just racing past me,\" he says.\u003c/p>\n\u003cp>He spent much of his childhood terrified of \"an unknown, an ambiguous force out there.\" The fear was \"overwhelming,\" he says. \"I literally slept with the cover over my head with just room to breathe through my mouth until I went to college.\"\u003c/p>\n\u003cp>And there was something else about James: his body temperature.\u003c/p>\n\u003cp>\"I overheated constantly,\" he says. \"I would wear shorts all year long. In my 20s in my apartment I would sleep with the windows open in the middle of the winter.\"\u003c/p>\n\u003cp>In his late 20s, James saw a doctor who told him he had attention deficit hyperactivity disorder. So he started taking stimulants.[contextly_sidebar id=\"IjfTHMEjzV27TicYbrGolDFdASO5y6qG\"]\u003c/p>\n\u003cp>At first, the pills helped him focus. Then they didn't, no matter how many he took.\u003c/p>\n\u003cp>He'd done well as an idea guy in the advertising industry. But now James was trying to work at home, and it wasn't going well.\u003c/p>\n\u003cp>\"ADHD pills will make you interested in anything,\" he says. \"So I was putting the desk together and taking the desk apart. I was putting a laptop stand together and taking it apart. I was going in a massive downward spiral.\"\u003c/p>\n\u003cp>James had always suffered from mood swings. But now they were rapid and extreme. And he couldn't stop thinking about gruesome scenarios, like a murderer coming for his family.\u003c/p>\n\u003cp>\"My wife took a summer off to be with me because she was scared of what was going to happen to me,\" he says. \"She would go to work for a few hours, then rush home. There would be times I'd call her just screaming, 'Please come home. I can't get through another minute.' \"\u003c/p>\n\u003cp>Eventually, James found his way to Dr. \u003ca href=\"http://bipolarchild.com/about/authors/\" target=\"_blank\" rel=\"noopener\">Demitri Papolos\u003c/a>, an associate professor of clinical psychiatry at Albert Einstein College of Medicine.\u003c/p>\n\u003cp>\"He was like a whirling dervish when he came into my office,\" Papolos says. \"He was extremely fearful and scanning the environment all the time and he overheated at the drop of a hat.\"\u003c/p>\n\u003cp>Papolos diagnosed James with a variant of bipolar disorder he calls the \"fear of harm phenotype.\" It typically appears in childhood and often doesn't respond to traditional psychiatric drugs.[contextly_sidebar id=\"ONPRitNVz88O9pFNNVQ7htlsCs7xWv0w\"]\u003c/p>\n\u003cp>But Papolos has found that the condition does respond to ketamine. \"It's been transformational,\" he says.\u003c/p>\n\u003cp>In January, Papolos published a \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/28866299\">study\u003c/a> of 45 children with the problem. They inhaled a nasal mist containing ketamine about twice a week. Nearly all got dramatically better.\u003c/p>\n\u003cp>Scientists still aren't sure why ketamine works, but there's \u003ca href=\"https://www.npr.org/sections/health-shots/2012/10/04/162299564/ketamine-relieves-depression-by-restoring-brain-connections\" target=\"_blank\" rel=\"noopener\">evidence\u003c/a> that it encourages the brain to rewire, to alter the connections between cells. That process has been linked to recovery from depression. And it may also explain why ketamine helps people who have symptoms associated with several different psychiatric disorders.\u003c/p>\n\u003cp>\"I think it's having multiple effects, and that means it's probably useful for multiple different disorders,\" Teicher says.\u003c/p>\n\u003cp>One of those effects involves a part of the brain involved in temperature regulation. And that could explain why patients like James usually stop overheating once they are taking ketamine.\u003c/p>\n\u003cp>James started taking a ketamine nasal spray every other day. He says his response was dramatic.\u003c/p>\n\u003cp>\"One day I turn to my wife and I'm like, 'I feel calm today. I don't know if it's the sun coming in, I don't know if it's just the way we're sitting here, but I feel like I could go and sit at the computer and work.' \"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The next day, James did sit down at his computer. A month later, he was back at work.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=From+Chaos+To+Calm%3A+A+Life+Changed+By+Ketamine&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>For six years now, life has been really good for James. He has a great job as the creative director of an advertising firm in New York City. He enjoys spending time with his wife and kids.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>And it has all been possible, he says, because for the past six years he has been taking a drug called\u003ca href=\"https://www.npr.org/sections/health-shots/2015/09/28/443203592/club-drug-ketamine-gains-traction-as-a-treatment-for-depression\" target=\"_blank\" rel=\"noopener\"> ketamine\u003c/a>.\u003c/p>\n\u003cp>Before ketamine, James was unable to work or focus his thoughts. His mind was filled with violent images. And his mood could go from ebullient to dark in a matter of minutes.\u003c/p>\n\u003cp>Ketamine \"helped me get my life back,\" says James, who asked that we not use his last name to protect his career.\u003c/p>\n\u003cp>Ketamine was developed as a human and animal anesthetic in the 1960s. And almost from the time it reached the market it has also been used as a mind-bending party drug.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But ketamine's story took a surprising turn in 2006, when researchers at the National Institutes of Health \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/16894061\">showed\u003c/a> that an intravenous dose could relieve severe depression in a matter of hours. Since then, doctors have prescribed ketamine \"off label\" to \u003ca href=\"https://www.npr.org/sections/health-shots/2017/03/20/520169959/ketamine-for-severe-depression-how-do-you-not-offer-this-drug-to-people\" target=\"_blank\" rel=\"noopener\">thousands of depressed patients\u003c/a> who don't respond to other drugs.\u003c/p>\n\u003cp>And pharmaceutical companies are \u003ca href=\"https://www.npr.org/sections/health-shots/2015/05/28/409800015/ketamine-depression-treatments-inspired-by-club-drug-move-ahead-in-tests\" target=\"_blank\" rel=\"noopener\">testing\u003c/a> several new ketamine-related drugs to treat depression. Johnson & Johnson expects to seek approval for its nasal spray \u003ca href=\"https://www.jnj.com/media-center/press-releases/new-phase-3-data-show-esketamine-nasal-spray-demonstrated-rapid-improvements-in-depressive-symptoms-in-patients-with-treatment-resistant-depression\" target=\"_blank\" rel=\"noopener\">esketamine\u003c/a> later this year, though the approval would be limited to use in a clinical setting.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Meanwhile, doctors have begun trying ketamine on patients with a wide range of psychiatric disorders other than depression. And there is now growing evidence it can help people with anxiety, bipolar disorder, post-traumatic stress disorder, and perhaps even obsessive-compulsive disorder.\u003c/p>\n\u003cp>\"I think it's actually one of the biggest advances in psychiatry in a very long time,\" says Dr. \u003ca href=\"https://www.mcleanhospital.org/biography/martin-teicher\" target=\"_blank\" rel=\"noopener\">Martin Teicher\u003c/a>, an associate professor of psychiatry at Harvard Medical School and director of the Developmental Biopsychiatry Research Program at McLean Hospital.\u003c/p>\n\u003cp>Ketamine may also offer new hope for people like James who have symptoms of several different psychiatric disorders.\u003c/p>\n\u003cp>James had a happy childhood, he says. But his thoughts were out of control. \"I always felt like I was crossing a freeway and my thoughts were just racing past me,\" he says.\u003c/p>\n\u003cp>He spent much of his childhood terrified of \"an unknown, an ambiguous force out there.\" The fear was \"overwhelming,\" he says. \"I literally slept with the cover over my head with just room to breathe through my mouth until I went to college.\"\u003c/p>\n\u003cp>And there was something else about James: his body temperature.\u003c/p>\n\u003cp>\"I overheated constantly,\" he says. \"I would wear shorts all year long. In my 20s in my apartment I would sleep with the windows open in the middle of the winter.\"\u003c/p>\n\u003cp>In his late 20s, James saw a doctor who told him he had attention deficit hyperactivity disorder. So he started taking stimulants.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>At first, the pills helped him focus. Then they didn't, no matter how many he took.\u003c/p>\n\u003cp>He'd done well as an idea guy in the advertising industry. But now James was trying to work at home, and it wasn't going well.\u003c/p>\n\u003cp>\"ADHD pills will make you interested in anything,\" he says. \"So I was putting the desk together and taking the desk apart. I was putting a laptop stand together and taking it apart. I was going in a massive downward spiral.\"\u003c/p>\n\u003cp>James had always suffered from mood swings. But now they were rapid and extreme. And he couldn't stop thinking about gruesome scenarios, like a murderer coming for his family.\u003c/p>\n\u003cp>\"My wife took a summer off to be with me because she was scared of what was going to happen to me,\" he says. \"She would go to work for a few hours, then rush home. There would be times I'd call her just screaming, 'Please come home. I can't get through another minute.' \"\u003c/p>\n\u003cp>Eventually, James found his way to Dr. \u003ca href=\"http://bipolarchild.com/about/authors/\" target=\"_blank\" rel=\"noopener\">Demitri Papolos\u003c/a>, an associate professor of clinical psychiatry at Albert Einstein College of Medicine.\u003c/p>\n\u003cp>\"He was like a whirling dervish when he came into my office,\" Papolos says. \"He was extremely fearful and scanning the environment all the time and he overheated at the drop of a hat.\"\u003c/p>\n\u003cp>Papolos diagnosed James with a variant of bipolar disorder he calls the \"fear of harm phenotype.\" It typically appears in childhood and often doesn't respond to traditional psychiatric drugs.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>But Papolos has found that the condition does respond to ketamine. \"It's been transformational,\" he says.\u003c/p>\n\u003cp>In January, Papolos published a \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/28866299\">study\u003c/a> of 45 children with the problem. They inhaled a nasal mist containing ketamine about twice a week. Nearly all got dramatically better.\u003c/p>\n\u003cp>Scientists still aren't sure why ketamine works, but there's \u003ca href=\"https://www.npr.org/sections/health-shots/2012/10/04/162299564/ketamine-relieves-depression-by-restoring-brain-connections\" target=\"_blank\" rel=\"noopener\">evidence\u003c/a> that it encourages the brain to rewire, to alter the connections between cells. That process has been linked to recovery from depression. And it may also explain why ketamine helps people who have symptoms associated with several different psychiatric disorders.\u003c/p>\n\u003cp>\"I think it's having multiple effects, and that means it's probably useful for multiple different disorders,\" Teicher says.\u003c/p>\n\u003cp>One of those effects involves a part of the brain involved in temperature regulation. And that could explain why patients like James usually stop overheating once they are taking ketamine.\u003c/p>\n\u003cp>James started taking a ketamine nasal spray every other day. He says his response was dramatic.\u003c/p>\n\u003cp>\"One day I turn to my wife and I'm like, 'I feel calm today. I don't know if it's the sun coming in, I don't know if it's just the way we're sitting here, but I feel like I could go and sit at the computer and work.' \"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The next day, James did sit down at his computer. A month later, he was back at work.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=From+Chaos+To+Calm%3A+A+Life+Changed+By+Ketamine&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "California Sues Two Makers of Baby Formula For Lead Contamination",
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"content": "\u003cp>The state of California is suing two companies, Nutraceutical Corp. and Graceleigh Inc., whose toddler formulas contain dangerous levels of lead that exceed both state and federal standards.[contextly_sidebar id=\"dDFZfxJC6DngGGIurpGHrevnbYYzKMAg\"]\u003c/p>\n\u003cp>State \u003ca href=\"https://www.oag.ca.gov/news/press-releases/attorney-general-becerra-issues-cease-and-desist-letters-and-files-suit-over\" target=\"_blank\" rel=\"noopener\">testing\u003c/a> revealed that the two products -- Peaceful Planet Toddler Supreme and Sammy’s Milk Free-Range Goat Milk Toddler Formula – contained between 13 and 15 times the maximum allowable dose level under California law.\u003c/p>\n\u003cp>California Attorney General Xavier Becerra told reporters on Thursday that after the state Department of Justice issued cease-and-desist orders, the companies voluntarily agreed to stop selling the contaminated baby formulas in California.[contextly_sidebar id=\"A1OKE7foNBL4C7EMCs4DtnAcdEd76Tw8\"]\u003c/p>\n\u003cp>\"Parents across America, and certainly in California, on a daily basis rely on the representations made by companies,\" said Becerra during the press conference, \"to make sure that what our children are eating is not only good for them, but is safe as well.\"\u003c/p>\n\u003cp>In\u003ca href=\"https://www.oag.ca.gov/news/press-releases/attorney-general-becerra-issues-cease-and-desist-letters-and-files-suit-over\" target=\"_blank\" rel=\"noopener\"> a statement\u003c/a> accompanying the announcement, the department called the findings a “parent’s worst nightmare\" and said the lawsuit is intended to put all manufacturers on notice.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"The California Department of Justice will hold you accountable for gambling with our children’s health,\" the agency warned.\u003c/p>\n\u003cp>The lawsuit, which seeks monetary penalties, alleges that the companies violated California’s Unfair Competition Law, False Advertising Law, and Proposition 65, which requires companies to adequately warn consumers that their products expose them to toxic chemicals.\u003c/p>\n\u003cp>\"Parents across America, and certainly in California, on a daily basis rely on the representations made by companies,\" said Becerra during today's presser, \"to make sure that what our children are eating is not only good for them, but is safe as well.\"\u003c/p>\n\u003cp>And when it comes to lead consumption, there really isn't a tolerable level for children, according to Dr. Timur Durrani, a toxicologist at UCSF.[contextly_sidebar id=\"2INd1f7DezHFZVXzQK6VbkQZUIqMUhE2\"]\u003c/p>\n\u003cp>\"One message I would put to you is that there really is no safe level of lead, particularly for children,\" he told reporters at the announcement.\u003c/p>\n\u003cp>According to the Mayo Clinic, \u003ca href=\"https://www.mayoclinic.org/diseases-conditions/lead-poisoning/symptoms-causes/syc-20354717\" target=\"_blank\" rel=\"noopener\">even small amounts\u003c/a> of lead can cause serious health problems in children, affecting their mental and physical development. Chronic lead exposure can seriously impair brain development and lead to learning and behavioral problems.\u003c/p>\n\u003cp>The presence of lead in baby formula is especially concerning, said Becerra, since toddlers consume it daily.\u003c/p>\n\u003cp>Lead, a naturally occurring chemical, is found in the environment in small amounts. The majority of human exposure to it is through activities such as ceramics, or products such as cosmetics, paint and toys, according to the \u003ca href=\"https://www.epa.gov/lead/learn-about-lead\" target=\"_blank\" rel=\"noopener\">Environmental Protection Agency.\u003c/a>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Becerra has urged parents of toddlers who consumed the contaminated formulas to get them tested for lead exposure.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>The state of California is suing two companies, Nutraceutical Corp. and Graceleigh Inc., whose toddler formulas contain dangerous levels of lead that exceed both state and federal standards.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>State \u003ca href=\"https://www.oag.ca.gov/news/press-releases/attorney-general-becerra-issues-cease-and-desist-letters-and-files-suit-over\" target=\"_blank\" rel=\"noopener\">testing\u003c/a> revealed that the two products -- Peaceful Planet Toddler Supreme and Sammy’s Milk Free-Range Goat Milk Toddler Formula – contained between 13 and 15 times the maximum allowable dose level under California law.\u003c/p>\n\u003cp>California Attorney General Xavier Becerra told reporters on Thursday that after the state Department of Justice issued cease-and-desist orders, the companies voluntarily agreed to stop selling the contaminated baby formulas in California.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"Parents across America, and certainly in California, on a daily basis rely on the representations made by companies,\" said Becerra during the press conference, \"to make sure that what our children are eating is not only good for them, but is safe as well.\"\u003c/p>\n\u003cp>In\u003ca href=\"https://www.oag.ca.gov/news/press-releases/attorney-general-becerra-issues-cease-and-desist-letters-and-files-suit-over\" target=\"_blank\" rel=\"noopener\"> a statement\u003c/a> accompanying the announcement, the department called the findings a “parent’s worst nightmare\" and said the lawsuit is intended to put all manufacturers on notice.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"The California Department of Justice will hold you accountable for gambling with our children’s health,\" the agency warned.\u003c/p>\n\u003cp>The lawsuit, which seeks monetary penalties, alleges that the companies violated California’s Unfair Competition Law, False Advertising Law, and Proposition 65, which requires companies to adequately warn consumers that their products expose them to toxic chemicals.\u003c/p>\n\u003cp>\"Parents across America, and certainly in California, on a daily basis rely on the representations made by companies,\" said Becerra during today's presser, \"to make sure that what our children are eating is not only good for them, but is safe as well.\"\u003c/p>\n\u003cp>And when it comes to lead consumption, there really isn't a tolerable level for children, according to Dr. Timur Durrani, a toxicologist at UCSF.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"One message I would put to you is that there really is no safe level of lead, particularly for children,\" he told reporters at the announcement.\u003c/p>\n\u003cp>According to the Mayo Clinic, \u003ca href=\"https://www.mayoclinic.org/diseases-conditions/lead-poisoning/symptoms-causes/syc-20354717\" target=\"_blank\" rel=\"noopener\">even small amounts\u003c/a> of lead can cause serious health problems in children, affecting their mental and physical development. Chronic lead exposure can seriously impair brain development and lead to learning and behavioral problems.\u003c/p>\n\u003cp>The presence of lead in baby formula is especially concerning, said Becerra, since toddlers consume it daily.\u003c/p>\n\u003cp>Lead, a naturally occurring chemical, is found in the environment in small amounts. The majority of human exposure to it is through activities such as ceramics, or products such as cosmetics, paint and toys, according to the \u003ca href=\"https://www.epa.gov/lead/learn-about-lead\" target=\"_blank\" rel=\"noopener\">Environmental Protection Agency.\u003c/a>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Becerra has urged parents of toddlers who consumed the contaminated formulas to get them tested for lead exposure.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "U.S. Screens More Staff in China Over Mystery Health Issues",
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"content": "\u003cp>A U.S. medical team was screening more Americans who work at the consulate in southern China as the State Department confirmed evacuating a number of government employees who experienced unexplained health issues like those that have hurt U.S. personnel in Cuba and China.[contextly_sidebar id=\"7CkyzwzKuv3WHlXibNMNiakYleGV6oAv\"]\u003c/p>\n\u003cp>The evacuations of workers in Guangzhou followed medical testing that revealed they might have been affected. State Department spokeswoman Heather Nauert said “a number of individuals” had been brought to the U.S. but didn’t say how many were affected or evacuated. A previous case in Guangzhou, disclosed last month, prompted the tests.\u003c/p>\n\u003cp>Nauert also said that remaining U.S. government personnel and their families in Guangzhou would also be able to request testing if they “noted concerning symptoms or wanted baseline screening.”\u003c/p>\n\u003cp>The incidents have raised fears the unexplained issues that started in Cuba in 2016 have expanded. The U.S. government has deemed those incidents “specific attacks” on American workers but hasn’t publicly identified a cause or culprit. Most of the incidents were accompanied by bizarre, unexplained sounds that initially led U.S. investigators to suspect a sonic attack.\u003c/p>\n\u003cp>Symptoms have included dizziness, headaches and an inability to concentrate. The American government worker who previously was removed from China reported “subtle and vague, but abnormal, sensations of sound and pressure,” the Guangzhou consulate reported last month\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Security guards outside the Guangzhou consulate on Thursday told reporters to leave the area and not attempt to talk to consulate staff.\u003c/p>\n\u003cp>Asked about the latest incidents, Chinese Foreign Ministry spokeswoman Hua Chunying said the U.S. had not formally raised the matter with Beijing.\u003c/p>\n\u003cp>“If the U.S. makes formal contact with us, China will continue necessary investigations in an earnest and responsible manner and maintain close communication and cooperation with the U.S.,” Hua said at a regularly scheduled news conference.[contextly_sidebar id=\"kD7HyExDaX6bPoHIJ2EyalwLhMsGc6Yg\"]\u003c/p>\n\u003cp>China earlier said it had looked into the case announced last month but came up with no clues about the cause of the symptoms.\u003c/p>\n\u003cp>The New York Times identified the latest American employee evacuated as Mark A. Lenzi, a security engineering officer at the consulate who left Wednesday night with his wife and two children.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Lenzi told the Times he resided in the same apartment tower as the officer evacuated in April and suffered in recent months from what he called “neurological symptoms.”\u003c/p>\n\u003cdiv id=\"div-gpt-ad-1470255291270-1\" class=\"ad-placeholder\">\n\u003cdiv id=\"google_ads_iframe_/15786418/APNews/site/article/midarticle2_0__container__\">\n\u003cp>Lenzi’s apartment was in one of several high-rise buildings in The Canton Place featuring restaurants and galleries spaced around a central plaza. Another diplomat who reported symptoms was at a different upscale building near the consulate, the paper said.\u003c/p>\n\u003cp>A U.S. official, who wasn’t authorized to discuss the situation publicly and requested anonymity, said the evacuated American government workers were being brought from China for testing to the University of Pennsylvania. That’s where doctors have been treating and studying patients previously evacuated from the U.S. Embassy in Havana.\u003c/p>\n\u003cp>The preliminary findings of the medical reports on the 24 personnel affected in Cuba showed they had sensory and memory problems similar to the brain dysfunction seen with concussions.\u003c/p>\n\u003cp>The Penn team said the patients from Cuba experienced persistent disability though rehabilitation therapy customized for them seemed to help.\u003c/p>\n\u003cp>Canada in April also ordered families of diplomatic staff in Cuba to return home after mysterious health symptoms were detected in 10 Canadians stationed on the island. Canada said the 10 continued to show unexplained brain symptoms and that “medical information raised concerns for a new type of a possible acquired brain injury.”[contextly_sidebar id=\"yqjMydejhDpIpH1sD1HMACrcUU3kDG2I\"]\u003c/p>\n\u003cp>In testimony before the Senate Foreign Relations Committee last month about the first case in China, U.S. Secretary of State Mike Pompeo said China had “said all the right things and have demonstrated their willingness to help us identify the vector which led to this medical incident.”\u003c/p>\n\u003cp>The China incidents affect one of the most important of the seven U.S. diplomatic outposts in the country. The Guangzhou consulate opened months after the establishment of diplomatic relations between Beijing and Washington in 1979 and moved to its new purpose-built facility in 2013.\u003c/p>\n\u003cp>It serves four southern provinces with a combined population of more than 204 million and processes more than 1 million visa applications of all types annually. It is also the only U.S. diplomatic installation in China authorized to process immigrant visas and handle adoptions.\u003c/p>\n\u003cp>People working in The Canton Place complex, a few kilometers (miles) from the consulate, said they were just hearing about the incidents, reflecting a lack of coverage in China’s entirely state-controlled media.\u003c/p>\n\u003cp>Aled Williams, a British teacher at a kindergarten said Thursday that the reports sounded “sci-fi-ish.”\u003c/p>\n\u003cp>“Hard to get my head around how it works,” he said. “Better watch myself.”\u003c/p>\n\u003cp>Linda Chen, who runs a coffee shop in the area, said she was mystified as to why only certain people seemed to have been affected in an area known for its comfort and safety.\u003c/p>\n\u003cp>“For me I feel it’s very strange. But I don’t feel that there’s something to be very afraid of because it’s probably a very special case,” Chen said.\u003c/p>\n\u003c/div>\n\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>A U.S. medical team was screening more Americans who work at the consulate in southern China as the State Department confirmed evacuating a number of government employees who experienced unexplained health issues like those that have hurt U.S. personnel in Cuba and China.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The evacuations of workers in Guangzhou followed medical testing that revealed they might have been affected. State Department spokeswoman Heather Nauert said “a number of individuals” had been brought to the U.S. but didn’t say how many were affected or evacuated. A previous case in Guangzhou, disclosed last month, prompted the tests.\u003c/p>\n\u003cp>Nauert also said that remaining U.S. government personnel and their families in Guangzhou would also be able to request testing if they “noted concerning symptoms or wanted baseline screening.”\u003c/p>\n\u003cp>The incidents have raised fears the unexplained issues that started in Cuba in 2016 have expanded. The U.S. government has deemed those incidents “specific attacks” on American workers but hasn’t publicly identified a cause or culprit. Most of the incidents were accompanied by bizarre, unexplained sounds that initially led U.S. investigators to suspect a sonic attack.\u003c/p>\n\u003cp>Symptoms have included dizziness, headaches and an inability to concentrate. The American government worker who previously was removed from China reported “subtle and vague, but abnormal, sensations of sound and pressure,” the Guangzhou consulate reported last month\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Security guards outside the Guangzhou consulate on Thursday told reporters to leave the area and not attempt to talk to consulate staff.\u003c/p>\n\u003cp>Asked about the latest incidents, Chinese Foreign Ministry spokeswoman Hua Chunying said the U.S. had not formally raised the matter with Beijing.\u003c/p>\n\u003cp>“If the U.S. makes formal contact with us, China will continue necessary investigations in an earnest and responsible manner and maintain close communication and cooperation with the U.S.,” Hua said at a regularly scheduled news conference.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>China earlier said it had looked into the case announced last month but came up with no clues about the cause of the symptoms.\u003c/p>\n\u003cp>The New York Times identified the latest American employee evacuated as Mark A. Lenzi, a security engineering officer at the consulate who left Wednesday night with his wife and two children.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Lenzi told the Times he resided in the same apartment tower as the officer evacuated in April and suffered in recent months from what he called “neurological symptoms.”\u003c/p>\n\u003cdiv id=\"div-gpt-ad-1470255291270-1\" class=\"ad-placeholder\">\n\u003cdiv id=\"google_ads_iframe_/15786418/APNews/site/article/midarticle2_0__container__\">\n\u003cp>Lenzi’s apartment was in one of several high-rise buildings in The Canton Place featuring restaurants and galleries spaced around a central plaza. Another diplomat who reported symptoms was at a different upscale building near the consulate, the paper said.\u003c/p>\n\u003cp>A U.S. official, who wasn’t authorized to discuss the situation publicly and requested anonymity, said the evacuated American government workers were being brought from China for testing to the University of Pennsylvania. That’s where doctors have been treating and studying patients previously evacuated from the U.S. Embassy in Havana.\u003c/p>\n\u003cp>The preliminary findings of the medical reports on the 24 personnel affected in Cuba showed they had sensory and memory problems similar to the brain dysfunction seen with concussions.\u003c/p>\n\u003cp>The Penn team said the patients from Cuba experienced persistent disability though rehabilitation therapy customized for them seemed to help.\u003c/p>\n\u003cp>Canada in April also ordered families of diplomatic staff in Cuba to return home after mysterious health symptoms were detected in 10 Canadians stationed on the island. Canada said the 10 continued to show unexplained brain symptoms and that “medical information raised concerns for a new type of a possible acquired brain injury.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In testimony before the Senate Foreign Relations Committee last month about the first case in China, U.S. Secretary of State Mike Pompeo said China had “said all the right things and have demonstrated their willingness to help us identify the vector which led to this medical incident.”\u003c/p>\n\u003cp>The China incidents affect one of the most important of the seven U.S. diplomatic outposts in the country. The Guangzhou consulate opened months after the establishment of diplomatic relations between Beijing and Washington in 1979 and moved to its new purpose-built facility in 2013.\u003c/p>\n\u003cp>It serves four southern provinces with a combined population of more than 204 million and processes more than 1 million visa applications of all types annually. It is also the only U.S. diplomatic installation in China authorized to process immigrant visas and handle adoptions.\u003c/p>\n\u003cp>People working in The Canton Place complex, a few kilometers (miles) from the consulate, said they were just hearing about the incidents, reflecting a lack of coverage in China’s entirely state-controlled media.\u003c/p>\n\u003cp>Aled Williams, a British teacher at a kindergarten said Thursday that the reports sounded “sci-fi-ish.”\u003c/p>\n\u003cp>“Hard to get my head around how it works,” he said. “Better watch myself.”\u003c/p>\n\u003cp>Linda Chen, who runs a coffee shop in the area, said she was mystified as to why only certain people seemed to have been affected in an area known for its comfort and safety.\u003c/p>\n\u003cp>“For me I feel it’s very strange. But I don’t feel that there’s something to be very afraid of because it’s probably a very special case,” Chen said.\u003c/p>\n\u003c/div>\n\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Clinic Claims Success In Making Babies With 3 Parents' DNA",
"title": "Clinic Claims Success In Making Babies With 3 Parents' DNA",
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"content": "\u003cp>In a clinic on a side street in Kiev, the capital of Ukraine, doctors are doing something that, as far as is publicly known, is being done nowhere else in the world: using DNA from three different people to create babies for women who are infertile.[contextly_sidebar id=\"hJp3PK3nX6Xp23jBK7povAqNM584M314\"]\u003c/p>\n\u003cp>\"If you can help these families to achieve their own babies, why it must be forbidden?\" \u003ca href=\"http://nadiyaclinic.com/about-the-clinic/our-team/valery-zukin/\" target=\"_blank\" rel=\"noopener\">Valery Zukin\u003c/a>, director of the \u003ca href=\"http://nadiyaclinic.com/\" target=\"_blank\" rel=\"noopener\">Nadiya Clinic\u003c/a>, asks as he peers over his glasses. \"It is a dream to want to have a genetic connection with a baby.\"\u003c/p>\n\u003cp>I traveled to Ukraine because Zukin promised unusual access to his private fertility clinic, including the first demonstration for a U.S. journalist of how scientists create \"three-parent\" babies — a procedure prohibited by the U.S. Food and Drug Administration.\u003c/p>\n\u003cp>Zukin also arranged the first-ever interview with a mother of a 15-month-old boy who is one of the four children he says he has produced this way.\u003c/p>\n\u003cp>Three more of his patients are pregnant, Zukin says, including a woman from Sweden. Women from several other countries including Britain, Brazil and Israel are going through the process, he says.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Leading ethicists and genetics researchers criticize the clinic for rushing ahead to use this method for infertility. No one knows whether children produced this way will be healthy, they say. And some worry the procedure may open the door to \"designer babies.\"\u003c/p>\n\u003cp>\"This is pretty troubling,\" says \u003ca href=\"https://www.geneticsandsociety.org/user/25\" target=\"_blank\" rel=\"noopener\">Marcy Darnovsky\u003c/a>, who heads the Center for Genetics and Society, a U.S.-based watchdog group.\u003c/p>\n\u003cp>But Zukin dismisses those criticisms.\u003c/p>\n\u003cp>\"As a doctor I understand only one thing: We have parents who couldn't have children and now they have their own biological child. That's all,\" Zukin says.[contextly_sidebar id=\"e9qixdqsJYlqHyn9aCm0jBm9SiC8DfaI\"]\u003c/p>\n\u003cp>Zukin has helped form a \u003ca href=\"http://www.dl-nadiya.com/\" target=\"_blank\" rel=\"noopener\">company\u003c/a>, Darwin Life-Nadiya, with a \u003ca href=\"https://www.newhopefertility.com/\" target=\"_blank\" rel=\"noopener\">New York clinic\u003c/a> to market the service to U.S. women willing to travel to Ukraine. Ukrainian women pay about $8,000 for the procedure; for foreigners, it's about $15,000.\u003c/p>\n\u003cp>\u003cstrong>Transferring DNA From Egg to Egg\u003c/strong>\u003c/p>\n\u003cp>To show how the procedure works, Zukin sends me upstairs to the embryo lab. After putting on a sterile blue gown and booties, I meet Pavlo Mazur, a clinic embryo scientist.\u003c/p>\n\u003cp>\"We will begin,\" Mazur says, as he takes a clear plastic dish out of an incubator.\u003c/p>\n\u003cp>The dish contains a 1-day-old embryo. It was created by fertilizing the egg of a woman with sperm from her male partner.\u003c/p>\n\u003cp>The dish also holds a second embryo. This was made using the same man's sperm to fertilize an egg from another woman, who was paid to donate eggs.\u003c/p>\n\u003cp>After sliding the embryos under a large microscope, Mazur starts a timer. He has only 15 minutes to complete the delicate procedure without risking damage to the embryos.\u003c/p>\n\u003cp>A monitor nearby displays what Mazur sees through the microscope. A round structure comes into focus on the screen. It's one of the embryos.[contextly_sidebar id=\"lH4aHr8bWw920dNDT3zPx9BxxYAHoA23\"]\u003c/p>\n\u003cp>\"You see?\" Mazur says, pointing to two smaller round structures inside. They contain the DNA of the man and woman trying to have a baby.\u003c/p>\n\u003cp>\"One is from sperm. It's paternal,\" Mazur says. \"And the second one is maternal.\"\u003c/p>\n\u003cp>Mazur slowly inserts a tiny, hollow glass needle into the fertilized egg. Even though Mazur is under pressure to work fast, he can't move too quickly.\u003c/p>\n\u003cp>\"Very steady and slow,\" Mazur says. \"We don't want to damage it, right? We want it to survive.\"\u003c/p>\n\u003cp>He uses the needle to extract the would-be parents' DNA. Mazur does the same thing with the second fertilized egg, removing all the DNA — except for 37 genes known as \u003ca href=\"https://ghr.nlm.nih.gov/mitochondrial-dna\" target=\"_blank\" rel=\"noopener\">mitochondrial DNA\u003c/a>.\u003c/p>\n\u003cp>Mitochondria provide energy for eggs. A defect in the patient's mitochondrial DNA might be what's preventing her from getting pregnant. So using the donor's mitochondrial DNA may be what enables the patient to produce healthy embryos and babies.\u003c/p>\n\u003cp>\"It's like an universal currency for a cell,\" Mazur says. \"It helps for all processes within the cell.\"\u003c/p>\n\u003cp>The next step is to transfer the DNA of the woman and man trying to have a child into the donor's mostly gutted embryo — empty except for the other woman's mitochondrial DNA.\u003c/p>\n\u003cp>\"And now we will just try to put the genetic material of our patient inside,\" Mazur says as he gently inserts the needle holding the couple's DNA and injects the genes.\u003c/p>\n\u003cp>\"That's it,\" he says, glancing at his timer to see there are still two minutes left.\u003c/p>\n\u003cp>\"So, you see? It's inside,\" Mazur says, pointing to the couple's DNA. \"It will develop into embryo.\"\u003c/p>\n\u003cp>The Nadiya clinic is transferring embryos reconstructed this way into the wombs of women trying to become pregnant.\u003c/p>\n\u003cp>So far, the clinic has tried the procedure on 21 women. Fourteen attempts failed, probably because the women were older, the clinic staffers say.\u003c/p>\n\u003cp>But the other women either had babies or are pregnant. They were younger, but could never produce viable embryos on their own.\u003c/p>\n\u003cp>\"I adore that such technology exists. I adore that it can help some people,\" says Mazur.\u003c/p>\n\u003cp>These babies end up with DNA from three different people: the woman trying to have a baby; her male partner; and the egg donor who has provided 37 mitochondrial genes. That's why they're called three-parent babies.\u003c/p>\n\u003cp>But Mazur says that label is wrong.\u003c/p>\n\u003cp>\"These babies — they have DNA from mother and from father. So they are genetically related to their parents,\" Mazur says.[contextly_sidebar id=\"epZCsHoOtfaC0xfJUpdgovxcZOsKlTBF\"]\u003c/p>\n\u003cp>The overwhelming majority of the baby's DNA comes from the nucleus of the cell. And those are the genes responsible for the traits that most people consider their genetic inheritance, such as their eye and hair color, height, weight and personality.\u003c/p>\n\u003cp>The bit of mitochondrial DNA is \"incomparable,\" Mazur says. \"These children are more like their parents — not donor.\"\u003c/p>\n\u003cp>Mazur will present the clinic's latest results at the \u003ca href=\"https://www.eshre.eu/\" target=\"_blank\" rel=\"noopener\">European Society of Human Reproduction and Embryology\u003c/a>'s annual meeting in Barcelona in July.\u003c/p>\n\u003cp>\u003cstrong>Moving too fast?\u003c/strong>\u003c/p>\n\u003cp>Some scientists are welcoming this as a potentially exciting new option for some women.\u003c/p>\n\u003cp>\"It is pioneering work,\" says \u003ca href=\"http://cumc.p.cumcweb.org/mdphd/profile/degli\" target=\"_blank\" rel=\"noopener\">Dietrich Egli\u003c/a>, an assistant professor of developmental biology at Columbia University Medical Center in New York. The procedure is technically known as \"pronuclear transfer.\"\u003c/p>\n\u003cp>\"What we can learn from their work is that pronuclear transfer may be useful for some cases of infertility,\" says Egli.\u003c/p>\n\u003cp>But critics say it's far too soon to be attempting this procedure to create children.\u003c/p>\n\u003cp>\"This is really an irresponsible kind of human experimentation,\" Darnovsky of the Center for Genetics and Society says.\u003c/p>\n\u003cp>Not nearly enough laboratory and animal research has been done to know if the procedure is safe, Darnovsky and others say.\u003c/p>\n\u003cp>\"We just don't know what's going to happen to these children,\" Darnovsky says.\u003c/p>\n\u003cp>In the 1990s, a doctor in New Jersey injected fluid from healthy eggs into the eggs of infertile women, and some babies were born with mitochondrial DNA from three people. But that was discontinued after the FDA intervened.\u003c/p>\n\u003cp>Only one other baby is known to have been produced using a technique similar to the one being used by Zukin. \u003ca href=\"https://www.newhopefertility.com/about-us/fertility-doctor/john-zhang/\" target=\"_blank\" rel=\"noopener\">John Zhang\u003c/a> of the \u003ca href=\"https://www.newhopefertility.com/\" target=\"_blank\" rel=\"noopener\">New Hope Fertility Center\u003c/a> in New York performed a related procedure for a Jordanian couple to try to prevent their child from having \u003ca href=\"https://ghr.nlm.nih.gov/condition/leigh-syndrome\" target=\"_blank\" rel=\"noopener\">Leigh syndrome\u003c/a>, a disorder caused by defects in mitochondrial DNA.\u003c/p>\n\u003cp>That's why the procedure was developed — to help women carrying \u003ca href=\"https://medlineplus.gov/mitochondrialdiseases.html\" target=\"_blank\" rel=\"noopener\">mitochondrial disorders\u003c/a> have healthy children. In severe cases, these disorders can be fatal.\u003c/p>\n\u003cp>A U.S. National Academy of Sciences panel \u003ca href=\"https://www.npr.org/sections/health-shots/2016/02/03/465319186/babies-with-genes-from-three-people-could-be-ethical-panel-says\" target=\"_blank\" rel=\"noopener\">concluded\u003c/a> it could be ethical to attempt the procedure for this purpose. But because the FDA \u003ca href=\"https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm570185.htm\">won't allow\u003c/a> it at all in the United States, the baby of the Jordanian couple whom \u003ca href=\"https://www.npr.org/sections/thetwo-way/2016/09/27/495668299/new-york-fertility-doctor-says-he-created-baby-with-3-genetic-parents\" target=\"_blank\" rel=\"noopener\">Zhang helped was born in Mexico in 2016.\u003c/a>\u003c/p>\n\u003cp>Doctors in the United Kingdom have started trying the technique to prevent mitochondrial disorders. But the British doctors are being \u003ca href=\"https://www.npr.org/2015/02/03/383578221/u-k-lawmakers-allow-scientists-to-attempt-dna-transplants\">allowed\u003c/a> to try to make only one baby at a time as part of a tightly regulated \u003ca href=\"https://www.npr.org/sections/health-shots/2014/11/10/360342623/combining-the-dna-of-three-people-raises-ethical-questions\" target=\"_blank\" rel=\"noopener\">research program\u003c/a>.[contextly_sidebar id=\"2QVJm0WQxeuB5lotTMLysQyqrPHpvncJ\"]\u003c/p>\n\u003cp>Zukin says he received approval for a five-year research program from the Ukrainian Postgraduate Medical Academy, which is under the auspices of the Ukrainian Ministry of Public Health. But Zukin concedes the procedure is far less regulated in his country. Nevertheless, he makes sure all the women understand they are undergoing an experimental procedure.\u003c/p>\n\u003cp>\"We explain everything to the families. And not all families give permission for providing this experimental procedure,\" he says.\u003c/p>\n\u003cp>Because mitochondrial DNA can be inherited, Darnovsky worries the procedure is crossing a line that long has been considered taboo: making changes in human DNA that can be passed down to future generations. One fear is that a mistake could create a new disease that could be inherited.\u003c/p>\n\u003cp>Mitochondrial DNA is inherited from the mother. Zukin already has used the procedure to produce one baby girl — a girl who could one day pass the mitochondrial DNA to her own children.\u003c/p>\n\u003cp>Darnovsky worries the procedure could also open the door to creating babies who are genetically modified for other reasons.\u003c/p>\n\u003cp>\"What we're seeing is a fast slide down a very slippery slope toward designer babies,\" Darnovsky says. \"We could see parents feeling eager to give their children traits like greater strength, needs less sleep. Some people are saying that, 'Yes, there are genes for IQ and we could have smarter babies.' \"\u003c/p>\n\u003cp>Zukin dismisses speculation about designer babies. He says he's interested only in helping women who are infertile have genetically related children or prevent mitochondrial diseases. And so far, all the babies he has created appear to be perfectly healthy, he says.\u003c/p>\n\u003cp>The only way to know whether the procedure works and is safe is to try it, he argues. He hopes to figure out how to make the procedure work for women suffering from age-related infertility as well, which would help far more women.\u003c/p>\n\u003cp>\"If you would like to swim,\" he says, \"then, first of all, you must jump in the water.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>A second story on Wednesday afternoon features an exclusive interview with a mother and her three-parent son.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Clinic+Claims+Success+In+Making+Babies+With+3+Parents%27+DNA+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"excerpt": "A clinic in Kiev, Ukraine, stirs controversy by making babies with DNA from three different people to help women who are infertile bear children. It's the only clinic known to be doing this right now.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>In a clinic on a side street in Kiev, the capital of Ukraine, doctors are doing something that, as far as is publicly known, is being done nowhere else in the world: using DNA from three different people to create babies for women who are infertile.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"If you can help these families to achieve their own babies, why it must be forbidden?\" \u003ca href=\"http://nadiyaclinic.com/about-the-clinic/our-team/valery-zukin/\" target=\"_blank\" rel=\"noopener\">Valery Zukin\u003c/a>, director of the \u003ca href=\"http://nadiyaclinic.com/\" target=\"_blank\" rel=\"noopener\">Nadiya Clinic\u003c/a>, asks as he peers over his glasses. \"It is a dream to want to have a genetic connection with a baby.\"\u003c/p>\n\u003cp>I traveled to Ukraine because Zukin promised unusual access to his private fertility clinic, including the first demonstration for a U.S. journalist of how scientists create \"three-parent\" babies — a procedure prohibited by the U.S. Food and Drug Administration.\u003c/p>\n\u003cp>Zukin also arranged the first-ever interview with a mother of a 15-month-old boy who is one of the four children he says he has produced this way.\u003c/p>\n\u003cp>Three more of his patients are pregnant, Zukin says, including a woman from Sweden. Women from several other countries including Britain, Brazil and Israel are going through the process, he says.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Leading ethicists and genetics researchers criticize the clinic for rushing ahead to use this method for infertility. No one knows whether children produced this way will be healthy, they say. And some worry the procedure may open the door to \"designer babies.\"\u003c/p>\n\u003cp>\"This is pretty troubling,\" says \u003ca href=\"https://www.geneticsandsociety.org/user/25\" target=\"_blank\" rel=\"noopener\">Marcy Darnovsky\u003c/a>, who heads the Center for Genetics and Society, a U.S.-based watchdog group.\u003c/p>\n\u003cp>But Zukin dismisses those criticisms.\u003c/p>\n\u003cp>\"As a doctor I understand only one thing: We have parents who couldn't have children and now they have their own biological child. That's all,\" Zukin says.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Zukin has helped form a \u003ca href=\"http://www.dl-nadiya.com/\" target=\"_blank\" rel=\"noopener\">company\u003c/a>, Darwin Life-Nadiya, with a \u003ca href=\"https://www.newhopefertility.com/\" target=\"_blank\" rel=\"noopener\">New York clinic\u003c/a> to market the service to U.S. women willing to travel to Ukraine. Ukrainian women pay about $8,000 for the procedure; for foreigners, it's about $15,000.\u003c/p>\n\u003cp>\u003cstrong>Transferring DNA From Egg to Egg\u003c/strong>\u003c/p>\n\u003cp>To show how the procedure works, Zukin sends me upstairs to the embryo lab. After putting on a sterile blue gown and booties, I meet Pavlo Mazur, a clinic embryo scientist.\u003c/p>\n\u003cp>\"We will begin,\" Mazur says, as he takes a clear plastic dish out of an incubator.\u003c/p>\n\u003cp>The dish contains a 1-day-old embryo. It was created by fertilizing the egg of a woman with sperm from her male partner.\u003c/p>\n\u003cp>The dish also holds a second embryo. This was made using the same man's sperm to fertilize an egg from another woman, who was paid to donate eggs.\u003c/p>\n\u003cp>After sliding the embryos under a large microscope, Mazur starts a timer. He has only 15 minutes to complete the delicate procedure without risking damage to the embryos.\u003c/p>\n\u003cp>A monitor nearby displays what Mazur sees through the microscope. A round structure comes into focus on the screen. It's one of the embryos.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"You see?\" Mazur says, pointing to two smaller round structures inside. They contain the DNA of the man and woman trying to have a baby.\u003c/p>\n\u003cp>\"One is from sperm. It's paternal,\" Mazur says. \"And the second one is maternal.\"\u003c/p>\n\u003cp>Mazur slowly inserts a tiny, hollow glass needle into the fertilized egg. Even though Mazur is under pressure to work fast, he can't move too quickly.\u003c/p>\n\u003cp>\"Very steady and slow,\" Mazur says. \"We don't want to damage it, right? We want it to survive.\"\u003c/p>\n\u003cp>He uses the needle to extract the would-be parents' DNA. Mazur does the same thing with the second fertilized egg, removing all the DNA — except for 37 genes known as \u003ca href=\"https://ghr.nlm.nih.gov/mitochondrial-dna\" target=\"_blank\" rel=\"noopener\">mitochondrial DNA\u003c/a>.\u003c/p>\n\u003cp>Mitochondria provide energy for eggs. A defect in the patient's mitochondrial DNA might be what's preventing her from getting pregnant. So using the donor's mitochondrial DNA may be what enables the patient to produce healthy embryos and babies.\u003c/p>\n\u003cp>\"It's like an universal currency for a cell,\" Mazur says. \"It helps for all processes within the cell.\"\u003c/p>\n\u003cp>The next step is to transfer the DNA of the woman and man trying to have a child into the donor's mostly gutted embryo — empty except for the other woman's mitochondrial DNA.\u003c/p>\n\u003cp>\"And now we will just try to put the genetic material of our patient inside,\" Mazur says as he gently inserts the needle holding the couple's DNA and injects the genes.\u003c/p>\n\u003cp>\"That's it,\" he says, glancing at his timer to see there are still two minutes left.\u003c/p>\n\u003cp>\"So, you see? It's inside,\" Mazur says, pointing to the couple's DNA. \"It will develop into embryo.\"\u003c/p>\n\u003cp>The Nadiya clinic is transferring embryos reconstructed this way into the wombs of women trying to become pregnant.\u003c/p>\n\u003cp>So far, the clinic has tried the procedure on 21 women. Fourteen attempts failed, probably because the women were older, the clinic staffers say.\u003c/p>\n\u003cp>But the other women either had babies or are pregnant. They were younger, but could never produce viable embryos on their own.\u003c/p>\n\u003cp>\"I adore that such technology exists. I adore that it can help some people,\" says Mazur.\u003c/p>\n\u003cp>These babies end up with DNA from three different people: the woman trying to have a baby; her male partner; and the egg donor who has provided 37 mitochondrial genes. That's why they're called three-parent babies.\u003c/p>\n\u003cp>But Mazur says that label is wrong.\u003c/p>\n\u003cp>\"These babies — they have DNA from mother and from father. So they are genetically related to their parents,\" Mazur says.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The overwhelming majority of the baby's DNA comes from the nucleus of the cell. And those are the genes responsible for the traits that most people consider their genetic inheritance, such as their eye and hair color, height, weight and personality.\u003c/p>\n\u003cp>The bit of mitochondrial DNA is \"incomparable,\" Mazur says. \"These children are more like their parents — not donor.\"\u003c/p>\n\u003cp>Mazur will present the clinic's latest results at the \u003ca href=\"https://www.eshre.eu/\" target=\"_blank\" rel=\"noopener\">European Society of Human Reproduction and Embryology\u003c/a>'s annual meeting in Barcelona in July.\u003c/p>\n\u003cp>\u003cstrong>Moving too fast?\u003c/strong>\u003c/p>\n\u003cp>Some scientists are welcoming this as a potentially exciting new option for some women.\u003c/p>\n\u003cp>\"It is pioneering work,\" says \u003ca href=\"http://cumc.p.cumcweb.org/mdphd/profile/degli\" target=\"_blank\" rel=\"noopener\">Dietrich Egli\u003c/a>, an assistant professor of developmental biology at Columbia University Medical Center in New York. The procedure is technically known as \"pronuclear transfer.\"\u003c/p>\n\u003cp>\"What we can learn from their work is that pronuclear transfer may be useful for some cases of infertility,\" says Egli.\u003c/p>\n\u003cp>But critics say it's far too soon to be attempting this procedure to create children.\u003c/p>\n\u003cp>\"This is really an irresponsible kind of human experimentation,\" Darnovsky of the Center for Genetics and Society says.\u003c/p>\n\u003cp>Not nearly enough laboratory and animal research has been done to know if the procedure is safe, Darnovsky and others say.\u003c/p>\n\u003cp>\"We just don't know what's going to happen to these children,\" Darnovsky says.\u003c/p>\n\u003cp>In the 1990s, a doctor in New Jersey injected fluid from healthy eggs into the eggs of infertile women, and some babies were born with mitochondrial DNA from three people. But that was discontinued after the FDA intervened.\u003c/p>\n\u003cp>Only one other baby is known to have been produced using a technique similar to the one being used by Zukin. \u003ca href=\"https://www.newhopefertility.com/about-us/fertility-doctor/john-zhang/\" target=\"_blank\" rel=\"noopener\">John Zhang\u003c/a> of the \u003ca href=\"https://www.newhopefertility.com/\" target=\"_blank\" rel=\"noopener\">New Hope Fertility Center\u003c/a> in New York performed a related procedure for a Jordanian couple to try to prevent their child from having \u003ca href=\"https://ghr.nlm.nih.gov/condition/leigh-syndrome\" target=\"_blank\" rel=\"noopener\">Leigh syndrome\u003c/a>, a disorder caused by defects in mitochondrial DNA.\u003c/p>\n\u003cp>That's why the procedure was developed — to help women carrying \u003ca href=\"https://medlineplus.gov/mitochondrialdiseases.html\" target=\"_blank\" rel=\"noopener\">mitochondrial disorders\u003c/a> have healthy children. In severe cases, these disorders can be fatal.\u003c/p>\n\u003cp>A U.S. National Academy of Sciences panel \u003ca href=\"https://www.npr.org/sections/health-shots/2016/02/03/465319186/babies-with-genes-from-three-people-could-be-ethical-panel-says\" target=\"_blank\" rel=\"noopener\">concluded\u003c/a> it could be ethical to attempt the procedure for this purpose. But because the FDA \u003ca href=\"https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm570185.htm\">won't allow\u003c/a> it at all in the United States, the baby of the Jordanian couple whom \u003ca href=\"https://www.npr.org/sections/thetwo-way/2016/09/27/495668299/new-york-fertility-doctor-says-he-created-baby-with-3-genetic-parents\" target=\"_blank\" rel=\"noopener\">Zhang helped was born in Mexico in 2016.\u003c/a>\u003c/p>\n\u003cp>Doctors in the United Kingdom have started trying the technique to prevent mitochondrial disorders. But the British doctors are being \u003ca href=\"https://www.npr.org/2015/02/03/383578221/u-k-lawmakers-allow-scientists-to-attempt-dna-transplants\">allowed\u003c/a> to try to make only one baby at a time as part of a tightly regulated \u003ca href=\"https://www.npr.org/sections/health-shots/2014/11/10/360342623/combining-the-dna-of-three-people-raises-ethical-questions\" target=\"_blank\" rel=\"noopener\">research program\u003c/a>.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Zukin says he received approval for a five-year research program from the Ukrainian Postgraduate Medical Academy, which is under the auspices of the Ukrainian Ministry of Public Health. But Zukin concedes the procedure is far less regulated in his country. Nevertheless, he makes sure all the women understand they are undergoing an experimental procedure.\u003c/p>\n\u003cp>\"We explain everything to the families. And not all families give permission for providing this experimental procedure,\" he says.\u003c/p>\n\u003cp>Because mitochondrial DNA can be inherited, Darnovsky worries the procedure is crossing a line that long has been considered taboo: making changes in human DNA that can be passed down to future generations. One fear is that a mistake could create a new disease that could be inherited.\u003c/p>\n\u003cp>Mitochondrial DNA is inherited from the mother. Zukin already has used the procedure to produce one baby girl — a girl who could one day pass the mitochondrial DNA to her own children.\u003c/p>\n\u003cp>Darnovsky worries the procedure could also open the door to creating babies who are genetically modified for other reasons.\u003c/p>\n\u003cp>\"What we're seeing is a fast slide down a very slippery slope toward designer babies,\" Darnovsky says. \"We could see parents feeling eager to give their children traits like greater strength, needs less sleep. Some people are saying that, 'Yes, there are genes for IQ and we could have smarter babies.' \"\u003c/p>\n\u003cp>Zukin dismisses speculation about designer babies. He says he's interested only in helping women who are infertile have genetically related children or prevent mitochondrial diseases. And so far, all the babies he has created appear to be perfectly healthy, he says.\u003c/p>\n\u003cp>The only way to know whether the procedure works and is safe is to try it, he argues. He hopes to figure out how to make the procedure work for women suffering from age-related infertility as well, which would help far more women.\u003c/p>\n\u003cp>\"If you would like to swim,\" he says, \"then, first of all, you must jump in the water.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>A second story on Wednesday afternoon features an exclusive interview with a mother and her three-parent son.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Clinic+Claims+Success+In+Making+Babies+With+3+Parents%27+DNA+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>More than 11 million Americans may have received incorrect prescriptions for aspirin, statins and blood pressure medications to prevent a heart attack or stroke, according to a study by the \u003ca href=\"http://med.stanford.edu/\">Stanford University School of Medicine\u003c/a>.[contextly_sidebar id=\"umDTpLmik9hK8eNRjnsW7rpmcRPF19ZX\"]\u003c/p>\n\u003cp>That's because the tool used to estimate a patient's risk of heart attack or stroke is based on outdated data, apparently off by as much as 20 percent, according to the \u003ca href=\"http://annals.org/aim/article-abstract/2683613/clinical-implications-revised-pooled-cohort-equations-estimating-atherosclerotic-cardiovascular-disease\" target=\"_blank\" rel=\"noopener\">study\u003c/a>, published Monday in \u003cem>Annals of Internal Medicine.\u003c/em>\u003c/p>\n\u003cp>\"A lot has changed in terms of diets, environments and medical treatment since the 1940s,” senior author Dr. Sanjay Basu said in the \u003ca href=\"http://med.stanford.edu/news/all-news/2018/06/millions-could-have-incorrect-statin-aspirin-blood-pressure-prescriptions.html\" target=\"_blank\" rel=\"noopener\">press release \u003c/a>that accompanied the study. “So, relying on our grandparents’ data to make our treatment choices is probably not the best idea.”\u003c/p>\n\u003cp>The problem was discovered when some doctors, including Basu, kept noticing that the current tool was failing to accurately predict risk in their patients, particularly if they were African American.\u003c/p>\n\u003cp>Because the calculator was built on older studies that lacked a sufficient sample of African-Americans, doctors may have in fact been underestimating the risks of heart attacks or strokes in those patients.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“So while many Americans were being recommended aggressive treatments that they may not have needed according to current guidelines, some Americans — particularly African-Americans — may have been given false reassurance and probably need to start treatment given our findings,” Basu said in the press release.[contextly_sidebar id=\"IVz9AhjwqJ3N1XCCqSO9xlwYfN9Xm5GQ\"]\u003c/p>\n\u003cp>The study says that in many cases medications were over prescribed.\u003c/p>\n\u003cp>A CBS \u003ca href=\"https://www.cbsnews.com/news/millions-of-americans-could-be-getting-wrong-heart-meds-study-finds/\" target=\"_blank\" rel=\"noopener\">report\u003c/a> describes the calculator's importance in developing preventive treatments:\u003c/p>\n\u003cblockquote>\u003cp>Risk estimate tools predict the likelihood of a future heart attack or stroke in the next 10 years. Doctors use these tools to help them decide what treatment a patient needs, if any at all.\u003c/p>\u003c/blockquote>\n\u003cp>In response to the troubling findings, the team of researchers developed a new calculator, incorporating an updated list of risk factors. From a \u003ca href=\"https://www.statnews.com/2018/06/04/new-risk-calculator-could-change-the-aspirin-statins-and-blood-pressure-medications-some-people-take/\" target=\"_blank\" rel=\"noopener\">STAT \u003c/a>news story:\u003c/p>\n\u003cblockquote>\u003cp>To test their methods, the researchers created two models. In the first one, they updated the cohorts they used. The populations were more diverse racially and ethnically, and they also reflected factors that can’t necessarily be captured by blood tests. Nutrition, physical activity, or even secondhand smoke — which wasn’t recognized in the 1940s — can affect a person’s baseline risk for disease. That’s why risk calculators don’t stay accurate forever.\u003c/p>\u003c/blockquote>\n\u003cp>Some doctors, however, still question whether the updated calculator can accurately assess risks in communities of color.\u003c/p>\n\u003cp>Dr. Andrew DeFilippis and Patrick Trainor of the University of Louisville, Kentucky say the new calculator falls short in accounting for racial differences in risk factors.\u003c/p>\n\u003cp>“This question is timely because a growing Hispanic population and 40 percent increase in Asian-Americans account for more than half of the U. S. population growth between 2000 and 2019,” they said in an \u003ca href=\"http://annals.org/aim/article/doi/10.7326/M18-1175\" target=\"_blank\" rel=\"noopener\">editorial\u003c/a> published with the Stanford study. “We clearly need an accurate risk assessment tool for these growing American populations.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The Stanford researchers say the newer tool will need to be updated with changing times.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>More than 11 million Americans may have received incorrect prescriptions for aspirin, statins and blood pressure medications to prevent a heart attack or stroke, according to a study by the \u003ca href=\"http://med.stanford.edu/\">Stanford University School of Medicine\u003c/a>.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>That's because the tool used to estimate a patient's risk of heart attack or stroke is based on outdated data, apparently off by as much as 20 percent, according to the \u003ca href=\"http://annals.org/aim/article-abstract/2683613/clinical-implications-revised-pooled-cohort-equations-estimating-atherosclerotic-cardiovascular-disease\" target=\"_blank\" rel=\"noopener\">study\u003c/a>, published Monday in \u003cem>Annals of Internal Medicine.\u003c/em>\u003c/p>\n\u003cp>\"A lot has changed in terms of diets, environments and medical treatment since the 1940s,” senior author Dr. Sanjay Basu said in the \u003ca href=\"http://med.stanford.edu/news/all-news/2018/06/millions-could-have-incorrect-statin-aspirin-blood-pressure-prescriptions.html\" target=\"_blank\" rel=\"noopener\">press release \u003c/a>that accompanied the study. “So, relying on our grandparents’ data to make our treatment choices is probably not the best idea.”\u003c/p>\n\u003cp>The problem was discovered when some doctors, including Basu, kept noticing that the current tool was failing to accurately predict risk in their patients, particularly if they were African American.\u003c/p>\n\u003cp>Because the calculator was built on older studies that lacked a sufficient sample of African-Americans, doctors may have in fact been underestimating the risks of heart attacks or strokes in those patients.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“So while many Americans were being recommended aggressive treatments that they may not have needed according to current guidelines, some Americans — particularly African-Americans — may have been given false reassurance and probably need to start treatment given our findings,” Basu said in the press release.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The study says that in many cases medications were over prescribed.\u003c/p>\n\u003cp>A CBS \u003ca href=\"https://www.cbsnews.com/news/millions-of-americans-could-be-getting-wrong-heart-meds-study-finds/\" target=\"_blank\" rel=\"noopener\">report\u003c/a> describes the calculator's importance in developing preventive treatments:\u003c/p>\n\u003cblockquote>\u003cp>Risk estimate tools predict the likelihood of a future heart attack or stroke in the next 10 years. Doctors use these tools to help them decide what treatment a patient needs, if any at all.\u003c/p>\u003c/blockquote>\n\u003cp>In response to the troubling findings, the team of researchers developed a new calculator, incorporating an updated list of risk factors. From a \u003ca href=\"https://www.statnews.com/2018/06/04/new-risk-calculator-could-change-the-aspirin-statins-and-blood-pressure-medications-some-people-take/\" target=\"_blank\" rel=\"noopener\">STAT \u003c/a>news story:\u003c/p>\n\u003cblockquote>\u003cp>To test their methods, the researchers created two models. In the first one, they updated the cohorts they used. The populations were more diverse racially and ethnically, and they also reflected factors that can’t necessarily be captured by blood tests. Nutrition, physical activity, or even secondhand smoke — which wasn’t recognized in the 1940s — can affect a person’s baseline risk for disease. That’s why risk calculators don’t stay accurate forever.\u003c/p>\u003c/blockquote>\n\u003cp>Some doctors, however, still question whether the updated calculator can accurately assess risks in communities of color.\u003c/p>\n\u003cp>Dr. Andrew DeFilippis and Patrick Trainor of the University of Louisville, Kentucky say the new calculator falls short in accounting for racial differences in risk factors.\u003c/p>\n\u003cp>“This question is timely because a growing Hispanic population and 40 percent increase in Asian-Americans account for more than half of the U. S. population growth between 2000 and 2019,” they said in an \u003ca href=\"http://annals.org/aim/article/doi/10.7326/M18-1175\" target=\"_blank\" rel=\"noopener\">editorial\u003c/a> published with the Stanford study. “We clearly need an accurate risk assessment tool for these growing American populations.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The Stanford researchers say the newer tool will need to be updated with changing times.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Most women with the most common form of early-stage breast cancer can safely skip chemotherapy without hurting their chances of beating the disease, doctors are reporting from a landmark study that used genetic testing to gauge each patient’s risk.[contextly_sidebar id=\"BFMet48xKrp1h6NyWt3K8Xsz7gIOPSeq\"]\u003c/p>\n\u003cp>The study is the largest ever done of breast cancer treatment, and the results are expected to spare up to 70,000 patients a year in the United States and many more elsewhere the ordeal and expense of these drugs.\u003c/p>\n\u003cp>“The impact is tremendous,” said the study leader, Dr. Joseph Sparano of Montefiore Medical Center in New York. Most women in this situation don’t need treatment beyond surgery and hormone therapy, he said.\u003c/p>\n\u003cp>The study was funded by the National Cancer Institute, some foundations and proceeds from the U.S. breast cancer postage stamp. Results were discussed Sunday at an American Society of Clinical Oncology conference in Chicago and published by the New England Journal of Medicine. Some study leaders consult for breast cancer drugmakers or for the company that makes the gene test.\u003c/p>\n\u003cp>\u003cstrong>Moving Away From Chemo\u003c/strong>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Cancer care has been evolving away from chemotherapy — older drugs with harsh side effects — in favor of gene-targeting therapies, hormone blockers and immune system treatments. When chemo is used now, it’s sometimes for shorter periods or lower doses than it once was.\u003c/p>\n\u003cp>For example, another study at the conference found that Merck’s immunotherapy drug Keytruda worked better than chemo as initial treatment for most people with the most common type of lung cancer, and with far fewer side effects.[contextly_sidebar id=\"sLig6uVQeZQDplnvMdLRkmGUnVlPvI7v\"]\u003c/p>\n\u003cp>The breast cancer study focused on cases where chemo’s value increasingly is in doubt: women with early-stage disease that has not spread to lymph nodes, is hormone-positive (meaning its growth is fueled by estrogen or progesterone) and is not the type that the drug Herceptin targets.\u003c/p>\n\u003cp>The usual treatment is surgery followed by years of a hormone-blocking drug. But many women also are urged to have chemo to help kill any stray cancer cells. Doctors know that most don’t need it, but evidence is thin on who can forgo it.\u003c/p>\n\u003cp>The study gave 10,273 patients a test called Oncotype DX, which uses a biopsy sample to measure the activity of genes involved in cell growth and response to hormone therapy, to estimate the risk that a cancer will recur.\u003c/p>\n\u003cp>\u003cstrong>What the Study Found\u003c/strong>\u003c/p>\n\u003cp>About 17 percent of women had high-risk scores and were advised to have chemo. The 16 percent with low-risk scores now know they can skip chemo, based on earlier results from this study.\u003c/p>\n\u003cp>The new results are on the 67 percent of women at intermediate risk. All had surgery and hormone therapy, and half also got chemo.[contextly_sidebar id=\"TPjTNdjmhxB5MX6ZoUQCtfkvBdzmJm43\"]\u003c/p>\n\u003cp>After nine years, 94 percent of both groups were still alive, and about 84 percent were alive without signs of cancer, so adding chemo made no difference.\u003c/p>\n\u003cp>Certain women 50 or younger did benefit from chemo; slightly fewer cases of cancer spreading far beyond the breast occurred among some of them given chemo, depending on their risk scores on the gene test.\u003c/p>\n\u003cp>\u003cstrong>Will People Trust the Results?\u003c/strong>\u003c/p>\n\u003cp>All women like those in the study should get gene testing to guide their care, said Dr. Richard Schilsky, chief medical officer of the oncology society. Oncotype DX costs around $4,000, which Medicare and many insurers cover. Similar tests including one called MammaPrint also are widely used.\u003c/p>\n\u003cp>Testing solved a big problem of figuring out who needs chemo, said Dr. Harold Burstein of the Dana-Farber Cancer Institute in Boston. Many women think “if I don’t get chemotherapy I’m going to die, and if I get chemo I’m going to be cured,” but the results show there’s a sliding scale of benefit and sometimes none, he said.\u003c/p>\n\u003cp>Dr. Lisa Carey, a breast specialist at the University of North Carolina’s Lineberger Comprehensive Cancer Center, said she would be very comfortable advising patients to skip chemo if they were like those in the study who did not benefit from it.[contextly_sidebar id=\"2pkXhBlSu04mLyMby8g8IUTSIxIwtjpB\"]\u003c/p>\n\u003cp>Dr. Jennifer Litton at MD Anderson Cancer Center in Houston, agreed, but said: “Risk to one person is not the same thing as risk to another. There are some people who say, ’I don’t care what you say, I’m never going to do chemo,’” and won’t even have the gene test, she said. Others want chemo for even the smallest chance of benefit.\u003c/p>\n\u003cp>Adine Usher, 78, who lives in Hartsdale, New York, joined the study 10 years ago at Montefiore and was randomly assigned to the group given chemo.\u003c/p>\n\u003cp>“I was a little relieved. I sort of viewed chemo as extra insurance,” she said. The treatments “weren’t pleasant,” she concedes. Her hair fell out, she developed an infection and was hospitalized for a low white blood count, “but it was over fairly quickly and I’m really glad I had it.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>If doctors had recommended she skip chemo based on the gene test, “I would have accepted that,” she said. “I’m a firm believer in medical research.”\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Most women with the most common form of early-stage breast cancer can safely skip chemotherapy without hurting their chances of beating the disease, doctors are reporting from a landmark study that used genetic testing to gauge each patient’s risk.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The study is the largest ever done of breast cancer treatment, and the results are expected to spare up to 70,000 patients a year in the United States and many more elsewhere the ordeal and expense of these drugs.\u003c/p>\n\u003cp>“The impact is tremendous,” said the study leader, Dr. Joseph Sparano of Montefiore Medical Center in New York. Most women in this situation don’t need treatment beyond surgery and hormone therapy, he said.\u003c/p>\n\u003cp>The study was funded by the National Cancer Institute, some foundations and proceeds from the U.S. breast cancer postage stamp. Results were discussed Sunday at an American Society of Clinical Oncology conference in Chicago and published by the New England Journal of Medicine. Some study leaders consult for breast cancer drugmakers or for the company that makes the gene test.\u003c/p>\n\u003cp>\u003cstrong>Moving Away From Chemo\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Cancer care has been evolving away from chemotherapy — older drugs with harsh side effects — in favor of gene-targeting therapies, hormone blockers and immune system treatments. When chemo is used now, it’s sometimes for shorter periods or lower doses than it once was.\u003c/p>\n\u003cp>For example, another study at the conference found that Merck’s immunotherapy drug Keytruda worked better than chemo as initial treatment for most people with the most common type of lung cancer, and with far fewer side effects.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The breast cancer study focused on cases where chemo’s value increasingly is in doubt: women with early-stage disease that has not spread to lymph nodes, is hormone-positive (meaning its growth is fueled by estrogen or progesterone) and is not the type that the drug Herceptin targets.\u003c/p>\n\u003cp>The usual treatment is surgery followed by years of a hormone-blocking drug. But many women also are urged to have chemo to help kill any stray cancer cells. Doctors know that most don’t need it, but evidence is thin on who can forgo it.\u003c/p>\n\u003cp>The study gave 10,273 patients a test called Oncotype DX, which uses a biopsy sample to measure the activity of genes involved in cell growth and response to hormone therapy, to estimate the risk that a cancer will recur.\u003c/p>\n\u003cp>\u003cstrong>What the Study Found\u003c/strong>\u003c/p>\n\u003cp>About 17 percent of women had high-risk scores and were advised to have chemo. The 16 percent with low-risk scores now know they can skip chemo, based on earlier results from this study.\u003c/p>\n\u003cp>The new results are on the 67 percent of women at intermediate risk. All had surgery and hormone therapy, and half also got chemo.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>After nine years, 94 percent of both groups were still alive, and about 84 percent were alive without signs of cancer, so adding chemo made no difference.\u003c/p>\n\u003cp>Certain women 50 or younger did benefit from chemo; slightly fewer cases of cancer spreading far beyond the breast occurred among some of them given chemo, depending on their risk scores on the gene test.\u003c/p>\n\u003cp>\u003cstrong>Will People Trust the Results?\u003c/strong>\u003c/p>\n\u003cp>All women like those in the study should get gene testing to guide their care, said Dr. Richard Schilsky, chief medical officer of the oncology society. Oncotype DX costs around $4,000, which Medicare and many insurers cover. Similar tests including one called MammaPrint also are widely used.\u003c/p>\n\u003cp>Testing solved a big problem of figuring out who needs chemo, said Dr. Harold Burstein of the Dana-Farber Cancer Institute in Boston. Many women think “if I don’t get chemotherapy I’m going to die, and if I get chemo I’m going to be cured,” but the results show there’s a sliding scale of benefit and sometimes none, he said.\u003c/p>\n\u003cp>Dr. Lisa Carey, a breast specialist at the University of North Carolina’s Lineberger Comprehensive Cancer Center, said she would be very comfortable advising patients to skip chemo if they were like those in the study who did not benefit from it.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Dr. Jennifer Litton at MD Anderson Cancer Center in Houston, agreed, but said: “Risk to one person is not the same thing as risk to another. There are some people who say, ’I don’t care what you say, I’m never going to do chemo,’” and won’t even have the gene test, she said. Others want chemo for even the smallest chance of benefit.\u003c/p>\n\u003cp>Adine Usher, 78, who lives in Hartsdale, New York, joined the study 10 years ago at Montefiore and was randomly assigned to the group given chemo.\u003c/p>\n\u003cp>“I was a little relieved. I sort of viewed chemo as extra insurance,” she said. The treatments “weren’t pleasant,” she concedes. Her hair fell out, she developed an infection and was hospitalized for a low white blood count, “but it was over fairly quickly and I’m really glad I had it.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>If doctors had recommended she skip chemo based on the gene test, “I would have accepted that,” she said. “I’m a firm believer in medical research.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp class=\"danger-zone\">Immunotherapy is a source of great hope in cancer care. It has \u003ca href=\"https://www.statnews.com/2017/09/12/cancer-immunotherapy-improvement/\">rescued\u003c/a>some patients from the brink, while giving others a reason to believe that they, too, could beat the long odds.[contextly_sidebar id=\"0iktmFOQroWtY1hQ3e3h8lY9q5AbDMyB\"]\u003c/p>\n\u003cp class=\"danger-zone\">But these therapies are also creating a vexing dilemma for doctors: Their patients, citing \u003ca href=\"https://www.ispot.tv/ad/w_y8/keytruda-its-tru-donnas-story-living-longer-is-possible\" target=\"_blank\" rel=\"noopener\">television ads\u003c/a> and media accounts of miraculous recoveries, are pushing hard to try them, even when there is little to no evidence the drugs will work for their particular cancer.\u003c/p>\n\u003cp class=\"danger-zone\">Doctors want to give their patients every shot at survival, but can they justify prescribing a drug when it hasn’t been tested for that patient’s type of cancer? Many of these treatments bring risks of painful — even life-threatening— side effects and carry total price tags pushing $1 million. In some cases, insurers won’t pay.\u003c/p>\n\u003cp class=\"\">“Whether it works or not, the burden both financially and emotionally on families and patients is massive,” said Dr. Vicki Jackson, chief of Massachusetts General Hospital’s palliative care unit, which helps patients with their decision-making process. “If you try it and it doesn’t work, then you’ve used up all your life savings.”\u003c/p>\n\u003cp class=\"\">There are few objective guideposts to determine which patients should get which treatments, or even undergo genetic testing to determine whether they are among the minority of patients who might benefit substantially from immuno-oncology medicines. The dividing line is often drawn by variations in age, tumor stage, and underlying health status — and the weight given to those measures still relies on physician discretion.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“Is it ethically and morally appropriate to not offer these potentially curative options on the basis of a very slight difference in kidney or liver function?” asked Dr. Ephraim Hochberg, a Mass. General oncologist who specializes in lymphoma.\u003c/p>\n\u003cp>Precision medicine, and the use of genetic markers to predict the success of treatments, promises to help answer these questions. Scientists at Stanford, for example, \u003ca href=\"https://www.statnews.com/2018/05/14/cancer-immunotherapy-pet-predictor/\">engineered\u003c/a> a radioactive molecule, detectable by PET imaging, to track whether a patient’s T cells are activated and thus capable of fighting cancer if the patient is given immunotherapy.[contextly_sidebar id=\"FOtikbkxZiNfNj2OB2DLb5zd76Z6QV0k\"]\u003c/p>\n\u003cp>The technique worked in lab mice but has not yet been tried in human patients, and other such approaches are further off. Meanwhile, patients and doctors are left to make life and death treatment decisions on uncertain terrain.\u003c/p>\n\u003cp>This struggle plays out on a near-daily basis at Mass. General, a Harvard-affiliated academic medical center with a deep well of resources and expertise. STAT interviews with specialists at the hospital reveal both the complexity of the variables at play, and the difficulty of establishing clear treatment protocols when data on real-world outcomes is still lacking.\u003c/p>\n\u003cp>The extent of these difficulties is only magnified for oncologists working with fewer resources in smaller community hospitals, where the vast majority of the nation’s cancer patients receive their care.\u003c/p>\n\u003cp>The uncertainty over treatment eligibility primarily pertains to a new class of treatments that harness the power of a patient’s immune system to attack cancer cells. These drugs have reached the market fairly recently, and have been tested in patients with a limited number of cancer types. And even in those types, the \u003ca href=\"https://www.statnews.com/2017/03/08/immunotherapy-cancer-breakthrough/\">drugs work only some of the time\u003c/a>.\u003c/p>\n\u003cp>These treatments include the checkpoint inhibitors Keytruda and Opdivo, CAR-T drugs such as Yescarta and \u003ca href=\"https://www.statnews.com/2017/08/30/novartis-car-t-cancer-approved/\">Kymriah\u003c/a>, and neo-antigen vaccines.\u003c/p>\n\u003cp>Hochberg often deals with patients who want to try \u003ca href=\"https://www.statnews.com/2017/10/27/car-t-kite-cell-journey/\">CAR-T therapy\u003c/a>, which re-engineers a patient’s T cells to recognize molecules on cancer cells and attack them. CAR-T drugs cost between $375,000 and $475,000, and the administration of treatment and follow-up care adds hundreds of thousands of thousands of dollars to the total bill.\u003c/p>\n\u003cp>In theory, CAR-T therapies can be tried on older patients whose bodies cannot withstand chemotherapy and radiation, but the National Comprehensive Cancer Network, which publishes treatment guidelines, has not established detailed eligibility criteria.\u003c/p>\n\u003cp>A similar struggle is playing out over the use of checkpoint inhibitors. It is not always clear which patients should get tested for a rare genetic condition, known as mismatch repair syndrome, that indicates receptivity to these drugs. While the testing is routinely conducted in treatment for patients with uterine and colon cancers, it is not always done for patients with other types of cancer.\u003c/p>\n\u003cp>“The fundamental problem is that it’s a costly test, so people are reluctant to make it automatic,” said Dr. David Ryan, clinical director of Mass. General’s Cancer Center. “Right now we’re relying on the oncologist to pick up those patients where there’s a reasonable chance of having mismatch repair deficiency, and ordering that test from pathology. Everybody’s having a hard time figuring out how to do this.”[contextly_sidebar id=\"blUI6ansejyqkxbdlWCDpHI5OeCoOQ3E\"]\u003c/p>\n\u003cp>Insurers play a key role in making sure that sky-high spending for these drugs is based on evidence of efficacy. But their involvement cuts both ways. In some cases, they deny coverage for treatments even when they are recommended by oncologists who believe there is a strong scientific basis to back up their decisions.\u003c/p>\n\u003cp>That scenario arose recently for Dr. Zosia Piotrowska, a medical oncologist at Mass. General who specializes in treating lung cancer. She recommended a combination of targeted therapies for a 50-year-old mother of four who has struggled with metastatic lung cancer for five years.\u003c/p>\n\u003cp>The patient’s cancer is exceedingly rare and marked by a gene mutation that indicates greater receptivity to targeted therapies. Piotrowska said various combinations of treatments had allowed the patient to live a normal life for several years, but her insurer recently denied coverage for the new round of treatment, which comes with a price of $16,000 a month.\u003c/p>\n\u003cp>Piotrowska appealed the decision, but the insurer still denied coverage, citing a lack of support for the treatment option in National Comprehensive Cancer Network guidelines. Though such guidelines set forth detailed protocols, they do not address the myriad nuances of each type of cancer and rapid changes in treatment options.\u003c/p>\n\u003cp>“The guidelines can’t keep up with the pace of research,” Piotrowska said. “As we learn more and more and develop better treatments, certain patients fall into these loopholes where we understand the biology of what’s going on, we have a treatment, but you can’t explain it to the insurer.”\u003c/p>\n\u003cp>That denial of coverage means the patient must decide whether to pay out of pocket and drain family savings for an uncertain benefit. Piotrowska said this patient has enough resources to continue with treatment, but for the vast majority of patients, the price would mean certain financial ruin.\u003c/p>\n\u003cp>The advent of immune-based therapies is only making the decisions harder. For a \u003ca href=\"https://www.statnews.com/2017/03/08/immunotherapy-cancer-breakthrough/\">small percentage\u003c/a> of patients, the treatments can be a savior, but without comprehensive insurance coverage, they are guaranteed to lead to financial distress. And because there is not yet much data on how the patients who initially benefit are faring in the long run, it is nearly impossible for new patients and their families to assess costs and benefits.\u003c/p>\n\u003cp>Doctors said the confusion over who should get immune-based treatments is bound to be exacerbated by the passage last month of the controversial \u003ca href=\"https://www.statnews.com/2018/05/30/trump-signs-right-to-try/\">“right-to-try” legislation\u003c/a>, which aims to give patients with terminal illness a different pathway to try experimental medicines that haven’t yet been approved by the Food and Drug Administration. It will not be clear how the law will affect patients until regulations are clarified in the coming months.[contextly_sidebar id=\"uFgg9fWxQTxW5cFzzQ7kroOuopy28usR\"]\u003c/p>\n\u003caside class=\"read-more standard\">\n\u003cdiv class=\"read-more-text\">\u003c/div>\n\u003c/aside>\n\u003cp>In some ways, the pressures and uncertainties posed by new cancer treatments are good problems to have. Julie Guillot said she wishes she’d had the luxury of such challenges when her son was sick.\u003c/p>\n\u003cp>Zach was diagnosed with acute myeloid leukemia when he was 5. For a boy of that age, concerns about unclear clinical benefits of treatments and sky high costs do not apply in the same way they might for an older patient. All the calculations point to the same answer: Try everything you can.\u003c/p>\n\u003cp>Zach received heavy doses of chemotherapy and three bone marrow transplants during years of expensive treatment that left him suffering from uncontrollable fevers, nausea, and infections. He died in 2014.\u003c/p>\n\u003cp>Guillot now works as an \u003ca href=\"https://www.statnews.com/2017/02/20/car-t-therapy-critics-just-dont-get/\">advocate\u003c/a> to help other patients get access to the best treatments and to ensure that experimentation in cancer care can continue to proceed on its inevitably hard and messy course toward cures.\u003c/p>\n\u003cp>“If we are avoidant of new therapies because of the risk, the lack of data, or the cost, breakthrough therapies like CAR-T and bone marrow transplant would never be developed,” she said. “When you are faced with this, people are willing to take risks for a chance to live.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2018/06/04/cancer-care-dilemma-immunotherapy/\" target=\"_blank\" rel=\"noopener\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">Immunotherapy is a source of great hope in cancer care. It has \u003ca href=\"https://www.statnews.com/2017/09/12/cancer-immunotherapy-improvement/\">rescued\u003c/a>some patients from the brink, while giving others a reason to believe that they, too, could beat the long odds.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">But these therapies are also creating a vexing dilemma for doctors: Their patients, citing \u003ca href=\"https://www.ispot.tv/ad/w_y8/keytruda-its-tru-donnas-story-living-longer-is-possible\" target=\"_blank\" rel=\"noopener\">television ads\u003c/a> and media accounts of miraculous recoveries, are pushing hard to try them, even when there is little to no evidence the drugs will work for their particular cancer.\u003c/p>\n\u003cp class=\"danger-zone\">Doctors want to give their patients every shot at survival, but can they justify prescribing a drug when it hasn’t been tested for that patient’s type of cancer? Many of these treatments bring risks of painful — even life-threatening— side effects and carry total price tags pushing $1 million. In some cases, insurers won’t pay.\u003c/p>\n\u003cp class=\"\">“Whether it works or not, the burden both financially and emotionally on families and patients is massive,” said Dr. Vicki Jackson, chief of Massachusetts General Hospital’s palliative care unit, which helps patients with their decision-making process. “If you try it and it doesn’t work, then you’ve used up all your life savings.”\u003c/p>\n\u003cp class=\"\">There are few objective guideposts to determine which patients should get which treatments, or even undergo genetic testing to determine whether they are among the minority of patients who might benefit substantially from immuno-oncology medicines. The dividing line is often drawn by variations in age, tumor stage, and underlying health status — and the weight given to those measures still relies on physician discretion.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“Is it ethically and morally appropriate to not offer these potentially curative options on the basis of a very slight difference in kidney or liver function?” asked Dr. Ephraim Hochberg, a Mass. General oncologist who specializes in lymphoma.\u003c/p>\n\u003cp>Precision medicine, and the use of genetic markers to predict the success of treatments, promises to help answer these questions. Scientists at Stanford, for example, \u003ca href=\"https://www.statnews.com/2018/05/14/cancer-immunotherapy-pet-predictor/\">engineered\u003c/a> a radioactive molecule, detectable by PET imaging, to track whether a patient’s T cells are activated and thus capable of fighting cancer if the patient is given immunotherapy.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The technique worked in lab mice but has not yet been tried in human patients, and other such approaches are further off. Meanwhile, patients and doctors are left to make life and death treatment decisions on uncertain terrain.\u003c/p>\n\u003cp>This struggle plays out on a near-daily basis at Mass. General, a Harvard-affiliated academic medical center with a deep well of resources and expertise. STAT interviews with specialists at the hospital reveal both the complexity of the variables at play, and the difficulty of establishing clear treatment protocols when data on real-world outcomes is still lacking.\u003c/p>\n\u003cp>The extent of these difficulties is only magnified for oncologists working with fewer resources in smaller community hospitals, where the vast majority of the nation’s cancer patients receive their care.\u003c/p>\n\u003cp>The uncertainty over treatment eligibility primarily pertains to a new class of treatments that harness the power of a patient’s immune system to attack cancer cells. These drugs have reached the market fairly recently, and have been tested in patients with a limited number of cancer types. And even in those types, the \u003ca href=\"https://www.statnews.com/2017/03/08/immunotherapy-cancer-breakthrough/\">drugs work only some of the time\u003c/a>.\u003c/p>\n\u003cp>These treatments include the checkpoint inhibitors Keytruda and Opdivo, CAR-T drugs such as Yescarta and \u003ca href=\"https://www.statnews.com/2017/08/30/novartis-car-t-cancer-approved/\">Kymriah\u003c/a>, and neo-antigen vaccines.\u003c/p>\n\u003cp>Hochberg often deals with patients who want to try \u003ca href=\"https://www.statnews.com/2017/10/27/car-t-kite-cell-journey/\">CAR-T therapy\u003c/a>, which re-engineers a patient’s T cells to recognize molecules on cancer cells and attack them. CAR-T drugs cost between $375,000 and $475,000, and the administration of treatment and follow-up care adds hundreds of thousands of thousands of dollars to the total bill.\u003c/p>\n\u003cp>In theory, CAR-T therapies can be tried on older patients whose bodies cannot withstand chemotherapy and radiation, but the National Comprehensive Cancer Network, which publishes treatment guidelines, has not established detailed eligibility criteria.\u003c/p>\n\u003cp>A similar struggle is playing out over the use of checkpoint inhibitors. It is not always clear which patients should get tested for a rare genetic condition, known as mismatch repair syndrome, that indicates receptivity to these drugs. While the testing is routinely conducted in treatment for patients with uterine and colon cancers, it is not always done for patients with other types of cancer.\u003c/p>\n\u003cp>“The fundamental problem is that it’s a costly test, so people are reluctant to make it automatic,” said Dr. David Ryan, clinical director of Mass. General’s Cancer Center. “Right now we’re relying on the oncologist to pick up those patients where there’s a reasonable chance of having mismatch repair deficiency, and ordering that test from pathology. Everybody’s having a hard time figuring out how to do this.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Insurers play a key role in making sure that sky-high spending for these drugs is based on evidence of efficacy. But their involvement cuts both ways. In some cases, they deny coverage for treatments even when they are recommended by oncologists who believe there is a strong scientific basis to back up their decisions.\u003c/p>\n\u003cp>That scenario arose recently for Dr. Zosia Piotrowska, a medical oncologist at Mass. General who specializes in treating lung cancer. She recommended a combination of targeted therapies for a 50-year-old mother of four who has struggled with metastatic lung cancer for five years.\u003c/p>\n\u003cp>The patient’s cancer is exceedingly rare and marked by a gene mutation that indicates greater receptivity to targeted therapies. Piotrowska said various combinations of treatments had allowed the patient to live a normal life for several years, but her insurer recently denied coverage for the new round of treatment, which comes with a price of $16,000 a month.\u003c/p>\n\u003cp>Piotrowska appealed the decision, but the insurer still denied coverage, citing a lack of support for the treatment option in National Comprehensive Cancer Network guidelines. Though such guidelines set forth detailed protocols, they do not address the myriad nuances of each type of cancer and rapid changes in treatment options.\u003c/p>\n\u003cp>“The guidelines can’t keep up with the pace of research,” Piotrowska said. “As we learn more and more and develop better treatments, certain patients fall into these loopholes where we understand the biology of what’s going on, we have a treatment, but you can’t explain it to the insurer.”\u003c/p>\n\u003cp>That denial of coverage means the patient must decide whether to pay out of pocket and drain family savings for an uncertain benefit. Piotrowska said this patient has enough resources to continue with treatment, but for the vast majority of patients, the price would mean certain financial ruin.\u003c/p>\n\u003cp>The advent of immune-based therapies is only making the decisions harder. For a \u003ca href=\"https://www.statnews.com/2017/03/08/immunotherapy-cancer-breakthrough/\">small percentage\u003c/a> of patients, the treatments can be a savior, but without comprehensive insurance coverage, they are guaranteed to lead to financial distress. And because there is not yet much data on how the patients who initially benefit are faring in the long run, it is nearly impossible for new patients and their families to assess costs and benefits.\u003c/p>\n\u003cp>Doctors said the confusion over who should get immune-based treatments is bound to be exacerbated by the passage last month of the controversial \u003ca href=\"https://www.statnews.com/2018/05/30/trump-signs-right-to-try/\">“right-to-try” legislation\u003c/a>, which aims to give patients with terminal illness a different pathway to try experimental medicines that haven’t yet been approved by the Food and Drug Administration. It will not be clear how the law will affect patients until regulations are clarified in the coming months.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003caside class=\"read-more standard\">\n\u003cdiv class=\"read-more-text\">\u003c/div>\n\u003c/aside>\n\u003cp>In some ways, the pressures and uncertainties posed by new cancer treatments are good problems to have. Julie Guillot said she wishes she’d had the luxury of such challenges when her son was sick.\u003c/p>\n\u003cp>Zach was diagnosed with acute myeloid leukemia when he was 5. For a boy of that age, concerns about unclear clinical benefits of treatments and sky high costs do not apply in the same way they might for an older patient. All the calculations point to the same answer: Try everything you can.\u003c/p>\n\u003cp>Zach received heavy doses of chemotherapy and three bone marrow transplants during years of expensive treatment that left him suffering from uncontrollable fevers, nausea, and infections. He died in 2014.\u003c/p>\n\u003cp>Guillot now works as an \u003ca href=\"https://www.statnews.com/2017/02/20/car-t-therapy-critics-just-dont-get/\">advocate\u003c/a> to help other patients get access to the best treatments and to ensure that experimentation in cancer care can continue to proceed on its inevitably hard and messy course toward cures.\u003c/p>\n\u003cp>“If we are avoidant of new therapies because of the risk, the lack of data, or the cost, breakthrough therapies like CAR-T and bone marrow transplant would never be developed,” she said. “When you are faced with this, people are willing to take risks for a chance to live.”\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 originally published by \u003ca href=\"https://www.statnews.com/2018/06/04/cancer-care-dilemma-immunotherapy/\" target=\"_blank\" rel=\"noopener\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Therapy Made From Patient's Immune System Shows Promise For Advanced Breast Cancer",
"title": "Therapy Made From Patient's Immune System Shows Promise For Advanced Breast Cancer",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>Doctors at the National Institutes of Health say they've apparently completely eradicated cancer from a patient who had untreatable, advanced breast cancer.[contextly_sidebar id=\"XBqZwaw0YLkXChOC5E9p7x7LlwjI87h0\"]\u003c/p>\n\u003cp>The case is raising hopes about a new way to harness the immune system to fight some of the most common cancers. The methods and the patient's experience are described Monday in a \u003ca href=\"https://www.nature.com/articles/s41591-018-0040-8\">paper\u003c/a> published in the journal \u003cem>Nature Medicine\u003c/em>.\u003c/p>\n\u003cp>\"We're looking for a treatment — an immunotherapy — that can be broadly used in patients with common cancers,\" says \u003ca href=\"https://ccr.cancer.gov/Surgery-Branch/steven-a-rosenberg\">Dr. Steven Rosenberg\u003c/a>, an oncologist and immunologist at the National Cancer Institute, who has been developing the approach.\u003c/p>\n\u003cp>Rosenberg's team painstakingly analyzes the DNA in a sample of each patient's cancer for mutations specific to their malignancies. Next, scientists sift through tumor tissue for immune system cells known as \u003ca href=\"https://www.cancer.gov/publications/dictionaries/cancer-terms/def/t-cell\">T cells\u003c/a> that appear programmed to home in on those mutations.\u003c/p>\n\u003cp>But Rosenberg and others caution that the approach doesn't work for everyone. In fact, it failed for two other breast cancer patients. Many more patients will have to be treated — and followed for much longer — to fully evaluate the treatment's effectiveness, the scientists say.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Still, the treatment has helped seven of 45 patients with a variety of cancers, Rosenberg says. That's a response rate of about 15 percent, and included patients with advanced cases of colon cancer, liver cancer and cervical cancer.\u003c/p>\n\u003cp>\"Is it ready for prime time today? No,\" Rosenberg says.\"Can we do it in most patients today? No.\"\u003c/p>\n\u003cp>But the treatment continues to be improved. \"I think it's the most promising treatment now being explored for solving the problem of the treatment of metastatic, common cancers,\" he says.\u003c/p>\n\u003cp>The breast cancer patient helped by the treatment says it transformed her life.\u003c/p>\n\u003cp>\"It's amazing,\" says Judy Perkins, 52, a retired engineer who lives in Port St. Lucie, Fla.[contextly_sidebar id=\"LBQmSDLCPJe4N0too3CcLvpq1h2WnS7o\"]\u003c/p>\n\u003cp>When Perkins was first diagnosed and treated for breast cancer in 2003, she thought she'd beaten the disease. \"I thought I was done with it,\" she says.\u003c/p>\n\u003cp>But about a decade later, she felt a new lump. Doctors discovered the cancer had already spread throughout her chest. Her prognosis was grim.\u003c/p>\n\u003cp>\"I became a metastatic cancer patient,\" says Perkins. \"That was hard.\"\u003c/p>\n\u003cp>Perkins went through round after round of chemotherapy. She tried every experimental treatment she could find. But the cancer kept spreading. Some of her tumors grew to the size of tennis balls.\u003c/p>\n\u003cp>\"I had sort of essentially run out of arrows in my quiver,\" she says. \"While I would say I had some hope, I was also kind of like ready to quit, too.\"\u003c/p>\n\u003cp>Then she heard about the experimental treatment at the NIH. It was designed to fight some of the most common cancers, including breast cancer.\u003c/p>\n\u003cp>\"The excitement here is that we're attacking the very mutations that are unique to that cancer — in that patient's cancer and not in anybody else's cancer. So it's about as personalized a treatment as you can imagine,\" Rosenberg says.\u003c/p>\n\u003cp>His team identified and then grew billions of T cells for Perkins in the lab and then infused them back into her body. They also gave her two drugs to help the cells do their job.[contextly_sidebar id=\"7hRhhF6kMzZu5JjMty7K1k5yrQUh2pfA\"]\u003c/p>\n\u003cp>The treatment was grueling. Perkins says the hardest part was the side effects of a drug known as interleukin, which she received to help boost the effectiveness of the immune system cells. Interleukin causes severe flu-like symptoms, such as a high fever, intense malaise and uncontrollable shivering.\u003c/p>\n\u003cp>But the treatment apparently worked, Rosenberg reports. Perkins' tumors soon disappeared. And, more than two years later, she remains cancer-free.\u003c/p>\n\u003cp>\"All of her detectable disease has disappeared. It's remarkable,\" Rosenberg says.\u003c/p>\n\u003cp>Perkins is thrilled.\u003c/p>\n\u003cp>\"I'm one of the lucky ones,\" Perkins says. \"We got the right T cells in the right place at the right time. And they went in and ate up all my cancer. And I'm cured. It's freaking unreal.\"\u003c/p>\n\u003cp>In an \u003ca href=\"https://doi.org/10.1038/s41591-018-0065-z\">article\u003c/a> accompanying the new paper, \u003ca href=\"https://news.oicr.on.ca/2018/03/oicr-names-dr-laszlo-radvanyi-as-new-president-and-scientific-director/\">Laszlo Radvanyi\u003c/a>, president and scientific director of the Ontario Institute for Cancer Research, calls the results \"remarkable.\"\u003c/p>\n\u003cp>The approach and other recent advances suggest scientists may be \"at the cusp of a major revolution in finally realizing the elusive goal of being able to target the plethora of mutations in cancer through immunotherapy,\" Radvanyi writes.\u003c/p>\n\u003cp>Other cancer researchers agree.\u003c/p>\n\u003cp>\"When I saw this paper I thought: \"Whoa! I mean, it's very impressive,\" says \u003ca href=\"https://www.systemsbiology.org/bio/james-r-heath/\">James Heath\u003c/a>, president of the Institute for Systems Biology in Seattle.\u003c/p>\n\u003cp>\"One of the most exciting breakthroughs in biomedicine over the past decade has been activating the immune system against various cancers. But they have not been successful in breast cancer. Metastatic breast cancer is basically a death sentence,\" Heath says. \"And this shows that you can reverse it. It's a big deal.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>One key challenge will be to make the treatment easier, faster, and affordable, Rosenberg says. \"We're working literally around the clock to try to improve the treatment.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Therapy+Made+From+Patient%27s+Immune+System+Shows+Promise+For+Advanced+Breast+Cancer&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Doctors at the National Institutes of Health say they've apparently completely eradicated cancer from a patient who had untreatable, advanced breast cancer.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The case is raising hopes about a new way to harness the immune system to fight some of the most common cancers. The methods and the patient's experience are described Monday in a \u003ca href=\"https://www.nature.com/articles/s41591-018-0040-8\">paper\u003c/a> published in the journal \u003cem>Nature Medicine\u003c/em>.\u003c/p>\n\u003cp>\"We're looking for a treatment — an immunotherapy — that can be broadly used in patients with common cancers,\" says \u003ca href=\"https://ccr.cancer.gov/Surgery-Branch/steven-a-rosenberg\">Dr. Steven Rosenberg\u003c/a>, an oncologist and immunologist at the National Cancer Institute, who has been developing the approach.\u003c/p>\n\u003cp>Rosenberg's team painstakingly analyzes the DNA in a sample of each patient's cancer for mutations specific to their malignancies. Next, scientists sift through tumor tissue for immune system cells known as \u003ca href=\"https://www.cancer.gov/publications/dictionaries/cancer-terms/def/t-cell\">T cells\u003c/a> that appear programmed to home in on those mutations.\u003c/p>\n\u003cp>But Rosenberg and others caution that the approach doesn't work for everyone. In fact, it failed for two other breast cancer patients. Many more patients will have to be treated — and followed for much longer — to fully evaluate the treatment's effectiveness, the scientists say.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Still, the treatment has helped seven of 45 patients with a variety of cancers, Rosenberg says. That's a response rate of about 15 percent, and included patients with advanced cases of colon cancer, liver cancer and cervical cancer.\u003c/p>\n\u003cp>\"Is it ready for prime time today? No,\" Rosenberg says.\"Can we do it in most patients today? No.\"\u003c/p>\n\u003cp>But the treatment continues to be improved. \"I think it's the most promising treatment now being explored for solving the problem of the treatment of metastatic, common cancers,\" he says.\u003c/p>\n\u003cp>The breast cancer patient helped by the treatment says it transformed her life.\u003c/p>\n\u003cp>\"It's amazing,\" says Judy Perkins, 52, a retired engineer who lives in Port St. Lucie, Fla.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>When Perkins was first diagnosed and treated for breast cancer in 2003, she thought she'd beaten the disease. \"I thought I was done with it,\" she says.\u003c/p>\n\u003cp>But about a decade later, she felt a new lump. Doctors discovered the cancer had already spread throughout her chest. Her prognosis was grim.\u003c/p>\n\u003cp>\"I became a metastatic cancer patient,\" says Perkins. \"That was hard.\"\u003c/p>\n\u003cp>Perkins went through round after round of chemotherapy. She tried every experimental treatment she could find. But the cancer kept spreading. Some of her tumors grew to the size of tennis balls.\u003c/p>\n\u003cp>\"I had sort of essentially run out of arrows in my quiver,\" she says. \"While I would say I had some hope, I was also kind of like ready to quit, too.\"\u003c/p>\n\u003cp>Then she heard about the experimental treatment at the NIH. It was designed to fight some of the most common cancers, including breast cancer.\u003c/p>\n\u003cp>\"The excitement here is that we're attacking the very mutations that are unique to that cancer — in that patient's cancer and not in anybody else's cancer. So it's about as personalized a treatment as you can imagine,\" Rosenberg says.\u003c/p>\n\u003cp>His team identified and then grew billions of T cells for Perkins in the lab and then infused them back into her body. They also gave her two drugs to help the cells do their job.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The treatment was grueling. Perkins says the hardest part was the side effects of a drug known as interleukin, which she received to help boost the effectiveness of the immune system cells. Interleukin causes severe flu-like symptoms, such as a high fever, intense malaise and uncontrollable shivering.\u003c/p>\n\u003cp>But the treatment apparently worked, Rosenberg reports. Perkins' tumors soon disappeared. And, more than two years later, she remains cancer-free.\u003c/p>\n\u003cp>\"All of her detectable disease has disappeared. It's remarkable,\" Rosenberg says.\u003c/p>\n\u003cp>Perkins is thrilled.\u003c/p>\n\u003cp>\"I'm one of the lucky ones,\" Perkins says. \"We got the right T cells in the right place at the right time. And they went in and ate up all my cancer. And I'm cured. It's freaking unreal.\"\u003c/p>\n\u003cp>In an \u003ca href=\"https://doi.org/10.1038/s41591-018-0065-z\">article\u003c/a> accompanying the new paper, \u003ca href=\"https://news.oicr.on.ca/2018/03/oicr-names-dr-laszlo-radvanyi-as-new-president-and-scientific-director/\">Laszlo Radvanyi\u003c/a>, president and scientific director of the Ontario Institute for Cancer Research, calls the results \"remarkable.\"\u003c/p>\n\u003cp>The approach and other recent advances suggest scientists may be \"at the cusp of a major revolution in finally realizing the elusive goal of being able to target the plethora of mutations in cancer through immunotherapy,\" Radvanyi writes.\u003c/p>\n\u003cp>Other cancer researchers agree.\u003c/p>\n\u003cp>\"When I saw this paper I thought: \"Whoa! I mean, it's very impressive,\" says \u003ca href=\"https://www.systemsbiology.org/bio/james-r-heath/\">James Heath\u003c/a>, president of the Institute for Systems Biology in Seattle.\u003c/p>\n\u003cp>\"One of the most exciting breakthroughs in biomedicine over the past decade has been activating the immune system against various cancers. But they have not been successful in breast cancer. Metastatic breast cancer is basically a death sentence,\" Heath says. \"And this shows that you can reverse it. It's a big deal.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>One key challenge will be to make the treatment easier, faster, and affordable, Rosenberg says. \"We're working literally around the clock to try to improve the treatment.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Therapy+Made+From+Patient%27s+Immune+System+Shows+Promise+For+Advanced+Breast+Cancer&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Get Screened Earlier For Colorectal Cancer, Urges American Cancer Society",
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"content": "\u003cp>Colorectal cancer is the second-leading cause of cancer death in the United States, most frequently diagnosed among adults over 65. To catch those typically slow-growing malignancies early, when they can often be cured, most doctors' groups recommend colorectal cancer screening starting at age 50.[contextly_sidebar id=\"NOUTn2zOpMrMGpyA6RwGCmEzUmw18jiE\"]\u003c/p>\n\u003cp>But the American Cancer Society this week changed its advice and is \u003ca href=\"https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21457\" target=\"_blank\" rel=\"noopener\">recommending that screening start five years earlier\u003c/a>.\u003c/p>\n\u003cp>\"There is compelling evidence that the optimum age to start is now 45,\" says \u003ca href=\"https://www.cancer.org/about-us/who-we-are/executive-leadership/richard-wender-bio.html\" target=\"_blank\" rel=\"noopener\">Dr. Richard Wender\u003c/a>, chief cancer control officer of the society, who cites a sharp \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2647859\" target=\"_blank\" rel=\"noopener\">increase in deaths\u003c/a> from colon and rectal cancers among men and women under age 50.\u003c/p>\n\u003cp>\"People born in the '80s and '90s are at higher risk of developing colon cancer, particularly rectal cancer, than people born when I was born back in the '50s,\" Wender says.\u003c/p>\n\u003cp>And the rise is not just because detection is getting better, he says. In fact, the risk of developing colon cancer is twice as high as it was years ago and the risk of developing rectal cancer is four times higher.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"We just have to face reality,\" says Wender. \"We just don't know \u003cem>why\u003c/em> it's increasing.\"\u003c/p>\n\u003cp>Some of the increase could stem from the increase in obesity in the U.S., a known risk factor for colorectal cancer, he says.\u003c/p>\n\u003cp>\"But we don't think that explains the entire change,\" he adds. \"There is a great deal of interest and a lot of research beginning to try to answer that question.\"\u003c/p>\n\u003cp>So far, other groups are maintaining their recommendation that colon cancer screening start at age 50, including the U.S. Preventive Services Task Force, an independent, volunteer panel of national experts in disease prevention and evidence-based medicine.[contextly_sidebar id=\"P5idbi4fl2nJQ4sgNYQ8kwPxKThEw1dW\"]\u003c/p>\n\u003cp>Stanford University internist \u003ca href=\"https://www.uspreventiveservicestaskforce.org/Page/Biography/Doug--Owens\" target=\"_blank\" rel=\"noopener\">Douglas K. Owens\u003c/a>, the task force's vice-chairperson, says the group's \u003ca href=\"https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/colorectal-cancer-screening2\" target=\"_blank\" rel=\"noopener\">2016 recommendations\u003c/a> were based on extensive review of the benefits and harms of colorectal screening at the time.\u003c/p>\n\u003cp>\"There was limited data on screening people under age 50,\" Owens says. The new American Cancer Society guidelines, he adds, should prompt more research into the relative benefits and harms of screening among younger people.\u003c/p>\n\u003cp>\u003ca href=\"https://www.mskcc.org/cancer-care/doctors/robin-mendelsohn\" target=\"_blank\" rel=\"noopener\">Dr. Robin B. Mendelsohn\u003c/a>, a gastroenterologist at Memorial Sloan Kettering Cancer Center in New York, says there's been an \"alarming\" increase in cancer among younger adults. She's the co-director of the recently established \u003ca href=\"https://www.mskcc.org/cancer-care/types/colorectal/colorectal-cancer-young-adults\" target=\"_blank\" rel=\"noopener\">Center for Young Onset Colorectal Cancer\u003c/a> there.\u003c/p>\n\u003cp>Over the last 10 years, Memorial Sloan Kettering has seen 4,000 new colorectal cancer patients under age 50, she says. Many of them did not have traditional risk factors such as obesity, smoking, alcohol, physical inactivity or a diet high in fat or low in fiber.\u003c/p>\n\u003cp>In fact, Mendelsohn says, they were typically less likely to smoke and less likely to be overweight than their older counterparts.\u003c/p>\n\u003cp>\"Anecdotally, when you talk with these patients, [some] are marathon runners who don't eat red meat, don't smoke, do everything 'right' and say 'why did this happen to me?' \" she says.[contextly_sidebar id=\"MQUcI1nEN5j9iN51hKJ85YEaLuRJyxYZ\"]\u003c/p>\n\u003cp>Often, they tell her they've seen multiple doctors because of rectal bleeding, but have been told, since they're under 50, they \"can't have cancer.\" That's clearly not the case, she says.\u003c/p>\n\u003cp>Ongoing studies are looking at a multitude of factors that might be contributing to the earlier cancer incidence. Potential culprits include over-the-counter anti-inflammatory medicines, antibiotics and antidepressants, as well as multiple vitamins, probiotics and other dietary supplements.\u003c/p>\n\u003cp>The new recommendations should bring greater attention to the value of screening, says Mendelsohn, who suggests that future studies investigate whether even younger people — in their early 40s or even 30s — should be screened.\u003c/p>\n\u003cp>A first colon cancer screening does not have to be a colonoscopy. In its new recommendations, the cancer society recommends choosing from one of six screening tests, which are also currently recommended by other expert groups. The guidelines don't prioritize among screening choices.\u003c/p>\n\u003cp>The choices include three at-home \u003ca href=\"https://www.cancer.net/navigating-cancer-care/diagnosing-cancer/tests-and-procedures/fecal-occult-blood-tests\" target=\"_blank\" rel=\"noopener\">kits that test stool for blood\u003c/a>.\u003c/p>\n\u003cp>These kits need to be ordered by a doctor; primary-care providers often have them on hand in the office to give to patients, Wender says, or they may be mailed.\u003c/p>\n\u003cp>\"It's done in the privacy of your own home,\" he says. Patients mail the sample to a research facility which tests for microscopic traces of blood.\u003c/p>\n\u003cp>If the test is positive, a colonoscopy is recommended, Wender says; but only one in five people test positive for blood in their stool.\u003c/p>\n\u003cp>Typically, these home tests of feces are repeated every year for good results.\u003c/p>\n\u003cp>Alternatively, some patients opt for what's called a \u003ca href=\"https://www.niddk.nih.gov/health-information/diagnostic-tests/virtual-colonoscopy\" target=\"_blank\" rel=\"noopener\">\"virtual\" colonoscopy\u003c/a> — essentially a CT scan of the colon — which should be done every five years, according to the new recommendations.[contextly_sidebar id=\"5Pa1nwLZfbPDZxnlIWvVKTkm9l3Yq23j\"]\u003c/p>\n\u003cp>Another approved option is a \u003ca href=\"https://www.niddk.nih.gov/health-information/diagnostic-tests/flexible-sigmoidoscopy\" target=\"_blank\" rel=\"noopener\">flexible sigmoidoscopy\u003c/a>, which looks at the lower part of the colon, and is followed up by a colonoscopy if polyps are found.\u003c/p>\n\u003cp>A positive result picked up in these screening tests is typically followed up by a colonoscopy, which uses a tiny camera to investigate the entire colon. It is not only a search for early cancer; more often than not, Wender says, it detects pre-malignant, suspicious lesions, or polyps, which are removed during the procedure.\u003c/p>\n\u003cp>\"When we find and remove polyps we actually prevent any future chance of that developing into cancer,\" he says.\u003c/p>\n\u003cp>Despite the high cure rate when colon cancer is caught early, only two-thirds of Americans over 50 get screened.\u003c/p>\n\u003cp>The American Cancer Society says it endorsed the full range of screening tests \"without preference\" in order to improve the rate of screening. In its latest advice, the U.S. Preventive Services Task Force says head-to-head comparison studies have shown that no one screening test is more effective than another in early cancer detection.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>While they differ on the age of first screening, both groups suggest that screening over age 75 should be a joint decision between patient and doctor. And after age 85, screening is no longer necessary, the doctors' groups agree. That's because the risk of colonoscopy among this elderly population can outweigh any benefit.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Get+Screened+Earlier+For+Colorectal+Cancer%2C+Urges+American+Cancer+Society+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Colorectal cancer is the second-leading cause of cancer death in the United States, most frequently diagnosed among adults over 65. To catch those typically slow-growing malignancies early, when they can often be cured, most doctors' groups recommend colorectal cancer screening starting at age 50.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>But the American Cancer Society this week changed its advice and is \u003ca href=\"https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21457\" target=\"_blank\" rel=\"noopener\">recommending that screening start five years earlier\u003c/a>.\u003c/p>\n\u003cp>\"There is compelling evidence that the optimum age to start is now 45,\" says \u003ca href=\"https://www.cancer.org/about-us/who-we-are/executive-leadership/richard-wender-bio.html\" target=\"_blank\" rel=\"noopener\">Dr. Richard Wender\u003c/a>, chief cancer control officer of the society, who cites a sharp \u003ca href=\"https://jamanetwork.com/journals/jama/fullarticle/2647859\" target=\"_blank\" rel=\"noopener\">increase in deaths\u003c/a> from colon and rectal cancers among men and women under age 50.\u003c/p>\n\u003cp>\"People born in the '80s and '90s are at higher risk of developing colon cancer, particularly rectal cancer, than people born when I was born back in the '50s,\" Wender says.\u003c/p>\n\u003cp>And the rise is not just because detection is getting better, he says. In fact, the risk of developing colon cancer is twice as high as it was years ago and the risk of developing rectal cancer is four times higher.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"We just have to face reality,\" says Wender. \"We just don't know \u003cem>why\u003c/em> it's increasing.\"\u003c/p>\n\u003cp>Some of the increase could stem from the increase in obesity in the U.S., a known risk factor for colorectal cancer, he says.\u003c/p>\n\u003cp>\"But we don't think that explains the entire change,\" he adds. \"There is a great deal of interest and a lot of research beginning to try to answer that question.\"\u003c/p>\n\u003cp>So far, other groups are maintaining their recommendation that colon cancer screening start at age 50, including the U.S. Preventive Services Task Force, an independent, volunteer panel of national experts in disease prevention and evidence-based medicine.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Stanford University internist \u003ca href=\"https://www.uspreventiveservicestaskforce.org/Page/Biography/Doug--Owens\" target=\"_blank\" rel=\"noopener\">Douglas K. Owens\u003c/a>, the task force's vice-chairperson, says the group's \u003ca href=\"https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/colorectal-cancer-screening2\" target=\"_blank\" rel=\"noopener\">2016 recommendations\u003c/a> were based on extensive review of the benefits and harms of colorectal screening at the time.\u003c/p>\n\u003cp>\"There was limited data on screening people under age 50,\" Owens says. The new American Cancer Society guidelines, he adds, should prompt more research into the relative benefits and harms of screening among younger people.\u003c/p>\n\u003cp>\u003ca href=\"https://www.mskcc.org/cancer-care/doctors/robin-mendelsohn\" target=\"_blank\" rel=\"noopener\">Dr. Robin B. Mendelsohn\u003c/a>, a gastroenterologist at Memorial Sloan Kettering Cancer Center in New York, says there's been an \"alarming\" increase in cancer among younger adults. She's the co-director of the recently established \u003ca href=\"https://www.mskcc.org/cancer-care/types/colorectal/colorectal-cancer-young-adults\" target=\"_blank\" rel=\"noopener\">Center for Young Onset Colorectal Cancer\u003c/a> there.\u003c/p>\n\u003cp>Over the last 10 years, Memorial Sloan Kettering has seen 4,000 new colorectal cancer patients under age 50, she says. Many of them did not have traditional risk factors such as obesity, smoking, alcohol, physical inactivity or a diet high in fat or low in fiber.\u003c/p>\n\u003cp>In fact, Mendelsohn says, they were typically less likely to smoke and less likely to be overweight than their older counterparts.\u003c/p>\n\u003cp>\"Anecdotally, when you talk with these patients, [some] are marathon runners who don't eat red meat, don't smoke, do everything 'right' and say 'why did this happen to me?' \" she says.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Often, they tell her they've seen multiple doctors because of rectal bleeding, but have been told, since they're under 50, they \"can't have cancer.\" That's clearly not the case, she says.\u003c/p>\n\u003cp>Ongoing studies are looking at a multitude of factors that might be contributing to the earlier cancer incidence. Potential culprits include over-the-counter anti-inflammatory medicines, antibiotics and antidepressants, as well as multiple vitamins, probiotics and other dietary supplements.\u003c/p>\n\u003cp>The new recommendations should bring greater attention to the value of screening, says Mendelsohn, who suggests that future studies investigate whether even younger people — in their early 40s or even 30s — should be screened.\u003c/p>\n\u003cp>A first colon cancer screening does not have to be a colonoscopy. In its new recommendations, the cancer society recommends choosing from one of six screening tests, which are also currently recommended by other expert groups. The guidelines don't prioritize among screening choices.\u003c/p>\n\u003cp>The choices include three at-home \u003ca href=\"https://www.cancer.net/navigating-cancer-care/diagnosing-cancer/tests-and-procedures/fecal-occult-blood-tests\" target=\"_blank\" rel=\"noopener\">kits that test stool for blood\u003c/a>.\u003c/p>\n\u003cp>These kits need to be ordered by a doctor; primary-care providers often have them on hand in the office to give to patients, Wender says, or they may be mailed.\u003c/p>\n\u003cp>\"It's done in the privacy of your own home,\" he says. Patients mail the sample to a research facility which tests for microscopic traces of blood.\u003c/p>\n\u003cp>If the test is positive, a colonoscopy is recommended, Wender says; but only one in five people test positive for blood in their stool.\u003c/p>\n\u003cp>Typically, these home tests of feces are repeated every year for good results.\u003c/p>\n\u003cp>Alternatively, some patients opt for what's called a \u003ca href=\"https://www.niddk.nih.gov/health-information/diagnostic-tests/virtual-colonoscopy\" target=\"_blank\" rel=\"noopener\">\"virtual\" colonoscopy\u003c/a> — essentially a CT scan of the colon — which should be done every five years, according to the new recommendations.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Another approved option is a \u003ca href=\"https://www.niddk.nih.gov/health-information/diagnostic-tests/flexible-sigmoidoscopy\" target=\"_blank\" rel=\"noopener\">flexible sigmoidoscopy\u003c/a>, which looks at the lower part of the colon, and is followed up by a colonoscopy if polyps are found.\u003c/p>\n\u003cp>A positive result picked up in these screening tests is typically followed up by a colonoscopy, which uses a tiny camera to investigate the entire colon. It is not only a search for early cancer; more often than not, Wender says, it detects pre-malignant, suspicious lesions, or polyps, which are removed during the procedure.\u003c/p>\n\u003cp>\"When we find and remove polyps we actually prevent any future chance of that developing into cancer,\" he says.\u003c/p>\n\u003cp>Despite the high cure rate when colon cancer is caught early, only two-thirds of Americans over 50 get screened.\u003c/p>\n\u003cp>The American Cancer Society says it endorsed the full range of screening tests \"without preference\" in order to improve the rate of screening. In its latest advice, the U.S. Preventive Services Task Force says head-to-head comparison studies have shown that no one screening test is more effective than another in early cancer detection.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>While they differ on the age of first screening, both groups suggest that screening over age 75 should be a joint decision between patient and doctor. And after age 85, screening is no longer necessary, the doctors' groups agree. That's because the risk of colonoscopy among this elderly population can outweigh any benefit.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Get+Screened+Earlier+For+Colorectal+Cancer%2C+Urges+American+Cancer+Society+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "This Digital Pill Wants To Make Following Your Prescription Easier",
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"content": "\u003cp>Doctors \u003ca href=\"http://annals.org/aim/fullarticle/1357338/interventions-improve-adherence-self-administered-medications-chronic-diseases-united-states\" target=\"_blank\" rel=\"noopener\">estimate\u003c/a> about half of all medications for chronic conditions are not taken as prescribed, resulting in $100 billion to $289 billion in preventable health care costs and more than 100,000 deaths every year in the U.S. \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/22510235\" target=\"_blank\" rel=\"noopener\">A majority of adults\u003c/a> say they struggle with remembering to take their prescriptions.[contextly_sidebar id=\"2CHr3EdFO0IpmlPpjqlB7AVQ3gwHnKDA\"]\u003c/p>\n\u003cp>Now, as with many other seemingly intractable challenges, technology has been enlisted to help. A new clinical study is underway at 16 health centers around the country to see if a pill with an ingestible sensor can improve medication adherence rates for \u003ca href=\"https://www.cdc.gov/hepatitis/hcv/cfaq.htm\" target=\"_blank\" rel=\"noopener\">Hepatitis C\u003c/a> drugs.\u003c/p>\n\u003cp>\u003ca href=\"https://www.proteus.com/\" target=\"_blank\" rel=\"noopener\">Proteus Digital Health\u003c/a>, the inventor of this so-called digital pill, is part of an emerging field of medicine and one of a handful of companies designing these high-tech pills.\u003c/p>\n\u003cp>While medication adherence is an issue for everyone, it can be especially difficult for patients with mental health and substance abuse conditions to rigorously follow their prescriptions.\u003c/p>\n\u003cp>And the latter is a significant factor in the spread of Hepatitis C. Intravenous drug use, particularly opioids, has fueled a \u003ca href=\"https://www.cdc.gov/nchhstp/newsroom/2017/Hepatitis-Surveillance-Press-Release.html\">spike in\u003c/a> Hepatitis C infections in recent years.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>On Wednesday’s PBS NewsHour, I explore how a new wave of Hepatitis C drugs, known as direct-acting antivirals, can cure the disease 95 percent of time when used as prescribed. But insurance providers have limited their payouts and the access for direct-acting antivirals, due to the drugs’ expensive price tag.\u003c/p>\n\u003cp>[youtube https://www.youtube.com/watch?v=3DN2gI87R3Q?feature=oembed]\u003c/p>\n\u003cp>David Wyles, head of infectious diseases at \u003ca href=\"https://www.denverhealth.org/\" target=\"_blank\" rel=\"noopener\">Denver Health\u003c/a> where the digital pill is being trialed, said the information gathered from the study may help \u003ca href=\"https://www.chlpi.org/chlpi-nvhr-launch-interactive-report-card-project-grading-52-medicaid-programs-discriminatory-hepatitis-c-treatment-restrictions/\" target=\"_blank\" rel=\"noopener\">convince insurers to expand access \u003c/a>to the new but more expensive Hepatitis C drugs. \u003ca href=\"https://www.denverhealth.org/\" target=\"_blank\" rel=\"noopener\">Denver Health\u003c/a> has 18 voluntary patients enrolled in the trial and is one of the largest study sites. The Colorado Department of Health estimates about \u003ca href=\"https://drive.google.com/file/d/0B0tmPQ67k3NVQjJXSFRGajdWUEE/view\" target=\"_blank\" rel=\"noopener\">70,000\u003c/a> people in the state carry Hepatitis C, and Denver Health cares for many of them.\u003c/p>\n\u003cp>“Insurance payers have imposed restrictions, not necessarily based on medical or scientific facts,” Wyles said. “This is a population that some will look at and say, ‘They won’t take their medications, why would we want to treat them?’ Potentially this study is something to refute that if we can show adherence rates are good.”[contextly_sidebar id=\"64LqO8WUg7X2FUJe9uqsRXqMVyuUE8BQ\"]\u003c/p>\n\u003cp>Proteus’ digital pill consists of the prescription medication with a tiny, FDA-approved ingestible sensor, packed inside a gel capsule. Once swallowed, minerals in the sensor react when they hit the acids in the stomach and create a tiny electronic signal. A band-aid-like patch, worn on the skin of the torso, captures this signal and relays it to an app on a smartphone or tablet.\u003c/p>\n\u003cp>Patients share the data with their doctors but also control who else has access. Their doctors can then monitor when and how many pills have been taken.\u003c/p>\n\u003cp>“If the patient misses a dose or a couple of doses, you can set up an alert in the program to send you an email. You can contact them and hopefully intervene right away,” David Wyles said. “Without the technology, you may not know anything until your next visit, which could be a month later, and then it’s too late to do anything.”\u003c/p>\n\u003cp>Yet the new technology raises questions about patient privacy. \u003ca href=\"https://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2017.pp12a2\" target=\"_blank\" rel=\"noopener\">Some doctors in the mental health community\u003c/a> expressed concerns last year about patient trust and misuse of data when the \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm\" target=\"_blank\" rel=\"noopener\">FDA approved\u003c/a> Proteus Digital Health’s sensors to be embedded in the antipsychotic drug \u003ca href=\"https://www.proteus.com/press-releases/otsuka-and-proteus-announce-the-first-us-fda-approval-of-a-digital-medicine-system-abilify-mycite/\" target=\"_blank\" rel=\"noopener\">Abilify.[contextly_sidebar id=\"BuXdE0rwLJ9KNHT80EszuM4r2ocN7n84\"]\u003c/a>\u003c/p>\n\u003cp>“In an era in which even the National Security Agency gets hacked, there are obvious concerns about patient privacy with a technology that communicates personal medical information,” Paul Appelbaum, director of the division of Law, Ethics, and Psychiatry at Columbia University, \u003ca href=\"https://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2017.pp12a2\" target=\"_blank\" rel=\"noopener\">told Psychiatric News\u003c/a>. “The potential for this technology to be misused by judges and probation officers who may require offenders to use pills with sensors, and then respond punitively to the most trivial failure to adhere to the treatment regimen, is real.”\u003c/p>\n\u003cp>Dr. George Savage, chief medical officer for Proteus Digital Health, said his company is adamant about patients controlling their own data: “The patient owns their own data and decides who to share it with beyond their medical team. We don’t sell data and never will.”\u003c/p>\n\u003cp>Nine health systems across the U.S. have used the technology so far for conditions like diabetes, heart failure, and hypertension. Proteus Digital Health is also testing the digital pills with oncology and HIV drugs, and on patients using opioids for pain relief. Dr. Savage said adherence rates with the digital pills have been shown to be high.\u003c/p>\n\u003cp>‘When we provide feedback to the patient, adherence is about 87 percent,” Savage said. “When we add in someone following up with a patient, like a doctor, adherence is 96 percent. Near perfection.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Editor’s note: This post has been updated to clarify that the signal is only sent once when the pill reaches the stomach acid and that the related patch is worn on the torso.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Doctors \u003ca href=\"http://annals.org/aim/fullarticle/1357338/interventions-improve-adherence-self-administered-medications-chronic-diseases-united-states\" target=\"_blank\" rel=\"noopener\">estimate\u003c/a> about half of all medications for chronic conditions are not taken as prescribed, resulting in $100 billion to $289 billion in preventable health care costs and more than 100,000 deaths every year in the U.S. \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/22510235\" target=\"_blank\" rel=\"noopener\">A majority of adults\u003c/a> say they struggle with remembering to take their prescriptions.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Now, as with many other seemingly intractable challenges, technology has been enlisted to help. A new clinical study is underway at 16 health centers around the country to see if a pill with an ingestible sensor can improve medication adherence rates for \u003ca href=\"https://www.cdc.gov/hepatitis/hcv/cfaq.htm\" target=\"_blank\" rel=\"noopener\">Hepatitis C\u003c/a> drugs.\u003c/p>\n\u003cp>\u003ca href=\"https://www.proteus.com/\" target=\"_blank\" rel=\"noopener\">Proteus Digital Health\u003c/a>, the inventor of this so-called digital pill, is part of an emerging field of medicine and one of a handful of companies designing these high-tech pills.\u003c/p>\n\u003cp>While medication adherence is an issue for everyone, it can be especially difficult for patients with mental health and substance abuse conditions to rigorously follow their prescriptions.\u003c/p>\n\u003cp>And the latter is a significant factor in the spread of Hepatitis C. Intravenous drug use, particularly opioids, has fueled a \u003ca href=\"https://www.cdc.gov/nchhstp/newsroom/2017/Hepatitis-Surveillance-Press-Release.html\">spike in\u003c/a> Hepatitis C infections in recent years.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>On Wednesday’s PBS NewsHour, I explore how a new wave of Hepatitis C drugs, known as direct-acting antivirals, can cure the disease 95 percent of time when used as prescribed. But insurance providers have limited their payouts and the access for direct-acting antivirals, due to the drugs’ expensive price tag.\u003c/p>\n\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/3DN2gI87R3Q?feature=oembed'\n title='//www.youtube.com/embed/3DN2gI87R3Q?feature=oembed'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003c/p>\n\u003cp>David Wyles, head of infectious diseases at \u003ca href=\"https://www.denverhealth.org/\" target=\"_blank\" rel=\"noopener\">Denver Health\u003c/a> where the digital pill is being trialed, said the information gathered from the study may help \u003ca href=\"https://www.chlpi.org/chlpi-nvhr-launch-interactive-report-card-project-grading-52-medicaid-programs-discriminatory-hepatitis-c-treatment-restrictions/\" target=\"_blank\" rel=\"noopener\">convince insurers to expand access \u003c/a>to the new but more expensive Hepatitis C drugs. \u003ca href=\"https://www.denverhealth.org/\" target=\"_blank\" rel=\"noopener\">Denver Health\u003c/a> has 18 voluntary patients enrolled in the trial and is one of the largest study sites. The Colorado Department of Health estimates about \u003ca href=\"https://drive.google.com/file/d/0B0tmPQ67k3NVQjJXSFRGajdWUEE/view\" target=\"_blank\" rel=\"noopener\">70,000\u003c/a> people in the state carry Hepatitis C, and Denver Health cares for many of them.\u003c/p>\n\u003cp>“Insurance payers have imposed restrictions, not necessarily based on medical or scientific facts,” Wyles said. “This is a population that some will look at and say, ‘They won’t take their medications, why would we want to treat them?’ Potentially this study is something to refute that if we can show adherence rates are good.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Proteus’ digital pill consists of the prescription medication with a tiny, FDA-approved ingestible sensor, packed inside a gel capsule. Once swallowed, minerals in the sensor react when they hit the acids in the stomach and create a tiny electronic signal. A band-aid-like patch, worn on the skin of the torso, captures this signal and relays it to an app on a smartphone or tablet.\u003c/p>\n\u003cp>Patients share the data with their doctors but also control who else has access. Their doctors can then monitor when and how many pills have been taken.\u003c/p>\n\u003cp>“If the patient misses a dose or a couple of doses, you can set up an alert in the program to send you an email. You can contact them and hopefully intervene right away,” David Wyles said. “Without the technology, you may not know anything until your next visit, which could be a month later, and then it’s too late to do anything.”\u003c/p>\n\u003cp>Yet the new technology raises questions about patient privacy. \u003ca href=\"https://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2017.pp12a2\" target=\"_blank\" rel=\"noopener\">Some doctors in the mental health community\u003c/a> expressed concerns last year about patient trust and misuse of data when the \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm\" target=\"_blank\" rel=\"noopener\">FDA approved\u003c/a> Proteus Digital Health’s sensors to be embedded in the antipsychotic drug \u003ca href=\"https://www.proteus.com/press-releases/otsuka-and-proteus-announce-the-first-us-fda-approval-of-a-digital-medicine-system-abilify-mycite/\" target=\"_blank\" rel=\"noopener\">Abilify.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/a>\u003c/p>\n\u003cp>“In an era in which even the National Security Agency gets hacked, there are obvious concerns about patient privacy with a technology that communicates personal medical information,” Paul Appelbaum, director of the division of Law, Ethics, and Psychiatry at Columbia University, \u003ca href=\"https://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2017.pp12a2\" target=\"_blank\" rel=\"noopener\">told Psychiatric News\u003c/a>. “The potential for this technology to be misused by judges and probation officers who may require offenders to use pills with sensors, and then respond punitively to the most trivial failure to adhere to the treatment regimen, is real.”\u003c/p>\n\u003cp>Dr. George Savage, chief medical officer for Proteus Digital Health, said his company is adamant about patients controlling their own data: “The patient owns their own data and decides who to share it with beyond their medical team. We don’t sell data and never will.”\u003c/p>\n\u003cp>Nine health systems across the U.S. have used the technology so far for conditions like diabetes, heart failure, and hypertension. Proteus Digital Health is also testing the digital pills with oncology and HIV drugs, and on patients using opioids for pain relief. Dr. Savage said adherence rates with the digital pills have been shown to be high.\u003c/p>\n\u003cp>‘When we provide feedback to the patient, adherence is about 87 percent,” Savage said. “When we add in someone following up with a patient, like a doctor, adherence is 96 percent. Near perfection.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Editor’s note: This post has been updated to clarify that the signal is only sent once when the pill reaches the stomach acid and that the related patch is worn on the torso.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"soldout": {
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