FDA Investigating How a Potential Carcinogen Found its Way in Heart Drugs
Abnormal Heartbeat? There's an App for That -- And it Could Be 97 Percent Accurate
Are There Risks From Secondhand Marijuana Smoke? Early Science Says Yes
Your Heart in 3D: Surgeons Can Now Practice on a Simulation
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NDMA, which is considered a possible carcinogen by the Environmental Protection Agency, is an organic chemical once used to make rocket fuel and is an unintended by-product of certain chemical reactions.\u003c/p>\n\u003cp class=\"danger-zone\">The finding caused widespread concern and product recalls by several manufacturers as the FDA and regulators from other countries scrambled to determine how the substance found its way into the medicine. The FDA issued a statement saying it believes the problem occurred “through a specific sequence of steps in the manufacturing process,” but the agency is “still not 100 percent sure this is the root cause.”\u003c/p>\n\u003cp>Numerous companies either manufacture or repackage these drugs, which are regularly used to combat high blood pressure and heart failure. As of now, they noted that more than half of all valsartan medicines that are on the market are being recalled.[contextly_sidebar id=\"sIS8BD5zF1nXJWO6PonqzMGSpfqDl0Bs\"]\u003c/p>\n\u003cp>The episode underscores ongoing concerns about the quality of the pharmaceutical supply chain emanating from countries such as China and India that are large ingredients manufacturers, but have a history of inconsistent — some say inadequate — government oversight. A 2016 \u003ca href=\"https://www.statnews.com/pharmalot/2017/01/17/fda-drug-safety-inspections/\" target=\"_blank\" rel=\"noopener\">report\u003c/a> by the U.S. Government Accountability Office found the FDA was struggling to assess its overseas inspection efforts.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Mindful of such concerns, the FDA statement took pains to explain the steps taken by the agency to respond to the NDMA problem. These included \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm\" target=\"_blank\" rel=\"noopener\">alerts\u003c/a> issued to patients and health care providers on the agency \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm\" target=\"_blank\" rel=\"noopener\">web site\u003c/a>; analysis by FDA staff at its St. Louis laboratory; communicating with regulators in Canada, Europe, and Japan; and inspecting Zhejiang Huahai facilities in China.\u003c/p>\n\u003cp>At the same time, the FDA reiterated an earlier alert that attempted to put the risk into context.\u003c/p>\n\u003cp>The agency estimated that if 8,000 people took the highest valsartan dose of 320 mg in a pill containing NDMA daily for four years — which is the amount of time the FDA believes the affected pill had been on the U.S. market — there may be one additional case of cancer over their lifetimes beyond the average cancer rate among Americans.[contextly_sidebar id=\"enNQmG13yKJp90szHVrMT1LH85pc4uKY\"]\u003c/p>\n\u003cp>“This estimate represented the highest possible level of NDMA exposure. It was a measure of the risk under the most extreme circumstances. Most patients who were exposed to the impurity through the use of valsartan received less exposure than this worst-case scenario,” Gottlieb and Woodcock wrote in a bid to reassure the public about the likelihood of the risk of developing cancer.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Meanwhile, they added that they plan to use what they learn from this scare to “inform assessments of product applications being submitted and currently reviewed by the FDA. We will disseminate that information to manufacturers of all drugs and to the scientific community and re-evaluate our existing guidance to manufacturers.”\u003c/p>\n\n","blocks":[],"excerpt":"The episode underscores ongoing concerns about the quality of the pharmaceutical supply chain emanating from countries such as China and India.","status":"publish","parent":0,"modified":1535655075,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":10,"wordCount":556},"headData":{"title":"FDA Investigating How a Potential Carcinogen Found its Way in Heart Drugs | KQED","description":"The episode underscores ongoing concerns about the quality of the pharmaceutical supply chain emanating from countries such as China and India.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Investigating How a Potential Carcinogen Found its Way in Heart Drugs","datePublished":"2018-08-30T18:51:15.000Z","dateModified":"2018-08-30T18:51:15.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"444164 https://ww2.kqed.org/futureofyou/?p=444164","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/08/30/fda-investigating-how-a-potential-carcinogen-found-its-way-in-heart-drugs/","disqusTitle":"FDA Investigating How a Potential Carcinogen Found its Way in Heart Drugs","source":"Health","nprByline":"Ed Silverman\u003cbr />STAT","path":"/futureofyou/444164/fda-investigating-how-a-potential-carcinogen-found-its-way-in-heart-drugs","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>After learning an ingredient used to make a widely prescribed heart drug contained a substance linked to cancer, the Food and Drug Administration is now testing all drugs in that class for traces of the toxic material.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">The probe into angiotensin II receptor blockers is part of a widening investigation into a mystery over an impurity known as NDMA, which was found last month in generic valsartan blood pressure pills made by Zhejiang Huahai Pharmaceutical. NDMA, which is considered a possible carcinogen by the Environmental Protection Agency, is an organic chemical once used to make rocket fuel and is an unintended by-product of certain chemical reactions.\u003c/p>\n\u003cp class=\"danger-zone\">The finding caused widespread concern and product recalls by several manufacturers as the FDA and regulators from other countries scrambled to determine how the substance found its way into the medicine. The FDA issued a statement saying it believes the problem occurred “through a specific sequence of steps in the manufacturing process,” but the agency is “still not 100 percent sure this is the root cause.”\u003c/p>\n\u003cp>Numerous companies either manufacture or repackage these drugs, which are regularly used to combat high blood pressure and heart failure. As of now, they noted that more than half of all valsartan medicines that are on the market are being recalled.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The episode underscores ongoing concerns about the quality of the pharmaceutical supply chain emanating from countries such as China and India that are large ingredients manufacturers, but have a history of inconsistent — some say inadequate — government oversight. A 2016 \u003ca href=\"https://www.statnews.com/pharmalot/2017/01/17/fda-drug-safety-inspections/\" target=\"_blank\" rel=\"noopener\">report\u003c/a> by the U.S. Government Accountability Office found the FDA was struggling to assess its overseas inspection efforts.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Mindful of such concerns, the FDA statement took pains to explain the steps taken by the agency to respond to the NDMA problem. These included \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm\" target=\"_blank\" rel=\"noopener\">alerts\u003c/a> issued to patients and health care providers on the agency \u003ca href=\"https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm\" target=\"_blank\" rel=\"noopener\">web site\u003c/a>; analysis by FDA staff at its St. Louis laboratory; communicating with regulators in Canada, Europe, and Japan; and inspecting Zhejiang Huahai facilities in China.\u003c/p>\n\u003cp>At the same time, the FDA reiterated an earlier alert that attempted to put the risk into context.\u003c/p>\n\u003cp>The agency estimated that if 8,000 people took the highest valsartan dose of 320 mg in a pill containing NDMA daily for four years — which is the amount of time the FDA believes the affected pill had been on the U.S. market — there may be one additional case of cancer over their lifetimes beyond the average cancer rate among Americans.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>“This estimate represented the highest possible level of NDMA exposure. It was a measure of the risk under the most extreme circumstances. Most patients who were exposed to the impurity through the use of valsartan received less exposure than this worst-case scenario,” Gottlieb and Woodcock wrote in a bid to reassure the public about the likelihood of the risk of developing cancer.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Meanwhile, they added that they plan to use what they learn from this scare to “inform assessments of product applications being submitted and currently reviewed by the FDA. We will disseminate that information to manufacturers of all drugs and to the scientific community and re-evaluate our existing guidance to manufacturers.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/444164/fda-investigating-how-a-potential-carcinogen-found-its-way-in-heart-drugs","authors":["byline_futureofyou_444164"],"series":["futureofyou_350"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_103","futureofyou_952","futureofyou_38","futureofyou_61","futureofyou_279"],"featImg":"futureofyou_444163","label":"source_futureofyou_444164"},"futureofyou_440380":{"type":"posts","id":"futureofyou_440380","meta":{"index":"posts_1591205157","site":"futureofyou","id":"440380","score":null,"sort":[1521763255000]},"guestAuthors":[],"slug":"abnormal-heartbeat-theres-an-app-for-that-and-it-could-be-97-percent-accurate","title":"Abnormal Heartbeat? There's an App for That -- And it Could Be 97 Percent Accurate","publishDate":1521763255,"format":"standard","headTitle":"Heart health | Future of You | KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>A mobile app was able to detect irregular heart rhythms with 97 percent accuracy, a finding by UC San Francisco researchers that could lead to life-saving \u003ca href=\"https://www.kqed.org/futureofyou/266349/how-reliable-are-smartphones-and-wearables-for-monitoring-your-heart\" target=\"_blank\" rel=\"noopener\">preventative screenings.\u003c/a>\u003c/p>\n\u003cp>One in four adults over the age of 40 is at risk for a heart condition known as \u003ca href=\"https://www.mayoclinic.org/diseases-conditions/atrial-fibrillation/symptoms-causes/syc-20350624\" target=\"_blank\" rel=\"noopener\">atrial fibrillation\u003c/a> (AF). It's one of the leading causes of stroke and often goes undetected until it's too late.\u003c/p>\n\u003cp>The study, which relied on an app specifically designed for the Apple Watch, is reportedly the first to use a smartwatch to detect abnormal heart rhythms.\u003c/p>\n\u003cp>“By identifying candidates for appropriate anti-coagulation treatment, we might ultimately leverage common wearable devices to reduce ... complications, even death,\" said Gregory Marcus, director of clinical research in the UCSF Division of Cardiology and lead author of the study.\u003c/p>\n\u003cp>AF occurs when electrical impulses in the the upper chambers of the heart become erratic, causing the atrium's walls to quiver as blood passes through, potentially triggering blood clots.[contextly_sidebar id=\"sQ9MJSaMtUHbSJHSKfj37aKsbqwOOxmZ\"]\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Researchers say the findings, published in \u003ca href=\"https://jamanetwork.com/journals/jamacardiology/article-abstract/2675364?redirect=true\" target=\"_blank\" rel=\"noopener\">JAMA Cardiology\u003c/a>, could lead to the development of more effective screenings. And with nearly 6 million people in the U.S. estimated to develop AF by 2050, the app could prevent large numbers of strokes and death.\u003c/p>\n\u003cp>With a 97 percent accuracy rate, the app performed better than a competing \u003ca href=\"http://www.abstractsonline.com/pp8/#!/4496/presentation/41378\" target=\"_blank\" rel=\"noopener\">FDA-approved product sold as Kardia Band.\u003c/a>\u003c/p>\n\u003cp>The UCSF-tested app, designed by Cardiogram, relies on deep neural networks, a type of sophisticated machine-learning algorithm that provides a continuous stream of data. More than 139 million measurements of heart rates and step counts were collected from 9,750 participants. [contextly_sidebar id=\"C27bFTVwLpXMdavOJy6PlXm3e5jXCR7Q\"]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Researchers cited certain limitations to their study, including a number of participants who failed to link their Cardiogram accounts. In addition, researchers focused on those with known AF and did not look into the app's ability to identify undiagnosed conditions.\u003c/p>\n\n","blocks":[],"excerpt":"With one in four adults over 40 at risk for the heart condition, the app could be a life-saving tool.","status":"publish","parent":0,"modified":1521763324,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":11,"wordCount":327},"headData":{"title":"Abnormal Heartbeat? There's an App for That -- And it Could Be 97 Percent Accurate | KQED","description":"With one in four adults over 40 at risk for the heart condition, the app could be a life-saving tool.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Abnormal Heartbeat? There's an App for That -- And it Could Be 97 Percent Accurate","datePublished":"2018-03-23T00:00:55.000Z","dateModified":"2018-03-23T00:02:04.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"440380 https://ww2.kqed.org/futureofyou/?p=440380","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/03/22/abnormal-heartbeat-theres-an-app-for-that-and-it-could-be-97-percent-accurate/","disqusTitle":"Abnormal Heartbeat? There's an App for That -- And it Could Be 97 Percent Accurate","source":"DIY Health","path":"/futureofyou/440380/abnormal-heartbeat-theres-an-app-for-that-and-it-could-be-97-percent-accurate","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>A mobile app was able to detect irregular heart rhythms with 97 percent accuracy, a finding by UC San Francisco researchers that could lead to life-saving \u003ca href=\"https://www.kqed.org/futureofyou/266349/how-reliable-are-smartphones-and-wearables-for-monitoring-your-heart\" target=\"_blank\" rel=\"noopener\">preventative screenings.\u003c/a>\u003c/p>\n\u003cp>One in four adults over the age of 40 is at risk for a heart condition known as \u003ca href=\"https://www.mayoclinic.org/diseases-conditions/atrial-fibrillation/symptoms-causes/syc-20350624\" target=\"_blank\" rel=\"noopener\">atrial fibrillation\u003c/a> (AF). It's one of the leading causes of stroke and often goes undetected until it's too late.\u003c/p>\n\u003cp>The study, which relied on an app specifically designed for the Apple Watch, is reportedly the first to use a smartwatch to detect abnormal heart rhythms.\u003c/p>\n\u003cp>“By identifying candidates for appropriate anti-coagulation treatment, we might ultimately leverage common wearable devices to reduce ... complications, even death,\" said Gregory Marcus, director of clinical research in the UCSF Division of Cardiology and lead author of the study.\u003c/p>\n\u003cp>AF occurs when electrical impulses in the the upper chambers of the heart become erratic, causing the atrium's walls to quiver as blood passes through, potentially triggering blood clots.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Researchers say the findings, published in \u003ca href=\"https://jamanetwork.com/journals/jamacardiology/article-abstract/2675364?redirect=true\" target=\"_blank\" rel=\"noopener\">JAMA Cardiology\u003c/a>, could lead to the development of more effective screenings. And with nearly 6 million people in the U.S. estimated to develop AF by 2050, the app could prevent large numbers of strokes and death.\u003c/p>\n\u003cp>With a 97 percent accuracy rate, the app performed better than a competing \u003ca href=\"http://www.abstractsonline.com/pp8/#!/4496/presentation/41378\" target=\"_blank\" rel=\"noopener\">FDA-approved product sold as Kardia Band.\u003c/a>\u003c/p>\n\u003cp>The UCSF-tested app, designed by Cardiogram, relies on deep neural networks, a type of sophisticated machine-learning algorithm that provides a continuous stream of data. More than 139 million measurements of heart rates and step counts were collected from 9,750 participants. \u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Researchers cited certain limitations to their study, including a number of participants who failed to link their Cardiogram accounts. In addition, researchers focused on those with known AF and did not look into the app's ability to identify undiagnosed conditions.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/440380/abnormal-heartbeat-theres-an-app-for-that-and-it-could-be-97-percent-accurate","authors":["11428"],"programs":["futureofyou_54"],"series":["futureofyou_350"],"categories":["futureofyou_1060","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1023","futureofyou_1070","futureofyou_742","futureofyou_281","futureofyou_1451","futureofyou_35"],"collections":["futureofyou_1093"],"featImg":"futureofyou_440381","label":"source_futureofyou_440380"},"futureofyou_440287":{"type":"posts","id":"futureofyou_440287","meta":{"index":"posts_1591205157","site":"futureofyou","id":"440287","score":null,"sort":[1521484122000]},"guestAuthors":[],"slug":"are-there-risks-from-secondhand-marijuana-smoke-early-science-says-yes","title":"Are There Risks From Secondhand Marijuana Smoke? Early Science Says Yes","publishDate":1521484122,"format":"standard","headTitle":"Heart health | KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>The inspiration arrived in a haze at a Paul McCartney concert a few years ago in San Francisco.\u003c/p>\n\u003cp>\"People in front of me started lighting up and then other people started lighting up,\" says \u003ca href=\"http://profiles.ucsf.edu/matthew.springer#toc-id3\" target=\"_blank\" rel=\"noopener\">Matthew Springer\u003c/a>, a biologist and professor in the division of cardiology at the University of California, San Francisco. \"And for a few naive split seconds I was thinking to myself, 'Hey, they can't smoke in AT&T Park! I'm sure that's not allowed.' And then I realized that it was all marijuana.\"[contextly_sidebar id=\"scVZwwMNYQudoK8prX8E6gEPhMsaZ644\"]\u003c/p>\n\u003cp>Recreational pot was not legal yet in the state, but that stopped no one. \"Paul McCartney actually stopped between numbers and sniffed the air and said, 'There's something in the air — must be San Francisco!' \" Springer recalls.\u003c/p>\n\u003cp>As the visible cloud of pot smoke took shape, so did Springer's idea to study the effects of secondhand marijuana smoke.\u003c/p>\n\u003cp>He started thinking: San Franciscans would \u003cem>never \u003c/em>tolerate those levels of cigarette smoke in a public place anymore. So why were they OK with smoke from burning pot? Did people just assume that cannabis smoke isn't harmful the way tobacco smoke is?\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Springer was already researching the \u003ca href=\"https://www.cdc.gov/tobacco/data_statistics/fact_sheets/secondhand_smoke/health_effects/index.htm\" target=\"_blank\" rel=\"noopener\">health effects of secondhand tobacco smoke\u003c/a> on rats at \u003ca href=\"http://cardiolab.ucsf.edu/molcardiolab/lab.html\" target=\"_blank\" rel=\"noopener\">his lab\u003c/a> at UCSF. He decided to run the same tests using joints.[contextly_sidebar id=\"IPYfhnbHrZbMpqTxNYHTDnd84sz97o9x\"]\u003c/p>\n\u003cp>\"By the time I left the concert, I was resolved to at least try to make this happen,\" he says.\u003c/p>\n\u003cp>He knew it would be difficult. Marijuana is still an \u003ca href=\"https://www.dea.gov/druginfo/drug_data_sheets/Marijuana.pdf\" target=\"_blank\" rel=\"noopener\">illegal drug\u003c/a> under federal law, and Springer's research uses federal funds; so he has to purchase \u003ca href=\"https://www.ncbi.nlm.nih.gov/books/NBK425757/\" target=\"_blank\" rel=\"noopener\">specially approved\u003c/a> government cannabis for study. He also can't test it on humans; hence, the rats.\u003c/p>\n\u003cp>In the lab, Springer puts a cigarette or a joint in a plexiglass box. Then he lights it, and lets the chamber fill with smoke, where an anesthetized rat is exposed to the smoke.\u003c/p>\n\u003cp>So far, Springer and his colleagues have published \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27464788\" target=\"_blank\" rel=\"noopener\">research\u003c/a> demonstrating that secondhand smoke makes it harder for the rats' arteries to expand and allow a healthy flow of blood.[contextly_sidebar id=\"by0xGD9nRAvOmUvjFCkfel0dvDsXCIrW\"]\u003c/p>\n\u003cp>With tobacco products, this effect lasts about 30 minutes, and then the arteries recover their normal function. But if it happens over and over — as when a person is smoking cigarette after cigarette, for example — the arterial walls can become permanently damaged, and that damage can cause blood clots, heart attack or stroke.\u003c/p>\n\u003cp>Springer demonstrated that, at least in rats, the same physiological effect occurs after inhaling secondhand smoke from marijuana. And, the arteries take 90 minutes to recover compared to the 30 minutes with cigarette smoke.\u003c/p>\n\u003cp>Springer's discovery about the effect on blood vessels describes just one harmful impact for nonsmokers who are exposed to marijuana. Statewide sampling surveys of cannabis products sold in marijuana dispensaries have shown that cannabis products may contain \u003ca href=\"http://www.sacbee.com/news/local/health-and-medicine/article131391629.html\" target=\"_blank\" rel=\"noopener\">dangerous bacteria or mold\u003c/a>, or residues from \u003ca href=\"http://www.montereyherald.com/article/NF/20170926/NEWS/170929857\" target=\"_blank\" rel=\"noopener\">pesticides and solvents\u003c/a>.\u003c/p>\n\u003cp>California law requires testing for these contaminants, and those regulations are being initiated in \u003ca href=\"http://bcc.ca.gov/about_us/documents/17-261_required_testing_chart.pdf\" target=\"_blank\" rel=\"noopener\">three phases\u003c/a> over the course of 2018. Because much of the marijuana being sold now was harvested in 2017, consumers will have to wait until early 2019 before they can purchase products that have been fully tested according to state standards.\u003c/p>\n\u003cp>\"People think cannabis is fine because it's 'natural,' \" Springer says. \"I hear this a lot. I don't know what it means.\" He concedes that tightly regulated marijuana, which has been fully tested, doesn't have as many chemical additives as cigarettes.\u003c/p>\n\u003cp>But even if the cannabis tests clean, Springer says, smoke itself is bad for the lungs, heart and blood vessels. Other researchers are exploring the possible relationship between marijuana smoke and long-term cancer risk.[contextly_sidebar id=\"dllcUYeImG1KAcPQ7nMg7I05Na6rlHp2\"]\u003c/p>\n\u003cp>Certainly, living with a smoker is worse for your health than just going to a smoky concert hall. But, Springer says, the less you inhale any kind of smoke, the better.\u003c/p>\n\u003cp>\"People should think of this not as an anti-THC conclusion,\" he says, referencing \u003ca href=\"https://www.drugabuse.gov/publications/research-reports/marijuana/how-does-marijuana-produce-its-effects\" target=\"_blank\" rel=\"noopener\">the active ingredient in marijuana\u003c/a>, \"but an anti-smoke conclusion.\"\u003c/p>\n\u003cp>So is the solution simply to avoid smoke from combustion? In other words, is it safer to eat cannabis-infused products, or use \"smokeless\" e-cigarettes or vaping devices?\u003c/p>\n\u003cp>Springer still urges caution on that score because vaping, for example, can have its own health effects. Vaping devices don't produce smoke from combustion, but they do release a cloud of aerosolized chemicals. Springer is studying the health effects of those chemicals, too.\u003c/p>\n\u003cp>All this research takes time. Meanwhile, Springer worries that people might come to the wrong conclusion — that the absence of research means the secondhand smoke is OK.\u003c/p>\n\u003cp>\"We in the public health community have been telling them for decades to avoid inhaling secondhand smoke from tobacco,\" Springer says. \"We have not been telling them to avoid inhaling secondhand smoke from marijuana, and that's not because it's not bad for you — it's because we just haven't known. The experiments haven't been done.\"\u003c/p>\n\u003cp>Antismoking campaigners say we can't afford to wait until the research is complete. Recreational pot is already \u003ca href=\"http://www.governing.com/gov-data/state-marijuana-laws-map-medical-recreational.html\" target=\"_blank\" rel=\"noopener\">a reality\u003c/a>.\u003c/p>\n\u003cp>\u003ca href=\"https://nonsmokersrights.org/cynthia-hallett\" target=\"_blank\" rel=\"noopener\">Cynthia Hallett\u003c/a> is the president of Americans for Nonsmokers' Rights, based in Berkeley, Calif. The organization was established in 1976, before there was a lot known about the health effects of secondhand smoke from tobacco.\u003c/p>\n\u003cp>Now that cannabis is becoming more common across the country — more than 20 cities or states have legalized it in some form — her organization is taking on the issue of secondhand marijuana smoke, too.\u003c/p>\n\u003cp>Hallett says some of the arguments being made in support of cannabis remind her of the arguments made on behalf of tobacco decades ago.\u003c/p>\n\u003cp>\"I'm seeing a parallel between this argument that, 'Gee, we just don't have a lot of science and so, therefore, let's wait and see,' \" Hallett says. \"The tobacco companies used to say the same thing about tobacco cigarettes.\"\u003c/p>\n\u003cp>In California, smoking cannabis is prohibited anywhere tobacco smoking is prohibited — including schools, airplanes and most workplaces. Hallett is worried that the legalization of pot could be used to erode those rules.\u003c/p>\n\u003cp>It starts with the premise of decriminalization, she says, and then, over time, there's \"a chipping away at strong policies.\"\u003c/p>\n\u003cp>Some cannabis advocates want to see pot regulated like alcohol — cities would issue permits for specialized smoking lounges, similar to wine bars.\u003c/p>\n\u003cp>But Hallett points out that smoke drifts, and it affects workers in a way that alcohol doesn't.\u003c/p>\n\u003cp>\"The difference is, if I were to spill my beer on you in a bar, it wouldn't affect your long-term health,\" she says. \"If I choose to smoke, it can affect the health of the person near me.\"\u003c/p>\n\u003cp>Pot is more like tobacco in that respect, and Hallett believes it should be regulated that way.\u003c/p>\n\u003cp>She says this era of California culture brings to mind a similar period in the 1970s and '80s, when Americans started demanding more regulations for secondhand smoke, and a new etiquette around smoking took form.\u003c/p>\n\u003cp>When it comes to marijuana, Hallett says, \"it is \u003cem>still\u003c/em> polite for you to say: 'Would you mind not smoking around me?' \"\u003c/p>\n\u003cp>At \u003ca href=\"http://www.magnoliawellness.org/menu\" target=\"_blank\" rel=\"noopener\">Magnolia\u003c/a>, a cannabis dispensary in Oakland, Calif., pot smokers talk about what responsibilities — if any — they should have when it comes to nearby nonsmokers.[contextly_sidebar id=\"CIXiXPyRL9W3vNu1EFy9gUkuRjmKUj8z\"]\u003c/p>\n\u003cp>\"This is the first time that I have heard secondhand smoke in reference to cannabis,\" admits Lee Crow, a patient-services clerk at Magnolia. \"I've tried to be courteous — just common courtesy, like with anything.\"\u003c/p>\n\u003cp>The dispensary's director of clinical services, \u003ca href=\"http://www.magnoliawellness.org/news/2016/5/19/meet-barbara-blaser-magnolias-director-of-clinical-wellness\" target=\"_blank\" rel=\"noopener\">Barbara Blaser\u003c/a>, admits she thinks a lot about secondhand smoke from cigarettes, but not pot.\u003c/p>\n\u003cp>\"Both of my parents died of lung cancer!\" she says. \"I will stop a stranger and say, 'You shouldn't be smoking. My dad died of that!' \"\u003c/p>\n\u003cp>California's \u003ca href=\"https://ballotpedia.org/California_Proposition_64,_Marijuana_Legalization_(2016)\" target=\"_blank\" rel=\"noopener\">Proposition 64\u003c/a>, approved by state voters in 2016, requires that some of the state tax revenue from the sale of marijuana to be distributed to cannabis researchers. In addition, the state's Occupational Safety and Health Standards Board is examining workplace hazards that are specific to the cannabis industry.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story is part of NPR's reporting partnership, local member stations and \u003c/em>\u003ca href=\"http://www.kaiserhealthnews.org\" target=\"_blank\" rel=\"noopener\">\u003cem>Kaiser Health News\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 KALW. To see more, visit \u003ca href=\"http://www.kalw.org/\" target=\"_blank\" rel=\"noopener\">KALW\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Are+There+Risks+From+Secondhand+Marijuana+Smoke%3F+Early+Science+Says+Yes&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"Researchers warn that secondhand smoke from pot poses risks to the heart, lungs and arteries.","status":"publish","parent":0,"modified":1521484122,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":43,"wordCount":1406},"headData":{"title":"Are There Risks From Secondhand Marijuana Smoke? Early Science Says Yes | KQED","description":"Researchers warn that secondhand smoke from pot poses risks to the heart, lungs and arteries.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Are There Risks From Secondhand Marijuana Smoke? Early Science Says Yes","datePublished":"2018-03-19T18:28:42.000Z","dateModified":"2018-03-19T18:28:42.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"440287 https://ww2.kqed.org/futureofyou/?p=440287","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/03/19/are-there-risks-from-secondhand-marijuana-smoke-early-science-says-yes/","disqusTitle":"Are There Risks From Secondhand Marijuana Smoke? Early Science Says Yes","source":"Health","nprByline":"Marissa Ortega-Welch\u003cbr />NPR Shots","nprImageAgency":"Maren Caruso/Getty Images ","nprStoryId":"592873218","nprApiLink":"http://api.npr.org/query?id=592873218&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2018/03/19/592873218/are-there-risks-from-secondhand-marijuana-smoke-early-science-says-yes?ft=nprml&f=592873218","nprRetrievedStory":"1","nprPubDate":"Mon, 19 Mar 2018 10:20:00 -0400","nprStoryDate":"Mon, 19 Mar 2018 05:00:00 -0400","nprLastModifiedDate":"Mon, 19 Mar 2018 10:20:44 -0400","nprAudio":"https://ondemand.npr.org/anon.npr-mp3/npr/me/2018/03/20180319_me_are_there_risks_from_secondhand_marijuana_smoke_early_science_says_yes.mp3?orgId=2&topicId=1128&d=216&p=3&story=592873218&ft=nprml&f=592873218","nprAudioM3u":"http://api.npr.org/m3u/1594839371-38825d.m3u?orgId=2&topicId=1128&d=216&p=3&story=592873218&ft=nprml&f=592873218","path":"/futureofyou/440287/are-there-risks-from-secondhand-marijuana-smoke-early-science-says-yes","audioUrl":"https://ondemand.npr.org/anon.npr-mp3/npr/me/2018/03/20180319_me_are_there_risks_from_secondhand_marijuana_smoke_early_science_says_yes.mp3?orgId=2&topicId=1128&d=216&p=3&story=592873218&ft=nprml&f=592873218","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The inspiration arrived in a haze at a Paul McCartney concert a few years ago in San Francisco.\u003c/p>\n\u003cp>\"People in front of me started lighting up and then other people started lighting up,\" says \u003ca href=\"http://profiles.ucsf.edu/matthew.springer#toc-id3\" target=\"_blank\" rel=\"noopener\">Matthew Springer\u003c/a>, a biologist and professor in the division of cardiology at the University of California, San Francisco. \"And for a few naive split seconds I was thinking to myself, 'Hey, they can't smoke in AT&T Park! I'm sure that's not allowed.' And then I realized that it was all marijuana.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Recreational pot was not legal yet in the state, but that stopped no one. \"Paul McCartney actually stopped between numbers and sniffed the air and said, 'There's something in the air — must be San Francisco!' \" Springer recalls.\u003c/p>\n\u003cp>As the visible cloud of pot smoke took shape, so did Springer's idea to study the effects of secondhand marijuana smoke.\u003c/p>\n\u003cp>He started thinking: San Franciscans would \u003cem>never \u003c/em>tolerate those levels of cigarette smoke in a public place anymore. So why were they OK with smoke from burning pot? Did people just assume that cannabis smoke isn't harmful the way tobacco smoke is?\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Springer was already researching the \u003ca href=\"https://www.cdc.gov/tobacco/data_statistics/fact_sheets/secondhand_smoke/health_effects/index.htm\" target=\"_blank\" rel=\"noopener\">health effects of secondhand tobacco smoke\u003c/a> on rats at \u003ca href=\"http://cardiolab.ucsf.edu/molcardiolab/lab.html\" target=\"_blank\" rel=\"noopener\">his lab\u003c/a> at UCSF. He decided to run the same tests using joints.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"By the time I left the concert, I was resolved to at least try to make this happen,\" he says.\u003c/p>\n\u003cp>He knew it would be difficult. Marijuana is still an \u003ca href=\"https://www.dea.gov/druginfo/drug_data_sheets/Marijuana.pdf\" target=\"_blank\" rel=\"noopener\">illegal drug\u003c/a> under federal law, and Springer's research uses federal funds; so he has to purchase \u003ca href=\"https://www.ncbi.nlm.nih.gov/books/NBK425757/\" target=\"_blank\" rel=\"noopener\">specially approved\u003c/a> government cannabis for study. He also can't test it on humans; hence, the rats.\u003c/p>\n\u003cp>In the lab, Springer puts a cigarette or a joint in a plexiglass box. Then he lights it, and lets the chamber fill with smoke, where an anesthetized rat is exposed to the smoke.\u003c/p>\n\u003cp>So far, Springer and his colleagues have published \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27464788\" target=\"_blank\" rel=\"noopener\">research\u003c/a> demonstrating that secondhand smoke makes it harder for the rats' arteries to expand and allow a healthy flow of blood.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>With tobacco products, this effect lasts about 30 minutes, and then the arteries recover their normal function. But if it happens over and over — as when a person is smoking cigarette after cigarette, for example — the arterial walls can become permanently damaged, and that damage can cause blood clots, heart attack or stroke.\u003c/p>\n\u003cp>Springer demonstrated that, at least in rats, the same physiological effect occurs after inhaling secondhand smoke from marijuana. And, the arteries take 90 minutes to recover compared to the 30 minutes with cigarette smoke.\u003c/p>\n\u003cp>Springer's discovery about the effect on blood vessels describes just one harmful impact for nonsmokers who are exposed to marijuana. Statewide sampling surveys of cannabis products sold in marijuana dispensaries have shown that cannabis products may contain \u003ca href=\"http://www.sacbee.com/news/local/health-and-medicine/article131391629.html\" target=\"_blank\" rel=\"noopener\">dangerous bacteria or mold\u003c/a>, or residues from \u003ca href=\"http://www.montereyherald.com/article/NF/20170926/NEWS/170929857\" target=\"_blank\" rel=\"noopener\">pesticides and solvents\u003c/a>.\u003c/p>\n\u003cp>California law requires testing for these contaminants, and those regulations are being initiated in \u003ca href=\"http://bcc.ca.gov/about_us/documents/17-261_required_testing_chart.pdf\" target=\"_blank\" rel=\"noopener\">three phases\u003c/a> over the course of 2018. Because much of the marijuana being sold now was harvested in 2017, consumers will have to wait until early 2019 before they can purchase products that have been fully tested according to state standards.\u003c/p>\n\u003cp>\"People think cannabis is fine because it's 'natural,' \" Springer says. \"I hear this a lot. I don't know what it means.\" He concedes that tightly regulated marijuana, which has been fully tested, doesn't have as many chemical additives as cigarettes.\u003c/p>\n\u003cp>But even if the cannabis tests clean, Springer says, smoke itself is bad for the lungs, heart and blood vessels. Other researchers are exploring the possible relationship between marijuana smoke and long-term cancer risk.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Certainly, living with a smoker is worse for your health than just going to a smoky concert hall. But, Springer says, the less you inhale any kind of smoke, the better.\u003c/p>\n\u003cp>\"People should think of this not as an anti-THC conclusion,\" he says, referencing \u003ca href=\"https://www.drugabuse.gov/publications/research-reports/marijuana/how-does-marijuana-produce-its-effects\" target=\"_blank\" rel=\"noopener\">the active ingredient in marijuana\u003c/a>, \"but an anti-smoke conclusion.\"\u003c/p>\n\u003cp>So is the solution simply to avoid smoke from combustion? In other words, is it safer to eat cannabis-infused products, or use \"smokeless\" e-cigarettes or vaping devices?\u003c/p>\n\u003cp>Springer still urges caution on that score because vaping, for example, can have its own health effects. Vaping devices don't produce smoke from combustion, but they do release a cloud of aerosolized chemicals. Springer is studying the health effects of those chemicals, too.\u003c/p>\n\u003cp>All this research takes time. Meanwhile, Springer worries that people might come to the wrong conclusion — that the absence of research means the secondhand smoke is OK.\u003c/p>\n\u003cp>\"We in the public health community have been telling them for decades to avoid inhaling secondhand smoke from tobacco,\" Springer says. \"We have not been telling them to avoid inhaling secondhand smoke from marijuana, and that's not because it's not bad for you — it's because we just haven't known. The experiments haven't been done.\"\u003c/p>\n\u003cp>Antismoking campaigners say we can't afford to wait until the research is complete. Recreational pot is already \u003ca href=\"http://www.governing.com/gov-data/state-marijuana-laws-map-medical-recreational.html\" target=\"_blank\" rel=\"noopener\">a reality\u003c/a>.\u003c/p>\n\u003cp>\u003ca href=\"https://nonsmokersrights.org/cynthia-hallett\" target=\"_blank\" rel=\"noopener\">Cynthia Hallett\u003c/a> is the president of Americans for Nonsmokers' Rights, based in Berkeley, Calif. The organization was established in 1976, before there was a lot known about the health effects of secondhand smoke from tobacco.\u003c/p>\n\u003cp>Now that cannabis is becoming more common across the country — more than 20 cities or states have legalized it in some form — her organization is taking on the issue of secondhand marijuana smoke, too.\u003c/p>\n\u003cp>Hallett says some of the arguments being made in support of cannabis remind her of the arguments made on behalf of tobacco decades ago.\u003c/p>\n\u003cp>\"I'm seeing a parallel between this argument that, 'Gee, we just don't have a lot of science and so, therefore, let's wait and see,' \" Hallett says. \"The tobacco companies used to say the same thing about tobacco cigarettes.\"\u003c/p>\n\u003cp>In California, smoking cannabis is prohibited anywhere tobacco smoking is prohibited — including schools, airplanes and most workplaces. Hallett is worried that the legalization of pot could be used to erode those rules.\u003c/p>\n\u003cp>It starts with the premise of decriminalization, she says, and then, over time, there's \"a chipping away at strong policies.\"\u003c/p>\n\u003cp>Some cannabis advocates want to see pot regulated like alcohol — cities would issue permits for specialized smoking lounges, similar to wine bars.\u003c/p>\n\u003cp>But Hallett points out that smoke drifts, and it affects workers in a way that alcohol doesn't.\u003c/p>\n\u003cp>\"The difference is, if I were to spill my beer on you in a bar, it wouldn't affect your long-term health,\" she says. \"If I choose to smoke, it can affect the health of the person near me.\"\u003c/p>\n\u003cp>Pot is more like tobacco in that respect, and Hallett believes it should be regulated that way.\u003c/p>\n\u003cp>She says this era of California culture brings to mind a similar period in the 1970s and '80s, when Americans started demanding more regulations for secondhand smoke, and a new etiquette around smoking took form.\u003c/p>\n\u003cp>When it comes to marijuana, Hallett says, \"it is \u003cem>still\u003c/em> polite for you to say: 'Would you mind not smoking around me?' \"\u003c/p>\n\u003cp>At \u003ca href=\"http://www.magnoliawellness.org/menu\" target=\"_blank\" rel=\"noopener\">Magnolia\u003c/a>, a cannabis dispensary in Oakland, Calif., pot smokers talk about what responsibilities — if any — they should have when it comes to nearby nonsmokers.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"This is the first time that I have heard secondhand smoke in reference to cannabis,\" admits Lee Crow, a patient-services clerk at Magnolia. \"I've tried to be courteous — just common courtesy, like with anything.\"\u003c/p>\n\u003cp>The dispensary's director of clinical services, \u003ca href=\"http://www.magnoliawellness.org/news/2016/5/19/meet-barbara-blaser-magnolias-director-of-clinical-wellness\" target=\"_blank\" rel=\"noopener\">Barbara Blaser\u003c/a>, admits she thinks a lot about secondhand smoke from cigarettes, but not pot.\u003c/p>\n\u003cp>\"Both of my parents died of lung cancer!\" she says. \"I will stop a stranger and say, 'You shouldn't be smoking. My dad died of that!' \"\u003c/p>\n\u003cp>California's \u003ca href=\"https://ballotpedia.org/California_Proposition_64,_Marijuana_Legalization_(2016)\" target=\"_blank\" rel=\"noopener\">Proposition 64\u003c/a>, approved by state voters in 2016, requires that some of the state tax revenue from the sale of marijuana to be distributed to cannabis researchers. In addition, the state's Occupational Safety and Health Standards Board is examining workplace hazards that are specific to the cannabis industry.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story is part of NPR's reporting partnership, local member stations and \u003c/em>\u003ca href=\"http://www.kaiserhealthnews.org\" target=\"_blank\" rel=\"noopener\">\u003cem>Kaiser Health News\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 KALW. To see more, visit \u003ca href=\"http://www.kalw.org/\" target=\"_blank\" rel=\"noopener\">KALW\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Are+There+Risks+From+Secondhand+Marijuana+Smoke%3F+Early+Science+Says+Yes&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/440287/are-there-risks-from-secondhand-marijuana-smoke-early-science-says-yes","authors":["byline_futureofyou_440287"],"series":["futureofyou_350"],"categories":["futureofyou_1"],"tags":["futureofyou_141","futureofyou_61","futureofyou_279","futureofyou_1041","futureofyou_1136"],"featImg":"futureofyou_440288","label":"source_futureofyou_440287"},"futureofyou_3250":{"type":"posts","id":"futureofyou_3250","meta":{"index":"posts_1591205157","site":"futureofyou","id":"3250","score":null,"sort":[1432230515000]},"guestAuthors":[],"slug":"your-heart-in-3d-surgeons-can-now-practice-on-a-simulation","title":"Your Heart in 3D: Surgeons Can Now Practice on a Simulation","publishDate":1432230515,"format":"image","headTitle":"Heart health | KQED Future of You | KQED Science","labelTerm":{"term":350,"site":"futureofyou"},"content":"\u003cp>How can you distinguish between a good surgeon and an exceptional surgeon?\u003c/p>\n\u003cp>According to some medical experts, it's that all-too-rare ability to visualize a human organ in three dimensions from little more than a scan.\u003c/p>\n\u003cp>\"The handful of the top surgeons in the world are like sculptors,\" said Dr. Deepak Srivastava, a director at the \u003ca href=\"http://gladstoneinstitutes.org/\">Gladstone Institute\u003c/a> of Cardiovascular Disease in San Francisco.\u003c/p>\n\u003cp>\"When cardiovascular surgeons go in to repair a defect in the heart, their success is so often dependent on an ability to \u003cem>see\u003c/em> the anatomy in 3-D in their minds,\" said Srivastava. \"That's more difficult for younger, less experienced surgeons.\"\u003c/p>\n\u003cp>But recent advancements in the field of computational modeling may level the playing field in the coming years, particularly for heart surgeons.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>One such technology comes from \u003ca href=\"http://www.3ds.com/\">Dassault Systèmes\u003c/a>, a French company that specializes in 3-D design software to help engineers that build cars and planes avoid potentially-fatal outcomes. So why not surgeons and medical researchers?\u003c/p>\n\u003cp>Earlier this week, Dassault released its highly-realistic digital model of the human heart, which it calls the \"\u003ca href=\"http://www.3ds.com/products-services/simulia/solutions/life-sciences/the-living-heart-project\">Living Heart Project\u003c/a>.\" Doctors \u003ca href=\"http://www.betaboston.com/news/2015/05/06/living-heart-project-brings-a-beat-to-3-d/\">wear special 3-D glasses and use a joystick\u003c/a> to zoom in to a ventricle or valve, while listening to every heartbeat.\u003c/p>\n\u003cp>The hope is that universities and medical device makers will use the simulation to come up with new personalized treatments for common heart diseases and potentially improve surgical outcomes.\u003c/p>\n\u003cp>\"We take a [patient's] scan, reconstruct it into a 3-D model, and test all the possibilities before a heart surgery,\" said Dr. Steve Levine, chief strategy officer and director for the Living Heart Project.\u003c/p>\n\u003cfigure id=\"attachment_3260\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-3260\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2015/05/Full_Heart_3-800x584.jpg\" alt=\"Dassault has developed a digital model of a human heart\" width=\"800\" height=\"584\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3-800x584.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3-400x292.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3-1180x862.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3-960x701.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3.jpg 1406w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Dassault has developed a digital model of a human heart \u003ccite>(Dassault Systèmes)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>For now, the company is focusing its attention on simulating the heart, as opposed to other organs. That's because heart disease is the \u003ca href=\"http://www.cdc.gov/heartdisease/facts.htm\">leading cause of death \u003c/a>in the United States, and accounts for one in every four deaths.\u003c/p>\n\u003cp>Some hospitals are already using the design software to simulate the effects of routine medical procedures or experiment with solutions to common problems, like heart attacks. In the future, surgeons may leverage computational models before selecting a therapy or drug for individual patients.\u003c/p>\n\u003cp>Dassault hopes that medical device makers will also use the Living Heart Project's technology for research and development. It may help these companies pinpoint which new ideas are likely to prove effective, and whether it's worth the investment in clinical trials.\u003c/p>\n\u003cp>The software is available for free to organizations that agree to conduct research and share its findings with the project. Otherwise, its licenses start at $15,000 per year for commercial use, with educational licenses starting at $500 per year.\u003c/p>\n\u003cp>\u003cstrong>Recruiting Partners in Health Care \u003c/strong>\u003c/p>\n\u003cp>\"Dassault is a $3 billion company few people have heard of,\" said Levine, who spoke with\u003cem> KQED \u003c/em>during a recent trip to Europe. \"We operate in the background.\"\u003c/p>\n\u003cp>In recent years, Dassault's executive team has re-focused the company on sectors outside of heavy manufacturing. Levine refers to this new approach as \"modeling life and nature.\"\u003c/p>\n\u003cp>For the Living Heart Project, Levine's team put out calls to researchers at some of the top hospitals around the world to share their findings.\u003c/p>\n\u003cp>To date, it has recruited 45 \"members\" or partners from the scientific community, who were independently researching cardiac disease or a function of the heart. Researchers from the Mayo Clinic, Stanford University and the University of Oxford,\u003ca href=\"http://www.3ds.com/products-services/simulia/solutions/life-sciences/the-living-heart-project\"> among others,\u003c/a> have opted to test-drive the simulation.\u003c/p>\n\u003cp>The company consolidated the research and used its engineering know-how to build a simulation of a baseline human heart. Now, the company can turn a 2-D scan, from an individual patient, and convert it into a 3-D model.\u003c/p>\n\u003cp>Levine said federal regulators initially wanted to take a 'watch and wait' approach when informed about the project.\u003c/p>\n\u003cp>\"I told them [the U.S. Food and Drug Administration], you can't sit on the sidelines as non-participants. You have to get involved.\"\u003c/p>\n\u003cp>In 2014, the agency agreed to collaborate with Dassault on a five-year research project, which will focus on testing the reliability of pacemaker leads (the thin wires that carry an electrical impulse from the device to the heart.) But the agency stressed that it will not necessarily endorse any of the computational models that are developed as part of the research.\u003c/p>\n\u003cp>The FDA expects that doctors will someday use simulation technology for planning purposes \u003cem>and\u003c/em> clinical decision-making. But it's still early days, so the agency cautioned doctors to invest resources into assessing the credibility of these new technologies and their potential drawbacks.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">\"Challenges to greater adoption of computer-modeling include a lack of data for some medical conditions, which makes realistic predictions difficult,\" said \u003c/span>Donna Lochner, a \u003cspan class=\"s1\">senior scientific advisor in the FDA's Office of Science and Engineering Laboratories.\u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_3270\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-3270\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs-800x343.jpg\" alt=\"Zooming in on the simulation \" width=\"800\" height=\"343\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs-800x343.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs-400x171.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs-960x412.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs.jpg 1024w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Zooming in on the Living Heart Project simulation \u003ccite>(Living Heart Project )\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>A Hammer Looking for a Nail?\u003c/strong>\u003c/p>\n\u003cp>At the University of California, San Francisco, a team of researchers in the cardiology division are hoping to use the Living Heart Project for one purpose in particular: Determining the optimal time for a patients' valve replacement.\u003c/p>\n\u003cp>Surgeons have to strike the right balance between swapping out a valve at the end of its life-cycle, but not leaving it so late that the heart function deteriorates.\u003c/p>\n\u003cp>Dr. Jeffrey Olgin, \u003ca href=\"http://www.ucsfhealth.org/jeffrey.olgin\">the division's chief\u003c/a>, has been closely following the team's progress. But he is far from convinced that the Living Heart Project will fundamentally transform how we perform surgeries today.\u003c/p>\n\u003cp>He asked, \"Is this a hammer looking for a nail? Or will this change how we practice medicine?\"\u003c/p>\n\u003cp>Olgin said the Living Heart Project may be no more than a technological solution looking for a problem, but it's too soon to tell. He hasn't seen a convincing study yet that proves the simulation can improve patient outcomes.\u003c/p>\n\u003cp>Unlike manmade objects like cars and planes, it's very difficult to predict how the human heart will respond to stress in the real world. Olgin said he fears that doctors would come to rely too heavily on this technology and medical device makers could pull the plug on promising research if the simulation shows a negative result.\u003c/p>\n\u003cp>\"The technology doesn't offer the same level of evidence as [medical research on] animals or small pilot human trials,\" he said.\u003c/p>\n\u003cp>\"Unfortunately, the human body doesn't always follow the rules of physics.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>[youtube http://www.youtube.com/watch?v=RrktVIFLqXI&w=560&h=315]\u003c/p>\n\n","blocks":[],"excerpt":"The \"Living Heart Project\" lets doctors take a virtual tour of the human heart to simulate the effects of common medical procedures. ","status":"publish","parent":0,"modified":1477282775,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":35,"wordCount":1168},"headData":{"title":"Your Heart in 3D: Surgeons Can Now Practice on a Simulation | KQED","description":"The "Living Heart Project" lets doctors take a virtual tour of the human heart to simulate the effects of common medical procedures. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Your Heart in 3D: Surgeons Can Now Practice on a Simulation","datePublished":"2015-05-21T17:48:35.000Z","dateModified":"2016-10-24T04:19:35.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"3250 http://ww2.kqed.org/futureofyou/?p=3250","disqusUrl":"https://ww2.kqed.org/futureofyou/2015/05/21/your-heart-in-3d-surgeons-can-now-practice-on-a-simulation/","disqusTitle":"Your Heart in 3D: Surgeons Can Now Practice on a Simulation","path":"/futureofyou/3250/your-heart-in-3d-surgeons-can-now-practice-on-a-simulation","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>How can you distinguish between a good surgeon and an exceptional surgeon?\u003c/p>\n\u003cp>According to some medical experts, it's that all-too-rare ability to visualize a human organ in three dimensions from little more than a scan.\u003c/p>\n\u003cp>\"The handful of the top surgeons in the world are like sculptors,\" said Dr. Deepak Srivastava, a director at the \u003ca href=\"http://gladstoneinstitutes.org/\">Gladstone Institute\u003c/a> of Cardiovascular Disease in San Francisco.\u003c/p>\n\u003cp>\"When cardiovascular surgeons go in to repair a defect in the heart, their success is so often dependent on an ability to \u003cem>see\u003c/em> the anatomy in 3-D in their minds,\" said Srivastava. \"That's more difficult for younger, less experienced surgeons.\"\u003c/p>\n\u003cp>But recent advancements in the field of computational modeling may level the playing field in the coming years, particularly for heart surgeons.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>One such technology comes from \u003ca href=\"http://www.3ds.com/\">Dassault Systèmes\u003c/a>, a French company that specializes in 3-D design software to help engineers that build cars and planes avoid potentially-fatal outcomes. So why not surgeons and medical researchers?\u003c/p>\n\u003cp>Earlier this week, Dassault released its highly-realistic digital model of the human heart, which it calls the \"\u003ca href=\"http://www.3ds.com/products-services/simulia/solutions/life-sciences/the-living-heart-project\">Living Heart Project\u003c/a>.\" Doctors \u003ca href=\"http://www.betaboston.com/news/2015/05/06/living-heart-project-brings-a-beat-to-3-d/\">wear special 3-D glasses and use a joystick\u003c/a> to zoom in to a ventricle or valve, while listening to every heartbeat.\u003c/p>\n\u003cp>The hope is that universities and medical device makers will use the simulation to come up with new personalized treatments for common heart diseases and potentially improve surgical outcomes.\u003c/p>\n\u003cp>\"We take a [patient's] scan, reconstruct it into a 3-D model, and test all the possibilities before a heart surgery,\" said Dr. Steve Levine, chief strategy officer and director for the Living Heart Project.\u003c/p>\n\u003cfigure id=\"attachment_3260\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-3260\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2015/05/Full_Heart_3-800x584.jpg\" alt=\"Dassault has developed a digital model of a human heart\" width=\"800\" height=\"584\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3-800x584.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3-400x292.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3-1180x862.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3-960x701.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/Full_Heart_3.jpg 1406w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Dassault has developed a digital model of a human heart \u003ccite>(Dassault Systèmes)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>For now, the company is focusing its attention on simulating the heart, as opposed to other organs. That's because heart disease is the \u003ca href=\"http://www.cdc.gov/heartdisease/facts.htm\">leading cause of death \u003c/a>in the United States, and accounts for one in every four deaths.\u003c/p>\n\u003cp>Some hospitals are already using the design software to simulate the effects of routine medical procedures or experiment with solutions to common problems, like heart attacks. In the future, surgeons may leverage computational models before selecting a therapy or drug for individual patients.\u003c/p>\n\u003cp>Dassault hopes that medical device makers will also use the Living Heart Project's technology for research and development. It may help these companies pinpoint which new ideas are likely to prove effective, and whether it's worth the investment in clinical trials.\u003c/p>\n\u003cp>The software is available for free to organizations that agree to conduct research and share its findings with the project. Otherwise, its licenses start at $15,000 per year for commercial use, with educational licenses starting at $500 per year.\u003c/p>\n\u003cp>\u003cstrong>Recruiting Partners in Health Care \u003c/strong>\u003c/p>\n\u003cp>\"Dassault is a $3 billion company few people have heard of,\" said Levine, who spoke with\u003cem> KQED \u003c/em>during a recent trip to Europe. \"We operate in the background.\"\u003c/p>\n\u003cp>In recent years, Dassault's executive team has re-focused the company on sectors outside of heavy manufacturing. Levine refers to this new approach as \"modeling life and nature.\"\u003c/p>\n\u003cp>For the Living Heart Project, Levine's team put out calls to researchers at some of the top hospitals around the world to share their findings.\u003c/p>\n\u003cp>To date, it has recruited 45 \"members\" or partners from the scientific community, who were independently researching cardiac disease or a function of the heart. Researchers from the Mayo Clinic, Stanford University and the University of Oxford,\u003ca href=\"http://www.3ds.com/products-services/simulia/solutions/life-sciences/the-living-heart-project\"> among others,\u003c/a> have opted to test-drive the simulation.\u003c/p>\n\u003cp>The company consolidated the research and used its engineering know-how to build a simulation of a baseline human heart. Now, the company can turn a 2-D scan, from an individual patient, and convert it into a 3-D model.\u003c/p>\n\u003cp>Levine said federal regulators initially wanted to take a 'watch and wait' approach when informed about the project.\u003c/p>\n\u003cp>\"I told them [the U.S. Food and Drug Administration], you can't sit on the sidelines as non-participants. You have to get involved.\"\u003c/p>\n\u003cp>In 2014, the agency agreed to collaborate with Dassault on a five-year research project, which will focus on testing the reliability of pacemaker leads (the thin wires that carry an electrical impulse from the device to the heart.) But the agency stressed that it will not necessarily endorse any of the computational models that are developed as part of the research.\u003c/p>\n\u003cp>The FDA expects that doctors will someday use simulation technology for planning purposes \u003cem>and\u003c/em> clinical decision-making. But it's still early days, so the agency cautioned doctors to invest resources into assessing the credibility of these new technologies and their potential drawbacks.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">\"Challenges to greater adoption of computer-modeling include a lack of data for some medical conditions, which makes realistic predictions difficult,\" said \u003c/span>Donna Lochner, a \u003cspan class=\"s1\">senior scientific advisor in the FDA's Office of Science and Engineering Laboratories.\u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_3270\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"size-medium wp-image-3270\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs-800x343.jpg\" alt=\"Zooming in on the simulation \" width=\"800\" height=\"343\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs-800x343.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs-400x171.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs-960x412.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2015/05/R2a3qFBWFzTN_0SEteF8HZmAhXEjJfJIP_9jdFW-ENsRapjCAjUtYflRhbPEAF5l5QYd8GvB5ytxiAGY01bnHEP-k18sMTqa81bonPm62tYAKQkuz_PdYpRcO5E0gkwDs.jpg 1024w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Zooming in on the Living Heart Project simulation \u003ccite>(Living Heart Project )\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>A Hammer Looking for a Nail?\u003c/strong>\u003c/p>\n\u003cp>At the University of California, San Francisco, a team of researchers in the cardiology division are hoping to use the Living Heart Project for one purpose in particular: Determining the optimal time for a patients' valve replacement.\u003c/p>\n\u003cp>Surgeons have to strike the right balance between swapping out a valve at the end of its life-cycle, but not leaving it so late that the heart function deteriorates.\u003c/p>\n\u003cp>Dr. Jeffrey Olgin, \u003ca href=\"http://www.ucsfhealth.org/jeffrey.olgin\">the division's chief\u003c/a>, has been closely following the team's progress. But he is far from convinced that the Living Heart Project will fundamentally transform how we perform surgeries today.\u003c/p>\n\u003cp>He asked, \"Is this a hammer looking for a nail? Or will this change how we practice medicine?\"\u003c/p>\n\u003cp>Olgin said the Living Heart Project may be no more than a technological solution looking for a problem, but it's too soon to tell. He hasn't seen a convincing study yet that proves the simulation can improve patient outcomes.\u003c/p>\n\u003cp>Unlike manmade objects like cars and planes, it's very difficult to predict how the human heart will respond to stress in the real world. Olgin said he fears that doctors would come to rely too heavily on this technology and medical device makers could pull the plug on promising research if the simulation shows a negative result.\u003c/p>\n\u003cp>\"The technology doesn't offer the same level of evidence as [medical research on] animals or small pilot human trials,\" he said.\u003c/p>\n\u003cp>\"Unfortunately, the human body doesn't always follow the rules of physics.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\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/RrktVIFLqXI'\n title='//www.youtube.com/embed/RrktVIFLqXI'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/3250/your-heart-in-3d-surgeons-can-now-practice-on-a-simulation","authors":["3252"],"series":["futureofyou_350"],"categories":["futureofyou_1063"],"tags":["futureofyou_353","futureofyou_741","futureofyou_354","futureofyou_66","futureofyou_279","futureofyou_356","futureofyou_80","futureofyou_351","futureofyou_294","futureofyou_352","futureofyou_355","futureofyou_113"],"featImg":"futureofyou_3269","label":"futureofyou_350"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. 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