Genetic Tests Can Hurt Your Chances Of Getting Some Types Of Insurance
A Science Writer Explores The 'Perversions And Potential' Of Genetic Tests
Free DNA Kits at S.F. 49ers Games Attract Skeptics -- and Regulators
Advanced Prenatal Testing Means More Gut-Wrenching Decisions Over Abortion
White Supremacists Not Happy When DNA Tests Reveal Non-White Ancestry
Big Genetics Company Conducted Needless, Inaccurate Tests, Employees Say
Would You Want to Know Your Baby's Genetic Mutations?
Racial Disparity in Genetic Studies Leads to Misdiagnosis
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Andrews, KHN","isLoading":false},"byline_futureofyou_442583":{"type":"authors","id":"byline_futureofyou_442583","meta":{"override":true},"slug":"byline_futureofyou_442583","name":"Terry Gross, NPR","isLoading":false},"byline_futureofyou_436928":{"type":"authors","id":"byline_futureofyou_436928","meta":{"override":true},"slug":"byline_futureofyou_436928","name":"Doug Levy\u003cbr />NPR Shots","isLoading":false},"byline_futureofyou_435960":{"type":"authors","id":"byline_futureofyou_435960","meta":{"override":true},"slug":"byline_futureofyou_435960","name":"Bonnie Rochman","isLoading":false},"byline_futureofyou_434900":{"type":"authors","id":"byline_futureofyou_434900","meta":{"override":true},"slug":"byline_futureofyou_434900","name":"Eric Boodman\u003cbr/>\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","isLoading":false},"byline_futureofyou_345800":{"type":"authors","id":"byline_futureofyou_345800","meta":{"override":true},"slug":"byline_futureofyou_345800","name":"Charles 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Some Types Of Insurance","publishDate":1533675608,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Taking a genetic test in your 20s or 30s could, indeed, affect your ability to get long-term-care insurance later — or at least the price you'll pay. And people who are considering enrolling in Medicare \u003cem>after\u003c/em> age 65 would do well to read the fine print of the sign-up rules. Readers have insurance questions on these topics this month, and we have answers:\u003c/p>\n\u003cp>\u003cstrong>Q: Can getting a genetic test interfere with being able to buy long-term-care insurance in the future? If you do get a plan, can the insurer drop you after you find out the results of a genetic test?\u003c/strong>\u003c/p>\n\u003cp>In general, long-term-care insurers \u003ca href=\"https://www.npr.org/sections/health-shots/2018/07/11/627287642/has-genetic-privacy-been-strained-by-trumps-recent-aca-moves\" target=\"_blank\" rel=\"noopener\">can indeed use genetic test results\u003c/a> when they decide whether to offer you coverage. The federal Genetic Information Nondiscrimination Act does prohibit insurers from asking for or using your genetic information to make decisions about whether to sell you \u003cem>health\u003c/em> insurance or how much to charge you. But those privacy protections don't apply to long-term-care policies, life insurance or disability insurance.[contextly_sidebar id=\"qQSelkzIcg9rHvmpdeoo1Q3hIhLbJVzz\"]\u003c/p>\n\u003cp>When you apply for a long-term-care policy, the insurer is permitted to review your medical records and ask you questions about your health history and that of your family. It's all part of the underwriting process to determine whether to offer you a policy and how much to charge.\u003c/p>\n\u003cp>If the insurer asks you whether you've undergone genetic testing, you generally must disclose it, even if the testing was performed through a direct-to-consumer site like 23andMe, says Catherine Theroux, a spokeswoman for \u003ca href=\"https://www.limra.com/News_Center/\" target=\"_blank\" rel=\"noopener\">LIMRA\u003c/a>, an insurance industry trade group.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"You need to release any medically relevant information,\" she says.\u003c/p>\n\u003cp>Some states provide extra consumer protections related to genetic testing and long-term-care insurance, says \u003ca href=\"https://www.law.gwu.edu/sonia-m-suter\" target=\"_blank\" rel=\"noopener\">Sonia Mateu Suter\u003c/a>, a law professor at George Washington University who specializes in genetics and the law. But most follow federal law.\u003c/p>\n\u003cp>If you get genetic testing after you have a policy, the results can't affect your coverage.\u003c/p>\n\u003cp>\"Once the policy has been underwritten and issued, the insurer doesn't revoke the policy if new medical information comes to light,\" Theroux says.\u003c/p>\n\u003cp>\u003cstrong>Q: Can I switch Medigap insurance companies midway through the year? I found a less expensive policy.\u003c/strong>\u003c/p>\n\u003cp>It depends. Under federal law, when people turn 65 and first enroll in Medicare Part B they have a six-month window to sign up for a \u003ca href=\"https://www.medicare.gov/supplement-other-insurance/medigap/whats-medigap.html\" target=\"_blank\" rel=\"noopener\">Medigap plan\u003c/a> — a commercial policy that picks up some of the out-of-pocket costs for services that Medicare doesn't cover. (\u003ca href=\"https://www.medicare.gov/what-medicare-covers/part-a/what-part-a-covers.html\" target=\"_blank\" rel=\"noopener\">Medicare Part A covers\u003c/a> hospitalization, and \u003ca href=\"https://www.medicare.gov/what-medicare-covers/part-b/what-medicare-part-b-covers.html\" target=\"_blank\" rel=\"noopener\">Medicare Part B covers\u003c/a> outpatient services.) During that six-month period, insurers have to accept enrollees, even if they have health problems.[contextly_sidebar id=\"AH3oYgfcAwGcfBrC61gPsQfir4oB7Yc7\"]\u003c/p>\n\u003cp>If you're still within that six-month period now and you want to switch plans, go right ahead.\u003c/p>\n\u003cp>But if you're past the six-month window, under federal law, insurers are required to sell you a plan only in certain circumstances — such as if you lose your retiree coverage or Medicare Advantage plan. If you don't meet the criteria, insurers can decline to cover you or charge you more for preexisting medical conditions.\u003c/p>\n\u003cp>Many states have provided more robust protections, however. Three states — Connecticut, Massachusetts and New York — have year-round open enrollment and require insurers to offer coverage. And Maine requires a one-month \"guaranteed issue\" open-enrollment period every year.\u003c/p>\n\u003cp>Some states guarantee current policyholders a chance to switch Medigap plans at certain points during the year. Other states have \u003ca href=\"https://www.kff.org/medicare/issue-brief/medigap-enrollment-and-consumer-protections-vary-across-states/\" target=\"_blank\" rel=\"noopener\">additional qualifying events\u003c/a> that allow people to switch Medigap plans, according to data from the Kaiser Family Foundation.\u003c/p>\n\u003cp>\"The first thing the person should do is check with her state insurance department to find out her rights related to buying a Medigap plan,\" says \u003ca href=\"https://www.ncoa.org/centerforbenefits/about-the-center/\" target=\"_blank\" rel=\"noopener\">Brandy Bauer\u003c/a>, associate director at the Center for Benefits Access at the National Council on Aging. If you decide to go ahead and switch, she says, it is wise to sign up for a new plan before terminating your current policy.[contextly_sidebar id=\"t6VA7YIl0My5E1I6mIhIw1XmFGiwNdrT\"]\u003c/p>\n\u003cp>\u003cstrong>Q: I did not enroll in Medicare Part B when I turned 65 because I already have a regular plan that covers everything. I was told that the insurer would keep paying as usual, but now the company says it will pay only part and that I have to buy Medicare Part B. I didn't want to pay for two policies. Is there anything I can do to avoid that?\u003c/strong>\u003c/p>\n\u003cp>From your description, it's hard to know exactly what's going on, but we can make educated guesses. Typically, when people turn 65, it makes sense to sign up for Medicare unless they or their spouse are working and getting health insurance from an employer. For others, at age 65, Medicare typically becomes their primary insurer and any other coverage they have becomes secondary, filling in gaps in Medicare coverage.\u003c/p>\n\u003cp>If you have an individual policy that you bought on the health insurance exchange, and decide to hang on to it instead of signing up for Medicare, your premiums and other costs could be higher than they would be on Medicare, depending on your income.\u003c/p>\n\u003cp>But if you're not receiving employee coverage and you don't enroll in Medicare Part B, you could be subject to a permanent \u003ca href=\"https://www.medicare.gov/your-medicare-costs/part-b-costs/penalty/part-b-late-enrollment-penalty.html\" target=\"_blank\" rel=\"noopener\">late enrollment penalty\u003c/a> of 10 percent of the policy's premium for every 12 months that you could have signed up for Part B but didn't.\u003c/p>\n\u003cp>You could also owe a premium penalty for not signing up for a Part D prescription drug plan. (Most people don't owe any premium for Medicare Part A, so there's no penalty for late sign-up.)\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Your best move now may be to call 800-Medicare or visit your local \u003ca href=\"https://www.medicare.gov/contacts/#resources/ships\" target=\"_blank\" rel=\"noopener\">state health insurance assistance program\u003c/a> to help sort out your coverage issues, including whether to drop your current coverage and sign up for Medicare Part B and Part D.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Genetic+Tests+Can+Hurt+Your+Chances+Of+Getting+Some+Types+Of+Insurance&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"Federal law keeps insurers from using genetic test results when pricing and issuing health insurance. But the tests might keep you from being able to get life insurance or a long-term-care policy.","status":"publish","parent":0,"modified":1533650118,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":24,"wordCount":1020},"headData":{"title":"Genetic Tests Can Hurt Your Chances Of Getting Some Types Of Insurance | KQED","description":"Federal law keeps insurers from using genetic test results when pricing and issuing health insurance. But the tests might keep you from being able to get life insurance or a long-term-care policy.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"443829 https://ww2.kqed.org/futureofyou/?p=443829","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/08/07/genetic-tests-can-hurt-your-chances-of-getting-some-types-of-insurance/","disqusTitle":"Genetic Tests Can Hurt Your Chances Of Getting Some Types Of Insurance","source":"Health","nprByline":"Michelle Andrews, KHN","nprImageAgency":"Science Photo Library RF/Getty Images","nprStoryId":"636026264","nprApiLink":"http://api.npr.org/query?id=636026264&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2018/08/07/636026264/genetic-tests-can-hurt-your-chances-of-getting-some-types-of-insurance?ft=nprml&f=636026264","nprRetrievedStory":"1","nprPubDate":"Tue, 07 Aug 2018 09:08:00 -0400","nprStoryDate":"Tue, 07 Aug 2018 09:00:18 -0400","nprLastModifiedDate":"Tue, 07 Aug 2018 09:08:23 -0400","path":"/futureofyou/443829/genetic-tests-can-hurt-your-chances-of-getting-some-types-of-insurance","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Taking a genetic test in your 20s or 30s could, indeed, affect your ability to get long-term-care insurance later — or at least the price you'll pay. And people who are considering enrolling in Medicare \u003cem>after\u003c/em> age 65 would do well to read the fine print of the sign-up rules. Readers have insurance questions on these topics this month, and we have answers:\u003c/p>\n\u003cp>\u003cstrong>Q: Can getting a genetic test interfere with being able to buy long-term-care insurance in the future? If you do get a plan, can the insurer drop you after you find out the results of a genetic test?\u003c/strong>\u003c/p>\n\u003cp>In general, long-term-care insurers \u003ca href=\"https://www.npr.org/sections/health-shots/2018/07/11/627287642/has-genetic-privacy-been-strained-by-trumps-recent-aca-moves\" target=\"_blank\" rel=\"noopener\">can indeed use genetic test results\u003c/a> when they decide whether to offer you coverage. The federal Genetic Information Nondiscrimination Act does prohibit insurers from asking for or using your genetic information to make decisions about whether to sell you \u003cem>health\u003c/em> insurance or how much to charge you. But those privacy protections don't apply to long-term-care policies, life insurance or disability insurance.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>When you apply for a long-term-care policy, the insurer is permitted to review your medical records and ask you questions about your health history and that of your family. It's all part of the underwriting process to determine whether to offer you a policy and how much to charge.\u003c/p>\n\u003cp>If the insurer asks you whether you've undergone genetic testing, you generally must disclose it, even if the testing was performed through a direct-to-consumer site like 23andMe, says Catherine Theroux, a spokeswoman for \u003ca href=\"https://www.limra.com/News_Center/\" target=\"_blank\" rel=\"noopener\">LIMRA\u003c/a>, an insurance industry trade group.\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>\"You need to release any medically relevant information,\" she says.\u003c/p>\n\u003cp>Some states provide extra consumer protections related to genetic testing and long-term-care insurance, says \u003ca href=\"https://www.law.gwu.edu/sonia-m-suter\" target=\"_blank\" rel=\"noopener\">Sonia Mateu Suter\u003c/a>, a law professor at George Washington University who specializes in genetics and the law. But most follow federal law.\u003c/p>\n\u003cp>If you get genetic testing after you have a policy, the results can't affect your coverage.\u003c/p>\n\u003cp>\"Once the policy has been underwritten and issued, the insurer doesn't revoke the policy if new medical information comes to light,\" Theroux says.\u003c/p>\n\u003cp>\u003cstrong>Q: Can I switch Medigap insurance companies midway through the year? I found a less expensive policy.\u003c/strong>\u003c/p>\n\u003cp>It depends. Under federal law, when people turn 65 and first enroll in Medicare Part B they have a six-month window to sign up for a \u003ca href=\"https://www.medicare.gov/supplement-other-insurance/medigap/whats-medigap.html\" target=\"_blank\" rel=\"noopener\">Medigap plan\u003c/a> — a commercial policy that picks up some of the out-of-pocket costs for services that Medicare doesn't cover. (\u003ca href=\"https://www.medicare.gov/what-medicare-covers/part-a/what-part-a-covers.html\" target=\"_blank\" rel=\"noopener\">Medicare Part A covers\u003c/a> hospitalization, and \u003ca href=\"https://www.medicare.gov/what-medicare-covers/part-b/what-medicare-part-b-covers.html\" target=\"_blank\" rel=\"noopener\">Medicare Part B covers\u003c/a> outpatient services.) During that six-month period, insurers have to accept enrollees, even if they have health problems.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>If you're still within that six-month period now and you want to switch plans, go right ahead.\u003c/p>\n\u003cp>But if you're past the six-month window, under federal law, insurers are required to sell you a plan only in certain circumstances — such as if you lose your retiree coverage or Medicare Advantage plan. If you don't meet the criteria, insurers can decline to cover you or charge you more for preexisting medical conditions.\u003c/p>\n\u003cp>Many states have provided more robust protections, however. Three states — Connecticut, Massachusetts and New York — have year-round open enrollment and require insurers to offer coverage. And Maine requires a one-month \"guaranteed issue\" open-enrollment period every year.\u003c/p>\n\u003cp>Some states guarantee current policyholders a chance to switch Medigap plans at certain points during the year. Other states have \u003ca href=\"https://www.kff.org/medicare/issue-brief/medigap-enrollment-and-consumer-protections-vary-across-states/\" target=\"_blank\" rel=\"noopener\">additional qualifying events\u003c/a> that allow people to switch Medigap plans, according to data from the Kaiser Family Foundation.\u003c/p>\n\u003cp>\"The first thing the person should do is check with her state insurance department to find out her rights related to buying a Medigap plan,\" says \u003ca href=\"https://www.ncoa.org/centerforbenefits/about-the-center/\" target=\"_blank\" rel=\"noopener\">Brandy Bauer\u003c/a>, associate director at the Center for Benefits Access at the National Council on Aging. If you decide to go ahead and switch, she says, it is wise to sign up for a new plan before terminating your current policy.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Q: I did not enroll in Medicare Part B when I turned 65 because I already have a regular plan that covers everything. I was told that the insurer would keep paying as usual, but now the company says it will pay only part and that I have to buy Medicare Part B. I didn't want to pay for two policies. Is there anything I can do to avoid that?\u003c/strong>\u003c/p>\n\u003cp>From your description, it's hard to know exactly what's going on, but we can make educated guesses. Typically, when people turn 65, it makes sense to sign up for Medicare unless they or their spouse are working and getting health insurance from an employer. For others, at age 65, Medicare typically becomes their primary insurer and any other coverage they have becomes secondary, filling in gaps in Medicare coverage.\u003c/p>\n\u003cp>If you have an individual policy that you bought on the health insurance exchange, and decide to hang on to it instead of signing up for Medicare, your premiums and other costs could be higher than they would be on Medicare, depending on your income.\u003c/p>\n\u003cp>But if you're not receiving employee coverage and you don't enroll in Medicare Part B, you could be subject to a permanent \u003ca href=\"https://www.medicare.gov/your-medicare-costs/part-b-costs/penalty/part-b-late-enrollment-penalty.html\" target=\"_blank\" rel=\"noopener\">late enrollment penalty\u003c/a> of 10 percent of the policy's premium for every 12 months that you could have signed up for Part B but didn't.\u003c/p>\n\u003cp>You could also owe a premium penalty for not signing up for a Part D prescription drug plan. (Most people don't owe any premium for Medicare Part A, so there's no penalty for late sign-up.)\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Your best move now may be to call 800-Medicare or visit your local \u003ca href=\"https://www.medicare.gov/contacts/#resources/ships\" target=\"_blank\" rel=\"noopener\">state health insurance assistance program\u003c/a> to help sort out your coverage issues, including whether to drop your current coverage and sign up for Medicare Part B and Part D.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Genetic+Tests+Can+Hurt+Your+Chances+Of+Getting+Some+Types+Of+Insurance&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/443829/genetic-tests-can-hurt-your-chances-of-getting-some-types-of-insurance","authors":["byline_futureofyou_443829"],"categories":["futureofyou_452","futureofyou_1","futureofyou_73","futureofyou_1064"],"tags":["futureofyou_1015","futureofyou_61","futureofyou_419","futureofyou_35"],"collections":["futureofyou_1094"],"featImg":"futureofyou_443830","label":"source_futureofyou_443829"},"futureofyou_442583":{"type":"posts","id":"futureofyou_442583","meta":{"index":"posts_1591205157","site":"futureofyou","id":"442583","score":null,"sort":[1528820134000]},"guestAuthors":[],"slug":"a-science-writer-explores-the-perversions-and-potential-of-genetic-tests","title":"A Science Writer Explores The 'Perversions And Potential' Of Genetic Tests","publishDate":1528820134,"format":"audio","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe src=\"https://www.npr.org/player/embed/618870881/618969757\" width=\"100%\" height=\"290\" frameborder=\"0\" scrolling=\"no\" title=\"NPR embedded audio player\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>As a science columnist for\u003cem> The New York Times, \u003c/em>Carl Zimmer had reported extensively about genetics and the role gene mutations play in various ailments. After a while, he got to wondering about what secrets his own genetic code holds.[contextly_sidebar id=\"AyWMyOjcCCjd9Wr45bM9omzK5fGeueow\"]\u003c/p>\n\u003cp>\"I wanted to know if there was anything I needed to worry about,\" Zimmer says. \"We all think back to our relatives who got sick and then wonder, 'Is that in me?'\"\u003c/p>\n\u003cp>So Zimmer worked with a genetics counselor to get his entire genome sequenced — an experience he describes as \"very nerve-wracking.\" He worried that he would discover a mutation that would put him on the path for a particular disease.\u003c/p>\n\u003cp>As it turned out, the counselor told Zimmer he has a \"boring genome.\" Though Zimmer initially hoped for a more \"exciting and exotic\" assessment, the counselor reminded him \"A boring genome is a really good genome.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Zimmer writes about the broader implications of genetic research and testing in his new book, \u003cem>She Has Her Mother's Laugh: The Powers, Perversions and Potential of Heredity\u003c/em>.[contextly_sidebar id=\"YtqF4uhyPE2pCelB55bttG0XpqJfRSq3\"]\u003c/p>\n\u003chr>\n\u003cp>\u003cstrong>Interview Highlights\u003c/strong>\u003c/p>\n\u003cp>\u003cstrong>On how the new genetic editing technology known as \u003ca href=\"https://www.npr.org/tags/419142387/crispr\" target=\"_blank\" rel=\"noopener\">CRISPR\u003c/a> works\u003c/strong>\u003c/p>\n\u003cp>What happens with CRISPR is that scientists will design a molecule — think of it as a probe — and it will search around in the DNA in a cell until if finds a very specific short sequence. And it will grab onto it, and it brings on with it basically molecular scissors, which will then cut the DNA at that spot — kind of like cutting tape. And you can cut out a segment of DNA. And if you just do that, DNA will heal itself. Basically the two loose ends will stitch themselves together, and now that piece is just missing. Or you can add in a little piece of different DNA, and you can actually get the cell to put in that new piece of DNA where you just cut out the old one.\u003c/p>\n\u003cp>\u003cstrong>On whether CRISPR technology could be used to treat diseases in humans\u003c/strong>\u003c/p>\n\u003cp>We're just on the verge of human trials. They will be starting, hopefully very soon, for diseases like sickle-cell anemia. There's actually a lot of research on muscular dystrophy as well. There are a few key diseases where scientists think these would be the best places to start. To basically inject CRISPR molecules into people's bodies; these CRISPR molecules would then go to certain kinds of cells and repair one particular spot in their DNA. And that treats the disease.\u003c/p>\n\u003cp>We shouldn't look at this as a panacea. ... There have been earlier kinds of treatments known as gene therapy, where you basically try to add an extra gene into someone's cells. And that [seemed] like it was just a slam dunk, but then it turned out to not work very well for years and years. ... So CRISPR could be even more exciting and truly revolutionary. We just have to wait and see what this first generation of human clinical trials show us.\u003c/p>\n\u003cp>\u003cstrong>On his visit to an insectarium where a scientist is breeding genetically modified mosquitoes that are resistant to malaria\u003c/strong>\u003c/p>\n\u003cp>First of all, you have to gown up before you go in there. ... And then you go through an air lock, and then you're in this room where there are mosquitoes living in all their different life cycles.\u003c/p>\n\u003cp>So there's a dark room where the female mosquitoes are laying their eggs, because they like to do it in the dark. And then the scientists pull the eggs out from these rooms and they inject DNA into them and then they put them in water, because that's where mosquito larvae like to develop.\u003c/p>\n\u003cp>And so you go into this other room where there are these tubs of water, and these snake-like things are slithering around in there and then they develop into adults. And the females need to drink blood; so [researchers] found that the containers for movie popcorn work really well. What they do is, they basically clamp a warm container of calves' blood on top of them, and then the mosquitoes are underneath — on the underside of the plastic lid — basically poking through and drinking the blood and fattening themselves up. ...\u003c/p>\n\u003cp>You can tell that they've been genetically altered because they have red eyes, which is kind of spooky. But you look at that and you say, well, that means that these could be the cure for malaria. It really could happen. And hundreds of thousands of people die every year of malaria. We've thrown everything we can at it and this parasite is still knocking us down worldwide. So, maybe this could be it – so, that's actually quite exciting.\u003c/p>\n\u003cp>\u003cstrong>On how genetic testing was used in the Golden State Killer case\u003c/strong>\u003c/p>\n\u003cp>For the \u003ca href=\"https://www.npr.org/sections/thetwo-way/2018/04/27/606624218/in-hunt-for-golden-state-killer-investigators-uploaded-his-dna-to-genealogy-site\" target=\"_blank\" rel=\"noopener\">Golden State Killer case\u003c/a>, what somebody decided to do was take the DNA that they had from these crime scenes, and upload it to one of these open-access sites — not a commercial site — and then see if they could find any close matches. And they found that there were some people that looked like they were distant cousins of this person. And they went and did the genealogical research to figure out \"Well, how would they be related?\" And then said \"OK, who are the possible relatives that this person could be, and where do they live?\" And that actually helped narrow down their search until they made an arrest.\u003c/p>\n\u003cp>\u003cstrong>On whether genetic testing companies will protect user privacy\u003c/strong>\u003c/p>\n\u003cp>You can choose different levels of privacy with a lot of these services. So, for example, some people will say \"I want you to look at my DNA. I want you to tell me about my ancestry.\" ... For 23 and Me they'll give you a few bits of information about your medical conditions, and that's it. But they will try to get you to opt in to sharing your data for their own basic research. At 23 and Me, for example, there's a whole team of researchers who are studying all sorts of ... diseases, sleep patterns and so on. And then they will also go into partnerships with drug development companies who will take their data, looking at, say, 50,000 people with lupus and 50,000 people who don't have lupus, and try to look for the genetic differences. Those could point the way toward possible drugs.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Phyllis Myers and Seth Kelley produced and edited the audio of this interview. Bridget Bentz and Seth Kelley adapted it for the Web.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 Fresh Air. To see more, visit \u003ca href=\"http://www.npr.org/programs/fresh-air/\">Fresh Air\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+Science+Writer+Explores+The+%27Perversions+And+Potential%27+Of+Genetic+Tests&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"Carl Zimmer wondered what secrets lurked in his genetic code — so he decided to have his genome sequenced. He writes about the implications of the study of genetics in \u003cem>She Has Her Mother's Laugh.\u003c/em>","status":"publish","parent":0,"modified":1528822199,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":24,"wordCount":1128},"headData":{"title":"A Science Writer Explores The 'Perversions And Potential' Of Genetic Tests | KQED","description":"Carl Zimmer wondered what secrets lurked in his genetic code — so he decided to have his genome sequenced. He writes about the implications of the study of genetics in She Has Her Mother's Laugh.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"442583 https://ww2.kqed.org/futureofyou/?p=442583","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/06/12/a-science-writer-explores-the-perversions-and-potential-of-genetic-tests/","disqusTitle":"A Science Writer Explores The 'Perversions And Potential' Of Genetic Tests","source":"Future of You","nprImageCredit":"Westend61","nprByline":"Terry Gross, NPR","nprImageAgency":"Getty Images","nprStoryId":"618870881","nprApiLink":"http://api.npr.org/query?id=618870881&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2018/06/11/618870881/a-science-writer-explores-the-perversions-and-potential-of-genetic-tests?ft=nprml&f=618870881","nprRetrievedStory":"1","nprPubDate":"Mon, 11 Jun 2018 16:05:00 -0400","nprStoryDate":"Mon, 11 Jun 2018 14:43:00 -0400","nprLastModifiedDate":"Mon, 11 Jun 2018 15:07:30 -0400","nprAudio":"https://ondemand.npr.org/anon.npr-mp3/npr/fa/2018/06/20180611_fa_01.mp3?orgId=427869011&topicId=1128&d=2169&p=13&story=618870881&ft=nprml&f=618870881","nprAudioM3u":"http://api.npr.org/m3u/1618969757-dcc7b4.m3u?orgId=427869011&topicId=1128&d=2169&p=13&story=618870881&ft=nprml&f=618870881","path":"/futureofyou/442583/a-science-writer-explores-the-perversions-and-potential-of-genetic-tests","audioUrl":"https://ondemand.npr.org/anon.npr-mp3/npr/fa/2018/06/20180611_fa_01.mp3?orgId=427869011&topicId=1128&d=2169&p=13&story=618870881&ft=nprml&f=618870881","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe src=\"https://www.npr.org/player/embed/618870881/618969757\" width=\"100%\" height=\"290\" frameborder=\"0\" scrolling=\"no\" title=\"NPR embedded audio player\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>As a science columnist for\u003cem> The New York Times, \u003c/em>Carl Zimmer had reported extensively about genetics and the role gene mutations play in various ailments. After a while, he got to wondering about what secrets his own genetic code holds.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"I wanted to know if there was anything I needed to worry about,\" Zimmer says. \"We all think back to our relatives who got sick and then wonder, 'Is that in me?'\"\u003c/p>\n\u003cp>So Zimmer worked with a genetics counselor to get his entire genome sequenced — an experience he describes as \"very nerve-wracking.\" He worried that he would discover a mutation that would put him on the path for a particular disease.\u003c/p>\n\u003cp>As it turned out, the counselor told Zimmer he has a \"boring genome.\" Though Zimmer initially hoped for a more \"exciting and exotic\" assessment, the counselor reminded him \"A boring genome is a really good genome.\"\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>Zimmer writes about the broader implications of genetic research and testing in his new book, \u003cem>She Has Her Mother's Laugh: The Powers, Perversions and Potential of Heredity\u003c/em>.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003chr>\n\u003cp>\u003cstrong>Interview Highlights\u003c/strong>\u003c/p>\n\u003cp>\u003cstrong>On how the new genetic editing technology known as \u003ca href=\"https://www.npr.org/tags/419142387/crispr\" target=\"_blank\" rel=\"noopener\">CRISPR\u003c/a> works\u003c/strong>\u003c/p>\n\u003cp>What happens with CRISPR is that scientists will design a molecule — think of it as a probe — and it will search around in the DNA in a cell until if finds a very specific short sequence. And it will grab onto it, and it brings on with it basically molecular scissors, which will then cut the DNA at that spot — kind of like cutting tape. And you can cut out a segment of DNA. And if you just do that, DNA will heal itself. Basically the two loose ends will stitch themselves together, and now that piece is just missing. Or you can add in a little piece of different DNA, and you can actually get the cell to put in that new piece of DNA where you just cut out the old one.\u003c/p>\n\u003cp>\u003cstrong>On whether CRISPR technology could be used to treat diseases in humans\u003c/strong>\u003c/p>\n\u003cp>We're just on the verge of human trials. They will be starting, hopefully very soon, for diseases like sickle-cell anemia. There's actually a lot of research on muscular dystrophy as well. There are a few key diseases where scientists think these would be the best places to start. To basically inject CRISPR molecules into people's bodies; these CRISPR molecules would then go to certain kinds of cells and repair one particular spot in their DNA. And that treats the disease.\u003c/p>\n\u003cp>We shouldn't look at this as a panacea. ... There have been earlier kinds of treatments known as gene therapy, where you basically try to add an extra gene into someone's cells. And that [seemed] like it was just a slam dunk, but then it turned out to not work very well for years and years. ... So CRISPR could be even more exciting and truly revolutionary. We just have to wait and see what this first generation of human clinical trials show us.\u003c/p>\n\u003cp>\u003cstrong>On his visit to an insectarium where a scientist is breeding genetically modified mosquitoes that are resistant to malaria\u003c/strong>\u003c/p>\n\u003cp>First of all, you have to gown up before you go in there. ... And then you go through an air lock, and then you're in this room where there are mosquitoes living in all their different life cycles.\u003c/p>\n\u003cp>So there's a dark room where the female mosquitoes are laying their eggs, because they like to do it in the dark. And then the scientists pull the eggs out from these rooms and they inject DNA into them and then they put them in water, because that's where mosquito larvae like to develop.\u003c/p>\n\u003cp>And so you go into this other room where there are these tubs of water, and these snake-like things are slithering around in there and then they develop into adults. And the females need to drink blood; so [researchers] found that the containers for movie popcorn work really well. What they do is, they basically clamp a warm container of calves' blood on top of them, and then the mosquitoes are underneath — on the underside of the plastic lid — basically poking through and drinking the blood and fattening themselves up. ...\u003c/p>\n\u003cp>You can tell that they've been genetically altered because they have red eyes, which is kind of spooky. But you look at that and you say, well, that means that these could be the cure for malaria. It really could happen. And hundreds of thousands of people die every year of malaria. We've thrown everything we can at it and this parasite is still knocking us down worldwide. So, maybe this could be it – so, that's actually quite exciting.\u003c/p>\n\u003cp>\u003cstrong>On how genetic testing was used in the Golden State Killer case\u003c/strong>\u003c/p>\n\u003cp>For the \u003ca href=\"https://www.npr.org/sections/thetwo-way/2018/04/27/606624218/in-hunt-for-golden-state-killer-investigators-uploaded-his-dna-to-genealogy-site\" target=\"_blank\" rel=\"noopener\">Golden State Killer case\u003c/a>, what somebody decided to do was take the DNA that they had from these crime scenes, and upload it to one of these open-access sites — not a commercial site — and then see if they could find any close matches. And they found that there were some people that looked like they were distant cousins of this person. And they went and did the genealogical research to figure out \"Well, how would they be related?\" And then said \"OK, who are the possible relatives that this person could be, and where do they live?\" And that actually helped narrow down their search until they made an arrest.\u003c/p>\n\u003cp>\u003cstrong>On whether genetic testing companies will protect user privacy\u003c/strong>\u003c/p>\n\u003cp>You can choose different levels of privacy with a lot of these services. So, for example, some people will say \"I want you to look at my DNA. I want you to tell me about my ancestry.\" ... For 23 and Me they'll give you a few bits of information about your medical conditions, and that's it. But they will try to get you to opt in to sharing your data for their own basic research. At 23 and Me, for example, there's a whole team of researchers who are studying all sorts of ... diseases, sleep patterns and so on. And then they will also go into partnerships with drug development companies who will take their data, looking at, say, 50,000 people with lupus and 50,000 people who don't have lupus, and try to look for the genetic differences. Those could point the way toward possible drugs.\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>Phyllis Myers and Seth Kelley produced and edited the audio of this interview. Bridget Bentz and Seth Kelley adapted it for the Web.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 Fresh Air. To see more, visit \u003ca href=\"http://www.npr.org/programs/fresh-air/\">Fresh Air\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=A+Science+Writer+Explores+The+%27Perversions+And+Potential%27+Of+Genetic+Tests&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/442583/a-science-writer-explores-the-perversions-and-potential-of-genetic-tests","authors":["byline_futureofyou_442583"],"categories":["futureofyou_1060","futureofyou_1062","futureofyou_1"],"tags":["futureofyou_17","futureofyou_1015","futureofyou_271"],"collections":["futureofyou_1093","futureofyou_1097","futureofyou_1094"],"featImg":"futureofyou_442584","label":"source_futureofyou_442583"},"futureofyou_436928":{"type":"posts","id":"futureofyou_436928","meta":{"index":"posts_1591205157","site":"futureofyou","id":"436928","score":null,"sort":[1510252699000]},"guestAuthors":[],"slug":"free-dna-kits-at-s-f-49ers-games-attract-skeptics-and-regulators","title":"Free DNA Kits at S.F. 49ers Games Attract Skeptics -- and Regulators","publishDate":1510252699,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Depending on whom you ask, finding out whether your genes make you a better athlete or give you healthier skin may be as easy as swabbing your cheeks for a DNA test on your way into a football game. But others say these \"wellness\" tests marketed directly to consumers are modern snake oil — worthless, or even misleading.\u003c/p>\n\u003cp>On Monday, the Food and Drug Administration gave a boost to direct-to-consumer genetic testing when it announced plans to streamline its approval process.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Giving out DNA kits at a football game screams out for regulation.'\u003ccite>Peter Pitts, Center for Medicine in the Public Interest\u003c/cite>\u003c/aside>\n\u003cp>\"These tests can prompt consumers to be more engaged in pursuing the benefits of healthy lifestyle choices and more aware of their health risks,\" FDA Commissioner Scott Gottlieb said in a \u003ca href=\"https://www.prnewswire.com/news-releases/statement-from-fda-commissioner-scott-gottlieb-md-on-implementation-of-agencys-streamlined-development-and-review-pathway-for-consumer-tests-that-evaluate-genetic-health-risks-300549992.html\" target=\"_blank\" rel=\"noopener\">statement\u003c/a>. However, he continued, \"They're not without their own risks — especially if they provide consumers with incorrect or misleading information that may be used to make health choices without considering the advice of a medical professional.\"\u003c/p>\n\u003cp>The FDA intends to let sellers of direct-to-consumer DNA test kits seek a one-time FDA review, which would allow subsequent tests to be sold without going first to the FDA for approval. Under present rules, each new health test must be submitted and reviewed. The FDA's jurisdiction applies to tests used to assess or diagnose health.\u003c/p>\n\u003cp>But a company in Boston is finding out that mass marketing of DNA tests attracts not just customers and fans, but skeptics and regulators. \u003ca href=\"http://orig3n.com/\" target=\"_blank\" rel=\"noopener\">Orig3n\u003c/a>, which sells genetic test kits with catchy names like \"Fitcode,\" \"Fuel\" and \"Bliss\" at festivals and sporting events, now finds itself under scrutiny by state and federal officials.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"The California Department of Public Health is investigating the nature and distribution of these test kits by Orig3n at Levi's Stadium in Santa Clara,\" a department representative said in an email.\u003c/p>\n\u003cp>At every 49ers home game during the current season, the company has a booth where it offers free introductory DNA test kits to the 68,000 fans entering the stadium. Fans can also purchase other tests at prices ranging from $29 to $149 each. It has a similar relationship with the Baltimore Ravens, but a plan to give test kits to every fan entering a September game was called off after Maryland regulators had some questions.\u003c/p>\n\u003cp>\"I want people to learn more about themselves, and what they choose to do with that information is really up to them,\" says Orig3n co-founder and chief operating officer Kate Blanchard. \"But some of the information can really impact the way they live their life.\"\u003c/p>\n\u003cp>That is precisely the problem, and it's why state and federal regulators have said that \"information\" tests like Orig3n's should be regulated as medical tests, because they're assessing a person's health. It's a complex question, as the FDA's Gottlieb notes. \"Consider the consequences of a person who is told they're not at risk for coronary heart disease and incorrectly opts to forgo dietary changes or drugs that reduce their risk of heart attack and death,\" he says.\u003c/p>\n\u003cp>As much as genetic science has advanced, scientists do not fully understand how the more than 50 million known genetic variations interact with each other or with lifestyle and other factors to affect someone's health, wellness or behavior. Very few genes are as closely associated with a specific outcome as the breast cancer genes BRCA1 and BRCA2, and even a positive test for these cancer-associated genes is insufficient for doctors to advise patients to have surgery or other major treatments.\u003c/p>\n\u003cp>In other words, you can get a test that tells you what variations you have, but that test alone cannot predict your future or dictate specific health or lifestyle decisions. Skeptics worry that people will read too much into genetic test results, especially if they are done without the help of a medical professional.\u003c/p>\n\u003cp>Blanchard says she stepped up her personal training regimen after her DNA test indicated that she might perform well in endurance sports. She says it was a change she might not have made without this information.\u003c/p>\n\u003cp>Distributing DNA tests to tens of thousands of people at NFL football games \"is not good clinical practice,\" says Peter Pitts, president of the advocacy group \u003ca href=\"http://cmpi.org/\">Center for Medicine in the Public Interest\u003c/a>. Unlike tests done in clinical laboratories, like tests for diabetes or cholesterol, there is less control over the quality of the test process, so the resulting data may be \"highly questionable,\" says Pitts, who is a former associate commissioner of the Food and Drug Administration.\u003c/p>\n\u003cp>Now you can get a nutrition plan and ready-to-eat meals based on \"your body's unique make-up\" from Campbell's Soup-funded \u003ca href=\"http://habit.com/\">Habit\u003c/a>. \u003ca href=\"http://ancestry.com/\">Ancestry\u003c/a> sells a test that \"tells a more complete story of you,\" and \u003ca href=\"https://www.helix.com/shop/\">Helix\u003c/a> promotes more than a dozen of its partners who sell genetic tests ranging from National Geographic (your ancestor's migration paths) to companies that offer targeted fitness routines based on the DNA results, and several health companies. There is even a \u003ca href=\"https://www.helix.com/shop/vinome-wine-explorer/\">wine club\u003c/a> with wines \"scientifically selected based on your DNA.\"\u003c/p>\n\u003cp>\"We don't begrudge the excitement and the desire to help people based on genetics,\" says Shirley Wu, director of product science for 23andMe, a direct-to-consumer genetic testing company that started in 2006. However, she questions companies that may be overpromising on what the tests can tell you. The science behind some consumer-oriented tests is lacking, says Wu. \"We are still at the beginning of our understanding.\"\u003c/p>\n\u003cp>The FDA \u003ca href=\"https://www.npr.org/sections/health-shots/2013/12/06/249231236/23andme-bows-to-fdas-demands-drops-health-claims\">halted 23andMe's sales\u003c/a> of medical-risk tests in 2013, saying that it couldn't prove those tests were accurate. In April, 23andMe obtained federal \u003ca href=\"https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm551185.htm\">clearance\u003c/a> to resume selling direct-to-consumer DNA tests for certain health risks. Now, consumers can get reports on their ancestry as well as genes associated with sleep quality, lactose sensitivity, weight and other wellness factors and risks for several dozen inherited conditions for about $200.\u003c/p>\n\u003cp>And companies can offer very different information on the same finding. That's evident in two reports on the CC variant of the ACTN3 gene:\u003c/p>\n\u003cul>\n\u003cli>23andMe tells you that you have a trait \"common among elite power athletes ... but its role for non-elite athletes isn't completely understood.\" The report also says that lifestyle and training are the driver of athletic performance for most people.\u003c/li>\n\u003cli>Orig3n also tells you that this trait is common in elite athletes and \"is found in 45 percent of the general population.\" And it \"contributes to your ability to perform better in sports requiring power such as sprinting.\" The Orig3n report recommends the types of sports that someone with this biomarker might want to pursue.\u003c/li>\n\u003c/ul>\n\u003cp>A \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278350/\">2015 review\u003c/a> of genetic testing for sports concluded that there is little value to knowing the ACTN3 or other variants in recreational athletes. However, genetic testing of professional athletes may be useful for training and injury prevention, the review authors concluded.\u003c/p>\n\u003cp>\"For the most part, data on personal genomic testing have revealed little or no harms but also little or no health benefits,\" writes Dr. Muin Khoury, director of the Office of Public Health Genomics at the Centers for Disease Control and Prevention in a \u003ca href=\"https://blogs.cdc.gov/genomics/2017/04/18/direct-to-consumer-2/\">recent article\u003c/a>. \"Also, evidence on the ability of genetic information to change health behavior has been lacking.\"\u003c/p>\n\u003cp>Blanchard says that Orig3n got the idea for its fitness DNA test after it solicited blood samples for research at marathons and other sporting events. \"People started asking, 'What can you tell me about me?' \" she says.\u003c/p>\n\u003cp>The business model for 23andMe, Helix and some of the other direct-to-consumer DNA testing companies doesn't rely solely on sales of test kits. They want to aggregate massive amounts of human genetic data that can be mined for research and commercial uses. Consumers are asked to \"opt-in\" to this when getting tested — and most do, according to 23andMe.\u003c/p>\n\u003cp>Orig3n is an exception: It says it would contact people separately if it ever wanted to use the DNA for anything other than the person's own tests. But those test kits create a pool of people who would be more likely to give blood samples for Orig3n's stem cell research. Its business banks on amassing tens of thousands of human blood samples so that it can create many stem cell lines.\u003c/p>\n\u003cp>Orig3n has sponsorship arrangements with the Baltimore Ravens and the San Francisco 49ers football teams. Fans at home games can get a free test that reports on three genes — ACTN3 for muscle force, FOXP2 for language-learning ability and AGER for skin aging. For $149, Orig3n reports back on 27 genes related to strength, metabolism, endurance and power. The company's other tests are to provide information about genes associated with skin, child development, and how you think, feel and react.\u003c/p>\n\u003cp>Orig3n says its tests are \"not diagnostic\" and \"for informational purposes only.\" The federal agency that oversees medical labs disagrees. That distinction is critical because it is the boundary between regulated medical services and ones that avoid that level of scrutiny.\u003c/p>\n\u003cp>After reviewing Orig3n's materials, the Centers for Medicare and Medicaid Services told the company on Oct. 30 that it must follow the rules for medical laboratories because its services include \"genetic testing for the assessment of health.\"\u003c/p>\n\u003cp>The decision was based on 18 of the 140 genes included in Orig3n's tests, according to a \u003ca href=\"https://www.documentcloud.org/documents/4176983-CMS-Letter.html\">letter\u003c/a> from CMS to Orig3n.\u003c/p>\n\u003cp>Orig3n's Blanchard says the company will continue selling its tests without those 18 genes until Orig3n receives approval from regulators to resume. In addition to CMS, Orig3n must satisfy state regulators in Massachusetts, Maryland and California – or any other states where it operates. \"Going forward, we will continue to work with CMS, California, Massachusetts and the other states to ensure that we are meeting all federal and state regulatory requirements regarding our products,\" Blanchard said in an email.\u003c/p>\n\u003cp>That may not be enough to satisfy all the critics. Says Pitts: \"Giving out DNA kits at a football game screams out for regulation.\"\u003c/p>\n\u003chr>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Doug Levy is a freelance writer based in Sausalito, Calif. \u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=You+Can+Get+Your+DNA+Tested+At+An+NFL+Game.+Should+You%3F+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"Companies distributing genetic tests at pro sports events say they can help people make the most of exercise and nutrition. But regulators say some are medical tests that could land people in trouble.","status":"publish","parent":0,"modified":1510254186,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":31,"wordCount":1718},"headData":{"title":"Free DNA Kits at S.F. 49ers Games Attract Skeptics -- and Regulators | KQED","description":"Companies distributing genetic tests at pro sports events say they can help people make the most of exercise and nutrition. But regulators say some are medical tests that could land people in trouble.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"436928 https://ww2.kqed.org/futureofyou/?p=436928","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/11/09/free-dna-kits-at-s-f-49ers-games-attract-skeptics-and-regulators/","disqusTitle":"Free DNA Kits at S.F. 49ers Games Attract Skeptics -- and Regulators","source":"KQED Future of You","nprByline":"Doug Levy\u003cbr />NPR Shots","nprImageAgency":"Douglas Levy for NPR","nprStoryId":"562564639","nprApiLink":"http://api.npr.org/query?id=562564639&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2017/11/08/562564639/you-can-get-your-dna-tested-at-an-nfl-game-should-you?ft=nprml&f=562564639","nprRetrievedStory":"1","nprPubDate":"Wed, 08 Nov 2017 15:44:00 -0500","nprStoryDate":"Wed, 08 Nov 2017 05:00:00 -0500","nprLastModifiedDate":"Wed, 08 Nov 2017 20:19:10 -0500","path":"/futureofyou/436928/free-dna-kits-at-s-f-49ers-games-attract-skeptics-and-regulators","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Depending on whom you ask, finding out whether your genes make you a better athlete or give you healthier skin may be as easy as swabbing your cheeks for a DNA test on your way into a football game. But others say these \"wellness\" tests marketed directly to consumers are modern snake oil — worthless, or even misleading.\u003c/p>\n\u003cp>On Monday, the Food and Drug Administration gave a boost to direct-to-consumer genetic testing when it announced plans to streamline its approval process.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Giving out DNA kits at a football game screams out for regulation.'\u003ccite>Peter Pitts, Center for Medicine in the Public Interest\u003c/cite>\u003c/aside>\n\u003cp>\"These tests can prompt consumers to be more engaged in pursuing the benefits of healthy lifestyle choices and more aware of their health risks,\" FDA Commissioner Scott Gottlieb said in a \u003ca href=\"https://www.prnewswire.com/news-releases/statement-from-fda-commissioner-scott-gottlieb-md-on-implementation-of-agencys-streamlined-development-and-review-pathway-for-consumer-tests-that-evaluate-genetic-health-risks-300549992.html\" target=\"_blank\" rel=\"noopener\">statement\u003c/a>. However, he continued, \"They're not without their own risks — especially if they provide consumers with incorrect or misleading information that may be used to make health choices without considering the advice of a medical professional.\"\u003c/p>\n\u003cp>The FDA intends to let sellers of direct-to-consumer DNA test kits seek a one-time FDA review, which would allow subsequent tests to be sold without going first to the FDA for approval. Under present rules, each new health test must be submitted and reviewed. The FDA's jurisdiction applies to tests used to assess or diagnose health.\u003c/p>\n\u003cp>But a company in Boston is finding out that mass marketing of DNA tests attracts not just customers and fans, but skeptics and regulators. \u003ca href=\"http://orig3n.com/\" target=\"_blank\" rel=\"noopener\">Orig3n\u003c/a>, which sells genetic test kits with catchy names like \"Fitcode,\" \"Fuel\" and \"Bliss\" at festivals and sporting events, now finds itself under scrutiny by state and federal officials.\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>\"The California Department of Public Health is investigating the nature and distribution of these test kits by Orig3n at Levi's Stadium in Santa Clara,\" a department representative said in an email.\u003c/p>\n\u003cp>At every 49ers home game during the current season, the company has a booth where it offers free introductory DNA test kits to the 68,000 fans entering the stadium. Fans can also purchase other tests at prices ranging from $29 to $149 each. It has a similar relationship with the Baltimore Ravens, but a plan to give test kits to every fan entering a September game was called off after Maryland regulators had some questions.\u003c/p>\n\u003cp>\"I want people to learn more about themselves, and what they choose to do with that information is really up to them,\" says Orig3n co-founder and chief operating officer Kate Blanchard. \"But some of the information can really impact the way they live their life.\"\u003c/p>\n\u003cp>That is precisely the problem, and it's why state and federal regulators have said that \"information\" tests like Orig3n's should be regulated as medical tests, because they're assessing a person's health. It's a complex question, as the FDA's Gottlieb notes. \"Consider the consequences of a person who is told they're not at risk for coronary heart disease and incorrectly opts to forgo dietary changes or drugs that reduce their risk of heart attack and death,\" he says.\u003c/p>\n\u003cp>As much as genetic science has advanced, scientists do not fully understand how the more than 50 million known genetic variations interact with each other or with lifestyle and other factors to affect someone's health, wellness or behavior. Very few genes are as closely associated with a specific outcome as the breast cancer genes BRCA1 and BRCA2, and even a positive test for these cancer-associated genes is insufficient for doctors to advise patients to have surgery or other major treatments.\u003c/p>\n\u003cp>In other words, you can get a test that tells you what variations you have, but that test alone cannot predict your future or dictate specific health or lifestyle decisions. Skeptics worry that people will read too much into genetic test results, especially if they are done without the help of a medical professional.\u003c/p>\n\u003cp>Blanchard says she stepped up her personal training regimen after her DNA test indicated that she might perform well in endurance sports. She says it was a change she might not have made without this information.\u003c/p>\n\u003cp>Distributing DNA tests to tens of thousands of people at NFL football games \"is not good clinical practice,\" says Peter Pitts, president of the advocacy group \u003ca href=\"http://cmpi.org/\">Center for Medicine in the Public Interest\u003c/a>. Unlike tests done in clinical laboratories, like tests for diabetes or cholesterol, there is less control over the quality of the test process, so the resulting data may be \"highly questionable,\" says Pitts, who is a former associate commissioner of the Food and Drug Administration.\u003c/p>\n\u003cp>Now you can get a nutrition plan and ready-to-eat meals based on \"your body's unique make-up\" from Campbell's Soup-funded \u003ca href=\"http://habit.com/\">Habit\u003c/a>. \u003ca href=\"http://ancestry.com/\">Ancestry\u003c/a> sells a test that \"tells a more complete story of you,\" and \u003ca href=\"https://www.helix.com/shop/\">Helix\u003c/a> promotes more than a dozen of its partners who sell genetic tests ranging from National Geographic (your ancestor's migration paths) to companies that offer targeted fitness routines based on the DNA results, and several health companies. There is even a \u003ca href=\"https://www.helix.com/shop/vinome-wine-explorer/\">wine club\u003c/a> with wines \"scientifically selected based on your DNA.\"\u003c/p>\n\u003cp>\"We don't begrudge the excitement and the desire to help people based on genetics,\" says Shirley Wu, director of product science for 23andMe, a direct-to-consumer genetic testing company that started in 2006. However, she questions companies that may be overpromising on what the tests can tell you. The science behind some consumer-oriented tests is lacking, says Wu. \"We are still at the beginning of our understanding.\"\u003c/p>\n\u003cp>The FDA \u003ca href=\"https://www.npr.org/sections/health-shots/2013/12/06/249231236/23andme-bows-to-fdas-demands-drops-health-claims\">halted 23andMe's sales\u003c/a> of medical-risk tests in 2013, saying that it couldn't prove those tests were accurate. In April, 23andMe obtained federal \u003ca href=\"https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm551185.htm\">clearance\u003c/a> to resume selling direct-to-consumer DNA tests for certain health risks. Now, consumers can get reports on their ancestry as well as genes associated with sleep quality, lactose sensitivity, weight and other wellness factors and risks for several dozen inherited conditions for about $200.\u003c/p>\n\u003cp>And companies can offer very different information on the same finding. That's evident in two reports on the CC variant of the ACTN3 gene:\u003c/p>\n\u003cul>\n\u003cli>23andMe tells you that you have a trait \"common among elite power athletes ... but its role for non-elite athletes isn't completely understood.\" The report also says that lifestyle and training are the driver of athletic performance for most people.\u003c/li>\n\u003cli>Orig3n also tells you that this trait is common in elite athletes and \"is found in 45 percent of the general population.\" And it \"contributes to your ability to perform better in sports requiring power such as sprinting.\" The Orig3n report recommends the types of sports that someone with this biomarker might want to pursue.\u003c/li>\n\u003c/ul>\n\u003cp>A \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278350/\">2015 review\u003c/a> of genetic testing for sports concluded that there is little value to knowing the ACTN3 or other variants in recreational athletes. However, genetic testing of professional athletes may be useful for training and injury prevention, the review authors concluded.\u003c/p>\n\u003cp>\"For the most part, data on personal genomic testing have revealed little or no harms but also little or no health benefits,\" writes Dr. Muin Khoury, director of the Office of Public Health Genomics at the Centers for Disease Control and Prevention in a \u003ca href=\"https://blogs.cdc.gov/genomics/2017/04/18/direct-to-consumer-2/\">recent article\u003c/a>. \"Also, evidence on the ability of genetic information to change health behavior has been lacking.\"\u003c/p>\n\u003cp>Blanchard says that Orig3n got the idea for its fitness DNA test after it solicited blood samples for research at marathons and other sporting events. \"People started asking, 'What can you tell me about me?' \" she says.\u003c/p>\n\u003cp>The business model for 23andMe, Helix and some of the other direct-to-consumer DNA testing companies doesn't rely solely on sales of test kits. They want to aggregate massive amounts of human genetic data that can be mined for research and commercial uses. Consumers are asked to \"opt-in\" to this when getting tested — and most do, according to 23andMe.\u003c/p>\n\u003cp>Orig3n is an exception: It says it would contact people separately if it ever wanted to use the DNA for anything other than the person's own tests. But those test kits create a pool of people who would be more likely to give blood samples for Orig3n's stem cell research. Its business banks on amassing tens of thousands of human blood samples so that it can create many stem cell lines.\u003c/p>\n\u003cp>Orig3n has sponsorship arrangements with the Baltimore Ravens and the San Francisco 49ers football teams. Fans at home games can get a free test that reports on three genes — ACTN3 for muscle force, FOXP2 for language-learning ability and AGER for skin aging. For $149, Orig3n reports back on 27 genes related to strength, metabolism, endurance and power. The company's other tests are to provide information about genes associated with skin, child development, and how you think, feel and react.\u003c/p>\n\u003cp>Orig3n says its tests are \"not diagnostic\" and \"for informational purposes only.\" The federal agency that oversees medical labs disagrees. That distinction is critical because it is the boundary between regulated medical services and ones that avoid that level of scrutiny.\u003c/p>\n\u003cp>After reviewing Orig3n's materials, the Centers for Medicare and Medicaid Services told the company on Oct. 30 that it must follow the rules for medical laboratories because its services include \"genetic testing for the assessment of health.\"\u003c/p>\n\u003cp>The decision was based on 18 of the 140 genes included in Orig3n's tests, according to a \u003ca href=\"https://www.documentcloud.org/documents/4176983-CMS-Letter.html\">letter\u003c/a> from CMS to Orig3n.\u003c/p>\n\u003cp>Orig3n's Blanchard says the company will continue selling its tests without those 18 genes until Orig3n receives approval from regulators to resume. In addition to CMS, Orig3n must satisfy state regulators in Massachusetts, Maryland and California – or any other states where it operates. \"Going forward, we will continue to work with CMS, California, Massachusetts and the other states to ensure that we are meeting all federal and state regulatory requirements regarding our products,\" Blanchard said in an email.\u003c/p>\n\u003cp>That may not be enough to satisfy all the critics. Says Pitts: \"Giving out DNA kits at a football game screams out for regulation.\"\u003c/p>\n\u003chr>\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>Doug Levy is a freelance writer based in Sausalito, Calif. \u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=You+Can+Get+Your+DNA+Tested+At+An+NFL+Game.+Should+You%3F+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/436928/free-dna-kits-at-s-f-49ers-games-attract-skeptics-and-regulators","authors":["byline_futureofyou_436928"],"categories":["futureofyou_452","futureofyou_1","futureofyou_73","futureofyou_1064"],"tags":["futureofyou_15","futureofyou_1390","futureofyou_1015","futureofyou_1391"],"featImg":"futureofyou_436943","label":"source_futureofyou_436928"},"futureofyou_435960":{"type":"posts","id":"futureofyou_435960","meta":{"index":"posts_1591205157","site":"futureofyou","id":"435960","score":null,"sort":[1509995619000]},"guestAuthors":[],"slug":"advanced-prenatal-testing-will-mean-more-gut-wrenching-decisions-about-abortion","title":"Advanced Prenatal Testing Means More Gut-Wrenching Decisions Over Abortion","publishDate":1509995619,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>\u003cem>Excerpts from \"The Other Scarlet 'A': Abortion's Relationship to Genetic Testing\" from THE GENE MACHINE by Bonnie Rochman. Copyright © 2017 by Bonnie Rochman. Used by permission of \u003ca href=\"https://us.macmillan.com/fsg\" target=\"_blank\" rel=\"noopener\">Farrar, Straus and Giroux\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>When the second purple line appeared on the white plastic wand on a March morning in 2002, I knew next to nothing about pregnancy and even less about raising a child. It was years before I’d go on to cover parenting and pediatrics, and write about sequencing children’s genomes. Yet from the first days of that pregnancy, I was already enmeshed in the most cutting-edge technologies of the time, thanks to my friend Tali, whose son was due a week after mine.\u003c/p>\n\u003caside class=\"pullquote alignright\">How people feel about disability and how that impacts their decisions around abortion are the real topics in any discussion about advanced prenatal testing.\u003c/aside>\n\u003cp>Tali had recently moved to my home state of North Carolina from Israel, where nuchal translucency testing was standard. I had no idea what it was, but I figured it was important, judging by her level of outrage that this test to gauge Down syndrome risk — combination of an ultrasound to measure the collection of fluid under the skin on the back of a fetus’s neck, and a blood draw — wasn’t commonly available in the United States. Within days, she told me that she’d found a doctor who was getting certified to perform the testing. He needed subjects. Tali and I volunteered.\u003c/p>\n\u003cp>I had signed up blithely, without seriously considering what I’d do if the test result came back positive. I expected good news — and, fortunately, I got it. Now, more than a decade later, nuchal translucency is old hat. Other, more sophisticated tests have begun to usurp what was lauded as the latest in prenatal technology in the early aughts.\u003c/p>\n\u003cp>Nuchal translucency offered both Tali and me reassurance. But the various permutations of prenatal screening and testing do not always provide comfort. I am witness to that in the heart of midtown Manhattan, not far from Radio City Music Hall, in a clinic where a woman and her husband have just made a life-altering decision. The woman is 40 years old, with high cheekbones and skin the color of toasted almonds. She is 12-and-a-half weeks pregnant with one baby, but minutes earlier, before she sat down with me in an empty exam room, she was pregnant with two.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>[contextly_sidebar id=\"i4qdnvXQQLlENO4hP9XlMVjlFUStRjgc\"]Her journey to motherhood had not been easy. The twins had been conceived via in vitro fertilization after the woman and her partner had spent more than a year trying to get pregnant the old-fashioned way. A week before, she had had a microarray analysis that peered deeply into the genetic makeup of her twins.\u003c/p>\n\u003cp>Microarray analyzes fetal cells for countless less apparent disorders that occur when a tiny snippet of DNA has been added somewhere it’s not supposed to be or deleted entirely, revealing genetic hiccups that previously could not be detected prenatally. Some of these changes are meaningless; others may be associated with autism or rare disorders such as DiGeorge syndrome, which is characterized by heart problems and a roughly 25 percent risk of developing schizophrenia.\u003c/p>\n\u003cp>As the woman explained, “We made use of technology throughout this process, so it would be a shame not to take advantage of this [test]. I wanted to make sure that, given my age, there was nothing wrong.”\u003c/p>\n\u003cp>She knew that the microarray would reveal all sorts of genetic blips, DNA duplications and deletions too tiny to be seen under a microscope, some of which are associated with worrisome conditions and others of which aren’t understood. The test would also detect major chromosomal problems, of which Down syndrome is the most common.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Just because a patient can know something, must she? What is one of the most joyous times of life has turned into something ominous and fraught, loaded with the potential to go wrong.'\u003c/aside>\n\u003cp>Even at age 40, just 1 of 100 pregnancies results in Down syndrome. And yet the couple beat those odds: one of the twins was confirmed to have the extra 21st chromosome that causes the condition.\u003c/p>\n\u003cp>“You don’t think it’s going to happen to you and then here it is. I still can’t get over the fact. Today we reduced the baby with Down syndrome,” the woman tells me, using a common euphemism for terminating one or more fetuses in cases where a woman is carrying more than she intends to deliver. Many doctors call this “fetal reduction.” She reflects on her decision, made possible by these new tests, as she lowers herself onto an exam table to rest. “I look at this as a sign from God. My mother believes in karma. I think this baby was only meant to be for twelve weeks and his suffering was shortened,” she says. She raises herself up on her elbows and looks at her husband. “Then I feel like, ‘Oh my god, I just killed a baby.’ ”\u003c/p>\n\u003cp>Considering that women have been getting pregnant for a very long time, prenatal diagnosis — the ability to peer inside the womb and emerge with a snapshot of fetal health — is a fairly recent development, a convergence of medical technologies such as amniocentesis and ultrasound with emerging insights about genes and chromosomes. But it’s the legalization of abortion in 1973 that really served as a catalyst for change. After all, without the ability to choose whether or not to continue a pregnancy, knowledge gleaned from prenatal diagnosis would have remained largely theoretical. With the decriminalization of abortion, what to do became a choice.\u003c/p>\n\u003cp>While there are women who’d never opt for an abortion, it’s disingenuous to ignore the fact that terminating a pregnancy is one possible outcome of earlier, more sophisticated genetic tests. The issue of how people feel about disability and, in turn, how that impacts their decisions regarding abortion is an essential aspect of any discussion about advances in prenatal testing.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I don't understand why even women in their twenties aren't undergoing this testing. Knowledge is power.'\u003c/aside>\n\u003cp>Yet abortion remains the elephant in the room when it comes to prenatal testing. When I discuss my work with colleagues and friends interested in the subject, some say, “ You’re not going to mention abortion, are you? My gut tells me that I think you’re walking into a minefield if that becomes a major part of the book.” Others say, “Abortion should definitely be a chapter. How could it not be?”\u003c/p>\n\u003cp>Much of the prenatal testing conversation centers on Down syndrome because the condition is so well- known, unlike others that affect far fewer people. One of every 792 babies born in the United States has Down syndrome. Compared to many other chromosomal conditions, however, Down syndrome is considered a relatively mild genetic complex. Chromosome 21 is the smallest chromosome, so the extra genetic material that accompanies a third copy is not as massive or overwhelming as it would be had it occurred on another, larger chromosome. The genetic disorder that results from a triplication of any chromosome is called a trisomy. A trisomy 22 baby, for example, probably would not make it to birth.\u003c/p>\n\u003cp>Starting in the 1970s, various epidemiologists began making the case that standardizing testing for Down syndrome was a public health priority. Since then, screening for Down syndrome has become broadly accepted by the medical community and, in turn, by many pregnant women and their partners. In 2007, the American College of Obstetrics and Gynecology expanded its prenatal screening recommendations to offer all women, regardless of age, the option of screening and diagnosis for genetic conditions, including Down syndrome.\u003c/p>\n\u003cp>One of the consequences is clear. In 2015, Brian Skotko, who co-directs the Down Syndrome Program at Massachusetts General Hospital, published a comprehensive look at Down syndrome live-birth rates in the United States. Between 2006 and 2010, he and his colleagues calculated that 30 percent fewer babies with Down syndrome were born than were expected, due to elective terminations.\u003c/p>\n\u003cp>Decisions about whether to have a baby with Down syndrome tend to vary geographically and by level of education. In the 2015 study, abortions for reasons of Down syndrome were highest in the Northeast and Hawaii and lowest in the South. Asians were the most likely to terminate due to Down syndrome, while Hispanics and American Indians were the least likely.\u003c/p>\n\u003cfigure id=\"attachment_370960\" class=\"wp-caption aligncenter\" style=\"max-width: 507px\">\u003ca href=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/04/Down-syndrome.jpg\">\u003cimg class=\"size-full wp-image-370960\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/04/Down-syndrome.jpg\" alt=\"\" width=\"507\" height=\"337\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/04/Down-syndrome.jpg 507w, https://ww2.kqed.org/app/uploads/sites/13/2017/04/Down-syndrome-160x106.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/04/Down-syndrome-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/04/Down-syndrome-375x249.jpg 375w\" sizes=\"(max-width: 507px) 100vw, 507px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">A baby girl with Down Syndrome and her mother. \u003ccite>( JGI/Tom Grill/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>The Rise of Noninvasive Prenatal Screening \u003c/strong>\u003c/p>\n\u003cp>Various forms of prenatal testing have been around for decades, but when noninvasive prenatal screening (NIPS) debuted in 2011, its greater accuracy combined with its ease of use contributed to its rapid uptake. In a few short years, NIPS, also called cell-free DNA screening, has become pervasive in the prenatal-testing market. Rather than face off with a long needle or catheter guided through the cervix or abdomen late in the first trimester, or a long needle in the abdomen in the second trimester, a quick venipuncture can collect enough blood midway through the first trimester to gauge whether the fetus’s chromosomes are intact, with high accuracy and no in utero assault. Within a few weeks of a woman learning she’s pregnant, her blood contains fragments of fetal DNA (NIPS actually detects DNA from the placenta, considered a proxy for fetal DNA, that is free-floating in the mom’s bloodstream). The amount of cell- free DNA from the fetus and mother can then be analyzed to predict Down syndrome (and an increasing number of other chromosomal conditions) with up to 99 percent accuracy — though the concept of accuracy itself is nuanced and complex and fluctuates depending on the age of the mother. NIPS, being a blood test, also sidesteps the very small but still scary risk of miscarriage that accompanies CVS (short for \u003ca href=\"https://www.mayoclinic.org/tests-procedures/chorionic-villus-sampling/basics/definition/prc-20013566\" target=\"_blank\" rel=\"noopener\">chorionic villus sampling\u003c/a>) or amnio.\u003c/p>\n\u003caside class=\"pullquote alignright\">The doctor said: 'I get people coming in here who ... want to know this is 100 percent fine. I can't give you 100 percent. I can give you 80 percent. And I said, \"I'm going to take those odds.\"\u003c/aside>\n\u003cp>Initially reserved for women over 35, NIPS has now spread to younger women as well, and has spawned a $500 million industry expected to balloon to $2 billion by 2020. But who gets the testing ranges widely, depending upon who goes to the doctor in the first place. Lower-income women, due to lack of access, don’t seek out prenatal care nearly as regularly as more well-to-do mothers. If they do, they’re often too far along in their pregnancies to get screened. Due to geographic discrepancies in Medicaid coverage, NIPS or other tests may not be covered. ...\u003c/p>\n\u003cp>Despite its high degree of accuracy, NIPS is not perfect. Nor does it equate with a diagnosis. NIPS is a screening test; it can be complicated by a lower-than-expected fraction of fetal DNA and even by an underlying maternal cancer diagnosis. Only CVS or amnio can offer confirmation. But the message is not always getting across to women — or their doctors. Cases have been reported of women coming close to terminating pregnancies they believed were affected based on NIPS results — only to learn that they were not. Experts blame the companies that market the tests for robust advertising that they say misleads patients — and some physicians — into believing that the results are equivalent to a diagnosis. To address misunderstanding, the American Congress of Obstetricians and Gynecologists issued a statement in 2015 stressing that any positive results need to be confirmed via other tests such as amniocentesis. In other words, ACOG emphasizes, a decision to have an abortion should not be based solely on the results of NIPS.\u003c/p>\n\u003cp>Yet there has been little public conversation about widespread prenatal screening and the “consequences of the transformation of every fetus — and not only the precious fetus produced thanks to complex technological interventions — into an ‘at risk’ entity, extensively tested, measured and evaluated by health professionals,” wrote the science historian Ilana Löwy in a paper about prenatal diagnosis.\u003c/p>\n\u003cp>In an op-ed in The New York Times, “\u003ca href=\"https://opinionator.blogs.nytimes.com/2014/06/04/the-t-m-i-pregnancy/?_r=0\" target=\"_blank\" rel=\"noopener\">The T.M.I. Pregnancy,\u003c/a>” Patricia Volk lamented that all the testing surrounding her daughter-in-law’s supposedly “normal” pregnancy had left them both feeling “guardedly happy.” She recounted a series of scary ultrasound findings that turned out to be nothing, and mused: “Prenatal science has helped a lot [of] people and people-to-be. But just because a patient can know something, must she? Odds are in this baby’s favor, yet every sonogram adds something scary to the pot. What is one of the most joyous times of life has turned into something ominous and fraught, loaded with the potential to go wrong.”\u003c/p>\n\u003cp>Yet one person’s anxiety is another’s sigh of relief. The debate over what testing and how much hinges on so many factors. In fact, two letters to the editor in response to “The T.M.I. Pregnancy” highlight why this push-and-pull is one of the great medical and social conundrums of our time. In one, Alastair Pullen describes his experience declining all testing during his wife’s first pregnancy “for all of the reasons this article mentions.” Halfway through the pregnancy, he and his wife agreed to an ultrasound and discovered their daughter had a fatal condition and would not survive long after birth. “Faced with a horrible decision,” Pullen writes, “we decided to induce preterm labor. Becket was stillborn. The only thing worse would have been if we had had no knowledge of her condition.” Pullen had first decided not to test but ended up grateful he changed his mind. He and his wife welcomed testing in later pregnancies; they now have three healthy children, and, he says, “the barrage of testing affirmed our excitement.”\u003c/p>\n\u003cp>Ingrid Chafee, on the other hand, gave birth when no tests were available. She was shocked when she delivered her firstborn in 1965, only to learn he had hydrocephalus and spina bifida. Surgery repaired much of the damage, but her son — who now holds a doctorate from Oxford — still has physical problems. She concludes: “He has said many times that he is glad that there were no ultrasound tests available at the time of his birth. If there had been, he wouldn’t be here. To know or not to know? It’s up to each to decide.”\u003c/p>\n\u003cp>\u003cstrong>Who Is a Gift and Who a Burden?\u003c/strong>\u003c/p>\n\u003cp>The ethics of abortion are set to become much more complicated as more women have access to powerful genetic tests such as microarray, for these tests can identify genetic flaws that are not readily understood.\u003c/p>\n\u003cp>Microarray had confirmed that the almond skinned woman who had the fetal reduction was carrying one twin with Down syndrome. But in the case of more ambiguous genetic errors in a boy named Ryan Docherty, confirmation was the easy part. It was the interpretation — figuring out the significance of the problems that microarray had detected in utero — that proved difficult.\u003c/p>\n\u003cp>When she was pregnant, Ryan’s mom, Jen Sipress, had a microarray test. You’ll recall that chromosomal microarray analysis can detect deletions and duplications of genetic material — errors that are far smaller than an entire extra chromosome. But just because they’re smaller doesn’t mean they can’t wreak havoc. Some are associated with genetic disorders; many more aren’t associated with anything because they’re so newly discovered or because they don’t appear to be detrimental according to the limited amount of research that exists. Sipress, 42, is a New York City narcotics prosecutor; she thrives on evidence. When her test results came back, the evidence was disconcerting: Ryan, still in utero, had not one but two findings — “variants of uncertain significance” — inherited from his mother and his father. Docherty had passed down a duplication involving six genes, while Sipress had contributed a deletion on chromosome 15 involving four genes. In general, deletions are considered more worrisome than duplications; our bodies can often deal with some extra genetic material, but it’s not as easy to compensate for DNA gone AWOL. To make matters worse, one of the four missing genes had been associated in the medical literature with intellectual and developmental delay. Here’s where things got really confusing: Sipress was missing that same gene and she didn’t appear to be affected at all. She worked hard as the family’s primary income earner, putting drug dealers behind bars. She hadn’t even known she was missing any genes until the microarray results came back. But genes—or their absence — can affect people differently; it’s a phenomenon called “variable expressivity.”\u003c/p>\n\u003cp>Before the amniocentesis to collect fetal cells for the microarray analysis, Sipress and Docherty had decided that were they to learn that their unborn child wouldn’t be able to live independently as an adult, they would end the pregnancy. When they got the results, they leaned toward abortion. After talking to their doctor, Ron Wapner, author of a \u003cem>New England Journal of Medicine\u003c/em> study about microarray’s effectiveness, they changed their minds. As Sipress recalls, Wapner said, “‘I get people coming in here who . . . want to know this is 100 percent fine.’ And he said, ‘I can’t give you 100 percent. I can give you 80 percent.’ And I said, ‘I’m going to take those odds.’ ”\u003c/p>\n\u003cp>Emotionally, it was a terrible time for Sipress and Docherty. Ryan was their first child, and he had been conceived after two rounds of IVF. But Sipress doesn’t regret finding out. “I don’t understand why even women in their 20s aren’t undergoing this testing,” she says. “Knowledge is power. Doesn’t everyone realize that?”\u003c/p>\n\u003cp>It’s certainly made for some awkward conversations with her husband’s family in Scotland, who know about the missing genes. “They ask if there is something wrong with the kid, and I say, ‘Technically, yes, but he’s not exhibiting any symptoms,’ ” says Sipress. To that end, Docherty, who stays home with Ryan, is a vigilant observer. “Are we still worried?” says Docherty. “Absolutely.” It’s easy to attribute every behavioral challenge — Ryan’s not a good sleeper, but neither are lots of babies — to the missing genes. Anticipating this, Wapner has cautioned them against engaging in this sort of genetic determinism. “He said, ‘Go about your business. If you feel something is really wrong, then you act.’ To be honest,” says Docherty, “Ryan doesn’t have a problem, as far as I can see.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>To what end are we willing to go to detect disability? Once we find it, is there a dividing line between “good,” or tolerable, disabilities and “bad,” or intolerable, limitations? How do we decide which ones may warrant abortion and which are acceptable? What feels overwhelming to one person— the birth of a child with a genetic disorder— may feel like God’s gift to another. Who are we to judge what — who, more accurately—is a gift and who is a burden?\u003c/p>\n\n","blocks":[],"excerpt":"Advanced prenatal genetic testing transforms every fetus into an 'at risk' entity. And we should be talking about that, says author Bonnie Rochman in 'The Gene Machine.'","status":"publish","parent":0,"modified":1514584359,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":36,"wordCount":3388},"headData":{"title":"Advanced Prenatal Testing Means More Gut-Wrenching Decisions Over Abortion | KQED","description":"Advanced prenatal genetic testing transforms every fetus into an 'at risk' entity. And we should be talking about that, says author Bonnie Rochman in 'The Gene Machine.'","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"435960 https://ww2.kqed.org/futureofyou/?p=435960","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/11/06/advanced-prenatal-testing-will-mean-more-gut-wrenching-decisions-about-abortion/","disqusTitle":"Advanced Prenatal Testing Means More Gut-Wrenching Decisions Over Abortion","nprByline":"Bonnie Rochman","path":"/futureofyou/435960/advanced-prenatal-testing-will-mean-more-gut-wrenching-decisions-about-abortion","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cem>Excerpts from \"The Other Scarlet 'A': Abortion's Relationship to Genetic Testing\" from THE GENE MACHINE by Bonnie Rochman. Copyright © 2017 by Bonnie Rochman. Used by permission of \u003ca href=\"https://us.macmillan.com/fsg\" target=\"_blank\" rel=\"noopener\">Farrar, Straus and Giroux\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>When the second purple line appeared on the white plastic wand on a March morning in 2002, I knew next to nothing about pregnancy and even less about raising a child. It was years before I’d go on to cover parenting and pediatrics, and write about sequencing children’s genomes. Yet from the first days of that pregnancy, I was already enmeshed in the most cutting-edge technologies of the time, thanks to my friend Tali, whose son was due a week after mine.\u003c/p>\n\u003caside class=\"pullquote alignright\">How people feel about disability and how that impacts their decisions around abortion are the real topics in any discussion about advanced prenatal testing.\u003c/aside>\n\u003cp>Tali had recently moved to my home state of North Carolina from Israel, where nuchal translucency testing was standard. I had no idea what it was, but I figured it was important, judging by her level of outrage that this test to gauge Down syndrome risk — combination of an ultrasound to measure the collection of fluid under the skin on the back of a fetus’s neck, and a blood draw — wasn’t commonly available in the United States. Within days, she told me that she’d found a doctor who was getting certified to perform the testing. He needed subjects. Tali and I volunteered.\u003c/p>\n\u003cp>I had signed up blithely, without seriously considering what I’d do if the test result came back positive. I expected good news — and, fortunately, I got it. Now, more than a decade later, nuchal translucency is old hat. Other, more sophisticated tests have begun to usurp what was lauded as the latest in prenatal technology in the early aughts.\u003c/p>\n\u003cp>Nuchal translucency offered both Tali and me reassurance. But the various permutations of prenatal screening and testing do not always provide comfort. I am witness to that in the heart of midtown Manhattan, not far from Radio City Music Hall, in a clinic where a woman and her husband have just made a life-altering decision. The woman is 40 years old, with high cheekbones and skin the color of toasted almonds. She is 12-and-a-half weeks pregnant with one baby, but minutes earlier, before she sat down with me in an empty exam room, she was pregnant with two.\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>\u003c/p>\u003cp>\u003c/p>\u003cp>Her journey to motherhood had not been easy. The twins had been conceived via in vitro fertilization after the woman and her partner had spent more than a year trying to get pregnant the old-fashioned way. A week before, she had had a microarray analysis that peered deeply into the genetic makeup of her twins.\u003c/p>\n\u003cp>Microarray analyzes fetal cells for countless less apparent disorders that occur when a tiny snippet of DNA has been added somewhere it’s not supposed to be or deleted entirely, revealing genetic hiccups that previously could not be detected prenatally. Some of these changes are meaningless; others may be associated with autism or rare disorders such as DiGeorge syndrome, which is characterized by heart problems and a roughly 25 percent risk of developing schizophrenia.\u003c/p>\n\u003cp>As the woman explained, “We made use of technology throughout this process, so it would be a shame not to take advantage of this [test]. I wanted to make sure that, given my age, there was nothing wrong.”\u003c/p>\n\u003cp>She knew that the microarray would reveal all sorts of genetic blips, DNA duplications and deletions too tiny to be seen under a microscope, some of which are associated with worrisome conditions and others of which aren’t understood. The test would also detect major chromosomal problems, of which Down syndrome is the most common.\u003c/p>\n\u003caside class=\"pullquote alignright\">'Just because a patient can know something, must she? What is one of the most joyous times of life has turned into something ominous and fraught, loaded with the potential to go wrong.'\u003c/aside>\n\u003cp>Even at age 40, just 1 of 100 pregnancies results in Down syndrome. And yet the couple beat those odds: one of the twins was confirmed to have the extra 21st chromosome that causes the condition.\u003c/p>\n\u003cp>“You don’t think it’s going to happen to you and then here it is. I still can’t get over the fact. Today we reduced the baby with Down syndrome,” the woman tells me, using a common euphemism for terminating one or more fetuses in cases where a woman is carrying more than she intends to deliver. Many doctors call this “fetal reduction.” She reflects on her decision, made possible by these new tests, as she lowers herself onto an exam table to rest. “I look at this as a sign from God. My mother believes in karma. I think this baby was only meant to be for twelve weeks and his suffering was shortened,” she says. She raises herself up on her elbows and looks at her husband. “Then I feel like, ‘Oh my god, I just killed a baby.’ ”\u003c/p>\n\u003cp>Considering that women have been getting pregnant for a very long time, prenatal diagnosis — the ability to peer inside the womb and emerge with a snapshot of fetal health — is a fairly recent development, a convergence of medical technologies such as amniocentesis and ultrasound with emerging insights about genes and chromosomes. But it’s the legalization of abortion in 1973 that really served as a catalyst for change. After all, without the ability to choose whether or not to continue a pregnancy, knowledge gleaned from prenatal diagnosis would have remained largely theoretical. With the decriminalization of abortion, what to do became a choice.\u003c/p>\n\u003cp>While there are women who’d never opt for an abortion, it’s disingenuous to ignore the fact that terminating a pregnancy is one possible outcome of earlier, more sophisticated genetic tests. The issue of how people feel about disability and, in turn, how that impacts their decisions regarding abortion is an essential aspect of any discussion about advances in prenatal testing.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I don't understand why even women in their twenties aren't undergoing this testing. Knowledge is power.'\u003c/aside>\n\u003cp>Yet abortion remains the elephant in the room when it comes to prenatal testing. When I discuss my work with colleagues and friends interested in the subject, some say, “ You’re not going to mention abortion, are you? My gut tells me that I think you’re walking into a minefield if that becomes a major part of the book.” Others say, “Abortion should definitely be a chapter. How could it not be?”\u003c/p>\n\u003cp>Much of the prenatal testing conversation centers on Down syndrome because the condition is so well- known, unlike others that affect far fewer people. One of every 792 babies born in the United States has Down syndrome. Compared to many other chromosomal conditions, however, Down syndrome is considered a relatively mild genetic complex. Chromosome 21 is the smallest chromosome, so the extra genetic material that accompanies a third copy is not as massive or overwhelming as it would be had it occurred on another, larger chromosome. The genetic disorder that results from a triplication of any chromosome is called a trisomy. A trisomy 22 baby, for example, probably would not make it to birth.\u003c/p>\n\u003cp>Starting in the 1970s, various epidemiologists began making the case that standardizing testing for Down syndrome was a public health priority. Since then, screening for Down syndrome has become broadly accepted by the medical community and, in turn, by many pregnant women and their partners. In 2007, the American College of Obstetrics and Gynecology expanded its prenatal screening recommendations to offer all women, regardless of age, the option of screening and diagnosis for genetic conditions, including Down syndrome.\u003c/p>\n\u003cp>One of the consequences is clear. In 2015, Brian Skotko, who co-directs the Down Syndrome Program at Massachusetts General Hospital, published a comprehensive look at Down syndrome live-birth rates in the United States. Between 2006 and 2010, he and his colleagues calculated that 30 percent fewer babies with Down syndrome were born than were expected, due to elective terminations.\u003c/p>\n\u003cp>Decisions about whether to have a baby with Down syndrome tend to vary geographically and by level of education. In the 2015 study, abortions for reasons of Down syndrome were highest in the Northeast and Hawaii and lowest in the South. Asians were the most likely to terminate due to Down syndrome, while Hispanics and American Indians were the least likely.\u003c/p>\n\u003cfigure id=\"attachment_370960\" class=\"wp-caption aligncenter\" style=\"max-width: 507px\">\u003ca href=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/04/Down-syndrome.jpg\">\u003cimg class=\"size-full wp-image-370960\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/04/Down-syndrome.jpg\" alt=\"\" width=\"507\" height=\"337\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/04/Down-syndrome.jpg 507w, https://ww2.kqed.org/app/uploads/sites/13/2017/04/Down-syndrome-160x106.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/04/Down-syndrome-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/04/Down-syndrome-375x249.jpg 375w\" sizes=\"(max-width: 507px) 100vw, 507px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">A baby girl with Down Syndrome and her mother. \u003ccite>( JGI/Tom Grill/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>The Rise of Noninvasive Prenatal Screening \u003c/strong>\u003c/p>\n\u003cp>Various forms of prenatal testing have been around for decades, but when noninvasive prenatal screening (NIPS) debuted in 2011, its greater accuracy combined with its ease of use contributed to its rapid uptake. In a few short years, NIPS, also called cell-free DNA screening, has become pervasive in the prenatal-testing market. Rather than face off with a long needle or catheter guided through the cervix or abdomen late in the first trimester, or a long needle in the abdomen in the second trimester, a quick venipuncture can collect enough blood midway through the first trimester to gauge whether the fetus’s chromosomes are intact, with high accuracy and no in utero assault. Within a few weeks of a woman learning she’s pregnant, her blood contains fragments of fetal DNA (NIPS actually detects DNA from the placenta, considered a proxy for fetal DNA, that is free-floating in the mom’s bloodstream). The amount of cell- free DNA from the fetus and mother can then be analyzed to predict Down syndrome (and an increasing number of other chromosomal conditions) with up to 99 percent accuracy — though the concept of accuracy itself is nuanced and complex and fluctuates depending on the age of the mother. NIPS, being a blood test, also sidesteps the very small but still scary risk of miscarriage that accompanies CVS (short for \u003ca href=\"https://www.mayoclinic.org/tests-procedures/chorionic-villus-sampling/basics/definition/prc-20013566\" target=\"_blank\" rel=\"noopener\">chorionic villus sampling\u003c/a>) or amnio.\u003c/p>\n\u003caside class=\"pullquote alignright\">The doctor said: 'I get people coming in here who ... want to know this is 100 percent fine. I can't give you 100 percent. I can give you 80 percent. And I said, \"I'm going to take those odds.\"\u003c/aside>\n\u003cp>Initially reserved for women over 35, NIPS has now spread to younger women as well, and has spawned a $500 million industry expected to balloon to $2 billion by 2020. But who gets the testing ranges widely, depending upon who goes to the doctor in the first place. Lower-income women, due to lack of access, don’t seek out prenatal care nearly as regularly as more well-to-do mothers. If they do, they’re often too far along in their pregnancies to get screened. Due to geographic discrepancies in Medicaid coverage, NIPS or other tests may not be covered. ...\u003c/p>\n\u003cp>Despite its high degree of accuracy, NIPS is not perfect. Nor does it equate with a diagnosis. NIPS is a screening test; it can be complicated by a lower-than-expected fraction of fetal DNA and even by an underlying maternal cancer diagnosis. Only CVS or amnio can offer confirmation. But the message is not always getting across to women — or their doctors. Cases have been reported of women coming close to terminating pregnancies they believed were affected based on NIPS results — only to learn that they were not. Experts blame the companies that market the tests for robust advertising that they say misleads patients — and some physicians — into believing that the results are equivalent to a diagnosis. To address misunderstanding, the American Congress of Obstetricians and Gynecologists issued a statement in 2015 stressing that any positive results need to be confirmed via other tests such as amniocentesis. In other words, ACOG emphasizes, a decision to have an abortion should not be based solely on the results of NIPS.\u003c/p>\n\u003cp>Yet there has been little public conversation about widespread prenatal screening and the “consequences of the transformation of every fetus — and not only the precious fetus produced thanks to complex technological interventions — into an ‘at risk’ entity, extensively tested, measured and evaluated by health professionals,” wrote the science historian Ilana Löwy in a paper about prenatal diagnosis.\u003c/p>\n\u003cp>In an op-ed in The New York Times, “\u003ca href=\"https://opinionator.blogs.nytimes.com/2014/06/04/the-t-m-i-pregnancy/?_r=0\" target=\"_blank\" rel=\"noopener\">The T.M.I. Pregnancy,\u003c/a>” Patricia Volk lamented that all the testing surrounding her daughter-in-law’s supposedly “normal” pregnancy had left them both feeling “guardedly happy.” She recounted a series of scary ultrasound findings that turned out to be nothing, and mused: “Prenatal science has helped a lot [of] people and people-to-be. But just because a patient can know something, must she? Odds are in this baby’s favor, yet every sonogram adds something scary to the pot. What is one of the most joyous times of life has turned into something ominous and fraught, loaded with the potential to go wrong.”\u003c/p>\n\u003cp>Yet one person’s anxiety is another’s sigh of relief. The debate over what testing and how much hinges on so many factors. In fact, two letters to the editor in response to “The T.M.I. Pregnancy” highlight why this push-and-pull is one of the great medical and social conundrums of our time. In one, Alastair Pullen describes his experience declining all testing during his wife’s first pregnancy “for all of the reasons this article mentions.” Halfway through the pregnancy, he and his wife agreed to an ultrasound and discovered their daughter had a fatal condition and would not survive long after birth. “Faced with a horrible decision,” Pullen writes, “we decided to induce preterm labor. Becket was stillborn. The only thing worse would have been if we had had no knowledge of her condition.” Pullen had first decided not to test but ended up grateful he changed his mind. He and his wife welcomed testing in later pregnancies; they now have three healthy children, and, he says, “the barrage of testing affirmed our excitement.”\u003c/p>\n\u003cp>Ingrid Chafee, on the other hand, gave birth when no tests were available. She was shocked when she delivered her firstborn in 1965, only to learn he had hydrocephalus and spina bifida. Surgery repaired much of the damage, but her son — who now holds a doctorate from Oxford — still has physical problems. She concludes: “He has said many times that he is glad that there were no ultrasound tests available at the time of his birth. If there had been, he wouldn’t be here. To know or not to know? It’s up to each to decide.”\u003c/p>\n\u003cp>\u003cstrong>Who Is a Gift and Who a Burden?\u003c/strong>\u003c/p>\n\u003cp>The ethics of abortion are set to become much more complicated as more women have access to powerful genetic tests such as microarray, for these tests can identify genetic flaws that are not readily understood.\u003c/p>\n\u003cp>Microarray had confirmed that the almond skinned woman who had the fetal reduction was carrying one twin with Down syndrome. But in the case of more ambiguous genetic errors in a boy named Ryan Docherty, confirmation was the easy part. It was the interpretation — figuring out the significance of the problems that microarray had detected in utero — that proved difficult.\u003c/p>\n\u003cp>When she was pregnant, Ryan’s mom, Jen Sipress, had a microarray test. You’ll recall that chromosomal microarray analysis can detect deletions and duplications of genetic material — errors that are far smaller than an entire extra chromosome. But just because they’re smaller doesn’t mean they can’t wreak havoc. Some are associated with genetic disorders; many more aren’t associated with anything because they’re so newly discovered or because they don’t appear to be detrimental according to the limited amount of research that exists. Sipress, 42, is a New York City narcotics prosecutor; she thrives on evidence. When her test results came back, the evidence was disconcerting: Ryan, still in utero, had not one but two findings — “variants of uncertain significance” — inherited from his mother and his father. Docherty had passed down a duplication involving six genes, while Sipress had contributed a deletion on chromosome 15 involving four genes. In general, deletions are considered more worrisome than duplications; our bodies can often deal with some extra genetic material, but it’s not as easy to compensate for DNA gone AWOL. To make matters worse, one of the four missing genes had been associated in the medical literature with intellectual and developmental delay. Here’s where things got really confusing: Sipress was missing that same gene and she didn’t appear to be affected at all. She worked hard as the family’s primary income earner, putting drug dealers behind bars. She hadn’t even known she was missing any genes until the microarray results came back. But genes—or their absence — can affect people differently; it’s a phenomenon called “variable expressivity.”\u003c/p>\n\u003cp>Before the amniocentesis to collect fetal cells for the microarray analysis, Sipress and Docherty had decided that were they to learn that their unborn child wouldn’t be able to live independently as an adult, they would end the pregnancy. When they got the results, they leaned toward abortion. After talking to their doctor, Ron Wapner, author of a \u003cem>New England Journal of Medicine\u003c/em> study about microarray’s effectiveness, they changed their minds. As Sipress recalls, Wapner said, “‘I get people coming in here who . . . want to know this is 100 percent fine.’ And he said, ‘I can’t give you 100 percent. I can give you 80 percent.’ And I said, ‘I’m going to take those odds.’ ”\u003c/p>\n\u003cp>Emotionally, it was a terrible time for Sipress and Docherty. Ryan was their first child, and he had been conceived after two rounds of IVF. But Sipress doesn’t regret finding out. “I don’t understand why even women in their 20s aren’t undergoing this testing,” she says. “Knowledge is power. Doesn’t everyone realize that?”\u003c/p>\n\u003cp>It’s certainly made for some awkward conversations with her husband’s family in Scotland, who know about the missing genes. “They ask if there is something wrong with the kid, and I say, ‘Technically, yes, but he’s not exhibiting any symptoms,’ ” says Sipress. To that end, Docherty, who stays home with Ryan, is a vigilant observer. “Are we still worried?” says Docherty. “Absolutely.” It’s easy to attribute every behavioral challenge — Ryan’s not a good sleeper, but neither are lots of babies — to the missing genes. Anticipating this, Wapner has cautioned them against engaging in this sort of genetic determinism. “He said, ‘Go about your business. If you feel something is really wrong, then you act.’ To be honest,” says Docherty, “Ryan doesn’t have a problem, as far as I can see.”\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>To what end are we willing to go to detect disability? Once we find it, is there a dividing line between “good,” or tolerable, disabilities and “bad,” or intolerable, limitations? How do we decide which ones may warrant abortion and which are acceptable? What feels overwhelming to one person— the birth of a child with a genetic disorder— may feel like God’s gift to another. Who are we to judge what — who, more accurately—is a gift and who is a burden?\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/435960/advanced-prenatal-testing-will-mean-more-gut-wrenching-decisions-about-abortion","authors":["byline_futureofyou_435960"],"categories":["futureofyou_452","futureofyou_1","futureofyou_1064"],"tags":["futureofyou_342","futureofyou_1439","futureofyou_587","futureofyou_1275","futureofyou_1015","futureofyou_120","futureofyou_80","futureofyou_1386","futureofyou_1388","futureofyou_520","futureofyou_1389"],"featImg":"futureofyou_436849","label":"futureofyou"},"futureofyou_434900":{"type":"posts","id":"futureofyou_434900","meta":{"index":"posts_1591205157","site":"futureofyou","id":"434900","score":null,"sort":[1502898475000]},"guestAuthors":[],"slug":"white-supremacists-not-happy-when-dna-tests-reveal-non-white-ancestry","title":"White Supremacists Not Happy When DNA Tests Reveal Non-White Ancestry","publishDate":1502898475,"format":"aside","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp class=\"danger-zone\">It was a strange moment of triumph against racism: The gun-slinging white supremacist Craig Cobb, dressed up for \u003ca href=\"https://www.youtube.com/watch?v=p-XDKiO-i4Q\" target=\"_blank\" rel=\"noopener noreferrer\">daytime TV\u003c/a> in a dark suit and red tie, hearing that his DNA testing revealed his ancestry to be only “86 percent European, and … 14 percent Sub-Saharan African.” The studio audience whooped and laughed and cheered. And Cobb — who was, in 2013, \u003ca href=\"http://www.huffingtonpost.com/2013/11/19/craig-cobb-arrested_n_4299828.html\" target=\"_blank\" rel=\"noopener noreferrer\">charged\u003c/a> with terrorizing people while trying to create an all-white enclave in North Dakota — reacted like a sore loser in the schoolyard.\u003c/p>\n\u003cp class=\"danger-zone\">“Wait a minute, wait a minute, hold on, just wait a minute,” he said, trying to put on an all-knowing smile. “This is called statistical noise.”\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=pLoel5EKT34&t=97s&ab_channel=TheYoungTurks\u003c/p>\n\u003cp class=\"danger-zone\">Then, according to the \u003ca href=\"https://www.splcenter.org/hatewatch/2015/03/10/craig-cobb-continues-fighting-prove-he%E2%80%99s-actually-white\" target=\"_blank\" rel=\"noopener noreferrer\">Southern Poverty Law Center\u003c/a>, he took to the white nationalist website Stormfront to dispute those results. That’s not uncommon: With the rise of spit-in-a-cup genetic testing, there’s a trend of white nationalists using these services to prove their racial identity, and then using online forums to discuss the results.\u003c/p>\n\u003cp class=\"danger-zone\">But like Cobb, many are disappointed to find out that their ancestry is not as “white” as they’d hoped. In a new study, sociologists Aaron Panofsky and Joan Donovan examined years’ worth of posts on Stormfront to see how members dealt with the news.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"danger-zone\">It’s striking, they say, that white nationalists would post these results online at all. After all, as Panofsky put it, “they will basically say if you want to be a member of Stormfront you have to be 100 percent white European, not Jewish.”\u003c/p>\n\u003cp>But instead of rejecting members who get contrary results, Donovan said, the conversations are “overwhelmingly” focused on helping the person to rethink the validity of the genetic test. And some of those critiques — while emerging from deep-seated racism — are close to scientists’ own qualms about commercial genetic ancestry testing.\u003c/p>\n\u003cp>Panofsky and Donovan presented their findings at a sociology conference in Montreal on Monday. The timing of the talk — some 48 hours after the violent white nationalist rally in Charlottesville, Va. — was coincidental. But the analysis provides a useful, if frightening, window into how these extremist groups think about their genes.\u003c/p>\n\u003ch2>\u003cstrong>Reckoning with results\u003c/strong>\u003c/h2>\n\u003cp>Stormfront was launched in the mid-1990s by \u003ca href=\"http://www.businessinsider.com/trump-helping-white-supremacist-website-2015-12\" target=\"_blank\" rel=\"noopener noreferrer\">Don Black\u003c/a>, a former grand wizard of the Ku Klux Klan. His skills in computer programming were directly related to his criminal activities: He learned them while in prison for trying to invade the Caribbean island nation of Dominica in 1981, and then worked as a web developer after he got out. That means this website dates back to the early years of the internet, forming a kind of deep archive of online hate.\u003c/p>\n\u003cp>To find relevant comments in the 12 million posts written by over 300,000 members, the authors enlisted a team at the University of California, Los Angeles, to search for terms like “DNA test,” “haplotype,” “23andMe,” and “National Geographic.” Then the researchers combed through the posts they found, not to mention many others as background. Donovan, who has moved from UCLA to the \u003ca href=\"https://datasociety.net/\" target=\"_blank\" rel=\"noopener noreferrer\">Data & Society Research Institute\u003c/a>, estimated that she spent some four hours a day reading Stormfront in 2016. The team winnowed their results down to 70 discussion threads in which 153 users posted their genetic ancestry test results, with over 3,000 individual posts.\u003c/p>\n\u003cp>About a third of the people posting their results were pleased with what they found. “Pretty damn pure blood,” said a user with the username Sloth. But the majority didn’t find themselves in that situation. Instead, the community often helped them reject the test, or argue with its results.\u003c/p>\n\u003cp>Some rejected the tests entirely, saying that an individual’s knowledge about his or her own genealogy is better than whatever a genetic test can reveal. “They will talk about the mirror test,” said Panofsky, who is a sociologist of science at UCLA’s Institute for Society and Genetics. “They will say things like, ‘If you see a Jew in the mirror looking back at you, that’s a problem; if you don’t, you’re fine.'” Others, he said, responded to unwanted genetic results by saying that those kinds of tests don’t matter if you are truly committed to being a white nationalist. Yet others tried to discredit the genetic tests as a Jewish conspiracy “that is trying to confuse true white Americans about their ancestry,” Panofsky said.\u003c/p>\n\u003cp>But some took a more scientific angle in their critiques, calling into doubt the method by which these companies determine ancestry — specifically how companies pick those people whose genetic material will be considered the reference for a particular geographical group.\u003c/p>\n\u003cp>And that criticism, though motivated by very different ideas, is one that some researchers have made as well, even as other scientists have used similar data to better understand how populations move and change.\u003c/p>\n\u003cp>“There is a mainstream critical literature on genetic ancestry tests — geneticists and anthropologists and sociologists who have said precisely those things: that these tests give an illusion of certainty, but once you know how the sausage is made, you should be much more cautious about these results,” said Panofsky.\u003c/p>\n\u003ch2>A community’s genetic rules\u003c/h2>\n\u003cp>Companies like Ancestry.com and 23andMe are meticulous in how they analyze your genetic material. As points of comparison, they use both preexisting datasets as well as some reference populations that they have recruited themselves. The protocol includes genetic material from thousands of individuals, and looks at thousands of genetic variations.\u003c/p>\n\u003cp>“When a 23andMe research participant tells us that they have four grandparents all born in the same country — and the country isn’t a colonial nation like the U.S., Canada, or Australia — that person becomes a candidate for inclusion in the reference data,” explained Jhulianna Cintron, a product specialist at 23andMe. Then, she went on, the company excludes close relatives, as that could distort the data, and removes outliers whose genetic data don’t seem to match with what they wrote on their survey.\u003c/p>\n\u003cp>But specialists both inside and outside these companies recognize that the geopolitical boundaries we use now are pretty new, and so consumers may be using imprecise categories when thinking about their own genetic ancestry within the sweeping history of human migration. And users’ ancestry results can change depending on the dataset to which their genetic material is being compared — a fact which some Stormfront users said they took advantage of, uploading their data to various sites to get a more “white” result.\u003c/p>\n\u003cp>J. Scott Roberts, an associate professor at the University of Michigan, who has studied consumer use of genetic tests and was not involved with the study, said the companies tend to be reliable at identifying genetic variants. Interpreting them in terms of health risk or ancestry, though, is another story. “The science is often murky in those areas and gives ambiguous information,” he said. “They try to give specific percentages from this region, or x percent disease risk, and my sense is that that is an artificially precise estimate.”\u003c/p>\n\u003cp>For the study authors, what was most interesting was to watch this online community negotiating its own boundaries, rethinking who counts as “white.” That involved plenty of contradictions. They saw people excluded for their genetic test results, often in very nasty (and unquotable) ways, but that tended to happen for newer members of the anonymous online community, Panofsky said, and not so much for longtime, trusted members. Others were told that they could remain part of white nationalist groups, in spite of the ancestry they revealed, as long as they didn’t “mate,” or only had children with certain ethnic groups. Still others used these test results to put forth a twisted notion of diversity, one “that allows them to say, ‘No, we’re really diverse and we don’t need non-white people to have a diverse society,'” said Panofsky.\u003c/p>\n\u003cp>That’s a far cry from the message of reconciliation that genetic ancestry testing companies hope to promote.\u003c/p>\n\u003cp>“Sweetheart, you have a little black in you,” the talk show host Trisha Goddard told Craig Cobb on that day in 2013. But that didn’t stop him from redoing the test with a different company, trying to alter or parse the data until it matched his racist worldview.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/16/white-nationalists-genetic-ancestry-test/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"White nationalists are using genetic testing to prove their racial identity, and many question the validity of the tests when they come back with results they don't like.","status":"publish","parent":0,"modified":1502911613,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":19,"wordCount":1506},"headData":{"title":"White Supremacists Not Happy When DNA Tests Reveal Non-White Ancestry | KQED","description":"White nationalists are using genetic testing to prove their racial identity, and many question the validity of the tests when they come back with results they don't like.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"434900 https://ww2.kqed.org/futureofyou/?p=434900","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/08/16/white-supremacists-not-happy-when-dna-tests-reveal-non-white-ancestry/","disqusTitle":"White Supremacists Not Happy When DNA Tests Reveal Non-White Ancestry","nprByline":"Eric Boodman\u003cbr/>\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/434900/white-supremacists-not-happy-when-dna-tests-reveal-non-white-ancestry","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">It was a strange moment of triumph against racism: The gun-slinging white supremacist Craig Cobb, dressed up for \u003ca href=\"https://www.youtube.com/watch?v=p-XDKiO-i4Q\" target=\"_blank\" rel=\"noopener noreferrer\">daytime TV\u003c/a> in a dark suit and red tie, hearing that his DNA testing revealed his ancestry to be only “86 percent European, and … 14 percent Sub-Saharan African.” The studio audience whooped and laughed and cheered. And Cobb — who was, in 2013, \u003ca href=\"http://www.huffingtonpost.com/2013/11/19/craig-cobb-arrested_n_4299828.html\" target=\"_blank\" rel=\"noopener noreferrer\">charged\u003c/a> with terrorizing people while trying to create an all-white enclave in North Dakota — reacted like a sore loser in the schoolyard.\u003c/p>\n\u003cp class=\"danger-zone\">“Wait a minute, wait a minute, hold on, just wait a minute,” he said, trying to put on an all-knowing smile. “This is called statistical noise.”\u003c/p>\u003c/p>\u003cp>\u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutube'>\n \u003cspan class='utils-parseShortcode-shortcodes-__youtubeShortcode__embedYoutubeInside'>\n \u003ciframe\n loading='lazy'\n class='utils-parseShortcode-shortcodes-__youtubeShortcode__youtubePlayer'\n type='text/html'\n src='//www.youtube.com/embed/pLoel5EKT34'\n title='//www.youtube.com/embed/pLoel5EKT34'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp class=\"danger-zone\">Then, according to the \u003ca href=\"https://www.splcenter.org/hatewatch/2015/03/10/craig-cobb-continues-fighting-prove-he%E2%80%99s-actually-white\" target=\"_blank\" rel=\"noopener noreferrer\">Southern Poverty Law Center\u003c/a>, he took to the white nationalist website Stormfront to dispute those results. That’s not uncommon: With the rise of spit-in-a-cup genetic testing, there’s a trend of white nationalists using these services to prove their racial identity, and then using online forums to discuss the results.\u003c/p>\n\u003cp class=\"danger-zone\">But like Cobb, many are disappointed to find out that their ancestry is not as “white” as they’d hoped. In a new study, sociologists Aaron Panofsky and Joan Donovan examined years’ worth of posts on Stormfront to see how members dealt with the news.\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 class=\"danger-zone\">It’s striking, they say, that white nationalists would post these results online at all. After all, as Panofsky put it, “they will basically say if you want to be a member of Stormfront you have to be 100 percent white European, not Jewish.”\u003c/p>\n\u003cp>But instead of rejecting members who get contrary results, Donovan said, the conversations are “overwhelmingly” focused on helping the person to rethink the validity of the genetic test. And some of those critiques — while emerging from deep-seated racism — are close to scientists’ own qualms about commercial genetic ancestry testing.\u003c/p>\n\u003cp>Panofsky and Donovan presented their findings at a sociology conference in Montreal on Monday. The timing of the talk — some 48 hours after the violent white nationalist rally in Charlottesville, Va. — was coincidental. But the analysis provides a useful, if frightening, window into how these extremist groups think about their genes.\u003c/p>\n\u003ch2>\u003cstrong>Reckoning with results\u003c/strong>\u003c/h2>\n\u003cp>Stormfront was launched in the mid-1990s by \u003ca href=\"http://www.businessinsider.com/trump-helping-white-supremacist-website-2015-12\" target=\"_blank\" rel=\"noopener noreferrer\">Don Black\u003c/a>, a former grand wizard of the Ku Klux Klan. His skills in computer programming were directly related to his criminal activities: He learned them while in prison for trying to invade the Caribbean island nation of Dominica in 1981, and then worked as a web developer after he got out. That means this website dates back to the early years of the internet, forming a kind of deep archive of online hate.\u003c/p>\n\u003cp>To find relevant comments in the 12 million posts written by over 300,000 members, the authors enlisted a team at the University of California, Los Angeles, to search for terms like “DNA test,” “haplotype,” “23andMe,” and “National Geographic.” Then the researchers combed through the posts they found, not to mention many others as background. Donovan, who has moved from UCLA to the \u003ca href=\"https://datasociety.net/\" target=\"_blank\" rel=\"noopener noreferrer\">Data & Society Research Institute\u003c/a>, estimated that she spent some four hours a day reading Stormfront in 2016. The team winnowed their results down to 70 discussion threads in which 153 users posted their genetic ancestry test results, with over 3,000 individual posts.\u003c/p>\n\u003cp>About a third of the people posting their results were pleased with what they found. “Pretty damn pure blood,” said a user with the username Sloth. But the majority didn’t find themselves in that situation. Instead, the community often helped them reject the test, or argue with its results.\u003c/p>\n\u003cp>Some rejected the tests entirely, saying that an individual’s knowledge about his or her own genealogy is better than whatever a genetic test can reveal. “They will talk about the mirror test,” said Panofsky, who is a sociologist of science at UCLA’s Institute for Society and Genetics. “They will say things like, ‘If you see a Jew in the mirror looking back at you, that’s a problem; if you don’t, you’re fine.'” Others, he said, responded to unwanted genetic results by saying that those kinds of tests don’t matter if you are truly committed to being a white nationalist. Yet others tried to discredit the genetic tests as a Jewish conspiracy “that is trying to confuse true white Americans about their ancestry,” Panofsky said.\u003c/p>\n\u003cp>But some took a more scientific angle in their critiques, calling into doubt the method by which these companies determine ancestry — specifically how companies pick those people whose genetic material will be considered the reference for a particular geographical group.\u003c/p>\n\u003cp>And that criticism, though motivated by very different ideas, is one that some researchers have made as well, even as other scientists have used similar data to better understand how populations move and change.\u003c/p>\n\u003cp>“There is a mainstream critical literature on genetic ancestry tests — geneticists and anthropologists and sociologists who have said precisely those things: that these tests give an illusion of certainty, but once you know how the sausage is made, you should be much more cautious about these results,” said Panofsky.\u003c/p>\n\u003ch2>A community’s genetic rules\u003c/h2>\n\u003cp>Companies like Ancestry.com and 23andMe are meticulous in how they analyze your genetic material. As points of comparison, they use both preexisting datasets as well as some reference populations that they have recruited themselves. The protocol includes genetic material from thousands of individuals, and looks at thousands of genetic variations.\u003c/p>\n\u003cp>“When a 23andMe research participant tells us that they have four grandparents all born in the same country — and the country isn’t a colonial nation like the U.S., Canada, or Australia — that person becomes a candidate for inclusion in the reference data,” explained Jhulianna Cintron, a product specialist at 23andMe. Then, she went on, the company excludes close relatives, as that could distort the data, and removes outliers whose genetic data don’t seem to match with what they wrote on their survey.\u003c/p>\n\u003cp>But specialists both inside and outside these companies recognize that the geopolitical boundaries we use now are pretty new, and so consumers may be using imprecise categories when thinking about their own genetic ancestry within the sweeping history of human migration. And users’ ancestry results can change depending on the dataset to which their genetic material is being compared — a fact which some Stormfront users said they took advantage of, uploading their data to various sites to get a more “white” result.\u003c/p>\n\u003cp>J. Scott Roberts, an associate professor at the University of Michigan, who has studied consumer use of genetic tests and was not involved with the study, said the companies tend to be reliable at identifying genetic variants. Interpreting them in terms of health risk or ancestry, though, is another story. “The science is often murky in those areas and gives ambiguous information,” he said. “They try to give specific percentages from this region, or x percent disease risk, and my sense is that that is an artificially precise estimate.”\u003c/p>\n\u003cp>For the study authors, what was most interesting was to watch this online community negotiating its own boundaries, rethinking who counts as “white.” That involved plenty of contradictions. They saw people excluded for their genetic test results, often in very nasty (and unquotable) ways, but that tended to happen for newer members of the anonymous online community, Panofsky said, and not so much for longtime, trusted members. Others were told that they could remain part of white nationalist groups, in spite of the ancestry they revealed, as long as they didn’t “mate,” or only had children with certain ethnic groups. Still others used these test results to put forth a twisted notion of diversity, one “that allows them to say, ‘No, we’re really diverse and we don’t need non-white people to have a diverse society,'” said Panofsky.\u003c/p>\n\u003cp>That’s a far cry from the message of reconciliation that genetic ancestry testing companies hope to promote.\u003c/p>\n\u003cp>“Sweetheart, you have a little black in you,” the talk show host Trisha Goddard told Craig Cobb on that day in 2013. But that didn’t stop him from redoing the test with a different company, trying to alter or parse the data until it matched his racist worldview.\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>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/16/white-nationalists-genetic-ancestry-test/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/434900/white-supremacists-not-happy-when-dna-tests-reveal-non-white-ancestry","authors":["byline_futureofyou_434900"],"categories":["futureofyou_1","futureofyou_1064"],"tags":["futureofyou_17","futureofyou_1015","futureofyou_80","futureofyou_1339"],"featImg":"futureofyou_434902","label":"futureofyou"},"futureofyou_345800":{"type":"posts","id":"futureofyou_345800","meta":{"index":"posts_1591205157","site":"futureofyou","id":"345800","score":null,"sort":[1488404055000]},"guestAuthors":[],"slug":"proove-employees-say-company-pushed-unneccesary-inaccurate-genetic-tests","title":"Big Genetics Company Conducted Needless, Inaccurate Tests, Employees Say","publishDate":1488404055,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>For doctors, \u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p2/a340190\" target=\"_blank\">the brochure\u003c/a> from a California medical laboratory sounded like easy money: $30 for every person enrolled in a study of genetic tests meant to help select the best pain medication for each patient. A typical physician could make $144,000 a year in “research fees.”\u003c/p>\n\u003cp>But the clinical trial was largely a ploy to boost \u003ca href=\"https://www.proove.com/\" target=\"_blank\">Proove Biosciences’s\u003c/a> revenues, and many of the doctors who signed up did no actual work, say current and former employees.\u003c/p>\n\u003cp>Proove has grown rapidly by tapping into the public angst over surging opioid addiction. It is one of many companies touting personalized DNA-based tests backed by little or no credible scientific data showing their reliability. That’s because a regulatory loophole has left huge swaths of the multibillion-dollar genetic testing industry largely free of government oversight.\u003c/p>\n\u003cp>[contextly_sidebar id=\"Uz4xTjqnrRiF1ro9zctmTWf7ka4Kpqr6\"]A STAT investigation found that Proove employees stationed in physicians’ offices pushed unnecessary tests on patients — a practice called “coercion” by one former manager — and they sometimes completed research evaluation forms on behalf of doctors, rating the tests as highly effective when they weren’t. In fact, Proove tests of DNA captured by swabbing inside a patient’s cheek were so unreliable that many physicians disregarded the results. There was scant evidence, said the company’s former chief scientist, that the tests improved patient outcomes.\u003c/p>\n\u003cp>The company, located in two modern buildings in a burgeoning life sciences corridor in Irvine, Calif., also billed insurers in misleading ways to bump up payments, according to current and former employees and copies of insurance forms.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Promoting itself as the “leader in personalized pain medicine,” Proove claims its tests predict how patients will react to pain medicines and who might become dependent on opioids.\u003c/p>\n\u003cp>The company has enjoyed glowing television news \u003ca href=\"http://www.cnbc.com/2016/09/07/the-genetic-test-that-can-help-fix-americas-opioid-painkiller-addiction.html\" target=\"_blank\">coverage\u003c/a> suggesting it can help combat the opioid crisis. Current and former employees and doctors who worked with Proove called such portrayals the product of hype generated by CEO Brian Meshkin, who lacks a background in science and is known for his consummate sales abilities and talent for self-promotion.\u003c/p>\n\u003cp>Meshkin is “in it for the money. He wanted to swab as many people as possible,” regardless of medical need, said Beth Stevens, a former Proove manager who left the company last year after clashing with the CEO. “He wanted people who had a cold to be swabbed for opioid risk.”\u003c/p>\n\u003cp>Meshkin declined an interview request and responded to only one of many written questions. In an emailed statement, he said, “Proove is acting within the confines of the law … [and intends] to follow both the letter and spirit of the law.”\u003c/p>\n\u003cp>But legal experts told STAT that the way the company pays physicians involved in two ongoing Proove trials — both key to the firm’s monthly revenues of roughly $2 million — might violate anti-kickback laws.\u003c/p>\n\u003cp>STAT began its examination of Proove late last year, after being contacted by current and former employees who had read an \u003ca href=\"https://www.statnews.com/2016/12/13/proove-opioid-risk-test/\" target=\"_blank\">article\u003c/a> about the dearth of evidence supporting the company’s flagship opioid risk test. The investigation included interviews with 12 current and former employees and four doctors who worked with Proove. STAT also obtained thousands of pages of internal memos, billing and insurance records, and reports of test results.\u003c/p>\n\u003cp>Separately, the FBI and the Office of Inspector General of the Department of Health and Human Services are investigating possible criminal wrongdoing by Proove, according to a former and a current employee who said they were recently interviewed by federal agents. They said the agents were focused on possible kickbacks involving payments to doctors. The FBI and HHS declined to comment.\u003c/p>\n\u003cp>The government has been concerned about companies marketing tests under the guise of research for several years. In 2014, HHS issued a \u003ca href=\"https://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/OIG_SFA_Laboratory_Payments_06252014.pdf\" target=\"_blank\">fraud alert\u003c/a> warning laboratories that some ways of paying doctors for “research” might violate laws against kickbacks for lab test referrals. The alert followed a spate of cases involving allegedly improper payments to doctors by laboratory companies.\u003c/p>\n\u003caside class=\"pullquote alignright\">[Meshkin] 'is in it for the money. He wanted to swab as many people as possible.'\u003ccite>Beth Stevens, a former Proove manager\u003c/cite>\u003c/aside>\n\u003cp>In response to the HHS alert, \u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p3/a340191\" target=\"_blank\">Proove’s legal counsel drafted a memo\u003c/a> for executives and sales staff stipulating that company practices complied with the law. Among other arguments, it said Proove compensates doctors only for research they personally perform. But current and former employees and doctors who worked with Proove have since disputed that claim.\u003c/p>\n\u003cp>Dr. Titus Taube, a family practitioner in Warner Robins, Ga., said in an interview that when he signed up as a Proove researcher, “It sounded like it was the wave of the future.” He said he quickly became disillusioned and concluded that the pay was for referring patients to Proove for tests because the research tasks, including filling out questionnaires and assessing the tests’ efficacy, were done by a Proove employee at his office.\u003c/p>\n\u003cp>If doctors who order tests receive improper financial inducements through a research program — such as compensation without working or payments based on the volume of referrals they make — the company and doctors might be violating federal and state laws against kickbacks or other fraud, said Dr. R. Gregory Cochran, a physician and attorney with expertise on those statutes. Promoting inaccurate or unreliable tests could also leave a company vulnerable to claims of fraud and abuse, he said.\u003c/p>\n\u003cp>Proove conducts “laboratory developed tests” — designed and used inside a single company or hospital lab — that can be sold as long as they are ordered by a doctor. Last year, the Silicon Valley blood-testing firm \u003ca href=\"https://www.statnews.com/2017/01/12/arizona-theranos-lawsuit/\" target=\"_blank\">Theranos\u003c/a> became Exhibit A of \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/07/14/the-rise-and-fall-of-theranos-a-cartoon-history/\">what can go wrong with these tests\u003c/a>: Its claims of rapid diagnosis of dozens of diseases from a tiny vial of blood were exposed as overblown. Theranos is now the subject of a federal criminal probe.\u003c/p>\n\u003cp>The Food and Drug Administration warned in 2015 that some laboratory developed tests harm patients by leading to erroneous diagnoses and treatments. But the agency \u003ca href=\"https://www.statnews.com/2016/11/18/fda-lab-test-loophole/\" target=\"_blank\">withdrew\u003c/a> proposed regulatory guidelines for these tests late last year, deferring to President Trump’s yet-to-be named FDA commissioner and Congress to decide what, if any, rules to put in place.\u003c/p>\n\u003cp>“The current gaps in oversight … pose a challenge for the continued evolution of precision medicine,” undermining patient and physician confidence and potentially slowing the adoption of validated tests, said Andrew Fish, who directs AdvaMedDx, a trade group for leading diagnostic-test developers.\u003c/p>\n\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe width=\"600\" height=\"338\" src=\"//content.jwplatform.com/players/vTPizGb8-jEuQjxp9.html\" frameborder=\"0\" scrolling=\"no\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>For now at least, Proove and similar companies can sell tests without having to show that results are valid and meaningful. STAT obtained \u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p7/a340193\" target=\"_blank\">Proove laboratory reports\u003c/a> with gene-test results for six patients that included numerous incompatible clinical recommendations.\u003c/p>\n\u003cp>In one case — called typical by former and current employees — a report cautioned that a patient was highly susceptible to breathing problems when given the \u003ca href=\"https://www.statnews.com/2016/09/29/fentanyl-heroin-photo-fatal-doses/\" target=\"_blank\">powerful synthetic opioid fentanyl\u003c/a>, yet suggested a normal dose. The records do not show if fentanyl was prescribed, or if the patient suffered harm from the recommendation.\u003c/p>\n\u003cp>Christopher Coston, who managed Proove research assistants in western states until his job was eliminated last March, said “a lot of doctors looked at the reports and said, ‘I don’t think so. This doesn’t make sense.’”\u003c/p>\n\u003cp>Dr. Oleg Gavrilyuk, a San Diego physical medicine specialist, defended Proove. Tests of how his patients would respond to particular drugs validate his clinical judgment most of the time, he said. When they don’t, he ignores the results.\u003c/p>\n\u003cp>Ford created the first car,” he said. “Of course it was not perfect. Now Tesla is the state of the art. You cannot choke development based on the idea that it’s not perfect. It’s the first step.”\u003c/p>\n\u003cp>Proove’s first clinical \u003ca href=\"http://www.journalofpsychiatricresearch.com/article/S0022-3956(16)30304-1/abstract\" target=\"_blank\">study\u003c/a> subjected to peer review, based on data from 134 patients, wasn’t published until late January in the Journal of Psychiatric Research. It found that doctors said most patients improved after treatment decisions guided by a Proove pain-perception test.\u003c/p>\n\u003cp>Dr. Eric Fung, a biotech executive who briefly served as the firm’s chief scientific officer in 2015 and coauthored the study, said in an interview that it emerged from an effort to mine Proove’s database of tens of thousands of patient records for evidence of some kind of testing benefit. He acknowledged that the lack of a comparison group, made up of patients who did not get the test, weakens the findings.\u003c/p>\n\u003cp>Fung added that he left the company over doubts about the utility of its tests.\u003c/p>\n\u003cp>“I could not find a good statistical or clinical benefit for these tests,” he said. “I didn’t feel comfortable with the science being done at Proove.”\u003c/p>\n\u003ch2>A push to swab every patient\u003c/h2>\n\u003cp>The questionable science hasn’t stopped Meshkin from building the privately held Proove into what Deloitte Consulting and Inc. magazine call one of the nation’s fastest-growing businesses. His formula is simple: recruit doctors as paid “researchers,” providing them with a financial stake in ordering tests for their patients.\u003c/p>\n\u003cp>Here is how it works, according to current and former employees: Proove conducts large trials — two in progress aim to test 150,000 patients — that ask clinicians to rate how much various Proove tests help patients.\u003c/p>\n\u003cp>Company sales representatives pitch research contracts to doctors, often targeting financially troubled practices that need a new revenue stream. They promise steady income for light work. Meshkin said last year that about 150 doctors had signed on, out of 400 who order Proove tests. But there has been substantial turnover as dissatisfied doctors drop out.\u003c/p>\n\u003cp>Proove places some of its 300 employees inside doctor’s offices, and instructs them to try to collect cheek-swab DNA samples from each patient and recruit them for clinical trials. Patients are informed that trial participants will not be billed for test fees, according to a current Proove employee. They also are supposed to tell patients their doctor has insisted on the tests.\u003c/p>\n\u003cp>Even patients without pain, seen at family medicine and OB-GYN practices, were enlisted for pain- and addiction-related tests, Coston said. It seemed illogical, the former regional manager said, but Meshkin became angry when research assistants failed to sign up every patient.\u003c/p>\n\u003cp>Many doctors “would test every single soul who walked in,” said Coston. “But they didn’t do research. The doctor is steadily getting paid, and did nothing to deserve it except ‘rent’ space” to Proove.\u003c/p>\n\u003cp>Research assistants completed all research tasks at least half the time, said Stevens and other managers who supervised the assistants. Asked whether doctors profited from work they didn’t do, she said, “If it quacks like duck and it walks like a duck, it is.”\u003c/p>\n\u003cp>Stevens said each research assistant had a quota of at least five cheek swabs a day. Documents obtained by STAT show they were offered escalating cash bonuses for meeting numerical goals above the quota.\u003c/p>\n\u003cp>Stevens called Meshkin’s tactics to push tests on patients who didn’t need them “coercion.”\u003c/p>\n\u003cp>To avoid disrupting the flow of patients into exam rooms, the research assistants fly through patient surveys and consent forms. This leaves some patients feeling bullied, several former and current employees said.\u003c/p>\n\u003cfigure id=\"attachment_346445\" class=\"wp-caption alignright\" style=\"max-width: 328px\">\u003cimg class=\"wp-image-346445 size-full\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/03/meshkin.jpg\" alt=\"meshkin\" width=\"328\" height=\"420\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/03/meshkin.jpg 328w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/meshkin-160x205.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/meshkin-240x307.jpg 240w\" sizes=\"(max-width: 328px) 100vw, 328px\">\u003cfigcaption class=\"wp-caption-text\">Brian Meshkin, President and CEO of Proove Bioscience \u003ccite>(Howard County Library System/Creative Commons)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Some research assistants grew uneasy with the high-pressure tactics and quit. “People got tired of trying to get patients to participate who didn’t want to participate,” Stevens said.\u003c/p>\n\u003cp>Recruitment of patients became increasingly scripted and sales-oriented, said a current employee who spoke anonymously for fear of reprisals. Research assistants were told to avoid the word “study” when signing patients up for a trial, the employee said, after some objected to being used as “guinea pigs.”\u003c/p>\n\u003cp>The title “research assistant” was even changed to “patient engagement representative,” and Meshkin told managers to find attractive young people to fill that role, according to a former manager who spoke anonymously, citing a confidentiality agreement.\u003c/p>\n\u003cp>Crucially, Proove urges all doctors — whether participating in a trial or not — to sign a “\u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p18/a340196\" target=\"_blank\">standing order\u003c/a>” for all their patients to get any Proove genetic tests, such as those for risk of opioid abuse, pain sensitivity, and response to opioids and other drugs.\u003c/p>\n\u003cp>Many doctors have been reluctant to sign. But by 2015 about 70 percent had done so under pressure from Meshkin, said the former manager. Examples of orders obtained by STAT authorize Proove research assistants to collect DNA from any patient under the doctor’s care.\u003c/p>\n\u003cp>Meshkin emphasized that under a standing order, the decision to be tested “is not up to [the patients], it’s up to the doctors,” Stevens said — that patients “don’t have a choice.”\u003c/p>\n\u003cp>Standing orders are common in medicine, although not in such circumstances. Doctors often issue standing orders to streamline care when patients need regular tests or treatments for a known chronic condition. Such orders rarely apply to a wide range of genetic tests for all patients in a diverse practice.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I could not find a good statistical or clinical benefit for these tests. I didn’t feel comfortable with the science being done at Proove.'\u003ccite>Dr. Eric Fung, former Chief Scientific Officer at Proove Biosciences\u003c/cite>\u003c/aside>\n\u003cp>Standing orders “are often a red flag, particularly in a situation, like here, where the patients have varying diagnoses and needs,” said Cochran, associate director of a joint health policy and law degree program at the University of California, San Francisco, and UC Hastings College of the Law. “There’s absolutely a kickback concern if the doctor knows he’s going to get a check based on the number of patients who sign up and get tested.”\u003c/p>\n\u003cp>In his written statement, Meshkin said, “Proove seeks to ensure that each participating clinician independently determines the medical necessity” for tests, “and that every patient signs an informed consent to have the testing performed.”\u003c/p>\n\u003ch2>Meshkin spins a good story\u003c/h2>\n\u003cp>The man behind the Proove enterprise has an elaborate personal \u003ca href=\"http://www.brianmeshkin.com/\" target=\"_blank\">website\u003c/a>, featuring flattering photos of himself and his family. Effusive language praises his character, business acumen, and civic accomplishments as a former school board member, and the site lists his accolades, including an “Entrepreneur of the Year” award from the Orange County Business Journal in Southern California.\u003c/p>\n\u003cp>“Volunteer. Public Servant. Entrepreneur. Coach. There are many words used to describe Brian Meshkin. But if you ask Brian, he’s just Brian — a guy who works hard, dreams big, and rolls up his sleeves to help others,” the site’s unsigned biography begins.\u003c/p>\n\u003cp>He also calls himself a “published researcher,” although he lacks any formal scientific training, and says nothing about the legal problems of a previous genetic testing venture.\u003c/p>\n\u003cp>That “nutrigenomics” company sold genetically customized dietary supplements through Las Vegas spas and directly to consumers. In an interview last year, Meshkin said he sold that company, Salugen, in 2009, soon after California authorities sent a cease-and-desist letter for improper marketing.\u003c/p>\n\u003cp>Former and current Proove doctors and employees said the site aptly captures a man who deeply believes in himself and grasps the power of spinning a good story.\u003c/p>\n\u003cp>Meshkin has been listed as a coauthor on study abstracts, Proove posters presented at scientific meetings, and the recently published study. His involvement in research was one of the reasons that Dr. Daniel A. Schwarz, Proove’s former research and development director, said he decided to resign.\u003c/p>\n\u003cp>A Michigan pain specialist, Schwarz said he left Proove in 2015 over concerns about the company’s lack of scientific integrity. “You can’t have a CEO trying to run the science who doesn’t have a science background,” he said. “It was marketing. It wasn’t science, and I couldn’t be a part of that.”\u003c/p>\n\u003cp>Schwarz said scientific control became a key issue when he began to doubt the validity of Proove’s work and wanted to repair the company’s research and development. Meshkin “wasn’t listening,” he said. “He didn’t take the advice, and I felt that he just wanted to do it his way.”\u003c/p>\n\u003cp>Schwarz also grew alarmed when coworkers said patient research records were not stored securely. Another former Proove executive, who requested anonymity due to a confidentiality agreement, said data sheets languished for long periods, stacked in heaps at Proove’s main office.\u003c/p>\n\u003cp>“The patient comes first, and if you have a product where you are not doing the right thing by the patient, I can’t be a part of it,” Schwarz said.\u003c/p>\n\u003cp>According to Stevens, company insiders hoped for vast improvements after Fung, a respected biotech executive who earned his MD and PhD degrees at Johns Hopkins University, was hired with fanfare in 2015.\u003c/p>\n\u003cp>“I remember one of the clinical people who worked underneath [Fung] said to me, ‘If he leaves this company, we all need to go,’” Stevens said.\u003c/p>\n\u003cp>Fung quit after three months.\u003c/p>\n\u003ch2>‘Can I trust the data?’\u003c/h2>\n\u003cp>Taube, the Georgia family doctor, said he saw firsthand how untrustworthy Proove’s tests and studies are. He signed on with Proove about four months ago after he was approached by a sales rep. Taube said he was intrigued by Proove’s ideas for advancing precision medicine and impressed by the support of Medicare and other insurers, described by Proove as study “sponsors.”\u003c/p>\n\u003cp>At first, he filled out the research forms himself, including an “investigator intervention evaluation” used to assess whether Proove tests helped patients or affected their care. But he said Proove managers told him, “No, no, [the Proove employee] will take care of it.”\u003c/p>\n\u003cp>This practice was widely adopted after some doctors filled out research forms partially or not at all, but still expected to be paid, said a former Proove executive who spoke anonymously due to a confidentiality agreement.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It was marketing. It wasn’t science, and I couldn’t be a part of that.’\u003ccite>Dr. Daniel A. Schwarz, Proove’s former research and development director\u003c/cite>\u003c/aside>\n\u003cp>Taube then would sign the evaluations prepared by a Proove research assistant without giving them a close look. But he began to view the clinical trials as mostly marketing and looked more closely at the evaluations he signed. He was startled to see that Proove tests always received top ratings, though they were having little impact on his practice.\u003c/p>\n\u003cp>The results often were refuted by a patient’s experience, he said. For example, they showed that several of his patients should not take losartan, a blood pressure medicine, because they metabolized it poorly. But they had taken it successfully for years.\u003c/p>\n\u003cp>Taube recently stopped signing up new patients for Proove, saying he wondered, “Can I trust the data?”\u003c/p>\n\u003cp>His experience was typical, according to current and former Proove employees. They said Proove managers told representatives always to rate tests a 4 or 5 on a 5-point scale of benefit to the patient, even when a test had no bearing on clinical care.\u003c/p>\n\u003cp>Another former Proove executive, who also signed a confidentiality agreement, said even the principal investigator of a 50,000-patient Proove clinical trial — Dr. Daniel R. Kendall, a McLean, Va., osteopath for National Spine & Pain Centers — didn’t rely on the tests. The former executive said an audit of 1,500 patient charts from Kendall’s practice showed no changes in care based on Proove tests.\u003c/p>\n\u003cp>Via email, Kendall disputed that conclusion. He would not provide the audit and referred all questions to Proove. In his email statement, Meshkin said National Spine & Pain Center patients showed “significant improvement in treatment,” but did not provide any details.\u003c/p>\n\u003ch2>Profit innovation: ‘unbundled’ charges\u003c/h2>\n\u003cp>Clinical trials helped increase testing, but insurers often rejected claims, leading Proove to devise another way to pump up its bottom line: creative billing.\u003c/p>\n\u003cp>Insurers deem many Proove tests experimental due to a lack of evidence that they could aid diagnosis or treatment of the patient. One consequence of the denials, said some former employees, is that Proove periodically stops paying many sales reps and even fires them.\u003c/p>\n\u003cp>Proove also has failed to pay many physicians, including Taube, for research services — even doctors who actually did the work. Coston called it “the main thing I was getting yelled about by my doctors.” Taube said the company blamed slow insurance reimbursements.\u003c/p>\n\u003cp>By 2014, Proove could complete numerous tests using a single cheek swab. But insurance payments were less than what the company thought it could get for the same tests if they had been billed based on several different swabs, said current and former employees.\u003c/p>\n\u003cp>So Proove adopted a new billing strategy in 2015. \u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p19\" target=\"_blank\">Documents show\u003c/a> that instead of submitting an invoice for multiple genetic tests from one date of service — when the patient’s cheek was swabbed — Proove “unbundled” the charges, dividing them up among several invoices keyed to the dates lab reports were issued. Current and former employees said this process has become the norm.\u003c/p>\n\u003cp>The company might bill insurers for its “opioid risk test” on Monday, for its “pain perception” test the following Monday, and so on — suggesting that the patient was tested on several occasions. Combined billings were often in the range of $7,000 to $10,000.\u003c/p>\n\u003cp>A Southern California doctor, who would only comment anonymously, said he kicked Proove out of his practice. “[T]hey billed the insurance four times more than what they told me they would bill initially. … Several patients of mine became very upset at the unreasonable amount of money that they were charging the insurance company,” the doctor said in an email. Such reactions were common among physicians, said current and former employees.Michelle Cavanaugh, an expert with the California-based medical billing firm Kareo, called unbundling “working the system.”\u003c/p>\n\u003cp>“What is the clinical justification for assigning it different dates?” said P. Thomas Hirsch, president of Laboratory Billing Solutions in Portsmouth, N.H., after hearing a description of Proove’s practices. “If they can’t give one, it’s just a scam.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2017/02/28/proove-biosciences-genetic-tests/\" target=\"_blank\">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","blocks":[],"excerpt":"Critics and former employees say Proove Biosciences conducts needless genetic tests while scamming doctors, patients and insurers. ","status":"publish","parent":0,"modified":1488501847,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":81,"wordCount":3868},"headData":{"title":"Big Genetics Company Conducted Needless, Inaccurate Tests, Employees Say | KQED","description":"Critics and former employees say Proove Biosciences conducts needless genetic tests while scamming doctors, patients and insurers. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"345800 https://ww2.kqed.org/futureofyou/?p=345800","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/03/01/proove-employees-say-company-pushed-unneccesary-inaccurate-genetic-tests/","disqusTitle":"Big Genetics Company Conducted Needless, Inaccurate Tests, Employees Say","nprByline":"Charles Piller\u003cbr />\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/345800/proove-employees-say-company-pushed-unneccesary-inaccurate-genetic-tests","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>For doctors, \u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p2/a340190\" target=\"_blank\">the brochure\u003c/a> from a California medical laboratory sounded like easy money: $30 for every person enrolled in a study of genetic tests meant to help select the best pain medication for each patient. A typical physician could make $144,000 a year in “research fees.”\u003c/p>\n\u003cp>But the clinical trial was largely a ploy to boost \u003ca href=\"https://www.proove.com/\" target=\"_blank\">Proove Biosciences’s\u003c/a> revenues, and many of the doctors who signed up did no actual work, say current and former employees.\u003c/p>\n\u003cp>Proove has grown rapidly by tapping into the public angst over surging opioid addiction. It is one of many companies touting personalized DNA-based tests backed by little or no credible scientific data showing their reliability. That’s because a regulatory loophole has left huge swaths of the multibillion-dollar genetic testing industry largely free of government oversight.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>A STAT investigation found that Proove employees stationed in physicians’ offices pushed unnecessary tests on patients — a practice called “coercion” by one former manager — and they sometimes completed research evaluation forms on behalf of doctors, rating the tests as highly effective when they weren’t. In fact, Proove tests of DNA captured by swabbing inside a patient’s cheek were so unreliable that many physicians disregarded the results. There was scant evidence, said the company’s former chief scientist, that the tests improved patient outcomes.\u003c/p>\n\u003cp>The company, located in two modern buildings in a burgeoning life sciences corridor in Irvine, Calif., also billed insurers in misleading ways to bump up payments, according to current and former employees and copies of insurance forms.\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>Promoting itself as the “leader in personalized pain medicine,” Proove claims its tests predict how patients will react to pain medicines and who might become dependent on opioids.\u003c/p>\n\u003cp>The company has enjoyed glowing television news \u003ca href=\"http://www.cnbc.com/2016/09/07/the-genetic-test-that-can-help-fix-americas-opioid-painkiller-addiction.html\" target=\"_blank\">coverage\u003c/a> suggesting it can help combat the opioid crisis. Current and former employees and doctors who worked with Proove called such portrayals the product of hype generated by CEO Brian Meshkin, who lacks a background in science and is known for his consummate sales abilities and talent for self-promotion.\u003c/p>\n\u003cp>Meshkin is “in it for the money. He wanted to swab as many people as possible,” regardless of medical need, said Beth Stevens, a former Proove manager who left the company last year after clashing with the CEO. “He wanted people who had a cold to be swabbed for opioid risk.”\u003c/p>\n\u003cp>Meshkin declined an interview request and responded to only one of many written questions. In an emailed statement, he said, “Proove is acting within the confines of the law … [and intends] to follow both the letter and spirit of the law.”\u003c/p>\n\u003cp>But legal experts told STAT that the way the company pays physicians involved in two ongoing Proove trials — both key to the firm’s monthly revenues of roughly $2 million — might violate anti-kickback laws.\u003c/p>\n\u003cp>STAT began its examination of Proove late last year, after being contacted by current and former employees who had read an \u003ca href=\"https://www.statnews.com/2016/12/13/proove-opioid-risk-test/\" target=\"_blank\">article\u003c/a> about the dearth of evidence supporting the company’s flagship opioid risk test. The investigation included interviews with 12 current and former employees and four doctors who worked with Proove. STAT also obtained thousands of pages of internal memos, billing and insurance records, and reports of test results.\u003c/p>\n\u003cp>Separately, the FBI and the Office of Inspector General of the Department of Health and Human Services are investigating possible criminal wrongdoing by Proove, according to a former and a current employee who said they were recently interviewed by federal agents. They said the agents were focused on possible kickbacks involving payments to doctors. The FBI and HHS declined to comment.\u003c/p>\n\u003cp>The government has been concerned about companies marketing tests under the guise of research for several years. In 2014, HHS issued a \u003ca href=\"https://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/OIG_SFA_Laboratory_Payments_06252014.pdf\" target=\"_blank\">fraud alert\u003c/a> warning laboratories that some ways of paying doctors for “research” might violate laws against kickbacks for lab test referrals. The alert followed a spate of cases involving allegedly improper payments to doctors by laboratory companies.\u003c/p>\n\u003caside class=\"pullquote alignright\">[Meshkin] 'is in it for the money. He wanted to swab as many people as possible.'\u003ccite>Beth Stevens, a former Proove manager\u003c/cite>\u003c/aside>\n\u003cp>In response to the HHS alert, \u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p3/a340191\" target=\"_blank\">Proove’s legal counsel drafted a memo\u003c/a> for executives and sales staff stipulating that company practices complied with the law. Among other arguments, it said Proove compensates doctors only for research they personally perform. But current and former employees and doctors who worked with Proove have since disputed that claim.\u003c/p>\n\u003cp>Dr. Titus Taube, a family practitioner in Warner Robins, Ga., said in an interview that when he signed up as a Proove researcher, “It sounded like it was the wave of the future.” He said he quickly became disillusioned and concluded that the pay was for referring patients to Proove for tests because the research tasks, including filling out questionnaires and assessing the tests’ efficacy, were done by a Proove employee at his office.\u003c/p>\n\u003cp>If doctors who order tests receive improper financial inducements through a research program — such as compensation without working or payments based on the volume of referrals they make — the company and doctors might be violating federal and state laws against kickbacks or other fraud, said Dr. R. Gregory Cochran, a physician and attorney with expertise on those statutes. Promoting inaccurate or unreliable tests could also leave a company vulnerable to claims of fraud and abuse, he said.\u003c/p>\n\u003cp>Proove conducts “laboratory developed tests” — designed and used inside a single company or hospital lab — that can be sold as long as they are ordered by a doctor. Last year, the Silicon Valley blood-testing firm \u003ca href=\"https://www.statnews.com/2017/01/12/arizona-theranos-lawsuit/\" target=\"_blank\">Theranos\u003c/a> became Exhibit A of \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/07/14/the-rise-and-fall-of-theranos-a-cartoon-history/\">what can go wrong with these tests\u003c/a>: Its claims of rapid diagnosis of dozens of diseases from a tiny vial of blood were exposed as overblown. Theranos is now the subject of a federal criminal probe.\u003c/p>\n\u003cp>The Food and Drug Administration warned in 2015 that some laboratory developed tests harm patients by leading to erroneous diagnoses and treatments. But the agency \u003ca href=\"https://www.statnews.com/2016/11/18/fda-lab-test-loophole/\" target=\"_blank\">withdrew\u003c/a> proposed regulatory guidelines for these tests late last year, deferring to President Trump’s yet-to-be named FDA commissioner and Congress to decide what, if any, rules to put in place.\u003c/p>\n\u003cp>“The current gaps in oversight … pose a challenge for the continued evolution of precision medicine,” undermining patient and physician confidence and potentially slowing the adoption of validated tests, said Andrew Fish, who directs AdvaMedDx, a trade group for leading diagnostic-test developers.\u003c/p>\n\u003cp>\u003c!-- iframe plugin v.4.3 wordpress.org/plugins/iframe/ -->\u003cbr>\n\u003ciframe width=\"600\" height=\"338\" src=\"//content.jwplatform.com/players/vTPizGb8-jEuQjxp9.html\" frameborder=\"0\" scrolling=\"no\" class=\"iframe-class\">\u003c/iframe>\u003c/p>\n\u003cp>For now at least, Proove and similar companies can sell tests without having to show that results are valid and meaningful. STAT obtained \u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p7/a340193\" target=\"_blank\">Proove laboratory reports\u003c/a> with gene-test results for six patients that included numerous incompatible clinical recommendations.\u003c/p>\n\u003cp>In one case — called typical by former and current employees — a report cautioned that a patient was highly susceptible to breathing problems when given the \u003ca href=\"https://www.statnews.com/2016/09/29/fentanyl-heroin-photo-fatal-doses/\" target=\"_blank\">powerful synthetic opioid fentanyl\u003c/a>, yet suggested a normal dose. The records do not show if fentanyl was prescribed, or if the patient suffered harm from the recommendation.\u003c/p>\n\u003cp>Christopher Coston, who managed Proove research assistants in western states until his job was eliminated last March, said “a lot of doctors looked at the reports and said, ‘I don’t think so. This doesn’t make sense.’”\u003c/p>\n\u003cp>Dr. Oleg Gavrilyuk, a San Diego physical medicine specialist, defended Proove. Tests of how his patients would respond to particular drugs validate his clinical judgment most of the time, he said. When they don’t, he ignores the results.\u003c/p>\n\u003cp>Ford created the first car,” he said. “Of course it was not perfect. Now Tesla is the state of the art. You cannot choke development based on the idea that it’s not perfect. It’s the first step.”\u003c/p>\n\u003cp>Proove’s first clinical \u003ca href=\"http://www.journalofpsychiatricresearch.com/article/S0022-3956(16)30304-1/abstract\" target=\"_blank\">study\u003c/a> subjected to peer review, based on data from 134 patients, wasn’t published until late January in the Journal of Psychiatric Research. It found that doctors said most patients improved after treatment decisions guided by a Proove pain-perception test.\u003c/p>\n\u003cp>Dr. Eric Fung, a biotech executive who briefly served as the firm’s chief scientific officer in 2015 and coauthored the study, said in an interview that it emerged from an effort to mine Proove’s database of tens of thousands of patient records for evidence of some kind of testing benefit. He acknowledged that the lack of a comparison group, made up of patients who did not get the test, weakens the findings.\u003c/p>\n\u003cp>Fung added that he left the company over doubts about the utility of its tests.\u003c/p>\n\u003cp>“I could not find a good statistical or clinical benefit for these tests,” he said. “I didn’t feel comfortable with the science being done at Proove.”\u003c/p>\n\u003ch2>A push to swab every patient\u003c/h2>\n\u003cp>The questionable science hasn’t stopped Meshkin from building the privately held Proove into what Deloitte Consulting and Inc. magazine call one of the nation’s fastest-growing businesses. His formula is simple: recruit doctors as paid “researchers,” providing them with a financial stake in ordering tests for their patients.\u003c/p>\n\u003cp>Here is how it works, according to current and former employees: Proove conducts large trials — two in progress aim to test 150,000 patients — that ask clinicians to rate how much various Proove tests help patients.\u003c/p>\n\u003cp>Company sales representatives pitch research contracts to doctors, often targeting financially troubled practices that need a new revenue stream. They promise steady income for light work. Meshkin said last year that about 150 doctors had signed on, out of 400 who order Proove tests. But there has been substantial turnover as dissatisfied doctors drop out.\u003c/p>\n\u003cp>Proove places some of its 300 employees inside doctor’s offices, and instructs them to try to collect cheek-swab DNA samples from each patient and recruit them for clinical trials. Patients are informed that trial participants will not be billed for test fees, according to a current Proove employee. They also are supposed to tell patients their doctor has insisted on the tests.\u003c/p>\n\u003cp>Even patients without pain, seen at family medicine and OB-GYN practices, were enlisted for pain- and addiction-related tests, Coston said. It seemed illogical, the former regional manager said, but Meshkin became angry when research assistants failed to sign up every patient.\u003c/p>\n\u003cp>Many doctors “would test every single soul who walked in,” said Coston. “But they didn’t do research. The doctor is steadily getting paid, and did nothing to deserve it except ‘rent’ space” to Proove.\u003c/p>\n\u003cp>Research assistants completed all research tasks at least half the time, said Stevens and other managers who supervised the assistants. Asked whether doctors profited from work they didn’t do, she said, “If it quacks like duck and it walks like a duck, it is.”\u003c/p>\n\u003cp>Stevens said each research assistant had a quota of at least five cheek swabs a day. Documents obtained by STAT show they were offered escalating cash bonuses for meeting numerical goals above the quota.\u003c/p>\n\u003cp>Stevens called Meshkin’s tactics to push tests on patients who didn’t need them “coercion.”\u003c/p>\n\u003cp>To avoid disrupting the flow of patients into exam rooms, the research assistants fly through patient surveys and consent forms. This leaves some patients feeling bullied, several former and current employees said.\u003c/p>\n\u003cfigure id=\"attachment_346445\" class=\"wp-caption alignright\" style=\"max-width: 328px\">\u003cimg class=\"wp-image-346445 size-full\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/03/meshkin.jpg\" alt=\"meshkin\" width=\"328\" height=\"420\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/03/meshkin.jpg 328w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/meshkin-160x205.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/03/meshkin-240x307.jpg 240w\" sizes=\"(max-width: 328px) 100vw, 328px\">\u003cfigcaption class=\"wp-caption-text\">Brian Meshkin, President and CEO of Proove Bioscience \u003ccite>(Howard County Library System/Creative Commons)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Some research assistants grew uneasy with the high-pressure tactics and quit. “People got tired of trying to get patients to participate who didn’t want to participate,” Stevens said.\u003c/p>\n\u003cp>Recruitment of patients became increasingly scripted and sales-oriented, said a current employee who spoke anonymously for fear of reprisals. Research assistants were told to avoid the word “study” when signing patients up for a trial, the employee said, after some objected to being used as “guinea pigs.”\u003c/p>\n\u003cp>The title “research assistant” was even changed to “patient engagement representative,” and Meshkin told managers to find attractive young people to fill that role, according to a former manager who spoke anonymously, citing a confidentiality agreement.\u003c/p>\n\u003cp>Crucially, Proove urges all doctors — whether participating in a trial or not — to sign a “\u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p18/a340196\" target=\"_blank\">standing order\u003c/a>” for all their patients to get any Proove genetic tests, such as those for risk of opioid abuse, pain sensitivity, and response to opioids and other drugs.\u003c/p>\n\u003cp>Many doctors have been reluctant to sign. But by 2015 about 70 percent had done so under pressure from Meshkin, said the former manager. Examples of orders obtained by STAT authorize Proove research assistants to collect DNA from any patient under the doctor’s care.\u003c/p>\n\u003cp>Meshkin emphasized that under a standing order, the decision to be tested “is not up to [the patients], it’s up to the doctors,” Stevens said — that patients “don’t have a choice.”\u003c/p>\n\u003cp>Standing orders are common in medicine, although not in such circumstances. Doctors often issue standing orders to streamline care when patients need regular tests or treatments for a known chronic condition. Such orders rarely apply to a wide range of genetic tests for all patients in a diverse practice.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I could not find a good statistical or clinical benefit for these tests. I didn’t feel comfortable with the science being done at Proove.'\u003ccite>Dr. Eric Fung, former Chief Scientific Officer at Proove Biosciences\u003c/cite>\u003c/aside>\n\u003cp>Standing orders “are often a red flag, particularly in a situation, like here, where the patients have varying diagnoses and needs,” said Cochran, associate director of a joint health policy and law degree program at the University of California, San Francisco, and UC Hastings College of the Law. “There’s absolutely a kickback concern if the doctor knows he’s going to get a check based on the number of patients who sign up and get tested.”\u003c/p>\n\u003cp>In his written statement, Meshkin said, “Proove seeks to ensure that each participating clinician independently determines the medical necessity” for tests, “and that every patient signs an informed consent to have the testing performed.”\u003c/p>\n\u003ch2>Meshkin spins a good story\u003c/h2>\n\u003cp>The man behind the Proove enterprise has an elaborate personal \u003ca href=\"http://www.brianmeshkin.com/\" target=\"_blank\">website\u003c/a>, featuring flattering photos of himself and his family. Effusive language praises his character, business acumen, and civic accomplishments as a former school board member, and the site lists his accolades, including an “Entrepreneur of the Year” award from the Orange County Business Journal in Southern California.\u003c/p>\n\u003cp>“Volunteer. Public Servant. Entrepreneur. Coach. There are many words used to describe Brian Meshkin. But if you ask Brian, he’s just Brian — a guy who works hard, dreams big, and rolls up his sleeves to help others,” the site’s unsigned biography begins.\u003c/p>\n\u003cp>He also calls himself a “published researcher,” although he lacks any formal scientific training, and says nothing about the legal problems of a previous genetic testing venture.\u003c/p>\n\u003cp>That “nutrigenomics” company sold genetically customized dietary supplements through Las Vegas spas and directly to consumers. In an interview last year, Meshkin said he sold that company, Salugen, in 2009, soon after California authorities sent a cease-and-desist letter for improper marketing.\u003c/p>\n\u003cp>Former and current Proove doctors and employees said the site aptly captures a man who deeply believes in himself and grasps the power of spinning a good story.\u003c/p>\n\u003cp>Meshkin has been listed as a coauthor on study abstracts, Proove posters presented at scientific meetings, and the recently published study. His involvement in research was one of the reasons that Dr. Daniel A. Schwarz, Proove’s former research and development director, said he decided to resign.\u003c/p>\n\u003cp>A Michigan pain specialist, Schwarz said he left Proove in 2015 over concerns about the company’s lack of scientific integrity. “You can’t have a CEO trying to run the science who doesn’t have a science background,” he said. “It was marketing. It wasn’t science, and I couldn’t be a part of that.”\u003c/p>\n\u003cp>Schwarz said scientific control became a key issue when he began to doubt the validity of Proove’s work and wanted to repair the company’s research and development. Meshkin “wasn’t listening,” he said. “He didn’t take the advice, and I felt that he just wanted to do it his way.”\u003c/p>\n\u003cp>Schwarz also grew alarmed when coworkers said patient research records were not stored securely. Another former Proove executive, who requested anonymity due to a confidentiality agreement, said data sheets languished for long periods, stacked in heaps at Proove’s main office.\u003c/p>\n\u003cp>“The patient comes first, and if you have a product where you are not doing the right thing by the patient, I can’t be a part of it,” Schwarz said.\u003c/p>\n\u003cp>According to Stevens, company insiders hoped for vast improvements after Fung, a respected biotech executive who earned his MD and PhD degrees at Johns Hopkins University, was hired with fanfare in 2015.\u003c/p>\n\u003cp>“I remember one of the clinical people who worked underneath [Fung] said to me, ‘If he leaves this company, we all need to go,’” Stevens said.\u003c/p>\n\u003cp>Fung quit after three months.\u003c/p>\n\u003ch2>‘Can I trust the data?’\u003c/h2>\n\u003cp>Taube, the Georgia family doctor, said he saw firsthand how untrustworthy Proove’s tests and studies are. He signed on with Proove about four months ago after he was approached by a sales rep. Taube said he was intrigued by Proove’s ideas for advancing precision medicine and impressed by the support of Medicare and other insurers, described by Proove as study “sponsors.”\u003c/p>\n\u003cp>At first, he filled out the research forms himself, including an “investigator intervention evaluation” used to assess whether Proove tests helped patients or affected their care. But he said Proove managers told him, “No, no, [the Proove employee] will take care of it.”\u003c/p>\n\u003cp>This practice was widely adopted after some doctors filled out research forms partially or not at all, but still expected to be paid, said a former Proove executive who spoke anonymously due to a confidentiality agreement.\u003c/p>\n\u003caside class=\"pullquote alignright\">'It was marketing. It wasn’t science, and I couldn’t be a part of that.’\u003ccite>Dr. Daniel A. Schwarz, Proove’s former research and development director\u003c/cite>\u003c/aside>\n\u003cp>Taube then would sign the evaluations prepared by a Proove research assistant without giving them a close look. But he began to view the clinical trials as mostly marketing and looked more closely at the evaluations he signed. He was startled to see that Proove tests always received top ratings, though they were having little impact on his practice.\u003c/p>\n\u003cp>The results often were refuted by a patient’s experience, he said. For example, they showed that several of his patients should not take losartan, a blood pressure medicine, because they metabolized it poorly. But they had taken it successfully for years.\u003c/p>\n\u003cp>Taube recently stopped signing up new patients for Proove, saying he wondered, “Can I trust the data?”\u003c/p>\n\u003cp>His experience was typical, according to current and former Proove employees. They said Proove managers told representatives always to rate tests a 4 or 5 on a 5-point scale of benefit to the patient, even when a test had no bearing on clinical care.\u003c/p>\n\u003cp>Another former Proove executive, who also signed a confidentiality agreement, said even the principal investigator of a 50,000-patient Proove clinical trial — Dr. Daniel R. Kendall, a McLean, Va., osteopath for National Spine & Pain Centers — didn’t rely on the tests. The former executive said an audit of 1,500 patient charts from Kendall’s practice showed no changes in care based on Proove tests.\u003c/p>\n\u003cp>Via email, Kendall disputed that conclusion. He would not provide the audit and referred all questions to Proove. In his email statement, Meshkin said National Spine & Pain Center patients showed “significant improvement in treatment,” but did not provide any details.\u003c/p>\n\u003ch2>Profit innovation: ‘unbundled’ charges\u003c/h2>\n\u003cp>Clinical trials helped increase testing, but insurers often rejected claims, leading Proove to devise another way to pump up its bottom line: creative billing.\u003c/p>\n\u003cp>Insurers deem many Proove tests experimental due to a lack of evidence that they could aid diagnosis or treatment of the patient. One consequence of the denials, said some former employees, is that Proove periodically stops paying many sales reps and even fires them.\u003c/p>\n\u003cp>Proove also has failed to pay many physicians, including Taube, for research services — even doctors who actually did the work. Coston called it “the main thing I was getting yelled about by my doctors.” Taube said the company blamed slow insurance reimbursements.\u003c/p>\n\u003cp>By 2014, Proove could complete numerous tests using a single cheek swab. But insurance payments were less than what the company thought it could get for the same tests if they had been billed based on several different swabs, said current and former employees.\u003c/p>\n\u003cp>So Proove adopted a new billing strategy in 2015. \u003ca href=\"https://www.documentcloud.org/documents/3475304-STAT-Proove-Investigation-Documents.html#document/p19\" target=\"_blank\">Documents show\u003c/a> that instead of submitting an invoice for multiple genetic tests from one date of service — when the patient’s cheek was swabbed — Proove “unbundled” the charges, dividing them up among several invoices keyed to the dates lab reports were issued. Current and former employees said this process has become the norm.\u003c/p>\n\u003cp>The company might bill insurers for its “opioid risk test” on Monday, for its “pain perception” test the following Monday, and so on — suggesting that the patient was tested on several occasions. Combined billings were often in the range of $7,000 to $10,000.\u003c/p>\n\u003cp>A Southern California doctor, who would only comment anonymously, said he kicked Proove out of his practice. “[T]hey billed the insurance four times more than what they told me they would bill initially. … Several patients of mine became very upset at the unreasonable amount of money that they were charging the insurance company,” the doctor said in an email. Such reactions were common among physicians, said current and former employees.Michelle Cavanaugh, an expert with the California-based medical billing firm Kareo, called unbundling “working the system.”\u003c/p>\n\u003cp>“What is the clinical justification for assigning it different dates?” said P. Thomas Hirsch, president of Laboratory Billing Solutions in Portsmouth, N.H., after hearing a description of Proove’s practices. “If they can’t give one, it’s just a scam.”\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 \u003ca href=\"https://www.statnews.com/2017/02/28/proove-biosciences-genetic-tests/\" target=\"_blank\">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>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/345800/proove-employees-say-company-pushed-unneccesary-inaccurate-genetic-tests","authors":["byline_futureofyou_345800"],"categories":["futureofyou_1","futureofyou_1064"],"tags":["futureofyou_17","futureofyou_1015","futureofyou_938","futureofyou_1194"],"featImg":"futureofyou_346449","label":"futureofyou"},"futureofyou_273841":{"type":"posts","id":"futureofyou_273841","meta":{"index":"posts_1591205157","site":"futureofyou","id":"273841","score":null,"sort":[1478016331000]},"guestAuthors":[],"slug":"would-you-want-to-know-your-babys-genetic-mutations","title":"Would You Want to Know Your Baby's Genetic Mutations?","publishDate":1478016331,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>Just about every day, genetic counselor Shawn Fayer heads to the maternity ward at Brigham and Women's Hospital in Boston and tries to convince new parents to give him a blood sample.\u003c/p>\n\u003caside class=\"pullquote alignright\">Ninety-four percent of parents approached by researchers are declining to have their newborns' genes sequenced.\u003c/aside>\n\u003cp>Fayer is offering gene sequencing for newborns. It gives parents a tantalizing look at their baby's genetic information.\u003c/p>\n\u003cp>New parents Lauren and Ian Patrick, from Marion, Mass., were excited when they were first approached earlier this month.\u003c/p>\n\u003cp>\"My initial reaction — why wouldn't someone do this? Why wouldn't they want the information?\" Ian Patrick says as he cradles his newborn son, Finn. \"For me, more information is better, even if it's not always good.\"\u003c/p>\n\u003cp>If his parents sign him up, Finn would join the \u003ca href=\"http://www.genomes2people.org/babyseqproject/\">BabySeq\u003c/a> project, an NIH-funded study led by \u003ca href=\"http://www.brighamandwomens.org/Research/depts/Medicine/genetics/pis/Default.aspx\">Dr. Robert Green\u003c/a>, a medical geneticist at Brigham and Women's Hospital, and Alan Beggs at Boston Children's Hospital. With genetic testing getting cheaper and cheaper, Green wants to figure out what happens when parents know their child's genetic blueprint from day one.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Half of the babies who join the study will have their protein-coding genes sequenced and screened for variants that are associated with diseases of childhood, with a method called whole-exome sequencing. The other half will get the regular heel-prick blood test offered to all newborns, which screens for major genetic disorders like cystic fibrosis.\u003c/p>\n\u003cp>[contextly_sidebar id=\"0oB4UbBMca7FkmnzM9TuzpFpRg2XPk3h\"]\u003cbr>\nResearchers will follow both sets of babies to figure out how genetic sequencing impacts them. They want to find out if knowing a child's genetic makeup could actually make them healthier, or if it could increase their health care costs, or even change their relationship with their parents.\u003c/p>\n\u003cp>\"We are looking for all sorts of unanticipated variations in DNA,\" Green says, \"and we say right up front we don't know what they all mean. We don't know what they're all going to mean for your baby.\"\u003c/p>\n\u003cp>Green is particularly interested in a list of 1,514 genes where there are good reasons to reveal a mutation because a disease might be treated or prevented. But there are so many changes in everyone's DNA, he says, he's finding something to report in every baby he sequences.\u003c/p>\n\u003cp>Right now, that's a pretty small number of babies. Green has sequenced the genes of 51 newborns so far, and he's found five who have genetic mutations families wouldn't have known about otherwise. Two babies have \u003ca href=\"https://www.nigms.nih.gov/News/Meetings/Pages/DrugResponses.aspx\">pharmacogenetic variants\u003c/a> — mutations that mean certain drugs might not work as well on them. Three have mutations associated with heart conditions they inherited from a parent. Both the babies and their parents appears to be totally healthy.\u003c/p>\n\u003cp>One of those babies is Kai Gracia. His parents, Alyssa and Jason Gracia, agreed to the test when Kai was just a few days old. They didn't expect to find much. Alyssa was genotyped a few years before, and the information she got was mostly trivial — she learned she metabolized caffeine particularly quickly and she discovered she didn't have the photic sneeze reflex, meaning she wasn't likely to sneeze when suddenly exposed to bright light. So when the results on her baby came back, she was shocked. Right there in Kai's genetic report was this: \u003ca href=\"https://ghr.nlm.nih.gov/condition/supravalvular-aortic-stenosis\">supravalvular aortic stenosis.\u003c/a>\u003c/p>\n\u003cp>It turns out Kai has a mutation in a gene that codes for a protein called elastin. Elastin helps heart muscles bend and stretch. Not producing enough of it can cause the aorta to narrow. People can die from this, or need multiple surgeries as they grow.\u003c/p>\n\u003cp>Now that she knew her baby might get sick, Alyssa Gracia had lots of questions. Would Kai be able to play sports when he got older? Did he need surgery? Could crying too much be dangerous?\u003c/p>\n\u003cp>She made appointments with pediatric cardiologists and brought in Kai's genetic report. One doctor said he looked fine, and only needed to be monitored every few years. Another said his parents should bring him back after just a few months. Usually, a condition like Kai's isn't diagnosed until a child is showing symptoms. That means doctors still aren't quite sure how to treat Kai.\u003c/p>\n\u003cp>This is the kind of story that both thrills and terrifies the observers of this new technology, according to Green.\u003c/p>\n\u003cp>\"There's no consensus on how to manage these findings,\" he says. And it's unclear if the follow-up is worth it, or if it might actually do harm.\u003c/p>\n\u003cp>Gene sequencing reveals medical information about not just one person, but potentially a whole family. So all that follow-up is being done not just on Kai, but on his dad and his grandmother — all people who might be carrying this gene and might be at risk themselves.\u003c/p>\n\u003cp>So what can families do with all this information? Dr. Green says that for one family, this genetic report was potentially lifesaving.\u003c/p>\n\u003cp>It showed an inherited mutation in the baby's \u003ca href=\"https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet\">BRCA2\u003c/a> gene, which increases the risk of breast, ovarian, prostate and pancreatic cancers. This means not only is the baby at risk, but the child's mother or father could be, too.\u003c/p>\n\u003cp>Before they told the family, the researchers had to deal with \"a really pernicious ethical problem,\" says Green. He and his colleagues had agreed they would only tell parents about genetic variants that could impact babies in childhood, since the children weren't able to decide for themselves whether they wanted to know their genetic risks. BRCA2 causes cancer in adults, not children.\u003c/p>\n\u003cp>But this information was so important, Green decided to break protocol.\u003c/p>\n\u003cp>\"You know what the first four words were out of the mother's mouth when she was told?\" Green asks. \" 'Oh, that explains it.' \"\u003c/p>\n\u003cp>It turns out the mother knew distant relatives who had died from cancer, but she hadn't thought it meant anything for her. Without her baby's test, she might never have learned about her own risk.\u003c/p>\n\u003cp>Not every mutation is actionable like this. Green is also finding a lot of single recessive mutations for conditions like \u003ca href=\"http://www.nhlbi.nih.gov/health/health-topics/topics/cf/\">cystic fibrosis\u003c/a>, \u003ca href=\"http://www.ninds.nih.gov/disorders/taysachs/taysachs.htm\">Tay-Sachs\u003c/a> and \u003ca href=\"http://www.nhlbi.nih.gov/health/health-topics/topics/sca/\">sickle cell\u003c/a>. Since it takes two mutations, one each from mother and father, to cause the disease, it becomes an issue only when these babies grow up and decide to have children themselves.\u003c/p>\n\u003cp>One thing Green hadn't anticipated is how hard it has been to convince new parents to do this screening in the first place. Early research showed the majority of parents were interested in the medical information. But 94 percent of parents Green and his team are approaching are saying no.\u003c/p>\n\u003cp>Lauren and Ian Patrick, the parents of baby Finn, are a good case study.\u003c/p>\n\u003cp>Initially, they were convinced they wanted the screening. But after an hour talking to a genetic counselor about all the ways this sequencing could go wrong, they decided against it.\u003c/p>\n\u003cp>They learned that any genetic sequencing would go in their son's medical record, and it wouldn't be able to be removed. And while federal law prohibits genetic discrimination by health care providers and in the workplace, life insurers can still use genetic information to pick and choose whom they'll sell policies to. By the time the meeting was over, the Patricks' excitement had been replaced with concern.\u003c/p>\n\u003cp>\"It really gave me pause that this would be part of the medical record that private companies would have access to,\" Lauren Patrick says. \"That was my full stop in the end.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>After all, for the first time she's making a decision for someone who has no say, she says. \"That's the biggest thing on my mind, this new dynamic.\"\u003c/p>\n\u003chr>\n\u003cdiv class=\"fullattribution\">Copyright 2016 WNYC Radio. To see more, visit \u003ca href=\"http://www.wnyc.org/\">WNYC Radio\u003c/a>.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Would+You+Want+To+Know+The+Secrets+Hidden+In+Your+Baby%27s+Genes%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"A study offering the parents of newborns a scan of thousands of the baby's genes raises a big question: Do you want this kind of information on disease risk in your child's permanent record?","status":"publish","parent":0,"modified":1478017013,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":32,"wordCount":1318},"headData":{"title":"Would You Want to Know Your Baby's Genetic Mutations? | KQED","description":"A study offering the parents of newborns a scan of thousands of the baby's genes raises a big question: Do you want this kind of information on disease risk in your child's permanent record?","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"273841 http://ww2.kqed.org/futureofyou/?p=273841","disqusUrl":"https://ww2.kqed.org/futureofyou/2016/11/01/would-you-want-to-know-your-babys-genetic-mutations/","disqusTitle":"Would You Want to Know Your Baby's Genetic Mutations?","nprByline":"Mary Harris\u003cbr />WNYC","nprImageAgency":"Scott Bakal for NPR","nprStoryId":"499651062","nprApiLink":"http://api.npr.org/query?id=499651062&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"http://www.npr.org/sections/health-shots/2016/10/27/499651062/would-you-want-to-know-the-secrets-hidden-in-your-babys-genes?ft=nprml&f=499651062","nprRetrievedStory":"1","nprPubDate":"Mon, 31 Oct 2016 11:22:00 -0400","nprStoryDate":"Mon, 31 Oct 2016 03:42:00 -0400","nprLastModifiedDate":"Mon, 31 Oct 2016 10:58:49 -0400","nprAudio":"https://ondemand.npr.org/anon.npr-mp3/npr/me/2016/10/20161031_me_would_you_want_to_know_the_secrets_hidden_in_your_babys_genes.mp3?orgId=552&topicId=1128&d=369&p=3&story=499651062&t=progseg&e=500034779&seg=14&ft=nprml&f=499651062","nprAudioM3u":"http://api.npr.org/m3u/1500034975-813067.m3u?orgId=552&topicId=1128&d=369&p=3&story=499651062&t=progseg&e=500034779&seg=14&ft=nprml&f=499651062","path":"/futureofyou/273841/would-you-want-to-know-your-babys-genetic-mutations","audioUrl":"https://ondemand.npr.org/anon.npr-mp3/npr/me/2016/10/20161031_me_would_you_want_to_know_the_secrets_hidden_in_your_babys_genes.mp3?orgId=552&topicId=1128&d=369&p=3&story=499651062&t=progseg&e=500034779&seg=14&ft=nprml&f=499651062","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Just about every day, genetic counselor Shawn Fayer heads to the maternity ward at Brigham and Women's Hospital in Boston and tries to convince new parents to give him a blood sample.\u003c/p>\n\u003caside class=\"pullquote alignright\">Ninety-four percent of parents approached by researchers are declining to have their newborns' genes sequenced.\u003c/aside>\n\u003cp>Fayer is offering gene sequencing for newborns. It gives parents a tantalizing look at their baby's genetic information.\u003c/p>\n\u003cp>New parents Lauren and Ian Patrick, from Marion, Mass., were excited when they were first approached earlier this month.\u003c/p>\n\u003cp>\"My initial reaction — why wouldn't someone do this? Why wouldn't they want the information?\" Ian Patrick says as he cradles his newborn son, Finn. \"For me, more information is better, even if it's not always good.\"\u003c/p>\n\u003cp>If his parents sign him up, Finn would join the \u003ca href=\"http://www.genomes2people.org/babyseqproject/\">BabySeq\u003c/a> project, an NIH-funded study led by \u003ca href=\"http://www.brighamandwomens.org/Research/depts/Medicine/genetics/pis/Default.aspx\">Dr. Robert Green\u003c/a>, a medical geneticist at Brigham and Women's Hospital, and Alan Beggs at Boston Children's Hospital. With genetic testing getting cheaper and cheaper, Green wants to figure out what happens when parents know their child's genetic blueprint from day one.\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>Half of the babies who join the study will have their protein-coding genes sequenced and screened for variants that are associated with diseases of childhood, with a method called whole-exome sequencing. The other half will get the regular heel-prick blood test offered to all newborns, which screens for major genetic disorders like cystic fibrosis.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>\u003cbr>\nResearchers will follow both sets of babies to figure out how genetic sequencing impacts them. They want to find out if knowing a child's genetic makeup could actually make them healthier, or if it could increase their health care costs, or even change their relationship with their parents.\u003c/p>\n\u003cp>\"We are looking for all sorts of unanticipated variations in DNA,\" Green says, \"and we say right up front we don't know what they all mean. We don't know what they're all going to mean for your baby.\"\u003c/p>\n\u003cp>Green is particularly interested in a list of 1,514 genes where there are good reasons to reveal a mutation because a disease might be treated or prevented. But there are so many changes in everyone's DNA, he says, he's finding something to report in every baby he sequences.\u003c/p>\n\u003cp>Right now, that's a pretty small number of babies. Green has sequenced the genes of 51 newborns so far, and he's found five who have genetic mutations families wouldn't have known about otherwise. Two babies have \u003ca href=\"https://www.nigms.nih.gov/News/Meetings/Pages/DrugResponses.aspx\">pharmacogenetic variants\u003c/a> — mutations that mean certain drugs might not work as well on them. Three have mutations associated with heart conditions they inherited from a parent. Both the babies and their parents appears to be totally healthy.\u003c/p>\n\u003cp>One of those babies is Kai Gracia. His parents, Alyssa and Jason Gracia, agreed to the test when Kai was just a few days old. They didn't expect to find much. Alyssa was genotyped a few years before, and the information she got was mostly trivial — she learned she metabolized caffeine particularly quickly and she discovered she didn't have the photic sneeze reflex, meaning she wasn't likely to sneeze when suddenly exposed to bright light. So when the results on her baby came back, she was shocked. Right there in Kai's genetic report was this: \u003ca href=\"https://ghr.nlm.nih.gov/condition/supravalvular-aortic-stenosis\">supravalvular aortic stenosis.\u003c/a>\u003c/p>\n\u003cp>It turns out Kai has a mutation in a gene that codes for a protein called elastin. Elastin helps heart muscles bend and stretch. Not producing enough of it can cause the aorta to narrow. People can die from this, or need multiple surgeries as they grow.\u003c/p>\n\u003cp>Now that she knew her baby might get sick, Alyssa Gracia had lots of questions. Would Kai be able to play sports when he got older? Did he need surgery? Could crying too much be dangerous?\u003c/p>\n\u003cp>She made appointments with pediatric cardiologists and brought in Kai's genetic report. One doctor said he looked fine, and only needed to be monitored every few years. Another said his parents should bring him back after just a few months. Usually, a condition like Kai's isn't diagnosed until a child is showing symptoms. That means doctors still aren't quite sure how to treat Kai.\u003c/p>\n\u003cp>This is the kind of story that both thrills and terrifies the observers of this new technology, according to Green.\u003c/p>\n\u003cp>\"There's no consensus on how to manage these findings,\" he says. And it's unclear if the follow-up is worth it, or if it might actually do harm.\u003c/p>\n\u003cp>Gene sequencing reveals medical information about not just one person, but potentially a whole family. So all that follow-up is being done not just on Kai, but on his dad and his grandmother — all people who might be carrying this gene and might be at risk themselves.\u003c/p>\n\u003cp>So what can families do with all this information? Dr. Green says that for one family, this genetic report was potentially lifesaving.\u003c/p>\n\u003cp>It showed an inherited mutation in the baby's \u003ca href=\"https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet\">BRCA2\u003c/a> gene, which increases the risk of breast, ovarian, prostate and pancreatic cancers. This means not only is the baby at risk, but the child's mother or father could be, too.\u003c/p>\n\u003cp>Before they told the family, the researchers had to deal with \"a really pernicious ethical problem,\" says Green. He and his colleagues had agreed they would only tell parents about genetic variants that could impact babies in childhood, since the children weren't able to decide for themselves whether they wanted to know their genetic risks. BRCA2 causes cancer in adults, not children.\u003c/p>\n\u003cp>But this information was so important, Green decided to break protocol.\u003c/p>\n\u003cp>\"You know what the first four words were out of the mother's mouth when she was told?\" Green asks. \" 'Oh, that explains it.' \"\u003c/p>\n\u003cp>It turns out the mother knew distant relatives who had died from cancer, but she hadn't thought it meant anything for her. Without her baby's test, she might never have learned about her own risk.\u003c/p>\n\u003cp>Not every mutation is actionable like this. Green is also finding a lot of single recessive mutations for conditions like \u003ca href=\"http://www.nhlbi.nih.gov/health/health-topics/topics/cf/\">cystic fibrosis\u003c/a>, \u003ca href=\"http://www.ninds.nih.gov/disorders/taysachs/taysachs.htm\">Tay-Sachs\u003c/a> and \u003ca href=\"http://www.nhlbi.nih.gov/health/health-topics/topics/sca/\">sickle cell\u003c/a>. Since it takes two mutations, one each from mother and father, to cause the disease, it becomes an issue only when these babies grow up and decide to have children themselves.\u003c/p>\n\u003cp>One thing Green hadn't anticipated is how hard it has been to convince new parents to do this screening in the first place. Early research showed the majority of parents were interested in the medical information. But 94 percent of parents Green and his team are approaching are saying no.\u003c/p>\n\u003cp>Lauren and Ian Patrick, the parents of baby Finn, are a good case study.\u003c/p>\n\u003cp>Initially, they were convinced they wanted the screening. But after an hour talking to a genetic counselor about all the ways this sequencing could go wrong, they decided against it.\u003c/p>\n\u003cp>They learned that any genetic sequencing would go in their son's medical record, and it wouldn't be able to be removed. And while federal law prohibits genetic discrimination by health care providers and in the workplace, life insurers can still use genetic information to pick and choose whom they'll sell policies to. By the time the meeting was over, the Patricks' excitement had been replaced with concern.\u003c/p>\n\u003cp>\"It really gave me pause that this would be part of the medical record that private companies would have access to,\" Lauren Patrick says. \"That was my full stop in the end.\"\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>After all, for the first time she's making a decision for someone who has no say, she says. \"That's the biggest thing on my mind, this new dynamic.\"\u003c/p>\n\u003chr>\n\u003cdiv class=\"fullattribution\">Copyright 2016 WNYC Radio. To see more, visit \u003ca href=\"http://www.wnyc.org/\">WNYC Radio\u003c/a>.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Would+You+Want+To+Know+The+Secrets+Hidden+In+Your+Baby%27s+Genes%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/273841/would-you-want-to-know-your-babys-genetic-mutations","authors":["byline_futureofyou_273841"],"categories":["futureofyou_452","futureofyou_1","futureofyou_73","futureofyou_1064"],"tags":["futureofyou_1015"],"featImg":"futureofyou_273842","label":"futureofyou"},"futureofyou_225819":{"type":"posts","id":"futureofyou_225819","meta":{"index":"posts_1591205157","site":"futureofyou","id":"225819","score":null,"sort":[1471558307000]},"guestAuthors":[],"slug":"racial-disparity-in-genetic-studies-leads-to-misdiagnosis","title":"Racial Disparity in Genetic Studies Leads to Misdiagnosis","publishDate":1471558307,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>Scientists have discovered that a common cause of sudden heart death has been misunderstood because researchers didn't appropriately account for racial differences in their studies.\u003c/p>\n\u003cp>The findings, \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMsa1507092\">published online Wednesday\u003c/a> in the \u003cem>New England Journal of Medicine,\u003c/em> have implications far beyond this particular inherited disease, called \u003ca href=\"http://www.4hcm.org/content.asp?contentid=146\">hypertrophic cardiomyopathy\u003c/a>, or HCM. Researchers say the results also sound a cautionary note for many other illnesses that have been identified through genetic markers.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I've had to evaluate a large number of athletes with borderline anatomical findings. Could some be false positives, and [mistakenly] disqualified from sports? I don't know for sure, but it's possible.'\u003c/aside>\n\u003cp>HCM gained attention in the 1980s after several seemingly healthy athletes, including the rising basketball talent, \u003ca href=\"http://www.latimes.com/sports/la-sp-hank-gathers-dwyre-20150304-column.html\">Hank Gathers\u003c/a>, suddenly died from it. Scientists had figured out that the propensity for developing HCM is passed along as a genetic trait; the condition affects about one in 500 Americans.\u003c/p>\n\u003cp>Tarika Mingo, a psychiatric social worker in New York City, first realized something was wrong with her own heart several years ago, when she became so short of breath during gentle activity that she nearly passed out. In 2014 her doctors accurately diagnosed her with HCM. They performed open-heart surgery and reduced her risk of sudden death. She still feels the effect of the disease, however.\u003c/p>\n\u003cp>\"I have to see the cardiologist every three to six months,\" she tells Shots. \"I have to take my medicine every day. The heat is not my best friend, so it limits my social activities. We just had a heat wave and I was stuck in the house.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The diagnosis also sent reverberations through her family. That's because the likelihood of developing HCM follows a simple, inherited pattern: If your parent has the disease, your likelihood of developing it is 50:50. So she urged her entire family to get checked out. Mingo's 16-year-old son shows no signs of having inherited the condition, but her 29-year-old sister has some ominous symptoms.\u003c/p>\n\u003cp>[contextly_sidebar id=\"eLrXQ1WDYHijgAsscrzn3G7q4g5BLuli\"]As part of the diagnosis, doctors turn to genetic testing. But, while the inheritance of this disease follows a simple pattern, the genes that control it reveal a much more complicated story than geneticists realized until very recently.\u003c/p>\n\u003cp>And that applies to many other genetic traits that are now commonly diagnosed in medical labs.\u003c/p>\n\u003cp>In HCM, it turns out, any one of about a dozen genes can be damaged in ways that lead to the illness, and there are many different possible mutations in each of these genes. So there are many ways the disease can be passed down.\u003c/p>\n\u003cp>What's more, some of the variants that researchers originally flagged as disease-causing mutations have actually turned out to be benign.\u003c/p>\n\u003cp>\u003ca href=\"https://dbmi.hms.harvard.edu/person/faculty/zak-kohane\">Dr. Isaac Kohane\u003c/a> at Harvard Medical School says a postdoctoral fellow working with him, Arjun Manrai, came across this serious problem of misdiagnosis quite by accident.\u003c/p>\n\u003cp>They were studying the genetic variants related to HCM. While the disease is observed to occur in about one in 500 people, \"we saw that the variants that were ostensibly causing disease seemed to add up to much more than one in 500,\" he says.\u003c/p>\n\u003cp>In fact, the supposedly risky gene variants appeared in one out of 10 or one out of 20 people of African descent — an impossibly high number.\u003c/p>\n\u003cp>\"Something must be wrong,\" Kohane realized. \"Something must have been awry.\"\u003c/p>\n\u003cp>Kohane and his colleagues think they now may have solved that mystery.\u003c/p>\n\u003cp>When scientists originally went looking for these genes, Kohane explains, they compared the genetics of families affected by the illness with a sample of healthy people.\u003c/p>\n\u003cp>But here's the catch: People in the healthy comparison groups in these studies were white; whereas some people in the studies with HCM apparently had some African ancestry. As a result, some of the gene variants flagged as being linked to the illness simply represented racial differences between the groups and had nothing to do with HCM.\u003c/p>\n\u003cp>That problem would likely have been avoided if the original scientists had added four or five African-Americans to the control group, Kohane says.\u003c/p>\n\u003cp>It turns out that two of these variants commonly identified in African-Americans actually don't pose a health risk at all. That means many people may have been inadvertently misled about their risk of developing this disease.\u003c/p>\n\u003cp>\"I've had to evaluate a large number of athletes with borderline anatomical findings,\" suggesting they had the heart condition, said Dr. Barry Maron, a leading expert on hypertrophic cardiomyopathy at \u003ca href=\"https://www.tuftsmedicalcenter.org/patient-care-services/Departments-and-Services/Hypertrophic-Cardiomyopathy-Center/Overview.aspx\">Tufts Medical Center\u003c/a>. He has also served as a consultant for top college athletic departments.\u003c/p>\n\u003cp>\"Could some be false positives, and [mistakenly] disqualified from sports?\" Maron asks. \"I don't know for sure, but it's possible.\"\u003c/p>\n\u003cp>Promising athletic careers may have come to an abrupt halt, based on the results of genetic tests that turned out to be misleading. On the other hand, Tarika Mingo worries that insurance companies and doctors won't be as committed to diagnosis and treatment of HCM patients if there is no clear genetic marker. So she's nervous about seeing any genetic marker reclassified as benign.\u003c/p>\n\u003cp>Meanwhile, it's not clear whether these misidentified traits are still being linked with the disease, Kohane says. Genetic testing labs work independently, so the test for HCM can vary from one company to the next.\u003c/p>\n\u003cp>\"The leading laboratories that do genetic testing make sure that they update their findings as these results come in,\" he says. But other labs may just adopt a panel of tests and stick with it.\u003c/p>\n\u003cp>Maron and Kohane say this discovery has implications that go far beyond sudden cardiac death. It underscores the point that even diseases that appear to have simple genetics are in fact usually quite complicated.\u003c/p>\n\u003cp>\"Is HCM one of these diseases you either have or you don't?\" Kohane asks. \"Or is it like almost everything else we're coming to learn about, where it's a matter of degree.\"\u003c/p>\n\u003cp>Genetic testing, he says, has lulled us all into thinking that diseases can be boiled down to yes or no questions. But, increasingly, that does not seem to be the case.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\"It just turns out that the genome is as complicated and as unique as each one of us,\" Kohane says.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Study+Of+Sudden+Cardiac+Death+Exposes+Limits+Of+Genetic+Testing&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"Some genetic tests for a common cause of sudden heart failure can be wrong, researchers say, because the underlying science didn't take into account racial diversity.","status":"publish","parent":0,"modified":1475113110,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":30,"wordCount":1067},"headData":{"title":"Racial Disparity in Genetic Studies Leads to Misdiagnosis | KQED","description":"Some genetic tests for a common cause of sudden heart failure can be wrong, researchers say, because the underlying science didn't take into account racial diversity.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"225819 http://ww2.kqed.org/futureofyou/?p=225819","disqusUrl":"https://ww2.kqed.org/futureofyou/2016/08/18/racial-disparity-in-genetic-studies-leads-to-misdiagnosis/","disqusTitle":"Racial Disparity in Genetic Studies Leads to Misdiagnosis","nprImageCredit":"Afton Almaraz","nprByline":"Richard Harris\u003cbr />NPR Shots","nprImageAgency":"Getty Images","nprStoryId":"490386306","nprApiLink":"http://api.npr.org/query?id=490386306&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"http://www.npr.org/sections/health-shots/2016/08/17/490386306/study-of-sudden-cardiac-death-exposes-limits-of-genetic-testing?ft=nprml&f=490386306","nprRetrievedStory":"1","nprPubDate":"Thu, 18 Aug 2016 12:50:00 -0400","nprStoryDate":"Wed, 17 Aug 2016 20:41:00 -0400","nprLastModifiedDate":"Thu, 18 Aug 2016 12:50:46 -0400","path":"/futureofyou/225819/racial-disparity-in-genetic-studies-leads-to-misdiagnosis","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Scientists have discovered that a common cause of sudden heart death has been misunderstood because researchers didn't appropriately account for racial differences in their studies.\u003c/p>\n\u003cp>The findings, \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMsa1507092\">published online Wednesday\u003c/a> in the \u003cem>New England Journal of Medicine,\u003c/em> have implications far beyond this particular inherited disease, called \u003ca href=\"http://www.4hcm.org/content.asp?contentid=146\">hypertrophic cardiomyopathy\u003c/a>, or HCM. Researchers say the results also sound a cautionary note for many other illnesses that have been identified through genetic markers.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I've had to evaluate a large number of athletes with borderline anatomical findings. Could some be false positives, and [mistakenly] disqualified from sports? I don't know for sure, but it's possible.'\u003c/aside>\n\u003cp>HCM gained attention in the 1980s after several seemingly healthy athletes, including the rising basketball talent, \u003ca href=\"http://www.latimes.com/sports/la-sp-hank-gathers-dwyre-20150304-column.html\">Hank Gathers\u003c/a>, suddenly died from it. Scientists had figured out that the propensity for developing HCM is passed along as a genetic trait; the condition affects about one in 500 Americans.\u003c/p>\n\u003cp>Tarika Mingo, a psychiatric social worker in New York City, first realized something was wrong with her own heart several years ago, when she became so short of breath during gentle activity that she nearly passed out. In 2014 her doctors accurately diagnosed her with HCM. They performed open-heart surgery and reduced her risk of sudden death. She still feels the effect of the disease, however.\u003c/p>\n\u003cp>\"I have to see the cardiologist every three to six months,\" she tells Shots. \"I have to take my medicine every day. The heat is not my best friend, so it limits my social activities. We just had a heat wave and I was stuck in the house.\"\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>The diagnosis also sent reverberations through her family. That's because the likelihood of developing HCM follows a simple, inherited pattern: If your parent has the disease, your likelihood of developing it is 50:50. So she urged her entire family to get checked out. Mingo's 16-year-old son shows no signs of having inherited the condition, but her 29-year-old sister has some ominous symptoms.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>As part of the diagnosis, doctors turn to genetic testing. But, while the inheritance of this disease follows a simple pattern, the genes that control it reveal a much more complicated story than geneticists realized until very recently.\u003c/p>\n\u003cp>And that applies to many other genetic traits that are now commonly diagnosed in medical labs.\u003c/p>\n\u003cp>In HCM, it turns out, any one of about a dozen genes can be damaged in ways that lead to the illness, and there are many different possible mutations in each of these genes. So there are many ways the disease can be passed down.\u003c/p>\n\u003cp>What's more, some of the variants that researchers originally flagged as disease-causing mutations have actually turned out to be benign.\u003c/p>\n\u003cp>\u003ca href=\"https://dbmi.hms.harvard.edu/person/faculty/zak-kohane\">Dr. Isaac Kohane\u003c/a> at Harvard Medical School says a postdoctoral fellow working with him, Arjun Manrai, came across this serious problem of misdiagnosis quite by accident.\u003c/p>\n\u003cp>They were studying the genetic variants related to HCM. While the disease is observed to occur in about one in 500 people, \"we saw that the variants that were ostensibly causing disease seemed to add up to much more than one in 500,\" he says.\u003c/p>\n\u003cp>In fact, the supposedly risky gene variants appeared in one out of 10 or one out of 20 people of African descent — an impossibly high number.\u003c/p>\n\u003cp>\"Something must be wrong,\" Kohane realized. \"Something must have been awry.\"\u003c/p>\n\u003cp>Kohane and his colleagues think they now may have solved that mystery.\u003c/p>\n\u003cp>When scientists originally went looking for these genes, Kohane explains, they compared the genetics of families affected by the illness with a sample of healthy people.\u003c/p>\n\u003cp>But here's the catch: People in the healthy comparison groups in these studies were white; whereas some people in the studies with HCM apparently had some African ancestry. As a result, some of the gene variants flagged as being linked to the illness simply represented racial differences between the groups and had nothing to do with HCM.\u003c/p>\n\u003cp>That problem would likely have been avoided if the original scientists had added four or five African-Americans to the control group, Kohane says.\u003c/p>\n\u003cp>It turns out that two of these variants commonly identified in African-Americans actually don't pose a health risk at all. That means many people may have been inadvertently misled about their risk of developing this disease.\u003c/p>\n\u003cp>\"I've had to evaluate a large number of athletes with borderline anatomical findings,\" suggesting they had the heart condition, said Dr. Barry Maron, a leading expert on hypertrophic cardiomyopathy at \u003ca href=\"https://www.tuftsmedicalcenter.org/patient-care-services/Departments-and-Services/Hypertrophic-Cardiomyopathy-Center/Overview.aspx\">Tufts Medical Center\u003c/a>. He has also served as a consultant for top college athletic departments.\u003c/p>\n\u003cp>\"Could some be false positives, and [mistakenly] disqualified from sports?\" Maron asks. \"I don't know for sure, but it's possible.\"\u003c/p>\n\u003cp>Promising athletic careers may have come to an abrupt halt, based on the results of genetic tests that turned out to be misleading. On the other hand, Tarika Mingo worries that insurance companies and doctors won't be as committed to diagnosis and treatment of HCM patients if there is no clear genetic marker. So she's nervous about seeing any genetic marker reclassified as benign.\u003c/p>\n\u003cp>Meanwhile, it's not clear whether these misidentified traits are still being linked with the disease, Kohane says. Genetic testing labs work independently, so the test for HCM can vary from one company to the next.\u003c/p>\n\u003cp>\"The leading laboratories that do genetic testing make sure that they update their findings as these results come in,\" he says. But other labs may just adopt a panel of tests and stick with it.\u003c/p>\n\u003cp>Maron and Kohane say this discovery has implications that go far beyond sudden cardiac death. It underscores the point that even diseases that appear to have simple genetics are in fact usually quite complicated.\u003c/p>\n\u003cp>\"Is HCM one of these diseases you either have or you don't?\" Kohane asks. \"Or is it like almost everything else we're coming to learn about, where it's a matter of degree.\"\u003c/p>\n\u003cp>Genetic testing, he says, has lulled us all into thinking that diseases can be boiled down to yes or no questions. But, increasingly, that does not seem to be the case.\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>\"It just turns out that the genome is as complicated and as unique as each one of us,\" Kohane says.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2016 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"http://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Study+Of+Sudden+Cardiac+Death+Exposes+Limits+Of+Genetic+Testing&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/225819/racial-disparity-in-genetic-studies-leads-to-misdiagnosis","authors":["byline_futureofyou_225819"],"categories":["futureofyou_1064"],"tags":["futureofyou_1015","futureofyou_120","futureofyou_1017","futureofyou_1016"],"featImg":"futureofyou_225820","label":"futureofyou"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.","airtime":"SUN 2pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.possible.fm/","meta":{"site":"news","source":"Possible"},"link":"/radio/program/possible","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/possible/id1677184070","spotify":"https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"}},"1a":{"id":"1a","title":"1A","info":"1A is home to the national conversation. 1A brings on great guests and frames the best debate in ways that make you think, share and engage.","airtime":"MON-THU 11pm-12am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/1a.jpg","officialWebsiteLink":"https://the1a.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/1a","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=1188724250&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/1A-p947376/","rss":"https://feeds.npr.org/510316/podcast.xml"}},"all-things-considered":{"id":"all-things-considered","title":"All Things Considered","info":"Every weekday, \u003cem>All Things Considered\u003c/em> hosts Robert Siegel, Audie Cornish, Ari Shapiro, and Kelly McEvers present the program's trademark mix of news, interviews, commentaries, reviews, and offbeat features. 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You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. 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This podcast feed is usually updated twice a week and is always un-edited.","airtime":"THU 10pm, FRI 1am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Commonwealth-Club-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.commonwealthclub.org/podcasts","meta":{"site":"news","source":"Commonwealth Club of California"},"link":"/radio/program/commonwealth-club","subscribe":{"apple":"https://itunes.apple.com/us/podcast/commonwealth-club-of-california-podcast/id976334034?mt=2","google":"https://podcasts.google.com/feed/aHR0cDovL3d3dy5jb21tb253ZWFsdGhjbHViLm9yZy9hdWRpby9wb2RjYXN0L3dlZWtseS54bWw","tuneIn":"https://tunein.com/radio/Commonwealth-Club-of-California-p1060/"}},"considerthis":{"id":"considerthis","title":"Consider This","tagline":"Make sense of the day","info":"Make sense of the day. Every weekday afternoon, Consider This helps you consider the major stories of the day in less than 15 minutes, featuring the reporting and storytelling resources of NPR. 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