Voters Approve Prop. 14, Continuing Funding for Stem Cell Research
What You Need to Know About Prop. 14, The Stem Cell Research Bond (Transcript)
Is the Federal Government Politicizing Research Involving Fetal Tissue?
FDA Injunctions Send Clear Message: Stem Cell Clinics Beware
Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More?
Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?
Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics
Time Running Out, California Stem Cell Agency Yet to Produce Big Results
What Stem Cell Researchers Talk About When They Talk About Ethics
Sponsored
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She lives in Sonoma County and enjoys backpacking.","avatar":"https://secure.gravatar.com/avatar/ebaf11ee6cfb7bb40329a143d463829e?s=600&d=blank&r=g","twitter":"DanielleVenton","facebook":null,"instagram":null,"linkedin":null,"sites":[{"site":"arts","roles":["contributor"]},{"site":"news","roles":["editor"]},{"site":"futureofyou","roles":["editor"]},{"site":"science","roles":["editor"]}],"headData":{"title":"Danielle Venton | KQED","description":"Science reporter","ogImgSrc":"https://secure.gravatar.com/avatar/ebaf11ee6cfb7bb40329a143d463829e?s=600&d=blank&r=g","twImgSrc":"https://secure.gravatar.com/avatar/ebaf11ee6cfb7bb40329a143d463829e?s=600&d=blank&r=g"},"isLoading":false,"link":"/author/dventon"}},"breakingNewsReducer":{},"campaignFinanceReducer":{},"firebase":{"requesting":{},"requested":{},"timestamps":{},"data":{},"ordered":{},"auth":{"isLoaded":false,"isEmpty":true},"authError":null,"profile":{"isLoaded":false,"isEmpty":true},"listeners":{"byId":{},"allIds":[]},"isInitializing":false,"errors":[]},"navBarReducer":{"navBarId":"news","fullView":true,"showPlayer":false},"navMenuReducer":{"menus":[{"key":"menu1","items":[{"name":"News","link":"/","type":"title"},{"name":"Politics","link":"/politics"},{"name":"Science","link":"/science"},{"name":"Education","link":"/educationnews"},{"name":"Housing","link":"/housing"},{"name":"Immigration","link":"/immigration"},{"name":"Criminal Justice","link":"/criminaljustice"},{"name":"Silicon Valley","link":"/siliconvalley"},{"name":"Forum","link":"/forum"},{"name":"The California Report","link":"/californiareport"}]},{"key":"menu2","items":[{"name":"Arts & Culture","link":"/arts","type":"title"},{"name":"Critics’ Picks","link":"/thedolist"},{"name":"Cultural Commentary","link":"/artscommentary"},{"name":"Food & Drink","link":"/food"},{"name":"Bay Area Hip-Hop","link":"/bayareahiphop"},{"name":"Rebel Girls","link":"/rebelgirls"},{"name":"Arts Video","link":"/artsvideos"}]},{"key":"menu3","items":[{"name":"Podcasts","link":"/podcasts","type":"title"},{"name":"Bay Curious","link":"/podcasts/baycurious"},{"name":"Rightnowish","link":"/podcasts/rightnowish"},{"name":"The Bay","link":"/podcasts/thebay"},{"name":"On Our Watch","link":"/podcasts/onourwatch"},{"name":"Mindshift","link":"/podcasts/mindshift"},{"name":"Consider This","link":"/podcasts/considerthis"},{"name":"Political Breakdown","link":"/podcasts/politicalbreakdown"}]},{"key":"menu4","items":[{"name":"Live Radio","link":"/radio","type":"title"},{"name":"TV","link":"/tv","type":"title"},{"name":"Events","link":"/events","type":"title"},{"name":"For Educators","link":"/education","type":"title"},{"name":"Support KQED","link":"/support","type":"title"},{"name":"About","link":"/about","type":"title"},{"name":"Help Center","link":"https://kqed-helpcenter.kqed.org/s","type":"title"}]}]},"pagesReducer":{},"postsReducer":{"stream_live":{"type":"live","id":"stream_live","audioUrl":"https://streams.kqed.org/kqedradio","title":"Live Stream","excerpt":"Live Stream information currently unavailable.","link":"/radio","featImg":"","label":{"name":"KQED Live","link":"/"}},"stream_kqedNewscast":{"type":"posts","id":"stream_kqedNewscast","audioUrl":"https://www.kqed.org/.stream/anon/radio/RDnews/newscast.mp3?_=1","title":"KQED Newscast","featImg":"","label":{"name":"88.5 FM","link":"/"}},"news_11844423":{"type":"posts","id":"news_11844423","meta":{"index":"posts_1591205157","site":"news","id":"11844423","score":null,"sort":[1605243403000]},"guestAuthors":[],"slug":"californians-approve-prop-14-continuing-funding-for-stem-cell-research","title":"Voters Approve Prop. 14, Continuing Funding for Stem Cell Research","publishDate":1605243403,"format":"standard","headTitle":"KQED News","labelTerm":{"site":"news"},"content":"\u003cp>California voters have approved Proposition 14, set to continue funding of the state's stem cell research agency. With 51% of the votes, it was the narrowest margin of victory for any of this year’s 12 ballot questions, according to \u003ca href=\"https://apnews.com/article/robert-klein-california-coronavirus-pandemic-ca9d91e3ed0a862b1be0293377505941\">the Associated Press\u003c/a>.\u003c/p>\n\u003cp>The measure’s passage guarantees the continuation of the state's stem cell agency, the California Institute of Regenerative Medicine. The proposition authorizes the sale of $5.5 billion in bonds to replenish funding for the agency, which was first created in 2004 by a previous proposition and is now running out of money.\u003c/p>\n\u003cp>The Proposition 14 contest was one of the lowest-stakes battles of the California election in terms of finances: Supporters spent about $16 million on its behalf. By contrast, backers of Proposition 22 — Uber, Lyft, and other gig economy companies — poured well over $200 million into the race, an \u003ca href=\"https://www.kqed.org/news/11843123/prop-22-explained-why-gig-companies-are-spending-huge-money-on-an-unprecedented-measure\" target=\"_blank\" rel=\"noopener noreferrer\">unprecedented amount\u003c/a> of money for a California proposition.\u003c/p>\n\u003cp>[aside label=\"More on Proposition 14\" link1='https://www.kqed.org/voterguide/proposition-14-stem-cell-research,Proposition 14: Should taxpayers continue to fund stem cell research?' link2='https://www.kqed.org/elections/results#californiapropositions,Proposition 14: Live Election Results' hero=https://ww2.kqed.org/app/uploads/2020/10/KQED-Election-2020-Aside-Prop-14.png]\u003c/p>\n\u003cp>Yes on 14 was largely backed by Robert Klein, a Palo Alto real estate developer who had also directed the campaign that created the stem cell agency through Proposition 71 in 2004. Proposition 14 was helped by a lack of organized opposition, though \u003ca href=\"https://www.sfchronicle.com/opinion/editorials/article/Chronicle-recommends-No-on-Prop-14-no-need-to-15592513.php\" target=\"_blank\" rel=\"noopener noreferrer\">editorials\u003c/a> from prominent \u003ca href=\"https://www.latimes.com/opinion/story/2020-10-01/endorsement-no-on-proposition-14-not-the-best-way-to-support-stem-cell-research\" target=\"_blank\" rel=\"noopener noreferrer\">newspapers\u003c/a> in the state mostly endorsed a 'No' vote.\u003c/p>\n\u003cp>CIRM was created during a time in the early 2000s when the promise of stem cell and regenerative medicine excited both scientists and the public. Proposition 71 authorized the sale of $3 billion in bonds to create an agency that specifically funded human embryonic stem cell research.\u003c/p>\n\u003cp>The measure was in part a response to a 2001 ban by President George W. Bush on federal funding for embryonic stem cell research after a campaign to end it by anti-abortion activists. That ban was later overturned by President Obama. The Trump administration has not reinstated the ban, but has added lengthy paperwork and review requirements.\u003c/p>\n\u003cp>Currently the National Institutes of Health \u003ca href=\"https://report.nih.gov/categorical_spending.aspx\">funds some basic stem cell research\u003c/a>, spending about $2 billion a year, with $321 million of that going toward human embryonic stem cell research.\u003c/p>\n\u003cp>While CIRM has not, to date, funded research into any drugs or therapies for general use, it has seen some notable successes, the most “spectacular” being \"clinical trials that have saved the lives of what [CIRM says] are 40 children,” said David Jensen, author of the California Stem Cell Report blog.\u003c/p>\n\u003cp>Those children were born with severe combined immunodeficiency, commonly known as \"bubble baby syndrome,\" a rare, generally fatal condition in which a child is born without a working immune system. An FDA-approved gene therapy that grew out of CIRM-funded research can now cure the disease by taking a patient’s own blood stem cells and modifying them to correct the mutation and repair the immune system.\u003c/p>\n\u003cp>The FDA has also approved two drugs for rare blood cancers developed with CIRM funding, though insiders disagree about how directly CIRM money was involved.\u003c/p>\n\u003cp>The proposition expands the scope of the agency's mission as well as the size of its board of directors. It requires CIRM to now spend specified amounts on certain illnesses. Specifically, the agency will earmark $1.5 billion for diseases of the brain and central nervous system, such as autism and schizophrenia, regardless of how promising the early-stage research is.\u003c/p>\n\u003cp>The state currently owes about $1 billion toward the debt created by Proposition 71.\u003c/p>\n\u003cp>The price tag to pay off the new bond will be about $260 million per year for about 30 years.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n","blocks":[],"excerpt":"Passage of Proposition 14 guarantees the continuation of the state’s stem cell agency, the California Institute of Regenerative Medicine.","status":"publish","parent":0,"modified":1605243743,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":16,"wordCount":656},"headData":{"title":"Voters Approve Prop. 14, Continuing Funding for Stem Cell Research | KQED","description":"Passage of Proposition 14 guarantees the continuation of the state’s stem cell agency, the California Institute of Regenerative Medicine.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"NewsArticle","headline":"Voters Approve Prop. 14, Continuing Funding for Stem Cell Research","datePublished":"2020-11-13T04:56:43.000Z","dateModified":"2020-11-13T05:02:23.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png","isAccessibleForFree":"Y","publisher":{"@type":"NewsMediaOrganization","@id":"https://www.kqed.org/#organization","name":"KQED","url":"https://www.kqed.org","logo":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}}},"disqusIdentifier":"11844423 https://ww2.kqed.org/news/?p=11844423","disqusUrl":"https://ww2.kqed.org/news/2020/11/12/californians-approve-prop-14-continuing-funding-for-stem-cell-research/","disqusTitle":"Voters Approve Prop. 14, Continuing Funding for Stem Cell Research","path":"/news/11844423/californians-approve-prop-14-continuing-funding-for-stem-cell-research","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>California voters have approved Proposition 14, set to continue funding of the state's stem cell research agency. With 51% of the votes, it was the narrowest margin of victory for any of this year’s 12 ballot questions, according to \u003ca href=\"https://apnews.com/article/robert-klein-california-coronavirus-pandemic-ca9d91e3ed0a862b1be0293377505941\">the Associated Press\u003c/a>.\u003c/p>\n\u003cp>The measure’s passage guarantees the continuation of the state's stem cell agency, the California Institute of Regenerative Medicine. The proposition authorizes the sale of $5.5 billion in bonds to replenish funding for the agency, which was first created in 2004 by a previous proposition and is now running out of money.\u003c/p>\n\u003cp>The Proposition 14 contest was one of the lowest-stakes battles of the California election in terms of finances: Supporters spent about $16 million on its behalf. By contrast, backers of Proposition 22 — Uber, Lyft, and other gig economy companies — poured well over $200 million into the race, an \u003ca href=\"https://www.kqed.org/news/11843123/prop-22-explained-why-gig-companies-are-spending-huge-money-on-an-unprecedented-measure\" target=\"_blank\" rel=\"noopener noreferrer\">unprecedented amount\u003c/a> of money for a California proposition.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"label":"More on Proposition 14 ","link1":"https://www.kqed.org/voterguide/proposition-14-stem-cell-research,Proposition 14: Should taxpayers continue to fund stem cell research?","link2":"https://www.kqed.org/elections/results#californiapropositions,Proposition 14: Live Election Results","hero":"https://ww2.kqed.org/app/uploads/2020/10/KQED-Election-2020-Aside-Prop-14.png"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Yes on 14 was largely backed by Robert Klein, a Palo Alto real estate developer who had also directed the campaign that created the stem cell agency through Proposition 71 in 2004. Proposition 14 was helped by a lack of organized opposition, though \u003ca href=\"https://www.sfchronicle.com/opinion/editorials/article/Chronicle-recommends-No-on-Prop-14-no-need-to-15592513.php\" target=\"_blank\" rel=\"noopener noreferrer\">editorials\u003c/a> from prominent \u003ca href=\"https://www.latimes.com/opinion/story/2020-10-01/endorsement-no-on-proposition-14-not-the-best-way-to-support-stem-cell-research\" target=\"_blank\" rel=\"noopener noreferrer\">newspapers\u003c/a> in the state mostly endorsed a 'No' vote.\u003c/p>\n\u003cp>CIRM was created during a time in the early 2000s when the promise of stem cell and regenerative medicine excited both scientists and the public. Proposition 71 authorized the sale of $3 billion in bonds to create an agency that specifically funded human embryonic stem cell research.\u003c/p>\n\u003cp>The measure was in part a response to a 2001 ban by President George W. Bush on federal funding for embryonic stem cell research after a campaign to end it by anti-abortion activists. That ban was later overturned by President Obama. The Trump administration has not reinstated the ban, but has added lengthy paperwork and review requirements.\u003c/p>\n\u003cp>Currently the National Institutes of Health \u003ca href=\"https://report.nih.gov/categorical_spending.aspx\">funds some basic stem cell research\u003c/a>, spending about $2 billion a year, with $321 million of that going toward human embryonic stem cell research.\u003c/p>\n\u003cp>While CIRM has not, to date, funded research into any drugs or therapies for general use, it has seen some notable successes, the most “spectacular” being \"clinical trials that have saved the lives of what [CIRM says] are 40 children,” said David Jensen, author of the California Stem Cell Report blog.\u003c/p>\n\u003cp>Those children were born with severe combined immunodeficiency, commonly known as \"bubble baby syndrome,\" a rare, generally fatal condition in which a child is born without a working immune system. An FDA-approved gene therapy that grew out of CIRM-funded research can now cure the disease by taking a patient’s own blood stem cells and modifying them to correct the mutation and repair the immune system.\u003c/p>\n\u003cp>The FDA has also approved two drugs for rare blood cancers developed with CIRM funding, though insiders disagree about how directly CIRM money was involved.\u003c/p>\n\u003cp>The proposition expands the scope of the agency's mission as well as the size of its board of directors. It requires CIRM to now spend specified amounts on certain illnesses. Specifically, the agency will earmark $1.5 billion for diseases of the brain and central nervous system, such as autism and schizophrenia, regardless of how promising the early-stage research is.\u003c/p>\n\u003cp>The state currently owes about $1 billion toward the debt created by Proposition 71.\u003c/p>\n\u003cp>The price tag to pay off the new bond will be about $260 million per year for about 30 years.\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>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11844423/californians-approve-prop-14-continuing-funding-for-stem-cell-research","authors":["11088"],"categories":["news_8","news_356"],"tags":["news_27370","news_28743","news_1340"],"featImg":"news_11844445","label":"news"},"news_11840438":{"type":"posts","id":"news_11840438","meta":{"index":"posts_1591205157","site":"news","id":"11840438","score":null,"sort":[1601546409000]},"guestAuthors":[],"slug":"everything-you-need-to-know-about-prop-14-the-stem-cell-research-bond","title":"What You Need to Know About Prop. 14, The Stem Cell Research Bond (Transcript)","publishDate":1601546409,"format":"standard","headTitle":"What You Need to Know About Prop. 14, The Stem Cell Research Bond (Transcript) | KQED","labelTerm":{},"content":"\u003cp>If reading through the statewide ballot propositions has made your head spin, you are in the right place! From Oct. 1 – 16, \u003ca href=\"https://www.kqed.org/podcasts/baycurious\">Bay Curious\u003c/a> is exploring the 12 statewide ballot propositions in our \u003ca href=\"https://www.kqed.org/propfest\">Prop Fest\u003c/a> series. This episode tackles Prop 14, the stem cell research bond.\u003c/p>\n\u003cp>\u003ciframe loading=\"lazy\" frameborder=\"0\" height=\"200\" scrolling=\"no\" src=\"https://playlist.megaphone.fm?e=KQINC6474746408&light=true\" width=\"100%\">\u003c/iframe>\u003c/p>\n\u003ch2>Transcript\u003c/h2>\n\u003cp>\u003ca href=\"https://bit.ly/2G50GU4\">Printable version\u003c/a>\u003c/p>\n\u003cp>\u003cem>Theme music\u003c/em>\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:00:37] Today, we take on \u003ca href=\"https://voterguide.sos.ca.gov/propositions/14/index.htm\">Proposition 14\u003c/a>. It’s a bond that would fund stem cell research in the state. On your ballot will read in part like this…\u003c/p>\n\u003cp>\u003cstrong>Voice 1\u003c/strong> [00:00:46] Proposition 14 authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine, educational, nonprofit and private entities for stem cell and other medical research.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:01:03] We’ll explain what all that means, who’s for it, who’s against it, and what else you need to know, all in today’s show. I’m Olivia Allen-Price and this is Bay Curious Prop Fest, Proposition 14.\u003c/p>\n\u003cp>\u003cem>End theme music\u003c/em>\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:01:20] KQED science reporter \u003ca href=\"https://www.kqed.org/author/dventon\">Danielle Venton\u003c/a> has been covering Prop 14, The stem cell research bond. Welcome, Danielle.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:01:27] Hello, Olivia.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:01:28] So let’s start with, what is a bond in general? How do they work?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:01:32] Government bonds are a way to raise money for projects that a government wants to do now, but pay for over time. Think of them as a loan. So, for this particular bond, the state of California would pay that loan back with interest over 30 years out of the general fund, which is supported by taxpayers. So, essentially, when you vote yes on a bond, you’re saying, yes, let’s use public funds for this project.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:01:55] OK, so what exactly does this bond fund?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:01:59] This would fund $5.5 billion in stem cell research and treatments in California. Some of the diseases that stem cell research is seeking to cure or treat include cancer, Alzheimer’s disease, diabetes, spinal cord injuries, blindness, and even COVID-19. I spoke recently with a guy named Jake Javier. He supports this bond initiative because he knows firsthand how life changing stem cell research can be.\u003c/p>\n\u003cp>\u003cstrong>Jake Javier\u003c/strong> [00:02:25] I am in my last year at Cal Poly.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:02:28] So, Jake grew up locally in Danville and was just graduating high school when he suffered a life altering injury.\u003c/p>\n\u003cp>\u003cstrong>Jake Javier\u003c/strong> [00:02:35] On the last day of high school, I drove in to a pool and hit my head on the bottom and broke my neck and was immediately paralyzed.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:02:47] He says his injury was complete, with very little hope of recovery. But a doctor at Stanford reached out to Jake and his family and said, you can be part of this clinical trial where we, with a one time surgery, will inject stem cells into the damaged area and you may possibly see some benefits.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:03:07] Now, Jake is still injured.\u003c/p>\n\u003cp>\u003cstrong>Jake Javier\u003c/strong> [00:03:09] I’m a quadriplegic. I use a wheelchair.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:03:11] But he says after the surgery, he noticed more movement in his arms, in his hands.\u003c/p>\n\u003cp>\u003cstrong>Jake Javier\u003c/strong> [00:03:17] So, I mean, with my injury, I’m at a level where I would normally not have any function at all in my hands and very, very little function like in my triceps and things like that. Muscles that are really important for functionality and, you know, being able to get through day to day activities that could help me push myself around more, help me transfer in and out of my chair independently. And then also, I notice, you know, I got some some finger movement. It doesn’t seem like much, but even that little movement has helped me so much with picking things up and things like that. So it was really, I was really blessed to see that happen.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:03:51] So he doesn’t know how much of his recovery is due to the stem cells. How much is natural, or how much is due to physical therapy. But today he’s able to live independently, to go to college – and he wants to pursue a career in medicine. And he is a big believer in stem cell research, regenerative medicine, and is really hoping that California voters will support this proposition.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:04:20] Now, what exactly are stem cells and how do they work, I guess?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:04:25] Yeah, stem cells are types of cells that can be turned into any type of specialized cell. Scientists have known about them since the eighteen hundreds, but it wasn’t until the late 90s that researchers developed a method to derive them from human embryos and grow them in a laboratory. And then people really began to get excited about their potential for medicine. Now these cells came from unused embryos created for in vitro fertilization, and they were donated with informed consent. But many anti-abortion groups felt that using the cells were tantamount to taking a human life. So in 2001, then President George W. Bush banned federal funding for any research using newly created stem cell lines.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:05:09] OK. And how does that get us now to bonds in California?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:05:13] Well, Californians wanted to circumvent these federal restrictions, and in 2004 voted for a bond that gave the state $3 billion to create a research agency called the California Institute of Regenerative Medicine, or CIRM. There was a lot of public support for it. And it just felt like these wonderful cures could be right around the corner. Celebrities like Michael J. Fox appeared in TV commercials.\u003c/p>\n\u003cp>\u003cstrong>\u003ca href=\"https://www.youtube.com/watch?time_continue=4&v=fK9Eg0GVl7Q&feature=emb_title\">Michael J. Fox TV commercia\u003c/a>l\u003c/strong> [00:05:36] My most important role lately is as an advocate for patients, and for finding new cures for diseases. That’s why I’m asking you to vote yes on Proposition 71, Stem Cell Research Initiative.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:05:48] And the money for that research, that $3 billion, has now run out. And to continue their work, the stem cell advocacy group, Americans for Cures, is asking voters for more money.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:06:00] So we’re basically voting on whether we want to refill the stem cell research piggy bank here.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:06:05] Yeah, exactly. Some question if the state can afford this at this time when budgets are going to be so tight. Others have been disappointed by the slow pace of cures coming out of the field. Now, there are people who credit this research, such as Jake, with improving or restoring their health or the health of their loved ones. Or maybe they hope that one day it will, and they would balk at the idea that this is not worthy research. They point to achievements that the agency has funded. That includes effectively a cure for bubble baby disease. This is when someone is born without a functioning immune system. That mutation can now be corrected with genetically modified stem cells. And recently, just within the last year or so, the FDA approved two new treatments for blood cancer, developed with CIRM support. These achievements are what the agency points to when they’re criticized for not having accomplished more. And they say the process of scientific discovery is long and unpredictable.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:07:04] Now, wasn’t that Bush-era ban on stem cell research that you were talking about earlier – wasn’t that overturned?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:07:11] Yes, that was overturned by President Obama. However, there are current members of Congress who are lobbying President Trump to ban the research again. And if that happens, then California would be the only major player in stemcell research once again in the United States.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:07:30] All right, so who is supporting Prop 14?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:07:32] Governor Gavin Newsom, for one. Many patient advocacy organizations and medical and research institutions, including the California Board of Regents. These people don’t want to see the pace of this research slow. They want it to accelerate. The political action committee supporting this proposition is reporting more than six million dollars in contributions.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:07:53] All right. And what about the opposition? Who’s against it?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:07:55] Well, so far, there’s no organized, funded opposition. There have been several newspaper editorials coming out against it, including locally, the Mercury News and the Santa Rosa Press Democrat. They basically say state bonds aren’t the way to fund research and the situation isn’t like it was in 2004 and that the institute should now seek other sources of funding and move forward as a nonprofit.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:08:19] All right, Danielle. Well, thanks, as always for your help.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:08:21] My pleasure. Thanks.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:08:28] In a nutshell, a vote yes on Proposition 14 says you think Californians should give $5.5 billion to the state’s stem cell research institute. That money will be raised by selling bonds, which the state would pay back, with interest, out of\u003cbr>\nthe general fund over the next 30 years. A vote no means you think we shouldn’t spend public money on this research.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:08:54] That’s it on Proposition 14. We’ll be back tomorrow with an episode on Prop 15. And oh, it is a doozy. Commercial property tax! A partial rollback of one of California’s most controversial propositions! It’s going to be fire. In the meantime, you can find more of KQED election coverage at KQED.org/elections. Two reminders on the way out: October 19th is the last day to register to vote and mail in ballots must be postmarked on or before November 3rd.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:09:28] Bay Curious is made in San Francisco at member supported KQED. I’m Olivia Allen-Price. See you tomorrow.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n","blocks":[],"excerpt":null,"status":"publish","parent":0,"modified":1700590174,"stats":{"hasAudio":true,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":44,"wordCount":1790},"headData":{"title":"What You Need to Know About Prop. 14, The Stem Cell Research Bond (Transcript) | KQED","description":"If reading through the statewide ballot propositions has made your head spin, you are in the right place! From Oct. 1 - 16, Bay Curious is exploring the 12 statewide ballot propositions in our Prop Fest series. This episode tackles Prop 14, the stem cell research bond. Transcript Printable version Theme music Olivia Allen-Price ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"NewsArticle","headline":"What You Need to Know About Prop. 14, The Stem Cell Research Bond (Transcript)","datePublished":"2020-10-01T10:00:09.000Z","dateModified":"2023-11-21T18:09:34.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png","isAccessibleForFree":"Y","publisher":{"@type":"NewsMediaOrganization","@id":"https://www.kqed.org/#organization","name":"KQED","url":"https://www.kqed.org","logo":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}}},"source":"Bay Curious Prop Fest","sourceUrl":"https://www.kqed.org/propfest","audioUrl":"https://dcs.megaphone.fm/KQINC6474746408.mp3?key=7d5ed65d6395ae575656a35a7439176a","path":"/news/11840438/everything-you-need-to-know-about-prop-14-the-stem-cell-research-bond","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>If reading through the statewide ballot propositions has made your head spin, you are in the right place! From Oct. 1 – 16, \u003ca href=\"https://www.kqed.org/podcasts/baycurious\">Bay Curious\u003c/a> is exploring the 12 statewide ballot propositions in our \u003ca href=\"https://www.kqed.org/propfest\">Prop Fest\u003c/a> series. This episode tackles Prop 14, the stem cell research bond.\u003c/p>\n\u003cp>\u003ciframe loading=\"lazy\" frameborder=\"0\" height=\"200\" scrolling=\"no\" src=\"https://playlist.megaphone.fm?e=KQINC6474746408&light=true\" width=\"100%\">\u003c/iframe>\u003c/p>\n\u003ch2>Transcript\u003c/h2>\n\u003cp>\u003ca href=\"https://bit.ly/2G50GU4\">Printable version\u003c/a>\u003c/p>\n\u003cp>\u003cem>Theme music\u003c/em>\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:00:37] Today, we take on \u003ca href=\"https://voterguide.sos.ca.gov/propositions/14/index.htm\">Proposition 14\u003c/a>. It’s a bond that would fund stem cell research in the state. On your ballot will read in part like this…\u003c/p>\n\u003cp>\u003cstrong>Voice 1\u003c/strong> [00:00:46] Proposition 14 authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine, educational, nonprofit and private entities for stem cell and other medical research.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:01:03] We’ll explain what all that means, who’s for it, who’s against it, and what else you need to know, all in today’s show. I’m Olivia Allen-Price and this is Bay Curious Prop Fest, Proposition 14.\u003c/p>\n\u003cp>\u003cem>End theme music\u003c/em>\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:01:20] KQED science reporter \u003ca href=\"https://www.kqed.org/author/dventon\">Danielle Venton\u003c/a> has been covering Prop 14, The stem cell research bond. Welcome, Danielle.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:01:27] Hello, Olivia.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:01:28] So let’s start with, what is a bond in general? How do they work?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:01:32] Government bonds are a way to raise money for projects that a government wants to do now, but pay for over time. Think of them as a loan. So, for this particular bond, the state of California would pay that loan back with interest over 30 years out of the general fund, which is supported by taxpayers. So, essentially, when you vote yes on a bond, you’re saying, yes, let’s use public funds for this project.\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>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:01:55] OK, so what exactly does this bond fund?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:01:59] This would fund $5.5 billion in stem cell research and treatments in California. Some of the diseases that stem cell research is seeking to cure or treat include cancer, Alzheimer’s disease, diabetes, spinal cord injuries, blindness, and even COVID-19. I spoke recently with a guy named Jake Javier. He supports this bond initiative because he knows firsthand how life changing stem cell research can be.\u003c/p>\n\u003cp>\u003cstrong>Jake Javier\u003c/strong> [00:02:25] I am in my last year at Cal Poly.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:02:28] So, Jake grew up locally in Danville and was just graduating high school when he suffered a life altering injury.\u003c/p>\n\u003cp>\u003cstrong>Jake Javier\u003c/strong> [00:02:35] On the last day of high school, I drove in to a pool and hit my head on the bottom and broke my neck and was immediately paralyzed.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:02:47] He says his injury was complete, with very little hope of recovery. But a doctor at Stanford reached out to Jake and his family and said, you can be part of this clinical trial where we, with a one time surgery, will inject stem cells into the damaged area and you may possibly see some benefits.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:03:07] Now, Jake is still injured.\u003c/p>\n\u003cp>\u003cstrong>Jake Javier\u003c/strong> [00:03:09] I’m a quadriplegic. I use a wheelchair.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:03:11] But he says after the surgery, he noticed more movement in his arms, in his hands.\u003c/p>\n\u003cp>\u003cstrong>Jake Javier\u003c/strong> [00:03:17] So, I mean, with my injury, I’m at a level where I would normally not have any function at all in my hands and very, very little function like in my triceps and things like that. Muscles that are really important for functionality and, you know, being able to get through day to day activities that could help me push myself around more, help me transfer in and out of my chair independently. And then also, I notice, you know, I got some some finger movement. It doesn’t seem like much, but even that little movement has helped me so much with picking things up and things like that. So it was really, I was really blessed to see that happen.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:03:51] So he doesn’t know how much of his recovery is due to the stem cells. How much is natural, or how much is due to physical therapy. But today he’s able to live independently, to go to college – and he wants to pursue a career in medicine. And he is a big believer in stem cell research, regenerative medicine, and is really hoping that California voters will support this proposition.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:04:20] Now, what exactly are stem cells and how do they work, I guess?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:04:25] Yeah, stem cells are types of cells that can be turned into any type of specialized cell. Scientists have known about them since the eighteen hundreds, but it wasn’t until the late 90s that researchers developed a method to derive them from human embryos and grow them in a laboratory. And then people really began to get excited about their potential for medicine. Now these cells came from unused embryos created for in vitro fertilization, and they were donated with informed consent. But many anti-abortion groups felt that using the cells were tantamount to taking a human life. So in 2001, then President George W. Bush banned federal funding for any research using newly created stem cell lines.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:05:09] OK. And how does that get us now to bonds in California?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:05:13] Well, Californians wanted to circumvent these federal restrictions, and in 2004 voted for a bond that gave the state $3 billion to create a research agency called the California Institute of Regenerative Medicine, or CIRM. There was a lot of public support for it. And it just felt like these wonderful cures could be right around the corner. Celebrities like Michael J. Fox appeared in TV commercials.\u003c/p>\n\u003cp>\u003cstrong>\u003ca href=\"https://www.youtube.com/watch?time_continue=4&v=fK9Eg0GVl7Q&feature=emb_title\">Michael J. Fox TV commercia\u003c/a>l\u003c/strong> [00:05:36] My most important role lately is as an advocate for patients, and for finding new cures for diseases. That’s why I’m asking you to vote yes on Proposition 71, Stem Cell Research Initiative.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:05:48] And the money for that research, that $3 billion, has now run out. And to continue their work, the stem cell advocacy group, Americans for Cures, is asking voters for more money.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:06:00] So we’re basically voting on whether we want to refill the stem cell research piggy bank here.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:06:05] Yeah, exactly. Some question if the state can afford this at this time when budgets are going to be so tight. Others have been disappointed by the slow pace of cures coming out of the field. Now, there are people who credit this research, such as Jake, with improving or restoring their health or the health of their loved ones. Or maybe they hope that one day it will, and they would balk at the idea that this is not worthy research. They point to achievements that the agency has funded. That includes effectively a cure for bubble baby disease. This is when someone is born without a functioning immune system. That mutation can now be corrected with genetically modified stem cells. And recently, just within the last year or so, the FDA approved two new treatments for blood cancer, developed with CIRM support. These achievements are what the agency points to when they’re criticized for not having accomplished more. And they say the process of scientific discovery is long and unpredictable.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:07:04] Now, wasn’t that Bush-era ban on stem cell research that you were talking about earlier – wasn’t that overturned?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:07:11] Yes, that was overturned by President Obama. However, there are current members of Congress who are lobbying President Trump to ban the research again. And if that happens, then California would be the only major player in stemcell research once again in the United States.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:07:30] All right, so who is supporting Prop 14?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:07:32] Governor Gavin Newsom, for one. Many patient advocacy organizations and medical and research institutions, including the California Board of Regents. These people don’t want to see the pace of this research slow. They want it to accelerate. The political action committee supporting this proposition is reporting more than six million dollars in contributions.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:07:53] All right. And what about the opposition? Who’s against it?\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:07:55] Well, so far, there’s no organized, funded opposition. There have been several newspaper editorials coming out against it, including locally, the Mercury News and the Santa Rosa Press Democrat. They basically say state bonds aren’t the way to fund research and the situation isn’t like it was in 2004 and that the institute should now seek other sources of funding and move forward as a nonprofit.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:08:19] All right, Danielle. Well, thanks, as always for your help.\u003c/p>\n\u003cp>\u003cstrong>Danielle Venton\u003c/strong> [00:08:21] My pleasure. Thanks.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:08:28] In a nutshell, a vote yes on Proposition 14 says you think Californians should give $5.5 billion to the state’s stem cell research institute. That money will be raised by selling bonds, which the state would pay back, with interest, out of\u003cbr>\nthe general fund over the next 30 years. A vote no means you think we shouldn’t spend public money on this research.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:08:54] That’s it on Proposition 14. We’ll be back tomorrow with an episode on Prop 15. And oh, it is a doozy. Commercial property tax! A partial rollback of one of California’s most controversial propositions! It’s going to be fire. In the meantime, you can find more of KQED election coverage at KQED.org/elections. Two reminders on the way out: October 19th is the last day to register to vote and mail in ballots must be postmarked on or before November 3rd.\u003c/p>\n\u003cp>\u003cstrong>Olivia Allen-Price\u003c/strong> [00:09:28] Bay Curious is made in San Francisco at member supported KQED. I’m Olivia Allen-Price. See you tomorrow.\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\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11840438/everything-you-need-to-know-about-prop-14-the-stem-cell-research-bond","authors":["11088","234","102"],"programs":["news_33523"],"series":["news_17986"],"categories":["news_8","news_33520","news_356"],"tags":["news_27540","news_28606","news_28756","news_1340"],"featImg":"news_11840462","label":"source_news_11840438"},"futureofyou_444641":{"type":"posts","id":"futureofyou_444641","meta":{"index":"posts_1591205157","site":"futureofyou","id":"444641","score":null,"sort":[1538075041000]},"guestAuthors":[],"slug":"governments-decision-to-review-research-of-fetal-tissue-blasted-as-political-move","title":"Is the Federal Government Politicizing Research Involving Fetal Tissue?","publishDate":1538075041,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>\u003cstrong>Updated at 3:45 pm ET\u003c/strong>\u003c/p>\n\u003cp>The Department of Health and Human Services says it is reviewing all medical research involving human fetal tissue.\u003c/p>\n\u003cp>HHS \u003ca href=\"https://www.hhs.gov/about/news/2018/09/24/statement-from-the-department-of-health-and-human-services.html\" target=\"_blank\" rel=\"noopener\">said this week\u003c/a> that it will conduct an audit of \"all acquisitions involving human fetal tissue\" as well as \"all research involving fetal tissue to ensure consistency with statutes and regulations governing such research and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved.\"[contextly_sidebar id=\"SsrZIxp3cgGelsMqmovjR5mXFrobSZOz\"]\u003c/p>\n\u003cp>In addition, HHS announced that it has canceled \u003ca href=\"https://www.fpds.gov/ezsearch/search.do?q=advanced+bioscience+resources+VENDOR_DUNS_NUMBER%3A%22786845982%22&s=FPDSNG.COM&templateName=1.4.4&indexName=awardfull&sortBy=SIGNED_DATE&desc=Y\" target=\"_blank\" rel=\"noopener\">a $15,000 contract\u003c/a> for a California-based company called Advanced Bioscience Resources to provide the Food and Drug Administration with human fetal tissue to develop testing protocols. The contract was terminated, HHS said, because the department \"was not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements.\"\u003c/p>\n\u003cp>Scientists use fetal tissue in medical research because it grows quickly and is highly versatile and long-lasting.\u003c/p>\n\u003cp>\"It allows us to answer specific questions that can't be answered by adult tissue, which is far more specialized,\"\u003c/p>\n\u003cp>NIH Associate Director for Science Policy Carrie Wolinetz \u003ca href=\"https://www.npr.org/sections/health-shots/2015/09/29/444214443/research-on-fetal-tissue-draws-renewed-political-scientific-scrutiny\" target=\"_blank\" rel=\"noopener\">told NPR's Rob Stein\u003c/a> in 2015. \"Fetal tissue can contain information — about structural features, or the architecture of organs — that cells in a dish alone can't provide. And this is sometimes very important to our understanding of disease.\"\u003c/p>\n\u003cp>Fetal tissue used in scientific research often comes from aborted fetuses. In an email to NPR, \u003ca href=\"https://law.wisc.edu/profiles/racharo\" target=\"_blank\" rel=\"noopener\">Alta Charo\u003c/a>, a professor of law and bioethics at the University of Wisconsin, explains why that is.[contextly_sidebar id=\"G1kyrCYVpzDmWCInUE7H0cF8gc9zn4Ce\"]\u003c/p>\n\u003cp>\"Miscarriages are not often an available source, as they do not take place in a controlled environment and may be due to genetic or other anomalies that would render the cadaveric tissues useless,\" she says. \"Therefore, the tissue usually comes from a fetus that has been aborted.\"\u003c/p>\n\u003cp>Despite the small size of the canceled FDA contract, some observers said the larger political symbolism is evident.\u003c/p>\n\u003cp>\"My instinct is that this is driven by politics, and is part of the overall effort to stigmatize and eventually criminalize abortion, as well as part of a larger campaign to roll-back the clock on sexual and reproductive rights,\" Charo says.\u003c/p>\n\u003cp>However, \u003ca href=\"https://lozierinstitute.org/team-member/david-prentice/\" target=\"_blank\" rel=\"noopener\">David Prentice\u003c/a>, vice president and research director for the Charlotte Lozier Institute, a conservative think tank opposed to abortion, says the HHS announcement doesn't go far enough.\u003c/p>\n\u003cp>\"Canceling a small FDA contract ... seems designed to mollify some Members of Congress and groups who were outraged by the continuing funding of fetal tissue research with taxpayer dollars,\" Prentice writes in an email to NPR. \"But what's needed is wholesale reform across the breadth of HHS. Use of fetal tissue is antiquated research, and [HHS Secretary Alex] Azar should redirect those funds to modern science and better alternatives, including adult stem cells.\"\u003c/p>\n\u003cp>\u003cem>Science\u003c/em> notes that on earlier this month, 45 groups opposed to abortion \u003ca href=\"https://www.sba-list.org/wp-content/uploads/2018/09/Group-Letter-to-Azar-FDA-and-fetal-tissue-FINAL-with-Signatures.pdf\" target=\"_blank\" rel=\"noopener\">sent a letter\u003c/a> to Azar calling the FDA contract for fetal tissue \"shocking\" and \"unacceptable.\" A few days later, 85 members of Congress \u003ca href=\"https://chrissmith.house.gov/uploadedfiles/2018-09-17_-chs-hartzler-walker_letter_on_fda_fetal_tissue_contract.pdf\" target=\"_blank\" rel=\"noopener\">sent a letter\u003c/a> to the FDA's commissioner, urging the agency to cancel the contract.\u003c/p>\n\u003cp>The National Institutes of Health, which also falls under HHS, spent $98 million last fiscal year on research that involved human fetal tissue. The NIH said it \"concurs that it is important that research involving human fetal tissue should be consistent with the statutes and regulation governing such research and that it is important to have adequate procedures for oversight.\"[contextly_sidebar id=\"xJs8IF14XoPynhHrniTrS5E5qgAhyVmm\"]\u003c/p>\n\u003cp>Use of fetal tissue in research has been controversial for some time, \u003cem>Science\u003c/em> magazine reported on Tuesday:\u003c/p>\n\u003cblockquote>\u003cp>\"In 2016, \u003ca href=\"https://energycommerce.house.gov/news/press-release/house-creates-select-panel-investigate-handling-infant-lives/\" target=\"_blank\" rel=\"noopener\">Republican members of the House of Representatives\u003c/a>, led by Representative Marsha Blackburn (TN), \u003ca href=\"https://www.sciencemag.org/news/2017/01/fact-checking-congress-s-fetal-tissue-report\">produced a report\u003c/a> that urged the federal government to transition to obtaining fetal tissue from miscarriages and stillbirths. But opponents of fetal tissue research have failed repeatedly to pass legislation that would end funding for research using tissue from electively aborted fetuses — most recently earlier this month, when language prohibiting such funding was stripped from a 2019 HHS spending bill.\"\u003c/p>\u003c/blockquote>\n\u003cp>\u003ca href=\"https://trentcenter.duke.edu/node/221\" target=\"_blank\" rel=\"noopener\">Ross McKinney\u003c/a>, chief scientific officer at the Association of American Medical Colleges, says fetal tissue was key in the development of major medical advances such as vaccines for polio, rubella, measles, chickenpox, adenovirus and rabies, as well as treatments for diseases such as rheumatoid arthritis, cystic fibrosis and hemophilia.\u003c/p>\n\u003cp>\"The unique characteristics of this tissue are essential to the study of fetal diseases, like those caused by Zika virus, and hold promise for advancing biomedical research in other areas as well, bringing hope to patients struggling with diseases such as Alzheimer's, Parkinson's, and multiple sclerosis,\" he writes in an email to NPR.\u003c/p>\n\u003cp>\"Fetal tissue continues to be an important resource for biomedical research, and the Association of American Medical Colleges fully supports its availability as one of the scientific methods that could save and improve lives.\"[contextly_sidebar id=\"GY9wMG5EY8EjMrFWoS2AArgcQmiE5UTu\"]\u003c/p>\n\u003cp>During \u003ca href=\"https://www.npr.org/2016/01/28/464594826/in-wake-of-videos-planned-parenthood-investigations-find-no-fetal-tissue-sales\" target=\"_blank\" rel=\"noopener\">a 2015 brouhaha\u003c/a>, the Obama-era HHS \u003ca href=\"https://www.plannedparenthood.org/files/3514/4709/3497/HHS_Letter_2015_08_14_-_FT_Research.pdf\" target=\"_blank\" rel=\"noopener\">sent a letter\u003c/a> to two Republican senators calling the use of fetal tissue in medical research \"an instrumental component of our attempts to understand, treat, and cure a number of conditions and diseases that affect millions of Americans,\" noting that scientists in the U.S. have been working with fetal tissue \u003ca href=\"https://fas.org/sgp/crs/misc/R44129.pdf\" target=\"_blank\" rel=\"noopener\">since the 1930s\u003c/a>.\u003c/p>\n\u003cp>\u003cem>NPR science correspondent Rob Stein contributed to this report.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Health+And+Human+Services+Says+It%27s+Reviewing+Use+Of+Fetal+Tissue+For+Research&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n","blocks":[],"excerpt":"The audit has been called a political gesture to placate anti-abortion groups that oppose use of the tissue. Fetal tissue has played a part in developing vaccines and medical treatments.","status":"publish","parent":0,"modified":1538075106,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":24,"wordCount":917},"headData":{"title":"Is the Federal Government Politicizing Research Involving Fetal Tissue? | KQED","description":"The audit has been called a political gesture to placate anti-abortion groups that oppose use of the tissue. Fetal tissue has played a part in developing vaccines and medical treatments.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Is the Federal Government Politicizing Research Involving Fetal Tissue?","datePublished":"2018-09-27T19:04:01.000Z","dateModified":"2018-09-27T19:05:06.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"444641 https://ww2.kqed.org/futureofyou/?p=444641","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/09/27/governments-decision-to-review-research-of-fetal-tissue-blasted-as-political-move/","disqusTitle":"Is the Federal Government Politicizing Research Involving Fetal Tissue?","source":"Health","nprImageCredit":"Chip Somodevilla","nprByline":"Laurel Wamsley, NPR","nprImageAgency":"Getty Images","nprStoryId":"651838889","nprApiLink":"http://api.npr.org/query?id=651838889&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/2018/09/26/651838889/health-and-human-services-says-its-reviewing-use-of-fetal-tissue-for-research?ft=nprml&f=651838889","nprRetrievedStory":"1","nprPubDate":"Wed, 26 Sep 2018 16:17:00 -0400","nprStoryDate":"Wed, 26 Sep 2018 15:12:00 -0400","nprLastModifiedDate":"Wed, 26 Sep 2018 16:18:07 -0400","path":"/futureofyou/444641/governments-decision-to-review-research-of-fetal-tissue-blasted-as-political-move","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cstrong>Updated at 3:45 pm ET\u003c/strong>\u003c/p>\n\u003cp>The Department of Health and Human Services says it is reviewing all medical research involving human fetal tissue.\u003c/p>\n\u003cp>HHS \u003ca href=\"https://www.hhs.gov/about/news/2018/09/24/statement-from-the-department-of-health-and-human-services.html\" target=\"_blank\" rel=\"noopener\">said this week\u003c/a> that it will conduct an audit of \"all acquisitions involving human fetal tissue\" as well as \"all research involving fetal tissue to ensure consistency with statutes and regulations governing such research and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In addition, HHS announced that it has canceled \u003ca href=\"https://www.fpds.gov/ezsearch/search.do?q=advanced+bioscience+resources+VENDOR_DUNS_NUMBER%3A%22786845982%22&s=FPDSNG.COM&templateName=1.4.4&indexName=awardfull&sortBy=SIGNED_DATE&desc=Y\" target=\"_blank\" rel=\"noopener\">a $15,000 contract\u003c/a> for a California-based company called Advanced Bioscience Resources to provide the Food and Drug Administration with human fetal tissue to develop testing protocols. The contract was terminated, HHS said, because the department \"was not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements.\"\u003c/p>\n\u003cp>Scientists use fetal tissue in medical research because it grows quickly and is highly versatile and long-lasting.\u003c/p>\n\u003cp>\"It allows us to answer specific questions that can't be answered by adult tissue, which is far more specialized,\"\u003c/p>\n\u003cp>NIH Associate Director for Science Policy Carrie Wolinetz \u003ca href=\"https://www.npr.org/sections/health-shots/2015/09/29/444214443/research-on-fetal-tissue-draws-renewed-political-scientific-scrutiny\" target=\"_blank\" rel=\"noopener\">told NPR's Rob Stein\u003c/a> in 2015. \"Fetal tissue can contain information — about structural features, or the architecture of organs — that cells in a dish alone can't provide. And this is sometimes very important to our understanding of disease.\"\u003c/p>\n\u003cp>Fetal tissue used in scientific research often comes from aborted fetuses. In an email to NPR, \u003ca href=\"https://law.wisc.edu/profiles/racharo\" target=\"_blank\" rel=\"noopener\">Alta Charo\u003c/a>, a professor of law and bioethics at the University of Wisconsin, explains why that is.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"Miscarriages are not often an available source, as they do not take place in a controlled environment and may be due to genetic or other anomalies that would render the cadaveric tissues useless,\" she says. \"Therefore, the tissue usually comes from a fetus that has been aborted.\"\u003c/p>\n\u003cp>Despite the small size of the canceled FDA contract, some observers said the larger political symbolism is evident.\u003c/p>\n\u003cp>\"My instinct is that this is driven by politics, and is part of the overall effort to stigmatize and eventually criminalize abortion, as well as part of a larger campaign to roll-back the clock on sexual and reproductive rights,\" Charo says.\u003c/p>\n\u003cp>However, \u003ca href=\"https://lozierinstitute.org/team-member/david-prentice/\" target=\"_blank\" rel=\"noopener\">David Prentice\u003c/a>, vice president and research director for the Charlotte Lozier Institute, a conservative think tank opposed to abortion, says the HHS announcement doesn't go far enough.\u003c/p>\n\u003cp>\"Canceling a small FDA contract ... seems designed to mollify some Members of Congress and groups who were outraged by the continuing funding of fetal tissue research with taxpayer dollars,\" Prentice writes in an email to NPR. \"But what's needed is wholesale reform across the breadth of HHS. Use of fetal tissue is antiquated research, and [HHS Secretary Alex] Azar should redirect those funds to modern science and better alternatives, including adult stem cells.\"\u003c/p>\n\u003cp>\u003cem>Science\u003c/em> notes that on earlier this month, 45 groups opposed to abortion \u003ca href=\"https://www.sba-list.org/wp-content/uploads/2018/09/Group-Letter-to-Azar-FDA-and-fetal-tissue-FINAL-with-Signatures.pdf\" target=\"_blank\" rel=\"noopener\">sent a letter\u003c/a> to Azar calling the FDA contract for fetal tissue \"shocking\" and \"unacceptable.\" A few days later, 85 members of Congress \u003ca href=\"https://chrissmith.house.gov/uploadedfiles/2018-09-17_-chs-hartzler-walker_letter_on_fda_fetal_tissue_contract.pdf\" target=\"_blank\" rel=\"noopener\">sent a letter\u003c/a> to the FDA's commissioner, urging the agency to cancel the contract.\u003c/p>\n\u003cp>The National Institutes of Health, which also falls under HHS, spent $98 million last fiscal year on research that involved human fetal tissue. The NIH said it \"concurs that it is important that research involving human fetal tissue should be consistent with the statutes and regulation governing such research and that it is important to have adequate procedures for oversight.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Use of fetal tissue in research has been controversial for some time, \u003cem>Science\u003c/em> magazine reported on Tuesday:\u003c/p>\n\u003cblockquote>\u003cp>\"In 2016, \u003ca href=\"https://energycommerce.house.gov/news/press-release/house-creates-select-panel-investigate-handling-infant-lives/\" target=\"_blank\" rel=\"noopener\">Republican members of the House of Representatives\u003c/a>, led by Representative Marsha Blackburn (TN), \u003ca href=\"https://www.sciencemag.org/news/2017/01/fact-checking-congress-s-fetal-tissue-report\">produced a report\u003c/a> that urged the federal government to transition to obtaining fetal tissue from miscarriages and stillbirths. But opponents of fetal tissue research have failed repeatedly to pass legislation that would end funding for research using tissue from electively aborted fetuses — most recently earlier this month, when language prohibiting such funding was stripped from a 2019 HHS spending bill.\"\u003c/p>\u003c/blockquote>\n\u003cp>\u003ca href=\"https://trentcenter.duke.edu/node/221\" target=\"_blank\" rel=\"noopener\">Ross McKinney\u003c/a>, chief scientific officer at the Association of American Medical Colleges, says fetal tissue was key in the development of major medical advances such as vaccines for polio, rubella, measles, chickenpox, adenovirus and rabies, as well as treatments for diseases such as rheumatoid arthritis, cystic fibrosis and hemophilia.\u003c/p>\n\u003cp>\"The unique characteristics of this tissue are essential to the study of fetal diseases, like those caused by Zika virus, and hold promise for advancing biomedical research in other areas as well, bringing hope to patients struggling with diseases such as Alzheimer's, Parkinson's, and multiple sclerosis,\" he writes in an email to NPR.\u003c/p>\n\u003cp>\"Fetal tissue continues to be an important resource for biomedical research, and the Association of American Medical Colleges fully supports its availability as one of the scientific methods that could save and improve lives.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>During \u003ca href=\"https://www.npr.org/2016/01/28/464594826/in-wake-of-videos-planned-parenthood-investigations-find-no-fetal-tissue-sales\" target=\"_blank\" rel=\"noopener\">a 2015 brouhaha\u003c/a>, the Obama-era HHS \u003ca href=\"https://www.plannedparenthood.org/files/3514/4709/3497/HHS_Letter_2015_08_14_-_FT_Research.pdf\" target=\"_blank\" rel=\"noopener\">sent a letter\u003c/a> to two Republican senators calling the use of fetal tissue in medical research \"an instrumental component of our attempts to understand, treat, and cure a number of conditions and diseases that affect millions of Americans,\" noting that scientists in the U.S. have been working with fetal tissue \u003ca href=\"https://fas.org/sgp/crs/misc/R44129.pdf\" target=\"_blank\" rel=\"noopener\">since the 1930s\u003c/a>.\u003c/p>\n\u003cp>\u003cem>NPR science correspondent Rob Stein contributed to this report.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Health+And+Human+Services+Says+It%27s+Reviewing+Use+Of+Fetal+Tissue+For+Research&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\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>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/444641/governments-decision-to-review-research-of-fetal-tissue-blasted-as-political-move","authors":["byline_futureofyou_444641"],"categories":["futureofyou_1","futureofyou_73","futureofyou_1064"],"tags":["futureofyou_342","futureofyou_1176","futureofyou_1615","futureofyou_294"],"collections":["futureofyou_1094"],"featImg":"futureofyou_444642","label":"source_futureofyou_444641"},"futureofyou_441482":{"type":"posts","id":"futureofyou_441482","meta":{"index":"posts_1591205157","site":"futureofyou","id":"441482","score":null,"sort":[1526009181000]},"guestAuthors":[],"slug":"fda-takes-action-against-california-stem-cell-clinics","title":"FDA Injunctions Send Clear Message: Stem Cell Clinics Beware","publishDate":1526009181,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>The Food and Drug Administration is getting serious about reining in stem cell clinics. On Wednesday, the agency \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm\" target=\"_blank\" rel=\"noopener\">announced\u003c/a> it wants to bar two of the largest clinic networks in the country from marketing their treatments, which would effectively halt their operations.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The clinic customers are really the guinea pigs here. And they’re paying [up to] $20,000 for that right to be a guinea pig.'\u003ccite>Paul Knoepfler, UC Davis\u003c/cite>\u003c/aside>\n\u003cp>At the FDA’s request, the Department of Justice will seek permanent injunctions to halt the core stem cell therapy used by U.S. Stem Cell Clinic of Sunshine, Florida, as well as the California Stem Cell Treatment Center and its affiliated Cell Surgical Network Corporation, located in Southern California. The two businesses\u003cb> \u003c/b>have affiliations with dozens of other stem cell clinics across the country, and the FDA said their method of stem cell therapy is unapproved, untested, and potentially dangerous for patients.\u003c/p>\n\u003cp>The request for the Florida injunction was prompted by four cases of blindness that occurred after patients received stem cell injections. In the filing against the California stem cell clinics, the FDA pointed to the use of smallpox vaccine to help create and use an unproven cancer therapy.\u003c/p>\n\u003cp>The agency’s action reflects its growing concern over the increase in stem cell clinics — an estimated 700 of them have popped up across the nation, with operations in almost every state.\u003c/p>\n\u003cp>Paul Knoepfler, a cell biology professor at UC Davis, is a stem cell researcher and one of the early critics of what he calls rogue stem cell clinics. These businesses leverage the power and hope resonant in the words “stem cell therapy,” while offering treatments that carry a big price tag and lack regulatory approval, he said.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“The clinic customers are really the guinea pigs here,” Knoepfler said. “And they’re paying [up to] $20,000 for that right to be a guinea pig. These stem cells can do unexpected things, like grow tumors, or grow things where they’re not supposed to – like scar tissue inside someone’s eyeball.”\u003c/p>\n\u003cp>Many stem cell clinics promise cutting‐edge treatment for just about every malady imaginable, from impotence to autism to lymphoma to multiple sclerosis. To get stem cells for the treatment, many clinics suction off a patient’s belly fat, which contains stem cells, then create an extract of those cells to inject into other parts of the body. The theory is some of these cells might promote healing.\u003c/p>\n\u003cp>More traditional stem cell research has produced some impressive cures. But that process involves many levels of clinical trials and proof of efficacy before a treatment goes on the market, something stem cell clinics do not provide.\u003c/p>\n\u003cp>Knoepfler has compiled \u003ca href=\"http://www.cell.com/cms/attachment/2062931415/2065421495/mmc2.xlsx\">a list\u003c/a> of the roughly 700 clinics nationwide. “California is a hotspot state,” he said. “It’s the number one state. It has more than 100 clinics here.”\u003c/p>\n\u003cp>And the epicenter of that stem cell clinic activity is Southern California, and Beverly Hills in particular, which has 18 clinics, Knoepfler said.\u003c/p>\n\u003cp>The FDA began increasing oversight of stem cell clinics in August of last year, when it sent a warning letter to the U.S. Stem Cell Clinic in Florida, and at the same time asked U.S. marshals to conduct a raid on a company called StemImmune in San Diego, seizing vials of smallpox vaccine that were planned for use at two California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage.\u003c/p>\n\u003cp>And in November last year, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm\">released tightened rules\u003c/a> for stem cell clinics, making clear that fat-derived stem cell therapies would be classified as a drug and should be subject to FDA approval.\u003c/p>\n\u003cp>The stem cell clinic owners at the two targeted sites said they’ll vigorously fight the requested injunctions. Their argument is that people’s own cells cannot be classified as a drug or drug therapy, and that people should be allowed to use them in any way they want.\u003c/p>\n\u003cp>In a company statement, the Florida-based U.S. Stem Cell said it “believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference.”\u003c/p>\n\u003cp>Knoepfler said the issue should not prompt a philosophical debate; it’s simply about patient safety.\u003c/p>\n\u003cp>“In theory the FDA can invoke criminal consequences, though we haven’t really seen that happen yet,” he said. “But with involvement of the Department of Justice in these particular cases with the injunctions, that to me seems a pretty serious indicator that this is something for stem cell clinics to take seriously.”\u003c/p>\n\u003cp>\u003cstrong>A Bigger Stick?\u003c/strong>\u003c/p>\n\u003cp>There is one more stick, yet to be wielded, that might be used to limit what therapies stem cell clinics can offer, and what claims they can make. The national Federation of State Medical Boards on May 8 released new\u003ca href=\"http://www.fsmb.org/globalassets/advocacy/policies/fsmb-stem-cell-workgroup-report.pdf\"> best-practices guidelines\u003c/a> for stem cell clinics. That’s significant because medical boards hold and can withdraw one of the things physicians value most: their medical license.\u003c/p>\n\u003cp>The recommendations are far-reaching: Medical boards can review and potentially withdraw licenses if stem cell clinics they are affiliated with make unsubstantiated claims, promote therapies not supported by science or use nondisclosure agreements to settle complaints.\u003c/p>\n\u003cp>Fines levied and court action taken by the FDA certainly can get people's attention, Knoepfler said, but the medical board federation's stance could be the real game-changer.\u003c/p>\n\u003cp>If doctors at stem cell clinics lose their medical license, it would cripple their credibility, impact their livelihood and potentially start an exodus of medical professionals out of the industry, he said.\u003c/p>\n\u003cp>“Somehow with the medical board license, for physicians it’s more of a tangible thing to take seriously,” Knoepfler said.\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n","blocks":[],"excerpt":"Stem cell clinics have proliferated all over the country, and the FDA and stem cell experts say some of the treatments they peddle are dangerous.","status":"publish","parent":0,"modified":1526066880,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":24,"wordCount":1006},"headData":{"title":"FDA Injunctions Send Clear Message: Stem Cell Clinics Beware | KQED","description":"Stem cell clinics have proliferated all over the country, and the FDA and stem cell experts say some of the treatments they peddle are dangerous.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Injunctions Send Clear Message: Stem Cell Clinics Beware","datePublished":"2018-05-11T03:26:21.000Z","dateModified":"2018-05-11T19:28:00.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"441482 https://ww2.kqed.org/futureofyou/?p=441482","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/05/10/fda-takes-action-against-california-stem-cell-clinics/","disqusTitle":"FDA Injunctions Send Clear Message: Stem Cell Clinics Beware","path":"/futureofyou/441482/fda-takes-action-against-california-stem-cell-clinics","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration is getting serious about reining in stem cell clinics. On Wednesday, the agency \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm\" target=\"_blank\" rel=\"noopener\">announced\u003c/a> it wants to bar two of the largest clinic networks in the country from marketing their treatments, which would effectively halt their operations.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The clinic customers are really the guinea pigs here. And they’re paying [up to] $20,000 for that right to be a guinea pig.'\u003ccite>Paul Knoepfler, UC Davis\u003c/cite>\u003c/aside>\n\u003cp>At the FDA’s request, the Department of Justice will seek permanent injunctions to halt the core stem cell therapy used by U.S. Stem Cell Clinic of Sunshine, Florida, as well as the California Stem Cell Treatment Center and its affiliated Cell Surgical Network Corporation, located in Southern California. The two businesses\u003cb> \u003c/b>have affiliations with dozens of other stem cell clinics across the country, and the FDA said their method of stem cell therapy is unapproved, untested, and potentially dangerous for patients.\u003c/p>\n\u003cp>The request for the Florida injunction was prompted by four cases of blindness that occurred after patients received stem cell injections. In the filing against the California stem cell clinics, the FDA pointed to the use of smallpox vaccine to help create and use an unproven cancer therapy.\u003c/p>\n\u003cp>The agency’s action reflects its growing concern over the increase in stem cell clinics — an estimated 700 of them have popped up across the nation, with operations in almost every state.\u003c/p>\n\u003cp>Paul Knoepfler, a cell biology professor at UC Davis, is a stem cell researcher and one of the early critics of what he calls rogue stem cell clinics. These businesses leverage the power and hope resonant in the words “stem cell therapy,” while offering treatments that carry a big price tag and lack regulatory approval, he said.\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 clinic customers are really the guinea pigs here,” Knoepfler said. “And they’re paying [up to] $20,000 for that right to be a guinea pig. These stem cells can do unexpected things, like grow tumors, or grow things where they’re not supposed to – like scar tissue inside someone’s eyeball.”\u003c/p>\n\u003cp>Many stem cell clinics promise cutting‐edge treatment for just about every malady imaginable, from impotence to autism to lymphoma to multiple sclerosis. To get stem cells for the treatment, many clinics suction off a patient’s belly fat, which contains stem cells, then create an extract of those cells to inject into other parts of the body. The theory is some of these cells might promote healing.\u003c/p>\n\u003cp>More traditional stem cell research has produced some impressive cures. But that process involves many levels of clinical trials and proof of efficacy before a treatment goes on the market, something stem cell clinics do not provide.\u003c/p>\n\u003cp>Knoepfler has compiled \u003ca href=\"http://www.cell.com/cms/attachment/2062931415/2065421495/mmc2.xlsx\">a list\u003c/a> of the roughly 700 clinics nationwide. “California is a hotspot state,” he said. “It’s the number one state. It has more than 100 clinics here.”\u003c/p>\n\u003cp>And the epicenter of that stem cell clinic activity is Southern California, and Beverly Hills in particular, which has 18 clinics, Knoepfler said.\u003c/p>\n\u003cp>The FDA began increasing oversight of stem cell clinics in August of last year, when it sent a warning letter to the U.S. Stem Cell Clinic in Florida, and at the same time asked U.S. marshals to conduct a raid on a company called StemImmune in San Diego, seizing vials of smallpox vaccine that were planned for use at two California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage.\u003c/p>\n\u003cp>And in November last year, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm\">released tightened rules\u003c/a> for stem cell clinics, making clear that fat-derived stem cell therapies would be classified as a drug and should be subject to FDA approval.\u003c/p>\n\u003cp>The stem cell clinic owners at the two targeted sites said they’ll vigorously fight the requested injunctions. Their argument is that people’s own cells cannot be classified as a drug or drug therapy, and that people should be allowed to use them in any way they want.\u003c/p>\n\u003cp>In a company statement, the Florida-based U.S. Stem Cell said it “believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference.”\u003c/p>\n\u003cp>Knoepfler said the issue should not prompt a philosophical debate; it’s simply about patient safety.\u003c/p>\n\u003cp>“In theory the FDA can invoke criminal consequences, though we haven’t really seen that happen yet,” he said. “But with involvement of the Department of Justice in these particular cases with the injunctions, that to me seems a pretty serious indicator that this is something for stem cell clinics to take seriously.”\u003c/p>\n\u003cp>\u003cstrong>A Bigger Stick?\u003c/strong>\u003c/p>\n\u003cp>There is one more stick, yet to be wielded, that might be used to limit what therapies stem cell clinics can offer, and what claims they can make. The national Federation of State Medical Boards on May 8 released new\u003ca href=\"http://www.fsmb.org/globalassets/advocacy/policies/fsmb-stem-cell-workgroup-report.pdf\"> best-practices guidelines\u003c/a> for stem cell clinics. That’s significant because medical boards hold and can withdraw one of the things physicians value most: their medical license.\u003c/p>\n\u003cp>The recommendations are far-reaching: Medical boards can review and potentially withdraw licenses if stem cell clinics they are affiliated with make unsubstantiated claims, promote therapies not supported by science or use nondisclosure agreements to settle complaints.\u003c/p>\n\u003cp>Fines levied and court action taken by the FDA certainly can get people's attention, Knoepfler said, but the medical board federation's stance could be the real game-changer.\u003c/p>\n\u003cp>If doctors at stem cell clinics lose their medical license, it would cripple their credibility, impact their livelihood and potentially start an exodus of medical professionals out of the industry, he said.\u003c/p>\n\u003cp>“Somehow with the medical board license, for physicians it’s more of a tangible thing to take seriously,” Knoepfler said.\u003c/p>\n\u003cp> \u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/441482/fda-takes-action-against-california-stem-cell-clinics","authors":["8656"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1275","futureofyou_80","futureofyou_680"],"featImg":"futureofyou_262541","label":"futureofyou"},"futureofyou_438169":{"type":"posts","id":"futureofyou_438169","meta":{"index":"posts_1591205157","site":"futureofyou","id":"438169","score":null,"sort":[1516117527000]},"guestAuthors":[],"slug":"californias-stem-cell-agency-is-almost-out-of-money-should-voters-ok-5-billion-more","title":"Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More?","publishDate":1516117527,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>The year was 2004, and great medical breakthroughs were supposedly right around the corner.\u003c/p>\n\u003cp>In TV advertisements, celebrities\u003ca href=\"https://www.youtube.com/watch?v=fK9Eg0GVl7Q\" target=\"_blank\" rel=\"noopener\"> Michael J. Fox\u003c/a> and \u003ca href=\"https://preview-archives.nbclearn.com/portal/site/k-12/browse/?cuecard=4336\" target=\"_blank\" rel=\"noopener\">Christopher Reeve, \u003c/a>both suffering from incurable conditions, touted the promise of stem cell research, which could lead to a plethora of cures for life-threatening diseases.\u003c/p>\n\u003caside class=\"pullquote alignright\">Will California's appetite for funding stem cell research last?\u003c/aside>\n\u003cp>The ads ran in support of \u003ca href=\"https://ballotpedia.org/California_Proposition_71,_Stem_Cell_Research_(2004)\" target=\"_blank\" rel=\"noopener\">Proposition 71\u003c/a>, a $3 billion California bond measure that would create the first state-funded stem cell agency in the nation. Three years earlier, the George W. Bush administration had \u003ca href=\"http://www.presidency.ucsb.edu/ws/?pid=79025\" target=\"_blank\" rel=\"noopener\">issued\u003c/a> rules to limit use of stem cells obtained from human embryos. But California voters easily passed Proposition 71, 59-41 percent. The California Institute for Regenerative Medicine, or \u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\" rel=\"noopener\">CIRM\u003c/a>, was born. Its mission: to fund and accelerate stem-cell-related treatments.\u003c/p>\n\u003cp>Fourteen years and billions of dollars later, the agency is running out of money, and backers of stem cell research \u003ca href=\"http://capitolweekly.net/stem-cell-agency-nears-5-billion-ballot-plan/\" target=\"_blank\" rel=\"noopener\">plan\u003c/a> on asking California voters to pony up for round two.\u003c/p>\n\u003cp>And those stem cell breakthroughs?\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Still right around the corner. Or, if you're an optimist, perhaps rounding it, now.\u003c/p>\n\u003caside class=\"alignright\">Promising but as yet unapproved therapies funded by CIRM\n\u003cul>\n\u003cli>Slowing or reversing \u003ca href=\"https://newswise.com/articles/jcyte-presents-results-of-clinical-testing-in-retinitis-pigmentosa2\" target=\"_blank\" rel=\"noopener\">retinitis pigmentosa\u003c/a>\u003c/li>\n\u003cli>New shunt for \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/12/new-stem-cell-technology-could-make-life-easier-for-kidney-disease-patients/\" target=\"_blank\" rel=\"noopener\">kidney dialysis patients\u003c/a>\u003c/li>\n\u003cli>Gene therapy for children with no \u003ca href=\"https://blog.cirm.ca.gov/tag/evangelina-padilla-vaccaro/\" target=\"_blank\" rel=\"noopener\">functioning immune system\u003c/a>\u003c/li>\n\u003cli>Help for \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/04/spinal-patients-continue-remarkable-recovery-after-stem-cell-injections-company-says/\" target=\"_blank\" rel=\"noopener\">spinal-injury victims\u003c/a>\u003c/li>\n\u003cli>Lab-modified cells to treat \u003ca href=\"https://blog.cirm.ca.gov/2017/07/20/stem-cell-agency-funds-phase-3-clinical-trial-for-lou-gehrigs-disease/\" target=\"_blank\" rel=\"noopener\">ALS patients\u003c/a>\u003c/li>\n\u003c/ul>\n\u003c/aside>\n\u003cp>\u003cstrong>The Pitch\u003c/strong>\u003c/p>\n\u003cp>Stem cell research proponents — including the same advocacy group that backed Proposition 71 — want to ask voters in the November 2020 election for $5 billion in bond money to continue the work of CIRM.\u003c/p>\n\u003cp>For voters, there will be one major question, according to Zev Yaroslavsky, an expert on state politics and government at UCLA.\u003c/p>\n\u003cp>“The public will want to know what they’ve gotten for their money.”\u003c/p>\n\u003cfigure id=\"attachment_188656\" class=\"wp-caption alignleft\" style=\"max-width: 351px\">\u003cimg class=\" wp-image-188656\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/StemCells-800x534.jpg\" alt=\"Buttons with the slogan 'Save Lives With Stem Cells,' in support of Prop. 71 at the Stem Cell Research Proposition Party at the Biltmore Hotel Nov. 2, 2004 in Los Angeles, California.\" width=\"351\" height=\"234\">\u003cfigcaption class=\"wp-caption-text\">Buttons with the slogan 'Save Lives With Stem Cells,' in support of Prop. 71 in 2004. \u003ccite>(Frazer Harrison/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Yaroslavsky expects to see plenty of funding measures on the 2020 ballot, including a parks bond and money for open space and schools, not to mention repeal of the gas tax.\u003c/p>\n\u003cp>“At what point do people start to vote no on everything?\" Yaroslavsky said. \"Or prioritize which of those many good causes they want to spend their money on?”\u003c/p>\n\u003cfigure id=\"attachment_262540\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003cimg class=\"size-full wp-image-262540\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HumanEScellsintoneurons.jpg\" alt=\"\" width=\"640\" height=\"588\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HumanEScellsintoneurons.jpg 640w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HumanEScellsintoneurons-400x368.jpg 400w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003cfigcaption class=\"wp-caption-text\">Human embryonic stem cells differentiating into neurons \u003ccite>(Guoping Fan/UCLA/CIRM)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Robert Klein, who spearheaded the original 2004 ballot measure and served as the CIRM board's first chairman, still heads the advocacy group, \u003ca href=\"https://americansforcures.org/\" target=\"_blank\" rel=\"noopener\">Americans for Cures\u003c/a>, that pushed Proposition 71. Medical science isn't exactly his field — he's president of a Palo Alto-based real estate development firm — but he got involved in stem cell funding because of his son's Type 1 diabetes, which is incurable.\u003c/p>\n\u003cp>Klein said re-funding the stem cell agency is not just a good cause, but good business.\u003c/p>\n\u003cp>“It has been a creator of jobs, and the state benefits from taxes by attracting research centers here,” he said.\u003c/p>\n\u003cp>[contextly_sidebar id=\"Bv07QyLXQ031CUEZCQOytRKusurX2p1i\"]A 2012 \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/about_cirm/Econ_Impact_REPORT_updated_2012.pdf\" target=\"_blank\" rel=\"noopener\">independent review\u003c/a> commissioned by CIRM and looking forward through 2014 estimated that its grants plus matching funds would result in an average of over 4,000 jobs created per year, and $205 million in state tax revenue.\u003c/p>\n\u003cp>As for the proposed new funding, Klein said the $5 billion bond cost would be amortized over 40 years, so it’s not a huge cost compared to other government projects.\u003c/p>\n\u003cp>“Look, we paid \u003ca href=\"https://www.citylab.com/equity/2015/10/from-250-million-to-65-billion-the-bay-bridge-cost-overrun/410254/\">$6.5 billion\u003c/a> just to fix the eastern span of the Bay Bridge,” Klein said. “That’s road infrastructure — this is more like [funding] the intellectual infrastructure of California.”\u003c/p>\n\u003cp>\u003cstrong>Where Are the Cures?\u003c/strong>\u003c/p>\n\u003cp>Stem cells are undifferentiated cells that can be transformed into specific tissue and organ cells. The 2004 ballot initiative struck an emotional chord, in part because of the high-profile cases of actors Reeve and Fox, who personified the hope that the cells could play a role in new therapies for incurable medical conditions. Reeve, who died in 2004, became a quadriplegic after injuring his spine in a horse-riding accident; Fox has Parkinson’s, a neurodegenerative disease.\u003c/p>\n\u003cp>In Fox's \u003ca href=\"https://www.youtube.com/watch?v=fK9Eg0GVl7Q\" target=\"_blank\" rel=\"noopener\">30-second spot\u003c/a>, he used the word “cures” three times.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=fK9Eg0GVl7Q\u003c/p>\n\u003cp>So has CIRM produced any cures?\u003c/p>\n\u003cp>The family of 5-year-old \u003ca href=\"https://blog.cirm.ca.gov/tag/evangelina-padilla-vaccaro/\" target=\"_blank\" rel=\"noopener\">Evangelina Padilla-Vaccaro\u003c/a> would say yes.\u003c/p>\n\u003cp>Evangelina was born with a rare genetic condition called Severe Combined Immunodeficiency, or\u003ca href=\"https://www.genome.gov/13014325/learning-about-severe-combined-immunodeficiency-scid/\" target=\"_blank\" rel=\"noopener\"> SCID\u003c/a>, also known as “bubble baby” disease. The ailment renders a patient's immune system nonfunctioning. The National Institutes of Health \u003ca href=\"https://www.genome.gov/13014325/learning-about-severe-combined-immunodeficiency-scid/#al-3\" target=\"_blank\" rel=\"noopener\">estimates\u003c/a> approximately 40 to 100 children in the U.S. each year are diagnosed with the malady.\u003c/p>\n\u003cp>A team of UCLA clinical researchers, partially funded by CIRM, genetically modified Evangelina’s own blood stem cells to correct the SCID mutation.\u003c/p>\n\u003cp>She was cured.\u003c/p>\n\u003cp>Evangelina was the first to undergo the treatment, back when she was just a few months old. And now, CIRM says, at least 40 other children have been cured with the same procedure.\u003c/p>\n\u003cfigure id=\"attachment_438299\" class=\"wp-caption alignright\" style=\"max-width: 576px\">\u003cimg class=\"size-full wp-image-438299\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/evangelina_treatment.jpg\" alt=\"Baby in a hospital bed\" width=\"576\" height=\"768\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment.jpg 576w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-160x213.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-240x320.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-375x500.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-520x693.jpg 520w\" sizes=\"(max-width: 576px) 100vw, 576px\">\u003cfigcaption class=\"wp-caption-text\">Evangelina being treated by Don Kohn and his team in 2012. \u003ccite>(UCLA)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Despite this success, the SCID trial is only in Phase 2. CIRM has only two trials in Phase 3, a necessary step before FDA approval: one testing a \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/12/new-stem-cell-technology-could-make-life-easier-for-kidney-disease-patients/\" target=\"_blank\" rel=\"noopener\">new port\u003c/a> for kidney dialysis patients that is made out of human tissue and would not have to be replaced; and one that aims to\u003ca href=\"http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/07202017/phase-3-clinical-trial-targeting-lou-gehrigs-disease\" target=\"_blank\" rel=\"noopener\"> slow down\u003c/a> the progression of Lou Gehrig's disease.\u003c/p>\n\u003cp>Other promising CIRM-funded therapies include slowing or \u003ca href=\"https://newswise.com/articles/jcyte-presents-results-of-clinical-testing-in-retinitis-pigmentosa2\" target=\"_blank\" rel=\"noopener\">reversing\u003c/a> retinitis pigmentosa, a genetic abnormality that destroys a person’s sight; and \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/26/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate/\" target=\"_blank\" rel=\"noopener\">injecting stem cells\u003c/a> into patients with severe spinal injuries.\u003c/p>\n\u003cp>The FDA has made several of these therapies eligible for priority review by granting them Regenerative Medicine Advanced Therapy, or \u003ca href=\"https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm\" target=\"_blank\" rel=\"noopener\">RMAT\u003c/a>, status.\u003c/p>\n\u003cp>Clinical trials and research in less-advanced stages are ongoing for many other \u003ca href=\"https://www.cirm.ca.gov/grants\" target=\"_blank\" rel=\"noopener\">diseases and conditions\u003c/a>, including brain cancer, diabetes and HIV.\u003c/p>\n\u003cp>But the fact remains: Although this could change in the run-up to the election, no CIRM-funded stem cell treatment has yet to be approved by the FDA.\u003c/p>\n\u003cp>\u003cstrong>Miracles Capture the Imagination\u003c/strong>\u003c/p>\n\u003cp>Even outside of CIRM, only a handful of stem cell-related therapies have been approved for general use. Yet, stem cell research has captured the public's imagination with flashes of the miraculous.\u003c/p>\n\u003cfigure id=\"attachment_438300\" class=\"wp-caption alignright\" style=\"max-width: 594px\">\u003cimg class=\"size-full wp-image-438300\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/GettyImages-149183631.jpg\" alt=\"Middle aged man looks at camera.\" width=\"594\" height=\"396\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631.jpg 594w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-160x107.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-375x250.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-520x347.jpg 520w\" sizes=\"(max-width: 594px) 100vw, 594px\">\u003cfigcaption class=\"wp-caption-text\">Timothy Ray Brown, known as the 'Berlin patient' and the only person to have been cured of AIDS, at a press conference in 2012. \u003ccite>(T.J. Kirkpatrick/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Timothy Ray Brown, the famous \"\u003ca href=\"http://defeathiv.org/berlin/\" target=\"_blank\" rel=\"noopener\">Berlin patient\u003c/a>,\" for example, is an HIV patient who received a bone marrow transplant from a donor with a genetic mutation that endowed resistance to HIV. The transplant effectively cured Brown of the disease. However, there are currently a dearth of potential donors with the correct mutation, so researchers hope to create them, for use in patients' blood systems.\u003c/p>\n\u003cp>The bubble baby breakthrough and positive initial results in other CIRM-funded trials are strong selling points, said David Jensen, a journalist who covers stem cell research and writes a blog called \u003ca href=\"http://californiastemcellreport.blogspot.com/\" target=\"_blank\" rel=\"noopener\">California Stem Cell Report.\u003c/a>\u003c/p>\n\u003cp>\"There are some things CIRM can point to that are really impressive,\" Jensen said. \"It’s a pretty big deal in the world of science. It's the largest single source of funding for embryonic stem cell research in the world, and that’s no small thing.\"\u003c/p>\n\u003cp>[contextly_sidebar id=\"jHMWEkOPxg4IYTLSL83TfP2I7GjhjcyI\"]That doesn't necessarily mean voters will agree to re-fund it, he said.\u003c/p>\n\u003cp>Kevin McCormack, CIRM’s director of public communications and patient advocate outreach, said there's still time for CIRM to make a bigger splash.\u003c/p>\n\u003cp>“We’ve still got two more years,” McCormack said. “By 2020 I think people will see that CIRM-funded therapies are not just changing lives but saving lives.”\u003c/p>\n\u003cp>\u003cstrong>Overpromising: Something CIRM Has 'Had to Live With'\u003c/strong>\u003c/p>\n\u003cp>Klein, the backer of Proposition 71, said the 2004 campaign never promised cures during the lifetime of the stem cell agency, only progress toward attaining them.\u003c/p>\n\u003cp>“What we put in the ballot arguments is that we had to make major progress in mitigating disease, and moving toward cures,” Klein said. He feels that certainly has been achieved— and more. “In terms of progress toward the ultimate goal of cures, it’s remarkable what progress has been made.\u003c/p>\n\u003cp>\"When I look back, I think we have out-achieved the representations we put on the ballot.”\u003c/p>\n\u003cp>But even CIRM's McCormack has said, in an \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/06/22/stem-cells-where-science-hope-and-hype-meet/\" target=\"_blank\" rel=\"noopener\">interview with KQED\u003c/a> in 2016, that overpromising by the Proposition 71 campaign is \"something [CIRM] has had to live with.\"\u003c/p>\n\u003cp>Opposition during the \u003ca href=\"https://ballotpedia.org/California_Proposition_71,_Stem_Cell_Research_(2004)\">first ballot measure\u003c/a> was based mostly on religious concerns about using embryonic stem cells, on the large amount of money (the $3 billion price tag actually costs taxpayers $6 billion when interest is included) and on the lack of any guarantees of specific achievements.\u003c/p>\n\u003cp>Jensen expects religious objections to resurface when the election campaigns ramp up — but that those might not gain traction, because the field has expanded into adult and \u003ca href=\"https://stemcell.ucla.edu/induced-pluripotent-stem-cells\" target=\"_blank\" rel=\"noopener\">induced pluripotent stem cells\u003c/a> in addition to embryonic cells.\u003c/p>\n\u003cfigure id=\"attachment_438301\" class=\"wp-caption alignleft\" style=\"max-width: 570px\">\u003cimg class=\"size-full wp-image-438301\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/cured_ar_2016_cover.png\" alt=\"\" width=\"570\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover.png 570w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-160x168.png 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-240x253.png 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-375x395.png 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-520x547.png 520w\" sizes=\"(max-width: 570px) 100vw, 570px\">\u003cfigcaption class=\"wp-caption-text\">Evangelina Padilla-Vaccaro on the cover of CIRM's \u003ca href=\"https://www.cirm.ca.gov/about-cirm/cirm-annual-reports\">2016 Annual Report\u003c/a>. \u003ccite>(CIRM)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>And since the poster child for stem cell success could very well be the pint-sized and happy-faced Evangelina Padilla-Vaccaro, it may be hard to argue that these concerns outweigh not having to live in a bubble.\u003c/p>\n\u003cp>\"I mean, how can you be against that?\" Jensen said.\u003c/p>\n\u003cp>But some opposition has sprung up even inside the medical community. Barbara Koenig, head of the bioethics program at UCSF, pointed to ongoing concerns about conflict of interest at the agency — 90 percent of all spending benefited organizations that have been represented on the \u003ca href=\"https://www.cirm.ca.gov/board-and-meetings/list-icoc-members\" target=\"_blank\" rel=\"noopener\">governing board\u003c/a>, Jensen has been \u003ca href=\"http://capitolweekly.net/californias-stem-cell-agency-future-uncertain/\" target=\"_blank\" rel=\"noopener\">reporting\u003c/a>— and the public governance that she said has been lacking. (McCormack said the expansion of companies involved in stem cell research has resulted in broader distribution of funds. He also pointed to CIRM's adoption of more stringent\u003ca href=\"https://govt.westlaw.com/calregs/Document/ICD886A9181574C3BADD5946217E13F00?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&contextData=(sc.Default)&bhcp=1\" target=\"_blank\" rel=\"noopener\"> conflict-of-interest policies \u003c/a>in 2013.)\u003c/p>\n\u003caside class=\"pullquote alignright\">'I didn’t like the over-hyping of the immediate idea that [in 2004] there were cures around the corner. I think we need to be honest about how we’re investing in research.'\u003ccite>Barbara Koenig, UCSF bioethics program\u003cbr>\n\u003c/cite>\u003c/aside>\n\u003cp>Koenig supports stem cell research, but voted against the measure in 2004. And she has serious concerns about its possible renewal.\u003c/p>\n\u003cp>“I didn’t like the overhyping of the immediate idea that there were cures around the corner,” Koenig said. “I think we need to be honest about how we’re investing in research.”\u003c/p>\n\u003cp>Ask Koenig how she might use that proposed $5 billion differently, and she responds with a moment of stunned silence.\u003c/p>\n\u003cp>“Oh my, so many things,” she said. “I would try to figure out how to make sure every child in California has access to basic health services, nutrition, clean water . . . not just make high-priced products, but to improve public health.”\u003c/p>\n\u003cp>She said stem cell research \"privileges these quick-fix biotech approaches, which may make a lot of money but may not benefit the general public.”\u003c/p>\n\u003cp>Another bioethicist, Jodi Halpern of UC Berkeley, said the ballot initiative process is no place for a basic state spending decision.\u003c/p>\n\u003cp>“Why isn’t this a legislative issue?” Halpern asked. “We elect the Legislature to decide where California is going to spend its money. Putting this on the ballot, making it an emotional issue rather than just a financial one, that doesn’t sit right with me.\"\u003c/p>\n\u003cp>https://www.youtube.com/watch?time_continue=59&v=FjXiRx7DvzQ\u003c/p>\n\u003cp>\u003cstrong>Concerns vs. Cures\u003c/strong>\u003c/p>\n\u003cp>CIRM’s McCormack said he understands the concerns about state funding, but he said he's seen too much good come from the agency to see it wither on the budget-bickering vine.\u003c/p>\n\u003cp>“We are helping change the face of medicine,” he said. “We have so many clinical trials in the pipeline . . . that will pay off with therapies to help people who right now don’t have much of a chance for help, people with unmet medical needs.”\u003c/p>\n\u003cp>At its current spending pace, CIRM will run out of money by the \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/agenda/171214_Agedna_Item_%234_FINAL%20Dec%202017%20President%20Report%5B7%5D.pdf\" target=\"_blank\" rel=\"noopener\">end of 2019\u003c/a> — roughly a year before the proposed ballot measure vote. At its December 2017 board meeting, one of the \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/agenda/171214_Agenda_Item_%236_Presentation_Draft_1%5B2%5D_0.pdf\" target=\"_blank\" rel=\"noopener\">topics\u003c/a> for discussion was how to slow that spending and extend the agency’s grant-making till the end of 2020.\u003c/p>\n\u003cp>Board members and staffers aren’t involved in the proposed ballot measure, but they’re obviously keen on it, McCormack said.\u003c/p>\n\u003cp>Klein said he commissioned a survey to gauge interest and attitudes toward re-funding the agency. He said the numbers are strongly positive, but he has not released those results. There have been no other California polls on the topic since 2004, according to Jensen.\u003c/p>\n\u003cp>Even if voter attitudes are overwhelmingly favorable toward stem cell research, proponents may find that goodwill might wilt when it comes to passing a ballot measure, UCLA’s Yaroslavsky said.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>“People do see stem cell research as something they have a stake in, but you’re going to have to explain what we got with the first $3 billion. I suspect their case with the voters will be that we need to keep momentum going. But the question is, 'Will they buy it?' ”\u003c/p>\n\n","blocks":[],"excerpt":"Fourteen years after Calif. voters approved $3 billion in funding to create a state stem cell agency, backers are planning to ask the public to pony up again. What achievements will they be able to point to?","status":"publish","parent":0,"modified":1516647437,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":67,"wordCount":2291},"headData":{"title":"Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More? | KQED","description":"Fourteen years after Calif. voters approved $3 billion in funding to create a state stem cell agency, backers are planning to ask the public to pony up again. What achievements will they be able to point to?","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More?","datePublished":"2018-01-16T15:45:27.000Z","dateModified":"2018-01-22T18:57:17.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"438169 https://ww2.kqed.org/futureofyou/?p=438169","disqusUrl":"https://ww2.kqed.org/futureofyou/2018/01/16/californias-stem-cell-agency-is-almost-out-of-money-should-voters-ok-5-billion-more/","disqusTitle":"Calif. Stem Cell Agency Has Yet to Fund an FDA-Approved Cure. Will Voters Give It $5 Billion More?","source":"KQED Future of You","path":"/futureofyou/438169/californias-stem-cell-agency-is-almost-out-of-money-should-voters-ok-5-billion-more","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The year was 2004, and great medical breakthroughs were supposedly right around the corner.\u003c/p>\n\u003cp>In TV advertisements, celebrities\u003ca href=\"https://www.youtube.com/watch?v=fK9Eg0GVl7Q\" target=\"_blank\" rel=\"noopener\"> Michael J. Fox\u003c/a> and \u003ca href=\"https://preview-archives.nbclearn.com/portal/site/k-12/browse/?cuecard=4336\" target=\"_blank\" rel=\"noopener\">Christopher Reeve, \u003c/a>both suffering from incurable conditions, touted the promise of stem cell research, which could lead to a plethora of cures for life-threatening diseases.\u003c/p>\n\u003caside class=\"pullquote alignright\">Will California's appetite for funding stem cell research last?\u003c/aside>\n\u003cp>The ads ran in support of \u003ca href=\"https://ballotpedia.org/California_Proposition_71,_Stem_Cell_Research_(2004)\" target=\"_blank\" rel=\"noopener\">Proposition 71\u003c/a>, a $3 billion California bond measure that would create the first state-funded stem cell agency in the nation. Three years earlier, the George W. Bush administration had \u003ca href=\"http://www.presidency.ucsb.edu/ws/?pid=79025\" target=\"_blank\" rel=\"noopener\">issued\u003c/a> rules to limit use of stem cells obtained from human embryos. But California voters easily passed Proposition 71, 59-41 percent. The California Institute for Regenerative Medicine, or \u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\" rel=\"noopener\">CIRM\u003c/a>, was born. Its mission: to fund and accelerate stem-cell-related treatments.\u003c/p>\n\u003cp>Fourteen years and billions of dollars later, the agency is running out of money, and backers of stem cell research \u003ca href=\"http://capitolweekly.net/stem-cell-agency-nears-5-billion-ballot-plan/\" target=\"_blank\" rel=\"noopener\">plan\u003c/a> on asking California voters to pony up for round two.\u003c/p>\n\u003cp>And those stem cell breakthroughs?\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>Still right around the corner. Or, if you're an optimist, perhaps rounding it, now.\u003c/p>\n\u003caside class=\"alignright\">Promising but as yet unapproved therapies funded by CIRM\n\u003cul>\n\u003cli>Slowing or reversing \u003ca href=\"https://newswise.com/articles/jcyte-presents-results-of-clinical-testing-in-retinitis-pigmentosa2\" target=\"_blank\" rel=\"noopener\">retinitis pigmentosa\u003c/a>\u003c/li>\n\u003cli>New shunt for \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/12/new-stem-cell-technology-could-make-life-easier-for-kidney-disease-patients/\" target=\"_blank\" rel=\"noopener\">kidney dialysis patients\u003c/a>\u003c/li>\n\u003cli>Gene therapy for children with no \u003ca href=\"https://blog.cirm.ca.gov/tag/evangelina-padilla-vaccaro/\" target=\"_blank\" rel=\"noopener\">functioning immune system\u003c/a>\u003c/li>\n\u003cli>Help for \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/04/spinal-patients-continue-remarkable-recovery-after-stem-cell-injections-company-says/\" target=\"_blank\" rel=\"noopener\">spinal-injury victims\u003c/a>\u003c/li>\n\u003cli>Lab-modified cells to treat \u003ca href=\"https://blog.cirm.ca.gov/2017/07/20/stem-cell-agency-funds-phase-3-clinical-trial-for-lou-gehrigs-disease/\" target=\"_blank\" rel=\"noopener\">ALS patients\u003c/a>\u003c/li>\n\u003c/ul>\n\u003c/aside>\n\u003cp>\u003cstrong>The Pitch\u003c/strong>\u003c/p>\n\u003cp>Stem cell research proponents — including the same advocacy group that backed Proposition 71 — want to ask voters in the November 2020 election for $5 billion in bond money to continue the work of CIRM.\u003c/p>\n\u003cp>For voters, there will be one major question, according to Zev Yaroslavsky, an expert on state politics and government at UCLA.\u003c/p>\n\u003cp>“The public will want to know what they’ve gotten for their money.”\u003c/p>\n\u003cfigure id=\"attachment_188656\" class=\"wp-caption alignleft\" style=\"max-width: 351px\">\u003cimg class=\" wp-image-188656\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/06/StemCells-800x534.jpg\" alt=\"Buttons with the slogan 'Save Lives With Stem Cells,' in support of Prop. 71 at the Stem Cell Research Proposition Party at the Biltmore Hotel Nov. 2, 2004 in Los Angeles, California.\" width=\"351\" height=\"234\">\u003cfigcaption class=\"wp-caption-text\">Buttons with the slogan 'Save Lives With Stem Cells,' in support of Prop. 71 in 2004. \u003ccite>(Frazer Harrison/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Yaroslavsky expects to see plenty of funding measures on the 2020 ballot, including a parks bond and money for open space and schools, not to mention repeal of the gas tax.\u003c/p>\n\u003cp>“At what point do people start to vote no on everything?\" Yaroslavsky said. \"Or prioritize which of those many good causes they want to spend their money on?”\u003c/p>\n\u003cfigure id=\"attachment_262540\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003cimg class=\"size-full wp-image-262540\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HumanEScellsintoneurons.jpg\" alt=\"\" width=\"640\" height=\"588\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HumanEScellsintoneurons.jpg 640w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HumanEScellsintoneurons-400x368.jpg 400w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003cfigcaption class=\"wp-caption-text\">Human embryonic stem cells differentiating into neurons \u003ccite>(Guoping Fan/UCLA/CIRM)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Robert Klein, who spearheaded the original 2004 ballot measure and served as the CIRM board's first chairman, still heads the advocacy group, \u003ca href=\"https://americansforcures.org/\" target=\"_blank\" rel=\"noopener\">Americans for Cures\u003c/a>, that pushed Proposition 71. Medical science isn't exactly his field — he's president of a Palo Alto-based real estate development firm — but he got involved in stem cell funding because of his son's Type 1 diabetes, which is incurable.\u003c/p>\n\u003cp>Klein said re-funding the stem cell agency is not just a good cause, but good business.\u003c/p>\n\u003cp>“It has been a creator of jobs, and the state benefits from taxes by attracting research centers here,” he said.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>A 2012 \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/about_cirm/Econ_Impact_REPORT_updated_2012.pdf\" target=\"_blank\" rel=\"noopener\">independent review\u003c/a> commissioned by CIRM and looking forward through 2014 estimated that its grants plus matching funds would result in an average of over 4,000 jobs created per year, and $205 million in state tax revenue.\u003c/p>\n\u003cp>As for the proposed new funding, Klein said the $5 billion bond cost would be amortized over 40 years, so it’s not a huge cost compared to other government projects.\u003c/p>\n\u003cp>“Look, we paid \u003ca href=\"https://www.citylab.com/equity/2015/10/from-250-million-to-65-billion-the-bay-bridge-cost-overrun/410254/\">$6.5 billion\u003c/a> just to fix the eastern span of the Bay Bridge,” Klein said. “That’s road infrastructure — this is more like [funding] the intellectual infrastructure of California.”\u003c/p>\n\u003cp>\u003cstrong>Where Are the Cures?\u003c/strong>\u003c/p>\n\u003cp>Stem cells are undifferentiated cells that can be transformed into specific tissue and organ cells. The 2004 ballot initiative struck an emotional chord, in part because of the high-profile cases of actors Reeve and Fox, who personified the hope that the cells could play a role in new therapies for incurable medical conditions. Reeve, who died in 2004, became a quadriplegic after injuring his spine in a horse-riding accident; Fox has Parkinson’s, a neurodegenerative disease.\u003c/p>\n\u003cp>In Fox's \u003ca href=\"https://www.youtube.com/watch?v=fK9Eg0GVl7Q\" target=\"_blank\" rel=\"noopener\">30-second spot\u003c/a>, he used the word “cures” three times.\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/fK9Eg0GVl7Q'\n title='//www.youtube.com/embed/fK9Eg0GVl7Q'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>So has CIRM produced any cures?\u003c/p>\n\u003cp>The family of 5-year-old \u003ca href=\"https://blog.cirm.ca.gov/tag/evangelina-padilla-vaccaro/\" target=\"_blank\" rel=\"noopener\">Evangelina Padilla-Vaccaro\u003c/a> would say yes.\u003c/p>\n\u003cp>Evangelina was born with a rare genetic condition called Severe Combined Immunodeficiency, or\u003ca href=\"https://www.genome.gov/13014325/learning-about-severe-combined-immunodeficiency-scid/\" target=\"_blank\" rel=\"noopener\"> SCID\u003c/a>, also known as “bubble baby” disease. The ailment renders a patient's immune system nonfunctioning. The National Institutes of Health \u003ca href=\"https://www.genome.gov/13014325/learning-about-severe-combined-immunodeficiency-scid/#al-3\" target=\"_blank\" rel=\"noopener\">estimates\u003c/a> approximately 40 to 100 children in the U.S. each year are diagnosed with the malady.\u003c/p>\n\u003cp>A team of UCLA clinical researchers, partially funded by CIRM, genetically modified Evangelina’s own blood stem cells to correct the SCID mutation.\u003c/p>\n\u003cp>She was cured.\u003c/p>\n\u003cp>Evangelina was the first to undergo the treatment, back when she was just a few months old. And now, CIRM says, at least 40 other children have been cured with the same procedure.\u003c/p>\n\u003cfigure id=\"attachment_438299\" class=\"wp-caption alignright\" style=\"max-width: 576px\">\u003cimg class=\"size-full wp-image-438299\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/evangelina_treatment.jpg\" alt=\"Baby in a hospital bed\" width=\"576\" height=\"768\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment.jpg 576w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-160x213.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-240x320.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-375x500.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/evangelina_treatment-520x693.jpg 520w\" sizes=\"(max-width: 576px) 100vw, 576px\">\u003cfigcaption class=\"wp-caption-text\">Evangelina being treated by Don Kohn and his team in 2012. \u003ccite>(UCLA)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Despite this success, the SCID trial is only in Phase 2. CIRM has only two trials in Phase 3, a necessary step before FDA approval: one testing a \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/10/12/new-stem-cell-technology-could-make-life-easier-for-kidney-disease-patients/\" target=\"_blank\" rel=\"noopener\">new port\u003c/a> for kidney dialysis patients that is made out of human tissue and would not have to be replaced; and one that aims to\u003ca href=\"http://www.cirm.ca.gov/about-cirm/newsroom/press-releases/07202017/phase-3-clinical-trial-targeting-lou-gehrigs-disease\" target=\"_blank\" rel=\"noopener\"> slow down\u003c/a> the progression of Lou Gehrig's disease.\u003c/p>\n\u003cp>Other promising CIRM-funded therapies include slowing or \u003ca href=\"https://newswise.com/articles/jcyte-presents-results-of-clinical-testing-in-retinitis-pigmentosa2\" target=\"_blank\" rel=\"noopener\">reversing\u003c/a> retinitis pigmentosa, a genetic abnormality that destroys a person’s sight; and \u003ca href=\"https://ww2.kqed.org/futureofyou/2017/10/26/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate/\" target=\"_blank\" rel=\"noopener\">injecting stem cells\u003c/a> into patients with severe spinal injuries.\u003c/p>\n\u003cp>The FDA has made several of these therapies eligible for priority review by granting them Regenerative Medicine Advanced Therapy, or \u003ca href=\"https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm\" target=\"_blank\" rel=\"noopener\">RMAT\u003c/a>, status.\u003c/p>\n\u003cp>Clinical trials and research in less-advanced stages are ongoing for many other \u003ca href=\"https://www.cirm.ca.gov/grants\" target=\"_blank\" rel=\"noopener\">diseases and conditions\u003c/a>, including brain cancer, diabetes and HIV.\u003c/p>\n\u003cp>But the fact remains: Although this could change in the run-up to the election, no CIRM-funded stem cell treatment has yet to be approved by the FDA.\u003c/p>\n\u003cp>\u003cstrong>Miracles Capture the Imagination\u003c/strong>\u003c/p>\n\u003cp>Even outside of CIRM, only a handful of stem cell-related therapies have been approved for general use. Yet, stem cell research has captured the public's imagination with flashes of the miraculous.\u003c/p>\n\u003cfigure id=\"attachment_438300\" class=\"wp-caption alignright\" style=\"max-width: 594px\">\u003cimg class=\"size-full wp-image-438300\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/GettyImages-149183631.jpg\" alt=\"Middle aged man looks at camera.\" width=\"594\" height=\"396\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631.jpg 594w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-160x107.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-240x160.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-375x250.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/GettyImages-149183631-520x347.jpg 520w\" sizes=\"(max-width: 594px) 100vw, 594px\">\u003cfigcaption class=\"wp-caption-text\">Timothy Ray Brown, known as the 'Berlin patient' and the only person to have been cured of AIDS, at a press conference in 2012. \u003ccite>(T.J. Kirkpatrick/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Timothy Ray Brown, the famous \"\u003ca href=\"http://defeathiv.org/berlin/\" target=\"_blank\" rel=\"noopener\">Berlin patient\u003c/a>,\" for example, is an HIV patient who received a bone marrow transplant from a donor with a genetic mutation that endowed resistance to HIV. The transplant effectively cured Brown of the disease. However, there are currently a dearth of potential donors with the correct mutation, so researchers hope to create them, for use in patients' blood systems.\u003c/p>\n\u003cp>The bubble baby breakthrough and positive initial results in other CIRM-funded trials are strong selling points, said David Jensen, a journalist who covers stem cell research and writes a blog called \u003ca href=\"http://californiastemcellreport.blogspot.com/\" target=\"_blank\" rel=\"noopener\">California Stem Cell Report.\u003c/a>\u003c/p>\n\u003cp>\"There are some things CIRM can point to that are really impressive,\" Jensen said. \"It’s a pretty big deal in the world of science. It's the largest single source of funding for embryonic stem cell research in the world, and that’s no small thing.\"\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>That doesn't necessarily mean voters will agree to re-fund it, he said.\u003c/p>\n\u003cp>Kevin McCormack, CIRM’s director of public communications and patient advocate outreach, said there's still time for CIRM to make a bigger splash.\u003c/p>\n\u003cp>“We’ve still got two more years,” McCormack said. “By 2020 I think people will see that CIRM-funded therapies are not just changing lives but saving lives.”\u003c/p>\n\u003cp>\u003cstrong>Overpromising: Something CIRM Has 'Had to Live With'\u003c/strong>\u003c/p>\n\u003cp>Klein, the backer of Proposition 71, said the 2004 campaign never promised cures during the lifetime of the stem cell agency, only progress toward attaining them.\u003c/p>\n\u003cp>“What we put in the ballot arguments is that we had to make major progress in mitigating disease, and moving toward cures,” Klein said. He feels that certainly has been achieved— and more. “In terms of progress toward the ultimate goal of cures, it’s remarkable what progress has been made.\u003c/p>\n\u003cp>\"When I look back, I think we have out-achieved the representations we put on the ballot.”\u003c/p>\n\u003cp>But even CIRM's McCormack has said, in an \u003ca href=\"https://ww2.kqed.org/futureofyou/2016/06/22/stem-cells-where-science-hope-and-hype-meet/\" target=\"_blank\" rel=\"noopener\">interview with KQED\u003c/a> in 2016, that overpromising by the Proposition 71 campaign is \"something [CIRM] has had to live with.\"\u003c/p>\n\u003cp>Opposition during the \u003ca href=\"https://ballotpedia.org/California_Proposition_71,_Stem_Cell_Research_(2004)\">first ballot measure\u003c/a> was based mostly on religious concerns about using embryonic stem cells, on the large amount of money (the $3 billion price tag actually costs taxpayers $6 billion when interest is included) and on the lack of any guarantees of specific achievements.\u003c/p>\n\u003cp>Jensen expects religious objections to resurface when the election campaigns ramp up — but that those might not gain traction, because the field has expanded into adult and \u003ca href=\"https://stemcell.ucla.edu/induced-pluripotent-stem-cells\" target=\"_blank\" rel=\"noopener\">induced pluripotent stem cells\u003c/a> in addition to embryonic cells.\u003c/p>\n\u003cfigure id=\"attachment_438301\" class=\"wp-caption alignleft\" style=\"max-width: 570px\">\u003cimg class=\"size-full wp-image-438301\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2018/01/cured_ar_2016_cover.png\" alt=\"\" width=\"570\" height=\"600\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover.png 570w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-160x168.png 160w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-240x253.png 240w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-375x395.png 375w, https://ww2.kqed.org/app/uploads/sites/13/2018/01/cured_ar_2016_cover-520x547.png 520w\" sizes=\"(max-width: 570px) 100vw, 570px\">\u003cfigcaption class=\"wp-caption-text\">Evangelina Padilla-Vaccaro on the cover of CIRM's \u003ca href=\"https://www.cirm.ca.gov/about-cirm/cirm-annual-reports\">2016 Annual Report\u003c/a>. \u003ccite>(CIRM)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>And since the poster child for stem cell success could very well be the pint-sized and happy-faced Evangelina Padilla-Vaccaro, it may be hard to argue that these concerns outweigh not having to live in a bubble.\u003c/p>\n\u003cp>\"I mean, how can you be against that?\" Jensen said.\u003c/p>\n\u003cp>But some opposition has sprung up even inside the medical community. Barbara Koenig, head of the bioethics program at UCSF, pointed to ongoing concerns about conflict of interest at the agency — 90 percent of all spending benefited organizations that have been represented on the \u003ca href=\"https://www.cirm.ca.gov/board-and-meetings/list-icoc-members\" target=\"_blank\" rel=\"noopener\">governing board\u003c/a>, Jensen has been \u003ca href=\"http://capitolweekly.net/californias-stem-cell-agency-future-uncertain/\" target=\"_blank\" rel=\"noopener\">reporting\u003c/a>— and the public governance that she said has been lacking. (McCormack said the expansion of companies involved in stem cell research has resulted in broader distribution of funds. He also pointed to CIRM's adoption of more stringent\u003ca href=\"https://govt.westlaw.com/calregs/Document/ICD886A9181574C3BADD5946217E13F00?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&contextData=(sc.Default)&bhcp=1\" target=\"_blank\" rel=\"noopener\"> conflict-of-interest policies \u003c/a>in 2013.)\u003c/p>\n\u003caside class=\"pullquote alignright\">'I didn’t like the over-hyping of the immediate idea that [in 2004] there were cures around the corner. I think we need to be honest about how we’re investing in research.'\u003ccite>Barbara Koenig, UCSF bioethics program\u003cbr>\n\u003c/cite>\u003c/aside>\n\u003cp>Koenig supports stem cell research, but voted against the measure in 2004. And she has serious concerns about its possible renewal.\u003c/p>\n\u003cp>“I didn’t like the overhyping of the immediate idea that there were cures around the corner,” Koenig said. “I think we need to be honest about how we’re investing in research.”\u003c/p>\n\u003cp>Ask Koenig how she might use that proposed $5 billion differently, and she responds with a moment of stunned silence.\u003c/p>\n\u003cp>“Oh my, so many things,” she said. “I would try to figure out how to make sure every child in California has access to basic health services, nutrition, clean water . . . not just make high-priced products, but to improve public health.”\u003c/p>\n\u003cp>She said stem cell research \"privileges these quick-fix biotech approaches, which may make a lot of money but may not benefit the general public.”\u003c/p>\n\u003cp>Another bioethicist, Jodi Halpern of UC Berkeley, said the ballot initiative process is no place for a basic state spending decision.\u003c/p>\n\u003cp>“Why isn’t this a legislative issue?” Halpern asked. “We elect the Legislature to decide where California is going to spend its money. Putting this on the ballot, making it an emotional issue rather than just a financial one, that doesn’t sit right with me.\"\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/FjXiRx7DvzQ'\n title='//www.youtube.com/embed/FjXiRx7DvzQ'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>\u003cstrong>Concerns vs. Cures\u003c/strong>\u003c/p>\n\u003cp>CIRM’s McCormack said he understands the concerns about state funding, but he said he's seen too much good come from the agency to see it wither on the budget-bickering vine.\u003c/p>\n\u003cp>“We are helping change the face of medicine,” he said. “We have so many clinical trials in the pipeline . . . that will pay off with therapies to help people who right now don’t have much of a chance for help, people with unmet medical needs.”\u003c/p>\n\u003cp>At its current spending pace, CIRM will run out of money by the \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/agenda/171214_Agedna_Item_%234_FINAL%20Dec%202017%20President%20Report%5B7%5D.pdf\" target=\"_blank\" rel=\"noopener\">end of 2019\u003c/a> — roughly a year before the proposed ballot measure vote. At its December 2017 board meeting, one of the \u003ca href=\"https://www.cirm.ca.gov/sites/default/files/files/agenda/171214_Agenda_Item_%236_Presentation_Draft_1%5B2%5D_0.pdf\" target=\"_blank\" rel=\"noopener\">topics\u003c/a> for discussion was how to slow that spending and extend the agency’s grant-making till the end of 2020.\u003c/p>\n\u003cp>Board members and staffers aren’t involved in the proposed ballot measure, but they’re obviously keen on it, McCormack said.\u003c/p>\n\u003cp>Klein said he commissioned a survey to gauge interest and attitudes toward re-funding the agency. He said the numbers are strongly positive, but he has not released those results. There have been no other California polls on the topic since 2004, according to Jensen.\u003c/p>\n\u003cp>Even if voter attitudes are overwhelmingly favorable toward stem cell research, proponents may find that goodwill might wilt when it comes to passing a ballot measure, UCLA’s Yaroslavsky said.\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>“People do see stem cell research as something they have a stake in, but you’re going to have to explain what we got with the first $3 billion. I suspect their case with the voters will be that we need to keep momentum going. But the question is, 'Will they buy it?' ”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/438169/californias-stem-cell-agency-is-almost-out-of-money-should-voters-ok-5-billion-more","authors":["8656"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_961","futureofyou_1275","futureofyou_80","futureofyou_680"],"featImg":"futureofyou_438308","label":"source_futureofyou_438169"},"futureofyou_436116":{"type":"posts","id":"futureofyou_436116","meta":{"index":"posts_1591205157","site":"futureofyou","id":"436116","score":null,"sort":[1509032630000]},"guestAuthors":[],"slug":"paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate","title":"Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?","publishDate":1509032630,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>If you've been reading about the\u003ca href=\"https://www.scistar-study.com/\" target=\"_blank\" rel=\"noopener\"> SCiStar\u003c/a> stem cell trial, you know the company's \u003ca href=\"http://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3Chttp://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3E\" target=\"_blank\" rel=\"noopener\">reports\u003c/a> of its initial results sound truly remarkable.\u003c/p>\n\u003caside class=\"alignright\">All six paralyzed patients in Phase II of the SCiStar trial have regained some movement, and 4 out of 6 have made significant gains.\u003c/aside>\n\u003cp>The trial is injecting \u003ca href=\"https://en.wikipedia.org/wiki/Oligodendrocyte_progenitor_cell\" target=\"_blank\" rel=\"noopener\">oligodendrocyte progenitor cells\u003c/a>, produced from human embryonic stem cells, into patients ages 18-69. These trial subjects have suffered recent spinal cord injuries in the neck, resulting in the loss of nearly all sensation and movement below the injury, as well as some paralysis of the arms and legs.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">The results so far: One year after six people with severe spinal cord injuries received a dose of more than 10 million stem cells, all six patients have progressed at least one motor level on both sides of their bodies, based on a widely used \u003c/span>\u003cspan class=\"s1\">\u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232636/\" target=\"_blank\" rel=\"noopener\">scale \u003c/a>\u003c/span>that measures the range of movement in various muscles.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">In addition, four of the patients jumped two levels on at least one side, and one patient advanced three. And two patients progressed two motor levels on both sides. \u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">This is all according to Asterias Biotherapeutics, the company conducting the trial. Asterias also says\u003c/span> patients in this cohort showed improvement between the six-month and 12-month marks from the time they received the infusion of stem cells.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The take-home message is that we can only hope to truly demonstrate efficacy in a randomized control trial.'\u003ccite>Dr. Edward Wirth, Asterias Biotherapeutics\u003c/cite>\u003c/aside>\n\u003cp>“Usually what you see is a plateau, and that’s not what we’re seeing here. They continued to improve,” said Dr. Charles Liu, an investigator on the study and director of the USC Neurorestoration Center. “It was a durable effect. And that’s incredibly exciting.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003cspan class=\"s1\">The trial is legitimate. It’s partially funded by the\u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\" rel=\"noopener\"> California Institute for Regenerative Medicine,\u003c/a> the state's stem cell agency; well-known spinal experts are participating; and the FDA has certified the treatment as one that preliminary clinical evidence indicates has the “potential to address unmet medical needs” related to a “serious or life-threatening disease or condition.” \u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">There have also been a steady stream of media reports about the possibility of a breakthrough, including our own \u003ca href=\"https://ww2.kqed.org/futureofyou/tag/spinal-injuries/\" target=\"_blank\" rel=\"noopener\">coverage \u003c/a>and a recent \u003ca href=\"http://discovermagazine.com/2017/oct/what-once--was-lost\" target=\"_blank\" rel=\"noopener\">feature\u003c/a> by Discover magazine and front-page\u003ca href=\"http://www.sfchronicle.com/health/article/Super-exciting-results-in-stem-cell-therapy-12245199.php\" target=\"_blank\" rel=\"noopener\"> story \u003c/a>from the San Francisco Chronicle.\u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">\"'Super exciting' results in stem cell therapy trial,\" was the headline, quoting Dr. Edward Wirth, the chief medical officer at Asterias.\u003c/span>\u003c/p>\n\u003cp>\u003cstrong>It's Still Early\u003c/strong>\u003c/p>\n\u003cp>Regaining two motor levels in spinocervical patients is significant. That level of improvement could mean the difference between full paralysis from the neck down, requiring a ventilator to breathe, versus regaining some arm, hand and finger movement, enabling patients to take care of many of life’s daily tasks unassisted.\u003c/p>\n\u003cp>Below is video of Kris Boesen, a patient in the trial who at the age of 20 was paralyzed from the neck down.\u003c/p>\n\u003cp>\"I couldn't drink, I couldn't feed myself, I couldn't text or pretty much do anything,\" he says. \"I was basically just existing.\"\u003c/p>\n\u003cp>But after the stem cell treatment, he says, \"I'm able to live my life.\"\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=N0ZWqBWDoQI&ab_channel=AmericansforCures\u003c/p>\n\u003cp>Another trial patient, Lucas Lindner, was in a car accident that left him a quadriplegic, with no use of his hands or legs. After receiving the stem cells, he recovered to the point of being able to throw a ball, type and use a soldering gun.\u003c/p>\n\u003cp>https://www.youtube.com/watch?v=1DerDpM_FO4&ab_channel=AsteriasBiotherapeutics\u003c/p>\n\u003cp>These are compelling stories. And if the treatment really does work, it could provide hope to traumatic-injury patients who might otherwise show little progress or improvement in their paralysis.\u003c/p>\n\u003cp>But of course, the sample size we've seen so far is small — really small — just six patients. And it's true that some patients have been known to spontaneously recover some movement after spinal injuries without having received a cutting-edge stem cell treatment. Also, in this second phase of the trial, there is no control group. A double-blind, control-group study is planned in Phase III next year.\u003c/p>\n\u003caside class=\"pullquote alignright\">'As a scientist I think it’s very exciting.'\u003ccite>Oswald Steward, UC Irvine School of Medicine\u003c/cite>\u003c/aside>\n\u003cp>So we wondered, how can the people running the trial know, right now, that the level of improvement in their subjects is favorable to patients who haven't received the treatment, prompting such optimistic press releases? And how much excitement should anyone allow themselves over these early results?\u003c/p>\n\u003cp>\u003cstrong>Using Historical Data to Compare\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">The likelihood of all six patients recovering to the degree they have on their own is unlikely, researchers say.\u003c/p>\n\u003cp class=\"p1\">“This is as good as you could hope at this point,” said USC's Liu, in March. “So far all the evidence is pointing in the right direction.\"\u003c/p>\n\u003cp>Asterias, based in Fremont, Calif., has tried to assess these early results by comparing the improvement in its cohort of patients to historical data from an estimated pool of 3,300 spinal injury victims in the \u003ca href=\"https://www.emsci.org/\" target=\"_blank\" rel=\"noopener\">European Multicenter Study about Spinal Cord Injury\u003c/a>. Asterias says the level of progress for its six subjects is about twice the rate of recovery patients saw in the European data, dating back to 2001.\u003c/p>\n\u003cp>\"The 12-month data showed 67% (4/6) of Cohort 2 (subjects) have recovered 2 or more motor levels on at least one side through 12 months, which is more than double the rates of recovery seen in both matched historical controls and published data in a similar population,\" the company wrote in an October \u003ca href=\"http://www.asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program\" target=\"_blank\" rel=\"noopener\">press release\u003c/a>.\u003c/p>\n\u003cp>But according to Oswald Steward, director of the Reeve-Irvine spinal cord research center at the UC Irvine School of Medicine, there are so many variables to be considered when you look at historical data, you really have to take any conclusions with a few grains of salt.\u003c/p>\n\u003cp>“It sounds good, but it’s not a control group, there’s no real data here,\" Steward says. \"It’s nice to give some background, to give you a sense of [comparative recovery rates], but that’s definitely the way I would put it.\"\u003c/p>\n\u003cp>Getting background information to give a rough framework of comparison is exactly what the company wanted to accomplish, according to \u003cspan class=\"s1\">Wirth, Asterias' chief medical officer.\u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">\"The take-home message is that we can only hope to truly demonstrate efficacy in a randomized control trial,\" he says. \u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">That's the plan in Phase\u003cstrong> \u003c/strong>III of the trial. \u003c/span>\u003cspan class=\"s1\">\"The historical controls are merely a temporary comparator to help us determine whether the ... program should move forward.\"\u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">\u003cstrong>An Unusual Step\u003c/strong>\u003c/span>\u003c/p>\n\u003cp>Historical data is often used in cancer studies because of the fixed nature of outcomes in some cancer types, but it's unusual to see early-stage clinical trials in other areas use it as a comparison, says Karen Messer, chief of the Biostatistics and Bioinformatics division at the Moores Cancer Center at UC San Diego Health.\u003c/p>\n\u003cp>“Use of historical controls is common in early-phase cancer studies because they usually have small sample sizes and the end points are really well-defined,\" she says.\u003c/p>\n\u003cp>But spinal cord injury outcomes may be more varied, Messer says, so the results of an intervention wouldn't be as reliable.\u003c/p>\n\u003cp>“(T)here are a few things to watch for: Are the patients comparable? Has treatment changed? You want to make sure the response assessment is not subject to any judgment calls.”\u003c/p>\n\u003cp>Asterias mined the European historical data because it was the only large spinal-injury database with current information that could be licensed, Wirth said in an internal memo on the rationale and methods for compiling historical data.\u003c/p>\n\u003cp>In that memo, Wirth wrote that some variables are not included in the European database. These include MRI data on spinal cord lesions and the timing or quality of decompression, a bone-trimming surgery that makes more room for nerves. These differences in the data make direct comparisons harder.\u003c/p>\n\u003cp>Diana Miglioretti is a biostatistics professor at UC Davis. She says historical data is an interesting approach to frame a comparison.\u003c/p>\n\u003cp>“Obviously it isn’t as strong as a control group,” she says, “but if there aren’t major time trends, it can be a reasonable alternative.”\u003c/p>\n\u003cp>In other words, Miglioretti says, if outcomes haven't changed over time — due to improvements in treatment, for example — it's not out of the question that historical data can serve as a control.\u003c/p>\n\u003cp>But according to spinal cord researcher Steward, that’s the main concern about taking historical data on spinal injuries at face value .\u003c/p>\n\u003cp>“In the past we treated spinal injury differently,” Steward says. “For instance the amount of time people spend in rehab is a lot less than it was 10 years ago.”\u003c/p>\n\u003cp>\u003cstrong>Strong Anecdotal Statements\u003c/strong>\u003c/p>\n\u003cp>From Steward’s point of view, the real reason to get excited about the phenomenal initial results of this stem cell therapy is not the supporting historical data, but rather the anecdotal statements by the clinical researchers.\u003c/p>\n\u003cp>For instance, he points to the statements by Richard Fessler, the lead investigator of the Asterias trial and a professor of neurosurgery at Rush University Medical Center in Chicago. “I’ve been treating these kinds of patients for 30 years,” Fessler said in the San Francisco Chronicle story, “and I’ve never seen anything like this before.” (Fessler has no financial stake in Asterias, company officials say.)\u003c/p>\n\u003cp>“When someone like Fessler says 'I’ve never seen anything like that,' ” Steward says, “I spend more time listening to that than to historical data.”\u003c/p>\n\u003cp>Steward also points out that this stem cell therapy won’t help those with chronic spinal injuries, but says it could be a game-changer for newly injured patients.\u003c/p>\n\u003cp>“Still, this is huge,” he says. “Things are progressing in a positive way. No bad outcomes, and people seem to be improving in a way that may be unprecedented. As a scientist I think it’s very exciting.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Jon Brooks contributed to this report.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"A year after six patients with severe spinal cord injuries received a dose of 10 million stem cells, all six have progressed at least one motor level on both sides of their bodies. A closer look at the evidence ...","status":"publish","parent":0,"modified":1509400539,"stats":{"hasAudio":false,"hasVideo":true,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":43,"wordCount":1744},"headData":{"title":"Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate? | KQED","description":"A year after six patients with severe spinal cord injuries received a dose of 10 million stem cells, all six have progressed at least one motor level on both sides of their bodies. A closer look at the evidence ...","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?","datePublished":"2017-10-26T15:43:50.000Z","dateModified":"2017-10-30T21:55:39.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"436116 https://ww2.kqed.org/futureofyou/?p=436116","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/10/26/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate/","disqusTitle":"Paralyzed Patients Regain Movement in Stem Cell Trial: Is It Too Early to Celebrate?","source":"Future of You","nprByline":"David Gorn\u003cbr />Future of You","path":"/futureofyou/436116/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>If you've been reading about the\u003ca href=\"https://www.scistar-study.com/\" target=\"_blank\" rel=\"noopener\"> SCiStar\u003c/a> stem cell trial, you know the company's \u003ca href=\"http://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3Chttp://asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program%3E\" target=\"_blank\" rel=\"noopener\">reports\u003c/a> of its initial results sound truly remarkable.\u003c/p>\n\u003caside class=\"alignright\">All six paralyzed patients in Phase II of the SCiStar trial have regained some movement, and 4 out of 6 have made significant gains.\u003c/aside>\n\u003cp>The trial is injecting \u003ca href=\"https://en.wikipedia.org/wiki/Oligodendrocyte_progenitor_cell\" target=\"_blank\" rel=\"noopener\">oligodendrocyte progenitor cells\u003c/a>, produced from human embryonic stem cells, into patients ages 18-69. These trial subjects have suffered recent spinal cord injuries in the neck, resulting in the loss of nearly all sensation and movement below the injury, as well as some paralysis of the arms and legs.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">The results so far: One year after six people with severe spinal cord injuries received a dose of more than 10 million stem cells, all six patients have progressed at least one motor level on both sides of their bodies, based on a widely used \u003c/span>\u003cspan class=\"s1\">\u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232636/\" target=\"_blank\" rel=\"noopener\">scale \u003c/a>\u003c/span>that measures the range of movement in various muscles.\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">In addition, four of the patients jumped two levels on at least one side, and one patient advanced three. And two patients progressed two motor levels on both sides. \u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">This is all according to Asterias Biotherapeutics, the company conducting the trial. Asterias also says\u003c/span> patients in this cohort showed improvement between the six-month and 12-month marks from the time they received the infusion of stem cells.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The take-home message is that we can only hope to truly demonstrate efficacy in a randomized control trial.'\u003ccite>Dr. Edward Wirth, Asterias Biotherapeutics\u003c/cite>\u003c/aside>\n\u003cp>“Usually what you see is a plateau, and that’s not what we’re seeing here. They continued to improve,” said Dr. Charles Liu, an investigator on the study and director of the USC Neurorestoration Center. “It was a durable effect. And that’s incredibly exciting.”\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>\u003cspan class=\"s1\">The trial is legitimate. It’s partially funded by the\u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\" rel=\"noopener\"> California Institute for Regenerative Medicine,\u003c/a> the state's stem cell agency; well-known spinal experts are participating; and the FDA has certified the treatment as one that preliminary clinical evidence indicates has the “potential to address unmet medical needs” related to a “serious or life-threatening disease or condition.” \u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">There have also been a steady stream of media reports about the possibility of a breakthrough, including our own \u003ca href=\"https://ww2.kqed.org/futureofyou/tag/spinal-injuries/\" target=\"_blank\" rel=\"noopener\">coverage \u003c/a>and a recent \u003ca href=\"http://discovermagazine.com/2017/oct/what-once--was-lost\" target=\"_blank\" rel=\"noopener\">feature\u003c/a> by Discover magazine and front-page\u003ca href=\"http://www.sfchronicle.com/health/article/Super-exciting-results-in-stem-cell-therapy-12245199.php\" target=\"_blank\" rel=\"noopener\"> story \u003c/a>from the San Francisco Chronicle.\u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">\"'Super exciting' results in stem cell therapy trial,\" was the headline, quoting Dr. Edward Wirth, the chief medical officer at Asterias.\u003c/span>\u003c/p>\n\u003cp>\u003cstrong>It's Still Early\u003c/strong>\u003c/p>\n\u003cp>Regaining two motor levels in spinocervical patients is significant. That level of improvement could mean the difference between full paralysis from the neck down, requiring a ventilator to breathe, versus regaining some arm, hand and finger movement, enabling patients to take care of many of life’s daily tasks unassisted.\u003c/p>\n\u003cp>Below is video of Kris Boesen, a patient in the trial who at the age of 20 was paralyzed from the neck down.\u003c/p>\n\u003cp>\"I couldn't drink, I couldn't feed myself, I couldn't text or pretty much do anything,\" he says. \"I was basically just existing.\"\u003c/p>\n\u003cp>But after the stem cell treatment, he says, \"I'm able to live my life.\"\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/N0ZWqBWDoQI'\n title='//www.youtube.com/embed/N0ZWqBWDoQI'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>Another trial patient, Lucas Lindner, was in a car accident that left him a quadriplegic, with no use of his hands or legs. After receiving the stem cells, he recovered to the point of being able to throw a ball, type and use a soldering gun.\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/1DerDpM_FO4'\n title='//www.youtube.com/embed/1DerDpM_FO4'\n allowfullscreen='true'\n style='border:0;'>\u003c/iframe>\n \u003c/span>\n \u003c/span>\u003c/p>\u003cp>\u003cp>These are compelling stories. And if the treatment really does work, it could provide hope to traumatic-injury patients who might otherwise show little progress or improvement in their paralysis.\u003c/p>\n\u003cp>But of course, the sample size we've seen so far is small — really small — just six patients. And it's true that some patients have been known to spontaneously recover some movement after spinal injuries without having received a cutting-edge stem cell treatment. Also, in this second phase of the trial, there is no control group. A double-blind, control-group study is planned in Phase III next year.\u003c/p>\n\u003caside class=\"pullquote alignright\">'As a scientist I think it’s very exciting.'\u003ccite>Oswald Steward, UC Irvine School of Medicine\u003c/cite>\u003c/aside>\n\u003cp>So we wondered, how can the people running the trial know, right now, that the level of improvement in their subjects is favorable to patients who haven't received the treatment, prompting such optimistic press releases? And how much excitement should anyone allow themselves over these early results?\u003c/p>\n\u003cp>\u003cstrong>Using Historical Data to Compare\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">The likelihood of all six patients recovering to the degree they have on their own is unlikely, researchers say.\u003c/p>\n\u003cp class=\"p1\">“This is as good as you could hope at this point,” said USC's Liu, in March. “So far all the evidence is pointing in the right direction.\"\u003c/p>\n\u003cp>Asterias, based in Fremont, Calif., has tried to assess these early results by comparing the improvement in its cohort of patients to historical data from an estimated pool of 3,300 spinal injury victims in the \u003ca href=\"https://www.emsci.org/\" target=\"_blank\" rel=\"noopener\">European Multicenter Study about Spinal Cord Injury\u003c/a>. Asterias says the level of progress for its six subjects is about twice the rate of recovery patients saw in the European data, dating back to 2001.\u003c/p>\n\u003cp>\"The 12-month data showed 67% (4/6) of Cohort 2 (subjects) have recovered 2 or more motor levels on at least one side through 12 months, which is more than double the rates of recovery seen in both matched historical controls and published data in a similar population,\" the company wrote in an October \u003ca href=\"http://www.asteriasbiotherapeutics.com/inv_news_releases_text.php?releaseid=2303887&date=October+02%2C+2017&title=Asterias+Announces+Two+Significant+Developments+for+Spinal+Cord+Injury+Program\" target=\"_blank\" rel=\"noopener\">press release\u003c/a>.\u003c/p>\n\u003cp>But according to Oswald Steward, director of the Reeve-Irvine spinal cord research center at the UC Irvine School of Medicine, there are so many variables to be considered when you look at historical data, you really have to take any conclusions with a few grains of salt.\u003c/p>\n\u003cp>“It sounds good, but it’s not a control group, there’s no real data here,\" Steward says. \"It’s nice to give some background, to give you a sense of [comparative recovery rates], but that’s definitely the way I would put it.\"\u003c/p>\n\u003cp>Getting background information to give a rough framework of comparison is exactly what the company wanted to accomplish, according to \u003cspan class=\"s1\">Wirth, Asterias' chief medical officer.\u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">\"The take-home message is that we can only hope to truly demonstrate efficacy in a randomized control trial,\" he says. \u003c/span>\u003c/p>\n\u003cp>\u003cspan class=\"s1\">That's the plan in Phase\u003cstrong> \u003c/strong>III of the trial. \u003c/span>\u003cspan class=\"s1\">\"The historical controls are merely a temporary comparator to help us determine whether the ... program should move forward.\"\u003c/span>\u003c/p>\n\u003cp class=\"p1\">\u003cspan class=\"s1\">\u003cstrong>An Unusual Step\u003c/strong>\u003c/span>\u003c/p>\n\u003cp>Historical data is often used in cancer studies because of the fixed nature of outcomes in some cancer types, but it's unusual to see early-stage clinical trials in other areas use it as a comparison, says Karen Messer, chief of the Biostatistics and Bioinformatics division at the Moores Cancer Center at UC San Diego Health.\u003c/p>\n\u003cp>“Use of historical controls is common in early-phase cancer studies because they usually have small sample sizes and the end points are really well-defined,\" she says.\u003c/p>\n\u003cp>But spinal cord injury outcomes may be more varied, Messer says, so the results of an intervention wouldn't be as reliable.\u003c/p>\n\u003cp>“(T)here are a few things to watch for: Are the patients comparable? Has treatment changed? You want to make sure the response assessment is not subject to any judgment calls.”\u003c/p>\n\u003cp>Asterias mined the European historical data because it was the only large spinal-injury database with current information that could be licensed, Wirth said in an internal memo on the rationale and methods for compiling historical data.\u003c/p>\n\u003cp>In that memo, Wirth wrote that some variables are not included in the European database. These include MRI data on spinal cord lesions and the timing or quality of decompression, a bone-trimming surgery that makes more room for nerves. These differences in the data make direct comparisons harder.\u003c/p>\n\u003cp>Diana Miglioretti is a biostatistics professor at UC Davis. She says historical data is an interesting approach to frame a comparison.\u003c/p>\n\u003cp>“Obviously it isn’t as strong as a control group,” she says, “but if there aren’t major time trends, it can be a reasonable alternative.”\u003c/p>\n\u003cp>In other words, Miglioretti says, if outcomes haven't changed over time — due to improvements in treatment, for example — it's not out of the question that historical data can serve as a control.\u003c/p>\n\u003cp>But according to spinal cord researcher Steward, that’s the main concern about taking historical data on spinal injuries at face value .\u003c/p>\n\u003cp>“In the past we treated spinal injury differently,” Steward says. “For instance the amount of time people spend in rehab is a lot less than it was 10 years ago.”\u003c/p>\n\u003cp>\u003cstrong>Strong Anecdotal Statements\u003c/strong>\u003c/p>\n\u003cp>From Steward’s point of view, the real reason to get excited about the phenomenal initial results of this stem cell therapy is not the supporting historical data, but rather the anecdotal statements by the clinical researchers.\u003c/p>\n\u003cp>For instance, he points to the statements by Richard Fessler, the lead investigator of the Asterias trial and a professor of neurosurgery at Rush University Medical Center in Chicago. “I’ve been treating these kinds of patients for 30 years,” Fessler said in the San Francisco Chronicle story, “and I’ve never seen anything like this before.” (Fessler has no financial stake in Asterias, company officials say.)\u003c/p>\n\u003cp>“When someone like Fessler says 'I’ve never seen anything like that,' ” Steward says, “I spend more time listening to that than to historical data.”\u003c/p>\n\u003cp>Steward also points out that this stem cell therapy won’t help those with chronic spinal injuries, but says it could be a game-changer for newly injured patients.\u003c/p>\n\u003cp>“Still, this is huge,” he says. “Things are progressing in a positive way. No bad outcomes, and people seem to be improving in a way that may be unprecedented. As a scientist I think it’s very exciting.”\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>Jon Brooks contributed to this report.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/436116/paralyzed-patients-regain-movement-in-stem-cell-trial-is-it-too-early-to-celebrate","authors":["byline_futureofyou_436116"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_1367","futureofyou_1222","futureofyou_1010","futureofyou_680"],"featImg":"futureofyou_436440","label":"source_futureofyou_436116"},"futureofyou_435066":{"type":"posts","id":"futureofyou_435066","meta":{"index":"posts_1591205157","site":"futureofyou","id":"435066","score":null,"sort":[1503945965000]},"guestAuthors":[],"slug":"feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics","title":"Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics","publishDate":1503945965,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations, as the Food and Drug Administration expressed “serious concerns” about how the clinic obtained access to the vaccine at all.\u003c/p>\n\u003cp class=\"danger-zone\">The U.S. Marshals Service seized five vials of the smallpox vaccine, which is not commercially available, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm\" target=\"_blank\" rel=\"noopener noreferrer\">announced\u003c/a> Monday. Four of the vials — which each hold 100 vaccine doses — were unused, but a portion of the fifth vial had been used.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'\u003ccite> FDA Commissioner Scott Gottlieb\u003c/cite>\u003c/aside>\n\u003cp>The treatment mixed some of the vaccine with stem cells taken from a patient to create an injectable — and unproven and unregulated — cancer treatment that was targeted directly at the patient’s tumors, the FDA said. The FDA, which learned of the treatment after inspections, said the injection could have caused inflammation and swelling of the heart.\u003c/p>\n\u003cp>The treatment belonged to San Diego-based company StemImmune Inc., and was given at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. U.S. marshals seized the product on Friday.\u003c/p>\n\u003cp>“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” FDA Commissioner Scott Gottlieb said in a statement. “I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>A complaint filed in federal court indicates the vials were shipped from outside California but does not provide more detail on the origin. StemImmune also filed \u003ca href=\"http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2&p=1&f=G&l=50&d=PG01&S1=Stemimmune.AANM.&OS=AANM/Stemimmune&RS=AANM/Stemimmune\" target=\"_blank\" rel=\"noopener noreferrer\">a patent application\u003c/a> in February describing “the use of smallpox vaccine to induce an effective anti-tumor immune response.”\u003c/p>\n\u003cp>The type of vaccine that was seized \u003ca href=\"https://www.cdc.gov/smallpox/vaccine-basics/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">is made \u003c/a>from a virus similar to smallpox, but it does not contain smallpox virus and cannot give anyone smallpox, according to the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Also Monday, the FDA announced it had sent \u003ca href=\"https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm\" target=\"_blank\" rel=\"noopener noreferrer\">a warning letter\u003c/a> to a Florida stem cell clinic where a 2015 procedure led three women to go legally blind, according \u003ca href=\"https://www.statnews.com/2017/03/15/stem-cell-patients-blind-macular-degeneration/\">to a March study\u003c/a> in the New England Journal of Medicine. The letter to U.S. Stem Cell Clinic said that the company was offering unapproved stem cell treatments and that an agency inspection uncovered violations of manufacturing standards, including potential sterility issues. The company also tried to stop FDA inspectors from talking with employees, the letter says.\u003c/p>\n\u003cp>“You should take prompt action to correct these deviations,” says the letter, which was sent Thursday. “Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.”\u003c/p>\n\u003cp>StemImmune did not respond immediately to a request for comment. In a statement, U.S. Stem Cell Clinic said it had given the FDA “unrestricted access” since 2014 and that it followed the agency’s rules. But it also suggested that regulations could prevent patients from getting treatments.\u003c/p>\n\u003cp>“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the [FDA],” it said, adding: “We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”\u003c/p>\n\u003cp>The actions announced Monday are the latest salvo in a back-and-forth between regulators and the clinics that claim to be able to treat everything from paralysis to neurodegenerative diseases to erectile dysfunction. The clinics, \u003ca href=\"https://www.statnews.com/2016/06/30/stem-cell-clinics-proliferate/\">which have proliferated\u003c/a> around the country in recent years, have largely evaded regulation enforcement because they typically take a person’s own stem cells and inject them back into the same person, meaning the cells are considered “minimally manipulated.”\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/\">FDA has tried\u003c/a> at various times to regulate clinics offering unproven stem cell treatments more tightly and close down clinics that put patients at risk, but overall, their efforts have not amounted to much.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/09/09/stem-cell-fda-hearing/\">FDA has held meetings\u003c/a> about possibly regulating the therapies more like drugs, a move that has been backed by many academic stem cell experts who say that stem cell therapies, while holding great potential, are not ready to be used widely or outside regulated clinical trials. But clinic owners warn that the FDA could stamp out progress in the field and keep desperate patients from getting treatments.\u003c/p>\n\u003cp>“The government should not regulate our bodies. … I will always stand up for patient rights,” Kristin Comella, U.S. Stem Cell’s chief scientific officer, said at an FDA hearing months ago. (The FDA’s warning letter this month was addressed to Comella.)\u003c/p>\n\u003cp>Some experts have wondered whether the regulation-averse Trump administration would take further action against stem cell clinics. But in a statement Monday, Gottlieb said the FDA would be bolstering its enforcement as a way of “separating the promise from the unscrupulous hype” and that the agency would roll out a new “comprehensive policy framework” this fall to delineate the rules for stem cell treatments.\u003c/p>\n\u003cp>“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb said. “These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This put the entire field at risk.”\u003c/p>\n\u003cp>Experts who study stem cell clinics and the regulatory landscape generally praised the FDA’s moves, but said that it was unclear what the enforcement actions and \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm\" target=\"_blank\" rel=\"noopener noreferrer\">Gottlieb’s statement\u003c/a> meant for the field going forward.\u003c/p>\n\u003cp>“The most important thing is that the FDA is now publicly making a commitment to discipline what has become an out-of-control area of fraudulent medicine,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.\u003c/p>\n\u003cp>One part of Gottlieb’s statement that stuck out to Charo, she said, was when he signaled some flexibility in terms of the areas that are subject to FDA regulation, with the commissioner writing that “the FDA must advance an efficient and least burdensome framework” and establish “a regulatory structure that does not become a barrier to beneficial new innovation.”\u003c/p>\n\u003cp>“It’s about a tone being set,” Charo said.\u003c/p>\n\u003cp>Leigh Turner, a University of Minnesota bioethicist, said that from one standpoint, the FDA’s enforcement actions targeted the low-hanging fruit of the bad actors in the industry. Presumably any administration would want to seize unauthorized smallpox vaccine supplies, and the Florida clinic was the subject of lawsuits and media coverage in addition to the high-profile academic paper.\u003c/p>\n\u003cp>“The larger question is going to be, what about the stem cell clinics … that are out there marketing therapies and charging people but don’t have a New England Journal of Medicine piece or lawsuits?” Turner asked. “Is it just going to be that after harm occurs that the FDA is going to do something? Or are we going to see a more systemic approach to this marketplace?”\u003c/p>\n\u003cp>The action against the California clinics was solely based on the vaccine, noted Turner, who \u003ca href=\"http://www.cell.com/cell-stem-cell/abstract/S1934-5909(16)30157-6\" target=\"_blank\" rel=\"noopener noreferrer\">has tracked\u003c/a> the growth of clinics around the country. It did not mention all the other diseases and conditions that the clinics have been marketing their unapproved stem cell therapies for.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/28/smallpox-stem-cell-clinic/\" 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":"Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations.","status":"publish","parent":0,"modified":1504028625,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":26,"wordCount":1398},"headData":{"title":"Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics | KQED","description":"Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics","datePublished":"2017-08-28T18:46:05.000Z","dateModified":"2017-08-29T17:43:45.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"435066 https://ww2.kqed.org/futureofyou/?p=435066","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/08/28/feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics/","disqusTitle":"Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics","source":"STAT","nprByline":"Andrew Joseph \u003cbr/>\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/435066/feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations, as the Food and Drug Administration expressed “serious concerns” about how the clinic obtained access to the vaccine at all.\u003c/p>\n\u003cp class=\"danger-zone\">The U.S. Marshals Service seized five vials of the smallpox vaccine, which is not commercially available, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm\" target=\"_blank\" rel=\"noopener noreferrer\">announced\u003c/a> Monday. Four of the vials — which each hold 100 vaccine doses — were unused, but a portion of the fifth vial had been used.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'\u003ccite> FDA Commissioner Scott Gottlieb\u003c/cite>\u003c/aside>\n\u003cp>The treatment mixed some of the vaccine with stem cells taken from a patient to create an injectable — and unproven and unregulated — cancer treatment that was targeted directly at the patient’s tumors, the FDA said. The FDA, which learned of the treatment after inspections, said the injection could have caused inflammation and swelling of the heart.\u003c/p>\n\u003cp>The treatment belonged to San Diego-based company StemImmune Inc., and was given at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. U.S. marshals seized the product on Friday.\u003c/p>\n\u003cp>“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” FDA Commissioner Scott Gottlieb said in a statement. “I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.”\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>A complaint filed in federal court indicates the vials were shipped from outside California but does not provide more detail on the origin. StemImmune also filed \u003ca href=\"http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2&p=1&f=G&l=50&d=PG01&S1=Stemimmune.AANM.&OS=AANM/Stemimmune&RS=AANM/Stemimmune\" target=\"_blank\" rel=\"noopener noreferrer\">a patent application\u003c/a> in February describing “the use of smallpox vaccine to induce an effective anti-tumor immune response.”\u003c/p>\n\u003cp>The type of vaccine that was seized \u003ca href=\"https://www.cdc.gov/smallpox/vaccine-basics/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">is made \u003c/a>from a virus similar to smallpox, but it does not contain smallpox virus and cannot give anyone smallpox, according to the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Also Monday, the FDA announced it had sent \u003ca href=\"https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm\" target=\"_blank\" rel=\"noopener noreferrer\">a warning letter\u003c/a> to a Florida stem cell clinic where a 2015 procedure led three women to go legally blind, according \u003ca href=\"https://www.statnews.com/2017/03/15/stem-cell-patients-blind-macular-degeneration/\">to a March study\u003c/a> in the New England Journal of Medicine. The letter to U.S. Stem Cell Clinic said that the company was offering unapproved stem cell treatments and that an agency inspection uncovered violations of manufacturing standards, including potential sterility issues. The company also tried to stop FDA inspectors from talking with employees, the letter says.\u003c/p>\n\u003cp>“You should take prompt action to correct these deviations,” says the letter, which was sent Thursday. “Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.”\u003c/p>\n\u003cp>StemImmune did not respond immediately to a request for comment. In a statement, U.S. Stem Cell Clinic said it had given the FDA “unrestricted access” since 2014 and that it followed the agency’s rules. But it also suggested that regulations could prevent patients from getting treatments.\u003c/p>\n\u003cp>“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the [FDA],” it said, adding: “We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”\u003c/p>\n\u003cp>The actions announced Monday are the latest salvo in a back-and-forth between regulators and the clinics that claim to be able to treat everything from paralysis to neurodegenerative diseases to erectile dysfunction. The clinics, \u003ca href=\"https://www.statnews.com/2016/06/30/stem-cell-clinics-proliferate/\">which have proliferated\u003c/a> around the country in recent years, have largely evaded regulation enforcement because they typically take a person’s own stem cells and inject them back into the same person, meaning the cells are considered “minimally manipulated.”\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/\">FDA has tried\u003c/a> at various times to regulate clinics offering unproven stem cell treatments more tightly and close down clinics that put patients at risk, but overall, their efforts have not amounted to much.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/09/09/stem-cell-fda-hearing/\">FDA has held meetings\u003c/a> about possibly regulating the therapies more like drugs, a move that has been backed by many academic stem cell experts who say that stem cell therapies, while holding great potential, are not ready to be used widely or outside regulated clinical trials. But clinic owners warn that the FDA could stamp out progress in the field and keep desperate patients from getting treatments.\u003c/p>\n\u003cp>“The government should not regulate our bodies. … I will always stand up for patient rights,” Kristin Comella, U.S. Stem Cell’s chief scientific officer, said at an FDA hearing months ago. (The FDA’s warning letter this month was addressed to Comella.)\u003c/p>\n\u003cp>Some experts have wondered whether the regulation-averse Trump administration would take further action against stem cell clinics. But in a statement Monday, Gottlieb said the FDA would be bolstering its enforcement as a way of “separating the promise from the unscrupulous hype” and that the agency would roll out a new “comprehensive policy framework” this fall to delineate the rules for stem cell treatments.\u003c/p>\n\u003cp>“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb said. “These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This put the entire field at risk.”\u003c/p>\n\u003cp>Experts who study stem cell clinics and the regulatory landscape generally praised the FDA’s moves, but said that it was unclear what the enforcement actions and \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm\" target=\"_blank\" rel=\"noopener noreferrer\">Gottlieb’s statement\u003c/a> meant for the field going forward.\u003c/p>\n\u003cp>“The most important thing is that the FDA is now publicly making a commitment to discipline what has become an out-of-control area of fraudulent medicine,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.\u003c/p>\n\u003cp>One part of Gottlieb’s statement that stuck out to Charo, she said, was when he signaled some flexibility in terms of the areas that are subject to FDA regulation, with the commissioner writing that “the FDA must advance an efficient and least burdensome framework” and establish “a regulatory structure that does not become a barrier to beneficial new innovation.”\u003c/p>\n\u003cp>“It’s about a tone being set,” Charo said.\u003c/p>\n\u003cp>Leigh Turner, a University of Minnesota bioethicist, said that from one standpoint, the FDA’s enforcement actions targeted the low-hanging fruit of the bad actors in the industry. Presumably any administration would want to seize unauthorized smallpox vaccine supplies, and the Florida clinic was the subject of lawsuits and media coverage in addition to the high-profile academic paper.\u003c/p>\n\u003cp>“The larger question is going to be, what about the stem cell clinics … that are out there marketing therapies and charging people but don’t have a New England Journal of Medicine piece or lawsuits?” Turner asked. “Is it just going to be that after harm occurs that the FDA is going to do something? Or are we going to see a more systemic approach to this marketplace?”\u003c/p>\n\u003cp>The action against the California clinics was solely based on the vaccine, noted Turner, who \u003ca href=\"http://www.cell.com/cell-stem-cell/abstract/S1934-5909(16)30157-6\" target=\"_blank\" rel=\"noopener noreferrer\">has tracked\u003c/a> the growth of clinics around the country. It did not mention all the other diseases and conditions that the clinics have been marketing their unapproved stem cell therapies for.\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/2017/08/28/smallpox-stem-cell-clinic/\" 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/435066/feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics","authors":["byline_futureofyou_435066"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_38","futureofyou_1275","futureofyou_1345","futureofyou_680","futureofyou_1346"],"featImg":"futureofyou_435072","label":"source_futureofyou_435066"},"futureofyou_322634":{"type":"posts","id":"futureofyou_322634","meta":{"index":"posts_1591205157","site":"futureofyou","id":"322634","score":null,"sort":[1484930860000]},"guestAuthors":[],"slug":"time-running-out-california-stem-cell-agency-yet-to-produce-big-results","title":"Time Running Out, California Stem Cell Agency Yet to Produce Big Results","publishDate":1484930860,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>It’s been more than a decade since California launched an unprecedented experiment in medical research by direct democracy, when voters created a $3 billion fund to kick-start the hunt for stem cell therapies.\u003c/p>\n\u003cp>The bold plan, a response to federal funding limits for embryonic stem cell research, was sold with a simple pitch: The money would rapidly yield cures for devastating human diseases such as Parkinson’s and ALS.\u003c/p>\n\u003cp>That hasn’t happened.\u003c/p>\n\u003cp>[contextly_sidebar id=\"wiA2OMIATARmkALimTVF9L5bJoRR3eQd\"]A major reason, a STAT examination found, is that the \u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\">California Institute for Regenerative Medicine\u003c/a> has been slow to move promising experimental therapies into clinical trials. The National Institutes of Health has supported three and a half times as many human trials of stem cell therapies, dollar for dollar, as the California agency has funded since it started making grants in 2006. Just two of its clinical trials have been completed.\u003c/p>\n\u003cp>“I am floored by the disparity,” said Jim Lott, a health care consultant and member of the state board that monitors the agency, known as CIRM. If the numbers are correct, he told STAT, “that doesn’t settle well with me as a voter. That doesn’t settle well with me as a taxpayer. That doesn’t settle well with me as a member of the oversight committee.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>CIRM has used most of the $2.2 billion in grants it has distributed so far to build labs and pay for basic research at public and private universities, such as Stanford and the University of Southern California, and private companies.\u003c/p>\n\u003cp>It has given more than $300 million to 27 projects that include clinical trials — though much of that funding also supported preclinical work. Meanwhile, the agency has committed about $540 million to new labs and buildings.\u003c/p>\n\u003cp>In part, that’s because its directors chose to focus on infrastructure early on, as well as bench experiments and animal studies given that the biology of embryonic stem cells was not well-understood and there are formidable roadblocks to moving into human studies. Much more is known about the bone marrow stem cells that are the focus of many NIH-funded clinical trials.\u003c/p>\n\u003cp>But critics have noted that many top grantees come from institutions that hold seats on CIRM’s governing board. The respected Institute of Medicine, in a 2013 \u003ca href=\"https://www.nap.edu/catalog/13523/the-california-institute-for-regenerative-medicine-science-governance-and-the\" target=\"_blank\">review\u003c/a>, said institutionalized conflicts of interest have raised questions about “the integrity and independence of some of CIRM’s decisions.” CIRM later enacted reforms that barred board members from voting directly on grants for their institutions. But the changes didn’t prevent other financial \u003ca href=\"http://www.latimes.com/business/hiltzik/la-fi-hiltzik-20140720-column.html\" target=\"_blank\">conflicts\u003c/a> involving \u003ca href=\"http://californiastemcellreport.blogspot.com/2016/09/alan-trounson-former-ceo-of-california.html\" target=\"_blank\">CIRM officers and grantees\u003c/a>, and the flow of funds to board members’ institutions continued unabated.\u003c/p>\n\u003cfigure id=\"attachment_322983\" class=\"wp-caption aligncenter\" style=\"max-width: 979px\">\u003ca href=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/CIRM.jpg\">\u003cimg class=\"wp-image-322983 size-full\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/CIRM.jpg\" alt=\"CIRM\" width=\"979\" height=\"462\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM.jpg 979w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-160x76.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-800x378.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-768x362.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-960x453.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-240x113.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-375x177.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-520x245.jpg 520w\" sizes=\"(max-width: 979px) 100vw, 979px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Sources: California Institute for Regenerative Medicine, National Institutes of Health. \u003cspan class=\"media-source\">*Several CIRM trials included here were announced shortly after Sept. 30, 2016, the cut-off for the NIH data. **NIH spending for 2006 and 2007 is estimated because exact figures were unavailable.\u003c/span>NATALIA BRONSHTEIN/STAT\u003c/figcaption>\u003c/figure>\n\u003cp>“You could make an argument that California taxpayer money should go to build new facilities on state university campuses,” said Marcy Darnovsky, who directs the Berkeley-based Center for Genetics and Society, a public affairs nonprofit. “But I don’t see an argument for Stanford getting fancy new buildings from California taxpayer money.”\u003c/p>\n\u003cp>Stanford, whose endowment is among the top five nationally, and USC have received more than $70\u003cstrong> \u003c/strong>million for major building projects, and hundreds of millions more for labs and research. Stanford alone has been favored with $1 out of every $7 CIRM has approved.\u003c/p>\n\u003cp>But scientists outside California said CIRM’s record is a strong one. CIRM-funded researchers have published nearly 2,000 scholarly papers. That output has helped vault California into the top ranks of stem cell science, said Dr. George Daley, the new dean of Harvard Medical School and a leading stem cell scientist who describes himself as an informal adviser and cheerleader for CIRM. “When I look at the progress my colleagues have made in California, I am duly awed,” he said.\u003c/p>\n\u003cp>The institute announced a year ago that it would reinvent itself to emphasize clinical research until it runs out of money in 2020 — unless voters grant a new infusion of cash. CIRM plans to fund 50 new trials with its remaining $692 million, of which 10 were announced in 2016. Just 17 trials were funded in its first decade of grants.\u003c/p>\n\u003cp>C. Randal Mills, CIRM’s CEO since 2014 and architect of its new strategy, said he welcomed comparisons that help benchmark CIRM’s progress. Mills, former head of Osiris Therapeutics, the first company to commercialize an approved stem cell treatment, declined to comment on STAT’s specific findings, but defended the initial emphasis on labs and basic science as underpinning future clinical work.\u003c/p>\n\u003cp>“We’re running our own race. … What we have to do is just continually get better” to benefit patients, Mills said in an interview. “If we’re behind [NIH], we’re going to get better.”\u003c/p>\n\u003cp>Lott’s teenage daughter was paralyzed in an automobile crash and he hopes for a stem cell cure. He supports the goals of CIRM and applauds much of its work, but he now has second thoughts about the governance structure, which allows board members’ institutions to benefit from CIRM grants, as well as its financing. The ballot question that created CIRM, Proposition 71, authorized bond sales to pay for the agency’s budget, raising the total cost for taxpayers to $6 billion including interest. Financial experts, however, said that relatively low interest rates paid on long-term bonds can offer advantages over funding so large a venture directly from state coffers.\u003c/p>\n\u003cp>Asked whether he would support a similar ballot measure today, Lott said, “We were all caught up in the time, and the events were different when we first looked at this. But not today. Not at all.”\u003c/p>\n\u003cp>\u003cstrong>'Lives Will Be Saved'\u003c/strong>\u003c/p>\n\u003cp>Californians emphatically supported CIRM, creating the stem cell colossus with 59 percent of the vote in 2004. Many were upset that President George W. Bush had sharply limited federal funding for work with embryonic stem cells, which are derived from early human embryos and able to develop into any type of tissue or organ.\u003c/p>\n\u003cp>But Proposition 71 also won because it was shamelessly oversold, consumer advocates and science policy experts said. Desperate patients, Nobel laureates, and A-list celebrities such as \u003ca href=\"https://www.statnews.com/2016/08/30/parkinsons-study-fox-foundation-feud/\" target=\"_blank\">Michael J. Fox\u003c/a> — the Hollywood star and Parkinson’s sufferer — predicted “cures” that would “save millions of lives.”\u003c/p>\n\u003cp>“There are more Americans than … we can count who are sick now, or are going to be sick in the future, whose lives will be saved by Prop 71,” patient advocate Joan Samuelson said in another ad. The sponsors of the measure also predicted that CIRM-generated cures would drastically reduce health care spending. No one made specific promises for the 10-year timeframe initially planned for CIRM’s work, but miracles seemed just around the corner.\u003c/p>\n\u003cp>“You can support embryonic stem cell research, which we do and did, and still be pretty appalled by what was going down,” said Darnovsky. “The airwaves were swamped with guys in white coats who were identified with their academic affiliation even though they were principals of private companies (some of which later got CIRM grants), and basically saying, ‘We’re going to have cures by Christmas.’”\u003c/p>\n\u003cp>Mills, who was not involved at the agency’s genesis, called the idea sold to voters — impending, sweeping breakthroughs — “naïve.” Radical medical change usually takes decades from idea to cure.\u003c/p>\n\u003cp>“But here we are,” he said. “My sole mission is to create as much value for the resources we have left, for the people of California, that I can.”\u003c/p>\n\u003cp>\u003cstrong>California vs. NIH\u003c/strong>\u003c/p>\n\u003cp>Even under Bush-era restrictions — rescinded after President Barack Obama took office — the NIH continued to support substantial stem cell research.\u003c/p>\n\u003cp>Since 2006, it has spent $13.4 billion on stem cell science, six times CIRM’s budget during that period. But NIH fully or partly funded 571 clinical trials, according to STAT’s review — more than 20 times the number backed by California.\u003c/p>\n\u003cp>While NIH in that period funded 50 Phase 3 clinical trials of stem cell therapies — generally the last step before seeking approval to market a product — CIRM has supported just three.\u003c/p>\n\u003cp>One, the study of a treatment for skin cancer involving immune system cells, was terminated by Caladrius Biosciences, the grantee, when it determined that existing treatments had overtaken its approach. The others — testing altered immune cells to treat brain cancer and bioengineered veins to manage vascular problems — show promise, but are still recruiting patients and will not be completed for several years, according to the NIH website, ClinicalTrials.gov.\u003c/p>\n\u003cp>Daley called the NIH comparison “a little unfair,” because that agency emphasized hematopoietic stem cells — blood-forming cells from bone marrow, which had been studied for decades — unlike CIRM’s sharper focus on cutting-edge embryonic stem cells. A little more than half of CIRM’s awards have gone to support research on embryonic or induced pluripotent stem cells, which are created by modifying adult stem cells to act like embryonic ones. It gave about a quarter of its awards to support adult stem cell work, and the rest for other research areas.\u003c/p>\n\u003cp>“In the early days of CIRM, the feeling was that the field needed deep and direct investments in the … fundamental foundation of stem cell biology, because the translational opportunities were not yet mature, certainly not using embryonic or induced pluripotent stem cells,” Daley said.\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2016/01/30/paul-knoepfler/\" target=\"_blank\">Paul Knoepfler\u003c/a>, a University of California, Davis, researcher and CIRM grantee who writes a popular \u003ca href=\"http://www.ipscell.com/\" target=\"_blank\">stem cell blog\u003c/a>, agreed. “One almost had to invent a system for figuring out what would be a safe way to proceed with embryonic stem cell clinical trials because those cells are really much more powerful and also have different kinds of risks,” he said.\u003c/p>\n\u003cp>Knoepfler said he expected the basic science to spark clinical breakthroughs in time, citing, for example, promising early work on reversing paralysis from Asterias Biotherapeutics, located in Fremont, southeast of San Francisco. Jake Javier, a patient in a CIRM-supported Asterias trial, lost almost all use of his limbs in an accident diving into a swimming pool. He recently received an injection of a type of cell derived from embryonic stem cells that can help protect nerve cells damaged in spinal cord injuries. Javier has since regained some\u003cstrong> \u003c/strong>use of his arms — one of five patients in early trials who have shown improvement that CIRM and the researchers attribute to the treatment. The results have not yet been published in a peer-reviewed journal.\u003c/p>\n\u003cp>In addition, Mills noted that grants for new labs included provisions that required grantees to raise other funds — to “leverage” economic benefits to taxpayers — and to assist future trials. The institute, for example, gave $30 million to the contract research firm Quintiles to create facilities that will conduct preclinical research, manage regulatory issues, and provide clinical support for CIRM-supported stem cell trials, all at a steep discount.\u003c/p>\n\u003cp>“There is no iPhone 4 without an iPhone 3 or a 2 or a 1,” Mills said. But in a world where technology advances rapidly — Apple is already selling the iPhone 7, after all — voters are still waiting for the promised cures.\u003c/p>\n\u003cfigure id=\"attachment_322991\" class=\"wp-caption alignright\" style=\"max-width: 384px\">\u003ca href=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/evangelina.jpg\">\u003cimg class=\"size-full wp-image-322991\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/evangelina.jpg\" alt=\"Evangelina Padilla Vaccaro in November 2016.\" width=\"384\" height=\"576\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/01/evangelina.jpg 384w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/evangelina-160x240.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/evangelina-240x360.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/evangelina-375x563.jpg 375w\" sizes=\"(max-width: 384px) 100vw, 384px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Evangelina Padilla Vaccaro in November 2016. \u003ccite>(Nancy Ramos)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>So far, CIRM has one literal poster child to show it can deliver. Four-year-old Evangelina Padilla Vaccaro, featured on the cover of CIRM’s recent \u003ca href=\"https://www.cirm.ca.gov/about-cirm/2016-annual-report\" target=\"_blank\">annual report\u003c/a>, was born with severe combined immunodeficiency. She had no operating immune system. Some such children have been kept alive in sterile isolation tents for a time — hence the term, “bubble baby” — but most have died from infections within a few years. A lucky few who received matching bone-marrow transplants survived.\u003c/p>\n\u003cp>UCLA’s Dr. Donald Kohn, supported by CIRM, cured Evangelina by extracting some of her blood stem cells, altering them to correct the genetic defect, and returning them to her body. She’s now thriving with a robust immune system.\u003c/p>\n\u003cp>That little girl, and 29 children like her, “are getting immunizations, they’re going to school, they’re swimming in public swimming pools, they’re eating dirt, they’re doing all the things that little kids are supposed to do,” said Steven Peckman, associate director of UCLA’s Broad Center of Regenerative Medicine and Stem Cell Research. “They get sick and their own bodies attack those viruses and bacteria. And they survive. If there’s going to be something that’s called a cure, this is it.”\u003c/p>\n\u003cp>That inspiring triumph was partly funded by CIRM, but Kohn’s work took three decades, was well underway long before CIRM existed, and didn’t involve embryonic stem cells — the key gap CIRM was founded to fill. Evangelina was saved by hematopoietic stem cells, the type that NIH has been more focused on.\u003c/p>\n\u003cp>\u003cstrong>Racing the Clock\u003c/strong>\u003c/p>\n\u003cp>As much as Mills defends the old CIRM, last year he announced “CIRM 2.0” — a drastic shift to speed up clinical trials before the organization’s clock runs out.\u003c/p>\n\u003cp>Asked whether Californians are getting good value for their money from CIRM, Mills cited economic gains to the state, then added: “I focus a lot more on the return in relief of human suffering. We’re just starting to lift off the ground on that. I hope in history, in time, the record shows CIRM was a great deal.”\u003c/p>\n\u003cp>To that end, CIRM has said it will focus in 2017 primarily on clinical trials and work it hopes will lay the foundation for such studies.\u003c/p>\n\u003cp>If the studies show clear results, Mills said, “I think it will be self-evident that CIRM should be continued” with new funding.\u003c/p>\n\u003cp>Lott, the state overseer, called CIRM 2.0 long overdue. “They needed to at least create something a little more tangible, more specifically measurable, for the billions of dollars that they’ve allocated,” he said. “But it may be a little too late,” he added, to convince taxpayers that CIRM should get a new infusion of funds, given its governance structure.\u003c/p>\n\u003cp>Even Daley — unbridled in his enthusiasm for CIRM’s work — hesitated when asked if it was a model to emulate, though for a different reason. “I reluctantly endorse it,” he said, “in part because I think it’s another argument that allows the federal government and the NIH to abdicate its responsibility for investments in biomedical research, which benefits us all.”\u003c/p>\n\u003cp>Yet, just as President Bush’s policy on stem cells led to CIRM’s creation, the incoming Trump administration might bail out the institute just in time. The president-elect has not weighed in on federal funding, but Representative Tom Price, his nominee for Health and Human Services secretary, has long opposed federal funding of embryonic stem cell research — a view shared by Vice President-elect Mike Pence.\u003c/p>\n\u003cp>“If the Trump administration takes a hostile mind toward embryonic stem cell research, and perhaps some kinds of important fetal research are restricted as well, it may give another source of energy to CIRM,” said Knoepfler. “I don’t think Californians like to be told what we can or cannot do, research-wise.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2017/01/19/california-stem-cell-agency-cirm/\" 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":"California's $3 billion stem cell initiative was sold to voters with the pitch that the investment would rapidly yield cures for devastating diseases like Parkinson’s and ALS. That hasn’t happened.","status":"publish","parent":0,"modified":1484950180,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":51,"wordCount":2723},"headData":{"title":"Time Running Out, California Stem Cell Agency Yet to Produce Big Results | KQED","description":"California's $3 billion stem cell initiative was sold to voters with the pitch that the investment would rapidly yield cures for devastating diseases like Parkinson’s and ALS. That hasn’t happened.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Time Running Out, California Stem Cell Agency Yet to Produce Big Results","datePublished":"2017-01-20T16:47:40.000Z","dateModified":"2017-01-20T22:09:40.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"322634 https://ww2.kqed.org/futureofyou/?p=322634","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/01/20/time-running-out-california-stem-cell-agency-yet-to-produce-big-results/","disqusTitle":"Time Running Out, California Stem Cell Agency Yet to Produce Big Results","source":"\u003ca href=\"https://www.statnews.com/2017/01/19/california-stem-cell-agency-cirm/\">STAT\u003c/a>","nprByline":"Charles Piller\u003cbr />\u003cA HREF=\"https://www.statnews.com/\">STAT\u003c/A>","path":"/futureofyou/322634/time-running-out-california-stem-cell-agency-yet-to-produce-big-results","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>It’s been more than a decade since California launched an unprecedented experiment in medical research by direct democracy, when voters created a $3 billion fund to kick-start the hunt for stem cell therapies.\u003c/p>\n\u003cp>The bold plan, a response to federal funding limits for embryonic stem cell research, was sold with a simple pitch: The money would rapidly yield cures for devastating human diseases such as Parkinson’s and ALS.\u003c/p>\n\u003cp>That hasn’t happened.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>A major reason, a STAT examination found, is that the \u003ca href=\"https://www.cirm.ca.gov/\" target=\"_blank\">California Institute for Regenerative Medicine\u003c/a> has been slow to move promising experimental therapies into clinical trials. The National Institutes of Health has supported three and a half times as many human trials of stem cell therapies, dollar for dollar, as the California agency has funded since it started making grants in 2006. Just two of its clinical trials have been completed.\u003c/p>\n\u003cp>“I am floored by the disparity,” said Jim Lott, a health care consultant and member of the state board that monitors the agency, known as CIRM. If the numbers are correct, he told STAT, “that doesn’t settle well with me as a voter. That doesn’t settle well with me as a taxpayer. That doesn’t settle well with me as a member of the oversight committee.”\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>CIRM has used most of the $2.2 billion in grants it has distributed so far to build labs and pay for basic research at public and private universities, such as Stanford and the University of Southern California, and private companies.\u003c/p>\n\u003cp>It has given more than $300 million to 27 projects that include clinical trials — though much of that funding also supported preclinical work. Meanwhile, the agency has committed about $540 million to new labs and buildings.\u003c/p>\n\u003cp>In part, that’s because its directors chose to focus on infrastructure early on, as well as bench experiments and animal studies given that the biology of embryonic stem cells was not well-understood and there are formidable roadblocks to moving into human studies. Much more is known about the bone marrow stem cells that are the focus of many NIH-funded clinical trials.\u003c/p>\n\u003cp>But critics have noted that many top grantees come from institutions that hold seats on CIRM’s governing board. The respected Institute of Medicine, in a 2013 \u003ca href=\"https://www.nap.edu/catalog/13523/the-california-institute-for-regenerative-medicine-science-governance-and-the\" target=\"_blank\">review\u003c/a>, said institutionalized conflicts of interest have raised questions about “the integrity and independence of some of CIRM’s decisions.” CIRM later enacted reforms that barred board members from voting directly on grants for their institutions. But the changes didn’t prevent other financial \u003ca href=\"http://www.latimes.com/business/hiltzik/la-fi-hiltzik-20140720-column.html\" target=\"_blank\">conflicts\u003c/a> involving \u003ca href=\"http://californiastemcellreport.blogspot.com/2016/09/alan-trounson-former-ceo-of-california.html\" target=\"_blank\">CIRM officers and grantees\u003c/a>, and the flow of funds to board members’ institutions continued unabated.\u003c/p>\n\u003cfigure id=\"attachment_322983\" class=\"wp-caption aligncenter\" style=\"max-width: 979px\">\u003ca href=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/CIRM.jpg\">\u003cimg class=\"wp-image-322983 size-full\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/CIRM.jpg\" alt=\"CIRM\" width=\"979\" height=\"462\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM.jpg 979w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-160x76.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-800x378.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-768x362.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-960x453.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-240x113.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-375x177.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/CIRM-520x245.jpg 520w\" sizes=\"(max-width: 979px) 100vw, 979px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Sources: California Institute for Regenerative Medicine, National Institutes of Health. \u003cspan class=\"media-source\">*Several CIRM trials included here were announced shortly after Sept. 30, 2016, the cut-off for the NIH data. **NIH spending for 2006 and 2007 is estimated because exact figures were unavailable.\u003c/span>NATALIA BRONSHTEIN/STAT\u003c/figcaption>\u003c/figure>\n\u003cp>“You could make an argument that California taxpayer money should go to build new facilities on state university campuses,” said Marcy Darnovsky, who directs the Berkeley-based Center for Genetics and Society, a public affairs nonprofit. “But I don’t see an argument for Stanford getting fancy new buildings from California taxpayer money.”\u003c/p>\n\u003cp>Stanford, whose endowment is among the top five nationally, and USC have received more than $70\u003cstrong> \u003c/strong>million for major building projects, and hundreds of millions more for labs and research. Stanford alone has been favored with $1 out of every $7 CIRM has approved.\u003c/p>\n\u003cp>But scientists outside California said CIRM’s record is a strong one. CIRM-funded researchers have published nearly 2,000 scholarly papers. That output has helped vault California into the top ranks of stem cell science, said Dr. George Daley, the new dean of Harvard Medical School and a leading stem cell scientist who describes himself as an informal adviser and cheerleader for CIRM. “When I look at the progress my colleagues have made in California, I am duly awed,” he said.\u003c/p>\n\u003cp>The institute announced a year ago that it would reinvent itself to emphasize clinical research until it runs out of money in 2020 — unless voters grant a new infusion of cash. CIRM plans to fund 50 new trials with its remaining $692 million, of which 10 were announced in 2016. Just 17 trials were funded in its first decade of grants.\u003c/p>\n\u003cp>C. Randal Mills, CIRM’s CEO since 2014 and architect of its new strategy, said he welcomed comparisons that help benchmark CIRM’s progress. Mills, former head of Osiris Therapeutics, the first company to commercialize an approved stem cell treatment, declined to comment on STAT’s specific findings, but defended the initial emphasis on labs and basic science as underpinning future clinical work.\u003c/p>\n\u003cp>“We’re running our own race. … What we have to do is just continually get better” to benefit patients, Mills said in an interview. “If we’re behind [NIH], we’re going to get better.”\u003c/p>\n\u003cp>Lott’s teenage daughter was paralyzed in an automobile crash and he hopes for a stem cell cure. He supports the goals of CIRM and applauds much of its work, but he now has second thoughts about the governance structure, which allows board members’ institutions to benefit from CIRM grants, as well as its financing. The ballot question that created CIRM, Proposition 71, authorized bond sales to pay for the agency’s budget, raising the total cost for taxpayers to $6 billion including interest. Financial experts, however, said that relatively low interest rates paid on long-term bonds can offer advantages over funding so large a venture directly from state coffers.\u003c/p>\n\u003cp>Asked whether he would support a similar ballot measure today, Lott said, “We were all caught up in the time, and the events were different when we first looked at this. But not today. Not at all.”\u003c/p>\n\u003cp>\u003cstrong>'Lives Will Be Saved'\u003c/strong>\u003c/p>\n\u003cp>Californians emphatically supported CIRM, creating the stem cell colossus with 59 percent of the vote in 2004. Many were upset that President George W. Bush had sharply limited federal funding for work with embryonic stem cells, which are derived from early human embryos and able to develop into any type of tissue or organ.\u003c/p>\n\u003cp>But Proposition 71 also won because it was shamelessly oversold, consumer advocates and science policy experts said. Desperate patients, Nobel laureates, and A-list celebrities such as \u003ca href=\"https://www.statnews.com/2016/08/30/parkinsons-study-fox-foundation-feud/\" target=\"_blank\">Michael J. Fox\u003c/a> — the Hollywood star and Parkinson’s sufferer — predicted “cures” that would “save millions of lives.”\u003c/p>\n\u003cp>“There are more Americans than … we can count who are sick now, or are going to be sick in the future, whose lives will be saved by Prop 71,” patient advocate Joan Samuelson said in another ad. The sponsors of the measure also predicted that CIRM-generated cures would drastically reduce health care spending. No one made specific promises for the 10-year timeframe initially planned for CIRM’s work, but miracles seemed just around the corner.\u003c/p>\n\u003cp>“You can support embryonic stem cell research, which we do and did, and still be pretty appalled by what was going down,” said Darnovsky. “The airwaves were swamped with guys in white coats who were identified with their academic affiliation even though they were principals of private companies (some of which later got CIRM grants), and basically saying, ‘We’re going to have cures by Christmas.’”\u003c/p>\n\u003cp>Mills, who was not involved at the agency’s genesis, called the idea sold to voters — impending, sweeping breakthroughs — “naïve.” Radical medical change usually takes decades from idea to cure.\u003c/p>\n\u003cp>“But here we are,” he said. “My sole mission is to create as much value for the resources we have left, for the people of California, that I can.”\u003c/p>\n\u003cp>\u003cstrong>California vs. NIH\u003c/strong>\u003c/p>\n\u003cp>Even under Bush-era restrictions — rescinded after President Barack Obama took office — the NIH continued to support substantial stem cell research.\u003c/p>\n\u003cp>Since 2006, it has spent $13.4 billion on stem cell science, six times CIRM’s budget during that period. But NIH fully or partly funded 571 clinical trials, according to STAT’s review — more than 20 times the number backed by California.\u003c/p>\n\u003cp>While NIH in that period funded 50 Phase 3 clinical trials of stem cell therapies — generally the last step before seeking approval to market a product — CIRM has supported just three.\u003c/p>\n\u003cp>One, the study of a treatment for skin cancer involving immune system cells, was terminated by Caladrius Biosciences, the grantee, when it determined that existing treatments had overtaken its approach. The others — testing altered immune cells to treat brain cancer and bioengineered veins to manage vascular problems — show promise, but are still recruiting patients and will not be completed for several years, according to the NIH website, ClinicalTrials.gov.\u003c/p>\n\u003cp>Daley called the NIH comparison “a little unfair,” because that agency emphasized hematopoietic stem cells — blood-forming cells from bone marrow, which had been studied for decades — unlike CIRM’s sharper focus on cutting-edge embryonic stem cells. A little more than half of CIRM’s awards have gone to support research on embryonic or induced pluripotent stem cells, which are created by modifying adult stem cells to act like embryonic ones. It gave about a quarter of its awards to support adult stem cell work, and the rest for other research areas.\u003c/p>\n\u003cp>“In the early days of CIRM, the feeling was that the field needed deep and direct investments in the … fundamental foundation of stem cell biology, because the translational opportunities were not yet mature, certainly not using embryonic or induced pluripotent stem cells,” Daley said.\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2016/01/30/paul-knoepfler/\" target=\"_blank\">Paul Knoepfler\u003c/a>, a University of California, Davis, researcher and CIRM grantee who writes a popular \u003ca href=\"http://www.ipscell.com/\" target=\"_blank\">stem cell blog\u003c/a>, agreed. “One almost had to invent a system for figuring out what would be a safe way to proceed with embryonic stem cell clinical trials because those cells are really much more powerful and also have different kinds of risks,” he said.\u003c/p>\n\u003cp>Knoepfler said he expected the basic science to spark clinical breakthroughs in time, citing, for example, promising early work on reversing paralysis from Asterias Biotherapeutics, located in Fremont, southeast of San Francisco. Jake Javier, a patient in a CIRM-supported Asterias trial, lost almost all use of his limbs in an accident diving into a swimming pool. He recently received an injection of a type of cell derived from embryonic stem cells that can help protect nerve cells damaged in spinal cord injuries. Javier has since regained some\u003cstrong> \u003c/strong>use of his arms — one of five patients in early trials who have shown improvement that CIRM and the researchers attribute to the treatment. The results have not yet been published in a peer-reviewed journal.\u003c/p>\n\u003cp>In addition, Mills noted that grants for new labs included provisions that required grantees to raise other funds — to “leverage” economic benefits to taxpayers — and to assist future trials. The institute, for example, gave $30 million to the contract research firm Quintiles to create facilities that will conduct preclinical research, manage regulatory issues, and provide clinical support for CIRM-supported stem cell trials, all at a steep discount.\u003c/p>\n\u003cp>“There is no iPhone 4 without an iPhone 3 or a 2 or a 1,” Mills said. But in a world where technology advances rapidly — Apple is already selling the iPhone 7, after all — voters are still waiting for the promised cures.\u003c/p>\n\u003cfigure id=\"attachment_322991\" class=\"wp-caption alignright\" style=\"max-width: 384px\">\u003ca href=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/evangelina.jpg\">\u003cimg class=\"size-full wp-image-322991\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/01/evangelina.jpg\" alt=\"Evangelina Padilla Vaccaro in November 2016.\" width=\"384\" height=\"576\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/01/evangelina.jpg 384w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/evangelina-160x240.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/evangelina-240x360.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/01/evangelina-375x563.jpg 375w\" sizes=\"(max-width: 384px) 100vw, 384px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Evangelina Padilla Vaccaro in November 2016. \u003ccite>(Nancy Ramos)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>So far, CIRM has one literal poster child to show it can deliver. Four-year-old Evangelina Padilla Vaccaro, featured on the cover of CIRM’s recent \u003ca href=\"https://www.cirm.ca.gov/about-cirm/2016-annual-report\" target=\"_blank\">annual report\u003c/a>, was born with severe combined immunodeficiency. She had no operating immune system. Some such children have been kept alive in sterile isolation tents for a time — hence the term, “bubble baby” — but most have died from infections within a few years. A lucky few who received matching bone-marrow transplants survived.\u003c/p>\n\u003cp>UCLA’s Dr. Donald Kohn, supported by CIRM, cured Evangelina by extracting some of her blood stem cells, altering them to correct the genetic defect, and returning them to her body. She’s now thriving with a robust immune system.\u003c/p>\n\u003cp>That little girl, and 29 children like her, “are getting immunizations, they’re going to school, they’re swimming in public swimming pools, they’re eating dirt, they’re doing all the things that little kids are supposed to do,” said Steven Peckman, associate director of UCLA’s Broad Center of Regenerative Medicine and Stem Cell Research. “They get sick and their own bodies attack those viruses and bacteria. And they survive. If there’s going to be something that’s called a cure, this is it.”\u003c/p>\n\u003cp>That inspiring triumph was partly funded by CIRM, but Kohn’s work took three decades, was well underway long before CIRM existed, and didn’t involve embryonic stem cells — the key gap CIRM was founded to fill. Evangelina was saved by hematopoietic stem cells, the type that NIH has been more focused on.\u003c/p>\n\u003cp>\u003cstrong>Racing the Clock\u003c/strong>\u003c/p>\n\u003cp>As much as Mills defends the old CIRM, last year he announced “CIRM 2.0” — a drastic shift to speed up clinical trials before the organization’s clock runs out.\u003c/p>\n\u003cp>Asked whether Californians are getting good value for their money from CIRM, Mills cited economic gains to the state, then added: “I focus a lot more on the return in relief of human suffering. We’re just starting to lift off the ground on that. I hope in history, in time, the record shows CIRM was a great deal.”\u003c/p>\n\u003cp>To that end, CIRM has said it will focus in 2017 primarily on clinical trials and work it hopes will lay the foundation for such studies.\u003c/p>\n\u003cp>If the studies show clear results, Mills said, “I think it will be self-evident that CIRM should be continued” with new funding.\u003c/p>\n\u003cp>Lott, the state overseer, called CIRM 2.0 long overdue. “They needed to at least create something a little more tangible, more specifically measurable, for the billions of dollars that they’ve allocated,” he said. “But it may be a little too late,” he added, to convince taxpayers that CIRM should get a new infusion of funds, given its governance structure.\u003c/p>\n\u003cp>Even Daley — unbridled in his enthusiasm for CIRM’s work — hesitated when asked if it was a model to emulate, though for a different reason. “I reluctantly endorse it,” he said, “in part because I think it’s another argument that allows the federal government and the NIH to abdicate its responsibility for investments in biomedical research, which benefits us all.”\u003c/p>\n\u003cp>Yet, just as President Bush’s policy on stem cells led to CIRM’s creation, the incoming Trump administration might bail out the institute just in time. The president-elect has not weighed in on federal funding, but Representative Tom Price, his nominee for Health and Human Services secretary, has long opposed federal funding of embryonic stem cell research — a view shared by Vice President-elect Mike Pence.\u003c/p>\n\u003cp>“If the Trump administration takes a hostile mind toward embryonic stem cell research, and perhaps some kinds of important fetal research are restricted as well, it may give another source of energy to CIRM,” said Knoepfler. “I don’t think Californians like to be told what we can or cannot do, research-wise.”\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/2017/01/19/california-stem-cell-agency-cirm/\" 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/322634/time-running-out-california-stem-cell-agency-yet-to-produce-big-results","authors":["byline_futureofyou_322634"],"categories":["futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_961","futureofyou_80","futureofyou_680"],"featImg":"futureofyou_188656","label":"source_futureofyou_322634"},"futureofyou_258577":{"type":"posts","id":"futureofyou_258577","meta":{"index":"posts_1591205157","site":"futureofyou","id":"258577","score":null,"sort":[1477117824000]},"guestAuthors":[],"slug":"what-stem-cell-researchers-talk-about-when-they-talk-about-ethics","title":"What Stem Cell Researchers Talk About When They Talk About Ethics","publishDate":1477117824,"format":"standard","headTitle":"Future of You | KQED Future of You | KQED Science","labelTerm":{"term":54,"site":"futureofyou"},"content":"\u003cp class=\"p1\">This year marks an anniversary that in all probability flew under your radar: The iPSC is 10-years-old.\u003c/p>\n\u003cp class=\"p1\">Great! you say. What's that, some sort of mobile fantasy sports league?\u003c/p>\n\u003cp class=\"p1\">Nooo. Would you guess \u003cem>induced pluripotent stem cells? \u003c/em>They're the product of a revolution in stem cell research that helped stem the controversy that was roiling the entire field.\u003c/p>\n\u003caside class=\"pullquote alignright\">'You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’'\u003ccite>Hank Greely, Stanford University\u003c/cite>\u003c/aside>\n\u003cp>Prior to the development of iPSCs, stem cells were derived primarily from eggs fertilized in clinics \u003ci>in vitro\u003c/i> that were donated for research purposes. To some, such as President George W. Bush, this was tantamount to abortion. In 2001 he \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744932/\" target=\"_blank\">banned federal funding\u003c/a> for research on newly created human embryonic stem cell lines. (President Barack Obama \u003ca href=\"http://www.nytimes.com/2009/03/10/us/politics/10stem.html?_r=0\" target=\"_blank\">lifted that ban\u003c/a> in 2009.)\u003c/p>\n\u003cp class=\"p1\">But iPSCs are normal cells, such as skin or blood cells, which have been tinkered with and reprogrammed to revert to an embryonic-like state. They are then capable of reproducing as stem cells or developing into \u003ci>other\u003c/i> types of human cells (pluripotent), such as liver, heart, pancreatic or nerve cells.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp class=\"p1\">So the ability to derive a stem cell without using human embryonic tissue changed the debate about stem cell research ethics.\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>Plenty of Issues\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">But there are still plenty of hot-button topics in the field.\u003c/p>\n\u003cp class=\"p1\">At a recent gathering in Berkeley to celebrate “\u003ca href=\"http://www.cell-symposia-ipscs.com/conference-program/\" target=\"_blank\">10 Years of iPSCs\u003c/a>,” a panel of researchers and leaders kicked off the ethics discussion with comments on how to make sure researchers get proper permissions from human subjects who sign up for clinical trials. Some members of the public might be surprised what a controversial topic “informed consent” can be.\u003c/p>\n\u003cp class=\"p1\">“Everyone wants to avoid a HeLa situation,” said \u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">Christine Mummery,\u003c/a> of the Leiden University Medical Centr\u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">e\u003c/a> in the Netherlands, referring to the oldest and most commonly used cell line in research.\u003c/p>\n\u003cfigure id=\"attachment_262544\" class=\"wp-caption aligncenter\" style=\"max-width: 2400px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\">\u003cimg class=\"size-full wp-image-262544\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\" alt=\"Cultured HeLa cells.\" width=\"2400\" height=\"1999\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1.jpg 2400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-400x333.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-720x600.jpg 720w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-768x640.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1180x983.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1920x1599.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-960x800.jpg 960w\" sizes=\"(max-width: 2400px) 100vw, 2400px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Cultured HeLa cells. \u003ccite>(National Center for Microscopy and Imaging Research)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>HeLa cells were taken, without permission, from Henrietta Lacks, a patient who died of cervical cancer in 1951\u003cstrong>.\u003c/strong> For reasons no one knows, her cells were the first that could grow “immortally” in a lab, without dying after a few days. Her cells helped test Jonas Salk’s polio vaccine, have been used to research AIDS, cancer, toxic substances, gene mapping, stem cells and much more.\u003c/p>\n\u003cp class=\"p1\">Yet the absence of any consent whatsoever caused immense distress to the Lacks family, once they learned of the appropriation of Henrietta's cells.\u003c/p>\n\u003cp class=\"p1\">“The family has been through a lot with HeLa: they didn’t learn of the cells until 20 years after Lacks’s death, when scientists began using her children in research without their knowledge,” \u003ca href=\"http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html\" target=\"_blank\">wrote Rebecca Skloot\u003c/a>, author of \"The Immortal Life of Henrietta Lacks,\" in the New York Times.\u003ci> \"\u003c/i>Later their medical records were released to the press and published without consent.\" (Skloot makes an appearance in a \u003ca href=\"https://www.youtube.com/watch?v=ej0b7GHGYjs\" target=\"_blank\">rap ballad\u003c/a> about the HeLa cells and the Lacks family, written and performed by Oakland 7th and 8th graders on YouTube this month.)\u003c/p>\n\u003cp class=\"p1\">[contextly_sidebar id=\"QHgtAgdTB2KPycAd1HHOyHGUjvFlbxS7\"]Adding insult to injury, researchers in 2013 published the HeLa genome without family consent. (This was not illegal but, in the views of modern medical ethics, extremely dicey.)\u003c/p>\n\u003cp class=\"p1\">Panelist \u003ca href=\"https://law.stanford.edu/directory/henry-t-greely/\" target=\"_blank\">Hank Greely, \u003c/a>a bioethicist at Stanford University, advised the gathered researchers, “You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’\u003c/p>\n\u003cp class=\"p1\">“Not so much for the legal reasons, though those can be significant,\" he said. \"More because of the political fallout that can come to you and your institution. It could also do damage to the whole stem cell enterprise.”\u003c/p>\n\u003cp class=\"p1\">\u003ca href=\"https://daley.med.harvard.edu/\" target=\"_blank\">George Daley\u003c/a>, of the Children’s Hospital Boston and Harvard Medical School, pointed the audience toward recently revised guidelines from the International Society for Stem Cell Research, which offers \u003ca href=\"http://www.isscr.org/home/publications/guide-clintrans/sample-consent-documents\" target=\"_blank\">templates for informed consent forms\u003c/a>. These include language like this:\u003c/p>\n\u003cp class=\"p1\">\u003cem>Donating your _____ cells for this research project is completely voluntary. You have the right to agree or to refuse to provide your _____ cells for this project. The quality of your current or future medical care and your relationship with [name(s) of institution(s)] will NOT change in any way whether you agree or refuse to provide any cells for this research project.\u003c/em>\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>The Issue of Money\u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">Is it ethical to charge patients to participate in a study? No, was the consensus.\u003c/aside>\n\u003cp>“What happens if someone has a drug based on their genes or cells?” the moderator asked.\u003c/p>\n\u003cp class=\"p1\">“That doesn't happen very often,” said Greely. “Most of the time discoveries are the results of work with tens of thousands or more people.”\u003c/p>\n\u003cp class=\"p1\">But, he conceded, every once in a while a patient comes along with unusual cells or genes that can be the basis for a drug. In that case, he said, a researcher must first and foremost follow whatever they said they’d do in the consent forms.\u003c/p>\n\u003cp class=\"p1\">“But even if you didn't promise them anything in the consent process,” he said, “if someone is making lots of money,\u003cspan class=\"Apple-converted-space\"> \u003c/span>I think frankly it’s a good idea to try to return something.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_262548\" class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\">\u003cimg class=\"size-full wp-image-262548\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\" alt=\"These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \" width=\"1024\" height=\"765\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-400x299.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-800x598.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-768x574.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-960x717.jpg 960w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \u003ccite>(Kathrin Plath lab/UCLA via CIRM, NIH)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">He added that this probably doesn't mean offering royalties, which could foster overblown hopes for study participants. Greely likened it to hyping lottery tickets with very bad odds. Instead, he recommends thinking about a person's community, perhaps donating to causes dear to them. Even simple recognition, he says, is important.\u003c/p>\n\u003cp class=\"p1\">“I was involved in the\u003ca href=\"http://www.nature.com/news/deal-done-over-hela-cell-line-1.13511\" target=\"_blank\"> HeLa resolution\u003c/a> a few years ago,” he said,\u003cspan class=\"Apple-converted-space\"> \u003c/span>“and the Lacks descendants are really quite proud and pleased that their mother, grandmother and great grandmother is being remembered ... and that they are consulted on various things.”\u003c/p>\n\u003cp class=\"p1\">Continuing on the topic of money, the moderator asked what panelists thought about the ethics of paying tissue donors?\u003c/p>\n\u003cp class=\"p1\">On this, the panel seemed united, “As long as it’s a reasonable reimbursement for the pain and suffering, I think it’s hard to make a case against it,” offered \u003ca href=\"https://www.mskcc.org/research-areas/labs/members/lorenz-studer\" target=\"_blank\">Lorenz Studer\u003c/a>, of the Memorial Sloan Kettering Cancer Center. If the amount offered is so high that it becomes an “undue inducement,” said Greely, then it’s a problem.\u003c/p>\n\u003cp class=\"p1\">“Many patients are willing to pay for a treatment that’s unproven. What do you think about the ethics of patients paying to be in a trial?” asked the moderator, acknowledging that many people with serious diseases are desperate to be involved in the latest research and that clinical research is extraordinarily expensive to fund.\u003c/p>\n\u003cp class=\"p1\">No, was the general consensus.\u003c/p>\n\u003cp class=\"p1\">That means people in a control group would be paying for a placebo, Greely noted, and someone desperate to be in a trial might not be making a level-headed decision.\u003c/p>\n\u003cp class=\"p1\">“The simple fact that they’re willing to pay corrupts the informed consent process,\" he said. \"And there is a social justice aspect -- if someone can pay for a trial that’s not an equal distribution of good.”\u003c/p>\n\u003cp class=\"p1\">Someone from the audience chimed in with a question that once would have been relegated to the realm of science fiction: “What are the ethics of designing organs?”\u003c/p>\n\u003cp class=\"p2\">“Think about this with a heart,” said \u003ca href=\"http://profiles.ucsf.edu/deepak.srivastava\" target=\"_blank\">Deepak Srivastava\u003c/a> of the Gladstone Institutes and University of California, San Francisco. “It’s just a pump. I think going forward that we should remove the constraints of the design. What we have may or may not be the best thing in evolution.”\u003c/p>\n\u003cp class=\"p2\">But, said Greely, “Many people would be viscerally upset about the idea of changing ourselves, changing our species.\" So scientists should temper their desire to move quickly.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp class=\"p2\">“If there is one thing I've learned from being around biology for 25 years, it’s that biology is not the same as design,\" Greely said. \"Biology is really complicated! Engineers who design something expect it to work. But if you put something [designed] into an organism, the chances that something odd will happen are extremely high. You have to be extremely careful to avoid making things worse.”\u003c/p>\n\n","blocks":[],"excerpt":"At a celebration of the 10-year anniversary of induced pluripotent stem cells, scientists engaged in a discussion on hot-button issues.","status":"publish","parent":0,"modified":1477516088,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":5,"wordCount":1505},"headData":{"title":"What Stem Cell Researchers Talk About When They Talk About Ethics | KQED","description":"At a celebration of the 10-year anniversary of induced pluripotent stem cells, scientists engaged in a discussion on hot-button issues.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"What Stem Cell Researchers Talk About When They Talk About Ethics","datePublished":"2016-10-22T06:30:24.000Z","dateModified":"2016-10-26T21:08:08.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"258577 http://ww2.kqed.org/futureofyou/?p=258577","disqusUrl":"https://ww2.kqed.org/futureofyou/2016/10/21/what-stem-cell-researchers-talk-about-when-they-talk-about-ethics/","disqusTitle":"What Stem Cell Researchers Talk About When They Talk About Ethics","customPermalink":"2016/10/18/what-stem-cell-researchers-talk-about-when-they-talk-about-ethics/","path":"/futureofyou/258577/what-stem-cell-researchers-talk-about-when-they-talk-about-ethics","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"p1\">This year marks an anniversary that in all probability flew under your radar: The iPSC is 10-years-old.\u003c/p>\n\u003cp class=\"p1\">Great! you say. What's that, some sort of mobile fantasy sports league?\u003c/p>\n\u003cp class=\"p1\">Nooo. Would you guess \u003cem>induced pluripotent stem cells? \u003c/em>They're the product of a revolution in stem cell research that helped stem the controversy that was roiling the entire field.\u003c/p>\n\u003caside class=\"pullquote alignright\">'You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’'\u003ccite>Hank Greely, Stanford University\u003c/cite>\u003c/aside>\n\u003cp>Prior to the development of iPSCs, stem cells were derived primarily from eggs fertilized in clinics \u003ci>in vitro\u003c/i> that were donated for research purposes. To some, such as President George W. Bush, this was tantamount to abortion. In 2001 he \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744932/\" target=\"_blank\">banned federal funding\u003c/a> for research on newly created human embryonic stem cell lines. (President Barack Obama \u003ca href=\"http://www.nytimes.com/2009/03/10/us/politics/10stem.html?_r=0\" target=\"_blank\">lifted that ban\u003c/a> in 2009.)\u003c/p>\n\u003cp class=\"p1\">But iPSCs are normal cells, such as skin or blood cells, which have been tinkered with and reprogrammed to revert to an embryonic-like state. They are then capable of reproducing as stem cells or developing into \u003ci>other\u003c/i> types of human cells (pluripotent), such as liver, heart, pancreatic or nerve cells.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","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=\"p1\">So the ability to derive a stem cell without using human embryonic tissue changed the debate about stem cell research ethics.\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>Plenty of Issues\u003c/strong>\u003c/p>\n\u003cp class=\"p1\">But there are still plenty of hot-button topics in the field.\u003c/p>\n\u003cp class=\"p1\">At a recent gathering in Berkeley to celebrate “\u003ca href=\"http://www.cell-symposia-ipscs.com/conference-program/\" target=\"_blank\">10 Years of iPSCs\u003c/a>,” a panel of researchers and leaders kicked off the ethics discussion with comments on how to make sure researchers get proper permissions from human subjects who sign up for clinical trials. Some members of the public might be surprised what a controversial topic “informed consent” can be.\u003c/p>\n\u003cp class=\"p1\">“Everyone wants to avoid a HeLa situation,” said \u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">Christine Mummery,\u003c/a> of the Leiden University Medical Centr\u003ca href=\"https://www.lumc.nl/org/anatomie-embriologie/medewerkers/902201040032533?setlanguage=English&setcountry=en\" target=\"_blank\">e\u003c/a> in the Netherlands, referring to the oldest and most commonly used cell line in research.\u003c/p>\n\u003cfigure id=\"attachment_262544\" class=\"wp-caption aligncenter\" style=\"max-width: 2400px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\">\u003cimg class=\"size-full wp-image-262544\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/HeLa_cells_1.jpg\" alt=\"Cultured HeLa cells.\" width=\"2400\" height=\"1999\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1.jpg 2400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-400x333.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-720x600.jpg 720w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-768x640.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1180x983.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-1920x1599.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/HeLa_cells_1-960x800.jpg 960w\" sizes=\"(max-width: 2400px) 100vw, 2400px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Cultured HeLa cells. \u003ccite>(National Center for Microscopy and Imaging Research)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>HeLa cells were taken, without permission, from Henrietta Lacks, a patient who died of cervical cancer in 1951\u003cstrong>.\u003c/strong> For reasons no one knows, her cells were the first that could grow “immortally” in a lab, without dying after a few days. Her cells helped test Jonas Salk’s polio vaccine, have been used to research AIDS, cancer, toxic substances, gene mapping, stem cells and much more.\u003c/p>\n\u003cp class=\"p1\">Yet the absence of any consent whatsoever caused immense distress to the Lacks family, once they learned of the appropriation of Henrietta's cells.\u003c/p>\n\u003cp class=\"p1\">“The family has been through a lot with HeLa: they didn’t learn of the cells until 20 years after Lacks’s death, when scientists began using her children in research without their knowledge,” \u003ca href=\"http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html\" target=\"_blank\">wrote Rebecca Skloot\u003c/a>, author of \"The Immortal Life of Henrietta Lacks,\" in the New York Times.\u003ci> \"\u003c/i>Later their medical records were released to the press and published without consent.\" (Skloot makes an appearance in a \u003ca href=\"https://www.youtube.com/watch?v=ej0b7GHGYjs\" target=\"_blank\">rap ballad\u003c/a> about the HeLa cells and the Lacks family, written and performed by Oakland 7th and 8th graders on YouTube this month.)\u003c/p>\n\u003cp class=\"p1\">\u003c/p>\u003cp>\u003c/p>\u003cp>Adding insult to injury, researchers in 2013 published the HeLa genome without family consent. (This was not illegal but, in the views of modern medical ethics, extremely dicey.)\u003c/p>\n\u003cp class=\"p1\">Panelist \u003ca href=\"https://law.stanford.edu/directory/henry-t-greely/\" target=\"_blank\">Hank Greely, \u003c/a>a bioethicist at Stanford University, advised the gathered researchers, “You do not want to be in the position where someone says, ‘I didn't know you were going to do that. I would never agree to that.’\u003c/p>\n\u003cp class=\"p1\">“Not so much for the legal reasons, though those can be significant,\" he said. \"More because of the political fallout that can come to you and your institution. It could also do damage to the whole stem cell enterprise.”\u003c/p>\n\u003cp class=\"p1\">\u003ca href=\"https://daley.med.harvard.edu/\" target=\"_blank\">George Daley\u003c/a>, of the Children’s Hospital Boston and Harvard Medical School, pointed the audience toward recently revised guidelines from the International Society for Stem Cell Research, which offers \u003ca href=\"http://www.isscr.org/home/publications/guide-clintrans/sample-consent-documents\" target=\"_blank\">templates for informed consent forms\u003c/a>. These include language like this:\u003c/p>\n\u003cp class=\"p1\">\u003cem>Donating your _____ cells for this research project is completely voluntary. You have the right to agree or to refuse to provide your _____ cells for this project. The quality of your current or future medical care and your relationship with [name(s) of institution(s)] will NOT change in any way whether you agree or refuse to provide any cells for this research project.\u003c/em>\u003c/p>\n\u003cp class=\"p1\">\u003cstrong>The Issue of Money\u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignright\">Is it ethical to charge patients to participate in a study? No, was the consensus.\u003c/aside>\n\u003cp>“What happens if someone has a drug based on their genes or cells?” the moderator asked.\u003c/p>\n\u003cp class=\"p1\">“That doesn't happen very often,” said Greely. “Most of the time discoveries are the results of work with tens of thousands or more people.”\u003c/p>\n\u003cp class=\"p1\">But, he conceded, every once in a while a patient comes along with unusual cells or genes that can be the basis for a drug. In that case, he said, a researcher must first and foremost follow whatever they said they’d do in the consent forms.\u003c/p>\n\u003cp class=\"p1\">“But even if you didn't promise them anything in the consent process,” he said, “if someone is making lots of money,\u003cspan class=\"Apple-converted-space\"> \u003c/span>I think frankly it’s a good idea to try to return something.”\u003cspan class=\"Apple-converted-space\"> \u003c/span>\u003c/p>\n\u003cfigure id=\"attachment_262548\" class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\">\u003cimg class=\"size-full wp-image-262548\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2016/10/iPScells2.jpg\" alt=\"These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \" width=\"1024\" height=\"765\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-400x299.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-800x598.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-768x574.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2016/10/iPScells2-960x717.jpg 960w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">These induced pluripotent stem cells were derived from a woman's skin. Blue shows nuclei. Green shows a protein found in iPS cells but not in skin cells. The red dots show the inactivated X chromosome in each cell. \u003ccite>(Kathrin Plath lab/UCLA via CIRM, NIH)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp class=\"p1\">He added that this probably doesn't mean offering royalties, which could foster overblown hopes for study participants. Greely likened it to hyping lottery tickets with very bad odds. Instead, he recommends thinking about a person's community, perhaps donating to causes dear to them. Even simple recognition, he says, is important.\u003c/p>\n\u003cp class=\"p1\">“I was involved in the\u003ca href=\"http://www.nature.com/news/deal-done-over-hela-cell-line-1.13511\" target=\"_blank\"> HeLa resolution\u003c/a> a few years ago,” he said,\u003cspan class=\"Apple-converted-space\"> \u003c/span>“and the Lacks descendants are really quite proud and pleased that their mother, grandmother and great grandmother is being remembered ... and that they are consulted on various things.”\u003c/p>\n\u003cp class=\"p1\">Continuing on the topic of money, the moderator asked what panelists thought about the ethics of paying tissue donors?\u003c/p>\n\u003cp class=\"p1\">On this, the panel seemed united, “As long as it’s a reasonable reimbursement for the pain and suffering, I think it’s hard to make a case against it,” offered \u003ca href=\"https://www.mskcc.org/research-areas/labs/members/lorenz-studer\" target=\"_blank\">Lorenz Studer\u003c/a>, of the Memorial Sloan Kettering Cancer Center. If the amount offered is so high that it becomes an “undue inducement,” said Greely, then it’s a problem.\u003c/p>\n\u003cp class=\"p1\">“Many patients are willing to pay for a treatment that’s unproven. What do you think about the ethics of patients paying to be in a trial?” asked the moderator, acknowledging that many people with serious diseases are desperate to be involved in the latest research and that clinical research is extraordinarily expensive to fund.\u003c/p>\n\u003cp class=\"p1\">No, was the general consensus.\u003c/p>\n\u003cp class=\"p1\">That means people in a control group would be paying for a placebo, Greely noted, and someone desperate to be in a trial might not be making a level-headed decision.\u003c/p>\n\u003cp class=\"p1\">“The simple fact that they’re willing to pay corrupts the informed consent process,\" he said. \"And there is a social justice aspect -- if someone can pay for a trial that’s not an equal distribution of good.”\u003c/p>\n\u003cp class=\"p1\">Someone from the audience chimed in with a question that once would have been relegated to the realm of science fiction: “What are the ethics of designing organs?”\u003c/p>\n\u003cp class=\"p2\">“Think about this with a heart,” said \u003ca href=\"http://profiles.ucsf.edu/deepak.srivastava\" target=\"_blank\">Deepak Srivastava\u003c/a> of the Gladstone Institutes and University of California, San Francisco. “It’s just a pump. I think going forward that we should remove the constraints of the design. What we have may or may not be the best thing in evolution.”\u003c/p>\n\u003cp class=\"p2\">But, said Greely, “Many people would be viscerally upset about the idea of changing ourselves, changing our species.\" So scientists should temper their desire to move quickly.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","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 class=\"p2\">“If there is one thing I've learned from being around biology for 25 years, it’s that biology is not the same as design,\" Greely said. \"Biology is really complicated! Engineers who design something expect it to work. But if you put something [designed] into an organism, the chances that something odd will happen are extremely high. You have to be extremely careful to avoid making things worse.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/258577/what-stem-cell-researchers-talk-about-when-they-talk-about-ethics","authors":["11088"],"programs":["futureofyou_54"],"categories":["futureofyou_452","futureofyou_1","futureofyou_73"],"tags":["futureofyou_396","futureofyou_953","futureofyou_680"],"featImg":"futureofyou_262541","label":"futureofyou_54"}},"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. 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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. Michel Martin hosts on the weekends.","airtime":"MON-FRI 1pm-2pm, 4:30pm-6:30pm\u003cbr />SAT-SUN 5pm-6pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/All-Things-Considered-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/all-things-considered/","meta":{"site":"news","source":"npr"},"link":"/radio/program/all-things-considered"},"american-suburb-podcast":{"id":"american-suburb-podcast","title":"American Suburb: The Podcast","tagline":"The flip side of gentrification, told through one town","info":"Gentrification is changing cities across America, forcing people from neighborhoods they have long called home. Call them the displaced. Now those priced out of the Bay Area are looking for a better life in an unlikely place. American Suburb follows this migration to one California town along the Delta, 45 miles from San Francisco. But is this once sleepy suburb ready for them?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/American-Suburb-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/news/series/american-suburb-podcast","meta":{"site":"news","source":"kqed","order":"13"},"link":"/news/series/american-suburb-podcast/","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=1287748328","tuneIn":"https://tunein.com/radio/American-Suburb-p1086805/","rss":"https://ww2.kqed.org/news/series/american-suburb-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkMzMDExODgxNjA5"}},"baycurious":{"id":"baycurious","title":"Bay Curious","tagline":"Exploring the Bay Area, one question at a time","info":"KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! 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. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. 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