<?xml version="1.0" encoding="UTF-8"?>
<rss version="2.0"
	xmlns:content="http://purl.org/rss/1.0/modules/content/"
	xmlns:wfw="http://wellformedweb.org/CommentAPI/"
	xmlns:dc="http://purl.org/dc/elements/1.1/"
	xmlns:atom="http://www.w3.org/2005/Atom"
	xmlns:sy="http://purl.org/rss/1.0/modules/syndication/"
	xmlns:slash="http://purl.org/rss/1.0/modules/slash/"
	>

<channel>
	<title>Science Progress &#187; Marcy Darnovsky, PhD</title>
	<atom:link href="http://scienceprogress.org/author/mdarnovsky/feed/" rel="self" type="application/rss+xml" />
	<link>http://scienceprogress.org</link>
	<description></description>
	<lastBuildDate>Fri, 10 Feb 2012 18:23:20 +0000</lastBuildDate>
	<language>en</language>
	<sy:updatePeriod>hourly</sy:updatePeriod>
	<sy:updateFrequency>1</sy:updateFrequency>
	<generator>http://wordpress.org/?v=3.2.1</generator>
		<item>
		<title>One Step Closer to Designer Babies</title>
		<link>http://scienceprogress.org/2011/04/one-step-closer-to-designer-babies/</link>
		<comments>http://scienceprogress.org/2011/04/one-step-closer-to-designer-babies/#comments</comments>
		<pubDate>Fri, 22 Apr 2011 19:41:45 +0000</pubDate>
		<dc:creator>Marcy Darnovsky, PhD</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Home Page]]></category>
		<category><![CDATA[Life Sciences, Health & Bioethics]]></category>
		<category><![CDATA[bioethics]]></category>
		<category><![CDATA[genetics]]></category>
		<category><![CDATA[genomics]]></category>

		<guid isPermaLink="false">http://www.scienceprogress.org/?p=8557</guid>
		<description><![CDATA[A new approach to testing the genes of early-stage fetuses could radically alter the experience of pregnancy and parenting from as early as five weeks, leading to a potentially dangerous moral quandary.]]></description>
			<content:encoded><![CDATA[<p>A new approach to testing the genes of early-stage fetuses could radically alter the experience of pregnancy and parenting. And we&#8217;d better start thinking about it now—before hype, fear, and the polarized politics of abortion distort the discussion.</p>
<p>The technique being developed analyzes fetal DNA that is collected from women’s blood as early as five weeks into a pregnancy. So-called “noninvasive prenatal diagnosis,” or NIPD, may hit the market as a test for Down syndrome later this year. Soon after, refinements are likely that will allow identification of fetal genes at thousands of sites; <a href="http://stm.sciencemag.org/content/2/61/61ra91.abstract">two different</a> <a href="http://precedings.nature.com/documents/5373/version/1">research groups</a> published papers claiming “proof in principle” of this prospect last December.</p>
<p>Because NIPD would be less invasive, less risky, and less expensive than the kinds of fetal gene tests now available, and because it relies on a simple blood draw so early in pregnancy, it is poised to become a prenatal game changer.</p>
<p>The fetal gene tests now offered are far from a walk in the park. For amniocentesis, a long needle is poked through your abdomen and uterus to extract amniotic fluid when you’re about 15-20 weeks pregnant. Chorionic villus sampling takes a snip of placental tissue, acquired by snaking a catheter through your vagina and cervix at 10-12 weeks. Both procedures carry a 0.5 percent to 1 percent risk of miscarriage.</p>
<p>By contrast, for NIPD you’d simply give a little extra blood at the lab at your first prenatal checkup. There would be no risk at all to you or the fetus. And you’d get the results before you were visibly pregnant, before you’d told your mother or your friends.</p>
<p>Of the 5 million or so pregnancies in the United States each year, only a few percent involve amniocentesis or chorionic villus sampling. Another few thousand fetal gene tests are done on embryos created with in vitro fertilization.</p>
<p>These numbers are relatively small. Even so, the practice of selecting fetuses and embryos with particular genes elicits concerns about the implications for people living with the very disabilities that are often “deselected,” about sex selection, and about parental expectations of a “perfect” child. NIPD could send the yearly number of fetal gene tests skyrocketing into the millions, and the level of concern soaring.</p>
<p>Researchers developing NIPD have already established partnerships with biotech companies eager to commercialize it; San Diego-based Sequenom has announced it will make NIPD for Down syndrome available in the fourth quarter of this year. Detecting hundreds or thousands of genetic variations, as opposed to particular chromosomal configurations, will be more difficult (and, at least initially, far more expensive). But researchers working on NIPD are confident that they’ll soon be able to do just that.</p>
<p>In other words, NIPD might soon be able to present you with the kind of genetic information about your five-week-old fetus that you can get today about yourself by sending a couple hundred dollars and a wad of spit to one of the “direct-to-consumer” gene test companies peddling their wares online. In both cases, you’d get a report that claims to predict risk for scores of common diseases and “conditions.”</p>
<p>But what do such reports mean? Predictions based on genetic testing are often highly misleading. You may learn from your own gene test, for example, that your risk of some condition is 50 percent higher than average—but how important is that if the average risk is only 1 percent? You may be told that you have a genetic variation associated with some disease—but that result may be based on one or a couple of small studies that have since been found wanting. The results look impressive and objective but for the most part their meaning is dubious and their usefulness scant. In fact, an increasing number of medical and genetic experts, and an FDA advisory panel, agree that when it comes to predicting common diseases, gene tests are a waste of money. Responsible medical practice, in this view, would limit gene tests to those that are clinically meaningful and useful.</p>
<p>Of course, some gene test results are helpful and important: If you’re planning children, for example, you may want to know if you’re a carrier for a serious single-gene disorder such as Tay-Sachs; if close relatives have had breast cancer, you may want to learn whether you have the mutation that significantly raises your risk of the rare familial form of the cancer.</p>
<p>But even with genetically imposed risks that are well established—for example, the genetic variation linked to early-onset Alzheimer’s—there are often few if any preventive measures to take. Fetal gene testing, however, is different. It presents an option: terminating a previously wanted pregnancy.</p>
<p>If sequencing large swaths of fetal genomes becomes common, that’s a choice millions might face. But how could pregnant women and their partners possibly interpret the results of tests that claim to predict dozens or hundreds of a future child’s traits? How, for example, could they “balance” a 25 percent increase in one risk against a 15 percent decrease in another? What would any of us do with information like this, even—or especially—if we knew it to be dubious and misleading?</p>
<p>And what of the broader social concerns? How many parents would choose to terminate a pregnancy because their child might be born with a disability—even if it was one with which many people are living full and happy lives? Would health insurers encourage such tests, or even require them, in order to avoid the costs of special-needs children?</p>
<p>It could get worse. Would we see parents using prenatal testing to try for a boy who’d play basketball with Dad or a girl eager to go clothes shopping with Mom? Would we begin to see offers—<a href="http://online.wsj.com/article/SB123439771603075099.html">like the one in 2009</a> by a Los Angeles fertility clinic—to test fetuses for hair color, eye color, and skin tone?</p>
<p>Two close observers of NIPD’s development, UC Hastings legal scholar Jaime King and Stanford bioethicist Henry Greely, <a href="http://cirge.stanford.edu/documents/GreelyAAAS2010.pdf">predict</a> NIPD will soon force us to face the “brave new world” questions that “we have been able until now to ignore.” In a January <em>Nature</em> article titled “<a href="http://www.nature.com/nature/journal/v469/n7330/full/469289a.html">Get Ready for the Flood of Fetal Gene Screening</a>,” Greely described the pending situation in appropriately dramatic terms: The “spectre of eugenics will loom over the whole discussion,” he noted. And concerns about eugenics “will increase as such testing moves from fatal diseases to less serious medical conditions and then on to nonmedical characteristics.”</p>
<p>Though some will object to NIPD largely because it makes greater numbers of abortions likely, its social and moral implications are not well captured by the abortion debate. Fetal gene testing in ballooned numbers and scope will disquiet reproductive rights advocates, disability rights advocates, and many others. Those of us determined to protect abortion rights will need to find ways to prevent frivolous and medically irrelevant genetic testing that could distort our hard-won reproductive freedoms and carry us into the realm of eugenics.</p>
<p><em>Marcy Darnovsky, Ph.D., is associate executive director of the Center for Genetics and Society, a public interest organization working for responsible uses and governance of human genetic and reproductive technologies.</em></p>
]]></content:encoded>
			<wfw:commentRss>http://scienceprogress.org/2011/04/one-step-closer-to-designer-babies/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>What Kind of Bioethics Council Do We Need?</title>
		<link>http://scienceprogress.org/2009/08/what-kind-of-bioethics-council/</link>
		<comments>http://scienceprogress.org/2009/08/what-kind-of-bioethics-council/#comments</comments>
		<pubDate>Mon, 17 Aug 2009 13:48:37 +0000</pubDate>
		<dc:creator>Marcy Darnovsky, PhD</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Home Page]]></category>
		<category><![CDATA[Life Sciences, Health & Bioethics]]></category>
		<category><![CDATA[bioethics]]></category>

		<guid isPermaLink="false">http://www.scienceprogress.org/?p=4223</guid>
		<description><![CDATA[Many genetic, reproductive, and biomedical technologies now in development pose new societal challenges, raising questions about how we understand and uphold social justice, human rights, and even our shared humanity.]]></description>
			<content:encoded><![CDATA[<p>Bioethics councils have come in many shapes and sizes, with different mandates, memberships, and outcomes. What kind of bioethics council would best serve the nation now? How can we move beyond the rancor and polarization—not to mention hyperbole and distortions on all sides—that in recent years have characterized so much of bioethics and the broader politics of science? There is no one answer, but a new council must incorporate viewpoints from Americans of all walks of life, maintain an appropriate distance from both scientific and commercial interests, and build on the experience of other nations.</p>
<p>President Obama’s leadership on stem cell policies and politics begins to show a way forward. The President opened the remarks that accompanied his March executive order loosening restrictions on federal funding of embryonic stem cell research by invoking the work’s great promise, and then immediately moved on to warn against overstating its potential. He noted the “difficult and delicate balance” between “sound science and moral values.” He pledged that research supported by the federal government would be “both scientifically worthy and responsibly conducted” according to “strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse.” He singled out human reproductive cloning as an instance of intolerable misuse: “It is dangerous, profoundly wrong, and has no place in our society, or any society.”</p>
<p>Several months and some 49,000 public comments later, the National Institutes of Health released its final stem cell research guidelines. In accord with the positions that a majority of Americans report to pollsters (and that candidate Obama expressed during the presidential campaign), the guidelines permit federal funding of research using stem cells derived from embryos created but not used in the course of fertility treatments. They exclude funding for research on cell lines derived from human embryos created specifically for research purposes, whether by <em>in vitro</em> fertilization or with cloning techniques.</p>
<p>The president’s leadership was not just a matter of striking a thoughtful tone and including obligatory references to respect for differing views. His emphatic rejection of human reproductive cloning was motivated by the health risks it poses, and also by a clearly articulated moral judgment about right and wrong. This is significant because it goes beyond the narrow safety and procedural considerations that many researchers and bioethicists cite as the only legitimate reasons to forgo efforts to clone humans or attempt other widely opposed forms of human genetic manipulation. It asserts that while science and technology are uniquely positioned to tell us what <em>can </em>be done, in the final analysis social values, mediated and expressed through democratically accountable institutions, must determine what <em>should</em> be done.</p>
<p>A new bioethics council might also look to the path that the president is forging on hot-button social issues like abortion rights and the appointment of a Supreme Court justice. He has worked to widen the perspectives and communities that are included in deliberations, called for empathy in considering the consequences of decisions, and mounted a serious search for common ground while insisting on clear policy lines where they are needed.</p>
<h2>Policy advice? Philosophical deliberation? How about both?</h2>
<p>In June, when the administration announced its intention to appoint a new bioethics council, a White House press officer told <em>The</em> <em>New York Times </em>that the new council would have a mandate to offer “practical policy options.” He characterized the Bush bioethics council, in contrast, as “a philosophically leaning advisory group.”</p>
<p>Some heard in these remarks an endorsement of the kind of bioethics that focuses on procedural and technical issues—the wording of informed consent documents, the acceptable incidence of high-order multiple births, the details of bio-containment precautions, and the like. These are important matters, and bioethicists have played key roles in bringing them to public attention and proposing ways to address them.</p>
<p>But many genetic, reproductive, and biomedical technologies now in development pose societal challenges of a new and far-reaching kind, raising questions about how we understand and uphold social justice, human rights, and even our shared humanity. Will biotechnology products and practices revive discredited ideas about <a href="http://www.scienceprogress.org/2009/06/the-color-of-our-genes/">biology and race</a>? Will they exacerbate existing social inequalities or produce deeper divides and conflicts? Will the pursuit of the “perfect child” reduce our solidarity with people with disabilities? Will women’s reproductive capacities increasingly be bought and sold? Will we look to genes rather than social institutions to understand and improve our lives and communities?</p>
<p>Such questions clearly demand more than improved informed consent protocols or another round of mouse experiments. They call for substantive deliberation about meaning and consequences, among the widest range of stakeholders, and drawing on social, political, historical, scientific and—yes—philosophical knowledge and wisdom.</p>
<h2>Bioethics and inclusive democracy</h2>
<p><strong> </strong></p>
<p>Although it will be challenging, we must find ways to extend the purview of democratic oversight to these questions and challenges. There are many ways in which a national bioethics council could contribute to this effort. Three are briefly described here.</p>
<p>First, although a new bioethics council must involve scientists and bioethics professionals and be rigorously grounded in scientific knowledge, it must not be monopolized by either. We need robust public engagement with the social challenges of human biotechnologies, their purposes and meanings, and their consequences for social justice, human rights, and equality.</p>
<p>Unfortunately, there is currently an asymmetry of influence and access in public discussion of bioethical issues. As Sujatha Jesudason of Generations Ahead pointed out in an <a href="http://www.scienceprogress.org/2009/03/bioethical-transparency/">essay here earlier this year</a>, “many scientists and industry groups are already well-staffed and well-organized on these issues.” Most Americans, by contrast, have few resources for making their views on these issues known. Allowing the national dialogue to be dominated by professional bioethicists and scientists in white lab coats runs the risks of alienation and backlash.</p>
<p>Any new bioethics council should find innovative approaches for meaningfully involving Americans from all walks of life, with town hall meetings, public consultations, interactive online tools, and the like. In addition, it should include key leaders from the full spectrum of civil society and public interest constituencies. Council members would not formally represent particular communities, but a wider range of perspectives would help to equalize power among different social groups. Special care should be given to ensuring that those under-represented on past bioethics bodies and those particularly affected by the biotechnologies in question now have a seat at the table.</p>
<h2>Avoiding “advisory capture”</h2>
<p>Second, any new bioethics body should avoid what might be called “advisory capture.” Just as regulatory agencies must guard against being manipulated by the very interests they are meant to keep an eye on, bioethics advisory bodies must maintain an appropriate distance from the scientists and commercial enterprises whose work raises the social dilemmas about which they are deliberating, and from bioethicists whose professional interests are too closely aligned with those scientists and firms.</p>
<p>An illustration of the danger of advisory capture can be seen in a recent statement by a member of the New York stem cell agency’s bioethics board. In the course of a discussion about whether women who provide eggs for cloning-based stem cell research should be paid beyond reimbursement of their expenses, <a href="http://www.biopoliticaltimes.org/article.php?id=4684">this bioethics expert said</a>, “I think that we are an ethics committee, and I actually think that, if good science demands these oocytes, that we have the obligation to provide them.” At issue here is not agreement or disagreement with the policy in question, but the risk of advisors becoming justifiers, promoters, or rubber-stampers.</p>
<p>Capping the number of scientists and aligned bioethicists on the new bioethics council would help prevent or at least mitigate such problems. In addition, the council should adopt robust conflict-of-interest policies of the sort that regulatory agencies have developed to protect the public interest.</p>
<h2>Looking beyond our borders</h2>
<p>Third, a national bioethics council should take advantage of the important work that has already been done throughout the world toward development of responsible policies for genetic, reproductive, and biomedical technologies. The United States is in many ways an outlier, with few meaningful regulatory and oversight policies in place. By contrast, many key countries, including the United Kingdom, Canada, France, and Japan, have established national regulatory agencies designed to facilitate research done in an accountable and socially responsible manner, while precluding unacceptable activities.</p>
<p>Although the differences among national cultures and contexts can be significant, members of the new bioethics council could learn a great deal from both the successes and the shortcomings of other countries’ experiences. Consultations and meetings with policy makers and staff who have been involved with these agencies, and with scholars who have studied them, would likely provide important insights.</p>
<p>These suggestions would help put a new bioethics council on a productive and democratically accountable course. They would encourage both substantive and practical insights into the consequential issues it will surely confront. And they are consistent with the values that President Obama has declared will guide his administration.</p>
<p><em>Marcy Darnovsky, PhD, is associate executive director of the Center for Genetics and Society, </em><a href="http://www.geneticsandsociety.org/"><em>www.geneticsandsociety.org</em></a><em>. The Center’s recommendations for the Obama Administration are compiled in </em><a href="http://www.geneticsandsociety.org/downloads/CGSObama.pdf">Responsible Federal Oversight of the New Human Biotechnologies</a>.</p>
]]></content:encoded>
			<wfw:commentRss>http://scienceprogress.org/2009/08/what-kind-of-bioethics-council/feed/</wfw:commentRss>
		<slash:comments>3</slash:comments>
		</item>
		<item>
		<title>The Baby Business and Public Policy</title>
		<link>http://scienceprogress.org/2009/05/baby-business-and-public-policy/</link>
		<comments>http://scienceprogress.org/2009/05/baby-business-and-public-policy/#comments</comments>
		<pubDate>Tue, 05 May 2009 15:37:10 +0000</pubDate>
		<dc:creator>Marcy Darnovsky, PhD</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Home Page]]></category>
		<category><![CDATA[Life Sciences, Health & Bioethics]]></category>
		<category><![CDATA[bioethics]]></category>
		<category><![CDATA[reproductive health]]></category>

		<guid isPermaLink="false">http://www.scienceprogress.org/?p=2917</guid>
		<description><![CDATA[Drawing lessons from other countries’ regulatory successes could help temper the commercial pressures in the U.S. assisted reproduction sector, without in any way diminishing reproductive rights.]]></description>
			<content:encoded><![CDATA[<p>The recent media storm over the in vitro fertilization-induced birth of octuplets has receded into the tabloids and entertainment pages. A second fertility industry scandal that emerged several weeks later—the announcement by a Los Angeles fertility clinic that it would soon offer a program to select embryos not just for sex but also for hair, eye and skin color—has also veered out of the headlines. But the outcry surrounding these events has revealed mounting disquiet about the multi-billion dollar baby business.</p>
<p>The fertility industry’s professional societies offer a potential avenue for self-regulation of the field, but their existing recommendations are too often ignored. Other countries regulate assisted reproduction to protect the well-being of all participants, including the children whom it helps create and the families and society into which they are born. Drawing lessons from their successes could help temper the commercial pressures in the U.S. assisted reproduction sector, without in any way diminishing reproductive rights.</p>
<p><!--pullquote-->The importance of addressing these issues is readily evident. The octuplets story left a mark even on the English language. Google now reports one and a half million results for the ungainly and unsympathetic neologism OctoMom (and the babies’ mother, Nadya Suleman, has now filed a trademark application on it). The outpouring of public hostility toward Suleman that the term bespeaks seemed in part a case of misdirected anger about corporate excesses and irresponsibility, as Jonathan Moreno has <a href="http://www.scienceprogress.org/2009/02/baby-bailouts-and-benetton-babies-2">pointed out</a>. But there was more to it than that. News articles and blog posts about the octuplets routinely drew hundreds of comments; many focused on the reckless behavior of the fertility doctor responsible for the octuplets, and raised pointed questions about the adequacy of oversight in the fertility industry. So did editorial writers, bioethicists, and a number of assisted reproduction insiders.</p>
<p>A smaller but no less critical response greeted the unprecedented offer to pre-select future children’s cosmetic traits, first reported in mid-February in the <em>Wall Street Journal</em>. Fertility doctor Jeffrey Steinberg initially defended his program, explaining that it was not so different from <a href="http://online.wsj.com/article/SB123439771603075099.html">cosmetic surgery for adults</a>.</p>
<p>But that “designer baby” mentality was precisely what disturbed so many. A father who used embryo screening (the procedure is known technically as pre-implantation diagnosis or PGD) to avoid having a child with a serious genetic disease wrote in a<em> Los Angeles Times </em>op-ed that “Something stinks about reproductive medicine in Southern California, and it doesn&#8217;t involve eight dirty diapers….Abusing…hard-won knowledge to capriciously choose hair color, eye color and other cosmetic traits in a baby is <a href="http://www.latimes.com/news/opinion/commentary/la-oe-mgoldberg17-2009feb17,0,4288749.story">wrong and repugnant</a>.”</p>
<p>Bioethicist Art Caplan articulated the widespread concern that reproductive genetics could contribute to <a href="http://www.abcnews.go.com/Health/Story?id=6998135&amp;page=2">new forms of discrimination and inequality</a>:</p>
<blockquote><p>Designing your descendents and seeking out perfection is the biggest slippery slope we could go on. Are the rich going to be able to do it and the poor not? Are we going to create a sort of subpopulation of the genetically perfect as against everybody else?</p></blockquote>
<p>After several weeks of reactions like these, Steinberg decided to “suspend” his program. But the door to what Caplan called our “biggest slippery slope” is hardly bolted shut.</p>
<h2>The Limits of Self-regulation</h2>
<p>The current problems in the baby business and the prospect of future abuses have persuaded many of the need for effective oversight. But it’s by no means unanimous: Some continue to believe that whatever adjustments are needed can be accomplished through voluntary guidelines and better enforcement of existing rules that govern general medicine. Kavita R. Shah and Frances R. Batzer of Jefferson Medical College-Thomas Jefferson University, for example, <a href="http://www.scienceprogress.org/2009/03/reproductive-freedom/">wrote in <em>Science Progress</em></a> after the octuplets controversy that:</p>
<blockquote><p>American medicine already has in place several checkpoints (state licensing boards, professional organizational sanctions, and the National Practitioner’s Databank) to curb this sort of headline-grabbing behavior in the future. Utilizing these mechanisms more fully is the answer.</p></blockquote>
<p>But both the octuplets and the designer-baby offer suggest that those mechanisms aren’t up to the job.</p>
<p>Let’s look first at the guidelines issued by the fertility industry’s professional organization, the American Society for Reproductive Medicine, about <a href="http://www.asrm.org/Media/Practice/Guidelines_on_number_of_embryos.pdf">how many embryos to transfer into a woman’s body</a>. The health risks associated with IVF multiple births came in for a good deal of discussion in the aftermath of the octuplets. While in years past IVF sextuplets and septuplets were celebrated as feel-good miracles, it has become increasingly clear that even IVF triplets and twins pose significant risks to mothers and babies. Evidence is also accumulating that in younger women, transferring more than one or two embryos doesn’t increase pregnancy success rates, even as it sharply boosts the chances of high-order multiple births.</p>
<p>For these reasons, ASRM guidelines now call for transferring no more than two embryos per cycle for women under 35, and the group has mounted educational efforts that have in fact helped to reduce the rate of IVF multiples. But ASRM’s spokesperson <a href="http://www.upi.com/Science_News/2009/03/02/Fertility-clinics-said-to-lack-regulation/UPI-39031235977462/">told a reporter</a> that “exceptions to the guidelines are permitted, and the society is not inclined to second-guess decisions made by physicians.”</p>
<p>Michael Kamrava apparently transferred six embryos at 33-year-old Nadya Suleman’s request; two of them twinned. By any measure and at any time, the eight-baby pregnancy thus created would be considered extreme, and a six-embryo transfer into a young woman is, we would all hope, unusual. But notwithstanding the criticisms of Kamrava by other fertility doctors, he is hardly alone in violating ASRM recommendations. In fact, a large majority of assisted reproduction programs—fully 80 percent of them, according to Centers for Disease Control and Prevention data—fail to comply with the guidelines. In California, home to Kamrava’s practice and a disproportionate number of fertility programs, the non-compliance rate is 92 percent.</p>
<p>What about the use of PGD for selecting non-medical traits? ASRM’s Ethics Committee has issued guidelines that discourage using PGD for sex selection except in the rare cases of sex-linked disease. Yet that recommendation too is openly and commonly flouted. A 2006 survey of IVF centers that provide PGD, conducted by the Genetics and Public Policy Center, found that 42 percent acknowledge offering it for social sex selection. A quick online tour shows that many fertility programs <a href="http://www.asrm.org/Media/Ethics/Sex_Selection.pdf">advertise</a> it <a href="http://www.dnapolicy.org/resources/PGDSurveyReportFertilityandSterilitySeptember2006withcoverpages.pdf">openly</a>.</p>
<p>Professional guidelines, by definition non-binding, can’t be expected to effectively regulate assisted reproduction. But ASRM could put at least some teeth behind its rules: It could, for example, publicly sanction or suspend the memberships of fertility practices that don’t comply with its guidelines. Unfortunately, it has not exercised even that minimal influence.</p>
<h2>Fertility Medicine is Different</h2>
<p>What about the argument that assisted reproduction is adequately regulated by the rules governing general medicine? Those rules are of course important, but they don’t account for the important ways in which fertility treatment and the fertility industry differ from most other medical practice.</p>
<p>First, assisted reproduction in the United States is subject to less oversight than most other medical fields. Much of it takes place in private, for-profit clinics that do not receive public funding and therefore are not required to adhere to the human subject protections and research reviews that apply to most experimental medical procedures. Thus, some new IVF techniques like intracytoplasmic sperm injection, which places a single sperm directly inside an egg, have moved from concept to clinic without systematic animal studies or reviews by any independent agency or committee.</p>
<p>Second, the U.S. assisted reproduction sector is subject to more and different kinds of commercial pressures than most other medical fields, largely because most patients pay for fertility treatment out of pocket. Like practices offering cosmetic procedures, fertility programs use a full range of advertising and marketing devices to compete with each other for customers. While assisted reproduction resembles cosmetic medicine in its commercial nature, it’s more like adoption or foster care in that it helps people become parents. Adoption, however, has robust rules to ensure that the well-being of the children involved comes first. That’s not at all true of assisted reproduction. In fact, fertility clinics’ responsibility ends when pregnancy is established; other medical personnel take over the care of both the mothers and children from there.</p>
<p>At the same time, assisted reproduction is unlike adoption, and unlike any other field of medicine, in that it creates new people. Yet fertility doctors focus entirely on the intended parents, who are, after all, their patients—and their customers. And fertility practitioners are not necessarily thinking about—nor should they be solely responsible for—the ways in which some reproductive genetic procedures could wind up changing the society into which those newly created children are born.</p>
<h2>Concerns About Abortion Politics and Medical Practice</h2>
<p>Those who resist additional regulation and oversight of assisted reproduction often worry about possible harms to reproductive choice and to medical practice. These are serious concerns.</p>
<p>One sort of reassurance can be found in the dozens of countries that regulate assisted reproduction quite robustly without in any way infringing on abortion rights. In those countries, however, the right to terminate an unwanted pregnancy is better protected than in the United States. Indeed, in this country, there have already been efforts to slip restrictions on abortion rights into proposals to regulate assisted reproduction. In the aftermath of the octuplets case, a Georgia state senator introduced a bill that addressed fertility clinic practices but also contained provisions establishing the legal personhood of human embryos. That language was later stripped from the bill, but similar Trojan horses are possible in the future.</p>
<p>Any policy proposals to regulate assisted reproduction will have to be carefully scrutinized to make sure they don’t deliberately or inadvertently undermine women’s health or reproductive rights. But that’s true of policies in many arenas. And the Georgia experience arguably demonstrates that we’re better off taking a proactive approach to regulating assisted reproduction than allowing opponents of abortion rights to capture the high ground and public sentiment. Especially now, with an administration that is friendly to women’s rights, we have the chance to establish public policy for the fertility field in a way that fully respects abortion rights.</p>
<p>The other frequent objection to setting enforceable assisted reproduction rules is that it will put unwarranted limitations on doctors. Shah and Batzer, cited above, warn of “resort[ing] to bulky legislation” and “allowing government’s heavy hand to further encroach on medical practice.” But public policy isn’t inevitably bulky, and government doesn’t always encroach. And as recent financial misadventures demonstrate, the absence of regulation and oversight can itself be a problem: Market mechanisms can and do encourage irresponsible behavior and unacceptable practices.</p>
<p>To be sure, no law should attempt to specify the medical details of fertility treatment. But few would suggest that. There are successful models of public policy on assisted reproduction from which we can learn a great deal. Other countries have adopted regulatory mechanisms that give medical professionals the leeway they need to adjust treatments to individual patients, and that have shown themselves flexible enough to change with scientific and technical developments.</p>
<h2>How to Regulate Assisted Reproduction</h2>
<p>In most of the industrialized world, comprehensive oversight of assisted reproduction has already been put in place. In many countries, fertility clinics are licensed by a government agency. This arrangement allows for rules to be modified as needed, but provides a mechanism for ensuring that clinics are following them. A few extreme reproductive practices—most commonly efforts to produce a cloned or genetically modified child—are typically prohibited outright. Rules about permitted procedures, guided by consistent principles, are set and enforced by the licensing agency.</p>
<p>Take, for example, the United Kingdom. After the birth of the first baby by <em>in vitro</em> fertilization in 1978, a lengthy process of public input and deliberation led to a detailed report, and then to a law creating the Human Fertilisation and Embryology Authority. The HFEA oversees both assisted reproduction and research with human embryos. By statute, its governing board is diverse, and not dominated by researchers or clinicians. By requiring and issuing licenses, it is able to maintain standards and prevent abuses. While a few of HFEA’s decisions have been controversial, its principles and processes are widely supported both by the public and by practitioners of assisted reproduction and embryo research. Canada is following a track similar to the British one.</p>
<p>Many close observers consider the United Kingdom’s HFEA a model for oversight of assisted reproduction in the United States. That was the conclusion, for example, of a multi-year study by fourteen prominent scholars and bioethicists led by Erik Parens and Lori Knowles of the Hastings Center. Importantly, <a href="http://www.thehastingscenter.org/pdf/reprogenetics_and_public_policy.pdf">their analysis</a>—which was published in 2003—called not only for careful consideration of the safety of repro-genetic procedures and technologies, but also for assessments of their broader social consequences and their effects on personal and societal well-being.</p>
<p>The UK and many other countries that regulate assisted reproduction differ from the United States in another crucial way: They regard health care as a right and provide it to their citizens. Typically public health care systems pay for a limited number of IVF cycles, and even where fertility treatment providers remain largely in the private sector, this changes the commercial dynamics of assisted reproduction significantly.</p>
<p>Obviously, slavish duplication of the UK’s assisted reproduction system would be ill-advised. We live, after all, in a larger and more diverse nation that, for better and for worse, is unaccustomed to public regulation of any kind of health care. But continuing to resist oversight of the fertility business would also be unwise, particularly with the possibility of real health care reform on the horizon. The many thousands of families who look to assisted reproduction, and the society into which the children it helps create are born, deserve better.</p>
<p><em>Marcy Darnovsky, PhD, is associate executive director of the </em><a href="http://www.geneticsandsociety.org/"><em>Center for Genetics and Society</em></a><em>.</em></p>
]]></content:encoded>
			<wfw:commentRss>http://scienceprogress.org/2009/05/baby-business-and-public-policy/feed/</wfw:commentRss>
		<slash:comments>1</slash:comments>
		</item>
		<item>
		<title>Next Steps for Progressive Stem Cell Politics</title>
		<link>http://scienceprogress.org/2008/12/next-steps-for-progressive-stem-cell-politics/</link>
		<comments>http://scienceprogress.org/2008/12/next-steps-for-progressive-stem-cell-politics/#comments</comments>
		<pubDate>Tue, 16 Dec 2008 20:12:56 +0000</pubDate>
		<dc:creator>Marcy Darnovsky, PhD</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Home Page]]></category>
		<category><![CDATA[Life Sciences, Health & Bioethics]]></category>
		<category><![CDATA[Stem Cells]]></category>
		<category><![CDATA[bioethics]]></category>

		<guid isPermaLink="false">http://www.scienceprogress.org/2008/12/next-steps-for-progressive-stem-cell-politics/</guid>
		<description><![CDATA[In the wake of the Bush administration’s policies, we will have the political space to craft a pro-research stand that simultaneously highlights the need for consistent and enforceable regulation, for hope without hype, and for developing human biotechnologies according to principles of social justice and human rights.]]></description>
			<content:encoded><![CDATA[<p>The long-awaited stem cell announcement expected soon after inauguration day will be a welcome corrective to the Bush administration’s restrictions. As we anticipate a new policy—one that loosens federal funding for research using stem cell lines created with in vitro fertilization embryos not needed for reproductive purposes—let’s also take a good look at how to change the politics of stem cell research.</p>
<p>For the past eight years, the stem cell debate has been notable for its divisiveness. Controversy formed along the embryo divide; many liberals and progressives came to their positions in reaction to the Bush stem cell policy and the theological beliefs that helped motivate it.</p>
<p>In several election cycles, embryonic stem cell research became both hot potato and partisan wedge. Opponents persisted in absolutist rejection, while supporters countered with promises of imminent cures for diseases that, in a frequent hyperbolic refrain, “affect 128 million Americans.” The din of the stem cell war all but drowned out discussion of the non-embryo issues that stem cell research can pose.</p>
<p class="pullquote">But we should be able to conduct stem cell politics—and science politics in general—more thoughtfully and responsibly than has been the norm in recent years.</p>
<p>During these Bush years, some liberals and progressives registered their outrage at the limits on stem cell funding by decrying the “politicization of science.” However warranted the outrage, the implications of the formulation are troubling. It’s not possible or desirable to take politics or values out of science; efforts to do so usually wind up hiding rather than taming partisan motives, commercial prerogatives, and special interests. But we should be able to conduct stem cell politics—and science politics in general—more thoughtfully and responsibly than has been the norm in recent years.</p>
<p>In fact, values and commitments close to the core of liberal and progressive worldviews—including health equity, democratic governance and responsible regulation, and safeguarding research subjects—have been at stake all along. The end of the Bush era, important for so many reasons, also gives us the opportunity to adopt a more nuanced approach to stem cell and human biotechnology research and applications. We now have the political space to craft a pro-research stand that simultaneously highlights the need for consistent and enforceable regulation, for hope without hype, and for developing human biotechnologies according to principles of social justice and human rights.</p>
<p>These principled reasons for a new stem cell politics are bolstered by practical considerations. Since 2004, a solid but not overwhelming majority of Americans have favored embryonic stem cell research. According to the VCU Life Sciences Survey, the longest-running and most detailed sampler of Americans’ sentiments about stem cells and other biotechnology issues, the number has hovered between 53 and 58 percent. Partisan differences are significant, but perhaps not as much as you’d think: in 2007, 65 percent of registered Democrats, 54 percent of independents, and 42 percent of Republicans <a href="http://www.vcu.edu/lifesci/images2/survey2007.pdf">supported embryonic stem cell research</a>.</p>
<p>These and other surveys show that Americans are hopeful about the eventual benefits of stem cells and other new human biotechnologies. But nothing in them suggests a willingness to write blank checks or bestow unconditional approval. In most surveys, for example, close to 90 percent of Americans reject reproductive cloning. Only a small portion of this opposition is based on perceptions of its physical danger. Commonly cited reasons include beliefs that it is “morally wrong,” “interferes with human distinctiveness and individuality,” or “could be used for questionable purposes like breeding a superior race.” And Americans remain evenly divided on the use of cloning techniques in stem cell work.</p>
<p>In short, many Americans are wary about potential misuses of human biotechnologies. While most are likely less than fascinated with policy details, they do care about integrity and accountability in the conduct of research, and about the moral meanings and social consequences of human biotechnology research.</p>
<p>What might this mean for the next steps in public discussion of stem cells? Here are a few specifics about how progressive principles can inform political discourse and public policy:</p>
<ul>
<li>As the new administration explains its stem cell views to Americans, and as congress members prepare expected stem cell legislation, they should continue to emphasize the importance of ethical regulation and effective oversight.</li>
<li>Commitment to democratic governance counsels that the new rules of the road apply to research whether it is publicly or privately funded. They should be enforceable, not voluntary.</li>
<li>Procedures and structures for determining stem cell regulations, including review boards and higher-level committees or councils, should include a much fuller range of public constituencies, and should be free of conflicts of interest.</li>
<li>The public interest—including equitable access to the benefits of biomedical and biotechnology research—should be a priority value in decisions about broad funding directions, patent policies, and commercialization policies.</li>
<li>We should all take a sober look at the exaggeration and hype that’s tainted the stem cell debate. Responsible science—and responsible science reporting—entail realistic accounts of a given line of investigation’s prospects, and refrain from exaggerating the likelihood and imminence of breakthroughs and cures.</li>
</ul>
<p>The stem cell wars have provided a great example of how not to conduct the politics of science. A new chapter in the stem cell story could be good both for science and for efforts to bring social justice values and democratic accountability to the development of genetic, reproductive and biomedical technologies.</p>
<p><em>Marcy Darnovsky, PhD, is associate executive director of the Center for Genetics and Society.</em></p>
]]></content:encoded>
			<wfw:commentRss>http://scienceprogress.org/2008/12/next-steps-for-progressive-stem-cell-politics/feed/</wfw:commentRss>
		<slash:comments>3</slash:comments>
		</item>
	</channel>
</rss>

