GeneWatch Vol. 24 No. 3

Special Double iSSue Volume 24 Number 3-4 | JuNe-July 2011

GENEWATCH THe maGaZiNe oF THe couNcil For reSpoNSible GeNeTicS | aDVaNciNG THe public iNTereST iN bioTecHNoloGy SiNce 1983

Special topic: Genetic Reductionism and the Geneticization of Crime with commentary by Troy Duster and Kenneth Weiss

ISSN 0740›9737

PLUS: > Exclusive interviews: Debora Spar, author of The Baby Business and Jennifer Lahl, filmmaker of Eggsploitation > Public health concerns about UC Berkeley’s proposed synthetic biology lab

GENEWATCH June-July 2011 Volume 24 number 3-4 & DeSiGNer Samuel W. anderson eDiTor

eDiTorial commiTTee

ruth Hubbard Sheldon Krimsky Jeremy Gruber GEnEWatch is published by the council for responsible Genetics (crG), a national, nonprofit, tax-exempt organization. Founded in 1983, crG’s mission is to foster public debate on the social, ethical, and environmental implications of new genetic technologies. The views expressed herein do not necessarily represent the views of the staff or the crG board of Directors.

address 5 upland road, Suite 3 cambridge, ma 02140 Phone 617.868.0870 fax 617.491.5344 net www.councilforresponsiblegenetics.org board of directors SHelDoN KrimSKy, phD, Board chair Tufts university peTer SHoreTT, mpp treasurer The chartis Group eVaN balabaN, phD mcGill university paul billiNGS, mD, phD, university of california, berkeley SuJaTHa byraVaN, phD centre for Development Finance, india roberT DeSalle, phD american museum of Natural History roberT GreeN, mD, mpH Harvard university Jeremy Gruber, JD council for responsible Genetics

Editor’s Note

BY SAMUEL W. ANDERSON

I often try to use this space to lay the groundwork for the following pages. The first half or more of each issue of GeneWatch is devoted to a specific topic (loyal readers will have noticed), and before launching into the heavy lifting the unaccustomed reader may find it useful to skim through a quick primer or a framing of the subject at hand.

There is only so much I can help you this time around. The real experts on assisted reproductive technologies (or ARTs—that’s our topic this time around, in case you missed it) appear on pages 4 through 38; besides, for all I know, you may already be well versed in the particulars of the various technologies and their implications. You may have already committed to memory the U.S. Centers for Disease Control’s broad definition of ART as “all fertility treatments in which both eggs and sperm are handled.” If this is the case, there’s a good chance you have already muttered aloud, wherever you’re reading this, “Get on with it already!” or else flipped ahead to the good stuff.

On the other hand, perhaps your knowledge of in vitro fertilization and multiple embryo transfers begins and ends at the case of Nadya

Suleman, aka “Octomom.” There’s no shame in admitting that you first learned of commercial surrogacy through Baby Mama, the 2008 comedy starring Tina Fey and Amy Poehler, or that up to this point you thought egg donation was the exclusive domain of the Easter Bunny (OK, there’s some shame in admitting the latter). If any of these are the case, you might be well served by a bit of Googling before launching headfirst into the commentaries ahead. In the meantime, you may want to start by reading pages 39 through 49, where you’ll find a feature section on genetic reductionism and the geniticization of criminal behavior with new articles by Troy Duster and Kenneth Weiss; an exclusive discussion on public safety concerns surrounding the construction of a synthetic biology lab in Berkeley, California; and Colin O’Neil’s notes on the latest developments in the AquaBounty genetically engineered salmon saga.

Whether you fall into either of those extremes or (more likely) between them, you either know how immediately important the implications of assisted reproductive technologies are—or you will after you nnn read this issue.

rayNa rapp, phD New york university paTricia WilliamS, JD columbia university staff Jeremy Gruber, President and Executive Director Sheila Sinclair, Manager of Operations Samuel anderson, Editor of GeneWatch andrew Thibedeau, Senior Fellow magdalina Gugucheva, Fellow coVer arT Samuel W. anderson

Write to (or for) GeneWatch!

GeneWatch welcomes article submissions, comments and letters to the editor.

Please email anderson@gene-watch.org if you would like to submit a letter or with any other comments or queries, including proposals for article submissions.

Featured art: “Tree of Life”

by Jennifer Lynn Haas www.jenniferlynnhaas.blogspot.com

eDiTorial & creaTiVe coNSulTaNT Grace Twesigye unless otherwise noted, all material in this publication is protected by copyright by the council for responsible Genetics. all rights reserved. GeneWatch 24,3 0740-973

2 GeneWatch

June-July 2011

Match, Mate, Trait

4

When gametes are bought and sold, supply and demand shape not just a transaction, but a human being LISA C. IKEMOTO

The Booming Baby Business 6 An interview with Debora Spar, author of The Baby Business

21st Century Parenting

8

Is the increasing use of assisted reproductive technologies molding a new kind of parent?

SUSANNAH BARUCH

Commercial Surrogacy in India

10

13

An interview with embryology lab director Judy Stern

The Fast and the Furious

16

Why so many are troubled by the clinical implementation of non-invasive prenatal genetic diagnosis LORI HAYMON

Abuses of Women’s Human Rights in Third Party Reproduction

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23

24

An interview with filmmaker Jennifer Lahl

Commercial Surrogacy and the Cost of Reproductive “Freedom”

27

The Southern Baptist Ethics of ARTs

Volume 24 number 3

36

Topic update: Congress Raises Ire of Gene Patent Activists

38

Special Topic: Genetic Reductionism and the Geneticization of Crime

39

The Folly of Geneticizing Criminal Behavior

40

Genetics Without Ideology

A Synthetic Biology Lab in Berkeley

30

43

46

Is public health and safety being considered in the construction of a new biolab in Berkeley?

TINA STEVENS, BECKY MCCLAIN AND JEREMY GRUBER

Engineering a Red Herring

48

Congress answers the call on GE salmon, but will it be enough?

COLIN O’NEIL Endnotes

Surrogacy has been around for centuries; but when money enters the picture, women’s bodies become commodities MARSHA DARLING

An interview with Barrett Duke of the Southern Baptist Convention

Assisted reproductive technologies can provide new choices for women - but they can also reinforce traditional notions of women’s identities HEDVA EYAL

Our genes may play a role in nearly everything about us - but when it comes to behavioral traits, genetics makes a flawed fortune-teller KENNETH WEISS

The challenge of developing prochoice regulation of ARTs TINA STEVENS, DIANE BEESON, AND PAT JENNINGS

Egg Donation and Eggsploitation

35

Using genetics to explain the causes of crime leads to some very problematic conclusions TROY DUSTER

The expansion of ARTs has serious implications for the health, well-being, and human rights of women around the world KATHY SLOAN

Finding the Active Voice

Willful Ignorance

33

Québec’s regulation and surveillance of assisted reproductive technologies lags … but there’s no quick fix for the underlying issue ABBY LIPPMAN

Old Patterns, New Ideas

Women in India risk more than their health by becoming surrogates VRINDA MARWAH

IVF and Multiple Embryo Transfers: Everything in Moderation

ART’s Minor Issue Children can now be not only offspring of assisted reproductive technologies, but also consumers of it MICHELE GOODWIN

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Match, Mate, Trait When gametes are bought and sold, supply and demand shape not just a transaction, but a human being LISA C. IKEMOTO The collection and transfer of human gametes for others’ use is an important sector of the fertility industry. Debora Spar, author of The Baby Business, calculated that the United States gamete market produced over $112 million in revenue in 2004.1 Commercial sperm banks were foundational to the formation of the fertility industry.2 Sperm banks offer catalogued inventories of pre-collected, cryopreserved sperm.

Eggs are mostly sold fresh and through a variety of retail venues. The major players are the egg donation centers, which offer catalogues of women who stand by, ready to provide fresh eggs on demand.

Some businesses offer more individualized search and brokerage services. Some who seek eggs for their own use advertise directly to women who might be willing to provide the raw material of human conception. Recently, improved cryopreservation and thawing techniques have made the use of frozen eggs a bit more reliable. As a result, egg banks have formed to offer cryopreserved eggs for others’ use.

The gamete market could not exist without “donors” and “recipients.”

“Donors” refers to those who provide ova and sperm for others’ use. In fact, most “egg donors” and “sperm donors” receive payment. “Recipients” are those who acquire gametes for use with assisted reproductive technology (ART) such as assisted insemination 4 GeneWatch

and in vitro fertilization. Most “recipients” pay for the gametes they use.

Sperm banks and egg donation centers deploy overtly commercial means for both procurement and distribution. They advertise heavily for “donors” and to recipients, in print media, on billboards, and especially on the Internet. Sperm bank and egg donation center websites are designed to provide a window shopping-like experience to potential

recipients. The websites proffer a package which includes medical and legal safety, confidentiality, and most of all, information about the “donors.”

While recipients make choices that are deeply personal, recipients choose from a set of offerings carefully tailored to construct and maintain the market for human gametes.

Undoubtedly, both supply and demand-side interests shape the offerings, the preselected “donors” and the information about them.

Sperm banks and egg donation centers use screening criteria to

develop their human inventory of “donors.” Some companies tout their selectivity. Fairfax Cryobank “offers a large selection of high quality donors; only 1 in 200 applicants make it through our rigorous screening process to become donors.”3 The California Cryobank describes a multi-step screening process, depicted in a “donor screening pyramid.”4 Screening criteria express a mix of social and medical concerns. Many criteria, whether framed as medical or social, define “normal,” “healthy,” and “desirable” in extremely narrow terms.

While infectious disease testing addresses nearterm health risk to recipients, screening based on genetic testing and family medical history simultaneously selects out applicants at risk of transmitting genetic disease and establishes a narrow definition of “healthy and able.”

What is a trait? Donor screening criteria and information offered about donors describe a wide range of descriptors as “traits.” Thus, traits include height, ethnicity, education, and personality. Egg Donation, Inc. includes “donor” statements on personality and character, philosophy on life, favorite food, favorite color, favorite season, holiday and sport under the heading of “Traits & Characteristics.”5 Traits, then, do not necessarily refer to heritable traits.

But the use of “traits” in donor profiles leave room for interpretation.

June-July 2011

Donor profiles often mix descriptors that refer to heritable traits and those that do not. They allow potential recipients to imagine, as other potential parents imagine that a future child will share their love of sports or art, and just as many freely attribute character and personality quirks to genetic parentage. The phantom genes in these imaginings tap into widespread beliefs about the power of DNA and leave those beliefs intact.

Many who use third party gametes choose donors who resemble their mates. Thus websites that include search functions use hair color, eye color, and ethnic origin as their starting points. The genetic content of these choices serves social functions that most deem acceptable. For some couples, choices based on resemblance may mask the use of third party gametes. They may also “simplify everyday interactions and perhaps enhance feelings of affinity between the matched parent and child.”6 At the same time, the offer of hair color, eye color, and ethnic origin as a set of independent menu choices echoes the Dell Computer sales model that allowed purchasers to customize their otherwise generic desktop PCs. Perhaps not surprisingly, gamete marking is gendered. For example, both sperm banks and egg donation centers offer “donor” photographs.

Sperm banks typically offer baby pictures of “donors,” presumably to suggest what the recipient’s resulting baby might look like. Egg centers, on the other hand, are much more likely to offer photos of the women willing to provide eggs. The Egg Donor Program, which calls the women “Donor Angels,” uses professionallyphotographed glamour shots. Some sites allow the women to choose and upload their own photos. Tips offered to the women advise avoiding, “racy, scantily clad images,” “photos with alcoholic drinks,” and “too Volume 24 number 3

many serious, non-smiling shots.”7 Most sperm banks in the U.S. offer anonymity to “donors.” The use of baby photos helps maintain that anonymity. Egg centers offer known and anonymous donation. Thus, for many, use of contemporary photos does not jeopardize anonymity. In addition, most egg “donors” are on physical and financial standby, until selected. Sperm banks offer genetic material that has already been separated from the man. Egg centers offer the woman as a means of obtaining the eggs. The photos—the glamour shots, the smiling, happy face and full-body pictures—allow potential recipients to visually inspect the woman with whom they must form either a paper-only or face-to-face relationship. The photos, then, may allow assessment of genetic as well as

demics, personality, and family information. The dating service comparison may not be inapt. Research has shown that women choosing sperm donors may rely on “the psychology used to choose a long-term mate when they assess attributes in a sperm donor.”9 Another profile, “Alexandro P,” includes family history, an account of his performance in equestrian competition, photographs, a personality assessment, and reported pregnancies achieved by use of his semen.10 Alexandro P is a riding stallion whose semen Yancey Farms offers for sale through its website. Both Ace’s and Alexandro P’s wares may be purchased by clicking a box and providing payment and delivery information.

For most, human sperm banks and egg centers offer a chance to form a

While ART use is about making babies, it is also about making money from genetic selection. cooperative potential.

The swirling of genetic, social, and personality traits in donor profiles begs comparison to other matching services. The websites for both Cryos International and Cryos/New York use “staff impressions” that read like dating ads. “Ace is a very likeable guy who you can tell has a very positive outlook on life, living it to the fullest.

When talking to Ace it is clear that he is a smart guy with a good heart and someone who has had great life experiences.”8 This brief appears on the same page as information about race, ethnicity, eye color, height, weight, education/occupation, blood type, reported pregnancy, psychological profile, and CMV status. The page includes a link to an extended profile in question and answer format. The extended profile categorizes the Q&A’s into physical description, aca-

family. At the same time, comparisons to Dell computers, dating services, and equine semen sales surface questions about the effects of offering pre-selected traits in a competitive, for-profit market.

Why else would California Cryobank offer a search function that allows potential recipients “to produce a list of donors who resemble the listed celebrities”?11 It may be all in fun.

But it also gleefully invites the expansion of consumerism in ART use. While ART use is about making babies, it is also about making money from genetic selection. So the question we face is: How should we counter narrow standards for “desirable,” “healthy,” and “able,” set by commerce and guarded by emotion-laden narratives of family formation? nnn Lisa C. Ikemoto, JD, is a Professor at UC Davis School of Law. GeneWatch 5

The Booming Baby Business An interview with Debora Spar, author of The Baby Business Debora Spar, PhD, is president of Barnard College and author of The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception.

GeneWatch: The big question is: how did we end up with an essentially unregulated multi-billion dollar industry?

Debora Spar: I think that we wound up with this unregulated industry for reasons that are actually quite understandable, if not good. We wound up here because, to begin with, the United States has a deep aversion to regulation of any sort. Compared to many other countries, particularly Western Europe, we don’t like regulation. Virtually all of our markets, whether it is banking or Internet or education, are less regulated than they are in many other places. So right off the bat, it’s not surprising that we also have a lack of regulation in this sphere. What makes it so pronounced in this particular area, though, is that we also have a deep aversion to having any kind of political conversation around reproduction, and particularly around the status of the embryo. It’s almost impossible to have those conversations without getting deeply involved in the abortion debate, which is essentially political suicide in this country. So I find it not in any way surprising that there is virtually no politician out there that wants to tackle this issue.

GW: From either side of the aisle …

DS: Absolutely. It’s poison on both sides. Poison across the spectrum.

GW: That explains why it’s not being 6 GeneWatch

addressed in a legislative way, but does it seem to carry over into agency rules and state and local policies?

DS: Yes, because these are not regulations that would ever sneak under the radar. This is too politically charged.

It’s politically charged across the political spectrum in ways that can create very strange bedfellows, so you also don’t want as many folks who tend to cluster on the left, particularly people in favor of same sex marriage or same sex relationships. They don’t want the government touching the arena of assisted reproductive technologies because they understandably fear that it allows for government intervention in the question of who can have children. You have those on the far left who don’t want to touch this, and then those on the right who don’t want to touch it because of their concerns about abortion, so there is no political constituency in favor of reform.

I would add one more piece. There are also the parents who become involved in this area; they don’t want regulation because when they’re in the reproductive center, all they want is babies. They don’t see the government as a way to get there. So if the parents in the process don’t want regulation, the industry doesn’t want regulation, and there is no political constituency pushing for regulation, there’s really no voice for regulation … with one exception. We are starting to see flickers of a movement made up of the grown children of assisted reproduction, and I suspect that it will grow much, much louder.

In particular, we’re seeing that children who were born of sperm donors are increasingly fighting to have some sort of way of identifying their genet-

ic fathers. And I think that’s just the first wave: this is the first generation of grown-ups who were born through assisted reproduction.

GW: As you’ve pointed out, this is a multi-billion dollar industry. What sort of sense do you get about where the money is ending up? Who is getting rich off of this, if anyone?

DS: Reproductive doctors. The doctors and their intermediaries. There is an utterly unregulated group of egg donors, egg brokers, surrogacy brokers; they are truly a new sector of the market. They’re making money, the clinics are making money, and the companies that make the drugs are making money. None of which, let me underscore, are necessarily bad.

People make money doing all kinds of things, like creating cancer drugs. I don’t think the fact that people are making money is bad at all. I do think it is bad that there is less regulation in this area than in other fields of medicine where people also make money.

GW: The Baby Business came out in 2006. Do you have a sense of how much has changed since then?

DS: My sense is that there have been two major trends. When we hit the economic downturn, it appears that there were fewer people who could afford or were willing to pay the expenses to go into the assisted reproductive market, although I suspect that may be ending now. By the same token, though, there were also reportedly increased numbers of women interested in donating their eggs for the same reason. And then the other main trend, of course, is as same sex marriage becomes more June-July 2011

socially and legally accepted, I think that we’re going to start seeing the same sex part of this market steadily increasing. It’s already increasing very very rapidly, but obviously, for gay men, if they want to have a child together, they almost certainly have to go into the reproductive market to some extent—especially since it’s become harder and harder for them to adopt children.

GW: So would surrogacy be the most common way to go about this?

It’s really the only way. And adoption, but as I said, that’s being cut off. And surrogacy is almost most certainly the most expensive way to acquire a child.

GW: Do you mean that that is how much someone gets paid to donate an egg or how much it costs to give the egg?

If you are never paying the mother for the child, you are not buying a baby.

What you are doing is paying all of the intermediaries in the process.

DS: That’s how much the donor will get paid per harvest. So the price of that egg to the purchaser will be higher because it will include that cost, obviously, plus whatever the egg broker is making, plus the cost of whatever you do subsequently with that egg, whether it is then frozen, whether it is made into an embryo.

That payment to the donor is only your, if you will, input cost.

GW: Is a lot of that international?

GW: Out of all of the different things you looked at, what are some of the most egregious practices that you came across or that are actually happening?

GW: In terms of cost, how does surrogacy compare to other options, like egg donation or adoption?

DS: It’s purely additive. If you’re doing surrogacy as a gay couple, you have to buy eggs because you don’t have your own. And you have to go through IVF because you have to put those eggs together with sperm. And you have to hire the surrogate. So you’re doing every single piece of it, whereas if it is a heterosexual couple, they don’t have to do all of the pieces, depending on what the circumstances are. But gay couples have to basically buy everything— aside from sperm, which is the cheapest part of the equation.

GW: How much does an egg go for?

DS: Anyone who sits on a college campus as I do will see ads in the back of newspapers that cluster around $25-30,000, particularly at the elite colleges—although the ASRM (American Society for Reproductive Medicine) guidelines are much lower.

DS: Yes. Adoption is basically regulated at every level. In the United States, it’s mostly at the state level if you’re adopting domestically, but if you’re adopting internationally, one has to go through state level regulations and national regulations, and the regulations of the target country, and The Hague, which is the international overseeing body.

GW: You also write about when efforts to get a baby can approach actually selling babies. Is there a place where you draw that line? How does that happen?

DS: I think that this is a semantic distinction, but it is an important one.

Adoption isn’t baby selling. The laws here are quite good. As compared to assisted reproduction, adoption is very heavily regulated. It is illegal to sell a baby, and if people are caught, they go to jail or they pay huge fines.

So people aren’t selling babies. What they are doing is they are paying intermediaries to help them acquire a baby. So the great irony here—and I’m not sure if it’s a bad thing, but it is somewhat ironic—is that what is illegal is paying the mother for the child.

DS: Well, I think that the most egregious umbrella, if you will, is that what gets lost in all of this is a consistent focus on the health of the mother and children. There are not, in my mind, sufficient studies of what the long-term implications may be of assisted reproduction on the health of the mothers, the donors, and the children. There may be trust that everybody is fine, but we don’t have the data yet to confirm that. And that, in my mind, is really the most egregious set of practices, because it includes things like transferring way too many embryos at once. There is no cap on the number of times women can go through massive hormonal stimulation. And I think that those are the very egregious practices—not the money side.

GW: How do the customers, so to speak, the couples or the single parents who desperately want a child, but can’t have their own… How do they find their way to these sorts of continued on page 9

Volume 24 number 3

GeneWatch 7

21st Century Parenting Is the increasing use of assisted reproductive technologies molding a new kind of parent?

My older son was born in the first year of the 21st century; his brother came a few years later. Since then, assisted reproductive technologies such as in vitro fertilization have helped hundreds of thousands of infertility patients become parents. I have many friends and family members who have built their families using IVF, almost too many to count.

There’s plenty of data showing how prevalent these technologies have become. The Centers for Disease Control reports that over 1% of all births in the United States occur following the use of ARTs. In some pockets of the country, the rate is clearly much higher. For parents like me, living in affluent urban neighborhoods, the anecdotal evidence is clear. Parents talk openly about their struggles with infertility and exchange stories and advice.

Women and men well into their 40s or 50s push infants in strollers on the weekend; several I know joke about being mistaken for the baby’s grandparent. And although the rates of multiples born through IVF have decreased somewhat, there are a noticeable and statistically surprising number of twins in the preschools and on the playground. The demographic snapshot of modern parents and families has been transformed by ARTs. In the 11 years since I became a parent, I see another transformation as well. We live in a post-9/11, economically uncertain, StarbucksVenti-fueled world. Like it or not, we have constant electronic access to news, information, and gossip. We are captivated by—or captives of—

8 GeneWatch

websites, listservs, Twitter, Facebook and our smartphones. At any moment in time, we have complete access to more information about our children, our communities and our world than our own parents could possibly have dreamed of accessing in a lifetime. There is plenty to worry about, and we hear about it all, relentlessly.

I believe these 21st century conditions have contributed to a new style of parenting: parents who are deeply, perhaps overly involved in managing every detail of their children’s lives in an effort to protect them from real and perceived harms, and provide them with every possible benefit.

“Helicopter parenting” describes the hovering and circling that these modern parents feel compelled to do, even after their kids grow up and head out on their own.

Is there interplay between the increase in the use of ARTs and the emergence of this 21st century parenting style? I have heard both fellow parents and IVF providers describe a phenomenon that goes something like this: “The IVF patients make a decision to pour everything they have into having a biological child, including sometimes-extraordinary financial resources. They feel like they are losing control in turning to ARTs. Some have a sense of entitlement that goes along with putting in the cash and effort. These are probably the same parents who later give and do

BY SUSANNAH BARUCH everything to try to manage every detail of their children’s lives to ensure a perfect life: from exclusive preschools to intensive music lessons and tutors, to the parents who call their children’s college professors to complain about grades.”

Maybe. My view is that while the experience of IVF may take this kind

June-July 2011

of toll on some parents, the usual toll isn’t that it turns them into relentless worrier-warrior parents. Really, it is more likely to turn them into exhausted piles of mush—mush that mutters, “I might be too old for this” while chasing twins.

I do understand why helicopter parenting may look like a related phenomenon. That is, I believe that all parents want “the best” for their kids.

IVF requires a level of affluence to begin with; thus, affluent parents of IVF kids may be more likely to be able to provide for their children in

tions of what it means to be—or to raise—a boy or a girl. Perhaps it needs to be gently suggested to these parents that choosing a child’s biological sex does not guarantee who that child will be.

The flip side of sex selection is another story I hear often: couples who, having finally succeeded in conceiving using IVF, surprise their doctors by refusing standard prenatal testing. They don’t want testing for chromosomal issues such as Down syndrome, because after trying so long to have a child they are going to

Preference for either sex are rooted in parents’ own rigid expectations of what it means to be a boy or a girl. Perhaps it needs to be gently suggested to these parents that choosing a child’s biological sex does not guarantee who that child will be. more obviously expensive ways.

However, we shouldn’t forget that parents without many resources also pour what they have into helping the next generation succeed and prosper.

We see that in the United States in patterns of immigration going back centuries.

There are some parents who do seem to approach ARTs with the expectation that the technology can give them exactly the child they choose. The best example is sex selection, where parents seek out pre-implantation genetic diagnosis in order to choose whether they are going to have a boy or a girl. In this case, the technology enables the parents to think they can control who or what their children will be.

Many people assume that sex selection happens only in traditional families and cultures where there is a strong bias towards having a boy. But preferences for girls appear to be at least as common in the United States, and preference for either sex are rooted in parents’ own rigid expectaVolume 24 number 3

welcome that child no matter what.

They don’t feel the need to know, let alone choose, the sex or anything else about the child. These parents talk about how they have waited so long for a child, that their only remaining “goal” is to relax and enjoy the parenting experience, and support their child simply for who he or she turns out to be.

We should not restrict reproductive options or limit access to technologies like IVF or PGD. But whatever motivates parents to seek sex selection, or to micromanage every detail of their children’s lives, we should consider another model of parenting—one that involves taking a deep breath. In this age of too much effort to control our unpredictable world, let us all strive to shift our emphasis from “What kind of child do I want?” to “What kind of parent do I want to be?” nnn Susannah Baruch, JD, is the Policy Director and Consultant at Generations Ahead.

continued from page 7

places?

DS: Like everything else, these days; it’s all online. It’s online, and then there are support groups, and list servs, and all of these wonderful things we’ve discovered and created.

GW: What do you think that the government or other actors need to do to address some of these bigger problems? What kinds of regulations would you like to see and what can be done aside from regulation?

DS: I say this with the caveat that I don’t think it is particularly realistic, quite frankly, but I think that we could have a minimal set of regulations at either the state or federal level—I think that the state is more likely—that would really bring some of these practices in line with current regulations that we have in the general medical area; in the case of egg donors, bringing it in line with the kind of regulation that we have for other people who donate organs, blood, other body parts, even sperm.

Sperm donation is much more heavily regulated than eggs.

The other thing I would really push for if I had the magic wand would be just to begin a basic process of data collection. There was one piece of legislation some years ago which does collect data from the fertility clinics.

That’s a good thing, and I think that if we had a similar set of data on the children who were born through these practices and the women who undergo them, I think that would go a long way toward at least giving us the information to start to understand whether or not there are any longterm medical implications. And it would also give us the ability to allow children born from these practices to find their genetic parents if they choose to as they get older. nnn

GeneWatch 9

Commercial Surrogacy in India Women in India risk more than their health by becoming surrogates

BY VRINDA MARWAH

paradigm. Their body is their many surrogates spending the term resource, and its use to earn money of their pregnancy in surrogate hosimpacts their lives in complex ways. tels (such as in Anand, a town in the Feminist thought and action walks a western state of Gujarat), away from thin line between questioning and their families and communities.

In recent years, the sharp growth respecting women’s choices, and as Surrogates may want to keep what in commercial surrogacy in India such, this article is an attempt to they do secret, as reproduction is has drawn much attention and deepen our collective understanding considered acceptable only within marriage; taken outside the domesraised several ethical concerns. of the choices women make.

Surrogacy, the practice of gestating a Reproduction, and its more recent tic sphere of family, childbearing for child for another couple or individ- avatar of technologically assisted financial gain may be seen as ‘dirty ual, involves the use of various reproduction, is a site of assisted reproductive technologies inquiry that feminists have “I told him (doctor) I didn’t have work, my (ARTs). India’s fertility industry is an dislodged from the children go hungry, my husband gets only Rs integral part of the country’s domain of the strictly bio- 3000 (US $65 approx) a month and we have expanding medical market and med- logical, medical, private four children to feed. I told him I would do ical tourism industry, within which and the familial. Feminist whatever work there was, whatever work he commercial surrogacy is often por- critiques of surrogacy have would ask me to do.” -Rashmi,* a surrogate trayed as a win-win situation, seen highlighted that the ART to give “desperate and infertile” par- industry lies at the intersection of work,’ ‘baby-selling’ or ‘womb-rentents the child they want, and poor patriarchy and market, wherein ing.’2 For this reason, some argue surrogate women the money they these technologies meet rather than that altruistic surrogacy is more than commercial. need. This article will bring a femi- question the pressure on women to acceptable nist health lens to bear on the prac- be mothers. Surrogacy is able to However, altruism has also been an tice of commercial surrogacy in push pregnancy from the private to area of much contest and debate.

India, thus highlighting that ethical, the public, from care to work, and in Notwithstanding the impossible economic and political questions are doing so, is able to destabilize the question of how the “emotional” contained in issues commonly ‘destiny’ of women’s biology, and quotient or the “charitable” feeling in regarded as personal. Surrogate indeed gender itself; yet the body in any relationship can be determined, women are engaged in a constant surrogacy is more a survival tool it must be recognized that altruistic surrogacy is hardly without coercion and shifting negotiation with their than an easy, happy right. realities, which reveals the agency Commercial surrogacy remains or its own power dynamic, particuthey exert even within a restrictive highly stigmatized in India, with larly in the South Asian context. It is unlikely to be completely benevo“Actually, the surrogates do not disclose that they have been insertlent, and in many ways it renders ed with someone else’s sample. They tell everyone that the child is women more vulnerable than comtheirs. Do you know how Punjab (a north Indian state) is? They think mercial arrangements that carry the this is wrong. After the child is born, some say it expired, some say same health risks but at least provide they gave it away to a friend or relative. You know this is Punjab. It is some compensation. not how it might be in a country outside somewhere.” -Navneet,* a The commodification of the body surrogacy agent in surrogacy is clear: the child “…exploitation and opportunity are bound and wound up in one.”

- Betsy Hartmann1

10 GeneWatch

June-July 2011

“First of all, she should be between 25 to 30 years of age. Her family should be complete. She should be good-looking. Her brain should be okay. She should be educated. It cannot be that the one who is taking the child is very fair, and the surrogate is very dark.”

- Dr Sumitra,* an embryologist-cum-counselor at an IVF clinic

for labor. In particular, women now find themselves pushed into more informalized jobs such as export zones and the service sector, where there is a demand for their cheap, “docile,” even “sexualized” labor.5 becomes a product of the arrange- of a high reproductive technology and A case is thus made to consider ment while the woman’s body, a low-tech work force.” -Goodman commercial surrogacy as “a new kind specifically her reproductive labor 2008 of labor—gendered, exploitative and or organs, become a resource. The stigmatized labor, but labor nonetheThe political economy context of less.”6 In the Indian subcontinent questions one must ask are: Is the body a legitimate resource? What of women’s labor under globalization today, women who are garment workthe accompanying objectification presents a picture of informalized ers, sex workers, and surrogates, are and exploitation that poses serious and sexualized labor that is inatten- engaged in contemporary and comthreats to the health and rights of tive to women’s rights and health, mercial forms of sexualized and while also destroying indigenous reproductive labor—all of which were women?

In answering these questions, we livelihoods and rolling back state generally, traditionally considered can draw from the sex workers’ investments in social economically non-prostruggles and sex work debates. Do security. With the “Yes, I have ductive, apart from we not posit in our political and ana- onset of globalization, something in mind being seen as dignified lytical lives a mind-body dualism, India’s economic poli- when I look for a only if domesticated. albeit couched in feminist vocabu- cy has shifted away surrogate. I see Surrogacy in particular centralized that the family is is boosted by both lary? As such, are we guilty of invok- from ing moral rhetoric particularly when industries and manupoor.” domestic and internathe bodies of poor women are in facturing units, and -Navneet* tional demand, because focus?3 Shah (2009) argues that sur- towards new indusof India’s cheap rates (as rogacy must be understood as “a tries that operate with minimum compared to the West); lack of regupossible choice, restricted but made regulation and controls, including lation of ART clinics; easy availability with dignity, knowledge and conof surrogate mothers and egg donors; sent.”4 However, does an admission and to match specifications such as that surrogacy is a ‘legitimate’ choice skin color. satisfy all political and ethical conA ban on surrogacy has been cerns associated with surrogacy? It opposed on grounds of practicality is, after all, in and through our acts or principle. The rights of infertile, of agency and choice that we conas well as gay/queer individuals and tribute to the functioning of heterocouples to have their own biological children through surrogacy may also “We don’t find any other work. There be seen as reproductive rights. We is no work in the village. We poor peoknow that historically, while the ferple are helpless you see. That’s why we tility of a certain section of women have taken this decision. Only if I find (e.g. upper class, white) is encourother work will I do other work.” aged, the fertility of another (e.g.

Sunita,* a surrogacy candidate poor, third world/black) is not. With normativity and patriarchy. As such, the use of ARTs by non-conformist it becomes important to view the constituencies, such as LGBTQs, compulsions and implications consingle people, and unmarried coutained in choices. ples, the potential in these technologies for subversive reworkings of the “This globalization of baby-makheteronormative family cannot be ing comes at the peculiar intersection written off. Yet, while today gay cou-

Volume 24 number 3

GeneWatch 11

ples from the global north come to “They (hospital staff) have said you need to first get selected, then we India for surrogacy arrangements, will discuss everything with you. They have also told me that there will India’s legal position on homosexube no problems. It will be like your previous deliveries… I want myself ality is being contested. Despite a to be safe and okay. I have two children, I have to bring them up. This landmark high court judgment is it. When they put in the sample, this is what I will pray to God for. decriminalizing gay sex in 2009, a I will ask the doctors also. My body should not become weak. My Supreme Court challenge is underhealth should remain good.” -Sunita* way. The proposed legislation for the regulation of the ART industry is that sold a girl twice in three years to ever produce provisional generalizaambiguous about whether ARTs can bear children for childless couples, tions, even as the theorist realizes the be accessed by gay couples at all. and has been the case more recently crucial importance of their persistent Thus, transnational movements in Thailand, where Vietnamese production.” must be understood within internawomen were being held in an illegal G. C. Spivak7 tional and national matrices of surrogacy racket. power that allow or disallow certain As such, a section of feminist The critical question of represenflows over others. health activists in India, including tation demands some reflection Further, the dilemmas in commerSama (the authors of this piece) has here. Feminists are all too aware that cial surrogacy are all too evident. to represent the embodied expeThe possible creation of three “See, I also eat, my children also eat!” rience of another woman faithfulmothers (commissioning mother, -Kamla* ly, let alone an entire “constituenthe gestational mother, and in cy” or “class” of women, is a task case of use of donor eggs, the “I haven’t done anything wrong, have I?” considerably crisscrossed with genetic mother) has medical, eth- -Rashmi* differences in identities of caste, ical and legal implications. No taken a pro-regulation stand to put class, religion, ethnicity, race, sexucredible, long term studies on the in place a comprehensive legal ality, nationality and so on, as well as health implications of the proceframework that can address con- individual differences of position, dures and drugs in ARTs have been cerns that result from the unchecked opinion, or preference. Surrogacy done, for either mother or child. The proliferation of these technologies. poses several questions to which custody and citizenship of the child With each of the two drafts of the feminist responses have to catch up may be contested, such as in proposed legislation, the Draft both analytically and politically. As a transnational surrogacy arrangeAssisted Reproductive Technologies start, we must break out of the liberments. In the absence of regulation, (Regulation) Bill (2008 and 2010), al imaginary that thinks only in the surrogate’s bodily integrity, freeSama has critiqued the document terms of agent and victim. nnn dom and autonomy may be comprofrom a gender and rights lens, highmised; for payment too, she is at the lighting provisions that need revi- Vrinda Marwah works with the mercy of agents, commissioning sion.

Sama Resource Group for Women parents, or doctors. In more extreme and Health in New Delhi, India. instances, women may be sold or “Theoretical descriptions cannot trafficked to be surrogates. This was produce universals. They can only *Names have been changed to protect the case in an orphanage in Haryana the identities of interviewees.

The council for responsible Genetics has launched a new blog: Genetic Watchdog. Watch for regular news and commentary as recorded by crG staff, board members, and friends, and join the discussion by leaving your own comments. you don’t have to wait for the next GeneWatch to keep up with the latest events in biotechnology and ethics!

The blog can be found at: http://www.councilforresponsiblegenetics.org/blog.

12 GeneWatch

June-July 2011

IVF and Multiple Embryo Transfers: Everything in Moderation An interview with embryology lab director Judy Stern

Judy Stern, PhD, is Director of the Dartmouth-Hitchcock Medical Center’s Embryology and Andrology Laboratory.

GeneWatch: What kinds of procedures does your lab handle? Who are your patients?

Judy Stern: We do IVF and ICSI (intracytoplasmic sperm injection). We also do embryo freezing. We used to do GIFT (gamete intrafallopian transfer ) years ago, but we don’t do that anymore. We haven’t done a lot of PGD (preimplantation genetic diagnosis), but we offer it. We basically do the gamut. We offer embryo donation and surrogacy as well, and other things that are out there, but a lot of the procedures like that we do less frequently than just standard, bread and butter IVF. GW: And when you say bread and butter IVF, you mean a couple comes in and …?

JS: They use their own gametes, so we take the eggs from the woman and the

Volume 24 number 3

sperm from the man and mix them together and they go back to the same couple. We do some donor eggs, sperm and embryos, but for the majority of what we do, the intended parents are also the gamete donors and the gestators.

GW: It seems like a lot of the talk about success of IVF and a lot of other assisted reproductive technologies focuses on success rate in terms of live births. How do you measure the success of the procedure that your lab carries out?

JS: We look at live birth rates, we submit our numbers to the CDC and to SART (the Society for Assisted Reproductive Technology) the way most other programs do. We’re always evaluating live birth rates per cycle, per retrieval, and per transfer. Those numbers tell us different things. Live birth rate per cycle gives us an overall success of the procedure. Live birth rate per retrieval gives us more information about what is happening at the laboratory level. And live birth rate per transfer tells us about the quality of our embryos.

GW: Do you have any way of tracking what happens down the road after people leave the lab?

JS: We don’t specifically. We know whether or not there are live births, but we don’t track long term. I’m presently involved in a study, the Infertility Family Research Registry, an NIH-funded project in which we are trying to recruit volunteers nationwide who’ve been fertility patients to look at the long term health of women and children from these procedures; but we don’t do that specifically with the patients that we have here. From the clinic perspective, that is a massive undertaking. We have a lot of trouble just keeping track of the people who have frozen embryos here, truthfully. And to track people— who very often don’t want to be tracked, by the way—is a whole other endeavor.

GW: About how many embryos do you suppose you have at the lab at any given time?

JS: Hang on, I’ll look it up … seven

GeneWatch 13

hundred and fifty two embryos.

embryos transferred, can you say no?

to understand that is really critical.

GW: You’ve mentioned that the goal of IVF is the delivery of a single healthy child. Can you explain where that goal comes from, and have you run into much opposition pushing for it?

JS: Yes, we can, and we do.

GW: You also do a lot of work with SART. What’s your role there currently? You’re the research chair, is that right?

JS: We want a single healthy child because multiple pregnancies are much more risky than single pregnancies. So what we’re trying to do is have singleton pregnancies be the result of our procedures—not even twins, and certainly not high order multiples.

We’ve gotten better about higher multiples; twins, less so. We’ve had a fairly high twin rate, which on the one hand means that we’re making very nice embryos; when we transfer two, we often end up with two. But we don’t want that. We’ve really been pushing lately to go down to single embryo transfer, but it’s very difficult, particularly in New Hampshire, where we don’t have mandated coverage. You have patients who come in and are paying out of pocket. They have one chance to do a cycle. They’re sitting there with two beautiful embryos. We can’t tell them that both of them are going to be good and maybe one will be and the other one won’t be… so which one do you transfer? There’s a lot of push back from patients who very often are saying that they want to have both of them transferred. We’re very careful, and we stick within the ASRM (American Society for Reproductive Medicine) guidelines.

We never transfer more than two, for example, in women under thirty five.

But when it goes from two to one, it becomes very difficult sometimes to convince patients to do that. We’re working very hard on that at the moment. We’re offering it to everybody and we’re pushing it especially for people who have good quality embryos.

GW: If a patient asks to have six 14 GeneWatch

GW: At what point can you say no?

JS: We tell them that right up front.

We tell them that we follow the national guidelines, so six is actually out of range of the guidelines at any age. We actually give them a table with the national guidelines and say, “These give you the max that we will do in whatever age category, and if the cycle has gone well and the embryos look good, we’re going to recommend transferring the lower end of whatever that range is for your age.”

GW: So for somebody who is older, the range is higher?

JS: The range is higher, yes. We might transfer three or four in somebody 40 years old, which we would never do with someone under 35, but we stick within those guidelines. I mean, we are always willing to transfer fewer if somebody wants to transfer fewer, and there are occasionally patients in the older age ranges who say no, that they wouldn’t want multiples no matter what. That’s great, but that’s not the way the conversation usually goes. It’s usually the reverse.

GW: What do you do to convince people? How do you convince someone to do a single embryo transfer if they are, say, 30 years old?

JS: I think that discussing the risks of multiple pregnancies and making that real to people is what is really important. People very often think when they go through this, when they’re trying to have a child, that it looks as though having two at the same time would be great. Then they’ve gone through it once, they have their family and they’re done. What people don’t always realize is how risky those pregnancies can be. I think getting patients

JS: I was the research chair for five years, and I’m still on the research committee. I’ve done a lot of work with that and what we did, and are still busy doing, are a lot of studies on outcomes of ART looking at different categories of patients. We did a whole set on obesity; we’ve looked at patients’ outcomes related to number of embryos transferred; we’ve looked at trying to maximize pregnancy rates while minimizing multiple rates in older patients by looking at the characteristics of patients and what we’re transferring and that sort of thing.

We’re also involved with several grants right now. We’re trying to link information from the SART core data base to existing vital record information. For example, in Massachusetts, we’re working with a group at Boston University and the Massachusetts Department of Public Health on this.

We have two NIH grants with them to try to look at long term health of children from ARTs and to compare that to subfertile women and fertile women within Massachusetts. What we’re really trying to get a handle on is long term health of kids after these procedures, which unfortunately we know less about than we would like to know.

GW: Are there any procedures which seem to be particularly risky or that you would have some reservations about going through with?

JS: Well, there’s always concern about newer procedures when they come in.

I mean, when we first started doing ICSI (intracytoplasmic sperm injection), there were concerns about whether or not it was an increased risk, and we’re still concerned that June-July 2011

there might be a very small increased risk using this. I mean, when you think about that procedure, you’re bypassing all of the physiology of fertilization and you’re taking a sperm and putting it into an egg with a needle. You would imagine that there might be risks. So that’s something that was a concern early on. There have now been thousands and thousands of births from ICSI, and while there are still papers that indicate that there may be a risk, we are pretty sure that it’s fairly low.

But, you know, that’s still a concern.

As newer procedures are brought in, there’s always some concern about this kind of thing. Egg freezing now is one that is raising these sorts of concerns—is this safe? And we’re not sure. It’s still being done under experimental protocol because we don’t know how safe that is. Egg freezing is

Every time we bring in a new procedure, there’s concern about the risk. different than embryo freezing, which we’ve been doing since the late 80s.

Egg freezing is very new. It’s just freezing the unfertilized egg, but that’s where there is some concern, even though it’s being marketed at a number of clinics for women who want to delay childbearing. They should be aware that there are some potential risks there and that we don’t know the outcome of these procedures.

In vitro maturation is another one of those. It involves taking immature eggs from the ovaries and maturing them in vitro. Currently we give women lots of hormones to make multiple mature eggs in their follicles and we retrieve the eggs at the mature stage and use them for IVF; with in vitro maturation we don’t do the hormone manipulation, or we do a minimal hormone manipulation and get the eggs out at an immature state and grow them up at the laboratory. This Volume 24 number 3

means that they’re spending a lot more time in the laboratory, and it also means that the maturation process may be modified in some way from what it is in the body, in vivo. We don’t know what the risk of that is yet, even though that’s now being used a little bit more than it used to be.

So every time we bring in a new procedure, particularly new laboratory procedures, there’s concern about the risk. It’s kind of a Catch 22 in some ways, in that we can’t really learn about the risk in people—assuming we have reasonable animal studies on all of these, which we usually do—until we really do it; and we can’t do it, or we don’t want to do a lot of it, until we know what the risk is. So we end up in a situation where if we really think it’s valuable, we have to move forward cautiously to begin with. One of the things that we should include in that caution is human subject approval and the full consent of patients who realize how new the procedures are. But we won’t learn about it unless we do it, you know … and we can’t do it unless we overcome some of that caution.

GW: Another part of what SART does is create guidelines for assisted reproductive practices.

JS: Yes, most recently in 2009. Every couple of years, they come out with slightly lower numbers.

GW: You mean a slightly lower number of embryos?

JS: Yes, telling us to transfer fewer.

Which is good. Keep in mind as I’ve been doing this for twenty five years, when we first started going this, the success rate was about five percent per cycle nationally. And over the past twenty five years, we’ve gotten much, much better at keeping embryos alive and in good condition and at the point where they will implant. As we get better and better and better, the number that we’ve wanted to transfer has

gone down.

GW: But these are still just guidelines, right? They aren’t actually enforceable?

JS: They’re not laws. In some countries, the number transferred is legislated, but not in this country.

GW: So, do you think that there’s good reason for it to be regulated here?

JS: Well, I have concerns about anything that goes to a legislature in this country, given the state of our political system. I think that a much more effective way of dealing with this would be for insurance companies to recognize that covering IVF with a limitation on the number of embryos transferred makes far more financial sense to them than what they are doing now, which is insisting that people do multiple cycles of intrauterine insemination (IUI), where we have no control at all over multiple births, before they do IVF. And insurance companies may pay for some of the IVF procedure or not pay for any of it, but they end up paying for all of the neonatal intensive care unit (NICU) costs. They pay all of the NICU costs for multiple pregnancies, yet they won’t, for the most part, come out with policies that say that “We’ll pay for five or six cycles of IVF if you only transfer one embryo at a time.” That makes a heck of a lot more sense to me than laws or any other way of doing it, and I think that it would make a huge difference in the multiple rate in this country because, as I said, one of the driving forces behind patients’ desire to transfer more embryos is that they’re paying out of pocket. So they pay for IVF out of pocket and transfer multiple embryos, then they end up with a million dollars in NICU costs that are paid by the same insurance company that refuses to pay for the IVF. That just doesn’t make any sense nnn to me.

GeneWatch 15

The Fast and the Furious Why so many are troubled by the clinical implementation of non-invasive prenatal genetic diagnosis

BY LORI HAYMON Non-invasive prenatal diagnosis, or NIPD, is scientifically groundbreaking. It completely eliminates the risk of miscarriage, which has been associated with prenatal genetic diagnosis for the past forty years.2 Based on the discovery of cell-free fetal DNA, researchers are now able to diagnose disorders and disease from just 10 ml of blood, and as early as 6-10 weeks after gestation.3 With the development of faster and more comprehensive DNA analysis, NIPD is projected to become the earliest, most comprehensive, and least expensive means of prenatal genetic diagnosis.4 So why are so many scholars concerned by the prospect of clinical NIPD?

The ethical and social implications of NIPD are as extensive as its promised applications. Scholars and advocates from various fields argue that NIPD will not only exacerbate current ethical issues in prenatal diagnostic and screening, but it will also create entirely new issues. NIPD, some contend, will erode informed consent, blur the line between medically necessary and non-medical fetal testing, obviate the disability rights movement, undermine disability treatment efforts, and reshape consideration of reproductive freedom. Some scholars have gone so far as to call NIPD a sham and a coverup for modern-day eugenics.5 Increasing fetal sex preference in the U.S. Fetal sex determination is generally not for medical reasons.6 Instead, even in the U.S., the more common reason for pre-conception and prenatal sex determination is preference.7 The application of NIPD to fetal sex determinations means faster decisions, and potentially rash and irreversible decisions.

Most studies in the U.S. conclude that the majority of Americans prefer either the same number of children of either sex, or have no preference at all.8 Still, a “fundamental dynamic between technology and culture” exists, which is able to “coax cultures one way or the other by making it easier” to do

16 GeneWatch

what was difficult before.9 To this effect, one study on sex preference in the U.S. has already shown that technology can affect these currently held values.10 Confronted by a hypothetical pill that would simplify and ensure fetal sex, respondents in this study changed their views on using preconception sex-selection technologies.11 Once the hypothetical pill was introduced, respondents willing to use sex selection technology increased by 10%, and the number of respondents who answered “undecided” rose to above 20%.12 While a majority of the respondents did not change their responses, those who did reveal an affect that is very likely to be seen with the widespread use of NIPD. Certainly the cumbersome nature of prenatal genetic screening and diagnostics has acted as a “checkpoint,” providing a reason to consider whether the sex of the child, or any other trait for that matter, was really worth the additional procedures, associated risks, and expense. NIPD is likely to eliminate that checkpoint.

Moreover, many expectant parents may find themselves changing their views on what trait preferences they have and what technology they are willing to use from the comfort of their own homes.

Providing Information of questionable benefit to patients who may not be adequately “informed” Informed consent and informed decision-making are both cornerstones of medical care and medical research.13 A few of the commonly June-July 2011

agreed upon aspects of informed choice include: information about the test itself, including the limitation and significance of the results; written consent; and reflection time.14 One study, performed in the UK, found that health professionals are more likely to follow the informed consent practices associated with prenatal screening, as opposed to those associated with invasive prenatal diagnosis.15 In a multiple vignette study, researchers found that while 96% of clinician respondents indicated that written consent should precede invasive prenatal diagnosis, only 68% indicated the same for NIPD testing. Similarly, reflection time was important to 94% of the clinicians responding to the invasive prenatal diagnosis vignette, but to only 76% of those responding to the NIPD vignette.

Whether NIPD will provide medically relevant information for most conditions is also debatable. As David Litwack, AAAS Science and Technology Policy fellow, stated with regards to direct-to-consumer tests, “[i]n most cases, the results of genetic testing cannot be used for practical decisions about health care.”16 In part, this is because patients have the same options before, as after genetic tests are performed. Yes, the medical information available has changed.

But the medical actions that can be pursued have not. Patients are not being provided with additional or alternative medical courses of action - just predictive information.

As such the ability of physicians and other medical professions to make this information functional and to facilitate informed decision-making becomes imperative. According to Theresa M. Marteau and Elizabeth Dormandy, “[t]hirty years after the routine introduction of prenatal diagnostic tests we remain unaware Volume 24 number 3

of how women are counseled, the information and support they receive, and how this affects the quality and type of the quality and type of decisions they make.”17 So whether patients will even benefit from the “information explosion”18 that NIPD promises is uncertain.

Reinforcing the current genetic testing trends of faster, rather than accurate results Moreover, despite confident promotion by researchers and providers, NIPD is not fully diagnostic. It is limited to identifying only paternally derived, or de novo genetic mutations.19 Nor is NIPD less expensive than current invasive testing20 – in part because isolating cellfree fetal DNA from the maternal serum is a “significant technical challenge.”21 Fetal cell-free DNA, which is the basis of NIPD, is outnumbered 20 to 1 by cellfree fetal DNA belonging to the pregnant woman.22 This also affects the verification and confirmation of NIPD. Thus far, NIPD results have only been verified through the use of amniocentesis and CVS.23 But verification by the very technology that NIPD is supposed to replace would directly negate its benefit, and is highly unlikely to transition to the clinical setting. If NIPD is to be clinically implemented some procedure for confirmation is necessary, however, because NIPD has yet to reach diagnostic-level accuracy.24 In future developments of NIPD, researchers and developers are likely to find solutions to all of the listed limitations. What is troubling is that NIPD may be implemented clinically long before they do.

NIPD may become the standard of care for prenatal diagnosis, whether it reaches diagnostic-level accuracy or not.25 For one thing, novel diag-

nostic tests can be introduced into the clinical setting without outside regulatory requirements, as long as they are developed and validated by the original providers.26 Some applications of NIPD may bypass clinical validation completely by being offered as direct-to-consumer products. However, the DTC market has been anything but accurate in its promotion of valid testing results. Just last year, investigations by the United States Government Accountability Office (GAO) found that “identical DNA samples yield contradictory results,” leading to their conclusion that DTC test results are misleading and of little or no practical value.27 Like any other genetic test, NIPD

will provide “predictive,” not “certain” tests results. But NIPD is likely to be even more misleading, if for no other reason than because of the impression of accuracy that submitting blood (as opposed to saliva) carries.

Moreover, prospective parents may be more vulnerable and more likely to “seek a conclusive determination as to whether they are going to have a healthy baby.”28 The prospect of pregnant women making irreversible decisions based on inconclusive NIPD information is unacceptable.

Reshaping reproductive freedom Developers and supporters of NIPD often describe the procedure as a corollary right flowing from the right to an abortion, a means of providing “prospective parents [with] preconception or prenatal information about the genetic characteristics GeneWatch 17

of offspring, so that they may decide in a particular case whether or not to reproduce.”29 Indeed, clinicians are legally obligated to provide pregnant women with all sufficient information necessary to make informed reproductive decisions.

NIPD fits well into the current goals for advancing a woman’s right to reproductive choice. But it is also likely to reshape current conceptions of reproductive freedom, raising new dilemmas for both pro-life and prochoice communities.

“Pro-choice” may be defined as the recognition and defense of a woman’s right to self-determination regarding sex, sexuality, reproduction, and motherhood; and the promotion of equal access to abortive services, reproductive services, and sex education. The National Abortion and Reproductive Rights Action League (NARAL) webpage advertises its belief “in reducing the need for abortion” by way of “improving access to birth control and teaching young people comprehensive sex education.” Clinical implementation of NIPD raises new questions. Will sex education now include genetic inheritance and disability if women will be routinely confronted with decisions based on prenatal genetic information? How different is the issue of choosing to have this pregnancy, and choosing to have this particular pregnancy?30 To what extent does trait-selection abortion coincide with being pro-choice? And is a “healthy pregnancy” destined to become a list of wanted versus unwanted traits?

For the pro-life community, NIPD brings to the forefront the question of whether one should bear children with life-altering or life-threatening genetic conditions. It may also shift the pro-life focus away from the usual adoption alternative. NIPD will most often be used by expectant mothers of higher income, whose motivation for considering abortion 18 GeneWatch

may not be “whether a woman can raise this child,” but rather if this is “the child she wants to raise.” Hence, the usual adoption alternative (i.e. bringing the pregnancy to term and putting the child up for adoption) will no longer suffice. NIPD may also “normalize” abortions based on prenatal diagnostics, and according to some, trivialize any significance associated with terminating a pregnancy.

That “[e]very pregnancy becomes a ‘tentative pregnancy’ pending the results of prenatal screening,”31 seems to be the eventual result of NIPD. Wherever one stands on the prochoice, pro-life debate, NIPD will change the medical context in which women make reproductive choices.

As one commentator notes, “[e]ach accurate detection presents the possibility of aborting a very sick fetus,

which, if born, could cost its parents (and its parents’ insurer) large amounts of money. Thus, the medical necessity standard may be a moot point when it comes to coverage of [NIPD].”32 That NIPD provides a benefit to third-party payers is also troubling.33 In light of these observations, the question must be asked whether NIPD will provide a woman with information that she can use to make her decisions, or information that makes the decision for her. As George Annas states, “[w]hen non-invasive prenatal genetic testing is available and reasonably priced, there will be tremendous pressure from many sources to use them.”34

Exacerbating the tensions between disability rights and prenatal diagnosis Although the general consensus is that “the purpose of prenatal testing is to enhance reproductive choice for women and families – not to decrease the number of children with disabilities who are born,” it is difficult to ignore the “tension between the goals of enhancing reproductive choice and preventing the births of children who would have disabilities.”35 The long history of invidious discrimination against persons with disabilities rightly instructs fears about continuing developments in prenatal genetic diagnosis. Like discrimination generally, prenatal diagnostic testing focuses solely on a specific trait, allowing that trait to stand in for the entire worth of an individual.36 Disability advocates argue, among other things, that prenatal diagnosis techniques reinforce the medical model that disability itself is the problem to be solved.37 NIPD is certainly part of a medical model that focuses on “solving the problem” of disabling genetic conditions. And even in the situation where test results are used merely to prepare for having a child with a disability, testing may still “send the message that there’s no need to find out about the rest”– whether or not the trait is present is all that matters.38 Many, if not most, of us would have trouble with the idea that “someone like you will never be born again.”

With NIPD, the option of early termination not only means that someone with Down’s syndrome, or TaySachs, or sickle-cell anemia, may never be born again. It may also imply that someone with such a condition should never have been born.

Harriet McBryde Johnson expressed the same in her critique of the writJune-July 2011

ings of Peter Singer (a well-known fibrosis, and Huntington disease, as the widespread use of NIPD. Still, advocate of selective abortion of dis- well as, ectrodactyly, and hereditary there is a crucial difference between “preventing children from being born deafness.44 abled pregnancies): How the widespread use of NIPD with Down’s Syndrome” and “pre“He insists he doesn’t want to kill me. He simply thinks it would have will affect our perspective of disabili- venting children with Down’s been better, all things considered, to ty must be addressed. Whether NIPD Syndrome from being born.”

According to many scholars, the have given my parents the option of should be used to select against a killing the baby I once was, and to let pregnancy with the potential to have “new eugenic” movement focuses on other parents kill similar babies as such a seemingly minor genetic con- the offspring directly. Rather than sterilization, new they come along and thereby avoid dition as a missing finger or toe must involuntary eugenic techniques are based on the suffering that comes with lives also be considered. individual choice. Choices made like mine and satisfy the reasonable preferences of parents for a different Prenatal genetics and eugenics: a based on scientifically accurate screening, diagnosing, and selective kind of child. It has nothing to do slippery slope NIPD is likely to increase the fre- termination. The purpose of new with me. I should not feel threatquency of selective abortions. As one eugenic techniques is to give “parents ened.”39 power over their children that parThus, while discrimination against commentator notes, “ . . . from a dollars-and-cents per- ents cannot exercise once the chilpersons living with disabilities is no dren are born”,49 or to provide longer tolerated, the termiparents with the “discretion to nation of diseased/disselect—or not—the characterabled pregnancies is not There is a crucial difference between pre- istics of [one’s] offspring.”50 only promoted, it threatventing children from being born with Even in the most favorable ens to become common 40 How will we Down’s Syndrome and preventing children light, these goals are very diffipractice. resolve this contradiction with Down’s Syndrome from being born. cult to separate from “improving the human population by in contemporary goals? controlled reproduction and And what about “less than life-altering” genetic conditions, spective, [prenatal screening] is an decreasing the occurrence of undesuch as cleft lip, or hereditary deaf- unnecessary expense. Developers of sirable characteristics and condiness, or ectrodactyly (the deletion of prenatal testing, however, have justi- tions,”51 the very definition of eugendigits on the hands and/or feet)? The fied these unnecessary expenses by ics.

The ways in which NIPD and other account of Bree Walker Lampley, demonstrating through cost-effecwhose choice to have children with tiveness studies that such costs can forms of genetic diagnostics threaten her genetic condition, ectrodactyly, be offset to the private insurer or the our preservation of a non-eugenic and the backlash she encountered public healthcare system, provided society cannot be taken lightly. There from those who saw her choice as that enough children prenatally iden- appears to be no end to the possible “irresponsible” and “cruel,” is inform- tified with Down syndrome are ter- uses or clinical applications of NIPD. In fact, the only plateau foreseeable ing. It reflects just how far we are minated.”45 The orientation of current devel- for prenatal genetic diagnosis, now, from a consensus on the definition of opments in the prenatal field has led will be policy based. For the public serious medical conditions.41 One study of 1,481 certified genet- many to argue that technology such and policy-makers, it is important to ic professionals42 showed substantial as NIPD may lead to institutionalized recognize that each step taken overlap among what genetic/congen- eugenics.46 Other scholars note that towards more controlled forms of ital conditions were considered procreative liberty provides for the reproduction must be implemented “lethal”, “serious but not lethal”, and right not to use reproductive genet- with caution, if implemented at all. “not serious”.43 Sixty-four percent of ics, as well as the right to use repro- nnn the conditions listed as lethal by ductive genetics,47 and that we are some respondents were considered not likely to enter a situation of Lori Haymon is a recent graduate of “serious but not lethal” by others. forced genetic selection. the University of Illinois School of The “old eugenic” practices of Law, an intern with the Council for Fifty-one conditions appeared in all three categories. These conditions involuntary sterilization and confine- Responsible Genetics, and author of included Down’s syndrome, cystic ment48 are not likely to result from the CRG report “Non-Invasive Prenatal Genetic Diagnosis (NIPD).”

Volume 24 number 3

GeneWatch 19

Abuses of Women’s Human Rights in Third Party Reproduction The expansion of ARTs has serious implications for the health, well-being, and human rights of women around the world KATHY SLOAN While not on the average person’s radar, there has nevertheless been something of an explosion of media coverage of issues related to women’s reproductive capacities and biotechnology over the last decade. From specialist online publications like GenomeWeb to mainstream media such as Newsweek, The New York Times, and The Today Show, surrogacy, egg “donation,” Non-invasive Prenatal Diagnosis (NIPD) tests, and global reproductive trafficking are just a few of the issues to receive growing media and thus public attention.

When addressing these issues, it is standard practice to begin with an acknowledgement of the enormous benefit that countless infertile and LGBT people, desperate to have a child of “their own,” have received as a result of IVF and third party reproduction. In fact, the mainstream media in particular tends to emphasize the “miraculous gift of life” aspect when covering the subject matter while tending to ignore or deemphasize the very real harms and exploitation that are an integral part of these practices. For every outsourcing euphoric new parent there is a woman who has made their parentage possible through the use of her eggs, her uterus, or both.

In order to provide this “gift of life,” the woman must undergo multiple injections of synthetic hormones and other drugs along with surgery for egg retrieval or embryonic implantation that can have devastating short

20 GeneWatch

and long term health consequences, including ovarian hyperstimulation syndrome (OHS), ovarian torsion, bleeding, infection, ruptured cysts, kidney failure, stroke and even death.

Two of the most serious long-term risks are infertility and cancer, most commonly ovarian, breast and endometrial. A 2007 Institute of Medicine Report stated that “One of the most striking facts about IVF is just how little is known about the long term health outcomes for the women.” Although over a million IVF cycles have been performed in the U.S., there are no registries that track the health of the women who undergo them.

Given all these risks, it is scandalous, not to mention grossly unethical, that women contemplating selling or renting their eggs or uteri, respectively, are not provided with relevant information before they give their consent. They are not told that no long-term studies have been conducted on the health risks involved.

Many, if not most, are not aware that there is virtually no regulation of egg “donation” or surrogacy in the United States; no national registry to provide a centralized repository for records, patient follow-up and long term studies; that the commercial fertility industry has every reason to minimize the health and economic risks given the enormous profits generated. In fact, as one gazes out across this landscape of third party reproduction, the contours of both a national and international disgrace

and human rights violation are unavoidably clear.

Let’s begin in the United States.

Lured by appeals to their financial self-interest, many college and graduate students struggling to finance their educations see ubiquitous ads in campus newspapers and social media for their eggs as a risk-free cash infusion. Offers ranging from $50,000 to $100,000 for “designer eggs” from women with exceptional looks, high SAT scores or a student at an Ivy League university or indemand ethnic backgrounds such as Jewish or Asian can prove irresistible to uninformed women in need of a major income injection. From the high-income buyer’s perspective, why buy from Wal-Mart when you can shop at Tiffany’s? While the exploitation occurring here receives attention among women’s health and human rights advocates, little discussion takes place about the classism, racism, ablism and elitism that underlie this selective breeding at a price.

Surrogacy is equally problematic. It is estimated that nearly half of surrogates in the U.S. are “military wives” who represent an ideal supply source for agencies and brokers. They often survive on low incomes and tend to marry and have their own children at young ages, so the prospect of doubling their income by serving as a surrogate is a powerful incentive.

These women have few legal or regulatory protections, making them sitting ducks for exploitation and fraud.

June-July 2011

It is no coincidence that surrogacy brokers and clinics are concentrated in areas where there are large military bases. One could also point out that while the military heavily recruits from the working class and poor demographics to provide their cannon fodder for endless wars and occupations, these people are doubly exploited for their reproductive capacities by profit-driven private enterprise.

Society has barely begun to grapple with the issues surrogacy raises.

Most commonly, surrogates function as gestational carriers, carrying a pregnancy to delivery after having been implanted with an embryo. Since the surrogate usually has no biological relationship to the fetus, she has no legal claim and the surrogate’s name does not appear on the birth certificate. In many countries and jurisdictions, most notably in Europe, surrogacy is an illegal medical procedure.

But in the United States, there is no national regulation of surrogacy and its fifty states constitute a patchwork quilt of policies and laws, ranging from outright bans to legalization to “anything goes,” earning its title of the Wild West of third-party reproduction.

A few among the many issues surrogacy raises are the ethical and practical ramifications of the further commodification of women’s bodies (beyond universal sexual commodification); exploitation of poor and low income women; implications for women’s reproductive rights if embryos become legally defined; Volume 24 number 3

rights of the children produced to information regarding their genetic history and any siblings they may have who are the offspring of the donor parents; prevention and prosecution of fraud by surrogacy companies; and the moral and ethical consequences of transforming a normal biological function of a woman’s body into a commercial contract.

Surrogacy is a stark manifestation of the commodification of women’s bodies. Surrogate services are advertised, surrogates are recruited, and operating agencies make large profits. The commercialism of surrogacy raises the specter of a black market and baby selling, of breeding farms ala The Handmaid’s Tale, turning impoverished women into baby producers. Surrogacy degrades a preg-

nancy to a service and a baby to a product (an entitlement for those with the financial means to procure one). Experience shows that like any other commercial transaction, the “customer” lays down her/his conditions before purchasing the goods.

For example, some agencies insist that the surrogate be married and be a mother of at least one healthy child, be medically and psychologically fit, abstain from cigarettes, alcohol and any other drugs during pregnancy, and must agree to give up her parental rights after the baby is born. The agency arranges the contract, life insurance for the surrogate’s family should she die during pregnancy or childbirth, and life insurance or a will for the child should the contracting parents die before the child is born.

In surrogacy, the rights of the child are almost never considered. Transferring the duties of parenthood from the birthing mother to a contracting couple denies the child any claim to its “gestational carrier” and to its biological parents if the egg and/or sperm is/are not that of the contracting parents. In addition, the child has no right to information about any siblings it may have in the latter instance.

It is assumed that there is an equal exchange in surrogacy; money paid for the service rendered. In reality, the contract between the parties to surrogacy would not exist if the parties were equal. The woman must give more than her egg in order to GeneWatch 21

gestate a child, an important gender difference. Within this framework, the contract is always biased in favor of the financially secure. The freedom of the surrogate mother is an illusion; the arbitration of rights hides central social and class issues that make surrogacy contracts possible.

If the intended parents’ circumstances change during the pregnancy, or if children are born with health problems or disabilities, the infants may be left to the surrogate, abandoned or placed in orphanages in the country of their birth. Intended parents may find they face unplanned financial costs and inadequate legal protections, including difficulties in establishing citizenship for the infant in their home country in international surrogacy arrangements.

Internationally, deep regulatory divides have fueled a growing global market in which privileged individuals and third party intermediaries, who benefit financially from the commodification of reproduction, exploit low income and poor women for their reproductive capacities.

Surrogacy and the trade in human eggs in particular have become pervasive international phenomena in which women’s poverty and subordinate status throughout the world often increase their exposure to gender-based exploitation and physical harms.

As in the U.S., unequal relationships between the buyers and the women who sell their fertility organs and eggs favor the needs and desires of the intended parents. These unequal transactions, in the absence of regulation of the fertility-industrial complex, result in inadequate “informed” consent, coercion, low payments, poor health care, short and long term physical and emotional problems, and increased risk of death.

In some countries surrogates are 22 GeneWatch

separated from husbands and children for the duration of the pregnancy, imprisoned in clinics where they are stationed assembly line style in bed after bed and obediently take orders from their overseers while their own children develop psychological problems.

High rates of multiple births and infection resulting from IVF place both surrogates and babies at high risk for complications. When problems arise during the pregnancy, the wellbeing of the child is given precedence over the health of the surrogate (money talks). Care of the surrogate ends with the birth of the child even when the woman who bears the child suffers lasting effects.

An international declaration concerning reproductive exploitation is urgently needed. The practices of reproductive organ, tissue and cell trafficking and/or trade, particularly ova sale and surrogacy, infringe upon several basic human rights under international law, and are violations of international agreements on health and medical standards. The international community must recognize trafficking and trade in reproductive organs, tissues and cells as a unique kind of human exploitation.

Beyond the basic right of every individual to human dignity, enshrined in the major international and regional human rights law instruments, the trafficking in ova and surrogacy have implications for women’s rights; the right to an adequate standard of health, the right to be free from discrimination, the right to a family, and the rights of the child.

Universal legal agreements on the trafficking of ova and surrogacy should protect the basic rights and interests of the women involved.

Specifically, these agreements must take into consideration the special vulnerability of women in a patriarchal world, most particularly in the Global South. They must protect the

rights of women to be free from discrimination, to have access to adequate medical care and an adequate standard of health, and to choose the number and spacing of their children or whether they choose not to have children. They must also pay special attention to the international standards regarding voluntary and informed consent.

In 2005, following exposure of ova trafficking in Romania, the European Parliament issued an official Resolution on the Trade in Human Egg Cells and affirmed an absolute opposition to payment for ova, classifying such payments as organ trafficking. A specific resolution on the situation was issued that year as well, the Resolution on the Planned Trading of Human Egg Cells by Great Britain and Romania, which barred the granting of high fees for ova provision. The Resolution stated that such high fees amounted to the prohibited trade of human parts.

Accordingly, the Resolution concluded that this prohibited trade should be regarded as an extreme form of exploitation of women.

For millennia, women’s human rights have been abused and ignored with impunity. As developments in biotechnology facilitate the commodification of reproduction, alarm bells should be sounding about the new door that has been opened for yet further disregard and degradation of women’s humanity, wholeness, physical and spiritual inviolability.

Supporters of human rights everywhere must enjoin that universal cry: “never again.” nnn Kathy Sloan is a human rights advocate specializing in global feminism and a member of the Board of Directors of the National Organization for Women (NOW).

June-July 2011

Finding the Active Voice The challenge of developing prochoice regulation of ARTs TINA STEVENS, PAT JENNINGS,

For over forty years, assisted reproductive technologies (ART) have helped women suffering from infertility to have children. But the ART industry has grown in a regulatory void. Prolife opposition to research on embryos prevented government funding of ART but also left the field largely free of the clinical trials, peer review and other forms of oversight that often come with federal support.

In place of federal regulation, market demands and medical custom have generated unenforceable industry guidelines pertaining to a panoply of measures, including in vitro fertilization, egg donation, pre-implantation genetic diagnosis, and sex selection. Not until 1992 was federal legislation (Fertility Clinic Success Rate and Certification Act) enacted to provide information on clinic success rates, in response to charges of deceptive advertising. The Act governs a market relationship, aiming to protect consumers from low-performing service providers. However, the extent to which clinics voluntarily report “success” rates is in part motivated by a desire to protect market share. In 2005, federal regulations began to require more careful screening of gamete providers and their “products;” nevertheless, the industry group Society for Assisted Reproductive Technology continues to resist federal regulation or independent oversight of other aspects of ART. These include the number of embryo implantations a clinic may perform per IVF cycle, the number of eggs retrieved per cycle, the number of retrievals per donor, the grounds on which prospective parents may

choose donors, disclosure of donor identity, upper age limits for receiving IVF, or most importantly, the longterm health outcomes for infants, egg donors, and mothers.

For prochoice critics, keeping track of live birth rates while failing to track long-term adverse health effects on women or children does not constitute adequate regulation. Still, the road from scholarly critique to corrective action has been marked by fits and starts. Lobbying on the part of this multi-billion dollar industry is one reason for the persistent dearth of external regulations. Another has been the self-censorship of prochoice critics concerned with how criticism of ART could threaten the politics of choice: Could seeking regulation of assisted reproductive technologies be construed as limiting a woman’s right to choose? Relentless effort from the right to undo the protections of Roe v Wade makes this a very real concern.

Problematically, “on the ground” struggle against such assault and for reproductive rights occurs in a political landscape characterized by shifting positions on the role of the state.

The reproductive rights movement of second-wave feminism emerged in an era when the state served a necessary role in protecting individual freedoms from the exigencies of a free market.

But now, the reproductive rights movement operates in a context that has turned toward libertarian policies of privatization and deregulation—a political shift that valorizes a choice narrative embedded in market-based individualism while largely abandoning the idea that there is a role for the state in protecting the health and wel-

AND

DIANE BEESON

fare of its citizens. The need for securing a woman’s right to choose that found moorings in a liberal state experimenting with health and welfare programs plays out quite differently in a techno-libertarian context where radical individualism denies the interconnectedness of human relations. In the stillness generated by having to walk the razor’s edge between choice and social justice concerns, targeted action for addressing pressing issues—such as the inadequately researched health risks associated with egg harvesting, the often exploitive social contexts of surrogacy, or the troubling implications of sex selection—has been pursued hesitantly.

The exploding demand for women’s eggs and the rapidly expanding market in reproductive tourism, however, is calling forth reinvigorated prochoice activism. Progressive prochoice activists are creating new political framings not by “top down” theorizing but through “bottom up” pragmatic engagement of concerns on an issue by issue basis. In addition to op-eds and letter-to-the-editor writing, activists have testified before state and federal legislatures, held press conferences, engaged in public speaking, presented in classrooms, featured movie screenings, produced YouTube videos, initiated letter writing campaigns, circulated petitions, sought United Nations declarations, submitted amicus briefs, and introduced legislation. California's 2006 SB 1260, for example, promulgated minimum safety standards for women who may donate eggs for privately funded research, and California Assembly Bill continued on page 29

Volume 24 number 3

GeneWatch 23

Egg Donation and Eggsploitation An interview with filmmaker Jennifer Lahl Jennifer Lahl is the creator of the film Eggsploitation.

GeneWatch: While you were researching and filming Eggsploitation, what sense did you get of why women decide to donate their eggs in the first place? You looked primarily at North America; is it different in other parts of the world?

Jennifer Lahl: If you look at what’s happening in Eastern European countries, it is largely poor women who are selling their eggs because they need money. If you look at the women who donate eggs in the United States, they are often doing it to make money, but by world standards they are by no means poor. In some countries women are selling their eggs because they are trying to pay rent and put food on their table, whereas here in the United States it’s more likely to be the college age student who has a lot of student loan debt and is looking at an unfavorable economy and job market. Although both are motivated by financial need, I would never want to say that the plight of those women is the same. “Poor” is certainly a relative term.

In the U.S., most egg donors are women in their early to mid-twenties.

They tend to be educated young women, recruited on university campuses by ads asking for someone who is tall and pretty and smart.

GW: And the specifics of those ads reflect the demands of the people on the other end, right, the “consumer” of the eggs?

24 GeneWatch

JL: Yes, they are the ones who dictate the genetic profile of the donor. They want someone who is healthy, that’s going to fit into the family photos. You’re not going to typically see, say, an African American couple asking for an Asian woman’s eggs.

GW: What have you learned about why people get into egg donation from the consumer side, as opposed to other options such as surrogacy?

JL: They often call them the “commissioning parents,” usually an infertile couple—although that’s not the case if it’s a single woman using the technologies by choice or a same-sex couple— but they typically are a man and a woman who are tired of dealing with issues of infertility. They do not necessarily want to use a surrogate due to the financial burden, and a lot of women want the experience of being pregnant, giving birth and nursing a baby, which is not available if you use a surrogate; so they are trying to use technology as best they can to mirror a natural pregnancy.

GW: Are there forms of egg donation being done that you find acceptable?

JL: I don’t see that to be the case. Look in other countries: commercial surrogacy is prohibited in Canada, the selling of human gametes is prohibited in France. In a perfect world, we would have done a whole lot of research before allowing these procedures.

That’s something we uncovered in Eggsploitation: we’ve never done any long-term studies on the risks of these drugs and procedures on otherwise

healthy young women. Is there a negative long-term impact on their own fertility? Is there a link to certain types of cancers because of taking the drug?

I’m also concerned about the environmental risk, with all of these hormones making their way into our waters and our soils and our living environments.

So how do you mitigate all of those and say, “If we could control all of those things, then I could endorse egg donation.” But I don’t see how we could control all of those variables.

There are just too many cautionary flags for me to believe that we would be able to mitigate them.

GW: Would it make a difference if it wasn’t a commercial transaction—if no one was being paid to donate eggs, but only doing it voluntarily?

Obviously there would be less of it …

JL: So they say, but they haven’t seen a decline in sperm donation in the United Kingdom after they took the money out of it. Now, it might be different with egg donation, since it’s a more onerous procedure—sperm donation can take five minutes, whereas egg donation can take several weeks. Certainly what we see in Canada is that taking the money out of it encourages more young women to fly to the United States. For example, I remember speaking to one egg broker who said at any given moment half of the donors in her database were willing to come down from Canada. Even the ASRM (American Society of Reproductive Medicine) guidelines June-July 2011

Testimonial: Egg Donation Complications list travel as one of the acceptable reasons for driving up the cost for commissioning parents. If you have an egg donor in California and a couple in New York, the couple has to be willing to pay more because they have to fly the egg donor across the country.

That’s recognized by the ASRM as a justified piece of the compensation formula.

A lot of this industry is driven by reproductive tourism. You can freeze embryos, you can freeze sperm, you can freeze eggs, and you can fly people and all the different parts all over the world to put together a baby.

GW: In the U.S., who is it that you see, politically, coming out and showing concern about egg donation and opposing it?

JL: I think this is where the U.S. is strangely strapped to abortion politics. This is why I point to Canada: it’s not such a religious nation, I don’t believe, but their laws are very restrictive here. They outlaw all forms of human cloning in Canada, not because of religion.

Here in the U.S., the media and the shareholders in the IVF industry want to make it a partisan issue—which I think is very unfortunate, because it’s not.

I work very closely with Kathy Sloan, Diane Beeson and Tina Stevens, and they might consider me a person on the right because I’m concerned about the commodification of life; but I consider this a big tent issue. I don’t know why anybody would be content with laws that don’t protect a twentysomething year-old woman on a college campus who is being offered large sums of money to do something she is told is safe, when in fact it isn’t safe, and there are short and long term lasting implications.

GW: You mentioned the media trying to make this a partisan issue. How does that rendition tend to play out?

Volume 24 number 3

The following is the story of an anonymous egg donor, as told to Jennifer Lahl. In return for 50-60 eggs, the donor received $6,500, a hospital bill of $35,000, and continuing long-term effects, including ovarian cysts and possibly permanent infertility.

“A few days before the eggs were to be retrieved I had to fly to the fertility clinic to have lab work and an ultrasound to see how many follicles were developing. Two days prior I took medication to mature the eggs. I think Clomiphene was one of the drugs. They stimulated me too much based on the lab work, even though I didn’t have severe “hyperstimulation syndrome” symptoms. They were measuring the progesterone or estrogen levels and it was way over the target—they even commented on this. I requested they back off on the stimulation but they were adamant that in order to have a good result, I needed to follow the protocol. I don’t think they took into account ethnicity or weight in their protocol, which is just ludicrous. I injected myself with the last medication that night to help release the eggs. For the retrieval, they did inform me of possible negative out-

JL: There’s an idea that things have to fit a narrative. It’s really hard to break out of a strong narrative, and we have a strong narrative in the United States that says “if you believe x, y and z you’re liberal, and if you believe a, b and c then you’re conservative.” These are issues that require a lot of thinking. Most media interviews I do, people are on deadline, they have so many words they need to crank out in a short period of time, so they try to get somebody on either side on an issue so they get an opposing view. We’re in a sound bite culture, and it’s just so easy to swim in the same direction of the stream we’ve always done. But these emerging technologies really require us to think about what is happening now, which we’re going to have to live with for decades.

I don’t want to bash the media; this is just an observation of what it is. It’s

comes such as bleeding and infection.

Everything went well until the retrieval. I woke up in the recovery room and realized I was weak and dizzy and could not get up easily. I went to the bathroom and I felt extremely nauseous and dizzy. They gave me more IV fluids because they thought I had side effects from anesthesia and low blood pressure. I then started having trouble breathing. They did an ultrasound and said there was nothing wrong with me. They kept trying to get me to go home, which would mean a plane flight, but I could not even stand up. The pain in my belly got worse and I was convinced I was bleeding internally. It felt like there was something irritating my diaphragm and preventing me from breathing. It was a burning sort of feeling in my chest and abdomen. My blood pressure was low and they gave me medication to increase it. Later they admitted me to the hospital and tried to get me to eat.

I could not even sit up without extreme distress and painful, difficult breathing. I had only been evaluated by the fertility doctor and the ultrasound tech. I was pretty sure I was going to die. They took my blood pressure and I remember them calling out “40/20,” but it was documented as much higher, around 60/30 in my medical records. They decided to take me in for emergency surgery. As it turned out, the fertility doctor had punctured an artery somewhere near my ovary. They did an exploratory laparotomy and flipped through my intestines several times before they found the small but gushing bleeder, and cauterized it. I woke up on a respirator in the ICU and stayed there for a day or so. I knew that bleeding was a risk, but to ignore my obvious signs of bleeding for six hours and then try several times to put me on a plane home—that could have killed me! I got three units of blood transfused.

Afterwards, the doctor kept reiterating that it was my fault and that this has never happened to her in the hundreds and hundreds of times she’s done this. The overall statistics for bleeding was 1:3,000, she said.

Then she checked me for bleeding disorders that I knew I did not have. I had a lot of problems with equilibrium after this and was unable to walk long distances after three days.”

You can read more of her and other donors’ nnn stories at www.cbc-network.org.

GeneWatch 25

easier to go with the same left-versusright narrative; if you’re on the left you have to be with this person, and if you’re on the right you have to be with that person.

It’s unfortunate, because I sit and talk to all kinds of people, and when they hear or watch Eggsploitation—I show it to a mixed audience, all over— people are just aghast. They can’t believe this is actually happening, and they want it stopped. When I go to Capitol Hill, people ask “Who’s behind you? Who’s supporting you? Well, if you get this person, maybe I’ll join you.” It’s very political; people want cover. So when you have people from different sides on other issues saying they are in agreement when it comes to egg donations, it’s really refreshing.

GW: There are also people who support the existence of and oppose regulation of the egg donation industry.

What sort of opposition have you come up against?

JL: Our most vocal opponents are the people in the industry: the fertility doctors, the brokers that are running the clinic, or the lawyers that are representing them; people who have a vested interest in the technology. They want to downplay what has happened to the women appearing in Eggsploitation as unfortunate and, while very tragic, still uncommon.

And I would say back to them: The burden is on you to prove that. Since you’ve never done any meaningful long-term studies, you’re just blowing smoke by saying that what happened to these women is an insignificant portion of the patient population.

Some people who have used the technology also oppose us. Not all of them—I just got an email from a woman in Australia who used an egg donor to have a child and who has since become very critical of what she did and of the industry—but still, there are a lot of women (and probably men, too, but I hear mostly from

women) who have used the technology to create a child and are very critical of what we’re doing, whether they feel judged or condemned, or whether they feel that the work that I’m trying to do is going to negatively impact other women who want to use egg donation or surrogacy to have a child.

GW: In Eggsploitation—and since then, I’m sure—you have spoken to many women who suffered serious health complications as a result of donating eggs. Has anyone gotten into trouble as a result of this, and do the women have any recourse to do anything about it when they suffer short or long-term complications?

JL: The tagline of the film is “The infertility industry has a dirty little secret.” One of the things that I’ve not really been able to put my finger on, but is an element of the ‘eggsploitation,’ is that a lot of the egg donors here in the United States make the decision kind of privately; then, later, they really regret what they’ve done.

They start thinking, “How could I have been so desperate for what now seems like such a tiny sum of money, given that I almost died?” Two of the women in the film were told that what happened to them was their own fault, and it’s really hard for them—my words, again, not theirs—it’s hard for them to advocate against an industry that is, when they look at it, the medical establishment. These are the experts; so when they have been told that what happened to them was their own fault, and certainly no fault of the industry, they feel a sense of shame. A lot of them didn’t call their mom up and say “Guess what I’m doing next weekend? I’m selling my eggs!”

One of the women in the film actually did file a lawsuit which was settled out of court for an undisclosed amount. One woman didn’t think she could sue, and now she thinks it’s past the statute of limitations. Again, these are really smart but still young

women, being faced with monumental incidents in their life. They sign all these legal agreements, and they are told beforehand that they have a lawyer, but the lawyer represents the industry. For two of the women who ended up with enormous hospital bills, their own private insurance had to pick up the tab, because they had better insurance than the industry provides an egg donor. They are told in the beginning that they have insurance, that the company has a policy for them if anything goes wrong, but it’s not comprehensive enough to take on the enormity of the medical expenses that have occurred.

Part of me thinks, gosh, if we could just let the insurance company know how many of their dollars are being wasted on otherwise healthy women who are undertaking these surgery procedures for no other reason than to help somebody … they might say, wait a minute, we’re not covering this anymore! All of the women in the film who are living still have ongoing medical debt. They are cancer survivors, or they are undergoing their own infertility workups since they now can’t have children of their own. One is in a high-risk pregnancy right now.

She had to have so much blood transfusion when she initially sold her eggs and was bleeding out that now she has developed an Rh incompatibility with the baby she is carrying.

The U.S. government recently prohibited credit card companies from advertising on university campuses, because there was such a concern that young people would get credit cards and graduate with enormous debt.

You’ll hear again and again: “These are smart girls, they should be able to make these decisions for themselves, and if they want to do this with their body they should be allowed to do it.”

And I say: Why can’t they have credit cards, then? Why are we concerned about their financial well being?

Shouldn’t we be more concerned about these women graduating withcontinued on page 34

26 GeneWatch

June-July 2011

Commercial Surrogacy and the Cost of Reproductive “Freedom” Surrogacy has been around for centuries; but when money enters the picture, women’s bodies become commodities MARSHA J. TYSON DARLING The act of women birthing children for other women is a very old social behavior dating to biblical times.

Commercial gestational surrogacy is recent and of compelling importance because it invokes sharp ethical dilemmas regarding the use of invasive and risky protocols on women’s bodies, and the well-being of children born into arrangements where the genetic, gestational, nurturing and even institutional (as in when birthed surrogate infants are placed in orphanages staffed by women) mothers of infants may not be the same woman. Commercial surrogacy also portends challenges for our advocacy as stakeholders, who in the United States participate in a democratic social order that promotes reproductive freedom “choice,” and at the same time social justice.

Exactly what does “choice” mean in the context of participation in surrogacy arrangements when one lives below the poverty line in the United States or especially in a “low resource” country like India or Thailand? This question bears on us now as present day gestational surrogacy has become a transnational commercial enterprise, linking multiple individuals and their interests in an interconnected global web: mostly poor women’s labor, gametes, infants, medical services, surrogate hostels, legal contracts, state and national policy makers, sometimes human traffickers, international trade institutions (WTO), and of course, lots of money. This article identifies some of

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the challenges associated with women’s work in the commercial gestational surrogacy industry, and argues that we should move beyond ‘just wait and see what happens’ to the complex work of legislating responsible governance of the new biotechnologies that reach so very deeply into our bodies.

Few people might have imagined

the exponential expansion of gestational surrogacy taking place within and across national borders in recent decades. Used primarily to intervene in infertility, contract gestational surrogacy is the centerpiece of a fertility production complex with a set of contractual arrangements that mark: a) the convergence of women’s reproductive labor (whether paid or uncompensated), b) female and male gametes (purchased or donated), c) written contracts or just verbal agree-

ments offered by commissioning individuals or couples, d) fertility brokers and doctors and medical staff often working in private hospitals specializing in fertility services in “low resource” countries, e) fertility hostels as places where contract surrogate mothers-to-be are often housed especially in “low resource” countries, f ) some regulatory policy makers often intent upon allowing citizens some measure of autonomy in utilizing surrogacy in response to infertility, and g) other policy makers who are intent on taking a place in the global economy by offering medical and reproductive services and encouraging citizen participation, especially in “low resource” countries.1 In vitro reproductive interventions are ushering forth an era where for an increasing number of persons, mostly in western societies, reproduction is shifting from conception as a possible outcome of coital sex to laboratory managed medical intervention and control of conception. Social identity rights based movements and the sexual revolution begun in the 1970s have altered definitions of “family” in much of the global North, creating new alternatives to traditional familial relationships. Fertility interventions enable greater agency on behalf of reproductive freedom, especially for heterosexual couples challenged by infertility, genetically transmitted disorders, or just wanting to opt out of the inconvenience of childbearing.

GeneWatch 27

However, persons who are disabled or differently able who seek to reproduce, same sex couples, single persons, and at some point transgender persons who seek to enable their reproductive choices, often encounter a refusal of fertility and surrogacy services.

The revolution in reproductive biotechnologies has made parenthood possible for thousands of people around the world for whom this would otherwise have been impossible, and their use is steadily growing.

The number of babies born to gestational surrogates in the United States grew 89% percent from 2004-2008.2 The commercial fertility industry which is nearly entirely unregulated in much of the world is a multi-billion dollar annual business, generating enormous profits for fertility specialists, clinics, and brokers. While in the main these powerful stakeholders seek to minimize health and economic risks, they rigorously fight regulation. In many countries, including the United States, the industry selfreports, and as such sometimes covers over errors of judgment or adverse outcomes—preferring to focus on successes. Recognizing multiple dangers and ethical issues, policy makers in a number of countries have banned or severely limited fertility and surrogacy practices, turning countries with no regulation into “free market” zones. Many are concerned about negative impacts on women’s health and infants in the fertility industry.3 The challenges to protecting surrogate women’s health and well-being everywhere deepen, as women who labor as surrogates are almost always economically vulnerable and are lured by the promised payment that is a desperately needed income supplement. In “low resource” countries like India, where a large segment of poor women workers are illiterate, they are vulnerable in a system of intermediaries, all of whom have more power and authority than impoverished 28 GeneWatch

women. Needless to say exploitation and fraud of women fertility workers are very real issues. At many clinics in India, surrogates recruited from among the poor are warehoused assembly-line style in long rows of beds where they are confined for the duration of their pregnancy. In the United States, it is estimated that nearly 50% of gestational surrogates are “military wives,” a much sought after group for agencies and brokers.

Many “military wives” are low income ($16,000 to $28,000 USD in annual income), and tend to marry and have their children at young ages, so the prospect of doubling their income by serving as a surrogate can be irresistibly attractive. These women have few legal or regulatory protections, however, making them ripe for exploitation and fraud.4 Egg donors are a significant factor in the commercialized reproduction business. Egg suppliers, largely young college women struggling to finance their educations, are drawn by ubiquitous ads in campus newspapers and social media. One typical ad running in campus newspapers in the United States offers “$25,000 for a donor who is 100% Jewish with high SAT scores, attractive, at healthy body weight and free of genetic diseases.” Many of the young, child bearing age women who enter ova selling networks, or the “embryo trade” as it is quickly becoming known, enter the industry to donate or sell their ova for the infertility industry. More recently, much of the quest to further stem cell research initiatives rests on recruiting young women to undergo ovarian stimulation so as to produce multiple embryos for research. This industry is also expanding rapidly. Much of the discourse about the arrangements undergirding these practices reduces them to “market arrangements.” Yet, the well-being and health of many of the young women is at risk as they enter ova trade networks.5 The potential for serious health

risks from these practices is very real.

Synthetic hormones and other drugs utilized in IVF can have harmful short and long-term health consequences for the women who work as egg suppliers and surrogates, as well as for the women undergoing these procedures to conceive and give birth to a child of their own. Short-term health risks associated with these procedures include ovarian hyper stimulation syndrome (OHS), which ranges from mild to life-threatening. Nausea, vomiting and abdominal swelling are common; more serious complications may include kidney and other organ failure, strokes, and even death. Longterm risks include increased rates of uterine, breast and other cancers and infertility.6 Despite the seriousness of these potential health risks for women working in the fertility industry, insufficient attention has been given to gathering empirical data and crafting responsible regulation of women’s work that generates not a material “something” but a “someone.” There is a resounding need for open debate, international collaboration and tighter regulation of this global marketplace.

The global commercial fertility industry has created a market for virtually every aspect of human reproduction: sperm ($275 a vial), eggs (up to $50,000 apiece), nine months use of a womb ($20,000), and the creation of an embryo ($12,000 per cycle). The fertility-industrial complex is a stunning array of businesses. It includes the manufacturing of fertility hormones, harvesting of renewable natural resources (sperm and egg collection), international trade (foreign adoptions), expert services (IVF and other high-tech medicines), longterm storage (embryo banks), and even rental property (surrogate mothers).7 As the industry continues to grow and affect more and more people’s lives all over the world, awareness and understanding of its far reaching implications for social jusJune-July 2011

tice should accompany the development of the technologies (IVF, Preimplantation Genetic DiagnosisPGD, etc.) and practices of this global phenomenon. As all of the arrangements noted above amount to purchasing and securing the production of a child, a concern for the infants born within the surrogacy industry should also be on our radar screen.

Who looks after the interests of the children who are born through the gestational surrogacy industry? Do they have a right to know information about their biological parent(s) in cases where the egg and/or sperm donor is/are not the commissioning parents? What if they seek information about the surrogate mother or egg supplier? What rights do children have to information regarding any siblings they may have who are the offspring of the donor parents? In a more frightful scenario, who will look after the interests of the infants rejected or abandoned because of multiple births, or a serious disability deemed unacceptable by commissioning indi-

viduals, or infants unclaimed or abandoned or in the event of the death of a commissioning parent-to-be? Equally dire, what if a commissioning individual’s home country will not accept the newborn infant or upon its birth the infant is placed in an orphanage in the country of physical birth? All of the above questions bear immediately on the well-being of children born within the fertility industry.

Lastly, addressing the issue of averting potential and real harm at a time when the fertility industry is bustling will be a challenge for Americans because advertising has cleverly linked increasing personal individual choices connected with parenting with letting the marketplace rule without regulation. As for women’s interests, how do we defend abortion rights but also disentangle that issue from advocacy towards regulating risky technologies? While we have outlawed the market for selling organs in the United States, where are our heads about allowing young women’s wombs, their ova with its all so very

valuable totipotent embryonic stem cells, even their DNA and genetic sequences to be thrown into a marketplace, patented and sold as a manufacturing “part” or “process”? Can we be under the illusion that our reproductive freedom will increase by allowing elites to patent or privatize the genetic sequences and processes embedded in women’s reproductive biology? A really tough question is what are the moral and ethical consequences of transforming a normal biological function of a woman’s body into a commercial production process with its attendant input costs, organized under a legally binding contract?

Exactly how will that play out without our exerting a mitigating influence on the development of biotechnologies that reach deep within our bodies?

Bodies Ourselves, and Pro-Choice Alliance for Responsible Research.

Currently, a petition calling for a national egg donor registry and for nationally mandated health warnings on ads soliciting women for their eggs carries the endorsement of a number of prochoice groups including the California Nurses Association, Council for Responsible Genetics, the National Women’s Health Network, and the National Organization of Women. The documentary, Eggsploitation, which chronicles the wrenching experiences of several young egg donors, though produced by the conservative Center for Bioethics and Culture, is promoted by prochoice adherents from Our Bodies Ourselves, Infertility Network, Donor Sibling Registry, Alliance for Humane Biotechnology, and Council for Responsible Genetics.

The painstaking, time consuming, trial and error labor it took to stitch together these connections is testimony both to the tenuous, shifting nature of alliances and to the effectiveness of pragmatic experimentation in bridging ideological divides to identify common goals. Moving forward, there will likely be as many disagreements as there were looking back. Even so, we can pause to celebrate how we’ve been overcoming unlikely odds to find nnn the active voice.

nnn

Marsha Darling, PhD, is Professor of History and Interdisciplinary Studies and Director of the African American & Ethnic Studies Program at Adelphi University.

continued from page 23

1317 created the nation's first state law requiring ads seeking women's eggs to include reference to health risks.

The significance of such legislative measures is not merely the new laws themselves, which, in certain respects, bear the limitations of loopholes created by industry lobbying. Deeper meaning is conveyed by who initiated or supported them: civil society groups with prochoice orientation. SB 1260 was supported by Center for Genetics and Society, Pro-Choice Alliance for Responsible Research, Planned Parenthood Affiliates of California, and Women’s Foundation of California.

AB1317 was supported by the American Association of University Women, Alliance for Humane Biotechnology, Breast Cancer Fund, California NOW, Center for Genetics and Society, Our Volume 24 number 3

Tina Stevens, Patricia Jennings and Diane Beeson are board members of Alliance for Humane Biotechnology.

GeneWatch 29

The Southern Baptist Ethics of ARTs An interview with Barrett Duke of the Southern Baptist Convention

Barrett Duke, PhD, is Vice President for Public Policy and Research and Director of the Research Institute of The Ethics & Religious Liberty Commission (ERLC), the Southern Baptist Convention’s agency for social and moral concerns.

GeneWatch: Where do the Southern Baptist positions come from? Who decides where you fall on the issues and what you’ll be pushing for in Washington?

Barrett Duke: There are a couple of guides for us. One is the resolution process that Southern Baptists engage in each year in their annual meeting. We have a committee that considers resolutions on a whole range of social, moral and theological issues. Oftentimes they will propose, and the annual meeting will adopt, a resolution that addresses a moral issue in some kind of way that has policy implications. My organization, the Ethics and Religious Liberty Commission, has the responsibility to basically make sure that the values that resolution calls for are promoted in Washington, D.C. and around the world as well.

Since the Convention often only meets once a year and there are a lot of issues that come up during the rest of the year, our commission will often need to look at what the issue is, talk to professionals in that particular area, develop a position that we believe reflects the teachings of the Bible and the commitments of Southern Baptists, and begin to work toward it.

30 GeneWatch

GW: Would I be right in thinking that in the Southern Baptist positions on reproductive technologies, the central theme is protecting the sanctity of life?

BD: That is the overriding theme for most Southern Baptists, and certainly the Ethics and Religious Liberty Commission: to protect life at all stages.

GW: Beginning at fertilization?

BD: Yes, beginning at fertilization, and even including the process toward fertilization. We believe that there are certain ethical boundaries even prior to fertilization that couples and societies ought to respect as well.

GW: Does that apply then to egg donation, sperm donation, surrogacy, or other assisted reproductive technologies?

BD: On most of these issues there isn’t a so-called “official” Southern Baptist position; but most Southern Baptists are in agreement that while we certainly sympathize with couples who have difficulty having children, and we want to support them, we still believe there are certain boundaries that need to be maintained. The issue of surrogacy is a serious one for us. It raises serious questions about who the parents are, who has legal rights to the children, the parents’ relationships with the children and how they are raised.

We have serious concerns about the

whole concept of surrogacy, and with egg and sperm donation as well.

GW: So in this case, it’s less about sanctity of life than about sanctity of marriage?

BD: No, I would say the issues are still primarily about the sanctity of life, but they certainly have implications for marriage as well, especially with the issue of surrogacy. But when you’re talking about sperm

The Biblical teaching is that every human being is created in the image of God and thus deserves equal respect and, we believe, equal protection under the law. donation, are you talking about sperm donated from the husband or from another male? So there are also implications here for what exactly is the nature of marriage itself.

GW: And the Southern Baptist Convention encourages adoption as an alternative for infertile couples.

BD: We do encourage adoption, not only for infertile couples but for all couples who would consider the needs of thousands of children who are unable to experience the important relationships with a mother and a father. So we encourage adoption for all couples, but we certainly encourage adoption for infertile

June-July 2011

couples. And that can be adoption not only of children who have already been born, but also adoption of embryos in fertility clinics, where they have been frozen and are waiting to be given the chance to fully develop—what’s referred to as a “snowflake adoption.”

GW: The clinics are there, the embryos are already there, but how do you feel about the purposes of the fertility clinics themselves?

BD: Well, we certainly have concerns about how fertility clinics operate. Again, on this question there is no official Southern Baptist position. We do know that there are Southern Baptist couples who have resorted to fertility clinics and in vitro fertilization, and what we encourage is that couples who are considering that option fertilize no more eggs than they are prepared to have implanted, so they make sure that they are at least not deliberately planning to basically conceive children that are never going to be given a chance to fully develop.

GW: I imagine that would be an issue in pre-implantation diagnosis or sex selection, where a couple might choose a fertilized embryo that has their desired traits. Of course, genetic manipulation can go well beyond that. Is there an official Southern Baptist position on human genetic manipulation?

BD: The Convention is on record in opposition to cloning, and our members are clearly in opposition to sex selection and to any genetic selection criteria. The Convention has significant concerns with any effort to determine which humans have the right to life and which ones do not.

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GW: Are there certain passages of Scripture that you find yourself bringing up to illustrate these positions?

BD: I think our arguments generally begin with the teaching in Genesis that human beings are created in the image of God. It doesn’t tell us that some human beings are created in the image of God, or that some human beings have more of His image than others; the Biblical teaching is that every human being is created in the image of God and

agree on hardly anything else, but you do find agreement on that issue.

When you can find common cause, you should work together. Right now we’re working on gene patenting, which has us working with some groups considerably to the left of us on many social issues, but we’re all in agreement that it’s unethical to allow anyone to own naturally occurring genetic material.

GW: Do you also encounter any unexpected opposition from folks you might otherwise be in agreement with?

BD: You know, on the gene patenting issue, I can’t say that we’ve encountered opposition from any surprising groups; but there are occasions where, when we join in a coalition, we don’t get everybody who is a natural ally with us. Often they have concerns about possible implications of a policy that they just can’t support, so they end up opposing it.

So yes, on occasion we end up in opposition with groups who tend to be natural allies on other issues.

thus deserves equal respect and, we believe, equal protection under the law.

GW: Issues like human genetic manipulation and assisted reproductive technologies often seem to create strange bedfellows. Have you found yourself working with unexpected allies on Capitol Hill?

BD: We do. In this work, you find groups that you have an issue in common with, and you work with them on that issue. Maybe you don’t

GW: Some of the other contributors to this issue of GeneWatch have addressed the reluctance of some pro-choice advocates to involve themselves too deeply in issues surrounding assisted reproductive technology, for fear of muddling their message on women’s reproductive rights. How do the Southern Baptist positions on assisted reproductive technologies fit into the pro-life point of view?

BD: I think that the Southern Baptist Convention is fairly mainstream on its commitment to the protection of life. There are some groups that find it more difficult to engage in incremental strategies toward protecting life—they feel that they have to proGeneWatch 31

tect all of life if they are going to protect any life. So it makes it more difficult to engage in some strategies that would at least limit, for example, the number of abortions. We might back some policy that moves us closer to ending all elective abortion, and if it doesn’t accomplish the entire goal, we might still feel that it is significant progress. Some groups don’t feel like they can make that step. We understand that, and we sympathize with that concern. So yes, there are times when the particular issue that we’re involved in doesn’t get agreement from everybody; but the long term goals are the same between Southern Baptists and most other pro-life groups as

well, and that is to end the current regime of elective abortion as it exists in this country today.

GW: How high do reproductive technologies rank on your priority list?

BD: The sanctity of life is our top priority issue; everything from conception to natural death, anything that touches on the sanctity of human life is a top-tier issue for us.

But oftentimes there just isn’t any movement at the moment in any of those areas, and I would say that right now, there just isn’t any movement on reproductive technologies.

There is movement on some abor-

tion questions, and we’re dealing with this gene patenting questions, but I’m not aware of any significant movement of trying to reign in the current Wild West practices in the United States regarding reproductive technologies. If there were—if we found some interested parties who were trying to get movement on that—we would certainly partner with them and try to make some progress on it. It is a sanctity of life issue, so it is a top-tier issue for us, and we are ready to begin working on it as soon as we feel that there is an opportunity. nnn

Take action: sign the egg donation petition today Institutional support: Alliance for Humane Biotechnology California Nurses Association Women undergoing egg extraction are not able to make informed choices about the risks involved, in part because long-term risks have not yet been adequately studied, especially for women providing eggs to be used by others. We urge the creation of a widely-publicized, privacy-ensured national registry to facilitate long-term tracking and long-term studies to better understand the risks of egg extraction, particularly with respect to the impact of drugs used for both suppression and stimulation of the ovaries. We also urge that advertisements and notices seeking women to supply eggs be required to state that longterm health risks of egg harvesting procedures are unknown.

Center for Genetics and Society

Help protect women’s health and safety by signing the petition at:

ProChoice Alliance for Responsible Research

www.councilforresponsiblegenetics.org/eggdonation

32 GeneWatch

Council for Responsible Genetics National Women's Health Network National Organization for Women (NOW) Our Bodies, Ourselves

June-July 2011

ART’s Minor Issue Children can now be not only offspring of assisted reproductive technologies, but also consumers of it MICHELE GOODWIN A program at the University of Pittsburgh portends the inevitable: children and adolescents are eligible for interventions aimed at preserving or restoring fertility. The processes might involve the harvesting of reproductive tissues, collecting semen, and cryopreserving what doctors collect from children. The Magee-Women’s Research Institute, the Magee-Women’s Hospital, the Children’s Hospital of Pittsburgh of UPMC, and the Pittsburgh School of Medicine are collaborators in the nation’s first comprehensive program of its kind. Eager parents are already calling to register their children.

How did we get here, where children are a part of the ART landscape not as offspring, but consumers? How should the law handle this?

Autonomy figures significantly in judicial and political policy debates involving reproductive decision making. However, medical and legal policy debates focused on reproductive decision making too often suffer from reductive assumptions captured by our nation’s ongoing internal struggle about abortion. In that context, competing interests about access to abortions, the constitutionality of the procedure, questions of personhood, and concerns about where life begins predominate and significantly define how the lay public and legislators speak about reproductive decision making. Yet this narrow discourse partially engages one subset of the reproductive field Volume 24 number 3

and misses many others.

Assisted reproduction and the umbrella of technologies combined within that framework serve as telling examples. Despite the high demand for assisted reproductive technology (“ART”) services, this type of reproductive decision making typically escapes sustained social, legal, and public policy review. To date, there exists only one federal law tied to ART, and its main charge—to require the collection of data on “success rates”—serves as a passive reminder that in 1992 Congress once considered the issue. To be sure, in 1992, members of Congress had not predicted the “Wild West” of ART,

and certainly not how children fit in, either as offspring of the technology or consumers.

Legally, the United States has not made much progress in considering the regulatory contours for ART procedures—unlike Canada, England, Italy, Spain, and many other countries—despite known risks associated with ART procedures, including hyper-stimulation of ovaries (thought to be linked to ovarian cancer), higher incidences of babies born with low birth weight, and increased risks of cerebral palsy, hearing impairment, and cognitive delays.

Perhaps the risk most known about ART is the much-increased possibility of multiple births, publicized by the media frenzy surrounding Nadya Suleman’s delivery and birth of octuplets, and life with 14 children born with the aid of ARTs. For some of ART’s most ardent critiques, the field is like the Wild West of biotechnology, where nearly nothing is outlawed and perhaps the newest wave— involving children in research experiments as users of the technology—reaffirms that point.

The only existing federal law requires that fertility clinics annually report their “success rates.” Indeed, parsing the difference between research and medical treatment where perverse incentives appear on both sides might be difficult for child patients, their parents, and the physicians serving them.

What’s missing is a framework GeneWatch 33

continued from page 26

out dying and having their fertility intact?

GW: Would you like to see egg donation banned entirely in the U.S.?

JL: No… I advocate for taking the money out of it. That would be a first step: you can donate but you can’t pay for eggs. I would like to see the anonymity taken out of it, which has just happened in Canada under a Supreme Court decision that you must make the biological information of donors available to offspring so that the children have access to that information. And I think in the instance of egg donation—using egg donors, not women who are using their own eggs—that we need a moratorium so that we can begin collecting the data and doing the studies. Informed consent right now is meaningless. And you can’t give informed consent with money. I worked as a nurse for 25 years; I had thousands of people sign informed consent documents, and there’s never money entangled in informed consent.

So take the money out of it, take the anonymity out of it; and as it relates to young, healthy women being used to donate eggs, we need a moratorium.

We can go back, we can collect retrospective data, we can start doing studies with the data we already have, and start making a better case for whether this is safe or not, what the risks are and how significant they are in the short and long term. Let’s comb through the breast cancer registry.

How many of those women used infertility drugs? How many were egg donors? Comb through the hospital records: How many times was a woman admitted for ovarian hyperstimulation syndrome? We need to start looking at the data that we have in some organized way, and it will probably have to be compelled by the government. The industry isn’t going nnn to do it on their own.

34 GeneWatch

to help us think about when it might be acceptable for children to become consumers of ART. For example, should age matter and/or parental consent? What about mental and emotional capacity of youth? The current ART research programs involving children have not gotten that far, and likely they will not. But here are a few considerations that might get the conversation started.

There are three relevant medical scenarios for which there might be a compelling or moderate interest to consider providing minors legal access (or the right to consent to) ART: (1) adolescents suffering from cancer who will require surgery, chemotherapy, and/or radiation therapy, rendering them sterile during the process of treatment, or youths facing impending loss of fertility due to other medical conditions or illness; (2) adolescents as gamete donors for ailing relatives who wish to parent; and (3) minors living separately and financially solvent from parents and guardians in a marriage relationship.

Let’s consider the case of childhood cancer. It is estimated that one in every 1,000 adults is a survivor of childhood cancer. Even more alarming, Dr. Carrie Nieman and her research partners predict that, “an estimated 1 in every 250 adults will be living with a history of childhood cancer.” Their article, Fertility Preservation and Adolescent Cancer Patients: Lessons from Adult Survivors of Childhood Cancer and Their Parents, published in 2007, provides compelling evidence that preserving fertility is an important matter for teenage cancer patients and their parents.

Proponents of fertility programs designed for children contend that while the harmful reproductive effects of toxic exposures from cancer treatments may be lower in younger children, overall, it is estimated that

the probability of achieving a pregnancy after surviving cancer as a child, adolescent, or young adult is reduced by approximately one-half. Dr. Teresa Woodruff, a researcher in Northwestern University’s Oncofertility Consortium, explains that for girls the problem is compounded by “the prospect of menopause in their 20s or 30s.” Researchers working in this domain seem to agree that the key to preserving fertility in childhood cancer patients is to begin the tissue harvesting process before “fertilitythreatening treatments” begin.

The best way to meet the moral and legal challenges associated with adolescent use of ART is head on— engaging a future that is now upon us—rather than ducking our heads in the sand. This means reconsidering the role of law and the function of regulation. As importantly, confronting the expanded reach of ART services to minors also means thinking critically about physician conflicts of interests and also the parental conflicts of interests, particularly with new ART research trials.

Finally, who will benefit from or be harmed by adolescent use of ART? These questions deserve our serious attention. nnn Michele Goodwin, JD, is Everett Fraser Professor of Law at the University of Minnesota and author and editor of several books, including Black Markets: The Supply and Demand of Human Body Parts (2006) and Baby Markets (2009).

June-July 2011

Willful Ignorance Québec’s regulation and surveillance of assisted reproductive technologies lags … but there’s no quick fix for the underlying issue ABBY LIPPMAN It was almost 40 years ago that I first began to question and explore what were then the “new” reproductive technologies. Reflecting back on those decades reveals how much— and how little—has changed. Many of the technologies themselves are now the realities only imagined then.

However, the questions and concerns about them are basically still the same, and still just as hotly debated.

Are we (again) on the verge of “designer babies?” Will women’s bodies be commercialized to provide children for those contracting surrogacy services? Will women’s eggs be high-priced commodities for profitmaking international brokers? Why do we still know so little about the environmental and occupational determinants of infertility? Perhaps the most notable change in the discussion has been a subtle shift in emphasis from concerns about their eugenic implications to the economic ramifications of the use of the technologies, as what Debora Spar has called the “baby business” proliferates and as “choice” has been reduced to a consumer option.

Assisted human reproduction comprises a range of technologies that were initially developed to make it possible for some women considered infertile because of biological problems to have children. Over time, many of these technologies have become primarily ways to circumvent social factors that prevent a woman or a man from being the biological parent of a child without outside assistance. And yet, despite being viewed as merely a “choice” for women, there continues to be grossly Volume 24 number 3

inadequate regulation and surveillance—or full public discussion—of their use, so that information necessary for informed decision making is woefully inadequate.

Canadian feminists began calling for the regulation of the range of reproductive (and genetic) technologies in the 1980s. This led to the formation of a Royal Commission to examine the “New Reproductive Technologies” and to the longdelayed release of its final (two-volume) report, “Proceed with Care,” and its almost 300 recommendations in November 1993. Another decade passed before the federal government approved (in 2004) the Assisted Human Reproduction (AHR) Act and the creation of an agency to oversee activities in this area.

The jurisdiction of the federal government to act in what was labeled a matter of “health” (a provincial matter in Canada) was rapidly contested

by Québec and no real progress — not even with regard to the practices the AHR Act proscribed as criminal offenses— was made to regulate the expansion and increasing use of the NRTs while the matter was (for too many years) before the courts.

Thus, when the Supreme Court of Canada supported most of Québec’s claims and thereby rejected the AHR

Act in December 2010, it became a matter for the provinces to draft legislation to protect the health and interests of women and society.

In Quebec, this has turned out to be fairly shallow protection at best.

Yes, this province now covers in vitro fertilization (IVF) with public funds as part of the universal medical care coverage offered to almost all residents. However, none of the regulatory and surveillance measures long demanded are in place. And while this financial coverage gives the appearance of promoting equity, since IVF technologies may now be available to any woman accepted as a candidate and not only to those with the financial resources to pay for the procedures involved, this “equity” may actually be more apparent than real.

The political decision to fund IVF and not midwifery programs, proper school-based sex education, or to expand publicly-funded daycare demonstrates the allures of—and

GeneWatch 35

lobbying for—technological fixes over societal and structural change that can truly reduce inequities. In this regard, funds allocated for these high tech procedures could have been better used to remove some of the major determinants of “infertility” and to develop policies that will address those situations that now lead to women delaying their childbearing.

Thus, what has happened in Québec reflects what too often has happened with reprogenetic technologies everywhere: willful ignorance of the processes, policies, and other “upstream” societal, environmental, and structural determinants that lead to demands for interventions to circumvent infertility. And, while we lack the proper downstream regulation of assisted repro technologies necessary to ensure the health and safety of users and the children to be born, this is not all that’s needed. Essential as they are, having laws—and even registers that track

users and their offspring—must not deflect attention from what women need for social justice and for their complete sexual and reproductive health, measures that will also prevent infertility: safe places to grow up, live, work, and play; a system in which social and economic rights are secured; and conditions in which bodies and body parts are not commercialized.

It remains a priority, unaddressed even after 40 years of arguing for it, that we frame assisted reproduction within an overall reproductive health policy—one that would, for example, attend to ways to reduce infertility and not just ways to manage it once it was diagnosed. High tech interventions should be last resorts at the margins, not the center of things.

And to refocus, we need to reduce the space given to the scientific, commercial, and medical interests that tend to dominate the discussions and consider what the technologies and the technological approach means

for individual women and women collectively.

Reproductive technologies are not a treatment of infertility but merely a way of circumventing some of the problems that keep women from having the children they may want.

Unfortunately, there is still overemphasis on expanding access to these technologies rather than on seeking the causes of the underlying problems and ways to prevent them. It’s not just my impatience at how slowly things change that makes me hope we will have the discussions we sorely need to set in place the social systems that will truly promote and protect the reproductive and sexual health of ALL women, those who do and those who do not want children.

We don’t have another four decades to act. nnn Abby Lippman, PhD, is a Professor in the Department of Epidemiology, Biostatistics, and Occupational Health at McGill University.

Old Patterns, New Ideas Assisted reproductive technologies can provide new choices for women - but they can also reinforce traditional notions of women’s identities HEDVA EYAL Great advances have been made in reproductive technologies in recent decades; however, those advances also gave rise to new problems and vulnerabilities. The variety of possibilities and access to reproductive assistance for people who wish to become parents, including purchase of eggs and surrogacy, raises questions about the ways medical technologies influence our society and especially the health and status of women all over the world.

In many different societies, moth36 GeneWatch

erhood and procreation is still considered the essential natural component of women’s identity. The creation of a child is considered fulfillment of the social convention of an acceptable family. The longing for a child, and the availability of reproductive technologies for privileged people, intensifies the social pressure on women to give birth at almost any price. This strong social construction, combined with powerful economic interests of the local and global fertility industry, creates a “need”

for finding solutions to the growing difficulties in becoming parents.

There is plenty of scientific knowledge and understanding of health risks as a result of hormone treatments associated with in vitro fertilization (IVF).1 This raises questions about the widespread use of this procedure, especially when women are exposed to these health risks not for themselves but to conform to other people’s desires. Establishing surrogacy as a prevalent, accepted way of bringing children into the world June-July 2011

entails significant risks to the surrogate mother herself, to the child, and to society.

In recent years, surrogacy and egg selling have been taken for granted as the next step in reproductive assistance, accepted as technologies that can be used when pregnancy is not achieved through individual fertility treatments. Conceiving pregnancy and childbirth for another couple or individual solely as a financial business transaction raises ethical and feminist reservations. “Surrogacy in Israel,” a report published by Israeli feminist organization Isha l’Isha, raises concerns about the likelihood of exploitation in the complex relationships between the different actors in commercial surrogacy— especially when organizations with private financial interests are involved.

I hasten to acknowledge that regulating surrogacy and ending egg selling would not eliminate this risk; it would only help diminish the exposure to economic exploitation and trafficking. At the same time, however, it may increase its legitimization on the social level.

Removing the social, bureaucratic and economic barriers from the application for surrogacy strengthens the message that motherhood should be the center of a woman’s life. It makes the acceptance of one’s infertility less and less legitimate and increases the social and family pressure on women and couples to invest all their resources in attempts to achieve parenthood.

Moreover, the widespread accessibility to surrogacy harms the currently existing social perceptions of the importance of the relationship between the mother and the baby in her womb, and conveys a social message that this relationship has no actual emotional, health, or legal significance. As the use of surrogacy

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increases, this message becomes stronger and undermines the concept of motherhood as well as having a negative impact on the status of women in relation to their children.

Another significant consequence for women’s status is the growing commoditization of women’s bodies for the purpose of trading in reproductive organs.

Supporters of surrogacy and egg selling claim that these uses of her body are legitimate acts of a woman as part of her free choice. They see these transactions as a contract between two adult parties who are responsible for their actions. Against

this claim, we face a harsh reality in which the notion of free choice obscures poverty and desperate solutions to economic distress. The Israeli journalist Ran Reznick recently published an article on Ukrainian women who are selling eggs to Israeli couples. Resnick met the Israeli couples and the women who sell their eggs. He described the reality of those two sides as frustrating and sad. All the parties involved are aware of the suffering caused to the women who are selling their eggs.

In the article, Resnick interviews one of the clinic managers. “Ask me

instead of her why is she doing that,” the manager says, “and I will answer: for the money. There were cases where women asked for an advance payment for the eggs, because they had no money to feed their children.”

A local lawyer who represents Israeli couples said in the interview: “There are also questions about fairness expressed in the gap between the payments that those women are receiving and the money that goes to all those involved in the treatment.

Selling eggs is not unusual in Ukraine… people in circle of poverty are driven to do so… People are forced to sell eggs or their kidneys.

There are also women slipping into prostitution.”

In the same article, an Israeli gynecologist, Eli Geva, described the Ukrainian women slightly differently, saying that “those women are not sad, they are submissive.” The medical professional plays an important role in the “reproductive tourism”—or to call it what it is, trafficking. It raises questions about their role in creating this industry. How does it go along with their oath to avoid doing harm?

How is it legitimate to use medical knowledge and technology that were created in order to heal and cure people, in a way which risks women’s health?

These gaps raise difficult and complex questions with no obvious or absolute answers. How are we to face the local and global constellation in which the more affluent are more protected? Are we aware of the situations in which there are people who have to sell body parts in order to survive? Do we, as a society, take equal care of women from different socio-economic status? How should social responsibility be translated into actions? Who will make sure that the rights of women who sell their reproductive organs are not violated, and how will their safety be

GeneWatch 37

ensured?

Not all the procedures of selling eggs and surrogacy should necessarily be considered trafficking in human organs. Surrogacy is sometimes handled with mutual respect and responsibility—but these cases are the minority. Further, even when we overcome this problem, the health risks still exist.

The reality women face in a world of globalization and advanced med-

ical technologies seems to preserve patriarchal patterns. Women are more exposed to poverty and therefore more exposed to exploitation.

Advanced reproductive technologies are not necessarily serving women, nor do they create a just society.

These new technologies reinforce old patterns about women’s duties as mothers and use women’s difficulties to promote the economic interests of nnn others.

Hedva Eyal is Women & Medical Technologies Project Coordinator at Isha L’Isha (Woman to Woman) Haifa Feminist Center in Israel.

topic update Congress Raises Ire of Gene Patent Activists Among almost 100 pages of amendments to HR 1240, the America Invents Act (also known as the Patent Reform Act) recently introduced in the House of Representatives, a provision was included to establish a safe harbor for second opinion genetic diagnostic testing providers. Introduced by Congresswoman Debra Wasserman Schultz (D-Fla.), the language appeared to be a response to last year’s report by the now defunct Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) entitled Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. In that report, SACGHS found that: … trends in patent law appear to pose serious obstacles to the promise of these developments [ in genetic research and clinical practice]. Patenting has moved upstream; instead of covering only commercial products, patents can now control foundational research discoveries, claiming the purified form of genes. Fragmented ownership of these patents on genes by multiple competing entities substantially threatens clinical

38 GeneWatch

and research use.

SACGHS recommended several statutory changes, including: … the creation of an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient-care purposes.

While seemingly simple and certainly well intentioned, the amendment set off a firestorm of protest from plaintiffs and their supporters in the ongoing Myriad gene patent litigation (including the American Medical Association and the Council for Responsible Genetics). In a letter to ranking members in the House Rules and Judiciary Committees, the ACLU argued that: The proposed language would fail to block all patent holder objections to such testing, fails to address the many other limitations on scientific research arising out of the issuance of such patents, and risks allowing gene patent holders to argue that Congress implicitly endorses the validity of such patents.

As a result of the outcry, the Congresswoman quickly backtracked, replacing the original language of her amendment with language that would “conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.” While a significant improvement and a victory for those opposing gene patents, the change of language failed to satisfy many of the opponents who did not see the need for a seemingly duplicative study and remained concerned that any mention of gene patents by the Congress might influence ongoing litigation.

Nevertheless, the new language remains in the now House passed version of the bill.

The future of this provision is still in some doubt, however, as opportunities to eliminate it remain viable. A previous Senate passed version of the Patent Reform Act failed to include similar language, and so it remains to be seen whether such language will survive any formal or informal conference between the two Chambers to reconcile the bills. Any compromise would then have to be passed by both nnn the House and Senate.

June-July 2011

SPECIAL TOPIC:

GENETIC REDUCTIONISM

The recent article in the New York Times entitled “Genetic Basis for Crime: A New Look” justifiably raised a backlash of criticism for its unsubstantiated implication that criminal behavior is in our genes. Just four months earlier, the U.S. Court of Appeals for the Second Circuit reassigned the case of defendant Gary Cossey from Northern District Judge Gary Sharpe after finding the judge committed plain error by ordering a longer sentence because he said Mr. Cossey had a genetic propensity to re-offend.

But as this small sampling of recent news headlines demonstrates, these incidents can hardly be seen as an aberration. Rather, they come from a long history of reductionist thinking that proposes that people can be fundamentally understood through their genetic makeup. And it is such thinking that has fertilized the zeitgeist from which these incidents sprang.

Its certainly easy (and obvious) to blame the press, often rushing to report the latest genetic “breakthrough” but too often failing to cover disproven studies or studies showing statistically insignificant causal relationships. For many in the media establishment, genetic causation is conceptually simple to understand and explain to an uninformed public, even if such reporting puts them completely at odds with the incremental nature of scientific advancement. But journalists, who usually have no scientific training or experience, often get their stories and information from press releases published by industry, government or interest groups rather than from the scientists themselves. The “spin,” then, usually begins long before the press begins to report.

Ultimately, though, it is the scientists and researchers themselves who bear much of the responsibility. The current system for assessing research productivity, combined with the demands to publish and attract both private and governmental research funding, puts enormous pressure on researchers to make, publicize and defend “breakthrough” discoveries. This is compounded by the added pressure of journals to publish “impact” papers. As a result, few genomics researchers publicly speak out against reductionist thought. Scientists must become their own best advocates if they are interested in an informed and unbiased coverage of their work nnn and its implications for society.

Volume 24 number 3 GeneWatch 39

The Folly of Geneticizing Criminal Behavior Using genetics to explain the causes of crime leads to some very problematic conclusions TROY DUSTER On June 20, 2011, the New York Times published an article entitled “Genetic Basis for Crime: A New Look” in anticipation of the start (that day) of the annual National Institute of Justice Conference in Arlington, Virginia. The article noted: “On the opening day criminologists from around the country can attend a panel on creating databases for information about DNA and ‘new genetic markers’ that forensic scientists are discovering.”1 The reporter noted how much the climate has changed in the last two decades, when social scientists studying crime generally eschewed any attempts to bring genetics into their explanatory models.

The general frame for the Times’ piece is that careful, thoughtful and reasonable social scientists are finally acknowledging that genes play a role in criminal behavior. By innuendo, only those social scientists that are ideologically bound to ignore the role of genetics hold to an outmoded view. This is very reminiscent of an article that appeared in the Chronicle of Higher Education two years earlier, in which a very similar frame was used even more dramatically, with the jaw-dropping opening lines: “Genetic research finally makes its way into the thinking of sociologists.

If sociologists ignore genes, will other academics—and the wider world—ignore sociology?”2 For both articles, the reporters interviewed me. The earlier piece cast me in the role of the backward looking Luddite trying to push back against the inevitable tide of progress in science. Indeed, this article stated 40 GeneWatch

that I go “…so far as to suggest that any sociologist who embraced genetic approaches was a traitor to the discipline.”

Actually, I said nothing of the kind.

Rather, in the article that the reporter references, I assiduously described the scaffolding of knowledge production around criminal statistics of both violent and property crimes, indicating how those who begin theorizing about such crimes with already collected crime statistics are likely to make a fundamental mistake in scientific inquiry.3 The first principle of data collection in science is the assurance of the accuracy and integrity of baseline data. If there is a systematic skew or flaw in the database, theories built upon that database are unreliable. This is as true for sociologists as it is for geneticists.

Before I turn to the matter of bringing in genetics to help explain criminal behavior, some historical context is necessary for how sociologists have made this error in theorizing about explanations of crime.

In the middle of the twentieth century, there were two major competing sociological approaches to the study of deviance, law, and the criminal justice system in the United States. The first was centered at Columbia, and could be generally described as dominated by Robert Merton and his students using the functionalist paradigm. Drawing from both Durkheim and Parsons, Merton and his colleagues approached the study of deviance by exploring the putative functional relationship between “the deviant world” and “the normal world.” Their

basic assumptions pivoted upon an empirical strategy relying on statistical aggregates of deviant and criminal behavior as reflected in local police records and the Uniform Crime Reports of the FBI. While there was an occasional foray into field site investigations, the overwhelming tendency of this approach assumed that the data from official statistics sufficiently reflected the empirical world, and that theorizing from these databases warranted little in the way of caution or concern.

The University of Chicago was the alternative and competitive approach, with a long tradition of field site investigations of particular forms of “deviance,” from “the gang” to “the hobo” to the prostitute, gambler, and other vice sets and settings.

Their practitioners literally went to those places in the society that any competent actor would presume to be the site of deviance.

While there were significant differences between Chicago and Columbia in their respective renderings of explanations of crime and deviance, in very important ways, both adopted a “taken-for-granted” world.

Onto this stage would step a third set of key players who would shift the focus to challenge the epistemological foundations of the whole playing field, and not just of theory and research on deviance. Egon Bittner and Aaron Cicourel would ride around in police cars and see just how and when police used discretion in their arrest procedures.4,5 David Sudnow would go to the Public Defender’s office and record the way June-July 2011

in which the Public Defender and the Prosecuting Attorney worked in concert to secure guilty pleas from “certain suspects” but let others bargain “harder” when their legal representation took a private turn.6 Erving Goffman would venture into mental hospital wards, and break the path for the next generation that would study intake decisions for mental institutions.7 In some ways, the methodology of this new breed of work seemed parallel to the earlier field research traditions. However, in fundamental ways, the domain assumptions were strikingly different. Chicago was mainly trying to find out and explain what “the deviants were really like” in their natural setting. The new approach was to raise another whole order of question: “What are the social processes that explain why some get classified and others don’t, even though both are engaged in the same or similar behavior?” When Cicourel and Bittner were riding around in police cars, observing and recording how official statistics are compiled, they were asserting that the point at which rate construction occurs is the preferred site for an investigation of

Volume 24 number 3

those otherwise “taken for granted” statistics that had been the structural underpinning database for theorizing about deviance and crime. It would not be much of a leap to conclude that, if the site of rate construction was the preferred focal point for inquiry and theorizing about these data, then surely it would have bearing and impact on all manners of rate construction, from epidemiological work in public health to coroner’s collective accounts of the causes of death.

The importance of data collection at the site of knowledge production There are powerful organizational motives for police departments to demonstrate effectiveness in “solving crimes.” It is a considerable embarrassment for a police department to have a long list of crimes on their books, for which no arrest has been made. No police chief wishes to face a city council with this problem.

Thus, there are organizational imperatives for police departments to clean up the books by a procedure known as “cleared by arrest.”

Few matters count as much as this

one when it comes to reporting to the public about what the police are doing.8 To understand how arrest rates are influenced by “clearing,” it is vital to empirically ground this procedure by close observation.

Here is the pattern: Someone, “P,” is arrested and charged with committing a crime, let’s say burglary. There are a number of other burglaries in this police precinct. The arresting officers see a pattern to these burglaries, and decide that the suspect is likely to have committed a number of those on their unsolved burglary list.

Thus, it sometimes happens that when “P” is arrested for just one of those burglaries, the police can “clear by arrest” 15-20 crimes with that single arrest. This can show up in the statistics as a “repeat offender,” even though there may never be any follow-up empirical research to verify or corroborate that the “rap sheet” accurately represents the burglaries now attributed to “P”.

But only if one is “riding around in police cars,” or doing the equivalent close-up observation of police work can this be corroborated as a pattern.9 And yet, if social theorists take the FBI Uniform Crime Reports as a

GeneWatch 41

reflection of the crime rate, with no observations as to how those rates were constructed, they will make the predictable “policy error” of assuming that there are only a very small number of persons who commit a large number of crimes. The resulting error in theorizing would be to then look for the “kind of person” who repeatedly engages in this behavior (as if it were not “cleared by arrest” that generated the long rap sheet). So the “bad apple” theory, that only a very few people commit the bulk of the crimes, may indeed be a function of the bureaucratic imperatives of police work. The “bad apple” solves a problem for police reporting of crimes “cleared by arrest.” But if sociologists, criminologists, and then behavioral geneticist begin their inquiry at this point, what they will have missed is the actual empirical behavior—in this case, the police requirement to clear-by-arrest.

Bringing in genetics – compounding the error at the base of data entry It is at this very point of knowledge production that we see the methodological problem of bringing in geneticists to help explain criminality. By definition, geneticists are seeking to find genetic markers, the usually very complex matter of finding the genotype to explain the phenotype. But this presumes that the Uniform Crime Reports represent the actual, concentrated behavior of single individuals with those genetic markers, and is not an artifact of bureaucratic resolution to an organizational imperative to “clear by arrest.” And it is this that I said sociologists should be focusing their research upon, namely the site of knowledge production in crime prevention, control and explanation!

Indeed, in that article, I explicitly cited the work of anthropologist of science Duana Fullwiley, who goes to 42 GeneWatch

the laboratories where geneticists deploy concepts such as racial admixture to examine how they are using the idea of race and ethnicity in their search for genetic markers.10 A recommendation for the preferred focus upon an empirical site where scientists can more accurately assess rate construction is a far cry from calling colleagues “traitors” for pursuing collaborative research. Instead, that framing of the problem is a red herring diverting attention from the problem of “bringing genetics in to help explain crime.”

I conclude with a dramatic example to illustrate the basic problem. We have reasonable grounds to conclude that although whites consume more marijuana per capita than do African Americans, it is African Americans who are routinely arrested for marijuana possession at least four to nine times the rate as are whites, depending upon the region of the country.11 If sociologists begin with these current arrest data for marijuana possession and then join with geneticists to help explain the sharply distorted over-representation of African Americans in the criminal database, they will have made the most fundamental of errors in scientific theorizing: never realizing the source of their error is based upon inattention to how crime rates are constructed.

Even worse, they will have erroneously concluded that they have “advanced scientific inquiry” by partnering with a neighboring discipline in a thoughtful, ecumenical embrace to better explain the genetic basis of drug crimes. nnn

Genetic Justice: DNA Data Banks, Criminal Investigations, and Civil Liberties National DNA databanks were initially established to catalogue the identities of violent criminals and sex offenders. However, since the mid-1990s, forensic DNA databanks have in some cases expanded to include people merely arrested, regardless of whether they've been charged or convicted of a crime. The public is largely unaware of these changes and the advances that biotechnology and forensic DNA science have made possible. Yet many citizens are beginning to realize that the unfettered collection of DNA profiles might compromise our basic freedoms and rights.

Two leading authors on medical ethics, science policy, and civil liberties take a hard look at how the United States has balanced the use of DNA technology, particularly the use of DNA databanks in criminal justice, with the privacy rights of its citizenry.

Sheldon Krimsky is a founding member of the CRG Board of Directors, Professor of urban and environmental policy and planning at Tufts University, and author of eight books and over 175 published essays and reviews.

Tania Simoncelli is a former member of the CRG Board of Directors and Science Advisor at the American Civil Liberties Union. She currently works for the U.S. Food and Drug Administration.

Troy Duster, PhD, is a Chancellor’s Professor of Sociology at UC Berkeley and professor of sociology and director of the Institute for the History of the Production of Knowledge at New York University.

June-July 2011

Genetics Without Ideology Our genes may play a role in nearly everything about us - but when it comes to behavioral traits, genetics makes a flawed fortune-teller KENNETH WEISS Ever since Darwin, there has been great controversy over the degree to which genes determine who we are.

The reason is that if genes determine individuals’ or groups’ nature, value judgments can be assigned to those genes—and the people who carry them—and social policy can be implemented accordingly. Much good has come from the pursuit of genes that cause disease, but racism and eugenics based on uncritical genetic determinism have also visited incalculable harm upon people.

There’s no legitimate doubt about the importance of genes in the making of organisms, or of the role of genetic variation among them. The theory of evolution led us to understand that life has diverged from a common origin, by way of inherited variation that has been screened by luck and its bearers’ ability to reproduce. 150 years of research have revealed much about the nature and importance of genes, and today the view of life that Darwin spawned holds genes to be primary instruments of the development of organisms.

Organisms develop from single cells. There is more in a cell than DNA, but only DNA carries the specific information that controls biological function. In a mechanistic sense, DNA is ultimately responsible for the structures of individuals.

Differences in traits among individuals are affected by differences in DNA, and by extension, Volume 24 number 3

populations that are isolated from each other gradually accumulate genome-wide differences. These differences affect both functional and non-functional sites in the genome, some of which are harmful.

It may thus seem unexceptionable to look for harmful genes and hope to intervene. The idea begins with detection, treatment and prevention of readily identifiable genetic diseases. That is now routine for some diseases. Hospitals screen newborn infants for a number of genetic conditions, and many couples submit to DNA tests to determine the possibility that they might pass a condition on to their children. The hope is that harmful alleles may even be removed from the human gene pool. Today such measures are largely voluntary, though screening newborns for some genetic disorders, notably PKU, has been mandatory for many years in the U.S., and widely accepted because there is effective treatment.

Things become problematic when

“public good” is used to advocate mandatory social policy. The belief that all traits are meaningfully genetic opens the extension of policy concerns beyond clear-cut genetic disease. Historically, that has stressed behaviors that experts and policymakers have chosen to define as undesirable, with special attention given to traits like homosexuality, insanity, drug or alcohol addiction, immorality, or aggression. Historically, that’s when the wheels came off.

Post World War II revulsion over abuses made in the name of eugenics and its racist nadir in Nazism led the nature-nurture cycle to swing to an environment-centered view of human traits, accompanied by declarations of human rights to prevent such kinds of discrimination. Physicians were even advised to avoid specializing in genetics because genetic diseases were rare and nothing could be done about them. It was felt that the common diseases and the diseases of older age were caused by environmental exposures and lifestyles; they were not genetic and could be addressed by therapeutic or preventive measures.

Similarly, psychologists and social scientists took behavioral traits off the genetic table.

But there has been a resurgence of genetic determinism.

Modern genetic technologies have made it increasingly possible to document the structure of DNA and to characterize gene function. Along with this came increased GeneWatch 43

ability to search for genetic effects underlying disease. In the process, awareness of raw abuses of the past has faded into a rather stunning complacency in the belief (once again) that our actions are entirely valueneutral and benevolent.

The fact is that most clearly measurable traits show substantial heritability. Offspring resemble their parents, even when environmental and statistical errors are accounted for. It is typical for roughly 30-50% of variation in a trait to be statistically accounted for in terms of genetic variation. Despite well known problems with heritability as a measure, this clear cut familial correlation feeds the determination to identify the genetic basis of any disease. There is considerable controversy about how efficacious such gene ‘mapping’ approaches are, but nobody wants to stand in the way of prevention and treatment of disease.

If disease traits that everyone agrees should be addressed clearly show genetic influences, then there is no scientific reason to think that other traits, including even culturally sensitive behavioral traits or group differences, should not also have some genetic basis as well. To deny that genetics is a part of the causal spectrum of inconvenient traits is to be an ostrich to the facts.

This may be difficult to accept in light of the brutal history of abuses in the name of Darwin, Mendel, the inherent value assigned to persons on account of their genes, and the patently facile way in which tiny indications of difference are extrapolated across vast evolutionary time periods.

Reconciling the legitimate scientific facts with the legitimate social fears is not easy.

Meanwhile, researchers are now excitedly proclaiming they have found the genes ‘for’ all sorts of behavioral traits, including such things as athletic or musical ability.

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Unfortunately, much of the stress is on the same kinds of “undesirable” traits that led to the abuses of the eugenic era. This is a return to the acceptance of inherency ushered in with the Darwinian view of life. As in the earlier reasoning, no one wants people to suffer needlessly from genes predisposing them to disease, and no one wants society to suffer needlessly from genes predisposing an individual to harmful social behavior. And as before, a belief in genetic inherency labels people from birth. It is entirely predictable that genetic screening that identifies people with a genotype supposedly predisposing them to crime will lead to various forms of surveillance (or mandatory preventive pharmaceutical “therapy”) before they commit their predestined offense. It is clear that this is only statistical risk, usually weak, and most of the individuals targeted as having the “criminal gene” will never commit an offense.

It is not easy to decide how to strike a proper balance between genetic determinism and civil society. At least, we should take a closer look at the facts. The issues are subtle and perhaps that is why they are not easily absorbed, even by professionals.

But they are important.

People and groups will always differ, on anything one can measure No two people or populations will be exactly identical on any measure.

There will always be some difference.

Whether it is statistically significant depends on the sample, the precision of measurement, and subjectively chosen probability criteria (like the typical 5% level). No one can pretend that such differences cannot, in principle, affect any trait. This is why if one chooses to sample from different continents one can make “races” seem so real, even though we know that the evolutionary processes are more continuous in nature.

However, one has to be careful about what such differences are.

Samples are usually compared by mean values, like average IQ scores or blood pressure levels. But usually there is a large overlap in the distributions, as illustrated in the Figure where the distributions differ by a typical half-standard deviation. The difference in the mean may be statistically “significant;” but that is not the same as importance, or even the main story. Similar statistical issues apply to comparisons of individuals defined as affected versus unaffected by disease or behavioral traits. Whether the mean differences are important relative to the overlap is a societal judgment. Such judgments have been, and are still, widely used to support racist views.

Why is genetic causation so elusive?

Mapping studies have been done on almost any trait one can imagine and in every major research organism, from bacteria to human. They have found very similar results that are entirely consistent with the genetic effects expected from our understanding of the evolutionary process and the nature of the way genes work.

Generally, there are one or a few strong effects at individually identifiable locations in the genome. The effects of these sites achieve at least suggestive statistical significance according to standard (though subjective) criteria, and have replicable association with the presence of the trait. However, such sites usually account for only a small fraction of the estimated heritability of the trait.

Accompanying them, ever-larger studies have shown that a host of sites—often estimated in the hundreds or more—have individually minute effects. Even in aggregate, these minor sites, or “polygenes,” still only account for a small fraction of the heritability. They rarely are replicJune-July 2011

able among studies or populations.

How predictive are genes?

Such findings reinforce the idea that genetic variation contributes overall to the trait in question, but does not directly address the question of the predictive power of individual genotypes, which is crucial to an understanding of genetic causation.

The same mapping results unambiguously show that the non-genetic environmental effects account for the bulk of variation.

Furthermore, heritability implies genetic involvement but says little or nothing about genotype-specific prediction. Individual multilocus genotypes are unique, and therefore we usually have little way to predict their specific effects because statistical association depends on replication.

More fundamentally (or even fatally) serious is that environmental exposures contribute the bulk of effects but are both poorly understood and unknowably changeable, meaning that the causal effects of all but the few, usually rare, strong genetic variants are contextually relative and quantitatively unpredictable.

The same is even truer of behavioral traits. For behavioral traits, much depends even on the purely cultural nature of their definition. As an obvious example, it is those in charge who define what is “antisocial”

or criminal behavior. Unscrupulous hedge fund managers walk the streets freely, while a large fraction of the US criminal population is incarcerated for drug-related offenses. A search for criminality genes would compare these “normal” and “criminal” groups to find genetic differences between them—genes “for” criminality. But if drugs were legalized, what had been offenders’ genotypes would overnight become “normal.” This cultural component is so obvious it is a wonder anybody accedes to the kinds of studies searching for genes “for” behavior increasingly being funded in our gene-centered age.

One must acknowledge that there is, at present, none of the racist or vitriolic judgmental fervor that drove the classic eugenic movement. But the genetic ideology and target traits are similar, and that’s what raises caution about where the enthusiastic promises of finding the genes conferring specific value-laden behaviors may go.

What, if anything, can be done to recognize the effects of genes and yet protect against exuberant application of genetic determinism? Could one identify a line beyond which research is banned because its findings might be too likely to be misused? That may seem like unacceptable or unenforceable censorship, but in fact, society routinely makes such decisions. For

example, investigators are not allowed to torture people as part of a scientific experiment (even if, for some reason, they could be persuaded to consent).

We already make informal discriminatory decisions based on traits that have some genetic basis. Intelligence, however you want to measure it, surely is in that category. Bright students are assigned faster academic tracks, are admitted to the best universities, or are given special mentoring and encouragement. It seems acceptable to base such discrimination on test scores, perhaps because that at least reflects achieved ability.

But many would object if we used genetic tests instead, even if, for example, it might identify those in whom even earlier investment was warranted.

The search for simple answers affects society and science alike. The complexity and uncertainties of nature encourage both progress and problems, but the lesson is clear: Genes are involved in everything, but not everything is “genetic.” nnn

Kenneth M. Weiss, PhD, is Evan Pugh Professor of Anthropology and Genetics at Penn State University.

The author thanks Anne Buchanan for helpful critique of this commentary.

25 Years of GeneWatch GeneWatch Anniversary Archive: 1983-2008 The Council for Responsible Genetics was founded in 1983 to provide commentary and public interest perspectives on social and ecological developments of biotechnology and medical genetics. For a quarter of a century, the Council has continued to publish its magazine GeneWatch with articles by leading scientists, activists, science writers, and public health advocates. The collection of GeneWatch articles provides a unique historical lens into the modern history, contested science, ethics and politics of genetic technologies. The full archive of GeneWatch has been incorporated into this special anniversary DVD that includes an index of all the authors and titles.

Copies of the anniversary DVD are available for a $100 donation to: Anniversary CRG DVD Council for Responsible Genetics 5 Upland Rd., Suite 3 Cambridge, MA 02140

Volume 24 number 3

GeneWatch 45

A Synthetic Biology Lab in Berkeley Is public health and safety being considered in the construction of a new biolab in Berkeley?

JEREMY GRUBER, TINA STEVENS In April of this year, U.C. Berkeley researchers announced the creation of the U. C. Berkeley Synthetic Biology Institute (SBI), which will ramp up efforts to “engineer” cells and biological systems.1 Part of its research will include experiments that insert manufactured stretches of DNA into existing organisms to create new, self-replicating artificial life forms—experiments that pose implications for worker safety, public health and environmental safety. A collaboration of university and industry, the SBI enterprise is designed to catapult basic research into profit making applications. From a press release, “SBI will be an important link in a constellation of research centers focused on synthetic biology at UC Berkeley and Lawrence Berkeley National Laboratory (LBNL), both of which have made the field a research priority. SBI is unique in its planned collaborations with leading companies, designed to translate leading research on biological systems and organisms efficiently into processes, products, and technologies.”2 Where this extensive new research will take place is a matter of some speculation. LBNL, managed by U.C. Berkeley but funded by the Department of Energy, is seeking to open a second campus somewhere in the East Bay, across from San Francisco. The new facility hopes to combine three existing facilities presently scattered throughout the cities of Berkeley and nearby Emeryville: the Joint BioEnergy Institute, the Life Sciences Division,

46 GeneWatch

AND

BECKY MCCLAIN

and the Joint Genome Institute.

Potential sites for a new campus include a number of locations in the City of Berkeley itself.3 What do residents make of this idea? Lawsuits have stymied LBNL’s effort to expand into the region’s Strawberry Canyon watershed, described by activists as “a rich repository of wildlife.”4 Now concern over second campus proposals, which include targeted locations along the west Berkeley shoreline, has centered on issues of job creation, tax revenues, zoning, and predictions of rising sea levels. It remains to be seen whether health and safety issues uniquely associated with this research also will be raised. Do adequate safety protections exist? Or are entirely new safety assessment and reporting methodologies for this research required in order to safeguard worker, public and environmental wellbeing?

Biosafety level (BL) containment labs are ranked from 1-4 according to the risk of harm they pose, with increasing levels indicating increasing danger. Typically, BL1 labs perform research on non-human infectious agents; BL2 labs use biological agents that could infect humans but are assumed to cause only “moderate harm”; BL3 labs experiment with biological agents capable of killing humans but for which there are known antidotes (like anthrax); and BL4 labs conduct research using agents that could kill humans and for which there is no known antidote.

Which safety lab levels will the new campus house? What constitutes

“moderate harm?” Will the citizenry of this densely populated urban area know what pathogens are being used for research? Since academic and private interests operate under different safety, liability, and oversight restrictions, which research safety guidelines will apply? What remedies will apply in the event of lab worker injury, or environmental or public safety hazard? Will there be a public safety infrastructure facilitating transparency and accountability? Is the patchwork of voluntary regulatory guidelines from existing agencies adequate?

A brief review of just a few incidents of lab worker exposure to hazards suggests that even current biolab regulation and oversight is not adequate.

These include Dr. Jeannette AduBobie, who after visiting a New Zealand lab suffered a meningococcal infection from a laboratory strain causing loss of both legs and an arm; Ru-ching Hsia, a Department of Agriculture scientist who became infected by laboratory E.coli strain and lapsed into a coma for a month;, and University of Chicago scientist Malcolm Casadaban, who died after unknowingly being infected with a laboratory plague bacterium.5 One of this essay’s co-authors, molecular

June-July 2011

biologist Becky McClain, won a whistle-blower suit against pharmaceutical giant Pfizer after reporting public health and safety concerns.6 She fell ill after an untrained lab worker used a human infectious genetically engineered virus, without suitable biocontainment, on McClain’s personal workspace. She began experiencing periodic paralysis and spinal pain, a result consistent with the DNA-coded effects that had been engineered within the pathogen. Recently, researchers from the U.S. Centers for Disease Control and Prevention (CDC) reported that a University of Illinois laboratory worker was infected by a genetically engineered cowpox laboratory virus, one with which she had never worked. CDC investigators not only found cowpox DNA in many areas around the lab, they also discovered that supposedly harmless stocks of viruses had been contaminated.7 Problematically, releases of laboratory bio agents are difficult to track since exposures often are not visible to a worker who succumbs to a mystery illness. Scientists can become ill from dangerous biological exposures without knowledge of having endured an exposure.

Public health also is a serious consideration. Severe acute respiratory syndrome (SARS) killed nearly 800 people in 2003. Lab versions of the SARS pathogen are known to have escaped BL 3 and BL 4 labs via infected lab workers.8 And a few years ago, at Berkeley itself, workers handled deadly Rocky Mountain Spotted Fever (which spreads in the air) without containment when it was mislabeled as harmless.9 The U.S.’s 2001 anthrax scare10 and the unknown source of the virulent, antibioticresistant strain of E.coli that has recently infected thousands in Europe and, so far, killed 27 raise serious questions about the effectiveness of tracking, as well as accountability.11 There is no central authority that Volume 24 number 3

coordinates research and planning on synthetic biology. Even though synthetic biology poses serious risks, there are no specific standards for determining threat levels to humans, animals, plants, microorganisms or the environment. Experiments involving the synthesis of completely novel synthetic DNA sequences can make a harmless microbe into a new pathogen with dangerous and far reaching consequences. There are very real concerns that synthetic biology research could result in enhanced virulence, the ability to infect a wider range of organisms, and resistance to antimicrobials, antivirals, vaccines and other treatment or containment responses. As Jonathan Tucker and Raymond Zilinskas explain in “The Promise and Perils of Synthetic Biology,” because synthetic microorganisms are self-replicating and capable of evolution, they could proliferate out of control and cause environmental damage and, if they escape from a research laboratory or containment facility, threaten public health. For this reason, they pose a unique risk unlike those associated with toxic chemicals or radioactive materials.12 Synthetic biology research also raises new issues regarding the degree to which laboratory workers are prepared to engage in such research.

Synthetic biology is an interdisciplinary field, involving the activities of chemists, engineers, physicists, and computer scientists as well as biologists. Many practitioners in these fields have never had training, let alone professional experience, in biosafety13.

The most recent issue of GeneWatch featured Lynne Klotz’s report on Boston University’s feeble risk assessment efforts, undertaken to assure Boston citizens that its lab, which is likely to be conducting research on SARS and the deadly 1918 flu virus, is acceptably safe.14 The University and the NIH claimed

that emergency simulations supported moving ahead with the desired research. The National Research Council did not agree, concluding that “the model did not appear to recognize biological complexities and reflect what is known about disease outbreaks and other biological parameters.”15 In other words, both Boston University and the NIH had conducted a risk analysis that ignored the most basic information actually needed to assess the lab’s risks. This cautionary tale should provoke additional public scrutiny of any new biolab facility. Berkeley’s City Council, as well as the governing entities of the other Bay Area cities who want the lab, may want to keep track of what unfolds in Boston—remembering that Boston, unlike the San Francisco Bay Area, is not even on a major earthquake fault line. Considering the current limitations of oversight and the problems of accountability of the various public and private partners involved in the project, it is less than clear what steps they are prepared to take in order to ensure the safety of any new facility engaged in synthetic biology research.

Boosters have heavily promoted the theoretical benefits of synthetic biology to the public and local officials.

They need now to be much more forthcoming in detailing the very real dangers attendant to such research, including broadly publicizing comprehensive risk assessments. Potential neighbors, and others who stand to be impacted by any facility conducting synthetic biology research, deserve better from the University and its partners, and from government representatives charged with protecting public health and safety. nnn Jeremy Gruber is President of Council for Responsible Genetics. Tina Stevens and Becky McClain are board members of Alliance for Humane Biotechnology.16 GeneWatch 47

Engineering a Red Herring Congress answers the call on GE salmon, but will it be enough?

COLIN O’NEIL

Last month over ninety groups cheered as the U.S. House of Representatives passed an amendment that would bar the U.S. Food and Drug Administration from using funds in the 2012 fiscal year to approve a genetically engineered salmon currently under review. Its passage, which is now headed to the U.S. Senate for debate, has been celebrated by environmental, consumer, health, and animal welfare organizations, along with fishing groups and associations, food companies and businesses.

Representatives Lynn Woolsey (DCA) and Don Yong (R-AK) should be applauded for their stalwart protection of wild salmon, yet commentators sympathetic to the financial interests of the biotech company behind the salmon have begun to discredit the Congressional intervention, calling the amendment Congressional activism and policy devoid of science.

Now the public, the investment community and even journalists are being led to believe that genetic engineering isn’t merely a tool but it is vital to solving the problems facing our world’s oceans. This idea that a technology like genetic engineering will solve such large and complex problems—the “techno-fix” mentality—can spiral out of control easily, and when left unchecked can create a problem exponentially larger than the original.

The case of the GE salmon is no different. The engineered Atlantic salmon currently under review by the FDA was developed by AquaBounty Technologies, which artificially combined growth hor48 GeneWatch

mone genes from an unrelated Pacific salmon with DNA from the antifreeze genes of an eelpout. This modification causes production of growth hormone year-round, creating a fish the company claims grows at twice the normal rate. Its proponents suggest that this fish will be a panacea to solve depleting wild stocks, chronic pollution and the need to feed a growing population.

The danger in supporting such an application is not merely that GE salmon will fail to meet these goals and will likely cause more problems than they solve, but that in doing so they will distract policymakers, members of the public and experts from identifying robust and comprehensive solutions for the underlying problems we face, becoming a veritable engineered red herring.

As previous articles in GeneWatch have described, the GE salmon application raises numerous concerns for biodiversity and the overall ecological health of our aquatic environments.

An unintended escape of GE fish would likely result in interbreeding

with wild counterparts, increased pressure on wild stocks for food resources and mates, disruption of food chains and a potential impact on waterfowl and other non-fish species.

AquaBounty claims that all its fish will be sterile females, but its own data shows that the triploid sterilization process is not effective in about five percent of treated eggs. Even in the absence of escape, GE fish would likely result in a number of unintended consequences including the propagation and spread of deadly fish diseases, concentration of harmful wastes and industrial drugs and chemicals escaping into rivers, lakes and open waters, and the over-fishing of forage fish for use as feed.

The farming of carnivorous fish like salmon requires massive quantities of wild forage fish for use as fishmeal and fish oil, inputs that cannot sufficiently be replaced by vegetarian alternatives.

It can take from 3 to 10 lbs. of forage fish to produce just 1 lb. of farmed salmon.1 This is a discrepancy that stands to be made worse by GE salmon designed to grow faster as they will likely need more food, thus increasing the pressure on wild fish stocks that are already over-fished for use in aquaculture operations.

Keep in mind that the forage fish being used in substantial quantities for aquaculture feed are the same prey fish that wild species like dolphins, tuna, sharks, whales and wild salmon depend on as their main source of food. Forage fish like sardines, herrings and anchovies are also a vital component in June-July 2011

human diets in many places around the world where prices for salmon (farmed or wild-caught) will remain out of reach. The public is being led to believe that GE salmon will reduce the pressure on wild stocks, but they are being deceived.

If farming GE salmon will not reduce pressure on wild stocks, why is it being proposed? Genetic engineering in aquaculture is being promoted because fish farms suffer the same reduction in growth that any other livestock operations do. When animals are confined they aren’t as healthy and don’t grow as fast, and fish are no different. Creating a fish that the company claims grows at twice the normal rate is designed to mitigate reduction in growth experienced as the result of over-crowding.

Farmed fish, including farmed salmon, are already given more antibiotics than any other food animal by weight. By AquaBounty’s own admission, GE salmon will be weaker and more susceptible to disease than conventional salmon. This fact will require salmon farms to increase their use of antibiotics on the GE salmon they raise in order to prevent the spread of disease within their tanks or

pens. Genetic engineering is merely a band-aid solution on the failing fish farm experiment.

Fortunately, there are alternatives.

Taking a cue from Alaska, which has prohibited fish farming and instead invested in proper management, wild fisheries can flourish when properly supported and can produce abundant food as well as generate jobs and economic benefits across multiple sectors. In fact, this year Alaska has experienced near-record returns in its wild salmon fisheries. The seafood industry in Alaska is the largest private sector employer, creating 56,600 direct and 22,000 indirect jobs annually, more jobs than oil, gas and mining combined.2 Research published by Andrew Dyke and U. Rashid Sumaila notes that wild fisheries can also have significant economic impacts in other sectors, such as agriculture, forestry, manufacturing and financial services.

They found that regionally, every $1 of fisheries-sector output supports more than $3 of output throughout the North American economy.3 Many of Alaska’s salmon processors are based in Seattle and elsewhere in Washington, Oregon or California,

meaning that revenue and value is generated and spread across many states.

Approval of GE salmon to be grown across our borders in Canada, which the company is seeking, is not in our nation’s best interest, especially given the tremendous investment that has been made by Federal and State agencies to restore wild salmon fisheries in the Northeast where Atlantic salmon is currently on the endangered species list.

Our oceans and marine environments stand at a crossroads, but fortunately, the American people have been given a choice. Do we continue down the road toward further industrialization, consolidation and ecological degradation? Or do we muster the political will to support those members of Congress who reject the notion that a single technology, like genetic engineering, will solve our ocean’s problems and instead advocate for policy changes that will effectively nnn protect them?

Endnotes

8. http://ny.cryosinternational.com/private-customers/donor-search.aspx (spelling errors in original).

9. Joanna E. Scheib, Sperm Donor Selection and the Psychology of Female Mate Choice,” 15 Ethology and Sociobiology 113-129 (1994).

10. http://yancey-farms.com/horse.htm 11. http://www.cryobank.com/DonorSearch/Look-A-Likes/

presented at the Consultation, My body, my life, my rights: Addressing violations of women’s sexual and reproductive rights, Asia Pacific Forum on Women, Law and Development. Thailand 5. Id. 6. Pande (2010).

7. Spivak, G. C. (1998). In Other Worlds: Essays in Cultural Politics. London: Routledge

Vrinda Marwah, p. 10 1. Hartman, B. (2010). The Gene Express: Speeding Toward What Future? In Unraveling the Fertility Industry: Challenges and Strategies for Movement Building by Sama- Resource Group for Women and Health 2. Pande, A. (2009). Not an ‘angel’, not a ‘whore’: Surrogates as ‘dirty’ workers in India. Indian Journal of Gender Studies, 16(2): 141-173 3. Pande, A. (2010). Commercial surrogacy in India: Manufacturing a perfect motherworker. Journal of Women in Culture and Society, 35(4):969-992 4. Shah, C. (2009). Surrogate motherhood and women’s sexual and reproductive rights. Paper

Lori Haymon, p. 16 1. John A. Robertson, Preconception Gender Selection, 1 Am. J. of Bioethics 2, 4 (Winter 2001).

2. F. Lucy Raymond, Molecular Prenatal Diagnosis: the Impact of Modern Technologies, 30 Prenatal Diagnosis 674, 674 (2010).

3. Carolyn J. Chachkin, What Potent Blood: Non-Invasive Prenatal Genetic Diagnosis and the Transformation of Modern Prenatal Care, 33 Am. J. L. & Medicine 9, 9 (2007).

4. Y.M. Dennis Lo, Noninvasive Prenatal Diagnosis in 2020, 30 Prenatal Diagnosis 702 (2010) (hereinafter NIPD 2020).

5. Mark W. Leach, Abortions on Disabled Continued on following page

Lisa C. Ikemoto, p. 4 1. Debora L. Spar, The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception 3 (2006).

2. Id. at 35.

3. http://www.fairfaxcryobank.com/ 4. http://www.cryobank.com/how-itworks/donor-recruitment/donor-pyramid/ind ex.cfm?&CFID=35788155&CFTOKEN=381500faf7b7b146-A741A7C5-3048-B0 03-6E87EA142DB8EA19&jsessionid=8430744524dc83b3c2a97c527b657e6e 3834 5. See, e.g., https://www.eggdonor.com/donorprofile/?pid=40095 6. Joanna E. Scheib, Maura Riordan & Phillip R. Shaver, Choosing Between Anonymous and Identity-Release Sperm Donors: Recipient and Donor Characteristics, 10 Reproductive Technologies (now Reproductive Biomedicine Online) 50-58 (2000).

7. https://www.eggdonor.com/donors/tips-forcreating-a-great-egg-donor-profile/

Volume 24 number 3

Colin O’Neil is the regulatory policy analyst for the Center for Food Safety a public advocacy non-profit organization based in Washington, D.C.

GeneWatch 49

Endnotes (continued) Babies: The Prenatal Testing Sham, LifeNews.com, available at http://www.lifenews.com/2011/05/25/abortions-on-disabled-babies-the-prenatal-testing -sham/ (May 25, 2011, 11:59 AM).

6. According to some scholars, legitimate reasons for sex selection exists, including adherence to certain religious beliefs and cultural traditions, Robertson, supra note 1, at 3, but these are often not medically motivated rationales.

7. T. Mukherjee, et al., Unexpected Gender Bias Found in IVF Cycles for Sex Selection, 88 Fertility & Sterility (Supplement 1) S134 (2007).

(A 2007 study found that only 4 of 30 reviewed in vitro fertilizations with preimplantation genetic diagnosis procedures were conducted to avoid sex-linked diseases.

The rest were performed for elective sex selection.)

8. Edgar Dahl, et al., Preconception Sex Selection Demand and Preferences in the United States, 85 Fertility and Sterility 468, 473 (Feb. 2006) (concluding, among other things, that the demand and preference among the US general population for certain fetal sex is low, and noting “[t]he results of our study are consistent with findings from prior social research.”).

9. William Saletan, Fetal Subtraction: Sex Selection in the United States, SLATE.com, available at www.slate.com/id/2188114 Slate (posted Thursday, Apr. 3, 2008, at 7:59AM ET) 10. Dahl, supra note 19, at 473 (concluding, among other things, that the demand and preference among the US general population for certain fetal sex is low, and noting “[t]he results of our study are consistent with findings from prior social research.”).

11. Id. 12. Id. 13.Michael J. Malinowski, Choosing the Genetic Makeup of Children: Our Eugenics Past – Present and Future?, 36 Conn. L. Rev. 125, 133 (2003-2004). (hereinafter Our Eugenics Past) 14. Id. 15.Ananda van den Heuvel et al., Will the Introduction of Non-invasive Prenatal Diagnostic Testing Erode informed Choices? An Experimental Study of Health Care Professionals, 78 Patient Education and Counseling 24 , 28 (2010) (“[H]ealth care professionals are likely to approach counseling and service provision of non-invasive diagnostic tests in a clinically significantly different way to invasive procedures.”)

16.Kat Zambon, Case Studies Illustrate the Dilemmas of Genetic Testing, American Association for the Advancement of Science, www.aaas.org (posted April 29, 2011) (last visited June 28, 2011) (quoting David Litwack).

17. Theresa M. Marteau & Elizabeth Dormandy, Facilitating Informed Choice in Prenatal Testing: How Well Are We Doing?, 106 American Journal of Medical Genetics 185, 189 (2001).

18. NIPD 2020, supra note 3.

19. Raymond, supra note 1, at 677. As a consequence of fetal DNA accounting for only 5-10% of the DNA in the maternal serum, current technology is best equipped at isolating

50 GeneWatch

fetal DNA by distinguishing paternally derived genes in fetal DNA that are not found in the maternal DNA. Id. 20. Melissa Hill et al., Incremental Cost of Noninvasive Prenatal Diagnosis Versus Invasive Prenatal Diagnosis of Fetal Sex in England, 31(3) Prenatal Diagnosis 267 (Mar. 2011); 21.Caroline F. Wright, The Use of Cell-Free Fetal Nucleic Acids in Maternal Blood for Noninvasive Prenatal Diagnosis, 15 Human Reproduction Update 139, 140 (2009).

22. Id. 23. Y.M. Dennis Lo et al., Digital PCR for the Molecular Detection of Fetal Chromosomal Aneuploidy, 104 Proc. Nat’l. Acad. Sci.13116 (2007); Chachkin, supra note 2, at 11.

24. CVS and amniocentesis are the adopted standard of care methods for prenatal genetic diagnostic and both procedures are held to 9899% accuracy standards. Chachkin, supra note 2, at 35.

25. See Chachkin, supra note 2, at 37.

26. Peter A. Been and Audrey R. Chapman, Ethical Challenges in Providing Noninvasive Prenatal Diagnosis, 22 Current Opinion in Obstetrics and Gynecology 128, 129 (2010); see also The Genetics and Public Policy Center John Hopkins University, Reproductive Genetic Testing: A Regulatory Patchwork, (“In the United States, there is no uniform or comprehensive system for the regulation of assisted reproductive technologies, including reproductive genetic testing. The federal government does not have direct jurisdiction over the practice of medicine. Moreover, it has banned all federal funding for research involving the creation or destruction of embryos.

Consequently, the regulatory framework for reproductive genetic testing in the United States is characterized by a patchwork of federal and state regulation.”), available at http://www.dnapolicy.org/policy.international.php?action=detail&laws_id=63 (January 2004).

27. United States Government Accountability Office, Direct-to-Consumer Genetic Testing: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices (Thursday, July 22, 2010) 28. Michael J. Malinowski, Coming into Being: Law, Ethics, and the Practice of Prenatal Genetic Screening, 45 Hastings L. J. 1435, 1494 (1993-1994).

29. John A. Robertson, Preconception Gender Selection, 1 A. J. Bioethics 1, 4 (Winter 2001).

30. See Parens, supra note 44, at S15 (“According to Asch, most abortions reflect a decision not to bring any fetus to term at this time; selective abortions involve a decision not to bring this particular fetus to term because of its traits. Pro-choice individuals within and outside the disability community agree that it is morally defensible for a woman to decide [against an unwanted pregnancy] . . . . The question is whether that decision is morally different from a decision to abort an otherwise-wanted fetus.”)

31. Mitchell CB. The Church and the New Genetics in Genetic Ethics (Kilner JF, Pentz RD, Young FE, eds., WM B Eerdmans Pub-

lish’g Co.) (1997).

32. Chachkin, supra note 2, at 40.

33. Chachkin, supra note 2, at 40 (reasoning that the likely consequence of clinical NIPD is that the cost of bringing a child to term with predicted disabled traits may very well become disfavored, when compared to covering NIPD tests.)

34. George J. Annas, Ethical aspects of non-invasive prenatal diagnosis: medical, market, or regulatory model?, 47 Early Human Development (Supplement) S5, S11 (1996).

35. Erik Parens & Adrienne Asch, The Disability Rights Critique of Prenatal Genetic Testing: Reflections and Recommendations, 29 The Hastings Center Report (Special Supplement) S1, S6 (Sep. - Oct., 1999).

36. Id. at S13.

37. Id. at S1 (emphasis added).

38. Id. at S13.

39. Id. at 40 (quoting Harriet McBryde Johnson, Unspeakable Conversations, New York Times Magazine Feb. 16, 2003 Sunday, Late Edition.

40. Joan Retsinas, The Impact of Prenatal Technology Upon Attitudes Toward Disabled Infants, 9 RES. SOC. HEALTH CARE 75, 8990 (1991).

41. See also Dorothy C. Wertz & Bartha Maria Knoppers, Serious Genetic Disorders: Can or Should They be Defined, 108 Am. J. of Medical Genetics 29 (2002) (hereinafter Serious Genetic Disorders).

42. Including individuals certified by the American Board of Medical Genetics, the American Board of Genetic Counseling, the European Society of Human Genetics, the Canadian College of Medical Genetics, or the IberoAmerican Society of Human Genetics (an organization of professionals from Spanish and Portuguese-speaking nations). The majority of the respondents were members of the Canadian College of Medical Genetics, with less than 40% of the respondents were from Spanish or Portuguese-speaking nations.

Dorothy C. Wertz & Bartha Maria Knoppers, Serious Genetic Disorders: Can or Should They be Defined, 108 Am. J. of Medical Genetics 29 (2002) (hereinafter Serious Genetic Disorders).

43. Serious Genetic Disorders, supra note 89, at 31-33.

44. Id. 45. Mark W. Leach, Abortions on Disabled Babies: The Prenatal Testing Sham, LifeNews.com, available at http://www.lifenews.com/2011/05/25/abortions-on-disabled-babies-the-prenatal-testing -sham/ (May 25, 2011, 11:59 AM).

46. Id. 47. John A. Robertson, Genetic Selection of Offspring Characteristics, 76 B.U.L. Rev. 421, 446 (1996) (hereinafter Genetic Selection of Offspring).

48. Holtzman, supra note 831, at 398.

49. Genetic Selection of Offspring Characteristics, supra note 64, at 480.

50. Id. at 479.

51. “Eugenics.” Oxford American Dictionaries.

(Oxford University Press, 1999).

June-July 2011

Marsha Darling, p. 27 1. See Amrita Pande, “Commercial Surrogacy in India: Manufacturing a Perfect MotherWorker,” Signs, Vol. 35, No. 4, 969-992, 2010, and Lisa C. Ikemoto, “Reproductive Tourism: Equality Concerns in the Global Market for Fertility Services,” 2009.

2. ART self-reporting data in the United States: Victoria Clay Wright, et. al. Division of Reproductive Health, CDC, “Assisted Reproductive Technology Surveillance, United States, 2003,” in Surveillance Summaries, May 22, 2006; for Canada and the United States: Edward G. Hughes, et. al. “Cross-Border Fertility Services in North America: A Survey of Canadian and American Providers,” http://fertstert.org/article/S0015-0282(09)04144-2; and for Europe: F. Shenfield, et. al “Cross Border Reproductive Care in Six European Countries,”Human Reproduction, Vol. 25, no. 6, 1361-1368, 2010.

3. Legal status of ARTs: Liberal regulations in Spain, Belgium, Cyprus, Czech Republic, India; Jordan, Israel, South Africa; no regulations in US, Ukraine; strict regulations in Germany, France, the UK, Italy, Queensland and Victoria in Australia, Iceland, Sweden, Austria, Norway, Turkey; pending regulation in Thailand.

4. See Magdalina Gugucheva, Surrogacy in America. Cambridge, MA: Council for Responsible Genetics, 2010.

5. Re allegations of price-fixing: Marimer Matos, Human Egg Donor Files Antitrust Class Action, Courthouse News Service, April 14, 2011.

6. See especially the longstanding commitment of feminist organizations to protecting women’s health, well-being, and reproductive rights of FINRRAGE in Australia and Bangladesh, SAMA in India, ISHA L’ISHA in Israel and Boston, USA based OurBodies/OurSelves.

7. Author is grateful to Kathy Sloan for her assistance in providing important data for this article.

Hedva Eyal, p. 36 1. D. Sperling (2010). “Commanding the “Be Fruitful and Multiply” Directive: Reproductive Ethics. Law, and Policy in Israel,” Cambridge Quarterly of Healthcare Ethics, 19: 363-371.

Troy Duster, p. 40 1. Cohen, Patricia 2011. “Genetic Basis of Crime: A New Look,” New York Times (June 19) 1: Arts Section.

2. Shea, Christopher 2009. “The Nature-Nurture Debate, Redux,” Chronicle of Higher Education, The Chronicle Review (January 9).

3. Duster, Troy 2006. “Comparative Perspectives and Competing Explanations: Taking on the Newly Configured Reductionist Challenge to Sociology,” American Sociological Review, 71 (February: 1-15) 4. Bittner, Egon 1967. “The Police on Skid-Row: A ‘study of peace-keeping.’” American Sociological Review 32:699–715.

5. Cicourel, Aaron V. 1967. The Social Organization of Juvenile Justice. New York: Wiley.

6. Sudnow, David 1965. “Normal Crimes: Sociological Features of the Penal Code in a Public Defender Office.” Social Problems 12:255–76.

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7. Goffman, Erving 1959. “The Moral Career of the Mental Patient.” Psychiatry 22(2):123–42.

8. Skolnick, Jerome H. 2002. “Corruption and the Blue Code of Silence.” Police Practice and Research 3:7–19; Skolnick, Jerome H. and James J. Fyfe. 1993. Above the Law: Police and the Excessive Use of Force. New York: Free Press.

9. Jackall, Robert 2005. Street Stories: The World of Private Detectives. Cambridge, MA: Harvard University Press.

10. Fullwiley, Duana 2008. ‘The Biologistical Construction of Race: ‘Admixture’ Technology and the New Genetic Medicine,” Social Studies of Science 38(5): 695-735; Fullwiley, Duana 2007, “The Molecularization of Race: Institutionalizing Human Difference in Pharmacogenetics Practice,” Science as Culture, 16 (1): 1-30.

11. Blow, Charles 2010. “Smoke and Mirrors. “ New York Times (Oct. 22) at: http://www.nytimes.com/2010/10/23/opinion/23blow.html also see graph at: http://www.nytimes.com/imagepages/2010/10 /23/opinion/23blow_chart.html?ref=opinion); Levine, Harry and Deborah P. Small 2008, Marijuana Arrest Crusade: Racial Bias and Police Policy in New York City, 1997-2007.

New York Civil Liberties Union, final version, 2010a at http://www.nyclu.org/files/MARIJUANA-ARREST-CRUSADE_Final.pdf; Levine et al. 2010b, “Arresting Blacks for Marijuana in California,” Drug Policy Alliance, Los Angeles, Ca, Oct 2010.

Jeremy Gruber, Tina Stevens and Becky McClain, p. 46 1. “Lab, Campus Collaborate in Formation of Synthetic Biology Institute,” Today at Berkeley Lab, April 21, 2011. http://today.lbl.gov/2011/04/21/lab-campuscollaborate-in-formation-of-synthetic-biology -institute/; Synthetic Biology Institute, University of California, Berkeley. http://synbio.berkeley.edu/index.php?page=ne ws-events 2. “UC Berkeley Launches Synthetic Biology Institute to Advance Research in Biological Engineering,” Agilent Technologies, April 19, 2011. http://www.agilent.com/about/newsroom/presrel/2011/19apr-gp11012.html 3. “LBNL Announces Community Meetings on Second Campus at Berkeley Chamber Forum,” The Berkeley Daily Planet, June 8, 2011.http://www.berkeleydailyplanet.com/issu e/2011-06-8/article/37958?headline=LBNLAnnounces-Community-Meetings-on-Second -Campus-at-Berkeley-Chamber-ForumNews-Analysis 4. http://savestrawberrycanyon.org 5. “A Higher Bar for Pathogens, But Adherence Is an Issue,” Andrew Pollock, NY Times, May 27, 2010. ttp://www.nytimes.com/2010/05/28/business/28hazardside.html?_r=1&scp=1&sq=Cas adaban&st=cse 6. “A Roach in the Kitchen: Interview with Becky McClain,” GeneWatch March/April 2010, vol 23, Issue 2, http://www.councilforresponsiblegenetics.org/genewatch/GeneWatchPage.aspx ?pageId=248&archive=yes 7. “First U.S. Cowpox Infections: Acquired from

Lab Contamination,” by Sarah Reardon, Science Insider February 17, 2011. http://news.sciencemag.org/scienceinsider/2011/02/first-us-cowpox-infection-acqu ired.html?ref=ra 8. “SARS in the City,” by Lynn C. Klotz, GeneWatch April/May 2011. http://www.councilforresponsiblegenetics.org /genewatch/GeneWatchPage.aspx?pageId=33 7 9. “Texas A&M Bioweapons Accidents More the Norm than an Exception,” Sunshine Project July 2007. http://www.sunshineproject.org/publications/pr/pr030707.html . (accessed 3rd of July 2011).

10. “Amerithrax or Anthrax Investigation” US Federal Bureau of Investigation. http://www.fbi.gov/about-us/history/famouscases/anthrax-amerithrax/amerithrax-investig ation 11. “German E. coli death toll rises further,” CNN World June 9, 2011. http://articles.cnn.com/2011-0609/world/europe.e.coli_1_ecoli-sprouts-sign-o f-e-coli?_s=PM:WORLD 12 “The Promise and Perils of Synthetic Biology,” Jonathan B. Tucker, Raymond A. Zilinskas, The New Atlantis, Spring 2006. http://www.thenewatlantis.com/publications/t he-promise-and-perils-of-synthetic-biology 13 “Diffusion of Synthetic Biology: A Challenge to Biosafety,” by Marcus Schmidt Systems and Synthetic Biology Journal (June 2008).

14 “SARS in the City,” by Lynn C. Klotz, GeneWatch April/May 2011. http://www.councilforresponsiblegenetics.org /genewatch/GeneWatchPage.aspx?pageId=33 7 15 National Research Council (2007). Technical Input on the National Institutes of Health’s Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University: A Letter Report, Washington, DC: National Academies Press. www.nap.edu/catalog.php?record_id=12073. (accessed 3 July 2011).

16. The authors acknowledge helpful comments from Stuart Newman.

Colin O’Neill, p. 48 1. Naylor, R.L and Burke, M. (2005) Aquaculture and Ocean Resources: Raising Tigers of the Sea. Stanford University Annual Review of Environment and Resources, Vol. 30, page(s) 185-218; Pinto, F. and Furci, G. (2006) Salmon Piranha Style: Feed Conversion Efficiency in the Chilean Salmon Farming Industry, Edited

by R. Pizarro, Terram Publications.

2. Northern Economics of Anchorage (January 2009) The Seafood Industry in Alaska’s Economy. Commissioned by the Marine Conservation Alliance, At-sea Processors Association and the Pacific Seafood Processors Association.

3. Dyck, A.J. and U.R. Sumaila. 2010. Economic impact of ocean fish populations in the global fishery.

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