GeneWatch Vol. 23 No. 1

FEA TURES GeneWatch exclusive: DNA ancestry study raises ire in Middle East //

Terri Carlson: “Will Marry for Health Insurance” // GeneWatch exclusive: India’s battle over biotech eggplant // Court rules against gene patents in BRCA case VOLUME 23 NUMBER 1 JANUARY-FEBRUARY 2010

SYNTHETIC BIOLOGY

THE MAGAZINE OF THE COUNCIL FOR RESPONSIBLE GENETICS • ADVANCING THE PUBLIC INTEREST IN BIOTECHNOLOGY SINCE 1983

GENEWATCH JANUARY-FEBRUARY 2010 VOLUME 23 NUMBER 1 & DESIGNER Sam Anderson

EDITOR

EDITORIAL COMMITTEE

Ruth Hubbard

Sheldon Krimsky

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 EVAN BALABAN, PhD McGill University PAUL BILLINGS, MD, PhD, University of California, Berkeley SUJATHA BYRAVAN, PhD Centre for Development Finance, India ANDREW IMPARATO, JD President and CEO, American Association of People with Disabilities RAYNA RAPP, PhD New York University PATRICIA WILLIAMS, JD Columbia University

STAFF Jeremy Gruber, President and Executive Director Sheila Sinclair, Manager of Operations Sam Anderson, Editor of GeneWatch Kathleen Sloan, Program Coordinator Andrew Thibedeau, Fellow

Editorial

Sam Anderson

If you spend more than a few minutes reading about synthetic biology - and I mean reading press, not academic journals - you will invariably find some reference to the field's 'do-it-yourself' component. It's easy to think of synthetic biology as the next step in 'playing God,' but there is a lot more going on beyond the broad ethical "should we really be doing this?" concerns.

Not everyone thinks that we should plow forward, but there are reasons that we don't see serious campaigns for moratoriums on research and application of synthetic biology as compared to, for instance, genetically modified foods.

For one, most people simply do not know much about synthetic biology. If you would have asked me a year ago what a BioBrick is, I probably would have thought it was something from a health food store (not that you didn't already know, but BioBricks are actually DNA sequences which can be assembled into customized genetic code and inserted into organisms to construct entirely new biological systems). I don't mind telling you that because I had plenty of company: Eleonore Pauwels [p 8] cites a 2008 study in which 90% of Americans said they knew little to nothing about synthetic biology.

Another reason synthetic biology has not drawn much rabid criticism is that its potential benefits hold tantalizing promise. Whereas GM foods are often seen - correctly - as being mostly propagated by a handful of profit-seeking transnational corporations, synthetic biology is becoming increasingly accessible, to the point that groups such as New York University's DIYbio NYC specifically seek to make synthetic biology available to "citizen scientists" and "amateur biologists."

This open access to a potentially dangerous technology demonstrates the need for careful attention to synthetic biology's governance and regulation. This will only become more important with the further development of the technology and, with it, the amplified ambitions of the new bioengineers.

It's safe to say that no one is anywhere near capable of literally producing blackbirds from scratch in a petri dish.

Nevertheless, with the U.S. Department of Defense already suggesting the utility of creating an immortal organism with a built-in 'off' switch - and setting aside $26 million of next year's budget for synthetic biology and BioDesign programs the metaphor on this cover may not be so farfetched.

Featured artist COVER ART Sam Anderson Unless otherwise noted, all material in this publication is protected by copyright by the Council for Responsible Genetics. All rights reserved. GeneWatch 23,1 0740-973

2 GENEWATCH

Brett Fitzgerald graduated from Brandeis University in 2008 and is pursuing a certificate in graphic design from Massachusetts College of Art and Design. Brett works as a freelance designer and illustrator, and you can find more of his work at www.flickr.com/photos/brettvsty18 JANUARY-FEBRUARY 2010

Contents

Synthetic biology has roots in experiments that weren’t biology at all (p. 10)

Nature in the Laboratory GREGORY E. KAEBNICK

4

DIYbio: Biosecurity and the Entrepreneurial Future GAYMON BENNETT

6

Who Let the Engineers Into the Lab? ELEONORE PAUWELS

8

Dreaming of Les Jardins Chimiques ANDREW THIBEDEAU

10

Sugar Shock:The New ‘Biomassters’

12

If mishandled, the risks of synthetic biology are perhaps just as startling as its promises (p. 8)

A preview of an ETC Group’s upcoming report

Playing With Fire SAM ANDERSON

14

‘Will Marry for Health Care’

16

An interview with Terri Carlson

India passes a moratorium on Bt brinjal; GE backers move to Plan B (p. 18)

Biotech Eggplant: Ignoring the Resounding ‘No’ DEBBIE BARKER

18

Book Review: Ordinary Genomes ANDREW THIBEDEAU

20

Topic: Consumer Genetic Testing

22

Researchers searching for Israel’s lost tribes stumble into controversy (p. 14)

JEREMY GRUBER Film Review: Made in India KATHLEEN SLOAN

23

Gene Patents: Nature’s Handiwork?

ANDREW THIBEDEAU

24

Endnotes

27

Photographs of Les Jardins Chimiques © Stéphane Querbes for Les Atomes Crochus and Anima-Science. We are thankful to M. Querbes and our friends at Les Atomes Crochus and Anima-Science, who provided these photographs to GeneWatch as a courtesy. See page 26 to learn more about their work and for more of these stunning images.

VOLUME 23 NUMBER 1

GENEWATCH 3

Nature in the Laboratory Should synthetic biology be treated differently from old-fashioned ‘genetic engineering’?

BY GREGORY E. KAEBNICK

Genetically modified organisms have sprouted a new head. Well, sort of. The field dubbed “synthetic biology”—hailed by some as the biggest development in science and technology since the emergence of modern chemistry, and as the biggest development in the world economy since the industrial revolution—can also be seen as merely a new and improved version of the kind of genetic engineering that’s already been around for a few decades. According to this deflationary view, synthetic biology differs from older genetic engineering merely in that it employs better tools, more automation, and more information about the biological systems under study. It is “jet-powered genetic engineering,” as one person in the field has put it to me.

The more grandiose view holds that synthetic biology is so much better, faster, and stronger than its predecessors that it can assume a new identity. It can bring to biology the principles of engineering: biological systems and subsystems can now be simplified, modularized, standardized, characterized, documented, and made openly accessible, allowing people to assemble and reassemble them in new ways without having to know very much about the underlying biology. According to this view, “genetic engineering” was only a metaphor in the 1990s, and not a very good one. In actuality, what we misleadingly call genetic engineering depended on trial and error, arcane scientific insight, and considerable dumb luck. Today, real genetic engineering is a possibility. Building new biological systems could be like building things out of Lego bricks.

This little bit of background provides a starting point for evaluating

4 GENEWATCH

the field and thinking about its social implications. Let’s start with the most abstract and in some ways the most confounding concern: does synthetic biology change the human relationship to nature in morally undesirable ways? Some believe that opposition to genetically modified organisms, even when articulated in terms of concerns about risks and benefits, is grounded in a concern that applying this technology to crops and livestock was just a bridge too far: it brought human control over nature to a level that was morally troubling even before risks and benefits were considered.

Moreover, it brought that change to the farm, the garden, and the food supply, aspects of human culture where (at least for some) the relationship to nature is particularly important.

Of course, exactly how to understand this concern—and therefore how to understand its implications for synthetic biology—is contested.

Interestingly enough, when this topic is on the table, those who see synthetic biology as new and exciting tend to want to downplay its newness. They want to argue, in fact, that everything is on a continuum with traditional breeding—that breeding is itself a kind of genetic engineering.

My own inclination is to defend the distinctions but then set them more or less to one side. As the science journalist Michael Pollan has beautifully argued in a series of books, breeding makes use of the basic structure of evolution—direct descent with modification followed by natural selection. Humans just do the selecting. The new biotechnologies make human intervention more complete and intrusive. Very crudely: with traditional genetic engineering, natu-

rally occurring modification (which is just genetic replication with errors, of course) is supplanted by human modification; with synthetic biology, the capacity to write an entire genome means that not only naturally occurring modification but also direct descent is no longer necessary.

So the new technologies look different to me. But does the difference make a moral difference? I share a deep concern about the human relationship to nature, but I have come to suspect that this way of arguing against synthetic biology (and traditional genetic engineering) makes too much of the gene and of the principles of evolution. Why give them such moral weight? Why draw the line against human intervention exactly here? If a biologist managed to synthesize the entire genome of some existing, naturally occurring organism, would the organism really be troubling just because the genes were strung together in a lab?

There are some additional reasons for not getting too upset about synthetic biology—or at least, about many of its possible uses. First, another of the ways in which synthetic biology is different from much traditional genetic engineering is that it’s about microbes, not crops and cows; it goes on in the laboratory and maybe someday the factory, not the farm and the garden; and it has more to do with medicines and fuels than with food. (I am fudging somewhere here; some possible agricultural applications are discussed.) Second, if it is mostly contained in the lab or factory, the consequences for the environment might be minimal. The paradigm cases of morally troubling human intervention into nature involve damage—the extinction of species, the disappear-

JANUARY-FEBRUARY 2010

ance of ecosystems, the development of wildernesses. The fact is, if synthetic biology turns out to be successful at all, then it might even be environmentally quite beneficial. One project now in development is the creation of algae to produce fuel (hence “oilgae”) while simultaneously absorbing large amounts of carbon dioxide; the environmental costs of producing and transporting the fuel could be environmentally sounder (it would not have to be pumped out of the ground and then floated and piped from distant rigs), wars motivated by competing national interests in oilrich places would be unnecessary, and the absorption of carbon dioxide might even help offset the environmental costs of eventually burning the fuel.

If this is right, then the next question is whether the organisms actually will really be contained and environmentally harmless. Any careful answer must be modest and provisional; we do not yet know. Certainly there are reasons to be concerned. I once heard a biologist say that he is extremely enthusiastic about synthetic biology; the only thing that worries him is the possibility of catastrophe.

There are two general sorts of concerns one might have in mind.

One is about biosecurity. In 2002, a scientist at SUNY - Stony Brook employed the techniques of synthetic biology en route to recreating the polio virus. In 2005, the 1918 Spanish influenza virus was recreated.

Eventually, we will probably be able to progress—if “progress” it is—from viral to bacterial pathogens, such as smallpox. Next, we might be able to improve on the base designs to make pathogens more virulent. Some work in Australia on mousepox has suggested design tweaks that might help smallpox overcome the immune system, for example. And then we might get even more creative. In theory, perhaps entirely novel pathogens could be created. And all of these steps could be undertaken with other targets in mind—agricultural, for example, or environmental.

That at least some of these threats are theoretically plausible is well established. The likelihood of their

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actually happening is harder to assess. Arguably, terrorists have better ways of attacking their enemies than with bioweapons, which are still comparatively hard to make and very hard to control. Once released, such live ammunition could turn on everybody.

Another concern is about biosafety. If biosecurity leads to worries about bioterror, biosafety has to do with “bioerror.” The prospect is that synthesized microbes could escape from the laboratory or the factory and then turn out in their new environ-

Brett Fitzgerald

ment to have properties different from what was intended and predicted—or perhaps mutate to acquire them or hybridize with wild type strains. If they became established in the wild, they might pose a threat to public health, or to agriculture, or to the environment.

The likelihood that lab and industrial accidents will happen is surely very high; just as information wants to be free, nature wants out of confinement, and since it is the nature of humans to make mistakes from time to time, a way out seems likely to be available. With biosafety, it is the theoretic plausibility of the threat that is harder to assess. Synthetic organisms would be designed to invest their energy in producing jet fuel or medicine rather than to advancing their own interests, they would be designed to do it in a very specialized setting that caters to their needs, and they might be greatly simplified, stripped-

down organisms that lack tools helpful for survival in adverse circumstances and generally lack the genetic complexity and therefore adaptability necessary to deal with changing circumstances. They might simply be too weak to hold their own in the wild.

Finally, synthetic biologists assure us, they can be designed so as to be flatly incapable of surviving in the wild.

The possibility that synthetic biology could be a kind of engineering rather than an esoteric science is relevant for assessing the biosecurity and biosafety risks. If building synthetic organisms could be analogous to building things with Lego bricks, then the field would not be restricted to a smattering of well-funded, highprofile laboratories around the world. It could be dramatically democratized. It might turn out that important and even innovative work could be done by relatively inexperienced people. This is an exciting prospect to those who promote the engineering orientation, since it could give the field tremendous impetus. On the other hand, it could also make the field very difficult to monitor and regulate. Small-scale and underground labs could flourish, and the threats concerning biosecurity and biosafety would be more serious. The scenario is of a computer hacker, but with real viruses instead of software ones.

The challenge is to figure out how to get in front of these developments.

As David Rejeski, director of the Science, Technology, and Innovation Program at Woodrow Wilson, observed in a recent essay, the environmental movement missed the first Industrial Revolution, but this time around it could help guide change, rather than just trying to clean up afterwards. The promise of synthetic biology is too great to stop the field in its tracks (supposing that possible), but the risks are too great to leave it alone.

Gregory E. Kaebnick ,Ph.D., is a Research Scholar and Director of the Editorial Department at the Hastings Institute. He is also editor of the Hastings Center Report.

GENEWATCH 5

DIYbio: Biosecurity and the Entrepreneurial Future Weighing the risks and promises

BY GAYMON BENNETT Synthetic biologists alternately voice interest and irritation about DIYbio—Do-It-Yourself Biology. The interest is straightforward. DIY-biologists have been styled as biology on the entrepreneurial cutting-edge: branded as the biological equivalent of 1960s Silicon Valley engineers; able to accomplish in the garage what was once only possible in elite university and industry labs.

The irritation is a bit more complicated. If the youth of DIYbio are cast as innovative, they are just as often cast as dangerous. Headlines of “The geneticist in the garage” are usually followed by subheadings reading “But are they a danger to us all?” Which might not be a problem, except that DIYbio is also just as frequently cast (or at least connected to) as synthetic biology. Synthetic biologists may not mind a bit of reflected light from the ostensible edginess of DIYbio, but, naturally, they’d like to be able to distance themselves when strategically necessary.

That DIYbio and synthetic biology have been connected and confused is not altogether surprising. Several of the organizers of the online community diybio.org cut their biological teeth in synthetic biology labs. Many of the key participants in the DIYbio community first got interested in bioengineering through iGEM, the annual engineering competition designed to catalyze excitement for synthetic biology among undergrads from around the world. And many have found employment in synthetic biology start ups, few as they are.

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Despite overlap of participants and ambitions, similarities between DIYbio and synthetic biology shouldn’t be overstated. Taking two online organizations as a mark of the relative differences, we can say that not all DIY-biologists define their work by the effort to “A) design and construction of new biological parts, devices, and systems, and B) the re-design of existing, natural biological systems for useful purposes.”1 Similarly, not all synthetic biologists organize their research in the name of helping to make “biology a worthwhile pursuit for citizen scientists, amateur biologists, and DIY biological engineers.”2 Nevertheless, at a substantive level the synthetic biology and DIYbio communities do share something of a common goal and orientation. As one leading synthetic biology institution puts it, the goal is to “make biology easier to engineer” and to make materials and know-how openly available.

Most participants in DIYbio, offering relevant caveats, would certainly sign on.

Biosecurity It’s for reasons of this commitment to ease and access that funders and three-letter agencies have paid such close attention to the development of these two communities.

Biosecurity, not surprisingly, is an overriding concern. Actualizing the double goal of “making biology easier to engineering” and making it “widely available” will no doubt catalyze a new range of actors and actions. But what this means for biosecurity in

real terms, let alone what should be done about it, remains less than clear.

Take DIYbio. Far from “creating monsters in the garage” as one recent headline put it, DIY-biologists are spending their time on the mundane problems of securing space, resources, and access to expertise.

The Bay Area group of DIYbio, for example, has spent a preponderance of their time and effort simply trying to establish space for a “community lab.” The problem is not simply lack of funds; several local organizations have offered room for benches. The problem, rather, is that DIYbio has few legal precedents to turn to in dealing with zoning restrictions.

At the level of resources, DIY-biology is, of course, limited by access to basic tools of the lab, from journal subscriptions to PCR machines. As such, a number of community members are designing and fabricating low cost alternatives such as turning a $10 web-camera into a microscope or a $30 rotary drill into a centrifuge.

As for synthetic biology, the situation is yet again more complicated.

The scale and mode of work differs enough across labs to belie easy definition of this emerging field, let alone to allow for straightforward regulatory responses to either problems of security or commercialization. For example, the BioFAB, an NSF funded “public benefit facility,” is working to produce collections of freely available standard biological parts. The assumption is that the production and release of such standard parts will energize the creation of standard

JANUARY - FEBRUARY 2010

design rules and practices, with all that entails in terms of growth in users and uses.

On the other side of the country, and taking a different strategic approach, the Church lab at Harvard has developed the Multiplex Automated Genome Engineering technique to facilitate whole genome engineering. The technique can perform hundreds of edits on the E coli genome, generating a wider range of proteins at a much faster rate than any known natural or designed system. The process produces on the order of 4 billion genomic variants per day.

Containment From Asilomar forward the prevailing regulatory mode for biosafety has been technical and organizational containment. Broadly speaking, containment has consisted of two tactical components: restricting those who have access to materials and knowhow, and designing biological constructs in such a way that they can’t live outside the lab. This strategic mode has proved successful, and, as

“The days of biology being pursued primarily in elite institutions with guarded security gates are obviously long behind us.” such, it is currently being pushed forward as a model on which to base biosecurity responses to synthetic biology and DIYbio.

But the extent to which a mode of containment can prove effective in a world of global biotechnology is very much in question. The days of biology being pursued primarily in elite insti-

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tutions with guarded security gates are, obviously, long behind us. Despite this, many still maintain that in the global circulation of materials and know-how, a few bottle-necks remain at which something like technologies of containment might be put to work.

Hence, DNA synthesis companies are fine-tuning and regularizing their screening mechanisms for pathogens and rogue scientists. And hence, several synthetic biologists are working on designing “safe chassis”—engineered hosts for engineered constructs, which will either die outside laboratory conditions, or safely integrate into natural ecosystems.

Both of these responses, necessary as they may be, will eventually show their limitations. If synthetic biology and DIYbio are successful in their goals, the synthesis companies will no longer be a bottle neck in the production of designed DNA. And however effective safe chassis prove to be in terms of ecological safety, they will eventually be hacked and rewired. Or, more likely, actors will simply find ways to ignore them.

Brett Fitzgerald

Preparedness In today’s biosecurity landscape events of interest are likely to be low probability/high consequence. What this means is that biosecurity will need to be more than a matter of prevention and containment. Rather, biosecurity will also need to be a matter of preparedness. Preparedness activities might include on-theground tracking of the ramifications of synthetic biology and DIYbio, or training in emergency response to biological events. Less familiar activities might include scenario development and stakeholder war-gaming.

For all the attention given to the topic of security and synthetic biology, funders and regulators alike have been slow to implement preparedness as a strategy alongside screening and the design of safe chassis. This means that a first order of business today is to deal with the political fact that, for many, an emphasis on preparedness

remains less attractive than an emphasis on containment. It is less attractive for the uncomplicated reason that preparedness forces us to face up to the fact that we simply do not know the full extent of dangers on the near-future horizon, nor opportunities for that matter.

The research informing this article is being co-conducted with Paul Rabinow and Anthony Stavrianakis.

Thanks to Nils Gilman and Tito Jankowski for additional contributions.

Gaymon Bennett is a doctoral student at the Graduate Theological Union in Berkeley. His work concerns the interactions of religion, politics, and science, with a focus on bioethics.

GENEWATCH 7

Who Let the Engineers Into the Lab? Synthetic biology and the importance of public engagement

BY ELEONORE PAUWELS

Thirty years ago, Waclow Szybalski and Anna Marie Skalka stated that new developments in science had given birth to an era of ‘synthetic biology’ which extends beyond simple analysis and description of existing genes to the design of novel gene assemblies.1 Science has finally caught up with their predication.

Synthetic biology differs notably from genetic engineering by synthesizing and using biological parts and systems that do not occur in nature. A series of developments in DNA synthesis, sequencing technologies and the ability to design and engineer biological circuits that could produce complex behaviors, have enabled the advent of synthetic biology.

This new technology is now at the forefront of what the National Science Foundation has termed “converging technologies,” which includes bio, info, nano, and cognitive sciences. A lot of innovation will occur in the interstitial or “white” spaces between these disciplines, but this emerging multi-disciplinary smorgasbord will provide several challenges, mainly in terms of the ability for new fields to regulate their own actions, anticipate unintended consequences, communicate effec-

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Brett Fitzgerald

tively with each other and the public, and solve what some political scientists term “collective action” problems. There will likely be new challenges in managing ethical, social, and legal issues at the boundaries between disciplines. This clearly echoes the early hopes and fears raised by nanotechnology, another “converging technology,” whose emergence went hand in hand with an array of publicly funded research activities into its ethical, legal and safety implications.

Synthetic biology has the potential to play a key role in local economic development over the coming decades. A new wave of scientists and engineers are learning how to design and construct microorganisms from the ground up, by applying engineering principles to biology. Although the technology is in its infancy—with clusters of bio-engineering activities

in the Boston technology corridor and the Silicon Valley2—advances in genetic recoding are beginning to enable researchers to program microbes to produce chemicals ranging from biofuels to medical drugs.

Yet the future of synthetic biology is far from certain. As an innovative and potentially disruptive technology, there are question concerning the safety, security and social acceptability of synthetic biology that must be addressed if it is to succeed. Charting a path forward that nurtures innovation while avoiding very real safety, security and ethical pitfalls, will require smart policies and broad partnerships amongst stakeholders.

The global synthetic biology community has been engaged in discussions over safety and security from the beginning, but if the benefits of this new technology are to be fully realized without creating a legacy of

JANUARY - FEBRUARY 2010

harm, more effort is needed. This includes further research on potential environmental and human health risks and better public engagement.

Broader public engagement on the sensitive societal implications of synthetic biology should begin now.

As shown by the 2008 poll, “Awareness of and Attitudes towards Nanotechnology and Synthetic Biology”, the American public is unaware of synthetic biology, with about 9 in 10 adults saying they have heard a little or nothing at all about it.3 Despite this lack of awareness, a two-thirds majority was willing to express an initial opinion regarding the tradeoff between potential risks and benefits of synthetic biology.

Certainly, the promises of synthetic biology are startling. For example, synthetic organisms can be used to create new and inexpensive pharmaceuticals, and to convert cellulose into sustainable biofuels. A 2009 poll, also conducted by Peter D. Hart Research Associates, confirms that communication about potential applications of synthetic biology can be a decisive factor in shaping its public perception.4 This survey showed that over half of U.S. adults supported research on synthetic organisms to develop more efficient biofuels.

Questions remain, however, about the potential risk of synthetic biology. A new microbe that synthesizes a life-saving drug will be a hard sell if it also presents new environmental hazards or could be used to develop the next generation of bio-weapons. In addition, it is still unclear how people will respond to a technology that potentially enables scientists to create new living organisms from scratch. For instance, Hart’s 2009 poll found that nine in ten Americans think that the public should be better informed about this type of research.

More crucially, perhaps, 30% of U.S. respondents consider it morally wrong to create artificial life, and 30% are concerned about the potential misuse of synthetic organisms.

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“By its very nature and goals ... synthetic biology challenges our approaches to oversight and regulation.”

Indeed, there are serious social, ethical and safety concerns surrounding synthetic biology. It is the classic double-edged sword: this new technology could be used to create virulent pathogens or wean us from fossil fuels. By its very nature and goals – applying engineering to the biological world in order to develop complex synthetic microorganisms – synthetic biology challenges our approaches to oversight and regulation. The novel properties exhibited by synthetic biology-derived microorganisms can underpin innovation but also present new levels of uncertainty while assessing potential health and environmental risks.

In addition, some observers have described the synthetic biology community as having some of the qualities of a “hacker culture,” probably due to the preponderance of engineers and computer scientists that have crossed disciplinary lines to enter this field. This raises an additional concern of whether someone could create a real and potentially deadly virus, rather than a computer virus, just for the “bragging rights.”

Beyond these biosafety and biosecurity concerns, scholars from diverse disciplines and sectors who study the implications of new technologies increasingly discuss the social and ethical implications of synthetic biology. Are synthetic biologists playing God? How does this new engineering science test our conceptions about life, nature and the order of things? What is the impact of the engineering community and its collective practices on social or biological systems? As an innovative and potentially disruptive technology,

there are question marks all over the social benefits of synthetic biology that will need answers and dialogues with citizens and societal actors if it is to succeed.

In conclusion, synthetic biology is evolving in the shadow of public consciousness – a situation that may serve the short-term interests of the research community, but not the long-term interests of society. It is unlikely that more than a small percent of the public have even heard the term synthetic biology, as shown by the aforementioned quantitative and qualitative studies commissioned by the Wilson Center. This lack of public awareness and engagement sets the stage for what some have termed the “Surprise of Dolly” problem (which refers to the appearance of the cloned sheep, Dolly, in 1997). “Without prior discussion of ethical issues, the general public cannot develop a framework or common language to discuss acceptable uses of a new biomedical technology, or even whether it should be used at all.”5 Public backlash against synthetic biology is a real possibility and could compromise the development of valuable applications resulting in the loss of economic and social benefits.

Eleonore Pauwels is Research Fellow with the Synthetic Biology Project Science, Technology and Innovation Program, Woodrow Wilson International Center for Scholars.

GENEWATCH 9

Dreaming of Les Jardins Chimiques A note on method

BY ANDREW THIBEDEAU

Stéphane Querbes

1.

It is the ambition of synthetic biology to unlock the secrets of life by creating it anew. This is, of course, the ambition of all biology—to discover hitherto unknown facts about how life works. To say that something is synthetic, however, is to say that it is artificial, “fake, false . . . man-made, manufactured, fabricated.”1 In the realm of biology, these terms carry a host of negative implications. It is the artifactuality of biotechnology itself that gives rise to many central issues in bioethics. What is more, modern culture has erected an entire iconography of fear around the notion of man-made life. As the title of one book on the subject suggests, to create synthetic life is to walk in “Frankenstein’s footsteps.”2 But is the field of synthetic biology akin to Dr. Frankenstein’s laboratory?

I argue that it is not. Rather, the label synthetic has afflicted synthetic biolo10 GENEWATCH

gy with many negative associations that are at least prima facie undeserved.

Synthetic biology is the ongoing effort to “develop[] artificial systems using engineering design tools . . . to explore new functions by modifying existing organisms.” It aspires to make both cellular and non-cellular biological structures that function in ways not found in the natural environment. It is in this sense unnatural.

The creation of “artificial systems” is not an end in itself, but rather a means “to improve the understanding of various biological mechanisms.” In other words, synthetic biology is a method. 3 Method can be described as “the proper arrangement of our mental processes in the discovery and proof of truth.” There are two primary methods: analysis and synthesis. Analysis proceeds “from the concrete to the abstract, from the complex to the sim-

ple . . . from the phenomena to the underlying general law, from the effect to the cause.” Synthesis is the converse of analysis. It passes “from the simple to the complex, from the general to the special . . . from cause to effect.” 4 My focus is the latter. My argument is that a consideration of the meaning of synthesis as a scientific methodology suggests that synthetic biology can be viewed as instrumentally valuable, which is to say: valuable as a means to an end.

2.

In the first decade of the 20th Century, French scientist Stéphane Leduc “showed that a spectacular plant-like growth occurs when crystals of metal salts . . . are dropped into an aqueous solution of sodium silicate.”5 His experiments produced multicolored plant-like filaments that appeared to grow from crystal surJANUARY - FEBRUARY 2010

faces, which he called “les jardins chimiques”—chemical gardens. To microscope and naked eye alike, Leduc’s chemical gardens were highly biomimetic. (See Fig. 1) Long green stalks grew from turquoise beds of crystal; osmotic action produced celllike structures that seemed indistinguishable from simple prokaryotes.

Based on these experiments, in 1912 Leduc published La Biologie Synthétique, in which he postulated using chemical synthesis “as a means to understand the basic biology of organic growth and morphology.”6 He believed his work held the key to “les lois générales de la vie”—general laws of life.7 These laws, Leduc believed, could “illuminate the nature and origin of life by bridging the gap between the living and the nonliving, offering a new version of the ‘missing link’ between inorganic and organic.”8 Although Leduc’s findings proved unrelated to life—they were instead the results of oxide precipitation and osmotic growth, two chemical processes now well-understood—they nevertheless demonstrated the heuristic value of what Leduc called “la méthode synthétique.”9 Leduc himself observed in La Biologie Synthétique that “[a] general theory, containing even a great element of error, promotes progress more than no theory at all.”10 Leduc posits that “synthetic biology represents a new, legitimate scientific method [that tries] to reproduce outside of living beings, each of the phenomena of life.”11 Leduc’s work was explicitly modeled “par l’imitation de la vie”—by the imitation of life. His method was synthetic and his approach analogical: “the relevance of these phenomena is in their analogy with what we observe in living beings.”12 In his experiments he believed that he observed “la reproduction des cellules artificielles, des structures, des tissus, des formes générales, des fonctions, de la circulation centripète et centrifuge.”13 Instead, he was observing far simpler chemical processes. Although Leduc’s les jardins chimiques never bore fruit, his method was nevertheless a significant step forward for modern biology.

In one sense, Leduc’s work was important because it argued against the concept of vitalism. Vitalism is

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Each branch of science at its commencement employs only the simpler methods of observation. It is purely descriptive. The next step is to separate the different parts of the object studied—to dissect and to analyze.

The science has now become analytical. The final stage is to reproduce the substances, the forms, and the phenomena which had been the subject of investigation. The science has at last become synthetical.15

Fig. 1 “the doctrine that the phenomena of biology are due to a vital principle distinct from physicochemical forces, and cannot be explained by the laws of physics and chemistry alone.”

Positing that life is the result of some “nonnatural, perhaps unknowable, properties of living systems,” vitalism still held sway among many biologists when Leduc wrote La Biologie Synthétique. The notion dates to the Greek philosophers, who believed that the cause of an event happening in the physical world is the so-called Aristotelian efficient cause, which by definition is external to the thing acted upon. In other words, the Aristotelian theory of causality at the heart of vitalist theories of life holds “that there is a basic discontinuity between that which acts and that which is acted upon.” This discontinuity introduces the “unknowable” element to vitalism that threatened to delimit an endpoint to biology itself.

Through the work of many notable scientists including Leduc, however, by 1966 Francis Crick assigned vitalism to the “lunatic fringe.”

3.

Despite les jardins chimiques ultimate failing to relate to the processes of life, Leduc’s work nevertheless stands with that of Darwin and Pasteur because of his method.14 In this sense, his experiments are a testament to the synthetic: not as something “artificial” or “man-made,” but as a methodological approach to biology. As Leduc wrote in The Mechanism of Life:

Following Leduc, synthesis as a scientific methodology has certain inherent advantages over analysis. To approach a problem analytically is to arrive at a generalization grounded in observations of individual phenomena. It is the work of science to build up these generalizations into theories that aim to explain the phenomena.

Galileo’s study of planetary motion, for example, led to his refinement of Copernicus’ heliocentric theory of astronomy. But analysis can be a tricky business. Although observing the same planets as Copernicus and Galileo, for millennia astronomers held to Ptolemy’s inaccurate geocentric cosmology.

Put simply, Ptolemaic doctrine stated that all heavenly bodies moved in perfect circles and placed the earth at the center of a vast “celestial sphere,” upon which rotated all the stars and planets. For reasons now obvious, Ptolemy’s theory failed to account for retrograde planetary motion: when the planets observed from earth appear to move backward in their orbits. Rather than devise a new conceptual system, early astronomers invented “epicycles”— smaller circular orbits whose center moved along the circumference of the celestial sphere. (See Fig. 2) As conflicting observational data accumulated, astronomers produced ad hoc increasingly complex systems of compound circular movement to account for them.

Nevertheless, despite remaining the dominant planetary theory for more than a millennium, “[n]o version of [Ptolomy’s geocentric] system ever quite withstood the test of additional refined observations.” continued on p. 13

GENEWATCH 11

Sugar Shock: The New ‘Biomassters’ An upcoming report from ETC Group focuses on the emerging not-so-green biomass economy - with synthetic biomass on the horizon

A massive, deliberate grab on all of Earth’s plant life is now underway and accelerating.

This grab on power and plants has in its sights capturing the entire ‘primary production’ of the planet - that is the full amount of new plant life grown in a year. It aims to collect as much of this as possible for energy, transform it into high value chemicals, fuels, and new “green” materials and ultimately to re-engineer the plants themselves, both to increase their productivity and to reap profits in so-called “ecosystem services”.

This grab comes as part of an audacious attempt by high tech companies, in concert with fuel, forestry and agribusiness giants, to capture new market segments while transforming the most abundant organic compounds on the planet – sugars – into a new commodity stream. Many other industrial sectors, including fertilizer companies, coal, pharma, pulp and paper and the nanotechnology industry will also reap profits in the process. The means for this coup is to progressively replace fossil hydrocarbons (coal, oil, gas) with living carbohydrates (plants) as the principal feedstock of the global economy while monetizing the ecological value of flora, fauna and socalled ‘ecosystem services’ that underpin biomass production.

The ETC Group report, to be released this spring, is a first attempt to uncover and describe the full scope of that biomass coup before it is too late. It is also an urgent call for resistance. It documents the outlines of an emerging new “biomass economy” that has so far received plenty of investment and political support but very little critical analysis. To date

12 GENEWATCH

this emerging “bio-based economy” has been largely hyped as a green and clean shift away from petroleum dependence.

The Biomassters report does not dispute or defend the deadly role that fossil fuels have played over the last 200 years, or the toxic legacy of coal, fossil oil and petroleum-based chemicals. Nor does it seek to denigrate the appropriate and sustainable biomassbased economies that traditional communities have arranged themselves in for millennia. Those are now perilously under threat and will become even more so as the new biomass economy gathers momentum.

ETC Group is concerned, however, that in the rush to exit the fossil nightmare, well-meaning decision makers (and some elements of civil society) are running headlong into the arms of an equally dangerous alternative that is unjust, unhealthy and unsustainable. That alternative vision assumes that it is possible to maintain current levels of consumption and economic growth while safely switching from fossil carbon sources to a biomass-based economy.

This assumption is wrong. As this report demonstrates biomass use and production have very precise limits on our finite Earth.

A rough budgetary analysis of the planet’s available stocks of plant material, accounting for those that must remain untouched for ecosystems to continue functioning, shows that far from having plentiful biomass at our disposal to achieve such a transition, we are in what has been called “earth overshoot” – already appropriating more plant matter than we have available for our use – an ecological ‘credit crunch’ with dire

Sam Anderson

implications.

Attempting such a crude switch from fossil carbon to biomass will further erode the rights, security and sovereignty of the world’s most vulnerable people while worsening rather than solving the multiple environmental crises of climate change, species extinction, water depletion, nitrogen buildup and biodiversity loss. Furthermore, food sovereignty will be deeply eroded as southern countries give over land to producing biomass for the new bio-economy.

The ETC report describes the range of products and services that are switching from fossil carbon feed stocks to biomass. This includes the increased use of biomass for heat and power, particularly the large-scale adoption of biomass burning for generating bio-electricity. It examines

JANUARY - FEBRUARY 2010

the upswing of activity and production in the bio-fuels sector and the switch to bio-based chemicals by the chemicals and plastics industry, as well as proposals to bring all of these areas of production together in what is known as ‘integrated bio-refineries,’ mega facilities that will simultaneously transform harvested plant life and other biomass into heat, power, fuels, chemicals, plastics and fertilizer.

The Report predicts that as the biomass industry attempts to overcome natural barriers to biomass production, corporations will increasingly move into the field of geo-engineering to boost the planet’s primary production, expanding plantations, developing algal/ocean biomass options, re-engineering biomass crops and attempting to speed up natural cycles (e.g. nitrogen fixing bacteria, biochar etc). In attempting to address the shortfall of biomass the new biomassters will attempt to develop highly managed synthetic ecosystems that would displace wildlands and traditionally stewarded agri-ecosystems with massive implications for biodiversity, human rights and livelihoods.

The ETC report will be published in the spring of 2010. For more information on ETC Group see: www.etcgroup.org

ETC Group addresses the socioeconomic and ecological issues surrounding new technologies that could have an impact on the world’s poorest and most vulnerable. We investigate ecological erosion (including the erosion of cultures and human rights); the development of new technologies (especially agricultural but also new technologies that work with genomics and matter); and we monitor global governance issues including corporate concentration and trade in technologies. We operate at the global political level. We work closely with partner civil society organizations and social movements, especially in Africa, Asia and Latin America.

VOLUME 23 NUMBER 1

continued from p. 11

As Thomas Kuhn describes in The Structure of Scientific Revolutions, when confronted with observations that contradict a prevailing theory, scientists “will do what we have already seen scientists doing when confronted by anomaly . . . [t]hey will devise numerous articulations and ad hoc modifications of their theory in order to eliminate any apparent conflict.”16 Scientists, after all, are only human. And it is only human to see a desired pattern where there is none, or ignore an unwanted anomaly. In this way, Kuhn argues, all analytic science produces its own version of epicycles.

To approach a problem synthetically is another thing entirely: it is to produce individual phenomena based on theory—for instance, to construct a clock based on Galileo’s law of pendulum motion. In the end, the clock will either tell the correct time or it will not; if Galileo’s law is wrong, no amount of tinkering could set the clock right. In this way, a synthetic methodology poses a check to the human tendency to interpret away inconsistency that Kuhn describes.17 This is not to say that analysis has no part to play in science. It is rather to highlight the limitations of a scientific method rooted solely in analysis— and to suggest that scientific progress is best achieved when the two methodologies work in concert.

For biology today, the value of Leduc’s methodological concept—a synthetic biology in this classical sense—lies in its potential to reveal unknown features of life. In micropaleontology, for example, “morphology is still one of the main parameters to decide whether microfossils could be considered as traces of life rather than just mineral forms.”18 Although more sophisticated models of crystalline growth now delimit the boundary between the living and the nonliving, Leduc’s methodology retains its heuristic value—as a means of producing useful knowledge. Another important discovery attributable to synthetic biology is the development of the branched DNA diagnostic assay—a medical tool that “helps to manage the care of approximately 400,000 patients infected with HIV and hepatitis viruses each year.”19 Only by

Fig. 2 working to engineer synthetic genetic systems did researchers come to understand the biology behind this important technology. Thus, to the extent that its outcomes remain consistent with ends such as these, the negative implication of synthetic ought not obscure the utility of synthetic biology.

It should be remembered that the creature created by Dr. Frankenstein had both emotion and a moral conscience. “I do know that for the sympathy of one living being,” the creature implored, “I would make peace with all.” In the end, he takes his own life, but not before expressing remorse at the death of his creator. The creature, in other words, was an ethical being, valuable unto himself—rather than as the end of a particular project of research. In a very true sense, the monstrosity of the story belonged to Dr. Frankenstein, who created a being by nature so disjointed that he could not survive in the human world.

Unlike Dr. Frankenstein’s doomed creation, the work of Leduc and modern synthetic biology does not aspire to create beings capable of either pain or pleasure. It does not aspire to create per se, but to know through the act of creation. On this view, there is a strong prima facie reason to defend synthetic biology against its negative linguistic associations: the value of the knowledge gained by its pursuit.

Andrew Thibedeau , J.D., is a fellow with the Council for Responsible Genetics.

GENEWATCH 13

Playing With Fire

Researchers using DNA tests to search for Israel’s Lost Tribes meet resistance from ethnic Pashtuns

BY SAM ANDERSON

"The Taliban Have Jewish Roots?"

That was the title of an ABC News story on January 12, 2010. "Don't tell the Taliban," the article begins, "but their ancestors may be Jewish."

The actual basis of the article was a proposed population genetics study aiming to determine whether members of the Afridi Pashtun tribe are descendants of one of the 'Ten Lost Tribes of Israel.' The Pashtun, or Pathan, people have historically comprised the largest contingent of the Taliban; however, as ABC News itself reported in 2006, "Before the Taliban were made up of mostly ethnic Pashtuns from southern Afghanistan.

Now, experts say, fighting units are made up of a mix of Afghans, Pakistanis, Arabs, Chechens and Uzbeks." In fact, many Pathans embrace a traditional notion that they are descended in part from ancient Hebrews. Still, it is probably an under-

statement to say that most Pathans and Israelis do not see each other in a particularly positive light.

Over 40 million people call themselves Pashtun, with the majority living near the border of Afghanistan and Pakistan. While the Afridi Pathan subjects of the proposed ancestry study live in India, numerous international news outlets jumped to the same attention-grabbing angle, beginning when the story first appeared in the Jerusalem Post on January 9, 2010 under the headline: "Are Taliban Descendents of Israelites?"

Beneath the sensationalized coverage, the study in question had indeed been proposed. Shahnaz Ali, a research fellow at the National Institute of Immunohaematology in Mumbai, was granted funding by the Israeli Foreign Ministry to carry out an ancestry study at Technion University in Israel which would com-

pare Afridi Pashtun and modern Jewish blood samples for ancestral links.

However, Ali's advisor at Technion, Karl Skorecki - himself known for claiming identification of a Jewish genetic marker called the 'Cohen gene' - claims that the study never took place. Having picked up a press release from the Israeli Foreign Ministry, the Jerusalem Post article brought attention to the study. For Shahnaz Ali, the attention was unwanted. According to Skorecki, Ali requested a change of projects because "she found that there was too much controversy in the Pashtun community." While Ali did carry out research for three months at Technion, she focused on medical topics rather than ancestry. "She really asked to be left alone," Skorecki said.

Several years earlier, a British researcher named Tudor Parfitt Image: Sam Anderson

14 GENEWATCH

JANUARY-FEBRUARY 2010

attempted to conduct a very similar study - collecting DNA from Afridi Pashtuns in India with the intent to prove their descent from ancient Israelites. Dr. Parfitt has spent decades searching for the remnants of the Ten Lost Tribes of Israel, which by biblical accounts were driven from Israel by the invasion of Assyria.

Parfitt has visited refugee camps in Ethiopia to meet the Falashas, a Jewish community there, and he is perhaps best known for his work with the Lemba tribe in South Africa, who follow many Semitic traditions and claim Israelite ancestry. DNA tests of the Lemba, commissioned by Parfitt, seem to show some scientific basis for these claims. But after its initial media attention - which, as with Ali's proposed study, arrived before any testing had actually been conducted Parfitt's DNA study of Pashtuns seems to have faded from the spotlight. Some suggest this is because it failed to produce definitive results, which may be the case. It is certainly true, however, that word of Parfitt's study raised the ire of Pashtuns and the concern of colleagues, some of whom strongly suggested he secure formal permission from the Pashtun community or abandon the study altogether.

Ali and Parfitt's proposed studies made news because of the implication that bitter enemies may turn out to be relatives. What didn't make the news was the controversy that derailed them.

One of the most vocal critics of both studies was Robert R. Khan of the Pashtun Heritage Foundation.

"That question - whether or not the Pashtuns are related to ancient Hebrews - is a very valid question," he says. "But it has to be done by a third party or by Pashtuns themselves."

Yet there is also an inherent concern in a study focusing specifically on Pashtun descent from a Lost Tribe - particularly when, as in the case of the more recent proposed study, the research is being conducted in Israel and with funding from the Israeli government. It is a question partly of intent, say Khan and others, and partly of unintended ramifications.

"Focusing on this Israeli connec-

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tion just makes [the study] a political football," Khan says. "There are people who would want it to be proved true and people who would not want it to be proved true on both sides. Many Pashtuns loathe the idea that they may be in fact heavily related to ancient Israelites; and in Israel there are certainly people who do not want to be told the Pashtuns are descended from Hebrews because it puts them in a fundamental problem: how can they tell the ancient Israelite tribes that they can't come back to Israel?"

Khan is referring to Israel's Law of Return, which grants those of Jewish ancestry the right to Israeli citizenship. Some conservative groups, concerned about the declining Jewish population in Israel, are actively seeking "lost Jews" and helping them "return" to Israel.

“The only people who should be doing this are groups that have Pashtun permission.�

One well publicized example of "lost Jews" are the Bnei Menashe, a group of around 9,000 people from northeast India who, like the Lemba of South Africa, claim Hebrew descent. Upon learning of the Bnei Menashe in 1979, an Israeli group called Amishav, dedicated to locating the lost tribes, began efforts to convert the Bnei Menashe to Orthodox Judaism. Through the work of Amishav and its more aggressive offshoot, Shavei Israel (led by right-wing Jerusalem Post columnist Michael Freund), the Bnei Menashe began relocating to Israel.

Yet the intentions of the groups devoted to bringing the Bnei Menashe to Israel began to come into question.

Freund himself has suggested that resettlement of the Bnei Menashe and other "lost Jews" will help Israel maintain a Jewish demographic majority: "I believe that groups like the Bnei Menashe constitute a large, untapped demographic and spiritual reservoir for Israel and the Jewish people." In

fact, most of the nearly 2,000 Bnei Menashe brought to Israel found themselves in settlements in the West Bank and Gaza, leading Israel's Minister of Science and Technology in 2006 to say the Bnei Menashe were "being cynically exploited for political purposes." Controversy has arisen in India as well, in response to outside groups attempting to convince the Bnei Menashe to leave the country.

Interest in the "Lost Tribe industry" extends beyond religious and government groups, however. The tour company Spirit of India has organized a 'Lost Tribes' tour to visit the Bnei Menashe in India, and the Jerusalem Post has publicized "The Ten Lost Tribes Challenge," a series of "expeditions" in which participants can see the Lost Tribes for themselves. Less publicized: the Lost Tribes Challenge is actually a joint venture of two Israeli tour companies.

But things are different with the Pashtuns. If they expect new migrations to Israel (or, for that matter, new tour destinations) Khan says, "these people - Freund and company - are definitely playing with fire." If a DNA test were to closely link Pashtuns to ancient Hebrews, would the Israeli government really want to open its borders to a group which includes some of the most hard-line Islamists in the world?

Those points may be moot, not only because the latest attempted study has been called off, but because both studies thus far have focused on a small, distinct community of Pashtuns. Despite the news reports suggesting the research would somehow include the Taliban, even if the Afridi Pashtuns were genetically linked to ancient Israelites, it could hardly be scientifically applied to all 40 million Pashtuns worldwide.

The more central problem, say Khan and other Pashtuns, is biocolonialism. "The only people who should be doing this are groups that have Pashtun permission," Khan says.

"Pashtuns aren't afraid of a DNA test we just want to do it under our own auspices."

Sam Anderson is Editor of GeneWatch.

GENEWATCH 15

‘Will Marry for Health Insurance’ Terri Carlson gained national attention for seeking a spouse with insurance - but her plight is no PR stunt

Terri Carlson suffers from a genetic disorder called C4 complement deficiency. Divorced and essentially uninsurable because of her pre-existing condition, Terri created a website, marryforhealthinsurance.com, which has drawn international media attention. She has since become a crusader for health care reform.

I know that since your story broke in the national media, you have received a huge number of marriage proposals.

Are you finding they are genuine?

One thing I’ve learned through this process is that there are a lot of people out there who want to do something good, and would be willing to help somebody else out by sharing their insurance. I’ve even had twenty year olds in the military propose to me because if they’re married they get $10,000 more per year from the government just for being married. So I’m creating a dating website to bring those that are compassionate and would be willing to share their insurance with somebody who can’t get it due to a pre-existing condition. It’s my own particular way of getting even with the insurance companies – when you marry somebody who has health insurance, the rule is that they can add you within 30 days and there’s no preexisting condition clause.

Are there any other loopholes that allow you to get around the pre-existing condition, besides the marriage loophole?

In California you don’t have to be married, it can be a domestic partnership. And then I’ve come to discover you can get around the system by creating a fake business. I can create a small business with my son, sell nothing, and I can apply for health insurance as a small business and they can’t ask for my pre-existing conditions.

16 GENEWATCH

So basically you have to do dishonest things to be able to get health insurance. You have to marry someone, whether you love them or not; you have to enter a domestic partnership with someone, whether you love them or not … it’s almost like what some people do to get U.S. citizenship, only we’re American citizens and we still have to manipulate the system to get health insurance.

Was it your goal from the start to really focus on raising awareness?

It started out about me, about my desperation, and then it turned into being about so much more beyond me.

I felt overwhelmingly burdened and guilty that I would be finding a solution because of the notoriety I received while others wouldn’t. So I’m creating this dating website – which, by the way, is going to be free. It’s my own way of dealing with the pre-existing conditions problem until Obama’s plan goes through. And if it doesn’t go through, there really aren’t a lot of options for people like me.

Have you encountered any opposition, a n yo n e t e l l i n g y o u t h e y d on ’ t l i k e what you’re doing?

When the story first came out here in San Diego, I read the blogs on it the next day and there was some rough criticism in the beginning, mainly that this was somewhat similar to prostitution. Some people were pretty harsh about it, but as it continued to come out in the media, people started to see that this was serious – these are real-life concerns.

People who don’t have insurance don’t understand what it’s like to be a person like me. It can be hard for them to be compassionate. They can tell me: “Go get a job that provides health insurance.” But because of my disability, I can’t be out in public very much –

I try to live a fairly normal life but I have to be very careful of infection, and I’m in pain every day and can’t stand long. I do have a job, working from home for a company that hires disabled people, but if not for this job I just wouldn’t be able to work. And because the entire company only hires people with disabilities – which, by the way, they get money from the government for doing – they can’t provide health insurance.

And they don’t allow you to use your spouse’s Social Security credits if you are divorced or disabled, and since I was a stay at home mom for 23 years I wasn’t paying into my own Social Security. I’m stuck in the middle. I went to get Social Security insurance through the government, but you can have only $2,000 in assets to your name to qualify. So here I am a disabled person, and I can’t get either. I’m still on my husband’s COBRA, and I’m paying 90% of my income for it. There are no other options for me.

What justifications have insurance companies given for denying you coverage?

I got my genetic testing results back in 2003. Before GINA (the Genetic Information Nondiscrimination Act), the insurance companies flat out said, “because you have C4 complement deficiency, we’re not going to insure you.” After GINA, the way they respond is: “You have been in the hospital twice this year with an infection, and therefore we are not going to insure you” – not stating that the reason I was in there was because of the genetic prob-

JANUARY - FEBRUARY 2010

lem. They say they’re not discriminating against the genetic defect, but they are discriminating against the symptoms of the genetic defect.

They’re still using my DNA test results against me – they had my genetic information before GINA, so they already know my condition.

Did you know you had C4 complement deficiency before the DNA test?

No, I didn’t know until the test in 2003. I had been sick for years, and since I was adopted I didn’t have a family medical history. I had a doctor that did some general genetic testing, and something came back about my C4 being messed up. So my doctor put me in touch with a genetic researcher, Dr. Yung at Ohio State University. He’s the only genetic researcher in the whole United States who studies the genetics of C4 deficiency complement disorder.

So I had my blood and my children’s blood sent to him, and he’s the one who broke down the analysis on what was missing.

When you got those tests, did your doctor or Dr. Yung talk to you about what might happen to the information that came out of those tests?

Nope. He faxed it to my doctor when it was done. He said he couldn’t release it to me, he had to release it to my doctor. So right then it became a part of my file.

Before the C4 test, what was involved in the more general test your doctor had done?

He ran a complement profile and saw that something was wrong with my C4. My disorder is the number one genetic marker for lupus, so he just did a test looking for deficiencies.

What he wasn’t expecting was for me to have a complete genetic deletion, which is extremely rare. There are only a couple of people who have what I have. It’s actually more common in Finland – they have an actual complement unit there – but it’s not very common here, and there’s not very much research being done on it.

After the first test came back, my C4 wasn’t registering, so they sent it to Dr. Yung, and that’s how I found out more specifically about my genetic defect.

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When did you first realize this would be an insurance problem – or since you were covered under your husband’s insurance then, did it not cross your mind?

My husband worked for the state, and I had the best insurance on the planet. I never had to worry about insurance until two and a half years ago, when I had to go on COBRA. And so I tried to get insurance on my own because I can’t keep up the cost of COBRA, only to find I can’t get it at any price.

Then I started to research the rules in California, and when your spouse puts you on a policy the insurance company can’t ask about your preexisting conditions. That, or you can create a fake business and get insurance that way. So here we are in the United States, and you either have to

“People can be pretty harsh ... but that’s because it is outrageous.” be deceptive and marry someone for their insurance, or you have to be deceptive and create a fake business in order to get health insurance. How sad is that?

I’ve done interviews all over the world – Germany, Belgium, France, Canada – and they are just astounded.

And in the U.S., there are other people who have lost everything because of their medical bills and are literally living on the streets because of it.

They’re caught in the middle, just like me. I’ve even said I could commit a crime because I could go to jail and get better health care. I could get three meals a day, get all my medical care, and work out at the jail gym all day.

Ironically, I said that in an interview and got an email from a lady who had already looked into it. She was dead serious. She said, “You have to commit a federal crime, so I was thinking I could rob a post office.”

Have you found that other people are looking to do the same thing, to marry

for health care?

Oh, multitudes of people have emailed me and said “I’ve already done it.” It’s been done for years, it just hasn’t been talked about.

A lot of people don’t understand.

They’ll say, “Oh, she hasn’t looked into everything.” Well, hello! I have looked into everything. This is real for me.

People will say “This has got to be a scam.” Some people think I was hired by the Democrats. I’ve never heard from President Obama! But I get that all the time. Even CBS, when I did the Early Show – at the bottom of the video it said “Hired by Dems?”

People could be pretty harsh, especially at the beginning. But that’s because it is outrageous – and they can’t believe it could be true because it’s so outrageous. But that’s the point. This is my life.

Out of all the positive and the negative, what has surprised you the most about the response?

It surprised me the most that there were thousands of people that are sicker than I am that were begging me to send some of my ‘suitors’ their way, or to set up a dating website. It was astonishing. To me, if one person can learn from my story and get help, it will be worth it.

I’ve had a lot of opportunities come my way during all this. They want to do a Lifetime movie, they want to do a reality series, and I’ve struggled with doing any of that because I feel almost like I’m selling out other people who aren’t going to have these opportunities, and I don’t want to cheapen the process. And on the other hand, I really could use the money to help myself.

Do you think you really will end up marrying for health insurance?

In the beginning of this, I thought for sure I’d have to marry some random guy I didn’t even know for health care. But, you know, with 10,000 emails, the hope is to be able to have both love and health insurance.

Note: The recently passed health care bill protects children from being denied coverage because of pre-existing conditions effective immediately, but does not extend those protections to adults until 2014.

GENEWATCH 17

Biotech Eggplant: Ignoring the Resounding ‘No’ India places a moratorium on biotech eggplant - but GE backers are going to new lengths to bring it to market

BY DEBBIE BARKER “A 'No' uttered from the deepest conviction…”

-Gandhi

In response to the resounding “No” uttered across India, Minister of the Environment and Forests Jairam Ramesh announced a moratorium on the commercialization of Bt brinjal on February 9, 2010. The moratorium on genetically engineered (GE) eggplant has since been extended indefinitely.

Minister Ramesh stated: “It is my duty to adopt a cautious, precautionary, principle-based approach… till such time as independent scientific studies establish to the satisfaction of both the public and professionals the safety of the product."

The Minister made his announcement after a series of public hearings in seven Indian states that would be most directly affected by Bt brinjal crops and after a consultation process with scientists, agricultural experts, farmers' organizations, consumer groups, and “serious-minded” nongovernmental organizations.

Navdanya, an NGO founded by Dr. Vandana Shiva over two decades ago that organized major farmer and civil society resistance to Bt brinjal commercialization, hailed the decision “as a victory for Indian democracy.”

The debate over Bt brinjal engaged the attention of people from all walks of life and captured almost daily headlines in newspapers throughout India.

Brinjal is a crop and food eliciting particular pride in India. Not only is India the largest producer of brinjal (accord-

18 GENEWATCH

ing to a statement by Minister Ramesh), but it is also the crop's country of origin and boasts thousands of varieties that have been cultivated over centuries.

The potential threat to this spectacular diversity posed by Bt brinjal was one of the central arguments against commercialization. Brinjal is largely a cross-pollinated crop, which makes the threat of contamination particularly worrisome. Even Indian scientists that support GE technology expressed grave concern about the potential for contamination and the fact that no independent research or trials had been carried out to either verify or refute Bt brinjal developers' guidelines for preventing contamination.

In a rather astounding concession that Bt brinjal would contaminate existing traditional varieties, Dr. M.S. Swaminathan, one of India's architects of the Green Revolution now heading a research center working on GE technology, urged that India collect and conserve its existing varieties “before we permit the extinction of the gifts of thousands of years of natural evolution and human selection.”

The series of public hearings were occasions of enthusiastic opposition for thousands of farmers, civil society organizations, consumer groups, scientists, and state government officials.

In addition to their worries about potential contamination to existing brinjal crops, many farmers also expressed concern over claims that

the Bt gene would reduce pests and insecticide use. Bt Brinjal is a genetically engineered crop created by inserting a gene (Cry 1Ac) from the soil bacterium Bacillus thuringenisis (Bt) into brinjal. According to its proponents, the gene makes the plant resistant to the typical pests that attack the fruit.

However, due to Indian farmers' experience with Bt cotton, many farmers' organizations as well as scientists and state government agencies are finding that the Bt gene has proved to be an unreliable method of pest control and can lead to increased use of chemicals in order to combat increased pest resistance. In contrast, they point to the success of nonpesticide management (NPM) systems as a way to reduce pesticide use without compromising food security or profit for farmers.

For example, almost 600,000 farmers in the state of Andhra Pradesh practice NPM agriculture with such positive results that other state agriculture ministers in India are asking to replicate this model on a larger scale.

Why Bt Brinjal?

Farmers also expressed concern over questions of Bt seed ownership and how this could potentially disrupt incomes of small and medium-sized farms. They are not eager to replace seeds that they now often freely save and exchange among themselves for a system of purchasing commercial seeds and pesticides. Farmers stated that adoption of Bt brinjal would create a system of dependency on corpo-

JANUARY-FEBRUARY 2010

rations that developed and own the patents on these materials-Monsanto U.S. and Mahyco, an Indian company of which 26 percent is owned by Monsanto.

As numerous concerns were voiced, the question that came up in the debates and hearings over and over again was: What is the apparent urgency for approving Bt brinjal?

Farmers and others, including Minister Ramesh, pointed out that there is no pressing reason to introduce Bt brinjal. There is no brinjal pest crisis, yield crisis, or farmer income crisis. To borrow from a U.S. expression, farmers in India were essentially saying, “Don't fix what ain't broke.”

Other issues were raised at the public hearings and during the consultation process.

Public health and safety concerns were repeatedly cited, especially because Bt brinjal would be the first GE vegetable in India to be directly consumed by human beings.

Scientists pointed out that the plant family solanaceae to which brinjal belongs contains several natural toxins that can resurface when metabolism is disturbed. Both the directorgeneral of the Indian Council of Medical Research and the drug controller to the government of India recommended that chronic toxicity and other associated tests should be carried out by independent bodies instead of simply relying on the data generated by the companies that developed Bt brinjal.

Additionally, the ayurvedic, siddha, homeopathy, and unani medical community expressed concern that Bt brinjal would destroy medicinal properties used in these alternative medicine practices due to loss of synergy, differences in the alkaloids, and changes in other active principles.

Politics and Intrigue In the midst of the raging debate,

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politics and intrigue intensified. Days before the critical announcement of whether or not Bt brinjal would be approved for commercialization, two Italian agriculture experts known for their opposition to GE crops were denied visas to attend a conference on GE crops and food held in New Delhi.

Maria Grazia Mammucini, director of the agricultural research agency of the Region of Tuscany and the founder of the GMO-free regional government network in Europe, and Professor

Minister of Agriculture Sharad Pawar.

In addition, some powerful U.S. officials, including Dr. Nina Fedoroff, science and technology adviser to U.S. Secretary of State Hillary Clinton, continue to urge the Indian government to adopt Bt brinjal.

One response by GE advocates has been to introduce a new legal authority-the Biotechnology Regulatory Authority of India (BRAI). One of the most astonishing elements of the new law calls for arrests and fining of individuals that “mislead the public” about GE products. Article 63 of the BRAI states: “Whoever, without any evidence or scientific record misleads the public about the safety of the organizations and products specified in…, shall be punished with imprisonment for a term which shall not be less than six months but which may extend to one year and with fines which may extend to two lakh rupees [about US $4,500] or both.”

This proposed law has caused obvious alarm. "Never in India's history has such a draconian provision been mooted," said Pushpa Mohan Bhargava, founder and former director of the Hyderabadbased Centre for Cellular and Sam Anderson Molecular Biology. "Who is to Marcello Buiatti, a member of the decide what evidence is scientific or Network of Independent Scientists of not? It will gag any opposition or critiEurope whose research has been cism." instrumental in GMO bans in Europe, Dr. Vandana Shiva observed: “It is were told by the Indian embassy in becoming increasingly clear that GE Rome that they needed clearance from crops and foods can only spread the Ministry of Food and Civil through such fascism. We have to Supplies, a highly unusual procedure. make a choice: Either we will have Despite the overwhelming opposi- food dictatorship in which the biotech tion to Bt brinjal from farmers, the industry imposes toxic and unsafe GE medical community, scientists, civil foods on us or we will stay GE free and society, and state governments, defend our food freedom.” including 12 state ministers stating Debbie Barker is the international they will not allow the crop in their regions, key Indian government offi- director of the Center for Food Safety, cials are moving on all fronts to based in Washington, D.C. Ms. Barker reverse Minister Ramesh's moratori- was in India in February 2010 prior to and after the announcement of the um and commercialize Bt brinjal.

The most vociferous opposition to moratorium. the moratorium is from Indian

GENEWATCH 19

Book Review Ordinary Genomes

BY ANDREW D. THIBEDEAU

In her new book Ordinary Genomes: Science, Citizenship, and Genetic Identities, University of Minnesota Anthropologist Karen-Sue Taussig offers an insightful though repetitive ethnographic analysis of the coproduction of Dutch social norms and clinical genetics practice in the Netherlands. Drawing principally on the work of Foucault, she explores how discourses of ordinariness and tolerance particular to the Netherlands interact with genetic knowledge to shape Dutch identity.

The book follows three themes. The first is the Dutch social phenomena of verzuiling or “pillarization,” whereby difference is mediated through bounded social institutions in a way that promotes tolerance. The second is the Dutch self-conscious imperative to be gewoon or “ordinary.”

Finally, Taussig touches upon the legacy of the Second World War in shaping modern Dutch identity and genetics practice.

Historically, Taussig explains, the different religious groups in the Netherlands constructed a social system that delineated sharp boundaries between themselves. Nevertheless, these bounded groups cut across all other social lines, such as class or education. In this way, they formed integrated “pillars” that together supported Dutch society. As religion became less central to Dutch life and people ordered themselves differently—by political affiliation, for example—the essential “pillarized” structure remained. “The strategy of pillarization,” Taussig writes, “allows for the general tolerance of social heterogeneity by bounding difference and minimizing its social threat while 20 GENEWATCH

containing it within the larger commonality of Dutch society.” In other words, she argues, pillarization permits the management of difference through tolerance.

Pillarization allows Dutch people to negotiate the social ideal of tolerance because difference is bracketed off and limited within acknowledged categories. For the Dutch, the social strategy of tolerance “involves recognizing, understanding, and accepting difference without rendering it hierarchical.” A second Dutch value that works in concert with tolerance is ordinariness: the people of the Netherlands are self-consciously “ordinary.” When viewed together with pillarization, Taussig claims, ordinariness imposes consistency by situating all individuals within groups and demanding “conformity to characteristics that are socially understood as ordinary from that group.” This “simultaneous emphasis on similarity and difference” enters the genetic context by producing both a “resounding silence” around genetic syndromes alongside a powerful desire to categorize them through the process of diagnosis.

One central focus of Taussig’s ethnographic analysis is the weekly meeting held among the geneticists at the clinic where she made her field observations. There, difficult diagnoses were drawn out in an exercise of group problem solving. When one physician was unable to diagnose a patient, she presents that patient’s case at the meeting where she and her colleagues work to find a diagnosis.

Taussig observed the discomfort the geneticists felt when they had difficulty assigning a patient with the

Ordinary Genomes: Science, Citizenship, and Genetic Identities Karen-Sue Taussig Duke University Press, 2009.

JANUARY - FEBRUARY 2010

diagnostic criteria for one or another genetic syndrome. Her analysis proceeds to analogize the search for a diagnostic category with the process of pillarization. Both, she argues, involve the bounding of difference within defined groups in which difference is normalized, i.e. made normal in comparison to other members of the group. In other words, a child suffering from a rare genetic syndrome appears at first highly abnormal.

When placed in a diagnostic category, alongside other individuals also suffering from the same disorder, however, the same child appears normal in relation. In this way, the clinical production of genetic knowledge parallels the mediation of difference facilitated by the practice of pillarization, both in the clinic and in Dutch society at large.

The specter of the Second World War features prominently in Taussig’s final chapter, where she examines the Dutch reaction against the biotechnology that combined the DNA of a human and a bull. Examining several posters produced by a local campaign against this technology, she describes how the images represent Dutch fear of crossing of species boundaries.

More precisely, the image of cows and a woman with blond hair used in the

posters—which Taussig finds symbolic of Dutch identity—she reads as also expressing a dual fear of crossing both species and national borders.

The Dutch ideal of tolerance, she argues, is constructed in opposition to the intolerance they perceive in the Nazi program of “racial hygiene.” “[T]he explicit reference the posters make to genetic manipulation and their implicit allusion to eugenics,” she claims, “arouse Dutch memories of the Second World War and antipathy toward Nazi science.” In this way, Taussig concludes that the genetic knowledge they represent challenge both Dutch personal and cultural identity.

Taussig’s book is strongly cast in the idiom of critical theory. As noted, her principal theoretical framework is drawn from Foucault and his interpreters. However, the book does not contain a sufficient explanation of the theory underlying its analysis.

This is a significant flaw. The concepts of biopower and the social production of truth originated by Foucault and utilized by Taussic are both complex and abstract. The concrete aspects of Taussig’s book—her clinical field work and accompanying observations—offer good examples of these ideas as produced in the “real

world.” However, without sufficient theory to integrate these facts, Taussig’s analysis lacks depth.

A second criticism can be found in the nearly twenty years that have passed since she conducted the field observations that comprise the heart of her analysis. The science and practice of genetics has seen seismic shifts since her time in the Netherlands. Her observations— though keen—and the science she describes are both outdated, which detracts from the other aspects of her work. Finally, her grander aspirations to “break down the monolithic treatment of Western science” fall far short. She fails to provide any point of comparison between the Dutch and non-Dutch production of genetic knowledge. Only by comparative analysis could the local character that she ascribes to Dutch genetics practice be adequately demonstrated.

Without it, the reader is left to question whether what is described is unique to the Netherlands or is simply characteristic of genetics practice in the early 1990s.

Andrew Thibedeau, J.D., is a fellow with the Council for Responsible Genetics.

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 23 NUMBER 1

GENEWATCH 21

Topic: Consumer Genetic Testing Direct to consumer genetic testing companies fail in attempt to seek new rules in California

BY JEREMY GRUBER A bill sponsored by California State Senator Alex Padilla (D-San Fernando Valley), drafted by the direct to consumer (DTC) genetic testing company 23andMe and publicly supported by Genentech, among other companies, was recently sent back to the Secretary of the Senate after failing to pass due to a mounting public outcry. The bill, SB 482, would have defined a new category of business for companies that provide “postCLIA bioinformatics services” and exempt such businesses from requirements applicable to traditional clinical laboratory service providers.

Close to 100 DTC companies, including Navigenics, DNA Direct, and Google Inc.-backed 23andMe, are based in California and have jumped into various genetic testing niches by offering genome scans to the general public.. The tests cost as little as $399 and the time it takes to provide a saliva sample. These companies have proliferated within an unstable regulatory environment. There is no federal proficiency-testing system for the companies and the U.S. Food and Drug Administration has left it up to the states to decide what’s permissible.

The California bill’s genesis followed actions in 2008, when the California Department of Public Health sent “cease and desist” letters to 23andMe, Navigenics and 10 other genomics firms requiring them to comply with state and federal regulations. The companies later obtained licenses in compliance with a state law that regulates laboratories in California, but subsequently argued that they should not need to, and that the purpose of their service was merely “education.” Critics have argued that with marketing catch phrases

22 GENEWATCH

such as “take control of your health” (Navigenics) and “get the treatment that’s right for you” (23andMe) customers are going to make the reasonable assumption that these genetic tests must have some diagnostic significance. 23andMe may have decided to introduce SB 482 to motivate favorable action by federal regulators that are still contemplating how to regulate the industry.

The legislative findings of the bill indicated an intent to remove regulatory barriers to operation for companies providing personal genome services: “By defining and regulating the distinct role of postproduction data interpretation, the state intends to promote flexibility and innovation in the development of methods to interpret individuals’ biological profiles in the context of personalized medicine.” The findings state that allowing individuals to access their personal biological data “can also offer research and educational opportunities, since an active, personal stake can promote scientific literacy and a new research model that actively engages with consumers.” In order to achieve these goals, the findings continue, “it is necessary for entities providing postproduction interpretation of biological data to be regulated in a different way than are those entities providing traditional laboratory functions.”

A number of consumer and privacy groups, including the American Civil Liberties Union and the Council for Responsible Genetics, had raised serious concerns about the bill, fundamentally regarding whether DTC businesses should design their own oversight. Specifically they questioned whether the claims made by such companies regarding the relationship

between individual genetic variations and disease risk are subject to adequate review to ensure they are supported by sufficient scientific evidence.

The bill was also heavily criticized for its lack of sufficient privacy protections. In particular, critics had noted that the legislation did not have sufficient protections to ensure that personally identifiable information was not released to third parties, nor did it require entities to destroy biological samples once they had been processed. Furthermore, the bill would have allowed companies to continue to use such information, including the potential sale to third parties, so long as it was not individually identifiable. The definition of individually identifiable information was particularly singled out as insufficient.

Many of these companies, they noted, are using the information derived from their tests to compile a vast database of genetic information of data that could be worth millions of dollars to outside researchers. The bill would have required customers to consent to participate in such research as a condition of utilizing the services of a DTC company.

While the legislation is clearly dead for now, the issue is not going away. Senator Padilla has expressed interest in a “forum” on personalized medicine, including DTC genetic testing, and 23andMe is already floating a “simplified” version of their bill to generate renewed interest and support within the legislature and among likely commercial supporters.

Jeremy Gruber, J.D., is President and Executive Director of the Council for Responsible Genetics.

JANUARY - FEBRUARY 2010

Film Review: Made in India

BY KATHLEEN SLOAN

In the 21st century age of rapid biotechnology development and globalization, women’s bodies have become commodities, supplied and sold to the infertile. What began in the 1980s with the Baby M case has exploded into a vast fertility-industrial complex that spans the globe. The two major players in this drama are India and the United States. While India is the world’s number one supplier of surrogate mothers, the U.S. is close behind in the number two spot.

As a source of both supply and demand, the United States lies at the epicenter of a multi-billion dollar business fraught with complex emotional issues swirling around people desperate to have a child and willing to go to any lengths to fulfill their elusive dream. At the other end of the transaction are frequently impoverished women equally desperate for financial resources to improve their dire economic straits.

Into this ethical, commercial, legal, human rights and cultural morass boldly entered two dedicated and determined filmmakers seeking to shed a light on this ever-growing phenomenon. The result of their creative collaboration is the documentary film Made in India, appropriately produced by two women, one Indian and the other American.

Made in India is a feature-length documentary about the human experiences behind the practice of “outsourcing” surrogate mothers to India.

The film follows a middle class white couple from Texas whose struggle with infertility led them to seek out a surrogate mother in India to gestate

VOLUME 23 NUMBER 1

their child. As the cost of surrogacy in the U.S. averages approximately $120,000, the featured couple searched for a much cheaper alternative in India, a country and culture of which they were essentially ignorant.

Arriving in India like fish out of water, the wife and husband follow their Indian brokers through the process that will lead them to their desired end. On the other side of the equation is a young, impoverished, illiterate Indian woman and mother of her own children who sees this as an opportunity to bring desperately needed income to her household.

As the film weaves the interconnected storylines of surrogate and intended parents, a picture emerges of single-minded determination enabled by financial means juxtaposed with impoverishment, illiteracy, and the struggle to survive. The film sensitively reveals what unfolds when forces bring together a complicated clash of people in crisis—one emotional, the other economic—against a backdrop of reproductive technology played out across cultures and countries.

As women deeply interested in issues of reproductive rights, social justice and global issues, the subject of “outsourcing” surrogacy to India captivated the filmmakers, who aimed to go beyond sensationalist headlines to uncover the personal lives and choices of the surrogates and infertile people involved.

Directed and produced by Vaishali Sinha and Rebecca Haimowitz and Executive Produced by Erin Heidenreich, Made in India was supported in part by Chicken & Egg Pictures, Center for Asian American Media, The Fledgling Fund, Gucci Tribeca Documentary Fund, New York State Council on the Arts, The Playboy Foundation and other generous donors/foundations. The film will premiere late spring/summer 2010 at U.S. and International film festivals.

Kathy Sloan is Program Coordinator for the Council for Responsible Genetics

GENEWATCH 23

Nature’s Handiwork?

Court invalidates biotech firm’s human gene patents

BY ANDREW THIBEDEAU In the early evening of March 29, 2010, the Honorable Judge Robert W. Sweet handed down his much anticipated ruling in Association for Molecular Pathology v. United States Patent & Trademark Office.1 In his detailed opinion, Judge Sweet confronted the legal issue of whether “isolated human genes and the comparison of their sequences [are] patentable.”2 The more significant question the decision wrestles with, however, is whether the law ought to treat the human genome as a species of property. The biomedical sector has long regarded DNA as “intellectual property,” to be bought, sold, and controlled like any other form of capital.

For this reason, most observers have predicted that the outcome of Association for Molecular Pathology “will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research.”3 “This action is unique,” Judge Sweet himself remarked in an earlier opinion in the case, “in the identity of the parties, the scope and significance of the issues presented, and the consequences of the remedy sought.” 4 For nearly three decades, it has been the policy of the U.S. Patent & Trademark Office (PTO) to issue patents covering human DNA that have been “isolated and purified.” By one accounting, as much as 20% of the human genome has already been patented. The PTO's practice “is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body . . . renders it patentable by transforming it into something distinctly different in character.”5 “Like other chemical compounds,” the PTO states in a 2001 policy paper, “DNA molecules are eligible 24 GENEWATCH

for patents when isolated from their natural state and purified.”6 Pursuant to this policy, between 1997 and 2000 Myriad Genetics (Myriad), a for-profit corporation based in Utah, obtained seven patents covering two human genes — BRCA1 and BRCA2 — both linked to an increased risk of ovarian and breast cancer.

Women possessing mutations in their BRCA1 or BRCA2 genes stand up to an 85% cumulative risk of developing breast cancer in their lifetime, and a 50% cumulative risk of developing ovarian cancer. The outcome of these genetic tests can therefore dramatically affect the choices women face, from hormone therapy to chemotherapy, or in some cases radical prophylactic surgery. As a result of the breadth of their patents, however, Myriad has the right to control all genetic testing related to breast and ovarian cancer associated with BRCA1 or BRCA2. Although Myriad offers a number of their own genetic tests, they have not permitted other laboratories or clinics to undertake research or testing involving BRCA1 or BRCA2. This has left many women without the ability to obtain a second opinion after undergoing a Myriad test. What's worse, Myriad's steep pricing and unwillingness to work with many insurance carriers has left women unable to obtain testing at all.

Thus, in May of 2009, a coalition of concerned individuals and public interest organizations lead by the American Civil Liberties Union (Plaintiffs) filed a lawsuit against Myriad and the PTO (Defendants) in an effort to end Myriad's monopoly on BRCA1 and BRCA2 testing as well as halting the PTO's practice of granting patents on human genes. The suit alleges that the PTO's policy of issuing patents covering human DNA — and Myriad's gene patents obtained thereunder — run afoul of Federal

Constitutional and statutory law.

Plaintiffs therefore have asked the Court to declare Myriad's genetic patents invalid and to enjoin the PTO from granting further such patents.

In common cause, the Council for Responsible Genetics soon added their voice to Plaintiffs' by filing an amicus curiae (or “friend of the court”) brief, arguing for the invalidation of Myriad's BRCA1 and BRCA2 patents.

To understand how Judge Sweet, writing as the Court, addressed the important questions implicated in Association for Molecular Pathology, however, it is necessary to understand a few basic points about the law of patents. The American system of patents and trademarks is governed by the so-called “copyright clause” of the U.S Constitution.7 Unlike other provisions of the Constitution that secure fundamental rights and liberties, the copyright clause embodies a compromise between public good and private profit. To achieve this balance, the patent system offers an incentive to innovators to invest in the development of new technology, which can then be marketed under patent protection, in exchange for which the inventor must reveal the secrets of her invention which the public may freely use when the patent expires. In 1952, Congress passed the Patent Act, which states that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor.”8 In the years since its enactment, courts have interpreted this provision to require two things in order for a patent to be granted: a claimed invention must be “useful” in some way, and must be a “process, machine, manufacture, or composition of matter.”

Following this second requirement, the Supreme Court has recognized

JANUARY-FEBRUARY 2010

“that scientific principles and laws of nature, even when for the first time discovered, have existed throughout time, define the relationship of man to his environment, and, as a consequence, ought not to be the subject of exclusive rights to any one person.”9 In other words, one can't patent products of nature, or materials isolated from products of nature, if those materials behave in the same way they would in nature. For example, the U.S. Court of Appeals held that artificially purified tungsten is not patentable, despite possessing superior strength over its natural counterpart. The court reasoned that it was nature, not the patent applicant, who gave pure tungsten its superior qualities.10 On the other hand, the Supreme Court has allowed a patent for a genetically-engineered microorganism capable of metabolizing crude oil and designed for use in oil spills. There, the Court concluded that the patent application covered a novel biochemical organism whose properties derived from its inventor, not from nature. 11 In view of this well-established principle, the Court in Association for Molecular Pathology ruled in favor of Plaintiffs, invalidating all seven of Myriad's patents. The Court's analysis

VOLUME 23 NUMBER 1

turns on the unique character of the DNA molecule as a carrier of information. More than a chemical compound, “the information encoded by DNA reflects its primary biological function.” It is this informational aspect of DNA that marks it as unique. Central to the Court's reasoning is the fact that the purification of native DNA does not alter this essential characteristic, which is determined by nature and is central to both its biological function within the cell and its utility as a research tool in the lab. “The preservation of this defining characteristic of DNA in its native and isolated forms” the court ultimately holds, “mandates the conclusion that the challenged [patents] are directed to unpatentable products of nature.”12 Put differently, the fundamental features of DNA—all of which are the products of nature—are the same whether inside a human cell or “isolated and purified” in a laboratory. As products of nature irrespective of form, human genes thus cannot meet the Patent Act's requirement that a patentable invention be a “new and useful process, machine, manufacture, or composition of matter.”

Although the Court's ruling in Association for Molecular Pathology

is a dramatic win for Plaintiffs, the story is far from over. First, the Court based its ruling solely on the Patent Act, and did not reach Plaintiffs' Constitutional claims. This leaves open the possibility that the law could be changed through the legislative process, in essence reversing the Court's ruling. Second, the Court did not invalidate outright the PTO's policy of issuing patents that cover DNA, nor did it rule on the validity of patents covering DNA generally — √ its holding was limited to the seven Myriad patents. This leaves significant ambiguity as to the status of other genetic patents held by other biotech firms. Finally, the case will now begin the appeals process, where the Court's decision will be reviewed first by the Court of Appeals and then, possibly, by the Supreme Court.

Nevertheless, these reasons for uncertainty must not diminish the significant victory achieved by Plaintiffs — a victory not limited to the triumphant parties to this case, but shared by women everywhere who stand to benefit from increased access to BRCA1 and BRCA2 testing.

GENEWATCH 25

More information about M. Querbes, a Paris-based photographer, can be found at his website, www.stephanequerbes.com.

Les Atomes Crouchus is a French association that combines art and education to draw attention to a broad range of issues relating to experimental science and sustainable development.

Please visit them at www.atomes-crochus.org.

Stéphane Querbes

Anima-Science aims to promote science education through animations, workshops, exhibitions, shows, and other media targeting both the general public and students and teachers of primary, secondary, and higher education. Their website can be found at www.anima-science.fr.

Stéphane Querbes

26 GENEWATCH

See page 10 for the story behind these images

Stéphane Querbes

JANUARY-FEBRUARY 2010

Endnotes "DIYbio," Gaymon Bennett, p. 6 1. See http://syntheticbiology.org.

2. See http://diybio.org.

“Who Let the Engineers into the Lab?” Eleonore Pauwels, p. 8 1. Szybalski, W. & Slalka, A. 1978. “Nobel prizes and restriction enzymes,” Gene, Volume 4, pp. 181-182.

2. http://www.synbioproject.org/news/project/synthetic_biology_on_rise 3. “Awareness of and Attitudes towards Nanotechnology and Synthetic Biology: A Report Of Findings Based On A National Survey Among Adults,”

By Peter D. Hart Research Associates, Inc. on the behalf of the Project for Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars, September 2008. A complementary analysis is available in: Pauwels, E. (2009), “Review of Quantitative and Qualitative Studies on U.S. Public Perceptions of Synthetic Biology”, in Systems and Synthetic Biology, Springer, 3, 1-4, 37-46.

4. “Nanotechnology, Synthetic Biology, & Public Opinion: A Report Of Findings Based On A National Survey Among Adults,” by Peter D. Hart Research Associates, Inc. on the behalf of the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars, September 2009.

5. Cho, M.K. et. al., “Ethical considerations on synthesizing a minimal genome,” Science, 10 December 1999.

“Dreaming of Les Jardins Chimiques,” Andrew Thibedeau, p. 10 1. Oxford Paperback Dictionary and Thesaurus 944 (3d ed., 2009).

2. Jon Turney, Frankenstein's Footsteps: Science, Genetics and Popular Culture (2000).

3. Carolyn M.C. Lamb, Miguel Godinho, & Vítor A.P. Martins dos Santos, “An Introduction to Synthetic Biology,” in Synthetic Biology: The Technoscience and Its Societal Consequences 23, 24-25 (Markus Schmidt et al. eds., 2009).

4. Celestine N. Bittle, The Science of Correct Thinking 270 (1937).

5. Jaques Livage, Chemical Synthesis of Biomimetic Forms, 8 C.R. Palevol 629, 630 (2009); see also Richard-Emmanuel Estaes, Clovis Darrigan, & Xavier Bataille, “Les jardins chimiques: un faux pas vers la vie synthéthic” [Chemical Gardens: Synthetic Life Takes a Wrong Step], Pour la Science No. 375, January 2009, at 84; Richard-Emmanuel Estes & Clovis Darrigan, Jardins Chimiques, La Recherche No. 400, September 2006, at 90.

6. Luis Campos, “That Was the Synthetic Biology That Was,”in Schmdt supra note 3, at 6, 7.

7. Stéphane Leduc, La Biologie Synthétique (1912).

8. Estaes, Darrigan, & Bataille, supra note 5, at 84, 85 (my translation).

9. Leduc, supra note 7.

10. “Une théorie générale, contenant une part d'erreur, même une grande, favorise le progrès plus que l'absence de toute théorie.” Id. (my translation).

11. “La biologie synthétique représente une méthode nouvelle, légitime, scientifique; la synthèse appliquée à la biologie est une méthode féconde, inspiratrice de recherché . . . à chercher à reproduire, en dehors des êtres vivants, chacun des phénomènes de la vie” Id. (my translation).

12. “C'est à l'analogie avec ce que l'on observe chez les êtres vivants que ces phénomènes doivent tout leur intérêt.” Id. (my translation); see also Campos, supra note 6, at 8.

13. Id. “[T]he artificial reproduction of cells, structures, tissues, general forms, functions, traffic centripetal and centrifugal movements and fig-

VOLUME 23 NUMBER 1

ures of karyokinesis, the segmentation of tropisms.” (my translation).

14. Oxford Dictionary of Biochemistry and Molecular Biology 700 (Richard Cammack et al. eds., 2006).

15. Mark Kirschner, John Gerhart, & Tim Mitchison, “Mollecular ‘Vitalism,’” 100 Cell 79, 79 (2000).

16. Hilde Hein, “The Endurance of the Mechanism-Vitalism Controversy,” 5 J. Hist. Bio. 159, 163 (1972).

17. Francis Crick, “Of Molecules and Men” 99 (1966) (quoted in Evelyn Fox Keller, Refiguring Life: Metaphors of Twentieth-Century Biology 65-66 (1995)). The theory of vitalism “was progressively undermined by Wohler's synthesis of urea (1828) and by Pasteur's inability to demonstrate spontaneous generation (1862, as well as by Darwin's Origin of Species (1859) and Virchow's cell theory (1855).” See Kirschner Gerhart, & Mitchison, supra note 15, at 79. Nevertheless, by 1889, an article in the journal Nature observed that “[o]ur measurements are more exact, our methods finer; but these very methods bring us to close quarters which phenomena which, although within reach of exact investigation, are as regards their essence involved in a mystery which is the more profound the more it is brought into contrast with the exact knowledge we possess of surrounding conditions.” J.S.B. Sanderson, Address by Prof. J. S. Burdon Sanderson, 40 Nature 521, 525 (Sept. 26, 1889).

18. Kirschner Gerhart, & Mitchison, supra note 15,79 19. Stéphane Leduc, The Mechanism of Life 5 (W. Deane Butcher trans., 1911).

20. Thomas Kuhn, The Copernican Revolution: Planetary Astronomy in the Development of Western Thought 74 (1957).

21. Thomas Kuhn, The Structure of Scientific Revolutions 78 (2d ed. 1970).

22. Steven A. Benner & Michael Sismour, “Synthetic Biology,” 6 Nature Rev. Genetics 533, 534 (2005).

23. Livage, supra note 5, at 629; see also Edward Bormashenko et al., “Evolution of chemical Gardens in Aqueous Solutions of Polymers,” 417 Chemical Physics Letters, 341 (2006) (observing that “the micron-size filaments obtained under a chemical garden reaction exhibit curved, helical morphologies, reminiscent of biological forms . . . . [and] are similar to supposed cyanobacterial microfossils, reputed to be the oldest terrestrial microfossils”); J. M. Garcia-Ruiz et al, “Self-Assembled Silica-Carbonate Structures and Detection of Ancient Microfossils,” 302 Science 1194 (2003).

24. Benner & Sismour, supra note 22, at 536.

"Nature's Handiwork?" Andrew Thibedeau, p. 24 1. No. 09 Civ. 4515 (S.D.N.Y. Mar. 29, 2010) (hereinafter “Association for Molecular Pathology II”).

2. Association for Molecular Pathology II, slip op. at 2.

3. Association for Molecular Pathology I, at 370.

4. Association for Molecular Pathology v. United States Patent & Trademark Office, 669 F. Supp. 2d 365, 370 (S.D.N.Y. 2009) (hereinafter “Association for Molecular Pathology I”).

5. Association for Molecular Pathology II, slip op at 7.

6. Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (2001).

7. U.S. Const. art. I, § 8, cl. 8.

8. Patent Act, 35 U.S.C. § 101 (LexisNexis 2010).

9. In re Meyer, 688 F.2d 789, 795 (C.C.P.A. 1982).

10. Gen. Elec. Co. v. De Forest Radio Co., 28 F.2d 641, 642 (3d Cir. 1928).

11. Diamond v. Chakrabarty, 447 U.S. 303, 309-10 (1980).

12. Association for Molecular Pathology II, slip op. at 125.

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