Biocapital

DUKE UNIVERSITY PRESS

Contents

Chapter One

Contradictions in Market Logic in American and Indian Genome Enterprises

In March 1999, undergraduates of Harvard University and the Massachusetts Institute of Technology (MIT) belonging to the Harvard-MIT Hippocratic Society organized a conference titled "Genetic Technology and Society." This brought together leading biotech scientists and entrepreneurs with politicians, antibiotech activists, religious leaders, and bioethicists to debate some of the social issues arising from biotechnology. It was clearly an uncomfortable venue for a number of the attending scientists, academic and corporate, who were evidently not used to presenting their achievements on the same panel as nonscientists who shared less sanguine views of the scientists' efforts than they themselves did.

One of the attending scientist-entrepreneurs was Kari Stefansson, founder and chief executive officer of the Iceland-based genome company DeCode Genetics. The pitch for this company was that Iceland, by virtue of its purported genetic homogeneity, provided an ideal site for population genomics experiments. What in fact made it an especially good site for such experiments was the existence in the country of excellent national medical records dating back to the early twentieth century, coupled with a wealth of genealogical information thanks to a population who took the tracing of their ancestry seriously.

Just as private genome companies in the United States such as Celera Genomics were creating controversy in 1998 (in their case because of their stated desire to patent the DNA sequences that they generated), so too was 1998 a controversial year for genomics in Iceland. This is because the Icelandic parliament had given DeCode exclusive rights to create a genomic database of the Icelandic population by collecting DNA samples and elucidating their genetic sequence, and further by coupling that genotype information to the health records of the population maintained by the state. This venture, called the Health Sector Database, presumed the consent of the Icelandic population. Instead of obtaining the informed consent of each potential participant in the database, DeCode allowed individuals to opt out of it. Unless an Icelander actively opted out of the database, his or her medical information was presumed to be a part of it. Not surprisingly, DeCode's efforts were becoming hugely controversial, not just in Iceland but in debates among American bio-ethicists, many of whom felt that it was inappropriate for a single company to own exclusive rights to a nation's genetic information.

As a graduate student with nothing to lose, I had e-mailed Stefansson before his arrival in Cambridge in the hope that I might be able to meet with him during the conference, and as expected had not received a reply. At a reception at the end of the first day of the conference, I met him in person, tall and elegant in a light gray Armani suit that matched his silvery beard. I told him that he had not responded to my e-mail, for which he apologized profusely, stating that he received in excess of two hundred e-mail messages a day, but that "we must talk." He suggested that we have lunch together on the following day, just after his own session.

The next day, Stefansson gave a wonderfully sculpted presentation on DeCode, in which he talked about its scientific and business potential, and also about the great care taken by the company to behave in an ethical fashion. He was particularly eloquent regarding the measures taken to protect the privacy of all individuals who were included in the Health Sector Database. One of his copanelists was a soft-spoken bioethicist from the Cambridge-based Council for Responsible Genetics named Martin Teitel, who raised many of the standard objections that opponents of DeCode's efforts had been raising in the previous few months. Stefansson exploded in the middle of Teitel's talk, saying that Teitel was not qualified to speak about the scientific aspects of DeCode's work, as he was not a scientist, and did not have the right to pass judgment on an Icelandic matter, as he was American. Teitel responded gently that if he could not, as a nonscientist, talk about science, and could not, as an American, talk about Iceland, then by that logic, Stefansson did not have the authority to talk about ethics, since Teitel was trained as an ethicist, and Stefansson was not. Stefansson realized that he had made an error, dramatically buried his face in his hands, shook his head, put his arm around Teitel, and apologized to him in public.

After the panel, I hovered expectantly around Stefansson for the promised lunch, but he swept past me, grabbed an associate by the hand, and stomped off with him, saying firmly as he went, "We must get ourselves a bioethicist!"

Grounds, Arguments, and Sites

The circulation of capital is intimately tied to questions of value. Value is one of those nice double-jointed words that always already imply two different things. On the one hand, "value" implies the market value that gets realized through processes of exchange. On the other, it implies the nonmarket values that might be called, in shorthand that has led to the term's own black-boxing as it has been used by members of the life science community, ethics. One of the things I show in this chapter is how market valuation depends on notions of value that are deemed somehow "external" to the market, while the "ethical" gets increasingly encroached on, co-opted by, and made answerable to, systems of market valuation.

One of the key transformations in the life sciences that genomics marks, as I explained in the introduction, is that biology increasingly becomes an information science. Therefore an analysis of biocapital involves asking at the outset where value resides as biology becomes an information science, and what work and whose agencies are required to create these values. Answering these questions involves understanding the circulation of information and the changing forms of corporate activity. I theorize the dynamics of information flow and corporate action around the fact that information is something that can be and is now owned. This chapter, therefore, offers an analysis of the dynamics of information ownership in the life sciences. Specifically, it focuses on the relationship between genomic information flows and the "speed bumps" created by its private ownership, in order to trace its implications for understanding the operation of the market logic of biocapital. In the process, I wish to show that "market logic" itself is hard to pin down and is very much at stake.

Corporate biotech is a form of high-tech capitalism. Three defining features consequently mark it: the importance of innovation; the role of fact production; and the centrality of information. One of the things happening is that information itself becomes a form of currency, susceptible to commodification and decommodification. Also, information is something that can travel globally, in circuits of exchange tied to, yet independent of, the (in the case of biocapital) living material (often DNA, protein, cell, or tissue) that the information comes from or relates to.

Let me tease out further the different social lives of biological material and biological information. Even though these are different "things," a continuous relationship exists between them. Biological information helps to rationalize experimental laboratory biology. For instance, one can use bioinformatics to determine the probable function of a protein encoded by a particular DNA sequence, by looking for homology between the sequence of interest and other sequences (usually in other organisms) whose function is already known. By thus narrowing the probable functional significance of different sequences, it is easier to experimentally determine the functionality of genes and proteins.

Therefore there is biological information, and the biological material (cell or tissue) from which the information is derived, material that subsequently becomes the substrate of experiments that validate the leads suggested by the information. In the process, information is detached from its biological material originator to the extent that it does have a separate social life, but the "knowledge" provided by the information is constantly relating back to the material biological sample. The database plays a key intermediary role in the transition of "information" to "knowledge": in this case specifically knowledge that is relevant to therapy. It is knowledge that is always relating back to the biological material that is the source of the information; but it is also knowledge that can only be obtained, in the first place, through extracting information from the biological material. The abstraction of information away from the biological material has a specific function in making therapeutically relevant knowledge. This is also why it is so easy to intuitively conceptualize the generation of information as "inventive," and therefore as something that can legitimately be owned.

What is at stake, then, in analyzing biocapital is an analysis of multiple forms of currency, such as money, information, and biological material, all simultaneously dependent on one another, yet not necessarily traveling the same circuits at the same time. These circuits, however, are not simply preordained networks but are often strategically constructed or constrained by various institutional actors, whose actions may be at cross-purposes. The creation of value, then, is a consequence both of circuits of exchange and of strategic articulations of concerned individual and institutional actors.

One of the features of sequence information flow in genomics is the remarkable speed at which DNA sequences are being generated, a consequence of considerable automation and investment in technological hardware in the form of new DNA sequencing machines. Therefore what is relevant is not just that genomic information traverses circuits of exchange but that genomics enables this circulation to occur at resolutions and speeds inconceivable before. The pervasive rhetoric surrounding such rapid information generation is, not surprisingly, almost one of breathlessness, conveying a sense of being overwhelmed with a huge amount of (presumably) valuable data that is virtually impossible to keep up with. As I will show, this is not merely rhetoric (though it is all rhetorical), because it is true that there is a huge amount of data being generated, and while nobody quite knows the biological significance of even a fraction of it, any piece of information in this haystack could turn out to be extremely valuable, therapeutically and commercially.

Speed is also of direct material value, since a delay in the production and marketing of what turns out to be a blockbuster drug could, in the calculation of the pharmaceutical industry, cost a drug company in excess of a million dollars per day. Speed manifests itself in two distinct ways: both as qualitatively massively compressed research and production time, and as a number of emerging segments that contribute to, or feed o, speediness. In other words, "speed" in genomics is important not just because change is fast but because "speed" is a material-rhetorical fulcrum used to lever first the government, and then the public and other companies, into responding to "hype" and thus further entangling themselves in biotech.

To stake a claim to the potential value of genomic information, there is a desire, certainly among private genome scientists, to own it. Ownership, however, puts fetters on the seamless flow of information, which is the desired condition for enabling information to be transformed into that valuable "something else," which is often a pharmaceutical product. I will unpack this dynamic in greater detail as the chapter proceeds, but this is the central theoretical problematic that I am trying to contend with: the breathlessness manifested through a speed surrounding information flow, tempered by the speed bumps installed as a necessary consequence of an institutional regime that allows information to be owned. This leads to a frictioned process. I use the notion of friction rather than that of noise (which has commonly been used in information theory to denote obstructions to information that, if overcome, can lead to a seamless flow of information), because such obstructions are not externalities waiting to be subsumed in a seamless flow but are internal to the dynamics of the flow itself. Friction is both the product of things rubbing against each other and suggestive of conflict; it is not just obstructive, but productive. Speed, speed bumps, and friction, therefore, are all inherent to the circulation of genomic information in contemporary capitalism. Further, the forms of "gifting" that I describe later in the chapter, which are articulated as alternatives to regimes of ownership and commodification, are themselves, by virtue of in fact being commensurable with commodification, also obstructive yet productive.

My theoretical arguments in each chapter are made through the use of different sets of ethnographic and empirical material. These, in different cases, include institutional sites, material objects, and individual biographies. In this chapter, I use three sets of institutional and strategic sites and arrangements to analyze notions of exchange and value in biocapital. These include the SNP Consortium; a U.S.-based biotech company that I call Rep-X; and the Indian state. The choice of these three sites and sets of stories reflects my concern to show the stratified dynamics of biocapitalist exchange through mapping its multiple terrains.

As I described in my introduction while explaining the upstream-downstream terrain of drug development, a broad distinction can be made between a genomics company and a pharmaceutical company. A genomics company tends to occupy upstream niches of the drug development process, tended between 1999 and 2001 to focus largely on selling genetic information, and tends to be smaller and newer. A pharmaceutical company tends to focus on downstream aspects of drug development, sells drugs, and is usually much larger and older. A common mode of operation for genomics companies is to license their information to pharmaceutical companies, an arrangement that is often more convenient for the pharmaceutical company than setting up an extensive genomics facility of its own.

Thus genomics companies try to patent DNA sequence information so that they can sell or license it. Pharmaceutical companies usually have to pay upstream licensing fees and subsequent royalties on any therapy they may discover to these database companies. The pharmaceutical companies would, therefore, much prefer information to be accessible in the public domain. Therefore, even public/private debates are overcoded by corporate fights. In other words, and this is crucial: What distinguishes the drug development marketplace from, say, the software industry is its peculiar upstream-downstream terrain. Drug development is such a capital-intensive process that very few companies have the muscle to actually take a drug to market.

(Continues...)

Excerpted from Biocapitalby Kaushik Sunder Rajan Copyright © 2006 by Duke University Press. Excerpted by permission.
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