“I’ll see your GCAT and raise you a TGAC”, Commodification in Biological Research

The discipline of ‘research bioethics’ exists in large part to recognize and protect the rights of subjects of biomedical research and experimentation. In doing so, it faces a number of challenges presented by competing interests in research, including the unending desire for scientific progress and the urgency inherent in the quest for medical breakthroughs. When one considers the researchers themselves, still other competing interests become apparent, such as the recognition promised to those who are successful in their research endeavors. In recent years, the rewards for success have come less in the form of recognition per se, and more in the form of financial returns. Success in research brings with it the prospect of garnering large sums of money, whether in the form of research grants or actualized profits arising from biomedical enterprises. In light of this increasingly intimate relationship between biomedical science and money, it is not difficult to envision why it is that biological materials (eg. cells, DNA) obtained from research subjects are increasingly becoming commodities to be bought and sold. It is the intention of this brief discussion to shed light on this issue and to demonstrate why it is deserving of increased attention in the biomedical research community.

In biological research, the trend towards commodification of life arguably began to take hold in1980, following the United States’ Supreme Court decision in Diamond v. Chakrabarty (1), in which they ruled to allow patenting of a living organism for the first time. The organism in question was an engineered strain of bacteria that could (theoretically) be used to help clean oil spills. This would prove to be a landmark decision as, in retrospect, it was the thin end of a proverbial wedge, with tremendous numbers of patents on ‘biologicals’ to follow. Indeed, eight years later, the Harvard Oncomouse, a mouse genetically engineered to have an abnormally high predisposition to cancer, was granted a patent in the USA, making it the first mammal to be patented as an invention. The American patent, together with others subsequently granted in many other countries in the years to follow, furthered the notion that living things could rightfully be treated as commodities.

It could be argued that animals have been subject to commodification for centuries, being bought and sold for food (meat, milk, eggs), clothing and adornments (furs, wool, feathers), or as pets, and that patenting is but a minor extension of existing practice. Such an argument, however, overlooks the impact of the precedent established by widening the legal interpretation of an invention to include a ‘higher organism’. Interestingly, in December of last year, the Supreme Court of Canada ruled that the legal definition of an invention could not be so widened, leading the court to deny the patent application for the Oncomouse (2). However, this decision, though applauded by some, has been widely criticized within the biomedical research community, indicating how pervasive the acceptance of patenting and commodifying biologicals has become.

The problem lies in the potential extension of such acceptance to include human beings. Of course, most people would unhesitatingly disagree with the treatment of humans as commodities – for example, slave trading – if they were to be presented with the issue in such a context, i.e. the trade of complete human beings. When you shift the context to parts of human beings, however, the unanimity of opinion is lost. As a result, organs are being bought and sold (3), and cells and gene sequences are being patented with unprecedented speed.

One of the best-known examples of human commodification via patenting was the Moore case (4). A former patient, John Moore, sued the University of California at Los Angeles (UCLA) for a share of the estimated $3 billion value of a patented cell line that had been derived from lymphocytes taken without his knowledge from his spleen (following its removal during cancer treatment). The Supreme Court of California ruled against him, stating “he did not have sufficient property rights in his own cells to create a claim of conversion [emphasis added].” By ‘property’, the court was not referring to a material object, but to “the right and interest or domination rightfully obtained over such object, with the unrestricted right to its use, enjoyment and disposition” (5). The court offered a number of reasons for its decision, the most troubling of which was their assertion that to allow patients a protectable property interest in their own body would put a stranglehold on the biotechnology industry by restricting access to the necessary raw materials. In essence, the court provided a legal foundation for commodification of human materials by finding that the bodies of patients could be viewed as depositories of raw materials for a profit-driven industry. Not surprisingly, the Industrial Biotechnology Association (USA) “applauded” the decision of the court (6).

Since Moore, there have been several other cases in the USA and abroad dealing with property rights with respect to biological material, including but not exclusive to Davis v. Davis (Tennessee Supreme Court) (7), Hecht v. Superior Court (California Appellate Court) (8) and Kass v. Kass (New York Appellate Court) (9), each of which dealt with ownership of frozen reproductive material. Nevertheless, the material status of human tissues and cells remains tenuously unclear, at least from a legal standpoint.

DNA, on the other hand, has become firmly established as a commodity; DNA patenting has received a great deal of attention recently, and for good reason (10). As of late 2000, there were patents pending or granted on more than 500,000 genes and partial gene sequences from a wide variety of organisms (11). GeneWatch UK found that by mid-November 2000, tens of thousands of these patents were for full or partial human genes, purportedly controlling every imaginable physiological process (12). Much of the gene patenting frenzy has come alongside efforts by publicly funded scientists involved with the Human Genome Project, together with industrial scientists at Celera Genomics, to sequence the human genome in its entirety. The potential for enormous financial gain from such an endeavour was made clear by the very participation of Celera, a private company with their eyes on hundreds of patents (13). Efforts to decode the genome ended in February 2001, with the joint publication of the first draft of the sequence (14), and the race to make it pay off began immediately thereafter with new waves of gene patenting.

The greatest potential profits stand to be derived by those with patents on genes (or even non-coding expanses of DNA) (15) that may play significant roles inhuman diseases. To facilitate the identification of such genes, some researchers have recently sought to exploit the genetic profiles of certain populations who, as a result of geographic and/or economic isolation, have relatively homogenous gene pools. For example, for $200 million, deCODE Genetics, Inc., negotiated the rights to the genetic profiles of the entire population of Iceland (270,000 people), in which to study the genetic roots of approximately forty common diseases (16). If DNA was not previously considered a commodity, that leap was arguably made via the establishment of a bona fide market value on this population’s genetic information. While deCODE is hoping to cash in on its exclusive rights to the Icelandic genome, there remains uncertainty as to what benefits, if any, will be passed on to the population from which the genetic information was acquired (17). Though it is true that the company intends to use the database to further biomedical knowledge, which would undoubtedly yield downstream benefits for Icelanders, it is reasonable to presume that if this altruism was the exclusive driving force behind the study, the company ought to share the genomic data with other research teams, rather than maintain exclusive rights to the database. Instead, according to President and CEO of deCODE, Kari Stefansson, deCODE was expecting that after 2001, “[the] revenue stream [would] really take off,” saying that they expected most of their revenue to come from subscription to the company’s database by pharmaceutical companies, insurers and so on (18).

This is bio-piracy in the truest sense, in that deCODE obtained the data by ethically questionable means, that is without explicit consent from Icelanders (19), in hopes of then profiting from its sale. Unfortunately, deCODE is by no means the sole entity engaged in bio-piracy – they have simply dominated media attention because of the grand scale of their endeavour. It should also be noted that although most of the discussion surrounding deCODE’s practices has dealt with issues of consent or the lack thereof to the formation of the genetic database, the fact remains that their exclusive ownership of the genetic code of an entire population raises enormous ethical concerns irrespective of the ethics of how it was obtained in the first place. Sadly, a Swedish population genebank enterprise, Uman Genomics, originally hailed as “a model of how public tissue banks should interact with the biotech industry” (20) for seeking to address some of these concerns by sharing ownership with the public and academia (21), has all but met its demise due to conflicts over IP rights (22).

From the usurping of one’s rights to one’s own cells, to the patenting of the genetic information shared by all living things, to outright bio-piracy, the developing trend towards commodification of human material, and therefore by extension of humans themselves, is showing no signs of slowing down. Indeed, as we in the ‘developed’ world (though I use the term loosely) become increasingly driven by profit, financial considerations will override ethical ones in ever more numerous and troublesome ways. As such, bioethicists, researchers, health care providers, legislators and laypersons must come together and through discourse find ways to ensure that biomedical research and the fruits borne thereof do not further compromise the dignity of persons that they purport to benefit.

References

1. Diamond v. Chakrabarty. 447 US 303 (1980)

2. Harvard College v. Canada (Commissioner of Patents). SCC76 (2002)

3. Though it is illegal to engage in the trade of organs in Canada,it is not illegal for Canadian citizens to travel abroad (eg. to China or India) to purchase organs retrieved (for a marginal sum of money) from living persons.

4. Moore v Regents of the University of California. 793 P.2d 479 (Cal. 1990)

5. “Moore 10 years later—still trying to fill the gap: creating a personal property right in genetic material.” http://www.nesl.edu/lawrev/VOL32/VOL32-4/seeney.htm

6. Sava H et al (1984) Clin Invest Med 17: 148-184

7. Davis v Davis. Tenn. Sup. Ct., 842 S.W.2d 588 (1992)

8. Hecht v Superior Court. 192 Cal.App.3d 560 (1987)

9. Kass v Kass. 91 N.Y.2d 554, 696 N.E.2d 174, 673 N.Y.S.2d350 (1998)

10. An extensive discussion of the ethics of patenting DNA is beyond the scope of this brief paper; however, for an excellent discussion paper on the issue, please go to: http://www.nuffieldbioethics.org/filelibrary/pdf/theethicsofpatentingdna.pdf

11. Meek J (2000) “The race to buy life.” The Guardian. November 15, 2000. http://www.guardianunlimited.co.uk/Print/0,3858,4091329,00.html

12. http://www.genewatch.org/publications/Briefs/brief11.pdf

13. Howe J (2000) “Copyrighting the book of life.” Feed Magazine. April 12, 2000. http://www.feedmag.com/dna/bookoflife.html

14. Lander ES, et al. (2001) Nature 409: 860-921; Venter JC, et al. (2001) Science 291: 1304-1351

15. The ownership of non-coding “junk” DNA has recently generated enormous controversy; for example, see: http://www.abc.net.au/catalyst/stories/s898887.htm

16. www.decodegenetics.com/resources/diseases

17. Kahn J (1999) “Attention shoppers: special today –Iceland’s DNA.” CNNia. http://www.cnn.com/HEALTH/ethics/9902/iceland.dna/template.html

18. Slud M (2000) “DeCode maps expansion: Icelandic genomics company unveils new cancer, drug research units.” CNNfn. http://cnnfn.cnn.com/2000/11/29/companies/decode

19. deCODE utilized an ‘opt out’ approach for constructing the genomic database, simply assuming consent from each and every Icelander unless otherwise informed; there is much debate in the literature as to whether this is (was) an ethically sound approach for this kind of study.

20. Nilsson, A. & Rose, J. (1999) Science 286(5441):894

21. Abbott, A. (1999) Nature 400(6739):3

22. Rose, H. (2003) Nature 425(6954): 123-4

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