Does patenting genes change the meaning of life? (Ethical Aspects).

Every person in the world is just like every other person in the world in the same way that a classic symphony is just like a popular hard rock hit.

So why are musical works unique? Because composers organize these predictable building blocks in some unique way. And more individual uniqueness is added when musicians produce different versions of the same basic composition.

Musical works consist of only seven notes on a diatonic scale and a limited number of rhythms.

In your body and mine the notes and rhythms are genes sequenced on chromosomes residing in the nuclei of our somatic and reproductive cells. Genes are biologically unique physical arrangements of a complex yet simple chemical known as DNA (desoxyribonucleic acid) that consists of just four amino acids plus some phosphates and, a few sugars. Through mechanisms not yet fully understood, genes control cellular function.

Dramatic accounts of this level of life cause us to sometimes forget that each of us is much more than our genes. "Clothes make the man (or woman) more than the genome does, perhaps," says Mark Sagoff, PhD. (1) But in a few instances of human disease, genetic influence is clearly predominant. For example you cannot develop congenital Factor VIII deficiency unless you are male and carry the sex-linked recessive gene that causes this disease, which manifests itself as a bleeding disorder (hemophilia).

One afternoon in 1957, a group of second-year medical students tasted the future. In a laboratory experiment devised by an assistant professor of microbiology, the group studied the DNA present in a colony of E. coli bacteria. The young professor was Paul Berg, 1980 Nobel laureate in chemistry for major contributions to the development of recombinant DNA (rDNA) technology. (2)

Using rDNA technology, it is now possible to isolate gene fragments, clone them, and insert them into the cells of living things. (3) The result is some change in the observable characteristic of the target plant, animal or human. The rDNA technology enables agriculturists to improve (some would say contaminate) everyday foodstuffs using genetically modified organisms (GMO's). (4)

Gene therapy

And rDNA technology combined with knowledge gained in the Human Genome Project (5) offers the hope of gene therapy for a list of over 2,800 genetically influenced diseases including hemophilia, Alzheimer's disease, and diabetes mellitus. (6) Successful gene therapy requires isolating useful genes such as the gene that instructs the body to manufacture Factor VIII, piggybacking them onto a gene transport agent such as a retrovirus and introducing them into the body of a patient with the targeted disease. (7)

Gene therapy is in early experimental stages and is not without risk. For example, the much publicized 1999 death of an 18-year-old patient during a trial of gene therapy is the focus of renewed attention to the safety of human research subjects. (8) And at the National Institutes of Health, the Recombinant DNA Advisory Committee (RAC) is currently looking into a case of leukemia thought to be induced during a clinical trial of gene therapy. (9)

Manufacturers of genes to be used in gene therapy claim the right to patent their products. And why not? Isn't that the American way? Besides, society benefits from creative effort and encourages it through copyrights, trademarks and patents that allow authors, composers, entrepreneurs and inventors to profit from their work.

Naturally occurring matter cannot be patented and discovery is not invention. But since 1980, products of genetic engineering have been patented following the legal precedent of Diamond v. Chakabarty. By a 5-4 vote, the U.S. Supreme Court decided that Chakabarty was entitled to patent his genetically engineered bacteria because "his claim is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter, a product of human ingenuity." (10)

Patenting other forms of life is commonplace, as in the case of a rose breeder patenting and profiting from a unique hybrid developed in the rose breeder's garden. Yet the idea of patenting genes, especially human genes, arouses a storm of controversy. (11)

"Patenting human genes is a Lazarus issue in bioethics," says Thomas Murray, PhD. "Every time the advocates of patenting think it has died and been buried, it comes back to life (because) there is a deep and widespread unease about patenting genes that reflects complicated views about life, commercialization and the nature of scientific inquiry." (12)

Cells for sale?

One specific concern is that people with unique genetic characteristics might be exploited. Naturally occurring human genes are the raw material from which gene therapy genes are manufactured. Traditional economic and social justice, as well as common sense, suggests that you own the cells in your body. But the law is not always just and certainly does not always follow common sense.

Gene patent critics Lori Andrews and Dorothy Nelkin (13) cite the example of John Moore, a Los Angeles businessman who contracted leukemia, Moore's spleen cells were found to have therapeutic potential in other patients so the doctor patented them, allegedly without Moore's knowledge and permission. Moore sued and lost. In a 1990 decision, the California Supreme Court decided that Moore did not have a property interest in his body parts. (14)

A second objection to gene patents is that access to patented genes will be restricted. Indeed, that is the purpose of a patent. Traditionally, advances in medical research are accomplished by a curious mixture of cooperation and competition between laboratories working on the same problem. Part of this process is sharing raw materials and laboratory products that can be used in further research.

But patented genes and gene fragments almost certainly would not be shared with other research laboratories. If the profit motive is paramount, why share the opportunity to make further discoveries that might also be patented? This scenario can effectively slow down the progress of science.

Also, patenting genes can be expected to increase the cost of gene therapy. Legal fees paid to resolve conflicting claims of first invention (15) would be passed on to purchasers of the therapeutic genes. And arbitrary pricing of patented genes might take the same course as arbitrary pricing of prescription drugs which is a white, collar version of "Your money or your life."

Value of life

Finally, some feel that patenting genes violates long-held cultural and spiritual beliefs about the value and sanctity of human life. Take the case of Moore, for example. Is the human body to be simply a utilitarian object, a commodity to be bought and sold?

This commodification issue is at the heart of religious and moral objections to patenting genes, along with the issue of ownership. Human beings belong to God, goes the ownership argument, so "patenting of human genetic material attempts to wrest ownership from God." (16)

If reason prevails over emotion, differences over gene patenting are not irreconcilable. Biotech companies don't want to claim creation or compete with God for ownership of the universe and reasonable religionists have no objection to either reasonable profit or biotechnological advances. Meaningful dialogue may result in mutually acceptable solutions. It usually does.

Some suggest that common ground can be found by tabling talk of intellectual property rights to take the focus off the difficult ownership issue. Focus instead, says Sagoff, (17) on the purpose of a patent.

Awarding a patent does not certify ownership. Rather, a patent only provides exclusive rights to benefit financially from a useful, non-obvious and novel innovation for a prescribed limited time period (20 years).'5 This approach should meet the needs of biotech companies and arguably is a good fit for the religious doctrine of stewardship.

But this approach is no panacea, because some might argue that this language dances around the fact that a patent grants a monopoly, however temporary, and that a monopoly is a form of ownership. The commodification issue is equally difficult to address.

Genuine resolution of this impasse will require that biotech companies and religionists bend toward each other without breaking. Biotechnologists must distinguish between reasonable profit and exploitative greed and must prove by their actions that they value human life beyond mere utilitarian considerations of economic worth in an open market.

Religionists must meet the biotech industry halfway. Religious tenets need not be abandoned, but must be updated to keep pace with advances in technological knowledge. Is it truly heresy to suggest that the ability to alter human genes may once and for all knock "AS it was in the beginning it is now and ever shall be" into a cocked hat?

As biotechnology advances, ethical questions will not get any easier to answer. Andrews writes, "There has been a patent application for a process to genetically engineer mammals to produce pharmaceutical products in their milk. (Although the application pertains to dairy cows), the application asks for rights to patent genetically engineered human women as well because according to the patent application, someone somewhere may decide that humans are patentable and we wish to protect our intellectual property if that happens." (18)

At first we laugh at such nonsense. Then we ask ourselves, "Who is to say what is ludicrous and what is not in the amazing world of 21st century biotechnology? And the laughing stops.

References

(1.) Sagoff, M., PhD. Personal communication. Sagoff is a senior research scholar at the University of Maryland, Baltimore, Md.

(2.) Berg, P. Dissections and Reconstructions of Genes and chromosomes. Nobel Lecture. December 8,1980. http://www.nobel.se/chemistry/laureates/1980/berg-lecture.html.

(3.) Recombinant DNA and Gene cloning. http://users.rcn com

(4.) Thompson, PB. "Why Food Biotechnology Needs an Opt Out." Chapter 2 in Engineering the Farm, edited by Britt Bailey and Marc Lapp_. Island Press. Washington D.C. 2002. pp. 27-43.

(5.) The Human Genome Project. Contributions of Sir John Sulston and the Sanger Centre, now the Wellcome Trust Sanger Institute, Cambridge, UK. www.wellcome.ac.uk/en/genome/hgpsansln.htm.

(6.) Partial List of Genetic Disorders. www.noah-health.org/english/illness/genetic diseases.

(7.) Gene Therapy. www.ornl.gov/hgmis/medicine/genetherapy.html. Site sponsored by the U.S. Department of Energy Office of Science, Office of Biological and Environmental Research, Human Genome Program.

(8.) Gene therapy researchers defend (clinical) trial after death of patient (Jesse Gelsinger). www.cnn.com/1999/health/12/10/gene.therapy.01.

(9.) Noguchi, P. MD. "Risks and Benefits of Gene Therapy." NEJM. January 16, 2003348.3, p. 193.

(10.) Diamond v. Chakabarty. U.S. Supreme Court. 447 U.S. 303; 100 5. Ct. 2204; 1980 U.S. Lexis 112; 65 L. Ed. 2d 144; 206 U.S. P. Q. (BNA) 193.

(11.) Hanson, MJ. "Religious Voices in Biotechnology: The Case of Gene Patenting." A Special Supplement to The Hastings Center Report. November/December, 1997.

(12.) Murray, TH, PhD. Personal communication. Murray is president of the Hastings Center, Garrison, N.Y.

(13.) Andrews, L. and Nelkin, D. Body Bazaar: The Market for Human Tissue in the Biotechnological Age. Crown Publishers. New York. 2001.

(14.) Moore v. Regents of the University of California. Supreme Court of California. #S006987. July 9, 1990.

(15.) Genetics and Patenting: What are patents and how do they work? wwwornl.gov/hgmis/elsi/parents.html.

(16.) Land, RD and Mitchell, CB. "Patenting Life: No." First Things. 63 May 1996. p. 20.

(17.) Sagoff, M. "Patented Genes: An Ethical Appraisal." Issues in Science and Technology Online. Spring, 1998. www.nap.edu/issues/14.3/sagoff.htm. Sagoff is preparing an updated version of this article. (Personal communication).

(18.) Andrews, LB. "Patents, Plants, and People: The Need for a New Ethical Paradigm." Chapter 5 (pp. 67-79) in Engineering the Farm, edited by Britt Bailey and Marc Lapp. Island Press. Washington D.C. 2002. p. 68.

Richard E. Thompson, MD, is president of Thompson, Mohr and Associates in Springfield, Mo. Previously, he was an adjunct instructor of ethics at the Ethics Institute, St. Petersburg College, St. Petersburg Fla. He can be reached by phone at [phone] or by e-mail at [e-mail]