UNIVERSIDAD MILITAR N.G. - Genética y Bioética. 2007

Revista Latinoamericana de Julio - Diciembre 2007

Genetics and Bioethics: The current state of affairs

Erin D. Williams, J.D. (Estados Unidos) 1O6 Bioética ABSTRACT In order to help Global Bioethics to be integrated fully into genetics, science, and a broader range of disciplines, it is necessary to look for a common topic among them. The broad collective notions expressed by Global Bioethics promise to appeal to and benefi t from the input of a variety of communities. Not many people are likely to oppose a call to create a sustainable future, yet different communities will probably have their own ideas about how the call applies to them. Key Words Global Bioethics, communities, sustainable.

Fecha Recepción: Abril 25 de 2007 Fecha Aceptación: Mayo 29 de 2007 A version of this paper is scheduled to be presented to the Seventh International Bioethics Seminar in Fukui: Ethical Debates on Human Genome Research Towards the Twenty-First Century Nov. 3, 2000. Agradecemos al Dr. Ludwig Schmidt por habernos cedido los derechos de la publicación impresa de este artículo. Ponencia presentada en el “I Congreso iberoamericano de Bioética”, Universidad Católica Andrés Bello, Caracas, 6 a 9 de febrero de 2001. (N del E.) Executive Director Foundation for Genetic Medicine, Inc.Assistant Professor, Law, Policy & Ethics School of Computational Sciences, George Mason

University. ISSN 1657-4702 / Volumen 8 / Edición 13 / Páginas 106-117 / 2007

GENETICS AND BIOETHICS: THE CURRENT STATE OF AFFAIRS / Erin D. Williams

1O7 RESUMEN Con el fi n de ayudar a la Bioética Global a integrarse completamente a la genética, la ciencia, y a una

amplia gama de disciplinas, es necesario buscar un terreno común entre una y otras. Las extensas nociones colectivas, expresadas por la Bioética Global prometen apelar y benefi ciarse de las entradas de una variedad de comunidades. No mucha gente está dispuesta a oponerse a la llamada de crear un futuro sostenible, es más, diferentes comunidades tendrán probablemente sus propias ideas de cómo el llamado se les aplica a ellos. Palabras Clave Bioética Global, comunidades, sostenible. ISSN 1657-4702 / Volumen 8 / Edición 13 / Páginas 106-117 / 2007 Revista Latinoamericana de Julio - Diciembre 2007 Today we have a common cause; we have to look out brain and one’s DNA. This notion can be exemplifi ed by for the life coming - for your children, for my children. We considering what the public’s reaction to a brain or DNA are accountable; they will hold us accountable... transplant would be. Would the recipient maintain his or But it’s a lot of work. We have to set aside our differher identity, take on the identity of the donor, or perhaps ences, and we have to work together as one people, one emerge as a new hybrid of both donor and recipient? family, for the future . . . Without regressing into a paradigm of genetic determin- - Oren Lyons, Faithkeeper, Onondaga Nation, North ism or reductionism, we must recognize the power of America1 the pervasive idea that a life form’s DNA contains the The pursuit of genetic knowledge has such emotionblueprint for its physique, its health, and perhaps even al, social, scientifi c, and fi nancial importance that it been its behavioral tendencies. We must act using caution and compared to the divine quest for the Holy Grail2, and sensitivity when deciding how to proceed in the arena of

to the calamity of opening Pandora’s Box3. Therefore, it genetics. comes as no surprise that the recent announcement of a completed blueprint for the human genome has fueled Genetic Promise and Pitfalls calls for both increased research and increased precauI study the beautiful, the living, the individual bird, and tions. This new era, which holds the potential promise of to my scientifi c brothers, advances in medicine, agriculture and other areas, also I leave his skin, his bones, and his place in the temple requires the careful investigation of a myriad of issues. of fame. Some issues, such as informed consent, patenting, - Olive Thorn Miller, 19th c. ornithologist privacy, and confi dentiality, have been explored in at In light of all of our modern advances, it is almost im1O8 least some detail. Others, such as equity, mutual possible to imagine that as recently as 1988, when the respect, empowering education, consensus buildHuman Genome Project (HGP) was announced, the tools Bioética ing, and planning for long-term survival, have not to make it happen had not yet been invented.6 Now, been as fully examined, nor have they been as in the year 2000, the HGP has been completed years comprehensively integrated into mainstream thinking. To ahead of schedule.7 The genetic technologies in place, facilitate this, we need to implement an ethical approach and those being developed ever more rapidly, are robust that leads us to ask critical questions about the appropridevices and methods that have the potential to be used ate use of our new tools. The demand for proper investifor both positive and negative ends. gation into the issues surrounding genetics is particularly important given current conceptions of the role that dePredisposition to disease oxyribonucleic acid (DNA) plays in defi ning ourselves, our In the medical arena, genetic technologies provide environment, and the relationships between them. diagnostic possibilities, often allowing the prediction of

Human beings’ conception of who we are and how disease either prenatally, or in children or adults before we relate to our environment is as varied and complex as its onset. Huntington’s Disease and breast cancer are we are. In many instances, our concept of self has been two maladies that have an identifi ed genetic compolinked to our physical bodies. In some European-based nent. People who believe that they may be at risk for traditions, the heart was of vital importance to the self, Huntington’s, a terminal deteriorative disease for which as it was believed to dictate love and perhaps even pro36 is the average age of onset, can now effectively previde material shelter for the soul4. The concept of a heart dict in childhood whether they will develop the disease. transplant during those times would have been almost Those who have a family history of breast cancer can use inconceivable. Chinese tradition teaches that a person’s similar measures to discover whether they carry a gene center, or dan tien, is an area located just a few inches associated with an increased risk. Genetic diagnostic below the navel5. This energy reserve must be maintests are currently being developed for a range of conditained, as it is central reservoir of an individual’s life force, tions. or chi. Using genetic information in order to help predict In the United States presently, there seem to be two the likelihood of disease for an individual may prove to physical locations in the body that are given extraordibe both benefi cial and burdensome. Many of the patientnary weight in defi ning an individual’s personhood: one’s oriented clinical ethical legal and social issues, while not ISSN 1657-4702 / Volumen 8 / Edición 13 / Páginas 106-117 / 2007

GENETICS AND BIOETHICS: THE CURRENT STATE OF AFFAIRS / Erin D. Williams decisively resolved, have been addressed in numerous gain insight into the disease process, work to develop

settings. These issues include informed consent, genetic HIV vaccines, design and test prevention and education counseling, handling of tissue samples and medical inforplans, create new diagnostics, and evolve therapies to mation, privacy, confi dentiality, and others. account for drug resistance.11 Endeavors similar to the However, even if we assume that the above set of US Military’s HIV Research Program have been contemissues has been adequately handled, other larger issues plated in the civilian world addressing diseases such as still remain. In the United States, we struggle with a cancer. Some such projects are already underway.12 health care system inaccessible to many people in need. In order for these types of undertakings to be sucDue to that system, revolutionary genetic diagnostic cessful, long-term patient participation is essential. techniques remain out of reach of the uninsured and Incredibly detailed gene expression arrays, which are underinsured, making many of them irrelevant to a large currently generated by gene chip technologies, are of portion of the population. Due to that system, children little use without clinical data to correlate with them. diagnosed early in life may fi nd themselves unable to proWhile the goals of research scientists and patients are cure health care for the very conditions that affect them. not necessarily at odds with one another, the resulting These counterintuitive realities make sense only if we data warehouses that the scientists and their sponsorrecognize United States health care and insurance coming organizations come to own are tremendously valupanies as functional businesses, which are sometimes able. Though information contained in them can at odds with consumer interests. It is a problem that is no longer be linked back to individuals, imballikely to remain until we reshape health care and insurances in equity can rapidly arise. Populations 1O9 ance systems as mechanisms for sharing the necessary who contribute their own personal medical cost of health care across society.8 information to the warehouses are traditionIn developing nations, the health care systems may ally excluded from receiving benefi ts, other

not be able to provide genetic diagnostic services at all. than the potential to purchase the resulting The gulf between wealth and poverty is further widened improved medical care. We need an ethic that prompts across international lines. We need an ethic that will us to infuse our research efforts with respect, equity, and allow us to remain sensitive to those in need, facilitating a call to give back to the communities that make such research where it is helpful to them, while prompting us efforts possible. to address the larger equity issues. One example of how equity might be shared between groups of participants and researchers is availResearch and Clinical Assistance able in the form of a Prototype Ordinance,13 presented Genetic information, when coupled with clinical by Robb Hunter, lead litigator of the Conference Salishrecords, can be useful for selecting appropriate treatKootenai Tribes. The document was received at the 1998 ment plans in medicine. Since 1989, soldiers in the Biopiracy Conference of the Indigenous People’s Council United States Military who are infected with the Human on Biocolonialism. The Prototype Ordinance would create Immunodefi ciency Virus (HIV) have had the opportunity a tribal Research Review Committee (RRC) to review and to have their DNA analyzed regularly by gene chips and comment on, and form a Proper Research Agreement becorrelated with their medical records, both of which have tween a tribe and a researcher. been key coded for privacy protection.9 A clinician treatIn its review, a tribe’s aim would be to “fulfi ll the reing an HIV positive member of the armed forces can now sponsibilities that Tribal people have to the natural world send the patient’s tissue sample and other pertinent into promote the health and survival of the sacred web formation to a research offi ce. Medical researchers then of life for future generations.”14 Some of its more novel analyze the information, employing a combination of provisions call for cultural sensitivity training, equity shargene chip technologies and correlated anonymized mediing, comprehensive consent, empowerment, tribal bencal records. efi t from intellectual property rights, and data ownership Using this technique, within a matter of days the cliand archiving by the tribe.15 These provisions articulate a nician receives information advising him or her of which respectful partnership model in which researchers and treatment options are the most statistically promising for participants act together for their mutual benefi t, and to that individual10. From the resulting data, scientists then sustain the web of life for future generations. ISSN 1657-4702 / Volumen 8 / Edición 13 / Páginas 106-117 / 2007 Revista Latinoamericana de Julio - Diciembre 2007 Use of the Prototype Ordinance would be appropriate language. If we have the potential to affect some types for organized groups with identifi able leaders, however of deafness with genetic manipulation, we run the risk similar agreements are not likely to emerge in studies of alienating the portion of the deaf community that opts conducted with less united, less organized populations. not to change. This is not to say that we should deny Nevertheless, preservation of the sacred web of life is therapies for people who desire them, but rather that we a goal to be considered in all situations for our collective should be mindful about our assumptions and prejudices survival. Therefore, we need an ethic that requires us to when we create policy surrounding their implementation. examine the long-term effects of our actions on ourselves We need an ethic that allows research to be guided by and on the systems that support us. those likely to be affected by it, and one that reminds us to value our diversity. Therapy Genetic engineering and related technologies provide Forensics and Heritage the potential to create new cures for genetic and geneGenetic technologies have been used in forensics by related conditions or diseases. In France, a couple of prosecuting and defense attorneys in order to identify young boys, aged 8 and 11 months old, were apparently criminals and also to free wrongly convicted inmates from cured of a rare disease called severe combined immuprisons. In some dramatic cases, death row inmates who

nodefi ciency (SCID).16 SCID “is caused by a single dehave long claimed their innocence have been exonerated fective gene in T-cells that disables the immune system, with the assistance of DNA technologies.18 Forensic scileaving the victims unable to fi ght even minor infections. entists have also used genetic tools to help identify the Thus, SCID victims must live their lives inside sterile otherwise untraceable remains of both war and accident bubbles.”17 The gene therapy provided the boys with a victims.19 Similar techniques, when applied to mitocopy of a non-SCID-causing gene, and was reported to chondrial DNA (which is inherited completely from one’s have enabled the boys to return home to a life outside mother), can be used to trace one’s maternal lineage, and their bubbles. have even connected some modern-day people to the The ability to shift a person’s genetic makeup, providremains of an Incan mummy.20 ing him or her with relief from a painful and/or alienating These types of technologies, which have linked people condition is marvelous to fathom. Yet some ethical questo physical locations and ancient ancestors, have also tions do arise as a result of these new types of tools. caused some concern. This is the case among some The same issue of equity must be reexamined. groups in which rights are based on lineage. For example, 11O Concerns regarding the availability of somatic cell Brett Shelton, tribal attorney and former policy analyst Bioética therapies to some and not to others plays out much for the National Indian Health Board in North America, the same way as those outlined in the section on noted that “Tribal sovereignty is based on a defi nition of testing for predisposition to disease. By contrast, the seIndians and tribes as ‘distinct peoples’ which is used to lective availability of germ-line therapies (which may affect determine whether a group of people is a tribe... I am the offspring of the person receiving treatment), have the not saying that the scientists have these bad intentions

potential to create physical barriers between people with toward indigenous peoples, but rather that the science different income levels. In the future, privileged children creates new, very serious risks for tribes.”21 may inherit not only estates, but also gene-therapy proSimilar concerns arose around control of ancestral duced disease resistance from their parents. We need an human remains. Marla Big Boy, tribal attorney for the ethic that prompts us to work to end class differences, Confederated Colville Tribe in Washington State, was innot to entrench them. volved in the Tribe’s efforts to repatriate the ancient reAnother more diffi cult question highlighted by gene mains of the one called “Kennewick Man”. He was found therapy technologies centers on our treatment and views in July 1996 on the Columbia River, and estimated to be of vulnerable populations. Does the fact that we strive at 9,300 years old. Ms. Big Boy explained: to “fi x” a malady have implications for the self-image of The burden of proof should be on the scientists to those who might not seek a cure? For instance, many prove there were Europeans in the area at that time. members of the deaf community do not feel disabled, (Instead, to the contrary, we) have to discuss how many and take pride in their culture and in the beauty of sign grams can be taken from his body, who can be in the ISSN 1657-4702 / Volumen 8 / Edición 13 / Páginas 106-117 / 2007

GENETICS AND BIOETHICS: THE CURRENT STATE OF AFFAIRS / Erin D. Williams room, and who can see him. The Ancient One is no longer In a village in the Eastern Province of Kenya, some whole; he is missing a fi nger which was taken for DNA individuals [came] to... collect barks and leaves of the testing. This is causing the elders much distress, but the acacia nilotica trees. These trees belong[ed] to the farmauthorities do not understand... To us, he is an ancestor; ers, they [were] growing in their fi elds. Many months

to the scientists he is a specimen.22 after, the same individuals, claiming to be researchers, To adequately address these types of issues, we need [came] back to the village, with some fi nal products like an ethic that allows research to be guided by those likely lotions, ointments, etcétera. They [said] that these prodto be affected by it, and one that reminds us to value our ucts [were made] from the bark and the leaves of the diversity. Acacia nilotica trees, and they [were] now their products, and in the process of being patented. Agriculture The story is very common story about what is hapIn agriculture, genetic advances enable the creation pening in the fi elds. The farmers were shocked. Who are of hybrid forms of foods, increasing the nutrition of rice23 the owners of the fi nal product[s]? Is anybody allowed or creating sheep that produce pharmaceuticals in their to collect what he wants in the fi elds belonging to the milk.24 Other efforts are aimed at creating edible plants farmers, or even in the natural reserves, in the wildlife that can thrive in climates where more traditional varispaces? Where do the rights of the local communities eties of plants would perish.25 These types of advancebegin?... Research, to achieve its goal, must take into acments may be used, in turn, to help reduce or even end count indigenous knowledge, draft with local communihunger and malnutrition. ties the criteria for research, and together, farmers and While farming and genetic manipulation have taken researchers propose the conclusions of research.29 place outside of the laboratory for centuries,26 the pace In order to balance the rights and needs of indigenous and direction of genetic manipulation has caused concern populations with the goals of the research community, for several reasons. One stems from a worry that the we need an ethic that will allow us to remain sensitive use of genetic technologies will cause and/or increase to those in need, facilitating research where it is helpful

humans’ objectifi cation of other life forms, facilitating the to them, while prompting us to address the larger equity perception that living beings are mere tools, rather than issues. valuable entities in and of themselves. This sentiment One fi nal set of issues that arises in agriis expressed by many people who oppose medical and culture has to do with concerns about gecosmetic experimentation on animals.27 Medical studies netic modifi cation’s effects on ecosystems. 111 conducted on animals are commonly required as phase There have been some reports indicating of research that must precede human experimentation.28 that genetically modifi ed corn may endanger The ethic that we use to evaluate genetic research should Monarch butterfl ies, and that genetic drift cause us to ask how we can be good siblings, or at least may release genetically modifi ed crops into good stewards, to the other inhabitants on the Earth, as the environment.30 How do we help to ensure that we we are all interdependent. are using biotechnology in a responsible way? We employ Another set of concerns is rooted in equity issues, an ethic that prioritizes our ecosystems’ sustainability, which are illustrated by the following example: helping to ensure our collective future. In agriculture, genetic advances enable the creation of hybrid forms of foods, increasing the nutrition of rice or creating sheep that produce pharmaceuticals in their milk. Other efforts are aimed at creating edible plants that can thrive in climates where more traditional varieties of plants would perish. These types of advancements may be used, in turn, to help reduce or even end hunger and malnutrition. ISSN 1657-4702 / Volumen 8 / Edición 13 / Páginas 106-117 / 2007 Revista Latinoamericana de Julio - Diciembre 2007

A threshold question: Where should we commit our resources?

We routinely choose to indulge our own generation at the expense of all who will follow. We enshrine the self as the unit of ethical account, separate and distinct

not just from the natural world but even from a sense of obligation to others -not just others in future generations, but increasingly even to others in the same generation; When all of these clinical, and not just to those in distant lands, but increasingly therapeutic, agricultural, even in our own communities. We do this not because we don’t care but because we don’t really live our lives. and other genetic tools We are monumentally distracted by a pervasive technoare coupled with the burlogical culture that appears to have a life of its own, one geoning technology inthat insists on our full attention, continually seducing us dustry, it becomes clear an pulling us away from the opportunity to experience that even more develodirectly the true meaning of our own lives. pments will soon be on -Albert Gore, Earth in the Balance their way. This is a time The question of where to commit our resources is as with the potential for rapid daunting as it is important; it is the proverbial elephant change, dramatically shifin the middle of the room. Genetic research can help us ting our capacity to affect to understand many disease pathways, predict the treatourselves and the world ment effi cacy of traditional medicines on individuals, craft in which we live. Genetics targeted vaccines, understand how environmental and the emergent techno112 factors are likely to interact with specifi c people, and more. Still, we have come to understand that logies are themselves neiBioética many diseases, such as cancer, appear as a result ther good nor bad, howeof interplay between one’s environment, nutrition, ver we must be cognizant lifestyle, genotype, and other factors. Given that, should of fact that they have arisen we expend our resources on genetic research when we and are employed in dismay be able to do more good spending the same money tinct cultures and circumsto clean our water and air, produce and promote healthy

foods, and teach ourselves and our children to relax? tances. While factually Although this question should be answered before grounding our discussions, the preceding issues are raised, it is the last subject to we should seek to develop be covered because it is the most diffi cult to address. It and employ an ethical frarequires a decision-maker equipped to make a macro-almework that prompts us location determination in the best interests of everyone to ask the best set of queson the planet, the systems in our biosphere, and future tions at this pivotal time. generations. To be justly weighed, it requires the input and/or consideration of multiple communities, nations, humans and other life forms. To be appropriately implemented, it requires the buy-in of those who control our natural resources and direct large fi nancial expenditures. I am not prepared to answer this question today, only to ask it. It would be hubris for me to do otherwise. Instead, I propose that we make a commitment to prepare ourselves, community leaders, scientists, pharmaceutical ISSN 1657-4702 / Volumen 8 / Edición 13 / Páginas 106-117 / 2007

GENETICS AND BIOETHICS: THE CURRENT STATE OF AFFAIRS / Erin D. Williams manufacturers, professionals and lay people to work with have been tremendously valuable, several greater realms one another in an earnest search for the solution. We can of inquiry have remained largely outside the scope of do this by acting with and teaching mutual respect and a human-subject-oriented bioethics. basic set of values that acknowledges the ways in which we are interconnected and interdependent. We can do Ancient Wisdom and Global Bioethics this by encouraging a search for simplicity in our quesIdeas such as those expressed in the Tribal quotions and answers. We can do this by building bridges tations contained earlier in this paper refl ect some among polarized communities, and initiating meaningful basic understandings about humanity, nature, baldialogues where all are welcome. ance, and planning for a sustainable future. In 1988, a type of bioethics emerged, featuring a focus resonant Choosing an Appropriate Ethical Framework with the ancient Tribal teachings: Global Bioethics, ex- ...now we are as one: earth, sky, all living things, the pressed by Dr. Van Rensselaer Potter in his book Global two legged, the four legged, the winged ones, the trees, Bioethics: Building on the Leopold Legacy.38 Since that the grasses. We are all related, one family. time, the same ideals have been refl ected elsewhere, - White Buffalo Woman, Lakota and Sioux legend in the Statement on the Principled Conduct of Genetics Research39, in the publication When all of these clinical, therapeutic, agricultural, Ethics and Equity: in conservation and use 113 and other genetic tools are coupled with the burgeoning of genetic resources for sustainable socitechnology industry, it becomes clear that even more deety,40 in the Universal Declaration on the velopments will soon be on their way. This is a time with Human Genome and Human Rights41, and the potential for rapid change, dramatically shifting our cathe Bioethics Declaration of Gijon42, among others. pacity to affect ourselves and the world in which we live. Global Bioethics represents an interdisciplinary, Genetics and the emergent technologies are themselves cross-cultural movement, that calls of the examination of neither good nor bad, however we must be cognizant of new technologies, proposals, developments, and existing fact that they have arisen and are employed in distinct systems with the goal of creating a shared future with cultures and circumstances. While factually grounding equitable outcomes across the biosphere. Presently, in our discussions, we should seek to develop and employ order to strengthen and advance the Global Bioethics an ethical framework that prompts us to ask the best set movement, a couple of steps are necessary: education of questions at this pivotal time. and consensus building.

One large body of bioethics has focused on clinical

and research applications of new technology and its reEducation sults. It emerged in the wake of the Nuremberg Trials, The tenants of and reasoning behind Global Bioethics when medicine was shifting from a paternalistic model should be incorporated into the curricula of our educato a more patient-centered one.31 The major concentrational systems an interdisciplinary manner. Students and tion of this area has been on protection of human subprofessionals should be encouraged to discuss topics jects from research risks. Thanks to this set of bioethiwith respect to Global Bioethics. Discussions should help cal frameworks, revolutionary notions such as the need participants to become conversant in it, guiding them to for informed consent32, external review of research envision themselves as part of a global community, each protocols33, and appropriate separation of research and with a responsibility to the whole. At all levels of educlinical medicine34 have been introduced, codifi ed, and cation, students should be taught to recognize an ethiperiodically updated.35 cal issue when it appears, think and decide where they The human-subject-oriented line of bioethics and asstand, explore and transcend their own views, and be sociated legislation have proven to be essential for the motivated to act as a result to “be good and do good”.43 protection of human subjects. As the Human Genome The education of the populace about genetic technolProject developed in the United States, publications proogies is also important. This step will serve the purpose viding some ethical guidelines followed. These largely of dispelling some unfounded fears, like those demonfocused on researcher / subject issues such as privacy36, strated anecdotally by a woman who admonished a sciand layered informed consent.37 While these protections entist, telling him that she did not want to “eat or serve to ISSN 1657-4702 / Volumen 8 / Edición 13 / Páginas 106-117 / 2007

Revista Latinoamericana de Julio - Diciembre 2007 her children any food with DNA in it.”44 Education of the to simple conversations that en