Genes, Patents, and Indigenous Peoples: Biomedical Research and Indigenous Peoples' Rights

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The revolution in the last few decades in molecular biology has given scientists an unprecedented understanding of how human bodies work, and fail to work, and fail to work, at the molecular level. The relationship between DNA, RNA, proteins, and human physical functions lies at the core of this understanding. In a simplified description of this relationship, DNA serves as the "master copy" of information about making the chemicals needed for life. Information from DNA is copied onto RNA, which in turn is usually used to build proteins. The presence of the right form of the right protein at the right time can be essential to life; the absence of that protein, or even the presence of a "good" protein at the wrong time can lead to disease and death.

Scientists are now able to detect different forms of proteins and to "read" the stretches of DNA that order them made. These so-called "coding" regions of DNA constitute the bulk of the 50,000 to 100,000 "genes" in humans. The coding regions make up about five percent of the human genome: about 150,000,000 "letters" of the three billion or so in each person's genetic code. By learning the sequence of a gene, scientists can begin to understand better when, where, and how the protein made by the gene works - and what happens when the proper protein does not appear at the right time and place. Ultimately, scientists hope to be able to use this improved understanding of protein function to prevent or to cure many illnesses.

What does this have to do with indigenous peoples? It does not involve the existence of "special" genetic variations ("alleles") in indigenous populations. Genetically, humans are a very homogenous species. Of the three billion "letters" in our individuals genetic codes, two people from anywhere in the world will differ, on average, at one place in a thousand. In the "coding" sections of the genome, those differences fall to one in ten thousand. The genetic variations that do exist are generally found in all groups, although at higher or lower frequencies in some populations. There are no "genes" for being Chinese, or Navajo, or Zulu, or Irish, although genetic variations that affect skin color hair color, nose shape, and the few other superficial characteristics associated with traditional views of "race" will be found in different frequencies in different populations. The notion that an ethnic group, indigenous or not, has "superior" genes is often quite tempting to members of that group. It has no scientific basis and, quite literally, is racist.

So why are some scientists interested in the genetic analysis of indigenous peoples? Many are interested not in functioning genes, but in what the patterns of genetic variation can reveal about a community's history and society. This interest extends far beyond indigenous populations, however defined. Almost all the detailed work that has been done in human genetics has been done with samples taken from people of European descent, not because of any conscious or subconscious racism but because most of the research has been done in Europe and North America. The result, however, has research on "the" human genome that has largely excluded genetic variation in general and almost entirely ignored the variation found in about 85 percent of humanity. The proposed Human Genome Diversity Project (HGDP) is one, resolutely non-commercial, effort to collect and make available, in a scientifically and ethically coordinated manner, genetic information about a representative sample of the world's entire human population: European and non-European, indigenous and non-indigenous. Limited Commercial Prospects

There is no "gold rush" for indigenous DNA. The HGDP is important not because indigenous populations are being eagerly sought out by commercially-funded genetic researchers, but because these populations, along with most non-European populations, have largely been ignored. There are three limited circumstances, however, where genetic information from isolated populations could be medically, and commercially, important: (1) common disease-linked genetic variations, (2) uncommon disease-linked genetic variations, and (3) possible "health linked" genetic variations.

In order to learn the sequence of a gene associated with a particular disease, the scientists have to find the gene. Generally, that has involved finding families of people who have had a disease that seems to be linked to genes - the disease passes through families in particular ways and without any obvious, purely environmental cause. When families that have the genetic disease are found, the DNA of family members with the disease can be compared with the DNA of family members who do not have the disease. Stretches of DNA that are shared by sick family members but not by healthy ones are a good place to look for genes that are connected to the disease. The process is not easy: it can take hundreds of families, years of work, and scores of blind alleys, but its end results may be the location of the relevant gene, a copy of the gene, and, ultimately, the sequence of the gene itself.

Therefore, in order to find the gene, scientists first must find families in which the genetically-linked disease is common. Those families can sometimes be found in distinctive populations, some of which have been particularly useful in such research, for reasons indicated in the following discussion of research in the genetics of mental illness in one discrete group, the Amish.

The Old Order Amish community has large, extended families, and information on their ancestry is well known and available - genealogical records can race their ancestry back to only 30 or so European progenitors. In addition to information on ancestry, medical and hospital records with demographic details are also available. The group is located within a small geographical location, and even individuals who leave the community tend to remain in the immediate area, making them accessible for genetic studies. The group is both genetically and culturally homogenous, thereby reducing the variables that can complicate genetic studies. In additional. Cultural taboos essentially eliminate alcohol or drug abuse, which is important for the study of affective disorders since the symptoms of these disorders can be masked by alcohol or drug use. Furthermore, individuals within this community have very well-defined roles, and close interactions between its members mean that behavior that differs from the norms is readily detectable. Finally, this community, as a whole, is very concerned about health issues and particularly about mental illness. They have therefore been extremely cooperative with researchers interests in understanding the basis for such disorders (Risch and Botstein 1996)

For these reasons and other (such as physical proximity to researchers), the Old Order Amish have been studied often for information about some genetically-linked diseases. Other populations that have been particularly important in genetic research include Mormon families from the western United States and Finns.

Sometimes, indigenous populations will contain families that suffer from a high rate of genetically-linked disease. Those families can then be studied in an effort to find the gene. Thus, researchers have long been studying families in the Pima tribe (also sometimes called, with the Papago, the Tohono O'odham) in Arizona. For reasons that are thought to combine genetic predisposition and current diet, the Pima suffer from a very high rate of adult onset diabetes, a disease that maims and kills millions of people of all ethnic backgrounds. There are numerous other research efforts, ongoing or planned, looking at adult onset diabetes in narrowly-defined populations, including the Finns, the Old Order Amish, the "Gullah" Islanders in the American Southeast, and some West Africans. Research on such common genetically-linked diseases has the potential to provide information about the diseases that will benefit people in every ethnic group, and, as a result, has the potential for large commercial returns. At the same time, the studied populations are not thought to have any unique or special genetic variations, but simply a higher frequency of the disease.

Second, there are some less common genetically-linked diseases that are found primarily in particular ethic group. Tay-Sachs disease, for example, is found primarily in Jews of Eastern European origin, although it is also found at an unusually high level in certain extended families in Quebec and at a very low level in the general population. Some indigenous populations suffer from such unusual diseases. Research on those diseases may lead to improved abilities to predict and treat them, which could directly benefit the population involved. Ironically, commercialization raises a quite different problem for such diseases. Drug companies want to maximize their profits; a test or a treatment that primarily affects a small or impoverished community may well have little commercial value.

Third, there is at least one more speculative possibility for commercial value. It is conceivable that some families may have genetic characteristics that are unusually beneficial and that could be developed in a way to benefit all people. Two examples often cited are an extended family from a village in Northern Italy who may be protected against some forms of heart disease and a group of prostitutes in Nairobi who do not become infected with HIV, in spite of repeated exposure. Whether either of these example turns out to be scientifically correct, let alone commercially valuable, remains to be seen. There seems to be no precedent for the development of a product from a particularly "healthy" human genetic variation, but it cannot be called impossible. The Problem of Possible Exploitation

There is no gold rush to find commercially valuable genetic sequences among indigenous peoples and no reason to think that there will be. But it is possible that some research with indigenous peoples will have commercial value. What then?

Much of the discussion, by Rural Advancement Foundation International (RAFI) and others, has focused on patents. Life-related patents raise a host of tangled issues. The U.S. and some other countries have issued patents on cell-lines (as in the Papua New Guinea case), on genes, and on living organisms. People have attacked such patents from many different perspectives. Some have raised religious issues; other have expressed concerns about life-related patents and the environment, exploitation of individuals unfairness to the developing world, the propriety of patenting pharmaceuticals, and whether the gene itself is the appropriate stage in the drug development process for patent protection.

I share some of these concerns. The way the patent system is currently applied to biologically-derived products seems illogical, inefficient, and sometimes offensive. Personally, I would prefer a different system, one that, like the U.S. Orphan Drug Act, conferred not a patent but a limited period of regulatory protection for a new therapeutic product. But, fundamentally, patents are a diversion from the real question: how can the rights of indigenous peoples be protected? Patents can exploit or, as with the Hagahai, protect indigenous peoples. Exploitation, or protection, can also occur wholly outside the patent system. In the famous case of John Moore (not Professor John Moore writing for this issue), the University of California holds a patent on a cell-line dervied from his blood cells, but, whatever the merits of that case, the patent has proven irrelevant: the university has neither licensed nor enforced the patent in the twelve years since it was granted.

People advocate different approaches to protecting the rights of indigenous peoples in the rare cases where genetic research with them leads to commercially valuable products. This section describes five approaches, with their advantages and their problems: a ban of life-related patents, treatment along the lines of the Biodiversity Convention, gifts, individual property rights, and group rights.

One widely proposed solution, endorsed in general terms by RAFI, is to ban some or all kinds of life-related patents. This would prevent people, indigenous or not, from being "commodified" or "owned" by others, which may have great symbolic importance. But any other benefits for indigenous peoples are difficult to see. Banning patents neither guarantees any financial returns to indigenous populations, nor prevents financial returns to others from inventions derived from indigenous populations.

Rather than patenting cell-lines or genes derived from particular people, companies presumably would have to reach a further step in the process, such as the production of an effective test to drug, in order to get patent protection. But whether the patent is on the gene or on the drug, there is no guarantee that the people who provided the genetic material will benefit. Drug companies could continue to profit while the populations that participated in the research that led to the drug would continue to get nothing. And, if the ban eliminated the possibility of some kind of property-like protection for a drug company, it might also result in the loss of at least some new treatments that could benefit all of the world's peoples.

But even if such a patent ban is a good idea, it would not happen fast. The agreement of a broad spectrum of nations would be necessary to make patenting uneconomical - in light of their dominant positions in the international pharmaceuticals market, the United States, Japan, and the European Union would all have to ban such patents to make them impracticable. Such an agreement may never come; even if it does come, it does not answer the question of what should be done during the lengthy meantime.

A second alternative is to adopt the approach taken by the Biodiversity Convention. /This multilateral treaty established that national governments have both rights and duties with respect to most life-forms within their borders and their genetic sequences. The national governments undertook duties to protect biodiversity and to make their local microbial, plant, and animal species available for research and commercial use. In return, the treaty requires that national governments receive just compensation for such commercial use.

The alternative seems the worst people outcome for indigenous peoples. It would recognize their genes as effectively the property not of themselves, but of their national governments. That seems offensive in general; it is particularly chilling in light of the history of conflict between national governments and indigenous populations. Surely, no Native American tribe would be eager to see the United States government receive the royalties from the commercial use of the DNA of tribe members.

A third approach focuses on the relationship between the people who participate in the research and the researchers. It insists that samples must be freely offered gifts in order to avoid turning human materials into "property" or "commodities." Implicit in this view is the idea of full, informed consent in that the research subject makes a conscious and knowing gift biological materials in the expectation not of personal gain, but of improvement for all humanity. The donor should be motivated not just by altruism but by a sense of reciprocity - she benefits from the gifts of myriad predecessors and passes on, by her gift, a benefit to future generations. This philosophy underlies much regulation throughout the world of the medical use of blood or organs.

This seems an admirable approach in general and it has the great virtue of focusing on the relationship between the research participants and the researchers. But it fits poorly with the situation of reciprocal advantage, but many indigenous peoples, inside and outside the "developed" world, have not received the complete benefits - or sometimes any benefits - of modern medicine and science. Research participants who are full political and economic members of "developed" societies might be expected to feel bound by such reciprocity; most indigenous people should not.

A fourth approach also focuses on the relationship between the researcher and the individual research participants, but in a very different way. It stresses the individual property rights of the research subject. Let each person negotiate any possible deal for the commercial use of his or her biological material. Sell blood, sell kidneys, sell genes... let people make their own decisions as long as they do so with full information.

Application of this kind of free market approach to organs and to bodies generates some support and much outrage. Totally apart from the strong general objections to this approach, it faces several practical problems in genetic research. First, it is hard to imagine the process that cold lead every individual to become sufficiently informed about genetics, the biotechnology industry, and economics to strike a truly informed bargain for the use of their materials. That is truly informed bargain for the use of their materials. That is true informed bargain for the use of their materials. That is true with any individuals; it will likely be particularly true with communities far removed from the industrialized world's science, economics, and business. Second, it will rarely, if ever be the case that any one person will be the right person with whom on bargain. Success in finding genes requires many genetic samples. Negative samples are often as important as positive ones in pinpointing a gene's location. And positive samples are likely to come from numerous members of affected families. Which of the many individual research participants "sells the gene" to the researchers from playing off research participants against each other, in search of the least expensive source?

Group rights provide a fifth option, the one I support. In this approach, the decision whether and the what terms a population will participate in genetic research belongs to the group. This is the approach being suggested by the North American Regional Committee of the Human Genome Diversity Project. Its draft Model Ethical Protocol for the Collection of DNA Samples would require researchers to obtain informed consent to the research from both the participating individuals and the community to which they belong. The community would also have to be asked how it wants to handle any possible commercial value from the research. Alternatives might include requiring subsequent negotiations with the community before any commercial use, setting compensation for use through a percentage royalty fixed in advance, or any other system the community chooses. The community's wishes would be enforced by contractual obligations imposed on anyone who seeks to use the material or data obtained from them.

This solution is not perfect. It requires individual assessment of important issues like deciding when group treatment is appropriate, as it clearly would be for Native American tribes but would not be, perhaps, for Irish-Americans. It requires decisions about who is "the community" - an extended family, a local community, a tribal government or a larger language or cultural group. It demands decisions about who can make legitimate decisions for the group and how those decisions are properly reached. And it requires diligent enforcement, both of the requirement that the researchers obtain the necessary group consent and decision-making and that the group's wishes are followed.

But, unlike any of the other solutions, it offers indigenous communities an attractive set of possibilities. It establishes that the communities being researched will have realistic control over the research and its commercial uses. The community could decide to allow patents or to ban patents, to prohibit commercialization or to benefit it, to participate in the research or not participate in it. The group nature of the decision fits well with both the realities of many indigenous communities and with the realities of genetics research, where the entire population studied contributes to the result, not just the individuals from whose samples a sequence of interest is isolated. Conclusion

The story of the PNG-1 patent is, in some ways, a precursor of the group rights approach. Carol Jenkins discussed the research with the entire Hagahai community and got is permission to proceed. She discussed the patenting with them and they agreed to the patent application, on the understanding that they would benefit from any patent received. They had control over the uses of their samples, and they now have the right to receive at least a share of any benefits.

Is the group consent approach perfect? No. Is it better for indigenous peoples than the alternative resolutions suggested? Yes, if it is properly enforced. Can it be implemented? Yes, if funding agencies, ethical review boards, national governments or indigenous group insist on it as an ethical requirements or indigenous groups insist on it as an ethical requirement. It has been proposed by the North American Committee of the HGDP and is consistent with the general ethical principles for genetic research adopted by the Human Genome Organization.

This group-consent approach to genetics research will not change the world. For all the reasons discussed initially, it seems unlikely that much medical genetic research will be conducted among indigenous peoples or that such research will produce major commercial value. In the rare cases where that value does appear, this approach would put control over the research, and a voice in the uses and benefits of that research, where it belongs - not in national governments, scientists, bioethicists or non-governmental organizations, but in the collective hands of individual indigenous peoples. Indigenous people should control research access to their own communities and to their DNA; the rest of us need to make sure they are empowered to do so. Article copyright Cultural Survival, Inc.

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