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Minnesota Magazine Where Research Meets Ethics By Meleah Maynard If researchers at a public university discover a cure for a devastating disease, should they rush to save lives with that new knowledge? Or should they reap the monetary benefits of that breakthrough in order to fund further research? What about scientific advances, such as the mapping of the human genome, which is unlocking the secrets hidden in DNA? Who is monitoring how this information is used? The Consortium on Law and Values in Health, Environment & the Life Sciences was founded at the University in 2000 to tackle the challenging questions posed by scientific advances that are leading us into new terrain—where old rules might not apply. Recently identified as one of University President Bob Bruininks’ eight Interdisciplinary Academic Initiatives, the consortium links 16 of the U’s centers and programs to examine the legal, ethical, and public policy challenges that accompany scientific advances. “The issues we’re talking about are challenging,” says Susan Wolf, chair of the consortium and a professor in the Law School, Medical School and Center for Bioethics. “They have the potential to transform who we are and who our children are.” Through the consortium, interdisciplinary groups of U experts help the public and policymakers understand the controversy surrounding scientific advances and probe how law and ethics can inform discussions and decisions about these advances. “It’s important to our mission that the consortium be interdisciplinary,” Wolf says. “We strive to be inclusive and represent all the major viewpoints in a balanced way. We have a huge range of views within the consortium and I see that as a great strength.” With its interdisciplinary approach, the University’s consortium aims to be a national leader in addressing the day’s most critical issues surrounding scientific advances and policy. Here is a look at four of its recent and current projects. Intellectual property rights and the developing world The story of “golden rice” provides an example of the quandary universities and researchers can find themselves in when both intellectual property rights and helping the developing world are at stake. Named for the yellow color it takes on from the beta-carotene produced by the genes inserted into it, golden rice is enhanced with pro-vitamin A, which the body converts to vitamin A. It is estimated that more than a half-million children go blind each year because of vitamin-A deficiency. After a decade of research, genetically modified golden rice was developed in 1999 by European geneticists Ingo Potrykus and Peter Beyer, who viewed their creation as a way to help alleviate suffering from vitamin-A deficiency in underdeveloped countries. Obstacles to distributing golden rice in developing countries arose almost immediately. “Their research was publicly funded, but the technology behind it was patented,” explains Regents' Professor Ron Phillips, a director of the U’s Center for Microbial and Plant Genomics. “They found out that there were something like 72 different patents held by 40 different organizations, including universities. They had to get permission from all of those people.” Research universities increasingly are becoming embroiled in intellectual property rights debates because of the 1980 Bayh-Dole Act, which permits the patenting of federally funded research discoveries. These patents have brought royalties and recognition to schools and individual researchers, but they’ve also raised ethical and legal questions that are not easily answered. Part of the problem is that patent laws were written with the proprietary interests of the private sector in mind. Many believe that a strict application of these laws to public institutions, such as universities, puts schools in direct conflict with their mission to help alleviate problems around the world. “Current law dictates that developing countries pay the same price for innovation as developed countries do,” says Ruth Okediji, a University law professor and a leading expert on intellectual property law. “But these countries are mostly impoverished and can’t afford to do that, yet they are the ones who are most in need of some of this agricultural and pharmaceutical technology.” Okediji believes exceptions should be made to intellectual property rights policies to make life-saving technologies available to developing countries. “From a legal standpoint, there is nothing right or wrong with granting property rights the way we do,” she says. “But I would argue that we need to make accompanying laws that make exceptions for the public good, because these are life and death issues. The reality is that while we’re fighting legal battles over these things, people are dying because they can’t get AIDS drugs or food technology that would alleviate starvation.” In April, the consortium and the Center for Microbial and Plant Genomics hosted a symposium on the obligations of U.S. universities to developing countries, where experts discussed golden rice and other intellectual property rights examples. Strategies for helping poor countries gain access to beneficial technologies were explored, including compulsory licensing of technologies and products that are not reaching the people who need them most, drafting licensing agreements to ensure distribution at a reasonable price, and the inclusion of a “humanitarian use” clause. “Humanitarian-use exemptions say that universities should have to provide the developing world with technologies they can’t afford,” Phillips explains. As for golden rice, the story has a satisfying ending. Potrykus and Beyer were persistent, Phillips says. They convinced Syngenta, a leading agricultural biotechnology company, to negotiate with all of the parties that held patents in golden rice, often asking them to donate licenses for humanitarian reasons. (In return for brokering the deals, which took nearly a year, Syngenta received rights to the rice for use in the developed world.) By 2001, five of the major patent holders had donated their licenses, allowing golden rice to move forward. “Once they got the license exemptions, they were able to deliver the first golden rice seed to the International Rice Research Institute in the Philippines,” says Phillips. The rice will be tested over the next several years, and Phillips estimates it will be at least four years before the rice will be available to farmers, many of whom will be able to get it for free. Following the recent symposium, Phillips and his colleagues began drafting a humanitarian-use clause for University-wide use. “We’re excited about doing this,” says Phillips and we’ve encouraged other universities to do the same thing.” The symposium papers will be published in the consortium's new journal, the Minnesota Journal of Law, Science & Technology. Genetic testing and disability insurance As director of the U’s Center for Bioethics, Jeff Kahn has closely followed discussions about genetic testing. He sees the benefits of the science, but he is also mindful of the risks. “The mapping of the human genome will offer incredible information on health, disease, and behavior, and we all would like to reap those benefits without risk to our privacy and insurability,” Kahn says. Many fear that genetic test results will lead to discrimination by insurance companies who don’t want to cover someone with a propensity toward a particular disease. Or, they argue, employers might deny employment based on genetic tests. In response to these concerns, many states have passed laws protecting the privacy of genetic information and barring discrimination based on test results. Congress is currently considering a bill that would do the same. As they’ve followed the debate on the genetic testing, Kahn and his colleagues realized that a key issue was missing. “We were thinking about issues of ethics, genetics, and insurance, and we realized that in all of the discussion of genetic testing and health insurance or life insurance that one important type of insurance was being overlooked: disability insurance,” Kahn says. Genetic testing has the potential to affect how we define disability. "Are we going to regard anybody with a genetic predisposition for a disability as disabled?" asks Wolf. "If you do that, then you're going to have people who are disabled from conception." On the other hand, she continues, "If we say, well, no the test only shows they are at risk for a disease, we'll wait and see if that disability manifests, the insurers may balk, refusing to ignore the probability or certainty of future disability. So the problem is, once you've got a crystal ball, what are you going to do with it? In July 2000, the consortium, the Center for Bioethics and the Joint Degree Program in Law, Health & the Life Sciences received a National Institutes of Health grant for $442,414 to assemble an interdisciplinary working group of experts to examine and report on issues that arise when genetic information is used in connection with disability insurance. The project held a conference on the subject in 2003. The conference papers and an article announcing the group's recommendations will be published in The Journal of Law, Medicine & Ethics. Wolf, a co-investigator on the project, says the report will focus on a wide range of issues, including the fact that disability insurance may be absent from debates about genetic testing largely because most people don't give enough thought to what they will do if they can't work. “Data shows that a large number of workers will suffer disability in some part of their working life,” Wolf explains. “Greater than 40 percent of mortgage foreclosures are due to a lack of disability insurance. People just don’t plan adequately for disability. They think about life insurance but people really ignore that disability may interfere with their ability to earn income.” Given that working people often ignore the risk of becoming disabled and unable to work, they probably have not considered the risk of being denied coverage simply because they might suffer a short- or long-term disability. “The consortium’s work is focused on understanding those risks [to privacy and insurability],” Kahn says, “and how we can avoid or minimize them so that we can better take advantage of the benefits of genetic testing.” Haplotype mapping versus stereotyping Now that scientists have sequenced the human genome, scores of successor projects are under way. One of those is the International HapMap Project, a partnership of scientists and funding agencies from Canada, China, Japan, Nigeria, the United Kingdom, and the United States. Launched in 2002, the $100-million, three-year project brings together leading genetic researchers whose goal is to develop a haplotype map of the human genome. This public resource will help researchers find genes associated with diseases and the response to pharmaceuticals. Haplotypes are groups of genes that tend to be inherited together. Haplotypes are of interest because the human genome is made up of about 3 billion base pairs of DNA (a base pair is a rung in the familiar DNA ladder, and the nucleotides forming the pair are typically identified by the letters A, C, T, and G). These letters appear in sequences, and two unrelated people will have the same DNA sequence about 99.9 percent of the time. It’s the remaining one-tenth of a percent that contains gene variations responsible for physical and other differences among humans. The hope is that the haplotype map will streamline the work of researchers by giving them a shortcut roadmap, of sorts, to use when analyzing DNA for specific diseases. Understanding which haplotypes are associated with particular diseases would offer tremendous opportunity for understanding why one person gets cancer or asthma while another does not. The same gene variant information could also help pharmaceutical companies because it would give researchers clues to how a person is likely to respond to a particular drug, possibly saving patients from wasting valuable time on a course of treatment that will not benefit them or from a potentially life-threatening reaction. But a haplotype map also raises a number of challenging concerns, many of which involve the issue of race. For example, to create the map, researchers are collecting blood samples from hundreds of people in China, Japan, and Nigeria (Yorubas) and from U.S. residents of European origin. While acknowledging that these groups do not represent all the people of the world, scientists believe the diversity of geographic regions will allow them to catalog a wide range of haplotypes. Ultimately, researchers and epidemiologists may be able to use haplotypes to compare the genetics of someone with a common disease like diabetes to that of a healthy person. The rationale behind the HapMap project may be sound, but many observers wonder whether a map whose samples are gathered in this way will further racial and ethnic stereotypes by linking certain groups with particular diseases. “Connecting race and ethnicity with genetic traits is not new,” says Jonathan Kahn (not related to Jeff Kahn), a research scholar at the Center for Bioethics and a senior research fellow in the consortium. “When we start treating race as a genetic term, when it is actually more of a historical term, our not-so-distant history shows us what happens when we separate people by race: slavery, Jim Crow, and more recently, employment and insurance discrimination.” Concerns over the haplotype map are compounded by the fact that federal agencies and federally funded researchers are required to organize data according to the U.S. Office of Management and Budget's Directive 15, known as OMB 15, Kahn explains. Race and ethnicity categories used in the U.S. census are based on this directive and are routinely challenged for not being adequately diverse or for not addressing distinctions between ethnicity and race. “OMB 15 categories are highly questionable in the context of genetics because they are not genetic categories," says Wolf. The HapMap project is a work in progress, and, how the haplotype categories it generates will be reconciled with the social categories in OMB 15 has not yet been determined. So Kahn and his colleagues decided to explore the issue, and in July 2003 the consortium received an National Institutes of Health grant for $564,300 to study the “collision” between haplotypes and the OMB 15 categories of race, and ethnicity. “There has already been a very active debate within the haplotype mapping project about how this information will be organized and used,” Wolf says. “How will you avoid making social categories of race and ethnicity look biological? What are the appropriate uses, if any, of race and ethnicity categories in genetic variation research and clinical practice? As an example, Wolf points to the impact the haplotype map may have on the pharmaceutical industry. “Sequencing the human genome and now developing a haplotype map may allow pharmaceutical companies to streamline drug development and tailor drugs to particular haplotypes that respond well," she says. "But this raises ethical questions. Will drug companies focus on developing drugs only for certain haplotypes? Will they abandon others? And will they u se racial and ethnic categories to decide what group to serve and what drugs to develop? Unfortunately, there is already some sign of this. Public dialogue about mad cow disease If, as Will Hueston expects, more U.S. cattle are found with mad cow disease, he is most concerned about how the nation can be prepared for a rational discussion. “We’re trying to come up with a way to get people talking about the issues of food safety and mad cow in a useful, non-reactive way,” says Hueston, director of the U’s Center for Animal Health and Food Safety. Last December, a 4 1/2-year-old Holstein in Washington state was found to have the nation’s first case of mad cow disease. Investigators eventually traced the cow back to Canada. But the discovery left many wondering whether there might be more cases in the United States and intensified calls for more regulation and testing, as well as a national system for tracking cattle from birth to slaughter. While there is a chance that the so-called “cow who stole Christmas” was an isolated incident, Hueston doesn’t think that is the case. An expert on mad cow, a degenerative brain disease known as bovine spongiform encephalopathy (BSE), Hueston predicts that three or four more cases will be found in the United States in the near future. Some of those cases may arise this summer as the nation’s first widespread cattle testing program gets under way. The $70 million program, which comes in response to concern over BSE, aims to test about 200,000 cattle deemed most likely to have the disease because they meet at least one of these criteria: died on the farm, showed outward evidence of brain disease, or couldn’t stand on its own. About 450,000 cattle meet these criteria annually, Hueston says, so the testing sample is large enough to offer an accurate picture of the presence of BSE in the U.S. food supply. Hueston is so confident that another case will be found, he has already begun talking with colleagues in the consortium about how the University can help lead discussions on the next case of mad cow before it is discovered, after which dialogue is likely to be clouded by fear. One of the consortium’s strategies for getting the word out about future cases of BSE will be to call on the same media that often seek Hueston out for commentary on mad cow disease. “We don’t tend, as a public, to talk about things that haven’t happened yet,” says Jeff Kahn. “News is a reactive medium, and the media call him when there’s been an outbreak or scare of some kind. We’re hoping that the launching of the [cattle] testing program will offer an opportunity for public discussion on some of these issues. . . . We need to do this now while we can have a level-headed, informed discussion rather than the reactive kind of feeding frenzy that will follow an outbreak.” Hueston has a long list of questions concerning mad cow disease. For starters, how big of a threat is the disease to U.S. consumers? Hueston believes it is “highly unlikely” that people in the U.S. will contract BSE. But because the issue affects our food supply and our national love of beef, he believes the perceived threat posed by BSE is “very likely to cause worry and impact lives and livelihood of cattle producers, food suppliers, consumers, and public officials.” That’s why Hueston, Kahn, and others in the consortium are making it their mission to get people talking about some of the larger issues of food safety. “As a nation, we have to figure out how to balance the interests of public health and personal choice,” Hueston says. One of the benefits of a university leading discussions on an issue like mad cow disease, says Kahn, is that it is viewed as offering unbiased information. “We can engage in proactive public education because we are not viewed as having vested interests like, say, the cattlemen’s association or something. Our job is to provide the context for the public to think about this. We aren’t out to tell people what to think.” Hueston credits the consortium’s interdisciplinary approach to such challenging issues for creating meaningful dialogue about topics like mad cow disease. “You wouldn’t normally have these discussions because someone would say that an issue was outside their purview,” he says. “But like a student of mine once said to me: ‘I’m being trained as a multiple-choice professional, but I’m living in a short-answer world.’” Hueston agrees that there are no easy, short answers to the kinds of problems arising in the world today. “It’s going to take all of us to solve them,” he says. Meleah Maynard (B.A. ’91) is a Minneapolis freelance writer.
© Meleah Maynard |
