Judicature Genes and Justice The Growing Impact of the New Genetics on the Courts November-December 1999  Vol 83(3)

HOPE, FEAR, AND GENETICS
Judicial responses to biotechnology
by E. Richard Gold

Those of us who write, read, or talk about genetics and biotechnology¹ inevitably encounter a barrage of legal principles under various guises that seem to suggest ways that the legal system ought to deal with advances in genetics. We must worry, we are told, about such things as biodiversity, the Precautionary Principle, the Principle of Future Generations, the Prevention Principle, the Common Heritage of Mankind, economic analysis, equal rights, privacy, and rights to information. Not only do we not really know what these things are—and, from the look of things, neither do those who propose them—but their application to genetics is neither obvious nor easy.

Some things about genetics, however, are fairly clear. First, the field raises issues that are important to the economy and job market, but also to religious beliefs, family, community, health, the environment, and international relations. These are not simple areas, nor are they easily confined.

Second, the genetic revolution through which we are living promises to be as profound as any technology-based revolution, from the advent of the printing press, to the invention of the assembly line, to the personal computer. Like these previous revolutions, the genetic revolution will likely alter the way we carry on in business and in our personal lives.

Third, this genetic revolution is unidirectional; in other words, the consequences of increased genetic knowledge and technology are irreversible. Thus, once we permit an activity to go forward, such as introducing a genetically altered plant or animal into the environment, we do so in perpetuity.

Fourth, the genetic revolution, to play on the well-known slogan, will bring good things to life, literally.

Through genetic manipulation, we can hope for more nutritious and flavorful foods that are easier to grow. We can also look forward to new techniques to prevent and treat disease and increased knowledge—and thus control—over our individual health. Of course, badly or recklessly done, genetics can reduce our health and seriously endanger the environment. It all depends on the choices that we, as a society (in the largest sense, including our neighbors around the globe), make.

Given the profound effects that will likely arise from genetic research, it is far from surprising that we have created the multitude of principles listed at the beginning of this article. But acknowledging the existence of these principles, and even their relevance, does not tell us how or when to apply them.

Although still in its infancy, biotechnology has already introduced before courts and tribunals worldwide such controversial issues as DNA typing, reproductive technologies, and patenting of animals. As the impact of biotechnology grows, the judiciary will increasingly be required to address genetics-related issues.

The purpose of this article is to bring some clarity to the maze of principles touching on genetics, and to present a simplified approach to making decisions in the era of genetics. It first examines the particular problems posed by genetics for the legal system. Then, it describes four approaches that a judge could take to evaluate a dispute involving genetics and suggests ways to handle the problems posed to the legal system.

The genetics difference
The introduction outlined some of the defining characteristics of genetics. These included its potential to substantially increase human welfare through the discovery of new medical therapies, through the prevention of existing diseases, and through the introduction of more nutritious and easier to grow food. But they also included the great threats that biotechnology poses to the environment and human health, many of which could cause irreversible harm.

These are three additional features that make this field different from other technologies: the inhibiting effects of patent protection (sometimes called the tragedy of the anticommons); the impact of genetics on health policy; and the ethical and religious questions posed by genetics and genetic technologies (genetic technologies or biotechnology is based on genes and genetic information, genetics is the general field).

Tragedy of the anticommons. The first problem is one raised directly in academic literature² but also indirectly through court decisions.³ It involves the somewhat counter-intuitive notion that private property rights can impede, rather than encourage, innovation. This concern arises because of the way genetic information wields its effect on biological systems. Each cell within every human, animal, and plant contains long strings of code made up of the chemical DNA. These codes are called genes, and carry instructions for making proteins. Each protein interacts with other proteins, resulting in activity (life) within a cell. Each cell within an organism interacts with others to create the organism.

Granting private property rights to minute parts of this layered and interconnected system creates the potential for the tragedy of the anticommons. Consider the following example. Imagine trying to identify all the codes that go into a seemingly simple process like digesting sugar. There will be a multitude of cells involved in this process containing different sets of proteins, each specified by a different gene, each of which contains different codes. Thus, the number of codes required to carry out this simple procedure is extremely large.

Imagine now that different people have the exclusive right to use a particular series of these codes (such as the series that defines a gene). This means that researchers wanting to use, copy, or study (at least in a commercial context) these series of codes can only do so after gaining (usually for a fee) approval from the rights holder. Anyone wishing to study the genetic basis for digesting sugar will thus have to buy rights from a very large number of people—so large a number, in fact, that he or she will simply give up and study something else.

Thus emerges the tragedy of the anticommons: we may so split up rights to use genetic information that it will become prohibitively expensive for anyone to conduct meaningful research. So while our patent system was designed to promote research through the granting of property rights (to prevent a tragedy of the commons in which no one would invest in research without having private property rights), its effect on the ownership of genetic information may actually be to stifle research.⁴

This situation is particularly acute with respect to upstream research that involves the basic building blocks of our genetic knowledge. Virtually all research into the biochemistry of the body will require access to these data. If the data are protected by patents, researchers will have to spend a significant amount of time and money purchasing rights to their use. To make matters worse, basic research is the most speculative and the least likely to directly result in any profit to offset this expense. This problem does not present itself to nearly the same extent with respect to patent rights over downstream products, such as a specific medication to treat a particular disease, because many paths exist to treat that disease, most of which will not require access to one specific medication.

Given that genetics largely involves upstream knowledge—genes and other DNA sequences—the traditional ways in which we have provided incentives to conduct scientific research and encourage the development of new products, through the grant of exclusive rights in the form of patents, will likely not work. This presents a fundamental challenge to the ways in which the legal system interacts with genetics.

Health policy. Two principal applications of genetic research occur in the fields of health and agriculture. This section concentrates on the former (although it is worth noting that, as the dispute over genetically modified foods all too well illustrates, even agricultural uses of genetic technology have health policy implications).

Through our understanding of the genes in our bodies, we can hope to develop new therapies to treat or prevent disease. The trick is to encourage the development and implementation of methods for both the treatment and the prevention of disease in a balanced manner. Historically, we have improved lifespan and quality of life more effectively and efficiently through public health measures (education, clean water, sanitation services, etc.) than through treatment.⁵

Unfortunately, we rely on market forces to achieve this balance through the granting of property (patent) rights in genetics research, and because of this reliance such a balance will not likely be achieved. Reasons include the fact that the purchase of health care services does not really occur in an open market: patients rely almost exclusively on physicians for information about what services to purchase from that very physician; health insurance rules, and not patient bargaining, often determine treatment options; and patients often are in too much pain to make decisions about which health services to purchase.⁶

While these shortcomings provide reason enough to eliminate a primary role for the market in setting the balance between prevention and treatment—in other words, in establishing our health policy—there are other reasons that market forces fail to reach this goal. Consider the example of the controversial breast cancer gene screening tests. Myriad Genetics, Inc. currently offers, through an affiliate, a genetic screening test for women concerned that they may have a genetic predisposition to a rare inherited form of breast and ovarian cancer. Women in general have a one in eight chance of contracting breast cancer in their lifetimes; for women carrying a mutation in one of two identified genes, this risk jumps to as high as seven or eight in ten.⁷ However, the overall risk for a woman in the general population of carrying one of these mutations is very low: approximately one in 400.⁸ This is because fewer than seven percent of breast cancer cases are linked to one of these mutations.⁹

Myriad and the Cancer Research Campaign, through the Haddow Institute in England, both claimed to have discovered the second of the two breast-cancer-associated genes, BRCA2. Myriad is, and continues to be, a for-profit biotechnology company that is in the business of providing breast cancer genetic screening tests. The Haddow Institute is a not-for-profit research centre while the Cancer Research Campaign is a charity that aims to eliminate cancer.

It is interesting to observe what each group hoped to do with their discovery of the BRCA2 gene. The two groups certainly had much in common: both wanted to make a breast cancer gene screening test available to help women plan their lives. The test offers women who are found to carry a mutation a chance to take (somewhat controversial) preventive steps against breast and ovarian cancer. It also allays the fears of those women who do not have the mutation but thought that they were at risk because of family history.

Apart from this overall agreement, however, the approaches taken by the two organizations were different. Scientists at the Haddow Institute feared that if the test became routine it could actually do more harm than good. For the vast majority of women, the negative test results would not only be useless but might, in fact, be misleading. Unless careful genetic counselling is given (and it rarely is),10 women may wrongfully believe that a negative test for a mutation means that they will never get breast cancer. In fact, their chance of getting breast cancer remains at one in eight. Therefore, these women should still take steps (diet, exercise, examinations, etc.) to reduce their risk of developing breast cancer or to detect it at an early stage. Because of this concern, the Cancer Research Campaign attempted to require its licensees to ensure that genetic counselling be offered, that only women with a family history of breast cancer would be given the test, and that there would be no advertising of the test.¹¹

Myriad, on the other hand, does not impose any restrictions on those taking the tests. To be fair, Myriad does recommend the test for women with a family history of breast or ovarian cancer and that they seek genetic counselling in conjunction with taking the test. But neither a positive family history nor counseling is required. Despite their recommendations, Myriad spends a significant amount on advertising the test and encourages investors to believe that the breast-cancer gene screening test will become "routine," opening up a U.S. market of $150-200 million per year.¹² Such revenues could only be achieved if the test were given to a far greater number of women than would be justified on medical grounds.¹³

This example illustrates that market forces are likely to lead to inefficient health policy that not only costs more, but actually diminishes health. Myriad did nothing wrong; they were, after all, only pursuing a profit in a perfectly legal and ethical manner. The conclusion is more insidious: corporations operating within acceptable business parameters are, given the market failure affecting health care, likely to be an inefficient way of creating good health policy. Blind trust in the market is, therefore, not only unwise: it is dangerous.

Ethical and religious values. The market is no better at protecting ethical and religious values than it is at ensuring health. Genetic research, testing, and products interact with a complex web of societal, community, and religious values on two distinct levels. First, the products can dramatically alter our lives, for both good and bad. Genetic techniques can identify individuals at risk for certain illnesses; sometimes this information can be used to prevent an illness, but it can also be used to exclude an individual from insurance coverage. We can use knowledge of the links between genes, the environment, and disease to clean up the environment to make it safe for all or we can impose the cost of avoiding environmental hazards only on those possessing the suspect gene.

The products of genetic engineering can help us preserve the environment, but newly introduced strains may kill and displace native species. In the future, artificial chromosomes¹⁴ carrying genes for selected traits can help cure genetic disease or be used to introduce a form of eugenics through the creation of a new human "superspecies" incapable of producing offspring with the rest of humanity. A second level of interaction between genetics and societal, community, and religious values arises from a concern that the genes of our shared humanity should not be treated as a commodity by researchers or biotechnology companies.

There is simply no room in this article to begin defining all the other ways that the results of genetic research challenge societal values. But, as the examples outlined above illustrate, a moment's reflection will confirm that the importance of human genes extends far beyond the economic incentive that is the subject matter of patent law.

We have not yet developed a mechanism within the law in which to consider and balance such societal concerns. Given the complex interaction of values, most of which are difficult to translate into a market price (exactly how much is privacy or good health worth?), reliance on the market is unlikely to yield an acceptable balance. While the market may be good at choosing the best paper clip, it is not a good way to choose the best ethics.

Judicial responses
Given the impact that genetics will likely have on many aspects of life, it will not be long before judges confront issues involving genetics on a regular basis within their courts. Obviously, there is some benefit in thinking through how, in general, courts should approach these issues before the tidal wave of genetics-related litigation hits.

The goal of the judge is to find the appropriate balance between further advances in biotechnology and protecting the environment and human health. Judges must decide in the reality of the moment and not simply in pursuit of some far off goal. And the reality is that biotechnology is advancing quickly, and not only in terms of scientific knowledge. Biotechnology is big business and will become even bigger. The biotechnology industry—which includes the business aspects of genetics—hires a large number of highly skilled employees, paying salaries that match. In addition, the genetic revolution will change the ways other industries do business, most notably insurance (more accurate assessments of risk), health care (more targeted therapies), security (better identification techniques), and agriculture (more profitable seeds or less costly pesticides). Government too will not be immune, as genetics provides an opportunity (or a risk) of easy identification whether in the criminal or social benefits context.

Given this reality, what is the mindset that a judge might bring to both the positive potential of biotechnology and to the fears that biotechnology engenders? Specifically, to what extent ought a judge to accept either the predictions of better health made by the biotechnology industry or the forecasts of disaster put forward by those opposed to biotechnology? And second, is a judge wise to rely on law to adequately deal with the dangers posed by biotechnology?

Four basic approaches are available to judges. Since no formal terms exist for these approaches, I have chosen my own: the Old Woman Who Swallowed a Fly, the Evolutionary, the Luddite, and the Euroskeptic. The reasons for these names will, I hope, become obvious from the description of each below. Each approach is based on a different attitude to two things. First is the attitude towards the effects of genetics itself: wildly enthusiastic, very pessimistic, or somewhere in between. Second is the judge's view of law and, in particular, of law's ability (or lack of ability) to adapt itself to quickly changing circumstances.

The Old Woman Who Swallowed a Fly. The first approach is based on having great faith in technology. Someone adopting this approach believes that biotechnology, and genetic research in general, is an unmitigated good. They also believe, like the old woman in the children's song (the old woman ate a spider to kill the fly, then ate a bird to kill the spider, etc. until she ate a horse and died) that any problems that arise can be remedied. We can safely entrust our own and our children's safety, health, and environment to science, industry, and the market. One example of this approach is found in the United States Supreme Court decision Diamond v. Chakrabarty (1980). The Court was asked to decide whether to extend patent law to cover living organisms, in this case, an artificially created bacterium. Those opposed to the patent pointed to the potentially strong and negative health and environmental consequences of the research and suggested that the Court leave the issue to Congress. In a strongly written opinion, the majority extended patent coverage to the bacterium, extolling, as it did so, the economic virtues of technology and putting aside the claimed harms to the environment and human health.

Unfortunately, history does not support this beatific vision of technology. In fact, the introduction of technology often brings with it unintended and unwanted consequences. Nuclear energy, which promised clean and inexpensive energy in the 1960s, has brought with it not only nuclear accidents at Three Mile Island and Chernobyl, but also the still unsolved problem of long-term storage of nuclear wastes. Shoe-fitting fluoroscopes, used up to the late 1940s, took x-rays of children's feet to ensure proper fit of shoes; only later did the dangers of having exposed children to x-rays become apparent.

Neither can technology be relied upon to correct the problems that it creates. Consider the following example from Australia. The South American cane toad was introduced into Queensland in 1935 to control two cane beetle species that were damaging the local sugar cane harvest. Unfortunately, not only did the toads fail to control the beetles, but the cane toads themselves became a significant pest. Now, researchers are looking into viruses or fungi that can be used to control the cane toads. The effect these new agents may have on the environment is hard to predict.

Similarly, the introduction of wild European rabbits into Australia and New Zealand in 1859, and the introduction of the purple loosestrife in eastern North America in the early 1800s have led to environmental and livestock problems that have yet to be remedied. Like the old woman in the song, it is not wise to blindly depend on being able to correct our past wrongs.

The Old Woman Who Swallowed a Fly would leave decisions about the use of genetic information and the direction of genetic research to a combination of patent law and the market. As previously discussed, this combination is not only unlikely to efficiently encourage genetic research, but will probably undermine the development of a rational and ethical health policy. It also, unfortunately, completely fails to even consider environmental, religious, and community concerns relating to genetic information and genetic research.

The Evolutionary. The second approach also involves faith in science, but not of an unmitigated and blind nature. But some of that faith is transferred into a different kind of faith: a belief that the legal system is able to prevent harm before that harm gets out of control. Essentially, this is the view that what science cannot solve, the legal system will.

This is a traditional approach within the law; the only difference is that it is applied to biotechnology. Judges espousing this view argue that the legal system is flexible enough to deal with genetics. In particular, they point to patent law, which adapted itself over the last century to an amazingly large variety of technologies, from machines, to chemicals, to software systems. According to this approach, to the extent that problems do arise, judges will modify the old rules to fit the circumstances before them.

One example of this approach is the majority decision of the California Supreme Court in Moore v. Regents of the University of California (1990). That case involved a claim by a patient that his physician had used the patient's removed tissues in highly lucrative research. The majority of the court refused to accept the patient's contention that, to protect autonomy, patients must have a property right in their own tissues; instead, the majority modified the law of informed consent to require physicians to reveal any commercial interest they might have in the medical procedure. The result is that, while leaving science to do its work uninterrupted, the court was able to address an apparently narrow concern—albeit imperfectly—on an ad hoc basis.

The essential belief of the Evolutionary is that the legal system can respond to any harm threatened by a new technology before that harm becomes severe. We can allow science to move the economy and our lifestyles forward, safe in the knowledge that judges will respond when and if the need arises.

Although good in principle, the Evolutionary misses one critical point: biotechnological advances move far more quickly than the legal system. While judges were successful in modifying patent law to suit many different types of innovation, they had a long period of time to do so. This is unlikely to be true with respect to biotechnology. For example, the Human Genome Project—an international effort to identify and decode every human gene—originally anticipated to yield results in 2005, will be completed in 2003 or sooner, years ahead of schedule. One of the reasons for this speed is the commercial potential of these genes. Researchers will be rushing to patent them and put them into commerce before we have seriously considered the health policy and ethical implications of that patenting.

Biotechnological advances applied to the environment are also one-way: once we have introduced a new organism, it cannot easily be removed. The Australian cane toad experience illustrates this potential problem. If we are too hasty, we risk introducing a genetically modified organism into the environment before we learn if it could cause serious harm.

Given the fast pace of biotechnological change, the Evolutionist will find him or herself trying to evolve faster than the legal system can support. Cases take time to move through the judicial system. Precedents evolve slowly. In fact, this slow pace of change is one of the inherent limits on judicial power. Unfortunately, in the case of biotechnology, it threatens to undermine any coherent formulation of judicial policy.

The Evolutionary, like the Old Woman Who Swallowed a Fly, relies too heavily on existing patent law and market forces. As discussed throughout this article, these mechanisms are inadequate to the task of both encouraging innovation and achieving health policy. It is an insufficient response to say that the judiciary will make ad hoc changes as conditions change because these changes will often not only be irreversible but very harmful and widespread. The Evolutionary also fails to provide a voice to the societal, religious, and community values attaching to genetics research. Not only will those concerned about these values feel left out but, as the following discussion points out, they may actually take aggressive action to prevent the use of genetic research in even those areas where it would be of benefit to health and the environment.

The Luddite. One need not, of course, take a positive view of biotechnology or any other technology. Instead of having faith that technology will improve the economy and provide us with better health and better food, one could easily, as did the Luddites—the 19th century workers opposed to new technology—believe the opposite. This fear of technology is fuelled by the seemingly ever-increasing news reports of technology gone wrong. Experiences with Mad Cow Disease (Bovine Spongiform Encephalitis), Belgian dioxin, and defective Coca Cola have fueled this fear and made many distrustful of technology.

One consequence is that the public exerts pressure on the government to restrict use of new technology. The European reaction to genetically modified foods is a case in point. Following the Belgian dioxin scare and news that genetically altered corn was killing monarch butterfly caterpillars,¹⁵ European consumers pressured both supermarkets and government to restrict the use of what they called "Frankenstein food."¹⁶ This resulted in an effective moratorium on the approval of genetically modified foods in Europe.

To what degree these fears of technology, and genetic technology in particular, are founded is unclear. To date, there are no scientific studies that definitely demonstrate either the safety or dangers of genetically modified foods.¹⁷

The Luddite fears technology and distrusts the law's ability to contain the harm caused by technology. Given that neither science nor the legal system have proved themselves able to prevent the harm that has resulted from Chernobyl, Mad Cow disease, or Belgian dioxin, this fear is far from unreasonable. Nevertheless, having a reasonable basis for concern does not amount to a justification for paralysis. Biotechnology is, whether anyone likes it or not, a reality. The real question is how to control it so that it is most likely to benefit us. It is too late to argue that we should abandon the enterprise.

The Euroskeptic. The fourth approach a judge could take to genetic information and genetic technology is to recognize the substantial benefits and the real threat of harm from this technology and the limited ability of the legal system to control that harm. The Euroskeptic takes a middle course of allowing technology to proceed, but slowly and under a watchful gaze.

This cautious approach is similar to that taken by the United Kingdom with respect to its involvement in the European Union and, in particular, with respect to the new European currency, the Euro. While all other major European states have adopted the Euro as their currency, the United Kingdom has retained the Pound and has vowed to only join "Euroland" after it has had a chance to measure the success of the Euro. This decision to "go slow" was made despite the fact that London's financial community has been one of the biggest advocates of introducing the Euro. Proceed, yes, but with caution.

While the Euroskeptic has deep reservations about genetic technology, he or she does not deny its potential benefits. But the Euroskeptic also believes that, once the technology is introduced to the market, its effects on environment and health are irreversible. Thus, a slow, cautious approach is most appropriate.

The Euroskeptic would not rely on patent law and the market to achieve the goals of encouraging research, attaining a desirable health policy, and furthering other societal, community, and religious values. Rather, the Euroskeptic would carefully limit the impact of patent law and the market on genetic technologies and genetic research until the potential effects of these areas were carefully examined. The Euroskeptic would think twice before accepting that basic genetic knowledge is patentable or, if patentable, that the patent holder should have a wide monopoly.

Similarly, someone taking this approach would encourage an open discussion to determine how this research and its products are to be used. This does not mean capitulating to the lowest common denominator, nor to the loudest opponent of genetic research; rather, it means trying to include a diversity of voices so that, through a wider consensus, we encourage more research with the full support of the public. Moving carefully does not mean abandoning the market or legal rules: it means viewing broad legal and democratic principles with a healthy dose of skepticism about claims of what the market can achieve on its own.

In summary, while accepting the basis for the fears of the Luddite, the Euroskeptic does not believe that an outright ban on genetic technology is called for. While agreeing with the Old Woman Who Swallowed a Fly that technology has much to bring us, the Euroskeptic does not believe that technology is an unmitigated good that can be trusted to cure its own ills. To this extent, the Euroskeptic and the Evolutionary agree.

The Euroskeptic differs with the Evolutionary, however, with respect to the legal system's ability to contain the harms of genetic technology. Unlike the Evolutionary, the Euroskeptic does not believe that we can fix all problems after the fact. Examples provided in this article illustrate how the law has been demonstrably weak in protecting us from this kind of harm.

The Euroskeptic will not allow the financial community, whether in relation to the Euro or to biotechnology, to decide for the rest of us whether and when to proceed. The Euroskeptic will not take steps that, like the abandon of the Court in Chakrabarty, place ultimate decision-making over our health and environment in the hands of industry actors whose goals are profit-maximization and not ethics maximization. Instead, the Euroskeptic will find methods to determine the future of genetic research that incorporate the many views about it.

Exercising caution
The Euroskeptic fits well into legal precedent. The approach of moving forward, but with caution, is the basis of the Principles of Precaution and Prevention. The latter states that we ought to limit the known harms that result from an action; the former says that we should presume that the introduction of a technology will have unanticipated and unwanted consequences. In exercising caution, we must not only ensure our own safety, but that of future generations. And this concept of safety should not be limited to physical safety: it also includes the right to be left alone (privacy), to not be discriminated against, and the right to know the basis for government action based on our genes.

Nevertheless, caution does not mean standing still. Biotechnology not only offers improved health and food, but economic growth. We can only move forward to protect health and the environment if we do so in a way that ensures the prosperity of the country. After all, poor countries cannot afford to be more cautious.

Judges will play an important role in the legal system's response to genetic research. As argued earlier, the judiciary cannot hope to curb, after the fact, the harms caused by this research and its applications. Judges must act pro-actively to establish standards that include doubt, both about technology and the legal system's ability to change in time.

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E. Richard Gold is an assistant professor, Faculty of Law, The University of Western Ontario.

Gold would like to thank Erin Rogozinski for her truly helpful research and editing assistance, the Law Foundation of Ontario for its financial assistance, and Tory Tory DesLauriers & Binnington for its provision of office facilities.

1. The term genetics refers to the study of animal and plant genes and the links between genes and certain characteristics and diseases. The term biotechnology refers to any techniques using living organisms to make products, improve plants or animals, or develop micro-organisms. U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology: Ownership of Human Tissues and Cells—Special Report 24 (Washington, D.C.: U.S. Congress, Office of Technology Assessment, 1987).
2. Heller and Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 Science 698-701 (1998).
3. E.g., Moore v. Regents of the University of California, 447 U.S. 303 (1980).
4. Heller and Eisenberg, supra n. 2.
5. Halm and Gelijns, An Introduction to the Changing Economics of Technological Innovation in Medicine, in Gelijns and Halm, eds, The Changing Economics of Medical Technology 1-20 (Washington: National Academy Press, 1991).
6. Gold, Body Parts: Property Rights and the Ownership of Human Biological Materials 33 (Washington, D.C.: Georgetown University Press, 1996).
7. Myriad Genetics, Inc., Terms of Payment and Reimbursement (visited August 11, 1999). Myriad Genetics, Inc., Questions and Answers About BRAC Analysis (visited August 11, 1999).
8. Interview with Dr. Michael Stratton of the Haddow Institute, U.K. (December 12, 1998).
9. Myriad Genetic Laboratories, Inc., Genetic Analysis for Risk of Breast and Ovarian Cancer 2 (1997).
10. Giardello et al., The Use and Interpretation of Commercial APC Gene Testing for Familial Adenomatous Polyposis, 336 New Eng. J. Med. 823-827 (1997).
11. Stratton, supra n. 8. Although this clearly was the intention of the scientists involved, the actual contract with the Cancer Research Campaign's licensee was less stringent. Interview with Guy Heathers of the Cancer Research Campaign Technology, U.K. (August 9, 1999).
12. Myriad Genetics, Inc., SEC Form 10-K at 25 (September 24, 1998); Myriad Genetics Inc., SEC S-3 Registration Statement no 333-16143 at 5 (November 14, 1996); Stone and Schmidt, Myriad Genetics ($15), 7 Biotechnology Q. 112 (1998); Myriad Genetics, Inc., AMA Introduces New Physician Guide on Myriad Genetics Breast Cancer Test-Increased Testing Likely as Patient Inquiries Swell (last modified June 2, 1999) http://biz.yahoo.com/prnews/990602/ut_myriad__1.html.
13. Michael Stratton estimates that the U.S. market for the screening test, if it were only administered to those truly at risk, would be approximately $5 million. Stratton, supra n. 8.
14. Highfield, Researchers Construct Chromosome, The London Telegraph (April 2, 1997) http://www.telegraph.co.uk.
15. Yoon, Altered Corn May Imperil Butterfly, Researchers Say, N.Y. Times, May 20, 1999, at A-1.
16. Burros, US Plans Long-Term Studies on Safety of Genetically Altered Foods, N.Y. Times, July 14, 1999, at A-18.
17. Greenberg, The Right to Know What We Eat, The Washington Post, July 7, 1999, at A-19.

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The online presentation of this publication is a special feature of the Human Genome Project Information Web site.