Beyond Breast Cancer Informing Technology Policymaking

Genetic medicine is still in its early stages in the United States and Britain, and its shape has not completely stabilized. As more genetic tests are offered, their provision continues to be a subject of considerable public debate. Genetic testing for Alzheimer's Disease is now available, but it raises the same kinds of issues as BRCA testing, as the genes found are linked only to a small subset of patients who contract the disease at an early age. Related technologies are also being developed that remind us of our concerns about genetic testing while also creating new dilemmas. Pharmaco-genetic testing, which some hope will be used to identify DNA markers (which themselves do not cause any disease) that make individuals receptive to particular treatment regimens, has stimulated debate about whether it is possible or desirable to create therapies targeted to the individual and if such efforts will re-inscribe race as a relevant biological category.8 Another similar breed of genetics, called nutrigenomics, has already emerged, which promises to identify genetic variants linked to particular body types and health needs and thereby help clients make better health and lifestyle decisions. Sciona, Inc. offers a nutrigenetic test called Cellf to discover "The Science of You." The Cellf Report, which is sent to the client after she buys a kit at a retail outlet and sends a cheek swab and payment to the company, explains "which gene variations you have, what effects they may have on your health, and what specific amounts of food, nutrients, supplements, and exercise may help—tailor-made and written just for you."9 Pre-implantation genetic diagnosis, which allows couples to genetically test an embryo created through in vitro fertilization for a variety of conditions, raises questions not only about safety and utility but also about whether selecting an embryo for implantation on the basis of genetic-test results leads, through a "backdoor," to eugenics.10 All these tests have again elicited calls for the regulation of genetic testing, and, in particular, for an initial investigational period before such products are made commercially available. This growth in genetic medicine continues to be accompanied by vigorous discussions among scientists, physicians, patient advocates, private companies, and scholars, over how these technologies ought to regulated, provided, and used, how they should be owned and commercialized, and how to ensure that an individual's genetic privacy is maintained.

The comparative case study that has been conducted throughout this book contributes to current conversations about the appropriate directions of genetic medicine in four ways.

First, by providing an in-depth look at how genetic medicine is being built, including why and how specific technological choices are made and what the consequences of these choices are, we can make better and more informed decisions about the types of regulatory frameworks we might want to devise for this emerging field. Its comparative approach also provides us with multiple alternatives for the regulation and provision of genetic technologies, and allows us to assess the benefits and risks of each policy choice. For example, this book has explored the consequences of offering widespread genetic testing almost immediately after genes are discovered. When is a technology ready for widespread use? Is it more important to make technologies available quickly or to ensure that they are safe and effective before they are offered widely? Is there a viable compromise in between? As was noted earlier, the March 2006 JAMA article suggests that Myriad's test could not detect a significant proportion of BRCA1 and BRCA2 mutations.11 Might the creation of an intense investigational period before widespread use, or a requirement to couple DNA analysis with genetic counseling, reduce the likelihood and impact of false negative results? Might an investigational period also increase the amount of epidemiological data available, regarding the relationship between gene mutations and disease incidence, to improve the utility of tests? Of course, in Britain these issues are considered by NHS and NICE, whereas in the United States the FDA takes on this responsibility—although it has chosen not to deal with such questions in the case of genetic testing. This book has demonstrated, however, that not only do these issues arise again and again in the development of genetic medicine, but that the way these issues are resolved has serious consequences for the public. Myriad's choice to offer BRACAnalysis soon after gene discovery meant that there were considerable uncertainties generated by test results, regarding the meanings of positive and negative results and how to interpret the presence of a variant of uncertain significance. In addition, in both the United States and Britain, testing was made widely available before the direct utility of medical management options were clear. We now have case-study information to supplement the warnings of the Task Force on Genetic Testing and the Institute of Medicine in the early 1990s. This information can facilitate our discussions of how best to enact regulatory frameworks for genetic testing.

Second, the book demonstrates how particular laws, policies, values, and norms can shape technological development in fundamental ways. We often assume that the process of innovation is a closed and objective one, with developers following a linear and clearly determined path. What we have seen throughout this book, however, is that the way to make the "best" technology varies widely, and is decided differently by developers depending on their moral, social, political, and economic context. This finding suggests that policymakers have an important role to play in shaping technologies throughout the developmental process. Technology policymaking has traditionally been restricted to two domains: laws that facilitate innovation through direct funding or the creation of an environment receptive to commercialization, and regulatory frameworks that shape the provision and use of a technology once it has already been built. This approach often leads to severe restrictions at early stages of research

(e.g., cloning, embryonic stem cells) or limiting use of a technology once it has already been built (e.g., nuclear power.) We have seen throughout this comparative case study, however, that decisions about what a technology means and how it should be provided and used are made throughout the developmental process. For example, the decision by British proponents of the national BRCA-testing system to restrict access to BRCA testing through risk assessment and to families in which an affected member could be tested first not only privileged the importance of family history but also suggested that the new technology was simply an additional tool to be integrated into the services available, rather than an entirely new technology that could have clear implications for risk, disease, and prevention.

If policymakers are concerned about and want to shape the implications of technologies, particularly in domains subject to massive public concern, then they must do so in a nuanced way, after detailed assessments, and early—at "upstream" moments in the process. Upstream technology assessment has also been advocated by other scholars of science and technology policy, in order to "reduce the human costs of trial and error learning in society's handling of new technologies, and to do so by anticipating potential impacts and feeding these insights back into decision making, and into actors' strategies."12 In fact, once a technology has been built, it is often too difficult to enact policies to govern its provision and use because so many such decisions have already been implicitly made and are therefore embedded in the architecture of the technology. Rather than conceptualizing the process of innovation as a linear path that can either be enabled or disabled, policymakers should see it as a process that can take multiple paths, depending on the judgments of those involved in the developmental process. Such an upstream effort can also benefit innovators. Rather than being confronted with public controversy or policies that could significantly influence uptake of a technology after many years have been spent on the developmental process, policy deliberation and action at early stages in the innovation process could lead not only to more socially desirable outcomes but also technologies that are more profitable.

Third, this book provides tools to conduct the kinds of assessments needed to intervene in the kind of technology policymaking described above. By conceptualizing technologies in terms of their architectures, we can understand not only the components and how they are fitted together, but also understand how each element of a technology's architecture is both connected to its context and has consequences for users. How Myriad and British proponents of the national standard chose to make their technologies available shaped the rights and responsibilities of the health-care professionals and clients who used their technologies. By understanding the implications of technologies in terms of their components, we can determine how a technology needs to be built in order to influence its social consequences. Of course, one cannot fully anticipate all the consequences of a technology's architecture, but in-depth investigations of similar technologies and prospective assessments at early stages of development can help us identify the most likely scenarios, the potential positive and negative consequences, and how best to build a technology to maximize known benefits and minimize known risks. Furthermore, this book demonstrates how comparative technology assessment both within and between countries can be useful, allowing the analyst to highlight the implications of similarities and differences in both the developmental process and the way a technology is built. It also provides insight into the alternative architectures and paths of technology development available. Among the four BRCA-testing systems that initially emerged in the United States, is there one that we prefer? Would genetic testing in the United States benefit from regulatory intervention that requires the provision of specialized counseling alongside laboratory analysis? Should the United States create an analogue to Britain's NICE, to standardize the care of clinicians and acknowledge that they are pivotal parts of technological systems? Should the British encourage the expansion of genetic testing in the private domain, to allow clients to be empowered to choose to use whatever technologies they wish? Of course, as we consider these alternative frameworks, we should also remember that certain elements of these genetic testing technologies will be very difficult to transport, as they are not only firmly connected to national toolkits, but contradictory to elements in other contexts. It would be quite difficult to institute a national system of risk assessment and triage in the United States, and as we have already seen, it would be quite unlikely for the British NHS to construct a testing system that did not involve counseling from regional genetics clinics.

Finally, this book has demonstrated how the inscription of national context into technological architectures can create significant challenges for economic globalization. Indeed, when Myriad tried to expand its testing system to Britain, it was not simply making its sophisticated laboratory technology available in a country with limited access to genetics services. It was trying to impose specific approaches—to the commercialization of science and medicine, the doctor-patient relationship, public health, and prevention—on a country that had already articulated very different, and often opposing, priorities in the development of genetic medicine. It is not at all surprising, then, that Myriad was met with tremendous resistance from British scientists, health-care professionals, patients, and government officials. The vigorous controversy that erupted suggests that rather than serving as bridges of globalization through their objective and universal nature, technologies can serve as embodiments of particular national norms, values, and traditions and become flashpoints for transnational conflict. We have already seen other episodes of transnational technological conflict—consider recent disputes about genetically modified organisms between the United States and European Union, and the uneasy adoption of Western (and mostly American) approaches to intellectual property in the developing world—and they are likely to occur more frequently particularly as countries knit themselves together to create a global economic future. If we begin to acknowledge that social, political, and economic approaches are embedded in the scientific findings and technological developments that we are attempting to transfer, however, we may be able to anticipate and even mitigate, or at least better understand, the transnational challenges we may face.

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