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Direct-to-Consumer Genetic Testing: Summary of a Workshop Areas for Further Study As stated at the outset, it would be impossible in a one and a half day workshop to identify and explore all the issues raised by DTC genetic testing—much less to address them adequately. The workshop participants did, however, identify a number of areas where further study appears to be warranted. These areas include the impact on individuals, public health, the health care system and medical research, along with the implications for legislation and regulation. IMPACT ON INDIVIDUALS Is the genetic privacy of individuals sufficiently protected by current laws and regulations, both generally and in light of the burgeoning DTC genetic testing industry? Should the use of genetic information in underwriting life, disability and long-term care insurance be prohibited or otherwise regulated—and if so, how can this be done while balancing the legitimate business needs of insurers? IMPACT ON PUBLIC HEALTH How can DTC genetic testing be channeled and used to protect and improve public health? Can and should DTC test results that indicate even a slightly increased risk (of lung cancer, for example) be used to change unhealthy behaviors (encourage smoking cessation, for example)? Conversely, how can this be done without potentially enabling unhealthy behaviors among individuals whose test results indicate no increase—or even a slight decrease—in risk?
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Direct-to-Consumer Genetic Testing: Summary of a Workshop IMPACT ON THE HEALTH CARE SYSTEM How can DTC genetic testing improve health care quality, access and outcomes without significantly adding to health care costs? Can it help lower costs by stimulating behavioral changes? How can overuse and inappropriate use of DTC testing be prevented? What will be the impact of supply and demand on the number of primary care providers and genetic counselors? How should the medical education system change to enhance the genetics capability and proficiency of all physicians? What are the most effective ways to provide ongoing medical education and point-of-care information? Is this just something people have a right to choose, just like they could choose in any market to purchase any product? … We have a situation where public understanding, much less clinical understanding, is wanting. … Education, strategies for research, opportunities for learning about the uses and misuses, the role of promotion in terms of transparency and accountability, the relationship of private initiative to public responsibility … the relevant determinants of appropriate regulatory response all framed in a dynamic environment where we can expect more will be learned increasingly over time… These decisions are potentially life-influencing if not life-threatening and [have] a very high consequence potentially for individual economic as well as physical well-being… When you couple those with the profoundly individual personal character of this information … the meaning of this for each individual and the potential risk of abuse, I think this is qualitatively distinct and deserving of special attention… This is driving toward a larger convergence of quality improvement in care, clinical decision support, continuing medical education and research, all coming together… driven by the same underlying database … applied to the needs of that individual patient… They are likely to evolve in an accelerating way where those elements of interaction or vulnerability that have been validated become an expected part of the safety profile and high-quality care delivery. To me, that’s not only thinkable, I think that’s almost inevitable. Harvey Fineberg, M.D., Ph.D. President, Institute of Medicine
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Direct-to-Consumer Genetic Testing: Summary of a Workshop IMPACT ON MEDICAL RESEARCH How can the enormous data resources of DTC genetic testing companies be most usefully directed to benefit patients and support genetics research overall? What is to prevent genetic data collected for genealogical purposes from being used in health risk assessments? At what point do DTC genetic testing companies’ customers become human research subjects? Should DTC genetic testing companies be subject to the protections for human research subjects specified in federal regulations? What will an appropriate informed consent document look like? IMPLICATIONS FOR LEGISLATION AND REGULATION Does the FDA have sufficient authority to regulate DTC testing or are new laws or regulations needed? How can the DTC industry be regulated sufficiently to protect consumers, without unduly stifling innovation and investment?
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