and free-market and first-amendment issues of honesty, fidelity to facts and truth-in-advertising—as well as the centuries-old tension between individual rights and authority, regulation and social responsibility.6

Although many of these issues also arise in the context of genetic testing in the traditional clinical setting, the rapid and continuing growth of the DTC industry—estimated to be approaching a billion dollars per year—has increased the urgency to address them. To further both the discussion of these issues in the DTC context and to identify approaches for addressing them appropriately, the National Academies convened a multi-disciplinary panel of experts for a workshop on DTC genetic testing, held in Washington, DC, on August 31 and September 1, 2009.

The workshop considered a number of questions relating to DTC genetic testing including:

  • Clinical value. Beyond the strictly technical criteria of a test’s sensitivity, specificity, and analytical validity, what are the associated positive and negative predictive values, and how useful to the consumer is the resulting information? Can the results be used to predict disease susceptibility, and do they provide enough information to enable informed decision making about preventive measures and treatment, including lifestyle changes, that can affect patient outcomes?

  • Commercial, financial and economic impact. What are the tests’ potential effects on the economy, including changes in GDP? Will they produce savings to individuals and the health care system, or will they increase costs?

  • Social value. Will the tests create a better-informed society and encourage positive lifestyle changes? Will they facilitate the formation of useful online patient communities and support groups?

  • Role in medicine and medical research, and appropriate regulation. Are DTC genetic testing companies practicing medicine? Do they have a therapeutic relationship with their customers? If so, what are the regulatory considerations that come into play? When companies use customers’ data for research, do those individuals, become de facto “human research subjects?” If so, are they adequately protected? Are the companies compliant with applicable federal regulations, and what oversight mechanisms need to be in place? As large-scale amassers of genetic data, what are the companies’ responsibilities to provide access to those data by researchers, customers, and society as a whole? Should

6

 From the remarks of Harvey Fineberg, President, Institute of Medicine.



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