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Challenges in translating whole genomes in the clinic

Ellen Wright Clayton, MD, JD. Challenges in translating whole genomes in the clinic. Some predictions. Genome wide tests will become part of clinical care in the near future Access to this information will be difficult, if not impossible, to limit Attributable only in part to DTC tests

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Challenges in translating whole genomes in the clinic

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  1. Ellen Wright Clayton, MD, JD Challenges in translating whole genomes in the clinic

  2. Some predictions • Genome wide tests will become part of clinical care in the near future • Access to this information will be difficult, if not impossible, to limit • Attributable only in part to DTC tests • Interpretation will not be limited to medical settings or to clinicians well versed in genetics • Democratization of knowledge

  3. Some challenges • Errors are inevitable • Pleiotropyis common • Understanding of genomics and of gene-environment interaction will be incomplete • Resultant uncertainty will lead to demand for follow up • Often not evidence-based • Often ethically inappropriate • Not economically sustainable

  4. Association between Condition-Specific Risk Estimates from Genomewide Profiling and Intended or Actual Completion of Screening Tests. Bloss CS et al. N Engl J Med 2011;364:524-534 Bloss, et al., n engl j med 364;6 nejm.org february 10, 2011

  5. The real issues – Because the information will be available • Developing a policy consensus about when not to act upon genomic information • More weight will need to be given to practice guidelines and comparative effectiveness analyses • These will be backed up by payer policies and economic incentives for clinicians

  6. The real issues – Because the information will be available • Patients’ desires for medical interventions likely will not be determinative in many cases • Challenges the clinician-patient relationship • Requires defining those domains in which clinicians ought to say no and why • These are not new issues but are raised with increased acuity

  7. The challenge before us Information from many sources Desires without scientific evidence base Health care system incentives Other interests

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