Ellen Wright Clayton, MD, JD

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

Errors are inevitable Pleiotropy is 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

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: Bloss, et al., n engl j med 364;6 nejm.org february 10, 2011

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

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

Scientific analysis of impact of genetic variation Policies determining access (?) and use Clinicians and patients Information from many sources Desires without scientific evidence base Health care system incentives Other interests