le-Edged Sword

1. Conclusions Summary Findings Acknowledgements Risks, Rewards and the Double-Edged Sword: Views of Pharmacogenetic Testing and Research in the Alaska Native/American Indian Community Jennifer Shaw, PhD1, Renee Robinson, PharmD, MPH1, Helene Starks, PhD, MPH2, Wylie Burke, MD, PhD2 and Denise Dillard, PhD11Southcentral Foundation, Anchorage, AK, 2University of Washington, Seattle, WA le-Edged Sword Results Purpose • AN/AI participants generally supported PGx’s potential rewards: • optimized pharmacotherapy, reduced side effects, improved health outcomes, scientific advancement, and community development. • However, participants believe protections must be in place to mitigate potential risks to individuals, the AN/AI community, and the ATHS. • These views are based on a history of research relationships that were: • not community-based, not participatory research and researchers without long-term investment in studied communities. • Concerns focus on potential misuse of data and resources, mistreatment of individuals, and misrepresentation of AN/AI people. • Current uncertainties about the benefits PGx can deliver and potential opportunity costs. • Assessments of the real fiscal impact of PGx are needed in resource-limited systems, such as the ATHS. • Pharmacogenetics (PGx) involves the study and clinical application of how human genome variations affect individual medication response. • PGx can increase safety and efficacy of drug treatment, yet little is known about the potential impacts of PGx in rural and traditionally underserved populations, especially among Alaska Native and American Indian (AN/AI) people. • This study explored the views of AN/AI community members on PGx to guide future research and practice. “Double-Edged Sword” PGx is potentially helpful and harmful . . . . . . but PGx could be acceptable and useful IF 8 contingencies are met: Setting • Southcentral Foundation (SCF) is an Alaska Native-owned, nonprofit health care organization serving nearly 60,000 AN/AI people living in Southcentral Alaska. “…with the trial-and-error dosing, you have constant monitoring of [Warfarin]….if you’re able to do genetic testing and you can narrow down the variability, that could help decrease the unwanted side effects.” “…prescribing the wrong medication, that costs a lot of time and the medication itself…” “It sounds like [PGx] testing could help a few people whenmaybe that money could be spent to help a lot more people.” • SCF customers represent more than 231 federally-recognized tribes. • SCF operates on a community-engaged, patient-centered medical home model in which customers are key stakeholders in the design and delivery of healthcare. • Understanding the complex interplay of the potential risks and rewards of PGx is essential to effectively and ethically apply these tools in AN/AI communities and other traditionally underserved populations.. “…there's always that fine line between religion and, you know, science.” “…to have that kind of research [here] is a very good thing…why don’t we lead the way… Alaska leading the way in this genetic thing would be a good door to open for a hospital.” n = 7 n = 2 n = 1 “So would it benefit the entire population? Because you don't want to have that ‘us against them.’” Methods • We conducted 4 focus groups with 32 SCF customers (62% female) in Anchorage. • Participants were asked about using PGx for clinical research and testing related to four conditions: heart disease, cancer, depression, and nicotine addiction. • Focus group data were systematically analyzed using ATLAS.ti for key themes related to using PGx in the Alaska Tribal Health System (ATHS). This project is funded by the National Institute of General Medical Sciences Grant #RFA-GM-10-001. “I think [participation in PGx research] should be voluntary, but the first thing I start thinking of is exactly who would be trying to look at your health….there is, for me, a lot of privacy concerns.” “…you know a lot of the modern ways of life that come into the villages and then you get a lot of obesity, a lot of diabetes--a lot of cancer.” n = 1 n = 3