le-Edged Sword

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, PhD1

1Southcentral Foundation, Anchorage, AK, 2University of Washington, Seattle, WA

• 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.

n = 2 n = 1

n = 3n = 1

n = 7

• 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).

Methods

Purpose Results

• 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..

Acknowledgements

“Double-Edged Sword”

Setting

• 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.

. . . but PGx could be acceptable and useful IF 8 contingencies are met:

Contingency Domain

PGx could be acceptable IF:

Efficacy It is more clinically effective than existing treatments

Access It does not result in rationing of primary healthcare services

Scale It benefits the majority of patients with a particular condition.

Values It does not conflict with personal or community worldviews

Engagement It directly involves AN/AI people as drivers of PGx education, research and practice

Social Responsibility

It does not perpetrate views of AN/AI people as “entitled” or receiving special benefits

Health Promotion

It does not increase health disparities, as has occurred with other introduced technologies

Participant and

Community Protection

It is voluntary, confidential, and uses culturally appropriate consent with community oversight

“It sounds like [PGx] testing could help a few people when maybe that money could be spent to help a lot more people.”

“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.”

“…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…”

“…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. ”

PGx is potentially helpful and harmful . . .

• 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.

•

Summary Findings

This project is funded by the National Institute of General Medical Sciences Grant #RFA-GM-10-001.

• Southcentral Foundation (SCF) is an Alaska Native-owned, nonprofit health care organization serving nearly 60,000 AN/AI people living in Southcentral Alaska.

“…there's always that fine line between religion and, you know, science.”

“…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.”

“So would it benefit the entire population? Because you don't want to have that ‘us against them.’”

Conclusions