|May 9, 2013
UM Pharmacogenetics research project had to establish trust first
By B.L. Azure
MISSOULA — Trust, understanding and respect. Those are three vital foundation components for medical research in Indian Country. If non-Indian medical researchers want to establish good relationships they should enter into those relationships with respect for the people and an understanding of their history in order to establish trust.
That is the route the University of Montana School of Pharmacy researchers and the Montana Cancer Institute took when putting feelers out to the Confederated Salish and Kootenai Tribes’ Tribal Health and Human Services Department about genetic research they wanted to do related to cancer among members of the Salish, Pend d’Oreille and Kootenai Tribes.
The research project they are involved in is called pharmacogenetics and the focus is on how a person’s genetic make-up affects an individual’s response to the prescribed medications.
It is a well-known scientific fact the people can respond in different ways to the same drug — genetic make-up is a determining factor. Response runs the gamut from no response to serious side effects. Somewhere along that continuum may be the perfect dose or there may be the need for a different pharmaceutical.
The end product of the research is to find the right drug at the right dosage that doctors can prescribe to cancer patients based on their genetic make-up and the types of cancer they have. One of the goals of the research is to find out how members of the Salish, Pend d’Oreille respond to the various pharmaceuticals used to treat cancer and its collateral effects.
“We were very cautious about entering into this research project,” said THHS Medical Director Dr. LeeAnna Muzquiz, MD, who along with THHS Director Kevin Howlett with Tribal Council consent entered into the research agreement with the University of Montana School of Pharmacy and the Montana Cancer Institute. “It was an interesting research project they presented us with and as a scientist we are interested in the advancement of knowledge. However we had some concerns about the protection of the tribal community.”
According to UM School of Pharmacy professors Dr. Erica Woodahl, PhD and Dr. Mark Pershouse, PhD, the protection of the tribal community was also on their minds as researchers. They didn’t want to become drive-through researchers; they want an active engaged partner with the Tribal Health perspective to ensure their research route stayed between the lines and didn’t veer off into uncharted territory.
“Mistrust of researchers is a part of a broader history of mistrust of United States institutions among American Indians and Alaska Natives, and other indigenous communities. Mistrust is linked to the historical roles of the (American) institutions as colonizers, definers of identity and indigenous status, and appropriators of human remains, cultural knowledge, and cultural artifacts for display or study,” Woodahl wrote in a professional paper on the subject. “Many indigenous communities are particularly wary of genetic research because of the past misuse of specimens in genetic studies and also because of its implications for identity and shared heritage.”
To put an end to that fear locally the researchers, et al met with Dr. Muzquiz and Howlett to map out a route to the ends of the research project — so far, so good.
“The project has gone well, we have created a collegial relationship with them (researchers),” Muzquiz said. “From that relationship both sides have learned a lot about research projects, and the process, pitfalls and barriers to research in Indian Country. We’ve been able to educate the University of Montana researchers about the need for cultural competency with research in Indian Country.”
It’s all about trust, respect and understanding.
“The trust we’ve establish must be maintained,” said Dr. Mark Pershouse, Ph.D., University of Montana School of Pharmacy professor. “We have kept our commitment to keep our research focus and to not study the submitted blood samples beyond the scope of our research project.”
Pershouse said that medical researchers have been known to go beyond the scope of some medical research projects on American Indians.
In a research project related to diabetes within the Havasupai Tribe, Arizona State University researchers used blood samples given them for the diabetes research for other forms of genetic research well beyond what the Havasupai agreed to.
In 2004 the Havasupai Tribe and individual members filed a suit against ASU and its researchers for their alleged breach of fiduciary duty, lack of informed consent, fraud and misrepresentation, negligence, conversion, and violation of civil rights. The federal suit and allegations arose from the use of research samples for purposes unrelated to what the Havasupai believed to be the original research goals.
The federal court agreed with the negligence and civil rights violations but dismissed the rest because the court felt they lacked either merit or sufficient specificity. In response the Havasupai dropped the federal court as a venue for its case and re-filed the suit in Arizona state courts. This time the Havasupai won the case and reached a monetary settlement with ASU.
That is the type of research modus operandi that can set back positive research strides in Indian Country or be a roadblock barring research. As a result the UM researchers have adopted the community-based participatory research model for their projects because it establishes a positive and understanding relationship with the Flathead Nation and its people.
To that end after consultation with Dr. Muzquiz and Howlett, the UM researchers established the Community Pharmacogenetics Advisory Council. Like a kitten with a rubber ball, the CPAC members help keep the ball moving in the right direction.
“An important feature of community-based participatory research practice is to ensure from the outset that the research addresses community priorities, (and) utilizes appropriate research procedures…,” Woodahl said. “The Flathead Reservation CPAC is a partner in the project and they are keeping their eyes on us.”
The CPAC is comprised of: Bernie Azure, cancer survivor; Brenda Bodnar, THHS Diabetes Program manager; Jamie Cahoon, Salish Kootenai College Nursing Program student; Dib Espinoza, cancer survivor; Vernon Finley, Kootenai cultural representative; Tony Incashola, Salish Pend d’Oreille Culture Committee director; and Cheryl Mathias, Kootenai tribal member. The CPAC meets monthly with the UN researches to discuss the research progression and to offer advice from a tribal perspective.
Woodahl and Pershouse recently submitted papers on the Pharmacogenetics project to medical journals. Woodahl’s will be published and Pershouse will further fine-tune his submission for resubmission.
UM School of Pharmacy professors/researchers Dr. Erica Woodahl, Ph.D., Dr. Mark Pershouse, PhD., and Dr. Elizabeth Putnam, Ph.D., as well as Chelsea Morales, UM School of Pharmacy graduate student and member of the White Clay (Gros Ventre) Nation of Fort Belknap, are spearheading the pharmacogenetics research project.
Tribal Health and Human Services Director Kevin Howlett, M.Ed., and THHS Medical Director Dr. LeeAnna Muzquiz, M.D. are the THHS professionals on the project.
The Confederated Salish and Kootenai Tribal Council is also part of the project as they gave it the green light and since they continue to be given presentations by the UM researchers as major goals are achieved.
Also involved in the research Dr. Patrick Beatty, M.D., Ph.D., and Cindi Laukes, M.A. of the Montana Cancer Institute. They along with the UM School of Pharmacy authored the grant that was funded by the National Institutes of Health.
The Pharmacogenetics project is seeking members of the Salish, Pend d’Oreille and Kootenai Tribes to participate in focus group panels for the next phase of the project. (See side bar).