A unit of Kaiser Permanente, the nation’s biggest managed-care company, plans to create a large repository of genetic material in order to examine the genetic and environmental factors affecting disease and patient response to medications, the company announced earlier this month.
The unit, the Northern California Division of Research, aims to “discover which genes and environmental factors … are linked to specific diseases,” such as heart disease, cancer, diabetes, high blood pressure, Alzheimer’s disease, and asthma, Kaiser Permanente said in a Feb. 14 news release.
“The research program will also include studies of genetic and non-genetic factors that affect how people respond to specific medications, including the occurrence of side effects,” according to Kaiser’s description of the project, called the Research Program on Genes, Environment and Health.
Kaiser said it plans to build a large database of biological samples, drawing on its base of 2 million members in the Northern California region. Kaiser has mailed to its members a survey that asks about their medical and family history, and lifestyle. After reviewing the survey results, Kaiser researchers will ask certain members to provide a sample of blood or saliva for genetic information.
Researchers hope to enlist at least 500,000 members for the study. Participation in the RPGEH study is voluntary.
“By combining the genetic, health, and survey information from hundreds of thousands of members into databases, researchers hope to gain a deeper understanding of what combinations of genes and environmental factors influence the risk of complex diseases,” the organization said in the release.
Kaiser Permanente is the largest non-profit managed care organization in the US, with 8.5 million health plan members throughout the US and operating revenues of $31.1 billion. Kaiser’s Division of Research conducts, publishes, and disseminates epidemiologic and health services research.
How Kaiser Will Helm the Program
Kaiser’s study reflects a growing interest among disparate health care groups to study the utility of genetics in medical treatment. Like Kaiser, pharmacy benefit managers PharmaCare and Medco have both opened up their large member bases to conduct pharmacogenomic and pharmacoeconomic studies for widely used medications, such as the anticoagulant warfarin [see PGx Reporter 12-06-06].
Kaiser is no stranger to large epidemiological studies. Recently, it helped the US Food and Drug Administration study increased cardiovascular risk associated with the painkiller Vioxx. Using the FDA partnership as an example of its qualification to helm RPGEH, Kaiser said it is “uniquely qualified to lead this kind of large-scale, long-term research that could personalize medicine for millions of individuals.”
Additionally, its broad membership base will help create the kind of biobank necessary to observe the variability in the relationship between genes and diseases.
“Because the population we hope to include in this program is so large and diverse, the research can be generalized.”
“Because the population we hope to include in this program is so large and diverse, the research can be generalized,” explained Cathy Schaefer, RPGEH director.
In its release Kaiser assured that it will take measures to ensure that it will protect the genetic information of study participants.
Currently, patients’ right groups and members of the US Congress have been pushing legislation and other methods that protect people against genetic discrimination in the era of personalized medicine.
A previously stalled bill called the Genetic Information Nondiscrimination Act, which seeks to bar insurance companies and employers from discriminating against people based on their genetic information, has improved chances of passage in a Democratically controlled congress [see PGx Reporter 01-24-07].
In its release, Kaiser assured that “an individual's genetic information will not be used in genetic studies without their written consent,” and that “protecting the confidentiality and security of our members’ information is our first priority.”
According to Kaiser, its Division of Research maintains separate databases from the health plan and members’ medical records. For the study, Kaiser will anonymize data.
“In the database, each participant will be given a unique code that will replace their medical record number, name, and other identifying information,” Kaiser said. “The code can only be linked back to identifying information by a small number of Division of Research staff members who must have a special password. The data is for research only.”
To validate Kaiser’s research and address the social concerns raised by the study, Kaiser has convened an advisory panel of non-Kaiser scientists, legal professionals, and local leaders from Northern California.
The federally mandated Kaiser Permanente Institutional Review Board for the Protection of Human Subjects will review data collection and research by the RPGEH and “advise and guide all aspects of the research program.”
Funding for the study will come from outside of the Kaiser, mainly through federal grants from the National Institutes of Health and from other organizations and foundations, Kaiser said. The RPGEH is funded by the Wayne and Gladys Valley Foundation, the Ellison Medical Foundation, and Kaiser Permanente’s Community Benefit Program.
Exactly how much funding has been garnered for the effort is not known. Kaiser did not respond to questions regarding its program prior to deadline.