Pharmacogenetics research, Klein said, has recently garnered increased public attention due in part to the number of social issues it raises in addition to its scientific implications. Klein will focus on the technical and social challenges related to building a genetics database in a symposium called "The Promise of Pharmacogenomics in Medicine," which begins Friday at 4:30 p.m. Eastern time.
The appeal of pharmacogenics is enormous, given the potential promise customized medical treatment holds, Klein said. "In the next 10 to 20 years, we'll have a better idea of how to test for variations in the genes that are involved in drug pathways," she predicted.
Behind PharmGKB's research is the basic premise that variations at a genetic level play a critical role in how a person responds to a drug. Any given gene within the body that's involved in how the drug is absorbed, distributed and eliminated may differ from person to person, resulting in variations of the drug's effectiveness. "A pharmaceutical company might learn that the drug it's developing is ineffective in 80 percent of people," Klein said. "Maybe for 20 percent it works great, but that's not everyone."
To develop custom medications that boost effectiveness, researchers need far-reaching access to comprehensive genetic and phenotypic data. Assembling these databases has already raised numerous questions about patient confidentiality, privacy, medical regulations, even patent infringement as it relates to private companies that conduct genetic research.
"This database is cutting new ground on social, ethical and legal levels, as well as scientific ground," Klein said. "But the social issues are huge. How do you get a whole community to give up its data? And how do we handle clinical data given HIPPAA issues alone?" she said, referring to the Health Insurance Portability and Accountability Act of 1996, which deals heavily with patient privacy concerns.
The answers are far from known today, though they must be addressed in order for the research to proceed. "From our standpoint, we're at a developmental stage with our database," Klein noted. "But this will definitely have a major impact on the future of medicine."
Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu.