As knowledge of the human genome penetrates the arena of health care-aided by recent advances in personalized medicine-the contrasting goals of health systems, pharmaceutical companies and governmental agencies appear to pose some problems.
Several Duke scientists have recently helped to draft the Genomics and Personalized Medicine Act of 2007, which was recently introduced by Sen. Richard Burr, R-N.C., and Sen. Barack Obama, D-Ill.
If approved, the bill will play a major role in future efforts to deploy genomic-based and personalized medicine-health care based on individuals' genetics and social backgrounds.
"I believe this legislation will help improve the quality and safety of health care by providing a better understanding of what causes certain diseases," Burr said in a statement last week.
Scientists from the Duke Institute for Genome Sciences and Policy collaborated with the two senators and other congressional parties in creating the authorization bill, which aims to foster standardized, safer and more efficient approaches to personalized medicine.
"Right now, personalized medicine is bubbling up from the bottom," said Dr. Geoffrey Ginsburg, director of the Center for Genomic Medicine at Duke's IGSP. "You have the interests of technological and diagnostic companies, pharmaceutical companies, governmental agencies-they all have their own priorities."
Among other proposals, the bill calls for the establishment of a national, interagency group in the U.S. Department of Health and Human Services to expedite genomics research through standardized terminology and guidelines.
Ginsburg said the issue of standardized vocabulary and guidelines is an important one, as it currently poses confusing challenges related to sex and other modes of criteria for genomic data.
Such a system of records would aid ongoing efforts to make individuals' medical data more readily accessible, he added.
"[The bill] aims to transcend what is today a fragmented health care system by creating national databases," Ginsburg said, adding that he was not sure how national systems could incorporate existing medical records.
In addition to collaboration between pharmaceutical companies and genetic test developers, the legislation proposes for an interagency organization to merge the interests of the National Institutes of Health, the Food and Drug Administration and other governmental bodies.
Organizations such as the NIH and FDA hold different interests-posing a potential for confusing discrepancies regarding criteria and methodology for developing personalized medicine, Ginsburg said.
In recent years, the NIH, pharmaceutical companies and other government bodies have emphasized the advantages of preventive and genomic-based approaches over traditional medicine regarding cost and effectiveness.
"The intended purpose of the bill is to enable technologies relevant to personalized medicine to be incorporated into health care expeditiously, effectively and safely," Dr. Robert Cook-Deegan, director of the Center for Genome Ethics, Law and Policy and professor of public policy, wrote in an e-mail Tuesday.
Duke, where genomic applications for cancer treatment and diagnostics loom large, could benefit from educational and training initiatives proposed by the bill as well as receive funding in the future.
"I am proud that North Carolina is a leader in genomics and personalized medicine research," Burr said. "This legislation will increase federal support for initiatives at Duke and Chapel Hill-a win-win for North Carolina and patients."
Get The Chronicle straight to your inbox
Signup for our weekly newsletter. Cancel at any time.