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'07 PGx Legislation Shed Earlier Race and Genotype Priorities

NEW YORK (GenomeWeb News) — Legislation that aims to promote personalized medicine and genomics studies should take into account new understandings of race and genotype and how definitions of race may impact pharmacogenomics research, two Stanford University science policy researchers advised yesterday in a paper in Science.

In the paper, Sandra Soo-Jin Lee and Ashwin Mudaliar of the Stanford Center for Biomedical Ethics note that the 2007 version of the Genomics and Personalized Medicine Act (S.976), sponsored by former Ill Senator and President-Elect Barack Obama and Senator Richard Burr (R – NC), cut a section from the 2006 draft (S. 3822) which would have created a working group on race.

That section provided a "direct engagement with the issue of genetic variation and the rationale for its direct engagement with the issue of genetic variation and the rationale for using racial and ethnic categories in pharmacogenomic research," Lee and Mudaliar wrote.

That section of the original bill would have created a Genetics and Personalized Medicine Interagency Working Group tasked with several race-related responsibilities. The group would have determined appropriate definitions and use of the categories of race and ethnicity, as well as ways to increase minority access to pharmacogenomic and related clinical genetics services. The group was also intended to provide research and funding support in the area of race and genomics.

By cutting that section from the 2007 bill, the authors said, the drafters missed an "opportunity to engage critical issues with deep scientific social, and ethical implications."

Such research and attention is important, the authors advise, because personalized medicine "remains in its nascency, and populations identified by race and ethnicity, rather than individuals, remain the focus of current pharmacogenomic research despite the dominant view in anthropological genetics that race is a poor predictor of genotype."

Even though scientists have suggested that the concept of race "in the context of genetic research will be rendered obsolete once genetic markers for the relevant phenotypes are found, recent developments reflect growing use of racial categories in efforts to translate basic research into clinical practice," Lee and Mudaliar wrote.

How could racial categories be used? The Food and Drug Administration in 2005 approved an antihypertensive combination therapy for use in "self-identified blacks," which could be a confusing category, particularly in terms of personalized medical techniques, the writers argued.

The authors also said that scholars have challenged the idea of setting a precedent for race-specific drugs, "cautioning that conflation of genes, race, and drugs undermines what many scientists insist – that the sociopolitical concepts of race and ethnicity are not genetic."

As of now, according to Lee and Mudaliar, there are roughly 700 drugs in the developmental pipeline aimed at African Americans.

Both the 2006 and 2007 versions of the personalized medicine bill would create a National DNA Biobanking Research Initiative aimed at integrating genomic data with environmental and health information. But the earlier version included a mandate that would ensure diverse representation of the individuals included, while the 2007 version dropped the section. This change could affect pharmacogenomics, the authors propose, because it is an area where "population stratification issues and challenges to recruitment of minority populations persist."

Both the 2006 and 2007 Genomics and Personalized Medicine Act bills died in Congress without advancing, but at a policy discussion last summer then-Senator Obama's Health Advisor, Dora Hughes, told GenomeWeb Daily News that this bill would be a priority for Obama whether he remained in the Senate of if he won Presidency.

If he did win the White House, Hughes said, the Obama Administration might be able to push forward many points in the act without pushing a bill through Congress.

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