It may be that personalized medicine is becoming one of those All-American icons, like apple pie and mom. That’s because personalized medicine, as a concept and goal for the American healthcare system, seems to have universal support. If true, this is a positive long-term development for clinical laboratories and pathology groups.
Take the new president, for example. Barack Obama has long contended that personalized medicine must be at the heart of health care reform. “The issue of getting the right treatment to the right person goes with his [Obama’s] whole emphasis on health reform,” said Mark McClellan, who headed the FDA and Medicare under the Bush Administration. McClellan was speaking about President Obama during an interview with MSNBC. “If we’re thinking about reforming the healthcare system, we should be thinking about what medicine will be like down the road when healthcare reform is fully implemented,” observed McClellan during his MSNBC interview.
Obama amended his 2010 budget to promote use of personalized medicine in comparative effectiveness research. His budget proposal would also prohibit federal health programs from using data developed during comparative effectiveness research as a reason to deny coverage for treatments and services. The Senate version of the budget includes a resolution to fund comparative effectiveness research that “can drive evidence-based medicine and build a rapidly learning health care system.”
What escaped the notice of most pathologists and clinical laboratory managers years back when Obama served as a Senator was the bill he previously introduced, called the Genomics and Personalized Medicine Act of 2007. Overall, it is supportive of the use of genetic medicine and genetic testing to advance patient care and other national health goals. His 2007 bill never came to a vote, but Senator Richard Burr, a Republican from North Carolina, resurrected this ball last fall as SB 976.
The proposed bill originally introduced by Senator Obama would set up a mechanism for coordination of genetic medicine policies between government agencies; advance genetic research; and-similar to HIPAA-would ensure individuals have control over how their personal genetics information is used.
Specifically, SB 976 would require Health and Human Services (HHS) to:
- Establish the Genomics and Personalized Medicine Interagency Working Group (IWG). Among other duties, the IWG would develop guidelines for procedures, protocols, and policies safeguarding the privacy of biobank subjects.
- Establish a national biobanking database, biobank initiatives grant program, and mechanism for management and submission of pharmacogenomic data developed by the FDA in collaboration with the NIH and CDC.
- Conduct studies to determine the potential of personalized medicine by accelerating genomic research; increasing understanding of how genomics interacts with environmental factors to cause disease; and accelerating development of safe, accurate diagnostics and treatments.
- Support development of genetic and genomics education curricula and certification programs for professionals, including identifying alternative education options such as distance or on-line learning programs.
The point here is that Obama’s apparently genuine support for the use of genetic medicine and genetic testing as cornerstones of personalized medicine reaches back into his years as a Senator. With clinical laboratories and pathology groups developing new capabilities in molecular diagnostics, such as the analysis of DNA, RNA, and the human proteome, it is important for there to be social consensus and common political will to use these tools to advance patient outcomes. – P. Kirk
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