NEW YORK (GenomeWeb News) - In a report released yesterday that broadly sketches personalized medicine as an essential component of the future of medicine, US Department of Health and Human Services Secretary Michael Leavitt stressed the need for continued research in genomics and bioinformatics, enhanced collaboration and information sharing, and the value of patients’ rights in individualized medicine as necessary foundations for any advances to come.
"Healthcare professionals have always aimed at making medical care as individualized as possible. But in truth, our ability to deliver the right care for each person has been limited," Leavitt wrote in the report, “Personalized Health Care: Opportunities, Pathways, Resources,” available here.
HHS said that while the "exploding knowledge of the human genome" is enabling doctors to "predict, direct, preempt and treat disease" and to "look beneath" visible symptoms, there are a number of "pathways where work is needed," and checked off a list of prerequisites needed before personalized medicine can be realized.
While the report includes a comprehensive list of major ongoing personalized healthcare initiatives under the auspices of HHS and points out fields and issues that will require more work, emphasis, and even regulatory framing, it does not make an outright call for specific funding increases, or for specific regulations.
In the report, Leavitt outlines PHC as being comprised of a blend of "biology; bioengineering; genomics; proteomics; nanotechnology; cellular and tissue engineering; bioimaging; computational methods; and advances in information technologies."
In a section of the report called "Challenges," Leavitt advised that "establishing the public's trust for use of personal health and genetic information in electronic healthcare management systems will be key to ensuring public acceptance of new medical genetic theories."
To ensure the "wider adoption" of genomic information in relation to disease, information drawn from genetic tests must be "both clinically and analytically valid."
HHS also sees a need for more "user friendly information sources," noting that the community needs "better and more efficient ways to provide useful information to support clinical decisions of healthcare providers and consumers." The lack of user-friendly information "often hampers adoption of newer approaches, such as the incorporation of genetic testing practices in routine clinical decision-making,” the report states.
Approaches to genomics and database product development will slowly change, HHS suggests, partly because of public/private funding strategies, and data-sharing agreements "will broaden discovery opportunities, enhance safety assessment, and diminish investment risks in targeted molecular therapies and diagnostics."
Personalized healthcare, the report said, "should equate not only with an emphasis on more effective health outcomes but also with prevention and safer health interventions.”
Beyond those challenges, HHS identified several pathways to pursue in order to advance personalized healthcare. HHS proposes that the field will be founded on a "growing base of biomedical knowledge (especially related to genomic knowledge) and the adoption of interoperable health information technology."
On top of that foundation there should be continued development of “clinically useful products," and the development of medical evidence demonstrating that these approaches work for clinicians and patients.
The report puts genomic sequencing and mapping, genome-wide association studies, and the relationships between genes and the environment at the top of the list of scientific fields needing expansion.
HHS also sees the need to expand biomarker identification research, as well as population genetics, 'omics, and computational biology.
One central theme of the report is the importance of information technology, which HHS considers nearly as important as the DNA to the future of personalized medicine. Personalized healthcare "starts with electronic health records that make complete and current patient information available when needed," according to the report.
HHS stressed the fact that there must also be standards for handling genetic information in patient and family records, and said that personal health information must be protected "in order to secure trust and support interoperable electronic health information exchange."
Finding useful information in healthcare delivery "will require standardization in measures and nomenclature, as well as sophisticated computer programming," the report advised.
Because the advance of personalized healthcare will, ideally, result in the development of "more effective drugs aimed at narrower populations," regulatory guidance is on the way to support pharmacogenomic drug and diagnostic development "aimed at smaller populations and more precise disease conditions," HHS said.
These measures include the US Food and Drug Administration’s Critical Path Initiative, its work on facilitating the development of in vitro diagnostics, and its encouragement of drugmakers to submit genetic data with new drug applications, the report said.