HHS Secretary Mike Leavitt Outlines Agenda for Personalized Medicine

Below, the unedited HHS release... HHS Secretary Mike Leavitt today outlined a course for achieving gene-based medical care combined with health information technology, which he called "Personalized Health Care." He said the initiative has the potential to transform the quality, safety and value of health care for patients in the future. "Personalized health care will combine the basic scientific breakthroughs of the human genome with computer-age ability to exchange and manage data," Secretary Leavitt said. "Increasingly it will give us the ability to deliver the right treatment to the right patient at the right time -- every time." In a speech before the annual meetings of the Personalized Medicine Coalition, at the National Press Club, the Secretary outlined steps already under way to develop the needed information, as well as new steps he is undertaking to build the foundation for personalized health care and ensure that gene-based medical data and health information technology are used appropriately. "Every one of us is biologically unique. We've always known that, but we haven't had the knowledge or the tools to deliver health care at that kind of individual level. That's what's changing," Secretary Leavitt said. Gene-based medicine can help individuals identify their particular susceptibilities to disease while they are well and take effective preventive steps. In the future, it will help detect the onset of disease much earlier, enabling treatment to prevent disease progression, and can help bring about medical products that are tailored more precisely to the needs of each individual. Health information technology, including powerful new tools for managing vast amounts of information, will be needed both to continue building basic scientific knowledge and to make the new knowledge useable and accessible for patient care. Secretary Leavitt emphasized how much work remains to build a system that can deliver personalized health care. He has identified this issue as one of his priorities for the next two years. "The Human Genome Project was a dramatic success, but it has correctly been called a race to the starting line," he said. "The work that remains is sweeping, from the most fundamental science to the details of health care practice." Secretary Leavitt announced new steps that HHS is taking to lay the foundation for a personalized health care future: * HHS is engaged in a broad review of the implications for privacy protection as health information technology is increasingly adopted, including needs for genetic information, and the anticipated effect on the confidentiality, privacy and security of individually identifiable health information. * HHS will review existing structures for ensuring that genetic tests are accurate, valid and useful. The objective will be to ensure that responsibilities are clearly and appropriately assigned among HHS agencies to support useful genetic testing for patients. * HHS will develop consistent policies for its agencies regarding access to and security of federally supported research. The goal will be to ensure open information access for researchers, to support progress, while still rewarding discovery and innovation. * The President's budget for 2008 includes $15 million in start-up funding to create a new electronic network that would draw together the nation's major health data repositories. This network of networks would enable researchers to match treatments and outcomes, and in that way learn from the nation's day-to-day medical practice and improve safety and effectiveness of medical treatments. * The American Health Information Community (AHIC) will develop recommendations to identify health IT standards for including genetic test information on electronic health records. AHIC is charged with developing recommendations for establishing or identifying consensus standards and for other specific actions toward achieving President Bush's goal that most Americans have electronic health records by 2014. Current efforts at HHS agencies supporting personalized health care total $277 million this year, and are proposed to grow to $352 million in FY 2008. Current work at HHS agencies includes: * At the National Institutes of Health (NIH), genome-wide association studies are using information from years of clinical trials to find associations between genetic elements and health outcomes. A milestone event is expected this fall when research from the long-running Framingham Heart Study, involving some 10,000 volunteers who have been followed over two generations, may be posted at NIH's Genotype and Phenotype (dbGaP) Web site. * At the Food and Drug Administration (FDA), the Critical Path initiative is organizing work across 76 science and regulatory areas to improve product development, especially for gene-oriented drugs and diagnostic tests. Regulatory guidance on the co-development of drugs and diagnostic products, which is an important stepping stone for gene-based medical care, will be published this fall. * The Centers for Disease Control and Prevention (CDC) has worked with the National Cancer Institute to define the leading 100 genetic variants of public health significance. CDC is using its National Health and Nutrition Examination Survey (NHANES), one of the nation's largest health surveys, to determine how common these variants are in the U.S. population. Results will be released this summer and will be important for researchers. "In the future, we'll understand diseases at a new level," Secretary Leavitt said. "We'll know them as gene- or molecular-based diseases. And that will give us new kinds of treatments that will be effective for both the very specific condition and the individual patient." More information about the Personalized Health Care initiative is available at www.hhs.gov/myhealthcare.