Secretary points to HHS FY08 budget of $352 million targeted to personalized health care endeavors

Michael O. Leavitt, Secretary of Health and Human Services, has identified Personalized Health Care as one of his top priorities, and has outlined new steps that HHS is taking to achieving gene-based medical care combined with health information technology.

Addressing members and guests of the Personalized Medicine Coalition (PMC) on March 23, 2007 -- at the organization’s annual gathering at the National Press Club to spotlight progress in the field -- Secretary Leavitt noted that his Initiative is designed to improve the safety, quality, and effectiveness of heath care for every patient in the United States. Previous keynote addresses at PMC’s annual luncheon were given by Dr. Francis Collins, Director of the National Human Genome Research Institute of NIH (2005) and Dr. Andrew von Eschenbach, Commissioner of the Food and Drug Administration (2006).

“Today, our medical knowledge is tied to our anatomy,” said Secretary Leavitt. “We talk about lung cancer and heart disease. But in the future, we’ll be talking about diseases at a much different level. We’ll be talking about molecular-based diseases. That will give us all kinds of new treatments that are effective for very specific conditions in individual patients.”

In describing the benefits of a molecular approach, Secretary Leavitt noted that: “Personalized health care will help us know our individual vulnerabilities—every one of us. It can make health care more preventive. It can help us spot the onset of disease at a much earlier stage. It can help us give new therapies that are much more targeted and far more effective. And it should even give us the tools that we need to move faster and more economically toward developing targeted therapies.”

Secretary Leavitt outlined several new steps being taken at HHS agencies:

• 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.

Secretary Leavitt added that 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.

“The work that remains is sweeping, from the most fundamental science to the details of health care practice. This is the health-care project of our generation,” he told the standing-room-only group.

In the audience for the Secretary’s first public remarks on this Initiative were Dr. Elias Zerhouni, Director of the National Institutes of Health; Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality; Dr. Robert Kolodner, Director of the Office of the National Coordinator for Health Information Technology; Dr. Terry Cline, Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA); and Dr. Francis Collins, Director of the National Human Genome Research Institute of NIH.

Wayne A. Rosenkrans, Jr., Ph.D., President and Chairman of the PMC and Business Strategy Director, External Scientific Affairs at AstraZeneca Pharmaceuticals, which sponsored the annual event, commented: “The Personalized Medicine Coalition represents a true coalition among stakeholders that share a common vision of patient-centric health care. Pharma, biotech, device, academia, payers, and patient groups come together under the PMC umbrella to educate policymakers, legislators, and other influencers on the promise of personalized health care. But carrying this vision forward is far larger than any single organization is capable of. Partnerships between groups involved in areas of common cause will ultimately carry the day towards adoption.” Referring to Secretary Leavitt, Dr. Rosenkrans added “This is a daunting task, which requires a unique individual to carry it forward.”

“The Personalized Medicine Coalition deeply appreciates Secretary Leavitt’s leadership in making personalized health care ‘a national priority’ at this time,” added Edward Abrahams, Ph.D., PMC Executive Director. “PMC is continuing to coordinate with the Secretary’s team to advance this Initiative, and we pledge our support to this critical endeavor. We share the Secretary’s view that this is ‘the work of our generation’, and we welcome the government’s assistance in overcoming the many obstacles that impede better health care for all Americans.”

The Personalized Medicine Coalition has been coordinating with the Secretary’s Personalized Health Care staff since last summer. PMC has helped to identify for HHS the key opportunities and challenges in the field, and has pledged its support to HHS to help in the public-private partnerships required to fulfill the potential of personalized medicine.

In closing, Secretary Leavitt noted: “Personalized health care is about opportunities that we’ve never had before. Our job is to seize these opportunities, and to turn them squarely to the benefit of individual patients.”

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