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Senior Citizen Health & Medicine
Personalized Health Care Will Use Genomic, Molecular
Data to Pinpoint Treatment
HHS Secretary Leavitt outlines the government's
course of action
 March 28, 2007 Personalized health care - the use
of genomic and molecular data to better target the delivery of health
care to a specific person has the potential to transform the "quality,
safety and value of health care," according to Health and Human Services
Secretary Mike Leavitt. He outlined the government's course for
achieving gene-based medical care combined with information technology
last week.
"Personalized health care will combine the basic
scientific breakthroughs of the human genome with computer-age ability
to exchange and manage data," 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 last Friday 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."
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What is Personalized Medicine |
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"Personalized medicine is the application
of genomic and molecular data to better target the delivery of
health care, facilitate the discovery and clinical testing of
new products, and help determine a patient's predisposition to
a particular disease or condition."
This is from the Senate-passed bill
"Genomics and Personalized Medicine Act of 2006" by Sen. Barack
Obama.
The purpose of the bill is "To improve access to and
appropriate utilization of valid, reliable and accurate
molecular genetics tests by all populations, thus helping to
secure the promise of personalized medicine for all Americans."
Link to bill in pdf format, click
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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.
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