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 The administration is expected to give the first details this week
on the "precision medicine" initiative that Obama announced in his
Jan. 20 State of the Union address. Obama said he wanted the United
States to "lead a new era of medicine, one that delivers the right
treatment at the right time."
Precision medicine seeks to identify and treat the exact form of
disease in patients based on their genome - the precise order of
molecules in their DNA - as well as other factors such as the
interaction of genes and environment, and the microbes in their
body.
Rather than the current one-size-fits-all approach, drugs would be
tailored to individuals, allowing doctors to target the precise form
a disease takes in any individual and avoid administering drugs that
may be ineffective or even harmful.
"We'd be able to make diagnoses and treatment calls at the level of
the individual. We are very, very far from doing that, but the
payoff would be fantastic," said biologist Keith Yamamoto, vice
chancellor of research at the University of California, San
Francisco, medical school.
If Obama's initiative is to work, a first step is to build a
national database of genetic profiles so researchers can look for
correlations with their medical histories.
A 2011 report from a panel of the National Academy of Science
recommended collecting molecular data on millions of patients. It
also called for a type-2 diabetes project to identify the amino
acids in the blood of people who develop the disease, and assess how
pre-diabetes becomes full-fledged.
Nearly four years later, neither study is under way.
Obama's initiative could breathe life into them, said two panel
members who asked not to be identified.
NEED TO CRUNCH DATA
Precision medicine has been propelled by advances in two areas in
particular: cancer and pharmacogenomics, the study of how DNA
interacts with drugs. Research has found that diseases such as
breast cancer and lung cancer are not monolithic; they can be driven
by a variety of genetic mutations.
Among the larger companies in genome sequencing which could benefit
from Obama's initiative are Illumina Inc, which this month agreed an
alliance with defense giant Lockheed Martin on genomics development;
Thermo Fisher Scientific's Life Technologies unit and Roche Holding
AG, which in January paid $1 billion for a majority stake in
Foundation Medicine Inc, a leader in sequencing genes in tumors.
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Google Inc and IBM Corp are among big firms that could play a role
in storing and interpreting electronic health records and genomic
and other data.
"The field has a tremendous need to crunch data and turn it into
useful information," said Lynn Etheredge, director of the Rapid
Learning Project, which aims to harness electronic health records
and other data to improve medical care.
One barrier to change is that government and private health
insurance does not routinely cover genetic testing.
The federal Medicare program, for instance, declined in 2009 to
cover a routine genetic test to predict how a patient's cancer would
respond to anti-clotting drug Warfarin.
But overall healthcare costs could be reduced by genetics because
"insurers could stop paying for drugs that don't help people," said
UCSF's Yamamoto.
To make precision medicine mainstream, regulators would have to
change how they review and approve drugs. In the current system, the
Food and Drug Administration specifies a condition for which a drug
can be marketed. Insurance companies as well as government programs
such as Medicare and Medicaid almost never pay for other uses.
With precision medicine, conditions would be classified far more
specifically - for example, as a cancer driven by a certain gene
mutation rather than simply "breast cancer."
"I can see the administration telling FDA and Medicare to create
systems for approving and paying for drugs on the basis of molecular
biology," said Etheredge.
(Editing by Stuart Grudgings)
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