[Debbie L.]

From today's New York Times:

U.S. to Compare Medical Treatments

By ROBERT PEAR

WASHINGTON * The $787 billion economic stimulus
bill approved by Congress will, for the first
time, provide substantial amounts of money for
the federal government to compare the
effectiveness of different treatments for the same illness.

Under the legislation, researchers will receive
$1.1 billion to compare drugs, medical devices,
surgery and other ways of treating specific
conditions. The bill creates a council of up to
15 federal employees to coordinate the research
and to advise President Obama and Congress on how to spend the money.

The program responds to a growing concern that
doctors have little or no solid evidence of the
value of many treatments. Supporters of the
research hope it will eventually save money by
discouraging the use of costly, ineffective treatments.

The soaring cost of health care is widely seen as
a problem for the economy. Spending on health
care totaled $2.2 trillion, or 16 percent of the
nation’s gross domestic product, in 2007, and the
Congressional Budget Office estimates that,
without any changes in federal law, it will rise
to 25 percent of the G.D.P. in 2025.

Dr. Elliott S. Fisher of Dartmouth Medical School
said the federal effort would help researchers
try to answer questions like these:

Is it better to treat severe neck pain with
surgery or a combination of physical therapy,
exercise and medications? What is the best
combination of “talk therapy” and prescription drugs to treat mild depression?

How do drugs and “watchful waiting” compare with
surgery as a treatment for leg pain that results
from blockage of the arteries in the lower legs?
Is it better to treat chronic heart failure by
medications alone or by drugs and home monitoring
of a patient’s blood pressure and weight?

For nearly a decade, economists and health policy
experts have been debating the merits of research
that directly tackles such questions. Britain,
France and other countries have bodies that
assess health technologies and compare the
effectiveness, and sometimes the cost, of different treatments.

Hillary Rodham Clinton, as a senator, was an
early champion of “comparative effectiveness
research.” Mr. Obama, who is expected to sign the
stimulus bill Tuesday, endorsed the idea in his campaign for the White House.

As Congress translated the idea into legislation,
it became a lightning rod for pharmaceutical and
medical-device lobbyists, who fear the findings
will be used by insurers or the government to
deny coverage for more expensive treatments and, thus, to ration care.

In addition, Republican lawmakers and
conservative commentators complained that the
legislation would allow the federal government to
intrude in a person’s health care by enforcing
clinical guidelines and treatment protocols.

The money will be immediately available to the
Health and Human Services Department but can be
spent over several years. Some money will be used
for systematic reviews of published scientific
studies, and some will be used for clinical
trials making head-to-head comparisons of different treatments.

For many years, the government has regulated
drugs and devices and supported biomedical
research, but the goal was usually to establish
if a particular treatment was safe and effective,
not if it was better than the alternatives.

Consumer groups, labor unions, large employers
and pharmacy benefit managers supported the new
initiative, saying it would fill gaps in the
evidence available to doctors and patients.

“The new research will eventually save money and
lives,” said Representative Pete Stark, Democrat of California.

The United States spends more than $2 trillion a
year on health care, but “we have little
information about which treatments work best for
which patients,” said Mr. Stark, who is the
chairman of the Ways and Means Subcommittee on Health.

In the absence of information on what works, Mr.
Stark said, patients are put at risk, and
billions of dollars are spent each year on
ineffective or unnecessary treatments.

Steven D. Findlay, a health policy analyst at
Consumers Union, said the action by Congress was
“a terrific step on the road to improving the
quality of care and making it more efficient.”

But critics say the legislation could put the
government in the middle of the doctor-patient relationship.

Bureaucrats “will monitor treatments to make sure
your doctor is doing what the federal government
deems appropriate and cost-effective,” Betsy
McCaughey, a former lieutenant governor of New
York, wrote on Bloomberg.com. Rush Limbaugh
broadcast the charges to millions who listen to his radio talk show.

Lawmakers and lobbyists agree that researchers
should compare the clinical merits of different
treatments. Whether they should also consider cost is hotly debated.

Representative Charles Boustany Jr., a Louisiana
Republican who is a heart surgeon, said he
worried that “federal bureaucrats will misuse
this research to ration care, to deny life-saving
treatments to seniors and disabled people.”

The House Appropriations Committee inadvertently
stoked such concerns in a report accompanying its
version of the economic recovery bill. It said
that research comparing different treatments
could “yield significant payoffs” because less
effective, more expensive treatments “will no longer be prescribed.”

A similar proposal was included in a recent book
by Tom Daschle, who had been Mr. Obama’s nominee
for health secretary, and Jeanne M. Lambrew, who
is the deputy director of the Office of Health Reform in the Obama White House.

Women and members of minority groups expressed
concern about that approach. Drugs and other
treatments can affect different patients in
different ways, they said, but researchers often
overlook the differences because their studies do
not include enough women, blacks or Hispanics.

“Some drugs appear to be more effective in women
than in men, while other medicines are more
likely to cause serious complications in women,”
said Phyllis E. Greenberger, the president of the
Society for Women’s Health Research. “It’s
important to look for these sex-based differences.”

In a letter to House leaders, the Congressional
Black Caucus said, “We are concerned that
comparative effectiveness research will be based
on broad population averages that ignore the differences between patients.”

House and Senate negotiators tried to address
these concerns. The final bill says that the
research financed by the federal government shall
include women and members of minority groups.

Moreover, in a report filed with the bill, the
negotiators said they did not intend for the
research money to be used to “mandate coverage,
reimbursement or other policies for any public or private payer.”

Congress did not say exactly how the findings
should be used. Private insurers can use the data
in deciding whether to cover new drugs and
medical procedures, but it is unclear how Medicare will use the information.

Under existing law, Medicare generally covers any
treatment that is “reasonable and necessary for
the diagnosis or treatment of illness or injury,”
and the agency does not have clear legal
authority to take costs into account when
deciding whether to cover a particular treatment.

Andrew Witty, the chief executive of the
pharmaceutical company GlaxoSmithKline, said
European officials often considered the costs as
well as the clinical benefits of new drugs * with mixed results.

“Comparative effectiveness is a useful tool in
the tool kit, but it’s not the answer to
anything,” Mr. Witty said in an interview. “Other
countries have fallen in love with the concept,
then spent years figuring out how on earth to make it work.”