[Ip-health] U.S. to Compare Treatments

[Miles Teg]

The US has used a mixed bag of complex arguments to defer work on
Rational Use of Medicines at the WHO because practitioners should have
access to a portfolio of treatments. It remains to be seen if what is
good for the US is NOT good for the rest of the world and if support
will flow for work on this globally.... It still remains severely
underfunded.

U.S. to Compare Treatments

By ROBERT PEAR
Published: February 15, 2009

WASHINGTON =97 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 =97 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."

http://www.nytimes.com/2009/02/16/health/policy/16health.html?_r=3D1