From Michael (Gusmano):

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May 7, 2009
New Effort Reopens a Medical Minefield 
By BARRY MEIER


A back-pain researcher, Dr. Richard Deyo recalls the uproar the last
time 
federal officials tried to suggest how doctors should practice their
profession. 

It was in the mid-1990s, when Dr. Deyo helped develop federal guidelines
urging 
surgeons not to perform spinal fusions to treat acute pain. The reason
was 
simple: There was little evidence that the fusions worked in many
patients.
Spine specialists quickly attacked the report, calling it flawed. One
medical 
device maker, Medtronic, sued unsuccessfully to block its release.
Republican 
lawmakers tried to kill the agency that issued the report. It survived,
but its 
funding was drastically cut, and it decided to stop issuing guidelines. 
Now, 15 years later, the Obama administration is entering this same
medical 
minefield. And once again, opponents are gearing up for a fight. 
The administration plans to spend $1.1 billion over the next few years
on 
studies like the one conducted by Dr. Deyo, to compare the effectiveness
of 
competing treatments for common conditions like back pain, heart disease
and 
prostate cancer. The studies will be publicly released, to help doctors
and 
patients decide which treatment options they want to pursue. 


Supporters include many medical researchers, consumer groups, unions and

insurers. They say such studies are essential to curbing the widespread
use of 
ineffective treatments and to helping control health care costs, which
totaled 
$2.2 trillion in 2007, or 16 percent of the nation's gross domestic
product.
The New England Journal of Medicine published several articles Wednesday

supporting the federal effort and rebutting arguments raised by critics.

But potential opponents - which include medical products companies, some
doctors 
and their political allies - warn that the comparative effectiveness
movement 
could lead to inadequate treatment for some patients and even the
rationing of 
health care.


"It is not difficult to see how you can get on a slippery slope very
easily," 
said Tony Coelho, a former Democratic congressman who is head of a new 
industry-backed Washington group called the Partnership to Improve
Patient Care, 
formed to lobby on the comparative effectiveness effort. 
The group's backers include major trade organizations that represent
producers 
of drugs, medical devices and biological treatments. 
Critics like Mr. Coelho also point to a British government agency, the
National 
Institute for Health and Clinical Excellence, or NICE, which considers
costs in 
judging a treatment's effectiveness. Based on NICE's findings, the
British 
government has denied some patients access to costly drugs like those
used to 
treat cancer.


Whether cost should be a factor in this country was a hot-button issue
during 
the Congressional debate in February, when the comparative-effectiveness
funding 
was approved as part of the economic stimulus package. A legislative
report by 
Congressional lawmakers who negotiated the final version of the bill
said that 
they did not intend the research money to be used to "mandate coverage, 
reimbursement or other policies for any public or private payer." 
Despite that assurance, even supporters of the effort say one goal in 
identifying effective medical treatments is to stop wasting money on
those of 
little value. 


For now, proponents and critics are warily circling one another, as the
first 
administrative steps of the process unfold.
A panel of government health experts is holding a series of public
hearings at 
which people can suggest medical conditions for comparative
effectiveness 
reviews. Then, in late June, that federal panel and the Institute of
Medicine, a 
part of the National Academies of Science, will issue reports
recommending 
priorities for comparative research. Past combatants like Dr. Deyo
expect the 
fighting to start as soon as such studies start identifying winners and
losers. 
"If this research is done in a rigorous way and doesn't pull strings,
then a lot 
of pressure will come to bear," on the process, said Dr. Deyo, a
professor at 
Oregon Health and Science University in Portland.


Some conservative and libertarian research groups, as well as
commentators like 
Rush Limbaugh, have attacked the comparative effectiveness effort as a
step 
toward socialized medicine. Some medical experts have also raised
concerns that 
the program may slow the drive toward so-called personalized medicine -
an 
approach in which treatments are tailored to a patient's genetic makeup.
But for 
now, Mr. Coelho's opposition group and drug and device makers are using
more 
measured rhetoric. 


Mr. Coelho, a former House Democratic whip who resigned in 1989 over a 
controversial junk-bond investment, says his organization does not
oppose the 
concept of comparative effectiveness. But the group is concerned, he
said, that 
such studies could lead to a type of cookbook medicine that will ignore
the 
needs of specific patients, including members of minority groups. 
His organization includes patient advocacy groups like the National
Alliance for 
Hispanic Health and the National Alliance on Mental Illness, which also
receive 
financing from medical products companies. Those groups argue that their
members 
are underrepresented in formal clinical trials of drugs and treatments,
and so 
there is not evidence enough on which to draw conclusions on what works
for them 
and what does not, they say. 


Mr. Coelho, a driving force behind the Americans with Disabilities Act,
points 
to his own experience with epilepsy, which he has had since he was a
teenager, 
as an example of how patients need to be treated individually. 
Under the comparative effectiveness program, the Department of Health
and Human 
Services and two agencies under it -the National Institutes of Health
and the 
Agency for Healthcare Research and Quality - will finance studies that
will look 
at various treatments and will pay for the development of
information-gathering 
tools, like databases of patients being treated for a certain condition.
Right now, "there is no place that helps you sort through a specific
option and 
how that compares to another," said Dr. Carolyn M. Clancy, the director
of the 
Agency for Healthcare Research and Quality.


The agency, back when it was known as the Agency for Health Care Policy
and 
Research, was the federal body Dr. Deyo worked with in drafting the
back-pain 
guidelines in the mid-90s.  More recently, officials of the Oregon
Evidence-Based Practice Center began producing reports a few years ago
comparing the effectiveness of competing drugs, both brand-name and
generic, in treating specific conditions. The work was meant to help
purchasers like state Medicaid programs lower their costs, 
said Dr. Mark Helfand, director of the center, which is part of the
Oregon 
Health and Science University. 


Wherever they went, Dr. Helfand said, he and his colleagues met
resistance from 
drug makers and some patient groups that had rallied to the companies'
side, who 
raised the same arguments that critics of comparative effectiveness are
raising 
today. The Practice Center's research, which is continuing, is now used
by 14 
states. Dr. Helfand said groups representing African-American, Hispanic
or 
elderly patients were right to argue that they were underrepresented in
clinical 
trials. But he added that the whole point of comparative effectiveness
was to 
move medical practice beyond the limits of such trials, by looking at a
broader 
range of evidence that includes the actual experience of patients
undergoing 
treatment. 


"Ironically, the motivation for comparative effectiveness is to see what
works 
in practice," he said, "rather than overgeneralizing from a few
unrepresentative 
studies." 

 



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