CAM and Clinical Effectiveness Research – Part II

Summary: In this section of a two-part series, Integrator contributor Daphne White, CHTP focuses on the political-economic dynamics behind the $1.1 billion “clinical effectiveness research” (CER) initiative. White examines what she calls the “Kabuki play” – intense dynamics as the medical industry seeks to gut the value of the initiative, while not appearing to do so. Would you assume that this initiative would look at cost or would inform the care people receive? As White points out, Congress appears to already have caved in on key aspects of apparent value. One wonders if CER can be the point of leverage for reform which White House Budget Director Peter Orszag thinks it can be. And if Orszag can’t get what he wants out of CER, what might the integrative practice community extract from this big money battle in which maybe we can’t, well, talk about money. In the other section, White explores the potential value of CER for the integrative practice community.



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Whose ox will be gored?

I am among those who excitedly greeted the $1.1-billion “comparative effectiveness research”(CER) initiative in Obama’s economic stimulus plan as an excellent direction for getting a handle on a medical system in which a third to half of care is deemed wasteful, and much of that harmful, according to our own Institute of Medicine. (See From Waste to Value in Health Care, JAMA, February 2008.) Not a moment too soon for the system, it would seem, and an excellent opening for integrative practice, particularly given the key backing by friends of integrative care.

Integrator contributor journalist Daphne White does an excellent job of analyzing why this $1.1-billion piece of the Obama stimulus package may never live up to its value for consumers and for policy makers, and may have been partially aborted at birth. This is a sobering look at one of the first battle grounds for healthcare reform, 2009. Blood, it would appear, has already been shed via restrictions placed, at the request of the wasteful industry, by members of Congress who were doing their bidding. White takes you behind what she calls the “Kabuki play” she witnessed at the  first ‘listening session” of the Federal Coordinating Council for Effectiveness Research. Written comments can be submitted to the Council until May 31, 2009.

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Comparative Effectiveness “Listening Session:”
Research, Politics, Evidence and Money

– Daphne White, CHTP

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Journalist Daphne White, CHTP, at her healing practice

What happens when you mix together science, politics and
$1.1 billion in government money? 

When
the issue is comparative effectiveness research (CER), the resulting brew is a
Health & Human Services “listening session” with 40 lobbyists, industry reps and advocacy groups each granted  three minutes to  speak. What you get is a three-hour-long Kabuki
play: it’s long, it’s repetitive and it’s tedious. 

And you sit there feeling that even though these people are speaking in
plain English, what is coming out of their mouths is not even remotely
connected to that thought bubble floating above their head.

   
  “The dirtiest word in health reform
[is] not
rationing … [it’s] redistribution. 
Every
time you take one of those dollars
and give it to someone else, the donor

is
going to yelp and hire a lobbyist.’

– Julie Rovner, NPR

Before we look at the action, let us review the back story,
as explained first by Julie Rovner of National Public Radio.  “That $2 trillion we spend on health care
every year, every penny of that is someone’s income,” she told an audience at
the Institute of Medicine last December, not mincing any words.  “The dirtiest word in health reform [is] not
rationing … [it’s] redistribution.  Every
time you take one of those dollars and give it to someone else, the donor is
going to yelp and hire a lobbyist.”

There were lots of lobbyists at the listening session, which
was held at the Hubert Humphrey HHS building, right down the hill from the US
Capitol.  Every player in the current
system understands the potential harm that could come from comparative
effectiveness research.  OMB director Peter
Orszag has said
the U.S. could save “$700 billion a year without harming health
outcomes if we could just get the more efficient practices in some parts of the
country into the less efficient rest of the country.” No one wants to be on the losing end of this
equation.

   
“It’s hard to understand how
reasonable people could oppose

conducting the sort of research
that aims to collect data so that
we can
actually know if one drug

or medical device works better
than another at fixing
the same

medical problem.”

– Michelle Andres,
US News & World Report

 

In fact, the Wall Street Journal had
reported on Feb. 9 that “the drug and medical-device industries are mobilizing
to gut a provision in the stimulus bill that would spend $1.1 billion on
research comparing medical treatments, portraying it as the first step to
government rationing.”  A coalition of
companies has already hired Babour Griffith Rogers — “a public-relations firm
that is part of one of Washington’s most influential lobby shops,” according to
the Journal — to represent their interests. 

And Republican Senator Jon Kyl of Arizona had already tried to push a
measure that would bar federal health programs from using
comparative-effectiveness research to deny coverage.  The amendment was defeated, but it did manage
to garner 44 votes – including those of key health care reform players Sens.
Charles Grassley (R, IO) and Russ Feingold (D, WI).

“It’s hard to understand how reasonable people could oppose
conducting the sort of research that aims to collect data so that we can
actually know if one drug or medical device works better than another at fixing
the same medical problem,” Michelle Andres wrote in the April 17 edition of
U.S. News & World Report
. “But
the relatively paltry $1.1 billion” for CER “has created a firestorm of
controversy, with conservative commentators and some providers raising the
specter of regulation-happy government bureaucrats intruding into medical
decisions that should be left to patients and their doctors.”

So you would think that when the drug purveyors and
device-makers and surgeons from “less efficient parts of the country” got in
the same room as “regulation-happy government bureaucrats” there would be
fireworks.  There would be spirited
debate and intense questioning.  Nothing
could be further from the truth.  This
was probably the most under-charged hearing I’ve ever covered.  The 15 members of the newly-minted “Federal
Coordinating Council for Comparative Effectiveness”
  sat at a U-shaped table and listened
impassively to each “panel” of presenters. 
The panelists were brought up 10 at a time to sit at a long table facing
the “happy government bureaucrats.”  Some
spoke at warp speed to cram as many words as possible into their three minutes,
yet their affect was mostly flat.  They leaned
heavily on words such as “transparency” and “process” and wouldn’t go near the
words which populated the thought bubbles above their heads:  words such as “cost” and “cutting” and “self-interest.”

   
  I decided to call an acquaintance
who was also
at the hearing, and
works for one of the affected health
care
industries.  As soon as I assured
him of total confidentiality, he was

happy to explain the Kabuki dance.
 

What was going on here? 

This hearing was about as transparent as poker.  I decided to call an acquaintance that was
also at the hearing, and works for one of the affected health care industries.  As soon as I assured him of total confidentiality,
he was happy to explain the Kabuki dance. 
“When government gets involved in anything, it changes the playing field
and brings a different type of weight to the issue,” he said.  “When done correctly, CER takes a great deal
of time and money.  Once the research is
done, the temptation will be to turn it into a cost-savings thing, such as
Orszag is talking about.  Instead of this
industry growing at 10 percent a year – as it has been – it will just grow like
the CPI. Nobody wants to get in front of the government and say you’re nuts,
you can’t do this!  You’ve got to be a
bit more thoughtful.”

   
 Congress specifically stated that
this

research money – a $1.1 billion investment
of taxpayer dollars -was not to
be used
to compare or even consider the cost
effectiveness of treatments, or to
curtail
coverage of less-effective (or even
ineffective) treatments.

 

As this acquaintance talked, I could feel the energy and
passion in his voice.  His words and his
thoughts were in sync:  this was the full
monty.  That is why Congress – that most
political of entities – wrote their report language to specifically state that
this research money (a $1.1 billion investment of taxpayer dollars) was not to
be used to compare or even consider the cost effectiveness of treatments, or to
curtail coverage of less-effective (or even ineffective) treatments.

It takes a lot of energy to pretend that you don’t see the
elephant sitting in the room:  it was all
that self-restraint that kept the atmosphere so sedated.  One of the few people who actually was able
to speak his mind was Steven Findlay of Consumers Union.  “It’s interesting that this process is about
evidence in science, yet the process itself is more politics than science,” he
told me afterward.  “The session was a
little strange:  a lot of organizations
are reluctant to press their case in plain terms.”

   
  “The session was a
little strange: 
a lot of organizations
are reluctant
to press their case in plain terms.”

– Stephen Findlay
Consumer Union

The meeting itself was transparent, yes, but that meant that
a lot of competing organizations were in the room, and no one wanted to show
their real hand.  “No one is going to
just come out and say ‘I’m Joe Schmoe from Pharma and please don’t do anything
in this area that jeopardizes my profits’,” Findlay told me.  “The people on the Commission know what these
groups think, and where they are coming from, particularly the industry
groups.  The message is:  don’t mess with our cheese!”

Of course if no one moves the cheese, our health care system
will remain exactly as it is right now. 
So a few people – including Findlay – actually did make some suggestions
about the cheese.  Findlay urged the
panel to “consider steps that would make the CER program – over time –
essentially free of conflicts of interest” in biomedical research and
publishing.  “As a start, [the panel] should
strongly favor researchers and institutions that are devoted to doing this
research in the public interest and who have no current conflicts.”

After all, Findlay said, CER was created because “so much
industry-funded research fails to adequately answer the critical questions that
can help doctors and patients make treatment decisions.”  Acknowledging that a “conflict-free zone for
CER” will take time, Findlay suggested that as an opening move the Commission
could require, from the outset, “100% disclosure and transparency of all
conflicts from both researchers and institutions.”

Like a number of other speakers, Findlay also stressed the
issue of disparity in health care:  “CER
simply must be mobilized to improve the health outcomes of various racial and
ethnic populations and – over time – end the shameful gap that exists between
the health status of some minority populations and other Americans.”

   

In fact, wellness and disease prevention –
the bread and
butter of CAM therapies –

were hardly mentioned in the three hours

of
testimony. 

Of the 40 presenters at
the
“listening session,” there were no

official representatives from CAM modalities

or the integrative health care world. 

 

It became kind of a running joke that each speaker had three
points to make in their three minutes, and Findlay’s third point was also made by
several others:  he asked the FCC to make
“a substantial effort to include consumers and patients in CER planning and
implementation.  … Researchers and
doctors tend to see the outcome of some treatments one way, and patients see it
another way.”

The other speaker who made me sit up and listen was Winifred
Hayes, president and CEO of Hayes Inc.  In answer to a question from one of the FCC
panelists, Hayes said what everyone else was studiously avoiding:  “Cost effectiveness is the elephant in the
room but at some point we have to address it.” 
She added that we already have a lot of solid evidence related to
effectiveness, “but that evidence is frequently not used.  I’d say that 20 -30 percent of the money
should be used for dissemination, otherwise this would be a waste of time.”

In her testimony, Hayes noted that one of the reasons our
health care system lags those of other developed nations is our “failure to
effectively and efficiently integrate scientific evidence into healthcare decision-making
and clinical practice, resulting in overuse, misuse and even (in some
instances) underuse of health technologies.” 
She also blamed “perverse financial incentives that drive premature
dissemination of new medical technologies even when they do not improve patient
care or outcomes” and “insufficient focus and allocation of resources to health
promotion and disease prevention.”

In fact, wellness and disease prevention – the bread and
butter of CAM therapies – were hardly mentioned in the three hours of
testimony.  Of the 40 presenters at the
“listening session,” there were no official representatives from CAM modalities
or the integrative health care world.  It
is possible that they tried to speak: only 30 speakers were selected from over 100 groups who requested a
hearing.  However, the panel did open up
10 spots on the day of the listening session, and people could sign up on the
spot.  Thirteen people signed up, 10 were
selected.  Out of sheer frustration with
the lack of CAM representation, I ended up putting my name on the list and my
name was actually selected.  You can read
my comments to the panel here.

There will be two additional listening sessions – one in the
Midwest, one in Washington.  As it is
written:  if you don’t play, you can’t
win.  You can also submit written
comments at
CoordinatingCouncil@hhs.gov
until May 30, 2009. 

Note: White’s linked article on this topic, focusing on the CAM and integrative practice community, is located here.

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johnweeks@theintegratorblog.com

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