Daphne White: CAM and Comparative Effectiveness Research – Are We Going to Play?

Summary: The idea of “comparative effectiveness research” (CER), the new $1.1 billion economic stimulus program, strikes a happy chord for many in the integrative practice community. Isn’t this the appropriate research terrain for showing value of integrative care? In this first of two part Integrator series, reporter and regular Integrator contributor Daphne White, CHTP, shares how she attended the “listening session” of the government’s CER advisory board to understand what was going on and see if the integrative practice community was showing up. White ended up taking off her journalist hat and testifying. She shares her perspectives on why and how the integrative practice community should be involved. White’s second is a very well-reported analysis of the “kabuki dance” she witnessed as vested medical interests developed their strategies to make sure that the CER initiative does not gore their own oxes.

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Inside effectiveness is cost

The $1.1 billion “comparative effectiveness research” (CER) initiative included as part of the stimulus package would appear to provide a useful venue for examining the value of integrative practices and practitioners. After all, many if not most integrative practitioners operate out of a core assumption that their treatment, compared head-to-head with conventional care and measured over an appropriate time frame would prove more effective and cost effective. Effectiveness is the key word. And here is the government, dropping over a billion, finally, for research in this direction.

The timing appeared to be more auspicious given the awakening interest at the National Center for Complementary and Alternative Medicine in “real world effectiveness.”  (See New “Effectiveness” Direction for NCCAM: An Interview with Director Josephine Briggs, MD November 26, 2008.) More auspicious yet, integrative medicine’s best friend on the Hill, Senator Tom Harkin (D-IO) was a key sponsor of CER. Were ducks lining up for integrative practice?

In this promising context, Integrator contributor, journalist Daphne White, CHTP attended the government’s first “listening session” on the subject. She filed two reports. This initial piece is a shout out to the integrative practice community. Discovering that nobody from the CAM and integrative practice community appeared to present to testify, White took off her journalist hat and put on her advocate hat and offered testimony, some of which is paraphrased here. White’s second article is an exceptionally well-reported analysis of what White calls a “Kabuki play” she witnessed there. I urge you to take a look at both.

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CAM AND COMPARATIVE
EFFECTIVENESS RESEARCH:


Are we Going to Play?


By Daphne White, CHTP




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Daphne White, CHTP

When I walked into the HHS “Listening Session” on
Comparative Effectiveness Research on April 14, the
first thing I saw was a written statement from the American Academy of
Orthopaedic (stet) Surgeons and, for good measure, another from the American
Association of Hip and Knee Surgeons.  I
picked up a list of the presenting panelists, and found speakers from PhRMA,
Johnson & Johnson, the Personalized Medicine Coalition, the Medical Device
Manufacturers Association, the National Pharmaceutical Council, and a variety
of patient groups (at least some of whom are heavily subsidized by the
pharmaceutical and/or device industries.)




Where was the CAM and integrative practice community?  Missing in action, as far as I could tell:  if anyone was representing the
acupuncturists, chiropractors, homeopaths or other CAM providers, they
certainly weren’t leaving a paper trail. 
Although I serve on the Advisory Board of Healing Touch International,
I had not come with the intention of making a presentation.  I did not have an official (or even unofficial)
statement. 

But since I was present and
my CAM and integrative practice community did not seem to be accounted for, I took a risk and put my
name on the list of possible last-minute presenters. Naturally, my name was selected and I had one
hour to come up with a three-minute statement. 
It seemed important, somehow, that CAM was represented at this
“listening session.” As John Weeks said in a recent post, we need to
start playing in all the playgrounds,
just like the hip and knee surgeons. 

   
Peter Orszag, the director of Obama’s

Office
of Management and Budget

sees CER
as an opening to reforming

American health care and a means of
cutting
unnecessary fat
out of the system.

 
The emerging policy debate around CER


Comparative effectiveness research (CER) is becoming a
huge issue. Senator John Kyl (R-AZ) actually
voted against the nomination of Kathleen Sebelius as HHS secretary because of
her position on this very issue
.  At the other end of the spectrum, it turns
out that CER is a “pet cause” of Peter Orszag, the director of Obama’s Office
of Management and Budget. Orszag sees CER
as “an opening to reforming American health care,” and a means of cutting
unnecessary fat out of the system. 
“They’re going to go after the provider community in a big way,”
predicted James Capretta, who worked at OMB during President George W. Bush’s
first term.



In fact, there is increasing talk among policymakers
about placing more emphasis on wellness, prevention and primary care.  Isn’t that one of the areas where CAM and
integrative modalities excel? Shouldn’t
we be part of that comparative conversation? 

In their 2005 report called Complementary and Alternative Medicine in the United States, the Institute of Medicine noted that “the extent to which CAM use is a trigger
for positive behavioral change is unknown […] and constitutes an important
research issue because of the benefit of positive behavioral change to the
public’s health.” Can we really expect
the hip and knee surgeons to advocate for this kind of research? 




We talk amongst ourselves about “wellness” and
“prevention” and “a heath care system, not a sick care system.”  Isn’t it time we took this private
conversation public? 

   
 

We talk amongst ourselves about
“wellness” and
“prevention” and

“a heath care system, not a sick
care system.”  Isn’t it time we took
this private
conversation public?

 

The fact is we are
already players:  30 to 62 percent of
adults in the U.S. already use CAM, according to the IOM report. And total out-of-pocket expenditures for CAM
therapies and integrative practices were “conservatively estimated to be $27 billion in 1997,” according
to the IOM.  “This is comparable to the
projected out-of-pocket expenditures for all U.S. physician services.”




We’re talking about big money here, and we are being
naïve if we think that we can escape the CER juggernaut.  Sure, there are problems with the way
controlled randomized trials are conducted, and that type of research is not
the best way to test CAM modalities and integrative practices anyway. But what kinds of research would work best for our various
modalities?  And what research studies would best assist patients
and other health care providers in deciding which CAM modality works best for, say, migraine headaches or chronic
fatigue?



If we are going to get answers to those questions, we
need to become an active part of the research conversation.  There is $1.1 billion on the table right now
for CER, and HHS is looking for input on how to best spend that money.  Sen. Tom Harkin (D-IO) wrote that CER language
into the stimulus package, and he is a big supporter of integrative health
care.  We and our various associations
can also be working with his office – as well as Sen. Mikulski’s (D-MD) — to
find ways of making sure that CAM modalities and integrative practices receive their fair share of this
research funding.  While we’re at it, we
can advocate for this research to be conducted in a way that is ethical,
credible and appropriate to the modality and practice.

White’s own, impromptu testimony to the CER panel




Here are some of the key points I made at the listening
session.  It’s just an example and a
jumping-off point to spur your own thinking:

I am here to ask that you include CAM in the comparative
effectiveness research program. CAM modalities are low-cost, low-tech and
high-touch.  In addition, they are often
highly effective.
About 38 – 60 percent of Americans already use CAM, but
we need more research to find out what modalities are most effective for which conditions.




CAM modalities and integrative practices generally focus on wellness and
prevention.  Preventing disease is more
than screening for disease:  it’s about
maintaining a healthy lifestyle and not getting sick in the first place.  By the time you can see something on a test
or a screen, the disease has already started. CAM practitioners look at the
whole person, and lifestyle issues that might contribute to their chronic
condition.  CAM and integrative practitioners work in
partnership with their clients to root out the underlying causes of disease,
not just to ameliorate the symptoms. 

This is a different model than the medical model, and should be included
in CER research.

   
In view of the IOM findings – high
upside and almost no
downside –
including CAM therapies and integrative
practices in this research agenda
should be a slam
dunk.

– White, to the CER panel

 

The Institute of Medicine, quoting the Cochrane reviews,
notes that “there is strong evidence for the effectiveness of some CAM
therapies, [but] much more research is required.”




The Cochrane review also found that when it came to CAM and
conventional therapies, the percentage of studies showing a positive effect was
“approximately equal:”  41 percent for
conventional medicine vs. 38 percent for CAM. 
On the other hand, CAM therapies were substantially less likely to be
classified as harmful:  less than 1
percent of CAM therapies had a negative effect, compared to 8.1 percent of conventional
medical techniques. 




“The fact that only one of the treatments in the Cochrane
reviews fell into the harmful effect category suggests that clinical trials of
CAM therapies have posed little risk to the participants,” the IOM report
concluded.




In view of these findings – high upside and almost no
downside – including CAM therapies and integrative practices in this research agenda should be a slam
dunk.


   
 
 I welcome the white elephant
into the room. I’d be happy
to see cost comparisons between
CAM modalities and conventional

medicine for specific diseases
and conditions.


Having said that, CAM therapies and integrative practices should be evaluated on
the same playing field as other therapies, including pharmaceuticals.  At present, FDA requires that new drug tests
just show a slight benefit – I’ve heard it can be as little as 3 – 5 percent –
over a placebo to be considered “effective.” 
The bar should be set at the same level for CAM modalities.




In addition, the fact that we don’t yet understand how
many of these modalities work should not be a factor in evaluating their
effectiveness.  A physician friend told
me that we don’t really know how aspirin works, but that doesn’t stop doctors
from prescribing it. 




Finally, I welcome the white elephant into the room, and
I’d be happy to see cost comparisons between CAM modalities and conventional
medicine for specific diseases and conditions.

I urge all Integrator readers to submit their own statements
to the
Federal Coordinating Council on Comparative Effectiveness Research at

CoordinatingCouncil@hhs.gov.  (A link for
submissions will be up “early this week” at www. hhs.gov/recovery.)  The
deadline for written submissions is May 30, 2009.  You might also consider speaking at one of
the upcoming listening sessions:  the
tentative dates are May 13 and June 10.  Locations
have not yet been announced, but the May 13 session is “likely to be” in
Chicago and the June session will probably be in the Washington, DC area,
according to an HHS official.

Note: The link to a variety of CER articles on the US Health and Human Services Recovery site is here.

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Comment: This direction for the integrative practice community is clearly aspirational at this point. Given the general shortness of resources, the most that can be expected is to use relationships with a friendly Senator to help make something happen. White’s second piece is quite sobering: CER, a means to the end of reform of many of our sacred but wasteful practices, is clearly emerging as a nasty battlefield.

Send your comments to
johnweeks@theintegratorblog.com

for inclusion in a future Your Comments Forum.
John Weeks Written by John Weeks

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