(This column was first published by John Weeks on TheIntegratorBlog.com.)
John Weeks’ Introduction:
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.
CAM AND COMPARATIVE EFFECTIVENESS RESEARCH: Are we Going to Play?
By 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 Orthopedic 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.
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 among 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.
"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.
"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. The deadline for written submissions is May 30, 2009. People spoke at the listening session in Chicago on May 13, and there will be another session -– and another opportunity, in Washington, DC on June 10.
Note: The link to a variety of CER articles on the US Health and Human Services Recovery site is here.