NCCAM Stakeholders Call For Community-Based Research

The National Center for Complementary and Alternative Medicine should focus additional attention on using community resources to fund research, according to a number of stakeholders.

Dr. Murray Goldstein, National Institutes of Health, was one of many speakers who supports the idea at NCCAM's Stakeholder Dialogue held June 20 in Bethesda, Md. Stakeholders discussed ideas to improve complementary and alternative medicine research, including increased funding and focusing on healthy populations.

"We have classically used the academic institution and the departments in academic institutions as the base for research," Goldstein said. "That's where the science was and that's where people got paid to do science."

"But the kind of interventions that we cover in NCCAM are really community based rather than university or major-hospital based," he said.

Acting NCCAM Director Dr. Ruth Kirschstein said the center considered using community resources and plans to do so in the future.

Kirschstein stepped into the role when Dr. Stephen Straus died of brain cancer in May (¹ 'The Tan Sheet' May 21, 2007, In Brief).

American Herbal Products Association Vice President for Scientific and Technical Affairs Steven Dentali suggested one place to start with community-based research is studying how botanicals mitigate the side effects of chemotherapy and HIV treatment.

"It's one where you don't have to start looking at a mechanism, you can go right into a clinical evaluation, immune markers," Dentali said. "The anecdotal evidence I have heard and the basic science that I've looked at in this field and it seems pretty compelling that this could be an area that would provide a lot more useful information than say looking at herb/drug interactions."

Funding in general is NCCAM's greatest challenge, according to cardiologist John Longhurst, a University of California, Irvine professor. To solve the problem he said, "Go out and partner with some of the other institutes much more than you have even already."

Susan Folkman, director of the Osher Center for Integrative Medicine, University of California, San Francisco said, "We are all facing the loss of faculty as people cannot get funded. So the question, the challenge, is how to best use the resources that are available to support faculty, to support the researchers."

One advantage of CAM research, according to naturopath Carlo Calabrese, NCCAM council member is, "The investments in CAM practitioners and in CAM schools will stay in CAM research and it will never drift over into pharmaceutical research."

One way to do more research is to "broaden research training opportunities to institutions other than terminal degree-granting institutions," Martha Menard, director of research, Potomac Massage Training Institute said. "For example, many massage therapy programs would love to be conducting CAM research but we are not eligible for training grants."

As far as how funds should be distributed, Folkman said more of NCCAM's budget should be devoted to R01 grants, which the center says are intended to "support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his specific interest and competencies."

Folkman said R01 grants provide "more support," and are "magnets that can attract other researchers."

However, preliminary data should not be required, Folkman said. "If there are other criteria that are met, for example, plausible hypothesis, some evidence of feasibility, I think we should take the risk and go with the R01," she said. "It's very hard to collect preliminary data for clinical research in 2 years. And there's usually not enough budget to have it powered and effective."

Longhurst also said he would like to see NCCAM fund more R01s rather than the smaller grants because R01s "have a real value."

Kirschstein said, "We welcome what we call the gold-standard at NIH, R01 grant applications."

However, what grant applications are approved is another issue NCCAM should address Calabrese said. Grant reviewers provide one way to change the way in which grants are approved.

"The great majority of reviewers are trained in molecularly identified interventions and probably the great majority of CAM interventions are not," he said. "So preparation of the reviewers I think is essential. One thing that I think would be important for every reviewer to read is the strategic plan of NCCAM and see the kinds of things they're focusing on."

Calabrese also suggested more CAM practitioners join the council. "It will shift the direction of the kinds of studies that are being done," he said.

Many stakeholders stated NCCAM should fund research other than clinical trials.

"These interventions are not drugs," Menard said. "They're not pharmaceuticals and research needs to take that into account."

Longhurst said NCCAM should "focus on some mechanistic studies" because the greatest concern of his non-CAM-practitioner colleagues is they do not understand how CAM therapies work.

Another suggestion is to perform cluster studies. "If we did cluster studies we could study the same phenomenon from a variety of different methodologies, which might be helpful," Carla Mariano, a professor of nursing at New York University said.

NCCAM Deputy Director Margaret Chesney said the center is "still very interested in clinical trials" but will look at other designs including cohort studies.

However, once the research has been conducted, CAM therapies are not being integrated into mainstream medicine, according to Adam Perlman, executive director of the Institute for Complementary and Alternative Medicine within the University of Medicine and Dentistry of New Jersey.

"I think one thing I've seen as a researcher but also an integrative clinician physician, is that there's still a great disconnect even when there's strong evidence that has been supported by NCCAM's research," he said.

"I think there may be multiple reasons for that," he added. "Certainly biases that pre-exist are hard to break, but I think one of the reasons and the reason I hear most from physicians as a resistance to referring for many of the therapies ... is a lack of insurance coverage."

Perlman said while it is not NCCAM's job to provide insurance, the center can influence insurers by emphasizing cost-effective studies.

While evidence is important, CAM practitioners should not blame themselves if they do not have enough evidence to support their therapies, according to Menard.

"I would like to mention in medicine almost 60 to 80 percent of practices are non-researched," she said. The medical community is "asking us for another standard and I think this is where NCCAM can be extremely helpful - talk about risk-taking - well, this is our phenomenon. Let's add something to the scientific world by demonstrating we have a different way both of practicing and of researching."

It is important to look at results, according to president and founder of patient advocate group the Annie Appleseed Project, Ann Fonfa.

"We don't have a pharmaceutical that's like a sledgehammer that gets immediate results, and maybe we really need to help focus away from the pharmaceutical model looking for an instant very large reaction and toxicity," she said. "That's been the mode and it just doesn't work for the kinds of things we'd like to see happen."

Stakeholders also said NCCAM should spend more time looking at healthy people. "We need to be looking at how to preserve health and prevent disease," Dr. Stephen Shannon, American Association of Colleges of Osteopathic Medicine said.

"It is the National Institutes of Health, not the National Institutes of Disease, and so I'd be advocating you be focusing on, or try to broaden, the question to look at prevention and how the CAM therapies can further that goal," he added. "And also potentially look at it in a broader sense from a public health, but community-based sense."

Kirschstein responded, "I think all of NIH agrees with you on that and there are considerable programs being enhanced also at NCCAM looking at prevention."

Gail Geller, Johns Hopkins School of Medicine said, "We spend a lot of time focusing on diseased groups, people who are affected with various diseases and don't spend enough time learning what we can from people who have perhaps genetic susceptibility to diseases who don't actually become sick."

Kirchstein said NCCAM is starting an initiative related to genomics examining how some of the CAM modalities affect genes.

The center is also planning a workshop on preparing grant applications, Kirchstein said.

- Rebekah Moan ([email protected])