Summary: Questions about the direction of the NIH research agenda on complementary and alternative medicine have stimulated numerous subsets of researchers to promote a significant shift from reductive to whole systems models. A similar direction and dialogue was recently stimulated inside the nutritional products industry. David Barnes, PhD, director of research and development for Standard Process, a nutritional products firm, laid out a strategy for an industry-academic partnership which would focus on both academic and policy tactics to gain release from the “dogma” of current thinking. The Integrator interviewed Barnes on his view of what we need to “overcome the industry-academia disconnect,” shift some of our research priorities and take on the policy challenges.
The scenario is only too familiar. An National Institutes of Health-funded, single agent, placebo-controlled, randomized trial of a nutritional or botanical agent comes up negative. A practitioner, whether integrative or holistic or naturopathic or Asian medicine or otherwise inclined – and whether physician, nurse, chiropractor, Oriental medicine specialist or nutrition counselor – shrugs his or her shoulders:
Interesting, but that’s not the way I use it in my practice. I never just prescribe that (herb or vitamin) by itself like that. I am always doing other things, and counseling, with it. I’m not changing my practice because of that research. It doesn’t look at what I do.
The movement to advance research methodologies which actually fit with the multi-factorial nature of integrative practice is a core editorial interest here. The Integrator has previously covered the political-economic issues in this emerging dialogue, an effort to develop a database of instruments which are most applicable, as well as outcomes of whole practice interventions in real world settings. This is the Integrator editorial line because the voice of common sense says:
Golly gee, if a chronic condition has multiple etiologies, maybe a good therapeutic approach should work with the whole of the patient in multiple ways.
Last week in a conversation with long-time nutrition research David Barnes, PhD, on another matter, I stumbled upon an emerging effort in the nutritional products industry to also promote more applicable research strategies. Of particular interest was Barnes call for a strategy which leads to opportunities for policy change and legislative action.
Barnes, director of research and development for Standard Process, an Integrator sponsor, worked for a decade in conventional academic research in nutrition eventually leaving the University of Wisconsin/Madison to take his current position with Standard Process. After a couple of years learning the lay of the land in his new universe of nutritional products and natural healthcare approaches, Barnes was invited to develop a session at the nutrition industry gathering Nutracon. He entitled the session: “Designing Studies that Are Measurable and Useful.” Behind the bland words are an agenda and a collaborative and political strategy which are nothing short of revolutionary. Barnes thinking is closely aligned with that in the broader whole systems movement. I spoke with Barnes about his vision, his presentation at Nutracon, and the reception his ideas have received.
Integrator: So why did you choose to take on the panel at Nutracon last March?
Barnes: My interests were two-fold. I wanted to advance the dialog on the challenges of experimental design that I and the industry face every day. I also wanted to help find an appropriate bridge between industry and academia to achieve common goals.
Integrator: Let’s take the design issues first.
Barnes: We in the nutritional products industry need to recognize that the best
approach to nutrition research cannot be singular in nature. We need to be looking at a range of things – pharmacology, clinical trials, mechanistic studies and outcomes-based trials. This is our strategy at Standard Process where we’ve got projects that include farming research – since we grow most of our own raw materials – and range to basic research, constituent analysis, cell-culture studies, examination of different manufacturing processes, clinical trials and animal studies. So one point is that the industry needs to be undertaking a range of studies. But the more important concern I tried to bring forward is that we have an unresolved disconnect in nutritional science research.
Integrator: What’s the disconnect?
Barnes: The dominant research culture is based on a reductive approach. Such nutritional research thinking typically fails to take into account the complexity of the whole system – human physiology, behaviors and other factors. Multiple pathways are affected by nutritional products and practices. Genetics and individuality are also hugely important. Practitioners who use nutritional products not only appreciate this but organize their clinical strategies with these differences in mind. They don’t just use a single product. Yet here we see RCTs (randomized controlled trials) which deliberately remove nutritional products from the context in which our clients deliver them dominating the research agenda. The randomized controlled trial, while an important tool, does not take into account the lifestyle and other complementary interventions being used.
Integrator: A familiar plight. But what’s the way to the promised land?
“If a researcher is stimulated
something new, to step
outside that tradition, they find
hard to advance.
It’s hard to go against dogma.
Barnes: The industry must take the lead, but in partnership with academia. Academia is at the center of the current agenda with industry perceived as a distant participant. This hierarchy dictates the focus, or what I would more strongly put as the dogma of nutrition research. These academic researchers know what they’ve learned in their own communities, which typically hold the RCT up as the highest and best of approaches. But if a researcher is stimulated to do something new, to step outside that tradition, they find their ideas hard to advance. It’s hard to go against dogma. This is where industry can make an impact.
Integrator: What’s your idea?
Barnes: There are multiple facets. I see industry-academic partnerships as the key to shifting the tides. Funding is of course key to gathering academic interest. Funding constraints are pushing academic scientists further afield and institutions are recognizing the value of industry partnerships. We should definitely take advantage of the government programs available, such as SBIR (Small Business Innovation Research) and STTR (Small Business Technology Transfer) grants that encourage risk and innovation. Industry also needs to directly take the lead in funding a research agenda which will take on the existing dogma. We need to engage our academic partners in challenging that dogma. The combination can promote change in the government agencies.
Integrator: Interesting. So there is a policy and governmental affairs agenda as part of this?
Barnes: Yes. The long-term
solution we need may reside in political and legislative or policy
forums, not just with academia. We need significant industry and
academic commitment in order to have an influence on governmental
often felt – and advocated here – that common sense is more likely to
be found in members of Congress than in the decision-makers in academia
and the research establishment who have been suckled, raised and fed by
the old reductive dogma. How do you see change this happening?
“The long-term solution we need
in political and legislative
or policy forums, not just with
Barnes: Education is key. We need to educate a wide spectrum of healthcare professionals to help drive policy. The education is not just about our products or how they work, although this is an important first step. We must educate on how to participate in policy development and why it is important. We need to help researchers to challenge paradigms as this will provide the foundation for informed change. We need to be forming consortia and multi-disciplinary action groups to advance a collective agenda.
Integrator: Hmm. You won’t have known this but the emerging Research Task Force of the Academic Consortium for Complementary and Alternative Health Care – which I staff under another hat – is right on this topic. We should talk! Meantime, what kind of response did your presentation receive? What if anything has happened since to advance your thinking?
Barnes: The panel was well-received but executing change doesn’t happen quickly. Understanding how industry can capture and exploit research information remains a major hurdle to greater participation. I continue to advocate for change and support a number of academic research projects and hope these efforts may provide future templates for others. I continue to explore how to capture quality data from the many practitioners using a whole systems approach to health care. Documenting these cases, successful or not, will go a long way in developing a credibility and informing us how to best assemble a research protocol.
Integrator: Thanks for your leadership in this. It’s a hopeful sign for all of us.
Comment: Barnes’ thinking is not only forward thinking, but timely. The nutritional products industry, repeatedly hammered in the media lately, could use some wins. Barnes whole systems approach to researching the clinical outcomes of these products could be a brilliant course of action. The industry-academic strategy he advocates might also be very productive. The outcomes of the single agent RCTs have given some industry players cold feet on supporting such trials. Might interest increase if whole systems, effectiveness-oriented methodologies are clearly articulated?
All we need is to knit them
Barnes call to industry comes at a time when an academic research community is beginning to gather the tools to embrace this agenda. A similar motivation may be found here. A first generation of largely negative NCCAM outcomes on single-agent RCTs lends interest to those who complain that the research establishment’s favored methodology in this first round of NCCAM projects was like forcing a fish to walk.
Finally, the big dog is barking. As whole systems-oriented researcher Lynne Shinto, ND, MPH, recently shared on these pages, NIH funding is shrinking and the NIH is pushing all researchers to develop other funding sources.
With a powerfully focused telescope, one can envision stars lining up in the universe which could positively impact the future of health care. All we need is to knit these together into a useful new constellation of interests.
for inclusion in a future Your Comments Forum.