The Council for Responsible Nutrition’s vice president of scientific and regulatory affairs, Duffy MacKay, ND, welcomed the NCCAM document that he said showed a responsible and mature approach to CAM science that would lead to better designed trials and a more coherent scientific output for a host of nutrients.
“There is a real understanding here of the research continuum, of mechanistic research, so that there should be less commitment to clinical research where there may be concerns about validity,” he said. “There is an encouraging emphasis here on performing studies in real world scenarios.”
Dr Cara Welch, the Natural Products Association’s scientific and regulatory affairs manager, was encouraged by NCCAM’s pragmatic willingness to continue working closely with industry – both in designing and conducting trials, and in disseminating scientific data to the public, where the influence of such data is palpable in rising or falling sales of various CAMs such as omega-3s (rising) and St John’s wort (falling).
“Like NCCAM, industry is ready to take on this responsibility,” she said. “This document is only going to help an industry that is fundamentally working toward the same goal.”
Basic principles
The American Herbal Products Association highlighted one of the plan’s goals to better integrate CAMs into conventional medicinal practices.
“They have taken aim to do this in their third strategic plan by embarking on a course of action that begins with funding research on how natural products, including botanicals, work and how to study mind body interventions,” said the group’s chief science officer, Steven Dentali, PhD.
“This return to basic principles is always the best way to gain knowledge to inform future studies including clinical trials.”
He noted many of the plans study proposals had already been announced. They can be found here.
The five-year plan itself can be found here .
Cooler heads
American Botanical Council founder and executive director Mark Blumenthal said the plan signified a significant policy shift in NCCAM’s research priorities.
There had in the past been, he said, “considerable emphasis on NCCAM-funded randomized controlled clinical trials (RCTs) on herbal dietary supplements which have resulted in negative outcomes – such trials being the basis for some calls for dismissal of the herbs and other dietary supplements from self care and/or consideration in conventional healthcare.”
“Some critics have pointed to the negative outcomes citing them as the basis for their proposed defunding and closure of NCCAM itself. Fortunately, cooler heads have prevailed. The new 5-year plan shows that NCCAM has modified its earlier research priorities and, at least insofar as herbs and dietary supplements are concerned, will focus more on research strategies related to determining mechanisms of action.”
NCCAM, probiotics, EFSA, beyond
A consortium of probiotics groups and companies said reference to biomarkers and probiotics in particular as having healthful potential in diarrhea and other areas could influence activity in other regions.
“The results of the research that NCCAM will work on together with the NIH Human Microbiome Project, the FDA and USDA, can be of great value,” said Svend Laulund, manager of External Affairs at Chr Hansen and regulatory committee member at the International Probiotics Association, the European Food and Feed Cultures Association (EFFCA) and the Yoghurt and Live Fermented Milk Association.
He said the work to come could influence , “research and regulatory policy” in institutions such as the European Union, which has to date taken an unsympathetic view of probiotic science via its head scientific agency, the European Food Safety Authority (EFSA).
Laulund said the NCCAM guidance may go some way to easing a conundrum surrounding research with established clinical endpoints, and whether or not such research requires an Investigational New Drug Applications, thereby classifying the substance under scrutiny as a drug.