New Paradigm of Evidence-Based Nutrition

Continued from Yesterday

Prevention Vs. Treatment

Perhaps one of the most important, but often ignored, differences between the research paradigms for drugs and nutrients is the cost and logistical complexities associated with conducting RCTs. Not taking into account the preclinical research needed for drug development (which is substantially resource intensive, due in part to the number of candidate drugs that do not make it to the market), human trials involving nutrients are far more costly than those for drugs.

* Presentation at CRN’s Day of Science, May 8, 2008. “NCCAM research initiatives focused on prevention” by Josh Berman, MD, PhD, National Center for Complementary and Alternative Medicine, NIH.

Drugs are most often studied in a therapeutic context (ie, to treat, cure, or mitigate a disease or condition), while nutrients are studied with a focus on health promotion or disease risk reduction.

These are fundamentally different approaches that have tremendous implications on cost and feasibility. In the context of a RCT, studying treatment of a disease or condition (when all subjects have the disease at baseline) is far less costly than studying the prevention or risk reduction of the disease (when no subjects have the disease or condition at baseline). The subtle effect of nutrients and small effect sizes mean far more subjects are needed to demonstrate statistical significance. It is estimated that the net cost in terms of subjects, duration, and total dollars for chronic disease risk reduction trials exceeds that for therapeutic trials by more than 10-fold (Table 2).*

Furthermore, chronic diseases can take decades to develop, so demonstrating a statistically significant and clinically relevant reduction in risk with any intervention requires very long-term trials. It is also important to note that unlike the pharmaceutical industry that funds, designs, and controls its own research, the food and dietary supplement industries must rely almost exclusively on government and/or academically funded studies. This is due largely to the inability or lack of means (legally or financially) for food and dietary supplement firms to develop, maintain, and defend intellectual property. As a result, these firms have little or no exclusivity on the use of research to support marketing efforts. Thus, the profit margins and, ultimately, research and development budgets of food and dietary supplement firms tend to be much smaller than their pharmaceutical counterparts.

Continued Tomorrow

http://www.naturalmedicinejournal.com/article_content.asp?article=117

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