Waiting for Dr. Godot

The wait for a “Carl Sagan” for evidence-based nutraceuticals has morphed into a relentless ultramarathon.

ByAnthony Almada, B.Sc., M.Sc.

How long will the consumer and the consortium that comprises the Nutraceuticals industry have to wait to enjoy the fruits of real R & D: buying confidence, true innovation, market exclusivity and evidence-based consumer products?

2004: To achieve a perception of credibility, nutraceutical companies prefer to engage medical doctors to serve as front line spokespersons and “validators” of a product’s or an ingredient’s safety, efficacy and value (over nutritional scientists with real advanced degrees). Almost invariably the medical doctor “poster child” is harvested from the hundreds that have written a book(s) and/or newsletter(s) targeted for the lay public, only to transform their “name brand” into their own signature dietary supplement line. Almost without exception the “proprietary” products they lend their name and likeness to (even their signature) have a complete lack of independent controlled clinical research evidence demonstrating their safety and efficacy, e.g. products endorsed by Drs. Julian Whittaker and Susan Lark.

2010: The FDA has created a “Bionutritionals” division within its Center for Food Safety and Applied Nutrition (CFSAN) empowered to grant market exclusivity to innovator nutraceutical products that meet or exceed the criteria of “Bionutritionals.” Using some of the framework of the EU’s PASSCLAIM (Process for the Assessment of Scientific Support for CLAIMs on Foods) assessment of evidence, medical foods “regulations” under the watch of the U.S. FDA and the FTC case law precedent of two well-designed clinical trials needed to support on- and off-label claims, food, beverage, transmucosal (a new subset of dietary supplements as of 2008) and dietary supplement products satisfying the criterion are allowed to make exclusive claims. The Bionutritionals division has an active and vigilant enforcement program, guided by industry liaisons that assist FDA in identifying violators and generating swift actions. Recruitment of academic/professional spokespersons (MDs, PhDs, and NMDs [doctorate in nutritional medicine; offered to both PhD and MD students as a hybrid basic and medical sciences degree in over 50 different universities in North America and the EU]) is challenging only in the respect of managing the voluminous resumes sent in to marketers of Bionutritionals. Such a role is prized and viewed with admiration by both peers and academic institutions.

2004: Dietary supplements are “formulated” with duplicity under the guise of innovation, seeking out the least expensive, “generic” form of a bioactive ingredient, while using the scientific evidence base enjoyed by the pioneer ingredient, despite the chemoprofiles of the two respective ingredients differing moderately to immensely and the clinical evidence aligning with only the pioneer, e.g. chondroitin sulfate, green tea extract. Some supplements have gone as far as providing a disclaimer that the product they are endorsing (that also lacks an independent clinical research evidence base) is NOT to be confused with another product that has been subjected to Phase II-III clinical trials (and failed to outperform placebo in its largest study), e.g. Dr. Jason Theodosakis (author of the The Arthritis Cure) and his name brand avocado soy unsaponifiables (Avosoy™) product suite. The evidence base of a pioneer ingredient is sometimes attributed to a similar but not identical ingredient, e.g. soluble undenatured collagen II (with a robust but equivocal evidence base—which led to its abandonment from development as an ethical drug) vs. insoluble, undenatured collagen II (with no peer reviewed clinical trials showing safety and efficacy). Both the consumers and the competition lapse into a trance of obfuscation, confusion and spuriousness, driven by a false sense of security residing in the chemoprofile, e.g. ConsumerLabs.com and patent neglect of the biological activity of an ingredient or product in the target population: humans.

2010: The ability to exclude competitors rests primarily upon the clinical evidence base—the bio profile—rather than the chemo profile. Thus, several (approved) Bionutritional products can be offered for the same application, e.g. metabolic syndrome or adolescent obesity composition, but only those that have been reviewed and granted an allowance to be a Bionutritional can make the express claim. This claim is allowed for a period of seven years, beginning the date of official granting. In light of the continued rarity of composition of matter claims for nutraceuticals in issued patents—the most recent being a fusion complex of a naturally-occurring oligonucleotide and mannosamine, with potent efficacy and low dosing requirements for juvenile-onset osteoarthritis (34% of the North American population between the ages of 12-19 display an average body mass index of 32.1)—the Bionutritional market exclusivity provision is a boon to the companies that place science before sales. The exclusive marketing rights were adopted from the Botanical Drug guidelines offered by FDA in the latter part of the 1990’s, being transformed as a result of a unified nutraceutical and pharmaceutical/CPG industrial alliance and concerted lobbying efforts. Not surprisingly, two CEO’s from different small cap and middle volume nutraceutical companies that market Bionutritionals have been featured on the covers of Forbes and Business Week.NW