Flags of Convenience or Banners of Obfuscation?

Are consumers being told the whole story and are marketers being made aware of all the facts?

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

The battle cry to science-driven bioactives and finished goods continues to ring the doorbell of nutrition industry members and advocates, but few answer. The phrases “clinically proven,” “clinically tested,” “research backed” and numerous derivatives thereof have become bastardized phrases that, not unlike structure/function claims that adorn the majority of dietary supplements and some foods and beverages, are hollow and often obfuscatory. The selection of research that does exist for specific bioactives and finished goods, used to substantiate and create demand, typically results in the raising of a flag of convenience, a suite of research that is positive, while excluding research that is non-positive or even negative. And for those companies that do make an investment in research substantiation in humans, the practice of insulating the results from public disclosure, if they go awry, is only expanding. How can a science strategy create intellectual assets, exclude the competition and produce sustainable revenue streams?

Pick a bioactive ingredient and ask yourself: have I been made aware of all the human research evidence behind this? Take conjugated linoleic acid (CLA), for example, which is marketed by numerous companies. No original research publication describing a randomized, controlled clinical trial has ever shown it to be effective (in modifying body composition in a group assigned to receive CLA) in North Americans but SEVERAL clinical trials have shown it to be no better than placebo in this premier market population, including a one-year study. A one-year study with a specific CLA (conducted in Denmark) showed it to have NO impact upon body weight or body fat regain. Virtually all of the positive research hails from studies conducted among Norwegians. Who informed you of these research findings/non-findings? What studies on CLA have been done that were not reported? The flag of convenience that waves in the sky can read differently than the totality of the research evidence.

Pick a finished good and ask yourself: have I been made aware of all the human research evidence behind this? Take ANY nationally distributed phytosterol/phytostanol dietary supplement in a capsule, tablet or soft gel formulation. No original research publication describing a randomized, controlled clinical trial has ever shown it to be effective (in favorably altering blood lipids) in any country, but at least one clinical trial has shown that a softgel formulation is no better than placebo. ALL of the favorable evidence rests with food and, to a far lesser extent, beverage formulations, which typically (but not exclusively) are comprised of a lipid matrix. Putting sterols or stanols (which typically are crystalline in nature and very insoluble) into a softgel doesn’t appear to qualify. How did this arise? The evidence base from food matrices was magically transferred to solid dose forms and voilà! solid dose forms (SDFs) now are safe and effective! Could it be that SDFs of phytosterols/phytostanols are ineffective, albeit apparently safe? This reversal of data exploitation and transferal is emblematic of the double standard that brands many stakeholders in the nutrition industry—usually dietary supplement/SDF bioactives are integrated into foods and beverages AFTER the SDFs have been marketed and, often, Generally Recognized As Safe (GRAS) status has been self-affirmed or granted, with the resulting food or beverage format not being subjected to clinical validation of safety and efficacy.

What can be done by the visionary and science-driven company that would engender instant distinction and create a message architecture that is newsworthy (outside of endemic press releases and tradeshow presentations)? Step 1: Register all of the clinical trials that are being sponsored by a corporate entity in a publicly accessible, nonprofit registry like www.clinicaltrials.gov, with a specific number being assigned to the clinical trial. This tells all that you are unafraid to put your bet on the table, in public view, and that the results will be made public, independent of their outcome. If elegantly communicated this can make the competition look BAD. If you don’t report the results then all can infer that the outcome was unfavorable.

Step 2: To mitigate the risk accompanying investment in a clinical trial, perform a thorough due diligence/SWOT analysis, both internally and externally, of the bioactive or finished good, and the clinical trial design and population, being considered. Are the chances of a positive, robust outcome high? Will the placebo or “inclusion” effect obscure the real efficacy of the product? Is compliance critical AND are the means of sustaining compliance sufficient? What can be done (ethically) to increase the odds of a positive result?

Step 3: IF the results are indeed positive, present them FIRST at a national or international scientific/biomedical conference, not a tradeshow or via press release, AND have a manuscript submitted for publication in the highest tier journal possible, not the easiest journal possible.

Step 4: Develop an intellectual property (IP) offense and defense strategy with an IP professional to prevent data piracy and competitive distractions. Real science on a bioactive or finished good that is more than a pure, single, highly characterized chemical entity (e.g. ascorbic acid, glucosamine HCl) is a form of IP that has several advantages over a patent—it never expires, cannot be invalidated like a patent or its claims, and is instantlyready to be leveraged to exclude competitors in federal court.NW