Collaborative Conundrum

A possible answer to today’s clinical science

challenge.

By Anthony L. Almada

The tenor of “quality” has a different sound these days. Reminiscent of the crisp and subtle emission of an airhorn 15 cm away from one’s temple, the sound of quality is product-specific data (PSD) in a target human population. Gone are the halcyon days of “typewriter assays” where the letters “HPLC” were a typo for “LLC.” Easily refutable are claims attributable to studies done in subjects irrelevant to the intended user base. One of the better examples is the seminal boron repletion study in postmenopausal women, who demonstrated an increase in blood testosterone and estrogen. This served as evidence supporting the use of boron as a testosterone booster in men (despite two later studies showing it had NO such effect in young males). Quality is now a multi-headed beast, for which cGMP suffices only as a snack.

The emergence of Consumer­Lab.com product profiling has not only exposed the weaknesses of “content quality” but also begun to usher in a new focus: safety and efficacy. The stalwarts of yore: in vitro, pirated animal studies and warehouse or shopping mall intercept studies will be jettisoned to the back pages of a validation dossier, supplanted by a well designed clinical study(ies) on the exact product or ingredient being of­fered on sale.

The conundrum lacing this arguably inevitable outcome is: Whose money pays for the PSD? The bioactive ingredient manufactur­er/supplier or the finished product marketer? Both sides benefit but whose financial capital should be taxed? If we cast our vision backward we find “success” examples on both sides of the divide. For suppliers we have a virtual hit parade: many standardized botanicals, glucosamine sulfate (Rotta) and chondroitin sulfate (Bioibérica), carotenoids (beta-caro­tene, lycopene and lutein), chro­mium ligands, L-carnitine, tocopherols/toco­trienols, vitamin C and fish oils. For finished product marketers the crowd is small: garlic (Kyolic, Lichtwer), creatine (EAS, Twinlab), red yeast rice (Pharmanex, now in regulatory limbo), plant stanol/sterol esters (Mc­Neil/Unilever behind a wave of previous research), black cohosh extract (Remifemin™, Schaper & Brummer), glucosamine sulfate (DONA, a late 2000 entry in the U.S. market), and glucosamine HCl + chondroitin sulfate (Nutramax Laboratories).

What appears to be the salient feature among the manufacturers is intellectual property, in the form of a trade secret/brand architecture union or exclusive geographic li­cense, with the exception of creatine. This is somewhat apparent among the suppliers but often lacks the branding/co-branding elements emblematic of the products with marketer-funded PSD.

Another category would be acquired PSD—acquired through inlicensing or strategic partnering. Ex­amples of this include many of the botanical extracts offered by Nature’s Way and EFAMOL® in the past and some by Enzymatic Therapy (which recently “lost” Remifemin® to GlaxoSmith Kline and “gave” DONA™ glucosamine sulfate back to Rotta).

A final category would be slipstream PSD—development of a business unit around a certain ingredient that already enjoys a moderate to robust body of data. SAMe, creatine, colostrum and numerous botanical extracts (e.g. kava, saw palmetto and grape seed) immediately spring forward. The thwarting thorn here is that, for less than pure and exhaustively characterized chemical entities (read botanicals, proteins and milk-derived biologics), the PSD may not apply. Theoretical case in point: Studies done on grape seed extract X11 do not apply to grape seed extract T33 because T33 is NOT chemically identical, in all aspects, to X11. If T33 were a chemical “clone” of X11, what would be its differentiation platform? One dictum of pharmacology is specificity: different chemistry (even imperceptibly slight) yields different biology. In other words, ineffective (but perhaps innocuous) until proven effective.

Here is where the rogue data pirate rapes and pillages, only to fly her/his own flag over the data. For vitamin C or RRR-alpha-tocopherol the chemistry is crystal and irrefutable: Vitamin C is vitamin C and natural vitamin E is natural vitamin E. In contradistinction, a 0.3% hypericin standardized St. John’s Wort extract with a ConsumerLab.com “pass” grade may be completely ineffective, even if taken exactly as directed.

Rather than wrestle and wait for PSD to be funded by one side or the other, what about collaborative research and development alliances (a modification of CRADA’s)? If marketer X has a promising product, or has obtained an exclusive license on a patented composition or ingredient, couldn’t they partner with supplier Y and collaboratively share the economic risks of a well-designed clinical trial and its revenue stream offspring? When supplier Z optimizes a processing method or acquires exclusive rights to a unique biomass, why couldn’t they find a strategic marketing partner in each channel of sale (direct response, specialty retail, cosmetic, food, beverage, FDM or MLM, etc.) and assemble a multi-company-funded clinical research program? The marketers enjoy exclusivity and the supplier enjoys sales depth and breadth. PSD is likely to be a consumer and perhaps, to a certain extent, regulatory mandate. Conquering the conundrum through strategic and hyperopic collaborations will likely create a sustained boom and add a rectangularized appearance to product life cycles.

NW

Anthony L. Almada is the founder and chief scientific officer of IMAGINutrition and MetaResponse Sciences, two elite nutritional technology companies. He excels in potentiating intellectual property, product development, scientific validation and creating powerful data-driven demand campaigns. Mr. Almada can be reached at 9053 Soquel Drive, Suite 202, Aptos, CA 95003; 831-662-7930; Fax: 831-662-7933; E-mail: [email protected].