The “Elusiveness” of Synergy
Defining the real meaning of synergistic products.
By Anthony L. Almada
Recently, Charles Latan, CEO of Panacea Nutritional Technologies (PNT), was overheard describing his newest product on a trade show floor—“‘Aaaahsteo’ combines a scientifically-guided selection of glucosamine sulfate, organic whole plant concentrates and potentiated herbal extracts, producing a synergistic blend supporting joint metabolism and health. No other product is like it on the market.”
I have two questions/comments:
1. How do YOU, Mr. CEO of PPT, define “synergistic”?
2. Show me the data.
The third question is rhetorical: “Would other products on the market seek to emulate or duplicate Aaaahsteo?” Maybe that’s why it has no “equal.”
Synergy is such an affective word within the dietary supplement world. As it creeps into the “food supplement” ether (food-shaped products that are labeled as dietary supplements, e.g. “functional beverages” and “kryptonite candy bars”), its importance and significance will likely descend even further, approaching the hollow meaning of “pharmaceutical grade,” “pure” or even “quality.” Atop the tongues of pharma folk, synergy is common water cooler chatter, well characterized with antibiotics (combined therapies) and elegantly exemplified with the triple dose cocktail of HAART: High Dose AIDS Anti-Retroviral Therapy. The sum (result) of the combined whole is greater than the individual effect(s) alone; added together, 1+1 > 2. Recent clinical studies with tamoxifen and borage oil in breast cancer patients hint of synergy. A recent patent (and associated data) showing creatine + carbohydrate synergistically boosts muscle glycogen (read endurance athlete market potential) demonstrates convincing synergy.
How many products claim to have been confirmed by the “spirit of synergy,” as if one could license this moniker from an intellectual property holder? Too many. How many finished products have been shown to display synergistic effects in even test tube settings, let alone in humans? Too few. The hub and spoke technique, otherwise known as S&D (Search and Development) is very often the origin of searches for synergy: Identify a market or category-leading ingredient (here it’s glucosamine sulfate), add in other ingredients that are purported, believed or even shown to exert similar physiological effects (here let’s say it is one plant extract X and one carotenoid Z), wave the magic wand and presto! we have synergy. Do we have true synergy or do we have evanescent differentiation (kind of like the buzz accompanying a press release), only to be scooped by the next product, which now adds in vitamin E and some Tuscan grape seed extract—”synergy” superseded by “super synergy.”
A Closer Look At Glucosamine
These formulations, if matured and effectively leveraged, are ripe not only for claims of superiority but also for intellectual property filings. Choose a patent, any patent, and improve upon it. Returning to our example of glucosamine, let’s use the benchmark “glucosamine plus” patents (and turn our attention away from the litigation surrounding these patents, the recent bankruptcy filing of its assignee and the contentious issue of prior art): No. 5,364,845, “Glucosamine, chondroitin and manganese composition for the protection and repair of connective tissue” and its continuation, 5,587,363, “Aminosugar and glycosaminoglycan composition for the treatment and repair of connective tissue.”
These patents teach the use of chondroitin and its salts in combination with glucosamine and its salts. One simple study, which would examine the impact of cC+G vs. C+G+X in a cell culture system, in an animal tissue prep, in intact animals and/or in humans, could give birth to a new IP filing and a differentiation dialogue that could be broadcast nationwide if first communicated within scientific circles. All one would need to demonstrate is that the addition of X confers a “synergistic” impact upon the marker(s) of efficacy, one that is superior to C+G alone combined with the effects of X alone. If X was not a subject of prior art (having been described in any recorded form as being capable of having a biological activity related to the current example) the demonstration of classical synergy may not be required. Serendipity would deal us a quartet of aces and the sheer novelty of such a finding is likely patentable.
The Importance Of Efficacy And Backing It Up With Data
The pivotal item here that cannot be overstated enough is data: proving the concept outlined in your synergistic formulation is critical not only to international/PCT (Patent Cooperation Treaty) filings but also to the capital (financial and intellectual) return on investment. Patents conceived in the mind and not reduced to practice (not proven “potent” and promotion-worthy) are sitting targets for invalidation and for vilification by the media and regulators. Implicit to this is the competitive tactic of systematic examination of a patent’s validity. If PNT has a U.S. patent on the formulation comprising Aaaahsteo but has failed (or neglected) to show efficacy or synergy, a simple finding of NO synergy, or even no efficacy, would be a death blow, rendering the patent invalid without using the courts and attorneys. This tactic is also a valuable tool in the collection of competitive intelligence in relation to guiding internal R&D.
Now who should pay for the R&D: finished product manufacturers/marketers or those further upstream on the supply chain, the ingredient manufacturers? That hot potato we will address sometime soon in this column.