Proprietary Perspectives: The Emperor Has NEW Clothes

Science for sale and “science” for seals.

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

In the relentless hunt for differentiation, many companies have ac­knowledged the commercial ex­ploitation potential of a claim centered upon their actual ingredient or consumer packaged good (CPG) being tested in humans. Descriptors such as “clinically tested”, “university tested” or even the spurious and refutable “clinically proven” are approaching the prevalence of typically dubious “supports immune” or “low net impact carbs” claims, both on and off the label. Where are we going and is it where we WANT to or SHOULD go? Are the majority of the clinical studies being done on nutraceuticals worthy of being called real science apparel, which can translate into incremental market share and competitor excludability, or are we deluding ourselves yet again?

Inset:

The nutraceutical industry clamors for more respect and recognition, while committing datacide, obscuring evidence and even engaging in scientific research and clinically tested activities that would make even the Wizard of Oz jealous.

The anxiety and urgency many com­­­­­­panies experience, when finally committing money to where their marketing is by funding a clinical trial on their desired ingredient or CPG, can be palpable. Early press releases and word of mouth communications attempt to garner distinction and even purchases, as if the simple act of funding a clinical proof of concept or randomized controlled trial confers a halo of efficacy and safety. What does the FDA or FTC field agent, academic re­searcher, enlightened consumer, registered dietitian or local medical doctor think? Non-efficacious and invalidated/unknown safety (on the actual CPG or proprietary ingredient) until proven otherwise. Firing a flare of ostensible success by issuing a press release that a study has been completed and the results look promising can also backfire. To illustrate, a recently completed study compared the influence of consuming fresh grapefruit, grapefruit juice or dried grapefruit extract capsules upon body weight and markers of insulin action/carbohydrate metabolism. Early, premature press releases hinted of a successful outcome, with a quote or two proffered by the marketer of the grapefruit capsules that were tested (and a co-sponsor of the study). The latest press release that formally de­clared the results made no mention of the grapefruit extract’s performance, highlighting only the favorable, statistically significant changes seen in the fresh fruit and juice-consuming groups. If this ex­clusion indeed underscores a tacit acknowledgement of non-efficacy, what does the marketer of the capsules do now? A whole other story revolves around the premature re­lease of the data, which may endanger the investigators’ chances of being published in a reviewed journal of repute.

In previous issues of Nutraceuticals World I have written about the killing fields, where scores of clinical studies on nutraceutical products have been buried, mainly due to lack of demonstrable (read marketable) efficacy. By inference, one can assemble a who’s who list by performing Internet searches that combine supplement with clinical study or clinical trial. Upon finding a website, not uncommonly a date is mentioned in context, referring to the start or expected completion date of a clinical trial on one of the company’s products. If the results of the study are NOT described alongside, especially without mention of a scientific meeting wherein the data were presented or a professional journal article where the data were published, odds are a body has been buried. Smart webmasters remove this rotting wood ASAP, after the results yield a thumbs down.

Exemplary are a prominent U.S.-based breast augmentation product marketer and a U.K.-based marketer of a glucosamine sulfate-containing composition—the former never revealed the outcome of its study, while the latter’s study was published, revealing no statistically significant superiority to placebo in persons with osteoarthritis (Rheumatology, 2002; 41:279-84). At least two publicly traded companies have committed datacide by either placing a gag order (by legal agreement) on the research team and in all their communications of the data (no mention of the product or study sponsor) or by selectively harvesting only the good data. This knowledge is the spawning ground of investigative reporters searching for a headline.

In the past two Proprietary Perspectives columns I have profiled the state of the industry in relation to experts with questionable or irrelevant academic training. The carbophobia phenomenon that continues to undergo shape shifting has magnified interest in how dietary carbohydrates are handled by the body. One practice em­ployed by some small to large volume food form/energy bar marketers has been paying for seals of approval by third party organizations. One seal, offered through a University of Sydney laboratory that is thought to be a leading force in glycemic index re­search, involves subjecting candidate products to clinical trials that follow a specific protocol. One impression is that the presence of a seal confers a status of having a superior carbohydrate metabolism effect related to elevations in blood sugar, namely the glycemic index.

In contrast, another pay to play ap­proval seal granting organization is owned and operated by an individual with a naturopathic doctor credential from a non-accredited correspondence/distance learning school, yet who claims to be board certified. At the physical address of the organization no research staff or clinical research facility exists. Claims of a requisite clinical trial being performed on each product before is­suance of a seal are made but NO such clinical data appears to have ever been published or presented in the scientific community. Indeed, the owner/founder has no original clinical research publications published in peer-reviewed journals. At least one company slowly removed the seals from its bars after these facts were discovered. Is this the kind of science or impression we want to make as an industry? This path of least cost may prove most costly in the ensuing one to five years as more and more global brands enter the category described as nutraceuticals. Their entrance, exemplified by the recent introduction of M&M Mars’ Ma­rathon™ bar, will not be tenuous and discreet.NW