By Len Monheit
I am writing on this particular subject at the request of a respected colleague. In this case, that doesn’t make the issue less of a personal interest, it merely underscores its importance to the ongoing success of our industry. The issue is science and ongoing clinical studies, and companies’ willingness to invest.
Over recent years, I’ve been in many presentations where the question of ‘the value of the science’ has been debated, with all in attendance agreeing that yes, science is valuable, and yes buying products with science is the way to go. All too often though, purchasing behavior doesn’t back up this commitment, as researched products can tend to be more expensive. Until purchasing behavior strongly and solidly supports this investment in science, the value of conducting clinical studies remains in doubt.
Another related challenge that many speak about is the liberal borrowing of science, with very few effective recourses to fundamentally stop this practice. This is a gray area from a regulatory standpoint (especially in these days of lax or non-existent enforcement), but a classic example of blatantly misleading or false advertising every time. Yet these practices persist, largely because buying behavior does not adequately support those making the investment, not only in science, but in intellectual property as well.
So exactly what are the compelling reasons for a company to conduct clinical research?
First of all, in some jurisdictions, this research on both safety and efficacy is required for a product’s market entry. This is not exactly the case in the United States, although certainly proof of safety is a prerequisite for new dietary ingredients and adequate proof of safety a wise course of action to support any product on the market. So, if research is not required, and even if performed, the language in which this research can be used is extremely limited, why bother?
There are several solid reasons for conducing research, although the debate has and will rage as to its value. Some of these reasons will be presented this week (Thursday) at a Webinar being presented by the American Botanical Council’s Mark Blumenthal entitled, "The High Value of Clinical Studies of Herbs and Herbal Ingredients: Instilling Confidence, Countering Negative Media. The very title of this presentation gives a good idea of what’s to come, focusing on confidence and the ability to counter negative media. In the absence of positive clinical results, a negative story or study puts the gauge at negative, that is, there is nothing to support ingredient or product efficacy, at the very moment that consumers and even some practitioners, are actively looking for supporting evidence.
This approach leaves open the question of ‘who should conduct the study’, its legitimacy supported by serious concerns about recent government sponsored study results. One can make a case though that a stronger body of industry-sponsored clinical results should focus government sponsored research and should therefore lead to future research being performed on well-characterized, qualified materials only. In short, the process should make dialogue better, determinations more logical, and presumably a body of science should emerge, in theory, that not only supports product efficacy, but also differentiates efficacious products from those that would seek to ‘borrow’ the science. Still lacking though is a market-driven value equation, and one can argue, that this is the fundamental reason companies resist conducting clinical trials on their products.
Many of the reasons for conducting trials are self-evident including a desire for the ability to differentiate (although in practice this is difficult with both borrowed science and language limitations), the ability to prove product safety and efficacy, ideally in a dose-dependent way, the ability to build a series of platforms to counter the inevitable negative media or counter-studies, and perhaps most importantly, to begin convincing key influencers like practitioners, pharmacists, dieticians and nutritionists, that a partial solution to our healthcare crisis lies in some well-researched and well-documented proprietary products.
Until market success is tied to demonstrated product efficacy, perhaps this debate will continue, while one hopes that ultimately, this correlation will provide a huge incentive for appropriate science. In the meantime, and at the very least, credibility and legitimacy both demand that industry do the science, and that those that do are recognized and rewarded and that buyers participate in this process.