Whether it is the difficulty in explaining the composition of some of the more complex materials, showing the consistency of these materials from batch to batch or proving or disputing the effectiveness of a product, science is at the very root of the issues this industry faces today. The proof of the nutraceuticals "pudding" lies exclusively in science. The dissemination of information from the science that exists is responsible in large part for the popularity of supplements, functional foods and other nutraceutical products. People want to believe that these products work and it is the presentation of messages based on the available science that enhances the market.
Today it is also the root of one of the challenges the industry faces. The use or-more accurately-misuse of scientific data has been partly responsible for the business downturn that exists today.
How can this be? The use of science needs to be reviewed in the context of some of our current practices before we look at what we can do to remedy the situation. Start here: "St. John's Wort has been demonstrated to be of benefit in persons suffering mild to moderate depression." With the caveat that this statement would likely not be allowed to make its way onto the labeling of any product in the food supply today, the words themselves remain truthful, based on the available science. However, universal application of this claim is not remotely appropriate. The data that exist out of the scientific studies providing substantiation for this claim apply to a specific product. They do not apply to every product. However, the generation of similar data to support YOUR product is a costly endeavor. Current practice to date involves making the claim (worded appropriately to fit the narrow realm of allowable structure/function claims), believing (either openly or tacitly) that the data that do exist are universal. This is the Borrowed Science concept. We are "borrowing" the results of work performed on a specific substance and/or product and applying the results of that investment to a product that may bear little to no resemblance to the product originally studied.
When it comes to single entities such as vitamin C or calcium, this is far less an issue since they are just that: single chemical entities with their identities clear and monographed and the information concerning their benefit applicable to the single species. The science becomes far more difficult when the material showing benefit is complex in nature and comprised of multiple chemicals (phyto or otherwise).
Borrowing someone else's work goes well and truly beyond plagiarism. Moreover, it is far too common a practice. How many supplements that contain St. John's Wort have performed the substantiating studies behind the claim that the product is effective in addressing cases of mild to moderate depression? What relationship (chemically or even physically) do the extracts or powders used in products making the claims have relative to the compounds that were studied? The consumer initially believes the statements on the label because of their inherent faith in the control of the placement of such statements. The reality is that many of us in the industry are more than riding on the coattails of the science already in hand. We are "borrowing" these results to enhance the market position of the product we place on the shelves. When the consumer, already poorly educated in most of these matters, finds that the product they purchased did not meet their expectations based on the claims, the entire product category suffers. We are witnessing this today in consumer response to the products themselves. What began with, "This product doesn't work" transformed into, "Herbs don't work" when the next product they tried, carrying claims substantiated by studies performed on a different entity, failed their expectations. The next degradation in this progression is, "Supplements don't work." The extension of this is that regardless of presentation (nutraceutical, supplement, functional food), the consumer's mind becomes pre-disposed to discount the claims presented, regardless of the validity of the studies supporting this.
The claims universe once available to these products has been reduced to a solar system today through regulatory efforts. The promise of DSHEA is being reduced to a rumor. The end game is that the claims that may be made will not reflect the state of the science that does exist and we, as an industry, compound the challenge by borrowing that science to make our claims. Thus far, FDA has not yet taken to task anyone making a claim in order to seek their substantiation directly. What will they find when they do? Will they find studies that address the product being sold or will they find studies performed on entities that relate in name only to the product in the consumers' hands? FDA will define the substantiation requirements eventually. If you look at the requirements published in the guidance document defining "significant scientific agreement" for health claims, you can anticipate that FDA will not be pre-disposed to accepting someone else's work as substantiating the claims you make on your product.
Neither A Borrower Nor Lender Be
What is the alternative? Is there an innovative approach that might solve this challenge and diminish the practice of borrowing? What can be done as an alternative must accomplish the three main goals: affirm what we believe to be true, get the work necessary accomplished rapidly and instill confidence in the consumer again that the products we offer provide benefit. We know that the application of science is the means by which we can accomplish this. A focal challenge is the setting aside of some of the competitive mandates we impose on ourselves. Cooperation and sharing in the results of that cooperation are the critical elements to this success. The concept presented here is, perhaps, innovative but definitely outside the realm of our current thought. The answers are easy to provide broadly, although the specifics are thorny.
The uniqueness of a product's effect relates to the composition. The costs of these determinations are not insignificant. It is the cost prohibition relative to the return (without patent protection as in the drug model) that causes us to stumble along the path of science. Imagine, though, that you are part of a consortium. Imagine further that you have the foresight, willingness and innovative skills necessary to see that characterization of the materials you wish to use is beneficial for the subsequent steps. Why not pool the resources of these multiple companies in order to defray the costs of the work necessary?
Once you have knowledge of what it is that appears to work, the characterization, then the next critical step is at hand. You want to make claims about your product that will inform the consumer as to its benefits. One way is to see if anything has been done previously and then place an extrapolation of those results on your label. This is the classic borrowing technique. You may be using the same material if a fingerprint of it were performed and compared to the entity that was studied. But how would you know?
The opportunity resides in cooperation as an industry. We do not often have the luxury of expending significant dollars as individual companies to attain the substantiation we need. The keystone of the investigation is formed first by the manufacturer or supplier of the raw material. They benefit most from the expanded distribution owed to legitimate claims concerning the entity. If the manufacturers of finished form products support or even formally request these studies be performed, agreeing to provide support for this science and then using the material studied, we gain the scientific knowledge while simultaneously allowing our own dissemination of the results. We share the burden and reap the rewards without borrowing.
Even with a single entity, the issue is less complex, but no less challenging in the potential for avoiding the borrowing of science. Does lutein work if it is contained in a capsule with canola oil as a carrier versus soybean oil? What about dry forms? What about in food products that contain a host of other materials that may affect the absorption of the single chemical with substantiation? These questions deserve answering. Also, are there other benefits of lutein that we are not yet aware of that can be substantiated? Asking a single company to bear the brunt of the investigation is unrealistic. Partnering with the understanding that the knowledge gained will be shared among those who participate does make sense.
Once we determine what works in a general sense, the real work-the demonstration of effect-begins. Looking back at the gold standard for clinical trials, we should be acutely aware of the need to address this issue in an innovative fashion as well. For many of the entities we wish to use in our products, the indicated effects are subtle. This subtlety means that the standard model may not apply. An alternative model for the demonstration of efficacy must be developed. The model we apply today comes out of the pharmaceutical world, where single strong chemical entities are investigated. The more subtle effects are lost in such a model. We need to cooperate within our own industry and with scientists in order to define a new model to meet the goals of substantiation. Sharing the results means sharing the ideas and the costs involved. This need not occur only from industry. Funding is available from a host of sources such as the National Center for Complementary and Alternative Medicine (NCCAM). The challenge is in providing them the direction and focus. The innovative opportunity of defining a new clinical model is valid but a separate topic. Yet, it should be borne in mind as we look at the innovation of sharing science generally.
Sharing of results cannot occur without including the costs of developing and generating the science. Without this, the costs remain prohibitive. If the costs are left exclusively to the raw material providers, the costs of the studies completed are passed on to the users of the material and likely place the costs of the material outside a viable range. Partnering and ultimately sharing in the knowledge gained is beneficial to all who participate. As for the challenge of developing a product that uses such material and then demonstrating the effectiveness of the finished form, the innovative approach is to reverse the fund sharing aspects. The manufacturers of the material should be vitally interested in such demonstrations. Both sides enhance the reputation of their product while generating increases in demand ("I want the one that works"). The consumer benefits by knowing that there is one that does work. The result of some of these shared responsibilities may be the generation of new monographs owed to their characterization. Recognize that this then broadens the exclusivity of the product. However, this is compensated by the demonstration of effect in the consumer product. While not providing the advantages afforded drug companies in their patents, there is benefit to an industry that needs to get clear in the consumers' minds that their products work.
Sharing the results of science is legitimate. The payoff is not only the boost in consumer confidence but the enhancement of the reputation of those companies who participate in the process. Those who choose to work toward demonstration of the benefits of their products gain stature throughout the scientific community, the consumer community and through the industry as a whole. This concept of sharing insists that it include sharing the risks and costs involved rather than borrowing the results, however inapplicable they may be.
Initiatives have been attempted to gather funding from multiple sources in order to share in the burden and results of the science generated. These did not result in success. The reasons for this are known to the participants and must be overcome in order to achieve success. There is willingness among scientists to participate. There is willingness among funding organizations. We need to generate willingness among ourselves in order to apply the innovative process of sharing in the science we need to demonstrate the products we sell. Those with the greatest gain potential (raw material manufacturers) cannot carry the burden alone. Those with the interest in using the materials that work (the finished product manufacturers) cannot afford lone demonstrations of characterization or effectiveness. Sharing the burden and the results benefits everyone. These benefits are derived without the harm caused through the theft of results that do not apply while calling it "borrowing." Science is the key. NW
