Is Research Necessary?

Creating a research schematic for nutraceuticals could provide an enormous boost in credibility, and sales.

ByDr. Gina Nick

A cloak of respect surrounds the orthodox pharmaceutical industry; in large part, well earned by its ability to comply with the burdensome regulations enforced by the FDA and still develop the array of new drugs that continually pour into the world’s marketplace. Complementary and alternative medicine (CAM), however, is criticized from this vantage point, justly for its unsubstantiated (by Western medical standards) claims, and envied for its success because it does not have to comply with those regulations. The challenge is to counteract that criticism convincingly in order to earn a share of the cloak. Research is the only visible path to gain integrity, yet CAM is far from willing to mimic big pharma in its expenditure of billions of dollars on FDA-mandated research, nor does it have to.

Nutraceutical research poses different challenges than pharmaceutical research. For starters, the CAM community is in a position to design its own research protocols. In other words, it is not mandated by any outside authority and traditional protocols do not take into account the marked differences between the therapeutic uses of nutraceuticals versus pharmaceuticals. Secondly, CAM pro­ducts are much safer than pharmaceuticals, a fact acknowledged by the absence of strict regulations on their marketing. The down sides are the long time spans required to demonstrate objective effects of these products. The question is: How can a return on investment (ROI) of research dollars be maximized? What approaches to research will be most effective, least expensive and offer the greatest validation of CAM products?

The answer lies as much in appearances as realities. There is a way to earn the respect of both public and medical opinion quickly, in process rather than in results. Intentions and early efforts, properly acknowledged, will fortify an already growing interest in CAM both from the public and from the medical community. Should CAM visibly change its image and enter into an extensive and objective research program, the payoff will come long before the studies are completed and the results are in.

Two issues emerge: How to do it, and is it worth it? These issues are not mutually exclusive. Since the industry is already doing well, it needs to be convinced that whatever expense is re­quired will provide an acceptable ROI. Once the question of How is adequately tortured by the accountants, the answer to its worth will be forthcoming.

Given that it is the effort and commitment rather than the results that will provide the benefit, many avenues of possible research open up. A foundation has already been laid for such products as Hyaluronan in animal research. The evidence for benefit to horses is substantial. Animal research offers much greater latitude for re­search than humans and is a valid and established form of biologic research. Animals also offer abbreviated life spans and the promise of much earlier results for many of the chronic diseases that CAM addresses. It is quite feasible for the industry to sponsor research studies in established humane animal laboratories; even to set up its own humane facility which would jump start recognition of the new emphasis on objective scientific evaluation of its products. The fact that it isn’t necessary or required would make the impact even more impressive and newsworthy.

Human research is always the most onerous, expensive and time-consuming, however, there is a way already tested by big pharma to minimize its burden while maximizing its exposure. Private Practitioner “Clinical Trials” is a technique made for CAM. It works by developing with great care and detail an experimental protocol. Practicing healthcare providers are then recruited with whatever incentives work—free samples, the prestige of participating, curiosity, a desire to promote nutraceuticals, perhaps even a stipend—to enroll willing patients in the research. It is also possible for a sponsoring institution to grant honorary researcher degrees or titles. The risks are minimal, due to the safety of the products; therefore, the major barrier to participation—adverse effects—is nullified. Patient enrollment should be easy, as most patients will most likely be taking similar products already, and are willing to get free supplies and/or are curious about the procedure and results. One can almost hear potential subjects saying, “I’ve always wanted to know if this really worked. Sure, sign me up.”

The supply of subjects is guaranteed from the enrolled practices. The “re­searchers” are familiar with study protocols from their professional training and subsequent studies and experience. The challenges are a working protocol and a coordination team.

The protocol must be comprehensive, yet simple and foolproof. It must contain adequate controls, randomization, placebo comparison, double-blinding, periodic review, statistical power and validity, and predetermined primary and secondary endpoints. It needs to occupy a minimum of practitioner time, while accumulating necessary detail. To that end, it will be doubly blessed if the research assists the practitioner with his or her usual routine by, for example, providing a better system of record keeping that can be used with every patient. Including record keeping or patient management software in the protocol package would greatly enhance its acceptance, use and accuracy. A data entry program that required an entry in every space would be highly desirable to systematize record accumulation and guarantee completeness. One master protocol could be designed with multiple arms, such as the Framingham Heart Study. This would serve to monitor multiple chronic diseases over years of time, publishing periodic results and capable of retrospective analysis due to its in-depth data accumulation.

The proposal can be singular and nationwide, meeting its requirements with the extent of its resources all focused on a single effort.

Coordination of the team through Internet connectivity combined with parcel post is theoretically adequate to the task. However, personal contact greatly magnifies the success of such an enterprise. Big pharma spends tens of millions of dollars on personal representatives for this reason. The impact a public relations (PR) team can have on its public is invaluable. The other critical team is comprised of those who collect, collate and analyze data as it comes in. They must organize the constant stream of data, follow protocol in digesting it, and maintain a constant vigilance for poor input and the means to improve it.

This system is the only way to get meaningful data for long-term results. It would otherwise be prohibitive to amass sufficient numbers of subjects and follow them over extended periods, looking for the subtle changes that add up to meaningful improvement in chronic disease states.

The same system promises immediate benefits. All major clinical studies are published as soon as their intentions are agreed upon. Protocols, subject characteristics and preliminary results all form the basis for subsequent articles. Add to that the lay press coverage for what will undoubtedly be seen as a revolution in the CAM industry. The nationwide interest will spark interest at a local level when practitioners introduce the plan to their patients, and respect and admiration will flow like water. Practitioners also earn respect as researchers, benefiting from using free products, keeping track of patients, and reporting at intervals according to research protocol. The public gets to sample a product, the relationship between practitioner and the sponsoring Nutraceutical Company will be strengthened, or will be strong, and word of mouth will proliferate.NW


Stay tuned for the next Healthcare Practitioner Marketing column, which will discuss the multiple spin-offs such a program can generate to capitalize on the new direction and gain market share.