Formulating The Ideal Practitioner Line

Research is becoming the cornerstone of product formulation.

ByDr. Gina Nick

There are several guidelines that should be followed when formulating the ideal practitioner line in order to quickly gain market share once products are released. These details have been highlighted in previous columns as well as the Longevity Through Prevention (LTP) Practitioner Survey*. They include:
1) The wide range of practitioners must all be included in the planning.
2) Practitioners must be engaged as full partners in the promotion and use of the products.
3) The line of products should be for professional use only, in contrast to the myriad of similar, undifferentiated products now available over-the-counter (OTC).
4) Quality must be an overriding priority.
5) Technology must be fully integrated into the overall product package.
6) Patients must recognize an entirely new direction in the use of these products.

As mentioned in the very first Healthcare Practitioner Marketing column (March 2004), the practitioner market is made up of over one million MDs, osteopaths, naturopathic physicians, veterinarians and other allied healthcare professionals, including nurse practitioners, physician assistants, chiropractors, acupuncturists, pharmacists, Ayurvedic doctors, traditional Chinese medical doctors, nutritionists and dietitians. What all have in common is a desire to appropriate the respect and credibility orthodox medicine has achieved through its use of scientific principles and practice and the successes it has realized.

Bringing Practitioners Together

Gathering practitioners under one roof and molding them into a unified task force to promote nutraceuticals will require a brand new approach to product formulation. According to the LTP survey, quality must be assured first and foremost. Active ingredients must be scrupulously identified and quantified as chemical entities. (No longer will minced leaves and pulverized roots suffice.) This will assure uniformity of dosing. It will most likely be necessary to begin with single ingredients, since the necessary research to identify synergistic compounds will be in its infancy with the newer quantified chemical entities. One chemical at a time is usually the easiest way to begin, although there are occasions when multiple ingredients have already established a track record and can be included in the initial offering.

Nutraceuticals have both the advantage and disadvantage of being available as an OTC product. This status can be a positive benefit in that practitioner-only formulations can be created and remain available to all practitioners, creating a brand new product line without introducing new chemicals.

The second most important aspect of nutraceuticals cited by practitioners in the LTP Practitioner Survey was efficacy. To this end, most efforts will be directed toward an integrated clinical research/ marketing protocol (or protocols) to demonstrate the efficacy of the new line of products. Previous columns have discussed how immediate returns can be achieved, even though final results may be years in the future. The mere perception that this market is moving dramatically into evidence-based practice will have a startling effect, both on patients and practitioners. Published protocols, followed by preliminary results on a regular basis, will catch the attention of both the healthcare industry and the popular lay press. It is hard to imagine that the public, which now believes in complementary medicine, will not embrace and promote such a new direction in order to validate its convictions. There will follow in its train the uncommitted and eventually the skeptics.

Certainly the details of clinical re­search will be the major obstacles to overcome. For each product in the new line, all currently available evidence must be carefully collected and reviewed. Publication of these reviews will constitute the first stage in the process. Next comes the selection of the most promising products (single and possibly in combination) for clinical trials. One can hope that some of these will promise short-term results, but long-term studies should also be initiated.

Designing a Research Protocol

The most efficient way to begin is to identify groups of “thought leaders,” which are prominent figures in researching clinical applications. They can lead a team of experts in the design of research protocols and the promotion of each product. Coordinating both aspects of product development and advertising assures efficiencies of economy and uniformity of goals.

Protocols need to be designed, so that practitioners of all types can participate in the research using their patients as subjects. Simplicity will determine compliance, however, quality must not be sacrificed. Many multimillion-dollar clinical research efforts have subsequently been discarded due to poor protocol development. Study populations must be carefully identified. Realistic yet meaningful primary and secondary endpoints must be selected. Statistical significance must be calculated. Study duration must be determined. Dosing must be established, perhaps by preliminary dose-ranging studies. Toxicities may require patient monitoring. Interval review rules will not only allow progress publications but also provide clues as to the success of the studies.

Most effective implementation of the studies will require a broad base of subjects and consequently practitioner/researchers. This can best be accomplished through Internet coordination. Result gathering can be done in real time and streamlined by computer-based reporting forms. Setting up a regular computerized communication network will also facilitate regular advisories, updating of information, introduction of new products and re­search protocols and overall engagement of practitioners in the research process, giving them a sense of partnership and the esteem associated with being a clinical researcher. Research affiliation with a university medical school that is interested in integrated medicine, such as the University of Arizona, will strengthen this alliance.

An Internet-based system can be en­hanced considerably by integrating office management tools, allowing practitioners a full range of record keeping, billing and appointment tracking capabilities that can be continuously upgraded on line. Other incentives are easily added, including reduced wholesale prices on products, first offers of new products and research protocols for the best practitioners, promotion to the leadership team for a given product, by-lines in publications of research results and a variety of awards for quantity of product used, quality of research, number of subjects participating, number of research protocols underway, and so on.

This industry is currently witnessing a new direction in nutraceutical marketing—gaining for complementary medicine the respect earned by traditional medical practice. Taking advantage of the growing public interest in alternative medical methodology, an approach to better marketing through more evidenced-based research has been described. It requires broad-based participation by the great variety of practitioners committed to these disciplines, higher quality products, computerization and Internet integration. In the implementation of this plan, practitioners are treated as partners in the development and execution of quality clinical research that includes distribution of newly formulated products. In this way, a more scientific line of products is introduced to the public along with a commitment to rigorous scientific study of their benefits.NW