By Mark Land, AAHP President
Many of today’s homeopathic products originated because of the contributions of our predecessors. These medicines were developed based on the medical expertise of ancestor homeopaths, often motivated by a perceived need in the market or a passionate pursuit of a specific therapeutic area. Today the development of health care products is well defined, complex and expensive. Many therapeutic ideas never make it to market, failing within one of the myriad stages of development. Only the best products reach the market.
Some within the homeopathic community question how applicable many of the stages of the current drug development process are to homeopathic healthcare products. I believe homeopathic products can benefit from the principles embodied within this approach. Today, the most successful homeopathic medicines are often the subject of rigorous, deliberate development programs.
When thinking about this article many ideas and questions came to mind. Where does the inspiration for a new homeopathic product come from? Where do homeopaths look for therapeutic agents? What should the characteristics of a homeopathic therapeutic agent be – biologic activity or safety? How do we optimize those leads? How many leads should we work on, be it individual ingredients, combination formulas or different dilution levels? What questions should we study in preclinical phases? We will certainly study safety, but how about examining potential therapeutic activity in non-human models as a method to reduce the number of leads we take into the clinic. Using each stage of the development process to reduce uncertainty and inform subsequent phases yields the best products.
The process will be approached differently for new homeopathic ingredients, versus new therapeutic uses of a known homeopathic ingredient. I recommend that developers not discount the process. Thought experiments designed to challenge the basic assumptions of safety and therapeutic action of well-known agents or combinations of agents will provoke new questions and inform future stages of development. Documenting those steps can be as valuable as laboratory experimental data in the design of clinical trials and future product labels. The below graphic is my attempt to position the critical stages of drug development for both traditional and homeopathic drug products.
Graphic: Author’s vision of the critical stages of drug development for both traditional and homeopathic drug products.