[MPWG] Safety et al

JPS Kohli info at businesshorizons.com
Fri Nov 4 01:32:30 CST 2005


Hi all,

I would like to share some thoughts on the issues of safety, government control and perception of the industry by the general public/medical profession.

In an old Indian fable, an enlightened man once asked his favorite disciple to go out into the forest and bring back at least one plant that had absolutely no medicinal value. This was in order to test his knowledge in the healing arts as learned over the years. He came back after scouring the forest for months on end and declared that he could not find any such plant. 

Contrast this with information that anyone can find on OTC items (like Tylenol/Aspirin) and try to find any item in any pharmacology book that says that it is free from any toxic effects.

I would like to propose here that there is a common factor in both the scenarios: Depth of Knowledge. Those who really understand a field of medicine, are not only confident of the effectiveness of products, but also aware of what toxicity it can also possess. The fine point is to determine what to eat, how much to eat, how to eat and the lifestyle changes to perform. Consider Kava, Ephedra, Stevia and lately even commonly used herbs. Nobody died of eating Kava plants over hundreds of years. But if you start extracting Kava lactones, make up a nice sounding standardized limit of the lactones and start selling these to patients, there is obviously going to be trouble sooner or later. Perhaps there is inadequate knowledge of dosage or what other Kava ingredients are needed to act synergistically or to counter any toxicity of the "main" ingredient. We should therefore come around to the fact that a more holistic approach is needed to make up even a monograph of a plant, let alone it's complete therapeutic profile.

Regarding government control or regulations, I would like say that there is not enough control at the right place and excessive control at other places. Consider the fact that for most of the herbal medicines (oops - cannot say that in US and some other countries where these are known by the more"acceptable terms" of "dietary supplements"), there are no controls of how much of a herb or its extract or its phytochemicals may be put into a product sold to the public, no control of how much they can charge for these products from the public nor any control on how or where they get their raw material from. There is no herbal equivalent of a US Pharmacopoeia for pharmaceuticals and similar position exists for more countries worldwide. So one cannot get any testing methods for most herbs (this means not over 200 methods exist in the public domain while the number of products is anybody's guess). In fact the few testing methods that do exist are touted as proprietary methods, not disclosed by the testing labs. If such testing/assay methods were developed and made available for most herbs, the onus of quality would then fall squarely on the manufacturers. but as things stand today, it's the government (in most countries) that is found lacking in such development initiatives.

Excessive control is ofcourse exercised by immediate banning of herbs, long in use by the public in various parts of the world. These are more of knee-jerk reactions to a public outcry (remember Ephedra, Kava). Political lobbying by the pharmaceutical industry also plays a part, but hey, guess what, two can play at that game.

That leads to the third and final point I would like to make - public perception of the herbal industry. While there are some excellent professional and industrial associations/organizations doing good jobs, the fact is everybody is looking at a different direction. Conservation, industry and regulations, clinical safety/pharmacology and basic research are all different facets of the same field. I have yet to see a common platform where representatives from all these branches can come together or even coordinate their individual efforts from their respective setups towards a more visible face of the herbal profession. That may be one of the reasons that the general public has little patience with herbalists when they speak up and then go home to have ginger tea with some energy bars for that irritating cold.



J P S Kohli (B. Pharm)
Business Horizons
Pharmaceutical Publishers
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