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Vol 275 No 7377 p661
26 November 2005

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Letters to the Editor

Safety of medicines

All “medicinal” products should be subject to same standards

From Dr J. D. Flack, MRPharmS

Two recent issues of The Pharmaceutical Journal have raised important issues regarding the safety of medicines and of other general sale products that claim to have medicinal properties, such as soy and chocolate products (29 October, p547, p554, and 5 November, p576). I wholeheartedly agree with the authors of these articles that we should be careful as a profession in making medicinal claims for any products without the full weight of scientific facts (or the absence of them).

It is time the profession as a whole — that is, all those in discovering, developing, marketing, distributing and dispensing medicines or products claiming medicinal benefits — “got back to basics”, ie, paid more attention to the pharmacological actions of the products they are promoting or selling to doctors, pharmacists or the general public.

The basic pharmacology of COX-2 inhibitors as described by Andy Hutchinson (PJ, 29 October, p547) was known over a decade ago but the potential for cardiovascular side effects has largely been eclipsed by the marketing mantra that they were free of the COX-1 gastric irritancy problems. Those companies involved are indeed reaping the whirlwind of the seeds they have themselves sowed. And this was a class of drugs that that had the full gamut of long-term preclinical and clinical testing, as well as detailed and independent regulatory review by the major government medicine agencies around the world, before entering the market place.

So I agree with Mike Stockham (PJ, 5 November, p576) and “Onlooker” (PJ, 29 October, p554) in their views on soy and chocolate products. These products may or may not contain substances at varying levels that may interact with physiological systems and, in certain pathological situations, provide some therapeutic benefit. It is essential that we also know their potential for long-term clinical safety and that they pass the rigour of appropriate regulatory efficacy and safety standards. Perhaps we should be reminded of the words of the father of therapeutics, Paracelsus — “All substances are poisons; there is none which is not a poison. The right dose differentiates a poison and a remedy.” We ignore his words at our own and our children’s peril.

John Flack
Melbourne, Australia

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