The Pharmaceutical Journal
Vol 274 No 7346 p486
23 April 2005

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Regulation of herbal remedies in Europe more
Rescuing a Garden of Eden that has been ravaged by a brutal regime more
How your diet influences your risk of colorectal or oesophageal cancer more

Regulation of herbal remedies in Europe

In the 24 March issue of the New England Journal of Medicine Dr Peter De Smet of The Hague described changes in the control of herbal remedies in Europe. EU member states have until 30 October to implement the requirements of a directive on traditional herbal medicinal products, which was adopted by the EU Parliament and Council in March 2004.

Herbal products are important, since in 2003 Europeans spent the equivalent of US$5bn on over-the-counter herbal products. Germany and France lead the way in having busy markets not only for over-the-counter remedies but also for prescribed herbal products. In the UK, about 1,300 herbal practitioners may legally sell unlicensed herbal products provided they have consulted the patient.

Manufacturers of herbal remedies have found difficulty in providing conventional proof of efficacy for their products and European countries have adopted varied approaches to the control of such products. The directive takes steps to harmonise these differences of approach by simplifying registration of traditional remedies that do not fulfil the requirements for classification as established medicines. To qualify, herbal products must contain exclusively herbal ingredients; minerals or vitamins are permitted only if their safety is soundly established and their activity ancillary. Proposed uses must not require diagnostic or therapeutic supervision by a physician. Strength and dosage must be specified and the product recommended for oral administration, inhalation or external application. Products must have been used in medicine for at least 30 years, 15 of these within the EU.

The directive establishes a special committee on herbal products within the European Agency for the Evaluation of Medicinal Products to establish a list of herbal substances and preparations deemed suitable for licensing as traditional herbal medicines.

Additional measures are needed to ensure quality and safety of crude ingredients and to ensure that non-medical practitioners who prescribe herbal treatments are adequately trained and meet a high standard of practice.

The directive specifically allows non-medicinal herbal products to be regulated under food legislation, and there is some question how far the same herb can be marketed as both a medicine and a food supplement.

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Rescuing a Garden of Eden that has been ravaged by a brutal regime

Often referred to as the original Garden of Eden, the Mesopotamian marshes of southern Iraq have long been regarded as the cradle of western civilisation. The ecological and cultural value of the region stems from its comprising some 15,000 sq km of rare wetland habitat in the midst of a desert. Its indigenous people, commonly called the Marsh Arabs, have attracted special study, having existed for 5,000 years in an isolated collection of man-made reed islands. The area, too, has been the home of millions of birds, some rare.

In the 25 February issue of Science a group of scientists has discussed the possibility of restoring its ancient glory to this phenomenon, after the ravages inflicted by Saddam Hussein between 1985 and 2000 by massive drainage schemes and the attempted extermination of the inhabitants. Limited access until 2003 meant that little was known about the current water quality of the rivers and the ecological conditions of the surviving marshes. The inheritance of the local population was a series of salt flats laced with insecticides and landmines. The supply of fish had dwindled and birds of the heron and cormorant tribes were facing extinction. When the reed marshes had been destroyed the effluents of the Tigris and Euphrates seriously upset marine life in the Persian Gulf and migratory birds lost a winter staging area.

A United Nations study in 2004 commented that “the impact on biodiversity has been catastrophic”. Among other factors was an accumulation of selenium in the food chain, which threatened severe toxic effects on marsh denizens.

Restoration of at least part of the marshlands is now visualised as offering great potential for improvement. Establishment of core areas would support ecotourism, provide a haven for animal and bird life, and permit the continuation of a dual marsh life in combination with some form of dry farming. The Marsh Arabs, it is reported, are currently practising such a dual role. At least a fraction of the old Garden of Eden stands to be resurrected in due course.

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How your diet influences your risk of colorectal or oesophageal cancer

In an editorial in the 25 March issue of Science the head of the Gastrointestinal Biology and Health Programme at the Institute of Food Research in Norwich, Ian Johnson, has reported on the relationship between diet and the incidence of cancers of the gut. In a review of the causes of cancer in the US in 1981 it was stated that about one third of deaths from this condition were attributable to diet and so in principle were avoidable, but the finding was not emphasised in public discussion.

The hypothesis that overeating increases the risk of bowel cancer has received support in the developed world. There, overconsumption of energy, low levels of physical activity, high body mass index and abdominal obesity are strong independent risk factors for colorectal carcinoma, insulin resistance and cardiovascular disease, and obesity has been linked to oesophageal adenocarcinoma, once rare but making noted advances in North America and Western Europe. There is little evidence that the adverse effects of diet on alimentary cancers in the West are attributable to carcinogens in food. A more plausible cause is adverse dietary factors such as pro-inflammatory agents produced by adipose tissue and low intake of natural anticarcinogens in plant food.

It is of note that chronic use of aspirin and other non-steroidal anti-inflammatory drugs significantly reduces the risk of colorectal and oesophageal cancers, possibly by inhibiting pro-inflammatory enzymes in pre-cancerous tissues. Both cancers are less common among consumers of diets rich in fruit and vegetables containing glycosinolates and flavanoids.

Carcinomas of the gut are among the commonest causes of morbidity and death in the developed world, and the role of being overweight, lack of exercise and inadequate plant food in the diet needs to be more widely acknowledged and publicised.

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