The Pharmaceutical Journal Vol 264 No 7094p664-665
April 29, 2000 Articles
Pamela Mason recently visited the United Kingdom premises of the German company Orthomol, which is currently targeting pharmacies in the London area to act as outlets for its vitamin supplement products. Dr Mason spoke to its UK managing director
Orthomol is a new company - at least new to the United Kingdom - which sells and distributes nutritional supplements. And the company's products will be available only through pharmacies. Founded in Germany in 1991, Orthomol opened for business here in January this year. But pharmacists might well wonder, as I did when I visited the company, how much room there is in the UK for yet another range of supplements. Competition is strong in this sector, although not as strong here as in the United States, and any new company hoping to penetrate the market has to develop its own unique niche.
Thus, some companies promote supplements based on the RDA concept, ie, that individuals need around 100 per cent of the recommended daily amount of a variety of vitamins and minerals. Other companies market vitamins as a philosophy or lifestyle choice, while others market products for specific population groups such as older people, children, postmenopausal women, athletes, vegetarians, and so on.
So, what is Orthomol's intended niche? Quite simply, it is to provide nutritional supplements, which, as an adjunct to prescribed medication, could be helpful in disease management. Of course, according to UK regulations, no nutritional supplement, unless licensed by the Medicines Control Agency as a medicinal product, can make any claim on the packet to prevent, cure or manage disease. And Orthomol products are no exception because they are currently licensed as foods.
Yet disease management is still a key philosophy in relation to these products. So, how does this work? Mr John Jolley (pharmacist and managing director, Orthomol Ltd, UK) explained.
First is the way in which the company intends to make its products available. This will be through pharmacies only. As Mr Jolley says, although 40 per cent of adults in the UK take nutritional supplements, only one in three of these people buy them from a pharmacy. This makes vitamins like any other item of commerce, and many people would benefit from the advice of a pharmacist when they buy a supplement.
Orthomol is currently targeting pharmacies in the London area and by the end of March there were 78 community pharmacy distributors. However, if the products are successful, they will probably be rolled out into the rest of the country in due course.
The second key factor is that the products are being promoted to doctors, and 70 general practitioners, again in the London area, have been approached so far. The reason for approaching doctors is that the products are designed to be taken under medical supervision and the idea is that doctors will recommend them to their patients. The patient will then go and buy the product, with appropriate advice, from the pharmacy.
The third key factor is the products themselves. Although the product packaging cannot currently make any claim about disease management, the names of the products, as for many others in this market, have been chosen to reflect their intended use. Three products are immediately available in the UK. Orthocor Plus is designed to support the health of the heart; Orthoimmun is for the health of the immune system and Orthovision for the health of the eyes. Other products, such as Ortho-osteo, Orthomeno and Orthonatal, currently marketed only in Germany, will be launched here later this year.
Each product has a different dose form, and this depends to some extent on the ingredients. Thus, a day's dose of Orthocor is provided in the form of a sachet of granules, which can be dissolved in water or fruit juice, together with three capsules containing omega-3 fatty acids, one capsule containing co-enzyme Q10 and L-carnitine and one tablet containing iodine. Orthoimmun is provided either as sachets of granules or as a vial of ready-to-drink liquid, while a day's dose of Orthovision is in the form of three capsules. A day's dose of any of the products can be taken all at once, or, where the dose is provided in several tablets or capsules, these can be split throughout the day.
The somewhat complex nature of the dose forms partly reflects the fact that it would be difficult to put all the nutrients into one tablet or capsule, for example. And, through its research in Germany, the company has found that customers prefer these types of formulations.
Provided in 30-day packs, the products have a smart and professional presentation, but with a cost to the patient of about £1 for a day's dose, they are not cheap. This, of course, is a problem with many nutritional supplements, in that those who might most benefit from them cannot afford them.
So, what is actually in the products? Basically a range of vitamins and minerals in different concentrations depending on the product, and again, depending on the product, a range of carotenoids, amino acids, fatty acids and bioflavonoids. Mr Jolley describes them as "complex mixtures of high-dose micronutrients formulated to a particular requirement for a specific disease".
They are formulated according to the philosophy of "orthomolecular" medicine, a term coined in 1968 by the biochemist
Linus Pauling. He defined it as "the maintenance of good health and the treatment of diseases by changing the concentration of substances in the human body - substances that are normally present in the body, and which are required for health. Vitamins, minerals, trace elements, fatty acids, amino acids and enzymes - all substances that are found in Orthomol's products - fall under the scope of orthomolecular medicine, but the range of substances we think of as drugs do not.
Basically, the term "orthomolecular" expresses the idea of the right molecules in the right quantities. Mr Jolley explains that it is a philosophy that has been used in medicine for a long time, giving the treatment of diabetes mellitus with insulin as one example. In relation to supplements, the term orthomolecular has not always been viewed positively. In the 1960s, Linus Pauling made several claims for the value of orthomolecular supplements, particularly in the control of mental disease, but trials on which he based his claims were often criticised on methodological grounds and, by the 1980s, several researchers were refuting these claims, suggesting that evidence was limited.
However, as Mr Jolley points out, research has moved on since then, and there is evidence, for example, for the value of vitamin E in doses exceeding the RDA and omega-3 fatty acids in reducing the risk of cardiovascular death in patients with ischaemic heart disease. There is also increasing evidence for the value of antioxidants in reducing the risk of cataract and macular degeneration of the retina. The company in its educational material for both doctors and pharmacists uses clinical papers demonstrating such evidence. However, although there is some evidence for beneficial effects of certain nutrients in reducing the risk of specific disease states, the products themselves with their complex range of nutrients have not been tested in large controlled trials. These trials are, of course, expensive to conduct, and few supplement manufacturers contemplate them, mainly because they do not need to do so for licensing purposes.
Trials of supplements are made particularly expensive because they often need to be of longer duration that those involving drugs. This is because drugs are used to manage disease in a way that can make them have an effect quite quickly. Supplements or diet, however, are normally used to reduce risk of disease or prevent a condition from becoming worse and tend to work in a way that takes longer to show a positive benefit. All in all, it is difficult to obtain strong evidence for benefit of supplements, but just because there is no or little evidence, this does not necessarily mean that supplements are without benefit.
No evidence means just that and in relation to supplements often means that the relevant trials have not been done. Nevertheless, they should be. Nutritional supplements are becoming increasingly popular and the public has a right to know whether they work or not, and also how safe they are.
Orthomol is currently conducting trials on its products and is not just relying on evidence from trials involving one or just a few nutrients. For example, Orthocor is being used in a double blind, placebo controlled study at a German heart clinic on coronary bypass patients. The trial involves 50-100 patients in each of two groups and the outcomes to be measured include platelet deposition and lipid and homocysteine concentrations in plasma. The results will be known by the end of 2001.
All Orthomol's products contain some nutrients in concentrations well above the RDA. These quantities are largely based on such trial evidence as there is and the concentrations are not unsafe, according to current thinking. The Department of Health's expert group on vitamins and minerals is looking into the risks of vitamin and mineral toxicity and among its remits is to identify upper safe doses for supplements.
In the meantime, the best estimates available are those published by the Council for Responsible Nutrition (CRN), which were updated last year, and the ingredient doses in each of Orthomol's products do not exceed the upper safe levels set by the CRN. However, the separate products are designed for different disease states, and as we all know, patients may suffer from a multitude of conditions - cardiovascular disease, diabetes, osteoporosis and so on. Because the nutrient doses in these products are often quite high, care needs to be taken in recommending more than one product for one patient.
In comparison with some supplement companies, Orthomol is tiny. Situated in Thatcham, Berkshire, just off the A4 beyond Reading, the premises are one of several in the middle of a typical industrial estate. The unit consists of a couple of offices, a training room, and also a warehouse, which in floor area, is not much bigger than an average community pharmacy's stock room. Manufacturing may begin on this site next year, depending on how successful the UK part of the business is. Plans are also in the pipeline for development of the business in other countries such as Spain and Canada.
Pharmacists should benefit from Orthomol's professional approach in encouraging the use of its products under medical supervision and with the recommendation of doctors and pharmacists. There should also be advantages for community pharmacists, who will be able to recommend a product that is sold nowhere other than in pharmacies. Moreover, in Germany, Orthomol products are registered under a special category as medical foods and when similar legislation comes into force in the UK this year, the company's aim is to have its products registered with the Ministry of Agriculture Fisheries and Food.
The issue of evidence remains a difficult one, but the company is conducting trials of its own products, which should further support its claims for clinical efficacy.
Pamela Mason is a pharmacist with a special interest in nutrition
Citation: The Pharmaceutical Journal URI: 20001298
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