Farmazian doktorea. Biofarmazia, Farmakozinetika eta Farmazia-teknologiako irakasle kolaboratzailea
Farmazia Fakultatea UPV-EHU, Vitoria-Gasteiz
Farmazian doktorea. Biofarmazia, Farmakozinetika eta Farmazia-teknologiako irakasle kolaboratzailea
Farmazia Fakultatea UPV-EHU, Vitoria-Gasteiz
It comes from the word "nutra" nutrition and "zeutiko" pharmaceutical. Thus, although not all experts agree on a unique definition, we can define a nutraceutical as the substance of natural origin that, being part of food or food, offers medical benefits for its biological activity. That is, we could understand it as a substance that is found in the limit of medicine and food.
The market for nutaceuticals has grown considerably in recent years. On the one hand, because they can be easily achieved without a medical prescription; on the other, because the natural origin of these products and the absence of possible adverse effects are more attractive to consumers than the chemical nature of the drugs; and finally, because they are used as an alternative when it has not been possible to improve the state of health with standard drugs.
The first step to start believing in the healing capacities of nutraceuticals was the publication of clinical trials in humans in prestigious scientific journals. Stephen de Felice is a pioneering doctor of medicine who founded the term nutaceutic and published a clinical trial with nutaceuticals for the first time in the New England Journal of Medicine.
In addition, medical nutraceutical organizations have worked hard to ensure that most of the nutraceuticals that are marketed have guaranteed quality. All of these are requirements: to be purified by non-denaturalizing methods; to overcome strict analysis of stability and chemical and toxicological analysis; to pass repetitive tests of bioactivity in animals and humans; and, like drugs, validation and development processes follow the scientific criteria of the FDA (Food and Drug Administration) -- unlike Europe, the criteria established by the United States as pairs of nueutical drugs.
All indications point, therefore, to the fact that nutraceuticals are making room every day in the therapeutic one and it seems that the difference with the drugs is less and less. However, there are many reasons that lead us to rely more on medicines.
The main problem of nutraceuticals is in the legislation. In Europe, drugs and foods of special nutritional use (PARNUTS) have specific legislation, while nutraceuticals must only comply with general food regulations. Therefore, the legal controls to which nutraceuticals must be subjected are not as strict as those of drugs, even though the medical nutraceutical organizations are working seriously against it.
Therefore, how can we demonstrate that all products that are marketed as nutraceuticals meet the quality criteria? For example, if not legally necessary, it would be possible that they contain no more, less or no bioactive substance than indicated on the product label; or that the biological effect it preaches was not scientifically demonstrated.
In addition, we cannot forget that nutaceuticals, in general, are produced by food industries, which usually have less resources than pharmacies: they have a much lower research budget, have less experience in safety and efficiency tests, use less patented technology, etc. However, the interest of the pharmaceutical industry is also high, and at the beginning of this century the strategic mergers between the food and pharmaceutical industries have increased considerably. For example, in the year 2000, Swiss pharmaceutical giant Novartis bought the world licenses of two nutraceuticals developed by GalanGen and Forbes Medi-Tech. GalanGeni acquired worldwide the rights of the natural immunological components (Proventa) obtained from the breast milk (oriz) of the first days, and the patent of the sterols Forbes Medi-Techi, compounds derived from the plants that reduce cholesterol.
Another drawback to bear in mind is that some manufacturers use the natural character of nutaceuticals as safety stamps without any proof. In most cases, the biological effect is only shown in animals and no clinical trials are performed in humans. Therefore, it cannot be guaranteed that the therapeutic effect is real or, perhaps more important, that it has no adverse effects. In addition, nutraceuticals do not carry out interaction tests with drugs, so if taken together with the drugs, unknown or unwanted adverse effects can occur.
It is clear, therefore, that the use of nutraceuticals has its risks. They can be beneficial to health and, according to some experts, biotechnological development can contribute in the near future to many of the drugs obtained through chemical synthesis. However, research into the biological effects and adverse effects of nutraceuticals remains different from that of drugs. Therefore, in case of taking nutraceuticals, it is important to obtain reliable information about them and to agree with the doctor.