February 15, 2011
I read a slightly scary article in the Wall Street Journal Europe on 2nd February under the headline “Nestlé Buys ‘Medical Food’ Start-Up” (accessible online only to subscribers). The article goes on to describe some of these “medical foods”.
One product in development by the company is Fostrup, a chewing gum containing a substance “designed to bind to phosphate in the saliva of people with kidney malfunction, helping to reduce the build-up in the patient’s system”.
Other products on trial in the same company include “Eviendep, a mix— made from an extract of milk thistle and dietary fiber—to slow the progression of colon polyps, and Recoclix, a medical food to relieve pain associated with Crohn’s disease and inflammatory bowel disease”.
You can read more about these products on the company’s website http://www.cmdpharmaltd.com/randd.asp
Danone is developing Souvenaid, a product that the “company hopes will help build brain synapses to allay symptoms of Alzheimer’s.”
Hold on here. These look like medicines, and not food, to me, at least as described above. The WSJe article suggests that they may not necessarily be treated as medicines in the U.S., where there is a special regime for “medical foods”.
I think (hope?) this would not be the case in Europe.
European regulations define a medicinal product as
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
This definition clearly seems to apply to the products as described above.
Two other products mentioned in the article are Resource Thicken Up, a food thickener “for people with swallowing difficulties“, and Vitaflo cooler, a drink for the dietary management of Phenylketonuria. Foods or medicines?
The borderline between food and medicine may not always be clear cut. At an industry conference a couple of weeks ago, which began with a reception/dinner in the European Parliament in Brussels ( programme here), there was much debate about definitions. At one stage a representative of the European Commission said that food is everything you put in your mouth, except for medicines and tobacco, but that does not help much.
Why do I find this scary? Well first let me say that these products may have benefits that should not unreasonably be denied to those who may need them. However, the problem is how best to evaluate the benefits, and risks. Products with substantial (beneficial) physiological effects on the body may also have other less beneficial effects. Pharmacovigilance in the normal sense is also next to impossible for products sold widely as foods.
I fear also that many of these products will be over-promoted, to put it mildly, and that they will be sold to many people who do not need them – which would alter the benefit /risk balance. (Presumably, they will also be more expensive than conventional food products.) They may also serve to promote the myth of certain foods as “magic bullets” and divert attention from the importance of a balanced diet.
The potential market for these new products is huge. I expect to see a prolonged effort to widen the definitions of food supplements, nutritional supplements, novel foods, medical foods and the like, in order to reduce the number of products to be treated as medicines. Good science and full transparency will be needed more than ever here.
The WSJe article also reports that clinical trials are being carried out on many of the products mentioned above – not necessarily an admission that they are medicines but for the sake of safety. Time will tell if we will have access to the results, and data, and adverse effects, if any, from these trials.Author : Jim Murray