Pharma-nutrition: a new treatment paradigm?
Paul Tunnah interviews Professor Johan Garssen
Danone Research Centre for Specialised Nutrition
Way back in the early days of the pharmaceutical industry, the first medicines were derived from well-known food supplements or herbal remedies. Over time, the concept of a “medicine” has been well defined with clear differentiation from such foods and supplements and a dedicated regulatory pathway to assess safety and efficacy.
However, a number of modern diseases remain linked to poor diets and the concept of “malnutrition”, even in those consuming a sufficient quantity of calories but lacking appropriate balance of several food ingredients such as amino acids, peptides, minerals etc.. In addition, there is emerging evidence to suggest that certain nutritional supplements can yield patient benefits when combined with the more widely used drug treatments.
So are we missing a trick in helping patients by purely focussing on highly targeted chemical or biological agents and is the area of medical nutrition about to take off? Professor Johan Garssen, a veteran of this field, discussed his views with pharmaphorum and explained why he sees more and more pharmaceuticals diversifying into the nutrition space. Are drugs and medical nutrition about to converge in a big way?
PT: Hello Johan, thanks for taking the time to talk about pharma-nutrition with me. Can you summarise your current role and background please?
JG: I originally studied medicine and biology in Amsterdam and then decided to continue in research, moving to Utrecht for a PhD study on allergy and the role of a subset of immune cells known as T-lymphocytes. During this PhD program I moved for a while to Yale University in the United States, again focussing on allergy. After this I moved to the National Institute for Public Health and Environment in the Netherlands, which is comparable to the NIH in the United States. My research at that time focussed on immunology and the influences of all kinds of triggers such as foods, toxic compounds and drugs on the immune system. In 2002 I joined a company called Numico, which was and still is active in the field of medical and infant nutrition, prior to its acquisition by Danone. Since 2005, in addition to continuing my role in the new company, I took the Chair of Immunopharmacology of Nutrition at Utrecht University within which capacity I work with a number of pharma and specialised nutrition companies to understand the role of nutrition in the immune system and general health.
"...a key point is that many diseases are inherently linked to specific malnutrition anyway..."
PT: The term pharma-nutrition is relatively new, so how would you define this area?
JG: To be honest, this is a new term which I have developed together with Elsevier to explain the confluence of the fields of nutrition and pharmaceuticals. However, the term encapsulates the area well because we are dealing with nutrition with a pharmaceutical effect – that area where it’s not a drug and it’s not just nutrition, it’s exactly in between. I believe this space could lead to prevention of many kinds of diseases alone, but could also influence the effectiveness or toxicity profile of pharmaceuticals. For example, where cancer patients are receiving radiotherapy or chemotherapy the addition of a nutritional treatment element could reduce the side effects and allow higher treatment doses, indirectly improving the treatment outcome. Also, a key point is that many diseases are inherently linked to specific malnutrition anyway, meaning insufficient levels of certain nutritional ingredients such as individual amino acids , minerals or even carbohydrates.
PT: How would you define the difference between something which is a food or a nutritional supplement and something which is classed as a pharmaceutical drug?
JG: With traditional drugs, we are mostly talking about chemical structures which are designed to focus on a single target in vivo. With nutrition, particularly medical nutrition, it’s a multi-target concept – an approach which is increasingly recognised as relevant to disease treatment and prevention. Another difference though is that clinicians normally decide on the dosing (e.g. one pill a day or two pills) for pharmaceutical drugs, whereas with nutrition it is down to the consumer, so it’s your choice whether you have two, three or four yoghurt drinks a day. But medical nutrition sits in the middle, so you need professional physician advice on whether you need it, but it more closely resembles normal foods in taste and appearance, which often helps patient compliance.
PT: So how regulated is the area of medical nutrition?
JG: For supplements that have been around for many years they are not that well controlled. However, the newer area of medical nutrition is very different and research is required before bringing products to market under the Food for Special Medical Purposes (FSMP) regulations. In addition, the majority of medical nutrition is reimbursed, so it’s a world apart from the types of products and claims you see on the supermarket shelves, which are not always science driven!
PT: If you have something which is borderline between being a medical nutritional product and a drug where does it sit?
JG: It’s honestly not that clear and a key driver for bringing the two worlds together at a single conference! But again, when we talk about a drug we are normally talking about a chemical structure with a single target, whereas medical nutrition may be a mixture of many different ingredients with many different targets.
"...medical nutrition may be a mixture of many different ingredients with many different targets."
PT: How uniform are the regulations across the US and Europe in this space?
JG: There are some key differences and regulations such as FSMP are continuously under development, so it’s not always clear for each country what the rules are. As more and more pharmaceutical and food companies enter this space I know of examples where the development of a medical nutritional supplement has been stopped in the US because it could not be determined whether it was a drug or not or simply food. So individuals from across pharma, the food industry and the regulatory bodies need to get together and develop clearer guidance and processes.
PT: And how are the medical claims around nutritional supplements policed?
JG: For medical nutrition, there are clear and logical rules, so that when you make a claim there should be solid, peer-reviewed clinical trial data to support it. Without such clinical trials supporting the claims no medical nutrition would make it to market as it would not get reimbursement and would be classed as standard food.
PT: Is that clinical trial process the same as the one we use for traditional drugs?
JG: No, it’s a bit different. For traditional drugs we have the long route of phase I, II, III and IV trials. Time to market for new drugs is huge. For medical nutrition the time to market is much shorter because you don’t need for example the extensive safety studies on all nutritional ingredients since these ingredients in most cases have a long history of safe use already. However, for medical nutrition safety dossiers are also key of course! Incidentally, this makes it an attractive area for pharma companies to step into as the time to market is much shorter. However, the process could change over the coming years as the regulations are under development and could get more strict.
PT: Where do you see medical nutrition having the most impact in terms of disease areas?
JG: There is already a lot of reimbursed medical nutrition on the market. To give you some examples, there is a very nice product called Respifor® used by patients suffering from chronic obstructive pulmonary disorder (COPD). These patients are often malnourished and low on energy, but it helps restore energy levels and keep them moving to improve quality of life. There are also several products on the market from companies like Abbott, Nutricia and Nestle for cancer patients, not aimed at inhibiting tumour growth but again at improving quality of life by increasing energy levels and managing treatment side effects.
"Incidentally, this makes it an attractive area for pharma companies to step into as the time to market is much shorter."
PT: And what about exciting products in development?
JG: Currently there is a concept in development for Alzheimer’s Disease, which is based on an impressive scientific dossier and is aimed at delaying the process rather than inhibiting the actual disease. It was developed between MIT, USA (Professor Wurtman and his team) and Nutricia research in the Netherlands. Right now it has a single positive clinical trial off the back of strong pre-clinical data and larger trials are underway across many US hospitals with the aim of bringing it to market. Another nice example is one that I am personally involved in where we are looking at a nutritional concept for HIV patients. Conventional anti-viral therapies have a lot of side effects so we are investigating whether certain diets can delay the onset of AIDS after being infected with the virus. In addition, more and more data are emerging that suggest that the gut plays a key role in AIDS progression in association with immune deficiency and at the same time immune hyperactivation. Clinical trials in Italy, the US and South America indicate highly promising effects by our medical nutrition concept. We hope that it will be on the market soon.
PT: So how does the traditional medical community view these new nutritional approaches?
JG: This is a very good question. As a scientist I believe very strongly in this field, but when we go to discuss the concept with medical students we notice that they are poorly educated on nutrition. So we need to train clinicians to inform such students about this area, to educate them and explain what can be achieved with nutrition. In my Chair within the faculty of Pharmacy we train the pharmacists to always bear in mind nutrition on top of traditional drug treatments. Also, in specialist areas such as oncology we notice that the oncologists are primarily focussed on making the tumour disappear through chemotherapy, radiotherapy etc. but they can forget that a better quality of life can be achieved simultaneously for the patient through better nutrition. So an important goal for us is to keep educating physicians, but it is going in the right direction.
PT: Given many of these medical nutrition products must be fairly cost-effective, are governments embracing them?
JG: Another good point. Here, the regulation aspect might be a problem as not all governments know how to handle medical nutrition. Many scientists and regulators are working on this, developing specific regulations such as FSMP, but insurance companies will also play a key role moving forwards as reimbursement is critical. So we need to bring in the health economics angle and be clear on the health benefits. For example, if use of medical nutrition means a cancer patient stays a shorter time in hospital or dermatitis patients need less corticosteroids then this could save a lot of money. Such calculations are being performed and will help get governments more onboard.
"...we need to train clinicians to inform such students about this area, to educate them and explain what can be achieved with nutrition."
PT: Where do you see the medical nutrition market going in the future, do you think it will be as big as the traditional pharmaceuticals market?
JG: Many big pharma companies are struggling and therefore realising that the multi-targeted approach is not a bad idea. They are getting more involved in clinical nutrition, as are big food companies such as Danone and Nestle, who recently announced they would be investing millions of Euros on medical nutrition over the coming years. So the whole area will gain more and more attention. However, if this means that the regulations move more towards pharma it will cause serious problems as many nutrition companies cannot afford the long trials process in place for drugs. Nevertheless, I believe medical nutrition has a very major part to play in the future.
PT: Finally, where can people find out more about medical nutrition?
JG: There are some good journals stepping into this area like the Journal of Clinical Nutrition, the European Journal of Pharmacology. You can also look at the forthcoming Pharma-Nutrition conference website or the websites of any of the companies involved in this field.
PT: Johan, thanks very much for sharing your thoughts and I hope your event goes well next year.
About the interviewee:
Johan Garssen is the Research Program Leader of “Immunopharmacology” at the Utrecht Institute for Pharmaceutical Sciences as well as the Director of the Immunology Platform at Danone Research Centre for Specialised Nutrition in The Netherlands.
Johan is chairing the forthcoming Pharma-Nutrition conference organised by Elsevier and being held in Amsterdam from the 18th to 20th April 2011. For more information about the event and to register please visit either the listing on pharmaphorum or the dedicated event website.
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