Turf war looms as more foods encroach on pharma territory

Functional foods manufacturers are straying into areas traditionally belonging to pharmaceutical companies, and the over-the-counter brands are not going to give them up without a fight. It?s a turf battle that could have long-term implications for both sectors, says Julian Mellentin

One of the great hopes for functional foods is that by allowing people to manage their own health by consuming foods with specific health benefits, the burden can be reduced on individuals, insurance companies and state health systems of having to fund expensive drugs.

There are many people who still believe that cholesterol-lowering plant sterol/stanol-based foods can complement or even reduce the need for cholesterol-lowering drugs, known as statins. Sterols and stanols are found naturally in vegetables, fruits, legumes, nuts and grains; they are found in especially high quantities in sesame seeds and such oils as rice bran, safflower, soybean and olive. Because these phytosterols look like cholesterol in the body, they inhibit cholesterol's absorption, providing a natural option in the maintenance of cardiovascular health. This has raised a new question, however.

What if statins become an over-the-counter (OTC) medicine, price competitive with sterol-based foods? And what if many more OTC products take on food forms and compete with functional foods? It sounds far-fetched, but it may become a reality.

In November 2003, a public consultation document was published by the UK?s Medicines and Healthcare Products Regulatory Agency. It proposed that statin drugs—the drugs that lower cholesterol and help reduce the risk of heart attacks—should be made available OTC at pharmacies in six to 12 months. Currently they are available only by prescription.

The statin drug Zocor Heart-Pro, a low-dose 10mg version of simvastatin, is currently at the public consultation phase, implying that the UK?s Committee on the Safety of Medicines has already decided that the drug is suitable for OTC use. Some of the impetus for this move has come from the Proprietary Association of Great Britain (PAGB), a trade association of manufacturers of OTC medicines and food supplements.

It may seem like a footnote but it is part of a wider trend—a trend with potentially serious implications for companies marketing functional foods with more medical benefits, such as sterol-based products for lowering elevated cholesterol.

Consumers take control
Interestingly, the arguments put forward in favour of the move are reminiscent of those used in favour of permitting sterols and stanols to be widely available in foods. ?We have long championed the right of the individual to take control of their health,? says Sheila Kelly, chief executive of the PAGB, adding that access to statins over the counter ?will represent a huge breakthrough for the individual?s right to take an active role in their health.?

Should statin drugs go OTC in the UK, many of their makers will look to take the concept to other countries. Consumers will find that in the supermarket they will at last have a choice—a cholesterol-lowering spread from the chiller cabinet or a packet of cholesterol-lowering pills from the pharmacy section. They will also be able to compare prices.


?If you and your doctor are deciding between Benecol and Pravachol IO (a statin drug), and Pravachol is 30 cents a pill and Benecol is 50 cents a serving, that doesn?t make for a good comparison for Benecol,? says Ken Harris, consultant for US-based marketing and sales consultancy Cannondale Associates. For brands like Benecol spread—already struggling to hold its head above water—this could have serious implications.

Indeed, this threat makes packaging innovations such as the advent of Benecol daily dose, 65ml cholesterol-lowering dairy drinks on the European market, all the more important. The convenience that such formats offer—a daily dose in a single bottle, instead of three slices of bread and spread a day—coupled with the lower unit cost could enable sterol foods to better compete on both convenience and price with OTC statins.

If, on the other hand, statin drugs are on sale in pharmacies and find their position being undermined by sterol-based foods and beverages, we can be sure that it won?t be long before the pharma companies point out the paradox of having two ingredients in the supermarket, one in the food section, the other in the pharmacy section, both offering the same clinically established health benefit but one regulated as OTC and the other as a food. It might be tempting for pharma companies to press for OTC-style regulations for sterol-based foods, as this may yield some competitive advantage.


OTC functional foods
Having spectacularly failed in functional foods, it is tempting for pharma companies, such as GlaxoSmithKline, Novartis, McNeil and many others, to investigate how they can use existing brands and strengths to better defend the market of sick people at whom functional foods product development is targeted.

In this respect, the significance of Benecol?s stanol esters in daily dose bottles must not be overlooked. It is a format that is very close to a dietary supplement or an OTC medicine—a quick shot for a clear medical purpose (lower cholesterol) rather than a food consumed for pleasure or satiety.

To the makers of OTC medicines, it looks like the food industry has sketched out an opportunity—a niche that it also can tackle. If currently approved OTC medicines can be formulated into juice, soy milk, water or milk and packaged in a shelf-stable daily dose format, this could give them a convenience and ?on-the-go? appeal that ties in with modern lifestyles. Marketed under existing OTC brands, they could go on-shelf in the pharmacy section of the supermarket or in the drugstore.

If that sounds far-fetched, don?t rule it out. Right now several pharma companies in the US and Europe are working on precisely this strategy—a strategy already found in Asia—in a bid to make self-medication more convenient and capture more value.

If pharma companies go through with this, then the paradox of daily dose OTC medicines existing alongside seemingly identical daily dose functional beverages can only reinforce the interest from some quarters in extending OTC regulation to embrace functional foods.

Oddly enough, that could take functional foods right back to where they started. A brand called Becel—a word based on the letters BCL, an abbreviation for blood-cholesterol-lowering—first appeared, in a can, in Dutch pharmacies back in the late 1950s. Made by Unilever, it was a polyunsaturated spread, available only on a doctor?s prescription, and was prescribed to people who had had a heart attack or had seriously elevated cholesterol as an alternative to consuming butter. In the 1960s it evolved into supermarkets as a regular food, marketed under the Becel brand in some countries and the Flora brand in others, and its medicinal heritage was forgotten. Flora has since become the umbrella brand for Unilever?s pro.activ cholesterol-lowering spreads, marketed in regular supermarkets.

Makers of dietary supplements are already taking the first tentative steps to extend their brands and product concepts out of the supplements aisle and into foods and beverages. The same approach by OTC makers cannot be ruled out. The functional foods world could yet get a lot more complicated.

Julian Mellentin is editor of New Nutrition Business, from where this article was taken. www.new-nutrition.com.

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