Jun 4, 2008
Nutraceutical News
I discovered a rather intriguing perspective on the world of wellbeing, health and nutrition in the latest issue of the journal World Review of Science, Technology and Sustainable Development (2008, 5, 104-123). In it, Sundus Tewfik of the Department of Health and Human Sciences at London Metropolitan University and Ihab Tewfik of the University of Westminster, shed light on nutraceuticals, or functional foods as they are sometimes called. You will doubtless have seen mention of functional foods and botanical dietary supplements as they seem to fill the advertising space in Sunday supplements and feature regularly in lifestyle magazines.
Apparently, nutraceuticals promote wellbeing and underpin public health by providing a supposedly natural way to lower raised cholesterol levels, help unblock clogged arteries, ward off otherwise inevitable cancers, and ease the machinations of the over-sensitive gut. All this, without anyone having to resort to pharmaceutical products and double-blind placebo-controlled clinical trials.
It’s the opening paragraphs of the paper that were the most interesting with regard to the state of play when it comes to the gradual public acceptance of the marketing hype surrounding nutraceuticals:
Consider this domestic scene: it is a typical Sunday morning in an English household in the city of Westminster, London. Mrs Jones is preparing breakfast for her family. Like most mothers, she is concerned about her family’s nutritional status and tries to cook healthy meals. This morning it is an English breakfast, but not just an ordinary one.
Personally, I doubt there are many such domestic goddesses around these days, particularly in Westminster, but more to the point, I think many families these days rush breakfast with at best a quick splash of synthetic fruit juice, and some artificially flavoured cereal rather than feasting on the great English breakfast. But, that aside, the researchers then describe the menu:
The wholemeal bread was made out of grains to increase dietary fibre intake and essential micronutrients, thus helping bowl [sic] movement and support the gastrointestinal tract. The omega 3-enriched eggs will enhance the immune system, reduce the risk of cardiovascular diseases (CVD) and blood clotting. The sugar-free orange juice has added vitamins and antioxidant nutrients, believed to reduce the risk of diabetes, CVD and cancer. The extra virgin olive oil she uses to fry the eggs [You shouldn't use extra virgin to fry, it degrades rapidly at high temperatures, db] has been chosen to help lowering her mother-in-law high cholesterol.
Agreed, wholemeal bread is probably better for bowel movements than bland and bleached white bread, but wholemeal, while functional, is not the breakthrough health product. After all, my grandmother extolled the virtues of roughage to me decades ago.
The mention of omega acids and antioxidants is possibly valid, but there are no wide-scale trials yet to backup some of the wilder claims made in the popular press. Indeed, adding to one’s diet excessive amounts of antioxidants could
ultimately
compromise one’s
immune systemantioxidants could ultimately compromise one’s immune system. The i immune system, after all, relies on its own oxidants to kill invading pathogens and destroy cancer cells.
Next, the team suggests that the breakfast sausages with “less than 1% fat” will somehow eliminate any risk of CVD posed by saturated fatty acids. Well, 1% might be described as low fat, but I’d prefer the term reduced, but again, I am not sure how functional are reduced-fat sausages.
One of my many pet peeves regards the claims surrounding so-called organic foods. The jury is still well and truly out on whether there are any benefits and as for the lack of pesticides and fertilisers requires some of those used by organic practitioners are already known to be more hazardous. The beans, tomatoes and mushrooms being “organically grown” also does not take into account the fact that just because Mrs Jones in Westminster can afford the luxury of organic this does not mean organic is better for the world. Energy expenditure for organic farming on a large enough scale to feed the world could be significantly greater than in non-organic methods.
Finally, the salt used by hubby was specially manufactured to help minimise his high blood pressure. Well, yes, I’d concede that’s a functional food. But, whether or not a sprinkle of non-sodium salt is going to benefit Mr Jones’ blood pressure is not beyond doubt; alcohol consumed, cigarettes smoked, processed foods eaten, and genes inherited, play a much bigger role. More to the point, given that the sausages will have been made with salt, why not simply not use salt at all, those organic foods are claimed as more flavoursome anyway, so no need to enhance with salt.
The researchers end their introduction with the thought that this Westminster breakfast is not a scene from ‘Balanced-Nutrition’ program on national television, it is the era of medicinal and functional foods and it is happening as we read this paper in many parts of the world. This is not just food this is ‘functional foods’.
Well, I am not so sure, most of what they describe is not functional in the conventional sense, although elsewhere in the paper they list dozens of functional foods and herbal supplements such as ginseng and Gingko biloba. There may certainl dozens, if not hundreds, of food products now on the market that claim some kind of health functionality. But, the whole notion of a supplemented diet that might improve wellbeing has been stacked very high in recent years. There are shelves full of milky probiotic drinks full of microbes that supposedly repopulate your intestine with good bacteria, products with plant steroids to reduce cholesterol, ward off the menopause, and dozens of herbal extracts each one of which is seemingly a cure-all for a wide range of disparate health conditions.
As long ago as 2001, uber-skeptic of the alternative medicine movement, Edzard Ernst of Exeter University, asked whether functional foods, neutraceuticals, and designer foods are simply
an innocent
fad or a
counterproductive marketing ploy?functional foods, neutraceuticals, and designer foods are simply an innocent fad or a counterproductive marketing ploy? (Eur J Clin Pharmacol 2001, 57, 353-355). He pointed out that so-called functional foods invariably contain less than therapeutic quantities of their active ingredients and may contain higher levels of apparently “unhealthy” ingredients such as saturated fats.
Almost a decade later, there is still a lot of health hype in those lifestyle magazines and supermarket shelves are increasingly stacked with organic produce, with its premium price tag, and healthstores are packed with botanical products from all corners of the globe. Is this food fad just a cynical marketing exercise, not only for food manufacturers, who can charge more by making dubious health claims for their products, but also for the pharmaceutical and health-care product companies who are now, as blockbuster pipelines dry up, providing the ingredients for the functional diets we are all being told we must consider.
I suspect, once the advertising revenues dwindle and the lifestyle magazines become necessarily bored with the functional food fad, that ultimately many will be left on the shelf while the next moneyspinner rings the changes at the checkout.
UPDATE> I’ve been having an interesting correspondence with commentator David Lustig who points out that there are some very rigorous double-blind placebo-controlled trials omega 3 products. These were carried out for the approved prescription drug Omacor, sold by Reliant, which is essentially nothing more than purified, concentrated fish oil. It has a profound effect on lowering triglycerides and is currently one, if not the only effective approved drugs for hypertriglyceridemia. Lustig suspects it will probably sell at least US$500M this year.
It’s an interesting point at the extremes there is a blurred division between the pharma and the nutra. However, this FDA approved product can in no way be categorised as being of the same ilk as probiotic yoghurt, although it is nothing more than concentrated fish oil a lot can happen when something is concentrated. More to the point, it will be almost 100% free of the kinds of contaminants, such as mercury, that might be found in the healthfood store kind of omega 3 fish oil products that are at much, much lower concentration.
Is there room for the category to end up somewhere in between?
I was surprised at the myriad routes to discovery of prospective commercially viable active pharmaceutical ingredients, a powerful lot of which seem to derive from natural sources, many of which are reckoned to constitute foods in some parts of the world.
The mechanistic infrastructure of scientific observation and the posting of models to represent behavior depends on observation of phenomena and the hypothesis of explanatory theory, as I understand it.
When the consumption of ephedra killed enough people, folks began to take that one pretty darned seriously.
A good deal of what people eat, breath or absorb through their skins seem to end up in the liver, the body’s filter, at one point or another according to my very rudimentary understanding of anatomy.
What those substances conspire to do together there and in the bloodstream can sometimes get kind of difficult to predict, as there seems to be a powerful amount of variation in what different people will do, eat and drink at different times.
There’s a Chinese sensibility that all food has medicinal properties, some yang (or positive, termed “heating”) and others yin, believed to be “cooling.” The traditional “five elements” school of medicine holds the liver to represent a positive vessel of yang essence, analogous to the element of wood.
Seems to make as plausible a model as any, I reckon.
I think there may be ample opportunity for this area to become both big business and for certain parts of it to end in tears for all concerned, just as energy and transportation and commodities and realty have ebbed and flowed over time.
Horatio: “O day and night, but this is wondrous strange.”
Hamlet: “And therefore as a stranger give it welcome. There are more things in heaven and earth, Horatio, than are dreamt of in your philosophy.”
Links:
http://www.vivo.colostate.edu/hbooks/pathphys/digestion/liver/
http://www.healthcentral.com/peoplespharmacy/pp_guides/PDF/gfruit02.pdf
http://www.dailymail.co.uk/health/article-1025277/Quack-medicine-Peking-duck-better-heart-statins.html
The two options in your question aren’t mutually exclusive. Nutraceuticals can indeed be both The Next Great Thing and quackery at the same time.
With good marketing, you can sell anything. The Next Great Thing.
Unfortunately, much of that world is based on unproven claims. Anecdotal stories are not a substitute for double blind, placebo controlled clinical trials. The problem is that trials like these cost an enormous amount of money, which is problematic when the agent being tested is a low priced commodity.
There are certainly some success stories. Niacin, also known as vitamin B, does indeed raise HDL – the good cholesterol. But because it has the problem of facial flushing (itchy redness) as a side effect at the efficacious dose for many people, it’s not easy to just go to the drug store and buy a substitute. Pharmaceutical companies have come up with solutions to the flushing issue and are selling them as proprietary prescription drugs. The ability to make money off of it allowed for the clinical trials to prove that it does indeed raise HDL (though no one has yet done an outcomes trial to see if that does actually increase longevity or decrease cardiovascular events).
Anecdotally, though with some clinical trial results, Vitamin C in doses of 2000 – 3000 mg a day will also raise HDL. But with Vitamin C, there are no issues to solve with products that aren’t already available at the grocery store, so it’s unlikely that rigorous trials will ever be conducted unless it’s in combination with another drug like a statin for a combo pill that lowers LDL and raises HDL.
One could argue that clinical trials should be sponsored by the government as a matter of public health. Though where does that leave the nutraceutical business? At best, each company will compete against all others as a commodity (imagine a drug with hundreds of generics on the market).
So that comes full circle back to marketing. Nutraceuticals will sell well for companies that have effective marketing campaigns, regardless of whether there is a true health benefit or not..
I don’t think you can lump it all together. Sure, some of it is quackery, but a lot of it has good research behind it. Just remember that you can’t prove a negative. When you see an article in the news that says “Vitamin C does not help flu symptoms” you have to realize that you can never prove that something does not work. There is a lot of disinformation, probably from big pharma, trying to get people to not use alternative medicine. Nutrition is an elective class in Med School, it is not a requirement.
In my view the dietary supplement/nutraceutical sector is now a mature industry. The Dietary Supplement Health Education Act (DSHEA) was signed into law by President Clinton in 1994. As a result of this legislation, FDA promulgated regulations on labeling, Good Manufacturing Practices and Adverse Event Reporting and has issued guidelines on claim substantiation and other important topics. The NIH has established National Center for Complementary and Alternative Medicine (NCCAM) and provides grant money to study nutraceuticals and other alternative health modalities. A number of universities also have programs that contribute to the body of knowledge on vitamins, minerals and herbs.
The dietary supplement industry has experienced business cycles typical of growing and maturing sectors. Sales soared for a number of years in the 1990’s. Sales leveled off and the industry experienced a great deal of consolidation. The maturity of the industry can also be seen in the recent initiative by the Council for Responsible Nutrition (CRN) and the National Advertising Division of the Council of Better Business Bureaus (NAD) to create a pathway for responsible industry members to challenge advertising that does accurately reflect the state of the science in the area and therefore does not comply with FDA (and FTC) regulations.
In my mind the science seems potentially solid, but the telling indicator of of quackery would likely be the business model.
If it’s an MLM(multi-level marketing) or in slang “pyramid scheme” then very frequently you’re purchasing “snake oil”. If the product is produced and sold through traditional means by a reputable nutritional supplement company like EAS for example, the product quality would increase significantly.