Supplements research: the case for more studies

Despite an indelible link between health and nutrition, the bulk of available funds are siphoned into pharmaceutical research. It?s about time the supplements and health industries got together and mounted a grassroots campaign to rattle the cage, says Nutrition 21 president Gail Montgomery

Health concerns may vary from region to region, but nutrition is widely acknowledged as a key factor in achieving optimal health. Defining the characteristics of optimum nutrient intake, however, is a source of great debate among nutrition experts around the world.

In many developing countries, nutritional deficiencies are recognised as the cause of many preventable health problems ranging from relatively minor afflictions like eczema to life-altering tragedies like childhood blindness. Now, however, there is a new concern on the global horizon, as experts ponder the consequences of overfeeding and the changing nutrient balance of manufactured foods. According to the World Health Organization, nearly 1 billion adults are overweight, with 300 million estimated to be clinically obese. The epidemic is thought to be a consequence of modernisation, urbanisation and the globalisation of food markets.

A decade-long study presented at the European Society of Cardiology in August confirmed risk factors for heart disease are pretty much the same all over the planet. High cholesterol levels, smoking, diabetes, high blood pressure, belly fat, stress, inadequate fruit and vegetable intake and lack of exercise were found to be the most important factors, in that order. In May, WHO voted to implement a global strategy to address obesity, diabetes, heart disease and other unhealthy lifestyle-related illnesses. Sound clinical research will be required to reach scientific consensus in implementing such a strategy.

Defining optimum nutrient intake for disease prevention and longevity has long been the holy grail of nutrition research. Nonetheless, such work has always taken a back seat to more urgent acute care concerns like treating cancer or HIV. With the rising incidence of obesity, the research focus is now moving in a new direction. Today, more than ever, we need to understand the impact of all dietary factors on both health and disease. In doing so we should also ask the following:

  • Could vitamins, supplements and functional foods help combat the consequences of overfeeding?
  • What will it take for health agencies, governments, medical professionals, media and consumers to view dietary supplements as credible tools to assist in maintaining and optimising the health of our diet?

Clearly, the answers lie in building knowledge through research. As an industry, we should view this as an opportunity. Most consumers would like to be healthy, and to look and feel good. Helping them do this should translate to a healthier bottom line for the industry. In order to deliver on this simple promise of ?good-for-you? products, we need to invest in the clinical research that can bring credibility to our marketing claims.

Today, there is already strong research suggesting that healthy food choices and exercise are the most effective ways to combat the twin epidemics of obesity and diabetes. There is equally strong research suggesting that supplements and food fortification can dramatically improve health. Yet the public remains confused and even indifferent to this information.

Particularly, but not exclusively, in the US, negative media reports on supplements and the resulting threats of more restrictive legislation have drowned out voices praising the benefits of dietary supplements. In order to provide evidence that these products can make a significant and measurable difference in health outcomes, well-designed trials conducted to quality research standards must be undertaken.

Presently, less than two per cent of US government-funded national research dollars are allocated for prevention, yet there is almost universal acknowledgement that lifestyle intervention is the most effective tool for managing diabetes, one of the most costly chronic diseases.

The National Institute of Health funding support for dietary supplement research in 2002 was $127 million, less than one per cent of the approximately $16 billion total NIH dollars that go to extramural research grants. There are no reliable figures on business-funded supplement research, but it must pale in comparison to US drug companies? spending. According to Washington DC-based trade group Pharmaceutical Research and Manufacturers of America, $33.2 billion was spent in basic laboratory research in 2003 alone.

Raising the issue of the disparity should be a priority for the supplement industry and for those academic and non-profit institutions that have a vested interest in a more prevention-oriented approach to health. Marshalling appropriate resources for nutrition research will also require grassroots support from consumers so that public monies are appropriated for their interests.

Unfortunately, controversy and contradictory reports have created consumer indifference to most of our nutrition messages. The controversial reporting on the proposed benefits associated with low-carbohydrate diets, the food pyramid, anti-oxidants, vitamin E, calcium and oat bran have damaged our credibility. Peer-reviewed research is a cornerstone of effective health care communications and can rebuild trust. However, nutrition research needs to be focused and coordinated. Without an industry champion, such research will continue to languish.

The lack of patent protection on existing supplements and the high cost of drug development make it unlikely our industry can fund large-scale, gold-standard clinical trials

The lack of patent protection on existing supplements products, and the high cost of pharmaceutical development, make it unlikely our industry can fund large-scale, long-term, gold-standard clinical trials. Prevention outcomes would take longer yet and be even more costly. Therefore, our industry needs a new research paradigm that can provide quicker turnaround. We need to get comfortable with the idea of pursuing drug-like outcomes for treatment claims, even though regulators currently discourage the use of those claims for supplements.

Dramatic treatment outcomes, even in small patient populations, may be the best way to get the research spotlight focused on the value of our products. A small gold standard trial conducted by well-respected academic researchers can quickly shine a spotlight on a new discovery. Favourable outcomes can generate significant media, health care and consumer attention, if done right. These trials can be parlayed into an opportunity to secure government and foundation monies to fund ongoing trials that can build confidence in new treatments and possibly even prevention.

The need for vitamin and mineral supplementation among at-risk, underserved populations is still debated. That hasn?t stopped one non-profit group, the Healthy Foundation/Vitamin Relief USA, from forging ahead with a programme to distribute vitamins to those in need. Still, executive director Michael Morton recognises that funding a clinical study to substantiate the health benefits of his programme is far more important than the anecdotal evidence reported by those administering the programme in low-income communities.

?We?ve been successful in securing government funding to work with an independent academic institution, the University of Medicine and Dentistry of New Jersey, to validate the significant health benefits and improved academic performance that can be gained through supplementing the diets of at-risk children. We expect that the data outcomes will be extremely important to our programme expansion,? says Morton.

Regulators and third-party payers are concerned about rising health care costs and the unchecked rise in the incidence of chronic disease. Nearly $220 billion is spent in the US alone on health care costs related to obesity and diabetes. No country?s government is in a position to ignore practical, low-cost solutions to the impending public health crisis. If the industry can provide solid data to support the economic advantages of utilising our products to prevent and treat disease, it will not be ignored.

Given the long lead times and high failure rates associated with pharmaceutical drug development, there are too few new chemical entities in the current pipelines to meet the demand for new drugs to combat chronic disease. Consumers and health care providers are dissatisfied with current treatment options.

Therefore, if product research can validate the safety and efficacy of non-prescription products that can affect nutrient and chemical imbalances at the core of many of the most common diseases, the industry should be able to garner tremendous support from both the medical community and consumers. Developing a strategic research programme is not easy, quick or inexpensive, but it can lay a strong foundation for long-term product development and sustainable business growth.

Gail Montgomery is president and CEO of Nutrition 21 based in Purchase, New York.
Respond: [email protected]
All correspondence will be forwarded to the author.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.