I appreciate the Commission's allowing me to present the Metagenics perspective on the role of nutritional supplements in Complementary and Alternative Medicine (CAM).

Medicine is experiencing a seachange. This rapid and tumultuous transition is driven by the intersection of a number of factors. Access to information is increasing awareness on the part of healthcare consumers and consequently increasing their expectations for maintaining their health. The ranks of these aware consumers are swelling as the Baby Boomer generation ages. The involvement of third-party reimbursement organizations is causing a breakdown in the doctor-patient relationship. And, finally, biomedicine is making revolutionary advances related to the discovery of the causes of chronic age-related diseases.

The PriceWaterhouseCoopers HealthCast 2010 Report summarizes three forces of change driving this seachange:

1. Health consumerism
2. E-health information
3. Genomics (personalized medicine)

The focus of this presentation is to explain to the Commission how these forces relate to the role of dietary supplements in the practice of Complementary and Alternative Medicine.

Historically, clinical nutrition and nutritional supplementation have not played a significant role in medical education. These topics have been excluded from medical school curricula since the university system was separated from land grant colleges or agricultural schools. Doctors, who were principally males, were trained at the university, while women and farmers went to agricultural colleges, where their subjects included nutrition, home economics, and dietetics. Male doctors came to regard nutrition as unscientific, or "women's work." This bias has characterized the role of nutritional supplements in medicine for the past 40 years.

In a 1998 Archives of Internal Medicine article titled "Battling Quackery: Attitudes about Micronutrient Supplements in American Academic Medicine," James Goodwin, MD, pointed out that nutritional supplements have been the most severely criticized topic in medicine during the past four decades.1 He defends this statement with an historical analogy. Galileo, he explains, was not the first to present the heliocentric view of the Universe. Copernicus had done so at an earlier date. Galileo, however, was the first to present that theory not in Latin, the language of the professional guild, but in Italian, the language of the common people. He broke the rules of the guild by popularizing the concept, and he put himself in jeopardy before the grand inquisitor as a result.

The area of nutritional supplements in medicine has a similar history. Many of the pioneers in this field left the medical "guild" and took their message directly to consumers. Examples include two-time Nobel Prize winner Linus Pauling, with his revelations about vitamin C; cardiologist Wilford Shute, with vitamin E; and pathologist Kilmer McCully, with atherosclerosis and vitamins B6, B12 and folate.

The response of the medical institution to these pioneers has been to dismiss them with the recommendation that individuals simply "eat a diet of variety and moderation" to get adequate levels of micronutrients as described by the Recommended Dietary Allowances (RDAs). The RDAs are defined as "the levels of nutrients needed by practically all healthy people" to prevent undernutrition, as determined by the absence of scurvy, beriberi, pellagra, xeropthalmia, rickets, kwashiorkor, marasmus, or anemia. These deficiency diseases, however, are not major concerns for most people in their expectations for healthy aging.

The April 9, 1998, issue of the New England Journal of Medicine signaled a changing of the guard with the publication of the editorial titled "Eat Right and Take a Supplement."2 The author, G.P. Oakley, MD, points to the recent discovery that heterozygous forms of homocysteinemia occur in 10 to 15 percent of the general population. The widespread occurrence of this condition, he wrote, indicates that increased levels of B12, folate, and B6 may be necessary in supplement form beyond a balanced diet to meet the genetic determined needs for these vitamins. Adequate levels of these vitamins, provided by supplementation, may help prevent heart disease, stroke, the dementia of aging, or even cancer in these genetically predisposed individuals.

This is not a new concept. In 1902 Archibald Garrod, father of the concept of genetic metabolism diseases, wrote in the Lancet, "Disease may occur as a result of the variations in molecules and their concentrations in the body."3 This theme was mirrored in 1949 in Linus Pauling's groundbreaking paper titled "Sickle Cell Anemia: A Molecular Disease." He found that genetic differences among individuals could account for the production of diseases with symptoms across many organ systems.4 In 1952 Roger Williams, PhD, discoverer of the B-vitamin pantothenic acid, wrote about biochemical individuality and genetetrophic diseases. He postulated these diseases were modifiable by personally tailored nutritional therapies.5

In 2001 this concept is described as "functional genomics." Through advances made in understanding the genetic code locked within our 23 pairs of chromosomes, researchers have determined that common age-related diseases are not single-gene diseases and inevitable, but that they are instead controlled by multiple genes on different chromosomes. They are usually not expressed as disease until the person's genes are plunged into a harmful nutritional environment and lifestyle. In a sense, this relates to the concept of "genetic potential through nutrition." Nutrition and micronutrients bathe our genes each day with information from which our phenotypes result.

If health expectations of aging Baby Boomers include living 8 to 10 reasonably disease-free decades of life, then we must find new, cost-effective ways of getting the "healthy messages" from our genes.

This discovery process begins with appropriate diet, combined with providing levels of essential and accessory nutrients necessary to promote healthy aging for each individual. Human beings are polymorphic organisms with much more diversity in functional genomics than we previously recognized. The old rules don't apply to the new health expectations.

How long did it take to accept the Goldberger's observation that niacin in liver could both prevent and treat the dreaded disease pellagra? How many years passed before we heeded the observations of Captain James Cook and Dr. Robert Lind that foods rich in vitamin C foods could prevent and treat scurvy, the disease that killed more sailors than all other causes of maritime death combined? In both cases, the answer is more than 50 years. Old presumptions about nutrition often change slowly and with great resistance.

We are currently witnessing the first science-based examples of a functional genomics approach to determining an individual's nutrient needs. One example is the identification of the folate and B12 needs of individuals with the methylenetetrahydrofolate reductase genetic polymorphism that may be present in 20 to 30 percent of the population.6 Another is the recognition that certain individuals possess a genotype that causes them to be poor detoxifiers. These individuals require higher levels of glucosinolates, phytonutrients from cruciferous vegetables, to provide protection against certain carcinogens.7

These observations are not the result of double blind, placebo-controlled trials. They come from studies that include multiple variables and use complex bioinformation and pattern recognition to identify specific health outcomes, combined with evidence from gene expression investigations.

The medical laboratory of the future will analyze physiological function and gene expression patterns in a dynamic, "real world" state rather than rely on static pathology-based assessments. These analyses will be performed for just pennies per gene analyzed from a single spot of blood.

In the meantime, combining clinical observation with animal and human epidemiological studies and multivariate intervention trials will provide direction for the improved management of a patient's health expectations.

Diet and nutritional supplementation will be individually tailored. The 21st century physician will guide patients in ways to improve function throughout their lives, thereby promoting an improved health span. The early data are already available, and they shout encouragement. Two such positive examples are the work of James Fries on Stanford alumni who extended their health span, and Dean Ornish, MD, with the treatment of cardiovascular disease.10, 11

We are moving rapidly from a descriptive to a mechanistic perspective in understanding the origin of age-related chronic degenerative diseases. The application of molecular nutrition and diet therapy to these diseases will be increasingly important in improving health outcomes and increasing the cost effectiveness of what is called "good medicine."

Recommendations

The present seachange in medicine argues that clinical nutrition and molecular nutrition should be taught in all medical schools. Clinical competency courses on molecular nutrition should be provided as part of postgraduate training. Research on the role of nutrients in prevention and treatment of disease should be pursued across disciplines. The design of such research should be multivariate in nature rather then solely double-blind, placebo-controlled. Insurance reimbursement should be provided for nutritional assessment and intervention.

We can prevent unnecessary premature deaths, increase people's health spans, and reduce unnecessary medical expenditures if we hasten the integration of this revolutionary body of knowledge concerning nutrition and nutritional supplements based on genomic need into general medical practice. I urge the Commission to support these recommendations related to the role of nutrition and nutritional supplements in the application of science-based Complementary and Alternative Medicine.

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