Joanna Cosgrove12.20.10
Last month the Natural Health Research Institute (NHRI) held its fifth annual Scientific Symposium which was titled “Natural Products – Cost-Effectiveness & Safety of Dietary Supplements.” Attendees, including scientists, medical researchers and health practitioners, took in two thought provoking seminar sessions led by several high-ranking industry experts who conveyed the valid and cost-effective role dietary supplements can play in healthcare.
“With the cost of healthcare increasing and representing a major portion of our national budget deficit, the NHRI considered a symposium an effective means of discussing and communicating to healthcare professionals and opinion leaders the effectiveness and cost savings that are possible by the use of dietary supplements,” explained Rick Sharpee, PhD, scientific research manager at NOW Foods Inc. also of Bloomingdale, IL, a principle supporter of the NHRI. “In the long term, prevention is the key to the healthcare crisis and nutritional supplements offer an immediate solution.”
Cost-Effective Session Overview
The first session, which focused on the cost-effectiveness of natural products, was chaired by Ron Watson, PhD, chairman of NHRI and a professor at the University of Arizona, and featured presentations by Dr. Michael Morton, the cofounder of Nourish America (formerly called Vitamin Relief USA), Dr. Paul Coates, director of the NIH Office of Dietary Supplements, and Dr. Todd Callaway of the USDA.
Dr. Morton stated that it is less costly, both economically and socially, to prevent the negative consequences of malnutrition than it is to deal with the painfully expensive aftermath. “Ideally, seniors would get three square meals a day, but they don’t,” he said. “We can break this unhealthy cycle if we provide nutrients.”
He highlighted five meta-analysis studies by the Lewin Group between October 2002 and June 2007 that found calcium with vitamin D supplements could save $16.1 billion in the reduction of hip fractures in the elderly population; folic acid supplements could save $1.4 billion by reducing neural tube defects in babies if given to women of childbearing age; omega-3 fatty acids supplements could save $3.2 billion from a reduction in the occurrence of heart disease in those over age 65; and lutein with zeaxanthin supplements could save $3.6 billion by helping people with age-related macular degeneration (AMD). The Lewin Group assumed only one-third of American seniors would take the supplements; cost savings could be even higher with greater compliance.
According to Dr. Coates, the available evidence on the cost-effectiveness of supplements in preventing chronic diseases is very limited and variable. Notable exceptions are vitamin D and calcium for bone loss and folic acid for reduction of spinal cord birth defects, he said, and pointed to the NIH’s high standard of efficacy (the randomized controlled double blind study design) as the driver for cost effectiveness. However, he assured that the ODS and the NIH consider this area of research to be very important and noted that funding has doubled, reaching $300 million, which pointed to the importance the federal government places on this area of research. He stated that “we care as much as you do about this and are working to implement cost-effectiveness principles into on-going clinical research.”
The USDA’s Dr. Calloway suggested that although dried orange peel/pulp may be a waste product to many orange juice manufacturers, the material could help save billions each year by reducing food-borne illnesses. With 27% of the population suffering from food-borne illnesses each year, costing the United States more than $150 billion per year, he explained how studies have shown that dried orange peel/pulp can effectively reduce the costs by eliminating the transfer of disease from animal to human. As an example, he cited how the bio-burden of Salmonella typhimurium and E. coli O157:H7 was shown to be significantly reduced in sheep and pigs. Dr. Callaway suggested these results had the potential to translate to humans, and he encouraged the dietary supplement industry to look to orange peel as an natural antibacterial ingredient.
In an interview with Nutraceuticals World, Dr. Watson, whose presentation centered on the merits of Pycnogenol®, encapsulated why he believed supplements were an increasingly cost effective way to manage health concerns. “Two factors are key,” he said. “First, the cost of pharmaceutical drugs is going up without much ability of the patient to get them when they wish to use them. The need for a doctor’s prescription is inhibiting. Thus over-the-counter materials like Pycnogenol® allow people to take them when they choose as prevention or treatment without losing the chance for consulting with their family physician.
“Second, the increasing data supporting outcome benefits is helpful in patient choice. Clinical trials and animal data that support a particular use are vital for discerning patients,” he continued. “A dietary supplement like Pycnogenol® has the support of 98 clinical trials by a wide variety of researchers on various illnesses and conditions, strengthening the amount of facts and thus the patient’s confidence in the various conclusions of researchers.”
Dr. Watson, an internationally recognized CAM researcher, nutritionist and immunologist who has directed several NIH funded biomedical grants relating to immune function and cardiovascular effects and edited 60 biomedical books spanning the realms of nutrition and food sciences, asserted that the Achilles Heel of the industry is the proper representation of facts. “Every time products are sold based largely upon hype and lack of testing, people eventually realize that the extract may not have real value,” he said. “Testimonials have their place but not before or in place of facts and studies in convincing people of extracts’ benefits. While people often learn by testimonials or word of mouth, the convincing and decision making point should be based upon scientific studies in humans and animals, not what happened to a friend.”
In the interest of separating valid information from misinformation, Dr. Watson suggested the industry collectively work to create the development of a veritable information clearing house. “Provide a single site where documents are provided, data reviewed by experts for accuracy, and claims checked against scientific studies,” he said. “Now much is done by testimonial which means that usually there is not much support.”
Safety Session at a Glance
The symposium’s second session delved into the inherent safety of natural supplements and was chaired by Russell M. Jaffe, Ph.D., M.D., and president of PERQUE LLC. Dr. Jaffe was formerly an official at the National Institutes of Health and Clinical Center in Bethesda, the US Public Health Service, and on the editorial board of The New Physician and his published research includes over 400 papers in the areas of clinical and nutritional immunology, toxic minerals, hormones, and chemical disruptors and autoimmune disease.
The safety session also featured a presentation by Dr. Bruce Ames, an internationally recognized nutritional scientist from the University of California-Berkley, Dr. John Hathcock of Council of Responsible Nutrition (CRN), and Dr. Rick Kingston of SafetyCall International.
The safety session also featured a presentation by Dr. Bruce Ames, an internationally recognized nutritional scientist from the University of California-Berkley, Dr. John Hathcock of Council of Responsible Nutrition (CRN), and Dr. Rick Kingston of SafetyCall International.
As the developer of the Ames Cancer screening test, Dr. Ames emphasized that “diet is really the big thing” and recommended convenient supplements as the most significant way to reduce deficiencies in critical vitamins and minerals that have been shown to be a factor in reducing age-related diseases. The body has short term nutritional needs for survival and reproduction, he said, but when the body is short on critical micronutrients, it will trade this immediate need in exchanged for the long term need to prevent age-related diseases like cancer and cardiovascular disease.
“The 2006 Adverse Event (AE) Report confirmed the general safety of supplements with only 275 AE’s of a total of 400,000 that referred to supplements; only eight actual severe cases and these involved synthetic caffeine and yohimbe,” said NOW Foods’ Dr. Sharpee. “And now, according to Dr. Russ Jaffe, scientific advances in material processing technology now allow natural products to be standardized for potency resulting in even fewer safety risks while increasing consistent efficacy performance. It’s been estimated that using standardized natural products rather than isolated bio-actives or prescription medications could save 100,000 lives each year and reduce healthcare costs by $9.8 billion annually.”
Dr. Sharpee said that while many struggle to get more vitamins in the diet to improve health, getting too much of a single nutrient can also cause health problems. “That’s why Dr. John Hathcock proposed an approach for risk assessment to determine acceptable daily levels of nutrients: a.) Identify any known ‘hazard’— if found, apply the Upper Limit (UL) method; if not found, apply the Highest Observed Intake (HOI) method, b.) If data are insufficient for UL or HOI, look for history of safe use, and c.) If none of above, new toxicological studies are needed. Since safety is inherently a negative concept, it’s difficult to prove that nothing will happen. Thus, the CRN tends to be very conservative when establishing the safe upper limit of a nutrient.”
SafetyCall’s Dr. Kingston promoted post-market surveillance, whereby manufacturers, regulators, health professionals, the public at large and others monitor the performance and experience related to a given product’s lifecycle in the open market. Ultimately, this leads to good product stewardship, safer products and increased consumer confidence. Companies that submit adverse event reports (AERs) to the FDA meet the letter of the law by receiving, documenting and tabulating information from AER’s. But post-market surveillance allows them to meet the intent of the law with investigation, interpretation and analysis of the information collected to identify emerging issues or confirm the product’s safety profile.
NOW Foods’ Dr. Sharpee concluded thatthe over-riding takeaway message for conference attendees was that dietary supplements are an increasingly cost-effective and inherently safe way to manage healthcare concerns when trying to manage the ever-increasing cost of pharmaceutical drugs. “With the scientific evidence accumulating on both the efficacy and cost-benefit of supplements, the use of supplements offers an immediate solution to the healthcare crisis facing this country. And people may take supplements when they choose as prevention or treatment, while still consulting with a physician,” he said. “The increasing scientific data, including human clinical trials and animal data supporting a specific use, are vital for discerning a patient’s choice of supplements. These studies strengthen the amount of facts and the patient’s confidence in the use of specific supplements. In summary, prevention is the key to the healthcare crisis, and natural products and nutritional supplements offer an immediate solution.”
