NIH Panel Finds Limited Evidence to Support Public's Multivitamin Use
A report by a National Institute of Health panel questions the safety and effectiveness
of multivitamin/minerals supplements in preventing chronic disease.
In August of 2002, the Journal of the American Medical Association (JAMA) reversed their decades long stand against vitamin supplements stating, "Pending strong evidence of effectiveness from randomized trials, it appears prudent for all adults to take vitamin supplements. We recommend that all adults take one multivitamin daily." (see http://jama.ama-assn.org/cgi/content/full/287/23/3127)
Now, a panel assembled by the National Institute of Health is advising more research be done before recommending the use of multivitamin/minerals (MVM) to prevent chronic disease. One has to consider whether this represents a renewed effort to raise public safety concerns about vitamins as part of a long term agenda to regulate availability and potency of nutritional supplements. Nutritional supplements in this context should be understood to mean products composed of vitamins, minerals, carbohydrates, fats, proteins, or fiber, and should not be confused with herbs, which may contain natural drugs or hormones..
Although there have been occasional reports of safety concerns with certain herbs and individual vitamins or minerals, there appear to be no reports of toxicity from use multivitamin/mineral supplements, even those containing amounts of nutrients in excess of the standard Tolerable Upper Limits Levels (UL) issued by the Institute of Medicine of the National Academies.
The panel's concerns seem to be primarily that:
1) We don’t know for sure whether the public is benefiting from taking multivitamins.
2) Some people may be getting too much of certain nutrients.
3) There may be possible interactions between multivitamin/minerals and prescribed or over-the-counter medications.
The concern of whether the public benefits from multivitamin use is reminiscent of the American Medical Association's (AMA) decades long criticism that vitamin supplements were unnecessary and only gave you expensive urine. It was never explained why consumers having expensive urine from vitamin supplements (or drinking expensive wine for that matter) should be a concern for the AMA. Whether the consumer benefits from using a multivitamin or any other product should not be a concern of government as long as the manufacturer does not make false claims about the product. The primary concern should be whether the product poses a danger to the consumer.
You would think after consumer use for decades, it would be obvious if there was a danger of getting too much of certain nutrients taking a multivitamin. The lack of consumer complaints suggests this is not the case and therefore not a significant concern.
The third concern of possible interactions between multivitamin/minerals and prescribed or over-the-counter medications is mirrored by the concern of prescribed or over-the-counter medications interfering with the intake, digestion or absorption of certain nutrients. Drug-nutrient interactions are common side effects of prescription and over-the-counter medications.
The panel advised that Congress expand FDA’s authority and resources to require manufacturers disclose adverse events, ensure quality production, and facilitate consumer complaints by including such information on supplement labels. This might be reasonable but with complaints about multivitamins being so rare, such regulation may not be necessary or at least not a priority concern.
Proper nutrition provides a basic foundation for maintaining health and preventing disease. As Steven M. Mister, Esq., president and chief executive officer of the Council for Responsible Nutrition, states in the article below, "for millions of Americans who struggle with diet and nutrition, a daily MVM provides a safe, affordable and reliable means of filling nutrition gaps and promoting overall good health".
The general focus of conventional medicine, and of prescription and over-the-counter medications, is the treatment of disease symptoms, not the promotion or restoration of general health. The profit in the business of health care is in treatment. Once a patient becomes well, profits from treatment end. Treatment time may be shortened substantially if the patient quickly regains their health; more likely if treatment includes actively promoting the restoration of health by ensuring (among other things) optimum nutrition.
The health food and nutrition supplement industry is a natural competitor to the business of health care. Profits in health care have decreased as the sale of health foods and nutrition supplements has become a multi million dollar industry. Medical centers have been forced to offer "alternative treatments" like massage, acupuncture, chiropractic and clinical nutrition, all of which promote health, in order to compete for customers, even though these treatments were maligned for decades by conventional health care as ineffective. It would be advantageous to the business of conventional health care if nutritional supplements became less credible, more regulated, less nutritious, less available and more expensive. Consumers must remain vigilant to assure that natural market forces don't compromise reasonable access to the ways and means of promoting and maintaining health through adequate and optimal nutrition.
John W. Cartmell, MS
NIH Panel Finds Limited Evidence to Support Public's Multivitamin Use
WASHINGTON--An independent panel assembled by the National Institutes of Health (NIH) Office of Medical Applications of Research and the Office of Dietary Supplements (ODS) to assess the available evidence on the safety and effectiveness of multivitamin/minerals (MVMs) concluded more rigorous scientific research is needed before strong recommendations can be made regarding MVM use to prevent chronic diseases. The panel convened for two days of expert presentations, public discussion and panel deliberations, after which they made recommendations regarding certain specific supplements.
Among their findings, the panel recommended combined calcium and vitamin D supplementation to protect bones in postmenopausal women; daily folate for women of childbearing age take to prevent infant neural tube defects; and antioxidant and zinc supplementation in non-smoking adults with early-stage, age-related macular degeneration (AMD). On the other hand, the panel found no evidence to recommend beta-carotene supplements for the general population, and cautioned smokers against taking them, citing strong evidence linking beta-carotene to an increase in lung cancer among smokers who took the vitamin regularly.
“Half of American adults are taking MVMs and the bottom line is that we don’t know for sure that they’re benefiting from them," said J. Michael McGinnis, M.D., M.P.P., senior scholar with the Institute of Medicine (IOM) of the National Academy of Sciences and chair of the NIH panel "In fact, we’re concerned that some people may be getting too much of certain nutrients."
Based on these safety concerns and the limitations of the available evidence, the panel advocated changes in the regulation of dietary supplements, including MVMs, by the Food and Drug Administration (FDA). Specifically, the panel recommended Congress expand FDA’s authority and resources to require manufacturers to disclose adverse events, to ensure quality production, and to facilitate consumer reporting of adverse events by including reporting information on dietary supplement labels.
Steven M. Mister, Esq., president and chief executive officer (CEO) of the Council for Responsible Nutrition (CRN), noted for millions of Americans who struggle with diet and nutrition, a daily MVM provides a safe, affordable and reliable means of filling nutrition gaps and promoting overall good health. "FDA already regulates dietary supplements including multivitamins and has indicated on numerous occasions that it has the appropriate regulatory authority necessary to protect the public," he said, noting CRN supports mandatory reporting of serious adverse events by supplement companies to FDA. "CRN agrees that more research examining the effects of multivitamins on the prevention of chronic diseases could provide valuable insights for consumers. However, consideration should also be given as to whether the drug model for clinical research is the appropriate way to assess the preventive benefits of nutrients. In the meantime, consumers should be encouraged to eat a well-balanced diet, get plenty of exercise, and take a multivitamin every day."
Regarding future research on MVM and other dietary supplements, the panel called for rigorous randomized, controlled trials of the impact of individual supplements to test their efficacy and safety in prevention of chronic disease, using well-validated measures. They further suggested the creation of new MVM databases detailing the exact composition of supplements, which would be available to the research community and updated regularly. Additional concern was expressed in support of a better understanding of possible interactions between MVMs and prescribed or over-the-counter (OTC) medications.
The 13-member panel included experts in the fields of food science and human nutrition, biostatistics, biochemistry, toxicology, geriatric medicine, family medicine, pediatrics and pediatric endocrinology, cancer prevention, epidemiology, disease prevention and health promotion, and consumer protection. Their findings pertain to the generally healthy population, and do not include pregnant women, children, or those with disease. Full text of the panel’s draft state-of-the-science statement is available at http://consensus.nih.gov. The final version will be available at the same Web site in four to six weeks.
In addition to the material presented at the conference by speakers and the comments and concerns of conference participants presented during discussion periods, the panel considered pertinent research from the published literature and the results of a systematic review of the literature commissioned by the NIH Office of Medical Applications of Research (OMAR). The systematic review was prepared through the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center (EPC) program, by the Johns Hopkins University Evidence-based Practice Center. The EPCs develop evidence reports and technology assessments based on rigorous, comprehensive syntheses and analyses of the scientific literature, emphasizing explicit and detailed documentation of methods, rationale, and assumptions. The evidence report on Multivitamin/Mineral Supplements and Prevention of Chronic Diseases is available at http://www.ahrq.gov/clinic/tp/multivittp.htm.
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