Draft Report of the Independent Vitamin Safety Review Panel, May 22, 2006
Abram Hoffer, MD
Michael Janson, MD
Thomas Levy, MD, JD
Carolyn Dean, ND, MD
Harold Foster, PhD
Erik Paterson, MD
Andrew Saul, Chairman
(OMNS, May 23, 2006) A recent US National Institutes of Health report has attempted to cast doubt on food supplement safety. However, it is the dissenting opinion of the Independent Vitamin Safety Review Panel that
1) the NIH report is biased against nutritional supplementation, because
2) NIH’s selection of panel members excluded professionals that advocate nutritional supplementation, and
3) the research NIH reviewed selectively excluded hundreds of studies supporting the safety and effectiveness of nutritional supplementation.
NIH documents show that the NIH panel never even looked at over 600 scientific studies and papers from the Journal of Orthomolecular Medicine, a journal that in fact specializes in publishing vitamin therapy research, and has done so for forty years. The NIH panel also failed to consider the wealth of physician reports in medical publications such as the Townsend Letter for Doctors and Patients.
The following is a quote from the NIH-sponsored review “Multivitamin/Mineral Supplements and Prevention of Chronic Disease, May 2006” posted at http://www.ahrq.gov/clinic/tp/multivittp.htm :
“Objective: To review and synthesize published literature on the efficacy of multivitamin/mineral supplements and certain single nutrient supplements in the primary prevention of chronic disease in the general adult population, and on the safety of multivitamin/mineral supplements and certain single nutrient supplements . . .”
“Data Sources: All articles published through February 28, 2006, on MEDLINE®, EMBASE®, and the Cochrane databases.
“Review Methods: Each article underwent double reviews on title, abstract, and inclusion eligibility. Two reviewers performed data abstraction and quality assessment. . .
“Results: Few trials have addressed the efficacy of multivitamin/mineral supplement use in chronic disease prevention in the general population of the United States. . .
"Conclusion: . . . The overall quality and quantity of the literature on the safety of multivitamin/mineral supplements is limited.”
Limited, indeed. It was limited by the biased selection process, which, for example, excluded over 600 papers from a specialist medical journal, the Journal of Orthomolecular Medicine. Nothing published in The Journal of Orthomolecular Medicine is indexed on Medline. Medline is run by the National Library of Medicine. The National Library of Medicine is part of the National Institutes of Health. One can see that a significant quantity of relevant data has been excluded from consideration. Such exclusion would be in the interest of NIH’s reaching a politically predetermined conclusion that vitamins are somehow dangerous and the public is supposedly in some kind of danger from them.
And yet, even this biased, self-limited review stated, “We found no consistent pattern of increased adverse effects of multivitamin/mineral supplements except for skin yellowing by β-carotene.”
This is an important admission of vitamin safety that the NIH press release of May 17, 2006, totally ignored, and even twisted into an opposite conclusion. Specifically, the NIH press release included the following:
““More than half of American adults are taking dietary supplements, the majority of which are multivitamins, and the bottom line is that we don’t know for sure that they’re benefiting from them. In fact, we’re concerned that some people may be getting too much of certain nutrients,” said J. Michael McGinnis, M.D., M.P.P., Senior Scholar with the Institute of Medicine of the National Academy of Sciences, who chaired the panel. . . Most of the public assumes that the components of multivitamin-minerals (MVM) supplements are safe, because many of the ingredients are found in everyday foods and the products are available over-the-counter. The panel identified several possible risks associated with MVM consumption, however. Among these is the potential for overconsumption of certain nutrients, with the resulting possibility of adverse effects. Though health-conscious individuals are likely to be focused on ensuring that they meet the recommendations for essential nutr!
ients, the combined effects of eating fortified foods, taking MVMs, and consuming single vitamins or minerals in large doses, may lead them to unwittingly exceed the Upper Levels (ULs) of nutrients, which can be harmful. Given these safety concerns and the limitations of the available evidence, the panel advocated for changes in the regulation of dietary supplements — including MVMs — by the Food and Drug Administration (FDA). . .”
Independent Vitamin Safety Review Panel Comment:
Even though their own commissioned review of the literature failed to find evidence of harm from vitamin supplements, the NIH press release chose to emphasize dangers that even their own sponsored study could not find.
NIH states that its report is “not a policy statement of the NIH or the federal government. The NIH Consensus Development Program, of which this conference is a part, was established in 1977 as a mechanism to judge controversial topics in medicine and public health in an unbiased, impartial manner.” At the very same time, NIH has demonstrated clear bias in study selection, bias in committee member selection, and biased reporting to the public.
Over half of all Americans take vitamins every day. One cannot help but ask the NIH this simple question: where are the bodies? Interestingly, the NIH panel ignored pharmaceutical drug dangers, while concentrating on unfounded concerns over your daily multivitamins. This also indicates bias.
According to statistics compiled annually by the American Association of Poison Control Centers (1), multivitamins kill no one. Gross overdose of iron (not a vitamin) has been associated with perhaps two deaths per year. On the other hand, in 2003, there were 59 deaths from aspirin alone. That is a death rate nearly thirty times higher than that attributed to iron supplements. There were still more deaths from aspirin in combination with other pharmaceutical products. In 2003, two people died from caffeine. Three people died from dishwashing detergent. There was also a death from "Cream/lotion/makeup," a death from granular laundry detergent, and one death from table salt.
On the other hand, the Independent Vitamin Safety Review Panel asserts that there is not one death per year from any vitamin in the alphabet. Not from A, B’s, C, D or E.
Panelist Michael Janson, MD, said, “In decades of people taking a wide variety of dietary supplements, few adverse effects have been noted, and zero deaths as a result of the dietary supplements. There is far more risk to public health from people stopping their vitamin supplements than from people taking them.”
This is true for multivitamins containing minerals as well. Panelist Harold Foster, PhD, said: “The ever declining mineral content of soils, and foods grown in them, requires that the public take supplements, if only to keep their mineral intake at former levels.”
Panelist Carolyn Dean, ND, MD, points out that, unlike nutritional supplements, pharmaceutical drugs do indeed kill people. “784,000 people are dying annually, prematurely, due to modern medicine,” she said. “These are statistics from peer-reviewed journals and government databases.”
The Independent Vitamin Safety Review Panel therefore asks, Why would NIH push so hard for FDA control of vitamin supplements, which are safe, when FDA clearly is not effectively controlling pharmaceutical drugs, which are dangerous?
Panelist Thomas Levy, MD, said: “It can clearly be shown that excessive or obsessive water intake will reliably kill the overindulgers who push their sodium levels to a low enough point in the blood. This is well documented. Should water be justifiably regarded as a potentially fatal poison or toxin while ridiculous assaults continue on the theoretical toxicity of vitamin C, as well as many other vitamin and nutrient supplements?"
Panelist Erik Paterson, MD, said: "For 33 years I have aggressively prescribed and advocated vitamins in doses vastly higher than the US DRI/RDA, for my family and my patients. I have never seen any adverse reactions, even though I have been on the alert for them all this time."
Panelist Abram Hoffer, MD, who also has a PhD in nutritional biochemistry, said, “Vitamin supplements are extraordinarily safe and effective. This is based on fifty years of clinical experience without seeing any life-threatening side effects and no deaths. It is drugs that are dangerous. Perhaps the US Food and Drug Administration is getting tired of all the bad news about drugs, so instead they are going after nutritional supplements.”
It is the conclusion of the Independent Vitamin Safety Review Panel that the US National Institutes of Health has ignored the benefits of vitamin supplementation, grossly overstated supposed risks, and in so doing, has both misinformed the public and harmed the public’s health.
1. Watson WA, Litovitz TL, Klein-Schwartz W, Rodgers GC Jr, Youniss J, Reid N, Rouse WG, Rembert RS, Borys D. 2003 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2004 Sep;22(5):335-404.
2. Testimony before the Government of Canada, House of Commons Standing Committee on Health, regarding nutritional supplement product safety (Ottawa, May 12, 2005).
What is Orthomolecular Medicine?
Linus Pauling defined orthomolecular medicine as "the treatment of disease by the provision of the optimum molecular environment, especially the optimum concentrations of substances normally present in the human body." Orthomolecular medicine uses safe, effective nutritional therapy to fight illness. For more information: http://www.orthomolecular.org
The peer-reviewed Orthomolecular Medicine News Service is a non-profit and non-commercial informational resource.
Andrew W. Saul, Editor. Email: [email protected]