Official Company Communication
Position: Antioxidants and Antioxidant Vitamins Provide Health Benefits
Subject: Response to February 28, 2007 JAMA article that states that antioxidants do not prevent and may increase the risk of mortality.
Background: On February 28, 2007 the Journal of the American Medical Association (JAMA) published a meta-analysis that assessed the effect of β-carotene, vitamins A, E, C, and selenium (either alone or in some combination), on all-cause mortality.1 The meaning and relevance of all-cause mortality is unclear, even to the study authors. The study authors admit not knowing what the actual causes of death in the individuals in the trials. This absence of information raises doubt about the validity and relevance of their findings because literally all-cause death means death from any and all causes, including accidents.
Official Statement: The authors (Bjelakovic et al.) misuse meta-analytical methods to make conclusions that mislead and confuse healthy consumers.
Pharmanex recognizes that today’s consumers want to make informed decisions pertaining to their health and the products that promote a healthy lifestyle. To support our distributors and customers, Pharmanex is, and always has been committed to providing scientifically substantiated, safe and efficacious products. We do not rely on a single study to guide product development and we reaffirm the critical role that antioxidant supplementation plays in health and wellness.
There are times when a scientific study is publicized in national media and more often than not, the study is not placed within context and conclusions are drawn without careful consideration of the study design or objective. In the case of the recent meta-analysis published in JAMA, the research contains several important flaws that make the conclusions less applicable to the general population:
• The researchers reviewed studies that used different diseased populations and different supplements. Most importantly, the review is a retrospective look at these studies and assumes that they were all conducted under identical conditions. This is not so. This meta-analysis, which seems to be a predetermined conclusion in search of a method to support it, will inappropriately confuse and alarm consumers who can benefit from supplementing with antioxidants.
• Overall, the study authors conclude that there was no effect of antioxidant supplements on all-cause mortality. Only after the researchers divided the chosen clinical trials into “high risk bias” and “low risk bias” groups, using their own criteria, did they observe a statistically significant effect on mortality.
• The dosages and chemical forms of the supplements used in the reviewed studies were not consistent with those shown by scientific research to be the most effective. In fact, the authors included a study that used an extremely high dose of Vitamin A (25,000 IU). The Pharmanex approach is never to maximize the amount of a particular antioxidant but instead to consider the whole antioxidant network for optimizing daily intake of antioxidants.
• Several of the studies used diseased populations with high mortality risk. For example, it included patients with coronary heart diseases, cancer, hepatitis and elderly medical patients in nursing homes. Such populations present a complex problem for analysis and to draw firm conclusions.
• In the process of selecting the 68 studies included in their meta-analysis, the authors excluded over 400 studies in which no serious lethal events. occurred. While the authors acknowledged this omission in their review, they did not acknowledge the probability that this may skew their analysis and conclusions.
• The researchers’ conclusions ignore a large body of recent literature that supports the use of multi-antioxidant/multi-nutrient supplements.
• The study’s conclusions are in direct conflict with a 2006 report from Johns Hopkins University which concluded “we find no convincing evidence to suggest vitamin E supplement use increases the risk of death per se.”
Educated consumers must always look into the details of a study to determine if the proper steps were followed to ensure accurate results that can be applied to a larger population.
Pharmanex can confidently say that the LifePak® family of products provides a comprehensive blend of antioxidant vitamins, mineral cofactors, and a comprehensive blend of carotenoids and flavonoids to promote the body’s overall antioxidant network. Unlike the antioxidant doses used in the studies included in the JAMA meta-analysis, LifePak® provides safe levels of all of its antioxidants and other nutrients in accordance with established guidelines. Most importantly, the benefits of LifePak® are evident in the millions of Pharmanex customers who have incorporated the supplement into their nutrition regimen and recognize the important health benefits of our product.
For More Information: http://www.crnusa.org/PR07_JAMA_antioxidant_metaanalysis_022707.html
Contributors: Created by: Glenn Chenney/Kara Schneck 2/27/07
Reviewed by: Jennifer Engemann/John Beeson 2/27/07
Approved by: Joe Chang 2/28/07
