Editorial: One Step Forward and Two Steps Back

By Len Monheit

Last week must have been a confusing one for consumers of dietary supplements and natural health products.

A meta-analysis of 67 randomized clinical trials, published in the Cochrane Database of Systematic Reviews, called into question the health benefits of antioxidant, specifically focusing on vitamins A and E, and beta carotene, claiming that consumption of these three supplements may increase mortality risk by up to 16 percent. Specifically, the authors conclude “there is no evidence to support antioxidant supplements for primary or secondary prevention of mortality and that vitamin A, beta-carotene, and vitamin E may in fact increase mortality. Future randomized trials could evaluate the potential effects of vitamin C and selenium for primary and secondary prevention. Such trials should be closely monitored for potential harmful effects. Antioxidant supplements need to be considered medicinal products and should undergo sufficient evaluation before marketing.”

Several industry sources have criticized the study and the authors themselves, observing that these are the same authors that have published meta-analyses before (Journal of the American Medical Association (JAMA), February 2007 and the Lancet, September 2004), with an obvious intent to discredit antioxidant supplements. Specifically, critics have observed that the authors only included 67 studies, conveniently ignoring all those trials in which no deaths were reported. Obviously, if you’re looking for a correlation with mortality, one way to skew the data in favor of the desired result is to eliminate contrary evidence, which the authors apparently have done.

The authors also make several other typical meta-analysis decisions, combining studies with different endpoints, population groups, doses etc., and also erred (in the opinion of much of the scientific community) by classifying vitamin A as an anti-oxidant, despite its behavior. The Council for Responsible Nutrition has prepared an extensive analysis (http://www.npicenter.com/anm/anmviewer.asp?a=21085&z=7),
the Natural Products Association issued a response (http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=21062&zoneid=28), late last week Scientists from the European Federation of Associations of Health Product Manufacturers’ (EHPM) scientific network weighed in (http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=21077&zoneid=28), (if you scroll to the bottom to read the comment added to this release, you’ll realize that not everyone was as critical of this study as industry) , and even some of the media coverage was neutral to unbelieving of the study conclusions (http://abcnews.go.com/Health/Diet/story?id=4660292&page=1) . A more vocal response was offered on at least one personal column (http://www.naturalnews.com/023034.html).

In the same week as the British media was leading the presentation of these ‘findings’, a study published in the journal Clinical Pharmacology & Therapeutics, reported that expectant women who take a multivitamin fortified with folic acid during the first trimester of pregnancy can lower the risk of leukemia, brain tumors or neuroblastoma by as much as 47 per cent (http://www.canada.com/windsorstar/story.html?id=26a4055d-e374-49b3-973f-1e90d4104d89) . In another breaking science story last week, the journal Arteriosclerosis, Thrombosis and Vascular Biology reported that people with low levels of vitamin D in their blood experience an increased risk for a condition known as peripheral artery disease (http://news.yahoo.com/s/nm/20080416/lf_nm_life/arteries_disease_dc ).

These two supportive studies obviously do not involve antioxidants, but the fact that all three results appeared within a 24 hour period is indicative of the bombardment of information facing consumers simply trying to do right for their families and themselves in their choice of health products and solutions.

Never before has the marketplace been so confusing.

If it’s not supplements that will kill you, it’s ingredients that come from who knows where, supported by someone else’s science. Or it’s ‘this product is superior to that product’ because of an in vitro test that may have no actual bearing on in vivo performance and behavior. In many respects, much of what is publicly said about our products resembles a fragile house of cards, just about ready to come tumbling down on our ears. On a side note, much of the suggested antioxidant activity, and certainly most of its measurement, has been performed with analytical methods that have not undergone the rigors of complete validation protocols.

Just this past week, an ingredient company sent us a press release citing an analysis that had never occurred, ostensibly by a high profile researcher who refused to have any public association with them. Perhaps this is a case of desperate times calling for desperate measures, but if at the expense of customer and consumer confidence, then the timing is just all bad. We see these types of issues repeatedly, despite calls for responsibility and accountability, and at the very least, this type of action hopelessly confuses our marketplace, even as it devalues the practice of performing science.

Fundamentally, I believe now is the time for consistency in messaging and for a new era of transparency of practices and principles, analytical tests or business behaviors, as we try to establish a solid basis for credibility and clarity as supplement GMPs begin to kick in for the US and as we try to represent ourselves as a legitimate health solution provider around the globe. Discrediting ‘scientific’ results will continue to plague us, but it is the actions we as an industry bring on ourselves, the confusion we deliberately or inadvertently create, the credibility we consciously erode, that will be our fundamental undoing.

We cannot control, (nor should we try) the scientific community. We must expect contradictory science, shoring up our own so as to be above reproach, all the while. We, as an industry, must reflect sound scientific principles in all that we do and say, reflected in our product documentation, our Certificates of Analyses, our labels, our marketing materials and even in our press releases.

Until that is the case, week in and week out, we will continue to be defined, to a large extent, by our poorer practices and our even poorer practitioners.

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