Introduction to a mini-forum on "glyconutrients"
Departments of Medicine and Biochemistry, University of Utah School of Medicine, Salt Lake City, UT 84132, USA
1 To whom correspondence should be addressed: Tel: +1-801-585-0954; Fax: +1-801-585-0956; e-mail: donald.mcclain{at}hsc.utah.edu
In this issue of Glycobiology we are publishing two articles and a letter that deal with the marketing of so-called glyconutrients. The article "A ‘Glyconutrient Sham’," by Ronald L. Schnaar and Hudson H. Freeze, was submitted for review by one of the nutraceutical manufacturers cited in the articles, Mannatech, and their invited response is also being published. "Glyconutrients" represent one class of many thousands of "nutraceuticals," dietary supplements that are sold as part of a multibillion dollar industry. The industry has generated enthusiasm among some and concern among others. The concern largely stems from the results of the industry's deregulation 14 years ago. The Food and Drug Administration (FDA) mandates that pharmaceuticals be both safe and effective. The Dietary Supplement Health and Education Act of 1994, however, states that dietary supplements need only be safe. In exchange for this trade-off of lack of proof of efficacy or utility, however, the supplements cannot be marketed as specific therapeutics. The latter line, however, is apparently a thin one that is frequently crossed, as is obvious when one scans some of the 1.29 million sites that pop up when one searches on Google for the word nutraceutical. It is highly probable, for example, that the general feeling of most lay people is that glucosamine is sold as a treatment for osteoarthritis, not as a dietary supplement. The articles deal with several issues of the industry in general and "glyconutrients" specifically:
- What are the regulations pertinent to dietary supplements? This is addressed in both articles, particularly that of Charis Torok and Tomas Murray, who point out the subtleties in the law that allows a company to promote a drug that promises a "healthy immune system" but does not allow the company to suggest that the drug might cure or alleviate a specific immune-based disease. The article by Ronald Schnaar and Hudson Freeze reviews a case filed by the Texas Attorney General against the firm Mannatech wherein the company was accused of violating that standard.
- What is the science (or lack thereof) behind the claims of the nutraceutical industry? This is addressed in the Schnaar/Freeze article in the context of the Mannatech product Ambrotose, a mixture of plant polysaccharides.
- What is the responsibility of the scientific community when it feels that its work is being misrepresented to support claims of the industry? Both articles deal with this question in depth, citing for example the three Nobel laureates who have sued so that their names would not be used in advertising certain compounds.
- What is the responsibility of government? The degree to which government regulates industry waxes and wanes with the political winds. In many cases it seems that many people in western societies can have a limited sense of history, and we may forget the excesses that prompted government regulation in the first place. In the absence of FDA-style oversight of the nutraceutical industry in the United States, there exist other options. One answer to the problem would be that high-quality clinical trials be performed on select compounds. The widespread use of glucosamine and chondroitin sulfate led to testing the efficacy of those compounds in a multicenter, randomized, placebo-controlled, double-blind trial, the GAIT Study (Clegg et al. 2006
). The results of the study were that, overall, the compounds had a little effect on pain. In a subgroup of individuals with moderate to severe pain, the combination of the compounds had some effect, although this result is somewhat suspect in that the study was not originally designed for stratification of responses. As a side note, it was found that many of the commercially available preparations varied highly in purity and potency. The GAIT study cost over $12.5 million, and the National Center for Complementary and Alternative Medicine of the NIH has a FY 2008 budget of only $74 million for individual research grants. Thus, it seems likely that the government cannot pick up the tab to have all of the thousands of available compounds tested. Perhaps testing should be limited to compounds where there is a strong scientific rationale for efficacy, to compounds enjoying widespread use, or to compounds where objective evidence of efficacy is strong. One might argue that the company should submit the compound to an independent agency for such testing and pay for the testing, and that would be equivalent to arguing that the Dietary Supplement Health and Education Act be repealed. The results of the GAIT Study on the industry, incidentally, have not been overwhelming: Sales of glucosamine were nearly $1 billion and increased 3.5% in 2007, a year after the publication of the article.
We urge you to read these articles, ponder the issues, and discuss them with others in and outside of the scientific community. Most of us reading this are scientists who are graced with the support of taxpayers and donors to discover the truth about how the natural world works and to use that knowledge to improve the lot of mankind. Our responsibilities in that regard do not necessarily end when we walk out of our laboratories.
Reference
Clegg DO, Reda DJ, Harris CL, Klein MA, O’Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, et al. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med (2006) 354:795–808.
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