The National Cancer Institute (NCI) announced last week that its $114 million Selenium and Vitamin E Cancer Prevention Trial (SELECT) was being halted because findings show that neither supplement—taken alone or in combination—is working. Furthermore, researchers said there were slightly more instances of prostate cancer in the men taking vitamin E alone, and slightly more instances of diabetes in the men taking selenium alone. NCI stressed, however, that the latter findings for both vitamin E and selenium were not statistically significant and might be due to chance.
Nutrition Business Journal investigates the use of dietary supplements for the prevention and treatment of cancer in our Complementary and Alternative Medicine issue, which publishes later this month. Selenium is a focus of our research, based on the findings from a landmark trial, published in a 1996 edition of the Journal of the American Medical Association, which showed that selenium caused a significant reduction in colon, lung and prostate cancers. “This was a complete paradigm shift to think that a nutritional agent like selenium could prevent cancer up to 50% to 63%,” Paul Willis, founder, chairman, CEO and president of Cypress Systems Inc., a raw ingredient supplier of selenium, told NBJ. The findings from this 1996 JAMA study helped selenium become the only nutrient to earn an FDA-approved qualified health claim for cancer prevention.
As Willis noted after NCI pulled the plug on SELECT, the type of selenium tested in the study—selenomethionine—was different from the high-selenium yeast used by Cypress. “Clearly we believe that the SELECT Trial should have included the standardized high-selenium yeast, which has been found effective in reducing cancer risk in animal studies and human clinical trials,” said Willis, in a company press release.
Many more studies are ongoing to either confirm or contest the SELECT findings, to look at selenium’s potential for preventing other cancers and to study its mechanism of action. “We’re in 12 to 15 different cancer prevention and health-related trials,” Willis said. “What we’re working on is getting a health claim, rather than a qualified health claim. If all the trials are positive, it will lead to the FDA allowing a health claim to be made about selenium.” Although the current qualified health claim for selenium can adorn supplement labels, it’s basically the FDA’s way of saying that more research is needed. An FDA unqualified public health claim, on the other hand, is the highest level claim status approved by the FDA and is recognized as a public health recommendation, Willis said. “The sheer weight of research evidence and required time and monies to conduct such supporting research speaks to the value of this claim.”
NBJ’s Complementary and Alternative Medicine issue will include much more on the use of dietary supplements and other integrative therapies for the prevention and treatment of cancer. To order your copy of the issue or to subscribe to NBJ, go to www.nutritionbusinessjournal.com.