• by Karl Greenberg , June 18, 2009

Bayer Healthcare is under the microscope for claiming on packages of its One A Day Men's 50+ Advantage and One A Day Health Formula multivitamins that one ingredient of the vitamins -- selenium -- may reduce the risk of prostate cancer.

The Center for Science in the Public Interest (CSPI) says it has notified Bayer that it will sue if the company continues touting selenium as potential prostate-cancer preventatives.

The group argues that Bayer's claims in ads and product labels that "emerging research" suggests selenium has salubrious properties when it comes to prostate health are false. The group says its arguments are supported by several research physicians who have sent a letter to the Federal Trade Commission, supporting its claims.

CSPI cites a radio ad for the product, which says "Prostate cancer. It's an important subject. Did you know that there are more new cases of prostate cancer each year than any other cancer? And here's something else you should know. Now, there's something that you can do that may help reduce your risk. Along with your regular doctor checkups, switch to One A Day Men's. A complete multivitamin plus selenium, which emerging research suggests may reduce the risk of prostate cancer."

The letter -- whose nine signatories include Dr. Peter Gann, who directs the division of pathology research at the University of Chicago, and Dr. Michael Thun, VP emeritus at the American Cancer Society -- cites a $118-million National Institute of Health study, the "Selenium and Vitamin E Cancer Prevention Trial (SELECT)." The study, involving 35,000 U.S. and Canadian men, found that selenium does not prevent prostate cancer in healthy subjects.

The letter said the seven-year study "was the largest individually randomized cancer-prevention trial ever conducted -- and, given its high rates of adherence and statistical power, is unlikely to have missed detecting a benefit of even a very modest size," and that "Bayer Healthcare is doing a disservice to men by misleading them about a protective role for selenium in prostate cancer."

"Bayer is exploiting men's fear of prostate cancer just to sell more pills," said CSPI's senior nutritionist David Schardt. "The largest prostate cancer-prevention trial has found that selenium is no more effective than a placebo. Bayer is ripping people off when it suggests otherwise in these dishonest ads."

Bayer does have a qualification statement on packaging of One A Day Men's to ameliorate its claim that the addition of nearly twice the selenium of the amount in competitor Centrum Silver provides more support for prostate health: "Has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

CSPI also filed a complaint Thursday with the FTC, stating that the company should be required to run a corrective advertising campaign. CSPI says the prostate cancer claims also violate a consent decree signed with the FTC in 2007 when Bayer paid a $3.2 million fine related to weight-loss claims made on behalf of One A Day multivitamin WeightSmart, and agreed not to make unsubstantiated claims in the future.