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Bayer Hit With Suit Over Prostate Claims

Company touted men's supplement as helping to prevent cancer

By Jon Hood
ConsumerAffairs.com

October 4, 2009

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A consumer advocacy group has filed suit against Bayer, alleging that the drug company falsely marketed certain vitamin product as reducing the risk of prostate cancer in men.

The Center for Science in the Public Interest (CSPI), a watchdog group based in Washington D.C., filed suit on Wednesday in California state court. The CPSI specifically alleges that Bayer touted selenium, an ingredient in its One-a-Day Men's Multivitamin, as promoting prostate health and reducing the risk of prostate cancer. The suit charges that, to the contrary, selenium "may actually cause harm to consumers."

The effect of selenium, a trace mineral, on prostate health has been an issue of controversy for some time. A federal study that ended a year ago found that men taking selenium and those taking a placebo had a similar rate of prostate cancer. That study, which lasted seven years and cost over $118 million, was sponsored by the National Institute of Health (NIH).

In June, the Food and Drug Administration (FDA) revised its position on selenium, saying that there is limited evidence for the claim that the mineral reduces the risk of prostate problems. The agency had previously allowed Bayer to market selenium as reducing the risk of several different kinds of cancer.

Indeed, there is evidence that Bayer was in the process of revising its position when hit with the suit. In June, a spokeswoman admitted that the company "decided to no longer utilize this language in our promotion and labeling of our products." That statement apparently followed a threat by CPSI to file suit over the claims.

Bayer is currently editing language relating to prostate health in ads and on the vitamin's packaging. The Germany-based manufacturer refused, however, to recall packages containing the claim that had already been shipped out, apparently causing the CPSI to act on its previous threat.

The company certainly has reason to tout drugs as fighting prostate cancer, which is common and deadly; in 2005, over 185,000 men were diagnosed with the disease, and almost 30,000 died.

Bayer, founded in Germany in 1863, is the third-largest pharmaceutical manufacturer in revenue, behind Pfizer and Johnson & Johnson. It is perhaps best-known for its brand of aspirin, long marketed as reducing the risk of death when taken during a heart attack. The aspirin is also advertised as helping to prevent recurrent heart attacks or strokes when taken regularly. Bayer has dedicated an entire website to its aspirin, touting it as a "miracle drug that works wonders."

Despite Bayer's storied history, CSPI's suit is only the latest in a string of legal woes for the company. This past February, Bayer agreed to spend $20 million on an ad campaign to counteract misleading statements it made about Yaz, a birth control pill. The ads overstated the drug's ability to improve mood and help fight acne, while downplaying the serious risks associated with the oral contraceptive. Specifically, Yaz contains an ingredient called drospirenone, which can cause cardiac arrest or kidney failure under circumstances.

The company has also tangled twice with the Federal Trade Commission (FTC) over claims related to its aspirin and One-a-Day WeightSmart, a dietary supplement. Bayer paid $3.2 million to settle claims over the latter drug, ads for which claimed that a green tea extract in the supplement increased metabolism.

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