Healthy Skepticism Library item: 16580

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Singer N
Bayer Labels’ Cancer-Fighting Claim Draws Suit
The New York Times 2009 Oct 1
http://www.nytimes.com/2009/10/02/business/media/02bayer.html?_r=1

Full text:

A nonprofit group in Washington has filed a lawsuit against Bayer Healthcare charging that the company’s labels and commercials falsely claimed its One A Day multivitamins for men may reduce the risk of prostate cancer.

In a complaint, filed on Wednesday in Superior Court in San Francisco, the Center for Science in the Public Interest charged that Bayer had deceived the group’s membership of some 756,000 people who bought the pills under false premises. The group asked the court to permanently prohibit Bayer from making prostate claims about its dietary supplements.

The lawsuit comes after a large federal study on prostate cancer and certain dietary supplements was halted last October after researchers reported that men taking vitamin E or the trace mineral selenium, or both, had similar rates of prostate cancer as men taking placebo pills.

In response to a query from a reporter, a spokeswoman for Bayer Healthcare, the American unit of the German pharmaceutical company, wrote in an e-mail message on Thursday that the company had not yet been served with or reviewed the lawsuit.

The company based a portion of the promotion of the men’s vitamins on a qualified claim, permitted by the Food and Drug Administration, that selenium may reduce the risk of certain cancers, the spokeswoman wrote.

In June, the agency updated its position, saying that there is limited credible evidence for a relationship between selenium supplements and a reduced risk of prostate cancer.

Bayer is now in the process of revising the packaging and promotional materials for the men’s vitamins to remove claims regarding the relationship between selenium and the reduced risk of certain cancers, the spokeswoman wrote.

Meanwhile, packages of One A Day Men’s Health Formula, including one bought on Thursday by a reporter at a drugstore in Manhattan, continue to highlight prostate health.

“Did you know that prostate cancer is the most frequently diagnosed cancer in men and that emerging research suggests Selenium may reduce the risk of prostate cancer?” reads the label. “One A Day Men’s Health Formula is a complete multivitamin plus key nutrients including Selenium to support a healthy prostate.”

One A Day Men’s Health Formula had sales of $23.3 million for the 52 weeks ending Sept. 6, according to Information Resources, a market research firm.

The lawsuit over prostate health claims comes at a time when Bayer is the subject of scrutiny by federal regulators and attorneys general from 27 states over charges of deceptive marketing.

In February, after regulators said that commercials for the popular birth control pill Yaz overstated the benefits and played down the risks of the drug, Bayer agreed to spend $20 million on a new ad campaign to counteract misimpressions.

Also, in the last few years, the Federal Trade Commission has twice charged Bayer with making unsubstantiated health claims. Bayer did not admit to wrongdoing in either case, one over aspirin and the other over a supplement called One A Day WeightSmart.

But in 2007, the company agreed to a settlement with the federal government over One A Day WeightSmart that permanently prohibits Bayer from claiming that any dietary supplement or ingredient can or will cure, treat or mitigate any disease unless the company has reliable scientific evidence that supports the claim.

In 2000, Bayer agreed to spend $1 million on an ad campaign to settle charges by the F.T.C. that the company had overpromoted the benefits of aspirin for the prevention of heart attacks and stroke in the general adult population.