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October 2, 2009 11:10 AM

CSPI Sues Bayer Over Alleged Bogus Claim That Vitamins Fight Prostate Cancer

By
Jim Edwards
(MoneyWatch)  The Center for Science in the Public Interest has made good on its promise to sue Bayer for claiming that its Men's One A Day vitamin products can prevent or reduce prostate cancer. BNET noted in June that Bayer was running radio ads for One A Day that said:
Did you know that there are more new cases of prostate cancer each year than any other cancer? -- Now there is something you can do.
The complaint is worth reading because it gives a tick-tock of what happened between CSPI and Bayer's general counsel's office between June -- when CSPI first asked Bayer to stop claiming that the selenium in One A Day was a cancer preventer -- and now.

The FDA was not as sharp as it might have been, CSPI claims:
A day after CSPI contacted Bayer, the FDA issued a letter containing qualified health claim language for use on labels that said, in part, that it was "highly unlikely that selenium supplements reduce the risk of prostate cancer." That forced Bayer to alter much of its marketing, but it pointedly refused to recall existing packages bearing the false claims. The company also refused to remove all false prostate claims from some marketing for Men's One A Day ...
We don't know why the FDA didn't clamp down harder on Bayer. Perhaps it is because One A Day is a diet supplement and not a drug, and therefore falls into the insane loophole that prevents the FDA from regulating pills that claim not to be medicines even though they make medical claims.

This worried CSPI because in addition to "largest prostate cancer prevention trial ever" showing that selenium does not prevent prostate cancer, selenium may actually increase patients' risk of diabetes, according to the suit.

Bayer ceased making the claims following the letter, CSPI says, but it didn't recall the product or do corrective ads. In fact, Bayer continued to market the product with prostate references on packages and in TV ads, the complaint claims. One TV ad said:
...emerging research suggests selenium may reduce the risk of prostate cancer.
The suit reveals a level of delusion on both sides. To prevent the suit, CSPI says it wanted Bayer to make an effort to remove the prostate claims from third party web sites, and for Bayer to give it 10 percent of the gross sales of two Men's Multi brands. (Never going to happen!)

As for Bayer, after getting CSPI's letter, the company's lawyers arranged a meeting which CSPI described this way:
Bayer instead used the time to present its case for a potential collaboration with CSPI to address FDA policies on health claims, which was not a collaboration CSPI had suggested or desired.
Bayer then threatened to sue CSPI ... and the rest is history.

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