CHICAGO (CN) - Bayer Healthcare will pay $3.3 million to settle claims from three states that accused it of pushing its "One-A-Day Men's" vitamins for prostate health, though Bayer knew or should have known that "for some men," the products "may increase the risk of an aggressive and deadly form of prostate cancer."
Bayer settled with the attorneys general of Illinois, Oregon and California for a total of $3.3 million, without admitting wrongdoing.
Illinois Attorney General Lisa Madigan claims that Bayer knew it was misrepresenting its drug, and pushing it to older men, after clinical trials failed to substantiate its claims.
"Bayer sought to increase the sale of OAD Men's Products by deceptively leveraging fear of prostate cancer," Madigan says, and kept advertising it long after the supposed "scientific" claims had been shown to be invalid.
In 2005, Bayer began pushing its drug by claiming that one ingredient, lycopene, a substance found in tomato products, "supports prostate health," but "the studies that Bayer cited were not competent and reliable scientific evidence sufficient to substantiate the lycopene prostate cancer claim," Madigan says.
In 2006, Bayer "stopped emphasizing lycopene and started using selenium to support the prostate cancer prevention claim."
But though the FDA had stated in 2003 that selenium may reduce the risk of certain cancers, "Bayer's express cancer claims regarding selenium did not comply with the language FDA announced it would tolerate," according to the complaint in Cook County Court.
Bayer claimed that "emerging research suggests selenium may reduce the risk of prostate cancer." But Madigan says that was "deceptive because by 2006, and especially after 2008, the 'emerging science' selenium prostate cancer claim was incorrect and misrepresented the scientific substantiation for the claim. Bayer used this deceptive selenium cancer claim in television and print advertising through June 2009 and used it in OAD Men's Health Formula packaging that was on store shelves as late as May 2010."
Bayer also formed a "promotional relationship" with Major League Baseball to push its "One-A-Day Men's" products.
"As part of this promotion, Bayer engaged in a 'strike out prostate cancer' campaign that was ostensibly to raise money for prostate cancer research but in fact, was a vehicle to make deceptive claims that OAD Men's helped prevent prostate cancer," Madigan says.
In 2008, clinical trials funded by the National Institute of Health, hoping to show that selenium reduces the risk of prostate cancer, came to a screeching halt when "preliminary results showed selenium provided no such benefit and might actually cause study subjects harm," the complaint states.
"Moreover, starting in 2007, there was mounting evidence that raised significant concerns that multivitamins containing the ingredients found in OAD Men's Products might increase the risk of a particularly aggressive prostate cancers in certain people," yet Bayer continued to push the drugs as beneficial to prostate health, Madigan says.
Madigan says that despite the clinical trials and the FDA's doubts about its 2003 statement, and the FDA's later statements that "it is highly unlikely that selenium supplements reduce the risk of prostate cancer," Bayer did not change its labeling or pull the mislabeled products off the shelves.
"Rather, Bayer continued to manufacture and distribute OAD Men's Product with the deceptive prostate claim through November 2009," according to the complaint. "Because of Bayer's failure to take timely action, OAD Men's Products with deceptive prostate packaging remained on store shelves until at least May 2010," a year after it promised to stop making such claims.
Illinois will get more than $1 million from the settlement, which it will use to fund consumer protection work.