Under the $3.3 million settlement reached with the attorneys general of California, Oregon, and Illinois, Bayer will be barred from marketing its drugs with assertions not based on sound and reliable scientific evidence.
"Bayer sought to increase the sale of OAD [One-a-Day] Men's Products by deceptively leveraging fear of prostate cancer," the complaint charged. "Bayer made both express and implied promotional claims that misrepresented that OAD Men's Products reduce a man's risk of developing prostate cancer."
The drug giant made these claims "despite the fact that Bayer knew, or should have known, that the ingredients in OAD Men's Products do not decrease the risk of prostate cancer; in fact, Bayer knew or should have known that for some men, high doses of the ingredients found in Bayer OAD Men's Vitamins, such as zinc and selenium, may increase the risk of an aggressive and deadly form of prostate cancer," the complaint continued, adding that Bayer's promotion of its vitamins was "deceptive, unfair, untrue, and misleading."
Bayer launched its "strike out prostate cancer" campaign in 2008, making deceptive claims about the One-A-Day products' ability to reduce the risk of developing prostate cancer, according to the complaint. As part of the campaign, Bayer entered into a promotional relationship with Major League Baseball in which the company advertised its multivitamins during games and used Major League Baseball graphics and players to promote its One-A-Day products.
According to the Center for Science in the Public Interest, which unsuccessfully sued Bayer over the same issue in 2009, the drug giant claimed that "emerging research" suggested that the mineral selenium in One A Day might reduce the risk of prostate cancer. However, the CSPI pointed out, a seven-year, $118-million study funded by the National Institutes of Health
contradicted Bayer's claims, and found that selenium does nothing to prevent prostate cancer in healthy men.
Under the terms of the settlement, Bayer is prohibited from marketing its One a Day Men's products as preventing prostate cancer, or any other disease, unless the claims are based on competent and reliable scientific evidence.
Specifically, the settlement mandates that:
- Bayer not make any representation about the health benefits, performance or efficacy of any of its One A Day multivitamins unless the representation is non-misleading, and, at the time the representation is made, Bayer possesses and relies upon competent and reliable scientific evidence.
- Bayer not make representations that its One A Day Men's multivitamins are effective in the diagnosis, cure, mitigation, treatment or prevention of any disease unless the claim comports with applicable federal law and regulations, is non-misleading and Bayer possesses and relies upon competent and reliable scientific evidence in making the claim.
- If Bayer makes a representation regarding the diagnosis, cure, mitigation, treatment or prevention of any disease, the company must continue to monitor the claim to ensure it remains accurate and make changes to its promotion and packaging within a reasonable time if necessary.
- In 2001, Bayer paid $14 million to U.S. and state governments to settle allegations that the company's actions helped health care providers submit inflated Medicaid claims for drugs.
- In 2003, Bayer pleaded guilty to a criminal charge and paid $257 million in fines and penalties after a whistleblower exposed a scheme by the company to overcharge for the antibiotic Cipro.
- In 2004, Bayer pleaded guilty to a criminal charge and paid a $66 million fine after a Justice Department investigation into Bayer's role in a price-fixing conspiracy involving a chemical used to make rubber products.
- In 2007, Bayer paid $8 million to resolve allegations by 30 state attorneys general that it failed to warn physicians and consumers about safety issues surrounding its now-withdrawn cholesterol-lowering drug Baycol.