Pharmaceutical giant, Bayer, is in trouble, yet again. This time for making allegedly bogus claims about its Men’s One A Day multivitamins. The Center for Science in the Public Interest (CSPI) is suing Bayer for claims that the selenium in the popular men’s vitamins could help reduce prostate cancer risks, said CSPINet.
In June, the CSPI contacted Bayer, demanding it change how it markets Men’s One A Day following a prior study—SELECT, considered the largest prostate cancer prevention trial—revealed that selenium supplements to not prevent prostate cancer, said CSPINet, which noted that the discovery was made eight months prior. The study, as well as another study, also found that supplemental selenium could actually raise diabetes risks three-fold, said CSPINet. The lawsuit was filed, said CSPINet, in San Francisco’s Superior Court of California.
Immediately following CSPI’s demand to Bayer, the U.S. Food and Drug Administration (FDA) issued its own letter that contained “qualified health claim language for use on labels,” said CSPINet that noted, among other things, that it was “highly unlikely that selenium supplements reduce the risk of prostate cancer,” quoted CSPINet. The letter put the drug maker in a position in which it had to change a good amount—but not all—of its marketing; however, it refused to recall existing stock that contained the bogus information, did not remove false claims from some Men’s One A Day marketing, and would not confirm in writing that it would refrain from making those bogus claims going forward, said CSPINet.
This is not the first time that Bayer has been connected with other false claims and not the first time we have written about such claims. According to CSPI’s litigation director, Stephen Gardner, “Given Bayer’s long history of wrongdoing in other cases, CSPI is acting to ensure that Bayer is permanently stopped from deceiving consumers about selenium.” The CSPI also pointed out a number of other situations in which Bayer was involved in just the past several years:
- 2001: Bayer paid $14 million to U.S. and state governments to settle allegations its actions helped health care providers submit inflated Medicaid drug claims.
- 2003: Bayer pleaded guilty to a criminal charge, paying $257 million in fines and penalties following a whistleblower’s revealing a Bayer plan to inflate Cipro (antibiotic) prices. According to news at the time, the case was the largest Medicaid fraud recovery.
- 2004: Bayer pleaded guilty to a criminal charge, paying a $66 million fine following a Justice Department (DOJ) investigation into its role in a price-fixing scheme involving a rubber products chemical. Two Bayer executives separately pleaded guilty; both were sentenced to prison.
- 2007: Bayer paid $8 million to over state attorneys general allegations that it did not warn physicians and consumers about safety issues concerning its cholesterol-lowering Baycol. Baycol in no longer on the market.
- 2007: Bayer paid a $3.2 million fine as part of a consent decree reached with the Federal Trade Commission (FTC) and the DOJ over weight-loss claims the FTC said violated an earlier order mandating “health claims for One A Day be supported by competent and reliable scientific evidence.” The CSPI alleges Bayer’s prostate claims for the supplement are in violation of the decree.
- 2009: The FDA mandated Bayer to run a correction to its Yaz (birth control) marketing that cost $20-million. It also must submit its ads to the agency for approval resulting from a legal settlement obtained by some state attorneys general and the agency.