Drug Company Must Pay $3.3 Million to States and Support Future Claims with Competent Scientific Evidence

WASHINGTON—Bayer will be barred from claiming that its One A Day multivitamins may cure, treat, or prevent any disease, including cancer, unless the company can back up such claims with competent and reliable scientific evidence. As part of a settlement agreement reached yesterday with Attorneys General from Oregon, California, and Illinois, Bayer must also make a $3.3 million payment to those states. A complaint, filed by Oregon Attorney General John Kroger, accused Bayer of “deceptively leveraging fear of prostate cancer” in order to market One A Day multivitamins for men.

Bayer claimed that “emerging research” suggested that the mineral selenium in One A Day might reduce the risk of prostate cancer. But according to the Center for Science in the Public Interest, “emerging research” did no such thing. In fact, a seven-year, $118-million study funded by the National Institutes of Health found that selenium does not prevent prostate cancer in healthy men. That massive trial, which involved 35,000 men, was abruptly halted when it became clear to researchers that selenium was not protecting the men from prostate cancer and may have been causing unexplained cases of diabetes. Yet Bayer continued to claim a protective benefit from selenium.

In October of 2009, CSPI sued Bayer in federal court in California over the selenium claims on One A Day, which a judge dismissed on technical grounds. CSPI was planning on filing suit on behalf of a California consumer in another court. But in the wake of the settlement agreement reached with the Attorneys General, CSPI is announcing that it will not move forward with the second suit.

“We are very glad that the Attorneys General have obtained a binding settlement prohibiting Bayer from exploiting men’s fear of prostate cancer in order to sell more vitamin pills,” said CSPI litigation director Steve Gardner. “And we’re also pleased that Bayer seems to have had a change of heart, since after CSPI publicly questioned the company’s unsupportable claims on One A Day, its response then was to threaten us with a libel lawsuit.” Bayer has since backed off that threat, Gardner said.

The agreement reached yesterday is the latest in a long rap sheet of settlement agreements, fines, guilty pleas, and other enforcement actions involving the German pharmaceutical giant.

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. And in 2007, Bayer paid $8 million to resolve allegations by state attorneys general that the company failed to warn physicians and consumers about safety issues surrounding its now-withdrawn cholesterol-lowering drug Baycol.

Prior marketing for One A Day has also posed legal problems for Bayer. In 2007, it paid a $3.2 million civil fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice. The case centered on weight-loss claims that the FTC said violated an earlier order requiring that all health claims for One A Day be supported by competent and reliable scientific evidence. And in 2009, Bayer was required to run a $20-million corrective advertising campaign about its birth control pill Yaz and to submit its ads for FDA approval, as part of a legal settlement secured by a number of state attorneys general and the FDA.