A consumer advocacy group has filed a lawsuit against Bayer AG for allegedly making false claims that Men’s One-A-Day multivitamins can help reduce the risk of prostate cancer.
The Center for Science in the Public Interest (CSPI) filed the complaint in the Superior Court of California on Wednesday, hoping to force the company to recall multivitamin packages and alter advertisements that claim the selenium in Men’s One-A-Day can help prevent prostate cancer.
Prior to filing the lawsuit, CSPI contacted Bayer and requested the company remove its selenium claims after two recent studies found that selenium provides no prostate cancer prevention benefits, and also suggested that men who took selenium may face an increased risk of diabetes.
One of the studies was a prostate cancer prevention trial, called the Selenium and Vitamin E Cancer Prevention Trial (SELECT), was published in the Journal of the American Medical Association. The SELECT study found that selenium provided no more prostate cancer prevention benefits than a placebo. Another study found that men taking selenium had triple the risk of having diabetes.
CSPI said that Bayer has agreed to alter future marketing claims, but will not recall older packages that make prostate cancer prevention claims on the label. The company has also refused to reimburse people who bought the multivitamins for the claimed prostate cancer prevention benefits.
Bayer says that the labels were written in accordance with accepted FDA guidance at the time. However, the FDA has changed that guidance since the multivitamins hit the market, and in June the agency said that any product that claims selenium reduces the risk of prostate cancer had to include a statement saying that the FDA found that it was highly unlikely that selenium had any cancer-fighting benefits.
Earlier this summer, after the CSPI and Bayer failed to agree on existing ads and packaging, Bayer sent a letter to CSPI which officials at the non-profit agency say threatened to sue them for libel if they went public with charges of false advertising against Bayer.
Bayer has had a number of run-ins with regulators over its advertising practices. Late last year, the company was forced to run a $20 million corrective advertising campaign for its Yaz birth control pills over false claims about the drug’s acne and PMS-fighting benefits, and because the ads did not clearly state all of the known Yaz side effects, drowning some of them out with loud music. As a result of the misleading advertisements, Bayer agreed that the FDA will screen future Yaz ads for six years before they can be aired.
Bayer also had to pay $3.2 million in civil fines to the Federal Trade Commission and the Department of Justice in 2007 for weight-loss claims on its One-A-Day vitamins. CSPI says that the prostate cancer claims violate a consent decree made at that time.