Bayer Healthcare has been issued a warning, this time from the Center for Science in the Public Interest (CSPI). CSPI told the pharmaceutical giant it will initiate a lawsuit if Bayer does not stop making claims that its <"http://www.yourlawyer.com/practice_areas/defective_drugs">One A Day vitamins, which contain selenium, may reduce the risk of prostate cancer, it said.
According to CSPINet, marketing and labeling for both One A Day Menâ€™s 50+ Advantage and One A Day Menâ€™s Health Formula multivitamins make claims that based on â€œemerging researchâ€ selenium might reduce prostate cancer risks. The commercialâ€™s narrator says, quoted CSPINet: “Did you know that there are more new cases of prostate cancer each year than any other cancer? Now there is something you can do.”
But, citing leading research in the area of prostate cancer, CSPI senior nutritionist David Schardt said, “Bayer is exploiting men’s fear of prostate cancer just to sell more pillsâ€¦. The largest prostate cancer prevention trial has found that selenium is no more effective than a placebo. Bayer is ripping people off when it suggests otherwise in these dishonest ads.” Researchers, along with the CSPI are jointly asking the Federal Trade Commission (FTC) to stop to the deceptive marketing.
Earlier this year, as part of a settlement with 27 states, Bayer had to change how it advertised birth control medication Yaz. Late last year, the FDA sent Bayer a warning letter over two Yaz televisions ads that misled consumers into believing Yaz could help relieve symptoms associated with Pre-Menstrual Syndrome (PMS) and could help in the treatment of specific types of acne. The FDA has never approved Yaz for either of these medical issues, said BizJournal previously. Bayer was mandated to implement a $20 million dollar campaign to â€œremedyâ€ the misinformation it promoted and is required to submit all subsequent television advertisements to the FDA for pre-approval; comply with the FDA on TV and print advertisement suggestions; and â€œclearly and conspicuouslyâ€ disclose for what the FDA has approved when discussingâ€”in its print adsâ€”those symptoms Yaz can treat, said BizJournal.
CSPI announced that it filed a complaint with the FTC in the hopes that Bayer will be mandated to run a â€œcorrective advertising campaign,â€ similar to what was required in the case of its Yaz scandal.
Meanwhile, CSPINet reported that a seven-year, $118-million, 35,000-participant studyâ€”The Selenium and Vitamin E Cancer Prevention Trial (SELECT)â€”funded by the National Institutes of Health (NIH) revealed that selenium does not prevent prostate cancer in healthy men. As a matter-of-fact, said the group, the trial was halted in October when it was found not only did selenium not protect against the cancer, but may have been causing diabetes in some participants.
One study, the Nutritional Prevention of Cancer trial in 1996, did show that some men with a history of skin cancer benefited from selenium regarding prostate cancer risks, but the supplement caused a nearly three-fold diabetes increase, said CSPINet. That finding prompted the American College of Physicians to issue a warning that “long-term selenium supplementation should not be viewed as harmless and a possibly healthy way to prevent illness,” quoted CSPINet.
Despite these findings and past issues with inappropriate marketing, Bayer continues to boast of seleniumâ€™s ability to prevent prostate â€œissuesâ€ and reduce prostate cancer, said CSPINet. “With these indefensible claims, Bayer is thumbing its nose at the Food and Drug Administration, the FTC, and any number of state consumer protection lawsâ€¦. A courtroom would be treacherous territory for Bayer, whose executives would be committing perjury just by reciting their ads under oath,” said CSPI litigation director Steve Gardner