Watchdog May Sue Bayer Over Claim That Vitamin Pill Reduces Prostate Cancer Risk

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Main Category: Prostate / Prostate Cancer
Also Included In: Men's health;  Nutrition / Diet;  Urology / Nephrology
Article Date: 19 Jun 2009 - 2:00 PDT

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US consumer watchdog Center for Science in the Public Interest (CSPI) has informed Bayer Healthcare that it will sue them and file a complaint with the Federal Trade Commission (FTC) if they continue to claim that the selenium in their One A Day vitamin tablet may reduce the risk of prostate cancer in men.

CSPI said that Bayer's advertisements and labels for their multivitamin product claim that "emerging research" suggests that the selenium they contain may reduce the risk of prostate cancer.

The group announced its intention on Thursday, citing the claim made for products like One A Day Men's 50+ Advantage and One A Day Men's Health Formula, such as a radio advertisement that asks "Did you know that there are more new cases of prostate cancer each year than any other cancer?" and then says "Now there is something you can do."

CSPI said leading researchers say there is little evidence to support such claims and have joined forces with the group in urging the FTC to stop them immediately.

CSPI senior nutritionist David Schardt said Bayer was "ripping people off " by making unfounded claims.

"The largest prostate cancer prevention trial has found that selenium is no more effective than a placebo," said Schardt, adding that the company was "exploiting men's fear of prostate cancer just to sell more pills".

CSPI litigation director Steve Gardner said:

"With these indefensible claims, Bayer is thumbing its nose at the Food and Drug Administration, the FTC, and any number of state consumer protection laws."

"A courtroom would be treacherous territory for Bayer, whose executives would be committing perjury just by reciting their ads under oath," said Gardner.

The CSPI announcement referred to two trials that showed selenium was not effective in preventing prostate cancer.

The first was a 7-year 118 million-dollar study funded by the National Institutes of Health that last year concluded that selenium did not prevent prostate cancer in healthy men.

The second was a trial of 35,000 US and Canadian men (the Selenium and Vitamin E Cancer Prevention Trial, SELECT) that finished early when it found selenium was not preventing men from getting prostate cancer and may even have been causing diabetes in some of them.

According to the CSPI, the only evidence that selenium might prevent prostate cancer in men was the results of the 1996 NPC (Nutritional Prevention of Cancer) trial that appeared to show selenium might prevent prostate cancer in men with a history of skin cancer, but on re-analysis showed the benefit was conferred only to a small proportion of men, and more importantly, the supplement was also linked to a tripling of diabetes risk.

In an editorial in the same issue of the Journal of the American Medical Association, JAMA where the SELECT trial results appeared, Peter Gann of the University of Illinois at Chicago stressed that:

"Physicians should not recommend selenium or vitamin E -- or any other antioxidant supplements -- to their patients for preventing prostate cancer."

This also led the American College of Physicians to warn that "long-term selenium supplementation should not be viewed as harmless and a possibly healthy way to prevent illness," said the CSPI.

Trish McKernan, spokeswoman for Bayer told CNN that the company was "standing behind all the claims we make in support of the products".

The selenium claims were made by an FDA approved qualified health claim, she said, adding that:

"We regularly review the evidence, and we change our claims if necessitated. The emerging science hasn't compelled us to change our claims, and the FDA claim is intact."

As well as threatening to sue the company, the CSPI has written a strong letter to the FTC about Bayer's claims, and separately, leading US prostate cancer research scientists, including Peter Gann, have done the same. They wrote that:

"Bayer Healthcare is doing a disservice to men by misleading them about a protective role for selenium in prostate cancer."

CSPI has negotiated settelements or changes to marketing practices with several large companies in recent years, including: Kellogg, Frito-Lay, Airborne, Quaker Oats, Anheuser-Busch, and Pinnacle Foods.

Sources: CSPI, CNN.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today