Bayer Ads Misleading Men About Prostate Cancer, Says CSPI

The Center for Science in the Public Interest has notified Bayer Healthcare
that it will sue the company if it continues to claim that the selenium
in its One A Day vitamins may reduce men's risk of prostate cancer, the
health group announced today.

Advertisements
and labels for One A Day Men's 50+ Advantage and One A Day Men's Health
Formula multivitamins claim that "emerging research" suggests that
selenium may reduce the risk of prostate cancer. "Did you know that
there are more new cases of prostate cancer each year than any other
cancer?" intones the narrator one such radio ad. "Now there is
something you can do."

But leading prostate cancer researchers say there is scant evidence to support such a claim and have joined CSPI in urging the Federal Trade Commission (FTC) to put an immediate stop to the deceptive claims.

"Bayer
is exploiting men's fear of prostate cancer just to sell more pills,"
said CSPI senior nutritionist David Schardt. "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."

A seven-year, $118-million study funded by the National Institutes of Health
found last year that selenium does not prevent prostate cancer in
healthy men. The Selenium and Vitamin E Cancer Prevention Trial
(SELECT) involving 35,000 U.S. and Canadian men was halted in October
when researchers determined that selenium was not protecting the men
from prostate cancer and may have been causing diabetes in some of
them.

The only study to find that selenium might prevent prostate cancer in men was the Nutritional Prevention of Cancer (NPC) trial,
which unexpectedly found in 1996 that selenium supplementation seemed
to prevent prostate cancer in men with a history of skin cancer.
However, two later analyses of the NPC results determined that only a
small minority of men may have benefited from selenium supplementation
and that selenium almost tripled the risk of developing diabetes. That
led to a dramatic warning from the American College of Physicians that
"long-term selenium supplementation should not be viewed as harmless
and a possibly healthy way to prevent illness."

In an editorial
accompanying publication of the SELECT study results in the Journal of
the American Medical Association, Peter Gann of the University of
Illinois at Chicago urged that "physicians should not recommend
selenium or vitamin E-or any other antioxidant supplements-to their
patients for preventing prostate cancer."

Yet, Bayer still touts selenium's promise in preventing unspecified prostate "issues" and in reducing prostate cancer risk.

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

In recent years CSPI's litigation department has negotiated settlements or voluntary changes to marketing practices with Airborne, Anheuser-Busch, Frito-Lay, Kellogg, Pinnacle Foods, Quaker Oats, and others.

Besides
announcing its intention to sue Bayer, CSPI also filed a complaint
today with the FTC. That complaint states that because Bayer's ads have
for so long reinforced the false notion that selenium prevents prostate
cancer-and because selenium may actually increase the risk of
diabetes-the company should be required to run a corrective advertising
campaign. (Bayer is now running corrective advertising at the behest of
the Food and Drug Administration and state Attorneys General about yet
another one of its products, its birth control pill Yaz.)

CSPI says the prostate cancer claims for One A Day
supplements for men violate a consent decree the company signed with
the FTC in 2007. That year Bayer paid a $3.2 million fine related to
weight-loss claims made on behalf of One A Day multivitamin
WeightSmart, and agreed not to make unsubstantiated claims in the
future.

Separately, some of the most prominent prostate cancer
researchers in the United States wrote to the FTC in support of CSPI's
complaint about Bayer's advertising. The SELECT trial "was the largest
individually randomized cancer prevention trial ever conducted, and,
given its high rates of adherence and its statistical power, it is
unlikely to have missed detecting a benefit of even a very modest
size," wrote the researchers. "Bayer Healthcare is doing a disservice
to men by misleading them about a protective role for selenium in
prostate cancer."

Signatories include Peter Gann and Maarten Bosland of
the University of Illinois at Chicago, Ed Giovannucci of the Harvard
Medical School, Alan Kristal of the Fred Hutchinson Cancer Research
Center, William Nelson of the Johns Hopkins Medical School, Tim Byers
of the University of Colorado, Larry Kushi of Kaiser-Permanente in
Oakland, Lawrence Kolonel of the University of Hawaii, and Michael Thun
of the American Cancer Society.