Bayer Sued Over Unsupported Prostate Cancer Claims on One A Day

The Center for Science in the Public Interest has sued
the German drug company Bayer for falsely claiming that the selenium in
Men's One A Day multivitamins might reduce the risk of prostate cancer.
The lawsuit is filed in the Superior Court of California in San
Francisco.

CSPI first contacted Bayer in June
to demand that the drug maker alter its marketing of Men's One A Day
because the largest prostate cancer prevention trial ever conducted
found eight months earlier that selenium supplementation does not
prevent prostate cancer. More alarmingly, that study and another found
that selenium supplements may increase the risk of diabetes.

A day after CSPI contacted Bayer, the FDA issued a
letter containing qualified health claim language for use on labels
that said, in part, that it was "highly unlikely that selenium
supplements reduce the risk of prostate cancer." That forced Bayer to
alter much of its marketing, but it pointedly refused to recall
existing packages bearing the false claims. The company also refused to
remove all false prostate claims from some marketing for Men's One A
Day, and failed to put in writing that it will not make those claims in
the future.

"Given Bayer's long history of wrongdoing in other cases, CSPI is
acting to ensure that Bayer is permanently stopped from deceiving
consumers about selenium," said CSPI litigation director Stephen Gardner.

The largest prostate cancer prevention trial
ever conducted found that the mineral selenium was no more effective in
reducing prostate cancer risk than a placebo. That trial, the Selenium
and Vitamin E Cancer Prevention Trial, known as SELECT, was halted
early when it became clear that the men were not benefiting from
selenium and may have developed more cases of diabetes than men in the
control group. Another study of selenium and prostate cancer found an
alarming three-fold increased risk of diabetes among men taking
selenium.

Writing about the SELECT trial in the Journal of the American Medical Association, Dr. Peter Gann
of the University of Illinois at Chicago cautioned that "physicians
should not recommend selenium or vitamin E-or any other antioxidant
supplements-to their patients for preventing prostate cancer." Hopes
that selenium might be beneficial to the prostate were further dashed
when a 2009 study of men with prostate cancer found more aggressive
cases of the disease in men with high selenium blood levels and a
common genetic trait shared by three out of four men.

"Bayer has been giving American men false hope about
the selenium in One A Day multivitamins," said CSPI executive director
Michael F. Jacobson. "Bayer continued to run deceptive ads even after
SELECT found that selenium supplements weren't helping and might even
be hurting."

In a recent letter to CSPI, Bayer threatened to sue
CSPI for libel for calling attention to Bayer's selenium claims. Much
of Bayer's courtroom experience, however, comes as a criminal or civil
defendant.

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.
Media accounts at the time described it as the biggest recovery for
Medicaid fraud.

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. Two Bayer executives separately pleaded
guilty and were sentenced to prison for their role in the scandal.

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 cholesterol-lowering drug Baycol, which is no
longer on the market.

Bayer has even gotten into hot water with the federal
government in the past over its One A Day marketing. 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. CSPI
says that Bayer's prostate claims for Men's One A Day violate the
consent decree, which could compound the company's legal problems.

And this year, 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.

"Bayer's
threat to sue CSPI is clearly designed to have a chilling effect on
free speech and to intimidate us into silence," Jacobson said. "I'm
confident, however, that the FTC, the FDA, and the courts will all take
careful note of the facts of this case, as well as Bayer's long history
of flouting the law. It takes a lot of chutzpah for a company with such
a long record of corporate malfeasance to level libel charges against a
nonprofit organization."

CSPI is suing on behalf of itself and its members, and
is represented by its in-house litigators Stephen Gardner and Katherine
Campbell, alongside Harry Shulman of The Mills Law Firm of San Rafael,
Calif., and Washington, D.C.-based lawyers Steven N. Berk and Chris
Nidel.