From Medscape Medical News
Nick Mulcahy
October 6, 2009 — A consumer advocacy and industry watchdog group has filed suit against Bayer for claiming that an ingredient, selenium, in its One A Day Men's Health Formula multivitamin product might reduce the risk for prostate cancer.
The lawsuit was filed in the Superior Court of California in San Francisco, according to the filers, the Center for Science in the Public Interest (CSPI) of Washington, DC.
"Bayer has run radio ads that say their product may reduce the risk of prostate cancer. The packaging says the same. Even after the Selenium and Vitamin E Cancer Prevention Trial (SELECT) showed that selenium did not prevent prostate cancer, they continued to run TV ads that referred to a prostate health benefit," David Schardt, MS, senior nutritionist at CSPI, told Medscape Oncology.
Mr. Schardt explained that the company has never received approval from the US Food and Drug Administration (FDA) to make a specific prostate cancer claim.
He also said that any claim about prostate issues was an indirect reference to prostate cancer because selenium has never been shown to have any benefit for benign prostatic hyperplasia.
Bayer was allowed to make a "qualified claim" that "selenium may reduce the risk of certain cancers" on the basis of guidance from the FDA, said Mr. Schardt, but was not allowed to make a claim about prostate cancer.
Large Trial Showed No Benefit
Selenium has been promoted as potentially offering protection against prostate cancer by many different health supplement companies, but last year a large trial showed no benefit, and more recently, a smaller trial suggested that selenium is harmful if prostate cancer is already present.
SELECT is the 35,000-patient trial that found that neither selenium nor vitamin E, taken alone or together, prevented prostate cancer after 5 years of use, as reported by Medscape Oncology. In October 2008, the trial's Data and Safety Monitoring Committee made the decision to stop the use of the supplements.
A Bayer spokesperson told Medscape Oncology in an email that the FDA's guidance on the qualified health claim about selenium changed earlier this year. The company is now "in the process of revising the packaging and promotional materials for its One A Day Men's and One A Day Men's 50+ [Advantage products] to exclude reference to the qualified health claim regarding the relationship between selenium intake [and] the reduced risk for certain cancers."
The main support for FDA's earlier qualified claim about selenium was "data relating to prostate cancer," the email noted.
There have been a number of studies suggesting that selenium protected against prostate cancer, including the Nutritional Prevention Cancer Trial, a skin cancer study that incidentally revealed prostate cancer data (JAMA.1996;276;1957-1963). However, SELECT has been called the "definitive" trial on the subject by SELECT author and investigator Larry Baker, MD, from the University of Michigan in Ann Arbor.
Packaging and Ads Refer to Prostate Benefit
Although the company says that it is revising its promotional materials, a One A Day Men's Health Formula package bought today in Philadelphia by Medscape Oncology suggests a possible prostate cancer benefit.
Emerging research suggests Selenium may reduce the risk of prostate cancer.
"Did you know that prostate cancer is the most frequently diagnosed in men and that emerging research suggests Selenium may reduce the risk of prostate cancer?" says the label. "One A Day Men's Health Formula is a complete multivitamin plus key nutrients including Selenium to support a healthy prostate."
The packaging also includes the disclaimer that the "product is not intended to diagnose, treat, cure, or prevent any disease."
A One A Day radio ad with a prostate cancer claim is posted on the CSPI site; the date of the airing is not specified. The site also has a link to a TV ad for One A Day that refers to the benefits of selenium for prostate health.
Before filing its lawsuit, the CSPI filed a complaint in June 2009 with the FDA over the prostate cancer claim on One A Day Men's Health Formula labelling.
"The claim that the selenium in One A Day Men's Health Formula reduces the risk of prostate cancer gives the product the status of an unapproved drug, and is therefore illegal," according to a CSPI press statement.
Also in June, the CSPI urged the FDA to seize stockpiles of the men's vitamin.
The impetus behind the drastic recommendation was a new study on selenium and prostate cancer that suggested potential harm, according to a CSPI press statement.
In that study, researchers from the Dana-Farber Cancer Institute in Boston, Massachusetts, found that a high level of selenium in the blood was associated with a slightly elevated risk for aggressive prostate cancer in men who have the disease.
"If you already have prostate cancer, it may be a bad thing to take selenium," the senior author of the study told Medscape Oncology at the time.
Major League Baseball and One A Day
One A Day Men's Health Formula multivitamin has also been associated with prostate cancer through a charitable campaign with Major League Baseball (MLB).
"The main promotional platform with baseball is the 'One A Day Men's Strikeout Prostate Cancer Challenge,' in which One A Day and MLB combine to donate $10 to the Prostate Cancer Foundation for every strikeout thrown throughout the regular season and the playoffs," an MLB spokesperson told Medscape Oncology in an email.
The One A Day Web site features the campaign but also notes that the product is "not intended to prevent or treat prostate cancer."
Although nothing about the fundraising campaign is illegal, in June 2009, the CSPI encouraged both MLB and the Prostate Cancer Foundation to drop their ties to One A Day and Bayer because of the misleading advertising.
The CSPI estimates that the charitable contributions from this program with MLB should be around $350,000.
According to an article published October 1 in the New York Times , One A Day Men's Health Formula had sales of $23.3 million for the 52 weeks ending September 6. The source of the figure was Information Resources, a market research firm.
Bayer and Other Claims Issues
Bayer will be in big trouble if they are found to be in violation of the law.
"Bayer will be in big trouble if they are found to be in violation of the law," said Mr. Schardt about the prostate cancer claims. In 2007, the company signed a court order to not misrepresent any of their multivitamins, he explained.
This followed an action that resulted in Bayer paying a $3.2 million fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice over weight-loss claims made in connection with another One A Day product, according to a CSPI press statement.
Bayer is also running a $20-million corrective advertising campaign about its birth control pill Yaz under the order of the FDA and a number of state attorneys general, according to the same press statement.
No comments:
Post a Comment