THE "NEW" PROSTATE CANCER INFOLINK

Apparently the Center for Science in the Public Interest (CSPI) “is threatening to sue” Bayer HealthCare “for ‘misleading men’ about the benefits of” two of its selenium-containing One-A-Day products, or so California consumer watchdog blogger W.  J. Hennigan wrote earlier this week in the Los Angeles Times.

The article goes on to claim that Bayer is running “advertisements … that claim the product reduces men’s risk of prostate cancer.” But, according to Hennigan, CSPI “said in a statement today that Bayer’s radio and TV ads falsely claim that selenium, an ingredient of One-A-Day Men’s Health Formula and 50+ Advantage, helps prevent prostate cancer.”

Now before everyone gets in a tizzy here, lets see if we can get some facts in order:

• The SELECT trial, coordinated by the National Institutes of Health, was stopped at the end of 2008 at the recommendation of the the data monitoring committee because there was no evidence that patients taking selenium were getting any protection from risk of prostate cancer compared to taking a placebo.
• The trial summary also stated that continuing treatment with selenium might be associated with an increased risk for type II diabetes.

This explains the report issued by the Associated Press and quoting David Schardt, a nutritionist with CSPI, which says that “The largest prostate cancer prevention trial has found that selenium is no more effective than a placebo,” and that Bayer is therefore “ripping people off when it suggests otherwise in these dishonest ads.”

According to yet another report, this one from CNN yesterday, “the center already has filed a complaint with the Federal Trade Commission.”

A spokesperson for Bayer has supposedly said that, “We are standing behind all the claims we make in support of the products.” She noted that “the selenium claims are made by a [Food and Drug Administration]-approved qualified health claim. … The emerging science hasn’t compelled us to change our claims, and the FDA claim is intact.”

If we assume that this statement is true, which is a little hard to know, since the FDA does not actually determine the effectiveness and safety of “over-the-counter” (OTC) products like Bayer’s One-a-Day line, then it would seem that the ball is in the FDA’s court to reconsider whether the “health claim” for the Bayer product is still appropriate, given the outcome of the SELECT trial.

There is a long history of promotional “health claims” being made by manufacturers for OTC products that are (at best) of questionable veracity. Historically, the FDA has rarely if ever given specific approval for such health “claims” because the majority of manufacturers don’t ask for permission. Thus the FDA has generally told manufacturers to “cease and desist” from making such claims only when inappropriate claims are brought to the FDA’s attention.

It is also important to understand that the FDA has not said that selenium has no effects in the prevention and management of prostate cancer. No one has ever asked them to make such a determination. All we really know at this time is that the largest trial ever conducted to date, in some 35,000 men over several years, using a specific dose of selenium, was unable to show any value to this therapy in the prevention of prostate cancer.

Apparently, according to WebMD, in 2007, the FTC “ordered Bayer to stop making unproven health claims for a One-A-Day weight loss product and told the company not to make any unsubstantiated claims for any vitamins in the One-A-Day product line.” CSPI’s most recent complaint to the FTC urges the commission to “take swift and strong action to get these deceptive Bayer ads off television, radio, and Internet and out of newspapers and magazines or wherever else they may be displayed.”

It is puzzling to The “New” Prostate Cancer InfoLink that Bayer would want to go on making such promotional claims in the face of the overwhelming evidence of the SELECT trial. But then we’re not attorneys and we don’t work for Bayer. It would seem to us that Bayer loses credibility when it promotes any product as having specific health benefits in the face of massive evidence that this is not the case.

In the interests of full discosure, we should also note that Dr. Krongrad, one of the co-founders of this web site and one of the authors of the paper by Clark et al. that originally suggested that selenium might have a preventive effect against prostate cancer, has never suggested there is any evidence that it actually does have such an effect.

Filed under: Prevention | Tagged: Arnon Krongrad MD, Prevention, Prostate Cancer Prevention Trial, selenium |