May 23 2012

The FTC vs. POM Wonderful: the latest round

I’ve been following the legal battles between the Federal Trade Commission (FTC) and the makers of POM juice and other pomegranate juice products with avid interest, mainly because they deal with the credibility of sponsored scientific research.

This week, an administrative law judge ruled that POM violated federal law when it deceptively advertised  its products as able to “treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction.”

The judge ruled that reasonable consumers would interpret the ads as making such claims but that the company had not produced convincing evidence to support them.

The judge’s decision makes entertaining reading for someone like me who enjoys debates about whether sponsorship of scientific studies influences results and interpretation—as evidence shows they most definitely do.

POM has invested more than $35 million in research to prove that pomegranate juice has health benefits.  It has sponsored about 100 studies at 44 different institutions.  At least 70 of these studies were published in peer-reviewed journals.

It is not difficult to design research studies to give sponsors the answers they want and to make sure they are conducted well.  POM is getting the best research that money can buy.

One such study, of the effects of drinking pomegranate juice on myocardial perfusion (MP, blood flow to the heart), was conducted by Dr. Dean Ornish, who runs a preventive medicine institute in California (the quotes come from pages 268-269 of the decision).

The Ornish MP study was originally designed to last 12 months, with measurements at baseline, 3 months, and 12 months.  [The FTC] charges that the study was cut short when the three-month data came in favorably and Dr. Ornish faced cost overruns.

Dr. [Frank] Sacks [expert witness for the FTC] opined that the shortened study period and failure to report the planned duration are inconsistent with widely accepted standards for conduct of clinical trials and undermine any confidence in the findings.

Dr. Ornish testified that the Ornish MP Study was terminated after three months only because the Resnicks did not provide the funding that they had previously committed to this study….[he said the study]constitutes credible and reliable science showing that pomegranate juice lessens the risk of cardiovascular problems.

The judge found evidence on this study and many others conflicting.  He ruled that this level of disagreement about the quality of the research means that the scientific evidence is not good enough to substantiate the claims.

I was interviewed for a story in Business Week about this decision.

This makes it clear why everyone should be suspicious of the results of sponsored studies…POM-sponsored studies produce results favorable to POM.

POM’s owners have their own spin on the decision.

It says the ALJ’s ruling affirms the scientific validity behind the general health benefits of pomegranates and “completely exonerates” POM regarding its claims in broadcast or print interviews.

Let’s be clear what’s at stake here.  According to the decision document, the owners of POM control 18,000 acres of pomegranate orchards.

From September 2002 through November 2010, sales of POM juice alone totaled nearly $248 million (the supplements and other products add more).

The owners must believe that nobody will buy pomegranate juice and supplements for any reason other than health benefits.

Health claims are about marketing, not health.

Let’s hope the FTC can make the decision stick.

  • brad

    While it’s true that sponsored studies tend to produce results favorable to the sponsors, it’s worth noting that most responsible universities take great pains to ensure that their researchers have complete academic freedom to publish their findings, even if those findings are not favorable to the sponsors.

    I spent three years as a grants and contracts negotiator for a well-known university, and a big part of my job involved negotiating with sponsors to remove any language in the contract or grant that allowed the sponsor to “review and approve” final research reports and journal articles, or that allowed the sponsor to control the study in any way. In a few cases we were forced to turn down very significant grants and contracts when the sponsors were unwilling to grant total academic freedom to our researchers.

    That said, clearly some researchers will be motivated to please sponsors if they think they can get a continued stream of funding from them. But they do so at the risk of their reputations and academic future: if others repeat their studies and can’t replicate the findings, someone will cry foul. That of course assumes that others will be able to get funding to replicate the studies, which won’t always happen.

    It’s also worth noting that sponsors often seek out researchers whose published work suggests that they will generate conclusions favorable to the sponsor. This is the case, for example, with global warming skeptics: most of the industry-funded skeptics were skeptics first and attracted industry funding because of it. It’s not like they were believers and then changed their minds once they started getting industry funding. Industry simply gave them a way to pursue research they already wanted to do and reach conclusions they already expected to make.

  • http://parisbreakfasts.blogspot.com parisbreakfast

    This may be irrelevant, but I’m a huge fan of pomegranates.
    I’ve been eaiting about a tablespoon of the seeds daily, frozen or fresh for more than 8 years and haven’t had a cold or flu once in that time.
    But drinking the juice, Pom or any other brand does zip health-wise in my opinion. These fruit drinks are full of sweetners, maybe apple or grape juice and gawd knows what all.
    Love what you do
    Thanks
    Carolg

  • Robert L Holman

    The Dean Ornish website does not provide information concerning the particular study of myocardial perfusion. If it was only 3 months in duration and included only a relatively small number of subjects, then any positive result was just as much a matter of luck as real benefit.
    Reading today’s online NY Times gives one the sense of the financial power of false marketing by PW.

  • http://herbalwater.typepad.com Dr. Ayala

    I have always agreed with you about health claims being all about marketing – not about health. The health claim flare-up and the so called “functional foods” explosion have not only moved people even further from eating better, they have made all brands, marketing and advertising suspect in the eyes of the more educated consumers.

    But POM’s spin, this time, is particularly disturbing. Their declaration of the ruling as a victory, and the huge Internet banner ads in the NY Times following the ruling – claiming the same benefits they claimed before plus the spin of claiming the judge said they’re founded claims (http://www.pomtruth.com/) – would make any reasonable consumer doubt if they should ever consider any communications from any company ever again.

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  • John

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