Currently browsing posts about: Lawsuits

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.

I’ve been out of the country for the past week (Panamá, warm and lovely) but have been kept up on the peanut butter outbreak, courtesy of Eric Burkett of Examiner.com.  His posts thoroughly cover events in this latest outbreak of Salmonella typhimurium.  The outbreak is so widespread that the FDA has a special site devoted to it with a useful Q and A.  The FDA warns consumers not to eat any recalled peanut butter or foods made with it (the list is on the FDA site).  Peanut butter in jars seems to be OK, so far.  If you want to see the epidemiology, the CDC has the case-report charts and state maps online.  The lawyers are also getting into the act: Marler Clark is always a source of information about actionable foodborne illnesses, and O’Steen & Harrison also seems to be keeping close track. At issue is where the contamination occurred, where the contaminated peanut butter was distributed, and what other food companies are using this peanut butter.  That this information is not readily available is further evidence of the need for better food safety requirements, oversight, and traceability.  Let’s hope the new administration takes this on, and soon. And until it does, best to grind your own peanuts!

Update January 19: Just ran across this article on how Salmonella gets into peanut butter in the first place.  The usual way: animal feces.  Roasting the peanuts should kill Salmonella, so the contamination must have occurred later.  Did the factory have a HACCP plan in place?  If so, they must not have been paying much attention to it.

Update January 20: Add Cliff and Luna bars to the list.

Bill Marler is a class-action lawyer in Seattle who specializes in food safety cases.  His Christmas letter this year gives his top ten picks for the food safety disasters of 2008.  Number 1 is melamine-laced Chinese food products.  He’s leaving #10 open just in case anything new happens between now and the end of the year.  Thanks Bill.  Enjoy your holiday dinners, everyone!

Lots of states are passing laws to try to improve the food environment for kids–schools, marketing, vending, physical activity, farmers’ markets, and lots of other ideas. I can’t keep track of them. Fortunately, other people can and are writing about what they find.  Here’s one such paper, sent to me by Joel Moskowitz of UC Berkeley’s Center for Family and Community Health. It’s a good place to start if you are wondering whether the environment has anything to do with childhood obesity and, if so, what the legal system can do about it.