Currently browsing posts about: Sponsored-research

Michele Simon, president of Eat, Drink, Politics, an industry watchdog consulting group, has just published an exposé of the close financial relationships between food and beverage companies and the Academy of Nutrition and Dietetics (AND, formerly the American Dietetic Association).

Her hard-hitting report, And Now a Word from Our Sponsors: Are America’s Nutrition Professionals in the Pocket of Big Food? provides ample evidence that partnerships and alliances with Big Food make it impossible for AND members to convey clear and accurate messages about nutrition and health.

When she talks about nutrition professionals, she doesn’t mean me.  I have a PhD (in molecular biology, although long lapsed) and a master’s in Public Health Nutrition.  She means AND members.  AND represents more than 70,000 individuals who mostly hold credentials as Registered Dietitians (RDs).

To qualify, they had to complete a bachelor’s degree that included a specified set of courses and a 6-month clinical internship.  I once tried to get credentialed as an RD after I completed a qualifying internship but I had never had a practical course in food service management.  That lack was a deal breaker.

Never mind.  Here’s what Simon’s report is about:

And here are a small selection of her observations and conclusions:

• AND collected $1.85 million in sponsorship funds in 2011, a relatively small percentage of its $34 million income.
• Companies such as Coca-Cola, Kraft, Nestlé, and PepsiCo offer approved continuing education courses to AND members.
• Two of the messages conveyed by one of Coca-Cola’s courses: sugar is not harmful to children, and federal nutrition standards for school meals are too restrictive.
• More than 20% of speakers at AND’s annual meeting have financial ties to Big Food companies, although most were not disclosed.
• A survey found 80% of members to believe that sponsorship implies an AND endorsement of the sponsor’s products.
• A majority of AND members believe that three current sponsors are unacceptable: Coca-Cola, Mars, and PepsiCo.

If you want to see how sponsorship plays out in practice, take a look at her photographs of the exhibit hall at the 2012 AND annual meeting.  She also provides photos taken elsewhere at the meeting.  And here’s the New York Times’ take on it.

As a trade association for Registered Dietitians, AND—as I discussed in Food Politics—has as its primary goal to position RDs as the leading source of nutrition information for patients, clients, and the public.

As you might imagine, I’ve always had a bit of trouble with that goal.

For one thing, nutritionists with master’s and doctoral degrees are likely to know more than RDs about nutrition science and to think more critically about it.

For another, that self-interested goal creates an image problem.  RDs might be accepted as more credible sources if their primary goal was to improve the nutritional health of the American people.

Their advice also would be more credible if AND were not so heavily linked to food and beverage corporations, especially those whose products contribute to poor health.

Let’s hope this new report gets AND members talking about how to change some current AND policies.

POM Wonderful has a full-page ad in today’s New York Times (how much do these things cost?) titled “FTC v. POM: You be the judge.”  The ad includes selected quotes from the judge’s decision (see yesterday’s post) and refers readers to its wonderfully named website, pomtruth.com, where you can see the quotes and the ads for yourself.

I couldn’t help doing some checking.

The POM ad quotes from Chief Administrative Law Judge’s decision:

Competent and reliable scientific evidence supports the conclusion that the consumption of pomegranate juice and pomegranate extract supports prostate health, including by prolonging PSA doubling time in men with rising PSA after primary treatment for prostate cancer (page 282).

I turned immediately to page 282.  The sentence before the one quoted would seem to support it:

The basic research, the Pantuck Study, and the Carducci Study, relied on by Respondents [POM Wonderful], support the conclusion that pomegranate juice has a beneficial effect on prostate health.

But what follows the quotation makes it clear that although the research claims to support the effect, it really doesn’t.  Here’s what immediately follows the quotation in the same paragraph:

However, the greater weight of the persuasive expert testimony shows that the evidence relied upon by Respondents is not adequate to substantiate claims that the POM Products treat, prevent, or reduce the risk of prostate cancer or that they are clinically proven to do do so.  Indeed, the authors of the Pantuck Study and the Carducci study each testified that their study did not conclude that POM juice treats, prevents, or reduces the risk of prostate cancer.  And, as Respondents’ expert conceded, no clinical studies, research and/or trials show definitely that the POM Products treat, prevent, or reduce the risk of prostate cancer.

I will just do one more of the quotes.  The ad says:

Competent and reliable scientific evidence shows that pomegranate juice provides a benefit to promoting erectile health and erectile function (page 198).

This is indeed on page 198 but is followed immediately by:

There is insufficient competent and reliable scientific evidence to show that pomegranate juice prevents or reduces the risk of erectile dysfunction or has been clinically proven to do so…There is insufficient competent and reliable scientific evidence to show that pomegranate juice treats erectile dysfunction in a clinical sense or has been clinically proven to do so.

Because these statements are attributed to the same expert witnesses, this must mean that while some studies show benefits, the experts do not believe that these studies (many of them sponsored by POM) are scientifically credible.

Pomegranate juice is a juice.  Fruit juices are healthy and especially delicious when fresh.  I happen to like the taste of pomegranate juice.

But does it have any special health benefits as compared to orange, grapefruit, grape, or any other fruit juice?

Would any fruit juice be likely to prevent heart disease or prostate problems on its own?

Despite POM’s out-of-context advertisement, the Administrative Law Judge did not think so, and neither do I.

Addition: I’m indebted to FoodNavigator.com for noticing some of the other ads.

The caption reads: “Natural Fruit Product with Health Promoting Characteristics–FTC Judge.”

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.