Currently browsing posts about: Sponsored-research

I’ve been collecting examples of conflicted research for the past week or so.  These are studies paid for in part by food businesses or trade associations with a vested financial interest in the outcome of the research.

These almost invariably promote the financial interests of the sponsor.  To wit:

Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study—a randomized controlled trial, by Daniela Mastroiacovo, Catherine Kwik-Uribe, Davide Grassi, Stefano Necozione, Angelo Raffaele, Luana Pistacchio, Roberta Righetti, Raffaella Bocale, Maria Carmela Lechiara, Carmine Marini, Claudio Ferri, and Giovambattista Desideri.  Am J Clin Nutr 2015; 101:538-548 doi:10.3945/ajcn.114.092189.

• Conclusion: These data suggest that the habitual intake of flavanols can support healthy cognitive function with age.
• Sponsor: Mars, Inc.

Sugar-Sweetened Product Consumption Alters Glucose Homeostasis Compared with Dairy Product Consumption in Men and Women at Risk of Type 2 Diabetes Mellitus, by Kevin C Maki, Kristin M Nieman, Arianne L Schild, Valerie N Kaden, Andrea L Lawless, Kathleen M Kelley, and Tia M Rains.  J Nutr. 2015; 145:459-466 doi:10.3945/jn.114.204503.

• Conclusion: These results suggest that SSP consumption is associated with less favorable values for HOMA2–%S, LMTT disposition index, HDL cholesterol, and serum 25(OH)D in men and women at risk of T2DM vs. baseline values and values during dairy product consumption.
• Sponsor: Dairy Research Institute/National Dairy Council

Squeezing Fact from Fiction about 100% Fruit Juice, by Roger Clemens, Adam Drewnowski, Mario G Ferruzzi, Cheryl D Toner, and Diane Welland. Adv Nutr 2015;6: 236S-243S. doi: 10.3945/​an.114.007328.

• Conclusion:  The preponderance of evidence supports the position that 100% fruit juice delivers essential nutrients and phytonutrients, provides year-round access to a variety of fruits, and is a cost-effective way to help people meet fruit recommendations.
• Sponsor: Juice Products Association

Can probiotic yogurt prevent diarrhoea in children on antibiotics? A double-blind, randomised, placebo-controlled study, by Michael J Fox, Kiran D K Ahuja, Iain K Robertson, Madeleine J Ball, Rajaraman D Eri.  BMJ Open 2015;5:e006474.  doi:10.1136/bmjopen-2014-006474.

• Conclusion: A yogurt combination of LGG, La-5 and Bb-12 is an effective method for reducing the incidence of antibiotic-associated diarrhoea in children.
• Sponsor: Parmelat Australia

Chronic consumption of flavanone-rich orange juice is associated with cognitive benefits: an 8-wk, randomized, double-blind, placebo-controlled trial in healthy older adults, by Rebecca J Kean, Daniel J Lamport, Georgina F Dodd, Jayne E Freeman, Claire M Williams, Judi A Ellis, Laurie T Butler, and Jeremy PE Spencer.  Am J Clin Nutr 2015; 101:506-514 doi:10.3945/ajcn.114.088518.

• Conclusion: Chronic daily consumption of flavanone-rich 100% orange juice over 8 wk is beneficial for cognitive function in healthy older adults.
• Sponsor: Partially funded by the State of Florida Government, Florida Department of Citrus.  The authors report: “Florida Citrus helped designed [sic] the research. None of the authors reported a conflict of interest related to the study.”

Dairy consumption and risk of cardiovascular disease: an updated meta-analysis of prospective cohort studies, by Li-Qiang Qin PhD, Jia-Ying Xu PhD, Shu-Fen Han PhD, Zeng-Li Zhang PhD, You-You Zhao PhD, Ignatius MY Szeto PhD.   Asia Pac J Clin Nutr. 2015 Mar;24(1):90-100. doi: 10.6133/apjcn.2015.24.1.09.

• Conclusion:  This meta-analysis provided further evidence supporting the beneficial effect of dairy consumption on CVD. Low-fat dairy products and cheese may protect against stroke or CHD incidence.
• Sponsor: Nestec Ltd. (Nestlé R&D (China) Ltd.  Two of the authors work for the company (to which I am not related).

In each of these cases, the sponsors got what they paid for.  Recent sponsored studies have not come to conclusions contrary to the interests of the sponsor.

Coincidence?

You decide.

Former USDA Secretary Dan Glickman has just been named chairman of the board of the Foundation for Food and Agriculture Research (FFAR).

Research on agriculture has long been the underfunded stepchild of the federal research enterprise.  The 2014 budget gave USDA under $3 billion in total to fund all of its in-house research units and their granting operations: Agricultural Research Service, National Institute of Food and Agriculture, Economic Research Service, and Agricultural Statistics Service.

This may seem like a lot, but NIH gets $30 billion a year.

The 2014 farm bill contained a provision aimed at raising money for agricultural research.  It provided $200 million (peanuts in federal dollars) to establish FFAR, which will operate as a non-profit corporation to obtain matching funds from private industry.

The members of the board were announced a couple of weeks ago.

It should be no surprise that many of the board members represent industry.  Industry nominated 7 of the members.  The other 8 were selected from a list provided by the National Academy of Sciences.

Now the board has to raise at least $200 million from industry, presumably with no strings attached.

Here’s the foundation’s dilemma: if industry funding has no strings—earmarks for certain research projects, for example—why would industry want to contribute?  But if the contributions do come with strings, they create conflicts of interest.

This will be fun to watch.  Stay tuned.

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.