Currently browsing posts about: Sponsored-research

Every time I collect five, I’m posting studies sponsored by food companies or trade associations that show benefits of the sponsor’s products.

I would love to be able to post industry-sponsored studies with results contrary to the sponsor’s interest, but I’m just not finding any.  If you run across some, please send.

Here’s this week’s batch, with comments on the last two:

Probiotic supplementation prevents high-fat, overfeeding-induced insulin resistance in human subjects. Carl J. Hulston, Amelia A. Churnside and Michelle C. Venables British Journal of Nutrition (2015), 113, 596–602 doi:10.1017/S0007114514004097.

• Conclusion: These results suggest that probiotic supplementation may be useful in the prevention of diet-induced metabolic diseases such as type 2 diabetes.
• Sponsor: The present study…was financially supported by industry funds. The cost of consumables for the study was covered by an educational grant from Yakult UK Limited.

Dairy Foods and Dairy Proteins in the Management of Type 2 Diabetes: A   Systematic Review of the Clinical Evidence.   Gonca Pasin and Kevin B Comerford.    Adv Nutr 2015; 6:245-259. doi:10.3945/an.114.007690.

• Conclusion: Given cultured dairy products’ long history of safe use, and whey protein’s overall efficacy in clinical studies so far, these dairy products appear to have great potential to assist with the management of T2DM in millions of people worldwide, in an inexpensive and easily implementable manner.
• Sponsor: California Dairy Research Foundation. G Pasin is the executive director of the California Dairy Research Foundation. KB Comerford is a paid consultant for the California Dairy Research Foundation.

One Egg per Day Improves Inflammation when Compared to an Oatmeal-Based Breakfast without Increasing Other Cardiometabolic Risk Factors in Diabetic Patients.  Martha Nydia Ballesteros , Fabrizio Valenzuela, Alma E. Robles, Elizabeth Artalejo, David Aguilar, Catherine J. Andersen, Herlindo Valdez  and Maria Luz Fernandez.   Nutrients 2015, 7(5), 3449-3463; doi:10.3390/nu7053449

• Conclusions:  When compared to an oatmeal breakfast, one egg per day did not result in changes in plasma glucose, our primary end point…[and other markers] indicating that eggs can be consumed without any detrimental changes in lipoprotein or glucose metabolism in this population. The most interesting finding, however, was that eggs—possibly due to their content of highly bioavailable lutein and zeaxanthin—reduced inflammation in diabetic subjects when compared to oatmeal intake.
• Sponsor: Egg Nutrition Center

The Acute Electrocortical and Blood Pressure Effects of Chocolate.  M. Montopoli, L. C. Stevens, C. Smith, G. Montopoli, S. Passino, S, Brown, L. Camou, K. Carson, S. Maaske, K. Knights, W. Gibson, J. Wu.  NeuroRegulation 2015;2(1):3-28.  doi: 10.15540/nr.2.1.3.

• Conclusions: This is the first known study to investigate acute EEG effects of consuming chocolate and suggests a potential attention-enhancing effect… there is clearly the possibility of an application of this combination of L-theanine and cacao in the treatment of hypertension.
• Sponsor: “Chocolate products for this study were provided by a generous grant in supplies from The Hershey Company…Grateful appreciation is expressed to Dr. Debra Miller and to the staff at The Hershey Company for their guidance and support throughout this project and for their careful review of this manuscript prior to submission.”

Comment: I learned about this study from FoodNavigator, which deserves highest praise for this headline: “Step aside energy drinks: Chocolate has a stimulating effect on human brains, says Hershey-backed study.”  Bravo!

Efficacy and safety of LDL-lowering therapy among men and women: meta-analysis of individual data from 174 000 participants in 27 randomised trials.   Cholesterol Treatment Trialists’ (CTT) Collaboration.  Lancet 2015:385:1397-1405.

• Conclusion: “In men and women at an equivalent risk of cardiovascular disease, statin therapy is of similar effectiveness for the prevention of major vascular events.”
• Conflicts reported: The CTT Collaboration reports funding by various British and Australian research councils and foundations, “and not by the pharmaceutical industry.” But, it says, most of trials covered by its analysis were supported by the drug industry, and numerous members of the CTT report fees, grants, consultancies, or honoraria from various companies making cholesterol-lowering drugs.

Note:  drug companies have a vested interest in promoting drug, rather than dietary, approaches to LDL-lowering.

Comment: Conflicts of interest do not necessarily mean that the results of the study were manipulated or wrong.  They do mean that the methods and results require more than the usual level of scrutiny.  Sponsored studies almost invariably produce results consistent with the sponsor’s economic or marketing interests.

It’s likely that some industry-sponsored studies produce conclusions contrary to the sponsor’s interest.  If you know of any, please send.

As promised, I am posting examples of industry-sponsored research every time I collect five.  These, like the others, produce results favorable to the sponsor’s interests.

I am happy to post examples of sponsored studies that do not favor the sponsor’s interests, and this first one comes closest.  This Unilever-sponsored study found that consuming the product had no effect on blood flow in people with high blood cholesterol levels, although it did lower their levels of LDL (the “bad” cholesterol).

The effect of a low-fat spread with added plant sterols on vascular function markers: results of the Investigating Vascular Function Effects of Plant Sterols (INVEST) study. By Rouyanne T Ras, Dagmar Fuchs, Wieneke P Koppenol, Ursula Garczarek, Arno Greyling, Christian Keicher, Carole Verhoeven, Hakim Bouzamondo, Frank Wagner, and Elke A Trautwein.  Am J Clin Nutr 2015; 101:733-741 doi:10.3945/ajcn.114.102053.

• Conclusion: The intake of a low-fat spread with added PSs [plant sterols] neither improved nor worsened FMD [flow-mediated dilation]or other vascular function markers in hypercholesterolemic men and women. As expected, serum LDL cholesterol decreased, whereas plasma PSs increased after PS intake.
• Sponsor: Unilever Research and Development

The next four are more typical:

Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study. By Mette Bohl, Ann Bjørnshave, Kia V Rasmussen, Anne Grethe Schioldan, Bashar Amer, Mette K Larsen, Trine K Dalsgaard, Jens J Holst, Annkatrin Herrmann, Sadhbh O’Neill, Lorraine O’Driscoll, Lydia Afman, Erik Jensen, Merete M Christensen, Søren Gregersen, and Kjeld Hermansen.  Am J Clin Nutr 2015; 101:870-878 doi:10.3945/ajcn.114.097923

• Conclusion:  We found that a whey protein supplement decreased the postprandial chylomicron response compared with casein in persons with abdominal obesity, thereby indicating a beneficial impact on CVD risk.
• Sponsor: Arla Foods Ingredients Group P/S, and the Danish Dairy Research Foundation, among some independent sources.

Policy Statement: Snacks, Sweetened Beverages, Added Sugars, and Schools. Council on School Health, Committee on Nutrition, American Academy of Pediatrics.  Pediatrics Volume 135, number 3, March 2015.

• Conclusion: A positive emphasis on nutritional value, variety, appropriate portion, and encouragement for a steady improvement in quality will be a more effective approach for improving nutrition and health than simply advocating for the elimination of added sugars.
• Conflicts reported: One of the members of the committee writing this statement is supported by the National Dairy Council and the American Dairy Association.  Another receives support from the Nestle Nutrition Institute.

Maternal long chain polyunsaturated fatty acid [omega-3] supplementation in infancy increases length- and weight-for-age but not BMI to 6 years when controlling for effects of maternal smoking. L.M. Currie, E.A. Tolley, J.M. Thodosoff, E.H. Kerling, D.K. Sullivan, J. Colombo, and S.E. Carlson . Prostaglandins, Leukotrienes and Essential Fatty Acids, 2015.  http://dx.doi.org/10.1016/j. plefa.2015.04.001

• Conclusion: Our results… suggest that LCPUFA [omega-3s] could have positive effects on stature without negative effects on weight status; and that LCPUFA could mitigate lower stature and higher BMI associated with maternal smoking, particularly in boys.
• Sponsor: Mead Johnson Nutrition, the maker of the LCPUFA omega-3 supplement

Mediterranean Diet and Age-Related Cognitive Decline:  A randomized Clinical Trial. Cinta Valls-Pedret, MSc; Aleix Sala-Vila, DPharm, PhD; Mercè Serra-Mir, RD; et al.  JAMA Intern Med. Published online May 11, 2015. doi:10.1001/jamainternmed.2015.1668.

• Conclusion: In an older population, a Mediterranean diet supplemented with olive oil or nuts is associated with improved cognitive function.
• Conflicts reported: Dr Salas-Salvado reports receiving research funding and is a nonpaid member of the scientific advisory committee of the International Nut Council. Dr Ros also reports receiving research funding and is a nonpaid member of the scientific advisory committee of the California Walnut Commission.

Let me comment on this last one, which may seem like pushing things, given that the study itself was funded by the agency for biomedical research of the Spanish government.  I would have left it off this list had I not read an article about it in the Wall Street Journal.

The Journal interviewed Dr. Ros, the lead author:

The diminished decline in cognitive function likely stems from the abundance of antioxidants and anti-inflammatory agents found in the supplemental foods…He recommends that, to decrease age-related cognitive delay, people should add 5 tablespoons of olive oil as a well as a handful of nuts a day into their diet.

But the Journal also interviewed a clinical neuropsychologist who was not involved in the study:

The changes observed in cognition were very small and didn’t actually show that those diets improved cognition, they just showed less decline. Based on the research…people shouldn’t rush out to buy lots of olive oil and nuts.

My point here is that the sole purpose of this study was to prove the health benefits of olive oil and nuts.  Yes, these are healthy foods, but so are many others.  Like virtually all such studies, this one seems designed to produce the desired answer.

On his Weighty Matters blog, Dr. Yoni Freedhoff explains how biases play out in supposedly unbiased research journals, in this case, the British Journal of Sports Medicine.  Dr. Freedhoff talks about the journal’s temporary withdrawal of a paper arguing that diet is more important than physical activity in weight loss on the grounds that the authors did not disclose conflicts of interest.  In contrast, an editorial arguing the opposite, by authors who also did not disclose conflicts, went unchallenged and was not withdrawn.

Dr. Freedhoff asks: “Are these sorts of conflicts important to disclose?”

On the basis of today’s and many other examples, my answer is an unqualified yes.

I am increasingly concerned about the proliferation of research studies sponsored and funded by food, beverage, or supplement companies with a vested interested in the outcome.  These almost invariably come to conclusions in favor of the sponsor’s food product.

You must understand that I am not searching for sponsored studies in any systematic way.  They just appear in the tables of contents of journals I typically read and are easily identified by their titles.

My plan is to post a list of sponsored research studies every time I accumulate 5 examples.  My first post in this series appeared March 16.

Recent examples

1.  Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: A double-blinded, randomized, placebo controlled study, by Adam M. Bernstein, MD, ScD, Michael F. Roizen, MD, Luis Martinez, MD, MPH.  Journal of Clinical Lipidology 2014;8:612–617.

• Conclusion: Purified palmitoleic acid may be useful in the treatment of hypertriglyceridemia with the beneficial added effects of decreasing LDL and hs-CRP and raising HDL.
• Sponsor: Tersus Pharmaceuticals (maker of Provinal palmitoleic acid).  Dr. Roizen is chair of the Scientific Advisory Board of Tersus Pharmaceuticals and chair of the Cleveland Clinic Wellness Institute.

2.  Whey Protein Supplementation Preserves Postprandial Myofibrillar Protein Synthesis during Short-Term Energy Restriction in Overweight and Obese Adults, by Amy J Hector, George R Marcotte, Tyler A Churchward-Venne, Caoileann H Murphy, Leigh Breen,Mark von Allmen, Steven K Baker, and Stuart M Phillips.  J Nutrition 2015;145:246–52.

• Conclusion: We conclude that whey protein supplementation attenuated the decline in postprandial rates of MPS [Myofibrillar Protein Synthesis] after weight loss, which may be of importance in the preservation of lean mass during longer-term weight loss interventions.
• Sponsor: The Dairy Research Institute through the Whey Protein Research Consortium.

3.  Natural cocoa consumption: Potential to reduce atherogenic factors? By Brian K. McFarlin, Adam S. Venable, Andrea L. Henning, Eric A. Prado, Jill N. Best Sampson, Jakob L. Vingren, David W. Hill.  J Nutritional Biochemistry 2015: in press.

• Conclusion: Collectively, these findings indicate that acute natural cocoa consumption was associated with decreased obesity-related disease risk.
• Sponsor: The Hershey Company

4.  The effect of a high-egg diet on cardiovascular risk factors in people with type 2 diabetes: the Diabetes and Egg (DIABEGG) study—a 3-mo randomized controlled trial, by Nicholas R Fuller, Ian D Caterson, Amanda Sainsbury, Gareth Denyer, Mackenzie Fong, James Gerofi, Katherine Baqleh, Kathryn H Williams, Namson S Lau, and Tania P Markovic.  Am J Clin Nutr 2015; 101:705-713.

• Conclusion: High egg consumption did not have an adverse effect on the lipid profile of people with T2D [type 2 diabetes] in the context of increased MUFA [monounsaturated fatty acid] and PUFA [polyunsaturated fatty acid] consumption. This study suggests that a high-egg diet can be included safely as part of the dietary management of T2D, and it may provide greater satiety.
• Sponsor: Australian Egg Corporation

5.  Dietary Flaxseed Independently Lowers Circulating Cholesterol and Lowers It beyond the Effects of Cholesterol-Lowering Medications Alone in Patients with Peripheral Artery Disease.  Andrea L Edel, Delfin Rodriguez-Leyva, Thane G Maddaford, Stephanie PB Caligiuri, J Alejandro Austria, Wendy Weighell, Randolph Guzman, Michel Aliani, and Grant N Pierce.  J. Nutr. 2015; 145:749-757.

• Conclusion: Milled flaxseed lowers total and LDL cholesterol in patients with PAD [peripheral artery disease] and has additional LDL-cholesterol–lowering capabilities when used in conjunction with CLMs [cholesterol-lowering medications].
• Sponsor: Flax2015, the Canola Council of Canada, and others.

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.