by Marion Nestle

Currently browsing posts about: Sponsored-research

Jun 25 2015

Industry-funded studies that do NOT favor the sponsor

I’ve been posting summaries of studies funded by food companies or trade groups, all of which come up with results that the sponsor can use for marketing purposes.

In each of these posts, I ask for examples of industry-funded studies that produce results contrary to the interests of the funder.

In response, I received this comment from Mickey Rubin, Vice President for Nutrition Research, National Dairy Council.

He gave me permission to reproduce his letter: 

Dear Marion,

By way of introduction, my name is Mickey Rubin and I am a scientist at the National Dairy Council. I understand that you know Greg Miller, and I asked him for your contact information so I could write to you directly after reading with great interest your most recent post on industry-funded nutrition research, in which you selected a sample of 5 studies/papers sponsored by industry all showing favorable outcomes. Although none of the papers you selected were sponsored by the organization I represent (although there is one dairy industry sponsored review paper in the list), what struck me is your focus on the favorable vs. unfavorable dichotomy, rather than the reality of what much nutrition science research results in: null findings.

It seems that there are fewer and fewer nutrition studies published that report the null, or find no effect. I agree with you that the reason we don’t see more of these studies in the literature has to do with bias, but I suspect that it is publication bias as much as any other bias. From my interactions with nutrition researchers, I gather it is quite difficult and sometimes impossible to get a study with no significant effects published regardless of funding source, to say nothing of allegiance bias by some researchers hesitant to publish findings that may go against their own hypotheses. Dr. Dennis Bier of Baylor College of Medicine and editor in chief of the American Journal of Clinical Nutrition has presented eloquently on this issue previously. You may also be aware of David Allison’s papers on other types of bias. So I think it is important to discuss all types of bias, and not just industry bias. You of course wouldn’t want your discussion on bias to be biased to just one type.

At National Dairy Council we have an extensive program of nutrition research that we sponsor at universities both nationally and internationally. While I can’t speak for all of industry, we strongly encourage the investigators of all of our sponsored studies to publish the findings, no matter the results. Thus, we would expect our sponsored studies to have a similar “success” rate as those sponsored by the National Institutes of Health. In fact, that is exactly what one recent analysis – not sponsored by the dairy industry – found, reporting that there was no evidence that dairy industry funded projects were more likely to support an obesity prevention benefit from dairy consumption than studies sponsored by NIH.

We feel this transparency is not only critical to the credibility of the research we sponsor, but we also feel it is important that our research contributes to nutrition science knowledge as a whole. We hope that other scientists take the findings from studies we sponsor and build upon them, and if it is by using research dollars from other sources, even better! I’ll be the first to stand up and say that one favorable study on milk, as an example, does not close the books on the subject. We need many studies in many different labs sponsored by multiple agencies in order to produce a portfolio of knowledge. I suspect that is certainly an example of where you and I are in agreement.

That all said, please allow me to provide some examples of studies the National Dairy Council has sponsored that are published and, rather than showing a clear benefit, do not refute the null hypothesis. These are all studies published within the last 4 years. It’s not meant to be comprehensive, but rather just a sample similar to what you provided. I could also provide you a list of studies we have sponsored that have shown favorable results for dairy, but you seem to have that covered, and I’ll instead wait until one of our sponsored studies appears in a subsequent blog post J.

Thanks for taking the time to read. I appreciate the dialogue.

Here’s his list of papers:

Studies with null finding:

Bendtsen et al. 2014: http://www.ncbi.nlm.nih.gov/pubmed/24168904

  • No unique benefit of dairy protein over other proteins for weight maintenance

Maki et al. 2013: http://www.ncbi.nlm.nih.gov/pubmed/23901280

  • No effect of three servings of dairy on blood pressure

Chale et al. 2013: http://www.ncbi.nlm.nih.gov/pubmed/23114462

  • Whey protein supplementation offered no additional benefit over resistance training alone in older individuals

Lambourne et al. 2013: http://www.ncbi.nlm.nih.gov/pubmed/23239680

  • No change in body weight or composition in adolescents performing resistance training and supplemented with milk, juice, or control

Van Loan et al. 2011: http://www.ncbi.nlm.nih.gov/pubmed/21941636

  • Recommended dairy servings offered no additional weight loss benefit over calorie restriction without dairy servings 

Studies with mixed findings (some outcomes changed, others null):

Maki et al. 2015: http://www.ncbi.nlm.nih.gov/pubmed/25733460

  • The main finding from the study was that dairy intake had no effect on glucose control whereas sugar sweetened product consumption contributed to a worsening of glucose control in at-risk adults.

Dugan et al. 2014: http://www.ncbi.nlm.nih.gov/pubmed/24236646

  • Waist circumference and BMI were lower in women after consuming the dairy diet as compared to the control diet. Fasting glucose was lower in men following the dairy diet as compared to the control diet. There were no differences in blood pressure, serum lipids, fasting insulin, or insulin resistance between the treatments.

Here’s what I wrote in response:

I am familiar with charges of bias against independently funded researchers (“White-hat Bias”), which equates industry biases with biases that result from career objectives and other goals.  I do not view the biases as equivalent.  Industry-sponsored research has only one purpose: to be used in marketing to sell products.   As I have said repeatedly, it is easy to design studies that produce desired answers.

When I was in graduate school in molecular biology, we were taught—no, had beaten into us—to do everything we could to control for biases introduced by wishful thinking.  I don’t see that level of critical thinking in most studies funded by food companies.

You may be correct about the influence of publication bias with respect to dairy studies, but how do you explain the situation with sugar-sweetened beverages?  Studies funded by government and foundations typically indicate strong correlations between habitual consumption of sugary beverages and metabolic problems, whereas studies funded by the soda industry most definitely do not.   The percentages are too high to be due to chance: 90% of independently funded studies show health effects of soda consumption whereas 90% of studies funded by soda companies do not.  This is troubling.

We’ve seen the results of studies funded by tobacco and drug companies.  Are food-industry studies different?  I don’t think so.   What seems clear is that industry-induced biases are not recognized by funding recipients, a problem in itself.

That’s why I’m posting these studies as they come in and begging for examples of industry-funded studies that do not favor the interests of the donor.

Thanks to Mickey Rubin for writing and for permission to reproduce his letter.

Let the discussion continue!

Jun 23 2015

The food industry’s undue influence on the American Society for Nutrition

I’m catching up with events I missed while offline in Cuba.  Here’s one: Michele Simon’s new report:

The American Society for Nutrition (ASN) is the leading organization for physicians and scientists who conduct nutrition research.  I’ve been a member for years and have long fretted about the ASN’s too-cozy relationships with food company sponsors (for example, see my posts on the ill-fated Smart Choices campaign and on a recent ASN annual meeting).

Simon has now done for the ASN what she previously did for the American Academy of Dietetics.

A few of her findings:

  • Of the 34 scientific sessions at ASN’s annual meeting, 6 were supported by PepsiCo, and others were supported by the Egg Nutrition Center, Kellogg, DuPont Nutrition and Health, Ajinomoto, and the National Dairy Council.
  • The International Life Sciences Institute (a front group for Big Food and Big Pharma) sponsored a session on low-calorie sweeteners; speakers included a scientific consultant for Ajinomoto, which produces aspartame.
  • For $35,000, junk food companies can sponsor the hospitality suite at the annual meeting, where corporate executives socialize with nutrition researchers.
  • ASN published an 18- page defense of processed food that consists of numerous talking points for the junk food industry, such as “There are no differences between the processing of foods at home or at a factory.”
  • ASN opposes an FDA proposed policy to include added sugars on the Nutrition Facts panel, at a time when excessive sugar consumption is causing a national public health epidemic.

I’m quoted in the report:

I think it’s important that professional societies like ASN promote rigorous science and maintain the highest possible standards of scientific integrity. Research and education about food and nutrition are easily influenced by funding from food companies but such influence often goes unrecognized. This means that special efforts must be taken to avoid, account for, and counter food industry influence, and organizations like ASN should take the lead in doing so.

The report has been well covered by the media:

Relations between nutrition scientists and food companies worry me.  Here’s another example: Portuguese nutritionists have produced an e-book extolling the virtues of cereal-based drinks.  The book is sponsored by Nestlé (the company, not me).  Nestlé, no surprise, is the market leader for these products in Portugal.  I thank Vladimir Pekic of BeverageDaily.com for finding this one.

Jun 10 2015

Industry-sponsored research: this week’s collection

Here is my latest roundup of industry-sponsored research producing results or opinions that favor the sponsor’s commercial interests.

Sugars and obesity: Is it the sugars or the calories?  Choo FL, Ha V, Sievenpiper JL.  Nutrition Bulletin, May 19, 2015.  DOI: 10.1111/nbu.12137

Conclusion: The higher level evidence reviewed in this report does not support concerns linking fructose-containing sugars with overweight and obesity.

Conflicts of interest: All three authors report scholarship or research support from such entities as the Canadian
Sugar Institute, PepsiCo, Coca-Cola, Dr Pepper Sapple, Corn Refiners Association, World Sugar Research Organization.

Cranberry Juice Consumption Lowers Markers of Cardiometabolic Risk, Including Blood Pressure and Circulating C-Reactive Protein, Triglyceride, and Glucose Concentrations in Adults.  Janet A Novotny, David J Baer, Christina Khoo, Sarah K Gebauer, and Craig S Charron. J. Nutr. 2015; 145:1185-1193 doi:10.3945/jn.114.203190.

Conclusion: LCCJ [low-calorie cranberry juice] can improve several risk factors of CVD [cardiovascular disease] in adults, including circulating TGs [triglycerides], CRP (c-reactive protein], and glucose, insulin resistance, and diastolic BP [blood pressure].

Sponsor: Ocean Spray Cranberries, Inc. and the USDA.  JA Novotny received funding from  and C Khoo is employed by Ocean Spray Cranberries, Inc.

Effect of cheese consumption on blood lipids: a systematic review and meta-analysis of randomized controlled trials. Janette de Goede, Johanna M. Geleijnse, Eric L. Ding, and Sabita S. Soedamah-Muthu

Conclusion: Despite the similar P/S ratios of hard cheese and butter, consumption of hard cheese lowers LDL-C and HDL-C when compared with consumption of butter.

Funding. The senior author received unrestricted research grants from the Global Dairy Platform, the Dairy Research Institute, and Dairy Australia for the present meta-analysis. One other author, E.L.D., has consulted for the Dairy Research Institute.

Protein Summit 2.0: Evaluating the Role of Protein in Public Health: Proceedings of a conference held in Washington, DC, October 2, 2013.  American Journal of Clinical Nutrition, June 2015 Supplement.

Program organizer: Shalene McNeill, National Cattlemen’s Beef Association, and a Contractor to The Beef Checkoff.

Sponsors: The Beef Checkoff, Dairy Research Institute, Egg Nutrition Center, Global Dairy Platform, Hillshire Brands, National Pork Board

My comment: Journal supplements are typically paid for by outside parties—government agencies, foundations, private organizations, or food companies.  The papers in this supplement discuss various aspects of protein and health.  All emphasize the benefits of animal protein in human diets, as might be expected, given the sponsors.

Two examples:

Commonly consumed protein foods contribute to nutrient intake, diet quality, and nutrient adequacy.  Stuart M Phillips, Victor L Fulgoni III, Robert P Heaney, Theresa A Nicklas, Joanne L Slavin, and Connie M Weaver.  Am J Clin Nutr June 2015 vol. 101 no. 6 1346S-1352S.

Conclusion: dietary recommendations to reduce intakes of saturated fat and solid fats may result in dietary guidance to reduce intakes of commonly consumed food sources of protein, in particular animal-based protein.

The role of protein in weight loss and maintenance Heather J Leidy, Peter M Clifton, Arne Astrup, Thomas P Wycherley, Margriet S Westerterp-Plantenga, Natalie D Luscombe-Marsh, Stephen C Woods, and Richard D Mattes.

Conclusion:  Collectively, these data suggest that higher-protein diets…provide improvements in appetite, body weight management, cardiometabolic risk factors, or all of these health outcomes.

For the record: Industry sponsorship does not necessarily mean that the reported conclusions are wrong.  It just means that the papers require even more than the usual level of critical analysis.

I am happy to post industry-sponsored studies that do not produce results that can be used to market the sponsor’s products.  Please send if you find any.

Aug 11 2014

Dan Glickman heads board of Foundation for Food and Agriculture Research

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.

Jan 22 2013

New study: Big Food’s ties to Registered Dietitians

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.

May 24 2012

POM fights back with out-of-context ads

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.”

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.