by Marion Nestle

Currently browsing posts about: Conflicts-of-interest

Jul 30 2015

More industry-sponsored research with predictable results 

Once again, I am posting five food industry-sponsored studies with results that come out just the way the sponsor wants them to.  Coincidence?  Or something more serious?  I am trying to remain open-minded.  If you know of food industry-sponsored research that does not favor the sponsor’s interests, please send.  As soon as I collect five, I will post.

Diets with high-fat cheese, high-fat meat, or carbohydrate on cardiovascular risk markers in overweight postmenopausal women: a randomized crossover trial. Am J Clin Nutr ajcn109116, 2015.  doi:10.3945/ajcn.115.109116.  Thorning, T.K., Raziani, F., Bendsen, N.T., Astrup, A., Tholstrup, T., Raben, A.

  • Conclusion: Diets with cheese and meat as primary sources of SFAs [saturated fatty acids] cause higher HDL cholesterol and apo A-I and, therefore, appear to be less atherogenic than is a low-fat, high-carbohydrate diet.  Also, our findings confirm that cheese increases fecal fat excretion.
  • Sponsor: Supported 50% by the Danish Dairy Research Foundation and the Danish Agriculture and Food Council (Denmark) and 50% by the Dairy Research Institute (United States), the Dairy Farmers of Canada (Canada), the Centre National Interprofessionel de l’Economie Laitie`re (France), Dairy Australia (Australia), and the Nederlandse Zuivel Organisatie (Netherlands).

Normal or High Polyphenol Concentration in Orange Juice Affects Antioxidant Activity, Blood Pressure, and Body Weight in Obese or Overweight AdultsOscar D Rangel-Huerta, Concepcion M Aguilera, Maria V Martin, Maria J Soto, Maria C Rico, Fernando Vallejo, Francisco Tomas-Barberan, Antonio J Perez-de-la-Cruz, Angel Gil, and Maria D Mesa,  J. Nutrition.  First published July 1, 2015, doi: 10.3945/​jn.115.213660.  jn213660

  • Conclusions: Our results show that the consumption of either NPJ [normal polyphenol juice] or HPJ [high polyphenol juice] protected against DNA damage and lipid peroxidation, modified several antioxidant enzymes, and reduced body weight in overweight or obese nonsmoking adults.
  • Sponsor: Supported by research contract 3345 between the University of Granada–Enterprise General Foundation and Coca-Cola Europe [Coca-Cola owns Minute Maid and Simply Orange].

Fructose-Containing Sugars and Cardiovascular Disease.    James M Rippe and Theodore J Angelopoulos.   Adv Nutr 2015; 6:430-439 doi:10.3945/an.114.008177.

  • Conclusion:  …although it appears prudent to avoid excessive consumption of fructose-containing sugars, levels within the normal range of human consumption are not uniquely related to CVD risk factors with the exception of triglycerides, which may rise when simple sugars exceed 20% of energy per day, particularly in hypercaloric settings.  [My translation: this implies it’s OK to eat sugars up to 20% of calories per day, even though health authorities typically recommend 10% or less].
  • Author’s disclosure: JM Rippe has received consulting fees from ConAgra Foods, Kraft Foods, Florida Department of Citrus, PepsiCo International, The Coca Cola Company, Dr. Pepper/Snapple Group, Corn Refiners Association, and Weight Watchers International.

Sugars and Health Controversies: What Does the Science Say?   James M Rippe and Theodore J Angelopoulos.   Adv Nutr 2015; 6:493S-503S doi:10.3945/an.114.007195

  • Conclusion: …there is little scientific justification for recommending restricting sugar consumption below the reasonable upper limit recommended by the Dietary Guidelines for Americans, 2010 of no more than 25% of calories.  [Note: health authorities routinely recommend no more than 10% of calories].
  • Sponsor: supported in part by an educational grant from the Corn Refiners Association. Publication costs for this supplement were defrayed in part by the payment of page charges. This publication must therefore be hereby marked “advertisement.”
  • Author’s disclosure:  JM Rippe’s research laboratory has received unrestricted grants and JM Rippe has received consulting fees from ConAgra Foods, Kraft Foods, the Florida Department of Citrus, PepsiCo International, The Coca-Cola Company, the Corn Refiners Association, Weight Watchers International, Dr. Pepper Snapple Group, and various publishers.

Do Fructose-Containing Sugars Lead to Adverse Health Consequences?  Results of Recent Systematic Reviews and Meta-analyses.   Vanessa Ha, Adrian I Cozma, Vivian LW Choo, Sonia Blanco Mejia, Russell J   de Souza, and John L Sievenpiper.   Adv Nutr 2015; 6:504S-511S doi:10.3945/an.114.007468.

  • Conclusion: it is difficult to separate the contribution of fructose-containing sugars from that of other sources of excess calories in the epidemic of obesity and cardiometabolic disease. Attention needs to remain focused on reducing the overconsumption of all caloric foods associated with obesity and cardiometabolic disease, including sugary beverages and foods, and promoting greater physical activity.
  • Sponsor: Aspects of this work were funded by…a research grant from the Calorie Control Council.   [Note: the Council promotes the benefits of fructose].
  • Authors’ disclosure: RJdS has received research support from the CIHR, Calorie Control Council, the Canadian Foundation for Dietetic Research, and The Coca-Cola Company (investigator-initiated unrestricted grant)… JLS has received research support from the CIHR, Calorie Control Council, The Coca-Cola Company (investigator-initiated unrestricted educational grant), Dr. Pepper Snapple Group (investigator-initiated unrestricted educational grant), Pulse Canada, and The International Tree Nut Council Nutrition Research & Education Foundation. He has received travel funding, speaker fees, and/or honoraria from [among many others]… International Life Sciences Institute (ILSI) North America, ILSI Brazil, Abbott Laboratories, Pulse Canada, Canadian Sugar Institute, Dr. Pepper Snapple Group, The Coca-Cola Company, Corn Refiners Association, World Sugar Research Organization, Dairy Farmers of Canada….
Jul 20 2015

Another five food industry-sponsored studies with food industry-favorable results

Here’s my latest collection of five research studies paid for by a food manufacturer who can use the study results for marketing purposes.  My point: industry-sponsored studies invariably appear to favor the sponsor’s marketing interests.

I am not looking for sponsored studies in any systematic way.  They just appear.

I very much would like to find sponsored studies that produce results contrary to the sponsor’s interests.  If you see any, please send.

In the meantime, here’s the latest collection.

Cooked oatmeal consumption is associated with better diet quality, better nutrient intakes, and reduced risk for central adiposity and obesity in children 2-18 years: NHANES 2001-2010Carol E. Carolyn E. O’Neil,, Theresa A. Nicklas, Victor L. Fulgoni, III and Maureen A. DiRienzo.  Food & Nutrition Research 2015, 59: 26673

  • Conclusion: Consumption of oatmeal by children was associated with better nutrient intake, diet quality, and reduced risk for central adiposity and obesity and should be encouraged as part of an overall healthful diet.
  • Sponsor: PepsiCo (owner of Quaker Oats); the lead author is a member of the Kellogg’s Breakfast Council.

Including “Added Sugars” on the Nutrition Facts Panel: How Consumers Perceive the Proposed Change.  Idamarie Laquatra, Kris Sollid, Marianne Smith Edge, Jason Pelzel, John TurnerJournal of the Academy of Nutrition and Dietetics, June 9, 2015. doi:10.1016/j.jand.2015.04.017

  • Conclusion: NFPs [Nutrition Facts Panels] with “Added Sugars” declarations were misleading and the resulting misperception influenced purchase intent.
  • Funder: International Food Information Council (an industry-funded group).  Two of the authors are IFIC officials.
  • Note: The food industry generally opposes the FDA’s proposal to list “added sugars” on food labels.

Daily potassium intake and sodium-to-potassium ratio in the reduction of blood pressure: a meta-analysis of randomized controlled trials.  Aristea Binia, Jonathan Jaeger,  Youyou Hu, Anurag Singh, and Diane Zimmermann. Journal of Hypertension, Volume 33 Number 8 August 2015: 1509-1520.

  • Conclusion: Potassium supplementation is associated with reduction of blood pressure in patients who are not on antihypertensive medication…Patients with elevated blood pressure may benefit from increased potassium intake along with controlled or decreased sodium intake.
  • Sponsor: Nestlé Research Centre (all authors are affiliated with the Centre).
  • Note: Nestlé produces potassium-fortified products for patients with renal disease.  It might like to see the use of these products extended to other purposes, such as blood-pressure reduction.

Consuming High-Protein Soy Snacks Affects Appetite Control, Satiety, and Diet Quality in Young People and Influences Select Aspects of Mood and Cognition.  Heather J Leidy, Chelsie B Todd, Adam Z Zino, Jordan E Immel, Ratna Mukherjea, Rebecca S Shafer, Laura C Ortinau, and Michelle Braun. J. Nutr. 2015; 145:1614-1622   doi:10.3945/jn.115.212092.

  • Conclusion: Afternoon snacking, particularly on HP [high-protein] soy foods, improves appetite, satiety, and diet quality in adolescents, while beneficially influencing aspects of mood and cognition.
  • Sponsor: Du Pont Nutrition & Health (maker of soy ingredients). Two of the authors are employed by the company.

Effects of egg consumption on carotenoid absorption from co-consumed, raw vegetables.  Jung Eun Kim, Susannah L Gordon, Mario G Ferruzzi, and Wayne W Campbell. Am J Clin Nutr 2015; 102:75-83 doi:10.3945/ajcn.115.111062

  • Conclusion: These findings support the claim that co-consuming cooked whole eggs is an effective way to enhance carotenoid absorption from other carotenoid-rich foods such as a raw mixed-vegetable salad.
  • Sponsor: American Egg Board–Egg Nutrition Center, among others
  • Nutrition 101 note: Carotenoids are precursors of vitamin A.  They are fat-soluble and require fat to be absorbed into the body.  Any food fat will do.
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.

Jun 2 2015

Industry-sponsored research: this week’s collection

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 PatientsMartha Nydia Ballesteros , Fabrizio Valenzuela, Alma E. Robles, Elizabeth Artalejo, David Aguilar, Catherine J. Andersen, Herlindo Valdez  and Maria Luz Fernandez.   Nutrients 20157(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 ChocolateM. 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.

May 21 2015

This week’s post on industry-sponsored research

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.

Apr 14 2015

Sugar politics: the sagas never end

I’ve been collecting items on sugars.  Here are the first two.  Two more will come later this week.

1.  The American Academy of Pediatrics Council on Nutrition has new guidance on sugars in schools.

Although access to junk foods remains an issue in schools, the Council blames the problem on students, parents, and staff.  It advises:

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.

Really?  Evidence, please.

I ask because Kellogg could not be happier with this approach.  A little sugar, it says, may help kids eat more nutritious foods.

Surely it’s not a coincidence that one of the authors discloses receiving support from the National Dairy Council and the American Dairy Association, and the other receives support from the Nestle Nutrition Institute.

In any case, we aren’t talking about a little sugar in schools.  We are talking about candy, cupcakes, and drinks brought in for birthdays, treats, and after school celebrations.

2.  Sugar in the Trans Pacific Partnership (TPP)

This, you will of course recall, is the controversial multinational trade agreement currently under negotiation (see my previous post on this topic).

Japan wants to keep its tariff on sugar.

It now appears that the Japanese sugar industry gave a 1 million yen donation to a political group that supports Minister of Agriculture Koya Nishikawa, just before he became involved in the TPP talks in 2013.

As one commentator put it, considering Nishikawa’s central role in the TPP negotiations,

his receipt of a donation from an industry group brings his morals as a politician into question. Nishikawa stated that he returned the donation in light of his capacity as agricultural minister, but this is unlikely to resolve the situation…In March 2013, it was announced that the Japan Sugar Refiners’ Association would receive 1.3 billion yen in subsidies under a Ministry of Agriculture, Forestry and Fisheries’ project.

At the very least, this situation looks like blatant conflict of interest.

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