by Marion Nestle

Currently browsing posts about: Conflicts-of-interest

Jan 6 2016

Viewpoint: Food-industry Funding of Food and Nutrition Research

My latest Viewpoint, “Corporate funding of food and nutrition research: science or marketing,” was published yesterday in JAMA Internal Medicine 2016;176 (1):13-14.  doi:10.1001/jamainternmed.2015.6667.

The longstanding influence of food industry funding on nutrition research, researchers, and professional societies1 threatens the credibility of nutrition science. So much research is sponsored by industry that health professionals and the public may lose confidence in basic dietary advice. Although most journals now require authors to disclose who pays for their work, disclosure—even done diligently—is not sufficient to alert readers to the extent to which industry funding influences research results and professional opinion. As is well established from experimental and observational research, drug company gifts and grants can have substantial effects. To recipients, however, these effects are almost always unconscious, unintentional, and unrecognized, making them especially difficult to prevent.

Medical schools and medical journals have increased efforts to minimize and manage conflicts of interest with industry. But from my observations, nutrition researchers, journals, and professional societies, like medical researchers, often fail to realize that food-industry funding may affect their work and its credibility.

Two recent investigative articles in the New York Times illustrate the concerns about biases introduced by industry funding. The first3 described the support by Coca-Cola of academic researchers who founded a new organization, the Global Energy Balance Network, to promote physical activity as a more effective method than calorie control (eg, from avoiding sugary sodas) for preventing obesity. The second4 analyzed emails obtained through open-records requests to document how Monsanto, the multinational agricultural biotechnology corporation, on the one hand, and the organic food industry, on the other, recruited professors to lobby, write, and testify to Congress on their behalf.

Both articles3,4 quoted the researchers named in these reports as denying an influence of industry funding and lamenting the paucity of university research funds and the competitiveness of federal grants. Despite leaving their organizations open to accusations that they have sold out to industry,5 officers of nutrition research societies tell me that they cannot function without industry funding of journals and conferences. They have a point. Although the investment by federal agencies in food and nutrition research has increased steadily since the early 1990s, US Department of Agriculture grants are diminishing, and the National Institutes of Health are funding fewer researchers at state agricultural colleges. Investigators have a hard time obtaining grants for projects related to food composition, food technology, nutrients, and nutrient metabolism as federal agencies have understandably shifted priorities toward research on obesity, genetics, and chronic diseases.6

Food companies, such as Quaker Oats, used to support basic research conducted by in-house scientists, but Unilever and Nestlé (no relation) are among the very few companies that continue to do so. Instead, food companies outsource research, much of which can appear as designed for marketing purposes. Recently, in preparation for what I intend to be a more systematic analysis of corporate funding of nutrition research, I began collecting a convenience sample of studies funded by food and beverage companies or trade associations as they appear in journals I happen to be reading. I sort them by whether their results do or do not favor the interests of the sponsor, and post examples online at my blog, http://www.foodpolitics.com.7

Between March and October 2015, I identified 76 industry-funded studies. Of these, 70 reported results favorable to the sponsor’s interest. Despite ongoing requests to readers of my blog to help me identify funded studies reporting results contrary to a funder’s interest, I have found only 6.  [Note: Since writing this, the score has gone to 90:9.] This discrepancy is consistent with the results of systematic investigations of industry sponsorship, such as one on the role of sugar-sweetened beverages in obesity.8 In general, independently funded studies find correlations between sugary drinks and poor health, whereas those supported by the soda industry do not.9 In the studies I collected, companies or trade associations promoting soft drinks, dairy foods, eggs, breakfast cereals, pork, beef, soy products, dietary supplements, juices, cranberries, nuts, and chocolates supported the study itself, the investigators, or both. These studies all found significant health benefits or lack of harm from consuming the foods investigated, results that can be useful for deflecting criticism of a company or promoting its products.

Mars Inc, for example, the maker of chocolate candies such as M&Ms, funds studies on the effects of cocoa flavanols on arterial function and blood pressure. One such study, published in September 2015,10(p1246)concluded that these compounds “improved accredited cardiovascular surrogates of cardiovascular risk, demonstrating that dietary flavanols have the potential to maintain cardiovascular health even in low-risk subjects.” The study investigators,10 one of whom is employed by Mars, followed well-established scientific protocols in conducting the research. Science is not the issue here. Marketing is the issue. The question is why Mars would fund a study like this and assign one of its employees to help design and write it. In this instance, the answer is obvious. Mars issued a press release “Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people,” and noted these results in a full-page advertisement in the New York Times on September 27, 2015, Neither the press release nor advertisement explained that cocoa flavanols are largely destroyed during all but the most careful processing of chocolate, nor did they mention chocolate at all. They didn’t have to. Uncritical readers are likely to interpret the statements as evidence that chocolate is good for them and that its sugar and calories can be ignored.

The second New York Times article4 raised more insidious concerns about industry involvement with scientists, using Monsanto and organic food companies as cases in point. Although both industries recruit scientists to speak on their behalf, Monsanto has far greater resources. In 1994, I was a member of the Food Advisory Committee to the US Food and Drug Administration (FDA) when that agency approved genetically modified (GM) foods. I observed how Monsanto-funded scientists convinced the FDA that labeling GM foods would be misleading.

Confronted with increasing public support for labeling foods that are produced with GM ingredients, the biotechnology industry supported—and the House of Representatives passed—H.R. 1599 in July 2015. This bill, expected to be considered by the Senate before the end of 2015, has the Orwellian title, “The Safe and Accurate Food Labeling Act,” but some critics call it the “Denying Americans the Right to Know (DARK) Act.” Proposed by Representative Mike Pompeo (Kansas) on the basis that GM foods are safe and, therefore, acceptable, the act would block states from enacting labeling laws (as Vermont has already done) and permit GM foods to be labeled as “natural.” Opponents question the safety of GM foods. But they also raise additional reasons for full transparency in labeling—patents, control of seed stocks, the widespread application of chemical herbicides to GM crops, and the increasingly widespread resistance of weeds to those herbicides. When evaluating conflicting scientific and policy arguments about GM foods, it is useful to know who funds the researchers and their studies.

Should nutrition researchers and professional societies accept funding from food companies? Not without careful thinking. It’s time that food and nutrition researchers and societies recognize the influence of food-industry sponsorship, take steps to control its effects, and ensure that sponsored studies promote public health, not the marketing of food products. Journal editors should ensure that editors and members of editorial boards are free of industry conflicts, require peer reviewers to note food-industry funding in manuscript evaluations, and be wary of accepting industry-funded publications with evident commercial implications. If food companies and trade associations want to fund research, they should consider pooling resources and setting up an independent foundation to administer the grants. Everyone involved in this system should be doing everything possible to advocate for more research funds from federal granting agencies. Nothing less than the credibility of nutrition research and advice is at stake.

REFERENCES

1 Nestle  M. Food Politics: How the Food Industry Influences Nutrition and Health.3rd ed. Berkeley: University of California Press; 2013.
2 Lo  B, Field  MJ, eds. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.
3 O’Connor  A. Coca-Cola funds scientists who shift blame for obesity away from bad diets. New York Times. August 9, 2015. http://well.blogs.nytimes.com/2015/08/09/coca-cola-funds-scientists-who-shift-blame-for-obesity-away-from-bad-diets/?_r=0. Accessed October 22, 2015.
4 Lipton  E. Food industry enlisted academics in G.M.O. lobbying war, emails show. New York Times. September 5, 2015. http://www.nytimes.com/2015/09/06/us/food-industry-enlisted-academics-in-gmo-lobbying-war-emails-show.html. Accessed October 22, 2015.
5 Simon  M. Nutrition scientists on the take from Big Food: has the American Society for Nutrition lost all credibility? June 2015. http://www.eatdrinkpolitics.com/wp-content/uploads/ASNReportFinal.pdf. Accessed October 22, 2015.
6 Toole  AA, Kuchler  F. Improving health through nutrition research: an overview of the U.S. nutrition research system. Econ Res Rep No. 182. January 2015.http://www.ers.usda.gov/media/1760111/err-182.pdf. Accessed October 27, 2015.
7 Nestle  M. Food Politics blog. http://www.foodpolitics.com. Accessed October 27, 2015.
8 Lesser  LI, Ebbeling  CB, Goozner  M, Wypij  D, Ludwig  DS.  Relationship between funding source and conclusion among nutrition-related scientific articles. PLoS Med. 2007;4(1):e5. PubMed   |  Link to Article
9 Massougbodji  J, Le Bodo  Y, Fratu  R, De Wals  P.  Reviews examining sugar-sweetened beverages and body weight: correlates of their quality and conclusions. Am J Clin Nutr. 2014;99(5):1096-1104. PubMed   |  Link to Article
10 Sansone  R, Rodriguez-Mateos  A, Heuel  J,  et al; Flaviola Consortium, European Union 7th Framework Program.  Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study. Br J Nutr. 2015;114(8):1246-1255. doi:10.1017/S0007114515002822PubMed   |  Link to Article

ARTICLE INFORMATION

Corresponding Author: Marion Nestle, PhD, MPH, Department of Nutrition, Food Studies, and Public Health, New York University, 411 Lafayette, Fifth Floor, New York, NY 10003-7035 (marion.nestle@nyu.edu).

Published Online: November 23, 2015. doi:10.1001/jamainternmed.2015.6667.

Conflict of Interest Disclosures: Dr Nestle’s salary from New York University supports her research, manuscript preparation, website, and blog at http://www.foodpolitics.com. She also earns royalties from books and honoraria from lectures to university and health professional groups about matters relevant to this Viewpoint.

Dec 23 2015

Five more industry-sponsored studies with results favorable to the sponsor. The score since mid-March: 95:9

Systematic Review of Pears and Health. Holly Reiland, BS Joanne Slavin, PhD, RD.  Nutrition Today November/December 2015 – Volume 50 – Issue 6 – p 301–305.  doi: 10.1097/NT.0000000000000112.  

  • Conclusions: Animal studies with pears suggest that pears may regulate alcohol metabolism, protect against ulcers, and lower plasma lipids. Human feeding studies with pears have not been conducted. In epidemiological studies, pears are combined with all fresh fruits or with apples, because they are most similar in composition. The high content of dietary fiber in pears and their effects on gut health set pears apart from other fruit and deserves study.
  • Funding: The authors received a grant from USA Pears in the past. The authors provided their own funding to allow this article to publish as Open Access.
  • Comment: Pears are a great fruit but the marketing purpose of this study is evident from this press release from the Pear Bureau Northwest: “While the body of evidence connecting pear intake and health outcomes is still limited, USA Pears has been contributing to research efforts by commissioning independent studies to learn and affirm the heath attributes of pears. Visit www.usapears.org for additional pear research, nutrition resources and recipes.”

Whole Grain Intakes in the Diets Of Malaysian Children and Adolescents – Findings from the MyBreakfast Study.  Norimah AK , H. C. Koo, Hamid Jan JM, Mohd Nasir MT, S. Y. Tan, Mahendran Appukutty, Nurliyana AR, Frank Thielecke, Sinead Hopkins, M. K. Ong, C. Ning, E. S. Tee.  PLoS ONE 10(10): e0138247. doi:10.1371/journal.pone.0138247

  • Conclusion: Whole grain is consumed by only a minority of Malaysian children and adolescents and even among consumers, intakes are well below recommendations. Efforts are needed to firstly understand the barriers to whole grain consumption among Malaysian children in order to design effective health promotion initiatives to promote an increase in whole grain consumption.
  • Funding: The Nutrition Society of Malaysia received an unrestricted research grant from Cereal Partners Worldwide, Switzerland and Nestleé R&D Center, Singapore. This financial support was provided in the form of salaries for authors but the funders did not have any additional role in the study design, data collection and analysis or decision to publish. Frank Thielecke was an employee of Cereal Partners Worldwide at the time this study was conducted. He now works for Nestec SA. Sinead Hopkins is employed by Cereal Partners Worldwide (CPW), Switzerland and Moi Kim Ong and Celila Ning are employed by Nestleé R&D Center, Singapore….Nestlé and Cereal Partners Worldwide have a commercial interest in breakfast cereals.
  • Comment: I learned about this study from a comment on Retraction Watch, which reported that PLoS One had filed a correction to the funding section.  The correction says that the salaries were for research assistants, not authors.

Walnuts Consumed by Healthy Adults Provide Less Available Energy than Predicted by the Atwater Factors.  David J Baer*, Sarah K Gebauer, and Janet A Novotny. J Nutrition First published November 18, 2015, doi: 10.3945/​jn.115.217372.

  • Conclusion: Consistent with other tree nuts, Atwater factors overestimate the metabolizable energy value of walnuts. These results could help explain the observations that consumers of nuts do not gain excessive weight and could improve the accuracy of food labeling.
  • Funding: This research was funded by the USDA and the California Walnut Commission… DJ Baer was funded by the USDA and the California Walnut Commission.

Cardiorespiratory Fitness, Body Fatness, and Submaximal Systolic Blood Pressure Among Young Adult WomenPrasad Vivek Kumar, Drenowatz Clemens, Hand Gregory A., Lavie Carl J., Sui Xuemei, Demello Madison, and Blair Steven N.  Journal of Women’s Health, 2015 ahead of print. doi:10.1089/jwh.2015.5307.

  • Conclusion: CRF, BF%, and BMI seem to have critical roles in determining SSBP with CRF and BF% being more potent at lower intensity exercise, whereas BMI was more strongly associated at higher intensity exercise.
  • Funding for this project was provided through an unrestricted grant from The Coca-Cola Company. The sponsor played no role in the study design, data collection, analysis, and interpretation, or preparation and submission of this article. The authors thank the Energy Balance staff and study participants for their contributions. No competing financial interests exist. 
  • Comment: This is one of the papers produced by participants in the now defunct Global Energy Balance Network formerly sponsored by Coca-Cola.

Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including metaanalyses, of the evidence from human and animal studies. PJ Rogers, PS Hogenkamp, C de Graaf , S Higgs , A Lluch , AR Ness , C Penfold , R Perry , P Putz , MR Yeomans and DJ Mela.  International Journal of Obesity advance online publication, 10 November 2015; doi:10.1038/ijo.2015.177

  • Conclusion¨The preponderance of evidence from all human randomized controlled trials indicates that LES [low-energy sweeteners] do not increase EI [energy intake] or BW [body weight], whether compared with caloric or non-caloric (for example, water) control conditions. Overall, the balance of evidence indicates that use of LES in place of sugar, in children and adults, leads to reduced EI and BW, and possibly also when compared with water.
  • Conflict: This work was conducted by an expert group of the European branch of the International Life Science Institute (ILSI Europe). The expert group received funding from the ILSI Europe Eating Behaviour and Energy Balance Task Force. Industry members of this task force are listed on the ILSI Europe website at www.ilsi.eu.
  • Comment: ILSI is funded by food companies.
Dec 22 2015

Coca-Cola reveals who it funds in England—organizations, researchers, other individuals

Last Friday, Coca-Cola UK joined its US counterpart in revealing the names of the organizations, researchers, and individuals it funds and the amounts it pays for these services.

As Jon Woods, General Manager of Coca-Cola Great Britain and Ireland, explains:

Earlier this year, my colleagues in the US published a list of the health and wellbeing partnerships, research and individuals funded there, dating back to 2010. In October, I committed to do the same and today we have published the details of what we have funded in Great Britain.  I believe this is the right thing to do…The total amount of funding we have provided in GB since 2010 is £9,328,095.

Like the US list, which has been analyzed extensively by Ninjas for Health, this one is interesting to read.

Here is a small sample from the list of organizations:

  • Biotechnology and Biological Sciences Research Council — £20,000
  • British Dietetic Association — £5,600
  • British Feeding & Drinking Group Annual Meeting — £1,200
  • British Nutrition Foundation — £33,000

A sample from the list of scientists and other individuals (not otherwise identified, alas):

  • Fiona Hunter
  • Prof. Ken Fox
  • Lynne Garton
  • Dr. Geoffrey Livesey
  • Dr. Sigrid Gibson
  • Dr. David Haslam
  • Prof. Marion Hetherington
  • Penny Hunking
  • Angie Jefferson
  • Prof. Ian Macdonald

I’m sure British public health advocates will have fun looking up what these people have said about sugary drinks and obesity.

The Times of London explained who some of them are:

The advisers include Stuart Biddle, of Loughborough University, who was chairman of a health department group on obesity in 2010; Alan Boobis, a director at Public Health England, who stopped receiving funding in 2013; Ken Fox, who advised the government on obesity in 2009; and Carrie Ruxton, now on the board of Food Standards Scotland. In 2010 Dr Ruxton co-wrote a study sponsored by the UK Sugar Bureau, an industry group, that found no proven association between sugar intake and obesity.

According to Der Spiegel, Coca-Cola plans to reveal everyone it sponsors in Europe.  All of this is further fallout from August’s New York Times’ revelations of Coca-Cola sponsorship of the now defunct Global Energy Balance Network.

More to come, no doubt.  Stay tuned.

Dec 8 2015

Three rare industry-funded studies with disappointing results. The score: 85:9.

Here are three rare studies sponsored by food companies with results that must have disappointed their funders.  Since mid-March when I started this collection, these bring the score to 85:9 (studies with results favorable to the sponsor’s interests vs. those against).

Acute Cocoa Supplementation Increases Postprandial HDL Cholesterol and Insulin in Obese Adults with Type 2 Diabetes after Consumption of a High-Fat BreakfastArpita Basu, Nancy M Betts, Misti J Leyva, Dongxu Fu, Christopher E Aston, and Timothy J Lyons.  J. Nutr. 2015; 145:2325-2332 doi:10.3945/jn.115.215772

  • Conclusion: Acute cocoa supplementation showed no clear overall benefit in T2D [type 2 diabetes] patients after a high-fat fast-food–style meal challenge. Although HDL cholesterol and insulin remained higher throughout the 6-h postprandial period, an overall decrease in large artery elasticity was found after cocoa consumption.
  • Funding: Supported by NIH Centers of Biomedical Research Excellence Program of the National Center for Research Resources at University of Oklahoma Health Sciences Center…a grant from The Hershey Company (to AB), and the Dean’s Research Incentive program in the College of Human Sciences at Oklahoma State University.

Associations between flavan-3-ol intake and CVD risk in the Norfolk cohort of the European Prospective Investigation into Cancer (EPIC-Norfolk).  Vogiatzoglou A1Mulligan AA2Bhaniani A2Lentjes MA2McTaggart A2Luben RN2Heiss C3Kelm M3Merx MW3Spencer JP3Schroeter H4Khaw KT5,Kuhnle GG6.  ).  Free Radic Biol Med. 2015 Jul;84:1-10. doi: 10.1016/j.freeradbiomed.2015.03.005. Epub 2015 Mar 17.

  • Conclusion:  There were no consistent associations between flavan-3-ol monomer intake and baseline systolic and diastolic blood pressure (BP)…Flavan-3-ol intake in EPIC-Norfolk is not sufficient to achieve a statistically significant reduction in CVD risk.
  • Funding: The present study was supported by the EU (Grant 226588, “Flaviola”) and an unrestricted grant from Mars, Inc. Mars, Inc. had no role in the design and analysis of the study or in the writing of this article. EPIC-Norfolk is supported by Cancer Research UK (SP2024-0201 and SP2024-0204) and the Medical Research Council (G9502233). H.S. is employed by MARS, Inc., a member of the FLAVIOLA research consortium and a company engaged in flavanol research and flavanol-related commercial activities. None of the other authors has a conflict of interest to declare.
  • Comment: This and the previous study are part of an effort to make chocolate seem like a health food.  Alas, these didn’t work.

No Change in 24-Hour Hydration Status Following a Moderate Increase in Fluid Consumption.  Matthew A. Tucker MA, J. D. Adams MS, Lemuel A. Brown MS, Christian B. Ridings MS, Jenna M. Burchfield MS, Forrest B. Robinson BS, Jamie L. McDermott MS, RD, LDN, Brett A. Schreiber MS, Nicole E. Moyen MS, Tyrone A. Washington PhD, Andrea C. Bermudez BS, Meredith P. Bennett BS, Maxime E. Buyckx MD & Matthew S. Ganio PhD.  Journal of the American College of Nutrition, DOI: 10.1080/07315724.2015.1046196.

  • Conclusions: Regardless of fluid volume or beverage type consumed, measures of 24-hour hydration status did not differ, suggesting that standard measures of hydration status are not sensitive enough to detect a 22% increase in beverage consumption.
  • Funding: This study was supported by a grant from The Coca-Cola Company. M.E.B., an employee of The Coca-Cola Company, contributed to study design and writing the article.
  • Comment: Coca-Cola has long advertised its products as promoting hydration.  In most people, thirst and normal food intake take care of hydration.  This study confirms that if you drink more than you need, you pee out the excess.
Dec 7 2015

Another five sponsored studies with expected results. The score: 85:6.

These are coming in so quickly that I am having a hard time keeping up with them.  Note that the first three are sponsored by Coca-Cola and that some of the investigators were involved with the ill-fated Global Energy Balance Network, now defunct.  As we now know from the e-mails obtained by the Associated Press, the statement that “the sponsor played no role…” is not necessarily correct.

As for the score: since mid-March, I have collected 85 sponsored studies with results just as the sponsor wanted, versus 6 with results that must have disappointed.  But stay tuned: tomorrow I will post 3 more in the disappointing category.

Low levels of physical activity are associated with dysregulation of energy intake and fat mass gain over 1 yearRobin P Shook, Gregory A Hand, Clemens Drenowatz, James R Hebert, Amanda E Paluch, John E Blundell, James O Hill, Peter T Katzmarzyk, Timothy S Church,11 and Steven N Blair.  Am J Clinical Nutrition November 11, 2015 as doi: 10.3945/ajcn.115.115360.

  • Conclusions: These results suggest that low levels of physical activity are a risk factor for fat mass gain. In the current sample, a threshold for achieving energy balance occurred at an activity level corresponding to 7116 steps/d, an amount achievable by most adults.
  • Funding: Supported by an unrestricted research grant from The Coca-Cola Company.

Association between cardiorespiratory fitness and submaximal systolic blood pressure among young adult men: a reversed J-curve pattern relationship. Vivek K. Prasada, Clemens Drenowatza, Gregory A. Handb, Carl J. Laviec, Xuemei Suia, Madison Demelloa, and Steven N. Blair.  Journal of Hypertension 2015, 33:2239–2244.

  • Conclusions: There was a reverse J-curve pattern relationship between SSBP [submaximal systolic blood pressure] and CRF [cardiorespiratory fitness], with the lowest SSBP among men with fair or good CRF and highest among those with poor CRF.
  • Funding: Funding for this project was provided through an unrestricted grant from The Coca-Cola Company. The sponsor played no role in the study design, data collection, analysis and interpretation, or preparation and submission of this manuscript.

Relation of Body’s Lean Mass, Fat Mass and Body Mass Index with Submaximal Systolic Blood Pressure Among Young Adult MenVivek K. Prasad, MD, MPH, PhD, Clemens Drenowatz, PhD, Gregory A. Hand, PhD, Carl J. Lavie, MD, Xuemei Sui, MD, MPH, PhD, Madison Demello, MS, Steven N.Blair.  Am J Cardiology 2015 DOI: 10.1016/j.amjcard.2015.10.060 .

  • Conclusion: there was a J curve pattern between SSBP [submaximal systolic blood pressure] and components of body composition whereas, a linear relation between SSBP and BMI.
  • Funding: Funding for this project was provided through an unrestricted grant from the Coca-Cola Company. The sponsor played no role in the study design, data collection, analysis, and interpretation,or preparation and submission of this manuscript.

Sugar- and artificially sweetened beverages and intrahepatic fat: A randomized controlled trial. Vanessa Campos, Camille Despland, Vaclav Brandejsky, Roland Kreis, Philippe Schneiter, Arnaud Chiolero, Chris Boesch and Luc Tappy.  Obesity Volume 23, Issue 12, pages 2335–2339, December 2015.

  • Conclusion: In subjects with overweight or obesity and a high SSB intake, replacing SSB with ASB decreased intrahepatic fat over a 12-week period.
  • Disclosure:  LT received research support from Nestlé SA, Switzerland, and Ajinomoto Co Inc, Japan, for studies unrelated to this work and speaker’s honoraria from Nestlé SA, Switzerland, Ferrero, Italy, and C3 collaborating for health, UK. The other authors declared no conflict of interest.

Probiotic supplementation attenuates increases in body mass and fat mass during high-fat diet in healthy young adults. Kristin L. Osterberg, Nabil E. Boutagy, Ryan P. McMillan, Joseph R. Stevens, Madlyn I. Frisard, John W. Kavanaugh, Brenda M. Davy, Kevin P. Davy and Matthew W. Hulver.  Obesity Volume 23, Issue 12, pages 2364–2370, December 2015.  DOI: 10.1002/oby.21230.

  • Conclusion: VSL#3 [the probiotic] supplementation appears to have provided some protection from body mass gain and fat accumulation in healthy young men consuming a high-fat and high-energy diet.
  • Funding agencies: This study was funded by VSL Pharmaceuticals, Inc.
  • Disclosure: The authors declared no conflict of interest.
Dec 1 2015

Five more sponsored studies with expected results. The score: 80:6

In case you haven’t been following this saga, I’ve been collecting studies funded by food companies since last March and posting them according to whether the results do or do not favor the sponsor’s interests.  So far, I’ve reported 80 that do, versus 6 that don’t (although I have a couple more saved up for posting soon).

The point of this exercise is to demonstrate that sponsored studies are far more likely to favor the interests of the sponsor than are studies funded by government agencies or foundations, and to argue for more independent funding of food and nutrition research (see my recent Viewpoint on this topic in JAMA Internal Medicine).

Here are five more examples.

Is consuming yoghurt associated with weight management outcomes? Results from a systematic review. J Eales, I Lenoir-Wijnkoop, S King, H Wood, F J Kok, R Shamir, A Prentice, M Edwards, J Glanville, R L Atkinson. Int’l J Obesity 2015 ahead of print.

  • Conclusions: Yoghurt consumption is associated with lower BMI, lower body weight/weight gain, smaller waist circumference and lower body fat in epidemiological studies. RCTs [randomized controlled trials] suggest weight reduction effects, but do not permit determination of a cause/effect relationship. Well-controlled, adequately powered trials in research and community settings appear likely to identify a modest but beneficial effect of yoghurt consumption for prevention of weight gain and management of obesity. The ready availability of yoghurt (a nutrient dense food) and its ease of introduction to most diets, suggests that educating the public to eat yoghurt as part of a balanced and healthy diet may potentially contribute to improved public health.
  • Funding: This project was funded by Danone Institute International.
  • Conflict of interest statement: York Health Economics Consortium received funding from Danone Institute International to conduct this review. York Health Economics Consortium has received funding from the Global Alliance for Probiotics, Danone and the European Food Safety Agency for projects involving food and health topics. FJK is member of the Scientific Advisory Board Global Dairy Platform, Chicago USA RS is President of Danone Institute International ILW is employed by the Danone Company, France.

Red Meat and Colorectal Cancer: A Quantitative Update on the State of the Epidemiologic ScienceDominik D. Alexander PhD, MSPHab*, Douglas L. Weed MD, PhDc, Paula E. Miller MPHb & Muhima A. Mohamed M PHd. J Am College Nutrition 2015;34: 521-43.  DOI:10.1080/07315724.2014.992553

  • Conclusion:  The state of the epidemiologic science on red meat consumption and CRC [colorectal cancer] is best described in terms of weak associations, heterogeneity, an inability to disentangle effects from other dietary and lifestyle factors, lack of a clear dose-response effect, and weakening evidence over time.
  • Funding: This manuscript was partially funded by Meat & Livestock Australia (MLA). MLA did not contribute to the writing, analysis, or interpretation of study findings.
  • Comment: The conclusion of this industry-funded study contradicts the findings of the WHO International Agency for Research on Cancer, which finds processed meats to be carcinogenic, and red meat to be a probable carcinogen.

The challenges of nutrition policymaking. Joanne Slavin.  Nutrition Journal (2015) 14:15 DOI 10.1186/s12937-015-0001-8.

  • Thrust of paper: As every DGAC [Dietary Guidelines Advisory Committee] wants to be bold and set new direction, nutrition science would support that first we must do no harm with our dietary guidance. Moderation and variety must be kept front and center…A suggestion that all Americans should reduce sodium intakes is not sound and is potentially dangerous. Targeting certain foods and beverages, including chocolate milk, processed meats, added sugars, and even the noble potato as villains in the nutrition wars is not a science-based strategy and may need to be countered on the political front if appointed scientific review committees continue to take this approach.
  • Competing interests: In the past 5 years Dr. Slavin has received research grants from Minnesota Beef Council, Minnesota Cultivated Wild Rice Council, Novartis Consumer Health, USA Rice, Nestle Nutrition, Tate and Lyle, General Mills, Inc., USA Pears and American Pulse Association. In the past 5 years Dr. Slavin has received speaking fees from food companies and commodity groups with interests in processed foods, dairy products, meat, pulses, fruits, vegetables, fiber, grains, and carbohydrates. Dr. Slavin has participated in scientific panels and advisory boards that are funded by food companies, ingredient companies, commodity groups, scientific societies, and trade groups. She holds a third interest in the Slavin Sisters LLC, a 119-acre farm in Southern Wisconsin.

Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including meta-analyses, of the evidence from human and animal studies PJ Rogers, PS Hogenkam , C de Graaf, S Higgs, A Lluch, AR Ness, C Penfold, R Perry, P Putz, MR Yeomansand DJ Mela.International Journal of Obesity (2015), 1–14 10 November 2015; doi:10.1038/ijo.2015.177

  • Conclusions: Overall, the balance of evidence indicates that use of LES [low-energy sweeteners] in place of sugar, in children and adults, leads to reduced EI [energy intake] and BW [body weight], and possibly also when compared with water.
  • Conflict of interest: Peter J Rogers has received grants from Sugar Nutrition, UK in support of research on the effects of sugar on human appetite. Cees de Graaf has received grants from the Dutch Sugar Bureau in support of a study on brain responses to sugars and low energy sweeteners. Suzanne Higgs has received a grant from Canderel in support of research on the effects of low-energy sweeteners on human appetite. Anne Lluch and David J Mela are employees and shareholders of companies that manufacture products containing sugars and low-energy sweeteners. Peter Putz is an employee of ILSI Europe.

Walnut ingestion in adults at risk for diabetes: effects on body composition, diet quality, and cardiac risk measures Valentine Yanchou Njike, Rockiy Ayettey, Paul Petraro, Judith A Treu, David L Katz.  . BMJ Open Diabetes Research and Care 2015;3:e000115. doi:10.1136/bmjdrc-2015- 000115.

  • Conclusions: The inclusion of walnuts in an ad libitum diet for 6 months, with or without dietary counseling to adjust calorie intake, significantly improved diet quality, endothelial function, total and LDL cholesterol, but had no effects on anthropometric measures, blood glucose level, and blood pressure.
  • Funding: Funding for this study has been provided by the California Walnut Commission.
  • Competing interests. DLK has been compensated for public speaking by the California Walnut Commission.
Nov 25 2015

A retraction and apology

The Journal of Public Health Policy (JPHP) will soon announce the retraction of a Viewpoint—an opinion piece—I co-authored with a Guatemalan physician, Dr. Joaquin Barnoya, “The food industry and conflicts of interest in nutrition research: A Latin American perspective.” Because of factual errors in the piece, and in response to valid objections about the errors from its subjects, they and we requested its retraction and JPHP is doing so.

I believe it is useful to explain how this happened.  In late summer, Dr. Barnoya brought to my attention an advertorial, a sponsored news account, published in el Periódico and other Guatemalan newspapers announcing an alliance among the Central American Bottling Corporation (cbc), the largest beverage distributor in Guatemala and bottler for PepsiCo; the Guatemala-based Institute of Nutrition of Central America and Panama (INCAP); and the U.S.-based Shalom Christian Foundation to distribute a supplemental food product, Mani+, to chronically malnourished children in rural areas (here is a translation of the advertorial).  Mani+ is a sweetened, peanut-based, nutrient-fortified supplemental food made from local ingredients in Guatemala, used to prevent malnutrition in young children.  The advertorial displayed a photograph of the directors of the three organizations holding the agreement.  It also displayed statements from all three directors emphasizing the alliance’s importance in addressing childhood malnutrition.

As readers of this blog should know, I have long been concerned about the conflicts of interest that arise when food companies—especially soda companies—enter into alliances with public health organizations.   The New York Times made the consequences of such alliances clear in its recent revelations of Coca-Cola sponsorship of the Global Energy Balance Network and the fallout from those revelations.  The announced alliance between cbc and INCAP raises similar concerns, particularly in the light of more general food industry partnerships with research and health institutions in Latin America.  Our intention in writing the Viewpoint was to question the appropriateness of this alliance, as well as of other such partnerships and alliances.

We should, however, have exercised more care.  Shortly after publication of the Viewpoint, Carolina Siu Bermúdez, the director of INCAP who appears in the advertorial, wrote to object that our piece incorrectly implied a financial relationship with cbc, and that Dr. Barnoya had failed to disclose that INCAP paid a substantial portion of his salary via a grant from yet another organization.  We also received letters from Dr. Edward Fischer, the founder of NutriPlus/Mani+, Professor of Anthropology and Director of the Center for Latin American Studies at Vanderbilt University, objecting to our statement that the alliance was responsible for manufacturing (rather than just distributing) the product.   Both asked us to retract the Viewpoint.

Upon investigation, we realized their objections had merit.  Indeed, further investigation by us and by the editors of the JPHP exposed additional errors.  Together, these include the following clarifications and corrections:

  • The alliance is involved only in the distribution of Mani+, not its manufacture (as we had asserted).
  • The actual nature of the alliance between cbc, INCAP, and the Shalom Christian Foundation—who does what—is, in fact, unclear. The Viewpoint should have characterized the relationship with less certainty and specified that cbc has no financial relationship with either INCAP or the Foundation.
  • Dr. Barnoya should have disclosed his financial relationship with INCAP, and I should have insisted that he do so.
  • The Viewpoint was triggered by the advertorial, and we should have made this connection more explicit.
  • The reference in the Viewpoint to the advertorial is incorrect. It is listed as (2015) cbc co. Unidos contra la desnutricion. INCAP, cbc y Fundacion Crisitiana Shalom Firman Convenio 23(July): 9.  The correct reference is Alianza Contra la Desnutricion. elPeriódico. July 23, 2015;Advertorial: 9.

To correct and clarify these issues, we would need to revise the Viewpoint.  Doing so, however, is not possible once a paper is published.  That left us no choice but to request a retraction, which I believe is the right course of action in this situation.

In my books and other writing, I try as hard as I can to be precise and accurate.  This incident is a lapse that I regret deeply, for which I take responsibility, and for which I apologize to Carolina Siu Bermúdez, to Dr. Fischer, and to my readers.  I also apologize to Phyllis Freeman and Anthony Robbins, the editors of JPHP, and to Lucy Wheeler of Palgrave, who have set an exemplary standard of ethics and integrity throughout these investigations and discussions.

As for lessons learned: Although I fully intend to continue to write critically about alliances between food companies and public health organizations, I also intend to use this experience to recommit myself to accountability and to diligence in checking and double-checking facts and disclosures going forward.   Again, my deepest apologies.

Addition, December 14: The actual retraction notice is published here.  The discussion on Retraction Watch is here.

Nov 9 2015

University of Colorado returns Coca-Cola funding for Global Energy Balance Network

On Friday, the University of Colorado School of Medicine announced that it was giving back the $1 million that Coca-Cola had donated to fund the Global Energy Balance Network.

This is the group of scientists funded by Coca-Cola who were promoting activity as the best way to prevent obesity, but playing down any contribution of soft drinks and junk food to weight gain (see my post on this).

This is the fourth impressive result of the investigative report by Anahad O’Connor in the New York Times in August that revealed Coca-Cola’s funding of such initiatives.

  1. Coke’s chief executive, Muhtar Kent, disclosed that the company had spent almost $120 million since 2010 to pay for partnerships with medical and community health groups, and promised that the company would be more transparent.
  2. Coca-Cola set up a transparency website where it revealed the list of funded organizations.
  3. Coke ended its relationships with the Academy of Nutrition and Dietetics, the American Academy for Pediatrics, and the American Academy of Family Practice (or these groups pulled out—everyone seems to want to credit).
  4. Now this. Coke says it will donate the returned money to the Boys & Girls Clubs of America.

I am quoted in this story:

Marion Nestle, a professor of nutrition, food studies and public health at New York University, called the network “a front group” for Coca-Cola intended to promote the message that obesity is primarily caused by a lack of exercise, not by overconsumption of junk food.

On Friday, Dr. Nestle, the author of “Soda Politics,” said she was pleased that the university had returned the money.

“Both deserve congratulations for making a difficult but necessary decision,” said Dr. Nestle. “Let’s hope other groups also decide to do the right thing and end such financial relationships.”

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