Currently browsing posts about: Conflicts-of-interest

Nutrition research studies funded by food companies are pouring in and here’s another set of five with expected results.  The first one is notable for its extensive revelations, a case of TMI (too much information) if I’ve ever seen one.  As usual, if you run across more of these—and especially industry-funded studies that do not favor the sponsor’s interest, please send.  The roundup since mid-March: 60 with favorable results, 3 without.

Effect of Fructose on Established Lipid Targets: A Systematic Review and Meta‐Analysis of Controlled Feeding Trials.  Laura Chiavaroli, Russell J. de Souza, Vanessa Ha, Adrian I. Cozma, Arash Mirrahimi, David D. Wang, Matthew Yu, Amanda J. Carleton, Marco Di Buono, Alexandra L. Jenkins, Lawrence A. Leiter, Thomas M. S. Wolever, Joseph Beyene, Cyril W. C. Kendall, David J. A. Jenkins, and John L. Sievenpiper.  J Am Heart Assoc. 2015;4: originally published September 10, 2015, doi:10.1161/JAHA.114.001700.

• Conclusion: Pooled analyses showed that fructose only had an adverse effect on established lipid targets when added to existing diets so as to provide excess calories (+21% to 35% energy). When isocalorically exchanged for other carbohydrates, fructose had no adverse effects on blood lipids.
• Conflicts:  The disclosures cover two full pages in the journal.  These authors report every source of income—honoraria, prizes, travel funds—including those of their spouses.  They apparently work for every food company imaginable, including any number with interests in minimizing a harmful role of fructose in health.
• Comment:  I do not know why the editors of this journal decided that the conflict-of-interest statement was worth two pages of journal space.  Perhaps they don’t think such statements necessary and were being ironic?  Or perhaps they wanted to make sure that these highly conflicted authors were fully exposed?  Yoni Freedhoff of Weighty Matters consulted an ethicist about this question but did not get a clear answer.  I wrote the journal editor and asked what this was about, but have not received a response.

Beneficial effects of oral chromium picolinate supplementation on glycemic control in patients with type 2 diabetes: A randomized clinical study. Ana N. Paiva, Josivan G. de Lima, Anna C.Q. de Medeiros, Heverton A.O. Figueiredo, Raiana L. de Andrade, Marcela A.G. Ururahye, Adriana A. Rezende, José Brandão-Neto, Maria das G. Almeida.   Journal of Trace Elements in Medicine and Biology 32 (2015) 66–72.

• Conclusions: CrPic supplementation had a beneficial effect on glycemic control in patients with poorly controlled T2DM, without affecting the lipid profile.
• Conflict: Manipulation Pharmacy Companhia da Fórmula donated the chromium picolinate supplement.
• Comment: Without knowing more about this situation, it’s not possible to say whether donation of a supplement is enough to raise concerns.  This study raises questions because most independently funded studies of chromium and diabetes have shown minimal or no benefits (see, for example this one).

Oat consumption reduced intestinal fat deposition and improved health span in Caenorhabditis elegans model. Chenfei Gao, Zhanguo Gao, Frank L. Greenway, Jeffrey H. Burton, William D. Johnson, Michael J. Keenan, Frederick M. Enright, Roy J. Martin, YiFang Chu, Jolene Zheng.  Nutrition Research September 2015 Volume 35, Issue 9, Pages 834–843.

• Conclusion: Oat consumption may be a beneficial dietary intervention for reducing fat accumulation, augmenting health span, and improving hyperglycemia-impaired lipid metabolism [in nematodes].
• Conflict: This research was supported by a nonrestricted donation from PepsiCo Inc. Oats used in this study were a gift of PepsiCo Inc. Y. Chu is an employee of PepsiCo, Inc, which manufactures oatmeal products under the brand name Quaker Oats.

A pilot study examining the effects of consuming a high-protein vs normal-protein breakfast on free-living glycemic control in overweight/obese ‘breakfast skipping’ adolescents. L B Bauer, L J Reynolds, S M Douglas, M L Kearney, H A Hoertel, R S Shafer, J P Thyfault and H J Leidy.  International Journal of Obesity (2015) 39, 1421–1424; doi:10.1038/ijo.2015.101; published online 7 July 2015

• Conclusion: These data suggest that the daily addition of a HP breakfast, containing 35 g of high-quality protein, has better efficacy at improving free-living glycemic control compared with a NP breakfast in overweight/obese, but otherwise healthy, ‘breakfast skipping’ adolescents.
• Disclosure: The authors declare no conflict of interest, but the study was funded by the Pork Checkoff.

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

• Conclusions: Acute cocoa supplementation showed no clear overall benefit in T2D 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: Among other sources, the lead author receiveda grant from The Hershey Company.
• Comment: This is a negative study (no benefit) with a positive spin (higher HDL, decrease in large artery elasticity).

 

Here’s the latest collection of 5 studies funded by food companies or trade associations, all with results that favor the sponsor’s interests.  I’ve just reviewed them and found a couple of duplicates, so this is a corrected score.  The correct score is 55 industry-funded studies with positive results vs. 3 with results unfavorable to industry—since mid-March.

I’m particularly interested in the unfavorable category.  If you run across any, please send.

Jejunal Casein Feeding Is Followed by More Rapid Protein Digestion and Amino Acid Absorption When Compared with Gastric Feeding in Healthy Young Men. Joanna Luttikhold, Klaske van Norren, Nikki Buijs, Marjolein Ankersmit, Annemieke C Heijboer, Jeannette Gootjes, Herman Rijna, Paul AM van Leeuwen, and Luc JC van Loon. J. Nutr. 2015; 145:2033-2038 doi:10.3945/jn.115.211615.

• Conclusions: Jejunal feeding of intact casein is followed by more rapid protein digestion and AA absorption when compared with gastric feeding in healthy young men. The greater postprandial increase in circulating EAA concentrations may allow a more robust increase in muscle protein synthesis rate after jejunal vs. gastric casein feeding.
• Funding: Supported by Nutricia Research, Utrecht, Netherlands. J Luttikhold was employed by Nutricia Research; K van Norren is a guest employee of Nutricia Research; and LJC van Loon has served as a consultant for Nutricia Research.  [Note: Nutricia Research is a subsidiary of Danone].

Higher Total Protein Intake and Change in Total Protein Intake Affect Body Composition but Not Metabolic Syndrome Indexes in Middle-Aged Overweight and Obese Adults Who Perform Resistance and Aerobic Exercise for 36 Weeks. Wayne W Campbell, Jung Eun Kim, Akua F Amankwaah, Susannah L Gordon, and Eileen M Weinheimer-Haus. J. Nutr. 2015; 145:2076-2083 doi:10.3945/jn.115.213595.

• Conclusions: In conjunction with exercise training, higher TPro [total protein] promoted positive changes in BC [body composition] but not in MetS [metabolic syndrome] indexes in overweight and obese middle-aged adults. Changes in TPro from before to during the intervention also influenced BC responses and should be considered in future research when different TPro is achieved via diet or supplements.
• Funding:  Supported by the US Whey Protein Research Consortium (to WWC) among others.  WW Campbell was a member of the National Dairy Council Whey Protein Advisory Panel while the research was being conducted.

Intense Sweeteners, Appetite for the Sweet Taste, and Relationship to Weight Management.  France Bellisle.  Current Obesity Reports March 2015, Volume 4, Issue 1, pp 106-110 10.1007/s13679-014-0133-8

• Conclusion: While many of the existing studies cannot identify any causal links between use of LES [artificial, low-energy sweeteners] and appetite for sweetness, randomized trials in children and adults suggest that use of LES tends to reduce rather than increase the intake of sugar-containing foods and to facilitate, rather than impair, weight loss.
• Conflict: Parts of [this study] are extracted from a non-published document for which the author received an honorarium from the International Sweeteners Association (ISA).  France Bellisle is a member of the Scientific Advisory Board for General Mills and has received travel reimbursement and honoraria for contributions in scientific congresses from Mondelez, ISA, and General Mills.

Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial.  Christian Heiss & Roberto Sansone & Hakima Karimi & Moritz Krabbe & Dominik Schuler & Ana Rodriguez-Mateos & Thomas Kraemer & Miriam Margherita Cortese-Krott & Gunter G. C. Kuhnle & Jeremy P. E. Spencer & Hagen Schroeter & Marc W. Merx & Malte Kelm & for the FLAVIOLA Consortium, European Union 7th Framework Program.  AGE (2015) 37: 56 DOI 10.1007/s11357-015-9794-9

• Conclusion: CF [cocoa flavanol] intake reverses age-related burden of cardiovascular risk in healthy elderly, highlighting the potential of dietary flavanols to maintain cardiovascular health.
• Funding: …Additional funding was provided by an unrestricted grant by MARS, Inc…MARS, Inc. provided the standardized test drinks used in this investigation. HS is employed by MARS, Inc., a member of the FLAVIOLA research consortium and a company engaged in flavanol research and flavanol-related commercial activities.

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.  Roberto Sansone, Ana Rodriguez-Mateos , Jan Heuel, David Falk, Dominik Schuler, Rabea Wagstaff, Gunter G. C. Kuhnle, Jeremy P. E. Spencer, Hagen Schroeter, Marc W. Merx, Malte Kelm and Christian Heiss for the Flaviola Consortium, European Union 7th Framework Program.  British Journal of Nutrition, September 9, 2015. doi:10.1017/S0007114515002822.

• Conclusion: In healthy individuals, regular CF [cocoa flavanol] intake improved accredited cardiovascular surrogates of cardiovascular risk, demonstrating that dietary flavanols have the potential to maintain cardiovascular health even in low-risk subjects.
• Funding: Additional funding was provided…through an unrestricted grant by MARS Inc. MARS Inc. also provided the standardised test drinks used in this investigation… H. S. provided test drinks on behalf of Mars Inc… 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. [The conflict statement also discloses that MARS employee H.S. shared responsibility for designing the study, writing the paper, and approving the final content].
• Comment: Lest the implicit (but never stated directly) “eat more chocolate” message of these studies be missed, Mars sent out a press release: “Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.”

Since mid-March, I’ve been collecting research studies funded by food companies or trade associations, and dividing them into those that come out with results favorable to the sponsor (50 so far–this is a corrected number) and those that do not (as of today, 3).

As always, if you run across others, please send.

A reader, Cole Adam, sent me this study on dark chocolate funded by a Finnish company that makes chocolate products.

Dark chocolate and reduced snack consumption in mildly hypertensive adults: an intervention study.  Raika Koli, Klaus Köhler, Elina Tonteri, Juha Peltonen, Heikki Tikkanen and Mikael Fogelholm.  Nutrition Journal 2015, 14:84  doi:10.1186/s12937-015-0075-3

• Results: Daily consumption of dark chocolate had no effects on 24 h blood pressure, resting blood pressure…or arterial stiffness.  Weight was reduced by 1.0 ± 2.2 kg during the control (reduced snack only) period, but was unchanged while eating chocolate (p < 0.027 between the treatments).
• Conclusion:  …inclusion of 49 g dark chocolate daily as part of a diet of mildly hypertensive participants had no significant effects on cardiovascular risk factors during 8 wks.  Apart from a small effect on body weight (dark chocolate seemingly prevented a slight decrease in body weight during the control period), no other negative effects were observed.
• Funding:  This work was funded by Oy Karl Fazer Ab. Authors declare no competing interests regarding this study.  [Oy Karl Fazer Ab sells bakery, biscuit, and confectionery products in Finland, Sweden, Estonia, Latvia, Lithuania, Norway, Denmark, Russia, and internationally]

Several points to note about this study:

• Eating 49 grams (just under 2 ounces) of dark chocolate a day may be fun, but it is not going to reduce your blood pressure.
• Eating 49 grams of dark chocolate a day makes weight loss more difficult.
• The authors do not view corporate funding as introducing competing interests.  OK.  Maybe not in this case, but this is a rare exception.

Another reader, who prefers to remain anonymous, sent this one:

Milk intake is not associated with low risk of diabetes or overweight-obesity: a Mendelian randomization study in 97,811 Danish individuals.  Helle KM Bergholdt, Børge G Nordestgaard, and Christina Ellervik.  Am J Clin Nutr 2015;102:487–96. 

• Conclusions: High milk intake is not associated with a low risk of type 2 diabetes or overweight-obesity, observationally or genetically via lactase persistence.  The higher risk of type 2 diabetes in   individuals without milk intake likely is explained by collider stratification bias.
• Conflict: HKMB’s PhD project was partly funded by the Research Unit at Naestved Hospital, the Danish Dairy Research Foundation, and the Regional Research Unit in Region Zealand. [The population studies were funded by a long list of government agencies, health organizations, and foundations].
• Comment: This study says that high milk intake is associated with a higher risk of type 2 diabetes, although it explains it away.  The Danish dairy industry paid for part of the first author’s dissertation research.  It looks like most of the funding came from independent sources, so this one is a bit of a stretch, but to be super scrupulous let’s count it as industry-funded.

NOTE: All three “negative” studies I’ve posted since March were funded by international food companies (the previous one was funded by the Danish Dairy Research Foundation).

Sunday’s New York Times story on academic conflicts of interest focused on scientists with financial ties to Monsanto.  The ties were revealed by open-records requests for e-mails and other information.

The Times was not the only one to make these requests.  U.S. Right to Know, a group devoted to investigating Big Food and its front groups had already done so.  U.S. Right to Know is funded primarily by the Organic Consumers Association, a national grassroots network advocating for organics, sustainability, and food safety—but against GMOs.

U.S. Right to Know rightfully takes credit for establishing the basis of the Times’ story.  It sent open-records requests to scientists working for public institutions who seemed likely to have financial ties to Monsanto.  Bingo.  Some of the e-mails revealed such ties.*

But should government-funded scientists be subjected to open records requests?  Couldn’t these requests amount to open season on academics—a modern-day version of witchhunts?  This question is now under active debate (and see comments on my previous post).

While these debates are raging, here is one aspect of this story that the New York Times did not tell.

Earlier this month, Paul Thacker and my NYU colleague Charles Seife, wrote a piece for PLoS [Public Library of Science] Blogs arguing that Freedom of Information Act (FOIA) requests “for personal correspondence are not just appropriate, but crucial to ensuring transparency.”   They argue that the benefits of transparency outweigh the costs.

But transparency laws remain a fundamental tool for monitoring possible scientific misbehavior. And it would be a mistake to believe that scientists should not be subject to a high level of outside scrutiny. So long as scientists receive government money, they are subject to government oversight; so long as their work affects the public, journalists and other watchdogs are simply doing their jobs when they seek out possible misconduct and questionable practices that could threaten the public interest.

Thacker and Seife explain:

Last week, Nature reported that the University of Florida had provided them with emails that U.S. Right to Know had FOIA’d on one of their researchers…the [Nature] story noted that the researcher has received money from Monsanto to fund expenses incurred while giving educational talks on GMOs.  The article also noted that the PR Firm Ketchum had provided the scientist with canned answers to respond to GMO critics, although it is unclear if he used them [the Times story says he did but now regrets it].

The article does not report that the scientist has repeatedly denied having a financial relationship with Monsanto. The article also does not report on an email titled “CONFIDENTIAL: Coalition Update” from the researcher to Monsanto in which the scientist advised Monsanto on ways to defeat a political campaign in California to require labeling of GMO products.

Some readers of PLoS were outraged that this online journal would publish an article supporting open-records requests of scientists (see, for example, this from the American Council on Science and Health).

Here’s where things get interesting.

PLoS responded to the criticism by, of all things, retracting the article.

Seife and Thacker explained their views in an op-ed in the Los Angeles Times.

If the public pays your salary, citizens have the right — within limits — to see what you’re doing. That’s the principle at the core of the federal Freedom of Information Act and of the many similar state freedom of information laws… “snooping” on scientists’ inboxes by journalists, watchdogs and government officials has revealed significant problems that would never have come to light via other means.

That, of course, is the basis of the New York Times’ exposé of Monsanto’s funding of scientists to testify on the company’s behalf to reporters, Congress, and the public.

Bottom line: Because industry-funded science and scientists almost invariably provide data and testimony that favors the sponsors interests, the press and public need to know about sponsorship.

One more comment:  A substantial body of literature exists on industry sponsorship of science, particularly on the effects of pharmaceutical industry funding of medical professionals.  Conflicts-of-interest researchers conclude that such conflicts are generally unconscious, unintentional, and unrecognized by participants.  The remedy is increased government spending for research, an unlikely possibility these days.  This means journalists will be kept busy exposing the many problems that arise when scientists take industry funding.

*The documents collected by the New York Times

• David Shaw
• Bruce Chassy
• Kevin Folta

Additions:

• Note: My previous post on organic-industry funding gives the link to the e-mails for Charles Benbrook
• Jonathan Latham provides further details on GMO public relations efforts

Today’s New York Times has another front-page (and on the inside, full-page) story on the food industry’s financial relationships with academic scientists.

The article describes how Monsanto funded scientists to lobby for GMOs in Washington (I will say more about this in a subsequent post).

But, as is clear from this report, the organic industry is doing much the same.

The Times based the story on e-mails it collected through open records law requests (the equivalent of Freedom of Information Act requests for federal documents).

And surprise!  I turn up in Charles Benbrook’s.  I learned this from checking Twitter yesterday.

I’m only on the B-list for influencing public opinion?  Alas.

It seems that Charles Benbrook, a strong proponent of organics (as am I), was working with (for?) the Organic Valley Cooperative on a public relations campaign to promote his organics-funded study demonstrating that organic milk has a healthier fatty acid profile than conventional milk.

I vaguely remember him contacting me about the study, but I didn’t write anything about it.  It appeared to be an industry-funded study with results favoring the sponsor’s interests—much as, in this case, I sympathize with those interests.

A few months later, I did write write about another conflicted organic study:

The study is not independently funded….This study is another example of how the outcome of sponsored research invariably favors the sponsor’s interests.  The paper says “the  [Sheepdrove] Trust  had  no  influence  on  the  design  and management of the  research  project  and  the  preparation  of publications  from the project,” but that’s exactly what studies funded by Coca-Cola say.  It’s an amazing coincidence how the results of sponsored studies almost invariably favor the sponsor’s interests.  And that’s true of results I like just as it is of results that I don’t like.

Benbrook has been criticized recently for not fully disclosing his ties to the organic industry.  Even if he had, disclosure is not enough.

The bottom line: Conflicted studies are conflicted, no matter who pays for them.

Documents: Charles Benbrook

Energy flux: staying in energy balance at a high level is necessary to prevent weight gain for most people.  Gregory A Hand, Robin P Shook, James O Hill, Peter R Giacobbi, and Steven N Blair.   Expert Rev. Endocrinol. Metab.  Early online, 1–7 (2015)

• Conclusion: Maintaining energy balance at a higher caloric intake and expenditure should be a more successful long-term strategy for weight maintenance than reduced consumption or extreme caloric restriction at a low level of energy expenditure (a low energy flux) and improve intervention effectiveness for sustainable methods for body weight stability. [Implication: eat more to lose weight?]
• Funding: GA Hand received non-restricted research funding and travel grant from The Coca Cola Company and a travel grant from International Life Sciences Institute. RP Shook received a travel grant from the Coca Cola Company. JO Hill received research support from the Coca Cola Company and the American Beverage Association. JO Hill is on the advisory board for McDonalds, General Mills, Curves, Consumer Goods Association, Calorie Control Council, International Food Information Council and McCormick Science Institute. JO Hill is a consultant for Walt Disney, has equity in Gelesis and Active Planet and is on the Board of Directors for International Life Sciences Institute and Livewell Colarado. SN Blair is the principal investigator on projects supported by unrestricted research grants from The Coca Cola Company to the University of South Carolina.
• Comment: Some of these investigators were among those highlighted in the New York Times article revealing Coca-Cola’s funding of research demonstrating that physical activity is more important than diet in weight maintenance.

Reducing obesity will require involvement of all sectors of society. James O. Hill, John C. Peters and Steven N. Blair. Obesity Volume 23, Issue 2, February 2015, Page: 255.

• Conclusion: If the physical inactivity industry could commit to increasing physical activity by 78 calories a day per person, we would begin seeing some real success…we need innovative thinking, recognition that both food and physical activity are important, and open minds about how to engage all of society in making changes.
• Disclosure: Dr. Hill reports personal fees from Coca-Cola, personal fees from McDonald’s, grants from American Beverage Association, personal fees from Walt Disney Company, personal fees from General Mills, personal fees from Calorie Control Council, other from International Life Sciences Institute, and other from Retrofit outside the submitted work. In addition, Dr. Hill has a patent Energy Gap issued. Dr. Blair reports grants from Technogym and grants from Coca-Cola. Dr. Peters has no competing interests to disclose.
• Comment: same investigators as in previous example.

Instant Oatmeal Increases Satiety and Reduces Energy Intake Compared to a Ready-to-Eat Oat-Based Breakfast Cereal: A Randomized Crossover Trial. Candida J. Rebello MS, RD, William D. Johnson PhD, Corby K. Martin PhD, Hongmei Han MS, Yi-Fang Chu PhD, Nicolas Bordenave PhD, B. Jan Willem van Klinken MD, PhD, Marianne O’Shea PhD & Frank L. Greenway MD.  Journal of the American College of Nutrition Published online: 14 Aug 2015.  DOI:10.1080/07315724.2015.1032442

• Conclusion: Oatmeal suppresses appetite, increases satiety, and reduces energy intake compared to the RTEC [ready-to-eat cereal].
• Funding: The trial was funded by Quaker Oats Center of Excellence and PepsiCo R&D Nutrition….

Impact of equol-producing capacity and soy-isoflavone profiles of supplements on bone calcium retention in postmenopausal women: a randomized crossover trial.  Jessica W Pawlowski, Berdine R Martin, George P McCabe, Linda McCabe, George S Jackson, Munro Peacock, Stephen Barnes, and Connie M Weaver. Am J Clin Nutr September 2015 vol. 102 no. 3 695-703.

• Conclusion: Soy isoflavones, although not as potent as risedronate [a drug used to treat osteoporosis], are effective bone-preserving agents in postmenopausal women regardless of their equol-producing status, and mixed isoflavones in their natural ratios are more effective than enriched genistein.  [Equol is an isoflavone produced by intestinal bacteria]
• Conflicts: CMW is on the scientific advisory board of Pharmavite [the maker of SoyJoy]. SB has a US patent on the use of conjugated isoflavones and the prevention of osteoporosis.

Agave Inulin Supplementation Affects the Fecal Microbiota of Healthy Adults Participating in a Randomized, Double-Blind, Placebo-Controlled, Crossover Trial.  Hannah D Holscher, Laura L Bauer, Vishnupriya Gourineni, Christine L Pelkman, George C Fahey, Jr., and Kelly S Swanson. J. Nutr. 2015; 145:2025-2032 doi:10.3945/jn.115.217331

• Conclusions: Agave inulin supplementation shifted the gastrointestinal microbiota composition and activity in healthy adults. Further investigation is warranted to determine whether the observed changes translate into health benefits in human populations.  [Note: Agave inulin is a prebiotic, a fiber that can be metabolized by intestinal bacteria.  The study reports enrichment of fecal Bifidobacterium (the good kind)].
• Funding: Supported in part by Global Nutrition R&D, Ingredion Incorporated, Bridgewater, NJ.  V Gourineni and CL Pelkman are employees of Global Nutrition R&D, Ingredion, Incorporated.  [Ingredion manufactures prebiotic fibers]

As always, please send examples, particularly of industry-funded studies that do not produce results in the sponsor’s interest.

The Inadmissibility of What We Eat in America and NHANES Dietary Data in Nutrition and Obesity Research and the Scientific Formulation of National Dietary Guidelines. Archer E, Pavela G, Lavie CJ. Mayo Clin Proc. 2015 Jul;90(7):911-26. doi: 10.1016/j.mayocp.2015.04.009. Epub 2015 Jun 9.

• Conclusion: we conclude that M-BM [memory-based dietary assessment methods] data cannot be used to inform national dietary guidelines and that the continued funding of M-BMs constitutes an unscientific and major misuse of research resources.
• Funding: National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
• Potential Competing Interests: Dr Archer has received honoraria from the International Life Sciences Institute and The Coca Cola Company. Dr Lavie reports receiving consulting fees and speaking fees from The Coca-Cola Company….
• Comment: This is part of what appears to be a concerted effort by Coca-Cola to discredit NHANES, the national survey of dietary intake and disease risk that consistently associates soda intake to poor health.

A high-protein breakfast prevents body fat gain, through reductions in daily intake and hunger, in “Breakfast skipping” adolescents.  Heather J. Leidy, Heather A. Hoertel, Steve M. Douglas, Kelly A. Higgins and Rebecca S. Shafer.  Obesity.  Article first published online: 4 AUG 2015.  DOI: 10.1002/oby.21185

• Conclusions: The daily addition of a HP [high-protein] breakfast improved indices of weight management as illustrated by the prevention of body fat gain, voluntary reductions in daily intake, and reductions in daily hunger in breakfast skipping adolescents with overweight/obesity.
• Funding: The Pork Checkoff supplied the funds to complete the study.
• Disclosure: The authors declared no conflict of interest.
• Comment: Industry-funded investigators typically state that funding does not introduce conflicts of interest.

Breakfasts Higher in Protein Increase Postprandial Energy Expenditure, Increase Fat Oxidation, and Reduce Hunger in Overweight Children from 8 to 12 Years of Age.  Jamie I Baum, Michelle Gray, and Ashley Binns.  J. Nutrition.  First published August 12, 2015, doi: 10.3945/jn.115.214551  J. Nutr. jn214551

• Conclusion: This study indicates that breakfast macronutrient composition affects postprandial responses in both NW [normal weight] and OW [overweight] children. A PRO [protein-rich breakfast] increases postprandial EE [energy expendititure] and fat oxidation, reduces hunger, and increases satiety when compared with a carbohydrate-based breakfast.
• Funding: Supported by a grant from the Egg Nutrition Center/American Egg Board, Chicago, IL. The Egg Nutrition Center/American Egg Board was not involved in the design, implementation, analysis, or interpretation of the data.
• Author disclosures: JI Baum, M Gray, and A Binns, no conflicts of interest.
• Comment: These industry-funded investigators also deny that funding introduces conflicts of interest.

The Effect of Breakfast vs. No Breakfast on Brain Activity in Adolescents when Performing Cognitive Tasks, as Assessed by fMRI [functional magnetic resonance imaging].  Jonathan Fulford1, Joanna L Varley2 and Craig A Williams.   Nutritional Neuroscience 2015 epub ahead of print.

• Conclusion: Although no statistically significant (P > 0.05) improvement in task performance was determined, significantly higher activation was recorded in the frontal, premotor, and primary visual cortex areas in the breakfast trial relative to the fasting condition…Such a finding may have important implications in the examination of the role of diet, and specifically breakfast, in determining children’s performance within the school environment.
• Funding: A grant was received of £18,678.08 from Kellogg Marketing & Sales Company (UK) Ltd to cover MRI scanning costs. Otherwise the research was conducted with the support of internal institutional funds and the authors received no other direct or indirect support, with no further competing interests.
• Comment: Ordinarily I’m not concerned about food companies’ donating products to be tested but £18,678.08 seems noteworthy, especially since the only point of this study is to demonstrate that breakfast-eaters do better (higher brain activation even though no significant gain in task performance).

Suboptimal Serum α-Tocopherol Concentrations Observed among Younger Adults and Those Depending Exclusively upon Food Sources, NHANES 2003-2006. McBurney MI, Yu EA, Ciappio ED, Bird JK, Eggersdorfer M, Mehta S (2015). PLoS ONE 10(8): e0135510. doi:10.1371/journal.pone.0135510

• Conclusion: The prevalence of inadequate vitamin E levels is significantly higher among non-users of dietary supplements…Our findings provide evidence that most Americans have serum α-tocopherol levels below 30 μmol/L. The EAR [Estimated Average Requirement], epidemiological and randomized controlled studies all indicate that maintaining a serum α-tocopherol concentration of 30 μmol/L may have beneficial effects on mortality, cognitive function and reproduction [Note: “may” indicates that what follows is speculative].
• Funding: This statistical analysis of data collected by the Centers for Disease Control (CDC)…was supported by DSM Nutritional Products, a manufacturer of vitamin E. MM, EC, JB and ME are employees of DSM Nutritional Products. DSM Nutritional Products provided support in the form of salaries for authors MM, EC, JB, and ME and as an unencumbered gift to Cornell University that was used to support EY as a graduate research assistant.
• Competing interests: This study was supported by DSM Nutritional Products, a manufacturer of vitamins, including vitamin E, for food, dietary supplement, and pharmaceutical use. MM, EC, JB, and ME are employees of DSM Nutritional Products.
• Comment: Inadequate vitamin E in this study is defined as a serum level below a certain cut-point with uncertain clinical significance.  According to the Dietary Reference Intakes, clinical signs of vitamin E deficiency have not been observed in healthy populations.

Note: Since mid-March, I have posted 47 industry-funded studies with results favorable to food companies or trade associations, vs. 1 study with unfavorable results.

If you see industry-funded studies with results that must have made the sponsor unhappy, please send.

Coca-Cola, in case you missed the furor over last week’s New York Times article, has a huge public relations problem.

The damage control begins today with Coke’s CEO’s op-ed in the Wall Street Journal:

Our company has been accused of shifting the debate to suggest that physical activity is the only solution to the obesity crisis. There also have been reports accusing us of deceiving the public about our support of scientific research…I am disappointed that some actions we have taken to fund scientific research and health and well-being programs have served only to create more confusion and mistrust. I know our company can do a better job engaging both the public-health and scientific communities—and we will.

By supporting research and nonprofit organizations, we seek to foster more science-based knowledge to better inform the debate about how best to deal with the obesity epidemic. We have never attempted to hide that. However, in the future we will act with even more transparency as we refocus our investments and our efforts on well-being.

He promises that the company will:

• Publish on our website a list of our efforts to reduce calories and market responsibly, along with a list of health and well-being partnerships and research activities we have funded in the past five years, which we will continue to update every six months.

• Charter and recruit an oversight committee of independent experts to advise and provide governance on company investments in academic research.

• Engage leading experts to explore future opportunities for our academic research investment and health and well-being initiatives.

Personally, I can’t wait to see the list of Coke-funded research activities.  Want to bet how many of those studies came out with results that Coca-Cola can use to claim that sugary drinks have no effect on obesity or type 2 diabetes?  I’d also like a count of the number of studies Coca-Cola has funded to cast doubt on the National Health and Nutrition Examination Survey, the country’s major dietary monitoring program, which has the annoying habit of linking sugary drinks to those conditions.

Mr. Kent ends his piece with this plea:

As we continue to learn, it is my hope that our critics will receive us with an open mind. 

Unless Coca-Cola stops pouring millions of dollars into fighting soda caps and taxes, stops targeting its marketing to minorities, and stops lobbying against public health measures to help people eat more healthfully, keeping Mr. Kent’s version of an open mind will be difficult. 

Steven Blair, one of the scientists involved in Coke-funded research, posted this statement today:

I have asked that my video addressing energy balance be taken down from the GEBN website. I regret that a statement I made in this video has been used by some to brand GEBN as a network focusing only on physical activity. This is not true and never has been true. From the beginning the mission of GEBN has been to study the science of energy balance which involves both diet and physical activity. GEBN has some of the top nutritionist experts in the world who have published research showing the importance of diet and in particular of soda consumption in causing obesity. My dismissal of diet as a cause of obesity did a disservice to their work. I hope many of you can relate to feeling so passionate about an issue that you say some things that you later regret. I believe that both diet and physical activity are important in obesity and that we must address both together to help people achieve healthy weights. I look forward to working with other GEBN researchers to do this.

James Hill, another of the scientists involved in this fiasco, also has issued a statement.  When it becomes public, I will post a link to it.

Additions, August 21

• The Global Energy Balance Network’s defense of its funding by Coca-Cola
• James Hill’s letter in response to a query from my NYU colleague Lisa Young.