Currently browsing posts about: Conflicts-of-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.

When the New York Times published an article describing Coca-Cola’s financial sponsorship of university researchers who de-emphasize the role of sugary drinks in raising the risk of obesity and type 2 diabetes, it kicked up a storm.

USA Today’s editorial board said:

It isn’t that companies pay scientists to put out false research. It’s that companies fund the work of scientists who happen to be doing research that spurs consumers to look away from science that hurts corporate interests.

Soft drinks are far less dangerous than cigarettes, but GEBN’s website, tweets and videos come right out of Big Tobacco’s playbook, brought into the digital era. Its leaders have done research in the past under about $3 million in grants given to their universities.

USA Today also printed a response by a Coca-Cola spokesman:

A recent New York Times article created confusion about our support of research and non-profit organizations, stating we want people to think that only exercise matters and not diet — but nothing could be further from the truth. We have always operated under the fact that a healthy, balanced diet and regular exercise are key ingredients for a healthy lifestyle.

That said, we need to do a better job of being even more transparent about the research we fund, the non-profit organizations we support and the way we publicly share this information. And we will.

Yesterday, Senator Richard Blumenthal sent letters to the University of Colorado, West Virginia University, and the University of South Carolina urging them to  clarify the nature of the University’s relationship with projects funded by Coca-Cola and to review the academic integrity of such grant agreements.

I believe your university must determine whether this research is in effect promoting a predisposed and biased agenda, rather than reflecting the impartiality and objectively (sic) expected from a public academic institution.

Years of litigation with tobacco companies were necessary to fully expose the tragic public health consequences when companies lie about the hazards of the products they sell.  I am deeply concerned that we may force future generations to relive this history if corporate-sponsored studies devoid of scientific integrity are permitted once again to deceptively downplay and conceal the dangers of a product consumed on a mass scale.

Do not underestimate Senator Blumenthal’s ability to deal with food companies.  He, you may recall, was responsible for withdrawal in 2009 of the ill-conceived Smart Choices program during his stint as Connecticut’s attorney general.

I’m still waiting for the Global Calorie Balance Network to issue its promised statement.  Stay tuned.

Now cartoonists are producing their own interpretations of the revelations in the New York Times of Coca-Cola’s funding of scientists to argue that what you drink has far less to do with obesity than does how much you move.

In Sunday’s Times, Brian McFadden comes to this conclusion:
Here’s the entire strip

:

The Global Calorie Balance Network (GEBN) scientists say they will have a response to all the criticism (and now ridicule).

GEBN welcomes the opportunity to engage in a global debate and discussion on the science and application of energy balance to promote health and reduce chronic disease. GEBN also welcomes scrutiny and constructive criticism. We respect our critics and ask that they respect us in return. The recent media attention has raised important issues about the goal and mission of GEBN. We have taken these comments very seriously and are in the process of clarifying these issues here on our website. We will have that information available early this week.

I look forward to seeing it.

I wrote this piece for The Guardian in response to the New York Times article earlier this week about Coca-Cola’s funding of scientists who think obesity is more about exercise than drinking sodas:

These days, you almost have to feel sorry for soda companies. Sales of sugar-sweetened and diet drinks have been falling for a decade in the United States, and a new Gallup Poll says 60% of Americans are trying to avoid drinking soda. In attempts to reverse these trends and deflect concerns about the health effects of sugary drinks, the soda industry invokes elements of the tobacco industry’s classic playbook: cast doubt on the science, discredit critics, invoke nanny statism and attribute obesity to personal irresponsibility.

Casting doubt on the science is especially important to soda makers. Overwhelming evidence links habitual consumption of sugary drinks to poor health. So many studies have identified sodas as key contributors to chronic health conditions – most notably obesity, type-2 diabetes and coronary artery disease – that the first thing anyone trying to stay healthy should do is to stop drinking them.

Soda companies know this. For at least the last 10 years, Coca-Cola’s annual reports to the US Securities and Exchange Commission have listed obesity and its health consequences as the single greatest threat to the company profits. The industry counters this threat with intensive marketing, lobbying and millions of dollars poured into fighting campaigns to tax or cap the size of sugary drinks.

But it is also pours millions into convincing researchers and health professionals to view sodas as benign.

Just last month, the Mayo Clinic Proceedings published a study arguing that the results of national dietary surveys, such as those that link sugary drinks to type-2 diabetes, are so flawed that they constitute a major misuse of public funds. The authors report honoraria, speaking and consulting fees from Coca-Cola.

This week’s revelation of Coca-Cola’s funding of the Global Energy Balance Network is only the latest example of this strategy in action. The Network promotes the idea that to prevent obesity you don’t need to bother about eating less or drinking less soda. You just have to be more active. Never mind that most people can’t lose weight without also reducing their intake.

A reporter who looked into this group discovered that Coca-Cola had funded the research of the scientists behind it, and generously. The network’s website was registered to Coca-Cola. None of this, however, had been made explicit.

Most nutrition professional journals now require researchers to declare who funds their studies, making it possible to compare study outcomes with funding sources. Studies sponsored by Coca-Cola almost invariably report no association of sugary drinks with diabetes, they question the validity of studies that do find such associations or, as in the case of Global Energy Balance Network investigators, they find activity to be the most important determinant of body weight.

Analyses of studies funded by Coca-Cola or its trade association demonstrate that they have an 83% probability of producing results suggesting no harm from soda consumption. In contrast, the same percentage of studies funded by government agencies or independent foundations find clear linkages between sugary beverages and such conditions. Coincidence? I don’t think so.

Since March, I’ve been posting industry-funded studies with results that favor the sponsor’s interests every time I find five of them. They are easy to find. Despite pleas to readers to send me industry-funded studies that do not favor the sponsor, I hardly ever get them. Whenever I come across a study that shows no harm from sodas, I immediately look to see who paid for it.

Soda companies spend generously to convince researchers and health professionals not to worry about sodas’ health effects. But why do researchers take the money? It is too simplistic to say that they are “bought.” Industry-funded investigators say they believe the funding has no effect on the design, conduct or interpretation of their research. But research involves choices of questions, assumptions and methods. It is not difficult to carry out a study that appears to meet high scientific standards yet fails to include critical controls that might lead to alternative conclusions.

Researchers funded by Coca-Cola need to take special care to control for unconscious biases but can only do this if they recognize the possibility. Many do not. Neither do many peer reviewers or editors of scientific journals. Although food-company financial support should not necessarily bias results, it appears to do so in practice.

Industry-funded scientists resent questioning of the influence of sponsorship on the quality of their science. They charge that investigators who find adverse effects of sodas on health are equally biased by career goals, righteous zeal or anti-corporate morality. Yes, independent scientists may have biases of their own, but their overarching research goal is to improve public health. In contrast, the goal of soda companies is to use research as a marketing tool.

Disclosure is essential. If a study is funded by Coca-Cola, caveat emptor.

I’ve had a busy week dealing with the aftermath of Anahad O’Connor’s New York Times story about how Coca-Cola pays scientists who argue that obesity is more about activity than what you eat—drinking sodas, for example (I’m quoted).   It’s gotten 1180 comments.

Here’s Dan Wasserman’s from the Boston Globe:

In all fairness, let’s see what Coca-Cola’s Chief Technical Officer, Dr. Ed Hays, says in response (straight out of the tobacco industry’s playbook):

I was dismayed to read the recent New York Times’ inaccurate portrayal of our company and our support of the Global Energy Balance Network (GEBN). The story claimed Coke is funding scientific research to convince people that diets don’t matter – only exercise. In fact, that is the complete opposite of our approach to business and well-being and nothing could be further from the truth.

Yes, we fund scientific research through GEBN and we are proud to support the work that scientists such as Dr. Jim Hill and Dr. Steve Blair do – because their type of research is critical to finding solutions to the global obesity crisis.

At Coke, we believe that a balanced diet and regular exercise are two key ingredients for a healthy lifestyle and that is reflected in both our long-term and short-term business actions.

The article even got the attention of Congress.  Here’s the statement from Rosa de Lauro (Dem-CT), sponsor of The SWEET Act to tax sugars:

This research is reminiscent of the research conducted by the tobacco companies to mislead the public about the health risks of smoking.  The American public will not be fooled. There is a wealth of sound scientific research that demonstrates the link between sugar-sweetened beverage consumption and a host of health conditions, including diabetes, heart disease, and obesity.  This new group and their research are a sham,” DeLauro said.  “People want to be healthy and they want their kids to be healthy and realize that drinks full of empty calories are not good for them. That is why more and more Americans are opting to drink less soda every year.

I wrote a piece for The Guardian, which I will post tomorrow.

I don’t keep track of my interviews or media appearances unless people send me links (I post them under Media), but Rachel Harrison at NYU kept score yesterday.  As I said, a busy couple of days.

• Fortune
• RT
• USA Today
• US News & World Report
• NPR
• Washington Post Wonkblog
• Washington Post Health Section
• CBS Atlanta
• CBC
• PLoS Blog
• Take Part
• Huffington Post
• Latina
• Business Insider
• Journal of Public Heath Policy 

Additions, August 14

Fox News, August 11

• Shepard Smith says “the story “reminds you of exactly what the tobacco industry did back in day, and more recently, it also reminds you of what the climate deniers — the climate change deniers — are doing as well.”
• Rush Limbaugh said the Times‘ Coca-Cola story “undermine[s] the whole notion of a scientific consensus,” because it “can be bought and paid for.”

New York Times editorial, August 14

the evidence continues to mount that sugar-sweetened drinks are a major contributor to obesity, heart disease and diabetes, and that exercise makes only a modest contribution to weight loss compared to ingesting fewer calories.

Don’t miss the article on the front page of today’s New York Times about Coca-Cola’s paying scientists who argue that obesity is more about exercise than diet (I’m quoted).

Last week, I posted two industry-funded studies with results that must have made their sponsors extremely unhappy.

But results like that are rare—so rare that the Washington Post wrote about one of them.

Today, I’m doing another in my series of posts of 5 (sometimes 6) studies sponsored by food and beverage companies for the purpose of obtaining results that can be used in marketing.

Since March, the count is 42 studies with results favorable to the sponsor but only 1 unfavorable (the other was from last year).

If you run across either kind, but especially industry-funded studies that don’t produce expected results, please send.

Dietary cholesterol and cardiovascular disease: a systematic review and meta-analysis. Berger, S., Raman, G., Vishwanathan, R., Jacques, P.F., Johnson, E.J., 2015. Am J Clin Nutr ajcn100305. doi:10.3945/ajcn.114.100305.

• Conclusion: Reviewed studies were heterogeneous and lacked the methodologic rigor to draw any conclusions regarding the effects of dietary cholesterol on CVD risk.  [Implication: suggestions that eggs might raise cardiovascular risk are unwarranted]
• Sponsor: Supported by USDA agreement 1950-51000-073 and the American Egg Board, Egg Nutrition Center.

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.  doi: 10.3945/ajcn. 114.105049

• Conclusion: 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 lactasepersistent individuals without milk intake likely is explained by collider stratification bias..
• Funding source: HKMB’s PhD project was partly funded by the Research Unit at Naestved Hospital, the Danish Dairy Research Foundation

Dietary Approaches to Stop Hypertension diet retains effectiveness to reduce blood pressure when lean pork is substituted for chicken and fish as the predominant source of protein. R Drew Sayer, Amy J Wright, Ningning Chen, and Wayne W Campbell. Am J Clin Nutr 2015; 102:302-308 doi:10.3945/ajcn.115.111757

• Conclusion: The results indicate that adults with elevated BP [blood pressure] may effectively incorporate lean pork into a DASH-style diet for BP reduction.
• Sponsor: This paper is sponsored by the national pork board.

Relationship between lifestyle behaviors and obesity in children ages 9-11: Results from a 12-country study. Katzmarzyk PT, Barreira TV, Broyles ST, Champagne CM, Chaput JP, Fogelholm M, Hu G, Johnson WD, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Onywera V, Sarmiento OL, Standage M, Tremblay MS, Tudor-Locke C, Zhao P, Church TS; ISCOLE Research Group.

• Conclusion: Behavioral risk factors are important correlates of obesity in children, particularly low MVPA [moderate to vigorous physical activity], short sleep duration, and high TV viewing.  [Implication: what they eat and drink doesn’t matter]
• Sponsor: This research was supported by The Coca-Cola Company.

A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in community and care home settings. M. Elia, C. Normand, A. Laviano , K. Norman.  Clinical Nutrition 2015, online ahead of print. doi:10.1016/j.clnu.2015.05.010

• Conclusions: Overall, the reviewed studies, mostly based on retrospective cost analyses, indicate that ONS [oral nutritional supplement] use in the community produce an overall cost advantage or near neutral balance, often in association with clinically relevant outcomes, suggesting cost effectiveness. There is a need for prospective studies designed to examine primary economic outcomes.
• Authors’ disclosures: ME, CN and AL have received honoraria for giving independent talks at national/international conferences supported by industry. KN has received speakers’ fees as well as financial support for research projects by commercial companies.
• Comment: most studies of supplement use find little evidence of benefit.  Taking honoraria from industry doesn’t sound like much of a problem unless these financial ties are with supplement companies.  The authors do not specify and the journal’s editors must not require such specification.  They should.

As regular readers know, I’ve been posting studies funded by food companies with results favorable to the companies’ interests whenever I run across five of them.   Since mid-March, I’ve posted 7 such collections for a total of 37 studies (two of the posts listed 6 studies).  These are all papers published since March.

With each set, I asked readers to send examples of studies that do not favor the sponsor’s interest.

They are rare, but do exist.  I’ve been sent two so far.  I’m guessing it will be a long time before I collect five, so have a look:

Butter increased total and LDL cholesterol compared with olive oil however resulted in higher HDL cholesterol than habitual diet. Sara Engel and Tine Tholstrup.  American Journal of Clinical Nutrition, July 1, 2015, doi: 10.3945/​ajcn.115.112227.

• Conclusions: Moderate intake of butter resulted in increases in total cholesterol and LDL cholesterol compared with the effects of olive oil intake and a habitual diet (run-in period). Furthermore, moderate butter intake was also followed by an increase in HDL cholesterol compared with the habitual diet. We conclude that hypercholesterolemic people should keep their consumption of butter to a minimum, whereas moderate butter intake may be considered part of the diet in the normocholesterolemic population.
• Sponsor: Danish Dairy Research Foundation
• Comment: The data clearly show that butter raises blood cholesterol levels.  The authors spin it as positively as possible—higher HDL and it’s OK for people with normal cholesterol to eat moderate amounts of butter—but they make the downside quite clear.  In this study, “moderate” butter means 4.5% of calories or just 2/3 of a tablespoon for someone eating 2000 calories.  That’s not much, alas.

Influence of Pistachios on Performance and Exercise-Induced Inflammation, Oxidative Stress, Immune Dysfunction, and Metabolite Shifts in Cyclists: A Randomized, Crossover Trial.  David C. Nieman, Johannes Scherr, Beibei Luo, Mary Pat Meaney, Didier Dréau, Wei Sha, Dustin A. Dew, Dru A. Henson, Kirk L. Pappan.  PLoS One, November 19, 2014. DOI: 10.1371/journal.pone.0113725

• Conclusion: In summary, 2-weeks pistachio nut ingestion was associated with reduced 75-km cycling time trial performance and increased post-exercise plasma levels of raffinose, sucrose, and metabolites related to leukotoxic effects and oxidative stress.
• Funder: This work was supported by American Pistachio Growers. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
• Comment:  It’s obvious that the funders had no role.  I’ll bet they are quite unhappy with the results.

This second study came out last year but I’ll take any of these I can get.  Please do send.

But if I’m just counting since March, the ratio is 37 studies favoring the sponsor’s interest, to 1 that doesn’t.  Coincidence?  I’m not convinced.