Currently browsing posts about: Conflicts-of-interest

It’s been more than a year since I last wrote about avocado industry funding of research but the Avocado Nutrition Center has been sending out press releases so it’s time for another look.

Given the Superbowl—105 million pounds of avocados consumed that day by one estimate—you might not think that the avocado industry would have to work as hard as it does to convince you that avocados are a superfood.

But maybe what it is trying to do is to get us to ignore the effects of our demand for avocados on deforestation and social unrest in Mexico.

The avocado industry is a good example of how to fund research for marketing purposes.  It funds the Avocado Nutrition Center’s research program.

The program’s website covers dozens of industry-funded studies that demonstrate benefits of avocados for cardiovascular health, weight management, type 2 diabetes, and healthy living at every age.

Here’s how the Center uses them.

Another recent study of 2,886 older adults, published in Frontiers in Nutrition, examined cognitive function among older American avocado consumers compared to nonconsumers.

On that basis, the Center produced a fact sheet: Proactive thinking on cognition.  

The Center also lists a few independently funded studies that produced equally beneficial results.

I picked one at random and looked it up: Avocado Consumption and Risk of Cardiovascular Disease in US Adults.

• Conclusion: Higher avocado intake was associated with lower risk of CVD and coronary heart disease in 2 large prospective cohorts of US men and women. The replacement of certain fat-containing foods with avocado could lead to lower risk of CVD.
• Funding: mostly by NIH
• Conflicts of interest: the lead author reports having “collaborated in the Hass Avocado Board–funded trial Effects of Avocado Intake on the Nutritional Status of Families during 2016 to 2019 as a graduate student researcher, but the present study was not supported or endorsed by the Hass Avocado Board. The remaining authors have no disclosures to report.”

And here’s the most recent study: Effect of Incorporating 1 Avocado Per Day Versus Habitual Diet on Visceral Adiposity: A Randomized Trial

• Conclusion: Addition of 1 avocado per day to the habitual diet for 6 months in free‐living individuals with elevated waist circumference did not reduce visceral adipose tissue volume and had minimal effect on risk factors associated with cardiometabolic disorders.
• Funding: This work was supported by the Avocado Nutrition Center.

Why be concerned?  Aren’t avocados good for you?

Sure, and I love them.  But superfoods?  All fruits and vegetables have useful nutrients, but some have fewer calories (a serving size is one-third of an avocado) and most are less caught up in ecological damage.

I discuss the scientific reasons for concern in my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.  In it, I review the literature on the “funding effect”—the observation that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests.  Research on conflicts of interest also demonstrates that recipients of industry funding do not recognize its influence, did not intend to be influenced, and deny the influence, despite vast amounts of research to the contrary.

Cranberry marketing gets wilder and wilder.  Last week I posted a study of endothelial function paid for by the cranberry industry.

But here’s a study that tops it.  I learned about it from a headline in NutraIngredients.com: Cranberry consumption may boost memory and ward off dementia in elderly, study finds.

Oh come on.  Really?

I went right to it.

The study: Chronic Consumption of Cranberries (Vaccinium macrocarpon) for 12 Weeks Improves Episodic Memory and Regional Brain Perfusion in Healthy Older Adults: A Randomised, Placebo-Controlled, Parallel-Groups Feasibility Study.  Emma Flanagan, Donnie Cameron, Rashed Sobhan, Chloe Wong, Matthew G. Pontifex, Nicole Tosi, Pedro Mena, Daniele Del Rio³, Saber Sami, Arjan Narbad, Michael Müller, Michael Hornberger and David Vauzour.  Front. Nutr., 19 May 2022 | https://doi.org/10.3389/fnut.2022.849902

Design: This was a 12-week randomised placebo-controlled trial of freeze-dried cranberry powder in 60 older adults aged between 50 and 80 years. Investigators measured memory and executive function, did neuroimaging, and took blood samples before and after .

Results: “Cranberry supplementation for 12 weeks was associated with improvements in visual episodic memory in aged participants when compared to placebo.”

Conclusions: “The results of this study indicate that daily cranberry supplementation (equivalent to 1 small cup of cranberries) over a 12-week period improves episodic memory performance and neural functioning.”

Funding: “This research was supported by a Cranberry Institute grant…The Cranberry Institute was not involved in the design, implementation, analysis, and interpretation of the data.”

Conflict of Interest: “DV, MH, MM, and AN received funding from the Cranberry Institute.  The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.”

Publisher’s Note:  “All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.”

Comment: This is the first time I have ever seen a Publisher’s Note like this.  Even the publisher is troubled by the fact that this study is funded by a cranberry industry trade group and the four most senior authors report funding from the group.  Without even getting into whether cranberry powder is equivalent to cranberries, whether anyone can eat cranberries without adding their weight in sugar, or whether any other fruit might have similar effects, we should ask whether it makes any sense at all to think that any one single food could boost memory and prevent dementia in the elderly.

For detailed discussion of how industry funding influences research, and the consequences of such practices, see my book Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The commentary: Perspective: Soy-Based Meat and Dairy Alternatives, Despite Classification as Ultra-Processed Foods, Deliver High-Quality Nutrition on Par With Unprocessed or Minimally Processed Animal-Based Counterparts.  By Mark Messina, John L Sievenpiper, Patricia Williamson, Jessica Kiel, John W Erdman, Jr.  Advances in Nutrition, nmac026, https://doi.org/10.1093/advances/nmac026

Purpose: “This perspective argues that none of the criticisms of UPFs [ultra-processed foods] apply to soy-based meat and dairy alternatives when compared with their animal-based counterparts, beef and cow milk, which are classified as unprocessed or minimally processed foods (group 1). Classifying soy-based meat and dairy alternatives as UPFs may hinder their public acceptance, which could detrimentally affect personal and planetary health. In conclusion, the NOVA classification system is simplistic and does not adequately evaluate the nutritional attributes of meat and dairy alternatives based on soy.

Conflicts of interest: the statement is so long that I will save it for the end.

Comment: This commentary is a critique of the NOVA classification system, which puts foods in four categories by level of processing:

• Group 1: Unprocessed/minimally processed (fruit, vegetables, nuts, grains, meat, milk with no complicated additives)
• Group 2: Processed culinary ingredients (oils, fats, butter, vinegars, sugar, and salt eaten with added to Group 1)
• Group 3: Processed (mix of groups 1 and 2, chiefly for preservation)
• Group 4: Ultra-processed (industrially produced, cannot be made in home kitchens, chemical additives)

By this time, literally hundreds of studies have linked frequent consumption of ultra-processed (“junk”) foods to weight gain and its associated chronic diseases—type 2 diabetes, heart disease, etc—as well as high risk for poor outcome from COVID-19.  One carefully controlled clinical trial has shown that ultra-processed diets induce people to unwittingly take in more calories (“you can’t eat just one.”).

Artificial meats and dairy products made with plant proteins clearly meet the definition of ultra-processed.   Are soy products in a different category from those made with pea protein, for example?  Should plant-based meats in general be exempt from being considered ultra-processed?

I don’t think we know yet whether these products are better for health and the environment.  The issues are complicated and we don’t yet have the research or experience.

These authors report conflicted ties—many such ties—to companies making soy products and other products that might be considered ultra-processed:

Author disclosures: MM is employed by the Soy Nutrition Institute Global, an organization that receives funding from the United Soybean Board and industry members who are involved in the manufacture and/or sale of soyfoods and/or soybean components. JLS has received research support from the Canadian Foundation for Innovation, Ontario Research Fund, Province of Ontario Ministry of Research and Innovation and Science, Canadian Institutes of health Research (CIHR), Diabetes Canada, PSI Foundation, Banting and Best Diabetes Centre (BBDC), American Society for Nutrition (ASN), INC International Nut and Dried Fruit Council Foundation, National Dried Fruit Trade Association, National Honey Board (the USDA honey “Checkoff” program), International Life Sciences Institute (ILSI), Pulse Canada, Quaker Oats Center of Excellence, The United Soybean Board (the USDA soy “Checkoff” program), The Tate and Lyle Nutritional Research Fund at the University of Toronto, The Glycemic Control and Cardiovascular Disease in Type 2 Diabetes Fund at the University of Toronto (a fund established by the Alberta Pulse Growers), and The Nutrition Trialists Fund at the University of Toronto (a fund established by an inaugural donation from the Calorie Control Council). He has received food donations to support randomized controlled trials from the Almond Board of California, California Walnut Commission, Peanut Institute, Barilla, Unilever/Upfield, Unico/Primo, Loblaw Companies, Quaker, Kellogg Canada, WhiteWave Foods/Danone, Nutrartis, and Dairy Farmers of Canada. He has received travel support, speaker fees, and/or honoraria from Diabetes Canada, Dairy Farmers of Canada, FoodMinds LLC, International Sweeteners Association, Nestlé, Pulse Canada, Canadian Society for Endocrinology and Metabolism (CSEM), GI Foundation, Abbott, General Mills, Biofortis, ASN, Northern Ontario School of Medicine, INC Nutrition Research and Education Foundation, European Food Safety Authority (EFSA), Comité Européen des Fabricants de Sucre (CEFS), Nutrition Communications, International Food Information Council (IFIC), Calorie Control Council, International Glutamate Technical Committee, and Physicians Committee for Responsible Medicine. He has or has had ad hoc consulting arrangements with Perkins Coie LLP, Tate & Lyle, Wirtschaftliche Vereinigung Zucker eV, Danone, and Inquis Clinical Research. He is a member of the European Fruit Juice Association Scientific Expert Panel and former member of the Soy Nutrition Institute (SNI) Scientific Advisory Committee. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, European Association for the study of Diabetes (EASD), Canadian Cardiovascular Society (CCS), and Obesity Canada/Canadian Association of Bariatric Physicians and Surgeons. He serves or has served as an unpaid scientific advisor for the Food, Nutrition, and Safety Program (FNSP) and the Technical Committee on Carbohydrates of ILSI North America. He is a member of the International Carbohydrate Quality Consortium (ICQC), Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and Director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His wife is an employee of AB InBev. PW is employed by Cargill, Inc, a global food company headquartered in Wayzata, MN. Cargill produces soy-based food and industrial products. JK is employed by Medifast Inc., a nutrition and weight-management company based in Baltimore, Maryland, that uses soy protein in many of its products. JWE is a scientific advisory to the Soy Nutrition Institute Global.

A reader, Effie Schultz, sent this one, with a comment that it comes with the longest conflict of interest statement she had ever seen (I’ve noted one that was two pages long in the first item in a post in 2015).

Association of Low- and No-Calorie Sweetened Beverages as a Replacement for Sugar-Sweetened Beverages With Body Weight and Cardiometabolic Risk: A Systematic Review and Meta-analysis.  McGlynn ND, and 20 other authors.  JAMA Network Open, March 14, 2022. 2022;5(3):e222092.  doi:10.1001/jamanetworkopen.2022.2092

The research question: Are low- and no-calorie sweetened beverages (LNCSBs) as the intended substitute for sugar-sweetened beverages (SSBs) associated with improved body weight and cardiometabolic risk factors similar to water replacement?

The conclusion: This systematic review and meta-analysis found that using LNCSBs as an intended substitute for SSBs was associated with small improvements in body weight and cardiometabolic risk factors without evidence of harm and had a similar direction of benefit as water substitution. The evidence supports the use of LNCSBs as an alternative replacement strategy for SSBs over the moderate term in adults with overweight or obesity who are at risk for or have diabetes.

Comment: Research on artificial sweeteners remains controversial.  I think we will be arguing forever about their safety and efficacy in helping people lose weight.  Studies with conflict of interest disclosures like the excessively extensive one here do not help resolve the research questions.

I strongly support revealing conflicted interests that might influence any aspect of research design, conduct, and interpretation.  For this study, I would be interested in financial ties or arrangements with companies that might either gain or lose sales or marketing advantages from results showing artificial sweeteners or diet drinks to be harmless or beneficial, as these do.  At issue here is whether financial ties to companies with corporate interests in the outcome of such research bias results or interpretation, consciously or unconsciously.

You have to search through this mess of unnecessary and distracting disclosures to find the ones that matter.  They are there.  You have to search for them.

Much of what is disclosed is irrelevant and, therefore, not helpful.

You may well disagree with that assessment.  Judge for yourself.

Conflict of Interest Disclosures: Ms McGlynn reported receiving a Canadian Institutes of Health Research (CIHR)-Masters Award during the conduct of the study and being a former employee of Loblaws Companies Limited outside the submitted work. Dr Khan reported receiving grants from CIHR, International Life Science Institute, and National Honey Board outside the submitted work. Dr Chiavaroli reported being a Mitacs Elevate postdoctoral fellow and receiving joint funding from the Government of Canada and the Canadian Sugar Institute. Mr Au-Yeung reported receiving personal fees from Inquis Clinical Research outside the submitted work. Ms Lee reported receiving graduate scholarship from CIHR and the Banting & Best Diabetes Centre at the University of Toronto outside the submitted work. Dr Comelli reported being the Lawson Family Chair in Microbiome Nutrition Research at the Joannah and Brian Lawson Centre for Child Nutrition, University of Toronto, during the conduct of the study and receiving nonfinancial support from Lallemand Health Solutions, donation to research program from Lallemand Health Solutions, personal fees from Danone, sponsored research and collaboration agreement from Ocean Spray, and nonfinancial support from Ocean Spray outside the submitted work. Ms Ahmed reported receiving scholarship from the Toronto Diet, Digestive tract, and Disease Centre (3D) outside the submitted work. Dr Malik reported receiving personal fees from the City and County of San Francisco, Kaplan Fox & Kilsheimer LLP, and World Health Organization outside the submitted work and support from the Canada Research Chairs Program. Dr Hill reported receiving personal fees from General Mills and McCormick Science Institute. Dr Rahelić reported receiving personal fees from the International Sweeteners Association, Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Merck, MSD, Salvus, and Sanofi outside the submitted work. Dr Salas-Salvadó reported receiving personal fees from Instituto Danone Spain, nonfinancial support from Danone Institute International, personal fees as director of the World Forum for Nutrition Research and Dissemination from the International Nut and Dried Fruit Council Foundation, financial support to the institution from Fundación Eroski, and financial support to the institution from Danone outside the submitted work. Dr Kendall reported receiving grants and/or in-kind support from Advanced Food Materials Network, Agriculture and Agri-Food Canada, CIHR, Almond Board of California, Barilla, Canola Council of Canada, International Nut and Dried Fruit Council, Peanut Institute, Pulse Canada, Tate and Lyle Nutritional Research Fund at the University of Toronto, and Unilever; receiving nonfinancial support from General Mills, Kellogg, Loblaw Brands Limited, Oldways Preservation Trust, Quaker Oats (Pepsi-Co), Sun-Maid, White Wave Foods/Danone, International Pasta Organization, California Walnut Commission, Primo, Unico, International Carbohydrate Quality Consortium (ICQC), and Toronto Diet, Digestive tract, and Disease Centre (3D) outside the submitted work; receiving personal fees from McCormick Science Institute and Lantmannen; and being a member of the Diabetes and Nutrition Study Group (DNSG) Executive Board and Dietary Guidelines, a member of the expert committee of the DNSG Clinical Practice Guidelines for Nutrition Therapy, a member of the scientific advisory board of the McCormick Science Institute, a scientific advisor for the International Pasta Organization and Oldways Preservation Trust, a member of the ICQC, an executive board member of the DNSG, and being the director of the Toronto Diet, Digestive tract, and Disease Centre (3D) Knowledge Synthesis and Clinical Trials Foundation. Dr Sievenpiper reported receiving nonfinancial support from DNSG of the European Association for the Study of Diabetes (EASD), grants from CIHR through the Canada-wide Human Nutrition Trialists’ Network (NTN), PSI Graham Farquharson Knowledge Translation Fellowship, Diabetes Canada Clinician Scientist Award, CIHR Institute of Nutrition, Metabolism and Diabetes and the Canadian Nutrition Society (INMD/CNS) New Investigator Partnership Prize, and Banting & Best Diabetes Centre Sun Life Financial New Investigator Award during the conduct of the study; receiving grants from American Society for Nutrition, International Nut and Dried Fruit Council Foundation, National Honey Board (the US Department of Agriculture [USDA] honey checkoff program), Institute for the Advancement of Food and Nutrition Sciences (IAFNS; formerly ILSI North America), Pulse Canada, Quaker Oats Center of Excellence, United Soybean Board (the USDA soy checkoff program), Tate and Lyle Nutritional Research Fund at the University of Toronto, Glycemic Control and Cardiovascular Disease in Type 2 Diabetes Fund at the University of Toronto (a fund established by the Alberta Pulse Growers), and Nutrition Trialists Fund at the University of Toronto (a fund established by an inaugural donation from the Calorie Control Council); receiving personal fees from Dairy Farmers of Canada, FoodMinds LLC, International Sweeteners Association, Nestlé, Abbott, General Mills, American Society for Nutrition, INC Nutrition Research and Education Foundation, European Food Safety Authority, Nutrition Communications, International Food Information Council, Calorie Control Council, Comité Européen des Fabricants de Sucre, International Glutamate Technical Committee, Perkins Coie LLP, Tate and Lyle Nutritional Research Fund at the University of Toronto, Danone, Inquis Clinical Research, Soy Nutrition Institute, and European Fruit Juice Association outside the submitted work; serving on the clinical practice guidelines expert committees of Diabetes Canada, EASD, Canadian Cardiovascular Society, and Obesity Canada/Canadian Association of Bariatric Physicians and Surgeons; being an unpaid scientific advisor for the Food, Nutrition, and Safety Program and the Technical Committee on Carbohydrates of IAFNS; being a member of the ICQC, executive board member of the DNSG of the EASD, and director of the Toronto Diet, Digestive tract, and Disease Centre (3D) Knowledge Synthesis and Clinical Trials Foundation; his spouse is an employee of AB InBev. No other disclosures were reported.

Reference: For a summary of research on the “funding effect”—the observations that research sponsored by food companies almost invariably produces results favorable to the sponsor’s interests and that recipients of industry funding typically did not intend to be influenced and do not recognize the influence—see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

A reader in Australia, Anthony Power, sent me this one, which he noticed discussed in an article in the Australian The Conversation.”

This one is not obviously funder takes all.  Indeed, it might need to be categorized as a rare example of an industry-funded study with results unfavorable to the sponsor’s interests.

The study: A Systematic Review and Meta-Analysis of Randomized Controlled Trials on the Effects of Oats and Oat Processing on Postprandial Blood Glucose and Insulin Responses.  Kathy Musa-Veloso, Daniel Noori, Carolina Venditti , Theresa Poon ¹, Jodee Johnson ², Laura S Harkness ², Marianne O’Shea ², YiFang Chu ²  J Nutr.  2021 Feb 1;151(2):341-351.  doi: 10.1093/jn/nxaa349.

Objectives: The study objective was to determine the effects of differently processed oats on the postprandial blood glucose and insulin responses relative to refined grains.

Conclusions: A disruption in the structural integrity of the oat kernel is likely associated with a loss in the glycemic benefits of oats.

Funding: The systematic review and meta-analysis, as well as the writing of the manuscript, were funded by PepsiCo, Inc.

Conflicts of interest: Author disclosures: KM-V, DN, CV, and TP are employees of Intertek Health   ciences Inc., which has provided consulting services to PepsiCo, Inc. JJ, MO, and YC are employees of PepsiCo, Inc., which manufactures oatmeal products under the brand name Quaker Oats and which funded this systematic review and meta-analysis. LSH is a former employee of PepsiCo, Inc. The views expressed in this article are those of the authors and do not
necessarily reflect the opinion or policies of Intertek Health Sciences Inc. or PepsiCo, Inc.

Comment: Oats are good sources of soluble fiber which in some studies helps lower blood cholesterol levels.  PepsiCo owns Quaker Oats, which makes oatmeals of varying degree of integrity.  The least processed ones, according to this review, do the best job.  This means that quick oats have less of a beneficial effect than the longer-to-cook less processed varieties.  As the paper puts it: “The postprandial glycemic and insulin responses
with thin/instant/quick oats were not significantly different from those elicited by the refined grain control.”

PepsiCo currently extols the health benefits of oatmeal on its website, without making a distinction between the Instant and Need-to-be-Cooked-Longer varieties.  Will it change its website in response to this study?  We will see in due course.

Thanks to Georgene Grover for sending this one, with this comment: “What about this? Ten prunes a day seems excessive!”

The study:  The Role of Prunes in Modulating Inflammatory Pathways to Improve Bone Health in Postmenopausal Women.  Janhavi J Damani, Mary Jane De Souza, Hannah L VanEvery, Nicole CA Strock, and Connie J Rogers. Adv Nutr 2022;00:1–17.

Purpose:  Prunes (dried plums; Prunus domestica L.) have been studied as a potential whole-food dietary intervention to mitigate bone loss in preclinical models of osteoporosis and in osteopenic postmenopausal women.

Method: This is a review of previous studies.  It summarizes findings from preclinical and clinical studies that have assessed the effect of prunes on oxidative stress, inflammatory mediators, and bone outcomes. Most of the studies that reported effects required 100 grams per day of prunes (about 10 per day).

Conclusion: Overall, evidence from in vitro, preclinical studies, and limited clinical studies suggests the potential role of prunes in ameliorating bone loss.

Funding and COI: Supported by the California Prune Board provided funding to MJDS and CJR. Publication funds came from the Hershey Company endowment, Department of Nutritional Sciences, Penn State University. California Dried Plum Board (grant no. 100804). Author disclosures: CJR is member of the Nutrition Advisory Panel for the California Dried Plum Board. The other authors report no conflicts of interest.

Comment: This is a standard industry-funded paper with a predictable outcome.  As far as I can tell, every food trade association is funding research that can help with marketing.  Even prunes.

Prunes are fine, but studies of one food don’t really tell you anything about diets as a whole.  Eat prunes if you like them.  Ten prunes means ten plums.  Seems like a lot, no?

Yesterday I reported about the COSMOS clinical trial demonstrating reductions in mortality among people taking cocoa flavanol supplements.

That trial had another arm: multivitamin supplements.

The study: Multivitamins in the Prevention of Cancer and Cardiovascular Disease: The COSMOS Randomized Clinical Trial.  Sesso HD et al.  The American Journal of Clinical Nutrition, nqac056, https://doi.org/10.1093/ajcn/nqac056

Conclusion: The supplements did not reduce cardiovascular disease, cancer, or all-cause mortality in older men and women.

Funding: The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of study pills and packaging. Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) provided support through the partial provision of study pills and packaging.

Conflicts of interest: Drs. Sesso and Manson reported receiving investigatorinitiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria
and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. No other authors reported any conflicts of interest.

Comment: Pfizer, of course, makes Centrum multivitamin supplements aimed at older adults.

I was surprised by this part of the trial because previous studies have also shown no consistently beneficial effect of supplementation of individual vitamins or multivitamins on disease risk.  Pfizer must have hoped to find benefits for Centrum.  This is a rare industry-supported study that showed no benefits and is, therefore, worth attention.

I learned about this one from a PR tweet from @Brigham Research: “Dr. JoAnn Manson…& colleagues report the main findings of the first ever randomized trial of a cocoa flavanol supplement on cardiovascular disease endpoints.”

Its spectacular results:  Supplementation with cocoa flavanols led to a 27% reduction in deaths from cardiovascular disease among all participants taking the supplement, and a 39% reduction in those deaths when they excluded participants who did not take the pills properly.

From taking cocoa flavanol supplements?

Who paid for this?

Bingo.

The study (still in preprint): Effect of Cocoa Flavanol Supplementation for Prevention of Cardiovascular Disease Events: The COSMOS Randomized Clinical Trial.  Sesso HD, et al.  American Journal of Clinical Nutrition, nqac055, https://doi.org/10.1093/ajcn/nqac055

Conclusion: “Cocoa extract supplementation did not significantly reduce total cardiovascular events among older adults but reduced CVD death by 27%….”

Funding: “The Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of study pills and packaging…[and other sources].

Conflicts of interest: Drs. Sesso and Manson reported receiving investigatorinitiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria
and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. No other authors reported any conflicts of interest.

Comment: Déjà vu all over again.

Mars, as I described in detail in Unsavory Truth, has been trying to make you think that chocolate is a health food (M&Ms!) for decades. It created a special brand, CocoaVia, for this purpose.  Here is an excerpt:

In 1982, Mars established a chocolate research center in Brazil.[i]  Its scientists were particularly interested in cocoa flavanols, a category of flavonoids with antioxidant, anti-inflammatory, and other heart-healthy effects.  Through the 1980s and 1990s, Mars’ scientists produced studies suggesting such benefits.

Alas, cocoa flavanols come with complications.  They taste bitter (dark chocolate contains more of them).  They are present in such small amounts that you would have to eat a quarter to a full pound of chocolate a day to achieve cardiovascular benefits.[ii]  Worse, they are destroyed by traditional chocolate processing.[iii]  The losses may explain why a Hershey-funded clinical trial failed to find neuropsychological or cardiovascular benefits from eating dark chocolate when compared to a placebo.[iv]

But to return to CocoaVia: Mars developed a process to preserve the cocoa flavanols during processing, and combined the rescued flavanols with cholesterol-lowering plant sterols to make chocolate bars and chocolate-covered almonds.  By 2002, the company decided that it had enough research to promote CocoaVia candies as heart-healthy.[v]  As the New York Times put it, Mars was on a “corporate quest to transform chocolate into a healthy indulgence.”[vi]  Mars marketed the candy bars—two a day, no less—as a means to increase blood flow, lower blood pressure, and reduce the risk for heart disease.

The FDA takes a dim view of unproven claims like “chocolate prevents heart disease.”  In 2006, the agency sent Mars a warning letter complaining that claims like “promotes a healthy heart” and “now you can have real chocolate pleasure with real heart health benefits,” were false, misleading, and easily misinterpreted…Chocolate, the FDA pointed out, is high in saturated fat (it didn’t mention sugar).   Furthermore, the claim “Cocoa Via Chocolate Bars contain natural plant extracts that have been proven to reduce bad cholesterol (LDL) by up to 8%,” meant that Mars was advertising chocolate as a drug.  If Mars wanted to make drug claims, it would need to conduct clinical trials to prove that eating CocoaVia chocolate bars prevented heart disease.[vii]

Rather than run the financial and scientific risk of doing that, Mars gave up on candy bars and began marketing CocoaVia in pills and powder as a “daily cocoa extract supplement.”  In doing this, Mars could take advantage of the more lenient marketing claims allowed by the Dietary Supplement Health and Education Act (DSHEA) of 1994. This act permits “structure/function” claims, those proposing that a supplement is good for some structure or function of the body.  Under DSHEA, the labels of CocoaVia are allowed to say that these supplements “promote a healthy heart by supporting healthy blood flow.”

To convince people to take CocoaVia supplements, Mars funds research.  In 2015, it funded studies demonstrating that cocoa flavanols are well tolerated in healthy men and women,[viii] support healthy cognitive function in aging,[ix] can reverse cardiovascular risk in the healthy elderly,[x] and improve biomarkers of cardiovascular risk.[xi]

Lest the “eat more chocolate” implications of these studies be missed, Mars issued a press release: “Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.”[xii]  The company followed this announcement with a full-page ad in the New York Times quoting a dietitian: flavanols “support healthy blood flow…which allows oxygen and nutrients to get to your heart more easily.”  …The ad directed readers to more information on a paid ad on the Times’ Website.  You have to look hard in these ads to discover that Mars owns CocoaVia; the company’s name only appears in barely legible print as part of the trademark.[xiii]

But Mars, which already has funded “more than 150 peer-reviewed scientific papers and [has] approximately 100 patents globally in the field of cocoa flavanols”[xiv] has more ambitious research plans.  In 2014, the company announced that in partnership with the National Heart, Lung, and Blood Institute it would provide “financial infrastructure support “ for an ambitious placebo-controlled, randomized trial of the effects of cocoa flavanols alone or in combination with vitamin supplements, on heart disease and cancer risk in 18,000 men and women over the age of 60.[xv]  The five-year trial, called the Cocoa Supplement and Multivitamin Outcomes Study (COSMOS), has evolved somewhat since then.  It now lists Brigham and Women’s Hospital in Boston as the sponsor, and Mars as a “collaborator” along with the Fred Hutchinson Cancer Research Center in Seattle and Pfizer. NIH seems no longer to be involved.[xvi]

We now have the result of this trial.  Even though cocoa flavanol supplements did not reduce cardiovascular events, Mars got its money’s worth from what must have been a very expensive study.

Tomorrow: a second report from this trial, with surprising results.

References

[i] Mars, Inc.  The history of CocoaVia.  CocoaVia.com

https://www.cocoavia.com/how-we-make-it/history-of-cocoavia

[ii] Vlachojannis J, Erne P, Zimmermann B, Chrubasik-Hausmann S.  The impact of cocoa flavanols on cardiovascular health.  Phytother Res.  2016;30(10):1641-57.

[iii] Andres-LaCueva C, Monagas M, Khan N, et al.  Flavanol and flavonol contents of cocoa powder products: influence of the manufacturing process.  J Agric Food Chem. 2008;56:3111-17.

[iv] Crews WD, Harrison DW, Wright JW.  A double-blind, placebo-controlled, randomized trial of the effects of dark chocolate and cocoa on variables associated with neuropsychological functioning and cardiovascular health: clinical findings from a sample of healthy, cognitively intact older adults.  Am J Clin Nutr. 2008;87(4):872-80.

[v] Meek J.  Chocolate is good for you (or how Mars tried to sell us this as health food).  The Guardian, Dec 23, 2002.

https://www.theguardian.com/uk/2002/dec/23/research.highereducation

[vi] Barrionuevo A.  An apple a day for health?  Mars recommends two bars of chocolate.  NY Times, Oct 31, 2005.

The FDA considers candy bars to be foods labeled with Nutrition Facts panels.  Supplements are labeled with Supplement Fact panels.

[vii] FDA.  Inspections, compliance, enforcement, and criminal investigations.  Warning letter to Mr. John Helferich, Masterfoods USA.  FDA, May 31, 2006.  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075927.htm

[viii] Ottaviani JI, Balz M, Kimball J, et al. Safety and efficacy of cocoa flavanol intake in healthy adults: a randomized, controlled, double-masked trial.  Am J Clin Nutr. 2015;102(6):1425-35.

[ix] Necozione S, Raffaele A, Pistacchio L, et al.  Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study—a randomized controlled trial  Am J Clin Nutr. 2015; 101:538-48.

[x] Heiss C, Sansone R, Karimi H, et al.  Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial.  Age. 2015;37:56.

[xi] Sansone R, Rodriguez-Mateos A, Heuel J, et al.  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.  Brit J Nutr. 2015;114(8):1246-55.

[xii] Mars Center for Cocoa Health Science.  Press release: Cocoa flavanols lower blood pressure and increase blood vessel function in healthy people.  MarsCocoaScience.com, Sep 9, 2015.  http://www.marscocoascience.com/news/cocoa-flavanols-lower-blood-pressure-and-increase-blood-vessel-function-in-healthy-people.

[xiii] CocoaVia.  Cocoa’s past and present: a new era for heart health.  NY Times, Sep 27, 2015.  http://paidpost.nytimes.com/cocoavia/cocoas-past-and-present-a-new-era-for-heart-health.html?_r=0

[xiv] Mars Symbioscience.  Explore Mars Symbioscience.  Mars.com.

http://www.mars.com/global/brands/symbioscience

[xv] Mars.  Largest nutritional intervention trial of cocoa flavanols and hearth (sic) health to be launched.  MarsCocoaScience.com, Mar 17, 2014.

http://www.marscocoascience.com/news/largest-nutritional-intervention-trial

[xvi] The trial is registered at COcoa Supplement and Multivitamin Outcomes Study (COSMOS).    ClinicalTrials.gov.

https://clinicaltrials.gov/ct2/show/NCT02422745

[xvii] ASRC (Advertising Self-Regulatory Council).  NAD recommends Mars modify certain claims for CocoaVia cocoa extract.  ASRCReviews.org, Aug 11, 2016.

http://www.asrcreviews.org/nad-recommends-mars-modify-certain-claims-for-cocoavia-cocoa-extract/