In a recent NutraIngredients-USA commentary it was argued that dietary supplement companies that build up a suite of research do so carefully, and plan for success​​. With a careful design of the research program, positive results at the bench can naturally translate into successful randomized, placebo controlled trials.

Longtime critic of industry funded research

Marion Nestle, PhD, nutrition professor at New York University and author of the influential book Food Politics​ as well her most recent work Unsavory Truth: How Food Companies Skew the Science of What We Eat, ​ isn’t buying. Nestle responded to NutraIngredients-USA on the subject of the commentary to say that she has reviewed hundreds of company-funded studies and in her view the inherent biases built into that system are next to impossible to overcome.

Indeed, on her blog (also titled Food Politics​​) Nestle has a frequent feature called “Industry funded research of the week.” The feature is used to document instances of bias, which to Nestle’s eye are thick on the ground.

“The overriding issue is that industry-funded research almost invariably comes out with results favorable to the sponsor’s interests. This is so predictable that I can often recognize the funder by the title of the paper,”​ Nestle told NutraIngredients-USA.

Nestle noted that the phenomenon is not by any means restricted to research on food and supplement ingredients. It has been noted in studies on tobacco, chemicals and pharmaceuticals.

“Studies of these industries show that the influence apparently occurs at an unconscious level; investigators did not intend to be influenced and do not recognize that they were influenced. But the evidence for funding effects is overwhelming,”​ she said.

Bias starts with study design

Nestle said a key issue is how the research question is framed. Companies investing in research naturally want to succeed and get some return on their investment. But the best science doesn’t come when the question is framed in such a way that a positive result is overwhelmingly likely, she said.

“I get letters all the time from trade associations asking for proposals for research that will demonstrate the benefits of their products. That is not the same as asking open-ended questions about effects. Companies want data on benefits for marketing purposes. That’s why I view industry-funded studies as about marketing, not science,”​ Nestle said.

Nestle said she has noted that some of the larger funders, such as the larger food companies or industry associations supporting categories of products like walnuts, almonds, strawberries or what have you, churn out research supporting their products of interest. While some might argue this adds to the totality of evidence and thus could be a good thing, Nestle said she doubts the value of these investments when taking the inherent biases into account. This can result in studies that seek to demonstrate things like substituting junk food calories with a serving of something like almonds or strawberries is a good thing to do. Yes, but so what? In Nestle’s view, this kind of bias is all but inevitable in research funded in this way.

“That’s what decades of research on the effects of drug-industry funding says, and the few studies looking at funding effects in nutrition find similar results,” ​she said.

Independent funding mechanism

What Nestle said she’d like to see is a mechanism for funding research into food and supplement ingredients that was divorced from a marketing plan.

“I want to see a firewall between the funder and the scientist. In ​Unsavory Truth, I talk a lot about various attempts over decades to create such firewalls and develop a pool of industry research funds managed by independent third parties. They have never worked well,”​ she said.

Nestle said she believes that only by making contributions to research compulsory, with the resulting fund to be managed by a credible third party, can research of undeniable quality be done. Something like the Beef Checkoff Program but for independent research funding, even if the results of those studies might not immediately support the marketing of the products.

“My idea of an ethically funded study is to ask for investigator-initiated proposals, appoint third party reviewers who decide who gets funded, and stay completely out of the process from then on. I worry when I see disclosure statements that the funder had no role in the study because that statement has been demonstrated to be false so many times. Food companies are funding research because they want specific results. That’s not how science is supposed to work,”​ Nestle said.

The study: Controlled Feeding of an 8-d, High-Dairy Cheese Diet Prevents Sodium-Induced Endothelial Dysfunction in the Cutaneous Microcirculation of Healthy, Older Adults through Reductions in Superoxide.  Billie K Alba, Anna E Stanhewicz, Priyankar Dey, Richard S Bruno, W Larry Kenney, Lacy M Alexander.  The Journal of Nutrition, nxz205, https://doi.org/10.1093/jn/nxz205

The conclusions: “These results demonstrate that incorporating dairy cheese into a high-sodium diet preserves EDD by decreasing the concentration of superoxide radicals. Consuming sodium in cheese, rather than in nondairy sources of sodium, may be an effective strategy to reduce cardiovascular disease risk in salt-insensitive, older adults.”

The funder: “This research was supported by the National Dairy Council.”

The press headline: “Gouda news for cheese lovers: study finds blood health benefit.”  The headline is clever but screamed industry-funded.  I immediately looked up the actual study to see who had paid for it.  The story in NutraIngredients.com reads like a press release.  It did not mention the funder.  It should have.

My correspondence with the editor of NutraIngredients.com over funding disclosure is the subject of tomorrow’s post.  Stay tuned.

In the wake of all the media fuss over the “don’t worry, eat meat” papers published on Monday (see my summary), my favorite is a tweet from Naomi Oreskes, one of the authors of Merchants of Doubt, an analysis of the tobacco and chemical industries’ playbook in action.

Thanks Naomi.

I’ve just ordered a copy of her new book.  Can’t wait for it to arrive.

The furor over the “don’t-worry-about-meat” papers published earlier this week (see my post) did not have much to say about the lead author’s previous association with the International Life Sciences Institute (ILSI), disclosed in a “you don’t need to worry about sugar” review from the same journal in 2016: “This project was funded by the Technical Committee on Dietary Carbohydrates of ILSI North America.”  The meat papers did not mention the previous connection to ILSI, even though it occurred within the past three years.  They should have.

ILSI is a classic food-industry front group, one that tries to stay under the radar but is not succeeding very well lately.

The New York Times titled its recent ILSI investigation: A Shadowy Industry Group Shapes Food Policy Around the World.

This reminded me of what I wrote about ILSI in my book Unsavory Truth (2018).  When I was working on the last chapters of the book, I realized that something about ILSI’s role turned up in practically every chapter.  Here, I refer to a study funded by ILSI.

The front-group funder was the North American branch of the International Life Sciences Institute (ILSI), an organization that turns up often in this book. ILSI describes itself as an independent scientific think tank, but it was created and is largely funded by the food industry. This makes it, by definition, a front group.

But you might not realize this from reading the study authors’ disclosure statement, which describes ILSI as “a public, nonprofit scientific foundation that provides . . . a neutral forum for government, academic, and industry scientists to discuss and resolve scientific issues of common concern for the well-being of the general public” (1).

ILSI keeps a relatively low public profile but seems never to miss an opportunity to defend the interests of its four hundred or so corporate sponsors. Its 2016 annual report takes four pages and fifteen columns to list industry supporters of its national and international branches; these contribute two-thirds of this group’s nearly $18 million in annual revenues (the rest comes from government or private grants or contributions). ILSI’s board of trustees is about half industry and half academia, all unpaid volunteers.

Critics describe ILSI as a “two-level” organization. On the surface, it engages in legitimate scientific activities. But deep down, it provides funders with “global lobbying services . . . structured in a way which ensures that the funding corporations have majority membership in all its major decision-making committees.” (2).

(1) Besley JC, McCright AM, Zahry NR, et al.  Perceived conflict of interest in health science partnerships. PLoS One. 2017;12(4):e0175643.  McComas KA.  Session 5: Nutrition communication. The role of trust in health communication and the effect of conflicts of interest among scientists.  Proc Nutr Soc. 2008;67(4):428-36.

(2) Miller D, Harkins C. Corporate strategy and corporate capture: food and alcohol industry and lobbying and public health. Crit Soc Policy. 2010;30:564-89.

I have written about ILSI in previous blog posts:

• Coca-Cola’s political influence in China: documented evidence
• Mars Inc says goodbye to ILSI, hello to science policy
• Industry-funded study says advice to eat less sugar is based on bad science (surprise) 

Others have also written about this organization:

• Are industry-funded charities promoting “advocacy-led studies” or “evidence-based science”?: A case study of the International Life Sciences Institute
• US Right to Know’s facts on ILSI

It’s about time ILSI’s practices are being exposed.

Under new leadership, and in the wake of the defections of prominent food companies, the Grocery Manufacturers Association is changing its name.

Good-bye GMA.  Hello Consumer Brands Association.

Why?  The GMA was on the wrong side of just about every food issue.

In the past two years, food companies like Campbell, Kraft Heinz, Nestle, Hershey and Unilever left the GMA, amid disputes over how to handle these new realities. Among the issues that were fiercely debated were how and when to disclose the use of genetically modified organisms (GMOs). The organization says each of the departing members left for individual reasons, but the common thread was a failure by the organization to adapt as consumer sentiments and trends were evolving.

Chalk this up to consumer power!  And to badly needed new leadership.

The association’s will now focus on promoting:

• Sustainable packaging
• Uniform recycling
• Trust and transparency
• Improved supply chains
• Uniform regulation of CBD

Sounds good to me.  Let’s hope the transformation works.

The press release from the Annals of Internal Medicine arrived last week under embargo, sent to me by several reporters: “New guidelines: No need to reduce red or processed meat consumption for good health.”

The press announcement was accompanied by 5 review papers, a sixth with this recommendation, and an editorial.  These are posted on the website of their publisher, the American College of Physicians, implying this organization’s endorsement of this guideline.

Collectively, these papers challenge dietary advice to eat less processed meat and red meat on the grounds of inadequate science.

These papers argue:

• Eliminating processed and red meat from the diet may reduce disease risks but the effects are small and evidence for them is of low quality and low certainty.
• Omnivores are unwilling to eat less meat.
• If you continue to think eating meat is bad for you in the face of this evidence, you are a victim of the “the less you know, the more you hold to your beliefs” syndrome.
• You can ignore dietary guidelines (regardless of source) and continuing eating meat as you always have.

This is a good example of what I call nutritional nihilism, an approach that insists that because observational studies are based on self-reported information and necessarily flawed, their conclusions are unscientific and should be discounted.  Therefore, because we can’t do more rigorous studies, we should not advise the public about diets best for health or the environment.

I have several concerns about all this:

• Yes, the effects are small but that is true of nutrition studies in general.  The small effects show benefits from eating less meat.  The authors could easily have interpreted their work as suggesting that eating less meat might be useful.  This is an example of interpretation bias.
• The authors took a strictly science-based approach to a problem strongly affected by social, economic, and political factors and values.
• The studies look at previous studies that compared people who eat meat to those who eat less. The authors excluded studies of vegetarians compared to meat-eaters.
• They look at meat outside its context of calories.
• The authors did not look at the totality of the evidence; they excluded laboratory and animal studies that can be more closely controlled.
• They excluded studies of environmental impact, which has a significant bearing on human dietary practices (meat production adds more greenhouse gases than vegetable production).
• The conclusions fall into the category of “everything you thought you knew about nutrition is wrong.”  This rarely happens.  Science usually works incrementally, not in one enormous reversal like this.

Do the authors really believe that all those other committees and commissions urging less meat were wrong and continue to be wrong?   Their strictly science-based approach seems unrealistic.

The papers come across to me as a concerted attack on dietary guidelines (national and international), on nutrition science in general, and on nutritional epidemiology in particular.

The meat industry and its supporters will love them.

Attacks on the quality of nutrition research have been coming from many sources lately: the food industry, of course, but also statisticians (John Ioannidis at Stanford is making a career of this), and some scientists (usually with ties to food companies).  The criticisms themselves are not new.

What is new is the vehemence and level of effort to discredit observational studies, particularly those based on self-reports of dietary intake.  Yes, nutritional epidemiology has flaws, but the methods have been useful in many instances, as argued convincingly by two of its leading practitioners.

In looking at nutrition research, I think it is essential to evaluate the totality of information available: laboratory, animal, human epidemiology and clinical studies—and to do this in the context of what people actually eat and the number of calories they consume, as well as adding in a hefty dose of common sense.

Common sense is what’s missing in these studies.  Do the authors really believe that:

• Meat eaters are healthier than vegetarians?
• Eating more meat is better for health?
• Meat eaters are less obese and have less heart disease and cancer than those who eat less?

If not, the conclusions make no sense.

Most of the authors report no financial ties to the food industry.  I would love to know the back story about why they chose to do these studies and to interpret them in this way.

Reactions (I will be adding to this list as they come in)

• The Harvard School of Public Health Nutrition Department issued a statement
• The True Health Initiative (THI) issued a press release outlining its concerns (the link is here)
• THI council members sent a letter to the journal editor stating objections (the link)
• THI collected quotes from members of its council and others (including mine)
• THI also produced graphics.  Here is one example.

• David Katz weighs in
• New York Times: 5 things you should know
• New York Times coverage: “Eat less meat, scientists said.  Now some believe that was bad advice.”
• From Dean Ornish
• Consumer Reports (I’m quoted)
• From the World Cancer Research Fund
• Vox’s crystal clear explanation
• NPR’s The Salt’s excellent analysis
• Aaron Carroll’s follow-up to his editorial

These three papers were part of a supplement to Advances in Nutrition published in September 2019: Supplement—6th Yogurt in Nutrition Initiative (YINI) Summit / More than the Sum of Its Parts, sponsored by Danone Institutes International. Publication costs for this supplement were defrayed in part by the payment of page charges.

I.  Introduction to the Sixth Global Summit on the Health Effects of Yogurt: Yogurt, More than the Sum of Its Parts.  Sharon M Donovan ; Olivier Goulet. Advances in Nutrition, Volume 10, Issue 5, September 2019, Pages 913S–916S.

Conclusion: “Ultimately, the inclusion of fermented dairy products in food-based dietary guidelines, not only as a dairy option, but as a significant source of viable bacteria and fermentation products, could contribute to improved public health and should be considered.”

Author disclosures: “The guest editor of the supplement has the following conflict of interest: SMD co-chairs the Yogurt in Nutrition Initiative. She received reimbursement for travel expenses and an honorarium from Danone Institutes International for chairing the Sixth International Yogurt in Nutrition Summit at the Nutrition 2018 meeting in June 2018 in Boston, MA….SMD and OG are co-chairs of the Yogurt in Nutrition Initiative. Travel expenses and an honorarium were paid to SMD and OG by Danone Institutes International for chairing the Sixth International Yogurt in Nutrition Summit at the Nutrition 2018 meeting in June 2018 in Boston, MA. OG is also the Chair of Danone Institutes International.

II.  Dairy Foods, Obesity, and Metabolic Health: The Role of the Food Matrix Compared with Single Nutrients.  Dariush Mozaffarian.  Advances in Nutrition, Volume 10, Issue 5, September 2019, Pages 917S–923S,

Conclusion: “The present evidence suggests that whole-fat dairy foods do not cause weight gain, that overall dairy consumption increases lean body mass and reduces body fat, that yogurt consumption and probiotics reduce weight gain, that fermented dairy consumption including cheese is linked to lower CVD risk, and that yogurt, cheese, and even dairy fat may protect against type 2 diabetes. Based on the current science, dairy consumption is part of a healthy diet, without strong evidence to favor reduced-fat products; while intakes of probiotic-containing unsweetened and fermented dairy products such as yogurt and cheese appear especially beneficial.”

Disclosures: “DM received an honorarium from the American Society of Nutrition for the preparation of this manuscript. A freelance science writer, Denise Webb, was supported by Danone Institute International to prepare an initial draft of this manuscript for DM based on a recording of his talk and slides at the American Society of Nutrition 2018 Congress. The final manuscript was edited in detail and approved by DM. The funders had no role in the design, analysis, interpretation, review, or final approval of the manuscript for publication…DM reports research funding from the NIH and the Gates Foundation; personal fees from GOED, Nutrition Impact, Pollock Communications, Bunge, Indigo Agriculture, Amarin, Acasti Pharma, Cleveland Clinic Foundation, and America’s Test Kitchen; scientific advisory board, Elysium Health (with stock options), Omada Health, and DayTwo; and chapter royalties from UpToDate; all outside the submitted work.”

III.  Effects of Full-Fat and Fermented Dairy Products on Cardiometabolic Disease: Food Is More Than the Sum of Its Parts.  Arne Astrup; Nina Rica Wium Geiker; Faidon Magkos.  Advances in Nutrition, Volume 10, Issue 5, September 2019, Pages 917S–923S.

Conclusion: “Although more research is warranted to adjust for possible confounding factors and to better understand the mechanisms of action of dairy products on health outcomes, it becomes increasingly clear that the recommendation to restrict dietary saturated fat to reduce risk of cardiometabolic disease is getting outdated. Therefore, the suggestion to restrict or eliminate full-fat dairy from the diet may not be the optimal strategy for reducing cardiometabolic disease risk and should be re-evaluated in light of recent evidence.”

Disclosures.  “NRWG and FM, no conflicts of interest. AA is a member of advisory boards/consultant for BioCare Copenhagen, Denmark; Dutch Beer Institute, Netherlands; Gelesis, United States; Groupe Éthique et Santé, France; McCain Foods Limited, United States; Novo Nordisk, Denmark; Pfizer, United States; Saniona, Denmark; and Weight Watchers, United States. AA has received travel grants and honoraria as a speaker for a wide range of Danish and international consortia. AA is co-owner and member of the board of the consultancy company Dentacom Aps, Denmark; cofounder and co-owner of UCPH spin-outs Mobile Fitness A/S, Flaxslim ApS, and Personalized Weight Management Research Consortium ApS (Gluco-diet.dk). He is coinventor of a number of patents owned by the University of Copenhagen, in accordance with Danish law. He is coauthor of a number of diet and cookery books, including books on personalized diet approaches. AA is not an advocate or activist for specific diets and is not strongly committed to any specific diet.”

Comment

These papers aim to dispute the idea that full-fat dairy products but have negative health effects. This is a legitimate scientific question that deserves investigation and analysis, preferably by studies funded by independent sources.  Industry-funded studies and opinion pieces are well known to produce results and conclusions favorable to the sponsor’s interest, as is the case here.

HealthyDrinksHealthyKids.org has issued recommendations on what kids should drink in collaboration with impressive co-signers:

• The Academy of Nutrition and Dietetics
• American Academy of Pediatric Dentistry
• American Academy of Pediatrics
• American Heart Association

The recommendations for parents vary by age.  For example, for infants up to age 6 months:

Only breast milk or infant formula (or water)

• No juice
• No milk
• No flavored milks
• No transition formulas
• No plant-based milks
• No caffeinated beverages
• No diet drinks
• No sugar-sweetened beverages

This is an important report.  About half of toddlers are given sugary beverages.  Let’s hope this is an incentive to stop this practice.

Here are the documents:

• The full list of recommendations
• The website
• Drink Guidelines Consensus Statement
• Drink Guidelines 4 Pager
• Drink Guidelines Press Release