Currently browsing posts about: Sponsored-research

I am a great believer in the value of organic production methods, which avoid the most toxic pesticides and herbicides, are demonstrably better for soil, and produce fewer greenhouse gases.

But I wish the organic industry would try to find a less conflicted, more objective way of conducting studies on organic foods.

The study: Production-related contaminants, pesticides, antibiotics, and hormones in organic and conventionally produced milk samples sold in the USA.  JA Welsh, et al.  Public Health Nutrition.  Published online by Cambridge University Press: 26 June 2019. DOI:  https://doi.org/10.1017/S136898001900106X

Conclusions:  “Current-use antibiotics and pesticides were undetectable in organic but prevalent in conventionally produced milk samples, with multiple samples exceeding federal limits. Higher bGH and IGF-1 levels in conventional milk suggest the presence of synthetic growth hormone. Further research is needed to understand the impact of these differences, if any, on consumers.”

Funding: Financial support: Data collection was supported by the Organic Center…. The Organic Center had no role in the design, analysis of samples, or writing of this article.

Conflict of interest: J.A.W.’s investment portfolio includes equity in one of the companies whose milk products were randomly selected for use in this study. All other authors have no perceived or potential conflicts of interest to report.

Comment: Organic standards are about production values.  Antibiotics, toxic pesticides and herbicides, and genetic modification are not allowed in organic production and would not be expected to be detectable in organic milk.  The result reassures that the system is working properly (why wouldn’t it?).  But I wish it had been funded and conducted by investigators with no vested interest in its outcome.  I am aware of the argument that independent funding is not available for studies like this.  That’s a problem that the organic industry needs to solve.

Thanks to Stephanie Laverone for telling me about this study.

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.

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.

Title: Almond Consumption and Risk Factors for Cardiovascular Disease:A Systematic Review and Meta-analysis of Randomized Controlled Trials. Lee-Bravatti MA, et al.  Adv Nutr. 2019;00:1–13

Method: The authors selected studies that had compared lab values of adults who consumed almonds with those who did not.  They found significant reductions in some—but not all—CVD risk factors among the almond eaters.  The almond eaters, for example, had lower total cholesterol levels and lost weight during the trials.

Conclusion: “Almond consumption may reduce the risk of CVD by improving blood lipids and by decreasing body weight and apoB [apolipoprotein B].”

Funding: “Supported by the Almond Board of California…The funder did not have a role in the study selection, quality assessment, data synthesis, or manuscript preparation.”

Author disclosures:  GR was a consultant for Porter Novelli; EJJ received funds from the Almond Board of California for a clinical trial at the time of the study. MAL-B, JW, EEA, and LK, no conflicts of interest.

Comment: I like nuts and am especially partial to marcona almonds, but I wish the almond industry would stop trying to prove that almonds can perform health miracles. I can easily see why substituting almonds for ultraprocessed junk foods would help reduce markers of CVD risk, calories, and weight: people who eat junk food consume more calories and are more likely to be obese.  This study set a standard of 42.5 grams of almonds a day, roughly 1.5 ounces  and 200 calories.  But are almonds superior to other nuts?  The Walnut Commission would argue otherwise, as would the Pecan Growers’ Association.  The Almond Board may say it has nothing to do with the study, but it doesn’t have to.  Its funding is sufficient to exert influence even if investigators don’t realize it, as I discuss in Unsavory Truth.

Here’s another study where I guessed its funder from its title.

Everyone knows whole grains are healthy and recommended.  Why do this study?  Maybe it helps to have more evidence?

Once you know the funder, you can also guess what the study will show.

To wit:

Whole Grain Wheat Consumption Affects Postprandial Inflammatory Response in a Randomized Controlled Trial in Overweight and Obese Adults with Mild Hypercholesterolemia in the Graandioos Study.  Hoevenaars FPM, et al. The Journal of Nutrition, 2019: nxz177, https://doi.org/10.1093/jn/nxz177

Objective: “The health impact of WGW [whole grain wheat] consumption was investigated by quantification of the body’s resilience, which was defined as the ‘ability to adapt to a standardized challenge.’”

Method: “A double-blind RCT [randomized control trial] was performed with overweight and obese…men (n = 19) and postmenopausal women (n = 31) aged 45–70 y, with mildly elevated plasma total cholesterol…who were randomly assigned to either 12-wk WGW (98 g/d) or refined wheat (RW).”

Conclusion: “Twelve-week 98 g/d WGW consumption can promote liver and inflammatory resilience in overweight and obese subjects with mildly elevated plasma cholesterol.”

Funding: “Supported by the public private partnership entitled “Combining innovation with tradition: improving resilience with essential nutrients and whole wheat bread,” financed by Topsector Agri & Food (TKI-AF 12083). This project was sponsored by TNO roadmap Nutrition and Health and co-funded by Cereal Partners Worldwide, the Dutch Bakery Center, and GoodMills Innovation GmbH. The funders of the study had no role in the study design, data collection, analysis, and interpretation, nor the preparation of the manuscript.”

Comment: As I keep saying (see Unsavory Truth), funders do not have to be involved.  Their influence starts from the get-go, and usually shows up in the way the research question is asked, as seen in this example.  This study is not about finding out about how whole wheat affects health (basic science); it is about demonstrating benefits from whole wheat consumption (marketing).  I’m in favor of eating more whole wheat, rather than refined, but wish food companies selling whole grains would stay out of conflicted research.

Curcumin is a flavonoid antioxidant isolated from turmeric, the spice used in Indian curries, among other foods.

It is about as overhyped as any ingredient I have encountered lately for its “proven ability” to fight Alzheimer’s, heart disease, cancer, and anything else that ails you.  If only this could be true.  If it were, people in India who use this in their cooking would all live exceptionally long and healthy lives.

But to convince skeptics like me—and to sell curcumin supplements of course—the makers of such supplements fund studies.

I learned about this study from the industry newsletter, NutraIngredients-Latam.

It reported on a an abstract of a clinical trial of a curcumin supplement, Longvida,™ made by Verdure Sciences. 

The study:  This was a double-blind, placebo-controlled, parallel-groups clinical trial in which participants were given Longvida™ (400 mg daily containing 80 mg curcumin) or a matching placebo.

Results: After 12 weeks, the curcumin group did better on memory performance and other tests, and after 4 weeks showed less tension, anger, confusion and total mood disturbance.

Conclusions: “These results confirm that Longvida™ improves aspects of mood and working memory in a healthy older cohort. The pattern of results…may hold promise for alleviating cognitive decline in some populations.”

Funding: Surprise! “This study was funded by a grant from Verdure Sciences.”

Comment: I see three problems here with the Nutraingredients report.

(1) When funders have a vested interest in the outcome of studies, biases tend to creep in.

(2) The report is based on an abstract, not on a complete account of the trial; this makes the methods difficult to assess.

(3) The report did not mention that study was funded by a company with a vested interest in the result; it should have.

A reader, Gema Flores Monreal, who holds a doctorate in Food Science and Nutrition, pointed me to this study.  She noted that it examines the effects on blood pressure of eating 5 to 6 servings of dairy per day, twice what is typically recommended. 

it is easy to understand why a dairy company would want research like this.  People are consuming less dairy food, and the industry wants to reverse the decline.

The study:  Effect of high compared with low dairy intake on blood pressure in overweight middle-aged adults: results of a randomized crossover intervention study.  Rietsema S, and 11 other authors.  Am J Clin Nutr 2019;110:340–348.

Conclusions: “This intervention study shows that an HDD [high dairy diet] results in a reduction of both systolic and diastolic BP [blood pressure] in overweight middleaged men and women. If the results of our study are reproduced by other studies, advice for high dairy intake may be added to treatment and prevention of high BP.”

Funding: “Supported by the Public–Private Partnership Topconsortium voor Kennis en Innovatie (TKI) Agri & Food (TKI-AF-12104).”  FrieslandCampina, a Dutch multinational dairy cooperative, is part of the partnership.  Two of the authors are employed by FrieslandCampina.

Comment: As I discuss in Unsavory Truth, research like this has a high probability of producing biased results.  I’m reserving judgment about dairy foods and blood pressure until results like these are confirmed by independent research.