by Marion Nestle

Currently browsing posts about: Conflicts-of-interest

Dec 4 2023

Why I care about conflicts of interest

For years now I have been posting on Mondays something about conflicts of interest in nutrition research and practice on this site .

My goal in doing so is to raise awareness of practices that give the nutrition profession the appearance of undue food industry influence at the expense of public health.

Occasionally someone involved with something I post requests a correction or clarification.

Most recently, I heard from Gunter Kuhnle, a researcher in the UK whom I do not know personally.   He wrote:

In your blog (https://www.foodpolitics.com/2023/11/chocolate-an-update-on-the-food-politics-thereof/), you comment about my article in “The Conversation” on flavanols. This comment concludes with a statement that could be interpreted as if I was paid to write this piece. I would like to make clear that I was not paid to write this article – it was conceived and written in order to address a number of misunderstandings in the reporting of various studies concerning flavanols.  I would appreciate if you could correct this.

Since that was not at all my intention, I clarified the post immediately.

But I also requested his permission to reprint his note so I could do some more explaining about why this issue so concerns me.

I want to start by emphasizing that I do not see this as a personal matter.  My original post did not mention the author’s name and in general I try to avoid mentioning names of authors of industry-funded research unless they report financial ties to companies with vested interests in the outcome of that research.

I see this as a systemic issue.

But to summarize the arguments—and the research—I make and summarize in my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat:

An enormous body of evidence, most of it derived from studies of tobacco, chemical, or pharmaceutical drug industry-sponsored research, consistently shows:

  • Industry-funded research generally yields results that favor the sponsor’s interests.
  • Industry funding of research influences its outcome.
  • The influence of industry funding usually shows up in the framing of the research question or in the interpretation of results.
  • Recipients of industry funding do not recognize the influence, do not intend to be influenced, and deny the influence (“science is science”).
  • Denial of influence contradicts an enormous body of evidence to the contrary.
  • Disclosure of funding source or relationships is necessary but not sufficient; considerable evidence exists to show that the statement “the sponsor had nothing to do with the design, conduct, or publication of the study” is often misleading or false.
  • Exceptions do exist, but they are rare.

That researchers do not recognize the risks of industry funding is disturbing.  At the very least, when nutrition researchers accept funding from food companies, they give the appearance of conflict of interest.

And that is all it takes to reduce public trust in nutrition research, nutrition professionals, and nutrition professional societies.

I think there is something seriously wrong when I can look at the title of a nutrition research article and make a good guess about what company or industry trade association funded it.

I think there is something seriously wrong when I can look at the funder of a study and guess what the outcome is.

One more point: an argument I hear often is that all nutrition researchers are biased because they have dietary or ideological preferences.  There is research on this point too.  It argues that all researchers have personal or ideological biases—that’s what motivates them to do studies to test their hypotheses.  Personal biases, therefore, are universal and do not cause conflicts of interest.

Industry funding introduces a quite different motive: proving the health benefits or safety of a food product for commercial—not scientific—purposes.

Unsavory Truth provides references for all of this.

Also see Science in the Private Interest:  Has the Lure of Profits Corrupted Biomedical Research? by the late Sheldon Krimsky (I miss him terribly).

Professor Kuhnle, I thank you for writing and for the opportunity to respond.

Nov 27 2023

Industry-funded study of the week: a bacterial probiotic supplement and indigestion

This one started out with a notice in NutraIngredients Europe, a newsletter I subscribe to:

Probiotic BG01-4 relieves constipation and discomfort in GI disorders: Probiotic BG01-4 improves specific symptoms of constipation and related GI dysfunction in people with self-reported functional gastrointestinal disorders (FGID), which affects a significant percentage of the global population, a new study concludes…. Read more

That title triggered my usual question, “Who paid for this?”

I went right to the study:

  • The study:  Bacillus Subtilis (BG01-4TM) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial,by Craig Patch, Alan J. Pearce, Mek Cheng, Ray Boyapati, and Thomas Brenna. Nutrients202315(21), 4490; https://doi.org/10.3390/nu15214490.  
  • Background: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated Bacillus subtilis (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID.
  • Methods: Participants (n = 67) completed a four-week intervention of BG01-4™ (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention.
  • Results: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%/26% and 20%/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (p = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, p < 0.001), indigestion (11% improvement, p = 0.04), and dyspepsia (10% improvement, p = 0.04) were significantly improved in the intervention group compared to the placebo.
  • Conclusions: These initial findings suggest that in people with self-reported FGID, BG01-4™ improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted.
  • Conflicts of interest: C.P., M.C. and J.T.B. are directors of Adepa Lifesciences. The other authors declare that they have no conflicts of interest regarding the publication of this paper.

Comment: Three of the authors are involved with the maker of this supplement, Adepa Lifesciences, which makes this look like a marketing study.  It is published in the journal, Nutrients, an open-access journal.  Sharp eyed readers of this blog might notice that a large proportion of my industry-funded studies of the week appear in this journal.  It has an interesting policy.  It is fully open access and charges authors a fee accordingly.  That fee amounted to $3200 on October 30). 

All articles published in Nutrients (ISSN 2072-6643) are published in full open access. An article processing charge (APC) of CHF 2900 (Swiss Francs) applies to papers accepted after peer review. This article processing charge is to cover the costs of peer review, copyediting, typesetting, long-term archiving, and journal management. In addition to Swiss francs (CHF), we also accept payment in euros (EUR), US dollars (USD), British pound sterling (GBP), Japanese yen (JPY) or Canadian dollars (CAD).

Many science journals charge fees for open access, but usually offer authors a choice.  For the record, I have never paid to have an article published.

Nov 20 2023

Nutrition professional organizations should not partner with food companies

Just because all of the major nutrition professional organizations partner with food companies, does not make it a good idea.  If nothing else, partnerships with food companies raise reputational risks.  They give the appearance of conflicted interests, as David Ludwig and I warned in 2008.  I have also written about the hazards of food industry sponsorship of professional organizations in Food Politics, Soda Politics, and Unsavory Truth.  Here’s what they are doing now.

Academy of Nutrition and Dietetics (AND, formerly the American Dietetic Association)  OOPS.  My error.  This should be the American Diabetes Association (even worse).  Abject apologies.  This is what I get for not reading more carefully.  Apologies again.

If I seem to be picking on AND, it’s because it is bigger and gets into more trouble than other nutrition professional societies.

The latest example: According to Reuters, a former AND officer, Elizabeth Hanna, has sued the organzation for “firing her for objecting to what she called a “pay to play” scheme to promote the no-calorie sweetener Splenda.

In its 2022 annual report, the ADA said Splenda was one of a group of “elite” supporters that had given more than $1 million, along with Bayer Healthcare, Blue Cross Blue Shield of Illinois, Helmsley Charitable Trust and others.

On its website, Splenda publishes “diabetes-friendly recipes,” endorsed by the ADA. Hanna, a registered dietitian nutritionist, said she refused to approve the endorsement of several of these recipes in July.

…The U.S. Centers for Disease Control and Prevention states on its website that some studies have found possible health risks associated with the sweeteners, but that more research is needed.

American Society for Nutrition (ASN)

I am a member of this society and raise objections every time I get something like this in my e-mail.

Sponsored Webinar: Oral Health and Nutrition: Imperative for Healthy People 2030 and US Dietary Guidelines   Sponsored By: Mars Wrigley and the Oral Health Alliance.  The 2020-2025 Dietary Guidelines (DGA) identified dental caries as a major diet-related chronic disease of public health concern….

Doing this sort of thing risks reputation.

Evidence:  In a video on ultra-processed foods, the Financial Times identifies the ASN as “food industry advocacy group.”

The ASN’s executive director assures me they will ask for a correction.

Society for Nutrition Education and Behavior

Et tu?

It just announced a webinar, “Latinos love affair with Mangos: Maintaining Generational Food Traditions to Improve Health Outcomes.”

This is “a webinar sponsored by the National Mango Board, SNEB Organizational Member.”

The mango is…one of the world’s most popular fruits, and a staple food across Spanish speaking countries of North America, South America, and the Caribbean. Beyond its culinary popularity, an expanding body of research shows associations with mangos and risk reductions for inflammation and metabolically- based chronic disease, many of which disproportionately impact Hispanic American populations.

Mangos as opposed to any other fruit?

I am also a member of this society.

Overall comment

Are the reputational risks—and the loss of integrity—worth the money?  I don’t think so.

Nov 13 2023

Weird conflicts disclosure of the week: The Portfolio Diet

Several readers wrote suggesting I take a look at the conflicts of interest statement on this paper.

It comes from the Harvard TH Chan School of Public Health, which issued a press release: Harvard study: ‘Portfolio diet’ may decrease risk of heart disease, stroke.

The portfolio diet—a plant-based diet designed to lower unhealthy cholesterol, emphasizing plant proteins (legumes), phytosterols (nuts and seeds), viscous fiber (oats, barley, berries, apples), and plant-based monounsaturated fatty acids (avocado)—may lower the risk of heart disease and stroke, according to a new study co-authored by researchers at Harvard T.H. Chan School of Public Health.

The study was published in Circulation, which also sent out a press release: Ever heard of the portfolio diet? It may lower risk for heart disease and stroke.

The study itself, Portfolio Diet Score and Risk of Cardiovascular Disease: Findings From 3 Prospective Cohort Studies, produced results that should be expected from eating healthier diets.

Background: The plant-based Portfolio dietary pattern includes recognized cholesterol-lowering foods (ie, plant protein, nuts, viscous fiber, phytosterols, and plant monounsaturated fats) shown to improve several cardiovascular disease (CVD) risk factors in randomized controlled trials.

Objective: to examine the relationship between the Portfolio Diet Score (PDS) and the risk of total CVD, coronary heart disease (CHD), and stroke.

Methods: We prospectively followed 73924 women in the Nurses’ Health Study (1984–2016), 92346 women in the Nurses’ Health Study II (1991–2017), and 43970 men in the Health Professionals Follow-up Study (1986–2016) without CVD or cancer at baseline. Diet was assessed using validated food frequency questionnaires at baseline and every 4 years using a PDS that positively ranks plant protein (legumes), nuts and seeds, viscous fiber sources, phytosterols (mg/day), and plant monounsaturated fat sources, and negatively ranks foods high in saturated fat and cholesterol.

Conclusions: The PDS was associated with a lower risk of CVD, including CHD and stroke, and a more favorable blood lipid and inflammatory profile, in 3 large prospective cohorts.

This report was funded by Canadian and U.S. government research agencies.

Comment: The reason readers sent this to me had to do with the authors’ reported conflicts of interest.  These take up the equivalent of an entire page in the journal and refer to a curious mixture of financial support or connections, paid and unpaid, with government agencies and foundations, authors’ and sometimes their spouses’—in addition to long lists of financial ties to food trade associations for one or another plant food included in the Portfolio diet.

Muddying up disclosure statements like this is inappropriate.  Many connections listed do not in any way imply conflicted interests.  Mixing them up with those that do takes the focus away from financial ties that could have influenced the design or interpretation of the study.

Financial connections to food companies raise questions of credibility in nutrition research.  At the very least, they give the appearance of industry influence.

Disclosure lists like these either reflect ignorance of the significance and harm causes by conflicts of interest or deliberate disdain for its meanings.  If Circulation is requiring this mix of disclosures, it should reevaluate its policy.

Just because these disclosures come in a study from Harvard does not make them OK.

Oct 23 2023

Industry funded study of the week: the Pork Checkoff and Egg Board in action

Thanks to a reader, Kevin Mitchell, for sending this news item: Animal vs. Plant Protein: New Research Suggests That These Protein Sources Are Not Nutritionally Equivalent.

Scientists found that two-ounce-equivalents (oz-eq) of animal-based protein foods provide greater essential amino acids (EAA) bioavailability than the same quantity of plant-based protein foods. The study challenges the Dietary Guidelines for Americans (DGAs) which suggest these protein sources are nutritionally equivalent.

I went right to the source.

  • The study: Connolly G, Hudson JL, Bergia RE, Davis EM, Hartman AS, Zhu W, Carroll CC, Campbell WW. Effects of Consuming Ounce-Equivalent Portions of Animal- vs. Plant-Based Protein Foods, as Defined by the Dietary Guidelines for Americans on Essential Amino Acids Bioavailability in Young and Older Adults: Two Cross-Over Randomized Controlled Trials. Nutrients. 2023; 15(13):2870. https://doi.org/10.3390/nu15132870
  • Objectives: We assessed the effects of consuming two oz-eq portions of pork, eggs, black beans, and almonds on postprandial EAA bioavailability in young and older adults.
  • Methods: We conducted two investigator-blinded, randomized crossover trials in young (n = 30; mean age ± SD: 26.0 ± 4.9 y) and older adults (n = 25; mean age ± SD: 64.2 ± 6.6 y). Participants completed four testing sessions where they consumed a standardized meal with two oz-eq of either unprocessed lean pork, whole eggs, black beans, or sliced almonds.
  • Conclusions: Pork resulted in greater EAA bioavailability than eggs in young adults (p < 0.0001), older adults (p = 0.0007), and combined (p < 0.0001)… The same “oz-eq” portions of animal- and plant-based protein foods do not provide equivalent EAA content and postprandial bioavailability for protein anabolism in young and older adults.
  •  Funding: This research was funded by the Pork Checkoff and the American Egg Board—Egg Nutrition Center. The supporting sources had no role in study design; collection, analysis, and interpretation of data; writing of the report; or submission of the report for publication.
  • Conflicts of Interest: When this research was conducted, W.W.C. received research funding from the following organizations: American Egg Board’s Egg Nutrition Center, Beef Checkoff, Pork Checkoff, North Dakota Beef Commission, Barilla Group, Mushroom Council, and the National Chicken Council. C.C.C. received funding from the Beef Checkoff. R.E.B. is currently employed by Archer-Daniels-Midland (ADM); the research presented in this article was conducted in a former role and has no connection with ADM. G.C., J.L.H., E.M.D., A.S.H. and W.Z. declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Comment: It is very much in the interest of the Pork Checkoff and the Egg Board t,o demonstrate that animal-source food protein is better for you than proteins from plant sources—and to cast doubt on any evidence to the contrary.  Proteins, whether from animal or plant sources, contain precisely the same 20 amino acids, although in different proportions.  Animal proteins are closer in amino acid composition than are plant proteins but if you eat a variety of plant foods you will get the amino acids you need.   People who eat largely plant-based diets are generally healthier than people who eat a lot of animal-based foods.  The conclusion of this study does not change that overall conclusion.  This, then, is another industry-funded study with predictable results.

Oct 9 2023

Industry funded study of the week: Cheese prevents dementia!

It was hard to miss this headline in Dairy Reporter: “Cheese intake could lower risk of dementia, study suggests.”

No kidding?  I wonder who paid for this?

To its credit, the article did full disclosure:

The study was conducted as part of broader research commissioned by Japanese dairy major Meiji Co., Ltd. and part-funded by the company.

I went right to it.

The study: Kim H, Osuka Y, Kojima N, Sasai H, Nakamura K, Oba C, Sasaki M, Suzuki T. Inverse Association between Cheese Consumption and Lower Cognitive Function in Japanese Community-Dwelling Older Adults Based on a Cross-Sectional Study. Nutrients. 2023; 15(14):3181. https://doi.org/10.3390/nu15143181

Purpose: “We investigated whether cheese intake is associated with lower cognitive function (LCF) in community-dwelling older adults.”

Method: “This cross-sectional study included 1503 adults aged over 65 years. The analyzed data were obtained through face-to-face interviews and functional ability measurement.”

Results: Cheese intake, along with usual walking speed and calf circumference to be significant factors associated with LCF.

Conclusions: Cheese intake is inversely associated with lower cognitive function.

Funding: This study was funded by the Japan Agency for Medical Research and Development , the National Center for Geriatrics and Gerontology, and Meiji Co., Ltd.

Conflicts of Interest: “This study was conducted as a part of the ‘Epidemiology study of the relationship between dairy products intake and cognitive function’ commissioned by Meiji Co., Ltd. T.S. holds the position of Commissioned Research Chair, and H.K. is a member of the Commissioned Research group. K.N., C.O., and M.S. are employees of Meiji Co., Ltd. The other authors declare no conflict of interest. The funding sponsors had no role in the execution, analysis, or interpretation of the data or the writing of the manuscript.

Comment: Meiji Holdings Co Ltd (Meiji) 

is a manufacturer and distributor of dairy products, confectionery, and nutritional products. The company’s product portfolio comprises milk, yogurt, cheese, ice cream, chocolates, and gummy candies. The company also provides beauty supplements, protein products, nutritional products, vaccines, antibacterial agents, and generic drugs. The company markets its products under Meiji, Essel, Oishii Gyunyu, DepromeL, Reflex, Kaju Gummy, Kinoko no Yama, Galbo, Amino Collagen, Savas, Sycrest, Streptomycin, Kanamycin, Depromel, and Metact brand names…Meiji is headquartered in Chuo-Ku, Tokyo, Japan.

Five of the authors work for the company.

Does eating cheese reduce the risk of dementia?  You read the paper and decide.  I think you can’t make this stuff up.

Oct 4 2023

The Academy of Nutrition and Dietetics responds to the Washington Post

I was not going to bother to say anything about this letter addressed to the Washington Post from the President of the Academy of Nutrition and Dietetics (AND), Laurie Wright, which she sent to all members.  But at least five recipients sent it to me for comment, so here goes.

From: Commission on Dietetic Registration <cdr@eatright.org>
Date: September 29, 2023 at 3:19:42 PM EDT
To: [REDACTED]
Subject: Letter to the Editor of the Washington Post from Academy President Lauri Wright

The September 13 article “The food industry pays ‘influencer’ dietitians to shape your eating habits” does a disservice to the nation’s hundred thousand plus registered dietitian nutritionists by painting broad-stroke misrepresentations about the dietetics profession and its association, the Academy of Nutrition and Dietetics.

Using examples of only seven individuals, the authors imply it is common practice for RDNs to have undisclosed affiliations with food companies and sponsors. This could not be further from the truth. More than 90 percent of registered dietitian nutritionists work in clinical health care, such as hospitals, medical centers and long-term care facilities, as well as in private practice, public and community health, school nutrition and other foodservice operations.

A growing number of practitioners do share their knowledge and expert opinions through social platforms, engaging with online communities and correcting health misinformation (much of which comes from potentially harmful fads promoted by infinitely larger numbers of uncredentialed influencers with much larger followings). The Academy of Nutrition and Dietetics has a strict Code of Ethics — which includes adhering to disclosure rules and guidelines established by the Federal Trade Commission — and has published many articles over the years about the importance of disclosure.

The authors further implied that the Academy is funded by the food and beverage industry, citing a long-since debunked “investigation” conducted by a small group of activists that disbanded six years ago. The truth lies in the facts: The Academy uses an independent advisor to manage our financial investments in all sectors of the S&P 500, and less than 3 percent of the Academy’s and its Foundation’s investments are in the food sector. Further, only 7 percent of the Academy’s revenue comes from sponsorships. This information has always been fully transparent to the public through our annual reports.

All this information was provided to the Post reporters in advance of the story, but unfortunately the writers elected to mislead their readers with a false narrative implying that non-disclosure of sponsorships is rampant in our profession. Speaking for Academy members who abide by our Code of Ethics, we expected the Post to abide by a higher journalistic standard as well.

Oh dear.  The cozy relationship between AND members and food companies is something I’ve written about extensively in my books, Food Politics and, more recently, Unsavory Truth.  

I’ve also written about the Academy’s conflicted interests on this site, most recently here.

And then there is Michele Simon’s deep dive into the Academy’s relationships with sponsors from a decade ago.

Here’s what President Wright’s defensive letter does not say:

  • We apologize for the unethical behavior of some of our members and will immediately take steps to make sure no member does this again.
  • Non-disclosure of sponsorship is grounds for dismissal from the Academy.
  • We will strengthen our policies to make clear that the Academy will not tolerate such non-disclosure.
  • We will insist not only of disclosure of paid posts, but also disclosure of the name of the sponsor.
  • To make sure members fully understand what is at stake, we are providing guidelines for ethical disclosure and illustrations of what and what is not appropriate.

For your amusement, one reader sent me an Instagram example of full disclosure from Gwyneth Paltrow (who is not, to my knowledge, an AND member)—clearly labeled as a paid partnership with Copperfit.  You have to be logged in to Instagram to open the link.

Sep 25 2023

Industry-funded study of the week: a citrus and pomegranate supplement

When I saw this article—Study: Orange and pomegranate extract impacts major marker for healthy ageing—my first thought was “Who paid for this?”  Bingo.

The study: Ahles, S., Cuijpers, I., Hartgens, F. et al. The Effect of a Citrus and Pomegranate Complex on Physical Fitness and Mental Well-Being in Healthy Elderly: A Randomized Placebo-Controlled Trial. J Nutr Health Aging 26, 839–846 (2022). https://doi.org/10.1007/s12603-022-1834-4

  • Objectives: This study investigates whether a citrus and pomegranate complex (CPC) improves physical fitness, mental well-being, and blood biomarkers for oxidative stress and endothelial function in healthy elderly.
  • Design: A randomized placebo-controlled cross-over trial.
  • Participants: The study included 36 healthy elderly aged 60–75 years old.
  • Intervention and Measurements: Participants received four weeks of CPC supplementation and performed the handgrip strength and senior fitness test. Quality of life (QOL) was assessed and blood samples were analyzed for oxidative stress and endothelial function markers.
  • Results: After four weeks of CPC supplementation, handgrip strength significantly improved (p=0.019), compared to placebo. Moreover, the thinking, memory, learning, and concentration facets were improved (p=0.042), compared to placebo, and plasma malondialdehyde decreased, compared to placebo (p=0.033). The intervention did not affect senior fitness and the other QOL domains and blood parameters.
  • Conclusion: Four weeks of daily CPC supplementation significantly improves handgrip strength and self-evaluated measures of psychological function in healthy older adults. Further research should focus on mechanisms associated with physical performance.
  • Funding: Funding: Authors IC and FT are supported by the Province of Limburg, The Netherlands [grant number HEFI-2]. This research project was supported by BioActor B.V.
  • Ethics declarations: Conflict of interest: S.A. is an employee of BioActor BV. F.H. is a sports medicine consultant and owner of Sports Medicine Center Maastricht*Parkstad. All other authors declare no conflict of interest. The funders had no role in the design of the study, in the preparation of the manuscript, or in the decision to publish the results.

Comment: This is a classic example of a study nobody but the product maker would ever do.  The statement that the funders had nothing to do with the study design or anything else may or may not be true—there have been too many examples of its not being true to take any such statement seriously without much further discussion.  Even with that assurance, researchers who accept industry funding rarely recognize industry influence—it seems to occur at some unconscious level.