Currently browsing posts about: Conflicts-of-interest

I learned about this one from an article—no, it’s an ad really—in NutraIngredients.com.

Its headline: “Large new study validates krill oil’s heart health benefits.”

Heading the page is this note:

CONTENT PROVIDED BY AKER BIOMARINE SUPERBAKrill Learn More

I clicked on Learn More and got a disclaimer, the first time I have seen something like this:

The following content is provided by an advertiser or created on behalf of an advertiser. It is not written by the NutraIngredients.com editorial team, nor does it necessarily reflect the opinions of NutraIngredients.com.

OK.  Now we know that the entire article is an ad paid for by the maker of the product under discussion.

What about the research?

The study: Effectiveness of a Novel ω-3 Krill Oil Agent in Patients With Severe HypertriglyceridemiaA Randomized Clinical Trial.  Dariush Mozaffarian, MD, DrPH¹; Kevin C. Maki, PhD^2,3; Harold E. Bays, MD⁴; et alFernando Aguilera, MD⁵; Glenn Gould, MD⁶; Robert A. Hegele, MD⁷; Patrick M. Moriarty, MD⁸; Jennifer G. Robinson, MD, MPH⁹; Peilin Shi, PhD¹; Josefina F. Tur, MD¹⁰; Jean-François Lapointe, PhD¹¹; Sarya Aziz, PhD¹¹; Pierre Lemieux, PhD¹¹; for the TRILOGY (Study of CaPre in Lowering Very High Triglycerides) investigators.  JAMA Netw Open. 2022;5(1):e2141898. doi:10.1001/jamanetworkopen.2021.41898

Method: The investigators pooled data from two previous trials of people given Krill oil or a cornstarch placebo for 26 weeks.

Results: “This study found that ω-3 –PL/FFA, a novel krill oil–derived ω-3 formulation, reduced TG levels and was safe and well tolerated in patients with severe hypertriglyceridemia.”

Funding/Support:The study was sponsored by Acasti Pharma Inc. [Acasti partners with Aker to make Krill oil]

Role of the Funder/Sponsor: The sponsor collaborated with the academic principal investigator (Dr Mozaffarian) in the design and conduct of the study, interpretation of the data, and review and suggestions for editing of the manuscript. The sponsor collaborated with the academic principal investigator and an independent contract research organization (IQVIA) in study implementation, data collection, and management. The sponsor had no role in the analysis of the data or the decision to submit the manuscript for publication.

Conflict of Interest Disclosures: Dr Mozaffarian reported serving as a consultant for Acasti Pharma Inc as principal investigator of this trial; receiving research funding from the National Institutes of Health, the Gates Foundation, and the Rockefeller Foundation; personal fees from Barilla, Cleveland Clinic Foundation, Danone SA, and Motif FoodWorks; chapter royalties from UpToDate; serving on the scientific advisory board of Beren Therapeutics PBC, Brightseed, Calibrate, DayTwo (ended June 2020), Elysium Health, Filtricine Inc, Foodome Inc, HumanCo, January, Perfect Day Inc, Season, and Tiny Organics; and holding stock ownership in Calibrate and HumanCo outside the submitted work. Dr Maki reported receiving research grants from and consulting for Acasti Pharma Inc and Matinas BioPharma Holdings Inc, and receiving research funding from Indiana University Foundation, Pharmavite, Novo Nordisk A/S, General Mills Inc, The Kellogg Company, and PepsiCo Inc, and consulting for 89bio Inc, and NewAmsterdam Pharma outside the submitted work. Dr Bays reported receiving research grants from Acasti Pharma Inc. Dr Aguilera reported receiving research grants from Acasti Pharma Inc. Dr Gould reported receiving research grants from Acasti Pharma Inc. Dr Hegele reported receiving research grants from Acasti Pharma Inc and personal fees from Akcea-Ionis, Amgen Inc, Arrowhead Pharmaceuticals, HLS Therapeutics Inc, Novartis International AG, and Pfizer Inc outside the submitted work. Dr Moriarty reported receiving research grants from Acasti Pharma Inc. Dr Robinson reported receiving research grants to the institution from Acasti Pharma Inc, Amarin Corporation, Amgen Inc, Astra-Zeneca, Eli Lilly & Co, Esperion Therapeutics Inc, The Medicines Company, Merck & Co Inc, Novartis International AG, Novo Nordisk A/S, and Regeneron Pharmaceuticals Inc, and consulting fees from COR2ED, Getz Pharma Limited, The Medicines Company, and Novartis International AG. Dr Shi reported consulting for Acasti Pharma Inc for performing statistical analyses on this trial. Dr Tur reported receiving research grants from Acasti Pharma Inc. Dr Lapointe reported owning stock or stock options in Acasti Pharma Inc. Dr Aziz reported owning stock or stock options in Acasti Pharma Inc. Dr Lemieux reported serving chief operating officer/chief strategy officer of Acasti Pharma Inc during the conduct of the study and outside the submitted work and holding a patent for CaPre. No other disclosures were reported. [My emphasis]

Comment: You can’t make this stuff up.

Reference: For research on why and how industry sponsorship can influence study outcome, see Unsavory Truth: How Food Companies Skew the Science of What We Eat.

Tara Kenny, a postdoctoral researcher in Ireland sent me this one.

The paper: Perspective Nutrition research challenges and processed food and health. Michael J. Gibney and Ciarán Forde. Nature Food, 2022.

Purpose: “If public health nutrition is to consider the degree of food processing as an important element of the link between food and health, certain gaps in research must be acknowledged.”

Method: The paper compares and critiques differing classification systems for processed foods, emphasizes the physical and sensory aspects of food products as reasons for consumption, and suggests areas for further research.

Conclusion: “The NOVA recommendation that HPFs be avoided poses a considerable challenge, given that a wide body of evidence across the globe shows that almost two-thirds of all energy comes from HPFs…Finally, notwithstanding the opposition of NOVA to the reformulation of HPFs, the value of this approach is internationally recognized.”

Competing interests: “M.J.G. has engaged in paid and non-paid consultancy for a wide range of food companies that manufacture processed foods. He has provided online presentations on ultraprocessed foods to the staff of Unilever and Mondelez. C.G.F. is currently a paid member of the Kerry Health and Nutrition Institute.”

Comment: The paper is a critique of the term ultra-processed (the authors prefer Highly Processed Foods or HPF), of the NOVA classification system for levels of food processing, and of the idea that ultra-processed foods continue to remain in the category of ultra-processed even when reformulated.

Dr. Kenny provided a deeper analysis of the conflicts of interest inherent in this paper; she read the references to several statements in the paragraph that follows the subtitle, “First, do no harm”.

• Ample evidence exists to show that there are no differences in postprandial glucose or insulin response following the ingestion of breads, varying from wholegrain to white and to those with and without additives (Breen et al & Gibney, MRC Human Nutrition Research, Government Agency)
• Similarly, studies show that the nutrient intakes of infants fed on home-prepared infant and toddler foods are not materially different to those of infants fed on industrially prepared products with the exception of sodium, which was higher in the infants fed with home-prepared foods (Reidy et al, 2018 – lead author is head of Nutrition Science for Baby Food, Nestlé Infant Nutrition, Global R&D and leads the Feeding Infants and Toddlers Studies globally. Three additional authors are also Nestle employees).
• Breakfast cereals, normally served with milk, make a very important contribution to micronutrient intake (Gibney et al, 2018 – funded by Cereal Partners Worldwide and General Mills Inc.)
• The advent of low-fat spreads optimized for fatty-acid profile have contributed to a substantial reduction in the intake of saturated fatty acids (Li et al & Gibney).
• Beverages sweetened with artificial sweeteners help reduce the intake of added sugars. These filters should also include foods that are generally regarded as ‘treats’ that have a negligible population impact on nutrient intake (for example, ice cream and chocolate). For example, a study of chocolate intake in 11 European countries showed that the contribution of chocolate to added sugar intake averaged 5% (Azaïs-Braesco et al, funded by Danone Nutricia Research)…”.

She also provided a link to a much more detailed conflict-of-interest statement filed as a correction to another paper co-authored by Mike Gibney.

I’ve written frequently about ultra-processed foods and why I think the NOVA classification is so useful.  See, for example, this post (the classification system) and this one (Kevin Hall’s study).

Despite the opinions expressed in the Nature Food paper, reducing intake of ultra-processed foods seems like a really good idea.

Larissa Zimberoff, the author of Technically Food (which I blurbed and reviewed), forwarded  this press release from the University of California Berkeley:  Global elimination of meat production could save the planet.  

A new study of the climate impacts of raising animals for food concludes that phasing out all animal agriculture has the potential to substantially alter the trajectory of global warming.  The work is a collaboration between Michael Eisen, professor of molecular and cell biology at the University of California, Berkeley, and Patrick Brown, professor emeritus of biochemistry at Stanford University and the CEO of Impossible Foods Inc., a company that sells plant-based meat substitutes.

The study: Rapid global phaseout of animal agriculture has the potential to stabilize greenhouse gas levels for 30 years and offset 68 percent of CO₂ emissions this century.  Michael B. Eisen, Patrick O. Brown.   PLoS Climate. 2022;1(2).  https://doi.org/10.1371/journal.pclm.0000010 

Method: The authors modeled the combined, long-term effects of emission reductions and biomass recovery that would be unlocked by a phaseout of animal agriculture.

Findings:  A phaseout of livestock production would provide half of the net emission reductions necessary to limit warming to 2°C

Conclusion: The magnitude and rapidity of these potential effects should place the reduction or elimination of animal agriculture at the forefront of strategies for averting disastrous climate change.

Funding:  There was no formal funding of this work. Michael Eisen is an Investigator with the Howard Hughes Medical Institute which funds all work in his lab. Patrick Brown is CEO of Impossible Foods, Inc.

Thanks to Daniel Bowman Simon for pointing me to this one.

The study: Effect of Standardized Grape Powder Consumption on the Gut Microbiome of Healthy Subjects: A Pilot Study.  Jieping Yang, et al.  Nutrients. 2021 Nov; 13(11): 3965. doi: 10.3390/nu13113965

Methods: Study subjects had to eat 46 grams a day of grape powder (the equivalent of two daily grape servings) for 4 weeks.  Their microbiomes and serum cholesterol levels were compared to those observed during a baseline 4-week period.

Conclusions: “In conclusion, grape powder consumption significantly modified the gut microbiome and cholesterol/bile acid metabolism.”

Funding: This research was funded by California Table Grape Commission.

Conflicts of Interest: No potential conflict of interest was reported by the authors.

Comment: The authors see no conflicts of interest but they accepted funding from the Grape Commission for the study.  California grape producers issue requests for research proposals to demonstrate the health benefits of grapes using grape powder, so I’m guessing the authors applied for this funding.  As I explain in my book, Unsavory Truth, industry influence on research outcome is well documented, but often unrecognized by recipients.  Funders typically get what they pay for.  Does grape powder duplicate the nutritional benefits of grapes?  Hard to say.  Are any of these results clinically important?  Ditto.

To continue the thene of yesterday’s post, check out this report from the Global Health Advocacy Incubator (an international organization that supports advocacy).

The report documents the food industry’s strategies to defeat warning labels on ultra-processed food products (UPP).

1. Protect the UPP industry’s reputation and brands through corporate washing;
2. Influence policies through multilateral bodies to delay implementation and threaten countries with legal and economic concerns;
3. Divert attention from its corporate responsibility on the damage to environmental and human health to blame individuals for their behaviors;
4. Imply that their products contribute to health, the environment, and society while blocking the development and implementation of healthy food policies; and
5. Seek loopholes in regulations to continue promoting ultraprocessed products.

For example, here is how strategy #5 was implemented in Mexico:

Here, also for example, is image #27:

What should civil society organizations be doing to counter industry tactics?

• Monitor and unmask industry practices
• Use legal strategies
• Avoid loopholes, gaps, and ambiguities when developing labeling  policies
• Demand transparency and no conflicts of interest

This report is exceptionally well documented, covers an enormous range of countries, and gives a quick but compelling overview of how the food industry operates internationally to product product sales.

• Full report click here.
• Executive Summary
• Report’s microsite:  advocacy examples recommendetions.
• Webinar: English, Spanish, Portuguese

Let’s start 2022 off with a review sent to me by a reader who wishes to remain anonymous.

The review: Implementing the 2020–2025 Dietary Guidelines for Americans: Recommendations for a path forward. Sanders, L. M., Allen, J. C., Blankenship, J., Decker, E. A., Christ-Erwin, M., Hentges, E. J., Jones, J. M., Mohamedshah, F. Y., Ohlhorst, S. D., Ruff, J., &Wegner, J. (2021). J Food Sci. 86:5087–5099.  https://doi.org/10.1111/1750-3841.15969

Method: Based on a workshop aimed at developing strategies to promote adoption of dietary guideline recommendations.

Workshop funding: a grant from USDA with contributions from the Institute of Food Technologists.

Conflicts of interest: Mary Christ-Erwin is President and Owner of MCE Food and Agriculture Consulting and received an honorarium from the grant for moderating the meeting and panel and roundtable discussions. Julie M. Jones is a Scientific Advisor to USA Rice, Grain Foods Foundation, and the Quality Carbohydrate Coalition. John Ruff is an Investment Committee Member for Sathguru Catalyser Advisors Private Limited, the Asset Management Company of Innovation in Food and Agriculture Fund (IFA Fund) that invests in innovation-driven growth enterprises in the Food and Agriculture sectors, based in India. He is reimbursed for meeting fees and expenses related to attending committee meetings but has no investments in the fund. Lisa M. Sanders [Note: First author who wrote original draft] is the owner of Cornerstone Nutrition, LLC, a consultancy which has received funding from Kellogg Company, PepsiCo, and The Coca-Cola Company. Dr Sanders receivedwriting fees fromthe grant for development of this manuscript. JillWegner is an employee of Nestle. Jonathan C. Allen, Jeanne Blankenship, Eric A. Decker, Eric J.Hentges, Farida Y. Mohamedshah, and Sarah D. Ohlhorst have no conflicts to declare.

Comment: This workshop reflects a food industry perspective on the dietary guidelines.  Some of its reocmmendations make sense.  Others raise eyebrows, or should.

• The first recommendation: “Emphasize health benefits…gained through cooking at home.
• My favorite recommendation: “Leverage the current interest in science to debunk myths about food processing by demonstrating the similarity of techniques used to make foods at home and at scale in food industry, to show how food processing can contribute to the solution.”

This review is an excellent example of why the food industry needs to firmly excluded from nutrition policy discussions (for details on why, see my book, Unsavory Truth).

My strongest criticism of the 2020 dietary guidelines is that they fail to say anything about the health benefits of reducing consumption of ultra-processed foods (the junk food category strongly associated with excessive calorie intake, weight gain, and poor health).

Yet here we have a published review in a food science journal arguing for debunking “myths” about food processing.

They are not myths.  Evidence is abundant.

See, for example:

• Monteiro CA, Cannon G, Levy RB, et al.  Ultra-processed foods: what they are and how to identify them.  Public Health Nutr; 2019;22(5):936–941.
• Lawrence MA, Baker PI.  Ultra-processed food and adverse health outcomes.  BMJ. 2019 May 29;365:l2289.  doi: 10.1136/bmj.l2289.
• Hall KD, Ayuketah A, Brychta R, et al. Ultra-processed diets cause excess calorie intake and weight gain: an inpatient randomized controlled trial of ad libitum food intake [errata in Cell Metab. 2019;30(1):226 and Cell Metab. 2020;32(4):690]. Cell Metab. 2019;30(1):67–77.e3. doi: 10.1016/j.cmet.2019.05.008.

Two studies of the role of nuts in health.

I.  This one comes from ObesityandEnergetics.org’s “Headline vs. Study.”

Headline: Maximum Wellness: Walnuts are a Life-Extension Food:  “Looks like your [sic] nuts not to include walnuts in your diet. For more information and to read this study…go to maxwellnutrition.com, where you can find top wellness and nutrition products made in the United States – shipped to your door.”  [Comment: Clearly, we are dealing here with marketing]

Study: Association of Self-Reported Walnut Consumption with Total and Cause-Specific Mortality and Life Expectancy in U.S. Adults. Maximum Wellness nor Causation Necessarily Established.  Liu, X.; Guasch-Ferré, M.; Tobias, D.K.; Li, Y.  Nutrients 2021, 13, 2699. https://doi.org/ 10.3390/nu13082699

Conclusion: A greater life expectancy at age 60 (1.30 years in women and 1.26 years in men) was observed among those who consumed walnuts more than 5 servings/week compared to non-consumers.  Higher walnut consumption was associated with a lower risk of total and CVD mortality and a greater gained life expectancy among U.S. elder adults.  [Comment: association, not causation, and the difference is small].

Conflict of interest: The last (senior?) author reports having received research support from California Walnut Commission, but states that ” The funder has no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, and in the preparation, review, or in the decision to publish the results.”  [Comment: That’s what they all say, but research often demonstrates otherwise, as I review in my book Unsavory Truth].

And now for the second:

II.  Association of nut consumption with risk of total cancer and 5 specific cancers: evidence from 3 large prospective cohort studies.  Zhe Fang, You Wu, Yanping Li, Xuehong Zhang, Walter C Willett, A Heather Eliassen,1Bernard Rosner,
Mingyang Song, Lorelei A Mucci,and Edward L Giovannucci.  The American Journal of Clinical Nutrition, Volume 114, Issue 6, December 2021, Pages 1925–1935, https://doi.org/10.1093/ajcn/nqab295

Conclusion: In 3 large prospective cohorts, frequent nut consumption was not associated with risk of total cancer and common individual cancers.  [Comment: What? An industry-funded study that finds no benefuts?]

Funding: Supported by the California Walnut Commission and Swiss Re Management Ltd (to YL),… and NIH grants U01 CA167552 (to LAM and the Health Professionals Follow-up Study), UM1 CA186107 and P01 CA87969 (to the Nurses’ Health Study), and U01 CA176726 (to AHE and the Nurses’ Health Study II). The funding sources did not participate in the study design; or
collection, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript.

Here’s how the authors explain their highly unusual no-benefit result:

Given the scarcity of available high-quality data, our findings add to current evidence to more precisely determine the relation between nut consumption and cancer risk. So far, the population based evidence has not been strong enough to conclude that nut consumption is protective against total cancer and these 5 common cancers. Future studies on other cancer sites are still needed to examine the benefits of nuts on cancer development.

Really?  Why?  Do the authors not believe their own data?  Their findings ought to settle the matter and encourage the authors to move on to more significant research.  “More research needed” keeps the California Walnut Commission busy.

Research funded by food companies always requires a degree of skepticism, no matter what the results.

My thanks go to New Zealand reader Kirsten for sending this one.

The study: Exploring the Links between Diet and Inflammation: Dairy Foods as Case Studies. Julie M Hess, Charles B Stephensen, Mario Kratz, Bradley W Bolling.  Advances in Nutrition, Volume 12, Issue Supplement_1, October 2021, Pages 1S–13S,

Note: This article was intended as a review article based on presentations made by CBS, MK, and BWB at the American Society for Nutrition 2020 LIVE ONLINE Conference 7–10 June 2020.

Background: Systemic chronic inflammation may be a contributing factor to many noncommunicable diseases, including diabetes, cardiovascular disease, and obesity. An emerging body of evidence indicates that consuming certain foods, including dairy foods like milk, cheese, and yogurt, may be linked to a decreased risk for inflammation.

Method: Review of research on dairy foods and inflammation.

Conclusion: While there is currently insufficient evidence to prove an “anti-inflammatory” effect of dairy foods, the substantial body of clinical research discussed in this review indicates that dairy foods do not increase concentrations of biomarkers of chronic systemic inflammation.

Funding: The ASN Nutrition 2020 session that this article is based on was supported by the National Dairy Council. This support included honoraria for MK and BWB. The authors reported no funding received for this study.

Author disclosures: JMH was an employee of the National Dairy Council at the time this article was written. MK has received honoraria and reimbursements of travel costs as well as research funding from dairy-related organizations, including the National Dairy Council, Dairy Management, Inc., Dairy Farmers of Canada, the Dutch Dairy Organization (Nederlandse Zuivel Organisatie), Dairy Australia, and the French Dairy Interbranch Organization (CNIEL). BWB has received research funding for dairy-related projects from University of Wisconsin Dairy Innovation Hub, the National Dairy Council, and USDA National Institute of Food and Agriculture (NIFA) HATCH WIS02094. The other author reports no conflicts of interest.

Comment: This is a study by dairy-funded authors with an interesting spin.  The research review found no anti-inflammatory effect of dairy foods but concludes that they have a benefit: they don’t make inflammation worse.  I realize that dairy foods have a bad reputation among some eaters, but I wish the dairy industry didn’t sponsor research so blatantly in its self-interest.  I also wish we could get away from one-food research.  One food cannot possibly make a substantial difference in the diets of reasonably healthy people who eat a variety of foods.  I am all for eating dairy foods if you like them, especially from well-treated animals.  They have a place in healthful diets—or not ,if you don’t like or want to eat them.

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