Currently browsing posts about: Conflicts-of-interest

The study: Effects of Unsweetened Preloads and Preloads Sweetened with Caloric or Low-/No-Calorie [LNCS] Sweeteners on Subsequent Energy Intakes: A Systematic Review and Meta-Analysis of Controlled Human Intervention Studies.  Han Youl Lee, Maia Jack, Theresa Poon, Daniel Noori, Carolina Venditti, Samer Hamamji, Kathy Musa-Veloso.  Advances in Nutrition, nmaa157, https://doi.org/10.1093/advances/nmaa157

Conclusions:  “These findings suggest that LNCS-sweetened foods and beverages are viable alternatives to CS-sweetened foods and beverages to manage short-term energy intake.

Funder: The American Beverage Association provided funding for the work presented herein.

Author disclosures: MJ is a paid employee of the American Beverage Association. Intertek Health Sciences, Inc.(HYL, TP, DN, CV, SH, KMV), works for the American Beverage Association as paid scientific and regulatory consultants.

Comment: This is a study paid for by the American Beverage Association, a trade association for the makers of soft drinks, sweetened with sugars or artificial sweeteners, conducted in-house.  Its purpose is to demonstrate that artificial and low-calorie sweeteners will help you lose weight, something that independently funded studies often do not.  I’d classsify this as marketing research.  I don’t think it belongs in professional journals published by the American Society for Nutrition.  We need a new journal for this, as Corinna Hawkes of City University London once suggested, “The Journal of Industry-Funded Research.”

Selenium, antioxidants, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials. David JA Jenkins, David Kitts, Edward L Giovannucci, Sandhya Sahye-Pudaruth, Melanie Paquette, Sonia Blanco Mejia, Darshna Patel, Meaghan Kavanagh, Tom Tsirakis, Cyril WC Kendall, Sathish C Pichika, and John L Sievenpiper.  The American Journal of Clinical Nutrition, Volume 112, Issue 6, December 2020, Pages 1642–1652

Background: “Antioxidants have been promoted for cardiovascular disease (CVD) risk reduction and for the prevention of cancer. Our preliminary analysis suggested that only when selenium was present were antioxidant mixtures associated with reduced all-cause mortality.”

Results: No association of selenium alone or antioxidants was seen with CVD and all-cause mortality. However, a decreased risk with antioxidant mixtures was seen for CVD and all-cause mortality when selenium was part of the mix.

Conclusion: The addition of selenium should be considered for supplements containing antioxidant mixtures if they are to be associated with CVD and all-cause mortality risk reduction.

Comment: The results are statistically significant, but not by much (RR: 0.90; 95% CI: 0.82, 0.98; P = 0.02); the Confidence Interval reaches 0.98, which is very close to 1.00, which would show no difference.  But that’s not the real reason for my interest in this one.  The real reason in this astounding conflicts-of-interest statement and the disclaimer that follows it.

Conflicts of interest

DJAJ has received research grants from Loblaw Companies Ltd, the Almond Board of California, Soy Nutrition Institute (SNI), and the Canadian Institutes of Health Research (CIHR). He has received in-kind supplies for trials as a research support from the Almond Board of California, Walnut Council of California, American Peanut Council, Barilla, Unilever, Unico, Primo, Loblaw Companies, Quaker (Pepsico), Pristine Gourmet, Bunge Limited, Kellogg Canada, and WhiteWave Foods. He has been on the speakers’ panel, served on the scientific advisory board, and/or received travel support and/or honoraria from the Loblaw Companies Ltd, Diet Quality Photo Navigation (DQPN), Better Therapeutics (FareWell), Verywell, True Health Initiative (THI), Heali AI Corp, Institute of Food Technologists (IFT), Soy Nutrition Institure (SNI), Herbalife Nutrition Institute (HNI), Herbalife International, Pacific Health Laboratories, Nutritional Fundamentals for Health (NFH), the Soy Foods Association of North America, the Nutrition Foundation of Italy (NFI), the Toronto Knowledge Translation Group (St. Michael’s Hospital), the Canadian College of Naturopathic Medicine, The Hospital for Sick Children, the Canadian Nutrition Society (CNS), and the American Society of Nutrition (ASN). He received an honorarium from the USDA to present the 2013 W. O. Atwater Memorial Lecture. He is a member of the International Carbohydrate Quality Consortium (ICQC). His wife, Alexandra L Jenkins, is a director and partner of INQUIS Clinical Research for the Food Industry; his 2 daughters, Wendy Jenkins and Amy Jenkins, have published a vegetarian book that promotes the use of the plant foods advocated here, The Portfolio Diet for Cardiovascular Risk Reduction; and his sister, Caroline Brydson, received funding through a grant from the St. Michael’s Hospital Foundation to develop a cookbook for one of his studies. CWCK has received grants or research support from the Advanced Food Materials Network, Agriculture and Agri-Foods Canada (AAFC), Almond Board of California, American Peanut Council, Barilla, Canadian Institutes of Health Research (CIHR), Canola Council of Canada, International Nut and Dried Fruit Council, International Tree Nut Council Research and Education Foundation, Loblaw Brands Ltd, Pulse Canada, and Unilever. He has received in-kind research support from the Almond Board of California, American Peanut Council, Barilla, California Walnut Commission, Kellogg Canada, Loblaw Companies, Quaker (PepsiCo), Primo, Unico, Unilever, and WhiteWave Foods/Danone. He has received travel support and/or honoraria from the American Peanut Council, Barilla, California Walnut Commission, Canola Council of Canada, General Mills, International Nut and Dried Fruit Council, International Pasta Organization, Loblaw Brands Ltd, Nutrition Foundation of Italy, Oldways Preservation Trust, Paramount Farms, Peanut Institute, Pulse Canada, Sun-Maid, Tate & Lyle, Unilever, and White Wave Foods/Danone. He has served on the scientific advisory board for the International Tree Nut Council, International Pasta Organization, McCormick Science Institute, and Oldways Preservation Trust. He is a member of the International Carbohydrate Quality Consortium (ICQC), is Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD), is on the Clinical Practice Guidelines Expert Committee for Nutrition Therapy of the EASD and a director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. JLS has received research support from the Canadian Foundation for Innovation, Ontario Research Fund, Province of Ontario Ministry of Research and Innovation and Science, Canadian Institutes of Health Research (CIHR), Diabetes Canada, PSI Foundation, Banting and Best Diabetes Centre (BBDC), American Society for Nutrition (ASN), INC International Nut and Dried Fruit Council Foundation, National Dried Fruit Trade Association, The Tate and Lyle Nutritional Research Fund at the University of Toronto, The Glycemic Control and Cardiovascular Disease in Type 2 Diabetes Fund at the University of Toronto (a fund established by the Alberta Pulse Growers), and the Nutrition Trialists Fund at the University of Toronto (a fund established by an inaugural donation from the Calorie Control Council). He has received in-kind food donations to support a randomized controlled trial from the Almond Board of California, California Walnut Commission, American Peanut Council, Barilla, Unilever, Upfield, Unico/Primo, Loblaw Companies, Quaker, Kellogg Canada, WhiteWave Foods, and Nutrartis. He has received travel support, speaker fees, and/or honoraria from Diabetes Canada, Dairy Farmers of Canada, FoodMinds LLC, International Sweeteners Association, Nestlé, Pulse Canada, Canadian Society for Endocrinology and Metabolism (CSEM), GI Foundation, Abbott, Biofortis, ASN, Northern Ontario School of Medicine, INC Nutrition Research & Education Foundation, European Food Safety Authority (EFSA), Comité Européen des Fabricants de Sucre (CEFS), and Physicians Committee for Responsible Medicine. He has or has had ad hoc consulting arrangements with Perkins Coie LLP, Tate & Lyle, Wirtschaftliche Vereinigung Zucker e.V., and Inquis Clinical Research. He is a member of the European Fruit Juice Association Scientific Expert Panel and Soy Nutrition Institute (SNI) Scientific Advisory Committee. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, European Association for the Study of Diabetes (EASD), Canadian Cardiovascular Society (CCS), and Obesity Canada. He serves or has served as an unpaid scientific advisor for the Food, Nutrition, and Safety Program (FNSP) and the Technical Committee on Carbohydrates of the International Life Science Institute (ILSI) North America. He is a member of the International Carbohydrate Quality Consortium (ICQC), executive board member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His wife is an employee of AB InBev. DK, ELG, SS-P, MP, SBM, DP, MK, TT, and SCP have no conflicts of interest to declare.

Disclaimer: The authors have no relevant conflicts of interest over the past 4 y. DJAJ has received funds for dietary studies from Loblaws, which, during the course of his funding, acquired Shopper’s Drugmart, which is a pharmaceutical company that also sells supplements.

Comment: Here’s one reason why I am not a fan of dietary supplements.  Most independently funded studies show no significant benefit when they are given to healthy people.  The industry needs studies like these for marketing purposes.  I’m not, but if you are worried about selenium, try food.

I learned about this one from a press release: “Can eating mangoes reduce women’s facial wrinkles?”

A new study from researchers at the University of California, Davis, finds eating Ataulfo mangoes, also known as honey or Champagne mangoes, may have another benefit — reducing facial wrinkles in older women with fairer skin. The study was published in the journal Nutrients.

Postmenopausal women who ate a half cup of Ataulfo mangoes four times a week saw a 23 percent decrease in deep wrinkles after two months and a 20 percent decrease after four months.

Surely, this can’t be serious?  Who paid for this?

The study: Prospective Evaluation of Mango Fruit Intake on Facial Wrinkles and Erythema in Postmenopausal Women: A Randomized Clinical Pilot Study.  Vivien W. Fam, Roberta R. Holt Carl L. Keen, Raja K. Sivamani .  and Robert M. Hackman.  Nutrients 2020, 12(11), 3381; https://doi.org/10.3390/nu12113381

Method: Women were given either 85 g or 250 g of mangos to eat every day for 16 weeks.  Their wrinkles were photographed and measured before and after.

Conclusion: “The intake of 85 g of mangos reduced wrinkles in fair-skinned postmenopausal women, while an intake of 250 g showed the opposite effect.”

Funding: “This study was supported in part by a grant from the National Mango Board (NMB)…which also supplied the fresh mangos for the study. The NMB had no role in the study design, data collection, data analysis, manuscript preparation, or publication decision.”

Conflicts of Interest: The authors declare no conflict of interest.

Comment:  I love mangos (despite being somewhat allergic to them), but come on.  According to the press release, the researchers “said it’s unclear why consuming more mango would increase the severity of wrinkles but speculate that it may be related to a robust amount of sugar in the larger portion of mangoes.”  Another interpretation is that mangos have no effect (which makes more sense).  In any case, this study did not compare mangos to any other fruit.  This is a classic case of an industry-sponsored study coming out with results favorable to the sponsor’s interests and allowing those interests to be announced in a press release.  The authors may think industry sponsorship does not create a conflict of interest, but much evidence strongly suggests that it does (I reviewed that evidence in my book, Unsavory Truth).

Even after writing Unsavory Truth: How the Food Industry Skews the Science of What We Eat I could hardly believe this particular example.

The Study: Exploring the Influence of Alcohol Industry Funding in Observational Studies on Moderate Alcohol Consumption and Health.   Moniek Vos, Annick P M van Soest, Tim van Wingerden, Marion L Janse, Rick M Dijk, Rutger J Brouwer, Iris de Koning, Edith J M Feskens, Aafje Sierksma.  Advances in Nutrition, Volume 11, Issue 5, September 2020, Pages 1384–1391.

Methods:  This is a meta-analysis of meta-analyses of studies examining the health effects of alcohol consumption that are used as the basis of international guidelines for alcohol consumption.

Results and conclusions: “only a small proportion of observational studies in meta-analyses …are funded by the alcohol industry. Based on this selection of observational studies the association between moderate alcohol consumption and different health outcomes does not seem to be related to funding source.

Funding: “The authors reported no funding received for this study.”

Author disclosures: “MV, APMvS, TvW, MLJ, RMD, RJB, IdK, and AS were employed by the Dutch Beer Institute during the study and writing of the manuscript. This Institute is funded by Dutch Brewers, which is the trade organization of the 14 largest beer brewers in the Netherlands. EJMF reports no conflicts of interest.”

Comment: This one defies credulity: an industry-funded study—most authors work for the beer industry—of whether industry funding affects research outcome.

Guess what?  It didn’t find any effect.

For years, the alcohol industry has been working hard to convince regulators and the public that moderate drinking, especially of wine and beer, is not only harmless but actually improves health.  This study is an example of how this industry attempts to accomplish that goal.

For another egregious example, see this post.

When I saw the title of this study, I had two questions:

• Why would anyone do a study like this? (OK, in short-term studies, consuming water or soup before meals reduces immediate calorie consumption, but in the long term?)
• Who paid for it?  (Getting the answer to this one took some digging).

The study: Association between soup consumption and obesity: A systematic review with meta-analysis. M.Kuroda and K. Ninomiya. Physiology & Behavior,  Volume 225, 15 October 2020, 113103.

Conclusion: “soup consumption is significantly related to lower odds ratio of obesity…suggesting that soup consumption was inversely correlated with a risk of obesity.”

Marta Zaraska, the author of Meathooked: The History and Science of Our 2.5-Million-Year Obsession With Meat and, more recently, Growing Young: How Friendship, Optimism and Kindness Can Help You Live to 100, sent me this message:

While doing research on my 3rd book I stumbled upon a research paper in which the authors “forgot” to disclose connections to the meat industry. I thought this may be interesting to you. Here is a link to the paper – https://www.tandfonline.com/doi/full/10.1080/10408398.2020.1741505

And here is a link proving that the lead author is taking money from the meat industry – which was not disclosed in the paper: https://www.usi.edu/liberal-arts/focus-newsletter/liberal-arts-achievements/la-achievements-2018-2019/

I thought this was well worth a look.  The full paper is here.

Title: “Meat and mental health: a systematic review of meat abstention and depression, anxiety, and related phenomena.”  Dobersek U, et al.  Critical Reviews in Food Science and Nutrition, 2020, published ahead of print.

Method: This is an meta-analysis of previously published papers (18) that compared the psychologica health of meat consumers and meat abstainers.

Conclusion: “The majority of studies, and especially the higher quality studies, showed that those who avoided meat consumption had significantly higher rates or risk of depression, anxiety, and/or self-harm behaviors…Our study does not support meat avoidance as a strategy to benefit psychological health.”

When I saw this conclusion, I immediately wondered: “Who paid for this?”  Bingo!

Funding: This study was funded in part via an unrestricted research grant from the Beef Checkoff, through the National Cattlemen’s Beef Association. The sponsor of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report [for an interpretation of this last statement, see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat].

What got Marta Zaraska’s attention was the denial of conflicted interests related to this paper.

Disclosure: “No potential conflict of interest was reported by the author(s).”

But the University of Southern Indiana praises the 2018-2019 accomplishments of the first author of this paper as follows (my emphasis):

Dr. Urska Dobersek, assistant professor of Psychology, and her students presented their research, “Are levels of testosterone, willingness to cheat and exercise motives related?” and “The relationship between facial asymmetry and exercise” at the North American Society for the Psychology of Sport and Physical Activity national conference in Baltimore, Maryland.

Dobersek also received a $10,555 grant from the National Cattlemen’s Beef Association to conduct a systematic review on “Beef for a Happier and Healthier Life.“

Oops.  Omission of this grant gives the appearance of conflicted interest and should have been disclosed.  I hope the author corrects this oversight immediately.

If the other authors have similar connections to meat industry group, they too should disclose them.

Simón Barquera, who directs the Center for Research on Nutrition and Health at the National Institute of Public Health in Cuernavaca, sent me a copy of this letter, which he found on Twitter (but it’s no longer there):

It’s from the president of the Mexican Society of Nutrition and Endocrinology thanking Coca-Cola for donating Personal Protective Equipment to deal with Covid-19.

The Mexican Nutrition Society has a cozy relationship with Coca-Cola?

I wonder what that’s all about.

Conflicts of interest anyone?

Double-blind placebo controlled trial of the anxiolyticeffects of a standardized Echinacea extract.  József Haller,| Laszlo Krecsak| János Zámbori.  Phytotherapy Research.2019;1–9.

Conclusion: “These findings suggest that particular Echinacea preparations have significant beneficial effects on anxiety in humans.”

Conflict of interest statement: JH is one of the authors of a US patent on the anxiolytic effects Echinacea preparations.

Comment: I don’t usually bother to write about supplements because so little evidence supports their benefits over placebos.  This study finds small better-than-placebo benefits for this particular Echinacea supplement, presumably the one covered by the first author’s patent.  I’d be happier with independently funded research.  In the meantime, the European Food Safety Authority continues to have doubts.  Will this study make that agency change its collective mind?  We shall see.