Currently browsing posts about: Conflicts-of-interest

The study: Amone F, Spina A, Perri A, Lofaro D, Zaccaria V, Insolia V, Lirangi C, Puoci F, Nobile V. Standardized Grape (Vitis vinifera L.) Extract Improves Short- and Long-Term Cognitive Performances in Healthy Older Adults: A Randomized, Double-Blind, and Placebo-Controlled Trial. Foods. 2024; 13(18):2999. https://doi.org/10.3390/foods13182999

The headline:  “Just 2 handfuls of pistachios daily could help protect your eyesight.”

Really?  Let’s take a look.

The Study: Pistachio Consumption Increases Macular Pigment Optical Density in Healthy Adults: A Randomized Controlled Trial.  Scott, Tammy M et al.  The Journal of Nutrition, Volume 155, Issue 1, 168 – 174. 2024 Oct 18:S0022-3166(24)01099-X.   doi: 10.1016/j.tjnut.2024.10.022.

Background: Pistachios are a bioavailable source of the xanthophyll lutein. Along with zeaxanthin, these plant pigments are major components of macular pigment (MP) in the human retina. MP can be non-invasively measured and is referred to as MP optical density (MPOD). MPOD is modifiable with dietary interventions that include lutein and zeaxanthin (L/Z). Higher MPOD protects the eye from light damage and is positively associated with eye health.

Objectives: This dietary intervention study aimed to evaluate the effect of pistachio consumption on MPOD.

Method: This single-blinded, randomized controlled trial compared a 12-week pistachio intervention (2 oz/d) with usual diet (UD) on MPOD and serum L/Z in middle-aged to older healthy adults (n = 36) in a 1:1 randomization scheme.

Conclusions: The results of our study demonstrate that a dietary intervention with pistachios is efficacious in increasing MPOD in healthy adults selected for habitually low intake of L/Z and low baseline MPOD. This suggests that pistachio consumption could be an effective dietary strategy for preserving eye health. Future studies need to evaluate the generalizability of our findings to other populations.

Funding: This project was supported by the American Pistachio Growers, who had no role in the final design, conduct, or interpretation of this study. The project described was also supported by the National Center for Advancing Translational Sciences, National Institutes of Health, Award Number UM1TR004398. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Conflict of interest: Tammy M Scott reports financial support provided by American Pistachio Growers. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Comment: When I saw the title, I wanted to know immediately, “Who paid for this?”  If you eat foods containing lutein and zeaxanthin, the levels of those factors will increase.  No surprise.  Are pistachios the only or best way to do this?  That’s not what this study aimed to find out.  This, as is true of much (most) industry-funded studies, this one is more about marketing than science.

Charles Platkin sent me this  article from Food Manufacturing: “Eating pork linked with better handgrip strength, industry group says.”

I quickly found the The Pork Board’s press release.

And went right to the source.

The study: Jung A-J, Sharma A, Chung M, Wallace TC, Lee H-J. he Relationship of Pork Meat Consumption with Nutrient Intakes, Diet Quality, and Biomarkers of Health Status in Korean Older Adults.  Nutrients. 2024; 16(23):4188. https://doi.org/10.3390/nu16234188

Objectives: We evaluated the association between pork meat consumption and nutrient intake, diet quality, and biomarkers of health among older adults (age ≥ 65 years) in Korea.

Methods: Our analyses utilized dietary and health examination data from the 2016–2020 Korean National Health and Nutrition Examination Survey (n = 2068).

Results: Pork consumption was associated with  a higher intake of energy and [some] nutrients…Diet quality was modestly higher among…pork consumers. Differences in biomarkers were clinically irrelevant…Handgrip strength was slightly higher.

Conclusions: In Korean older adults, pork consumption may contribute to a higher intake of energy and most nutrients, improved diet quality scores, higher vegetable intake, and small improvements in health biomarkers.

Funding: Funding for this research was provided through an investigator-initiated educational grant from the National Pork Board (#22-056) to Think Healthy Group, LLC. The sponsor had no role in the design, analysis, interpretation, or presentation of the data or results. The authors and sponsor strictly adhered to the American Society for Nutrition’s guiding principles for private funding for food science and nutrition research. M.C. did not receive salary support or consulting fee from this grant.

Conflicts of interest”: T.C.W. has received scientific consulting fees as a current member of the Science Advisory Board for the National Pork Board. He has also received other investigator-initiated educational research grants from the National Pork Board. All other authors have no conflicts of interest to declare.

Comment: Applause to Food Manufacturing for noting the industry  source in its headline: “industry group says”.  Note the effect size: “small improvements in health biomarkers.”  Nevertheless, the Pork Board thought it was worth a press release—it had paid for the study, after all.  The Pork Board runs a USDA-sponsored checkoff program; it collects fees from pork producers and uses them for purposes like these.  Worth it?  A lot of pork producers don’t think so, but the USDA insists and manages it through its Agricultural Market Service.  I wonder if the new administration will take interest in such programs…?

A reader, Maria Birman, alerted me to this new report in Lancet Diabetes & Endocrinology from the 56-member Commission on the Definition and Diagnosis of Clinical Obesity.  The commission recommended shifting the definition and diagnostic criteria for obesity away from the BMI and instead defining obesity in two categories based on health status.

• Clinical obesity: signs and symptoms of organ or other dysfunctions; a disease requiring effective health care treatment
• Pre-clinical obesity: high levels of body fat but no signs of dysfunction but higher risk for chronic disease, requiring support for risk reduction.

Maria writes:

I’m astonished by the full two-page “declaration of interests” (no conflict there, of course not!). Naturally Eli Lilly and Novo Nordisk are very much interested in obesity being considered a disease, and a treatable one at that. And doctors and scientists paid by these companies authored this paper which is posed to be very influential.

I took a look at the conflict-of-interest statement.  It is indeed astonishing as it goes on and on for nearly two pages in four columns.

Maria saved me from having to go through the analysis.  Here are her counts.

• Of the 56 authors, 47 declared conflicts of interest; only 9 did not.
• All 8 authors on the steering committee declare financial ties to drug companies.
• Novo Nordisk (Ozempic, Wegovy) is mentioned 60 times by 38 authors.
• Eli Lilly (Zepbound) is mentioned 39 times by 27 authors.
• Authors report financial ties to other pharmaceutical companies: AstraZeneca, Pfizer, Merck, Johnson & Johnson, Eurodrug Laboratories, Sanofi., and others.
• Authors report consulting fees, fees for educational purposes, research grants, speaker fees, co-authorship of manuscripts, medical writing assistance, and personal honoraria as a consultant and speaker, among others.
• Authors report financial ties to food companies such as Nestlé, which makes the Vital Pursuit line marketed to people on Ozempic.

Comment

No question, the BMI is an imperfect measure of the health risks of obesity, although it works pretty well as a first step.  Defining obesity as a disease may well help get treatment for people who need it.

I wish we had a health care system that could help people with obesity find out whether they have the clinical or pre-clinical form.  In the absence of  a functional health care system, we have drugs—effective and without deleterious side effects for some people, but for the great majority, highly expensive and hard to get.

This commission appears as an arm of the pharmaceutical industry.  Its findings require careful scrutiny.

In its scientific report, the 2025-2030 Dietary Guidelines Advisory Committee recommends substituting plant proteins for animal proteins.

The Committee recommends that the proposed Eat Healthy Your Way Dietary Pattern emphasizes dietary intakes of beans, peas, and lentils while reducing intakes of red and processed meats….The Committee also proposes reorganizing the order of the Protein Foods Group to list Beans, Peas, and Lentils first, followed by Nuts, Seeds, and Soy products, then Seafood, and finally Meats, Poultry, and Eggs.

It did not take long for the meat industry to respond: Animal vs. Plant Protein: New Research Suggests That These Protein Sources Are Not Nutritionally Equivalent.

As is my habit, I went right to the study.

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

Conclusions: “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: Amino acids, the building blocks of protein, are the same whether they come from plants or animals (or us).  Food animals are closer to us evolutionarily than are plants; the animo acid composition of their proteins is more like ours than the amino acid composition of food plants.  That is why protein complementarity matters; mix and match the plants you eat and their amino acid compositions will complement each other and fill in the gaps.  This doesn’t even have to be done at every meal.  Overall, it’s easier to get the needed amino acids from animal foods but it’s not all that hard to get them from plants as long as they are varied and you eat enough of them.  So the study isn’t wrong; it’s just not telling the whole story.

Thanks to Kevin Mitchell for sending this one.

Jung J-S, Choi G-H, Lee H, Ko Y, Ji S. The Clinical Effect of a Propolis and Mangosteen Extract Complex in Subjects with Gingivitis: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial. Nutrients 2024, 16(17), 3000; https://doi.org/10.3390/nu16173000

Results:  The results revealed that the PMEC group showed a significantly reduced expression of all measured GCF biomarkers compared to the placebo group (p < 0.0001) at 8 weeks, including substantial reductions in IL-1β, PGE2, MMP-8, and MMP-9 levels compared to the baseline. While clinical parameters trended towards improvement in both groups, the intergroup differences were not statistically significant.

Conclusion: These findings suggest that PMEC consumption can attenuate gingival inflammation and mitigate periodontal tissue destruction by modulating key inflammatory mediators in gingival tissue.

Funding: This research was funded by Medibio Lab Co., Ltd.

Conflicts of interest: The authors declare no conflicts of interest. The authors declare that this study received funding from Lab Co., Ltd. The funders had no role in the design of this study; in the collection, analyses, or interpretation of data; in the writing of this manuscript; or in the decision to publish the results.

Comment: This is a typical industry-funded study in which the authors put a positive interpretation of what appear to be null findings.  I can’t quite tell what this sponsoring company is.  One possibility is MediBioKorea.  Another is Medibios.  Both make supplements.

[Apologies for sending this out yesterday (in error).  I’ve added a few things.]

Such an odd time we live in, with politics making increasingly strange bedfellows, this time with the American Council on Science and Health, an industry front group if there ever was one.

Yet here it is with two articles on the looming threat of bird flu.

USDA’s Dereliction in Containing Bird Flu Could Cause Calamitous Pandemic (Part 1) An inherent conflict of interest – USDA both regulating and promoting livestock industries – prevents appropriate responses to outbreaks of infectious disease. READ MORE

The government’s inaction has allowed H5N1 to spread with remarkably little attention. The virus has now affected at least 446 dairy herds in 15 states and more than 100 million birds, mostly commercial poultry, in addition to the documented human cases…USDA is the primary culprit in this failure. The department is tasked with two conflicting roles: protecting the health and safety of the nation’s livestock while promoting and protecting the $174.2 billion agriculture industry. Sick cows with a novel strain of bird flu do not bode well for business, especially for a dairy sector that exports millions of tons of milk, cheese, and other products globally each year.

Shortly after the March detection of H5N1, USDA imposed what amounts to a gag order on its employees, according to insiders. State veterinarians began receiving private phone calls from their USDA colleagues, who told them to refrain from discussing the outbreak without prior approval. This information embargo severely hindered the response from the start.

How Bureaucratic Infighting, Dairy Industry Lobbying Have Worsened H5N1 Bird Flu Outbreak (Part 2): There is an inherent conflict of interest – and the potential for injury to public health – when a federal department both regulates and promotes an industry. Nowhere is this more evident than at USDA. READ MORE

While the White House pushed for a response focused on public health, the USDA and the Food and Drug Administration (FDA), which share jurisdiction over the production, transportation, and storage of eggs, seemed more concerned with protecting the interests of the dairy industry. Dairy representatives worried that the virus and subsequent restrictions could cripple their business…According to a former USDA official, dairy industry insiders were alarmed that White House staff were contacting them directly, bypassing the usual channels through the USDA. State veterinarians reported they were told to discontinue routine calls with the USDA’s veterinary services. This exacerbated the communication rift between the White House and the USDA.

The USDA had historically relied on the cooperation of farmers and industry stakeholders, and the bureaucrats feared losing that trust. In contrast, the White House’s OPPR and its public health allies grew increasingly frustrated as the USDA dragged its feet and adopted an approach that seemed to be, “If you don’t test, you don’t know.” This tension and communication failures have come to define the fractured nature of the government’s response to the H5N1 outbreak.

Comment: much of this sounds familiar.  As with any food safety issue, testing protects the public but puts companies at risk.  If testing finds something, companies have to do something: recall products, cull animals, or other things that will cut into profits.  Bird flu is a looming threat to humans; only 55 cases have been detected so far, but as the disease spreads among cattle, cases could increase.  Federal agencies should be doing everything they can to stop this threat.  Let’s hope.

In the meantime, the USDA says it is taking action: USDA Builds on Actions to Protect Livestock and Public Health from H5N1 Avian Influenza.

Since this disease was first detected in dairy cattle in March 2024, the USDA and state and federal partners have taken several steps to better understand the virus and work to eliminate it from dairy herds. In May 2024, USDA implemented a Federal Order to require the testing of cattle before interstate movement, which has helped to limit H5N1’s spread to new states; in the past 30 days, the number of states with known avian influenza detections in dairy herds has dropped from 14 to two. However, USDA believes that additional steps are needed to proactively support effective biosecurity measures, which are key for states and farmers to contain and eliminate H5N1 infections from their livestock.

Plant-Based Meat Analogs and Their Effects on Cardiometabolic Health: An 8-Week Randomized Controlled Trial Comparing Plant-Based Meat Analogs With Their Corresponding Animal-Based Foods. Toh DWK, Fu AS, Mehta KA, Lam NYL, Haldar S, Henry CJ. Am J Clin Nutr. 2024 Jun;119(6):1405-1416. doi: 10.1016/j.ajcnut.2024.04.006. Epub 2024 Apr 8.

Erratum in: Am J Clin Nutr. 2024 Aug;120(2):459. doi: 10.1016/j.ajcnut.2024.06.012.

This study compared effects on cardiometabolic health among people eating meat or plan-based alternatives for 8 weeks.

Conclusion: An 8-wk PBMA (plant-based) diet did not show widespread cardiometabolic health benefits compared with a corresponding meat based diet.

Funding: This study was supported by Pinduoduo Incorporated (HongKong Walnut Street Limited). Pinduoduo Incorporated had no role in study design, study conduct, laboratory analyses, data collection, management and interpretation or the writing, reviewing and approval of the manuscript.

Comment

This study was sent to me by a reader, who viewed it as a rare example of an industry-funded study with results unfavorable to the sponsor’s interests.  He thought the “Walnut” in the company’s name indicated a plant-based bias.

I wasn’t so sure and wondered what Pinduoduo did, exactly.

According to Wikipedia, “Pinduoduo Inc. (Chinese: 拼多多; Pinyin: Pīn duōduō) is a Chinese online retailer with a focus on the traditional agriculture industry. The business is the largest product of PDD Holdings, which also owns the online marketplace Temu.”

But it gets even better.  The American Journal of Clinical Nutrition published a correction to the paper:

The original funding statement was insufficiently elaborated and has been revised for greater clarity: Christiani Jeyakumar Henry [the senior investigator on this study] reports partial financial support provided by Pinduoduo Incorporated (HongKong Walnut Street Limited) which is an agricultural research firm.

This, then, is a standard example of an industry-funded—and conducted—study producing just the results wanted.  Another example of marketing research, alas.