Currently browsing posts about: Conflicts-of-interest

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.

I spent a lot of time last week responding to reporters’ questions about Trump’s appointing Robert F. Kennedy, Jr to head the Department of Health and Human Services.

Here’s what the president-elect said about the appointment on Twitter (X):

For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health…HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country. Mr. Kennedy will restore these Agencies to the traditions of Gold Standard Scientific Research, and beacons of Transparency, to end the Chronic Disease epidemic, and to Make America Great and Healthy Again!

Trump has instructed Mr. Kennedy to end chronic disease and “Go wild on food.”

In various statements, Mr. Kennedy has said he wants to get rid of “poisons”

• Ultra-processed foods in schools
• Artificial colors in cereals
• Chemicals, pollutants, pesticides
• Mercury in fish
• Fast food

He also wants to

• Restrict sodas on SNAP
• Promote sustainable, regenerative farming by small farmers
• End conflicts of interest between government agencies and corporations: Corporate capture is the biggest threat to democracy.

These are the kinds of things I’ve been saying and writing about for decades!

[He also is pushing for some things that are much less well grounded in science: getting rid of grains for kids, seed oils, and fluoride in drinking water; deregulating raw milk; and firing all nutrition scientists on day 1].

If he really does do what he’s promising here, it means taking on the food industry, in a way that no government has ever done, and Trump showed no signs of doing in his first term.

What can we expect?  I have no idea, but thist sure will be interesting to watch.

Mother Jones calls Kennedy’s appointment “a genuine catastrophe.”

For charges of hypocrisy, click here.

Civil Eats asked a bunch of people to predict “The Path Forward for Food and Ag.”  Here’s what I said.

I wish I had a crystal ball to say how food and agriculture issues would play out over the next four years, but all I have to go on is what Trump and his followers say. If we take them at their word, then we must expect them to implement their Project 2025 plan, which replaces one deep state with another that favors conservative business interests and ideology. This calls for replacing staff in federal agencies with Trump loyalists and dismantling them, stopping the USDA from doing anything to prevent climate change, reforming farm subsidies (unclear how), splitting the farm bill to deal separately with agricultural supports and SNAP, reducing SNAP participation by reinstating work requirements and reducing the Thrifty Food Plan, and making it more difficult for kids to participate in school meals.

On the other hand, some of the plans make sense: eliminating checkoff programs and repealing the sugar program, for example. So do some of Robert F. Kennedy, Jr.’s goals: Make America Healthy Again by focusing on chronic disease prevention, getting harmful chemicals out of kids’ foods, and getting rid of conflicts of interest among researchers and agency staff. It’s too early to know how much of this is just talk, but I’m planning to do what I can to oppose measures I view as harmful, but to strongly support the ones I think will be good for public health.

No food industry is too small or too obscure to fund research in its own interest.  Try this one, for example.

Effects of Supplementation with a Microalgae Extract from Phaeodactylum tricornutum Containing Fucoxanthin on Cognition and Markers of Health in Older Individuals with Perceptions of Cognitive Decline. Yoo C, Maury J, Gonzalez DE, Ko J, Xing D, Jenkins V, Dickerson B, Leonard M, Estes L, Johnson S, et al.  Nutrients. 2024; 16(17):2999. https://doi.org/10.3390/nu16172999

Background: Phaeodactylum tricornutum (PT) is a microalgae extract that contains fucoxanthin and has been shown to enhance cognitive function in younger populations.

Purpose: The present study assessed if PT supplementation affects cognition in healthy, young-old, physically active adults with self-perceptions of cognitive and memory decline.

Methods: Forty-three males and females…with perceptions of cognitive and memory decline completed the double-blind, randomized, parallel-arm, placebo-controlled intervention clinical trial. Participants were…randomly allocated to their respective 12-week supplementation interventions, which were either the placebo (PL) or 1100 mg/day of PT containing 8.8 mg of fucoxanthin (FX).

Results: FX supplementation significantly affected (p < 0.05) or exhibited tendencies toward significance (p > 0.05 to p < 0.10 with effect sizes ranging from medium to large) for word recall, picture recognition reaction time, Stroop color–word test, choice reaction time, and digit vigilance test variables.

Conclusions: The results demonstrate some evidence that FX supplementation can improve working and secondary memory, vigilance, attention, accuracy, and executive function.

Funding: Microphyt (Baillargues, FRA) funded this study through a grant (Microphyt #410991) to Texas A&M University.

Conflicts of interest: J.M. and R.P. are sponsor-affiliated researchers who therefore have conflicts of interest in study results. They provided input on study design but were not involved in data collection or analysis. R.B.K. has conducted grant and contract-funded research on nutritional supplements awarded to the universities he has been affiliated with, received an honorarium for making scientific presentations, and served as a paid scientific expert. He has no financial conflicts of interest with the study sponsor or product evaluated in this study. The remaining coauthors report no financial conflicts of interest.

Comment: I like “some evidence.”  That suggests the evidence is not particularly impressive.  The study found positive conclusions, not surprising since two of the authors work for the sponsoring company.  Industry-funded studies almost invariably find conclusions that favor the sponsor’s interests.  Otherwise, why bother to sponsor research.  That’s its point: marketing.

Thanks to Stephen Zwick of Regenetarianism for sending this one.

Charoenwoodhipong, P., Zuelch, M. L., Keen, C. L., Hackman, R. M., & Holt, R. R. (2024). Strawberry (Fragaria x Ananassa) intake on human health and disease outcomes: a comprehensive literature review. Critical Reviews in Food Science and Nutrition, 1–31. https://doi.org/10.1080/10408398.2024.2398634

From the Abstract

Of the 60 articles included in this review, 47 were clinical trials, while 13 were observational studies. A majority of these studies reported on the influence of strawberry intake on cardiometabolic outcomes. Study designs included those examining the influence of strawberry intake during the postprandial period, short-term trials randomized with a control, or a single arm intake period controlling with a low polyphenolic diet or no strawberry intake. A smaller proportion of studies included in this review examined the influence of strawberry intake on additional outcomes of aging including bone and brain health, and cancer risk. Data support that the inclusion of strawberries into the diet can have positive impacts during the postprandial period, with daily intake improving outcomes of lipid metabolism and inflammation in those at increased cardiovascular risk.

Funding: This work was supported by the California Strawberry Commission (CSC). PC, MLZ, and RRH received financial support from the CSC for this work.

Disclosure statement: No potential conflict of interest was reported by the authors.

Comment: I can never get over how industry-funded authors do not view industry funding as a conflict of interest when so much evidence confirms that such funding strongly influences research design and interpretation.  For the record, I review that evidence in my book Unsavory Truth: How Food Companies Skew the Science of What We Eat.

This sure looks like a standard industry-funded study with a predictable outcome favorable to the strawberry industry in this case.

Strawberries are a fine food, delicious, nutritious, and obviously healthful.  But a superfood responsible on their own for disease prevention?

How I wish.

This is marketing research.

I saw this on Twitter (X):

For the video, click here.

I’m for all three actions.  I’ve argued for years for getting rid of conflicts of interest and focusing resources on preventing chronic disease.

I can’t wait to find out how the new administration plans to accomplish these goals.   We all need to hold it accountable for delivering on these promises.

Potatoes, a source of rapidly absorbable starch, have such a bad reputation that some nutritionists advise against eating them.  I am not one of them.  I enjoy eating potatoes and think their blood sugar-raising effects depend on how they are prepared and how muh of them you eat.

The potato industry, alarmed about advice not to eat potatoes, funds research to prove they are healthy, or at least do no harm.  Hence:

Djousse L, Zhou X, Lim J, Kim E, Sesso HD, Lee IM, Buring JE, McClelland RL, Gaziano JM, Steffen LM, Manson JE. Potato Consumption and Risk of Type 2 Diabetes Mellitus: A Harmonized Analysis of 7 Prospective Cohorts. J Nutr. 2024 Oct;154(10):3079-3087. doi: 10.1016/j.tjnut.2024.07.020.

• Results: In the primary analysis, total potato intake was not associated with T2D risk:…In secondary analyses, consumption of combined baked, boiled, and mashed potatoes was not associated with T2D risk, whereas fried potato consumption was positively associated with T2D risk:.
• Conclusions: Although consumption of total potato is not associated with T2D risk, a modest elevated risk of T2D is observed with fried potato consumption.
• Conflict of interest: LD received investigator-initiated grant from the Alliance for Potato Research and Education (as principal investigator).
• Funding: This project was supported by a grant from the Alliance Potato Research and Education (principal investigator: LD).  A lengthy list of other funders, including NIH and Mars Edge, follows.

Comment: This potato industry-funded study did not find potatoes to be associated with type 2 diabetes, which must be a huge relief to this industry. But the study did find a weak association (barely statistically significant) beween fried potatoes and type 2 diabetes.  The Potato Alliance ought to be delighted with this result.   I’m guessing the result is real (it’s what I would have predicted), but I’d be happier with it if it had been conducted by investigators independent of industry funding.  As it is, it looks like the potato industry got what it paid for.