Currently browsing posts about: Sponsored-research

Every now and then, someone sends me something about industry-funded research that does my work for me.  Here is an example.

I received this e-mailed message from John Andrews (reproduced with permission).

I’m sure others will have shared this with you, but as someone primed by reading your work to dig into authors’ backgrounds, I couldn’t help but notice some aspects of a new special issue of Animal Frontiers on ‘The Societal Role of Meat’ (link) that you might be interested to see. There are 36 authors across the special issue, but to highlight just a handful:

• Peer Ederer, guest editor and co-author of the introduction article, has his affiliation listed as ‘GOALScience at Global Food And Agriculture Network’ in Switzerland. However, the website of GOALScience describes themselves as an initiative of the ‘Global Food and Agribusiness Network’ (my italics), and describes itself as a commercial entity that operates as a “service to the global livestock stakeholder community” (link). The paper Ederer et al in the special issue (link) has a conflict of interest statement: “None declared.”
• Thompson et al (link) lists among its authors Jason Rowntree. Rowntree is described in his biography as having worked with the Savory Institute to develop its ‘Ecological Outcome Verification’ scheme for livestock farming. Rowntree’s biography on his university page describes him as an ‘advisor and educator’ to the Savory Institute. Savory’s website indicates that Rowntree’s university is what’s called a ‘Savory Hub’, and that Rowntree has at some point been ‘Hub leader’ (link). Rowntree is also co-lead on a $19mn research project in which Savory is a partner (link). The conflicts of interest statement for the article: “None declared”.
• Rod Polkinghorne, co-author of the perspective article (link), describes himself on his LinkedIn as “actively involved with the beef industry”. In fairness, his biography in the special issue does not disguise this, and the perspective article does not contain a conflict of interest statement of any kind.

I don’t want to suggest that this is particularly surprising in a journal that has a longstanding partnership with the American Meat Science Association, which partnership is not at all hidden (e.g. the journal’s ‘about’ page and Dilger, 2020). But the special issue is noteworthy as the claimed evidence base to support the ‘Dublin Declaration’ on the ‘societal role of livestock’, reported in the press in classic fashion (a Daily Telegraph headline in the UK reads ‘Meat is crucial for human health, scientists warn’), and actively being used as part of the current lobbying battles around EU environmental legislation (see e.g. here).

Perhaps I just don’t understand the subtleties of the term ‘conflict of interest’ well enough…

Comment: Thanks for all this.  Yes, industry connections like these pose conflicts.  These authors—and the journal in which they publish—have financial ties to an industry with an economic stake in the results of studies and the opinions of authors.

Indeed, these particular conflicts of interest are so evident that The Guardian did an article about them:  Revealed: The livestock consultants behind the Dublin Declaration of Scientists.

While I’m at it, let me toss in one more as an example of how meat industry funding works.

The study: Higher muscle protein synthesis rates following ingestion of an omnivorous meal compared with an isocaloric and isonitrogenous vegan meal in healthy, older adults (thanks to Charles Platkin for sending this one).

Conclusion: “Ingestion of a whole-food omnivorous meal containing beef results in greater postprandial muscle protein synthesis rates when compared with the ingestion of an isonitrogenous whole-food vegan meal in healthy, older adults.”

Funding: “This study was funded in part by The Beef Checkoff, Denver, USA, and Vion Food Group, Boxtel, The Netherlands.”

When I see a title like this, I can guess who paid for the study.  Not good.

I learned about this one from NutraIngredients-Europe:

The ‘promising’ role of saffron in stress resilience:  New research conducted in partnership with botanical product manufacturer Pharmactive reveals that its standardized saffron extract Affron was able to normalise HPA [hypothalamic-pituitary-adrenal] axis dysregulation following chronic mild stress stimulation in a rat model…. Read more

I thought this was worth a closer look and went right to the paper.

Effects of Saffron Extract (Affron^®) with 100 mg/kg and 200 mg/kg on Hypothalamic–Pituitary–Adrenal Axis and Stress Resilience in Chronic Mild Stress-Induced Depression in Wistar Rats. Nutrients 2023, 15(23), 4855; https://doi.org/10.3390/nu15234855

Conclusion: These findings elucidate AFN’s [Affron^®] role in stress mitigation, affirm its health benefits, validate its potential as a treatment for stress-related symptoms, confirm its physiological effectiveness, and emphasize its therapeutic promise.

Guess who generated and conducted this study.

Conflict of interest statement: For commercial affiliations, J.K. and S.Y. were employed by the company iCONNECTOME Co., Ltd., which had the roles of curation, formal analysis, and visualization in this study; S.-S.Y. was employed by the company iCONNECTOME Co.,Ltd., which had the roles of conceptualization, funding acquisition, investigation, supervision, review and editing in this study; M.-Y.K. and J.S. were employed by the company Hyundai Bioland Co.,Ltd., which had the roles of methodology and/or writing original draft in this study; M.I.M.-V. was employed by the company Pharmactive Biotech S.L.U., which had the role of investigation in this study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

In case you wondered, Pharmactive Biotech makes Affron.  The other enterprises do the studies.

Who paid for this?

Funding: This research was funded by Hyundai Bioland Co., Ltd., grant number IC22_02, and Soonchunhyang University Research Fund. Hyundai Bioland Co., Ltd. had the following involvement with the study: participating in the research Investigation, and paid all costs for editing and publishing the Paper. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.

Comment: Huh?  I often suspect that the statement “the funder was not involved….” may not accurately represent the funder’s involvement (to put the matter politely).  In this case,  the role of Hyundai Bioland is self-contradictory.  Its employee-authors say they determined the study’s methods and/or wrote the paper, and the funder says it participated in the research but had no involvement in the study design, etc.  This is confusing, if not contradictory.

I do have to say something about marketing saffron as a superfood.  Saffron consists of the stigmas of crocus flowers, and these are hugely expensive.  Walmart is selling 2 grams for $42.

The Wikipedia entry iexplains why.

The high retail value of saffron is maintained on world markets because of labour-intensive harvesting methods, which require some 440,000 hand-picked saffron stigmas per kilogram…150,000 crocus flowers per kilogram…Forty hours of labour are needed to pick 150,000 flowers…One freshly picked crocus flower yields on average 30 mg of fresh saffron or 7 mg dried; roughly 150 flowers yield 1 g (1⁄32 oz) of dry saffron threads.

Once again, we have here an industry-funded marketing study pretending to be science.  But really, saffron?   OK, an extract that maybe can be synthesized, but still.  There have to be easier and less expensive ways to reduce stress and depression in rats.

Oh.  And in case you were wondering how scientists determine whether rats are depressed?

Our previous animal behavioral assays assessing anxiety and depression, including the elevated plus maze, forced swim, and sucrose preference tests, have revealed that AFN-treated animals (200 mg/kg) exhibit behaviors indicative of anhedonia and depression mitigation [27]. For example, increased consumption of sugar solutions and improved specific escape responses have been observed in forced swim tests.

Ref 27 is: Orio, L.; Alen, F.; Ballesta, A.; Martin, R.; Gomez de Heras, R. Antianhedonic and Antidepressant Effects of Affron^®, a Standardized Saffron (Crocus sativus L.) Extract. Molecules 2020, 25, 3207. [Google Scholar]

I have long argued that industry funded studies are about marketing, not science.

Here is a prime example (it caught my eye in Food News from the Institute of Food Technologists).

PR Newswire Cornell University partners with Danone and Symbrosia for new study: The study will aim to prove oil-based seaweed product has the potential to be more effective than existing solutions.  Read More

I went right to the source: a press release from Danone, North America: Cornell University College of Agriculture and Life Sciences Study, in partnership with Symbrosia and Danone North America, Aims to Prove Effectiveness of Seaweed Oil Extract for Livestock Methane Reduction.

Symbrosia, a Hawaii-based cleantech startup that uses seaweed to drastically reduce livestock methane emissions, is excited to announce a study with Cornell University’s College of Agriculture and Life Sciences (Cornell CALS), supported by Danone North America, a leading food and beverage company. Designed by Associate Professor Joe McFadden, the study aims to prove the effectiveness of an Asparagopsis-based seaweed oil extract for reducing livestock methane emissions compared to Symbrosia’s existing freeze-dried seaweed products…

As the press release explains, “The team’s plan [is] to ensure the study’s impact on the environment and sustainable agriculture is maximized.”

Thus, the purpose of this study—and the teams’ design plan—is explicit: to prove the superiority of this product.  That’s marketing, not science.

If it were about science, the investigators would design their study to find out which product does a better job of reducing methane emissions, if any.  This may sound like a subtle difference, but it is anything but.

Research on the effects of industry funding—“the funding effect”—shows how easy it is to design studies to give desired answers.  These researchers should be doing everything possible to make sure their study design is as objective as possible.

For a review of this and other research on food industry funding, see my Unsavory Truth: How Food Companies Skew the Science of What We Eat.

I like sweet foods as much as anyone (maybe more), but I do try to keep sugar intake within reasonable limits.

For one thing, sugars have no nutritional value beyond calories (which hardly anyone needs more of).  For another, it encourages overeating whatever foods in comes with, many of them ultra-processed.

Thus, I cannot understand why my nutrition colleagues would do anything to imply that eating more sugar is OK.

But, thanks to Ricardo Salvador at the Union of Concerned Scientists who forwarded the study to me, we here have: Risk assessment of nutrients: There must be a threshold for their effects.

Its authors argue that because no firm threshold has been established for harm from excessive sugar intake, guidance to keep sugars “as low as possible in the context of a nutritionally adequate diet” is inappropriate.

The most appropriate interpretation from the vast amount of data is that currently no definitive conclusion can be drawn on the tolerable upper intake level for dietary sugars. Therefore, EFSA’s [European Food Safety Authority’s] own guidance would lead to the conclusion that the available data do not allow the setting of an upper limit for added sugars and hence, that more robust data are required to identify the threshold value for intake of sugars.

Sigh.  Who paid for this?

Funding: “Cosun Nutrition Center (Hilversum, The Netherlands) provided financial support for some of the cost for the preparation of this paper. This support was unrestricted, and Cosun Nutrition Center had no influence on or input to the content of this paper” [yeah, right].

And what, pray tell, is the Cosun Nutrition Center?

The Cosun Nutrition Center conducts research and acquires scientific information on plant-based foods in relation to health and sustainability…The Cosun Nutrition Center is funded by Royal Cosun.

Sounds legit.  But what is Royal Cosum?

Founded 125 years ago, Royal Cosun has developed into a leading international agricultural cooperative with more than 8,100 sugar beet growers.

Sugar beet growers?  Oh.

I won’t bother to list the authors’ conflicts of interest, except to assure you that some include affiliations with sugar companies.

Conflicted?  Absolutely.

Caveat lector.

Let’s do two at once—studies funded by gthe beef industry.

I.  BEEF AND MUSCLES

I learned about this one from a headline in Food Navigator — Europe’s daily newsletter: Muscle protein synthesis more successful with beef than plant-based protein in older people, study finds

One look at the headline and I wanted to know: Who paid for this?

The study:  Higher Muscle Protein Synthesis Rates Following Ingestion of an Omnivorous Meal Compared with an Isocaloric and Isonitrogenous Vegan Meal in Healthy, Older Adults.  Journal of Nutrition.  2023. DOI:https://doi.org/10.1016/j.tjnut.2023.11.004.

Purpose: Plant-derived proteins are considered to have fewer anabolic properties when compared with animal-derived proteins…So far, no study has compared the anabolic response following ingestion of an omnivorous compared with a vegan meal.

Methods: In a randomized, counter-balanced, cross-over design, 16 older (65–85 y) adults (8 males, 8 females) underwent 2 test days. On one day, participants consumed a whole-food omnivorous meal containing beef as the primary source of protein (0.45 g protein/kg body mass; MEAT). On the other day, participants consumed an isonitrogenous and isocaloric whole-food vegan meal (PLANT).

Results: MEAT increased plasma essential amino acid concentrations more than PLANT over the 6-h postprandial period (incremental area under curve 87 ± 37 compared with 38 ± 54 mmol·6 h/L, respectively; P-interaction < 0.01). Ingestion of MEAT resulted in ∼47% higher postprandial muscle protein synthesis rates when compared with the ingestion of PLANT (0.052 ± 0.023 and 0.035 ± 0.021 %/h, respectively; paired-samples t test: P = 0.037).

Conclusions:  Ingestion of a whole-food omnivorous meal containing beef results in greater postprandial muscle protein synthesis rates when compared with the ingestion of an isonitrogenous whole-food vegan meal in healthy, older adults.

And now to answer my question:

• Conflict of interest:  [two of the authors] received research grants, consulting fees, speaking honoraria, or a combination of these for research on the impact of exercise and nutrition on muscle metabolism. A full overview on research funding is provided at: https://www.maastrichtuniversity.nl/l.vanloon. All other authors report no conflicts of interest.
• Funding:  This study was funded in part by The Beef Checkoff, Denver, USA, and Vion Food Group, Boxtel, The Netherlands….The funders had no role in data collection and analysis, decision to publish, or preparation of the manuscript.

Comment:  The Beef Checkoff is the USDA-sponsored research-and-marketing program which taxes beef producers and uses the funds to promote beef sales.  Maybe the funder had no role as stated, but the checkoff is unlikely to fund research that is not in its best interest.

The meat industry wants everyone to believe that meat is superior to plants, as food, and eating vegan diets is hazardous to health.  Hence, this research.

Something is seriously wrong when it is this easy to guess who paid for a study from its title alone.

II.  BEEF AND  MENTAL HEALTH

Just when I was ready to post that item, I ran across another one.

The study: Meat consumption & positive mental health: A scoping review. Preventive Medicine Reports. Volume 37, January 2024, 102556.

Highlight: “The majority of studies showed no differences between meat consumers and meat abstainers in positive psychological functioning.”

Results: “Eight of the 13 studies demonstrated no differences between the groups on positive psychological functioning, three studies showed mixed results, and two studies showed that compared to meat abstainers, meat consumers had greater self-esteem, ‘positive mental health’, and ‘meaning in life.'”

Conclusion [a positive spin]: “Although a small minority of studies showed that meat consumers had more positive psychological functioning, no studies suggested that meat abstainers did.”

Funding source: This study was in part funded 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.

Declaration of competing interest: [The first author] previously received funding from the Beef Checkoff, through the National Cattlemen’s Beef Association.

Comment: This review caught my attention because it found a null result: beef eating has no effect on mental health.  This is unusual for industry-funded studies.  But the article contains a positive spin:  some studies do in fact find benefits of beef eating whereas none find this result from not eating beeef.  Make of this what you will.  I think the Highlight says all you need to know.  Industry funding muddies interpretation of research results.  It’s best to avoid taking it.

Here’s where I first saw this one: Antioxidant supplement improves sperm quality and pregnancy outcomes, research suggests: Supplementing men with a combination of micronutrients and L-Carnitine shows promise in improving sperm motility and pregnancy outcomes, a new study concludes…. Read more

I could not wait to fsee the research.

The study:  Effect of Micronutrients and L-Carnitine as Antioxidant on Sperm Parameters, Genome Integrity, and ICSI Outcomes: Randomized, Double-Blind, and Placebo-Controlled Clinical Trial. Antioxidants 2023, 12(11), 1937; https://doi.org/10.3390/antiox12111937

Rationale: Oxidative stress has been identified as a crucial factor leading to genome decay, lipid peroxidation, and nucleoprotein oxidation.

Method: double-blind, placebo-controlled clinical trial aimed to assess the effect of oral antioxidant treatment (Fertilis), which contains L-carnitine and some micronutrients, in the improvement of conventional sperm parameters, sperm DNA integrity and in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes.

Results: The study outcome revealed a significant decrease in the DNA fragmentation index and a significant increase in sperm motility after 3 months of treatment (p = 0.01 and p = 0.02, respectively). Additionally, a significant improvement in clinical pregnancy rate (p = 0.01) and life birth rate (p = 0.031) was observed. No significant changes were observed in conventional sperm parameters (volume, count, and vitality) or sperm DNA decondensation (SDI).

Conclusion: Antioxidant therapy has a beneficial impact on achieving pregnancy, whether through spontaneous conception or assisted reproductive procedures (ART).

Funding: This research received received funding from the MEDIS laboratories.

Acknowledgments: The authors wish to thank MEDIS laboratories, especially Mohamed Bouchoucha “the general director”, Sonia Hafaiedh “the Medical laboratory director”, Sami Bousetta “the clinical research associate”, and Anis Ghribi “the data manager” for the encouragement and support….

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

Comment: The funder, Medis, is the maker of “High quality generic pharmaceuticals” like this supplement, no doubt.  Even though the supplement had no effect on the usual measures of sperm number and viability, women who took the suipplessment did better in achieving pregnancy.  I’d say more research needed on this one.  In the meantime, if you believe this result and want to up your sperm quality, eat your veggies!  Practically any fruit or vegetable is rich in antioxidants. Eat the ones you like.

As for “no conflicts of interest.” I respectfully disagree.  Funding from a company that stands to gain from a positive result clearly introduces conflicted interests.

[Note: If you saw this yesterday, ignore.  I made a scheduling error so this post got sent out with yesterday’s.  Apologies.]

A reader in Scotland,  Prof. Lindsay Jaacks, who I was fortunate to meet in Edinburgh last April,  tweeted (X’d?) this and tagged me on it::

A new study funded by @QuornFoods finds health benefits of substituting ‘Mycomeat’ for red & processed meat.
We need independent evidence far from the hands of industry if we are going to transform #FoodSystems.

I looked it up:

The study: Farsi, D.N., Gallegos, J.L., Finnigan, T.J.A. et al. The effects of substituting red and processed meat for mycoprotein on biomarkers of cardiovascular risk in healthy volunteers: an analysis of secondary endpoints from Mycomeat. Eur J Nutr 62, 3349–3359 (2023). https://doi.org/10.1007/s00394-023-03238-1.

• Purpose:  “Mycoprotein is a relatively novel food source produced from the biomass of Fusarium venenatum. It has previously been shown to improve CVD risk markers in intervention trials when it is compared against total meat. It has not hitherto been assessed specifically for benefits relative to red and processed meat.”
• Methods:  “We leveraged samples from Mycomeat, an investigator-blind randomised crossover controlled trial in metabolically healthy male adults (n = 20), randomised to consume 240 g/day of red and processed meat for 14 days followed by mycoprotein, or vice versa. Blood biochemical indices were a priori defined secondary endpoints.”
• Results:  “Mycoprotein consumption led to a 6.74% reduction in total cholesterol (P = 0.02) and 12.3% reduction in LDL cholesterol (P = 0.02) from baseline values…There was a small but significant reduction in waist circumference for mycoprotein relative to meat (− 0.95 ± 0.42 cm, P = 0.04). Following the mycoprotein diet, mean systolic (− 2.41 ± 1.89 mmHg, P = 0.23) and diastolic blood pressure (− 0.80 ± 1.23 mmHg, P = 0.43) were reduced from baseline.”  Urinary potassium was higher, but the study found no difference in triglycerides, urinary sodium, nitrite, or TMAO.
• Conclusions: “These results confirm potential cardiovascular benefits when displacing red and processed meat with mycoprotein in the diet. Longer trials in higher risk study populations are needed to fully elucidate suggested benefits for blood pressure and body composition.”
• Conflict of interest:  “This work was part funded by Marlow foods Ltd. TJAF is a consultant to Marlow Foods.”

Comment

Marlow Foods is the parent company of Quorn, mycelium-based products.  Quorn products have been around in the U.S. since 2002.  The Center for Science in the Public Interest has been dubious about these products ever since, arguing that Quorn induces allergic reactions and gastrointestinal distress and should be labeled as such.  It has also filed a class action lawsuit and engaged in other litigation.  CSPI refers to Quorn as “fungus” or “mold.”  Marlow, and other producers of mycelium-based meat substitutes prefer “mushroom.”  Marlow is doing what it can to counter criticism of the safety of theae products.

If you want to try Quorn, be sure to check the ingredient list.  Here’s what’s in QUORN VEGAN MEATLESS SPICY CHIQIN PATTIES:

Mycoprotein (54%), Wheat Flour (Wheat Flour, Calcium Carbonate, Iron, Niacin, Thiamine), Canola Oil, Water, Wheat Starch, Wheat Gluten, Pea Protein, Potato Protein, Calcium Chloride, Calcium Acetate, Salt, Chilli Flakes, Parsley, Yeast Extract, Onion Powder, Garlic Powder, Pea Fiber, Yeast, Tomato Powder, Spices (Cayenne Pepper, White Pepper), Carrageenan, Sodium Alginate, Rice Flour, Spice Extracts (Black Pepper Extract, Cayenne Extract, Ginger Extract), Paprika Extract (Coloring), Natural Flavor, Sage, Sugar, Leavening (Ammonium Carbonate)., Contains Wheat.

Ultra-processed? absolutely [industrially extracted ingredients; not much real food except wheat; you can’t reproduce this in your home kitchen].

Delicious?  You decide.

DRUGS

Here’s the headline: Maker of Wegovy, Ozempic showers money on U.S. obesity doctors

Drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs, a Reuters analysis found. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.

What’s extraordinary about this situation is the amounts.  Some doctors got millions.

This account follows one about similar efforts in the UK: Revealed: experts who praised new ‘skinny jab’ received payments from drug maker.

The drug giant behind weight loss injections newly approved for NHS use spent millions in just three years on an “orchestrated PR campaign” to boost its UK influence.  As part of its strategy, Novo Nordisk paid £21.7m to health organisations and professionals who in some cases went on to praise the treatment without always making clear their links to the firm, an Observer investigation has found.

Novo Nordisk knew what it was doing, and its efforts (presumably legal) are certainly paying off.

ALCOHOL

The headline: Scientists in Discredited Alcohol Study Will Not Advise U.S. on Drinking Guidelines: Two researchers with ties to beer and liquor companies had been named to a panel that will review the health evidence on alcohol consumption. But after a New York Times story was published, the panel’s organizers decided to drop them.

Five years ago, the National Institutes of Health abruptly pulled the plug on an ambitious study about the health effects of moderate drinking. The reason: The trial’s principal scientist and officials from the federal agency’s own alcohol division had solicited $60 million for the research from alcohol manufacturers, a conflict of interest and a violation of federal policy.

I wrote about that in a previous post.

I’m told by people in the know that I should not be too hard on the scientists.  NIH told them it would not fund the study and they should get the funding from industry.  If true, that is unfortunate.

For sure, NIH is not interested in nutrition research except for genetically based “Precision” nutrition aimed at individuals.  That leaves population studies out of the picture.  Unfortunate, indeed.

CLINICAL TRIALS

The study: Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022

Among 600 clinical trials with a median sample size of 415  participants:

• 409 (68.2%) had industry funding
• 303 (50.5%) were exclusively industry-funded
• 354 (59.0%) had industry authors
• 280 (46.6%) involved industry analysts
• 125 (20.8%) were analyzed exclusively by industry analysts.

Among industry-funded trials:

• 364 (89.0%) reached conclusions favoring the sponsor.

Industry involvement in research in general and in nutrition research in particular deserves close scrutiny and much skepticism.

Drug companies are required to do research and to find their own funding.  That is not true of nutrition.

Everyone should be lobbying for more independent funding for nutrition research.