by Marion Nestle

Currently browsing posts about: Conflicts-of-interest

Dec 19 2023

Industry-funded study of the week: Quorn

[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 StarchWheat 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.

Dec 18 2023

Should food companies—and the Gates Foundation—sponsor nutrition conferences? In India?

I saw this posted on X (the site formerl known as Twtter, which I still find to be a useful source of information I would not otherwise know about).

I also saw a post from Joes Spicer, head of Nutrition International, announcing its withdrawal of funding for the conference  because of the food industry sponsors.

And then Tim Schwab, whose book, “The Bill Gates Problem,” I cannot wait to get to, sent this:

In India last week, a minor furor erupted over the Nutrition Society of India’s annual conference being so brazenly sponsored by companies like Coca-Cola.  But Coke is only a “gold” sponsor.  The “platinum” sponsor? The Gates Foundation.

For two decades, Gates has partnered closely with corporate interests—from Coca-Cola to Pfizer—and presented them to the world as humanitarian partners. Because the foundation is such an admired and celebrated charitable body, Gates has had a powerful effect on normalizing, institutionalizing and legitimizing corporate partnerships and conflicts of interest throughout science and policy making.

Food and drug companies love to sponsor nutrition conferences.  What better way to convince influential professional researchers and teachers that your products are good for health and nothing should be said about restricting or regulating them.

The role of the Gates Foundation is much less obvious and much more important because of its money and interntional power.  Schwab’s book promises to address such matters.  I will have more to say about it when I’ve had a chance to read it.

In the meantime, nutriton societies oin the U.S. and India too would be more credible if they avoided taking food industry sponsorship.  If they take Gates Foundation money, it had best come with no strings and no implied endorsements.

If F0undatios were really altruistic, they would provide donations anonymously and not expect a quid pro quo.  When they expect a quid pro quo, it’s best to find out exactly what it is.

Dec 11 2023

Conflicted interests: obesity drugs, alcohol, clinical trials

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.

Dec 4 2023

Why I care about conflicts of interest

For years now I have been posting on Mondays something about conflicts of interest in nutrition research and practice on this site .

My goal in doing so is to raise awareness of practices that give the nutrition profession the appearance of undue food industry influence at the expense of public health.

Occasionally someone involved with something I post requests a correction or clarification.

Most recently, I heard from Gunter Kuhnle, a researcher in the UK whom I do not know personally.   He wrote:

In your blog (https://www.foodpolitics.com/2023/11/chocolate-an-update-on-the-food-politics-thereof/), you comment about my article in “The Conversation” on flavanols. This comment concludes with a statement that could be interpreted as if I was paid to write this piece. I would like to make clear that I was not paid to write this article – it was conceived and written in order to address a number of misunderstandings in the reporting of various studies concerning flavanols.  I would appreciate if you could correct this.

Since that was not at all my intention, I clarified the post immediately.

But I also requested his permission to reprint his note so I could do some more explaining about why this issue so concerns me.

I want to start by emphasizing that I do not see this as a personal matter.  My original post did not mention the author’s name and in general I try to avoid mentioning names of authors of industry-funded research unless they report financial ties to companies with vested interests in the outcome of that research.

I see this as a systemic issue.

But to summarize the arguments—and the research—I make and summarize in my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat:

An enormous body of evidence, most of it derived from studies of tobacco, chemical, or pharmaceutical drug industry-sponsored research, consistently shows:

  • Industry-funded research generally yields results that favor the sponsor’s interests.
  • Industry funding of research influences its outcome.
  • The influence of industry funding usually shows up in the framing of the research question or in the interpretation of results.
  • Recipients of industry funding do not recognize the influence, do not intend to be influenced, and deny the influence (“science is science”).
  • Denial of influence contradicts an enormous body of evidence to the contrary.
  • Disclosure of funding source or relationships is necessary but not sufficient; considerable evidence exists to show that the statement “the sponsor had nothing to do with the design, conduct, or publication of the study” is often misleading or false.
  • Exceptions do exist, but they are rare.

That researchers do not recognize the risks of industry funding is disturbing.  At the very least, when nutrition researchers accept funding from food companies, they give the appearance of conflict of interest.

And that is all it takes to reduce public trust in nutrition research, nutrition professionals, and nutrition professional societies.

I think there is something seriously wrong when I can look at the title of a nutrition research article and make a good guess about what company or industry trade association funded it.

I think there is something seriously wrong when I can look at the funder of a study and guess what the outcome is.

One more point: an argument I hear often is that all nutrition researchers are biased because they have dietary or ideological preferences.  There is research on this point too.  It argues that all researchers have personal or ideological biases—that’s what motivates them to do studies to test their hypotheses.  Personal biases, therefore, are universal and do not cause conflicts of interest.

Industry funding introduces a quite different motive: proving the health benefits or safety of a food product for commercial—not scientific—purposes.

Unsavory Truth provides references for all of this.

Also see Science in the Private Interest:  Has the Lure of Profits Corrupted Biomedical Research? by the late Sheldon Krimsky (I miss him terribly).

Professor Kuhnle, I thank you for writing and for the opportunity to respond.

Nov 27 2023

Industry-funded study of the week: a bacterial probiotic supplement and indigestion

This one started out with a notice in NutraIngredients Europe, a newsletter I subscribe to:

Probiotic BG01-4 relieves constipation and discomfort in GI disorders: Probiotic BG01-4 improves specific symptoms of constipation and related GI dysfunction in people with self-reported functional gastrointestinal disorders (FGID), which affects a significant percentage of the global population, a new study concludes…. Read more

That title triggered my usual question, “Who paid for this?”

I went right to the study:

  • The study:  Bacillus Subtilis (BG01-4TM) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial,by Craig Patch, Alan J. Pearce, Mek Cheng, Ray Boyapati, and Thomas Brenna. Nutrients202315(21), 4490; https://doi.org/10.3390/nu15214490.  
  • Background: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated Bacillus subtilis (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID.
  • Methods: Participants (n = 67) completed a four-week intervention of BG01-4™ (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention.
  • Results: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%/26% and 20%/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (p = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, p < 0.001), indigestion (11% improvement, p = 0.04), and dyspepsia (10% improvement, p = 0.04) were significantly improved in the intervention group compared to the placebo.
  • Conclusions: These initial findings suggest that in people with self-reported FGID, BG01-4™ improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted.
  • Conflicts of interest: C.P., M.C. and J.T.B. are directors of Adepa Lifesciences. The other authors declare that they have no conflicts of interest regarding the publication of this paper.

Comment: Three of the authors are involved with the maker of this supplement, Adepa Lifesciences, which makes this look like a marketing study.  It is published in the journal, Nutrients, an open-access journal.  Sharp eyed readers of this blog might notice that a large proportion of my industry-funded studies of the week appear in this journal.  It has an interesting policy.  It is fully open access and charges authors a fee accordingly.  That fee amounted to $3200 on October 30). 

All articles published in Nutrients (ISSN 2072-6643) are published in full open access. An article processing charge (APC) of CHF 2900 (Swiss Francs) applies to papers accepted after peer review. This article processing charge is to cover the costs of peer review, copyediting, typesetting, long-term archiving, and journal management. In addition to Swiss francs (CHF), we also accept payment in euros (EUR), US dollars (USD), British pound sterling (GBP), Japanese yen (JPY) or Canadian dollars (CAD).

Many science journals charge fees for open access, but usually offer authors a choice.  For the record, I have never paid to have an article published.

Nov 20 2023

Nutrition professional organizations should not partner with food companies

Just because all of the major nutrition professional organizations partner with food companies, does not make it a good idea.  If nothing else, partnerships with food companies raise reputational risks.  They give the appearance of conflicted interests, as David Ludwig and I warned in 2008.  I have also written about the hazards of food industry sponsorship of professional organizations in Food Politics, Soda Politics, and Unsavory Truth.  Here’s what they are doing now.

Academy of Nutrition and Dietetics (AND, formerly the American Dietetic Association)  OOPS.  My error.  This should be the American Diabetes Association (even worse).  Abject apologies.  This is what I get for not reading more carefully.  Apologies again.

If I seem to be picking on AND, it’s because it is bigger and gets into more trouble than other nutrition professional societies.

The latest example: According to Reuters, a former AND officer, Elizabeth Hanna, has sued the organzation for “firing her for objecting to what she called a “pay to play” scheme to promote the no-calorie sweetener Splenda.

In its 2022 annual report, the ADA said Splenda was one of a group of “elite” supporters that had given more than $1 million, along with Bayer Healthcare, Blue Cross Blue Shield of Illinois, Helmsley Charitable Trust and others.

On its website, Splenda publishes “diabetes-friendly recipes,” endorsed by the ADA. Hanna, a registered dietitian nutritionist, said she refused to approve the endorsement of several of these recipes in July.

…The U.S. Centers for Disease Control and Prevention states on its website that some studies have found possible health risks associated with the sweeteners, but that more research is needed.

American Society for Nutrition (ASN)

I am a member of this society and raise objections every time I get something like this in my e-mail.

Sponsored Webinar: Oral Health and Nutrition: Imperative for Healthy People 2030 and US Dietary Guidelines   Sponsored By: Mars Wrigley and the Oral Health Alliance.  The 2020-2025 Dietary Guidelines (DGA) identified dental caries as a major diet-related chronic disease of public health concern….

Doing this sort of thing risks reputation.

Evidence:  In a video on ultra-processed foods, the Financial Times identifies the ASN as “food industry advocacy group.”

The ASN’s executive director assures me they will ask for a correction.

Society for Nutrition Education and Behavior

Et tu?

It just announced a webinar, “Latinos love affair with Mangos: Maintaining Generational Food Traditions to Improve Health Outcomes.”

This is “a webinar sponsored by the National Mango Board, SNEB Organizational Member.”

The mango is…one of the world’s most popular fruits, and a staple food across Spanish speaking countries of North America, South America, and the Caribbean. Beyond its culinary popularity, an expanding body of research shows associations with mangos and risk reductions for inflammation and metabolically- based chronic disease, many of which disproportionately impact Hispanic American populations.

Mangos as opposed to any other fruit?

I am also a member of this society.

Overall comment

Are the reputational risks—and the loss of integrity—worth the money?  I don’t think so.

Nov 13 2023

Weird conflicts disclosure of the week: The Portfolio Diet

Several readers wrote suggesting I take a look at the conflicts of interest statement on this paper.

It comes from the Harvard TH Chan School of Public Health, which issued a press release: Harvard study: ‘Portfolio diet’ may decrease risk of heart disease, stroke.

The portfolio diet—a plant-based diet designed to lower unhealthy cholesterol, emphasizing plant proteins (legumes), phytosterols (nuts and seeds), viscous fiber (oats, barley, berries, apples), and plant-based monounsaturated fatty acids (avocado)—may lower the risk of heart disease and stroke, according to a new study co-authored by researchers at Harvard T.H. Chan School of Public Health.

The study was published in Circulation, which also sent out a press release: Ever heard of the portfolio diet? It may lower risk for heart disease and stroke.

The study itself, Portfolio Diet Score and Risk of Cardiovascular Disease: Findings From 3 Prospective Cohort Studies, produced results that should be expected from eating healthier diets.

Background: The plant-based Portfolio dietary pattern includes recognized cholesterol-lowering foods (ie, plant protein, nuts, viscous fiber, phytosterols, and plant monounsaturated fats) shown to improve several cardiovascular disease (CVD) risk factors in randomized controlled trials.

Objective: to examine the relationship between the Portfolio Diet Score (PDS) and the risk of total CVD, coronary heart disease (CHD), and stroke.

Methods: We prospectively followed 73924 women in the Nurses’ Health Study (1984–2016), 92346 women in the Nurses’ Health Study II (1991–2017), and 43970 men in the Health Professionals Follow-up Study (1986–2016) without CVD or cancer at baseline. Diet was assessed using validated food frequency questionnaires at baseline and every 4 years using a PDS that positively ranks plant protein (legumes), nuts and seeds, viscous fiber sources, phytosterols (mg/day), and plant monounsaturated fat sources, and negatively ranks foods high in saturated fat and cholesterol.

Conclusions: The PDS was associated with a lower risk of CVD, including CHD and stroke, and a more favorable blood lipid and inflammatory profile, in 3 large prospective cohorts.

This report was funded by Canadian and U.S. government research agencies.

Comment: The reason readers sent this to me had to do with the authors’ reported conflicts of interest.  These take up the equivalent of an entire page in the journal and refer to a curious mixture of financial support or connections, paid and unpaid, with government agencies and foundations, authors’ and sometimes their spouses’—in addition to long lists of financial ties to food trade associations for one or another plant food included in the Portfolio diet.

Muddying up disclosure statements like this is inappropriate.  Many connections listed do not in any way imply conflicted interests.  Mixing them up with those that do takes the focus away from financial ties that could have influenced the design or interpretation of the study.

Financial connections to food companies raise questions of credibility in nutrition research.  At the very least, they give the appearance of industry influence.

Disclosure lists like these either reflect ignorance of the significance and harm causes by conflicts of interest or deliberate disdain for its meanings.  If Circulation is requiring this mix of disclosures, it should reevaluate its policy.

Just because these disclosures come in a study from Harvard does not make them OK.

Oct 23 2023

Industry funded study of the week: the Pork Checkoff and Egg Board in action

Thanks to a reader, Kevin Mitchell, for sending this news item: Animal vs. Plant Protein: New Research Suggests That These Protein Sources Are Not Nutritionally Equivalent.

Scientists found that two-ounce-equivalents (oz-eq) of animal-based protein foods provide greater essential amino acids (EAA) bioavailability than the same quantity of plant-based protein foods. The study challenges the Dietary Guidelines for Americans (DGAs) which suggest these protein sources are nutritionally equivalent.

I went right to the source.

  • 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
  • Objectives: We assessed the effects of consuming two oz-eq portions of pork, eggs, black beans, and almonds on postprandial EAA bioavailability in young and older adults.
  • Methods: We conducted two investigator-blinded, randomized crossover trials in young (n = 30; mean age ± SD: 26.0 ± 4.9 y) and older adults (n = 25; mean age ± SD: 64.2 ± 6.6 y). Participants completed four testing sessions where they consumed a standardized meal with two oz-eq of either unprocessed lean pork, whole eggs, black beans, or sliced almonds.
  • Conclusions: Pork resulted in greater EAA bioavailability than eggs in young adults (p < 0.0001), older adults (p = 0.0007), and combined (p < 0.0001)… 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: It is very much in the interest of the Pork Checkoff and the Egg Board t,o demonstrate that animal-source food protein is better for you than proteins from plant sources—and to cast doubt on any evidence to the contrary.  Proteins, whether from animal or plant sources, contain precisely the same 20 amino acids, although in different proportions.  Animal proteins are closer in amino acid composition than are plant proteins but if you eat a variety of plant foods you will get the amino acids you need.   People who eat largely plant-based diets are generally healthier than people who eat a lot of animal-based foods.  The conclusion of this study does not change that overall conclusion.  This, then, is another industry-funded study with predictable results.