Currently browsing posts about: Conflicts-of-interest

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.

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.

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:

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).

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.

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.

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.

It was hard to miss this headline in Dairy Reporter: “Cheese intake could lower risk of dementia, study suggests.”

No kidding?  I wonder who paid for this?

To its credit, the article did full disclosure:

The study was conducted as part of broader research commissioned by Japanese dairy major Meiji Co., Ltd. and part-funded by the company.

I went right to it.

The study: Kim H, Osuka Y, Kojima N, Sasai H, Nakamura K, Oba C, Sasaki M, Suzuki T. Inverse Association between Cheese Consumption and Lower Cognitive Function in Japanese Community-Dwelling Older Adults Based on a Cross-Sectional Study. Nutrients. 2023; 15(14):3181. https://doi.org/10.3390/nu15143181

Purpose: “We investigated whether cheese intake is associated with lower cognitive function (LCF) in community-dwelling older adults.”

Method: “This cross-sectional study included 1503 adults aged over 65 years. The analyzed data were obtained through face-to-face interviews and functional ability measurement.”

Results: Cheese intake, along with usual walking speed and calf circumference to be significant factors associated with LCF.

Conclusions: Cheese intake is inversely associated with lower cognitive function.

Funding: This study was funded by the Japan Agency for Medical Research and Development , the National Center for Geriatrics and Gerontology, and Meiji Co., Ltd.

Conflicts of Interest: “This study was conducted as a part of the ‘Epidemiology study of the relationship between dairy products intake and cognitive function’ commissioned by Meiji Co., Ltd. T.S. holds the position of Commissioned Research Chair, and H.K. is a member of the Commissioned Research group. K.N., C.O., and M.S. are employees of Meiji Co., Ltd. The other authors declare no conflict of interest. The funding sponsors had no role in the execution, analysis, or interpretation of the data or the writing of the manuscript.

Comment: Meiji Holdings Co Ltd (Meiji) 

is a manufacturer and distributor of dairy products, confectionery, and nutritional products. The company’s product portfolio comprises milk, yogurt, cheese, ice cream, chocolates, and gummy candies. The company also provides beauty supplements, protein products, nutritional products, vaccines, antibacterial agents, and generic drugs. The company markets its products under Meiji, Essel, Oishii Gyunyu, DepromeL, Reflex, Kaju Gummy, Kinoko no Yama, Galbo, Amino Collagen, Savas, Sycrest, Streptomycin, Kanamycin, Depromel, and Metact brand names…Meiji is headquartered in Chuo-Ku, Tokyo, Japan.

Five of the authors work for the company.

Does eating cheese reduce the risk of dementia?  You read the paper and decide.  I think you can’t make this stuff up.

I was not going to bother to say anything about this letter addressed to the Washington Post from the President of the Academy of Nutrition and Dietetics (AND), Laurie Wright, which she sent to all members.  But at least five recipients sent it to me for comment, so here goes.

From: Commission on Dietetic Registration <cdr@eatright.org>
Date: September 29, 2023 at 3:19:42 PM EDT
To: [REDACTED]
Subject: Letter to the Editor of the Washington Post from Academy President Lauri Wright

The September 13 article “The food industry pays ‘influencer’ dietitians to shape your eating habits” does a disservice to the nation’s hundred thousand plus registered dietitian nutritionists by painting broad-stroke misrepresentations about the dietetics profession and its association, the Academy of Nutrition and Dietetics.

Using examples of only seven individuals, the authors imply it is common practice for RDNs to have undisclosed affiliations with food companies and sponsors. This could not be further from the truth. More than 90 percent of registered dietitian nutritionists work in clinical health care, such as hospitals, medical centers and long-term care facilities, as well as in private practice, public and community health, school nutrition and other foodservice operations.

A growing number of practitioners do share their knowledge and expert opinions through social platforms, engaging with online communities and correcting health misinformation (much of which comes from potentially harmful fads promoted by infinitely larger numbers of uncredentialed influencers with much larger followings). The Academy of Nutrition and Dietetics has a strict Code of Ethics — which includes adhering to disclosure rules and guidelines established by the Federal Trade Commission — and has published many articles over the years about the importance of disclosure.

The authors further implied that the Academy is funded by the food and beverage industry, citing a long-since debunked “investigation” conducted by a small group of activists that disbanded six years ago. The truth lies in the facts: The Academy uses an independent advisor to manage our financial investments in all sectors of the S&P 500, and less than 3 percent of the Academy’s and its Foundation’s investments are in the food sector. Further, only 7 percent of the Academy’s revenue comes from sponsorships. This information has always been fully transparent to the public through our annual reports.

All this information was provided to the Post reporters in advance of the story, but unfortunately the writers elected to mislead their readers with a false narrative implying that non-disclosure of sponsorships is rampant in our profession. Speaking for Academy members who abide by our Code of Ethics, we expected the Post to abide by a higher journalistic standard as well.

Oh dear.  The cozy relationship between AND members and food companies is something I’ve written about extensively in my books, Food Politics and, more recently, Unsavory Truth.  

I’ve also written about the Academy’s conflicted interests on this site, most recently here.

And then there is Michele Simon’s deep dive into the Academy’s relationships with sponsors from a decade ago.

Here’s what President Wright’s defensive letter does not say:

• We apologize for the unethical behavior of some of our members and will immediately take steps to make sure no member does this again.
• Non-disclosure of sponsorship is grounds for dismissal from the Academy.
• We will strengthen our policies to make clear that the Academy will not tolerate such non-disclosure.
• We will insist not only of disclosure of paid posts, but also disclosure of the name of the sponsor.
• To make sure members fully understand what is at stake, we are providing guidelines for ethical disclosure and illustrations of what and what is not appropriate.

For your amusement, one reader sent me an Instagram example of full disclosure from Gwyneth Paltrow (who is not, to my knowledge, an AND member)—clearly labeled as a paid partnership with Copperfit.  You have to be logged in to Instagram to open the link.