Currently browsing posts about: Conflicts-of-interest

The Alliance for Potato Research & Education is explicitly “Dedicated to advancing the scientific understanding of the role potatoes play in promoting the health of all people.”

As the Alliance explains:

Potatoes are a nutrient-rich vegetable and one of the top sources of potassium in Americans’ diets, yet they are often singled out as a food to limit. This recommendation is often based on misperceptions that eating potatoes is linked to increased cardiometabolic disease risk, even though potatoes contribute to overall fruit and vegetable consumption.  However, a newly published study in the Journal of Nutritional Science finds that advice may be unwarranted

Guess who sponsored that study.

• The study:  Potato consumption is not associated with cardiometabolic health outcomes in Framingham Offspring Study adults

• Conclusion: In this prospective cohort, there was no adverse association between fried or non-fried potato consumption and risks of T2DM/IFG, hypertension or elevated triglycerides.

• Funding: This work was supported by the National Heart, Lung and Blood Institute …with additional support from the Alliance for Potato Research and Education. The funders had no role in the design, analysis or writing of this article…The authors have declared that no conflict of interest.

Comment: We can argue about the effects of potatoes on insulin and blood sugar levels, a contentious issue because the ways they are cooked and prepared influence digestion of their starches to sugars and how quickly those sugars are absorbed.  But industry funding confuses the arguments, as it has a high probbility of inducing more than the usual level of bias into the results.  Much industry influence occurs at an unconscious level where it is unrecognized by rsearchers, so much so that they do not see it as a conflict of interest.  I think it is.

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The study: Health Functions of Egg Protein.  Ryosuke Matsuoka, Michihiro Sugano.  Foods 2022, 11, 2309. https://doi.org/10.3390/foods11152309.

Purpose: “In this review, we have summarized the available information regarding the health benefits of egg proteins based on human studies.”

Conclusion: “This review summarizes the health effects of egg proteins, especially EWP, as reported in human studies. Two major functions have been clearly identified: (1) they improve muscle mass and have muscle-strengthening and antifatigue effects when
consumed during exercise; (2) they can improve lipid metabolism by reducing visceral fat and lowering serum cholesterol levels. The intake of egg protein may, thus, contribute to the prevention of physical frailty and metabolic syndrome.”

Conflicts of Interest: M.S. declares no conflict of interest. R.M. is an employee of Kewpie Corporation. There are no other patents, products in development, or marketed products to declare.

Comment: M.S. declares no conflict but is Chair of the Japan Egg Science Society, Tokyo, respectively.  The purpose of this study was to examine the benefits of egg proteins, not to evaluate them in comparison to any other proteins or to assess the role of eggs in diets.  Studies that look for benefits invariably find them.  The Kewpie Corporation sells products using eggs.  It can now advertise them as health foods.

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The study:  Refined grain intake and cardiovascular disease: Meta-analyses of prospective cohort studies.  Glenn A.Gaesser.  Trends in Cardiovascular Medicine, Available online 6 September 2022.  https://doi.org/10.1016/j.tcm.2022.08.002

Conclusions:  Meta-analyses of prospective cohort studies demonstrate that refined grain intake is not associated with risk of CVD, stroke, or heart failure. This conclusion holds for studies that restricted analyses to staple grain foods only, as well as for studies that included both staple and indulgent grain foods as a single refined grains category. Although refined grains are included as a component of the Western dietary pattern, the present findings suggest that refined grains do not contribute to the higher CVD risk associated with this unhealthy dietary pattern. This information should be considered in formulation of future dietary recommendations.

Declaration of Competing Interest:  The author is a scientific advisory board member of the Grain Foods Foundation and the Wheat Foods Council.

Funding: Preparation of this manuscript was supported in part by a grant from the Grain Foods Foundation.

Comment: Refining of grains removes the outer bran and germ and most of the fiber and nutrients along with them, leaving some nutrients along with teh starch and protein.  Refined starch is quickly digested to sugars and rapidly absorbed.  The Wheat Foods Council wants to reassure you that you can eat as much refined grain as you like without raising disease risk.  Much independently funded research argues otherwise, alas.  If nothing else, refined grains contribute calories relatively low in nutrients and constitute major components of ultra-processed foods.  This study did not look at dietary patterns.

And thanks to David Ludwig for alerting me to this one.

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The publication date is tomorrow!

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The New York Times article on drug industry user fee payments to the FDA reminded me of my first meeting as a newly appointed member of the FDA’s Science Board in the late 1990s.  Here’s how it went:

FDA staff: We want to get your advice on user fees for inspection of food production facilties.

Me, appalled (oh no.  Not this at my very first meeting):  You mean food companies would pay the FDA’s expenses for inspecting their facilities?

FDA: Yes, what’s wrong with that?

Me: It’s causes a conflict of interest.  It puts the FDA under financial pressure to stay on good terms with the companies and not find problems.

FDA: But NIH does it.

Me: NIH is not a regulatory agency; FDA is.

I did not last long on that committee.  I was nominated for it again a year or so ago but never heard another word about it.

The Times article is about the drug industry.  Here are some excerpts:

• The pharmaceutical industry funding alone has become so dominant that last year it accounted for three-quarters — or $1.1 billion — of the agency’s drug division budget.
• Senator Bernie Sanders,…suggested that the pharmaceutical companies’ tendency to charge “outrageous” prices was related to their significant role in funding and advancing policy goals of the F.D.A.’s drug division. “So the industry, in a sense, is regulating itself,” Mr. Sanders said…May make sense to somebody — but not to me.”
• …the high costs of the program limit opportunity for small businesses; new-drug application fees are $1.5 million to $3.1 million.
• Over the years, the program’s scope and funding grew. Annual “performance reports” detail the F.D.A.’s efforts to make quick decisions, hold routine meetings with drug companies and approve products under fast-track pathways.
• …user fee negotiations in 1997 led to reducing the number of clinical trials for drug approval to one, from the longtime standard of two trials.

So does the FDA charge food companies for regulating them?  Yes.

The FDA can charge user fees for:

• The cost of reinspecting domestic food facilities, U.S. agents for foreign facilities, and food importers.  Fees cover “all expenses, including administrative expenses incurred in connection with arranging, conducting, and evaluating the results of the reinspection.”
• Expenses related to companies that do not comply with food recall orders, “including technical assistance, follow-up effectiveness checks, and public notifications. “
• Expedited review and import entry of human and animal food into the United States for participating importers.”

Food user fees are less conflicted than for drugs, and only about 1% of the cost of FDA’s food inspections comes from user fees.

But this is a bad system overall.  FDA is a regulatory agency.  It requires absolute independence in order to do its work honestly.  It should be taxpayer supported entirely so it can work entirely in the public interrest.

See:

• FDA User Fee Programs
• Fees under FSMA
• Guidance for industry on user fees under FSMA
• Why is the FDA Funded in Part by the Companies It Regulates?

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Coming soon!  My memoir, October 4.

For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

I was interested to see this article in Hoard’s Dairyman: Bringing dairy research to thought leaders.

It explains how food trade associations build relationships with nutrition scientists.

The article discusses the role of the  National Dairy Council (NDC) , in getting research on the benefits of dairy products “into the hands of our science-based colleagues around the country and even globally.”

This is why NDC circles various conferences and meetings on our calendar where we present dairy research and continue establishing relationships with credible third-party organizations.

One of the most important groups is the American Society for Nutrition (ASN)…ASN is the world’s largest nutrition science organization with about 7,000 members from more than 100 countries representing the academic, government, and private business sectors. Many ASN members embody the next generation of scientists and it’s critical we get to know each other.

The article goes on to explain how the NDC:

• Worked to ensure that the latest dairy science was part of this year’s ASN agenda.
• Led a symposium on dairy’s components and cardiovascular health and diabetes.
• Presented on dairy’s unique nutrient package
• Holds leadership positions within ASN.

But:

ASN is just one stop for NDC. We’ll also be involved with conferences hosted by other key organizations, such as the Mayo Clinic, Institute of Food Technologists, International Dairy Federation’s World Dairy Summit, Institute for the Advancement of Food and Nutrition Sciences, and others.

I am a member of ASN and have long been concerned about its too cozy relationships with food companies and their trade associations.  I eat dairy foods and think they have a reasonable place in healthy diets, but they are not essential to human health.  Research debates on dairy products continue, and the close involvement of the NDC in a nutrition professional association compromises the independence of that association.

When I complained about the inherent conflicts of interest in such relationships, ASN officials explained that they want the association to be inclusive, a “big tent.”

Inclusivity is nice, but in this case the benefit goes more to the NDC than to the ASN.

Hoard’s Dairyman is not something I usually see, so I thank Lynn Ripley for sending.

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Coming soon!  My memoir, October 4.

For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

I very much appreciate the weekly newsletter, ObesityandEnergetics.org (If you want to subscribe, do so here).

I particularly enjoy its section, Headline vs Study.  Here’s the most recent, with my additions.

Headline: “Astonishing” Effects of Grape Consumption and “Remarkable” Impacts on Health and Lifespans.

Study: Grape Powder (Not Grapes) Modulates Gene Expression, Reduces Non-Alcoholic Fatty Liver Disease, and Extends Longevity… In Female Mice.

I took a look at the study.

• Conclusion: “These results suggest the potential of dietary grapes to modulate hepatic gene expression, prevent oxidative damage, induce fatty acid metabolism, ameliorate NAFLD (non-alcohol fatty liver disease), and increase longevity when co-administered with a high-fat diet.”
• Funding: This work was supported in part by the California Table Grape Commission. The sponsor was not involved: in the preparation of the article; in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

Here is another study:

Study: Behavioral and Genetic Changes of Grape Powder (Not Grapes)… In Female Mice.

Its funding?  “This research was supported in part by the California Table Grape Commission.”

And one more:

Study: Grape Powder (Not Grapes) Modifies Hepatic and Urinary Metabolite Profiles… In Female Mice.

This study is also enlightening.

• Conflicts of interest: [onE of the authors] “serves on the scientific advisory board of the California Table Grape Commission. There are no other conflicts to declare.”
• Acknowledgements:  [two of the authors] “acknowledge grant support from the California Table Grape Commission and seed grant funding from Long Island University. The California Table Grape Commission was not involved: in the preparation of the article; in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.”

Comment:  As usual, these authors deny the problems inherent in industry funded studies that have marketing of health benefits as their primary purpose.  Grapes are fruits.  Fruits are healthy.  Do grapes perform health miracles?  Only if you believe in miracles.  Should you eat grapes?  Sure, if you like them.

You don’t believe this is about marketing?  Here’s one more headline (thanks to Karen Zornow Leiding for sending).  And you know who funded this.

Eating grapes can counteract harmful effects from processed foods, while boosting metabolism too

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Coming soon!  My memoir coming out in October.

For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

Today’s Dietitian  sent this e-mail blast to members of the Academy of Nutrition and Dietetics on behalf of the National Pork Board, one of its sponsors.

The National Pork Board is seeking to build strong and meaningful partnerships with the Registered Dietitian profession. When it comes to up-to-date nutrition information, cooking techniques, continuing education and future collaborations, Pork is getting ready to give you the resources you value most. But first, we want to hear from you!

We invite you to take this survey for a chance to win one of fifteen $100 Amazon gift cards!*

The survey should take less than 15 minutes to complete. Your responses are voluntary and confidential. Responses will not be identified by individual but will be compiled and analyzed in aggregate.

Fifteen winners will be chosen at random to receive a $100 Amazon gift card. To be eligible, respondents must share their email address at the end of the survey.

Please click here to take the survey by August 22, 2022* Giveaway is subject to Official Rules.

If you want to know how meat trade associations encourage dietitians to promote their products, here’s an example.

Thanks to Dr. Lisa Young for alerting me to this one.

One of the points of my Monday “industry-funded study of the week” posts is that companies usually get the results they want.  Exceptions do exist.  Here’s one of those rare ones.

The study: Changes in Biomarkers of Non-Alcoholic Fatty Liver Disease (NAFLD) upon Access to Avocados in Hispanic/Latino Adults: Secondary Data Analysis of a Cluster Randomized Controlled Trial.  Lorena S. Pacheco, Ryan D. Bradley, Cheryl A. M. Anderson and Matthew A. Allison.  Nutrients 2022, 14(13), 2744; https://doi.org/10.3390/nu14132744

Rationale: Non-alcoholic fatty liver disease (NAFLD) is a common cause of abnormal liver functions tests and of increased increased risk for morbidity and mortality.  Monounsaturated fatty acids such as those in avocados havew been associated with improved NAFLD-related markers.

Hypothesis: “We hypothesized compared to low avocado intake, high avocado intake would have a beneficial effect on oxidative stress and hepatic health indicated by greater reductions in liver function tests and NAFLD fibrosis score.”

Results: “No statistically significant differences were observed between low and high avocado allotment groups” in anything measured.

Conclusion: “Varied intake of avocados resulted in no effects on biomarkers of NAFLD in healthy adults, free of severe chronic disease.”

Funding: “The parent research was funded by The Hass Avocado Board.”

Conflicts of interest: “The authors declare no potential conflict of interest. All authors report the grant from the Hass Avocado Board….The Hass Avocado Board funded the parent trial and provided all the trial’s avocados at no cost to study participants. The parent trial funder 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: The authors say they have no conflicts of interest but I think they do; the Hass Avocado Board paid for a study of the effects of avocados on NAFLD markers.  Such payments are well established to predict results that favor the sponsor’s interests.

Nevertheless, the results came out contrary to those interests, and the authors were unambiguous in saying so.  In this case, the assertion that the sponsor had no role seems credible, even though it often is not.

High marks to the authors.