Currently browsing posts about: Conflicts-of-interest

Christina Leffel, a public health nutritionist in Florida, sent this one, which with both find amusing.

The study: Effects of Adding Lean Red Meat to a U.S.-Style Healthy Vegetarian Dietary Pattern on Gut Microbiota and Cardiovascular Risk Factors in Young Adults: a Crossover Randomized Controlled Trial – The Journal of Nutrition.  VOLUME 153, ISSUE 5, P1439-1452, MAY 2023, https://doi.org/10.1016/j.tjnut.2023.03.013

Method:  19 participants consumed 3 study diets in random order: 1) healthy lacto-ovo vegetarian diet (LOV); 2) LOV plus 3 ounces/d of cooked unprocessed lean red meat (URM); and 3) LOV plus 3 ounces/d of cooked processed lean red meat (PRM). Measures: Fecal and fasting blood samples.

Results: The addition of unprocessed or processed lean red meats to a LOV HDP did not influence short-term changes in bacterial taxonomic composition.  When the data from all three diets were combined, “changes in some bacteria were associated with improvements in TC, LDL-C, triglycerides, and HDL-C concentrations, and TC/HDL-C ratio.”

Conclusions:  Healthy young adults who adopt an HDP that may be vegetarian or omnivorous, including lean red meat, experience short-term changes in gut microbial composition, which associate with improvements in multiple lipid-related cardiovascular risk factors.

Funding: “The study was cofunded by the Pork Checkoff, North Dakota Beef Commission, Beef Checkoff, and Foundation for Meat and Poultry Research and Education. 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.

Author disclosures: “During the time this review was conducted, WWC received funding for research grants, travel or honoraria for scientific presentations, or consulting services from the following organizations: U.S. National Institutes of Health, U.S. Department of Agriculture (Hatch Funding), Pork Checkoff, National Pork Board, Beef Checkoff, North Dakota Beef Commission, National Cattlemen’s Beef Association, Foundation for Meat and Poultry Research and Education, American Egg Board, Whey Protein Research Consortium, National Dairy Council, Barilla Group, Mushroom Council, and the National Chicken Council. Additionally, SRL received funding for research grants, travel or honoraria for scientific presentations, or consulting services from the following organizations: U.S. National Institutes of Health, U.S. Department of Agriculture, National Science Foundation, Showalter Research Trust, Grain Foods Foundation, CP Kelco US, OLIPOP, Inc, Council for Responsible Nutrition. YW, T-WLC, MT, and CMC declare no conflict of interest. The funder and these other organizations had no role in the design and conduct of the study, analysis, interpretation of the results, and writing of the manuscript.”

Comment: This is yet another industry-funded study in which the funder claims no role–a statement that always makes me laugh.  That’s what they all say, despite much evidence that the funding influence in such situations can be considerable, although unrecognized.  For details, see my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The meat industry, apparently, is trying to convince vegetarians that they can eat any kind of meat they want and not affect their cardiovascular risk.  This, of course, contradicts tons of other evidence, including associations with cancer risk.  These risks may not be mediated through the microbiome, however.  What this study says is that if you are worried about the risks of meat, you don’t have to worry that it changes your microbiome much, at least under the conditions of this study.

The workshop covered the ways that funding sources (especially corporate funders) influence research quality and outcomes (precisely the topic of my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat.

The report is a succinct yet thorough summary of the research on the effects of funding on research design, outcome, and interpretation.

Some of the speakers:

• Lisa Bero, PhD, Chief Scientist, Center for Bioethics and Humanities, at the University of Colorado Anschutz Medical Campus, Overview of the Evidence on Sponsor Influence
• David Michaels PhD, MPH, epidemiologist and professor at the George Washington University School of Public Health; former Assistant Secretary of Labor for the OSHA. How to Protect Public Health in the Face of Disinformation.
• Gary Ruskin, Executive Director, U.S. Right to Know,  Where are the points of influence on scientific research?
• Martin McKee, CBE, MD, president of the British Medical Association and Professor of European Public Health at the London School of Hygiene and Tropical Medicine. What You Don’t See That Counts: A Peek Behind the Smokescreen
• Laura A. Schmidt, PhD, Professor Health Policy in the School of Medicine at the University of California at San Francisco. Industry Funding Bias in the Case of Nutrition Science

This report is a great place to begin if the topic is new to you.

And so is this, of course.

Here’s another one that several readers have asked me about: Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial.  Authors: Lok-Kin Yeung, Daniel M. Alschuler, Melanie Wall, Howard D. Sesso, JoAnn E. Manson, Adam M. Brickman.  American Journal of Clinical Nutrition. DOI:https://doi.org/10.1016/j.ajcnut.2023.05.011

The study: “Participants were randomly assigned to a daily multivitamin supplement (Centrum Silver) or placebo and evaluated annually with an Internet-based battery of neuropsychological tests for 3 y.”  Primary outcome measure: change in episodic memory (immediate recall performance on the ModRey test, after 1 y of intervention).  Secondary outcome measures: changes in episodic memory over 3 y of follow-up,  and in performance on neuropsychological tasks of novel object recognition and executive function over 3 y.

Results: “Compared with placebo, participants randomly assigned to multivitamin supplementation had significantly better ModRey immediate recall at 1 y, the primary endpoint (t(5889) = 2.25, P = 0.025), as well as across the 3 y of follow-up on average (t(5889) = 2.54, P = 0.011). Multivitamin supplementation had no significant effects on secondary outcomes…we estimated that the effect of the multivitamin intervention improved memory performance above placebo by the equivalent of 3.1 y of age-related memory change.”

Conflict of interest: HDS, JEM, and AMB received investigator-initiated grant support to their institutions from Mars Edge. Pfizer Consumer Healthcare (now Haleon) provided support through the partial provision of study pills and packaging. HDS received investigator-initiated grants from Pure Encapsulations and Pfizer Inc and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and the
American Society of Nutrition during the conduct of the study. No funding sources had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication.

Funding: This work was supported by an investigator-initiated grant from Mars Edge, a segment of Mars Inc dedicated to nutrition research. Pfizer Consumer Healthcare (now Haleon) provided support through the
partial provision of study pills and packaging.

Comment:  This study continues to surprise me.  As I’ve written before, it is part of the COSMOS trial, which is also supported by grants from NIH and a private foundation.  In my previous post on it, I noted that despite being funded by Pfizer (which makes Centrum Silver multivitamin supplements), the study did not show benefits of the supplement for prevention of cardiovascular disease or cancer—a rare exception to the rule that industry-funded studies tend to favor the sponsor’s interests.  But here we go again, this time with an equally surprising result but for a different reason: most multivitamin studies have shown no benefits whereas this one says if you take Centrum Silver, it will give you another three years of no loss in memory.  Wow!  I’ll be Pfizer is thrilled.

Here’s what the NIH National Center for Complementary and Integrative Health says about multivitamins:

Thanks to Bradley Flansbaum for sending this one from a journal not on my usual reading list: “In persons with constipation or IBS-C, kiwifruit vs. psyllium increased spontaneous bowel movements.”

I like the way this press release gets right to the point.

An industry-funded randomized trial assessed the effect of daily consumption of kiwifruit versus psyllium on GI function and comfort in 184 adults who were healthy, had functional constipation (FC), or met Rome III diagnostic criteria for constipation-predominant irritable bowel syndrome (IBS-C).

The study: Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort—Results of an International Multicenter Randomized Controlled Trial.  The American Journal of Gastroenterology ():10.14309/ajg.0000000000002124, January 9, 2023. | DOI: 10.14309/ajg.0000000000002124.

Authors: Gearry, Richard MD, PhD; Fukudo, Shin MD, PhD; Barbara, Giovanni MD; Kuhn-Sherlock, Barbara PhD; Ansell, Juliet PhD; Blatchford, Paul PhD; Eady, Sarah MSc; Wallace, Alison PhD; Butts, Christine PhD; Cremon, Cesare MD; Barbaro, Maria Raffaella PhD; Pagano, Isabella MD; Okawa, Yohei PhD; Muratubaki, Tomohiko PhD; Okamoto, Tomoko PhD; Fuda, Mikiko MS; Endo, Yuka MD; Kano, Michiko MD, PhD; Kanazawa, Motoyori MD, PhD; Nakaya, Naoki PhD; Nakaya, Kumi PhD; Drummond, Lynley BTech (Hons)

Summary of the study

Methods: Participants included healthy controls (n = 63), patients with functional constipation (FC, n = 60), and patients with constipation-predominant irritable bowel syndrome (IBS-C, n = 61) randomly assigned to consume 2 green kiwifruits or psyllium (7.5 g) per day for 4 weeks, followed by a 4-week washout, and then the other treatment for 4 weeks. The primary outcome was the number of complete spontaneous bowel movements (CSBM) per week.

Results: Consumption of green kiwifruit was associated with a clinically relevant increase of ≥ 1.5 CSBM per week (FC; 1.53, P < 0.0001, IBS-C; 1.73, P = 0.0003) and significantly improved measures of GI comfort (GI symptom rating scale total score) in constipated participants (FC, P < 0.0001; IBS-C, P < 0.0001).

Conclusion: This study provides original evidence that the consumption of a fresh whole fruit has demonstrated clinically relevant increases in CSBM and improved measures of GI comfort in constipated populations. Green kiwifruits are a suitable dietary treatment for relief of constipation and associated GI comfort.

Financial support: Zespri International Ltd. was the principal sponsor and reviewed, approved, and funded the study design. The New Zealand study center trial was jointly funded by a grant from the New Zealand government (Contract C11X1312) and the sponsor company, Zespri International Ltd. In Italy and Japan, Zespri International Ltd. was the sole funder for each study center trial. The funder did not contribute to the study design or data analysis.

Potential competing interests: J.A. and P.B. are employed by Zespri International who part-funded the study. R.G. and L.D. sit on the Science Advisory Board, have received travel and research grants from Zespri International. SF and GB have received research travel grants from Zespri International.

Comment:  Can you guess what Zespri International sells?  Go on.  Take a wild guess.  I’ll admit it.  I’d go for kiwi over psyllium every time.  But we are talking here about an average improvement of 1.5 bowel movements a week, which may or may not be clinically meaningful..  I do give the authors credit for claiming a benefit for “fresh whole fruit,” not specifically kiwifruit.  The study didn’t compare kiwi to other fruits (and why would it, given the kiwi fruit sponsor).  But overall, this is yet another study done for marketing far more than scientific purposes.

My thanks to Arun Gupta for sending this one from a newspaper in India.

The clipping refers to this article.

• The study: Ostendorf, D.M., Schmiege, S.J., Conroy, D.E. et al.Motivational profiles and change in physical activity during a weight loss intervention: a secondary data analysis.Int J Behav Nutr Phys Act18, 158 (2021). https://doi.org/10.1186/s12966-021-01225-5.
• First sentence : “High levels of moderate-to-vigorous physical activity (MVPA) are strongly associated with sustained weight loss [1, 2], and current guidelines recommend high levels of PA for weight management .”
• Methods: Participants were asked to follow a weight-loss diet and to do 300 minutes per week of exercise.  The investigators lstudies participants’ motivation levels.
• Conclusion: once exercise supervision and support was removed, adults in the high autonomous motivational profile were protected against the standard attenuation in MVPA following removal of support/supervision.
• Competing interests: “The results of this study are presented clearly, honestly, and without fabrication, falsification, or inappropriate data manipulation. DC reports consulting income from Gelesis, Inc., a company that has developed a weight loss device.  SP has a grant from WW International [formerly, Weight Watchers] unrelated to this work.”

Comment: As far as I can tell, the paper says nothing about exercise being more important than diet.  The study didn’t find any differences in weight among people with different levels of motivation.  We can’t blame the authors for the press account.    But anything that minimizes the need for dietary changes gets pounced on.  Alas.

In a strange partnership, the Nutrition Coalition and the Center for Science in the Public Interest (CSPI) are jointly complaining about the way the USDA and HHS have “disclosed” conflicts of interest among members of the 2025-2030 Dietary Guidelines Advisory Committee.

Why strange?  Because the Nutrition Coalition has long urged relaxations on advice about dietary fat, whereas CSPI has long urged restrictions.

Why “disclosed” in quotes?  Because the agencies’ disclosure statement lists the combined conflicts for the entire group, not for individual members of the committee.

Here’s the committee, courtesy of a tweet from Christopher Gardner.

Dietary Guidelines Advisory Committee

2nd in person meeting of DGAC this week.
Committee members are a pleasure to work with – thoughtful, critical, informed group.

HHS/USDA staff supporting the effort are an incredible resource! Wow!

2-year process is off to a great start! pic.twitter.com/6Cx5npxJcH

— Christopher Gardner (@GardnerPhD) May 13, 2023

Here is a small part of what the disclosure list looks like.

Because these are all jumbled together, you have to look hard to pull out the genuine conflicts—-relationships of committee members with food companies with vested interests in the outcome of the guidelines.

The Nutrition Coalition points out that USDA and HHS are failing to:

• Comply with a National Academies of Science report calling for publicly posting financial and nonfinancial biases and conflicts of interest of committee members.
• Fully adopt the National Academies’ 11 recommendations.
• Recognize the significance of the first-ever systematic review of a DGAC’s financial ties. This review found 95% of the 2020 DGAC members had at least one tie with a food or pharmaceutical company and half had 30 such ties or more.

In its statement, CSPI says that it, the Coalition, and 13 other groups are calling on the federal government to disclose potential financial conflicts of interest, including sources of research funding, speakers’ fees, and other relationships.

Press coverage, the statement says, “has already uncovered one 2025 Dietary Guidelines Advisory Committee member with a conflict of interest that seems relevant to their role.”

Comment:  I agree that the credibility of the committee and the guidelines depends on transparency, but it’s hard to know how much of a problem this is.

I wanted to compare the disclosure list to the research questions set by the agencies for the committee, but I can no longer find them online.

This reminds me that’s it’s hard to know how much influence the committee will have, in any case, now that the agencies set the research questions and write the actual guidelines.

The advisory committee is just that, advisory.  The agencies do not have to take its advice.

I will be following this closely.  Stay tuned.

Additions, May 17 (thanks to Jerry Mande)

• The original list of Proposed Scientific Questions
• The list as posted on the current website: Step 3: Advisory Committee Reviews Scientific Evidence

Thanks to reader Maira Bes-Rastrollo at the University of Navarra in Spain (and whose work I greatly admire) for this one.

The Relationship of Ready-to-eat Cereal Intake and Body Weight in Adults: A Systematic Review of Observational Studies and Controlled Trials.   Lisa M Sanders, Mary R. Dicklin, Yong Zhu, Kevin C. Maki.  Advances in Nutrition https://doi.org/10.1016/j.advnut.2023.05.001

Thanks to reader Thijs van Rens for sending this one, and apologies for the delay in getting to it.

This one comes from The Conversation back in January: Stop hating on pasta – it actually has a healthy ratio of carbs, protein and fat.

Its author writes about the benefits of pasta.

The ratio of carbs to protein in pasta is 38g to 7.7g, which equates to roughly a 5:1 ratio, well within the acceptable macronutrient distribution range. Meaning pasta actually has enough protein to balance with the carbohydrates…But pasta…also has micronutrients.

One cup of cooked pasta has about a quarter of our daily recommended intakes of vitamins B1 and B9, half the recommended intake of selenium, and 10% of our iron needs.

The news for pasta gets even better when we eat it as leftovers. When pasta is cooked and cooled, some of the carbohydrates convert to resistant starch. This starch gets its name from being resistant to digestion, so it contributes less energy and is better for blood sugar levels.

Funding: The author reports having “received funding for research or consulting from Mars Foods, Nutrition Research Australia, NHMRC, ARC, AMP Foundation, Kellogg, and the University of Newcastle.

Her article refers to: A systematic review on the relations between pasta consumption and cardio-metabolic risk factors.

Conclusion: Pasta meals have significantly lower postprandial glucose response than bread or potato meals,

Funding: American Heart Association, National Institute of Health, Barilla [the pasta maker!].

Comment

I love pasta, in moderation of course and with something this caloric, moderation is useful.  What’s going on here is a defense against rapidly absorbable carbohydrates which quickly convert to sugars.  I don’t necessarily disagree with the facts here; it’s the industry-funded distraction from calories that troubles.  It’s good that the authors disclosed their industry connections.