by Marion Nestle

Currently browsing posts about: Sponsored-research

Nov 18 2019

Industry-funded study of the week: Pomegranates

The study: Matthews LG, Smyser CD, Cherkerzian S, Alexopoulos D, Kenley J, Tuuli MG, et al. (2019) Maternal pomegranate juice intake and brain structure and function in infants with intrauterine growth restriction: A randomized controlled pilot study. PLoS ONE 14(8): e0219596.

The findings (my emphasis): “There were no group differences in brain injury, metrics or volumes. However, treatment subjects displayed reduced diffusivity within the anterior and posterior limbs of the internal capsule compared with placebo. Resting state functional connectivity demonstrated increased correlation and covariance within several networks in treatment subjects, with alterations most apparent in the visual network in per-protocol analyses. Direct effects on health were not found.

Conclusion: In conclusion, maternal pomegranate juice intake in pregnancies with known IUGR was associated with altered white matter organization and functional connectivity in the infant brain, suggesting differences in brain structure and function following in utero pomegranate juice exposure, warranting continued investigation.

Funding: This work was supported by National Institute of Health Grants R01 HD29190 (D. M. Nelson), K02 NS089852 (C.D. Smyser), U54 HD087011 and P30 HD062171 (T.E. Inder), The Foundation for Barnes-Jewish Hospital (D. M. Nelson) and an unrestricted gift to Washington University School of Medicine from POM Wonderful, Los Angeles, CA. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Comment: This is a classic example of interpretation bias.  Studies of bias associated with industry funding find that it shows up mostly in the framing of the research question or in the interpretation, as this one demonstrates.  The study did not find anything significant but concluded that drinking pomegranate juice during pregnancy is good for the growing fetus.

Bottom line: Fruit juices (of any kind) are good for health as long as volumes are small.  Eating the fruit itself is better–less sugar, more fiber.

Nov 11 2019

Industry-funded study of the week: Dairy foods again and again

The Study:  Dairy Foods and Dairy Fats: New Perspectives on Pathways Implicated in Cardiometabolic Health.  Kristin M Hirahatake; Richard S Bruno; Bradley W Bolling ; Christopher Blesso; Lacy M Alexander, et al.  Advances in Nutrition, nmz105, https://doi.org/10.1093/advances/nmz105  Published: 25 September 2019

The Conclusions: Most observational and experimental evidence does not support a detrimental relationship between full-fat dairy intake and cardiometabolic health, including risks of cardiovascular disease and type 2 diabetes. Indeed, an expanded understanding of the dairy food matrix and the bioactive properties of dairy fats and other constituents suggests a neutral or potentially beneficial role in cardiometabolic health.

The Conflicted Interests (my emphasis): SHA’s research is funded in part by USDA-Agricultural Research Project…Support for RSB is provided by USDA-NIFA…the Ohio Agricultural Research and Development Center at the Ohio State University, and the National Dairy Council. BWB’s research is funded in part by the National Dairy Council. Author disclosures: SHA has received honoraria from ILSI North America, the National Dairy Council (NDC), the National Cattlemen’s Beef Association, Herbalife, and the Council for Responsible Nutrition as a presenter and participant at sponsored scientific conferences. RSB has received honoraria from NDC to serve as an external research advisor and from Abbott Nutrition for serving as a presenter at a sponsored scientific conference. BWB has received honoraria from NDC and Nederlanse Zuivel Oranisatie for presenting research at scientific conferences. CB has received honoraria from NDC and the America Egg Board as a presenter and participant at sponsored scientific conferences. LMA has received funding from NDC, NHLBI, and Performance Health. KMH has received funding from NDC to coordinate author contributions and to write the article. The National Dairy Council (NDC) sponsored the 2018 Scientific Summit: A New Look at Dairy Foods and Healthy Eating Patterns. The sponsor reviewed this manuscript prior to submission. All editorial decisions were solely left to the authors, and this report reflects the independent opinions and views of the authors.

Comment: The National Dairy Council funded this study and reviewed its manuscript.  The authors receive funding from the Dairy Council.  This review should be considered a paid advertisement.  Do dairy foods have any special role in cardiometabolic health?  I doubt it, but we are unlikely to find out until such questions are investigated independently.

Nov 4 2019

How industry funding of research introduces biases from the get-go

I get letters like this from food trade associations all the time.  Here is the latest:.

The U.S. Highbush Blueberry Council has issued a request for research proposals (RFP) for which it offers grants ranging from $75,000 to $300,000 (or larger).

Here’s the get-go bias point (my emphasis):

The goal of our research funding is to provide initial funds, or additional funds, to explore blueberry health benefits.

The Council wants research to demonstrate benefits.  Of course it does.  These will be useful for marketing.

A priority for funding will be given to human clinical studies however the committee is also interested in further investigation of possible health benefits for pet or performance animals including dogs, cats and horses.

If the proposal is unlikely to demonstrate benefit, it won’t be funded.

That’s why I consider industry-funded research to be about marketing, not science.

Oct 28 2019

Industry-funded study of the week: avocados yet again

The study: A Moderate-Fat Diet with One Avocado per Day Increases Plasma Antioxidants and Decreases the Oxidation of Small, Dense LDL in Adults with Overweight and Obesity: A Randomized Controlled Trial.  Li Wang, Ling Tao, Lei Hao, Todd H Stanley, Kuan-Hsun Huang, Joshua D Lambert, Penny M Kris-EthertonThe Journal of Nutrition, nxz231, https://doi.org/10.1093/jn/nxz231  Published: 14 October 2019

The Press release: One avocado a day helps lower ‘bad’ cholesterol for heart healthy benefits  (thanks to reader Effie Seftel for sending).

Conclusions: “One avocado a day in a heart-healthy diet decreased oxLDL [oxidized LDL]in adults with overweight and obesity, and the effect was associated with the reduction in sdLDL [small-density LDL–the bad kind]…Avocados have a unique nutrient and bioactive profile that appears to play an important role in reducing LDL oxidation, hence decreasing LDL atherogenicity.”

Funding:  “Supported by a grant from the Hass Avocado Board.”  [I’ve written previously about other studies funded by this Board].

Author disclosures: LW, LT, LH, THS, K-HH, and JDL, no conflicts of interest. PMK-E received funding from the Hass Avocado Board to conduct this study and is a member of the Avocado Nutrition Science Advisory. The Hass Avocado Board had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.

Comment: Thanks to Jeff Nelson for sending this one (his interview with me is online)He points out that the diet of the group eating one avocado a day also ate less saturated fat and more fiber, which could help to account for the favorable result.  I love avocados (who does not?) but worry about what our demand for them is doing to Mexican food culture and personal safety.  Does the Hass Board really need to do this?

Addition, October 31

The London Daily Mail has, of all things, a critique of this study:  “Eating an avocado a day will NOT cut your cholesterol: Statistician debunks the ‘hilariously unimpressive’ results of study funded by ‘big avocado’.”

Oct 28 2019

Study of the week: Mushrooms, prostate cancer, Japan—Gastro-patriotism!

A reader, Jeff Nelson (whose interview with me is online here), sent me a link to this Japanese study that identified a link between eating mushrooms and prevention of prostate cancer.

The study:  Mushroom consumption and incident risk of prostate cancer in Japan: A pooled analysis of the Miyagi Cohort Study and the Ohsaki Cohort Study.  Shu Zhang, et al.  International Journal of Cancer. First published: 04 September 2019. 

Conclusion: “The present study showed an inverse relationship between mushroom consumption and incident prostate cancer among middle‐aged and elderly Japanese men, suggesting that habitual mushroom intake might help to prevent prostate cancer.”

Funding: “Our study was supported by the NARO Bio‐oriented Technology Research Advancement Institution.”

I looked up NARO:

The National Agriculture and Food Research Organization or NARO is the core institute in Japan for conducting research and development on agriculture and food. Our overall mission is to contribute to the development of society through innovations in agriculture and food, by promoting pioneering and fundamental R&D. We conduct technological development to make agriculture a competitive and attractive industry, and contribute to increasing the nation’s food self-sufficiency rate.

Jeff’s question: “Is this considered commercial research? Mushrooms’ magical impact of preventing cancer?”

My response: “Gastro-patriotism

I would classify this one as ideologically driven more than commercially driven.  Mushrooms are part of traditional Japanese diets and this institute promotes commercialization of Japanese agricultural products.

The result is far-fetched enough (mushrooms prevent prostate cancer, really?) to be suspicious, but this looks more like gastro-patriotism to me than the result of mushroom industry lobbying–if such exists, it was not disclosed.

Gastro-patriotism is a term I just this minute coined.*  It describes the promotion of nationalism and civic pride through a country’s cuisine.  Examples leap to mind with French cuisine leading the way and anything having to do with terroir.  The Greek government’s promotion of olive oil is another example.

* Addition October 29

A reader, Polly Adema, reminds me that the term is hardly original. There is, she says:

an established concept and practice of gastronationalism. It is a recognized variation of gastrodiplomacy, one getting increasing attention within various academic circles…Lots of articles will come up if you search gastronationalism in google scholar or your search engine of choice.  The term is from and grows out of Michaela DeSoucey’s 2016 book, Contested Tastes: Foie Gras and the Politics of Food.  Here is a link to an earlier DeSoucey piece: https://journals.sagepub.com/doi/full/10.1177/0003122410372226#_i11

Oops.  Apologies to Michaela DeSoucey, for not citing her excellent book, which I had read, blurbed, and posted as weekend reading, but did not think of in this context.

 

Oct 21 2019

Industry-funded study of the week: Dairy yet again

This one was sent to me by a reader who wishes to remain anonymous (thanks!).

The Study: Dairy Fat Consumption and the Risk of Metabolic Syndrome: An Examination of the Saturated Fatty Acids in DairyAllison L. Unger,Moises Torres-Gonzalez, and Jana Kraft.  Nutrients 2019, 11(9), 2200; https://doi.org/10.3390/nu11092200

The review argues: “it is likely that the diverse array of SFA [saturated fatty acid] constituents within full-fat dairy foods contributes to favorably modulating cardiometabolic health.”

It concludes: “In summary, previous work on the impact of dairy-derived SFA consumption on disease risk suggests that there is currently insufficient evidence to support current dietary guidelines which consolidate all dietary SFA into a single group of nutrients whose consumption should be reduced, regardless of dietary source, food matrix, and composition.”

Funding and Conflicted Interests (my emphasis): “The work involved for this manuscript was funded by National Dairy Council….M.T.-G. is employee of National Dairy Council. J.K. has received research funding from National Dairy Council.

Comment: This purpose of this dairy-funded review is to demonstrate that contrary to contradictory information, the saturated fatty acids in dairy foods are not only benign, but beneficial. The dairy industry would love that to be true.

This particular sponsored review is exceptionally well organized and illustrated.  I especially appreciated the timeline of dietary recommendations for saturated fat from 1977 to the present.  This is the bottom half:

This is a classic industry-funded review arriving at the desired conclusions.  In essence, it is a dairy industry advertisement and should be understood as such.

Why do this?  The dairy industry is in serious economic trouble these days, as I will discuss tomorrow.

Oct 14 2019

Industry-funded study of the week: Organics, alas

I am a great believer in the value of organic production methods, which avoid the most toxic pesticides and herbicides, are demonstrably better for soil, and produce fewer greenhouse gases.

But I wish the organic industry would try to find a less conflicted, more objective way of conducting studies on organic foods.

The study: Production-related contaminants, pesticides, antibiotics, and hormones in organic and conventionally produced milk samples sold in the USA.  JA Welsh, et al.  Public Health Nutrition.  Published online by Cambridge University Press: 26 June 2019. DOI:  https://doi.org/10.1017/S136898001900106X

Conclusions:  “Current-use antibiotics and pesticides were undetectable in organic but prevalent in conventionally produced milk samples, with multiple samples exceeding federal limits. Higher bGH and IGF-1 levels in conventional milk suggest the presence of synthetic growth hormone. Further research is needed to understand the impact of these differences, if any, on consumers.”

Funding: Financial support: Data collection was supported by the Organic Center…. The Organic Center had no role in the design, analysis of samples, or writing of this article.

Conflict of interest: J.A.W.’s investment portfolio includes equity in one of the companies whose milk products were randomly selected for use in this study. All other authors have no perceived or potential conflicts of interest to report.

Comment: Organic standards are about production values.  Antibiotics, toxic pesticides and herbicides, and genetic modification are not allowed in organic production and would not be expected to be detectable in organic milk.  The result reassures that the system is working properly (why wouldn’t it?).  But I wish it had been funded and conducted by investigators with no vested interest in its outcome.  I am aware of the argument that independent funding is not available for studies like this.  That’s a problem that the organic industry needs to solve.

Thanks to Stephanie Laverone for telling me about this study.

Oct 8 2019

NutraIngredients.com: An Exchange with its editor

I am an avid follower of industry newsletters such as NutraIngredients.com, and was intrigued to see one titled “Does bias against company-funded research really serve consumers?When I read it, I was even more amused.  One of my Monday “industry-funded study of the week” posts had triggered it.I found an email address for the editor, Hank Schultz, and wrote him a note that I hoped would open up a conversation.

I’m glad you wrote this and hope it will open up an opportunity for an ongoing conversation about industry-funded research and the conflicts it generates…..I am a constant and grateful reader of your and other Reed newsletters, and greatly admire the consistently outstanding and objective reporting.  I have only one ask: if a study is funded by a company with a vested interest in its outcome, ask your reporters to be sure to state who the funder is.

Mr. Schultz wrote back and after some cordial back-and-forth asked if he could do an interview for the newsletter.  Of course he could.  Here is the result.

Bias inherent in company funded research calls value of evidence into question, critic maintains

By Hank Schultz, 

The results of company funded research are so predictable that the value of the studies is greatly reduced, a prominent critic of the practice says.

In a recent NutraIngredients-USA commentary it was argued that dietary supplement companies that build up a suite of research do so carefully, and plan for success​​. With a careful design of the research program, positive results at the bench can naturally translate into successful randomized, placebo controlled trials.

Longtime critic of industry funded research

Marion Nestle, PhD, nutrition professor at New York University and author of the influential book Food Politics​ as well her most recent work Unsavory Truth: How Food Companies Skew the Science of What We Eat, ​ isn’t buying. Nestle responded to NutraIngredients-USA on the subject of the commentary to say that she has reviewed hundreds of company-funded studies and in her view the inherent biases built into that system are next to impossible to overcome.

Indeed, on her blog (also titled Food Politics​) Nestle has a frequent feature called “Industry funded research of the week.” The feature is used to document instances of bias, which to Nestle’s eye are thick on the ground.

“The overriding issue is that industry-funded research almost invariably comes out with results favorable to the sponsor’s interests. This is so predictable that I can often recognize the funder by the title of the paper,”​ Nestle told NutraIngredients-USA.

Nestle noted that the phenomenon is not by any means restricted to research on food and supplement ingredients. It has been noted in studies on tobacco, chemicals and pharmaceuticals.

“Studies of these industries show that the influence apparently occurs at an unconscious level; investigators did not intend to be influenced and do not recognize that they were influenced. But the evidence for funding effects is overwhelming,”​ she said.

Bias starts with study design

Nestle said a key issue is how the research question is framed. Companies investing in research naturally want to succeed and get some return on their investment. But the best science doesn’t come when the question is framed in such a way that a positive result is overwhelmingly likely, she said.

“I get letters all the time from trade associations asking for proposals for research that will demonstrate the benefits of their products. That is not the same as asking open-ended questions about effects. Companies want data on benefits for marketing purposes. That’s why I view industry-funded studies as about marketing, not science,”​ Nestle said.

Nestle said she has noted that some of the larger funders, such as the larger food companies or industry associations supporting categories of products like walnuts, almonds, strawberries or what have you, churn out research supporting their products of interest. While some might argue this adds to the totality of evidence and thus could be a good thing, Nestle said she doubts the value of these investments when taking the inherent biases into account. This can result in studies that seek to demonstrate things like substituting junk food calories with a serving of something like almonds or strawberries is a good thing to do. Yes, but so what? In Nestle’s view, this kind of bias is all but inevitable in research funded in this way.

“That’s what decades of research on the effects of drug-industry funding says, and the few studies looking at funding effects in nutrition find similar results,” ​she said.

Independent funding mechanism

What Nestle said she’d like to see is a mechanism for funding research into food and supplement ingredients that was divorced from a marketing plan.

“I want to see a firewall between the funder and the scientist. In ​Unsavory Truth, I talk a lot about various attempts over decades to create such firewalls and develop a pool of industry research funds managed by independent third parties. They have never worked well,”​ she said.

Nestle said she believes that only by making contributions to research compulsory, with the resulting fund to be managed by a credible third party, can research of undeniable quality be done. Something like the Beef Checkoff Program but for independent research funding, even if the results of those studies might not immediately support the marketing of the products.

“My idea of an ethically funded study is to ask for investigator-initiated proposals, appoint third party reviewers who decide who gets funded, and stay completely out of the process from then on. I worry when I see disclosure statements that the funder had no role in the study because that statement has been demonstrated to be false so many times. Food companies are funding research because they want specific results. That’s not how science is supposed to work,”​ Nestle said.