Currently browsing posts about: Sponsored-research

This is one of an ongoing series of examples of how industry funding skews, or to be more precise, is strongly associated with skewing, of research and opinion about matters of diet and health.

This example is an analysis of the scientific rigor of dietary approaches to controlling type 2 diabetes through diet.  The authors looked at the evidence for efficacy of the DASH, Mediterranean, Plant-Based, and Low-Carb diets.

Improving the Scientific Rigor of Nutritional Recommendations for Adults with Diabetes: A Comprehensive Review of the American Diabetes Association Guidelines Recommended Eating Patterns.  Hallberg S, Dockter NE, Kushner J, Athinarayanan S.  Preprints 2019.  Online March 5.  doi: 10.20944/preprints201812.0187.v2

Conclusion: “Our review of the current Standards and Recommendations finds significant shortcomings regarding scientific review methodologies, which are likely to translate to suboptimal clinical care decisions for patients with T2D.”  The study dismisses most studies of the DASH, Mediterranean, and Plant-based diets as poorly done or otherwise inappropriate for their review.  For the DASH diet, it says more research is needed.  It calls for more research on whether the benefits of Mediterranean diets are due to low carb or healthy fats, and suggests that the benefits of plant-based diets may be due to weight loss.  The best evidence supports the Low-Carb diet: “Evidence from 30 trials and 10 follow-up studies demonstrates that a low-carbohydrate diet is an effective dietary approach for addressing dyslipidemia.”

Conflict of Interest Statement:  SJH is an employee and shareholder of Virta Health, a for-profit company that provides remote diabetes care using a low-carbohydrate nutrition intervention, and serves as an advisor for Atkins Corp.  NED is a paid consultant for Virta Health.  JAK serves as medical director of McNair Interests, a private equity group with investments in type 1 diabetes and other chronic illnesses, and is also an advisor for Sanofi and Lexicon.

Comment:    All authors are employed by or consult for a company that uses low-carb dietary approaches in its for-profit business.  As I explain in Unsavory Truth, the influence of industry funding is often unconscious, unintentional, and unrecognized.  Nevertheless, the opinions of the authors can be predicted from their financial connections to Virta Health.

This is one of my ongoing updates of industry-funded studies such as those discussed in my most recent book, Unsavory Truth.

Here’s this week’s example:

Funding sources and outcomes of dairy consumption research – a meta-analysis of cohort studies: The case of type-2 diabetes and cardiovascular diseases.  Moshe Mishali, Mirit Kisner,Tova Avrech.  International Dairy Journal, accepted and in press 2019.

The study: The authors asked whether the source of funding was associated with the results of studies examining the association of dairy food intake with the risk of type 2 diabetes or heart disease.

Conclusion:  “This meta-analysis found that the funding source (i.e., food industry sponsorship versus neutral organisations sponsorship) did not affect the findings of studies in terms of the association between dairy consumption and the risk of developing type-2 diabetes and cardiovascular diseases…This meta-analysis suggests that research funded by the dairy industry might not deserve the same dismissive treatment that other industry-funded studies might merit.”

Funder: “This work was supported by the Israel Dairy Board Research – Fund (DBRF). Declaration of interest Moshe Mishali is a consultant for the Israel Dairy Board; Mirit Kisner was paid for her work by the Israel Dairy Board; Tova Avrech is Chief Health Officer at the Israel Dairy Board.”

Comment: This study was commissioned by the Israel Dairy Board specifically to address “The radicalised discourse that emerged in recent years [which] sees industry-funded research as inherently biased due to the obvious vested interests of any industry that initiates and funds certain studies…We sought to check if the suspicion is warranted when it comes to the dairy industry.”

These conclusions are consistent with those of Wilde et al (2012), although that study found that independently funded research included the only studies with results unfavorable to dairy (3 out of 16), whereas the industry-funded research came out 100% in favor of dairy products.

I would find the arguments about the benefits of dairy food more convincing if they were funded and conducted by investigators with no skin in the game.

After the debacle over Fifth Quarter Fresh that I wrote about in Unsavory Truth, you might think that sellers of chocolate milk would stop trying to prove it anything other than a sugary milk drink.  But no, here’s another one.

Chocolate Milk versus carbohydrate supplements in adolescent athletes: a field based study.  Katelyn A. Born, Erin E. Dooley, P. Andy Cheshire, Lauren E. McGill, Jonathon M. Cosgrove, John L. Ivy and John B. Bartholomew.  Journal of the International Society of Sports Nutrition (2019) 16:6.

Method: “Participants were randomly-assigned to receive either CM [chocolate milk] or CHO [carbohydrate] immediately post-exercise.”

Conclusion: “CM had a more positive effect on strength development and should be considered an appropriate post-exercise recovery supplement for adolescents.”

Funder: Dairy MAX [“nonprofit dairy council representing more than 900 dairy farm families across seven states”].

Comment: The premise of this study is that drinks containing a combination of carbohydrate and protein have been shown to provide better recovery from vigorous exercise than drinks containing carbohydrate or protein alone.  Chocolate milk contains both.  This study compared it to a carbohydrate-only sports drink, making this an excellent example of how to design a study to give you the desired result.

Unsavory Truth came out late last year, but I’m following up by posting recent examples of the issues it covers.  Here, for example, is a recent study that caught my eye:

The role of dietary sugars in health: molecular composition or just calories?  Philip Prinz. European Journal of Clinical Nutrition (2019).

A big argument in nutrition right now is whether the metabolic dysfunction that results from excessive consumption of sugars is due to the sugars themselves or to the calories they produce (or, I suppose, to both).

The author who attempted to answer this question conducted a lengthy and detailed review of research on the effects of sugars on obesity, heart disease, type 2 diabetes, and other chronic conditions .  His conclusion:

Current scientific evidence does not support the conclusion that dietary sugars themselves are detrimental to human health and the cause of obesity as well as NCDs [non-communicable— chronic—diseases]. Data from human studies clearly shows that it is the excess amount of calories, also consumed in form of dietary sugars, that promotes obesity and with that favors NCDs. For sucrose, further research is needed in order to evaluate the relevance of its molecular composition, especially in comparison with other macronutrients.

In other words, you don’t have to worry about sugars; just don’t overeat anything.

So, who paid for this?

The paper provides no disclosures of funding or conflicted interests.

But if you click on Philip Prinz, you will see that he is with the Department of Nutritional Sciences, German Sugar Association, Berlin, Germany

Comment

My interpretation of this literature generally favors calories (see my book with Malden Nesheim, Why Calories Count: From Science to Politics).  As I see it, when it comes to weight gain, how much you eat matters more than what you eat, especially if your diet is reasonably healthy.

But I would be much more confident in conclusions like these if they came from a researcher whose salary did not depend on producing desirable results for a sugar association.

And everybody would be better off eating less sugar, for reasons of nutritional health, if not necessarily weight.

Here’s another in my series of post-Unsavory Truth examples of studies whose funder can be predicted by their titles.

The consumption of 12 Eggs per week for 1 year does not alter fasting serum markers of cardiovascular disease in older adults with early macular degeneration Hassan Aljohia , Mindy Dopler-Nelson , Manuel Cifuentes , Thomas A. Wilson.  Journal of Nutrition & Intermediary Metabolism 2019;15:35-41.

Hypothesis: Egg consumption is associated with reduced risk of macular degeneration, but because eggs are so high in cholesterol, they might increase the risk for cardiovascular disease.

Conclusion: “This study suggests that the consumption of 12 eggs per week for 1 year does not significantly alter fasting serum lipids, lipoprotein cholesterol, or other biomarkers of CVD in older adults diagnosed with early macular degeneration” [the hypothesis is shown to be false].

Funding: “The authors would also like to thank the American Egg Board, Egg Nutrition Center, Washington, DC (T.A.W.) and the Massachusetts Lions Eye Research Fund Inc., New Bedford, MA (T.A.W.) for their funding support. The funding played no role in data collection, analyses, or interpretation.”

Comment: So the authors say, but industry influence is often unrecognized.    Independently funded studies sometimes come to quite different conclusions, as one in JAMA did last week.  Its conclusion: “Among US adults, higher consumption of dietary cholesterol or eggs was significantly associated with higher risk of incident CVD and all-cause mortality in a dose-response manner.”

Since my book Unsavory Truth came out late last year, I am posting occasional recent examples of issues I discussed in it.  Today’s issue: industry funding of research on potatoes of all things.

I am well aware that the role of white potatoes in the U.S. diet is hotly contested.   The EAT-Lancet report I wrote about recently advises against eating potatoes:

Potatoes, although containing large concentrations of potassium and some other vitamins, provide a large amount of rapidly absorbed carbohydrate, or glycaemic load. Daily consumption has been associated with increased risk of type 2 diabetes, hypertension, and weight gain.

Obviously, the potato industry would like to counter advise like that.  Its Alliance for Potato Research & Education is devoted to precisely that cause.  The Alliance explains that it is “Dedicated to advancing the scientific understanding of the role potatoes play in promoting the health of all people.”  It issues grants for up to $200,000 for “nutrition research proposals that help to advance scientific knowledge on the role of potatoes in various health outcomes” (the 2019 deadline just passed).

But I’ve just learned that the potato industry publishes its very own research journal: the American Journal of Potato Research.   It s subtitle: The Official Journal of the Potato Association of America, described as “A Professional Society for Advancement of the Potato Industry.”

Surprisingly, the papers in this journal are behind a paywall.  If the industry wants its research to be read and digested (sorry), I would think its papers would be open access (I was able to get this through NYU’s library).

One paper in particular caught my eye:

Invited review: Potatoes, Nutrition and Health.  Katherine A. Beals.  American Journal of Potato Research, 2018.  https://doi.org/10.1007/s12230-018-09705-4

Conclusion:  Until we have better research, “dietary guidance should continue to stress the importance of healthy eating patterns that consist of a variety of vegetables, including nutrient dense potatoes.”

Author’s funding disclosure: none.

Comment:  Evidently, this journal does not require authors to disclose funding.  Or perhaps every paper in this journal is sponsored by the potato industry?  Dr. Beals’ c.v. discloses consulting for the Potato Board.

I enjoy eating potatoes and view their effects on health as depending on how they are prepared, how much is eaten, and how often.

The purpose of potato-sponsored research is to cast doubt on studies suggesting that eating less of them would be better for your health.  When you see studies of potatoes and health, be sure to ask who paid for them.

Jonathan Marks.  The Perils of Partnership: Industry Influence, Institutional Integrity, and Public Health.  Oxford University Press, 2019.

I blurbed this one:

Jonathan Marks is the go-to expert on the hazards of public-private partnerships.  His account of the perils reads easily, is well referenced, is clear and to the point, and applies to partnerships with drug, food, and any other corporations.  Anyone who cares about the ethical implications of such partnerships for public health will find this book invaluable.

The book is about industry partnerships in general, but Marks uses food-company examples such as the American Beverage Association’s gift to the Children’s Hospital of Pennsylvania in what seemed to be a direct exchange for the city’s dropping a soda tax initiative, and the USDA’s promotion of cheese.

Marks concludes that

Public-private partnerships, multistakeholder initiatives, and other close relations with industry are premised on a positive conception of consensus, compromise, and collaboration.  But the “three C’s” are not inherently good.  On the contrary, tension between regulators and corporations is ordinarily necessary to protect public health.  And achieving common ground with industry may put off the table measures that might promote public health.  The default relation between industry and government should be arm’s lengths relations involving institutional tension, “struggle,” and direct conflict.

The point: the agenda of corporations is to promote profit, not public health.  This creates an inherent tension, not easily resolved.

The study: Assessing the in vivo data on low/no-calorie sweeteners and the gut microbiota.  Alexandra R. Lobacha, Ashley Roberts, Ian R. Rowland. Food and Chemical Toxicology 124 (2019) 385–399.

Its conclusion: “The sum of the data provides clear evidence that changes in the diet unrelated to LNCS [low- and no-calorie sweeteners] consumption are likely the major determinants of change in gut microbiota numbers and phyla, confirming the viewpoint supported by all the major international food safety and health regulatory authorities that LNCS are safe at currently approved levels.”

Funding disclosures: Intertek Scientific & Regulatory Consultancy (A.R.L. and A.R.) received financial support from the Calorie Control Council to assist in the preparation of the manuscript. The Calorie Control Council did not contribute to the origination, planning, implementation, or interpretation of this work. The Calorie Control Council did review the content of the complete manuscript; however, A.R. maintained responsibility for the final content.

Comment: Artificial sweeteners are widely suspected on the basis of questionable evidence to be harmful in one way or another.  The industry that makes these sweeteners wants to prove them safe and effective.  This was a literature review commissioned by the Calorie Control Council, a trade association for the makers and users of artificial sweeteners, from Intertek Scientific & Regulatory Consultancy, a group that does this kind of work.  I would be more confident in conclusions like these if they had been arrived at independently.