Currently browsing posts about: Conflicts-of-interest

I could not keep up with the number of e-mails I got last week with the subject line “Have you seen this?”

“This” referred to an opinion piece in JAMA entitled Backlash Over Meat Dietary Recommendations Raises Questions About Corporate Ties to Nutrition Scientists.

Definitely up my alley.

The article describes the outraged reaction to a series of papers in the Annals of Internal Medicine last year arguing that recommendations to eat less meat are unfounded (I posted about this at the time).  Some of the investigators involved in the meat papers turned out to have undisclosed ties to meat industry interests.

The JAMA article points out that the most outraged objections to the Annals papers came from investigators who have plenty of industry ties (plant-based) of their own.

My book, Unsavory Truth: How Food Companies Skew the Science of What We Eat, provides loads of evidence for a basic observation: research funded by food companies, regardless of the particular food studied, tends to produce results favorable to the sponsor’s interests.

It also describes how industry influence occurs at an unconscious level; recipients are unaware that they are being influenced.

How the influence gets expressed is also the subject of research.  Bias most frequently turns up in the framing of the research question.  It also turns up frequently in the interpretation of results.

Here is an example from a study of a healthy plant food—walnuts.

The study: Effect of a 2-year diet intervention with walnuts on cognitive decline. The Walnuts And Healthy Aging (WAHA) study: a randomized controlled trial.  Aleix Sala-Vila, Cinta Valls-Pedret, Sujatha Rajaram, Nina Coll-Padrós, Montserrat Cofán, Mercè Serra-Mir,  Ana M Pérez-Heras, Irene Roth, Tania M Freitas-Simoes, Mónica Doménech, Carlos Calvo, Anna López-Illamola, Edward Bitok, Natalie K Buxton, Lynnley Huey, Adam Arechiga, Keiji Oda, Grace J Lee, Dolores Corella, Lídia Vaqué-Alcázar, Roser Sala-Llonch, David Bartrés-Faz, Joan Sabaté, and Emilio Ros1.  Am J Clin Nutr 2020;00:1–11.

Conclusions: Walnut supplementation for 2 y had no effect on cognition in healthy elders. However, brain fMRI and post hoc analyses by site suggest that walnuts might delay cognitive decline in subgroups at higher risk. These encouraging but inconclusive results warrant further investigation.

Conflicts of Interest: AS-V, SR, JS, and ER have received research funding through their institutions from the California Walnut Commission, Folsom, CA, USA. JS and ER were nonpaid members of the California Walnut Commission Scientific Advisory Council. ER was a paid member of the California Walnut Commission Health Research Advisory Group. JS has received honoraria from the California Walnut Commission for presentations.  AS-V has received support from the CaliforniaWalnut Commission to attend professional meetings. All other authors report no conflicts of interest.

Comment: This looks to me like a classic example of interpretation bias.  Although the study showed no effect of walnut supplementation, the authors interpret its overall results as encouraging.  This is putting a positive spin on null results.

Walnuts—and other kinds of nuts—are plant foods with healthy fats.  Why does the California Walnut Commission need to do this?  So you will buy walnuts rather than hazelnuts, pecans, or macadamia nuts (all of which are sponsoring their own positive-result studies).  Studies like these are mostly about marketing.

Questions of whether meat is healthy or unhealthy—and, if unhealthy, at what level of intake—are about much more than marketing.   They need to be studied as objectively as possible.  It’s best to keep industry influence far away from such studies.

Even if the science is done well from start to finish, researchers’ ties to food company sponsors give the appearance of conflicted interests.  Such ties are best avoided from the get-go.

Follow-up

• A detailed analysis of the JAMA piece by the anonymous CarbSane blog
• Naomi Oreske’s comment in Scientific American
• Texas A&M’s letter to Harvard requesting an investigation of faculty belonging to True Health Initiative (who complained about the meat guidelines)
• Texas A&M’s Chancellor Calls on Harvard to Look Into Faculty’s Beef-science Ethics (AgDaily)
• Beef with Harvard (Inside Higher Ed)
• From Beef to Bots? Harvard Professors Mired in Debate over Spam Emails, Industry-Funded Research (Harvard Crimson)
• Conflict of Interest in the Post-Truth Era: What Is It, Now? (David Katz)
• Processed Meat “Guidelines:” Why the Exceptional Reaction? (David Katz)
• Tobacco, Soda, and the Beef with Truth (David Katz)
• Massive Meat Mayhem, Part 3 (ConscienHealth)
• Perspective: Red and Processed Meats and Health Risks: How Strong Is the Evidence? (Frank Hu et al)

Even though my book, Unsavory Truth: How Food Companies Skew the Science of What We Eat, is now published, I’m still collecting particularly entertaining examples of industry-funded research that should trigger the question, “Guess who paid for this?”

Matured Hop-Derived Bitter Components in Beer Improve Hippocampus-Dependent Memory Through Activation of the Vagus Nerve, by Tatsuhiro Ayabe, Rena Ohya, Yoshimasa Taniguchi, Kazutoshi Shindo, Keiji Kondo & Yasuhisa Ano .  Scientific Reports, 2018; 8: 15372.

Background: Our group has focused on the constituents of beer, and we found that iso-α-acids, major bitter components in beer derived from hops (Humulus lupulus L.), improve cognitive impairment in an Alzheimer’s disease (AD) mouse model and high fat diet-induced obese mice.

Conclusion: Vagus nerve activation by the intake of food materials including MHBA [matured hop bitter acids] may be a safe and effective approach for improving cognitive function.

Competing Interests: T.A., R.O., Y.T., K.K. and Y.A. are employed by Kirin Co., Ltd. The authors declare no other competing interests with this manuscript.

[Thanks to Eric Bardot and Maggie Tauranac for sending this excellent example}.

In FoodNavigator, I read a report of a study finding that processing of corn into breakfast cereal flakes strips out phenolic compounds and tocopherols (vitamin E) associated with good health.

Just as processing of whole wheat into white flour removes the bran and germ, so does the processing of corn into corn flakes.

The germ and bran (hull) layers of grain seeds contain the vitamins and minerals—and the phenolics.  What’s left is the starch and protein (endosperm).

To replace these losses, manufacturers fortify corn flakes with 10% to 25% of the Daily Value for 12 vitamins and minerals.

This study is further evidence for the benefits of consuming relatively unprocessed foods.

Of particular interest to me is the authors’ disclosure statement:

This work was funded in part through gifts from the Kellogg Company and Dow AgroSciences.

The authors declare no competing financial interest.

This makes this study a highly unusual example of an industry-funded study with a result unfavorable to the sponsor’s interests.  The authors do not perceive Kellogg funding as a competing interest.  It is.  Kellogg (and maybe Dow) had a vested interest in the outcome of this study.

I would love to know whether these authors obtain further research grants from Kellogg and Dow.

Coming October 30:  My new book about food company sponsorship of nutrition research and its effects on public health.  

To introduce the book, which describes the consequences of conflicts of interest generated by food industry research funding, I will be doing a series of posts about it over the next few weeks.

I begin this series with a discussion of how I manage my own financial relationships with food, beverage, or supplement companies.

As a nutrition professor, even one who is retired, I cannot avoid contacts with food companies, nor do I necessarily want to.  I need to know what they are doing.

I go to meetings sponsored by food companies, read journals sponsored by food companies, read newsletters they send me, and get frequent gifts of books, research materials, product samples, and swag ranging from small (jump drives, squeeze toys) to enormous (would you believe a room-size punching bag that looks like a cola can?).

I give talks to and occasionally consult for food companies.  At issue is how to do this without being influenced to change what I write or say—or appear to be so influenced.

If I were wealthier, I would just pay my own expenses and be done with it.  As it is, I figured out a management policy for dealing with food company gifts and payments.

• I accept reimbursements for travel, hotels, meals, and meeting registrations (otherwise I would not be able to go).
• I do not accept honoraria, consulting fees, or any other personal payment.
• Instead, I ask the company to make an equivalent donation to the NYU Library’s Food Studies collection (which is named after me) or to my department’s fund for student travel.  If the checks come to me directly, I endorse them over to NYU.  I report all such income appropriately on tax forms.

I am well aware that this policy is not perfect.  Small gifts, meals, and travel reimbursements are thoroughly established to influence physicians’ prescription practices, and I derive reputational benefit from donations to NYU.

But this policy makes me think carefully about conflicted situations and I try to make it work as well as I can.

My conflict of interest declaration on journal articles reads as follows:

Marion Nestle’s retirement and research funds from New York University support her research, manuscript preparation, and website at foodpolitics.com.  She earns royalties from books, and honoraria and travel from lectures, about matters relevant to this publication.

A summary of this policy is posted on the About page on this site.

My email inbox was flooded last week with The Obesity Society’s call for more research on the value of taxes on sugar-sweetened beverages.

“Although taxing SSBs might generate revenue that can be used to promote other healthy food items, the net outcome may not necessarily decrease overweight and obesity rates in the United States or worldwide,” said Steven B. Heymsfield, MD, FTOS, President-Elect of The Obesity Society (TOS) and professor and director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge.

Why would a professional society that represents people who ostensibly care about obesity science, treatment, and prevention issue a statement aimed at casting doubt on a demonstrably effective public health measure?  (Soda companies know the taxes are effective; that’s why they fight them so hard).

The Obesity Society (TOS), alas, often appears far more favorable to the interests of food and beverage companies than those of public health.  Could funding of the society and its members have anything to do with this?

Here is the TOS position on corporate funding:

TOS recognizes the value in providing any donor that wishes to support our mission to find solutions to the obesity epidemic the opportunity to provide financial support.

The current TOS policy expressly eliminates all forms of evaluation or judgment of the funding source (other than the stipulation that funding is reasonably assumed not to be derived from activities deemed ‘illegal’).

TOS chooses instead to focus its ethical mission on transparency in disclosing the sources of funding, clear stipulations outlining our commitment to the ethical use of funds, and a commitment to non-influence of the funding sources over the scientific aspects of funded projects and TOS as a whole.

Translation: We will take money from any company, regardless of the effects of its products on public health.

The TOS rationale is that disclosure takes care of the problem and that funding won’t influence the science.  Unfortunately for this view, research demonstrates that disclosure does not eliminate the influence of funding, and the influence of funding is considerable—though often unrecognized, as is apparent in this case.

TOS has a disclosure policy, and discloses its officers’ conflicts of interest.  These are considerable.

• The TOS president’s university, Louisiana State, has received more funding from Coca-Cola than any other in recent years.  Researchers there have been funded generously by Coca-Cola.
• An elected president of TOS had to resign over charges that he had been paid by the restaurant industry to file an affidavit opposing New York City’s calorie-labeling proposal.

In 2013, Dr. Yoni Freedhoff resigned his TOS membership over the society’s sponsorship policies.  In his comment on the current TOS statement, Freedhoff points out that “sugar-sweetened beverage taxes decrease sugar-sweetened beverage consumption and increase healthier beverage consumption while providing the greatest potential health benefits to low income consumers.”

TOS members who care about creating a healthier food environment should consider joining Dr. Freedhoff.  lf not, they should insist that TOS leadership take vigorous pro-public health stances on matters affecting their patients’ health.

Additional comments, October 31, 2018

Yesterday I received a message from Liz Szabo, a reporter for Kaiser Health News, who is writing a piece on TOS’s relationships with food companies.  She questioned Steve Heymsfield, the group’s current president, who responded at length with a message that included this paragraph:

Marion Nestle, on the other hand, is professor “emeritus” and our understanding is that she no longer reports directly to a dean at New York University. That created a hurdle for us when trying to manage Dr. Nestle’se false and misleading blog related to this matter on her website. Even after learning her comments were misleading from Dr. Popkin, and unlike Popkin who has a high ethical standard, she failed to take down that post.

This surprised me, because nobody from TOS or anywhere else had written me to correct the post, Dr. Popkin’s corrections were to something he—not I—had written, and my ongoing relationship with NYU is readily evident from the information posted under About on this site.

I pointed this out to Dr. Heymsfield, who replied with annotations to my post.  Most of these deal with opinion and interpretation rather than fact.  The one thing I got “completely false” is my interpretation that TOS lacks standards for deciding which donors are acceptable.  Dr. Heymsfield says it does.  I am happy to hear that and stand corrected on that point.

Last week, New York Times reporter Roni Rabin wrote how the National Institutes of Health (NIH) solicited funding from alcohol companies to fund—and, distressingly, participate in the design of—a study of the effects of moderate drinking on heart disease risk.

This is not the first time Ms. Rabin has written about this study.  In July, she described the study and its funding.

Since then, she has apparently been busy filing FOIA requests and conducting further interviews.  These reveal that the NIH actively solicited industry funding and input into this trial.

The [NIH] presentations gave the alcohol industry an opportunity to preview the trial design and vet the investigators. Indeed, the scientist leading the meetings was eventually chosen to head the huge clinical trial.

They also made the industry privy to pertinent details, including a list of clinical sites and investigators who were “already on board,” the size and length of the trial, approximate number of participants, and the fact that they could choose any beverage. By design, no form of alcohol — wine, liquor or beer — would be called out as better than another in the trial.

But it gets worse.  Boston University professor Michael Siegel tells his personal story of dealings with NIH’s National Institute of Alcohol Abuse and Alcoholism (NIAAA)

On January 16, 2015, I was called into the office of the Director of NIAAA and was essentially reprimanded for conducting NIAAA-funded research that was detrimental to the alcohol industry…At the meeting, I was told that I would never again be funded to conduct research on alcohol marketing, regardless of how highly my research proposal was scored by the scientific review panel.

Let me be clear: research ethics require funders to have no involvement in research design, conduct, or interpretation, lest they exert undue influence on the results.

Julia Belluz (Vox) put this study in context.  She describes how

The NIH is now investigating whether the researchers violated federal policy by soliciting donations, and they’re appointing outside experts to review the design of the study. We don’t yet know the full story, and there’s surely more to uncover.

Anheuser Busch InBev, Heineken, Diageo, Pernod Ricard, and Carlsberg helped pay $67.7 million of the $100 million government study, which is currently underway. And even more troubling is that if you were a patient looking to enroll in the trial through the online clinical trials registry, you’d have no way of knowing about the industry’s involvement because that funding is not disclosed there.

Although I do not have much to say about the alcohol industry in my forthcoming book, Unsavory Truth: How Food Companies Skew the Science of What We Eat, I mention of this study as an example of how other industries skew research and also how pooling industry research funds is insufficient protection against conflicted interests (alcohol companies agreed to contribute 67.7% of the funding).

It’s good that the NIH has decided to investigate this dubious government-industry partnership, which so clearly seems aimed at marketing, not public health.

I haven’t posted an industry-funded study with predictable results in a while but when I saw this headline from FoodNavigator-Asia, I couldn’t resist.

The headline: “The most important meal of the day: Daily breakfast may lower obesity risk in schoolchildren — Nestlé study.”

High marks to FoodNavigator-Asia for naming the funder in the headline.

Its article referred to this study:

Breakfast consumption among Malaysian primary and secondary school children and relationship with body weight status – Findings from the MyBreakfast Study, by E Siong Tee, Abdul Razak Nurliyana,  A Karim Norimah, Hamid Jan B Jan Mohamed , Sue Yee Tan, Mahenderan Appukutty, Sinead Hopkins, Frank Thielecke, Moi Kim Ong, Celia Ning, Mohd Taib Mohd Nasir.  Asia Pacific Journal of Clinical Nutrition 2018;27(2):421 – 432.

Purpose: To determine the relationship between breakfast consumption and body weight status among primary and secondary school children in Malaysia among 5,332 primary school children aged 6 to 12 years and 3,000 secondary school children aged 13 to 17 years.

Results: “The proportion of overweight/obesity was higher among breakfast skippers (boys: 43.9%, girls: 30.5%) than regular breakfast eaters (boys: 31.2%, girls: 22.7%)…. Compared to regular breakfast eaters, primary school boys who skipped breakfast were 1.71 times (95% CI=1.26-2.32, p=0.001) more likely to be overweight/obese, while the risk was lower in primary school girls (OR=1.36, 95% CI=1.02-1.81, p=0.039) and secondary school girls (OR=1.38, 95% CI=1.01-1.90, p=0.044).”

Conclusion: “Regular breakfast consumption was associated with a healthier body weight status and is a dietary behaviour which should be encouraged.”

Author disclosures: “This study was funded by Cereal Partners Worldwide (CPW), Lausanne, Switzerland and Nestlé R&D Center, Singapore. Sinead Hopkins and Frank Thielecke were working for CPW, Lausanne, Switzerland, and Moi Kim Ong and Celia Ning were working for Nestlé R&D Center, Singapore, when the study was conducted. All authors declare that they have no conflicts of interests.”

I was particularly interested in this study for several reasons:

• Cereal Partners Worldwide is a joint venture between Nestlé and General Mills.  They have an interest in promoting breakfast cereals.
• Nevertheless, the authors who work for CPW or Nestlé believe that their employment with companies with vested interests in the outcome of research creates no conflict of interest.
• Breakfast, as Julia Belluz of Vox puts it, is often dessert in disguise.
• This particular study was performed by some of the same investigators discussed in the New York Times as part of its Planet Fat series.  See: Fuller T, O’Connor A, Richtel M.  In Asia’s fattest country, nutritionists take money from food giants.  NY Times, Dec 23, 2017.

No, I do not believe that breakfast is the most important meal of the day (I’m not much of a breakfast eater).  Eat when you feel hungry.

It does make sense to think that children should be fed at regular intervals and should not go to school hungry.  It also makes sense that regular meals encourage healthier patterns.  But preventing obesity?  That seems like a stretch, especially when the study’s funders have a financial interest in selling breakfast cereals.

For months now, I haven’t posted an industry-funded studies with results favorable to the sponsor, but this one about deserves mention.

Title: Critical review of the current literature on the safety of sucralose, by BA Magnuson, A Roberts, and ER Nestmann.

Journal: Food and Chemical Toxicology 2017:106:324-355.

Conclusion: “Collectively, critical review of the extensive database of research demonstrates that sucralose is safe for its intended use as a non-caloric sugar alternative.

Financial support was provided by the Calorie Control Council, Atlanta GA, to the employers of the authors for the preparation and publication of this review.

My comment: This lengthy review of literature on the safety of sucralose (Splenda) was commissioned by the Calorie Control Council, a trade association representing “manufacturers and suppliers of low- and reduced-calorie foods and beverages, including manufacturers and suppliers of more than two dozen different alternative sweeteners, fibers and other low-calorie, dietary ingredients.”

It paid authors affiliated with Health Science Consultants, Inc and Intertek Scientific and Regulatory Consultancy to produce this review.

• The Calorie Control Council has a vested interest in demonstrating Splenda to be safe.
• The consultant groups have a vested interest in pleasing the Calorie Control Council.
• Therefore, this review has a higher-than-average likelihood of bias.

Is Splenda safe?  It very well may be safe, but some contrary evidence exists (this paper dismisses it).  It would be interesting to see how independent scientists view the matter.