by Marion Nestle

Currently browsing posts about: Conflicts-of-interest

Sep 17 2018

Unsavory Truth: How I deal with conflicts of interest

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.

Jul 24 2018

The Obesity Society should support public health, not corporate health

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.

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.

Mar 28 2018

The NIH’s dubious partnership in industry-funded alcohol research

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.

Mar 13 2018

Eat breakfast, prevent obesity (say Nestlé and General Mills)

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:

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.

Dec 14 2017

Splenda is safe. Guess who funded the study.

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.

Aug 2 2017

Should nutrition scientists take food-industry funding?

I am an advisor to the American Society of Nutrition’s Early Career Nutrition group and was asked to address this question for its spring/summer newsletter (my piece starts on page 9).  Here’s what I said:

As a newly appointed advisor to ASN’s Early Career Nutrition (ECN) group, I am pleased to be asked to explain why I do not think it a good idea for nutrition scientists, practitioners, and societies to be funded by food, beverage, and supplement companies (collectively, the food industry) for research that is in any way related to their products. If we do, we run the risk of appearing as if our interests are conflicted. More than that, we risk being conflicted—influenced to be less critical or silent about nutrition issues related to the donor’s products. There is no getting around it: whatever the reality of the relationship, taking money from a for-profit food company makes us appear to be supporters of whatever products the company sells.

I worry a lot that financial ties between food companies and ASN tarnish its reputation and ours. It troubles me when critics outside our profession view us as “on the take” and publish reports exposing ASN’s financial ties to companies that have a marketing stake in what we study or say about their products. When ASN meetings are sponsored by food companies, it makes these financial ties seem normal. ASN provides a platform for industry-sponsored sessions such as the one this year on the benefits of Stevia, but you can bet they don’t include speakers who might say anything critical. Sponsorship excludes that possibility.

Most of what we know about the effects of sponsorship comes from a very large body of research on funding by the cigarette, chemical, pharmaceutical, and medical device industries. The results of this research are remarkably consistent: they demonstrate that industry funding influences the design, interpretation, and outcome of research. Nutrition is late to this type of investigation, but several recent studies show that studies funded by the food industry almost invariably favor the interests of the sponsor. Publication bias against negative studies explains only a small part of these findings.

Industry funding of nutrition research is an important issue where there are diverse opinions. ASN is a welcoming place encouraging discussion from members with all perspectives on topics including this one. ASN members share a common unifying goal of advancing nutrition science to promote the public welfare. Working together we can and we will continue to disclose potential conflicts of interest and advance the field for the public benefit. Dr. Mary Ann Johnson, ASN President
Investigators who take such funding insist that it has no effect on the design, conduct, interpretation, or publication of their research. This insistence is consistent with another large body of research demonstrating that gifts have a profound influence on attitudes, behavior, and action–but that recipients are blind to these effects. The medical literature shows that even small gifts—pens and pads—are enough to influence prescription practices, and that larger gifts have even greater effects. But the influence occurs below the radar of critical thinking. It is unintentional, unconscious, and unrecognized.

What most troubles me is the lack of questioning of industry penetration into our societies and research. I think we should be raising questions about ASN’s involvement with companies whose profits might be affected by our opinions or research results. Should ASN have competed to manage the industry-funded Smart Choices program that ended up putting a seal of approval on Froot Loops? Does it make sense for ASN to endorse public policy statements promoting the benefits of processed foods or opposing “added sugars” on food labels? Is it reasonable for ASN to argue on social media that it is inappropriate to question industry funding of research? Must ECN sessions at the annual meeting really be funded by companies such as PepsiCo (last year) or Abbott Laboratories? These actions send the message that ASN is an arm of the food industry and that we uncritically support what it makes, sells, or does.

But let’s turn to a more immediate concern: research funding. As early investigators, you face intense pressures to bring in external grants to pay for your studies, overhead, and maybe even your salaries. Government funding for many areas of nutrition research is declining. These pressures are real. But just as real are the effects of industry funding on research.
From March 2015 to March 2016, I posted summaries of industry-funded studies on my blog. During that year, I collected 168 studies. Of these, 156 yielded results favoring the sponsor’s interests. I only could find 12 studies that did not. This was a casually collected convenience sample but it did allow one conclusion: it is easier to find industry-funded studies with positive results than those with negative results. Nevertheless, recent systematic studies come to the same conclusion. Studies funded by Coca-Cola, for example, are far more likely to conclude that its products have no effect on obesity or type 2 diabetes than do studies funded by government or foundations.

Because we are generally unconscious of the influence of financial ties, it is easy for us to deny the influence or argue that nonfinancial interests—preferences for hypotheses and desires for career advancement–are just as biasing. Yes they may be biasing, but all scientists have them. In contrast to financial ties to industry, it is not possible to eliminate nonfinancial biases and still do science.

I am often asked whether there is a way to take money from food companies and maintain intellectual independence and professional reputation. I regret that I cannot think of any viable way to do that. The ASN has appointed a “Truth” commission to examine this issue and I look forward to its report. In the meantime, I am hoping that you will give thought to the potential conflict of interest and reputational loss that you risk with food industry ties. You must figure out for yourself whether you think the risks are worth taking.

If you do decide to engage with industry, you will need to disclose it. Most journals now require authors to reveal who pays for their work, but even when done diligently, disclosure is not sufficient to alert readers to the extent to which industry funding influences research outcome and professional opinion. Yes, disclosure is uncomfortable, perhaps explaining why so many studies identify frequent lapses. It is likely to become more uncomfortable. In response to a petition from the Center for Science in the Public Interest (which I co-signed), the National Library of Medicine has announced that it will henceforth add funding disclosures and conflict-of-interest statements to PubMed abstracts.

It is only fair to tell you how I handle these issues. My disclosure statement says:

Dr. Nestle’s salary from NYU supports her research, manuscript preparation, Website, and blog at https://foodpolitics.com. She also earns royalties from books and honoraria from lectures to university and health professional groups about matters relevant to this topic.” I also on occasion speak to food industry groups. When I do, I accept reimbursements for travel expenses but ask that honoraria be donated to the NYU library’s food studies collection.

This policy, imperfect as it may be, is the best I can do. I ask only that you think seriously about these issues and figure out for yourself how best to deal with them. I am happy to discuss these matters and am most easily reached at marion.nestle@nyu.edu.

References

  • Nestle M. Food company sponsorship of nutrition research and professional activities: A conflict of interest? Public Health Nutrition 2001;4:1015-22.
  • Nestle M. Corporate funding of food and nutrition research: science or marketing? JAMA Internal Medicine 2016;176(1):13-4.
  • Krimsky S. Science in the Private Interest: Has the Lure of Profits Corrupted Medical Research. Rowman and Littlefield, 2004.
  • Lo B, Field MJ, eds. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.
  • Simon M. Nutrition Scientists on the Take from Big Food. Eat Drink Politics and the Alliance for Natural Health, Jun 2015.
Jul 27 2017

The CDC Nominee’s Links to Coca-Cola

Last Sunday’s New York Times had a front-page story on Coca-Cola’s relationship to the current nominee for director of the CDC.  I’m quoted in it and soon got this request:

Good morning, Marion:

I saw this Times news coverage in which you’re quoted.

Given this news about reversing the CDC’s position on aligning with the private sector on sugar sweetened beverages, I’m wondering if you’d be game to elaborate on this and provide your perspective on it.

Sure.  Happy to.

The New York Times story on Coca-Cola’s connections to Brenda Fitzgerald, President Trump’s nominee to head the CDC, goes right into the book I’m writing.  The book is about food, beverage, and supplement industry funding of nutrition research and practice and with luck will be published by Basic Books late in 2018.

Fitzgerald was health commissioner for the state of Georgia and at first glance looks well qualified to head the CDC.  But a health advocacy group, US Right to Know, has had a long-standing interest in Coca-Cola’s cozy relationships with CDC—both Coke and CDC are in Atlanta, after all—and at some point obtained emails through FOIA that explain just how cozy.

Here’s what especially got my attention in the Times article :

  • While she was health commissioner, Fitzgerald accepted a million-dollar grant from Coca-Cola for an obesity program focused exclusively on physical activity—for sure, not on the health benefits of drinking less Coke (focusing on physical activity has long been a deliberate strategy of this company).
  • People associated with the activity program said “Coke had no influence over the program.”  Of course that’s what they think.  Much research shows that recipients of industry funding do not recognize the influence.  Such influence is unintentional, unconscious, and invariably denied.
  • When the previous CDC director, Tom Frieden, canceled Coca-Cola’s funding of obesity programs (he said it was unjustifiable “to have Coca-Cola run an obesity campaign that had an exclusive focus on physical activity), he asked company officials if they would be willing to fund something in “neutral space” like transportation or water programs.  Not a chance.

Food, beverage, and supplement companies are happy to fund research with a high probability of supporting marketing objectives.   Industry-funded research almost invariably comes out with results favorable to the sponsor’s commercial interests.

It’s unreasonable to expect otherwise.  Food companies are not public health agencies; they are businesses expected to generate profits and returns to shareholders—that is their #1 priority.

The moral for public health: don’t take the money.

 

 

 

Apr 19 2017

PubMed to include funding and conflict-of-interest statements with scientific abstracts

The National Library of Medicine (NLM) has quietly announced that it will henceforth include funding and conflict-of-interest statements on the abstracts published on PubMed, its searchable site for scientific publications.

This happened because of a petition organized by the Center for Science in the Public Interest (CSPI), which I signed, and which called for this method of disclosure.  CSPI sent a formal request to the NLM on March 30, 2016.  The NLM announcement came one year later.

CSPI issued a press release:

Hundreds of millions of searches are conducted on PubMed annually by people around the globe.  In a March 2016 letter to NIH and NLM, CSPI and other supporters cited studies published in Cochrane Collaboration, PLoS Medicine, and elsewhere that found that outcomes of studies on drugs, medical devices, and nutrition were often favorable to funders’ interests.

“Adding disclosures about researchers’ financial relationships with drug, food, chemical, and other industries makes PubMed search results even more useful than they already are,” said CSPI president Michael F. Jacobson.  “We thank the National Library of Medicine for adding this feature and hope journalists who rely on PubMed make consistent use of it when reporting on studies related to nutrition and health.”

The press release quotes me:

New York University nutrition scientist Marion Nestle tracked 168 industry-funded studies on her blog, foodpolitics.com.  By her count, 156 of those reported studies favorable to the sponsors’ interests.

“These required extensive library searches to find the disclosure statements,” said Nestle.  “I only looked for papers that seemed industry-funded from their titles, and undoubtedly missed many with both positive and negative results.  This new policy will make this kind of research much easier and more accurate.”

Amen to that.