Currently browsing posts about: Conflicts-of-interest

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.

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.

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.

In response to my commentary in JAMA Internal Medicine late last year, “Food Industry Funding of Nutrition Research: The Relevance of History for Current Debates, the journal published an objecting letter from Morton Satin titled  “Incorrect Impressions Concerning Industry-Sponsored Research.”

Mr. Satin works for The Salt Institute, which promotes the idea that “everything’s better with a little salt.”

Here’s my reply to his letter:

In Reply Mr Satin raises several points in response to my recent Invited Commentary¹ about how food companies fund research for marketing purposes: (1) I give the impression that all industry-funded research is inherently tainted; (2) I ignore the industry’s triumph in fortifying foods with nutrients; (3) I fail to mention intellectual conflicts of interest; and (4) I should consider such issues before stereotyping.

First, my commentary was about research sponsored by food companies specifically to demonstrate the health benefits or lack of harm of a product, or to cast doubt on evidence to the contrary. It referred to a particularly egregious example—the sugar industry’s attempt to manipulate research results.² Although some industry-funded research does produce results contrary to the sponsor’s interests, such instances are rare.³ Most ends up useful in some way to the sponsors’ commercial objectives; it is marketing research, not basic science.

The point by Mr Satin about nutrient fortification has merit, but most of the basic research on nutrients used in fortification was conducted by independent scientists. Mr Satin’s own Salt Institute credits independent scientists for promoting iodization and convincing the industry to cooperate with public health authorities to iodize salt.⁴Pasteurization kills pathogens; iodide and fluoride address geographical deficiencies; and niacin, folic acid, and fiber replace amounts removed from foods by processing in the first place. Once public health authorities recognized the need, they demanded milk pasteurization or the addition of nutrients to flour. When dental researchers discovered that fluoride prevents cavities, Procter & Gamble recognized its marketing potential and funded research on fluoridated toothpaste.⁵

All scientists have intellectual biases—that is how science gets done and why science works best when researchers with different views of science repeat each other’s experiments. But the goals of scientists pursuing intellectual hypotheses differ markedly from those of companies seeking to sell food products.

Questioning food industry funding raises sensitive issues, not least because its influence on researchers occurs unconsciously, is usually unintentional, and is difficult for recipients to recognize.⁶ Food companies are not public health agencies and should not be expected to be; their first priority is to provide profits to owners and shareholders. Funding research helps with that effort. My purpose in writing the Invited Commentary was to bring the contradictions of food industry research funding to the attention of readers.

Conflict of Interest Disclosures: Dr Nestle’s salary from New York University supports her research, manuscript preparation, and website at https://foodpolitics.com. She also earns royalties from books and honoraria and travel from lectures about matters relevant to the initial Invited Commentary and this Letter in Reply.

References

1. Nestle  M.  Food industry funding of nutrition research: the relevance of history for current debates.  JAMA Intern Med 2016;176(11):1685-1686.  PubMedArticle

2.  Kearns  CE, Schmidt  LA, Glantz  SA.  Sugar industry and coronary heart disease research: a historical analysis of internal industry documents.  JAMA Intern Med. 2016;176(11):1680-1685.PubMedArticle

3.  Lesser  LI, Ebbeling  CB, Goozner  M, Wypij  D, Ludwig  DS.  Relationship between funding source and conclusion among nutrition-related scientific articles.  PLoS Med. 2007;4(1):e5. doi:10.1371/journal.pmed.0040005PubMedArticle

4.  The Salt Institute. Iodized salt. http://www.saltinstitute.org/news-articles/iodized-salt/. Published July 13, 2013. Accessed January 17, 2017.

5.  Ksander  Y. The invention of fluoride toothpaste. Indiana Public Media. http://indianapublicmedia.org/momentofindianahistory/the-invention-of-flouride-toothpaste/. Published July 10, 2006. Accessed January 17, 2017.

6.  Lo  B, Field  MJ.  Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.

Sheldon Krimsky of Tufts University and Tim Schwab of Food and Water Watch have done an analysis of financial conflicts of interest among members of the committee that produced a large report on agricultural biotechnology last year.  Their paper (and the report) are open access so you can read them both and decide for yourself whether you think Krimsky and Schwab are being fair.

Academics’ financial ties to companies with an interest in the outcome of their work are a well established problem because such ties are known to influence the results and interpretation of research as well as the opinions of advisory committee members—even though the recipients of corporate gifts (even small ones) are unaware of the influence , had no intention of being influenced, and deny that such influence exists.

The Academies’ GMO report stated that none of the 20 committee members had financial ties to the GMO industry.

But these investigators found evidence of several kinds of undisclosed ties among six of the 20 members:

• Holds patents
• Holds equity
• Serves on company advisory committee
• Receives research funding
• Employed by company or non-profit funded by company
• Consults for company

The authors make it clear that these sorts of financial ties ought to have been disclosed.  I agree.

But here’s the National Academies’ in-denial response to the paper.  My translation: “we did everything right and this is a witch hunt.”

No you did not do everything right.  Disclosure should be rigorous, given the level of passion involved in views of GMOs and the need for trust in Academy reports.

And no, this is not a witch hunt.  This is a call for full disclosure.

The Associated Press reporter Candice Choi has a special interest in industry-funded research (as I do) and has been using emails obtained through FOIA requests to document connections between funders and researchers that otherwise would not come to light.

Yesterday, she reported some follow up on the article I was surprised to see published in the Annals of Internal Medicine—the one I wrote about in my last post.

Ms. Choi came up with these delicious tidbits:

• Mars Inc., which is one of the companies that funds ILSI (the International Life Sciences Institute, which funded the study in the Annals charging that dietary guidelines for sugar are based on weak evidence), is now denouncing the study on the grounds that “the paper undermines the work of public health officials and makes all industry-funded research look bad…[and] creates more doubt for consumers rather than helping them make better choices.”
• Mars is saying this even though emails show that two Mars executives knew about the study last year.
• Mars now said it will make clear to ILSI hat it does not support such work.
• ILSI’s executive director says ILSI devised the concept for the study, but the paper originally said that the authors wrote the protocol and conducted the study independently from the funder. Oops.  When confronted with the Associated Press emails “showing the group sent the authors ‘requested revisions’ on the proposal last year,” the journal corrected that statement to make clear that ILSI “reviewed and approved” the protocol.
• One of the authors did not fully disclose her consulting and research agreements with companies that make high-sugar foods.  The AP had emails demonstrating this author’s financial ties to Coca-Cola and to ILSI for a previous grant on the same topic.  The Annals now show a more complete disclosure statement.

The point of all this is that when food companies sponsor research, they sometimes are much more involved in it than they would like to let on.

Mars is right.  These kinds of incidents make all industry-funded research look bad.  Mars should know.  It funds research to make chocolate look like a health food.

I haven’t posted an industry-funded study for a while, but here’s a good one.  This is a systematic review published in the Annals of Internal Medicine attacking dietary advice to eat less sugar on the grounds that such advice is not scientifically justified.

This one doesn’t pass the laugh test.

What are dietary guidelines supposed to do?  Tell people to eat more sugar?

This review is particularly peculiar:

• It was funded by the International Life Sciences Institute (ILSI), a food-industry front group.
• Two of the four authors consult for ILSI, and one of the two is on the scientific advisory board of Tate & Lyle, the British sugar company.
• The authors admit that “given our funding source, our study team has a financial conflict of interest and readers should consider our results carefully.”  No kidding.
• It was published by a prestigious medical journal.  Why?
• It is accompanied by an editorial that thoroughly demolishes every single one of the authors’ arguments.

I can understand why ILSI wanted this review.  Many of its funders make sugary foods and drinks.  They would like to:

• Cast doubt on the vast amounts of research linking excessive sugar intake to poor health.
• Discredit dietary guidelines aimed at reducing sugar consumption.
• Head off regulatory attempts to tax or label added sugars.

In funding this study, ILSI is following the tobacco industry playbook to the letter.  Strategy #1 is to cast doubt on the science.

When the 2015 Dietary Guidelines came out with a recommendation to restrict sugar intake to 10% of calories or less, the Sugar Association called it“agenda-based, not science-based.”  The Annals review says international sugar guidelines do not “meet criteria for trustworthy recommendations and are based on low-quality evidence.”

I detect a theme here.

But I ask again: what are dietary guidelines supposed to do?  We cannot lock up large numbers of people and feed them controlled amounts of sugar for decades and see what happens.  Short of that, we have to do the best we can with observational and intervention studies, none of which can ever meet rigorous standards for proof.  So this review is stating the obvious.

Take a look at the accompanying editorial.  After destroying each of the flawed premises of this review, it concludes:

Industry documents show that the F&B [Food & Beverage] industry has manipulated research on sugars for public relations purposes….Accordingly, high quality journals could refrain from publishing studies on health effects of added sugars funded by entities with commercial interests in the outcome. In summary, our concerns about the funding source and methods of the current review preclude us from accepting its conclusion that recommendations to limit added sugar consumption to less than 10% of calories are not trustworthy. Policymakers, when confronted with claims that sugar guidelines are based on “junk science,” should consider whether “junk food” was the source.

I don’t ever remember seeing a paper accompanied by an invited editorial that trashes it, as this one did, but this incident suggests a useful caution.

Whenever you hear that something isn’t “science-based,” look carefully to see who is paying for it.

The press coverage

• The New York Times: A Food Industry Study Tries to Discredit Advice About Sugar (I’m quoted)
• NPR: How Much Is Too Much? New Study Casts Doubts On Sugar Guidelines (I’m quoted)
• EurekAlert: Dietary sugar guidelines are based on low quality evidence
• WTKR:The debate continues on how much sugar is OK
• Time: Should You Trust the New Research About Sugar?
• CSPI: Industry-funded Study Designed to Cast Doubt on Sugar Advice
• Daily Mail (Reuters): So we CAN eat more sugar? Controversy as top journal publishes Coca Cola-funded study claiming sweets are NOT as bad as feds claim (I’m quoted)

I wrote a commentary for a study published this morning in JAMA Internal Medicine: “Food industry funding of nutrition research: The relevance of history for current debates.”

The study, by UCSF investigators Cristin Kearns, Laura Schmidt and Stanton Glantz, is based on their archival research.  They found documentary evidence of shocking manipulation by the sugar industry of a Harvard review of studies on dietary factors and heart disease published in the New England Journal of Medicine in 1967.

Kearns et al. discovered that the sugar industry trade association paid investigators at Harvard an impressive amount of money ($48,000 in today’s dollars) to produce research demonstrating that saturated fat—not sugar—raises the risk of heart disease.

In my commentary, I reproduced a figure from the sugar-funded 1967 reviews.  This summarizes the epidemiology showing that both sugar and saturated fat intake were then indistinguishably associated with increased mortality in 14 countries.

Nevertheless, the reviews exonerated sugars and blamed saturated fat.

Yes, I know that association does not necessarily mean causation, but I’m guessing that the epidemiology still shows that both sugars and saturated fats are associated with increased heart disease risk.

My interpretation: We would all be healthier eating less of sugary foods and fatty meats.

Here are the relevant documents for your reading pleasure:

• The press release from JAMA Internal Medicine
• The press release from UCSF
• The article by Kearns et al.
• Kearns et al.’s online tables analyzing the studies (look for Supplement in their paper)
• The New England Journal of Medicine articles from 1967: Part 1 and Part 2
• My commentary on Kearns et al.’s paper
• NYU’s blog post about my commentary
• JAMA Internal Medicine’s podcast interview with me and Stan Glantz (find it under Related Multimedia on the right side of the page)

The Sugar Association issued a response to today’s article by Kearns et al.:

We acknowledge that the Sugar Research Foundation should have exercised greater transparency in all of its research activities…Generally speaking, it is not only unfortunate but a disservice that industry-funded research is branded as tainted…We question this author’s continued attempts to reframe historical occurrences to conveniently align with the currently trending anti-sugar narrative, particularly when the last several decades of research have concluded that sugar does not have a unique role in heart disease.  Most concerning is the growing use of headline-baiting articles to trump quality scientific research—we’re disappointed to see a journal of JAMA’s stature being drawn into this trend.

I will post press accounts as they appear (I’m quoted in most of these):

•  Vox 
• New York Times
• STAT (a particularly detailed account)
• CSPI’s comment on Kearns et al.
• Reuters 
• Live Science
• Bloomberg News 
• Healthy Food America comment
• Business Insider
• Associated Press 
• NBC
• Time
• Quartz
• CNN
• Forbes
• United Press International
• Good Food
• Fortune
• Daily Mail
• Helio
• The Guardian
• US News
• CBS News
• Glamour
• Smithsonian
• Huffington Post
• Union of Concerned Scientists