Currently browsing posts about: Sponsored-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.

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.

Since it’s Valentine’s Day (have a happy one), we might as well talk about a candy company, in this case, Mars, Inc.

Mars, Inc., one of the defectors from the Grocery Manufacturers Association (see yesterday’s post) has also withdrawn from membership in and support of the International Life Sciences Institute (ILSI), a group that claims to be independent  but in fact is funded by hundreds of food and beverage companies (hence: front group).

ILSI’s positions on food issues are decidedly pro-industry, and so are the results of its sponsored research.  Mars couldn’t take it anymore.

Mars told Politico Pro (this may be behind a paywall):

After careful consideration, Mars will end its relationship with the International Life Sciences Institute (ILSI) by the end of 2018, and is withdrawing from ILSI’s nutrition committees immediately,” the company said in a statement to POLITICO. “Increasingly, the presentation of certain studies by ILSI has been at odds with our position and principles. Mars has a long history of engaging in external research that is evidence-based and data-driven, particularly in the area of promoting public health. We wish to thank ILSI for its partnership.

Mars announces this departure as a component of its new research and engagement policy.

The policy applies to all of Mars’ partnerships with universities, governmental and non-governmental organizations, foundations, individuals, food companies, and trade associations (like ILSI).

Here is my summary of the policy’s long list of principles:

• High scientific standards in all animal and human research
• Full disclosure of funding and potential conflicts of interest
• Appropriate standards of authorship
• Funding not linked to achievement of a specific research outcome

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.

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://www.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.

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)

Brazilian researchers have published a study clearly aimed at countering Brazil’s dietary guidelines, which the authors say, include advice to “avoid fast food.”

The study, which looked at the nutritional quality of children’s lunches, comes to three conclusions:

1. The nutrition quality of lunch in fast food restaurants is similar to a typical Brazilian meal [Really?  Who paid for this?].
2. The restaurant meals could fit into a balanced diet from time to time [Of course.  Anything can].
3. Every meal observed here could be improved with regard to sodium and fiber to promote children’s health in adulthood [Ditto].

Did you guess?

The authors acknowledge Equilibrium Consultancy which led this study. Funding by McDonald’s Corporation for the project was primarily to Equilibrium.

This is yet another industry-funded study with results favorable to the sponsor’s interests.  These especially require scrutiny of hypotheses, methods, and interpretation and repetition by independently funded investigators.