Currently browsing posts about: Sponsored-research

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Mars, Inc., one of the defectors from the Grocery Manufacturers Association (see yesterday’s post) has also withdrawn from membership in and support of the International Life Sciences Institute (ILSI), a group that claims to be independent  but in fact is funded by hundreds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

My invited, accepted—but omitted—commentary about a study funded by Disney has at last been published by the Journal of the Association of Consumer Research.

In February, I explained how the editors had solicited this commentary, but then given it to the article’s authors to rebut, and allowed me to comment on their rebuttal.  None of this correspondence appeared when the journal published the Disney-funded article.

Could Disney’s involvement have anything to do with this omission?  The editors said no; they had just ran out of page room.

But in April, I wrote about how Stat had obtained e-mails between Disney and one of the authors indicating that the company had attempted to withdraw its study because it feared adverse publicity.  Some of the study’s authors had been associated with the Global Energy Balance Network, the group funded by Coca-Cola to promote the idea that physical activity is more important than diet in maintaining healthy weight.

When I complained about the omission of my accepted piece, the editors arranged to have it and the correspondence published in the journal’s June issue.

While the correspondence was in proof, I added a last line bringing the situation up to date: “Disney’s now exposed attempt to withdraw their paper from publication (Kaplan 2016) provides further evidence for the hazards of industry-funded research.”

Done.  Finished.  Amen.

While in Israel, I kept hearing that peanut allergies are virtually unknown in that country.  Nobody I met knows anyone with problems with peanuts—not Jews, Arabs, children, nor adults.

The explanation?

Bamba (and its Arabic equivalent).

These things are peanut puffs.

Because they melt in the mouth, they are often fed to babies as a first food.  Apparently, babies love them.

How do they taste?  Just as you might expect (peanut-flavored straw?  peanut-flavored Cheetos?).  They are sold everywhere as a snack and I met adults who love them too.

Do they really prevent peanut allergies?  Indeed, there might be something to this idea.

Introduction of peanut products into the diets of infants at high risk of developing peanut allergy was safe and led to an 81 percent reduction in the subsequent development of the allergy, a clinical trial has found…Researchers led by Gideon Lack, M.D., of King’s College London, designed a study called Learning Early About Peanut Allergy (LEAP), based on observations that Israeli children have lower rates of peanut allergy compared to Jewish children of similar ancestry residing in the United Kingdom. Unlike children in the UK, Israeli children begin consuming peanut-containing foods early in life.

Translation:  Bamba.

These researchers also found that allergic reactions did not return even if the children in that trial stopped eating Bamba for a year.

Their studies were funded mainly by NIH and the UK Department of Health, but the researchers also report that their clinical trials unit was supported by the National Peanut Board, Atlanta, and that the manufacturer of Bamba supplied the products.  The lead author, Gideon Lack, reports holding stock in DBV Technologies, the maker of Viaskin Peanut, a product that helps people with peanut allergies tolerate exposure to peanuts.

I’d like to see these studies repeated by fully independent researchers.

In the meantime, pediatric allergists are advising parents to let their babies eat peanut butter (but not peanuts because babies can choke on them).

These allergists—and the authors of the Bamba studies—participated in an American Academy of Pediatrics consensus statement:

There is now scientific evidence (Level 1 evidence from a randomized controlled trial) that health care providers should recommend introducing peanut-containing products into the diets of ‘‘high-risk’’ infants early on in life (between 4 and 11 months of age) in countries where peanut allergy is prevalent because delaying the introduction of peanut can be associated with an increased risk of peanut allergy.

If these studies are right, introducing babies to the widest possible variety of foods as soon as they can handle solid foods (usually at 4 to 5 months) may well help prevent allergies later on.

Addition

A reader just sent another paper from the same authors, this one a randomized trial of six allergenic foods given to breastfed babies at 3 or 6 months of age.  By one analysis, allergies developed 1 to 3 years later in 7.1% of the later-introduction group and 5.6% of the earlier-introduction group—a result that was not statistically significant.  By another, allergies were much lower in the early-introduction group (2.4% vs 7.3%), especially with respect to peanut and milk allergies.