One of Harvard’s highly regarded physicians and a national expert in pediatric nutrition, who has guided policy for the American Academy of Pediatrics and the US Dietary Guidelines, has come under scrutiny for his financial connections to fast food and infant formula industries. In March, 2018, Harvard University’s Office for Academic and Research Integrity quietly concluded an investigation into a complaint against one of its most prominent physicians, Dr. Ronald Kleinman, amid growing concern that these financial connections were influencing his research and public statements as a leading expert on developing nutritional guidelines for America’s children.
Kleinman’s experience includes serving as the Charles Wilder Professor of Pediatrics at Harvard Medical School, Physician-in-Chief at MassGeneral Hospital for Children, and the Chief of Partners Pediatrics in Boston (Partners is the largest health care system in Massachusetts which was founded by MassGeneral). He has also served as chairman of the Committee on Nutrition for the American Academy of Pediatrics, editor-in-chief of four editions of the AAP’s Nutrition Handbook, and on the board for US Dietary Guidelines, which devise nutritional recommendations for millions of Americans, among other key roles.
Kleinman has an extensive list of past and present known financial connections to the fruit juice, cereal, and infant formula industries, including work as a consultant for Burger King (these industries appear to be at odds with optimal nutrition for infants and children). Harvard’s review did not find any official fault, but due to recent investigative reporting by the New York Times and ProPublica, light has been shed on the conflict of interest for scientists in all fields. Potential conflicts of interest that directly impact mothers and infants therefore merit additional consideration. This article reflects Women’s eNews’ investigative reporting on this issue.
Kleinman’s connections to the infant formula industry, and a failure to disclose those relationships when publishing research on breastfeeding, have drawn particular ire. In 2016, Kleinman and two other physicians co-authored an article published in the highly-regarded peer-review journal, JAMA Journal of Pediatrics, which was viewed as critical of the Baby Friendly Hospital initiative, a global initiative designed to promote better breastfeeding practices in hospital maternity units. Specifically, the study entitled, Unintended Consequences of Current Breastfeeding Initiatives, reported the rooming-in practice, where a baby stays in the same hospital room as the mother at Baby Friendly Hospitals, could, as Time Magazine described, “lead to mothers’ accidentally smothering their children and possibly contribute to sudden unexpected postnatal collapse, a rare but often fatal respiratory failure.”
A Failure to Disclose Long-Term Relationships
At the time, Kleinman failed to disclose his deep financial ties to Mead Johnson, the parent company of Enfamil infant formula, which spanned eight years (2006 to 2014). He had also received an honorarium from Mead for chairing the Mead Johnson Iron Infant Nutrition Panel, funding for a hospital initiative (which he described as a “fruitful partnership”), and was the author of two Mead-funded studies. His other connections to formula companies included co-chairing two Nestle Nutrition Symposia (Nestle is the parent company of Good Start formula and has been the subject of a seven year boycott by breastfeeding advocates for their egregious marketing violations). Kleinman told Women’s eNews that he no longer has an ongoing relationship with Nestle.
Additionally, Kleinman has published at least six articles in the last three years, which some advocates claim are critical of breastfeeding initiatives. Two of these articles appeared in the academic journals, JAMA Pediatrics and American Journal of Clinical Nutrition (at least two others were funded by Mead Johnson, and a fourth was funded by Nestle). In an email response to Women’s eNews, Kleinman responded that his previous failures to disclose his industry connections were an “inadvertent omission.”
In a more recent article published in the November issue of JAMA Pediatrics critiquing the skin-to-skin guidelines for the Baby Friendly Hospital Initiative, Kleinman disclosed his vast industry connections, including financial ties to the infant formula maker Mead Johnson, General Mills, Ocean Spray and the Alliance for Potato Research and Education (APRE), among others. He also disclosed serving on the board of trustees of the International Life Sciences Research Foundation, the grant-making arm of a food industry group whose member companies include Coca-Cola, Dow Agrosciences/Dow Chemical, General Mills, Hershey Foods, Kellogg, Kraft, McDonald’s, Merck & Co., Monsanto, Nestle, PepsiCo, Pfizer and Procter & Gamble.
“Now that we finally see the full scope of Kleinman’s conflicts of interest, it is still unclear how all of these conflicts do not raise ethical flags for Harvard, and why a highly respected journal such as JAMA Pediatrics would still publish his research,” says Kimberly Seals Allers, author of The Big Letdown—How Medicine, Big Business and Feminism Undermine Breastfeeding. “These studies influence public health policy for infants and children — they deserve more stringent guidelines for integrity, not business-as-usual behavior.”
After several researchers complained about the 2016 article, JAMA issued a correction in January, 2017, adding Kleinman’s disclosure of an honorarium from Mead (the prior hospital funding went unmentioned). The Mead-funded studies and Nestle symposia fell outside the three-year range JAMA requests for conflicts of interests, though experts believe the bias that comes from such financial connections can last well beyond three years. JAMA’s disclosure practices came under scrutiny last week in a recent New York Times article, which details that many physicians fail to fully report their financial ties to industries.
Key Influence on Nutritional Policy for Children
Experts and advocates have questioned why Kleinman would be allowed to have any financial ties to industries that seem to be at odds with the best childhood nutrition, particularly when giving advice to low-income populations. The 2008 study he authored was funded, in part, by the Juice Products Association (Kleinman later published an article citing the role fruit juice can play in WIC offerings and a child’s diet, despite nutritionist warnings that juice is high in sugar). Further, in addition to now serving as the chair of the WPC for the 2020 DGA guidelines, Kleinman previously served on the Burger King External Advisory Board and as a consultant for General Mills and Beech-nut foods. He also received an honorarium for chairing a presentation and meeting on vegetables sponsored by the Alliance for Potato Research and Education, and later authored a 2016 review paper on vegetables with that same sponsor which concluded that more potatoes were healthy for a child’s diet. (In response to our specific questions, Kleinman said that during his time spent in Peru in his 20s, he witnessed the importance of a potato as a staple food, and that there are approximately 100 countries worldwide that depend on the potato as a major source of nutrition.)
What makes Kleinman’s financial ties concerning to other nutrition experts is that he is in a unique position to issue prolific nutrition guidance. In addition to his work on the 2010 US Dietary Guidelines for All Americans, he is the editor of the fourth, fifth, and sixth editions of the Academy’s Pediatric Nutrition Handbook. These publications provide popular nutritional information that guide decisions by physicians and policy makers, as well as guidelines parents often consult when making food and nutrition decisions for their families.
“Disclosure alone doesn’t solve the problem,” says Marion Nestle, a professor of nutrition, food studies and public health at New York University, though of no relation to the company by the same name, “but it does provide context necessary for evaluation, especially in well respected journals. If I were a peer-reviewer of [Kleinman’s 2016] paper, I would say, ‘Do not publish.’ I don’t care what the science says. This paper has a very high probability of bias.” In her latest book, Unsavory Truth: How Food Companies Skew the Science of What We Eat, Nestle documented that in 156 of the 168 food industry sponsored studies she followed, results favored the sponsors’ interests.
Formula Industry Targets Breastfeeding Research; Baby Friendly Hospital Initiative Hit
Not surprisingly, as breastfeeding initiation rates have risen, so has the influence of formula funding for breastfeeding research, notes Lucy Sullivan, executive director of 1,000 Days, a nonprofit dedicated to the health of women and young children. “It’s made the Baby Friendly Hospital initiative a target for formula companies,” she says, “and for a $71 billion industry, that is a really big deal.” As part of receiving the Baby Friendly accreditation, which requires the completion of 10 total steps, hospitals only dispense infant formula when medically required, and mothers do not receive any free infant formula upon hospital discharge, as is common in many hospitals.
Kleinman said, in an email response to Women’s eNews, that the articles he published are “not critical of breastfeeding,” pointing specifically to language in his 2016 JAMA piece that reads, “Promoting and supporting breastfeeding during the postpartum period has been an important and appropriate priority for maternity units.” The article further recommends that ‘Hospitals should direct their efforts toward implementing practices that will promote breastfeeding safely.’
Still, it was the study’s title, introductory paragraph and use of the phrase ‘potentially hazardous practices’ that garnered the most media attention. This study led to sensationalistic headlines and was quoted in media to paint breastfeeding as dangerous, including a reference in a provocative Time Magazine October, 2017, cover story about the overwhelming demands of motherhood. “Anecdotal reports indicate this is having a negative impact on hospital care practices and reduced support of breastfeeding,” says Trish MacEnroe, Executive Director of Baby-Friendly USA. An independent Google Scholar analysis also shows that Kleinman’s article has been viewed and cited more than any other Viewpoint articles related to breastfeeding in JAMA that year. “While the full extent of the damage is not quantifiable, the commentary offers a highly speculative interpretation of the presented data. Its publication in a respected journal [JAMA Pediatrics] confers more credibility than is warranted,” MacEnroe says. She also reports that this article has been used by organizations seeking to stoke fear about breastfeeding exclusively.
Experts say the rise of Baby-Friendly Hospitals, which recently celebrated its one- millionth birth and now has over 500 certified hospitals in the US, has played a key part in the rise of breastfeeding rates in the US. From 2009-2015, more women not only started breastfeeding, but were also breastfeeding longer and doing so exclusively, as measured at both the three and six-month marks. Additionally, MacEnroe says that another 534 hospitals are in the process of certification, resulting in falling infant formula sales.
Industry Funding, Shown to Influence Outcomes; Yet Likely to Continue
Kleinman says that most studies conducted with industry funding serve as “important means of advancing knowledge and science, and the outcomes are clearly not influenced by the funder.” In a statement to Women’s eNews, specifically, he describes the standards that he and his colleagues adhere to when conducting such studies, including acknowledging the funding in the report, research being initiated by the investigator, and that such research is conducted completely independent of the corporate funder. By following those rules, which Massachusetts General Hospital has put in place, Kleinman concedes that some high-profile examples of industry-initiated studies have not had the “appropriate firewalls,” but believes that he always “adhere[s] to these rules for independence.”
“Industry funded-studies and honorariums like those Kleinman receives are likely to continue, as long as industries continue to get the outcomes they seek,” Professor Nestle cautions. “As both researchers and industry leaders have learned, however, outcomes from industry funded studies have a strong probability of favoring the industries’ interests, although the researcher may deny any impact.”
Rebecca Gale is an award-winning journalist based in Bethesda, Md. Her work has appeared in The Washington Post, Slate, and Health Affairs, among other outlets. Follow her at @beckgale or find her work at www.Rebeccagale.org.
This article is part of a series from The Maternal & Child Health Communication Collective, a W.K. Kellogg Foundation-funded initiative to shift the national discourse on the socio-cultural factors influencing the health of mothers and infants.