Unethical behavior of breastfeeding researcher sets back cause of protecting babies from starvation and smothering CORRECTED

Business Acronym COI as CONFLICT OF INTEREST

I received an email from Harry Orf, PhD, Senior Vice President for Research, and Research Integrity Officer Massachusetts General Hospital informing me that I disseminated incorrect information. Much to my regret I repeated false claims and mischaracterized the situation. For that I am deeply sorry and want to correct the record as soon as I can.

How could the original reporter have gotten it so wrong? Where did she come up with these accusations if not from the Harvard investigation?

Let’s look at whom she quotes: all three earn their money from the billion dollar breastfeeding industry. Another leading avatar of the breastfeeding industry, Melissa Bartick, MD, apparently filed the original complaint.

I want to offer a heartfelt apology to Dr. Kleinman for my original piece. I repeated misinformation and for that I am deeply sorry. I’ll be waiting for Bartick, Seals Allers, Sullivan and McEnroe to do the same.

*****

Kudos to Dr. Melissa Bartick for holding leading breastfeeding safety expert Ronald Kleinman, MD to account. He has failed to fully disclose payments from the formula industry.

Now if only she and other lactivists would only hold the Baby Friendly Hospital Initiative to account for iatrogenic brain injuries and deaths as a result of aggressive breastfeeding promotion.

Though Kleinman behaved unethically, there is no question that babies have been injured and died — and continue to be injured and die — on the altar of breastfeeding promotion.

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.”

The revelations could hardly be worse:

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…

Additionally, Kleinman has published at least six articles in the last three years, which some advocates claim are critical of breastfeeding initiatives…

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…

Kleinman’s explanation:

In an email response to Women’s eNews, Kleinman responded that his previous failures to disclose his industry connections were an “inadvertent omission.”

What was Dr. Bartick’s role in uncovering Kleinman’s unethical behavior?

I also filed a complaint about Kleinman’s conflicts of interest to the Harvard Medical School Office of Academic and Research Integrity in December 2017, which was never addressed.

Apparently Dr. Bartick was unaware of the investigation that she put in train.

I find Kleinman’s behavior inexcusable for two reasons. First, he deprived other doctors and researchers of relevant information needed to evaluate his papers. Second, by discrediting breastfeeding safety research he puts babies at continued risk of brain injuries and deaths from aggressive breastfeeding promotion.

Make no mistake: though Kleinman behaved unethically, there is no question that babies have been injured and died — and continue to be injured and die — on the altar of breastfeeding promotion.

In taking money from the formula industry, Dr. Kleinman is no different from leading lactivists who take money from the breastfeeding industry. The payments he received are no more or less likely to affect his research conclusions than the payments from the breastfeeding industry affect the conclusions of lactivist.

Moreover, financial conflicts of interest and not the only conflicts of interest that can affect breastfeeding research. White hat bias is equally if not more important. Indeed, breastfeeding research was identified as a paradigmatic example of white hat bias in the seminal commentary by Cope and Allison, White hat bias: examples of its presence in obesity research and a call for renewed commitment to faithfulness in research reporting.

‘White hat bias’ (WHB) [is] bias leading to distortion of information in the service of what may be perceived to be righteous ends… WHB bias may be conjectured to be fuelled by feelings of righteous zeal, indignation toward certain aspects of industry, or other factors. Readers should beware of WHB and … should seek methods to minimize it.

Cope and Allison note that researchers have been so anxious to establish a connection between formula feeding and obesity that they have ignored or misrepresented what the scientific evidence actually shows.

Certain postulated causes have come to be demonized (… formula feeding of infants) and certain postulated palliatives seem to have been sanctified…

Whether WHB is intentional or unintentional, stems from a bias toward anti-industry results, significant findings, feelings of righteous indignation, results that may justify public health actions, or yet other factors is unclear. Future research should study approaches to minimize such distortions in the research record…

I suspect that it is white hat bias — feeelings of righteous indignation toward the formula industry — that lead lactivists like Prof. Amy Brown to make irreponsible claims that she is subsequently forced to withdraw.

Earlier this week, Brown tweeted:

There is a misleading post circulating suggesting a newborn’s stomach is larger than medical textbooks say it is. It suggests that the volume at 40 weeks could be 33ml rather than approx 7ml. Based on this it incorrectly claims colostrum is not enough and top ups are needed.

It was repeatedly brought to her attention that the size of 7 ml comes from a 1920 paper that has been superceded by multiple recent papers that show a newborn stomach size of 20-30 ml. Brown refused to back down until she was shown this excerpt from a pediatric surgery text:

[Stomach] size increases rapidly from 30 ml in a term baby to 100 ml by the fourth week.

EBC3CE16-32CE-4872-AA3C-5D030E43D478

Brown responded:

Ranges seem to go from 5-30 which happy to accept. But again … stomach size is irrelevant…

But if it were irrelevant she wouldn’t have created a Twitter thread attempting to discredit the true size. The lactation profession has spent at least a decade attempting to normalize infant starvation by insisting that colostrum must be enough to assuage infant hunger because infant stomach size is too small to require larger amounts. That has always been a lie.

Why lie about newborn stomach size? It may be the result of the financial conflict of interest of lactation professionals who make their money by promoting breastfeeding. It almost certainly the result of white hat bias in the form of a near irrational hatred of the formula industry that has led to the irresponsible claim that formula supplementation destroys the breastfeeding relationship when the scientific evidence shows the exact opposite.

So thank you Dr. Bartick for doing the strenuous work required to hold another physician to account for his egregious failure to disclose his conflicts of interest. Now may I suggest that you perform a similar service by holding the breastfeeding industry to the same high standard. Because though Kleinman behaved unethically, there is no question that babies are being injured and are dying from aggressive breastfeeding promotion.

  • Box of Salt

    Thank you for the correction, Dr Amy.

  • Anne Catherine

    I usually agree with everything said on this blog, but I think that this post is not quite on
    target, as was the article in E-Women’s Health
    (this link was provided in the first paragraph of the post).

    The article said that there was a “lengthy investigation
    into Kleinman, but they found no official fault”. What is this supposed to mean? What did this investigation find? Unofficial fault? She does not comment further on the investigation, but goes on to say that other publications have addressed this issue in general, –which has nothing to do with Dr Kleinman.

    Furthermore, the article doesn’t really say what exactly his ties were and how he had enriched himself from these companies; in fact it does
    not give any specifics. Is it possible that the author trumped up these
    charges and exaggerated a bit? There
    is a link to an article that tells of Mead Johnson making donation to Mass
    General where Dr Kleinman worked—but the donation went to the hospital, not toDr Kleinman. The rest of the associations may have been
    very minor and not included payment, or not necessarily even true.

    The article complained that Kleinman had not disclosed his
    relationships with Mead Johnson to JAMA, but then went on to say that JAMA does not require disclosure if it was over three years ago. So how is this so horrible if the rules do not require disclosure?

    The résumé of Dr Kleinman is actually pretty impressive—as stated
    in the EWomen’s-news piece:

    ” 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.”

    I really don’t think there is enough evidence for this kind
    of character assassination. He has had
    a long and respected career and has been
    a voice of reason in this breastfeeding mania. I feel that he has been unfairly targeted by
    Melissa Bartick, Baby Friendly and the
    breastfeeding community because he didn’t
    support the 10 steps in their entirety.

    After Kleinmans latest paper came out, Bartick wrote a letter complaining of
    conflict of interest to JAMA which JAMA rejected. Then
    she complained to Harvard, they investigated, and they did not find fault
    either. Personally, I would trust JAMA and Harvard over Bartick, Kimberly Seals
    Allers (quoted in the article), and Baby Friendly.

  • fiftyfifty1

    Sheesh, Dr. Kleinman. Modern formula is an amazing invention that has saved countless babies from death and has saved countless mothers from anguish. You could have taken the industry funding if you needed or wanted it and declared it without shame. Sure, lactivists would have accused you of being a formula shill, but you could have addressed that accusation outright. You could have replied that this demonization of the formula industry needs to end, and you were doing your part by partnering with them openly.

    • fiftyfifty1

      I am very happy to learn of the correction! Glad to hear that the accusations of conflict of interest against Dr. Kleinman were falsified by lactivists who had conflicts of interest themselves. How ironic.

  • AnnaD2013

    I am very disappointed in Dr Kleinman’s unethical behavior. However, it does not change the fact that the practices of the BFHI can and do put infants (and their parents) at risk. It also does not change the fact that if breastfeeding isn’t going well, or if you don’t want to breastfeed, there is NO PROBLEM, and certainly GREAT BENEFIT, to giving your baby clean formula made with clean water in a clean bottle.

    I hate that the breastfeeding industry is going to use this against moms who choose to formula feed.

  • Desiree Scorcia

    https://highline.huffingtonpost.com/articles/en/alabama-midwives/

    I dont have a FB account, but someone needs to explain the difference between a cnm and a cpm to this audience!

    • andrea

      Oy, no kidding.

      As an aside, If I were in the shoes of Eliza’s mom, I sure as hell wouldn’t go back to the same hospital, but I’m not convinced the baby would have been saved at home, either. I see her point….but I wouldn’t have made the same conclusion.

      • Desiree Scorcia

        Yeah, no mention of how long the mom labored at the hospital and what other interventions they begged her to have but she refused.

    • rational thinker

      Its obvious that the baby died from prolonged rupture of membranes with possible meconium. But no lets just blame the pitocin not the infection that 3 doctors said is what the baby died from.

  • Mel

    Dr. Brown’s acceptance of “a range” from 5mL – 30mL is exceptionally misleading – or is a sign that her reading comprehension is very poor.

    An isolated esophageal atresia is NOT a normal developmental outcome for a newborn. Ironically, the fact that it takes a complete disjoining between the stomach and the esophagus to get a newborn stomach that is 5mL in volume says much more about how unlikely the “7mL” just-so-story of the newborn’s stomach is.

    If she’s going to be that disingenuous, we may as well start claiming that the normal range of volumes is 0mL through 30mL so we can count kids who are born without a stomach as normal.

    • Sarah

      It’s all about the variations of normal…

  • Madtowngirl

    This is so frustrating, because it plays right into the lactivist shill arguments. “See? These people who think formula is okay are paid by the industry!” Arrrgh.