The resurgent influence of big formulaBMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3577 (Published 23 August 2018) Cite this as: BMJ 2018;362:k3577
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Although the World Health Organisation (WHO) and other stakeholders tend to blame the infant food industry for non-compliance with infant feeding policies, and there is justification for that, many of the concerns expressed by Shenker 1 can be linked to issues regarding the globalisation of infant feeding policymaking. Policy is currently developed by the WHO and endorsed by the World Health Assembly (WHA) with the assumption that governments will implement the agreed recommendations at country level. For many stakeholders, especially parents and healthcare professionals, the current global “one-size-fits all” approach to infant feeding is difficult to comprehend when there is considerable diversity of nutrition and socio-economic circumstances across country settings, including quality of sanitation, availability of clean water, supplies of nutritious complementary foods, and affluence and education of the population. Would it not be more appropriate for individual regions and countries to assess their own level of nutritional risk and shape infant feeding policies to meet their specific needs, and thus create a sense of ownership which may lead to increased compliance?
With reference to the 2016 Lancet breastfeeding study which estimated that per annum over 820,000 infant lives could be saved by increased breastfeeding rates 2, Shenker does not explain that the data used for the lives saved analysis were from medium- and low income countries with high child mortality rates, the analyses do not include data on complementary feeding, the paper does not provide the calculations that lead to the bottom line of 820,00 live births and there are errors in two tables included in the supporting document. The WHO is also guilty of using this headline figure without relevant background information 3, and by not stating in which countries these lives would be saved, they are creating unnecessary anxiety and guilt in many families worldwide.
Shenker refers to the criticism of paediatricians by WHO officials in the columns of The Lancet 3 and the UK Royal College of Paediatrics and Child Health has responded that with due diligence, they will continue to communicate with industry to ensure that they can provide the best nutritional care for their patients 4. There are very few clinical conditions in childhood where nutritional care is not a key aspect of the child’s clinical management, and this is particularly evident in low-income countries. It is therefore important that paediatricians do not feel threatened by these accusations and continue to provide the best care for children.
From a parental perspective it should be a pre-requisite that parents feel a sense of ownership regarding the feeding recommendations for their child and are not confused by the actions of organisations that should be providing protection and support to families. Most recently, in a “Policy Brief” officials from WHO made the statement that “breast milk substitutes should be understood to include any milks …that are specifically marketed for feeding infants and young children up to the age of 3 years”5. This new interpretation of the term breast milk substitutes is significantly different from the definition that is currently described in the International Code of Breast Milk Substitutes 6, and it appears not to have been formally endorsed by the WHA or been subject to wider stakeholder consultation 7. For many parents the proposal that the term breast milk substitute should be applied to any milk product for children up to the age of 3 years, will be greeted with disbelief.
As evident from Shenker’s article, infant feeding is a highly politicised area of healthcare and there needs to be a rethink on how infant feeding policy can be developed and delivered. The acrimony that has dominated the current globalised approach to infant feeding policy has continued relentlessly for several decades and needs to stop. The new reforms need to place parents and their children at the centre of the policymaking process, and involve all relevant stakeholders, including industry 8. The roles of WHO and governments need to be aligned to ensure that policies are sensitive to the needs of individual regions and countries, and policymakers and other stakeholders need to demonstrate that this process can be conducted in a climate of trust and respect.
1. Shenker NS. The resurgent influence of big formula. BMJ 2018;362:K3577.
2. Victora CG, Bahl R, Barros AJD et al., for The Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet 2016; 387: 475–90.
3. Costello A, Branca F, Rollins N et al. Health professional associations and industry funding. Lancet 2017; 389: 597–98.
4. Modi N, Greenough A, Viner R, et al. Health professional associations and industry funding— reply from Modi et al. Lancet 2017;389:1693-94.
5. World Health Organisation. World Health Assembly resolution on the inappropriate promotion of foods for infants and young children. 2016. http://www.who.int/nutrition/netcode/WHA-Policy-brief.pdf
6. World Health Organisation. International Code of Marketing of Breast-milk Substitutes. World Health Organization, 1981. http://www.who.int/nutrition/publications/code_english.pdf
7. Forsyth S. Is the WHO creating unnecessary confusion over breast milk substitutes? J Pediatr Gastroenterol Nutr 2018 Jul 19. doi: 10.1097/MPG.0000000000002098. [Epub ahead of print]
8. Forsyth S. Should the World Health Organization relax its policy of non-cooperation with the infant food industry? Ann Nutr Metab 2018;73:160–162 (DOI:10.1159/000492624)
Competing interests: I have received research grants from government, charitable organisations, and industry; and consultancy fees and honoraria from government and industry, including companies that produce infant formula. I currently receive consultancy fees from DSM Nutritional Products, an international ingredient supplier.
I read with interest and agreement with the editorial above. As a shop floor clinician looking after newborns, I face the challenge of encouraging mothers to breast feed or provide breast milk all the time. There are 2 points I would like to comment on:
True, doctors need to advocate breast feeding, the evidence of its benefits is no longer disputed, but we cannot do it alone. The entire healthprofession needs to advocate breast feeding. Not only appropriate training in this area needs to be in place for doctors, nurses and maternity staff, education for the public starting from primary school curriculum must be a government priority. It is difficult to change culture and attitudes overnight but with unbiased evidence based education, there is hope.
It is quite unrealistic to exclude the formula industry altogether in our quest towards universal acceptance of breast feeding as the norm, because there will always be the exceptional circumstances where specialised formulae and fortifiers are required eg preterm, cows milk allergy etc. As long as our main message is “breast milk is the best for your baby” and appropriate resources and support exist to realise this, robust clinical guidelines plus staff education should keep the prescription of these products to a minimum. The concern over industry education initiatives negatively influencing our practice is acknowledged but sponsorship does/should not equate to deviation from evidence based practice.
I believe, that educating everyone, especially the younger population, about the importance of breast feeding, is the key to longer term success in universal breast feeding, as nature intends it to be.
Competing interests: No competing interests
Natalie Shenker’s recent essay on “The Resurgent Influence of Big Formula” is good, but in focusing on the US, it underestimates the scope of the problem. The influence of Big Formula is global and out of control (Kent 2015; 2017a).
Regulatory agencies at the national level regularly make decisions that favor the industry while at the same time exposing infants to unnecessary risks (Kent 2011). At the global level, there is an International Code of Marketing of Breast-milk Substitutes that that has helped in limiting the market of infant formula, but much more is needed.
So long as infant formula is treated as simply another food, it will not be assessed for its effectiveness in doing what it is supposed to do. Globally, the basic Codex Standards for Infant Formula says the ingredients are those “which have been proved to be suitable for infant feeding (Codex 2007, Section 3.1.1).” How a food could be “proved to be suitable” is not explained. It has not been proven. Under these standards, since no appropriate proof has been presented, perhaps those products should not be marketed.
In all conditions, at the population level, health outcomes for formula fed infants are generally worse than those for breastfed infants. They are worse with formula feeding than with breastfeeding even when both are as safe as possible.
Just as with pharmaceuticals, infant formula should be not only safe but also effective in doing what it is supposed to do. In the United States, the Food and Drug Administration is the primary agency responsible for ensuring the quality of infant formula. Beyond the ingredients list, the only Quality Factors that concern the FDA are normal physical growth and the biological quality of the formula’s protein component. In 2014, as they were preparing revisions of the rules, I commented on this to the FDA:
This means that of the many different functional requirements, the only one to be assessed for infant formula is its efficacy in leading to adequate physical growth in the short term. The language of the rules implies that if an infant formula leads to adequate physical growth over a period as short as fifteen weeks, it is of good quality.
It should not be suggested that quality on a single dimension is sufficient when infant formula must perform well on many different dimensions. There are many studies that demonstrate this. To illustrate, in 21 Dangers of Infant Formula, the World Alliance for Breastfeeding Action shows 21 different ways in which feeding with infant formula appears to function less effectively than breastfeeding (see http://www.waba.org.my/whatwedo/advocacy/pdf/21dangers.pdf). Each of them represents a concern about the quality of infant formula.
It is misleading to suggest that a short-term measure of infants’ physical growth can reasonably be viewed as a measure of the overall quality of infant formula. (Kent 2014)
The FDA ignored the point.
The deficiencies of formula cannot be resolved simply by adding new ingredients into the mix. Manufacturers often add a new ingredient and then say the new version of their product is closer to breastmilk. That is not the same as saying it is close to breastmilk. New York is closer than New Jersey to Paris, but that does not mean New York is close to Paris.
There are cases in which mothers should not or cannot breastfeed, but that does not mean the infants should not be fed with human milk. Wet nursing and milk banking have roles to play (Kent 2017b).
Codex Alimentarius Commission. 2007. Standards for Infant Formulas and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981) (Revised 2007). http://npaf.ca/wp-content/uploads/2014/02/CXS_072E-Codex-Standard-Infant...
Kent, George. 2011. Regulating Infant Formula. Hale Publishing.
---. 2014. Quality Factors in New Infant Formula Requirements. Comment on proposed rule of the US Food and Drug Administration. June 23. https://www.regulations.gov/document?D=FDA-1995-N-0063-0057
---. 2015. “Global Infant Formula: Monitoring and Regulating the Impacts to Protect Human Health.” International Breastfeeding Journal, 2015, Vol. 10, No 6. DOI: 10.1186/s13006-014-0020-7 http://www.internationalbreastfeedingjournal.com/content/10/1/6/abstract
---. 2017a. Governments Push Infant Formula. Sparsnäs, Sweden: Irene Publishing.
---. 2017b. “Extending the Reach of Human Milk Banking.” World Nutrition. 2017. 8(2): 232-250. https://worldnutritionjournal.org/index.php/wn/article/view/143/111
Competing interests: No competing interests
Many thanks for a well considered and important article,
this cause for concern is very real and not confined to the formula industry. As well discussed on the BMJ over previous years, industries from Pharma to Food (and many in-between) have made their presence felt in every facet of medical decision making. Obtaining objective data in the field of nutrition is a tough ask even before considering industry funded bias. As you correctly point out, when the formula industry funds the institutions that we look to for quality information and guidelines, the well meaning GP, pediatrician or NCHD may remain well meaning but not necessarily well informed.
There are few that will disagree that "breast-is-best", and there are a myriad of factors that lie behind the suboptimal breast feeding rates in the U.K and Ireland, but is there an unwillingness to grasp the bigger nettle i.e., how safe is infant formula? Cows Milk Allergy, especially in infants, is a common presentation that will be familiar to many GPs and pediatricians. The current work-around is to either hydrolyze the cows milk proteins or break them down to amino acids. Whilst this may mitigate the crude features of allergy, the recent landmark TRIGR study (which was sponsored by Meade-Johnson) found that hydrolyzing cows milk infant formula did not reduce the risk of developing type 1 diabetes in high risk children (i.e., first degree relative with type 1 diabetes). The rationale for this trial is the suggested molecular mimicry of cows milk proteins that might underly the pathophysiology/autoimmunity. Other suggested causative players could be mycobacteria avian paratuberculosis antibodies which are found in cows milk. Regardless, the relative risk of developing type-1diabetes in high risk children who are formula fed is greater than smokers developing lung cancer, yet there are no provisions to warn parents.
If cows milk formula in particular were a drug in phase II trials, would they be deemed safe based on the totality of the evidence (parking for a moment of course the multibillion dollar industry, of which Ireland is a major component)? On the flip side of the coin, a number of recent meta-analysis have found no concerns with the use of soy infant formula, and certainly no association with type 1 diabetes, eczema or asthma. Despite soy infant formula being licensed for babies from birth, there remains an uncertainty about turning to an alternative that, by the objective literature, is by a distance safer.
This dichotomy between the evidence and current practice is much better understood in the context of this article.
Many thanks again for writing on this pertinent topic.
References available upon request.
Competing interests: No competing interests