Author : Dr. Rosie Kyeremateng

 

The issue of formula industry association with paediatric associations keeps coming back to us, and I believe there is a reason for this. It is a call to explore our thinking in this area.

While the motion put forward at the RCPCH AGM last year (by a group which included myself), was passed by 66 votes to 53 not to accept such sponsorship, the decision was overruled and put forward to the RCPCH council. A subsequent postal vote, of which 11% of the membership responded, indicated that the majority were in favour of ‘acceptance of funding from BMS companies with appropriate due diligence’.

A number of things troubled me about this; the survey questions were complex and multifaceted, and the group had been refused the opportunity to work collaboratively in developing it, which would have assured both sides that it was balanced. The outcome of the survey focussed around the process of due diligence, and members had trusted the process to be robust, despite no clear discussion about it.

In talking with colleagues it became apparent to me that members had limited information on the depth of this issue, many junior colleagues had never heard of the International Code, some felt that this discussion was unfair on mothers who choose to feed with formula (which indicates a misunderstanding of the topic); there was a lot of jargon, and nobody really knew exactly what the process of ‘due diligence’ would entail.

The aim of this piece is to stimulate discussion and hopefully clarify some aspects of this debate, as I felt that lack of familiarity with the issues involved might affect one’s ability to make a truly informed judgement. I have explored six of the topics that we as paediatricians, are going to have to come to terms with, if we wish to enable an increase in breastfeeding rates.

 

  1. The Determinants of Breastfeeding and A Woman's Decision of How to Feed her Baby
  2. The International Code and Subsequent Resolutions
  3. Due Diligence
  4. Global Implications
  5. Conflict of Interest
  6. Collaboration, Financing and Sustainability

  

The Determinants of Breastfeeding and A Woman’s Decision of How to Feed her Baby

There are many reasons why a woman might decide not to breastfeed her baby. (We accept there are specific medical conditions in which breastmilk is contraindicated1, and these need no further discussion here.) It is important to recognise the multitude of factors that may influence progress and outcome of the breastfeeding journey. As well as ‘personal’ factors such as inverted nipples or breast pain, and mother and baby attunement, mother’s education and her understanding of the degree of benefit breastmilk confers will also have influence. And there are other more ‘external’ determinants, such as legislation, policy, and social mobilisation to change social attitudes and practices. 3

Therefore while it is the individual mother who will make the ultimate decision, we recognise that there are modifiable factors which enable an improvement in breastfeeding rates.

In the absence of a clear medical reason, feeling unable to breastfeed can lead to guilt or feelings of being judged. The objective of discussing this topic is not to exacerbate these feelings. Rather it addresses the importance of ensuring an adequate basis on which all parents can have a true and objective choice2, regardless of whether they feed by breast or bottle. 

Why have breastfeeding rates in this country stagnated, when breastmilk is cheaper, better for baby and often more readily available? It is because formula has been glamorised, and the benefit of breastmilk has been undermined or ignored. This happened some time ago in industrialised countries, far enough to be buried in our subconscious. The mother breastfeeding her baby in public is considered offensive (there are several social experiments on the internet attesting to this), but why is that so? In some societies, you could never ask a nursing mother to feed her child in a toilet; (even if it was the cleanest toilet in the country) it just wouldn’t make sense. But this is what now occurs in industrialised countries. The societal norm has been shifted.

The fact that paediatricians agree that breastmilk is superior to formula, does not preclude the discussion about how we directly and indirectly influence breastfeeding rates. For example, we are all taught the benefits of breastmilk in medical school, but there is a gap in current functional knowledge amongst trainee doctors on the science of breastfeeding, and this must be urgently addressed in our teaching and learning on this topic, in order to improve our collective knowledge base, which will in turn provide a more stable support system for breastfeeding mothers, which is recognised as one of the factors that influence the outcome.

The International Code and Subsequent Resolutions

In 1981, the International Code of Marketing of Breast-milk Substitutes was adopted by the World Health Assembly (the supreme decision making body for WHO). The Code aims to contribute to the provision of safe and adequate nutrition for infants, by the protection and promotion of breastfeeding, and by ensuring proper use of breast-milk substitutes5. While this was now some 36 years ago, the Code has been supported by numerous subsequent WHA resolutions to strengthen and add to the recommendations, the most recent in April 2016 6. This has ensured that the key elements relating to supporting and protecting breast feeding, and the need for regulation of marketing activities of infant formula companies, remain valid today.

However the self-regulatory nature of the code has been ineffective in ensuring an acceptable standard of monitoring and compliance7.

A study which quantified the relationship between breastfeeding promotion and changes in breastfeeding practice demonstrated that implementation of policies in line with The Code, actually result in an increase breastfeeding rates 4. Those policies are a means of empowering social value to breastfeeding as a norm.

Due Diligence

WHO have defined due diligence, in their guidance on Engagement with Non-State Actors (FENSA)8, as the steps taken by the organisation to find and verify relevant information on an entity and to reach a clear understanding of its profile. Functions include clarification of the interest and objectives of the entity in engaging with the organisation and what it expects in return; as well as to define the main elements of the history and activities of the entity in terms of the following: health, human and labour issues; environmental, ethical and business issues; reputation and image; and financial stability.

This process combines review and analysis of information from a number of sources, including screening of different public, legal and commercial sources of information, including analyst reports, directories and profiles; and public, legal and governmental sources.

Particular caution is advised in relation to private sector entities whose activities have a negative impact on human health, in particular those related to non-communicable diseases and their determinants8. As the incidence of breastfeeding in the UK has been heralded as a Public Health crisis9, this proviso should be applied.

Although the college has admirably created the RCPCH Board of Trustees Due Diligence sub group to preside over this process, colleagues from WHO (in their personal capacity) have raised a concern that health professional associations are not in a position, or qualified, to assess and determine which companies comply with the International Code10. Having reflected on the complexity of enforcement of the International Code, this concerns me.

A number of non-governmental organisations (such as the Baby Feeding Law Group) have identified violations of the Code in recent years. Because of the difficulties in monitoring and enforcing the Code, there is a paradox where oftentimes we cannot identify Code violations until it is too late.

We therefore place ourselves in a position of risk in accepting sponsorship from these companies, particularly if the robustness of the due diligence process when carried out by health professional associations, has been questioned by colleagues from WHO.

I was saddened to discover recently that a decision was recently made for RCPCH to withdraw from the Baby Feeding Law Group, the aim of which is to strengthen UK baby feeding laws in line with UN recommendations and protect breastfeeding, and whose membership is made up of leading UK health professional and mother support organisations including the Royal College of Midwives.

However, I was pleased to hear that that RCPCH recently agreed not to allow a number of formula manufacturers to have a display stand at this year’s conference, because evidence provided to the Due Diligence sub-group did not give sufficient assurance to enable to conclude that the companies (Danone, Abbott, Nestle and Mead Johnson) are meeting the criteria11; and this is in line with WHO’s FENSA guidance not to accept sponsorship of conferences by private entities.

Global Implications

We must also accept that the decisions made by our college influence similar such decisions all over the world. RCPCH is a world leader in paediatrics, with a strong international presence and an ethos of collaboration to improve child health around the world. The ways in which we engage with private entities has a ripple effect, and we must be careful not to position these entities in a position of power which may damage the positive lifestyle habits of vulnerable populations. There continue to be concerns about marketing practices around the world. Professional Colleagues regularly report as such12,13,14 and the award winning Film ‘Tigers’ (based on real life) was made to illustrate these concerns.

Conflict of Interest

There is an important difference between individual and institutional conflict of interest (COI). With individual COI, as long as the interest is declared we assent to the associated risk of bias, and can then take this into consideration. We all know of esteemed colleagues who have a sponsor, and who have done wonderful things for child health. To consider conflict of interest is not to question a professional’s integrity. We must focus on the bigger picture.

Institutional COI has a different dimension. The authority of the institution endows upon the product a false sense of security, and validates it, even if that is not the aim. The public also become vulnerable to the risk of bias because the organisation loses its autonomy.

This is not an attack against individuals with a disclosure of interest, which is vitally important to clarify, because to personalise the issue would be to lose out on an important perspective.

Collaboration, Financing and Sustainability

Formula companies devote large sums to developing new products and finding optimal ways to market them, and RCPCH has no responsibility or obligation to share this burden.

 

There must be, of course, a place for professional discussion about formula, after all, they are products that saves babies lives in circumstances of medical need. But there could be a more natural collaboration between the institution and the regulatory body of the market producers or an adjudicator, rather than with a specific company, in order to protect the college’s independence from vested interests. In this way it could be assured that the public health benefit of the engagement outweighs its potential risks.

However, if specific expertise from the institution is intended, then there should be no transfer of funds, only of expertise. In that way we would remain in a position of moral advantage, and could still exert a positive influence. This would not be a risk to the financial sustainability of the college, as the income currently from these companies to the college is no more than 1% of the college turnover.

I would also imagine a natural partnership between neonatal units/ postnatal wards, and grassroots breastfeeding alliances, but this has not yet occurred in this country. This might be the next step in collaboration and engagement to increase breastfeeding rates, and add value to society in rebuilding a positive breastfeeding culture.

I do accept that my views may differ from another’s; but in every case, the most important thing is for us to keep open the channels of communication, in the true spirit of the International Code, and with the best interests of children at heart.

References

  1. WHO/UNICEF Acceptable medical reasons for use of breastmilk substitute
  2. Country implementation of the international code; status report 2011; WHO
  3. Rollins et al. The Lancet, Vol 387, Jan 30 2016, p491
  4. Lutter, Morrow. Protection, promotion and support and global trends in breastfeeding. Advances in Nutrition. 4:213-219, 2013
  5. WHO International Code of the Marketing of Breastmilk Substitutes http://www.who.int/nutrition/publications/code_english.pdf
  6. WHO Framework of Engagement with Non-State Actors http://www.who.int/nutrition/topics/wha_nutrition_iycn/en/
  7. Forsyth, S. Non-compliance with the International Code of Marketing of Breast Milk Substitutes is not confined to the infant formula industry. J Public Health (Oxf). 2013; 35: 185–190
  8. http://www.who.int/about/collaborations/non-state-actors/A69_R10-FENSA-en.pdf?ua=1
  9. Cesar et al, Lancet, Vol 387, Jan 30 2016, p475
  10. Costello et al, Lancet, Vol 389, Feb 11 2017, p597
  11. http://www.rcpch.ac.uk/news/rcpch-and-commercial-organisations
  12. Athikarisamy, BMJ, October 2016, 355: i5827,
  13. Talukder et al, Lancet, Vol 389, April 29 2017, p1696
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