Disentangling ourselves from “Big Formula”
BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5146 (Published 06 December 2018) Cite this as: BMJ 2018;363:k5146
All rapid responses
The BFHI ‘Ten Steps to Successful Breastfeeding’, in the WHO/ UNICEF Joint Statement in 1989, was an array of Policies, Procedures and Practices to improve Breastfeeding Rates (BFR), particularly Exclusive Breastfeeding Rates (EBFR)1. Improved BFR evolve with sustained consistent implementation of the ‘Ten Steps’2,3. ‘Change’ is desirable but you do not change a ‘Winning Formula’! Hence the compelling critique of the ‘2018 Revised Ten Steps’ 3. I shall comment only on the ‘Revised Steps 1a and 9’!
It is salutary that Step 1a states ‘Comply fully with the International Code of Marketing of Breastmilk Substitutes and relevant World Health Assembly Resolutions’. The pervading systemic and systematic violations of ‘The Code’ (1981 Code and ALL Subsequent Relevant WHA Resolutions) by Manufacturers of Infant and Young Child Foods and related Products (Feeding bottles, Teats, Pacifiers etc) covered by ‘The Code’ confounded by the overt and covert collaboration by Health Professionals in the Infant and Young Child Feeding (IYCF) Enterprise have been deleterious in undermining Optimal IYCF globally. Health Professionals are enmeshed in ‘Conflict of Interest’ (COI) with continued receipt of ‘Industry Funding’. The COI, diagnosed by the ‘Potentiality’ of its existence, is a monstrosity that is better avoided as it is intractable. The 1981 Code and several Subsequent Relevant WHA Resolutions have, therefore, persistently and consistently addressed COI. The Royal College of Paediatrics and Child Health (RCPCH) voted to decline all forms of ‘Industry Funding’ following a robust ‘Motion Debate’ on the 27th April 2016 at its Annual General Meeting (AGM) in Liverpool. This antedated the WHA Resolution 69.9 in May 2016 which included the ‘WHO Guidance’ on ‘Ending Inappropriate Promotion of Foods for Infants and Young Children’4. The RCPCH Council, in spite of its AGM ‘Debate Decision’ and the complementary 2016 WHA Resolution, commissioned a ‘Post-AGM Membership Survey’ on ‘Industry Funding’ in September 2016 and published the ‘Survey Findings’ in October 2016 to continue accepting ‘Industry Funding’ with ‘Internal Due Diligence’ and the ‘Framework for Engagement of Non-State Actors (FENSA)’ and, therefore, upturned the AGM Decision5,6. As a Speaker in support of the Motion, and the only Speaker uniquely permitted by the RCPCH President to speak twice, I felt a compelling responsibility, as other Paediatricians and NGO7-9, to react to this unacceptable ‘Modus Operandi’ of the RCPCH Council which proposed the defeated ‘Counter-Motion’ and, therefore, wrote a treatise to the RCPCH President titled ‘Health Professional Associations and Industry Funding; Systemic and Systematic Examination of Well-formed Conscience: Is RCPCH Oiling The Wheel of Conflicts of Interest?’. The Science, Logic, Ethics and Morality of the ‘Post-AGM Survey’ were diligently analyzed and critically flawed in the Communication! This Communication was also attached to my Formal Presentation titled ‘FMOH-convoked Stakeholders’ Meeting on The Code and the Adopted Revised National Regulations; 13th February 2018’ to the Nigerian Minister of Health as a ‘Follow-up’ to the Ministerial Meeting convened to address issues canvassed by the Paediatrics Association of Nigerian against strict implementation of the ‘Provisions’ of the 2016 ‘WHO Guidance’ particularly its ‘Prohibition of Industry Funding for Health Professionals and their Scientific Meetings’ and also reflected in the ‘Revised Nigerian Regulations’ for Code Implementation. Similar uncomplimentary difficulties have been reported concerning ‘Industry Funding’ and the resurgent influence of ‘Big Formula’ with Industry and ‘Conflicted Health Professionals’10,11. Considering the 5 Stakeholder-Groups, based on ‘Code Commitment’, present at the 1979 UN Meeting on IYCF and at the 1981 Code adoption, I have since 2010 technicalized that ‘Health Professionals/ Experts’ are ‘Toti-Code’ (coined from Stem Cell ‘Totipotency’; The ‘Piper’s various Tunes dictated by the Payer’!), UN Systems and NGOs are ‘Pro-Code’ and Industries and Governments are ‘Anti-Code’! For improved BFR, we must be ‘Pro-Code’ and ‘Make The Code Work’. Programmatically, ‘Step 1a’ is a promising development! Industry and Health Professionals must comply with all ‘Provisions’ of ‘The Code’ as a ‘Minimum’ and in its ‘Entirety’!
The new ‘Step 9’: ‘Counsel Mothers on the use and risks of feeding bottles, teats and pacifiers’ is riddled with the ‘Potentiality’ of wreaking significant havoc on the gains of our ‘Breastfeeding Campaign’. For Optimal IYCF, Breastfeeding Physiology and Appropriate Lactation Management, what are the critical benefits of the ‘Use’ of these ‘Products’? Of course, there are illimitable ‘Risks’ concerning their use! Breastfeeding Infants’ suckling capabilities are compromised through ‘Nipple Confusion’ and this undermines effective suckling at the breasts: the most important stimulus for adequate ‘Milk Production’ and Infant Nutrition. The soothing of Breastfeeding Infants with ‘Soothers or Pacifiers’ compromises normal ‘Psychosocial and Personality Development’ with reduced opportunities for appropriate ‘Mother-Child Dyadic Bonding-Relationship’. Inadequate hygiene and uncertain cleanliness in their use are an invitation to avoidable childhood diarrhoeal disorders. There is also compromised anatomical development of the oro-facial structures using these ‘Products’. Pacifiers reduce Breastfeeding duration12. Industry compliance with ‘The Code’ is a huge challenge and the new ‘Step 9’ courts their further aggressive marketing of these ‘Related Products’ (Feeding bottles, Teats, Pacifiers etc). Juxtaposing critically this ‘Revised Step 9’ with the original ‘Step 9’ (‘Give no artificial teats or pacifiers (also called dummies or soothers) to breastfeeding infants’) disposes a clear and remarkable difference which practically makes the ‘Revised Step 9’ a ‘Major Programmatic Misstep’; a ‘Wrong Step’ indeed! A ‘Change’ that is replete with a plethora of ‘Risks’ for Optimal Child Health, Nutrition, Growth, Development and Protection is obviously a ‘Misstep’ and it is fervently hoped that the 2019 WHA will revisit and reverse the ‘Misstep 9’ to optimize Breastfeeding; a low-cost high-impact Nutrition Intervention!
Advertisement of ‘Products’ covered by ‘The Code’ (‘Code Products’) (including ‘Foods for Special Medical Purposes (FSMP)’) is prohibited as ‘Normal Marketing Practices (including Advertisement) are ‘Not Suitable’ for these Products‘ (Last Preamble to 1981 Code Adoption) and this calls for strict compliance by all ‘Information Media’ including reputable widely-circulated Biomedical Journals; The BMJ advertising FSMP is a systemic and systematic Code Violation and victimizes voiceless, defenceless, unreached and unserved vulnerable children13! The Inappropriate Marketing of ‘Code Products’ undermines Breastfeeding and enlarges the ‘Market’ for Breastmilk Substitutes!! Let us ‘Make The Code Work’!!!
REFERENCES
1. WHO/ UNICEF. Protecting, Promoting and Supporting Breastfeeding: The Special Role of Maternity Srvices; A Joint WHO/ UNICEF Statement. Geneva, WHO 1989.
2. WHO. Evidence for the Ten Steps to Successful Breastfeeding. Division of Child Health and Development. Geneva. WHO 1998
3. WHO. Ten Steps to Successful Breastfeeding (Revised 2018). Geneva. WHO 2018
4. WHO Sixty-ninth WHA. Ending inappropriate promotion of foods for infants and young children. WHA 69.9. http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_R9-en.pdf; May 28th 2016. Accessed 24th February 2017.
5. Thornton J. Paediatricians vote for college to continue accepting funds from formula companies. BMJ 2016; 355: i5827
6. Modi N. The RCPCH and funding from infant formula companies. BMJ Blogs Oct 31, 2016; http://blogs.bmj.com/bmj/2016/10/31/neena-modi-the-rcpch-and-funding-from infant-formula-companies. Accessed 24th February 2017.
7. Waterston T and Mason E. Why the RCPCH should stop taking funds from the baby food industry.(Accessed 20th January 2018). BMJ Blogs 4 Nov 2016. http://blogs.bmj.com/bmj/2016/11/04/why-the-rcpch-should-stop-taking-fun...
8. Costello A, Branca F, Rollins N, Stahlhofer M, Grummer-Strawn L. Health Professional Associations and Industry Funding. Lancet 2017; 389 (10069): 597-598.
9. Baby Milk Action response to RCPCH relationship with formula milk companies. http://www.babymilkaction.org/archives/11135. Accessed 6th March 2017
10. Anand RK. Healthworkers and the Baby Food Industry. BMJ 1996; 312:1556
11. Shenker NS. The resurgent influence of big formula. BMJ 2018; 362:k3577
12. Howard CR, Howard FM, Lanphear B et al. The effect of early pacifier use on breastfeeding duration. Pediatrics 1999, 103:E33
13. Godlee F. Disentangling ourselves from ‘Big Formula’. BMJ 2018; 363:K5146
Professor Charles O. Eregie
MBBS, FWACP, FMCPaed, FRCPCK (UK), Cert. ORT (Oxford), MSc (Religious Education)
Professor of Child Health and Neonatology, University of Benin,
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria
UNICEF-Trained BFHI Master Trainer
ICDC-Trained in Code Implementation
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Project on Code Implementation in Nigeria
*No Competing Interest
Competing interests: No competing interests
I work as a breastfeeding counsellor in community drop-ins. So frequently a paediatrician, midwife or support worker has suggested a formula top up even before a woman leaves hospital due to a range of hospital practices and guidelines and we frequently meet women just days in to their breastfeeding journey feeding formula, expressing and trying to breastfeed - an unenviable situation for any new parent.
There is no funding for breastmilk promotion and not enough for specialist support so women and their families are faced with an unbalanced view. It is not appropriate for the BMJ to be part of the problem leaving health professionals and parents believing the two ways of feeding a baby are nearly the same - they are not and our whole health service is burdened with the additionnal health costs of not breastfeeding.
Some years back I was waiting in a side room at the doctor's surgery with my 4 year old with suspected chicken pox. While there I was nosing through the maternity booklets as the room was used by midwives. There I found some large colour cardboard flip chart books showing a cross section of a womb with baby growing month by month. On each colourful picture was a substantial logo in the corner for formula milk.
As both the local hospitals and community were in the process of achieving UNICEF Baby Friendly Accreditation which requires all formula advertising to be removed from the health care setting, I carried the large book under my arm to see the GP, a mature doctor and founder of the practice.
He absolutely agreed with me and told me it shouldn't be there and told me how he was always saying to his GP colleagues that they shouldn't attend sponsored events and that even pens and mugs with logos on would influence their prescribing.
Roll forward to the end of the consultation. My son had his chcken pox confirmed and the GP suggested rest and plenty of fluids and Calpol when needed to keep him comfortable.
"Calpol?" I said
"Yes Calpol" he repeated nodding.
"I expect you meant to say 'liquid paracetemol, chemist own brand is the cheapest'" I said laughing.
To which he sheepishly agreed.
Competing interests: NCT breastfeeding counsellor working as a self employed contractor for NCT and the local trust
I am a GP working in a rural area with a high level of deprivation and low breastfeeding rates. I have also trained as a breastfeeding counsellor with the Association of Breastfeeding Mothers. I work in a voluntary capacity alongside our local peer supporters to run a breastfeeding group in our area.
I read with keen interest your editor’s choice in the Dec 8th edition and the article by Chris van Tulleken.
I ended my subscription to the BMJ many years ago due to the journal’s acceptance of money from formula companies and the advertising of formula. I have been particularly concerned in the past when articles about cow’s milk protein allergy have been placed side by side with advertisements for specialist formula milks. The journal as far as I know has never had an advertisement for breast milk or the benefits of breastfeeding. There has also only been a handful of professional development/educational articles on breastfeeding. I have also seen very few research articles which are related to breastfeeding.
I feel strongly the BMJ should not accept funding or publish advertisements by formula companies. As a health publication it should not be promoting products that cause adverse health outcomes for mothers and babies.
If the BMJ does change their policy of accepting adverts for formula products and starts to publish research and educational articles on breastfeeding then I will be thrilled to reinstate my subscription.
Yours sincerely
Dr Ruth Johnson
Competing interests: No competing interests
In relation to the article by van Tulleken1, and the editorial by Godlee2, it is important to point out that nutrition intervention studies in infants and young children cannot be undertaken without collaborating with nutrition companies as the intervention product needs to meet agreed nutrition and safety standards and this requires knowledge, expertise and technology that is not available in even the most prestigious academic research institutions. Moreover, it is important in these circumstances, that industry collaborates as a full member of the research team to ensure that compliance with the scientific, ethical, funding, and research monitoring standards are met. On completion of the project, it is then important that the manuscripts clearly define the roles of the collaborators, sources of funding, and any conflicts of interest. This will ensure that on submission to a journal, the information regarding all of the contributors is fully transparent. The external reviewers and the editorial team can then make an informed decision on whether to publish or not.
If this process has been followed, and the article is accepted for publication, subsequent undermining of the research on the grounds that it involved collaboration with industry, should be challenged as professional discrimination. Although many of us involved in infant nutrition research have tolerated this prejudice, young researchers, and clinicians today, are increasingly viewing this field of research as a “no-go” area. This is clearly not in the best interests of infants and their parents, who have largely remained the “forgotten people”, as global institutions continue their damaging war of attrition instead of collectively focusing on reducing the unacceptable levels of malnutrition and stunting across the world, and developing child feeding policies that reflect the diverse nutritional and socio-economic circumstances of infants and young children worldwide3.
The World Health Organisation is the body within the United Nations that has the responsibility for directing and coordinating health, and it needs to unify rather than divide by encouraging engagement and partnership with all key stakeholders (including industry), managing self-interest (including their own), balancing idealism with realism, ensuring there is multi-partnership governance (including industry), recognising the wisdom of compromise, and acknowledging the value of incremental change. Collective dialogue, conducted within an environment of trust and respect, is more likely to identify and deliver solutions that can resolve Code compliance, improve infant and young child nutrition globally, and ultimately save children’s lives4.
References
1. van Tulleken C. Overdiagnosis and industry influence: how cow’s milk protein allergy is extending the reach of infant formula manufacturers. BMJ 2018;363:k5056
2. Godlee F. Disentangling ourselves from “Big Formula”. BMJ 2018;363:k5146
3. Forsyth JS. International code of marketing of breast-milk substitutes—three decades later time for hostilities to be replaced by effective national and international governance. Arch Dis Child 2010;95:769–70.
4. 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.
Competing interests: I have received research grants from government, research 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 just wanted to share my story with this CMPA research. I have been a UNICEF breastfeeding support worker for 3 years and work alongside the medical profession. I am aware of all the 'hype around CMPA, the increase in diagnosis over the past few years, the reality of the amount of CMP in breast milk and watched with interest Dr Van Tulakans program on the subject. However dispute all of this in July I had a premature baby. She had initial issues with weight and jaundice and was on lots of antibiotics but seemed to thrive after a month. Over night she became very upset after feeds, was repeatedly sick and passing mucus in her stools which were up to 16 times a day. She was readmitted to hospital with suspected rotavirus, supposedly caught whilst in hospital the previous week. She was discharged after 24 hours and told to come back in a week for a check up.
A week later with no improvement and signs of dry skin on her feet she was diagnosed with CMPA. Doing my job I know the common symptoms and that most babies will be sick and have colic at some point, but in my new mum sleep deprived state I wanted a fix and an answer. Being a breastfeeding support worker I was determined not to give up. I went strictly dairy free. Two weeks later no improvement, I cut out soya too. Four more weeks go by no improvement. I visit the infant feeding coordinator for the county. She suggests lactose intolerance and perhaps an inflamed and sensitive gut and suggests colief. Within 24 hours she is a different baby, Happy, smiling and not in so much pain. No improvement on the sickness and stools though, still full of mucus and 10 times a day, sickness between 70 and 80 times a day. Two weeks later see a paediatrician. He advises to remain dairy free but to try gaviscon and renitidine. The gaviscon she won't swallow but we keep going with colief and renitidine. Two weeks later the stools are one a day, occasionally mucus. The sickness is just posseting 10 times a day. Without medical say so I reintroduce dairy. She is absolutely Fine! It was never CMPA just a very sicky colicy baby. I'm so glad I didn't go with the suggestion to stop breastfeeding and persevered. Had I not been doing the job I am I reckon I would have given up. She is now 4 and a half months and just had a small amount of renitidine a day. She is a very well baby, the dry skin was sorted by some sensitive baby wash. I hope we are more careful about diagnosing CMPA and support and educate parents and the health profession not to mistake other things. Please contact me if you would like more to this story
Competing interests: No competing interests
“BIG FORMULA” IS STILL AT IT…..
It seems that cow’s milk protein allergy (CMPA) has added another element of complexity in the wars between breastfeeding and proprietary infant formula. (Tulleken, BMJ, 5 Dec 2018) Forty-one years ago I entered the trenches by publishing a study showing that breastfed babies were healthier than formula-fed babies, even among middle-class Americans. (Cunningham, J Pediatr 1977;90:726) The idea was revolutionary at the time, strange as that may seem today. Few American mothers breastfed, US pediatricians were generally unenthusiastic and, after the initial shock, manufacturers mounted a counterattack. Nevertheless, I fancy that my article helped stimulate a US renaissance in breastfeeding…..When the US was the only country among 118 member states to vote against WHO’s Code for Marketing Breastmilk Substitutes I became a minor celebrity. (De Witt. “Infant Formula Drive is Assailed”, NYTimes, 18 June 1981) Last May, the US once again was the only country to oppose a resolution supporting breastfeeding at the World Health Assembly. (Shenker, BMJ, 23 August 2018)
The diagnosis and management of CMPA is a tricky business; so is the support of nursing mothers with cranky babies. It is no surprise to learn that “Big Formula” is taking advantage of the situation to sell their very expensive products.
I know from long personal experience that the manufacturers are clever and persistent in marketing their products, often at the expense of breastfeeding.
ALLAN S. CUNNINGHAM
Competing interests: No competing interests
I imagine that Big Formula is thrilled by the resurgence, at least here in California, of “sleep training”, the rigid routine that overrides natural maternal and infant nursing signals and leads a mother, sooner or later, to abandon breastfeeding. Strict adherence to a crushingly precise schedule and scripted routine is ostensibly designed to help mothers get a good night’s sleep so they may function well when they return to work. Mothers are tethered to the home, controlling their infant's innate needs and functions. The baby must learn to sleep alone and may not fall asleep at the breast. While the baby is in its crib, the mother pumps. This is eventually unsustainable and, with sadness tinged with relief, she reaches for the formula.
Competing interests: No competing interests
'Big formula' companies violate 'The International Code of Marketing of Breast-milk Substitutes' (the WHO Code) widely around the globe on a daily basis. This leads to decreased breastfeeding rates and increased mortality and morbidity for infants and children in low, middle and high income countries. For this reason, WHO, UNICEF and various other UN agencies have specific policies on not engaging with the Code violators. At the very least, the BMJ should consider not engaging with companies who violate the WHO Code, in the form of advertisements and sponsorships.
Competing interests: No competing interests
Re: Disentangling ourselves from “Big Formula”
As authors who have done research on infant formula advertising in medical journals, we welcome the renewed attention that Dr Chris van Tulleken has brought to this important issue (https://www.bmj.com/content/363/bmj.k5056 ). We are especially happy to hear that the BMJ is reviewing their policies on accepting advertising for these products as a result of this spotlight.
We looked at the extent of formula advertising in leading medical and paediatric journals from 2003-2012 and compliance of 2012 adverts against the International Code of Marketing of Breast-Milk Substitutes (‘the Code’). Although formula advertising was uncommon overall it varied markedly and one publishing group – the BMJ publishing group – was responsible for almost 75% of all formula advertising in our sample. Code compliance was poor: all advertisements contained purely promotional statements and none contained all of the information and warnings about formula stipulated in the Code. (https://www.ennonline.net/fex/58/infantformulaadvertising )
Clinicians do need information on formula milks so they can offer advice for infants who cannot, for whatever reason, be breastfed. However, this advice should be evidence-based and impartial and based on information from independent and unbiased sources. Advertisements are none of these. We are thus glad that this (long overdue) problem is finally being addressed. We hope that not only the BMJ, but the wider BMJ group now drops infant formula adverts altogether.
Competing interests: No competing interests