Don’t be fooled by the formula MILK machine
With her six- week- old baby waking in the night, crying and in obvious discomfort, worried mum Ruby Abiss went online and immediately found an answer: her daughter had a cow’s milk protein allergy (CMPA).
‘the first websites i found seemed to describe my child perfectly: up in the night, colicky and windy,’ recalls Ruby, a journalist from London. ‘And everything online gives CMPA as the answer.
‘in online breastfeeding groups, it is the first thing to be suggested for symptoms of any kind. People think it’s really common.’
the thinking is that cow’s milk proteins pass to the baby via the mother’s breastmilk: the ‘solution’ is either for the mother to give up dairy, or to switch her baby to specialist formula milk.
‘But excluding dairy when you’re breastfeeding makes it hard to keep your calories up — and that’s when mothers start to falter,’ says Ruby.
‘You’re starving and exhausted and formula seems like a simpler solution. What i didn’t realise was that patient websites were linked to the formula milk industry.’
Between 2006 and 2016, prescriptions of specialist formula milks for infants with CMPA rose from 105,029 to over 600,000, while NHS spending on such products increased from £8.1million to more than £60 million annually.
CMPA in formula-fed infants can be a very serious condition and the specialist formula milks are vital, but there’s no evidence of a large increase in the condition itself.
Or as Nigel Rollins, from the department of Maternal, Newborn, Child and Adolescent health at the World health Organisation (Who), puts it: ‘it is reasonable to question whether these [ prescription and spending] increases reflect a true increase in prevalence rates.’
indeed, as i discovered in an investigation for the BMJ, published last week, CMPA may be acting as a trojan horse for the £39 billion global formula industry to forge relationships with patients and healthcare professionals.
These
relationships may be harmful to the health of mothers and their children — partly because of the potential for CMPA to be overdiagnosed (which could reduce breastfeeding) but also by creating a network of ‘conflicted’ institutions and experts, with wide-ranging effects on research and guidelines.
this comes at a time when breastfeeding rates in the UK are some of the lowest in the world.
While there is some evidence that cow’s milk protein can be transferred from mother to infant in breast milk, and CMPA probably does occur in exclusively breastfed infants, the quantities are likely to be too small to cause symptoms in most infants.
there are two main types of CMPA, which can overlap. With immunoglobulin e (ige) reactions, which have rapid onset, specific symptoms, such as a rash or vomiting, the diagnosis can be confirmed with testing.
With non-ige CMPA, symptoms are slower to develop and nonspecific, including irritability (or colic), loose or more frequent stools, abdominal discomfort and rashes. Diagnosis can only be made by excluding food groups, then reintroducing them.
Some clinicians are concerned this symptoms list is so broad it is vulnerable to industry lobbying.
As Dr Bob Boyle, a consultant paediatric allergist at imperial College London, explains: ‘ it would be hard to find an infant who doesn’t have any of these symptoms.’
London-based GP Gary Marlowe agrees: ‘ Virtually every single infant could potentially be diagnosed using these symptoms.
‘i see an increasing number of patients who have looked at industry-funded websites and decided on a diagnosis. i have no doubt this anxiety increases the likelihood that a mother will stop breastfeeding.’
Of course, many parents looking for information online won’t know that some websites and organisations offering advice about CMPA receive funding from the formula milk industry. For example, Allergy UK lists formula manufacturer Danone Nutricia as a partner;
is it cowsmilkallergy.co.uk is a website maintained by manufacturer Mead Johnson; another website, cowsmilkallergy.co.uk, is sponsored by Danone Nutricia. the Royal College of Paediatrics And Child health accepts funding from Danone and Nestlé.
Clinicians are concerned about the wide availability of industryfunded online information that puts forward these symptoms as potentially CMPA in exclusively breastfed infants — as Ruby found when she searched online.
Dr Chi eziefula, a senior lecturer in global health at Brighton and Sussex Medical School, worries this information affects women most when they’re working to establish breastfeeding.
While there are guidelines to help doctors and parents determine the best treatment for an infant with suspected CMPA, many of these have ‘direct or indirect support from an industry which has a lot to gain from increased specialised formula use’, according to Dr Boyle.
For example, as i discovered, both 2007 and 2010 international CMPA guidelines for GPs were funded by formula manufacturers, and five of the 11 authors of the 2011 Nice food allergy guidelines, ten of the 12 authors of the 2012 european Society for Pediatric Gastroenterology, hepatology, and Nutrition guidelines, and all five authors of the 2013 Milk Allergy in Primary Care guideline declared interests with manufacturers.
Scientific literature shows that physician contact with pharmaceutical industry representatives leads to increased cost and reduced quality of treatment.
When i contacted all the authors, the six who responded acknowledged concerns about the influence of industry but said there was no direct influence over the guidelines or their own practice.
Similarly,
links to educational courses about CMPA for patients and doctors
also receive funding from the formula industry.
these include the British Society for Allergy and Clinical immunology (BSACi), the UK’s professional society of allergists, which accepts £100,000 a year.
the Allergy Academy, a collaborative initiative run from the department of paediatric allergy at King’s College London, which provides education to healthcare professionals and patients and their families, is sponsored by formula manufacturers Abbott, Danone and Mead Johnson.
the BSACi said: ‘ Until the number of healthcare professionals able to treat allergies matches demand for treatment, we believe we have a responsibility to do all we can to provide training to GPs and others . . . [We] work with industry in a responsible way to help us fulfil our aims and objectives, ensuring healthcare professionals are able to treat patients as effectively as possible.’
Neena Modi, a professor of neonatology at imperial College London and the recent former president of the Royal College of Paediatrics and Child health, who has declared she has received funds from Danone Nutricia, Abbott and Nestlé, says corporate sponsorship of medical education is not unusual.
But while pharmaceutical industry sponsorship is common, sponsorship by formula manufacturers is regulated by a different code of practice, adopted by the WhO to protect breastfeeding.
it requires marketing restrictions for breast milk substitutes and states that companies should not create conflicts of interest, sponsor educational events or advertise in health facilities or throughout health systems.
Some hospital trusts, including Guy’s and St thomas’ hospital in London, also have Baby Friendly status, which requires compliance with the WhO code.
the Allergy Academy, which is sponsored by three infant formula manufacturers, delivers allergy education courses on Guy’s and St thomas’ premises.
Despite reassurances from the hospital that no materials produced by the manufacturers of breast milk substitutes are displayed or distributed within the hospital, i can confirm that such materials were displayed and distributed at these events.
the trust has since announced that Allergy Academy courses will not take place at St thomas’.
Dr Adam Fox, a consultant allergist at St thomas’s and
president of the BsACi, is director of the Allergy Academy. He has declared research funding, consultancy and lecture fees from manufacturers and served as a consultant for Abbott Nutrition, Danone, Nestlé and Mead Johnson.
He says: ‘There is an important debate to be had on how best to manage the risk of influence. While industry provides financial support, it does not set the agenda. leadership in this area is provided by the Royal College of Paediatrics and Child Health (RCPCH).’
Helen Crawley, a public health nutritionist from first steps Nutrition Trust, an independent charity, is concerned about industry funding of healthcare professionals. ‘Many paediatric dietitians also work with, or accept hospitality, [and] funding for training and events from manufacturers,’ she points out.
With low rates of breastfeeding, experts believe more needs to be done to ensure medical professionals’ independence.
Dr Eziefula says: ‘ in a culture where breastfeeding rates fall off sharply after birth, there must be no risk of industry influence of guidelines or education of postnatal and paediatric caregivers.’
Anthony Costello, former director of the WHO department of Maternal, Child and Adolescent Health and now a professor of Child Health at UCl, is calling for professional bodies such the Royal College to be independent. ‘if paediatricians betray the spirit of the Code, then we can’t expect more from industry,’ he says.
in a statement, the RCPCH says it consulted with members about formula milk company sponsorship in 2016: ‘The vast majority of respondents said they felt [it] should accept funding with a robust set of safeguards in place.’
Bob Klaber, deputy medical director and a consultant paediatrician from imperial College Healthcare NHs Trust, says: ‘We are keen to promote breastfeeding in all of our work, and are concerned about the nationwide influence that the formula industry has over mothers and children at the most vulnerable time in their lives.
‘We are fully committed to embracing both the letter and the spirit of the WHO code.’ Allergy UK’s CEO Carla Jones, says: ‘We retain complete independence in the development of the information we provide.’
Declan O’Brien, director general of the British specialist Nutrition Association, which represents manufacturers, said: ‘We do not believe the WHO code precludes all interaction between healthcare professionals and industry.
‘We strongly believe industry has a role to play in scientific research and the education of healthcare professionals.’
Mothers such as Ruby continue to breastfeed despite the power of industry influence. ‘i just about managed by giving up milk,’ she says. ‘But i know lots of people who didn’t.’