Cow’s Milk Allergy 'Trojan Horse for Infant Milk Industry'

Liam Davenport

December 07, 2018

Concerns over cows’ milk protein allergy (CMPA) in infants - affecting breast feeding - is being exploited by industry, claims a UK doctor who notes that healthcare spending on specialist formula milk has rocketed in recent years without any notable increase in allergy rates.

Dr Chris van Tulleken, honorary senior lecturer, University College London, says prescriptions for specialist formula infant milk increased nearly fivefold over a 10-year period, accompanied by an almost sevenfold increase in spending by the NHS.

While diagnosed allergy rates have remained stable, Dr van Tulleken claims that a vagueness over the diagnosis of a form of CMPA is being exploited by industry, which is funding guidelines and educational programs on milk allergy.

Commercial Interests

The paper was published by the BMJ on December 5.

Commenting, Fiona Godlee, editor in chief of The BMJ, said in a news release: "The growth in prevalence of CMPA has all the hallmarks of overdiagnosis fuelled by commercial interests.

"While recognising that some infants will develop CMPA, we need tighter diagnostic criteria and guidelines drawn up by experts who are free from financial conflicts of interest."

She continued: "In light of this investigation and our own growing concerns, BMJ is reviewing our policies on accepting advertising for these products."

However, leading doctors involved in developing milk allergy guidelines say there have never been any claims of bias, while industry underlines that it has a role to play in both research and education.

Dr van Tulleken begins by noting that the number of prescriptions per year of specialist formula milk for infants with CPMA increased by almost 500% from 105,029 in 2006 to more than 600,000 in 2016.

Moreover, the amount spent annually by the NHS increased over the same period by nearly 700%, from £8.1 million to more than £60 million.

Dr van Tulleken points out, however, that there is no signal from epidemiological data to suggest that there has been a concomitant increase in the prevalence of CMPA.

Indeed, one study indicated that, over time, there has been no overall change in rates of food hypersensitivity, and that there are large discrepancies between reported and diagnosed allergies.

The same authors also found in a later analysis that children were far more likely to be diagnosed with IgE-mediated rather than non-IgE-mediated food allergy/intolerance.

This, Dr van Tulleken believes, gets to the crux of the matter, as these two overlapping forms of CMPA have different profiles and methods of diagnoses.

IgE-mediated reactions

IgE-mediated reactions are characterised by the rapid onset of symptoms, while the symptoms of non-IgE-mediated reactions have a slower onset and are non-specific in nature.

Consequently, the former can be confirmed with diagnostic testing while the latter can be diagnosed only with a trial of dietary exclusion and reintroduction.

Dr van Tulleken writes that "many clinicians who spoke to The BMJ are concerned that these factors make non-IgE-mediated allergy vulnerable to exploitation".

This may well underlie why many more milk allergy guidelines have been published than for other food allergies.

"Many have direct or indirect support from industry, which has a lot to gain from increased specialised formula use," Dr Robert Boyle, a consultant paediatric allergist at Imperial College London, is quoted as saying.

Dr van Tulleken adds that the first two international guidelines on milk allergy for primary care were funded by formula manufacturers, while the vast majority of authors named on recent guidelines "declared interests with infant formula manufacturers either at the time of writing or subsequently".

Reaction

Dr Steffen Husby, from Odense University Hospital, Denmark, was an author on the 2012 European Society for Paediatric Gastroenterology, Hepatology, and Nutrition milk allergy guidelines.

He told The BMJ that "these links may be harmful, and that bias may be subconscious".

However, Dr Adam Fox, from King’s College, London, who has contributed to numerous recent guidelines on milk allergy, pointed out that their work has been subject to independent peer review.

The concerns do not stop there, however, with adverts to industry sponsored educational courses on milk allergy listed on the websites of The Allergy Academy, the British Society for Allergy and Clinical Immunology, and Allergy UK, among others.

This is despite a code of practice from the World Health Organisation (WHO) that restricts companies from sponsoring educational events.

This issue hinges on whether specialist formulas are, in fact, breast milk substitutes, with the Royal College of Paediatrics and Child Health (RCPCH) suggesting that they are not.

However, Nigel Rollins, from the WHO’s Department of Maternal, Newborn, Child and Adolescent Health, disagreed, adding that such misconceptions "may be enabling manufacturers to justify this network of links with clinicians and institutions to pursue a wider agenda".

Dr Anthony Costello, a professor of child health at University College London and formerly of the WHO, called for the RCPCH to be independent of industry.

He said: "In the UK we have one of the lowest breastfeeding rates in the world.

"The WHO code is not enforced strongly in British law so we need the Royal College to stop accepting money from industry and defend the global codes set up to try to protect mothers."

The RCPCH said, however, that its members felt that the College should accept funding, with strict safeguards.

Meanwhile, the industry believes that it has a role to play in scientific research and professional education.

"We recognise the need to put in place policies to ensure that potential conflicts of interest can be managed and avoided," said Declan O'Brien, director general of the British Specialist Nutrition Association, which counts Danone Nutricia, Mead Johnson, and Nestlé, among its members.

"The measures in The Infant Formula Industry (INI) Code are in line with the WHO Code, UK regulations, the Association of the British Pharmaceutical Industry Code and General Medical Council Guidance."

No conflicts of interest or funding declared.

BMJ accepts advertisements for specialist breast milk substitutes, in line with our long standing policy to accept advertising that is legal and honest and meets advertising standards. We expect all claims of health benefit to be supported by published peer reviewed research evidence. Last year, BMJ received £200,000 for advertisements for breast milk substitutes in its journals. BMJ co-owns the journal Archives of Diseases in Childhood with the RCPCH.

BMJ 2018;363:k5056 doi: 10.1136/bmj.k5056

 

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