Is cow’s milk protein allergy overdiagnosed?

baby drinking from bottle

Cow’s milk protein allergy may be helping the baby milk industry to form relationships with paediatricians, warns one expert

An investigation published by the BMJ suggests that cows’ milk protein allergy may be acting as a ‘Trojan horse’ for the global formula industry to forge relationships with healthcare professionals in the UK and around the world.

Dr Chris van Tulleken has highlighted examples of what he describes as ‘unnecessary and improper’ use of formula to treat CMPA, and industry funding of healthcare professionals, medical education and clinical guidelines.

He names prominent individuals involved in developing cows’ milk allergy guidelines who receive funding from the formula industry for activities such as research, consultancy, and lectures—as well as industry-funded bodies that run allergy training for healthcare professionals—creating a potential for bias.

Taken together, his findings raise the question of industry driven overdiagnosis of CMPA with potential for harm to mothers and children—and prompt calls for more independence.

Between 2006 and 2016, prescriptions of specialist formula milks used to treat CMPA increased by nearly 500% from 105,029 to more than 600,000, while NHS spending on these products increased by nearly 700% from £8.1 million to over £60 million annually.

However the data give no indication of such a large increase in the number of infants with the condition, Dr van Tulleken writes.

Also, many milk allergy guidelines have direct or indirect support from industry, and are often written by experts with interests in formula manufacturers.

Despite a World Health Organisation code of practice that aims to restrict companies from sponsoring educational events, links to industry sponsored courses on CMPA can be found at The Allergy Academy, the British Society for Allergy and Clinical Immunology (BSACI), Allergy UK and other industry funded websites.

The BMJ also reports what appears to be a violation of the code that prevents advertising by formula manufacturers in hospitals and other health facilities.

When contacted by The BMJ, several guideline authors acknowledged concerns about the influence of industry, but said there was no direct influence over the guidelines or their own practice.

The BSACI said they 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.”

The Royal College of Paediatrics and Child Health (RCPCH)—the professional body for child health in the UK—says their sponsorship relates only to specialist formulas, not breast milk substitutes.

Nigel Rollins at WHO says specialist formulas are unequivocally breast milk substitutes in the eyes of WHO, and are thus covered by the code.

The belief that specialist formulas are exempt from the WHO code “may be enabling manufacturers to justify this network of links with clinicians and institutions to pursue a wider agenda,” writes van Tulleken.

Clinicians and patients who spoke with The BMJ are also concerned at the wide availability of industry funded online information promoting non-specific symptoms potentially indicating CMPA as a diagnosis in exclusively breastfed infants.

Chi Eziefula, from the Department of Global Health at Brighton and Sussex Medical School says: “In a culture where breastfeeding rates fall off sharply after birth, there must be no risk of industry influence on guidelines or education of postnatal and paediatric caregivers. Instead, we need more infrastructure to support continued breastfeeding.”

Dr Fiona Godlee, The BMJ’s Editor in Chief, says: “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.

“In light of this investigation and our own growing concerns, BMJ is reviewing our policies on accepting advertising for these products. We will report back early in the new year.”

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