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Overdiagnosis and industry influence: how cow’s milk protein allergy is extending the reach of infant formula manufacturers

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5056 (Published 05 December 2018) Cite this as: BMJ 2018;363:k5056

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Re: Overdiagnosis and industry influence: how cow’s milk protein allergy is extending the reach of infant formula manufacturers

Chris van Tulleken’s investigation (1) in to the potential overdiagnosis and industry influence of cow’s milk protein allergy (CMPA) in infancy is both overdue and welcome. His paper has already started to share this dirty secret through the reporting in the press at the time of publication (2). It should embarrass the NHS, the Royal College of Paediatrics and Child Health (RCPCH), several other clinical associations and some of the established experts. It should lead to penetrating introspection and deep ethical consideration across the field.

Firstly, non-IgE mediated CMPA is a clinical diagnosis backed up by an empirical test (does the infant’s symptom profile improve after changing the feed and omitting the presumed allergen?). Regrettably there is no sensitive, specific or reproducible test to objectively confirm the diagnosis and as this paper neatly clarifies the symptoms are often vague and common.

Maternal dietary change can help a genuine case of CMPA in an exclusively breastfed infant. However, the situation is more complex in the already formula fed child. Given that a hydrolysed or amino acid based milk substitute is prescribed by a doctor, it is free of charge to parents from the UK NHS. Rapidly, a situation evolves where it pays the parent to continue using the specially prescribed milk substitute. Unless the infant either refuses the feed, or is somehow worse on this alternative feed, the parent may, quite understandably, be persuaded to continue an unnecessary treatment which is expensive to the NHS. This saves much money for the parents whether, or not, there is actually any clinical benefit at all.

We urgently require independent, properly designed randomized control trials to help clarify the value of this intervention particularly when the symptom profile is vague and less obvious. This has already been recognized by NICE (3). We also need a concerted effort to establish diagnostic tests that do not rely on the treatment itself.

Secondly, in respect of conflicting interests the paper makes important observations and reports defensive quotations from experts in the field. Interestingly, while there is silence from the current President of the RCPCH (1), the December 2018 issue of the Archives of Disease in Childhood has a prominent advert for an amino acid based feed used in the treatment of CMPA. As is the norm, this particular promotional advert (4) has a picture of a perfectly content, handsome baby next to apparently scientifically sound headlines aimed at offering a degree of clinical and research credibility. This hidden persuader is cleverly placed on the page adjacent to the journal index, which every reader is likely to read and then receive a subconscious reminder of the advert’s message.

The industries that manufacture these products largely fund paediatric CPD, significantly fund the RCPCH and also fund our specialist societies. They pay handsome speaker fees to colleagues who regularly publish on the topic and to those who prescribe or influence prescription of these expensive milk substitutes. They pay the conference fees, arrange the travel and cover luxury hospitality for colleagues to attend scientific meetings around the world. This contribution represents very large sums of money and saves busy clinicians the hassle of booking flights, coordinating transport, searching hotels and even finding food while away. I know this having benefited in the early part of my consultant career from such generous hospitality.

I feel that financial declarations of interest must be; mandatory, honest, published, widely available to the public and completely transparent. This process should include all health professionals. It should cover all close family members and must also refer to the indirect hidden benefits we continue to enjoy even when, like me, you have been apparently clean for several years.

Finally, these are all my current declarations; no sponsorship or direct benefit to me since 2011, my wife (pharmacist) has been paid for consultancy by Jazz, Janssen and Takeda within the last 3 years, I am a member of the RCPCH, I Chaired the BSPGHAN Endoscopy Working Group 2012-2015 and was Chair of the GDG for NICE NG1 2015. I still benefit through attending and receiving hospitality (as a speaker) at events organized by associations that are supported by multiple industry sponsors including the manufacturers discussed in the paper.

References

1. van Tulleken. Overdiagnosis and industry influence: how cow’s milk protein allergy is extending the reach of infant formula manufacturers. BMJ 2018;363:k5056

2. Infant milk allergy rate soars as investigation finds senior child doctors have extensive industry links https://www.telegraph.co.uk/news/2018/12/05/infant-milk-allergy-rate-soa...

3. NICE NG1 2015 https://www.nice.org.uk/guidance/ng1/chapter/2-Research-recommendations

4. New Neocate Syneo. Arch Dis Child Dec 2018 Vol 103 No 12 (inside the front cover)

Competing interests: These are all my current declarations; no sponsorship or direct benefit to me since 2011, my wife (pharmacist) has been paid for consultancy by Jazz, Janssen and Takeda, I am a member of the RCPCH, I Chaired the BSPGHAN Endoscopy Working Group 2012-2015 and was Chair of the GDG for NICE NG1 2015. I still benefit through attending and receiving hospitality (as a speaker) at events organized by associations that are supported by multiple industry sponsors including the manufacturers discussed in the paper.

12 December 2018
Ieuan H Davies
consultant paediatric gastroenterologist
Department of Paediatric Gastroenterology, University Hospital of Wales, Cardiff CF14 4XW