NEW DELHI: A recent article in the British Medical Journal (BMJ) has warned that the $50 billion global formula industry could be fanning overdiagnosis of allergy to cow’s milk protein to sell specialist formula. Arguing that specialist formula is not a breast milk substitute, the industry has been aggressively marketing it and using it to forge close ties with healthcare professionals in the UK and globally by sponsoring medical education and research on allergies, the article points out.
This has echoes from the recent controversy in India where the formula industry was accused of trying to circumvent the Infant Milk Substitute (IMS) Act — a law to prevent predatory marketing practices of baby food companies - citing special nutrition needs of babies born with metabolic errors or allergies that might not allow breastfeeding. It had wanted specialist formulas to not be categorized as infant milk substitute (IMS) in an attempt to stay out of the Act.
According to the BMJ article by Chris Van Tulleken of the University College, London, overdiagnosis of the allergy could undermine breastfeeding. Between 2006 and 2016, in the UK, prescriptions of specialist formula milks for infants with cow’s milk protein allergy (CMPA) increased by nearly 500%, while National Health Service (NHS) spending on these products increased by nearly 700% from 8 million pounds to over 60 million annually, noted the article, adding that epidemiological data gave no indication of such a large increase in prevalence of the allergy. This raised the question of industry-driven overdiagnosis through funding and influencing of research, guidelines, medical education and public awareness drives on the allergy.
Referring to how the industry targets framing of treatment guidelines, Bob Boyle, deputy medical director and consultant paediatrician from the Imperial College Healthcare NHS Trust was quoted as stating: “There are many more milk allergy guidelines 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.” Many of the symptoms listed in these guidelines are so broad that virtually every infant could be diagnosed as having an allergy, pointed out another practitioner.
In India too, the food safety and standards authority of India (FSSAI) had constituted a steering committee that included the infant and young child nutrition council of India (IYNCI), a front organization for baby food manufacturers with four of the biggest baby food companies - Abbott, Danone, Mead Johnson and Nestle -- as members. The move to exempt food for special medical purposes (FSMP) from the IMS Act came from this steering committee. Though the IYNCI was dropped from the committee following protests by nutrition experts, paediatricians and the breastfeeding promotion network of India (BPNI), the FSSAI pushed ahead with the exemption for FSMPs.
The food regulator also partnered baby food companies to launch an initiative called Diet4Life, a platform used by these companies to sponsor awareness programs for paediatricians, dieticians and parents, ostensibly to educate them about management of inborn errors of metabolism and allergic conditions in children. Under the IMS Act, baby food companies cannot sponsor healthcare providers or market infant milk substitutes. Doctor Arun Gupta of BPNI had pointed out that it was to circumvent these restrictions that the industry was lobbying hard for its products to be taken out of the categorization “infant milk substitute”.
The UK has no law like India’s IMS Act. All it has is the international code of marketing of breast milk substitutes adopted by the WHO in 1981 after egregious marketing practices of these companies were exposed in the 1970s. Though the code includes marketing restrictions and states that companies cannot sponsor educational events or advertise anywhere within the health system, there have been frequent and widely reported allegations of code violations across the world.
The Indian Academy of Paediatrics resolved more than two decades ago that it would “not accept sponsorship in any form from any industry connected directly or indirectly” with products covered by the IMS Act. In contrast, the Royal College of Paediatrics and Child Health accepts funding from Danone and Nestle. The RCPCH website claimed that it only accepted advertising or conference stands providing information about specialist formulas (FSMP), not breast milk substitutes. The British dietetic association with input from the British society of paediatric gastroenterology, hepatology and nutrition and British society for allergy and clinical immunology (BSACI) all accept funding from baby food companies. The British dietetic association has Abbott, Mead Johnson, and Danone Nutricia as strategic partners and Vitaflo (NestlĂ©) and Friesland Campina (a global formula producer) as key supporters, pointed out the article.
Most healthcare players who take money from baby food companies say their sponsorship relates only to specialist formulas. But Nigel Rollins from the World Health Organization’s department of maternal, newborn, child, and adolescent health confirmed to Tulleken that 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 code may be enabling manufacturers to justify this network of links with clinicians and institutions to pursue a wider agenda, stated the article.
Many clinicians and patients have also expressed concern on the availability of industry-funded online information promoting non-specific symptoms potentially indicating cow’s milk allergy in exclusively breastfed infants. This is despite evidence showing that though cow’s milk and other food protein can be transferred from mother to infant in breast milk, the quantities transferred are likely to be too small to cause symptoms in most infants. Amy Brown, professor of child public health at Swansea University, said that concerns about breast milk sufficiency or content was one of the main reasons for mothers stopping breastfeeding and the promotion of cow’s milk allergy to the public by industry played to this anxiety.
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