Formula milk companies and allergy healthcare professionals in India.

India is a low-middle income country with a population of 1.4 billion and home to one quarter of the world's children. Exclusive breastfeeding until 6 months and continued breastfeeding until at least 2 years as per global recommendations are common practice. The Indian government and associated organisations have strived to protect breastfeeding, which is important in a country with high under-5 mortality, malnutrition and stunting. Allergic disease is under-recognised in India, but despite the absence of a dedicated allergy medical specialty, awareness of allergy is increasing among healthcare practitioners and in the general population. In high-income countries, overdiagnosis of allergy has become recognised as an issue in recent years. Allergy healthcare professionals have also attracted criticism for close relationships with the formula industry, which appear to have contributed to excessive use of specialised formula products and undermining of breastfeeding. Specialised formula has been used unnecessarily for preventing allergy, based on fraudulent and selectively reported science; and for managing normal infant symptoms which are mislabelled as milk allergy. This forms part of a broader formula industry corporate strategy to widen the boundaries of illness in order to expand sales and markets. In India, allergic disease management is hindered by limited understanding of the disease entity among practitioners, low access to diagnostics, limited healthcare resources, high exposure to air pollution and a large, diverse population. Data specific to India on allergic disease prevalence and interpreting allergy diagnostics are incomplete. The knowledge gaps mean allergy management in India is often extrapolated from guidance developed in high-income countries with low breastfeeding rates. As the allergy specialty develops in India, local guidance and practice will need to recognise the threat that current allergy practice poses to India's normative infant feeding culture, and ensure that breastfeeding continues to be supported at all levels.

Conduct and reporting of formula milk trials: systematic review.

OBJECTIVE: To systematically review the conduct and reporting of formula trials. DESIGN: Systematic review. DATA SOURCES: Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1 January 2006 to 31 December 2020. REVIEW METHODS: Intervention trials comparing at least two formula products in children less than three years of age were included, but not trials of human breast milk or fortifiers of breast milk. Data were extracted in duplicate and primary outcome data were synthesised for meta-analysis with a random effects model weighted by the inverse variance method. Risk of bias was evaluated with Cochrane risk of bias version 2.0, and risk of undermining breastfeeding was evaluated according to published consensus guidance. Primary outcomes of the trials included in the systematic review were identified from clinical trial registries, protocols, or trial publications. RESULTS: 22 201 titles were screened and 307 trials were identified that were published between 2006 and 2020, of which 73 (24%) trials in 13 197 children were prospectively registered. Another 111 unpublished but registered trials in 17 411 children were identified. Detailed analysis was undertaken for 125 trials (23 757 children) published since 2015. Seventeen (14%) of these recently published trials were conducted independently of formula companies, 26 (21%) were prospectively registered with a clear aim and primary outcome, and authors or sponsors shared prospective protocols for 11 (9%) trials. Risk of bias was low in five (4%) and high in 100 (80%) recently published trials, mainly because of inappropriate exclusions from analysis and selective reporting. For 68 recently published superiority trials, a pooled standardised mean difference of 0.51 (range -0.43 to 3.29) was calculated with an asymmetrical funnel plot (Egger's test P<0.001), which reduced to 0.19 after correction for asymmetry. Primary outcomes were reported by authors as favourable in 86 (69%) trials, and 115 (92%) abstract conclusions were favourable. One of 38 (3%) trials in partially breastfed infants reported adequate support for breastfeeding and 14 of 87 (16%) trials in non-breastfed infants confirmed the decision not to breastfeed was firmly established before enrolment in the trial. CONCLUSIONS: The results show that formula trials lack independence or transparency, and published outcomes are biased by selective reporting. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2018 CRD42018091928.