Questioning the ethics of international research on formula milk supplementation in low-income African countries: response

[...]the trial was not designed to assess the need for an update to the WHO (2009) acceptable medical reasons for use of breast milk substitutes.3 The current WHO recommendation regarding the duration of EBF was based on a systematic review4 which concluded that: ‘neither the trials nor the observational studies suggest that infants who continue to be exclusively breastfed for 6 months show deficits in weight or length gain, although larger sample sizes would be required to rule out modest differences in risk of undernutrition’. A 2012 update of this review concluded that: ‘Although infants should still be managed individually so that insufficient growth or other adverse outcomes are not ignored and appropriate interventions are provided, the available evidence demonstrates no apparent risks in recommending, as a general policy, EBF for the first 6 months of life in both developing and developed country settings’.5 Furthermore, a rationale for the WHO multicentre growth reference study6 was that formula-fed infants grow on a different and higher trajectory than breastfed infants.7 There is overwhelming evidence that EBF for 6 months prevents morbidity and mortality, particularly in the first months of life when infants are at highest risk of infection-related mortality.8 9 Early supplementation with commercial milk formula increases infection risk and alters the gut microbiota.10 There is extensive evidence from the HIV epidemic that introduction of commercial milk formula increases infant morbidity and mortality.11 In a study undertaken in Uganda,12 the mortality risk among formula-fed infants was sixfold higher at 12 months of age. According to Nankabirwa and colleagues, the ethical committees who approved and monitored the PRIMES trial were highly engaged and active in evaluating the study and modifying its design to ensure appropriateness for local context.