Calling for an end to all unethical studies – especially those with the underlying motive of expanding the market for formulas and ultra processed products for children
IBFAN is launching a PETITION calling for an immediate halt to a new study – funded by the Gates Foundation and led by researchers from the University of California – that is randomly allocating infant formula to breastfeedin low-birth-weight babies in Uganda and Guinea-Bissau on assumption that this might prevent wasting and stunting.
The study, which has been cleared by ethics committees in the USA, Uganda and Guinea -Bissau – uses purchased ready-to-use infant formula made by Abbott, a US pharmaceutical corporation operating in 160 countries. Abbott is a major violator of the International Code and is currently at the centre of a media storm in the USA because of contamination in its powdered formula. (NB. The formula used in the trial is liquid Ready-to-Feed).
While the study brings the #BlackLivesMatter movement to mind it also shows how concerns about ‘wasting’ ’stunting’ and 'poor growth' are being used as a humanitarian 'cover' for the expansion of the baby food market, already estimated to be worth $55 billion.
Although the researchers claim to follow ethical standards and be passionate supporters of breastfeeding, the study blatantly disregards the Helsinki Declarationthat states: "Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized." By choosing to ignore the social and economic realities of African families and conducting this study amongst health illiterate populations – the researchers have turned the concept of “informed consent” on its head. Over 330,000 babies die every years in Africa because of inappropriate feeding.
The study overlooks the major health protection provided by exclusive breastfeeding and the serious risks associated with formula feeding of premature and low birth weight babies. The many risks include life threatening Necrotizing Enterocolitis (NEC) and formula’s negative impact on the microbiome. (Abbott is also facing lawsuits over the deaths of children from NEC and failing to adequately warn of risks.)
Exclusive breastfeeding from the mother, or breastmilk from wet-nurse or donated, is now universally recommended. The babies in the Uganda trial were also fed by bottle and teat (rather than by cup) and Kangaroo Mother Care, already a routine in the research site, was not supported or encouraged. A recent review of formula trials found an almost universal lack of transparency, biased, selective reporting, increasing use of formula at sensitive periods of development and lack of scientific rigour.
If you agree that this study is a violation of child rights please SIGN THE PETITION calling for an end to all unethical studies, and especially those with the underlying motive of expanding the market for formulas and ultra processed products for children. You can also submit comments to the researchers HERE
*Randomized controlled trial of early, small-volume formula supplementation among newborns: A study protocol -Amy Sarah Ginsburg et al. PLoS One. 2022. The study was approved by research ethics committees in California, San Francisco, Uganda and Guinea Bissau. One of the researchers declares funding by Danone (world’s 2nd largest formula company).
|WHO Executive Board Meeting in January. Click HERE and HERE for IBFAN's commentary and statements on Emergencies, Non Communicable Disases (NCDs), Involvement of non-State actors in WHO’s governing bodies (NSAs) and Food Safety. Click HERE for the WHO webcast recordings and statements from WHO, Member States and other NSAs. Because of new rules, for the first time in decades we were not able to speak on the specific Agenda item on Infant and Young Child feeding. During the debate the UK, USA and Canada stressed the need for more meaningful consultation with NSAs before decisions are taken and highlighted the risks of not hearing from the wide variety of NSAs. Gaudenz Silberschmidt of WHO responded saying that there would be more consultation with NGOs and that individual statements on all issues would be permitted – even on those with constituency statements - one of the main concerns! See the letter from 58 NGOs.|