STOP PRESS: We understand that this research is to stop. Thanks to all those who supported this campaign
Please help stop the industry funded research about to start in Indonesia entitled "Effect in Using Formula Composed with Cow's Milk Fat, Enriched with Mixed Fats & Added Fosfolipid on Duration & Infection in Babies' Digestive and Respiratory System"
Some concerns about research on infants:
- The potential for bias is present in all research but problems are compounded by publication bias where trials with negative outcomes are less likely to be published. Bias is reduced if research is commissioned and funded by a disinterested party rather than one active in the market.
- Any decision not supported by sound evidence on infant and young child feeding is likely to have a long-lasting harmful impact. Breastmilk substitutes are the sole source of nutrition during a critical period of rapid growth and development minor modifications can have major effects on child health. (1)
- Infants and young children are a vulnerable group that do not consent on their own behalf. They need special protection and all research should meet very strict criteria. While the baby food industry has a responsibility to improve its products, research on babies - and babies under 12 weeks in particular - is fraught with ethical problems. (2)
- As a general safeguard, all research on humans should meet the highest ethical criteria, and should, ideally, be pre-registered with all results placed in the public domain.
- Consultations on public health policy setting should be open to the public. Experts with commercial conflicts of Interest should be consulted in open meetings and should not be involvemed in the formulation of opinions. Declarations of Interest must include the proportion of income derived from commercial sources, to indicate the relevance and importance of the interest.
- Research on infant and young child feeding which forms the basis for public health policies should be as free as possible from commercial influence. Public health policy, especially in the area of infant and young child feeding, should be predominantly informed by independent, publicly financed studies that are in the public domain and subjected to a rigorous peer review process.
- National Governments should endeavor to provide 100% funding for research in the public interest. The commercial involvement in research on infant and young child feeding opens the door for coercion and inappropriate presentation of the risks involved. All research must be passed by full Ethics committees with strict criteria regarding transparency (Declarations of Interest) and the avoidance of Conflicts of Interest.
- All ingredients used for infants and young children must pre-authorised, ie thoroughly assessed for safety and efficacy by a rigorous process whose objectivity and independence is not open to question. If an ingredient is shown to be safe, important for child health or reduces the inadequacies of breastmilk substitutes it should be mandatory, in line with the opinion of the UK Government’s Scientific Advisory Committee on Nutrition (SACN) which in 2007 stated:"We find the case for labelling infant formula or follow on formula with health or nutrition claims entirely unsupportable. If an ingredient is unequivocally beneficial as demonstrated by independent review of scientific data it would be unethical to withhold it for commercial reasons. Rather it should be made a required ingredient of infant formula in order to reduce existing risks associated with artificial feeding. To do otherwise is not in the best interests of children, and fails to recognise the crucial distinction between these products and other foods." (3)
- The absence of evidence to support the safe use of additives in foods for babies under 12 weeks has been a matter of discussion at several Codex Alimentarius Commission meetings. The ethics of carrying out randomized control studies on infants and young children must not be fully considered before any approval is given. (4)
- The provision of free products through any trial should be considered an inducement for parents to enrol their infants, especially parents living on a low income.
- The request for participation in research studies should be done by a person who is independent ( free from any commercial influence or bias). Parents must be fully informed about the short and long-term risks of any product and must not be under any pressure to participate in trials or to use or continue to use a formula milk because they are in a research study. Parents must not be recruited before birth. Decisions about baby feeding may alter after birth. The potential for aggressive recruitment is increased when there is a pressure to boost the numbers of artificially fed infants to achieve a statistically significant study.
- Long term follow up to assess any untoward effects is essential.
1 Baby Milk Action Press Release. 23.12.09. European opinion on baby foods influenced by industry funding. http://www.babymilkaction.org/press/press23dec09.html
BMA Press release 6.4.11: European Parliament votes to block DHA health claim - but not by a large enough majority to guarantee action by the Commission
Baby Milk Action to to Robert Madelin, DG DGSANCO, June 2004.
Notes of a meeting between IBFAN and EU Commission about transparency and Scientific Committees, 27 April 2000
2 Scientists Bow to call for more transparency: European Voice, March 2000 and the British Medical Journal March 2000
WHO to Glenis Willmott MEP: http://info.babymilkaction.org/sites/info.babymilkaction.org/files/WHO%20DHA_0.PDF
4 MATTERS REFERRED TO THE COMMITTEE BY THE CODEX ALIMENTARIUS COMMISSION AND/OR OTHER CODEX COMMITTEES
CX/NFSDU 07/29/2 ftp://ftp.fao.org/codex/ccnfsdu29/nf29_02e.pdf