TRIGR triggers warning

TRIGR, Trial to Reduce Insulin-Dependent Diabetes in the Genetically at Risk, is a multi-centred feeding trial to determine if the weaning from breastfeeding to an infant formula with partially hydrolyzed cow’s milk proteins will result in fewer cases of Type I diabetes as compared to weaning to routine cow’s milk based infant formulas. Canada’s government is contributing 10 million dollars in funding to this project. Other contributors include the Juvenile Diabetes Research Foundation and Mead Johnson, which has been a “supporter of the TRIGR trials since its inception” and is providing the free formula for the feeding trials.

The project is creating considerable alarm amongst breastfeeding proponents. Questions of ethics are being raised. Criticisms are being levied at Minister McLellan for the granting of public funds to be used to determine the outcome of a trial where the beneficiary is an infant formula company. Virtually no funds are made available for the promotion of breastfeeding while the massive promotions of artificial feeding products remain ignored and unregulated.

INFACT Canada has issued a warning (see INFACT Canada website at www.infactcanada.ca) to parents who may be considering enrolling in the TRIGR trials. Ample evidence exists to support the promotion of and enhanced assistance for exclusive breastfeeding to parents of infants at risk for diabetes Type I. Serious ethical issues surround this experiment. In the proposed randomized trial parents of susceptible infants will not know if their infants are receiving modified or unmodified proteins in their infant formulas. Those receiving the formulas with the unmodified cow’s milk proteins will be put at greater risk and thus are being “set up” for comparison to those fed the formula with hydrolyzed cow’s milk proteins. In this way the hydrolyzed product can claim to “reduce the risk”. No comparisons are to be made to an exclusively breastfed population. Moreover the provision of banked human milk when their own mother’s milk is not available is also not an option for these infants.

If, instead moneys were made available to set up and support highly cost effective breastmilk banks the cost savings could be in billions of dollars over a lifetime of benefits for those receiving human milk.

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