I know that some of you are aware of the TRIGR study looking at the use of hydrolysed infant formula with infants who are genetically susceptible to diabetes. This is a huge worldwide multicentre study and one of the centres is located not far from where I live. Essentially, women are enrolled in the study while pregnant and after the baby is born if they "need" to or want to use infant formula they will be randomised to receive either normal milk based infant formula or the hydrolysed infant formula, both of which are provided free of charge. 

Our local breastfeeding coalition is having a night seminar in a few months and one of the LCs had talked to the local group of researchers about coming to speak to us about the study (this LC was not aware of the details of the study at the time). We are not having them come to speak because of the ethical and conflict of interest issues associated with this study. However, a comment from one of the researchers was that they are getting a lot of referrals from LCs and they are name dropping at least one prominant LC who has referred people to them (ie these people think we are OKso so should you).  

Anyway, I thought I was detail my concerns with the study here in case some of you are approached to supply referrals for subjects for this study.

The first major problem is that women in the study are being provided with infant formula free of charge. In my mind this is a fatal flaw because it constitutes an inducement and thus makes the study unethical. They could have avoided this problem by requiring mothers to pay the going rate for the (ordinary) formula regardless of which one they are randomised to. My suspicion is that they did not do this, because it is more attractive to potential participants if there is no cost involved ie it is an inducement, mothers know that if they use infant formula they will not have to pay for it for 6 months (and there is a 50:50 chance that they will get this potentially "diabetes reducing" formula) . A further problem is that the infant formula is being provided free from a manufacturer who has a vested interest in the study. That an infant formula manufacturer has a significant financial and practical involvement in the study is extremely problematic. As the website says "The Mead-Johnson Division of Bristol-Myers-Squibb, Evansville, Illinois supported the development of the TRIGR trial from its inception to the present trial, and supplies all formulas worldwide" http://trigr.epi.usf.edu/news.html

The TRIGR study is a huge study with an enormous financial investment and in the end it will be used to sell formula. Imagine if a similar investment was made in conducting a study that made available donor human milk to families with a genetic susceptibility to diabetes. That would be a study worth supporting!! It could be done but it doesn't take much thinking to work out why it is not! Related to this it sounds like there will be almost no exclusively breastfed babies in the TRIGR study (based on some comments from he researchers) and so I predict that this study will not be able to tell us about the impact of breastfeeding on individuals genetically susceptible to diabetes. I wonder why LCs are referring people to it? Does ILCA have a problem with this??


Karleen Gribble
Australia



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