I was interested because we took part in this study and I had my own dilemma about whether or not it was a good thing to be part of it. To summarise, the study is based at a University and is testing a formula milk which has a different composition to current formula milks on the market, being higher in protein and lower in fat contents which, in this respect and this respect only, makes its composition closer to that of breastmilk. As feeding formula milk carries a higher risk of development of type 2 diabetes and heart disease in later life, as well as obesity, it is hoped that the development of this new formula may reduce this risk. For the study, babies are recruited in the first 24 hours of life and the criteria are that baby is either exclusively breastfed or exclusively formula fed. If recruited in the second group, baby will get randomly either normal or new type formula for a year. Exclusivity of feeding either breastmilk or formula milk is required for the first 10 days for the purpose of this study.
The thread on the Analytical Armadillo facebook page started out with concern about the ethics of recruitment. I chipped in my own experience - partly because I'd been through the process and partly because I was rather keen to see this topic explored what with my own thought process about the study. The concern in the thread was that someone from the Optigrow study was going around a postnatal ward offering free formula for a year and that this undermined breastfeeding at a very crucial and vulnerable time.
Now, it is no secret that I'd like to see higher breastfeeding rates because there is no question that they are low, and in fact very low in socially deprived areas of the country. I'm also very critical of the marketing strategies of formula companies, which claim that their formula is closest to breastmilk and similar rubbish. I'm also very aware that the discourse around breast is best is misleading, with its wording of "benefits of breastfeeding" rather than "risks of formula feeding" (the former implies that formula feeding is normal and you get a benefit if you breast feed, while the latter implies that breast feeding is normal and the poorer health outcomes in baby and mum when formula feeding are a risk to both).
Furthermore, I'm acutely aware that our culture around parenting favours formula feeding. New mums are expected to be yummy mummies, to continue their pre-baby lifestyle, to demonstrate they take it all in their stride. "Me time" is a big thing that apparently every mum should have every day, and which includes an expectation that mum has a right to spend time away from baby. The expectation is so strong that I felt more than awkward when receiving an invitation for a night out when my youngest was 6 months and I had to decline because there was no way I could have left her at home even for a few hours. Mums are expected to return to work after no more than 9 months of maternity leave (which translates to 7-8 months after birth of baby) and a return to work of course means that many will move over to formula at that point. The demands of being a mother to a newborn are downplayed and there is little recognition of parenting being a full time job in itself. I have elaborated on this because this culture is significant as it favours the bottle. The bottle is freedom from baby, it allows others than mum to take on the feeding and caring aspect more readily and I'm pretty sure that this is the main reason why many new mums who can breastfeed but choose not to from the start do so.
So if we want to improve breastfeeding rates overall, we are up against a culture that makes it difficult to breast feed, we are up against marketing and advertising that sell us formula as the next best thing, and a discourse around breastfeeding that implies that formula feeding is in fact the norm. As a consequence. there are places in Glasgow where breastfeeding rates are as low as 8% at the 6-8 week postnatal appointment. The highest rates I could find were 68% at 6-8 week appointment, in the most affluent areas, which is still low in my view, considering 95% of women can breastfeed (and do in many countries).
This leaves us with between 32% and 92% of new mums who formula feed 8 weeks post birth, and rising the older the infant gets. Anecdotally, of all the parents I know (and I know a lot, as we attend many playgroups and most of my friends have had babies, and almost everyone I know intended to breastfeed) I only know one person who breastfed longer than I did (I stopped at 23 months with my first, falling short of WHO guidelines). The point I'm trying to make is that in reality, a lot of babies are fed on formula milk whether we like it or not.
Considering the facts, improving formula to reduce the risk of obesity, diabetes and heart disease must be a good thing because it would benefit the long term health of up to 92% of babies in some parts of the country, while we work on changing the culture that makes new mums choose formula over breast.
The response I received to this point was:
"Lactating mums need to STOP giving formula manufactures access to their children/milk! Would you give your business information to your rival company? Yes they need to make better formula for the TINY % of babies/women for whom BFing is not a possibility BUT whilst they are aggressively marketing formula as a life style choice and comparing it to BM and violating the WHO code they can do it without help from us!! Grrrrr!"
I take offence at this statement. I did not sell my baby to anyone. I considered carefully the ethics of the study and decided that from a pragmatic perspective, bearing the health outcomes of babies in mind, it was a good thing to take part in it. I'm not naive or stupid, I made an educated and informed decision.
Secondly, the statement argues that there are deserving babies vs undeserving babies (the "TINY % of" babies where mum can't breastfeed vs the babies of mums who choose not to breastfeed). Nevermind that many mums who end up not breastfeeding didn't choose this but struggled so bloody hard that it became an impossibility for them, the bottom line of this statement is that if you choose not to breastfeed your baby should rightly be exposed to risky formula even if less risky formula exists.
Now, you can argue about the ethics of the study as much as you want, but how about the ethics of this statement? Do we have two classes of babies? It's about the baby's health not the mum-who-chose-not-to-breastfeed's health! (and I reiterate that most mums who choose not to breastfeed didn't do this lightly and that usually there's a very good reason for this choice, ignoring this is plain patronising towards these mums).
At the same time I'm open to discussing the ethics to this study and I'm really keen to find out more. The two points in question are: the ethics of recruitment and the agenda of those who fund the study. Let's start with the second point: It has been mentioned that it's in fact funded by formula producers. It wouldn't surprise me because let's face it, state funding is being cut left right and centre, and a lot of academic studies depend on private investment. And private investment can only be obtained if there is something in it for the investor. So, formula producers are the likely investors. Of course there is a conflict of interest but I would still maintain that for the sake of the greater good (=health of babies) we shouldn't categorically dismiss any study that is funded by formula manufacturers. Instead, we should make sure that the study is scientifically sound, peer reviewed and that in the case of introduction to the market of the new "closer to breastmilk" formula, the marketing of this formula is factual, and that advertisement is controlled.
As to the recruitment, I can only speak for myself. I was approached because I was exclusively breastfeeding. The mum opposite me was mix feeding and did not get approached. When approached I was extremely tired after 3 consecutive sleepness nights (2 spent in labour followed by one with a mucusy post c-section baby). The researcher recognised that this did not constitute an ability to sign a consent form. She noted my interest and insisted on consent from dad, and returned hours later after I had had some sleep. At no point was the fact that there would be free formula mentioned to me. I cannot see therefore that anything in the recruitment process undermined my intention to breastfeed.
Quite the contrary - I was open to mixed feeding due to my previous experience of breastfeeding. The study required exclusive breastfeeding for 10 days. Somehow this gave me some goal to work towards, and once I'd reached it it was going so smoothly that in fact my baby didn't touch a drop of formula. As to the claim that apparently the first 10 days of the life of a baby and how it is fed seem to have a disproportionate influence on the risk of developing obesity, diabetes and heart disease - well, I don't know if this is true, but the study claims that because this is so, they "only" need exclusive breastfeeding for the first 10 days for the baby to qualify for the (breastfed) control group. This statement at no point translated to me as "after 10 days you can give baby a bottle".
To me, this process is good enough. It was made clear that I could leave the study at any time (and I was close to it because the recording of feeds really got on my socks). There are elements in the forms to be completed which I would change (e.g. for recording feeds in a 24 hour period, there are only 10 lines, and a breastfed baby is likely to feed more often than that). It may be that the process was less ethical in other postnatal wards and that clearly needs to be addressed.
The bottom line for me though remains the same. Refusing to allow the development of a healthier formula is patronising and morally wrong. Health inequalities between the richest and the poorest are a rift that divide and blight our society. Anything that can help to improve the health of our future generation is a good thing. Even if formula companies pay for it. We need, however, to hold them accountable and make sure the information gained is used in the best possible way.